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t159 | t159_9 | no | 3) Provider referral means that health service personnel notify the partners. | Partner notification (PN) is the process whereby sexual partners of an index patient are informed of their exposure to a sexually transmitted infection (STI) and the need to obtain treatment. For the person (index patient) with a curable STI, PN aims to eradicate infection and prevent re‐infection. For sexual partners, PN aims to identify and treat undiagnosed STIs. At the level of sexual networks and populations, the aim of PN is to interrupt chains of STI transmission. For people with viral STI, PN aims to identify undiagnosed infections, which can facilitate access for their sexual partners to treatment and help prevent transmission. Objectives To assess the effects of different PN strategies in people with STI, including human immunodeficiency virus (HIV) infection. Search methods We searched electronic databases (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE) without language restrictions. We scanned reference lists of potential studies and previous reviews and contacted experts in the field. We searched three trial registries. We conducted the most recent search on 31 August 2012. Selection criteria Published or unpublished randomised controlled trials (RCTs) or quasi‐RCTs comparing two or more PN strategies. Four main PN strategies were included: patient referral, expedited partner therapy, provider referral and contract referral. Patient referral means that the patient notifies their sexual partners, either with (enhanced patient referral) or without (simple patient referral) additional verbal or written support. In expedited partner therapy, the patient delivers medication or a prescription for medication to their partner(s) without the need for a medical examination of the partner. In provider referral, health service personnel notify the partners. In contract referral, the index patient is encouraged to notify partner, with the understanding that the partners will be contacted if they do not visit the health service by a certain date. Data collection and analysis We analysed data according to paired partner referral strategies. We organised the comparisons first according to four main PN strategies (1. enhanced patient referral, 2. expedited partner therapy, 3. contract referral, 4. provider referral). We compared each main strategy with simple patient referral and then with each other, if trials were available. For continuous outcome measures, we calculated the mean difference (MD) with 95% confidence intervals (CI). For dichotomous variables, we calculated the risk ratio (RR) with 95% CI. We performed meta‐analyses where appropriate. We performed a sensitivity analysis for the primary outcome re‐infection rate of the index patient by excluding studies with attrition of greater than 20%. Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We included 26 trials (17,578 participants, 9015 women and 8563 men). Five trials were conducted in developing countries. Only two trials were conducted among HIV‐positive patients. There was potential for selection bias, owing to the methods of allocation used and of performance bias, owing to the lack of blinding in most included studies. Seven trials had attrition of greater than 20%, increasing the risk of bias. The review found moderate‐quality evidence that expedited partner therapy is better than simple patient referral for preventing re‐infection of index patients when combining trials of STIs that caused urethritis or cervicitis (6 trials; RR 0.71, 95% CI 0.56 to 0.89, I 2 = 39%). When studies with attrition greater than 20% were excluded, the effect of expedited partner therapy was attenuated (2 trials; RR 0.8, 95% CI 0.62 to 1.04, I 2 = 0%). In trials restricted to index patients with chlamydia, the effect was attenuated (2 trials; RR 0.90, 95% CI 0.60 to 1.35, I 2 = 22%). Expedited partner therapy also increased the number of partners treated per index patient (three trials) when compared with simple patient referral in people with chlamydia or gonorrhoea (MD 0.43, 95% CI 0.28 to 0.58) or trichomonas (MD 0.51, 95% CI 0.35 to 0.67), and people with any STI syndrome (MD 0.5, 95% CI 0.34 to 0.67). Expedited partner therapy was not superior to enhanced patient referral in preventing re‐infection (3 trials; RR 0.96, 95% CI 0.60 to 1.53, I 2 = 33%, low‐quality evidence). Home sampling kits for partners (four trials) did not result in lower rates of re‐infection in the index case (measured in one trial), or higher numbers of partners elicited (three trials), notified (two trials) or treated (one trial) when compared with simple patient referral. There was no consistent evidence for the relative effects of provider, contract or other patient referral methods. In one trial among men with non‐gonococcal urethritis, more partners were treated with provider referral than with simple patient referral (MD 0.5, 95% CI 0.37 to 0.63). In one study among people with syphilis, contract referral elicited treatment of more partners than provider referral (MD 2.2, 95% CI 1.95 to 2.45), but the number of partners receiving treatment was the same in both groups. Where measured, there was no statistical evidence of differences in the incidence of adverse effects between PN strategies. The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI. When combining trials of STI causing urethritis or cervicitis, expedited partner therapy was more successful than simple patient referral for preventing re‐infection of the index patient but was not superior to enhanced patient referral. Expedited partner therapy interventions should include all components that were part of the trial intervention package. There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy. There are too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. More high‐quality RCTs of PN strategies for HIV and syphilis, using biological outcomes, are needed. |
t159 | t159_10 | no | 4) Contract referral means that the patient is encouraged to notify partners but health service personnel will contact them if they do not visit the health service by a certain date. | Partner notification (PN) is the process whereby sexual partners of an index patient are informed of their exposure to a sexually transmitted infection (STI) and the need to obtain treatment. For the person (index patient) with a curable STI, PN aims to eradicate infection and prevent re‐infection. For sexual partners, PN aims to identify and treat undiagnosed STIs. At the level of sexual networks and populations, the aim of PN is to interrupt chains of STI transmission. For people with viral STI, PN aims to identify undiagnosed infections, which can facilitate access for their sexual partners to treatment and help prevent transmission. Objectives To assess the effects of different PN strategies in people with STI, including human immunodeficiency virus (HIV) infection. Search methods We searched electronic databases (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE) without language restrictions. We scanned reference lists of potential studies and previous reviews and contacted experts in the field. We searched three trial registries. We conducted the most recent search on 31 August 2012. Selection criteria Published or unpublished randomised controlled trials (RCTs) or quasi‐RCTs comparing two or more PN strategies. Four main PN strategies were included: patient referral, expedited partner therapy, provider referral and contract referral. Patient referral means that the patient notifies their sexual partners, either with (enhanced patient referral) or without (simple patient referral) additional verbal or written support. In expedited partner therapy, the patient delivers medication or a prescription for medication to their partner(s) without the need for a medical examination of the partner. In provider referral, health service personnel notify the partners. In contract referral, the index patient is encouraged to notify partner, with the understanding that the partners will be contacted if they do not visit the health service by a certain date. Data collection and analysis We analysed data according to paired partner referral strategies. We organised the comparisons first according to four main PN strategies (1. enhanced patient referral, 2. expedited partner therapy, 3. contract referral, 4. provider referral). We compared each main strategy with simple patient referral and then with each other, if trials were available. For continuous outcome measures, we calculated the mean difference (MD) with 95% confidence intervals (CI). For dichotomous variables, we calculated the risk ratio (RR) with 95% CI. We performed meta‐analyses where appropriate. We performed a sensitivity analysis for the primary outcome re‐infection rate of the index patient by excluding studies with attrition of greater than 20%. Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We included 26 trials (17,578 participants, 9015 women and 8563 men). Five trials were conducted in developing countries. Only two trials were conducted among HIV‐positive patients. There was potential for selection bias, owing to the methods of allocation used and of performance bias, owing to the lack of blinding in most included studies. Seven trials had attrition of greater than 20%, increasing the risk of bias. The review found moderate‐quality evidence that expedited partner therapy is better than simple patient referral for preventing re‐infection of index patients when combining trials of STIs that caused urethritis or cervicitis (6 trials; RR 0.71, 95% CI 0.56 to 0.89, I 2 = 39%). When studies with attrition greater than 20% were excluded, the effect of expedited partner therapy was attenuated (2 trials; RR 0.8, 95% CI 0.62 to 1.04, I 2 = 0%). In trials restricted to index patients with chlamydia, the effect was attenuated (2 trials; RR 0.90, 95% CI 0.60 to 1.35, I 2 = 22%). Expedited partner therapy also increased the number of partners treated per index patient (three trials) when compared with simple patient referral in people with chlamydia or gonorrhoea (MD 0.43, 95% CI 0.28 to 0.58) or trichomonas (MD 0.51, 95% CI 0.35 to 0.67), and people with any STI syndrome (MD 0.5, 95% CI 0.34 to 0.67). Expedited partner therapy was not superior to enhanced patient referral in preventing re‐infection (3 trials; RR 0.96, 95% CI 0.60 to 1.53, I 2 = 33%, low‐quality evidence). Home sampling kits for partners (four trials) did not result in lower rates of re‐infection in the index case (measured in one trial), or higher numbers of partners elicited (three trials), notified (two trials) or treated (one trial) when compared with simple patient referral. There was no consistent evidence for the relative effects of provider, contract or other patient referral methods. In one trial among men with non‐gonococcal urethritis, more partners were treated with provider referral than with simple patient referral (MD 0.5, 95% CI 0.37 to 0.63). In one study among people with syphilis, contract referral elicited treatment of more partners than provider referral (MD 2.2, 95% CI 1.95 to 2.45), but the number of partners receiving treatment was the same in both groups. Where measured, there was no statistical evidence of differences in the incidence of adverse effects between PN strategies. The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI. When combining trials of STI causing urethritis or cervicitis, expedited partner therapy was more successful than simple patient referral for preventing re‐infection of the index patient but was not superior to enhanced patient referral. Expedited partner therapy interventions should include all components that were part of the trial intervention package. There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy. There are too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. More high‐quality RCTs of PN strategies for HIV and syphilis, using biological outcomes, are needed. |
t159 | t159_11 | no | Five trials were conducted in developing countries and only two trials were performed among HIV‐positive patients. | Partner notification (PN) is the process whereby sexual partners of an index patient are informed of their exposure to a sexually transmitted infection (STI) and the need to obtain treatment. For the person (index patient) with a curable STI, PN aims to eradicate infection and prevent re‐infection. For sexual partners, PN aims to identify and treat undiagnosed STIs. At the level of sexual networks and populations, the aim of PN is to interrupt chains of STI transmission. For people with viral STI, PN aims to identify undiagnosed infections, which can facilitate access for their sexual partners to treatment and help prevent transmission. Objectives To assess the effects of different PN strategies in people with STI, including human immunodeficiency virus (HIV) infection. Search methods We searched electronic databases (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE) without language restrictions. We scanned reference lists of potential studies and previous reviews and contacted experts in the field. We searched three trial registries. We conducted the most recent search on 31 August 2012. Selection criteria Published or unpublished randomised controlled trials (RCTs) or quasi‐RCTs comparing two or more PN strategies. Four main PN strategies were included: patient referral, expedited partner therapy, provider referral and contract referral. Patient referral means that the patient notifies their sexual partners, either with (enhanced patient referral) or without (simple patient referral) additional verbal or written support. In expedited partner therapy, the patient delivers medication or a prescription for medication to their partner(s) without the need for a medical examination of the partner. In provider referral, health service personnel notify the partners. In contract referral, the index patient is encouraged to notify partner, with the understanding that the partners will be contacted if they do not visit the health service by a certain date. Data collection and analysis We analysed data according to paired partner referral strategies. We organised the comparisons first according to four main PN strategies (1. enhanced patient referral, 2. expedited partner therapy, 3. contract referral, 4. provider referral). We compared each main strategy with simple patient referral and then with each other, if trials were available. For continuous outcome measures, we calculated the mean difference (MD) with 95% confidence intervals (CI). For dichotomous variables, we calculated the risk ratio (RR) with 95% CI. We performed meta‐analyses where appropriate. We performed a sensitivity analysis for the primary outcome re‐infection rate of the index patient by excluding studies with attrition of greater than 20%. Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We included 26 trials (17,578 participants, 9015 women and 8563 men). Five trials were conducted in developing countries. Only two trials were conducted among HIV‐positive patients. There was potential for selection bias, owing to the methods of allocation used and of performance bias, owing to the lack of blinding in most included studies. Seven trials had attrition of greater than 20%, increasing the risk of bias. The review found moderate‐quality evidence that expedited partner therapy is better than simple patient referral for preventing re‐infection of index patients when combining trials of STIs that caused urethritis or cervicitis (6 trials; RR 0.71, 95% CI 0.56 to 0.89, I 2 = 39%). When studies with attrition greater than 20% were excluded, the effect of expedited partner therapy was attenuated (2 trials; RR 0.8, 95% CI 0.62 to 1.04, I 2 = 0%). In trials restricted to index patients with chlamydia, the effect was attenuated (2 trials; RR 0.90, 95% CI 0.60 to 1.35, I 2 = 22%). Expedited partner therapy also increased the number of partners treated per index patient (three trials) when compared with simple patient referral in people with chlamydia or gonorrhoea (MD 0.43, 95% CI 0.28 to 0.58) or trichomonas (MD 0.51, 95% CI 0.35 to 0.67), and people with any STI syndrome (MD 0.5, 95% CI 0.34 to 0.67). Expedited partner therapy was not superior to enhanced patient referral in preventing re‐infection (3 trials; RR 0.96, 95% CI 0.60 to 1.53, I 2 = 33%, low‐quality evidence). Home sampling kits for partners (four trials) did not result in lower rates of re‐infection in the index case (measured in one trial), or higher numbers of partners elicited (three trials), notified (two trials) or treated (one trial) when compared with simple patient referral. There was no consistent evidence for the relative effects of provider, contract or other patient referral methods. In one trial among men with non‐gonococcal urethritis, more partners were treated with provider referral than with simple patient referral (MD 0.5, 95% CI 0.37 to 0.63). In one study among people with syphilis, contract referral elicited treatment of more partners than provider referral (MD 2.2, 95% CI 1.95 to 2.45), but the number of partners receiving treatment was the same in both groups. Where measured, there was no statistical evidence of differences in the incidence of adverse effects between PN strategies. The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI. When combining trials of STI causing urethritis or cervicitis, expedited partner therapy was more successful than simple patient referral for preventing re‐infection of the index patient but was not superior to enhanced patient referral. Expedited partner therapy interventions should include all components that were part of the trial intervention package. There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy. There are too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. More high‐quality RCTs of PN strategies for HIV and syphilis, using biological outcomes, are needed. |
t159 | t159_12 | yes | Expedited partner therapy was more successful than simple patient referral in reducing repeat infection in patients with gonorrhoea, chlamydia or non‐gonococcal urethritis (six trials). | Partner notification (PN) is the process whereby sexual partners of an index patient are informed of their exposure to a sexually transmitted infection (STI) and the need to obtain treatment. For the person (index patient) with a curable STI, PN aims to eradicate infection and prevent re‐infection. For sexual partners, PN aims to identify and treat undiagnosed STIs. At the level of sexual networks and populations, the aim of PN is to interrupt chains of STI transmission. For people with viral STI, PN aims to identify undiagnosed infections, which can facilitate access for their sexual partners to treatment and help prevent transmission. Objectives To assess the effects of different PN strategies in people with STI, including human immunodeficiency virus (HIV) infection. Search methods We searched electronic databases (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE) without language restrictions. We scanned reference lists of potential studies and previous reviews and contacted experts in the field. We searched three trial registries. We conducted the most recent search on 31 August 2012. Selection criteria Published or unpublished randomised controlled trials (RCTs) or quasi‐RCTs comparing two or more PN strategies. Four main PN strategies were included: patient referral, expedited partner therapy, provider referral and contract referral. Patient referral means that the patient notifies their sexual partners, either with (enhanced patient referral) or without (simple patient referral) additional verbal or written support. In expedited partner therapy, the patient delivers medication or a prescription for medication to their partner(s) without the need for a medical examination of the partner. In provider referral, health service personnel notify the partners. In contract referral, the index patient is encouraged to notify partner, with the understanding that the partners will be contacted if they do not visit the health service by a certain date. Data collection and analysis We analysed data according to paired partner referral strategies. We organised the comparisons first according to four main PN strategies (1. enhanced patient referral, 2. expedited partner therapy, 3. contract referral, 4. provider referral). We compared each main strategy with simple patient referral and then with each other, if trials were available. For continuous outcome measures, we calculated the mean difference (MD) with 95% confidence intervals (CI). For dichotomous variables, we calculated the risk ratio (RR) with 95% CI. We performed meta‐analyses where appropriate. We performed a sensitivity analysis for the primary outcome re‐infection rate of the index patient by excluding studies with attrition of greater than 20%. Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We included 26 trials (17,578 participants, 9015 women and 8563 men). Five trials were conducted in developing countries. Only two trials were conducted among HIV‐positive patients. There was potential for selection bias, owing to the methods of allocation used and of performance bias, owing to the lack of blinding in most included studies. Seven trials had attrition of greater than 20%, increasing the risk of bias. The review found moderate‐quality evidence that expedited partner therapy is better than simple patient referral for preventing re‐infection of index patients when combining trials of STIs that caused urethritis or cervicitis (6 trials; RR 0.71, 95% CI 0.56 to 0.89, I 2 = 39%). When studies with attrition greater than 20% were excluded, the effect of expedited partner therapy was attenuated (2 trials; RR 0.8, 95% CI 0.62 to 1.04, I 2 = 0%). In trials restricted to index patients with chlamydia, the effect was attenuated (2 trials; RR 0.90, 95% CI 0.60 to 1.35, I 2 = 22%). Expedited partner therapy also increased the number of partners treated per index patient (three trials) when compared with simple patient referral in people with chlamydia or gonorrhoea (MD 0.43, 95% CI 0.28 to 0.58) or trichomonas (MD 0.51, 95% CI 0.35 to 0.67), and people with any STI syndrome (MD 0.5, 95% CI 0.34 to 0.67). Expedited partner therapy was not superior to enhanced patient referral in preventing re‐infection (3 trials; RR 0.96, 95% CI 0.60 to 1.53, I 2 = 33%, low‐quality evidence). Home sampling kits for partners (four trials) did not result in lower rates of re‐infection in the index case (measured in one trial), or higher numbers of partners elicited (three trials), notified (two trials) or treated (one trial) when compared with simple patient referral. There was no consistent evidence for the relative effects of provider, contract or other patient referral methods. In one trial among men with non‐gonococcal urethritis, more partners were treated with provider referral than with simple patient referral (MD 0.5, 95% CI 0.37 to 0.63). In one study among people with syphilis, contract referral elicited treatment of more partners than provider referral (MD 2.2, 95% CI 1.95 to 2.45), but the number of partners receiving treatment was the same in both groups. Where measured, there was no statistical evidence of differences in the incidence of adverse effects between PN strategies. The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI. When combining trials of STI causing urethritis or cervicitis, expedited partner therapy was more successful than simple patient referral for preventing re‐infection of the index patient but was not superior to enhanced patient referral. Expedited partner therapy interventions should include all components that were part of the trial intervention package. There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy. There are too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. More high‐quality RCTs of PN strategies for HIV and syphilis, using biological outcomes, are needed. |
t159 | t159_13 | no | Expedited partner therapy and enhanced patient referral resulted in similar levels of repeat infection (three trials). | Partner notification (PN) is the process whereby sexual partners of an index patient are informed of their exposure to a sexually transmitted infection (STI) and the need to obtain treatment. For the person (index patient) with a curable STI, PN aims to eradicate infection and prevent re‐infection. For sexual partners, PN aims to identify and treat undiagnosed STIs. At the level of sexual networks and populations, the aim of PN is to interrupt chains of STI transmission. For people with viral STI, PN aims to identify undiagnosed infections, which can facilitate access for their sexual partners to treatment and help prevent transmission. Objectives To assess the effects of different PN strategies in people with STI, including human immunodeficiency virus (HIV) infection. Search methods We searched electronic databases (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE) without language restrictions. We scanned reference lists of potential studies and previous reviews and contacted experts in the field. We searched three trial registries. We conducted the most recent search on 31 August 2012. Selection criteria Published or unpublished randomised controlled trials (RCTs) or quasi‐RCTs comparing two or more PN strategies. Four main PN strategies were included: patient referral, expedited partner therapy, provider referral and contract referral. Patient referral means that the patient notifies their sexual partners, either with (enhanced patient referral) or without (simple patient referral) additional verbal or written support. In expedited partner therapy, the patient delivers medication or a prescription for medication to their partner(s) without the need for a medical examination of the partner. In provider referral, health service personnel notify the partners. In contract referral, the index patient is encouraged to notify partner, with the understanding that the partners will be contacted if they do not visit the health service by a certain date. Data collection and analysis We analysed data according to paired partner referral strategies. We organised the comparisons first according to four main PN strategies (1. enhanced patient referral, 2. expedited partner therapy, 3. contract referral, 4. provider referral). We compared each main strategy with simple patient referral and then with each other, if trials were available. For continuous outcome measures, we calculated the mean difference (MD) with 95% confidence intervals (CI). For dichotomous variables, we calculated the risk ratio (RR) with 95% CI. We performed meta‐analyses where appropriate. We performed a sensitivity analysis for the primary outcome re‐infection rate of the index patient by excluding studies with attrition of greater than 20%. Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We included 26 trials (17,578 participants, 9015 women and 8563 men). Five trials were conducted in developing countries. Only two trials were conducted among HIV‐positive patients. There was potential for selection bias, owing to the methods of allocation used and of performance bias, owing to the lack of blinding in most included studies. Seven trials had attrition of greater than 20%, increasing the risk of bias. The review found moderate‐quality evidence that expedited partner therapy is better than simple patient referral for preventing re‐infection of index patients when combining trials of STIs that caused urethritis or cervicitis (6 trials; RR 0.71, 95% CI 0.56 to 0.89, I 2 = 39%). When studies with attrition greater than 20% were excluded, the effect of expedited partner therapy was attenuated (2 trials; RR 0.8, 95% CI 0.62 to 1.04, I 2 = 0%). In trials restricted to index patients with chlamydia, the effect was attenuated (2 trials; RR 0.90, 95% CI 0.60 to 1.35, I 2 = 22%). Expedited partner therapy also increased the number of partners treated per index patient (three trials) when compared with simple patient referral in people with chlamydia or gonorrhoea (MD 0.43, 95% CI 0.28 to 0.58) or trichomonas (MD 0.51, 95% CI 0.35 to 0.67), and people with any STI syndrome (MD 0.5, 95% CI 0.34 to 0.67). Expedited partner therapy was not superior to enhanced patient referral in preventing re‐infection (3 trials; RR 0.96, 95% CI 0.60 to 1.53, I 2 = 33%, low‐quality evidence). Home sampling kits for partners (four trials) did not result in lower rates of re‐infection in the index case (measured in one trial), or higher numbers of partners elicited (three trials), notified (two trials) or treated (one trial) when compared with simple patient referral. There was no consistent evidence for the relative effects of provider, contract or other patient referral methods. In one trial among men with non‐gonococcal urethritis, more partners were treated with provider referral than with simple patient referral (MD 0.5, 95% CI 0.37 to 0.63). In one study among people with syphilis, contract referral elicited treatment of more partners than provider referral (MD 2.2, 95% CI 1.95 to 2.45), but the number of partners receiving treatment was the same in both groups. Where measured, there was no statistical evidence of differences in the incidence of adverse effects between PN strategies. The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI. When combining trials of STI causing urethritis or cervicitis, expedited partner therapy was more successful than simple patient referral for preventing re‐infection of the index patient but was not superior to enhanced patient referral. Expedited partner therapy interventions should include all components that were part of the trial intervention package. There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy. There are too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. More high‐quality RCTs of PN strategies for HIV and syphilis, using biological outcomes, are needed. |
t159 | t159_14 | yes | Evidence about the effects of home sampling, where patients with chlamydia received a sample kit for the partner, was inconsistent (three trials). | Partner notification (PN) is the process whereby sexual partners of an index patient are informed of their exposure to a sexually transmitted infection (STI) and the need to obtain treatment. For the person (index patient) with a curable STI, PN aims to eradicate infection and prevent re‐infection. For sexual partners, PN aims to identify and treat undiagnosed STIs. At the level of sexual networks and populations, the aim of PN is to interrupt chains of STI transmission. For people with viral STI, PN aims to identify undiagnosed infections, which can facilitate access for their sexual partners to treatment and help prevent transmission. Objectives To assess the effects of different PN strategies in people with STI, including human immunodeficiency virus (HIV) infection. Search methods We searched electronic databases (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE) without language restrictions. We scanned reference lists of potential studies and previous reviews and contacted experts in the field. We searched three trial registries. We conducted the most recent search on 31 August 2012. Selection criteria Published or unpublished randomised controlled trials (RCTs) or quasi‐RCTs comparing two or more PN strategies. Four main PN strategies were included: patient referral, expedited partner therapy, provider referral and contract referral. Patient referral means that the patient notifies their sexual partners, either with (enhanced patient referral) or without (simple patient referral) additional verbal or written support. In expedited partner therapy, the patient delivers medication or a prescription for medication to their partner(s) without the need for a medical examination of the partner. In provider referral, health service personnel notify the partners. In contract referral, the index patient is encouraged to notify partner, with the understanding that the partners will be contacted if they do not visit the health service by a certain date. Data collection and analysis We analysed data according to paired partner referral strategies. We organised the comparisons first according to four main PN strategies (1. enhanced patient referral, 2. expedited partner therapy, 3. contract referral, 4. provider referral). We compared each main strategy with simple patient referral and then with each other, if trials were available. For continuous outcome measures, we calculated the mean difference (MD) with 95% confidence intervals (CI). For dichotomous variables, we calculated the risk ratio (RR) with 95% CI. We performed meta‐analyses where appropriate. We performed a sensitivity analysis for the primary outcome re‐infection rate of the index patient by excluding studies with attrition of greater than 20%. Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We included 26 trials (17,578 participants, 9015 women and 8563 men). Five trials were conducted in developing countries. Only two trials were conducted among HIV‐positive patients. There was potential for selection bias, owing to the methods of allocation used and of performance bias, owing to the lack of blinding in most included studies. Seven trials had attrition of greater than 20%, increasing the risk of bias. The review found moderate‐quality evidence that expedited partner therapy is better than simple patient referral for preventing re‐infection of index patients when combining trials of STIs that caused urethritis or cervicitis (6 trials; RR 0.71, 95% CI 0.56 to 0.89, I 2 = 39%). When studies with attrition greater than 20% were excluded, the effect of expedited partner therapy was attenuated (2 trials; RR 0.8, 95% CI 0.62 to 1.04, I 2 = 0%). In trials restricted to index patients with chlamydia, the effect was attenuated (2 trials; RR 0.90, 95% CI 0.60 to 1.35, I 2 = 22%). Expedited partner therapy also increased the number of partners treated per index patient (three trials) when compared with simple patient referral in people with chlamydia or gonorrhoea (MD 0.43, 95% CI 0.28 to 0.58) or trichomonas (MD 0.51, 95% CI 0.35 to 0.67), and people with any STI syndrome (MD 0.5, 95% CI 0.34 to 0.67). Expedited partner therapy was not superior to enhanced patient referral in preventing re‐infection (3 trials; RR 0.96, 95% CI 0.60 to 1.53, I 2 = 33%, low‐quality evidence). Home sampling kits for partners (four trials) did not result in lower rates of re‐infection in the index case (measured in one trial), or higher numbers of partners elicited (three trials), notified (two trials) or treated (one trial) when compared with simple patient referral. There was no consistent evidence for the relative effects of provider, contract or other patient referral methods. In one trial among men with non‐gonococcal urethritis, more partners were treated with provider referral than with simple patient referral (MD 0.5, 95% CI 0.37 to 0.63). In one study among people with syphilis, contract referral elicited treatment of more partners than provider referral (MD 2.2, 95% CI 1.95 to 2.45), but the number of partners receiving treatment was the same in both groups. Where measured, there was no statistical evidence of differences in the incidence of adverse effects between PN strategies. The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI. When combining trials of STI causing urethritis or cervicitis, expedited partner therapy was more successful than simple patient referral for preventing re‐infection of the index patient but was not superior to enhanced patient referral. Expedited partner therapy interventions should include all components that were part of the trial intervention package. There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy. There are too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. More high‐quality RCTs of PN strategies for HIV and syphilis, using biological outcomes, are needed. |
t159 | t159_15 | no | There were too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. | Partner notification (PN) is the process whereby sexual partners of an index patient are informed of their exposure to a sexually transmitted infection (STI) and the need to obtain treatment. For the person (index patient) with a curable STI, PN aims to eradicate infection and prevent re‐infection. For sexual partners, PN aims to identify and treat undiagnosed STIs. At the level of sexual networks and populations, the aim of PN is to interrupt chains of STI transmission. For people with viral STI, PN aims to identify undiagnosed infections, which can facilitate access for their sexual partners to treatment and help prevent transmission. Objectives To assess the effects of different PN strategies in people with STI, including human immunodeficiency virus (HIV) infection. Search methods We searched electronic databases (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE) without language restrictions. We scanned reference lists of potential studies and previous reviews and contacted experts in the field. We searched three trial registries. We conducted the most recent search on 31 August 2012. Selection criteria Published or unpublished randomised controlled trials (RCTs) or quasi‐RCTs comparing two or more PN strategies. Four main PN strategies were included: patient referral, expedited partner therapy, provider referral and contract referral. Patient referral means that the patient notifies their sexual partners, either with (enhanced patient referral) or without (simple patient referral) additional verbal or written support. In expedited partner therapy, the patient delivers medication or a prescription for medication to their partner(s) without the need for a medical examination of the partner. In provider referral, health service personnel notify the partners. In contract referral, the index patient is encouraged to notify partner, with the understanding that the partners will be contacted if they do not visit the health service by a certain date. Data collection and analysis We analysed data according to paired partner referral strategies. We organised the comparisons first according to four main PN strategies (1. enhanced patient referral, 2. expedited partner therapy, 3. contract referral, 4. provider referral). We compared each main strategy with simple patient referral and then with each other, if trials were available. For continuous outcome measures, we calculated the mean difference (MD) with 95% confidence intervals (CI). For dichotomous variables, we calculated the risk ratio (RR) with 95% CI. We performed meta‐analyses where appropriate. We performed a sensitivity analysis for the primary outcome re‐infection rate of the index patient by excluding studies with attrition of greater than 20%. Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We included 26 trials (17,578 participants, 9015 women and 8563 men). Five trials were conducted in developing countries. Only two trials were conducted among HIV‐positive patients. There was potential for selection bias, owing to the methods of allocation used and of performance bias, owing to the lack of blinding in most included studies. Seven trials had attrition of greater than 20%, increasing the risk of bias. The review found moderate‐quality evidence that expedited partner therapy is better than simple patient referral for preventing re‐infection of index patients when combining trials of STIs that caused urethritis or cervicitis (6 trials; RR 0.71, 95% CI 0.56 to 0.89, I 2 = 39%). When studies with attrition greater than 20% were excluded, the effect of expedited partner therapy was attenuated (2 trials; RR 0.8, 95% CI 0.62 to 1.04, I 2 = 0%). In trials restricted to index patients with chlamydia, the effect was attenuated (2 trials; RR 0.90, 95% CI 0.60 to 1.35, I 2 = 22%). Expedited partner therapy also increased the number of partners treated per index patient (three trials) when compared with simple patient referral in people with chlamydia or gonorrhoea (MD 0.43, 95% CI 0.28 to 0.58) or trichomonas (MD 0.51, 95% CI 0.35 to 0.67), and people with any STI syndrome (MD 0.5, 95% CI 0.34 to 0.67). Expedited partner therapy was not superior to enhanced patient referral in preventing re‐infection (3 trials; RR 0.96, 95% CI 0.60 to 1.53, I 2 = 33%, low‐quality evidence). Home sampling kits for partners (four trials) did not result in lower rates of re‐infection in the index case (measured in one trial), or higher numbers of partners elicited (three trials), notified (two trials) or treated (one trial) when compared with simple patient referral. There was no consistent evidence for the relative effects of provider, contract or other patient referral methods. In one trial among men with non‐gonococcal urethritis, more partners were treated with provider referral than with simple patient referral (MD 0.5, 95% CI 0.37 to 0.63). In one study among people with syphilis, contract referral elicited treatment of more partners than provider referral (MD 2.2, 95% CI 1.95 to 2.45), but the number of partners receiving treatment was the same in both groups. Where measured, there was no statistical evidence of differences in the incidence of adverse effects between PN strategies. The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI. When combining trials of STI causing urethritis or cervicitis, expedited partner therapy was more successful than simple patient referral for preventing re‐infection of the index patient but was not superior to enhanced patient referral. Expedited partner therapy interventions should include all components that were part of the trial intervention package. There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy. There are too few trials to allow consistent conclusions about the relative effects of provider, contract or other patient referral methods for different STIs. More high‐quality RCTs of PN strategies for HIV and syphilis, using biological outcomes, are needed. |
t160 | t160_1 | no | Unhealthy patterns of consumption of food, alcohol, and tobacco products are important causes of ill health. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_2 | no | Changing the availability (the range or amount of options, or both) of these products or their proximity (the distance at which they are positioned) to potential consumers could help people make healthier choices. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_3 | no | This review investigated whether altering the availability or proximity of food (including non‐alcoholic beverages), alcohol, and tobacco products changed people's selection (such as purchasing) or consumption of those products. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_4 | no | We searched for all available evidence from randomised controlled trials (a type of study in which participants are assigned to one of two or more treatment groups using a random method) to answer this question, and found 24 studies, all of which were conducted in high‐income countries. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_5 | no | Six studies involved availability interventions, of which four changed the relative proportion of less‐healthy to healthier options, and two changed the absolute number of different options available. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_6 | no | In statistical analyses that combined results from multiple studies, it was found that reducing the number of available options for a particular range or category of food(s) reduced selection of those food products (from analysing 154 participants) and possibly reduced consumption of those products (from 150 participants). | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_7 | no | However, the certainty of the evidence for these effects was low. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_8 | no | Eighteen studies involved proximity interventions. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_9 | no | Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_10 | no | One study found that this reduced selection of food (from analysing 41 participants), whilst in a statistical analysis combining results from multiple studies, it was found that placing food farther away reduced consumption of those food products (from analysing 1098 participants). | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_11 | yes | However, the certainty of the evidence for these effects was very low and low, respectively. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t160 | t160_12 | no | Mindful of its limitations, the current evidence suggests that changing the number of available food options or changing where foods are positioned could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes to food environments. | Overconsumption of food, alcohol, and tobacco products increases the risk of non‐communicable diseases. Interventions to change characteristics of physical micro‐environments where people may select or consume these products ‐ including shops, restaurants, workplaces, and schools – are of considerable public health policy and research interest. This review addresses two types of intervention within such environments: altering the availability (the range and/or amount of options) of these products, or their proximity (the distance at which they are positioned) to potential consumers. Objectives 1. To assess the impact on selection and consumption of altering the availability or proximity of (a) food (including non‐alcoholic beverages), (b) alcohol, and (c) tobacco products. 2. To assess the extent to which the impact of these interventions is modified by characteristics of: i. studies, ii. interventions, and iii. participants. Search methods We searched CENTRAL, MEDLINE, Embase, PsycINFO, and seven other published or grey literature databases, as well as trial registries and key websites, up to 23 July 2018, followed by citation searches. Selection criteria We included randomised controlled trials with between‐participants (parallel group) or within‐participants (cross‐over) designs. Eligible studies compared effects of exposure to at least two different levels of availability of a product or its proximity, and included a measure of selection or consumption of the manipulated product. Data collection and analysis We used a novel semi‐automated screening workflow and applied standard Cochrane methods to select eligible studies, collect data, and assess risk of bias. In separate analyses for availability interventions and proximity interventions, we combined results using random‐effects meta‐analysis and meta‐regression models to estimate summary effect sizes (as standardised mean differences (SMDs)) and to investigate associations between summary effect sizes and selected study, intervention, or participant characteristics. We rated the certainty of evidence for each outcome using GRADE. We included 24 studies, with the majority (20/24) giving concerns about risk of bias. All of the included studies investigated food products; none investigated alcohol or tobacco. The majority were conducted in laboratory settings (14/24), with adult participants (17/24), and used between‐participants designs (19/24). All studies were conducted in high‐income countries, predominantly in the USA (14/24). Six studies investigated availability interventions, of which two changed the absolute number of different options available, and four altered the relative proportion of less‐healthy (to healthier) options. Most studies (4/6) manipulated snack foods or drinks. For selection outcomes, meta‐analysis of three comparisons from three studies (n = 154) found that exposure to fewer options resulted in a large reduction in selection of the targeted food(s): SMD −1.13 (95% confidence interval (CI) −1.90 to −0.37) (low certainty evidence). For consumption outcomes, meta‐analysis of three comparisons from two studies (n = 150) found that exposure to fewer options resulted in a moderate reduction in consumption of those foods, but with considerable uncertainty: SMD −0.55 (95% CI −1.27 to 0.18) (low certainty evidence). Eighteen studies investigated proximity interventions. Most (14/18) changed the distance at which a snack food or drink was placed from the participants, whilst four studies changed the order of meal components encountered along a line. For selection outcomes, only one study with one comparison (n = 41) was identified, which found that food placed farther away resulted in a moderate reduction in its selection: SMD −0.65 (95% CI −1.29 to −0.01) (very low certainty evidence). For consumption outcomes, meta‐analysis of 15 comparisons from 12 studies (n = 1098) found that exposure to food placed farther away resulted in a moderate reduction in its consumption: SMD −0.60 (95% CI −0.84 to −0.36) (low certainty evidence). Meta‐regression analyses indicated that this effect was greater: the farther away the product was placed; when only the targeted product(s) was available; when participants were of low deprivation status; and when the study was at high risk of bias. The current evidence suggests that changing the number of available food options or altering the positioning of foods could contribute to meaningful changes in behaviour, justifying policy actions to promote such changes within food environments. However, the certainty of this evidence as assessed by GRADE is low or very low. To enable more certain and generalisable conclusions about these potentially important effects, further research is warranted in real‐world settings, intervening across a wider range of foods ‐ as well as alcohol and tobacco products ‐ and over sustained time periods. |
t161 | t161_1 | yes | Roughly half of all hip fractures are outside the hip joint capsule (extracapsular proximal femoral fractures). | Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures. Objectives To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2008), the Cochrane Central Register of Controlled Trials ( The Cochrane Library 2008, Issue 1), MEDLINE, EMBASE, CINAHL, Current Controlled Trials, orthopaedic journals, conference proceedings and reference lists of articles. Date of last search was January 2008. No language restriction was applied. Selection criteria All randomised and quasi‐randomised trials investigating operative techniques used in operations for the treatment of extracapsular hip fractures in adults. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Wherever appropriate, data were pooled. Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail‐plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. |
t161 | t161_2 | yes | Many of these will be fixed or stabilised using metal implants which are a combination of screws, rods and plates attached to the thigh bone. | Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures. Objectives To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2008), the Cochrane Central Register of Controlled Trials ( The Cochrane Library 2008, Issue 1), MEDLINE, EMBASE, CINAHL, Current Controlled Trials, orthopaedic journals, conference proceedings and reference lists of articles. Date of last search was January 2008. No language restriction was applied. Selection criteria All randomised and quasi‐randomised trials investigating operative techniques used in operations for the treatment of extracapsular hip fractures in adults. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Wherever appropriate, data were pooled. Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail‐plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. |
t161 | t161_3 | no | Various techniques such as the selective removal of bone (osteotomy), the pressing together of bone fragments (compression), the addition of bone cement, and methods for insertion of nails such as reaming, are used during surgery. | Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures. Objectives To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2008), the Cochrane Central Register of Controlled Trials ( The Cochrane Library 2008, Issue 1), MEDLINE, EMBASE, CINAHL, Current Controlled Trials, orthopaedic journals, conference proceedings and reference lists of articles. Date of last search was January 2008. No language restriction was applied. Selection criteria All randomised and quasi‐randomised trials investigating operative techniques used in operations for the treatment of extracapsular hip fractures in adults. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Wherever appropriate, data were pooled. Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail‐plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. |
t161 | t161_4 | no | This review included 11 randomised or quasi‐randomised trials. | Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures. Objectives To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2008), the Cochrane Central Register of Controlled Trials ( The Cochrane Library 2008, Issue 1), MEDLINE, EMBASE, CINAHL, Current Controlled Trials, orthopaedic journals, conference proceedings and reference lists of articles. Date of last search was January 2008. No language restriction was applied. Selection criteria All randomised and quasi‐randomised trials investigating operative techniques used in operations for the treatment of extracapsular hip fractures in adults. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Wherever appropriate, data were pooled. Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail‐plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. |
t161 | t161_5 | yes | The majority of the participants were female, usually aged around 80 years. | Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures. Objectives To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2008), the Cochrane Central Register of Controlled Trials ( The Cochrane Library 2008, Issue 1), MEDLINE, EMBASE, CINAHL, Current Controlled Trials, orthopaedic journals, conference proceedings and reference lists of articles. Date of last search was January 2008. No language restriction was applied. Selection criteria All randomised and quasi‐randomised trials investigating operative techniques used in operations for the treatment of extracapsular hip fractures in adults. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Wherever appropriate, data were pooled. Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail‐plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. |
t161 | t161_6 | yes | There were seven comparisons but the evidence for each of these was insufficient to draw conclusions. | Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures. Objectives To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2008), the Cochrane Central Register of Controlled Trials ( The Cochrane Library 2008, Issue 1), MEDLINE, EMBASE, CINAHL, Current Controlled Trials, orthopaedic journals, conference proceedings and reference lists of articles. Date of last search was January 2008. No language restriction was applied. Selection criteria All randomised and quasi‐randomised trials investigating operative techniques used in operations for the treatment of extracapsular hip fractures in adults. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Wherever appropriate, data were pooled. Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail‐plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. |
t161 | t161_7 | no | Thus, the review found that there was too little evidence from randomised trials to show which, if any, specific surgical techniques used during operations for extracapsular proximal femoral fractures are better. | Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures. Objectives To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2008), the Cochrane Central Register of Controlled Trials ( The Cochrane Library 2008, Issue 1), MEDLINE, EMBASE, CINAHL, Current Controlled Trials, orthopaedic journals, conference proceedings and reference lists of articles. Date of last search was January 2008. No language restriction was applied. Selection criteria All randomised and quasi‐randomised trials investigating operative techniques used in operations for the treatment of extracapsular hip fractures in adults. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Wherever appropriate, data were pooled. Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail‐plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. |
t162 | t162_1 | no | Endometriosis is the presence in inappropriate sites of tissue that normally lines the uterus. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_2 | no | It can cause pain and subfertility. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_3 | yes | Different treatments for endometriosis are available, one of which is laparoscopic ('key hole') surgery, performed to remove visible areas of endometriosis. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_4 | no | Cochrane review authors assessed the evidence on the use of laparoscopic surgery to treat pain and fertility problems in women with endometriosis. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_5 | yes | Laparoscopic surgical techniques include ablation, which means destruction of a lesion (for example by burning), and excision, which means cutting a lesion out. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_6 | no | We included 10 randomised controlled trials (involving 973 participants). | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_7 | yes | They were conducted in Australia, Canada, Egypt, Iran and the United Kingdom. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_8 | no | Most compared laparoscopic ablation or excision versus diagnostic laparoscopy only. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_9 | no | We found that laparoscopic surgery may be of benefit in treating overall pain and subfertility associated with mild to moderate endometriosis. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t162 | t162_10 | no | Laparoscopic excision and ablation were similarly effective in relieving pain, although this result came from a single study. | Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. Objectives To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. Search methods This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Selection criteria Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Data collection and analysis Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin‐releasing hormone analogue (GnRHa) (goserelin) with add‐back therapy. Common limitations in the primary studies included lack of clearly‐described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias. Laparoscopic surgery was associated with decreased overall pain (measured as ‘pain better or improved’) compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I 2 = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I 2 = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I 2 = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence). When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add‐back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence). The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI ‐1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. |
t163 | t163_1 | no | At present, doctors are not sure whether women with early cervical cancer who have had their womb and pelvic lymph nodes removed should be given radiotherapy. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_2 | no | If the woman has a combination of certain risk factors that put her at high risk of having a recurrence of her cancer, doctors often think that it would be a good idea to give her radiotherapy. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_3 | no | However, radiotherapy has never been shown to improve overall survival for these women and the combination of surgery and radiotherapy increases the risk of side effects and complications. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_4 | no | We searched for all the available randomised controlled trials (RCTs) that assessed whether radiotherapy (with or without chemotherapy) could improve survival in these women. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_5 | no | We found only two trials that compared the use of radiotherapy with no radiotherapy in women with early cervical cancer who had had their womb and pelvic lymph nodes removed and who were at risk of having a recurrence of their cancer. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_6 | no | These two trials enrolled 397 women. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_7 | yes | When we combined the findings from these two trials, we found that, on average, women who received radiotherapy were between 40% and 90% less likely to have a relapse of their cancer within 5 years than women who did not. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_8 | yes | However, because of the low number of deaths in the trials, we could not confirm whether radiotherapy helped to prolong life: our best estimate was that, 5 years after treatment, women who received radiotherapy were about 20% more likely to be alive than those who did not, but this estimate may not be very accurate and women's actual prospects could be anywhere between being three times more likely to be alive and being 60% more likely to be dead. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_9 | no | Although women who had radiotherapy tended to have more complications than women who did not, we could not be sure whether this was due to chance rather than the radiotherapy because few women reported complications. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t163 | t163_10 | yes | The main limitations of the review were that we did not find any trials that evaluated a combination of radiotherapy and chemotherapy and that the two trials of radiotherapy gave very little information about side effects. | This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications. Objectives To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early‐stage cervical cancer (FIGO stages IB1, IB2 or IIA). Search methods For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials. Selection criteria Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random‐effects meta‐analyses. Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta‐analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9). Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low. We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal. |
t164 | t164_1 | yes | Pneumonia is an inflammatory condition of the lungs. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_2 | yes | Treatment for pneumonia includes antibiotics, rest, fluids, management of complications and professional home care. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_3 | no | Oxygen supplementation is one way to help patients who cannot breathe adequately on their own. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_4 | no | Management of oxygen supplementation is divided into nasal cannula and mechanical ventilation. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_5 | yes | Mechanical ventilation is life‐supporting ventilation that involves the use of a machine called a ventilator, or respirator. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_6 | yes | There are two main types of mechanical ventilation: non‐invasive ventilation (NIV) and invasive ventilation. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_7 | yes | The former provides ventilatory support to a patient through a tightly fitted facial or nasal mask and the latter through a tube inserted into the windpipe through the mouth or the nose or a hole made in the windpipe through the front of the throat. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_8 | no | At present, oxygen therapy for individuals with pneumonia is commonly prescribed. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_9 | yes | However, inconsistent results on the effects of oxygen therapy on pneumonia have been reported and no systematic review has been conducted in patients with pneumonia to determine which delivery system of oxygen therapy leads to the best clinical outcomes. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_10 | yes | We searched the related literature and included three randomised controlled trials involving 151 adults with pneumonia aged around 60 years. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_11 | no | We did not include patients with pulmonary tuberculosis or cystic fibrosis. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_12 | no | We found that NIV can reduce the risk of death in the intensive care unit (ICU) and the need for endotracheal intubation, shorten ICU stay and length of intubation. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_13 | yes | Some outcomes and complications of oxygen therapy depended upon the delivery system and primary diseases. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_14 | yes | The most common complications of invasive ventilation are ventilator‐associated pneumonia. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t164 | t164_15 | no | However, we must be aware that oxygen therapy is just one of the treatments for pneumonia and the other standard treatments used by physicians are of equal importance. | Oxygen therapy is widely used in the treatment of lung diseases. However, the effectiveness of oxygen therapy as a treatment for pneumonia is not well known. Objectives To determine the effectiveness and safety of oxygen therapy in the treatment of pneumonia in adults older than 18 years. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library, www.thecochranelibrary.com (accessed 9 December 2011), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1948 to November week 3, 2011) and EMBASE (1974 to December 2011). Selection criteria Randomised controlled trials (RCTs) of oxygen therapy for adults with community‐acquired pneumonia (CAP) and nosocomial (hospital‐acquired) pneumonia (HAP or NP) in intensive care units (ICU). Data collection and analysis Two review authors independently reviewed abstracts and assessed data for methodological quality. Three RCTs met our inclusion criteria. The studies enrolled 151 participants with CAP or immunosuppressed patients with pulmonary infiltrates. Overall, we found that non‐invasive ventilation can reduce the risk of death in the ICU, odd ratio (OR) 0.28, 95% confidence interval (CI) 0.09 to 0.88; endotracheal intubation, OR 0.26, 95% CI 0.11 to 0.61; complications, OR 0.23, 95% CI 0.08 to 0.70; and shorten ICU length of stay, mean duration (MD) ‐3.28, 95% CI ‐5.41 to ‐1.61. Non‐invasive ventilation and standard oxygen supplementation via a Venturi mask were similar when measuring mortality in hospital, OR 0.54, 95% CI 0.11 to 2.68; two‐month survival, OR 1.67, 95% CI 0.53 to 5.28; duration of hospital stay, MD ‐1.00, 95% CI ‐2.05 to 0.05; and duration of mechanical ventilation, standard MD ‐0.26, 95% CI ‐0.66 to 0.14. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. We also found that some subgroups had a high level of heterogeneity when conducting pooled analyses. Non‐invasive ventilation can reduce the risk of death in the ICU, endotracheal intubation, shorten ICU stay and length of intubation. Some outcomes and complications of non‐invasive ventilation were varied according to different participant populations. Other than the oxygen therapy, we must mention the importance of standard treatment by physicians. The evidence is weak and we did not include participants with pulmonary tuberculosis and cystic fibrosis. More RCTs are required to answer these clinical questions. However, the review indicates that non‐invasive ventilation may be more beneficial than standard oxygen supplementation via a Venturi mask for pneumonia. |
t165 | t165_1 | yes | Nonsteroidal anti‐inflammatory drugs and opioids can significantly relieve the pain in acute renal colic, but opioids (especially pethidine) cause more adverse effects Acute renal colic occurs when mineral or organic solids pass though the urinary tract and obstruct the urinary flow. | Renal colic is a common cause of acute severe pain. Both opioids and nonsteroidal anti‐inflammatory drugs (NSAIDs) are recommended for treatment, but the relative efficacy of these drugs is uncertain. Objectives To examine the benefits and disadvantages of NSAIDs and opioids for the management of pain in acute renal colic. Search methods We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Randomised Controlled Trials (CENTRAL ‐ The Cochrane Library , MEDLINE, EMBASE and handsearched reference lists of retrieved articles. Selection criteria Randomised controlled trials (RCTs) comparing any opioid with any NSAID, regardless of dose or route of administration were included. Data collection and analysis Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as risk ratio (RR) and measurements on continuous scales are reported as mean differences (MD) with 95% confidence intervals. Subgroup analysis by study quality, drug type and drug route have been performed where possible to explore reasons for heterogeneity. Twenty trials from nine countries with a total of 1613 participants were identified. Both NSAIDs and opioids lead to clinically significant falls in patient‐reported pain scores. Due to unexplained heterogeneity these results could not be pooled although 10/13 studies reported lower pain scores in patients receiving NSAIDs. Patients treated with NSAIDs were significantly less likely to require rescue medication (RR 0.75, 95% CI 0.61 to 0.93, P = 0.007), though most of these trials used pethidine. The majority of trials showed a higher incidence of adverse events in patients treated with opioids, but there was significant heterogeneity between studies so the results could not be pooled. There was significantly less vomiting in patients treated with NSAIDs (RR 0.35, 95% CI 0.23 to 0.53, P < 0.00001). In particular, patients receiving pethidine had a much higher rate of vomiting compared with patients receiving NSAIDs. Gastrointestinal bleeding and renal impairment were not reported. Both NSAIDs and opioids can provide effective analgesia in acute renal colic. Opioids are associated with a higher incidence of adverse events, particularly vomiting. Given the high rate of vomiting associated with the use of opioids, particularly pethidine, and the greater likelihood of requiring further analgesia, we recommend that if an opioid is to be used it should not be pethidine. |
t165 | t165_2 | yes | It causes a sudden onset of severe pain, which radiates from the flank to the groin and requires immediate treatment with pain‐killers. | Renal colic is a common cause of acute severe pain. Both opioids and nonsteroidal anti‐inflammatory drugs (NSAIDs) are recommended for treatment, but the relative efficacy of these drugs is uncertain. Objectives To examine the benefits and disadvantages of NSAIDs and opioids for the management of pain in acute renal colic. Search methods We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Randomised Controlled Trials (CENTRAL ‐ The Cochrane Library , MEDLINE, EMBASE and handsearched reference lists of retrieved articles. Selection criteria Randomised controlled trials (RCTs) comparing any opioid with any NSAID, regardless of dose or route of administration were included. Data collection and analysis Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as risk ratio (RR) and measurements on continuous scales are reported as mean differences (MD) with 95% confidence intervals. Subgroup analysis by study quality, drug type and drug route have been performed where possible to explore reasons for heterogeneity. Twenty trials from nine countries with a total of 1613 participants were identified. Both NSAIDs and opioids lead to clinically significant falls in patient‐reported pain scores. Due to unexplained heterogeneity these results could not be pooled although 10/13 studies reported lower pain scores in patients receiving NSAIDs. Patients treated with NSAIDs were significantly less likely to require rescue medication (RR 0.75, 95% CI 0.61 to 0.93, P = 0.007), though most of these trials used pethidine. The majority of trials showed a higher incidence of adverse events in patients treated with opioids, but there was significant heterogeneity between studies so the results could not be pooled. There was significantly less vomiting in patients treated with NSAIDs (RR 0.35, 95% CI 0.23 to 0.53, P < 0.00001). In particular, patients receiving pethidine had a much higher rate of vomiting compared with patients receiving NSAIDs. Gastrointestinal bleeding and renal impairment were not reported. Both NSAIDs and opioids can provide effective analgesia in acute renal colic. Opioids are associated with a higher incidence of adverse events, particularly vomiting. Given the high rate of vomiting associated with the use of opioids, particularly pethidine, and the greater likelihood of requiring further analgesia, we recommend that if an opioid is to be used it should not be pethidine. |
t165 | t165_3 | yes | It can also cause nausea, vomiting, hypertension and blood in the urine. | Renal colic is a common cause of acute severe pain. Both opioids and nonsteroidal anti‐inflammatory drugs (NSAIDs) are recommended for treatment, but the relative efficacy of these drugs is uncertain. Objectives To examine the benefits and disadvantages of NSAIDs and opioids for the management of pain in acute renal colic. Search methods We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Randomised Controlled Trials (CENTRAL ‐ The Cochrane Library , MEDLINE, EMBASE and handsearched reference lists of retrieved articles. Selection criteria Randomised controlled trials (RCTs) comparing any opioid with any NSAID, regardless of dose or route of administration were included. Data collection and analysis Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as risk ratio (RR) and measurements on continuous scales are reported as mean differences (MD) with 95% confidence intervals. Subgroup analysis by study quality, drug type and drug route have been performed where possible to explore reasons for heterogeneity. Twenty trials from nine countries with a total of 1613 participants were identified. Both NSAIDs and opioids lead to clinically significant falls in patient‐reported pain scores. Due to unexplained heterogeneity these results could not be pooled although 10/13 studies reported lower pain scores in patients receiving NSAIDs. Patients treated with NSAIDs were significantly less likely to require rescue medication (RR 0.75, 95% CI 0.61 to 0.93, P = 0.007), though most of these trials used pethidine. The majority of trials showed a higher incidence of adverse events in patients treated with opioids, but there was significant heterogeneity between studies so the results could not be pooled. There was significantly less vomiting in patients treated with NSAIDs (RR 0.35, 95% CI 0.23 to 0.53, P < 0.00001). In particular, patients receiving pethidine had a much higher rate of vomiting compared with patients receiving NSAIDs. Gastrointestinal bleeding and renal impairment were not reported. Both NSAIDs and opioids can provide effective analgesia in acute renal colic. Opioids are associated with a higher incidence of adverse events, particularly vomiting. Given the high rate of vomiting associated with the use of opioids, particularly pethidine, and the greater likelihood of requiring further analgesia, we recommend that if an opioid is to be used it should not be pethidine. |
t165 | t165_4 | no | Opioids and non‐steroidal anti‐inflammatory drugs (NSAIDs) are commonly used to reduce the pain. | Renal colic is a common cause of acute severe pain. Both opioids and nonsteroidal anti‐inflammatory drugs (NSAIDs) are recommended for treatment, but the relative efficacy of these drugs is uncertain. Objectives To examine the benefits and disadvantages of NSAIDs and opioids for the management of pain in acute renal colic. Search methods We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Randomised Controlled Trials (CENTRAL ‐ The Cochrane Library , MEDLINE, EMBASE and handsearched reference lists of retrieved articles. Selection criteria Randomised controlled trials (RCTs) comparing any opioid with any NSAID, regardless of dose or route of administration were included. Data collection and analysis Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as risk ratio (RR) and measurements on continuous scales are reported as mean differences (MD) with 95% confidence intervals. Subgroup analysis by study quality, drug type and drug route have been performed where possible to explore reasons for heterogeneity. Twenty trials from nine countries with a total of 1613 participants were identified. Both NSAIDs and opioids lead to clinically significant falls in patient‐reported pain scores. Due to unexplained heterogeneity these results could not be pooled although 10/13 studies reported lower pain scores in patients receiving NSAIDs. Patients treated with NSAIDs were significantly less likely to require rescue medication (RR 0.75, 95% CI 0.61 to 0.93, P = 0.007), though most of these trials used pethidine. The majority of trials showed a higher incidence of adverse events in patients treated with opioids, but there was significant heterogeneity between studies so the results could not be pooled. There was significantly less vomiting in patients treated with NSAIDs (RR 0.35, 95% CI 0.23 to 0.53, P < 0.00001). In particular, patients receiving pethidine had a much higher rate of vomiting compared with patients receiving NSAIDs. Gastrointestinal bleeding and renal impairment were not reported. Both NSAIDs and opioids can provide effective analgesia in acute renal colic. Opioids are associated with a higher incidence of adverse events, particularly vomiting. Given the high rate of vomiting associated with the use of opioids, particularly pethidine, and the greater likelihood of requiring further analgesia, we recommend that if an opioid is to be used it should not be pethidine. |
t165 | t165_5 | no | The review found that both NSAIDs and opioids significantly reduce the pain. | Renal colic is a common cause of acute severe pain. Both opioids and nonsteroidal anti‐inflammatory drugs (NSAIDs) are recommended for treatment, but the relative efficacy of these drugs is uncertain. Objectives To examine the benefits and disadvantages of NSAIDs and opioids for the management of pain in acute renal colic. Search methods We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Randomised Controlled Trials (CENTRAL ‐ The Cochrane Library , MEDLINE, EMBASE and handsearched reference lists of retrieved articles. Selection criteria Randomised controlled trials (RCTs) comparing any opioid with any NSAID, regardless of dose or route of administration were included. Data collection and analysis Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as risk ratio (RR) and measurements on continuous scales are reported as mean differences (MD) with 95% confidence intervals. Subgroup analysis by study quality, drug type and drug route have been performed where possible to explore reasons for heterogeneity. Twenty trials from nine countries with a total of 1613 participants were identified. Both NSAIDs and opioids lead to clinically significant falls in patient‐reported pain scores. Due to unexplained heterogeneity these results could not be pooled although 10/13 studies reported lower pain scores in patients receiving NSAIDs. Patients treated with NSAIDs were significantly less likely to require rescue medication (RR 0.75, 95% CI 0.61 to 0.93, P = 0.007), though most of these trials used pethidine. The majority of trials showed a higher incidence of adverse events in patients treated with opioids, but there was significant heterogeneity between studies so the results could not be pooled. There was significantly less vomiting in patients treated with NSAIDs (RR 0.35, 95% CI 0.23 to 0.53, P < 0.00001). In particular, patients receiving pethidine had a much higher rate of vomiting compared with patients receiving NSAIDs. Gastrointestinal bleeding and renal impairment were not reported. Both NSAIDs and opioids can provide effective analgesia in acute renal colic. Opioids are associated with a higher incidence of adverse events, particularly vomiting. Given the high rate of vomiting associated with the use of opioids, particularly pethidine, and the greater likelihood of requiring further analgesia, we recommend that if an opioid is to be used it should not be pethidine. |
t165 | t165_6 | no | People experienced more adverse effects, such as vomiting, when using opioids (particularly pethidine) than when using NSAIDs. | Renal colic is a common cause of acute severe pain. Both opioids and nonsteroidal anti‐inflammatory drugs (NSAIDs) are recommended for treatment, but the relative efficacy of these drugs is uncertain. Objectives To examine the benefits and disadvantages of NSAIDs and opioids for the management of pain in acute renal colic. Search methods We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Randomised Controlled Trials (CENTRAL ‐ The Cochrane Library , MEDLINE, EMBASE and handsearched reference lists of retrieved articles. Selection criteria Randomised controlled trials (RCTs) comparing any opioid with any NSAID, regardless of dose or route of administration were included. Data collection and analysis Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as risk ratio (RR) and measurements on continuous scales are reported as mean differences (MD) with 95% confidence intervals. Subgroup analysis by study quality, drug type and drug route have been performed where possible to explore reasons for heterogeneity. Twenty trials from nine countries with a total of 1613 participants were identified. Both NSAIDs and opioids lead to clinically significant falls in patient‐reported pain scores. Due to unexplained heterogeneity these results could not be pooled although 10/13 studies reported lower pain scores in patients receiving NSAIDs. Patients treated with NSAIDs were significantly less likely to require rescue medication (RR 0.75, 95% CI 0.61 to 0.93, P = 0.007), though most of these trials used pethidine. The majority of trials showed a higher incidence of adverse events in patients treated with opioids, but there was significant heterogeneity between studies so the results could not be pooled. There was significantly less vomiting in patients treated with NSAIDs (RR 0.35, 95% CI 0.23 to 0.53, P < 0.00001). In particular, patients receiving pethidine had a much higher rate of vomiting compared with patients receiving NSAIDs. Gastrointestinal bleeding and renal impairment were not reported. Both NSAIDs and opioids can provide effective analgesia in acute renal colic. Opioids are associated with a higher incidence of adverse events, particularly vomiting. Given the high rate of vomiting associated with the use of opioids, particularly pethidine, and the greater likelihood of requiring further analgesia, we recommend that if an opioid is to be used it should not be pethidine. |
t166 | t166_1 | no | Acute postoperative pain is one of the most disturbing complaints after open heart surgery. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t166 | t166_2 | yes | It is related to impaired wound healing, chronic pain, or depression. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t166 | t166_3 | yes | Psychological treatment is designed to improve participant’ knowledge and to alter surgery‐related mental distress, negative beliefs and noncompliance. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t166 | t166_4 | no | It aims to reduce pain and anxiety, and to improve the postoperative recovery after open heart surgery. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t166 | t166_5 | no | This is an update of a review previously published in 2014 investigating whether psychological treatment could successfully reduce acute postoperative pain and improve the course of physical and psychological recovery of people undergoing open heart surgery. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t166 | t166_6 | no | We found 23 studies, including a total of 2669 participants, which reported effects of psychological treatment compared to a control group without psychological treatment on pain intensity, use of pain medication, mental distress, mobility, or time to extubation after surgery. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t166 | t166_7 | no | We do not know if psychological treatment reduces pain intensity, enhances mobility, or decreases intubation time after open heart surgery. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t166 | t166_8 | no | This is because there were not enough data to answer some parts of our review question, because there were problems with the design of some studies, or because results were conflicting. | This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. Objectives To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Selection criteria Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Data collection and analysis Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges’ g) and meta‐analysed data using a random‐effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. We added six studies to this update. Overall, we included 23 studies (2669 participants). For the majority of outcomes (two‐thirds), we could not perform a meta‐analysis since outcomes were not measured, or data were provided by one trial only. No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low‐quality evidence). Psychological interventions did not reduce pain intensity in the short‐term interval (g 0.39, 95% CI ‐0.18 to 0.96, 2 studies, 104 participants, low‐quality evidence), medium‐term interval (g ‐0.02, 95% CI ‐0.24 to 0.20, 4 studies, 413 participants, moderate‐quality evidence) or in the long‐term interval (g 0.05, 95% CI ‐0.20 to 0.30, 2 studies, 200 participants, moderate‐quality evidence). No study reported data on median time to re‐medication or on number of participants re‐medicated. Only two studies provided data on postoperative analgesic use in the short‐term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI ‐2.03 to 4.39, 2 studies, 104 participants, low‐quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium‐term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate‐quality evidence) and likewise in the long‐term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate‐quality evidence). Psychological interventions did not improve mobility in the medium‐term interval (g 0.23, 95% CI ‐0.22 to 0.67, 3 studies, 444 participants, low‐quality evidence), nor in the long‐term interval (g 0.09, 95% CI ‐0.10 to 0.28, 4 studies, 458 participants, moderate‐quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low‐quality evidence). Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions. Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate‐quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions. |
t167 | t167_1 | no | We reviewed the evidence about the effects of eculizumab for treating patients with paroxsymal nocturnal hemoglobinuria. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_2 | no | Paroxysmal nocturnal hemoglobinuria is a disorder of the hematopoietic stem cells (a cell that can self renew and differentiate into one or more cell types). | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_3 | no | It is characterized by episodes of intravascular hemolysis (destruction of red blood cells), and chronic hemolytic anemia. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_4 | yes | The intravascular destruction of red blood cells involves clinical findings in gastrointestinal, cardiovascular, pulmonary, cerebral, and urogenital systems, as well as clotting disorders. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_5 | no | The treatment of paroxysmal nocturnal hemoglobinuria has been largely empirical and symptomatic, with packed red blood cell transfusions, anticoagulation, and supplementation with folic acid or iron. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_6 | yes | Many different pharmacological interventions that are used for treating this medical disorder are not standardized. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_7 | no | Eculizumab is a newly available biological agent for preventing hemolytic anemia and severe clotting episodes. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_8 | no | We identified one study that included a limited number of patients comparing eculizumab with placebo. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_9 | yes | The study was published in 2006, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_10 | no | No patients died during the performance of this single study. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_11 | no | The study showed a moderate improvement in the quality of life in patients treated with eculizumab. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_12 | no | In addition, eculizumab reduced fatigue and the number of patients that withdrew from the study for any reason. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_13 | no | Eculizumab showed a higher proportion of patients with transfusion independence. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_14 | no | There was no difference between eculizumab and placebo in terms of adverse events, probably due to the low rate of events observed during the study. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t167 | t167_15 | no | The trial did not assess other relevant outcomes such as overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. | Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, not malignant, disease of the hematopoietic stem cells, associated with significant morbidity and mortality. It is a rare disease with an estimated incidence of 1.3 new cases per one million individuals per year. The treatment of PNH has been largely empirical and symptomatic, with blood transfusions, anticoagulation, and supplementation with folic acid or iron. Eculizumab, a biological agent that inhibits complement cascade, was developed for preventing hemolytic anemia and severe thrombotic episodes. Objectives To assess the clinical benefits and harms of eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria (PNH). Search methods We conducted a comprehensive search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2014, Issue 5), Ovid MEDLINE (from 1946 to 15 May 2014), EMBASE (from 1980 to 25 June 2014), and LILACS (from 1982 to 25 June 2014). We did not apply any language restrictions. Selection criteria We included randomized controlled trials (RCTs) irrespective of their publication status or language. No limits were applied with respect to period of follow‐up. We excluded quasi‐RCTs. We included trials comparing eculizumab with placebo or best available therapy. We included any patient with a confirmed diagnosis of PNH. Primary outcome was overall survival. Data collection and analysis We independently performed a duplicate selection of eligible trials, risk of bias assessment, and data extraction. We estimated risk ratios (RRs) and 95% confidence interval (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used a random‐effects model for analysis. We identified one multicenter (34 sites) phase III RCT involving 87 participants. The trial compared eculizumab versus placebo, and was conducted in the US, Canada, Europe, and Australia with 26 weeks of follow‐up. This small trial had high risk of bias in many domains (attrition and selective reporting). It was sponsored by a pharmaceutical company. No patients died during the study. By using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (scores can range from 0 to 100, with higher scores on the global health status and functioning scales indicating improvement), the trial showed improvement in health‐related quality of life in patients treated with eculizumab (mean difference (MD) 19.4, 95% CI 8.25 to 30.55; P = 0.0007; low quality of evidence). By using the Functional Assessment of Chronic Illness Therapy Fatigue instrument (scores can range from 0 to 52, with higher scores indicating improvement in fatigue), the trial showed a reduction in fatigue (MD 10.4, 95% CI 9.97 to 10.83; P = 0.00001; moderate quality of evidence) in the eculizumab group compared with placebo. Eculizumab compared with placebo showed a greater proportion of patients with transfusion independence: 51% (22/43) versus 0% (0/44); risk ratio (RR) 46.02, 95% CI 2.88 to 735.53; P = 0.007; moderate quality of evidence; and withdrawal for any reason: 4.7% (2/43) versus 22.72% (10/44); RR 0.20, 95% CI 0.05 to 0.88; P = 0.03; moderate quality of evidence. Due to the low rate of events observed, the included trial did not show any difference between eculizumab and placebo in terms of serious adverse events: 9.3% (4/43) versus 20.4% (9/44); RR 0.15, 95% CI 0.15 to 1.37; P = 0.16; low quality of evidence. We did not observe any difference between intervention and placebo for the most frequent adverse events. One participant receiving placebo showed an episode of thrombosis. The trial did not assess overall survival, transformation to myelodysplastic syndrome and acute myelogenous leukemia, or development or recurrence of aplastic anemia on treatment. This review has detected an absence of evidence for eculizumab compared with placebo for treating paroxysmal nocturnal hemoglobinuria (PNH), in terms of overall survival, nonfatal thrombotic events, transformation to myelodysplastic syndrome and acute myelogenous leukemia, and development and recurrence of aplastic anemia on treatment. Current evidence indicates that compared with placebo, eculizumab increases health‐related quality of life and increases transfusion independence. During the execution of the included trial, no patients died. Furthermore, the intervention seems to reduce fatigue and withdrawals for any reason. The safety profile of eculizumab is unclear. These conclusions are based on one small trial with risk of attrition and selective reporting bias. Therefore, prescription of eculizumab for treating patients with PNH can neither be supported nor rejected, unless new evidence from a large high quality trial alters this conclusion. Therefore, we urge the reader to interpret the trial results with much caution. Future trials on this issue should be conducted according to the SPIRIT statement and reported according to the CONSORT statement by independent investigators, and using the Foundation of Patient‐Centered Outcomes Research recommendations. |
t168 | t168_1 | no | Colony stimulating factors (CSFs) are naturally occurring hormones that control the production of circulating blood cells by the bone marrow. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t168 | t168_2 | no | Some CSFs also release stem cells from the bone marrow into the blood stream; these could help the brain repair itself after stroke. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t168 | t168_3 | no | In experiments of stroke, CSFs show the potential to improve disability caused by a stroke. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t168 | t168_4 | no | In this analysis, we assessed the effect of CSFs on outcome after stroke using data from clinical trials of people with recent stroke. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t168 | t168_5 | no | We included a total of 11 studies and 1275 participants. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t168 | t168_6 | yes | A higher death rate was observed in participants treated with erythropoietin (EPO) in three trials (782 participants); whether further trials of EPO will be performed early after stroke remains unclear. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t168 | t168_7 | no | In eight small trials involving 548 participants, patterns of improvement after a stroke were observed using granulocyte colony stimulating factor (G‐CSF) and further trials are ongoing. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t168 | t168_8 | no | Currently, there is insufficient evidence to support the use of CSFs in the treatment of people with recent stroke. | Colony stimulating factors (CSFs), also called haematopoietic growth factors, regulate bone marrow production of circulating red and white cells, and platelets. Some CSFs also mobilise the release of bone marrow stem cells into the circulation. CSFs have been shown to be neuroprotective in experimental stroke. Objectives To assess (1) the safety and efficacy of CSFs in people with acute or subacute ischaemic or haemorrhagic stroke, and (2) the effect of CSFs on circulating stem and blood cell counts. Search methods We searched the Cochrane Stroke Group Trials Register (last searched September 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library 2012, Issue 4), MEDLINE (1985 to September 2012), EMBASE (1985 to September 2012) and Science Citation Index (1985 to September 2012). In an attempt to identify further published, unpublished and ongoing trials we contacted manufacturers and principal investigators of trials (last contacted April 2012). We also searched reference lists of relevant articles and reviews. Selection criteria We included randomised controlled trials recruiting people with acute or subacute ischaemic or haemorrhagic stroke. CSFs included stem cell factor (SCF), erythropoietin (EPO), granulocyte colony stimulating factor (G‐CSF), granulocyte‐macrophage colony stimulating factor (GM‐CSF), macrophage‐colony stimulating factor (M‐CSF, CSF‐1), thrombopoietin (TPO), or analogues of these. The primary outcome was functional outcome at the end of the trial. Secondary outcomes included safety at the end of treatment, death at the end of follow‐up, infarct volume and haematology measures. Data collection and analysis Two review authors (TE and NS) independently extracted data and assessed trial quality. We contacted study authors for additional information. We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non‐significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G‐CSF. G‐CSF was associated with a non‐significant reduction in early impairment (mean difference (MD) ‐0.4, 95% CI ‐1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G‐CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G‐CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome. |
t169 | t169_1 | yes | Traditional Chinese Medicine has been practised for over 2000 years in China and the Far East, especially in Korea and Japan, it is a relatively new form of treament for physical and psychological conditions in the West. | Acupuncture, with many categories such as traditional acupuncture, electroacupuncture, laser acupuncture, and acupoint injection, has been shown to be relatively safe with few adverse effects. It is accessible and inexpensive, at least in China, and is likely to be widely used there for psychotic symptoms. Objectives To review the effects of acupuncture, alone or in combination treatments compared with placebo (or no treatment) or any other treatments for people with schizophrenia or related psychoses. Search methods We searched Cochrane Schizophrenia Group’s Trials Register (February 2012), which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO and clinical trials registries. We also inspected references of identified studies and contacted relevant authors for additional information. Selection criteria We included all relevant randomised controlled trials involving people with schizophrenia‐like illnesses, comparing acupuncture added to standard dose antipsychotics with standard dose antipsychotics alone, acupuncture added to low dose antipsychotics with standard dose antipsychotics, acupuncture with antipsychotics, acupuncture added to Traditional Chinese Medicine (TCM) drug with TCM drug, acupuncture with TCM drug, electric acupuncture convulsive therapy with electroconvulsive therapy. Data collection and analysis We reliably extracted data from all included studies, discussed any disagreement, documented decisions and contacted authors of studies when necessary. We analysed binary outcomes using a standard estimation of risk ratio (RR) and its 95% confidence interval (CI). For continuous data, we calculated mean differences with 95% CI. For homogeneous data we used fixed‐effect model. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. After an update search in 2012 the review now includes 30 studies testing different forms of acupuncture across six different comparisons. All studies were at moderate risk of bias. When acupuncture plus standard antipsychotic treatment was compared with standard antipsychotic treatment alone, people were at less risk of being 'not improved' (n = 244, 3 RCTs, medium‐term RR 0.40 CI 0.28 to 0.57, very low quality evidence ). Mental state findings were mostly consistent with this finding as was time in hospital (n = 120, 1 RCT, days MD ‐16.00 CI ‐19.54 to ‐12.46, moderate quality evidence ). If anything, adverse effects were less for the acupuncture group (e.g. central nervous system, insomnia, short‐term, n = 202, 3 RCTs, RR 0.30 CI 0.11 to 0.83, low quality evidence ). When acupuncture was added to low dose antipsychotics and this was compared with standard dose antipsychotic drugs, relapse was less in the experimental group (n = 170, 1 RCT, long‐term RR 0.57 CI 0.37 to 0.89, very low quality evidence ) but there was no difference for the outcome of 'not improved'. Again, mental state findings were mostly consistent with the latter. Incidences of extrapyramidal symptoms ‐ akathisia, were less for those in the acupuncture added to low dose antipsychotics group (n = 180, 1 RCT, short‐term RR 0.03 CI 0.00 to 0.49, low quality evidence ) ‐ as dry mouth, blurred vision and tachycardia. When acupuncture was compared with antipsychotic drugs of known efficacy in standard doses, there were equivocal data for outcomes such as 'not improved' using different global state criteria. Traditional acupuncture added to TCM drug had benefit over use of TCM drug alone (n = 360, 2 RCTs, RR no clinically important change 0.11 CI 0.02 to 0.59, low quality evidence ), but when traditional acupuncture was compared with TCM drug directly there was no significant difference in the short‐term. However, we found that participants given electroacupuncture were significantly less likely to experience a worsening in global state (n = 88, 1 RCT, short‐term RR 0.52 CI 0.34 to 0.80, low quality evidence ). In the one study that compared electric acupuncture convulsive therapy with electroconvulsive therapy there were significantly different rates of spinal fracture between the groups (n = 68, 1 RCT, short‐term RR 0.33 CI 0.14 to 0.81, low quality evidence ). Attrition in all studies was minimal. No studies reported death, engagement with services, satisfaction with treatment, quality of life, or economic outcomes. Limited evidence suggests that acupuncture may have some antipsychotic effects as measured on global and mental state with few adverse effects. Better designed large studies are needed to fully and fairly test the effects of acupuncture for people with schizophrenia. |
t169 | t169_2 | yes | Acupuncture inserts needles into the skin to stimulate specific points of the body (acupoints). | Acupuncture, with many categories such as traditional acupuncture, electroacupuncture, laser acupuncture, and acupoint injection, has been shown to be relatively safe with few adverse effects. It is accessible and inexpensive, at least in China, and is likely to be widely used there for psychotic symptoms. Objectives To review the effects of acupuncture, alone or in combination treatments compared with placebo (or no treatment) or any other treatments for people with schizophrenia or related psychoses. Search methods We searched Cochrane Schizophrenia Group’s Trials Register (February 2012), which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO and clinical trials registries. We also inspected references of identified studies and contacted relevant authors for additional information. Selection criteria We included all relevant randomised controlled trials involving people with schizophrenia‐like illnesses, comparing acupuncture added to standard dose antipsychotics with standard dose antipsychotics alone, acupuncture added to low dose antipsychotics with standard dose antipsychotics, acupuncture with antipsychotics, acupuncture added to Traditional Chinese Medicine (TCM) drug with TCM drug, acupuncture with TCM drug, electric acupuncture convulsive therapy with electroconvulsive therapy. Data collection and analysis We reliably extracted data from all included studies, discussed any disagreement, documented decisions and contacted authors of studies when necessary. We analysed binary outcomes using a standard estimation of risk ratio (RR) and its 95% confidence interval (CI). For continuous data, we calculated mean differences with 95% CI. For homogeneous data we used fixed‐effect model. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. After an update search in 2012 the review now includes 30 studies testing different forms of acupuncture across six different comparisons. All studies were at moderate risk of bias. When acupuncture plus standard antipsychotic treatment was compared with standard antipsychotic treatment alone, people were at less risk of being 'not improved' (n = 244, 3 RCTs, medium‐term RR 0.40 CI 0.28 to 0.57, very low quality evidence ). Mental state findings were mostly consistent with this finding as was time in hospital (n = 120, 1 RCT, days MD ‐16.00 CI ‐19.54 to ‐12.46, moderate quality evidence ). If anything, adverse effects were less for the acupuncture group (e.g. central nervous system, insomnia, short‐term, n = 202, 3 RCTs, RR 0.30 CI 0.11 to 0.83, low quality evidence ). When acupuncture was added to low dose antipsychotics and this was compared with standard dose antipsychotic drugs, relapse was less in the experimental group (n = 170, 1 RCT, long‐term RR 0.57 CI 0.37 to 0.89, very low quality evidence ) but there was no difference for the outcome of 'not improved'. Again, mental state findings were mostly consistent with the latter. Incidences of extrapyramidal symptoms ‐ akathisia, were less for those in the acupuncture added to low dose antipsychotics group (n = 180, 1 RCT, short‐term RR 0.03 CI 0.00 to 0.49, low quality evidence ) ‐ as dry mouth, blurred vision and tachycardia. When acupuncture was compared with antipsychotic drugs of known efficacy in standard doses, there were equivocal data for outcomes such as 'not improved' using different global state criteria. Traditional acupuncture added to TCM drug had benefit over use of TCM drug alone (n = 360, 2 RCTs, RR no clinically important change 0.11 CI 0.02 to 0.59, low quality evidence ), but when traditional acupuncture was compared with TCM drug directly there was no significant difference in the short‐term. However, we found that participants given electroacupuncture were significantly less likely to experience a worsening in global state (n = 88, 1 RCT, short‐term RR 0.52 CI 0.34 to 0.80, low quality evidence ). In the one study that compared electric acupuncture convulsive therapy with electroconvulsive therapy there were significantly different rates of spinal fracture between the groups (n = 68, 1 RCT, short‐term RR 0.33 CI 0.14 to 0.81, low quality evidence ). Attrition in all studies was minimal. No studies reported death, engagement with services, satisfaction with treatment, quality of life, or economic outcomes. Limited evidence suggests that acupuncture may have some antipsychotic effects as measured on global and mental state with few adverse effects. Better designed large studies are needed to fully and fairly test the effects of acupuncture for people with schizophrenia. |
Subsets and Splits