Target_Summary_ID
stringclasses 200
values | Target_Sentence_Index
stringlengths 4
7
| External
stringclasses 2
values | Target_Sentence
stringlengths 19
592
| Original_Abstract
stringclasses 200
values |
|---|---|---|---|---|
t21 | t21_19 | yes | MRI, as a single test, is not accurate for the early diagnosis of dementia due to Alzheimer's disease in people with MCI since one in three or four participants received a wrong diagnosis of Alzheimer's disease. | Mild cognitive impairment (MCI) due to Alzheimer's disease is the symptomatic predementia phase of Alzheimer's disease dementia, characterised by cognitive and functional impairment not severe enough to fulfil the criteria for dementia. In clinical samples, people with amnestic MCI are at high risk of developing Alzheimer's disease dementia, with annual rates of progression from MCI to Alzheimer's disease estimated at approximately 10% to 15% compared with the base incidence rates of Alzheimer's disease dementia of 1% to 2% per year. Objectives To assess the diagnostic accuracy of structural magnetic resonance imaging (MRI) for the early diagnosis of dementia due to Alzheimer's disease in people with MCI versus the clinical follow‐up diagnosis of Alzheimer's disease dementia as a reference standard (delayed verification). To investigate sources of heterogeneity in accuracy, such as the use of qualitative visual assessment or quantitative volumetric measurements, including manual or automatic (MRI) techniques, or the length of follow‐up, and age of participants. MRI was evaluated as an add‐on test in addition to clinical diagnosis of MCI to improve early diagnosis of dementia due to Alzheimer's disease in people with MCI. Search methods On 29 January 2019 we searched Cochrane Dementia and Cognitive Improvement's Specialised Register and the databases, MEDLINE, Embase, BIOSIS Previews, Science Citation Index, PsycINFO, and LILACS. We also searched the reference lists of all eligible studies identified by the electronic searches. Selection criteria We considered cohort studies of any size that included prospectively recruited people of any age with a diagnosis of MCI. We included studies that compared the diagnostic test accuracy of baseline structural MRI versus the clinical follow‐up diagnosis of Alzheimer's disease dementia (delayed verification). We did not exclude studies on the basis of length of follow‐up. We included studies that used either qualitative visual assessment or quantitative volumetric measurements of MRI to detect atrophy in the whole brain or in specific brain regions, such as the hippocampus, medial temporal lobe, lateral ventricles, entorhinal cortex, medial temporal gyrus, lateral temporal lobe, amygdala, and cortical grey matter. Data collection and analysis Four teams of two review authors each independently reviewed titles and abstracts of articles identified by the search strategy. Two teams of two review authors each independently assessed the selected full‐text articles for eligibility, extracted data and solved disagreements by consensus. Two review authors independently assessed the quality of studies using the QUADAS‐2 tool. We used the hierarchical summary receiver operating characteristic (HSROC) model to fit summary ROC curves and to obtain overall measures of relative accuracy in subgroup analyses. We also used these models to obtain pooled estimates of sensitivity and specificity when sufficient data sets were available. We included 33 studies, published from 1999 to 2019, with 3935 participants of whom 1341 (34%) progressed to Alzheimer's disease dementia and 2594 (66%) did not. Of the participants who did not progress to Alzheimer's disease dementia, 2561 (99%) remained stable MCI and 33 (1%) progressed to other types of dementia. The median proportion of women was 53% and the mean age of participants ranged from 63 to 87 years (median 73 years). The mean length of clinical follow‐up ranged from 1 to 7.6 years (median 2 years). Most studies were of poor methodological quality due to risk of bias for participant selection or the index test, or both. Most of the included studies reported data on the volume of the total hippocampus (pooled mean sensitivity 0.73 (95% confidence interval (CI) 0.64 to 0.80); pooled mean specificity 0.71 (95% CI 0.65 to 0.77); 22 studies, 2209 participants). This evidence was of low certainty due to risk of bias and inconsistency. Seven studies reported data on the atrophy of the medial temporal lobe (mean sensitivity 0.64 (95% CI 0.53 to 0.73); mean specificity 0.65 (95% CI 0.51 to 0.76); 1077 participants) and five studies on the volume of the lateral ventricles (mean sensitivity 0.57 (95% CI 0.49 to 0.65); mean specificity 0.64 (95% CI 0.59 to 0.70); 1077 participants). This evidence was of moderate certainty due to risk of bias. Four studies with 529 participants analysed the volume of the total entorhinal cortex and four studies with 424 participants analysed the volume of the whole brain. We did not estimate pooled sensitivity and specificity for the volume of these two regions because available data were sparse and heterogeneous. We could not statistically evaluate the volumes of the lateral temporal lobe, amygdala, medial temporal gyrus, or cortical grey matter assessed in small individual studies. We found no evidence of a difference between studies in the accuracy of the total hippocampal volume with regards to duration of follow‐up or age of participants, but the manual MRI technique was superior to automatic techniques in mixed (mostly indirect) comparisons. We did not assess the relative accuracy of the volumes of different brain regions measured by MRI because only indirect comparisons were available, studies were heterogeneous, and the overall accuracy of all regions was moderate. The volume of hippocampus or medial temporal lobe, the most studied brain regions, showed low sensitivity and specificity and did not qualify structural MRI as a stand‐alone add‐on test for an early diagnosis of dementia due to Alzheimer's disease in people with MCI. This is consistent with international guidelines, which recommend imaging to exclude non‐degenerative or surgical causes of cognitive impairment and not to diagnose dementia due to Alzheimer's disease. In view of the low quality of most of the included studies, the findings of this review should be interpreted with caution. Future research should not focus on a single biomarker, but rather on combinations of biomarkers to improve an early diagnosis of Alzheimer's disease dementia. |
t21 | t21_20 | yes | Future research should not focus on a single test (such as MRI), but rather on combinations of tests to improve an early diagnosis of Alzheimer's disease dementia. | Mild cognitive impairment (MCI) due to Alzheimer's disease is the symptomatic predementia phase of Alzheimer's disease dementia, characterised by cognitive and functional impairment not severe enough to fulfil the criteria for dementia. In clinical samples, people with amnestic MCI are at high risk of developing Alzheimer's disease dementia, with annual rates of progression from MCI to Alzheimer's disease estimated at approximately 10% to 15% compared with the base incidence rates of Alzheimer's disease dementia of 1% to 2% per year. Objectives To assess the diagnostic accuracy of structural magnetic resonance imaging (MRI) for the early diagnosis of dementia due to Alzheimer's disease in people with MCI versus the clinical follow‐up diagnosis of Alzheimer's disease dementia as a reference standard (delayed verification). To investigate sources of heterogeneity in accuracy, such as the use of qualitative visual assessment or quantitative volumetric measurements, including manual or automatic (MRI) techniques, or the length of follow‐up, and age of participants. MRI was evaluated as an add‐on test in addition to clinical diagnosis of MCI to improve early diagnosis of dementia due to Alzheimer's disease in people with MCI. Search methods On 29 January 2019 we searched Cochrane Dementia and Cognitive Improvement's Specialised Register and the databases, MEDLINE, Embase, BIOSIS Previews, Science Citation Index, PsycINFO, and LILACS. We also searched the reference lists of all eligible studies identified by the electronic searches. Selection criteria We considered cohort studies of any size that included prospectively recruited people of any age with a diagnosis of MCI. We included studies that compared the diagnostic test accuracy of baseline structural MRI versus the clinical follow‐up diagnosis of Alzheimer's disease dementia (delayed verification). We did not exclude studies on the basis of length of follow‐up. We included studies that used either qualitative visual assessment or quantitative volumetric measurements of MRI to detect atrophy in the whole brain or in specific brain regions, such as the hippocampus, medial temporal lobe, lateral ventricles, entorhinal cortex, medial temporal gyrus, lateral temporal lobe, amygdala, and cortical grey matter. Data collection and analysis Four teams of two review authors each independently reviewed titles and abstracts of articles identified by the search strategy. Two teams of two review authors each independently assessed the selected full‐text articles for eligibility, extracted data and solved disagreements by consensus. Two review authors independently assessed the quality of studies using the QUADAS‐2 tool. We used the hierarchical summary receiver operating characteristic (HSROC) model to fit summary ROC curves and to obtain overall measures of relative accuracy in subgroup analyses. We also used these models to obtain pooled estimates of sensitivity and specificity when sufficient data sets were available. We included 33 studies, published from 1999 to 2019, with 3935 participants of whom 1341 (34%) progressed to Alzheimer's disease dementia and 2594 (66%) did not. Of the participants who did not progress to Alzheimer's disease dementia, 2561 (99%) remained stable MCI and 33 (1%) progressed to other types of dementia. The median proportion of women was 53% and the mean age of participants ranged from 63 to 87 years (median 73 years). The mean length of clinical follow‐up ranged from 1 to 7.6 years (median 2 years). Most studies were of poor methodological quality due to risk of bias for participant selection or the index test, or both. Most of the included studies reported data on the volume of the total hippocampus (pooled mean sensitivity 0.73 (95% confidence interval (CI) 0.64 to 0.80); pooled mean specificity 0.71 (95% CI 0.65 to 0.77); 22 studies, 2209 participants). This evidence was of low certainty due to risk of bias and inconsistency. Seven studies reported data on the atrophy of the medial temporal lobe (mean sensitivity 0.64 (95% CI 0.53 to 0.73); mean specificity 0.65 (95% CI 0.51 to 0.76); 1077 participants) and five studies on the volume of the lateral ventricles (mean sensitivity 0.57 (95% CI 0.49 to 0.65); mean specificity 0.64 (95% CI 0.59 to 0.70); 1077 participants). This evidence was of moderate certainty due to risk of bias. Four studies with 529 participants analysed the volume of the total entorhinal cortex and four studies with 424 participants analysed the volume of the whole brain. We did not estimate pooled sensitivity and specificity for the volume of these two regions because available data were sparse and heterogeneous. We could not statistically evaluate the volumes of the lateral temporal lobe, amygdala, medial temporal gyrus, or cortical grey matter assessed in small individual studies. We found no evidence of a difference between studies in the accuracy of the total hippocampal volume with regards to duration of follow‐up or age of participants, but the manual MRI technique was superior to automatic techniques in mixed (mostly indirect) comparisons. We did not assess the relative accuracy of the volumes of different brain regions measured by MRI because only indirect comparisons were available, studies were heterogeneous, and the overall accuracy of all regions was moderate. The volume of hippocampus or medial temporal lobe, the most studied brain regions, showed low sensitivity and specificity and did not qualify structural MRI as a stand‐alone add‐on test for an early diagnosis of dementia due to Alzheimer's disease in people with MCI. This is consistent with international guidelines, which recommend imaging to exclude non‐degenerative or surgical causes of cognitive impairment and not to diagnose dementia due to Alzheimer's disease. In view of the low quality of most of the included studies, the findings of this review should be interpreted with caution. Future research should not focus on a single biomarker, but rather on combinations of biomarkers to improve an early diagnosis of Alzheimer's disease dementia. |
t22 | t22_1 | yes | NMIBC is a cancer (tumour) of the inner lining of the bladder that can be removed from the inside using small instruments and a light source, so‐called endoscopic surgery. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_2 | yes | These tumours can come back over time and spread into the deeper layers of the bladder wall. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_3 | yes | We know that different types of medicines that we can put into the bladder help prevent this. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_4 | no | Investigators have looked at the use of an electrical current to make medicines work better. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_5 | no | In this review, we wanted to discover whether using an electrical current was better or worse than not using an electrical current. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_6 | yes | We found three studies that were conducted between 1994 and 2003 with 672 participants that compared five different ways of giving this treatment. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_7 | no | Mitomycin (MMC) was the only medicine used together with electrical current. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_8 | yes | We are very unsure whether the use of an electrical current to give a course of MMC after endoscopic surgery is better or worse compared to giving a course of Bacillus Calmette‐Guérin (BCG; vaccine usually used in tuberculosis) or MMC without electrical current. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_9 | no | MMC given with electrical current together with BCG given over a long period of time may be better than BCG alone in delaying the tumour from coming back and from spreading into the deeper layer of the bladder wall. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t22 | t22_10 | no | Giving one dose of MMC with electrical current before endoscopic surgery may be better than one dose of MMC without electric current after surgery or surgery alone without further treatment. | Electromotive drug administration (EMDA) is the use of electrical current to improve the delivery of intravesical agents to reduce the risk of recurrence in people with non‐muscle invasive bladder cancer (NMIBC). It is unclear how effective this is in comparison to other forms of intravesical therapy. Objectives To assess the effects of intravesical EMDA for the treatment of NMIBC. Search methods We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE), two clinical trial registries and a grey literature repository. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The last search was February 2017. Selection criteria We searched for randomised studies comparing EMDA of any intravesical agent used to reduce bladder cancer recurrence in conjunction with transurethral resection of bladder tumour (TURBT). Data collection and analysis Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence (QoE) according to GRADE on a per outcome basis. We included three trials with 672 participants that described five distinct comparisons. The same principal investigator conducted all three trials. All studies used mitomycin C (MMC) as the chemotherapeutic agent for EMDA. 1. Postoperative MMC‐EMDA induction versus postoperative Bacillus Calmette‐Guérin (BCG) induction: based on one study with 72 participants with carcinoma in situ (CIS) and concurrent pT1 urothelial carcinoma, we are uncertain (very low QoE) about the effect of MMC‐EMDA on time to recurrence (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.64 to 1.76; corresponding to 30 more per 1000 participants, 95% CI 180 fewer to 380 more). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about serious adverse events (RR 0.75, 95% CI 0.18 to 3.11). 2. Postoperative MMC‐EMDA induction versus MMC‐passive diffusion (PD) induction: based on one study with 72 participants with CIS and concurrent pT1 urothelial carcinoma, postoperative MMC‐EMDA may (low QoE) reduce disease recurrence (RR 0.65, 95% CI 0.44 to 0.98; corresponding to 147 fewer per 1000 participants, 95% CI 235 fewer to 8 fewer). There was no disease progression in either treatment arm at three months' follow‐up. We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.50, 95% CI 0.27 to 8.45). 3. Postoperative MMC‐EMDA with sequential BCG induction and maintenance versus postoperative BCG induction and maintenance: based on one study with 212 participants with pT1 urothelial carcinoma of the bladder with or without CIS, postoperative MMC‐EMDA with sequential BCG may result (low QoE) in a longer time to recurrence (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77; corresponding to 181 fewer per 1000 participants, 95% CI 256 fewer to 79 fewer) and time to progression (HR 0.36, 95% CI 0.17 to 0.75; corresponding to 63 fewer per 1000 participants, 95% CI 82 fewer to 24 fewer). We are uncertain (very low QoE) about the effect of MMC‐EMDA on serious adverse events (RR 1.02, 95% CI 0.21 to 4.94). 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD: based on one study with 236 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.47, 95% CI 0.32 to 0.69; corresponding to 247 fewer per 1000 participants, 95% CI 341 fewer to 130 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.81, 95% CI 0.00 to 259.93; corresponding to 34 fewer per 1000 participants, 95% CI 193 fewer to 807 more) and serious adverse events (RR 0.79, 95% CI 0.30 to 2.05). 5. Single‐dose, preoperative MMC‐EMDA versus TURBT alone: based on one study with 233 participants with primary pTa and pT1 urothelial carcinoma, preoperative MMC‐EMDA likely (moderate QoE) results in a longer time to recurrence (HR 0.40, 95% CI 0.28 to 0.57; corresponding to 304 fewer per 1000 participants, 95% CI 390 fewer to 198 fewer) for a median follow‐up of 86 months. We are uncertain (very low QoE) about the effect of MMC‐EMDA on time to progression (HR 0.74, 95% CI 0.00 to 247.93; corresponding to 49 fewer per 1000 participants, 95% CI 207 fewer to 793 more) or serious adverse events (HR 1.74, 95% CI 0.52 to 5.77). While the use of EMDA to administer intravesical MMC may result in a delay in time to recurrence in select patient populations, we are uncertain about its impact on serious adverse events in all settings. Common reasons for downgrading the QoE were study limitations and imprecision. A potential role for EMDA‐based administration of MMC may lie in settings where more established agents (such as BCG) are not available. In the setting of low or very low QoE for most comparisons, our confidence in the effect estimates is limited and the true effect sizes may be substantially different from those reported here. |
t23 | t23_1 | no | Video communication software like Skype and FaceTime allows counsellors to see and hear people over the Internet to help them quit smoking. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_2 | no | Video counselling could help large numbers of people to quit smoking because more than four billion people use the Internet, and video communication software is free. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_3 | no | Our main focus was to learn if video counselling delivered individually or to a group could help people quit smoking and to learn how it compared with other types of support to help people quit. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_4 | no | We also studied the effect of real‐time video counselling on the number of times people tried to quit, the number of sessions they completed, their satisfaction with the counselling, their relationship or bond with the counsellor and the costs of using video communication to help people quit smoking. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_5 | yes | Both studies took place in the USA, and included people from rural areas or women with HIV. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_6 | no | Both studies gave one‐to‐one video sessions to individuals. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_7 | yes | There were eight video sessions in one study and four video sessions in the other study. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_8 | yes | Both studies compared video counselling to telephone counselling and looked at whether people quit smoking, the number of sessions they completed and their satisfaction with the programme. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_9 | no | One study examined the number of times people tried to quit and one study looked at the relationship or bond with the counsellor. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_10 | no | It is unclear how video counselling compares with telephone counselling in terms of helping people to quit smoking. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t23 | t23_11 | no | People who used video counselling were more likely than those who used telephone counselling to recommend the programme to a friend or someone in their family, but we found no differences in how satisfied they were, the number of video or telephone sessions completed, whether all sessions were completed and in the relationship or bond with the counsellor. | Real‐time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. Objectives To assess the effectiveness of real‐time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real‐time video counselling. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. Selection criteria We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real‐time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real‐time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. Data collection and analysis Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random‐effects meta‐analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow‐up. Analysis was based on the intention‐to‐treat principle. We considered participants with missing data at follow‐up for the primary outcome of smoking cessation to be smokers. We included two randomised trials with 615 participants. Both studies delivered real‐time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow‐up) across the two included studies when real‐time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I 2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real‐time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between‐group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants). There is very little evidence about the effectiveness of real‐time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High‐quality randomised trials comparing real‐time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real‐time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation. |
t24 | t24_1 | yes | Lumbar puncture involves getting a sample of spinal fluid though a needle inserted into the lower back. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_2 | no | Post‐dural puncture headache (PDPH) is the most common side effect of a lumbar puncture. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_3 | yes | The symptom of PDPH is a constant headache that gets worse when upright and improves when lying down. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_4 | no | Lots of drugs are used to treat PDPH, so the aim of this review was to assess the effectiveness of these drugs. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_5 | no | We included 13 small randomised clinical trials (RCTs), with a total of 479 participants. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_6 | no | The trials assessed eight drugs: caffeine, sumatriptan, gabapentin, hydrocortisone, theophylline, adrenocorticotropic hormone, pregabalin and cosyntropin. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_7 | yes | Caffeine proved to be effective in decreasing the number of people with PDPH and those requiring extra drugs (2 or 3 in 10 with caffeine compared to 9 in 10 with placebo). | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_8 | no | Gabapentin, theophylline and hydrocortisone also proved to be effective, relieving pain better than placebo or conventional treatment alone. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_9 | yes | More people had better pain relief with theophylline (9 in 10 with theophylline compared to 4 in 10 with conventional treatment). | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_10 | no | No important side effects of these drugs were reported. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t24 | t24_11 | no | The quality of the studies was difficult to assess due to the lack of information available. | This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post‐dural puncture headache'. Post‐dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness. Objectives To assess the effectiveness and safety of drugs for treating PDPH in adults and children. Search methods The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions. Selection criteria We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow‐up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data. Data collection and analysis Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta‐analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention‐to‐treat (ITT) analysis. We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH). Two RCTs reported data for PDPH persistence of any severity at follow‐up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option. Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome. Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment. There were no clinically significant drug adverse events. The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect. None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment. There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin). These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s. |
t25 | t25_1 | no | We reviewed the evidence about the effect of bracing on pulmonary disorders (lung diseases), disability, back pain, quality of life, and psychological and cosmetic issues in adolescent with idiopathic scoliosis. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_2 | no | We looked at randomized controlled trials (RCTs) and prospective controlled cohort studies (CCTs). | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_3 | yes | Scoliosis is a condition where the spine is curved in three dimensions (from the back the spine appears to be shaped like an 's' and the trunk is deformed). | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_4 | yes | It is often idiopathic, which means the cause is unknown. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_5 | yes | The most common type of scoliosis is generally discovered around 10 years of age or older, and is defined as a curve that measures at least 10° (called a Cobb angle; measured on x‐ray). | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_6 | yes | Because of the unknown cause and the age of diagnosis, it is called adolescent idiopathic scoliosis (AIS). | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_7 | no | While there are usually no symptoms, the appearance of AIS frequently has a negative impact on adolescents. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_8 | no | Increased curvature of the spine can present health risks in adulthood and in older people. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_9 | yes | Braces are one intervention that may stop further progression of the curve. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_10 | yes | They generally need to be worn full time, with treatment lasting until the end of growth (most frequently, from a minimum of two to four/five years). | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_11 | yes | However, bracing for this condition is still controversial, and questions remain about how effective it is. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_12 | yes | This review included seven studies, with a total of 662 adolescents of both genders. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_13 | no | AIS from 15° to more than 45° curves were considered. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_14 | yes | Elastic, rigid (polyethylene), and very rigid (polycarbonate) braces were studied. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_15 | no | Quality of life was not affected during brace treatment (very low quality evidence); quality of life, back pain, and psychological and cosmetic issues did not change in the long term (very low quality evidence). | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_16 | no | Rigid bracing seems effective in 20° to 40° curves (low quality evidence), elastic bracing in 15° to 30° curves (low quality evidence), and very rigid bracing in high degree curves above 45° (very low quality evidence); rigid was more successful than an elastic bracing (low quality evidence), and a pad pressure control system did not increase results (very low quality evidence). | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_17 | yes | Primary outcomes such as pulmonary disorders, disability, back pain, psychological and cosmetic issues, and quality of life should be better evaluated in the future. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t25 | t25_18 | no | Side effects, as well as the usefulness of exercises and other adjunctive treatments to bracing should be studied too. | Idiopathic scoliosis is a three‐dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) ‐2.10, 95% confidence interval (CI) ‐7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow‐up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow‐up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow‐up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow‐up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention‐to‐treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow‐up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta‐analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise‐based' trials, prospective controlled cohort studies, prospective studies conducted according to pre‐defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. |
t26 | t26_1 | yes | People are living longer, however, the very old often have many health problems and disabilities which result in them living and eventually dying in care homes. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_2 | no | Residents of such homes are highly likely to die there, making these places where palliative care is needed. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_3 | yes | Palliative care provides relief from pain and other distressing symptoms experienced by people reaching the end of life. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_4 | yes | Palliative care hopes to help people live as actively as possible until death, and their families cope with the illness and bereavement. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_5 | no | The aim of this review was to see how effective palliative care interventions in care homes are, and to describe the outcome measures used in the studies. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_6 | no | We found only three suitable studies (735 participants), all from the USA. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_7 | yes | There was little evidence that interventions to improve palliative care for older people in care homes improved outcomes for residents. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_8 | no | One study found that palliative care increased bereaved family members' perceptions of the quality of care and another found lower discomfort for residents with dementia who were dying. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_9 | no | There were problems with both of these findings. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_10 | yes | Two studies found that palliative care improved some of the ways in which care was given in the care home, however, we do not know if this resulted in better outcomes for residents. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t26 | t26_11 | no | There is a need for more high quality research, particularly outside the USA. | Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed. Objectives The primary objective was to determine effectiveness of multi‐component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures. Search methods The grey literature and the following electronic databases were searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (all issue 1, 2010); MEDLINE, EMBASE, CINAHL, British Nursing Index, (1806 to February 2010), Science Citation Index Expanded & AMED (all to February 2010). Key journals were hand searched and a PubMed related articles link search was conducted on the final list of articles. Selection criteria We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before‐and‐after studies and interrupted time series studies of multi‐component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning. Data collection and analysis Two review authors independently assessed studies for inclusion, extracted data, and assessed quality and risk of bias. Meta analysis was not conducted due to heterogeneity of studies. The analysis comprised a structured narrative synthesis. Outcomes for residents and process of care measures were reported separately. Two RCTs and one controlled before‐and‐after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end‐stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do‐not‐resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost‐effectiveness, and reducing bias. |
t27 | t27_1 | yes | Acute heart attacks and severe angina (heart pain) are usually due to blockages in the arteries supplying the heart (coronary arteries). | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_2 | no | These problems are collectively referred to as 'acute coronary syndrome' (ACS). | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_3 | no | ACS is very common and may lead to severe complications including death. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_4 | yes | Hyperbaric oxygen therapy (HBOT) involves people breathing pure oxygen at high pressures in a specially designed chamber. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_5 | yes | It is sometimes used as a treatment to increase the supply of oxygen to the damaged heart in an attempt to reduce the area of the heart that is at risk of dying. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_6 | no | We searched the medical literature for any studies that reported the outcome of patients with ACS when treated with HBOT. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_7 | yes | All studies included patients with heart attack and some also included patients with severe angina. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_8 | yes | The dose of hyperbaric oxygen was similar in most studies. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_9 | yes | Overall, we found some evidence that people with ACS are less likely to die or to have major adverse events, and to have more rapid relief from their pain if they receive hyperbaric oxygen therapy as part of their treatment. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_10 | no | However, our conclusions are based on relatively small randomised trials. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_11 | yes | Our confidence in these findings is further reduced because in most of these studies both the patients and researchers were aware of who was receiving HBOT and it is possible a 'placebo effect' has biased the result in favour of HBOT. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_12 | no | HBOT was generally well‐tolerated. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_13 | no | Some patients complained of claustrophobia when treated in small (single person) chambers and there was no evidence of important toxicity from oxygen breathing in any subject. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_14 | yes | One individual suffered damage to the eardrum from pressurisation. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t27 | t27_15 | no | While HBOT may reduce the risk of dying, time to pain relief and the chance of adverse heart events in people with heart attack and unstable angina, more work is needed to be sure that HBOT should be recommended. | Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes. This an update of a review previously published in May 2004 and June 2010. Objectives The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed: Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death? Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention? Is the administration of HBOT safe in both the short and long term? Search methods We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions. Selection criteria Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT. Data collection and analysis Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach. No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow‐up, in general there is little information on the longer‐term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well‐tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. |
t28 | t28_1 | no | The aim of this Cochrane Review was to find out what methods of skin preparation before caesarean section were most effective in preventing infection after the operation. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_2 | no | We collected and analysed all studies that assessed the effectiveness of antiseptics used to prepare the skin before making an incision (or cut) for the caesarean section. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_3 | no | We only included analysis of preparations that were used to prepare the surgical site on the abdomen before caesarean section; we did not look at handwashing by the surgical team, or bathing the mother. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_4 | yes | Infections of surgical incisions are the third most frequently reported hospital‐acquired infections. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_5 | yes | Women who give birth by caesarean section are exposed to infection from germs already present on the mother's own skin, or from external sources. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_6 | yes | The risk of infection following a caesarean section can be 10 times that of vaginal birth. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_7 | yes | Therefore, preventing infection by properly preparing the skin before the incision is made is an important part of the overall care given to women prior to caesarean birth. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_8 | yes | An antiseptic is a substance applied to remove bacteria that can cause harm to the mother or baby when they multiply. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_9 | yes | Antiseptics include iodine or povidone iodine, alcohol, chlorhexidine, and parachlorometaxylenol. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_10 | no | They can be applied as liquids or powders, scrubs, paints, swabs, or on impregnated 'drapes' that stick to the skin, which the surgeon then cuts through. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_11 | yes | Non‐impregnated drapes can also be applied, once the skin has been scrubbed or swapped, with the aim of reducing the spread of any remaining bacteria during surgery. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_12 | no | It is important to know if some of these antiseptics or methods work better than others. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_13 | yes | The review looked at what was best for women and babies when it came to important outcomes including: infection of the site where the surgeon cut the woman to perform the caesarean section; inflammation of the lining of the womb (metritis and endometritis); how long the woman stayed in hospital; and any other adverse effects, such as irritation of the woman's skin, or any reported impact on the baby. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_14 | yes | The evidence suggested that there was probably little or no difference between the various antiseptics in the incidence of surgical site infection, endometritis, skin irritation, or allergic skin reaction in the mother. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_15 | yes | However, in one study, there was a reduction in bacterial growth on the skin at 18 hours after caesarean section for women who received a skin preparation with chlorhexidine gluconate compared with women who received the skin preparation with povidone iodine, but more data are needed to see if this actually reduces infections for women. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t28 | t28_16 | no | The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. | The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014. Objectives To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. Search methods For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov , the WHO International Clinical Trials Registry Platform ( ICTRP ) (27 November 2017), and reference lists of retrieved studies. Selection criteria Randomised and quasi‐randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section. Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. Data collection and analysis Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach. For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi‐ or cluster‐RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases. Drape versus no drape This comparison investigated the use of a non‐impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low‐quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI ‐0.27 to 0.46 1 trial, 603 women). One‐minute alcohol scrub with iodophor drape versus five‐minute iodophor scrub without drape One trial compared an alcohol scrub and iodophor drape with a five‐minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very‐low quality evidence). We were uncertain whether the combination of a one‐minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five‐minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The available evidence from the trials that have been conducted was insufficient to tell us the best type of skin preparation for preventing surgical site infection following caesarean section. More high‐quality research is needed. We found four studies that were still ongoing. We will incorporate the results of these studies into this review in future updates. |
t29 | t29_1 | no | We wanted to find out if giving hydroxyurea to people with non‐transfusion dependent beta thalassaemia would reduce the need for blood transfusion. | Non‐transfusion dependent beta thalassaemia is a subset of inherited haemoglobin disorders characterised by reduced production of the beta globin chain of the haemoglobin molecule leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it is required when episodes of chronic anaemia occur. This chronic anaemia can impair growth and affect quality of life. People with non‐transfusion dependent beta thalassaemia suffer from iron overload due to their body's increased capability of absorbing iron from food sources. Iron overload becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin level have been found to require fewer blood transfusions. Hydroxyurea has been used to increase foetal haemoglobin level; however, its efficacy in reducing transfusion, chronic anaemia complications and its safety need to be established. Objectives To assess the effectiveness, safety and appropriate dose regimen of hydroxyurea in people with non‐transfusion dependent beta thalassaemia (haemoglobin E combined with beta thalassaemia and beta thalassaemia intermedia). Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of relevant journals. We also searched ongoing trials registries and the reference lists of relevant articles and reviews. Date of last search: 30 April 2016. Selection criteria Randomised or quasi‐randomised controlled trials of hydroxyurea in people with non‐transfusion dependent beta thalassaemia comparing hydroxyurea with placebo or standard treatment or comparing different doses of hydroxyurea. Data collection and analysis Two authors independently applied the inclusion criteria in order to select trials for inclusion. Both authors assessed the risk of bias of trials and extracted the data. A third author verified these assessments. No trials comparing hydroxyurea with placebo or standard care were found. However, we included one randomised controlled trial (n = 61) comparing 20 mg/kg/day with 10 mg/kg/day of hydroxyurea for 24 weeks. Both haemoglobin and foetal haemoglobin levels were lower at 24 weeks in the 20 mg group compared with the 10 mg group, mean difference ‐2.39 (95% confidence interval ‐ 2.8 to ‐1.98) and mean difference ‐1.5 (95% confidence interval ‐1.83 to ‐1.17), respectively. Major adverse effects were significantly more common in the 20 mg group, for neutropenia risk ratio 9.93 (95% confidence interval 1.34 to 73.97) and for thrombocytopenia risk ratio 3.68 (95% confidence interval 1.13 to 12.07). No difference was reported for minor adverse effects (gastrointestinal disturbances and raised liver enzymes). The effect of hydroxyurea on transfusion frequency was not reported. The overall quality for the outcomes reported was graded as very low mainly because the outcomes were derived from only one small study with an unclear method of allocation concealment. There is no evidence from randomised controlled trials to show whether hydroxyurea has any effect compared with controls on the need for blood transfusion. Administration of 10 mg/kg/day compared to 20 mg/kg/day of hydroxyurea resulted in higher haemoglobin levels and seems safer with fewer adverse effects. It has not been reported whether hydroxyurea is capable of reducing the need for blood transfusion. Large well‐designed randomised controlled trials with sufficient duration of follow up are recommended. |
t29 | t29_2 | yes | Thalassaemia is a genetic blood disorder causing defective adult haemoglobin (the oxygen carrying component of red blood cells). | Non‐transfusion dependent beta thalassaemia is a subset of inherited haemoglobin disorders characterised by reduced production of the beta globin chain of the haemoglobin molecule leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it is required when episodes of chronic anaemia occur. This chronic anaemia can impair growth and affect quality of life. People with non‐transfusion dependent beta thalassaemia suffer from iron overload due to their body's increased capability of absorbing iron from food sources. Iron overload becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin level have been found to require fewer blood transfusions. Hydroxyurea has been used to increase foetal haemoglobin level; however, its efficacy in reducing transfusion, chronic anaemia complications and its safety need to be established. Objectives To assess the effectiveness, safety and appropriate dose regimen of hydroxyurea in people with non‐transfusion dependent beta thalassaemia (haemoglobin E combined with beta thalassaemia and beta thalassaemia intermedia). Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of relevant journals. We also searched ongoing trials registries and the reference lists of relevant articles and reviews. Date of last search: 30 April 2016. Selection criteria Randomised or quasi‐randomised controlled trials of hydroxyurea in people with non‐transfusion dependent beta thalassaemia comparing hydroxyurea with placebo or standard treatment or comparing different doses of hydroxyurea. Data collection and analysis Two authors independently applied the inclusion criteria in order to select trials for inclusion. Both authors assessed the risk of bias of trials and extracted the data. A third author verified these assessments. No trials comparing hydroxyurea with placebo or standard care were found. However, we included one randomised controlled trial (n = 61) comparing 20 mg/kg/day with 10 mg/kg/day of hydroxyurea for 24 weeks. Both haemoglobin and foetal haemoglobin levels were lower at 24 weeks in the 20 mg group compared with the 10 mg group, mean difference ‐2.39 (95% confidence interval ‐ 2.8 to ‐1.98) and mean difference ‐1.5 (95% confidence interval ‐1.83 to ‐1.17), respectively. Major adverse effects were significantly more common in the 20 mg group, for neutropenia risk ratio 9.93 (95% confidence interval 1.34 to 73.97) and for thrombocytopenia risk ratio 3.68 (95% confidence interval 1.13 to 12.07). No difference was reported for minor adverse effects (gastrointestinal disturbances and raised liver enzymes). The effect of hydroxyurea on transfusion frequency was not reported. The overall quality for the outcomes reported was graded as very low mainly because the outcomes were derived from only one small study with an unclear method of allocation concealment. There is no evidence from randomised controlled trials to show whether hydroxyurea has any effect compared with controls on the need for blood transfusion. Administration of 10 mg/kg/day compared to 20 mg/kg/day of hydroxyurea resulted in higher haemoglobin levels and seems safer with fewer adverse effects. It has not been reported whether hydroxyurea is capable of reducing the need for blood transfusion. Large well‐designed randomised controlled trials with sufficient duration of follow up are recommended. |
t29 | t29_3 | no | This causes anaemia with different degrees of severity. | Non‐transfusion dependent beta thalassaemia is a subset of inherited haemoglobin disorders characterised by reduced production of the beta globin chain of the haemoglobin molecule leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it is required when episodes of chronic anaemia occur. This chronic anaemia can impair growth and affect quality of life. People with non‐transfusion dependent beta thalassaemia suffer from iron overload due to their body's increased capability of absorbing iron from food sources. Iron overload becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin level have been found to require fewer blood transfusions. Hydroxyurea has been used to increase foetal haemoglobin level; however, its efficacy in reducing transfusion, chronic anaemia complications and its safety need to be established. Objectives To assess the effectiveness, safety and appropriate dose regimen of hydroxyurea in people with non‐transfusion dependent beta thalassaemia (haemoglobin E combined with beta thalassaemia and beta thalassaemia intermedia). Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of relevant journals. We also searched ongoing trials registries and the reference lists of relevant articles and reviews. Date of last search: 30 April 2016. Selection criteria Randomised or quasi‐randomised controlled trials of hydroxyurea in people with non‐transfusion dependent beta thalassaemia comparing hydroxyurea with placebo or standard treatment or comparing different doses of hydroxyurea. Data collection and analysis Two authors independently applied the inclusion criteria in order to select trials for inclusion. Both authors assessed the risk of bias of trials and extracted the data. A third author verified these assessments. No trials comparing hydroxyurea with placebo or standard care were found. However, we included one randomised controlled trial (n = 61) comparing 20 mg/kg/day with 10 mg/kg/day of hydroxyurea for 24 weeks. Both haemoglobin and foetal haemoglobin levels were lower at 24 weeks in the 20 mg group compared with the 10 mg group, mean difference ‐2.39 (95% confidence interval ‐ 2.8 to ‐1.98) and mean difference ‐1.5 (95% confidence interval ‐1.83 to ‐1.17), respectively. Major adverse effects were significantly more common in the 20 mg group, for neutropenia risk ratio 9.93 (95% confidence interval 1.34 to 73.97) and for thrombocytopenia risk ratio 3.68 (95% confidence interval 1.13 to 12.07). No difference was reported for minor adverse effects (gastrointestinal disturbances and raised liver enzymes). The effect of hydroxyurea on transfusion frequency was not reported. The overall quality for the outcomes reported was graded as very low mainly because the outcomes were derived from only one small study with an unclear method of allocation concealment. There is no evidence from randomised controlled trials to show whether hydroxyurea has any effect compared with controls on the need for blood transfusion. Administration of 10 mg/kg/day compared to 20 mg/kg/day of hydroxyurea resulted in higher haemoglobin levels and seems safer with fewer adverse effects. It has not been reported whether hydroxyurea is capable of reducing the need for blood transfusion. Large well‐designed randomised controlled trials with sufficient duration of follow up are recommended. |
t29 | t29_4 | no | People with non‐transfusion dependent beta thalassaemia do not depend on regular transfusions for survival, but may require blood transfusion from time to time. | Non‐transfusion dependent beta thalassaemia is a subset of inherited haemoglobin disorders characterised by reduced production of the beta globin chain of the haemoglobin molecule leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it is required when episodes of chronic anaemia occur. This chronic anaemia can impair growth and affect quality of life. People with non‐transfusion dependent beta thalassaemia suffer from iron overload due to their body's increased capability of absorbing iron from food sources. Iron overload becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin level have been found to require fewer blood transfusions. Hydroxyurea has been used to increase foetal haemoglobin level; however, its efficacy in reducing transfusion, chronic anaemia complications and its safety need to be established. Objectives To assess the effectiveness, safety and appropriate dose regimen of hydroxyurea in people with non‐transfusion dependent beta thalassaemia (haemoglobin E combined with beta thalassaemia and beta thalassaemia intermedia). Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of relevant journals. We also searched ongoing trials registries and the reference lists of relevant articles and reviews. Date of last search: 30 April 2016. Selection criteria Randomised or quasi‐randomised controlled trials of hydroxyurea in people with non‐transfusion dependent beta thalassaemia comparing hydroxyurea with placebo or standard treatment or comparing different doses of hydroxyurea. Data collection and analysis Two authors independently applied the inclusion criteria in order to select trials for inclusion. Both authors assessed the risk of bias of trials and extracted the data. A third author verified these assessments. No trials comparing hydroxyurea with placebo or standard care were found. However, we included one randomised controlled trial (n = 61) comparing 20 mg/kg/day with 10 mg/kg/day of hydroxyurea for 24 weeks. Both haemoglobin and foetal haemoglobin levels were lower at 24 weeks in the 20 mg group compared with the 10 mg group, mean difference ‐2.39 (95% confidence interval ‐ 2.8 to ‐1.98) and mean difference ‐1.5 (95% confidence interval ‐1.83 to ‐1.17), respectively. Major adverse effects were significantly more common in the 20 mg group, for neutropenia risk ratio 9.93 (95% confidence interval 1.34 to 73.97) and for thrombocytopenia risk ratio 3.68 (95% confidence interval 1.13 to 12.07). No difference was reported for minor adverse effects (gastrointestinal disturbances and raised liver enzymes). The effect of hydroxyurea on transfusion frequency was not reported. The overall quality for the outcomes reported was graded as very low mainly because the outcomes were derived from only one small study with an unclear method of allocation concealment. There is no evidence from randomised controlled trials to show whether hydroxyurea has any effect compared with controls on the need for blood transfusion. Administration of 10 mg/kg/day compared to 20 mg/kg/day of hydroxyurea resulted in higher haemoglobin levels and seems safer with fewer adverse effects. It has not been reported whether hydroxyurea is capable of reducing the need for blood transfusion. Large well‐designed randomised controlled trials with sufficient duration of follow up are recommended. |
t29 | t29_5 | yes | Persistent anaemia affects growth, may delay puberty and reduce quality of life. | Non‐transfusion dependent beta thalassaemia is a subset of inherited haemoglobin disorders characterised by reduced production of the beta globin chain of the haemoglobin molecule leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it is required when episodes of chronic anaemia occur. This chronic anaemia can impair growth and affect quality of life. People with non‐transfusion dependent beta thalassaemia suffer from iron overload due to their body's increased capability of absorbing iron from food sources. Iron overload becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin level have been found to require fewer blood transfusions. Hydroxyurea has been used to increase foetal haemoglobin level; however, its efficacy in reducing transfusion, chronic anaemia complications and its safety need to be established. Objectives To assess the effectiveness, safety and appropriate dose regimen of hydroxyurea in people with non‐transfusion dependent beta thalassaemia (haemoglobin E combined with beta thalassaemia and beta thalassaemia intermedia). Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of relevant journals. We also searched ongoing trials registries and the reference lists of relevant articles and reviews. Date of last search: 30 April 2016. Selection criteria Randomised or quasi‐randomised controlled trials of hydroxyurea in people with non‐transfusion dependent beta thalassaemia comparing hydroxyurea with placebo or standard treatment or comparing different doses of hydroxyurea. Data collection and analysis Two authors independently applied the inclusion criteria in order to select trials for inclusion. Both authors assessed the risk of bias of trials and extracted the data. A third author verified these assessments. No trials comparing hydroxyurea with placebo or standard care were found. However, we included one randomised controlled trial (n = 61) comparing 20 mg/kg/day with 10 mg/kg/day of hydroxyurea for 24 weeks. Both haemoglobin and foetal haemoglobin levels were lower at 24 weeks in the 20 mg group compared with the 10 mg group, mean difference ‐2.39 (95% confidence interval ‐ 2.8 to ‐1.98) and mean difference ‐1.5 (95% confidence interval ‐1.83 to ‐1.17), respectively. Major adverse effects were significantly more common in the 20 mg group, for neutropenia risk ratio 9.93 (95% confidence interval 1.34 to 73.97) and for thrombocytopenia risk ratio 3.68 (95% confidence interval 1.13 to 12.07). No difference was reported for minor adverse effects (gastrointestinal disturbances and raised liver enzymes). The effect of hydroxyurea on transfusion frequency was not reported. The overall quality for the outcomes reported was graded as very low mainly because the outcomes were derived from only one small study with an unclear method of allocation concealment. There is no evidence from randomised controlled trials to show whether hydroxyurea has any effect compared with controls on the need for blood transfusion. Administration of 10 mg/kg/day compared to 20 mg/kg/day of hydroxyurea resulted in higher haemoglobin levels and seems safer with fewer adverse effects. It has not been reported whether hydroxyurea is capable of reducing the need for blood transfusion. Large well‐designed randomised controlled trials with sufficient duration of follow up are recommended. |
t29 | t29_6 | yes | However, transfusion should be avoided, if possible, because it leads to excess iron being deposited in various organs affecting how they function. | Non‐transfusion dependent beta thalassaemia is a subset of inherited haemoglobin disorders characterised by reduced production of the beta globin chain of the haemoglobin molecule leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it is required when episodes of chronic anaemia occur. This chronic anaemia can impair growth and affect quality of life. People with non‐transfusion dependent beta thalassaemia suffer from iron overload due to their body's increased capability of absorbing iron from food sources. Iron overload becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin level have been found to require fewer blood transfusions. Hydroxyurea has been used to increase foetal haemoglobin level; however, its efficacy in reducing transfusion, chronic anaemia complications and its safety need to be established. Objectives To assess the effectiveness, safety and appropriate dose regimen of hydroxyurea in people with non‐transfusion dependent beta thalassaemia (haemoglobin E combined with beta thalassaemia and beta thalassaemia intermedia). Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of relevant journals. We also searched ongoing trials registries and the reference lists of relevant articles and reviews. Date of last search: 30 April 2016. Selection criteria Randomised or quasi‐randomised controlled trials of hydroxyurea in people with non‐transfusion dependent beta thalassaemia comparing hydroxyurea with placebo or standard treatment or comparing different doses of hydroxyurea. Data collection and analysis Two authors independently applied the inclusion criteria in order to select trials for inclusion. Both authors assessed the risk of bias of trials and extracted the data. A third author verified these assessments. No trials comparing hydroxyurea with placebo or standard care were found. However, we included one randomised controlled trial (n = 61) comparing 20 mg/kg/day with 10 mg/kg/day of hydroxyurea for 24 weeks. Both haemoglobin and foetal haemoglobin levels were lower at 24 weeks in the 20 mg group compared with the 10 mg group, mean difference ‐2.39 (95% confidence interval ‐ 2.8 to ‐1.98) and mean difference ‐1.5 (95% confidence interval ‐1.83 to ‐1.17), respectively. Major adverse effects were significantly more common in the 20 mg group, for neutropenia risk ratio 9.93 (95% confidence interval 1.34 to 73.97) and for thrombocytopenia risk ratio 3.68 (95% confidence interval 1.13 to 12.07). No difference was reported for minor adverse effects (gastrointestinal disturbances and raised liver enzymes). The effect of hydroxyurea on transfusion frequency was not reported. The overall quality for the outcomes reported was graded as very low mainly because the outcomes were derived from only one small study with an unclear method of allocation concealment. There is no evidence from randomised controlled trials to show whether hydroxyurea has any effect compared with controls on the need for blood transfusion. Administration of 10 mg/kg/day compared to 20 mg/kg/day of hydroxyurea resulted in higher haemoglobin levels and seems safer with fewer adverse effects. It has not been reported whether hydroxyurea is capable of reducing the need for blood transfusion. Large well‐designed randomised controlled trials with sufficient duration of follow up are recommended. |
Subsets and Splits