Effectiveness of workplace interventions in rehabilitating musculoskeletal disorders and preventing its consequences among workers with physical and sedentary employment: systematic review protocol Physical rehabilitation interventions for adult patients with critical illness across the continuum of recovery: an overview of systematic reviews protocol A checklist designed to aid consistency and reproducibility of GRADE assessments: development and pilot validation Identifying the content of home-based health behaviour change interventions for frail older people: a systematic review protocol The impact of cash transfers on social determinants of health and health inequalities in Sub-Saharan Africa: a systematic review protocol Evaluation of the Quality of Prognosis Studies in Systematic Reviews A conversation with Joseph Lau. Epidemiologic analysis of breast cancer incidence, prevalence, and mortality in India Neuromuscular Electrical Stimulation for Intensive Care Unit–Acquired Weakness: Protocol and Methodological Implications for a Randomized, Sham-Controlled, Phase II Trial An international registry of systematic-review protocols Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany Effectiveness of Neuromuscular Electrical Stimulation on Lower Limbs of Patients With Hemiplegia After Chronic Stroke: A Systematic Review. Guidelines for Perioperative Care in Elective Rectal/Pelvic Surgery: Enhanced Recovery After Surgery (ERAS®) Society Recommendations Guidelines for Perioperative Care in Elective Colonic Surgery: Enhanced Recovery After Surgery (ERAS®) Society Recommendations Methods for Development of the European Commission Initiative on Breast Cancer Guidelines World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Probiotics Uses and misuses of the STROBE statement: bibliographic study
Background Musculoskeletal disorders ( MSDs ) are the leading cause of work disability and sickness absence worldwide . The prevalence of MSDs increases with age , consequently challenging sustainable employability among the growing ageing workforce . Knowledge of feasible and efficient workplace-based interventions to rehabilitate MSD or prevent its consequences is therefore warranted . This systematic review will evaluate the effectiveness of workplace-based interventions on MSDs and its consequences among adult workers with physical and sedentary work tasks , respectively . Methods We will search the following bibliographic data bases : PubMed ( including the data base ‘ MEDLINE ’ ) and Web of Science Core Collection ( including the data bases ‘ Science Citation Index Exp and ed ’ , ‘ Social Sciences Citation Index ’ and ‘ Arts & Humanities Citation Index ’ ) . Manual search es will also be performed . We will include r and omised controlled trials ( RCTs ) and non- RCTs reported in English in which ( 1 ) participants are adult workers with MSD , ( 2 ) interventions are aim ing at rehabilitating pain symptoms of MSD or preventing the consequences of MSD and ( 3 ) interventions are initiated and /or carried out at the workplace . The review will adhere to the ‘ Preferred Reporting Items for Systematic review s and Meta-Analyses ’ ( PRISMA ) guidelines for reporting systematic review s and the Institute for Work and Health ( IWH ) guidelines for workplace-based interventions . For the primary evaluation of the review , the quality assessment and evidence synthesis will conform to the IWH guidelines . Secondary evaluation will include a meta- analysis ( unless the included studies do not allow this due to heterogeneity ) and employ the risk of bias domains recommended by Cochrane along with the Grading of Recommendations , Assessment , Development and Evaluations ( GRADE ) approach on the studies with pain intensity as an outcome . Discussion This systematic review will provide knowledge on effective workplace-based interventions among physical and sedentary workers with MSD . RCTs are considered the most powerful experimental design in clinical trials , but solely including these may be too restrictive to underst and effective workplace-based interventions where r and omised and carefully controlled trials ( RCTs ) are not always possible . In order to maximize practical relevance , the selection process will , therefore , include both RCTs and non- RCTs and the quality assessment and evidence synthesis will conform to IWH guidelines focusing on developing practical guidelines for stakeholders . The result of this work will form the basis for industry-specific evidence -based recommendations on effective workplace-based interventions for rehabilitation of MSDs and its consequences that will later be operationalised into concrete and user-friendly practical tools for workplaces . Systematic review registration International Prospect i ve Register of Systematic Review s ( PROSPERO ) number CRD42018116752 Background Patients admitted to the intensive care unit with critical illness often experience significant physical impairments , which typically persist for many years following resolution of the original illness . Physical rehabilitation interventions that enhance restoration of physical function have been evaluated across the continuum of recovery following critical illness including within the intensive care unit , following discharge to the ward and beyond hospital discharge . Multiple systematic review s have been published appraising the exp and ing evidence investigating these physical rehabilitation interventions , although there appears to be variability in review methodology and quality . We aim to conduct an overview of existing systematic review s of physical rehabilitation interventions for adult intensive care patients across the continuum of recovery . Methods / design This protocol has been developed according to the Preferred Reporting Items for Systematic Review s and Meta-Analyses Protocol ( PRISMA -P ) guidelines . We will search the Cochrane Systematic Review Data base , Data base of Abstract s of Review s of Effectiveness , Cochrane Central Register of Controlled Trials , MEDLINE , Excerpta Medica Data base and Cumulative Index to Nursing and Allied Health Literature data bases . We will include systematic review s of r and omised controlled trials of adult patients , admitted to the intensive care unit and who have received physical rehabilitation interventions at any time point during their recovery . Data extraction will include systematic review aims and rationale , study types , population s , interventions , comparators , outcomes and quality appraisal method . Primary outcomes of interest will focus on findings reflecting recovery of physical function . Quality of reporting and method ological quality will be appraised using the PRISMA checklist and the Assessment of Multiple Systematic Review s tool . Discussion We anticipate the findings from this novel overview of systematic review s will contribute to the synthesis and interpretation of existing evidence regarding physical rehabilitation interventions and physical recovery in post-critical illness patients across the continuum of recovery . Systematic review registration PROSPERO CRD42015001068 Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently Background Meeting the needs of the growing number of older people is a challenge for health and social care services . Home-based interventions aim ing to modify health-related behaviours of frail older people have the potential to improve functioning and well-being . Previous review s have focused on whether such interventions are effective , rather than what might make them effective . Recent advances in behavioural science make possible the identification of potential ‘ active ingredients ’ of effective interventions , such as component behaviour change techniques ( BCTs ) , and intended intervention functions ( IFs ; e.g. to educate , to impart skills ) . This paper reports a protocol for a systematic review that seeks to ( a ) identify health behaviour change interventions for older frail people , ( b ) describe the content of these interventions , and ( c ) explore links between intervention content and effectiveness . The protocol is reported in accordance with Preferred Reporting Items for Systematic Review s and Meta-Analyses Protocol s ( PRISMA -P ) 2015 guidelines . Methods / design Studies will be identified through a systematic search of 15 electronic data bases , supplemented by citation tracking . Studies will be retained for review where they report r and omised controlled trials focusing on home-based health promotion delivered by a health professional for frail older people in community setting s , written in English , and either published from 1980 onwards , or , for registered trials only , unpublished but completed with results obtainable from authors . Interventions will be coded for their content ( BCTs , IFs ) and for evidence of effectiveness ( outcome data relating to behavioural and health outcomes ) . Analyses will describe characteristics of all interventions . Interventions for which effectiveness data are available will be categorised into those showing evidence of effectiveness versus those showing no such evidence . The potential for each intervention characteristic to contribute to change in behaviour or health outcomes will be estimated by calculating the percentage of all interventions featuring those characteristics that have shown effectiveness . Discussion Results will reveal the strategies that have been drawn on within home-based interventions to modify the health behaviours of frail older people , and highlight those more associated with positive changes in behaviour and health . Findings from this review will provide a useful basis for underst and ing , developing , and implementing behaviour change interventions in this field . Systematic review registration PROSPERO Background There is increasing pressure to address the social determinants of health ( SDoH ) and health inequities through the implementation of culturally acceptable interventions particularly in Sub-Saharan Africa ( SSA ) where health outcomes are generally poor . Available evaluation research on cash transfers ( CTs ) suggests that the programs may influence the wider determinants of health in SSA ; yet , there has been no attempt to synthesize the evidence regarding their contribution to tackling the SDoH and health inequalities . To date , nearly all the review s on CTs ' impact on health have predominantly featured evidence from Latin America with limited transferability to the social , cultural , and political environments in SSA . Therefore , the aim of this study is to undertake a systematic review to assess the role of CTs in tackling the wider determinants of health and health inequalities in SSA . Methods / design A systematic review of published and unpublished literature on CTs ’ impact on health and health determinants covering the period 2000–2016 will be undertaken . Studies will be considered for inclusion if they present quantitative or qualitative data , including all relevant study design s. The SDoH conceptual framework will be used to guide the data extraction process . EPPI Review er software will be used for data management and analysis . Studies included in the review will be analyzed by narrative synthesis and /or meta- analysis as appropriate for the nature of the data retrieved . Discussion This review will provide empirical evidence on the impact of CTs on SDoH to inform CT policy , implementation , and research in SSA . The protocol follows the Preferred Reporting Items for Systematic Review and Meta- Analysis Protocol s ( PRISMA -P ) . Systematic review registration This protocol has been registered with the PROSPERO international prospect i ve register of systematic review s , reference CRD42015025015 Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Dr. Joseph Lau is a world-leading expert in meta- analysis and systematic review s. Currently a professor in the Department of Health Services , Policy and Practice and co-director of the Center for Evidence -based Medicine at Brown University , Professor Lau has applied evidence -based methods to a variety of clinical , biomedical and healthcare topics ; has developed reliable and efficient methods and tools to conduct systematic review s and meta-analyses ; and has advanced an underst and ing on the impact of factors that may contribute to differences of results in scientific studies . His past research includes cumulative meta- analysis of r and omized controlled trials , comparison of results from large trials and meta-analyses of small trials , effect of baseline risk in the interpretation of clinical trial results , and empirical evaluation of existing methods of combining data . His current focus is on a Web-based repository of systematic review data , review s of diagnostic tests , nutrition , clinical practice guidelines , and dissemination of evidence -based methods to varied health-care disciplines . This report is a conversation from an adapted version of an interview , more or less chronologically arranged , between Joseph C. Cappelleri as interviewer and Joseph Lau as interviewee , with Meghan Ingerick recording and transcribing the interview Background : Breast Cancer ( BC ) is the leading cause of deaths in Indian women . Emerging reports reveal alarming evidence of increasing incidence and mortality of BC among young Indian women in addition to the late presentation and poor prognosis . Despite the significant incidence , there is a lack of reliable data re sources and comprehensive epidemiologic studies relating to BC . The objective of this protocol is to conduct a full-scale systematic review and meta-analyses on the incidence , prevalence , and mortality of BC in 29 states and seven union territories of India . Methods : Data sources used will be Cochrane Review , MEDLINE , PubMed , Scopus , Science Direct , Web of Science , and international and national cancer registries such as World Health Organization , International Agency for Research on Cancer ( IARC ) , and National Centre for Disease Information and Research (NCDIR)-National Cancer Registry Program initiated by Indian Council of Medical Research . Relevant data will be extracted using a predefined data collection form . A defined search strategy will be implemented along with selection criteria to obtain full-text articles of relevant studies . This study protocol was prepared according to the Preferred Reporting Items for Systematic Review s and Meta- Analysis for Protocol s 2015 guidelines . Odds ratios ( ORs ) will be used to measure effect size . The r and om or fixed-effects meta-analyses model will be employed to aggregate the pooled estimates ( ORs ) with 95 % confidence intervals ( CIs ) separately . A forest plot will be produced to assess ORs and 95 % CIs . Publication bias will be assessed using funnel plot , and Egger regression will be applied to test the symmetry of the funnel plot . Ethics and dissemination : This proposed study will be based on published studies and the data from cancer registries . Therefore , human research ethics approval is not required . The results of this study will be published in a peer- review ed journal . PROSPERO registration no : CRD42018084003 Background As the population ages and critical care advances , a growing number of survivors of critical illness will be at risk for intensive care unit (ICU)–acquired weakness . Bed rest , which is common in the ICU , causes adverse effects , including muscle weakness . Consequently , patients need ICU-based interventions focused on the muscular system . Although emerging evidence supports the benefits of early rehabilitation during mechanical ventilation , additional therapies may be beneficial . Neuromuscular electrical stimulation ( NMES ) , which can provide some muscular activity even very early during critical illness , is a promising modality for patients in the ICU . Objective The objectives of this article are to discuss the implication s of bed rest for patients with critical illness , summarize recent studies of early rehabilitation and NMES in the ICU , and describe a protocol for a r and omized , phase II pilot study of NMES in patients receiving mechanical ventilation . Design The study was a r and omized , sham-controlled , concealed , phase II pilot study with caregivers and outcome assessors blinded to the treatment allocation . Setting The study setting will be a medical ICU . Participants The study participants will be patients who are receiving mechanical ventilation for 1 day or more , who are expected to stay in the ICU for an additional 2 days or more , and who meet no exclusion criteria . Intervention The intervention will be NMES ( versus a sham [ control ] intervention ) applied to the quadriceps , tibialis anterior , and gastrocnemius muscles for 60 minutes per day . Measurements Lower-extremity muscle strength at hospital discharge will be the primary outcome measure . Limitations Muscle strength is a surrogate measure , not a patient-centered outcome . The assessment s will not include laboratory , genetic , or histological measures aim ed at a mechanistic underst and ing of NMES . The optimal duration or dose of NMES is unclear . Conclusions If NMES is beneficial , the results of the study will help advance research aim ed at reducing the burden of muscular weakness and physical disability in survivors of critical illness Support for prospect i ve registration of protocol s for systematic review s has been gathering momentum . The PRISMA statement , a guideline for reporting systematic review s and meta-analyses of studies that evaluate health-care interventions , advocates registration . Well-conducted systematic review s are accepted as the best- quality evidence to inform policy and practice , and the dramatic upward trend in the number of systematic review s published annually ( fi gure ) is set to continue . However , there is currently no single facility for identifying this type of research in advance of the appearance of the results of the review . There is concern about and evidence of publication and selective outcome -reporting biases associated with systematic review s. An open registry of review s captured at the protocol stage would facilitate good practice in systematic review s by providing transparency of the review process and outcomes . Discrepancies between the methods of the published review and those planned in the registered protocol could be more readily identifi ed . Registration might also encourage full publication of the review ’s fi ndings and transparency in changes to methods that could bias fi ndings . In both the prevention and revelation of potential bias , registration should improve quality and increase confi dence that policy or practice informed by the fi ndings of systematic review s are indeed drawing on best- quality evidence . A registry of protocol s of systematic review s could assist those planning new review s and updating existing ones . Easy access to information about ongoing review s should help to optimise the use of fi nite re sources by enabling funding and commissioning agencies to avoid unnecessary duplication and encourage collaboration . A comprehensive registry could also create opportunities for method ological and other research , both within and across disciplines . Existing access to systematic - review protocol s is limited to the outputs of individual organisations , such as the Cochrane and Campbell Collaborations and the Joanna Briggs Institute . The National Public Health Service for Wales is piloting an All Wales Systematic Review s Register , but , up to now , there has been no central ised comprehensive registry of systematic - review protocol s. We are developing an international facility to register the details of ongoing systematic review s in health and social care . Our registry is being established with the existing platform and infrastructure that supports the Data base of Abstract s of Review s of Eff ects ( DARE ) , the NHS Economic Evaluations Data base ( NHS EED ) and the Health Technology Assessment ( HTA ) data base produced by the Centre for Review s and Dissemination . The initial scope of the registry will be limited to systematic review s of the eff ectiveness of health interventions . However , the longterm aim is for the registry to include details of all ongoing systematic review s with a health-related outcome in the broadest sense . Ultimately , inclusion will encompass systematic review s of health-care interventions , and review s of the social determinants of health , of service delivery , and of risk factors and genetic associations . Our web-based registry will off er free public access , be electronically search able , and open to all prospect i ve registrants . Registration will require the provision of a minimum data set , the completeness of which will be checked automatically before registration . After acceptance , the registry ’s entry and protocol for the review , if available , will be loaded on the data base as a permanent entry and a unique identifi cation number issued . An audit trail for any amendments to the information will be available within the record . Links to result ing publications will be added . These provisions ensure that the registry will match the relevant criteria required of clinical trials registries Health care policy background Findings from scientific studies form the basis for evidence -based health policy decisions . Scientific background Quality assessment s to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic review s. Quality assessment tools ( QAT ) for assessing the study quality examine to what extent study results are systematic ally distorted by confounding or bias ( internal validity ) . The tools can be divided into checklists , scales and component ratings . Research questions What QAT are available to assess the quality of interventional studies or studies in the field of health economics , how do they differ from each other and what conclusions can be drawn from these results for quality assessment s ? Methods A systematic search of relevant data bases from 1988 onwards is done , supplemented by screening of the references , of the HTA reports of the German Agency for Health Technology Assessment ( DAHTA ) and an internet search . The selection of relevant literature , the data extraction and the quality assessment are carried out by two independent review ers . The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to r and omized trials , observational studies , diagnostic studies , systematic review s and health economic studies . Based on the number of covered items and domains , more and less comprehensive QAT are distinguished . In order to exchange experiences regarding problems in the practical application of tools , a workshop is hosted . Results A total of eight systematic method ological review s is identified as well as 147 QAT : 15 for systematic review s , 80 for r and omized trials , 30 for observational studies , 17 for diagnostic studies and 22 for health economic studies . The tools vary considerably with regard to the content , the performance and quality of operationalisation . Some tools do not only include the items of internal validity but also the items of quality of reporting and external validity . No tool covers all elements or domains . Design -specific generic tools are presented , which cover most of the content criteria . Discussion The evaluation of QAT by using content criteria is difficult , because there is no scientific consensus on the necessary elements of internal validity , and not all of the generally accepted elements are based on empirical evidence . Comparing QAT with regard to contents neglects the operationalisation of the respective parameters , for which the quality and precision are important for transparency , replicability , the correct assessment and interrater reliability . QAT , which mix items on the quality of reporting and internal validity , should be avoided . Conclusions There are different , design -specific tools available which can be preferred for quality assessment , because of its wider coverage of substantive elements of internal validity . To minimise the subjectivity of the assessment , tools with a detailed and precise operationalisation of the individual elements should be applied . For health economic studies , tools should be developed and complemented with instructions , which define the appropriateness of the criteria . Further research is needed to identify study characteristics that influence the internal validity of studies OBJECTIVE To investigate the effectiveness of neuromuscular electrical stimulation ( NMES ) with or without other interventions in improving lower limb activity  after chronic stroke . DATA SOURCES Electronic data bases , including PubMed , EMBase , Cochrane Library , PEDro ( Physiotherapy Evidence Data base ) , and PsycINFO , were search ed from the inception to January 2017 . STUDY SELECTION We selected the r and omized controlled trials ( RCTs ) involving chronic stroke survivors with lower limb dysfunction and comparing NMES or combined with other interventions with a control group of no electrical stimulation treatment . DATA EXTRACTION The primary outcome was defined as lower limb motor function , and the secondary outcomes included gait speed , Berg Balance Scale , timed Up and Go , 6-minute walk test , Modified Ashworth Scale , and range of motion . DATA SYNTHESIS Twenty-one RCTs involving 1481 participants were identified from 5759 retrieved articles . Pooled analysis showed that NMES had a moderate but statistically significant benefit on lower limb motor function ( st and ard mean difference 0.42 , 95 % confidence interval 0.26 - 0.58 ) , especially when NMES was combined with other interventions or treatment time within either 6 or 12 weeks . NMES also had significant benefits on gait speed , balance , spasticity , and range of motion but had no significant difference in walking endurance after NMES . CONCLUSIONS NMES combined with or without other interventions has beneficial effects in lower limb motor function in chronic stroke survivors . These data suggest that NMES should be a promising therapy to apply in chronic stroke rehabilitation to improve the capability of lower extremity in performing activities Background This review aims to present a consensus for optimal perioperative care in rectal/pelvic surgery , and to provide grade d recommendations for items for an evidence d-based enhanced recovery protocol . Methods Studies were selected with particular attention paid to meta-analyses , r and omized controlled trials and large prospect i ve cohorts . For each item of the perioperative treatment pathway , available English- language literature was examined , review ed and grade d. A consensus recommendation was reached after critical appraisal of the literature by the group . Results For most of the protocol items , recommendations are based on good- quality trials or meta-analyses of good- quality trials ( evidence grade : high or moderate ) . Conclusions Based on the evidence available for each item of the multimodal perioperative care pathway , the Enhanced Recovery After Surgery ( ERAS ) Society , European Society for Clinical Nutrition and Metabolism ( ESPEN ) and International Association for Surgical Metabolism and Nutrition ( IASMEN ) present a comprehensive evidence -based consensus review of perioperative care for rectal surgery Background This review aims to present a consensus for optimal perioperative care in colonic surgery and to provide grade d recommendations for items for an evidence d-based enhanced perioperative protocol . Methods Studies were selected with particular attention paid to meta-analyses , r and omised controlled trials and large prospect i ve cohorts . For each item of the perioperative treatment pathway , available English- language literature was examined , review ed and grade d. A consensus recommendation was reached after critical appraisal of the literature by the group . Results For most of the protocol items , recommendations are based on good- quality trials or meta-analyses of good- quality trials ( quality of evidence and recommendations according to the GRADE system ) . Conclusions Based on the evidence available for each item of the multimodal perioperative care pathway , the Enhanced Recovery After Surgery ( ERAS ) Society , International Association for Surgical Metabolism and Nutrition ( IASMEN ) and European Society for Clinical Nutrition and Metabolism ( ESPEN ) present a comprehensive evidence -based consensus review of perioperative care for colonic surgery In December 2003 , the European Council identified best practice as key for ensuring development of high- quality cancer-screening programs . To support national policies on cancer control , the European Union institutions progressed several initiatives on cancer . The European Commission ( EC ) Initiative on Breast Cancer ( ECIBC ) is the most recent of these projects and the most implementation driven . Within this initiative , the European Guidelines for Breast Cancer Screening and Diagnosis ( in short , European Breast Guidelines ) are being developed ( http://ecibc.jrc.ec.europa.eu/ ) . Guidelines are approaches to generally improve prevention , diagnosis , treatment , and follow-up of diseases , overcoming inappropriate variations by providing recommendations for best care . The new era of guidelines promises recommendations that are based on the best available evidence summarized in systematic review s while providing the necessary flexibility needed to individualize decisions . The best methods for development of practice guidelines have experienced intense elaboration and attention during the past decades ( 17 ) . The impetus for this attention has been the change from expert- or consensus-based to evidence -based health care recommendations . Although this change in terminology should express the shift from un systematic development of guidelines to systematic and trustworthy recommendations , it is often misunderstood and misconstrued as meaning that experts are now meaningless in the process or as if consensus through discussion is a matter of the past . Neither is correct . Experts from various disciplines and consensus as a result of deliberation remain a mainstay of health care guideline development ( 810 ) . These experts are responsible for prioritization of questions that should be addressed in guidelines ; judgments that result from interpretation of evidence , including the rating of the certainty of the available evidence ; and decisions about how the judgments on the different criteria bear on recommendations . What has changed over time in guideline development are the rules , the structure and explicitness of the process , and the guideline product . Indeed , review s of guideline development methodology and how guidelines can be improved have led to more structured and documented processes that allow a reduction of bias and provide balanced views of appropriately composed guideline panels ( 2 , 5 , 6 ) . Core components for trustworthy guideline development ( 13 , 5 , 7 , 11 ) include that guidelines be developed by a knowledgeable , multidisciplinary panel of experts and representatives from key affected groups ; be based on a systematic review of the existing evidence ; consider important patient subgroups and patient preferences as appropriate ; be based on an explicit and transparent process that minimizes distortions , biases , and conflicts of interest ( 12 ) ; provide a clear explanation of the logical relationships between alternative care options and health outcomes and provide ratings of both the quality of evidence and the strength of the recommendations ( 1316 ) ; and be reconsidered and revised as appropriate when important new evidence warrants modifications . In addition , greater transparency in linking the considered research evidence and the recommendations , as well as the requirement of making structured expert judgments , represents a shift in the guideline development paradigm ( 5 , 11 , 1719 ) . At the same time , developing guidelines for a large number of member states and those that aim to adapt the guidelines poses challenges , such as the feasibility of implementing strategies that may exist in some member countries but not others ( for example , organized population -based screening in Italy but not Greece ) . Addressing these challenges requires considerations that extend beyond strictly clinical efforts in guideline development and mastering the many factors that influence recommendations and their implementation . This article describes the rationale , methods , and processes the ECIBC has adopted to develop the European Breast Guidelines in the context of evolving international st and ards . It also describes an innovative approach to presenting , disseminating , and accelerating implementation of recommendations . Guideline Methodology and Development To adhere to the core requirements for guideline development , the EC has taken several steps . First , it selected , via an open call ( https://ecibc.jrc.ec.europa.eu/ guidelines -team ) , a panel with broad representation of expertise , knowledge , and background , which includes patients , health care professionals , epidemiologists , guideline method ologists , and others ( Appendix ) . These individuals voluntarily participate in the ECIBC and compose the guidelines development group ( GDG ) . Second , it ensured that all recommendations were supported by systematic review s of the evidence conducted by independent scientists from Cochrane Iberoamricathe systematic review team (SRT)following st and ard Cochrane Collaboration methods ( 20 , 21 ) . Third , because this is a women-centered initiative , we included women advocates in the GDG as full voting guideline group members . We separately considered important subgroups of women during recommendation development ( for example , different age groups ) , and we specifically focused on evidence that supports best ways of communicating this information to women to inform their decisions . Fourth , we applied EC conflict of interest rules ( http://ecibc.jrc.ec.europa.eu/rules ) , which are consistent with international recommendations , and used GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks to minimize the influence of competing interests on the recommendations ( 12 , 17 , 18 ) . These EtD frameworks help guideline panels use evidence in a structured , transparent way to inform decisions with a series of criteria , such as anticipated harms and benefits of the options considered , the certainty of the evidence for those effects , and the costs and feasibility of the options , to help them reach their decision . Fifth , using the GRADE approach to guideline development and its EtD frameworks , we focused our questions and recommendations on outcomes that matter to women and provided a rating of the certainty or quality of evidence and the strength of recommendations that is widely accepted as the reference st and ard ( Figures 1 and 2 ) . Sixth , our evidence review s are up to date when the recommendations are formulated , and we engage in international stakeholder feedback to ensure that recommendations remain timely and relevant to public health and clinical practice . The ECIBC is committed to review ing and updating the recommendations as required when new evidence becomes available . The general process is explained in Figure 3 and is based on the Guidelines International NetworkMcMaster Guideline Development Checklist ( https://hei grade .mcmaster.ca/ guideline -development/using-checklist ) ( 5 ) . Figure 1 . According to GRADE , certainty , quality , strength of evidence , or confidence in the estimate of effect is determined on the basis of a systematic review of the evidence for each outcome ( based on the domains risk of bias , indirectness , imprecision , inconsistency , and publication bias that lower certainty and , usually only for nonr and omized studies , large effects , doseresponse relations and opposing plausible residual confounding that may increase the certainty ) . For recommendations , the overall certainty is determined across outcomes based on the lowest certainty outcome among those critical for decision making for the specific context . The guidelines development group applies the GRADE Evidence -to-Decision frameworks to make recommendations that are made available on the European Commission Web site . ( Reproduced from reference 15 , with permission from Schnemann HJ . ) . GRADE = Grading of Recommendations Assessment , Development and Evaluation . Figure 2 . GRADE EtD frameworks . The GRADE EtD frameworks as available in the GRADE pro software ( www . grade pro.org ) . They help with structuring the entire guideline process into 4 sections and support the conduct of guideline group meetings , presentation , and implementation . They clarify the perspective that is taken by the guideline panel or decision maker and the type of question that is asked in the question section . The section on assessment includes the criteria if the problem is a priority , the balance of health benefits and harms , values and preferences related to the outcomes , cost , re sources and cost-effectiveness , equity , acceptability , and feasibility . Conclusions provide the decision or recommendation with a justification and implementation , as well as research considerations . The presentation function supports the conduct of guideline group meetings and facilitates the output of EtD frameworks to other implementation tools , such as Web sites , h and -held apps , and interactive decision aids . EtD = Evidence to Decision ; GRADE = Grading of Recommendations Assessment , Development and Evaluation ; HTA = health technology assessment ; PICO = population , intervention , comparators , and outcomes . Figure 3 . Approach to guideline development used by the European Commission Initiative on Breast Cancer . The European Commission JRC has oversight of the organization , budgeting , planning , and training . The JRC also manages conflicts of interest , documents all aspects of the work , and manages the membership and group processes . The guideline development group and JRC formulate the questions and work with the systematic review team on identifying and assessing the evidence . The guidelines development group is responsible for developing the recommendations . The JRC is responsible for most other aspects as described in the figure under dissemination , implementation , and updating . JRC = Joint Research Centre ; PICO = population , intervention , comparator , and outcomes . ( Reproduced with adaptation to the JRC process from Background Prevalence of  allergic diseases in infants , whose parents and siblings do not have allergy , is approximately 10 % and reaches 20–30 % in those with an allergic first-degree relative . Intestinal microbiota may modulate immunologic and inflammatory systemic responses and , thus , influence development of sensitization and allergy . Probiotics have been reported to modulate immune responses and their supplementation has been proposed as a preventive intervention . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations about the use of probiotics in the prevention of allergy . Methods We identified the most relevant clinical questions and performed a systematic review of r and omized controlled trials of probiotics for the prevention of allergy . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . We search ed for and review ed the evidence about health effects , patient values and preferences , and re source use ( up to November 2014 ) . We followed the GRADE evidence -to-decision framework to develop recommendations . Results Currently available evidence does not indicate that probiotic supplementation  reduces the risk of developing allergy in children . However , considering all critical outcomes in this context , the WAO guideline panel determined that there is a likely net benefit from using probiotics result ing primarily from prevention of eczema . The WAO guideline panel suggests : a ) using probiotics in pregnant women at high risk for having an allergic child ; b ) using probiotics in women who breastfeed infants at high risk of developing allergy ; and c ) using probiotics in infants at high risk of developing allergy . All recommendations are conditional and supported by very low quality evidence . Conclusions WAO recommendations about probiotic supplementation for prevention of allergy are intended to support parents , clinicians and other health care professionals in their decisions whether to use probiotics in pregnancy and during breastfeeding , and whether to give them to infants Objectives Appropriate reporting is central to the application of findings from research to clinical practice . The Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) recommendations consist of a checklist of 22 items that provide guidance on the reporting of cohort , case – control and cross-sectional studies , in order to facilitate critical appraisal and interpretation of results . STROBE was published in October 2007 in several journals including The Lancet , BMJ , Annals of Internal Medicine and PLoS Medicine . Within the framework of the revision of the STROBE recommendations , the authors examined the context and circumstances in which the STROBE statement was used in the past . Design The authors search ed the Web of Science data base in August 2010 for articles which cited STROBE and examined a r and om sample of 100 articles using a st and ardised , piloted data extraction form . The use of STROBE in observational studies and systematic review s ( including meta-analyses ) was classified as appropriate or inappropriate . The use of STROBE to guide the reporting of observational studies was considered appropriate . Inappropriate uses included the use of STROBE as a tool to assess the method ological quality of studies or as a guideline on how to design and conduct studies . Results The authors identified 640 articles that cited STROBE . In the r and om sample of 100 articles , about half were observational studies ( 32 % ) or systematic review s ( 19 % ) . Comments , editorials and letters accounted for 15 % , method ological articles for 8 % , and recommendations and narrative review s for 26 % of articles . Of the 32 observational studies , 26 ( 81 % ) made appropriate use of STROBE , and three uses ( 10 % ) were considered inappropriate . Among 19 systematic review s , 10 ( 53 % ) used STROBE inappropriately as a tool to assess study quality . Conclusions The STROBE reporting recommendations are frequently used inappropriately in systematic review s and meta-analyses as an instrument to assess the method ological quality of observational studies
No outcomes evaluated the effect on participation restrictions .
NMES , as an adjunct to current rehabilitation practice s in critically ill patients , may maintain muscle strength .
OBJECTIVE To review , in conformance with the Preferred Reporting Items for Systematic Review s and Meta-Analyses guidelines , the totality of evidence for the use of neuromuscular electrical stimulation ( NMES ) in the critical care setting , when compared with usual care , under all domains of the World Health Organisation , International Classification of Functioning , Disability and Health ( ICF ) framework .