Comparative Effectiveness of Dipeptidylpeptidase-4 Inhibitors in Type 2 Diabetes: A Systematic Review and Mixed Treatment Comparison The Effectiveness of Technology-Based Strategies to Promote Engagement With Digital Interventions: A Systematic Review Protocol Seeing the forests and the trees—innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol The effectiveness of yoga to prevent diabetes mellitus type 2 Systematic review automation technologies Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol Sources of evidence for systematic reviews of interventions in diabetes. The impact of cash transfers on social determinants of health and health inequalities in Sub-Saharan Africa: a systematic review protocol Community-based care for the management of type 2 diabetes: an evidence-based analysis. [Interventions to improve the management of diabetes mellitus in primary health care and outpatient community settings]. Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings Digital Education in Health Professions: The Need for Overarching Evidence Synthesis Technology-adaptable interventions for treating depression in adults with cognitive impairments: protocol for a systematic review The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials Update on AUA guideline on the management of benign prostatic hyperplasia. Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic review. Protocol for an overview of systematic reviews of interventions to reduce unscheduled hospital admissions among adults Mixed treatment comparison analysis provides internally coherent treatment effect estimates based on overviews of reviews and can reveal inconsistency. Sugammadex: when should we be giving it? Mineral Trioxide Aggregate vs. Calcium Hydroxide in Primary Molar Pulpotomy: A Systematic Review Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic review Behavioural interventions for type 2 diabetes: an evidence-based analysis. Single photon emission computed tomography for the diagnosis of coronary artery disease: an evidence-based analysis. Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Community-based care for chronic wound management: an evidence-based analysis. Can we rely on the best trial? A comparison of individual trials and systematic reviews Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: Methods of a decision-maker-researcher partnership systematic review Addressing Dichotomous Data for Participants Excluded from Trial Analysis: A Guide for Systematic Reviewers Treatment of surgical patients is evidence-based. Systematic reviews in endodontics--examples of GIGO? Evidence Synthesis for Decision Making 1 A systematic review of the clinical effectiveness of emergency endovascular therapy using mechanical thrombectomy in acute ischaemic stroke: implications for service delivery The provision and impact of online patient access to their electronic health records (EHR) and transactional services on the quality and safety of health care: systematic review protocol. Biofeedback for treatment of awake and sleep bruxism in adults: systematic review protocol A conversation with Joseph Lau. Caudal epidural steroid injection: a randomized controlled trial Texting and Mobile Phone App Interventions for Improving Adherence to Preventive Behavior in Adolescents: A Systematic Review The effectiveness of nurse‐led care in general practice on clinical outcomes in adults with type 2 diabetes An international registry of systematic-review protocols The Role of Acupuncture in Assisted Reproductive Technology Relative citation impact of various study designs in the health sciences. A Systematic Review of the Effect of Expectancy on Treatment Responses to Acupuncture Title and Abstract Screening and Evaluation in Systematic Reviews (TASER): a pilot randomised controlled trial of title and abstract screening by medical students Checklists of methodological issues for review authors to consider when including non-randomized studies in systematic reviews. Interventions for domestic violence among pregnant women in low- and middle-income countries: a systematic review protocol Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews How to write an evidence-based clinical review article. Epidemiologic analysis of breast cancer incidence, prevalence, and mortality in India Preoperative or postoperative therapy for resectable oesophageal cancer: an updated practice guideline. Systematic review data extraction: cross-sectional study showed that experience did not increase accuracy. Clinical effectiveness of first-line chemoradiation for adult patients with locally advanced non-small cell lung cancer: a systematic review. Reporting of prognostic markers: current problems and development of guidelines for evidence-based practice in the future Trials based on specific fracture configuration and surgical procedures likely to be more relevant for decision making in the management of fractures of the proximal humerus How has the impact of 'care pathway technologies' on service integration in stroke care been measured and what is the strength of the evidence to support their effectiveness in this respect? How has the impact of 'care pathway technologies' on service integration in stroke care been measured and what is the strength of the evidence to support their effectiveness in this respect? Herbal medicine Shaofu Zhuyu decoction for primary dysmenorrhea: a systematic review protocol Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review Reporting of Sex Effects by Systematic Reviews on Interventions for Depression, Diabetes, and Chronic Pain Towards systematic reviews that inform health care management and policy-making Measures for assessing practice change in medical practitioners How Quickly Do Systematic Reviews Go Out of Date? A Survival Analysis UK clinical guideline for the prevention and treatment of osteoporosis Physical Activity/Exercise and Type 2 Diabetes Effects of workplace-based dietary and/or physical activity interventions for weight management targeting healthcare professionals: a systematic review of randomised controlled trials Community pharmacy interventions for public health priorities: protocol for a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions Identifying the content of home-based health behaviour change interventions for frail older people: a systematic review protocol The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews Identifying, documenting, and examining heterogeneity in systematic reviews of complex interventions. A Systematic Review of Strategies for Implementing Empirically Supported Mental Health Interventions Overview of Systematic Reviews: Yoga as a Therapeutic Intervention for Adults with Acute and Chronic Health Conditions Examining the theory‐effectiveness hypothesis: A systematic review of systematic reviews
Objective To compare the safety and efficacy of the dipeptidylpeptidase-4 ( DPP-4 ) inhibitors in patients with type 2 diabetes and inadequate glycemic control . Design Systematic review of r and omized controlled trials ( RCTs ) , health economic evaluation studies , systematic review s , and meta-analyses , followed by primary Bayesian mixed treatment comparison meta-analyses ( MTCs ) , and secondary frequentist direct-comparison meta-analyses using a r and om-effects model . Outcomes were reported as weighted mean change from baseline , or odds ratio ( OR ) with 95 % credible interval . Data sources MEDLINE , MEDLINE In-Process , EMBASE , and BIOSIS via Dialog ProQuest ; Cochrane Central Register of Controlled Trials and Cochrane Data base of Systematic Review s via EBSCO ; four diabetes and two technical congress abstract s ; and health technology assessment organization websites . Eligibility criteria Patients with type 2 diabetes and inadequate glycemic control receiving any pharmacological anti-diabetic treatment . Data extraction and analysis Title/ abstract s were review ed for eligibility , followed by full-text review of publications remaining after first pass . A three-person team filtered articles and an independent review er checked a r and om selection ( 10 % ) of filtered articles . Data extraction and quality assessment of studies were also independently review ed . Five DPP-4 inhibitors ( alogliptin , linagliptin , saxagliptin , sitagliptin , and vildagliptin ) were compared via meta- analysis ( where data were available ) as monotherapy , dual therapy ( plus metformin , sulfonylurea , pioglitazone , or insulin ) , and triple therapy ( plus metformin/sulfonylurea ) . Results The review identified 6,601 articles ; 163 met inclusion criteria and 85 publications from 83 RCTs contained sufficient or appropriate data for analysis . MTCs demonstrated no differences between DPP-4 inhibitors in mean change from baseline in glycosylated hemoglobin ( HbA1c ) or body weight , or the proportions of patients achieving HbA1c < 7 % or experiencing a hypoglycemic event , apart from in patients on alogliptin plus metformin , who achieved HbA1c < 7 % more frequently than those treated with saxagliptin plus metformin [ OR 6.41 ( 95 % CI 3.15–11.98 ) versus 2.17 ( 95 % CI 1.56–2.95 ) ] . Conclusions This systematic review and MTC showed similar efficacy and safety for DPP-4 inhibitors as treatment for type 2 diabetes , either as monotherapy or combination therapy Background Digital interventions provide effective and potentially cost-effective models for improving health outcomes as they deliver health information and services that are widely disseminated , confidential , and can be tailored to needs of the individual user . Digital interventions have been used successfully for health promotion , mental health , and for enabling self-management of long-term conditions . However , their effectiveness is limited by low usage rates , with non-engagement a major challenge . Hence , it is crucial to find effective strategies to increase user engagement with digital interventions . Objective This systematic review will aim to evaluate the effectiveness of technology-based strategies  to promote engagement with digital interventions . Methods We will follow Cochrane Collaboration guidelines on systematic review methodology . The search strategy will be executed across seven e- data bases ( including MEDLINE , EMBASE , PsycINFO , CINAHL ) using the concepts “ digital intervention ” and “ engagement ” , limited by study type ( r and omized controlled trial ) . Grey literature and reference lists of included studies will be search ed . Titles and abstract s will be independently screened by 2 authors . Then the full text of potentially eligible papers will be obtained and double screened . Data from eligible papers will be extracted by 1 author and checked for accuracy by another author . Bias will be assessed using the Cochrane bias assessment tool . Narrative synthesis will report on all included studies , and where appropriate , data will be pooled using meta- analysis . All findings will be reported according to the Preferred Reporting Items for Systematic Review s and Meta-Analyses guidelines . Sources of heterogeneity will be further investigated if required . Results Our research is in progress . The final draft of the systematic review is being written and will be su bmi tted before the end of 2015 . Conclusions The review findings will inform research ers and digital intervention providers about optimal use of technology-based strategies to promote engagement with digital interventions . Trial Registration PROSPERO International Prospect i ve Register of Systematic Review s : CRD42014010164 ; http://www.crd.york.ac.uk/ PROSPERO /display_record.asp?ID = CRD42014010164#.VTZmmiFViko ( Archived by WebCite at http://www.webcitation.org/6XxQC8fT8 ) Background To improve quality of care and patient outcomes , health system decision-makers need to identify and implement effective interventions . An increasing number of systematic review s document the effects of quality improvement programs to assist decision-makers in developing new initiatives . However , limitations in the reporting of primary studies and current meta- analysis methods ( including approaches for exploring heterogeneity ) reduce the utility of existing syntheses for health system decision-makers . This study will explore the role of innovative meta- analysis approaches and the added value of enriched and up date d data for increasing the utility of systematic review s of complex interventions . Methods / Design We will use the data set from our recent systematic review of 142 r and omized trials of diabetes quality improvement programs  to evaluate novel approaches for exploring heterogeneity . These will include exploratory methods , such as multivariate meta-regression analyses and all-subsets combinatorial meta- analysis . We will then up date our systematic review to include new trials and enrich the data set by surveying authors of all included trials . In doing so , we will explore the impact of variables not , reported in previous publications , such as details of study context , on the effectiveness of the intervention . We will use innovative analytical methods on the enriched and up date d data set to identify key success factors in the implementation of  quality improvement interventions  for diabetes . Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results . Discussion This study will inform future systematic review s of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta- analysis . It will also result in an up date d comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes . Systematic review registration PROSPERO registration no. Background : Type 2 diabetes mellitus ( T2DM ) is becoming a leading problem worldwide . Emerging reports reveal alarming evidence of increasing prevalence of T2DM that has reached p and emic levels . Despite the significant incidence , there are limited reliable data re sources and comprehensive systematic review and meta- analysis on the effects of yoga on people who are a prediabetic or high risk for developing T2DM . Objective : The objective of this protocol is to conduct a full-scale systematic review and meta-analyses on the effects of yoga on people who are prediabetes or high risk of developing T2DM . Methods : The articles enrolled in the study will be retrieved from the online data bases between 2002 and the date the search es are executed . The search es will be repeated just before the final analyses and further relevant studies for inclusion . We will conduct a bibliographic search in data bases : Medline / PubMed , Scopus , Cochrane Library , EBSCO , and IndMED using keywords including prediabetes state , high risk for diabetes , metabolic syndrome , and yoga . 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 . There will be no language restrictions . Ethics and dissemination : The proposed study will be based on published studies and publicly available anonymized data without directly involving human participants and therefore requires neither formal human ethical review nor approval by a human research ethics committee . We published an outline of the protocol in the International Prospect i ve Register of Systematic Review s ( PROSPERO ) in 2018 . We plan to disseminate the findings of this systematic review and meta- analysis through publication in a peer- review ed journal and presentation at relevant conference proceedings . In addition , we believe the results of the systematic review will have implication s for policy and practice . We will prepare policymaker summary using a vali date d format , disseminate through social media and email discussion groups . Review registration number : PROSPERO registration number CRD Systematic review s , a cornerstone of evidence -based medicine , are not produced quickly enough to support clinical practice . The cost of production , availability of the requisite expertise and timeliness are often quoted as major contributors for the delay . This detailed survey of the state of the art of information systems design ed to support or automate individual tasks in the systematic review , and in particular systematic review s of r and omized controlled clinical trials , reveals trends that see the convergence of several parallel research projects . We surveyed literature describing informatics systems that support or automate the processes of systematic review or each of the tasks of the systematic review . Several projects focus on automating , simplifying and /or streamlining specific tasks of the systematic review . Some tasks are already fully automated while others are still largely manual . In this review , we describe each task and the effect that its automation would have on the entire systematic review process , summarize the existing information system support for each task , and highlight where further research is needed for realizing automation for the task . Integration of the systems that automate systematic review tasks may lead to a revised systematic review workflow . We envisage the optimized workflow will lead to system in which each systematic review is described as a computer program that automatically retrieves relevant trials , appraises them , extracts and synthesizes data , evaluates the risk of bias , performs meta- analysis calculations , and produces a report in real time Introduction Hearing loss is a major public health concern , affecting over 11 million people in the UK . While hearing aids are the most common clinical intervention for hearing loss , the majority of people that would benefit from using hearing aids do not take them up . Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids . These include hearing aids that can be customised using a smartphone , smartphone-based ‘ hearing aid ’ apps , personal sound amplification products and wireless hearing products . However , no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss . Methods and analysis The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss . Methods are reported according to the Preferred Reporting Items for Systematic review s and Meta-analyses Protocol s ( PRISMA -P ) 2015 checklist . Retrospective or prospect i ve studies , r and omised controlled trials , non-r and omised controlled trials , and before-after comparison studies will be eligible for inclusion . We will include studies with adult participants ( ≥18 years ) with a mild or moderate hearing loss . The intervention should be an alternative listening device to a conventional hearing aid ( comparison ) . Studies will be restricted to outcomes associated with the consequences of hearing loss . We will search relevant data bases to identify published , completed but unpublished and ongoing trials . The overall quality of included evidence will be evaluated using the GRADE system , and meta- analysis performed if appropriate . Ethics and dissemination No ethical issues are foreseen . The findings will be reported at national and international conferences , primarily audiology , and ear , nose and throat , and in a peer- review ed journal using the PRISMA guidelines . Review registration number PROSPERO CRD4201502958 AIMS To analyse the effect on systematic review s in diabetes interventions of including only trials that are indexed in medline , and to assess the impact of adding trials from other data bases and the grey literature . METHODS All systematic review s of diabetes interventions which included a meta- analysis of r and omized controlled trials , and were published since 1996 , were selected . The impact on the meta- analysis of including only those trials indexed in medline , and the effect of then adding trials from other sources , was assessed . Where possible this was measured quantitatively , by redoing the meta- analysis , otherwise a qualitative estimate was made . RESULTS Forty-four systematic review s met our inclusion criteria . There were 120 articles reporting trial data which were not indexed in medline . These came from 52 % of the review s. In 34 % of the review s , basing a meta- analysis on a search of only medline would miss trials that could affect the result . Sources of non- medline data which had the biggest effect on the meta-analyses were journal articles from central and embase ( mainly in Diabetes , Nutrition and Metabolism ) and unpublished data ( mainly from industry ) . The exceptions were journal articles on herbal medicine , mostly indexed in Chinese language data bases . CONCLUSIONS A search of only the medline data base is insufficient for systematic review s of diabetes , because in about 34 % of review s the missed trials could affect the results of the meta- analysis . It is recommended that central ( on the Cochrane Library ) also be search ed . Scanning meeting abstract s , and seeking unpublished data are also recommended if the intervention has only recently been introduced 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 UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes  : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine the efficacy of specialized multidisciplinary community care for the management of type 2 diabetes compared to usual care . CLINICAL NEED TARGET POPULATION AND CONDITION Diabetes ( i.e. diabetes mellitus ) is a highly prevalent chronic metabolic disorder that interferes with the body 's ability to produce or effectively use insulin . The majority ( 90 % ) of diabetes patients have type 2 diabetes . ( 1 ) Based on the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) , intensive blood glucose and blood pressure control significantly reduce the risk of microvascular and macrovascular complications in type 2 diabetics . While many studies have documented that patients often do not meet the glycemic control targets specified by national and international guidelines , factors associated with glycemic control are less well studied , one of which is the provider(s ) of care . Multidisciplinary approaches to care may be particularly important for diabetes management . According guidelines from the Canadian Diabetes Association ( CDA ) , the diabetes health care team should be multi- and interdisciplinary . Presently in Ontario , the core diabetes health care team consists of at least a family physician and /or diabetes specialist , and diabetes educators ( registered nurse and registered dietician ) . Increasing the role played by allied health care professionals in diabetes care and their collaboration with physicians may represent a more cost-effective option for diabetes management . Several systematic review s and meta-analyses have examined multidisciplinary care programs , but these have either been limited to a specific component of multidisciplinary care ( e.g. intensified education programs ) , or were conducted as part of a broader disease management program , of which not all were multidisciplinary in nature . Most review s also do not clearly define the intervention(s ) of interest , making the evaluation of such multidisciplinary community programs challenging . EVIDENCE -BASED ANALYSIS METHODS RESEARCH QUESTIONS What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a registered nurse , registered dietician and physician ( primary care and /or specialist ) for the management of type 2 diabetes compared to usual care ? [ Henceforth referred to as Model 1]What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a pharmacist and a primary care physician for the management of type 2 diabetes compared to usual care ? [ Henceforth referred to as Model 2 ] INCLUSION CRITERIA English language full-reportsPublished between January 1 , 2000 and September 28 , 2008R and omized controlled trials ( RCTs ) , systematic review s and meta-analysesType 2 diabetic adult population ( ≥18 years of age)Total sample size ≥30Describe specialized multidisciplinary community care defined as ambulatory-based care provided by at least two health care disciplines ( of which at least one must be a specialist in diabetes ) with integrated communication between the care providers . Compared to usual care ( defined as health care provision by non-specialist(s ) in diabetes , such as primary care providers ; may include referral to other health care professionals/services as necessary)≥6 months follow-up EXCLUSION CRITERIA Studies where discrete results on diabetes can not be abstract edPredominantly home-based interventions Inpatient-based interventions OUTCOMES OF INTEREST The primary outcomes for this review were glycosylated hemoglobin ( rHbA1c ) levels and systolic blood pressure ( SBP ) . SEARCH STRATEGY A literature search was performed on September 28 , 2008 using OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , the Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1 , 2000 and September 28 , 2008 . Abstract s were review ed by a single review er and , for those studies meeting the eligibility criteria , full-text articles were obtained . Reference lists were also examined for any additional relevant studies not identified through the search . Articles with unknown eligibility were review ed with a second clinical epidemiologist , then a group of epidemiologists until consensus was established . The quality of evidence was assessed as high , moderate , low or very low according to GRADE methodology . Given the high clinical heterogeneity of the articles that met the inclusion criteria , specific models of specialized multidisciplinary community care were examined based on models of care that are currently being supported in Ontario , models of care that were commonly reported in the literature , as well as suggestions from an Expert Advisory Panel Meeting held on January 21 , 2009 . SUMMARY OF FINDINGS The initial search yielded 2,116 unique citations , from which 22 RCTs trials and nine systematic review s published were identified as meeting the eligibility criteria . Of these , five studies focused on care provided by at least a nurse , dietician , and physician ( primary care and /or specialist ) model of care ( Model 1 ; see Table ES 1 ) , while three studies focused on care provided by at least a pharmacist and primary care physician ( Model 2 ; see Table ES 2 ) . Based on moderate quality evidence , specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinical ly significant reduction in HbA1c of 1.0 % compared with usual care . The effects of this model on SBP , however , are uncertain compared with usual care , based on very-low quality evidence . Specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinical ly significant reduction in both HbA1c of 1.05 % ( based on high quality evidence ) and SBP of 7.13 mm Hg ( based on moderate quality evidence ) compared to usual care . For both models , the evidence does not suggest a preferred setting of care delivery ( i.e. , primary care vs. hospital outpatient clinic vs. community clinic ) . Table ES1 : Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 1 Outcome Estimate of effect(95 % CI)Heterogeneity I(2)(p-value ) GRADE Glycosylated Hemoglobin ( HbA1c [%])-1.00 [ -1.27 , -0.73]4 % (p=0.37)Moderate- quality Subgroup : Moderate-to-High Quality -0.91 [ -1.19 , -0.62]0 % (p=0.74)Systolic Blood Pressure ( mm Hg)-2.04 [ -13.80 , 9.72]89 % (p=0.002)Very-low quality * Mean change from baseline to follow-up between intervention and control groupsTable ES2 : Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 2 Outcome Estimate of effect(95 % CI)Heterogeneity I(2)(p-value ) GRADE Glycosylated Hemoglobin ( HbA1c [%])-1.05 [ -1.57 , -0.52]0 % (p=0.75)High- quality Systolic Blood Pressure ( mm Hg)-7.13 [ -11.78 , -2.48]46 % (p=0.17)Moderate quality * Mean change from baseline to follow-up between intervention and control groups UNLABELLED This review should be cited as : Renders CM , Valk GD , Griffin S. Wagner EH , Eijk JThM van , Assendelft WJJ . Interventions to improve the management of  diabetes mellitus  in primary care , outpatient and community setting s ( Cochrane Review ) . In : The Cochrane Library , Issue 2 , 2001 . Oxford : Up date Software . A substantive amendment to this systematic review was last made on 29 June 2000 . Cochrane review s are regularly checked and up date d if necessary . BACKGROUND Diabetes is a common chronic disease that is increasingly managed in primary care . Different systems have been proposed to manage diabetes care . OBJECTIVES To assess the effects of different interventions , targeted at health professionals or the structure in which they deliver care , on the management of patients with diabetes in primary care , outpatient and community setting s. SEARCH STRATEGY We search ed the Cochrane Effective Practice and Organisation of Care Group specialised register , the Cochrane Controlled Trials Register ( Issue 4 1999 ) , MEDLINE ( 1966 - 1999 ) , EMBASE ( 1980 - 1999 ) , Cinahl ( 1982 - 1999 ) , and reference lists of articles . SELECTION CRITERIA R and omised trials ( RCTs ) , controlled clinical trials ( CCTs ) , controlled before and after studies ( CBAs ) and interrupted time series ( ITS ) analyses of professional , financial and organisational strategies aim ed at improving care for people with Type 1 or Type 2 diabetes . The participants were health care professionals , including physicians , nurses and pharmacists . The outcomes included objective ly measured health professional performance or patient outcomes , and self-report measures with known validity and reliability . DATA COLLECTION AND ANALYSIS Two review ers independently extracted data and assessed study quality . MAIN RESULTS Forty-one studies were included involving more than 200 practice s and 48,000 patients . Twenty-seven studies were RCTs , 12 were CBAs , and two were ITS . The studies were heterogeneous in terms of interventions , participants , setting s and outcomes . The method ological quality of the studies was often poor . In all studies the intervention strategy was multifaceted . In 12 studies the interventions were targeted at health professionals , in nine they were targeted at the organization of care , and 20 studies targeted both . In 15 studies patient education was added to the professional and organisational interventions . A combination of professional interventions improved process outcomes . The effect on patient outcomes remained less clear as these were rarely assessed . Arrangements for follow-up ( organisational intervention ) also showed a favourable effect on process outcomes . Multiple interventions in which patient education was added or in which the role of the nurse was enhanced also reported favourable effects on patients ' health outcomes . REVIEW ERS ' CONCLUSION : Multifaceted professional interventions can enhance the performance of health professionals in managing patients with diabetes .  Organisational interventions that improve regular prompted recall and review of patients  ( central computerised tracking systems or nurses who regularly contact the patient ) can also improve diabetes management . The addition of patient-oriented interventions can lead to improved patient health outcomes . Nurses can play an important role in patient-oriented interventions , through patient education or facilitating adherence to treatment ABSTRACT Background : Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India . Innovative approaches such as clinical decision support ( CDS ) software could play a major role in improving the quality of hypertension/diabetes care in primary care setting s. Objective : To describe the steps and processes in the development of mWellcare , a complex intervention based on mobile health ( mHealth ) technology . Methods : The Medical Research Council framework was used to develop mWellcare in four steps : ( 1 ) identify gaps in usual care through literature review and health facility assessment s ; ( 2 ) identify the components of the intervention through discussion s and consultations with experts ; ( 3 ) develop intervention ( clinical algorithms and mHealth system ) ; and ( 4 ) evaluate acceptability and feasibility through pilot testing in five community health centers . Results : Lack of evidence -based , integrated , and systematic management of chronic conditions were major gaps identified . Experts in information technology , clinical fields , and public health professionals identified intervention components to address these gaps . Thereafter , clinical algorithm context ualized to primary care setting s were prepared and the mWellcare intervention was developed . During the 2-month pilot , 631 patients diagnosed with hypertension and /or diabetes were registered , with a follow-up rate of 36.2 % . The major barrier was resistance to follow mWellcare recommended patient workflow , and to overcome it , we emphasized onsite training and orientation program to cover all health care team member in each CHC . Conclusion : A pilot-tested mWellcare intervention is an mHealth system with important components , i.e. integrated management of chronic conditions , evidence -based CDS , longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit , which will be used by nurses at primary health care setting s in India . The effectiveness and cost-effectiveness of the intervention will be tested through a cluster r and omized trial ( trial registration number NCT02480062 ) Synthesizing evidence from r and omized controlled trials of  digital health education  poses some challenges . These include a lack of clear categorization of digital health education in the literature ; constantly evolving concepts , pedagogies , or theories ; and a multitude of methods , features , technologies , or delivery setting s. The Digital Health Education Collaboration was established to evaluate the evidence on digital education in health professions ; inform policymakers , educators , and students ; and ultimately , change the way in which these professionals learn and are taught . The aim of this paper is to present the overarching methodology that we use to synthesize evidence across our digital health education review s and to discuss challenges related to the process . For our research , we followed Cochrane recommendations for the conduct of systematic review s ; all review s are reported according to the PRISMA ( Preferred Reporting Items for Systematic Review s and Meta-Analyses ) guidance . This included assembling experts in various digital health education fields ; identifying gaps in the evidence base ; formulating focused research questions , aims , and outcome measures ; choosing appropriate search terms and data bases ; defining inclusion and exclusion criteria ; running the search es jointly with librarians and information specialists ; managing abstract s ; retrieving full-text versions of papers ; extracting and storing large data sets , critically appraising the quality of studies ; analyzing data ; discussing findings ; drawing meaningful conclusions ; and drafting research papers . The approach used for synthesizing evidence from digital health education trials is commonly regarded as the most rigorous benchmark for conducting systematic review s. Although we acknowledge the presence of certain biases ingrained in the process , we have clearly highlighted and minimized those biases by strictly adhering to scientific rigor , method ological integrity , and st and ard operating procedures . This paper will be a valuable asset for research ers and method ologists undertaking systematic review s in digital health education Background Depression is a common comorbidity in individuals with cognitive impairment . Those with cognitive impairments face unique challenges in receiving the benefits of many conventional therapies for depression , and may have poorer outcomes in areas such as recovery and quality of life . However , the stigmatization of mental health disorders , cost barriers and physical disabilities may prevent these individuals from seeking mental health care . An online , self-help intervention specifically developed for adults with cognitive deficits and depression may be particularly beneficial to this population . We aim to inform the design of such an intervention through a systematic review by answering the following research question : among adults with cognitive impairment ( including those with acquired brain injuries or neurodegenerative diseases ) , which technology-amenable interventions have been shown to effectively decrease symptoms of depression ? Specifically , psychotherapeutic and /or behavioural interventions that could be delivered in a self-guided , online system will be included . Methods Comprehensive electronic search es will be conducted in MEDLINE , EMBASE , PsycINFO and CINAHL . Additional studies will be obtained through manually search ing the references of relevant systematic review s , contacting primary authors of select articles and tracking conference proceedings and trial registries . Article titles and abstract s will be screened using predefined eligibility criteria , and then judged for their amenability to the proposed self-help , technology-based intervention . The full text of those articles with selected interventions will then be screened to determine final eligibility for inclusion . Included articles will be categorized by intervention type and assessed for risk of bias using the Cochrane Effective Practice and Organization of Care Risk of Bias tool for non-r and omized trials , controlled before-after studies and interrupted time series . The primary outcome will be a change in score on a vali date d depression scale , and adverse events will be documented as a secondary outcome . After data extraction from selected articles , pooling of data and meta- analysis will be conducted if a sufficient pool of studies with comparable methodology and quality are identified . Alternatively , plain language summaries will be developed . The quality of evidence will be assessed using the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) system . Systematic review registration PROSPERO Background A systematic review , with or without a meta- analysis , should be undertaken to determine if the research question of interest has already been answered before a new trial begins . There has been limited research on how systematic review s are used within the design of new trials , the aims of this study were to investigate how systematic review s of earlier trials are used in the planning and design of new r and omised trials . Methods Documentation from the application process for all r and omised trials funded by the National Institute for Health Research Health Technology Assessment ( NIHR HTA ) between 2006 and 2008 were obtained . This included the : commissioning brief ( if appropriate ) , outline application , minutes of the Board meeting in which the outline application was discussed , full application , detailed project description , referee comments , investigator response to referee comments , Board minutes on the full application and the trial protocol . Data were extracted on references to systematic review s and how any such review s had been used in the planning and design of the trial . Results 50 r and omised trials were funded by NIHR HTA during this period and documentation was available for 48 of these . The cohort was predominately individually r and omised parallel trials aim ing to detect superiority between two treatments for a single primary outcome . 37 trials ( 77.1 % ) referenced a systematic review within the application and 20 of these ( i.e. 41.7 % of the total ) used information contained in the systematic review in the design or planning of the new trial . The main areas in which systematic review s were used were in the selection or definition of an outcome to be measured in the trial ( 7 of 37 , 18.9 % ) , the sample size calculation ( 7 , 18.9 % ) , the duration of follow up ( 8 , 21.6 % ) and the approach to describing adverse events ( 9 , 24.3 % ) . Boards did not comment on the presence/absence or use of systematic review s in any application . Conclusions Systematic review s were referenced in most funded applications but just over half of these used the review to inform the design . There is an expectation from funders that applicants will use a systematic review to justify the need for a new trial but no expectation regarding further use of a systematic review to aid planning and design of the trial . Guidelines for applicants and funders should be developed to promote the use of systematic review s in the design and planning of r and omised trials , to optimise delivery of new studies informed by the most up-to- date evidence base and to minimise waste in research PURPOSE To revise the 2003 version of the American Urological Association 's ( AUA ) Guideline on the management of benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS From MEDLINE ® search es of English language publications ( January 1999 through February 2008 ) using relevant MeSH terms , articles concerning the management of the index patient , a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms ( LUTS ) were identified . Qualitative analysis of the evidence was performed . Selected studies were stratified by design , comparator , follow-up interval , and intensity of intervention , and meta-analyses ( quantitative synthesis ) of outcomes of r and omized controlled trials were planned . Guideline statements were drafted by an appointed expert Panel based on the evidence . RESULTS The studies varied as to patient selection ; r and omization ; blinding mechanism ; run-in periods ; patient demographics , comorbidities , prostate characteristics and symptoms ; drug doses ; other intervention characteristics ; comparators ; rigor and intervals of follow-up ; trial duration and timing ; suspected lack of applicability to current US practice ; and techniques of outcomes measurement . These variations affected the quality of the evidence review ed making formal meta- analysis impractical or futile . Instead , the Panel and extractors review ed the data in a systematic fashion and without statistical rigor . Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases . Guideline statements concerning pharmacotherapies , watchful waiting , surgical options and minimally invasive procedures were either up date d or newly drafted , peer review ed and approved by AUA Board of Directors . CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms . The management of LUTS/BPH continues to evolve OBJECTIVES The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . INCLUSION CRITERIA Types of participants Adult caregivers who provide support for people with dementia living in the community ( non-institutional care).Types of interventions Interventions design ed to support caregivers in their role such as skills training , education to assist in caring for a person living with dementia and support groups/programs . Interventions of formal approaches to care design ed to support caregivers in their role , care planning , case management and specially design ated members of the healthcare team - for example dementia nurse specialist or volunteers trained in caring for someone with dementia . Types of studies This review considered any meta-analyses , systematic review s , r and omised control trials , quasi-experimental studies , cohort studies , case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . SEARCH STRATEGY The search sought to identify published studies from 2000 to 2005 through the use of electronic data bases . Only studies in English were considered for inclusion . The initial search was conducted of the data bases , CINAHL , MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group . A second more extensive search was then conducted using the appropriate Medical Subject Headings ( MeSH ) and keywords for other available data bases . Finally , h and search ing of reference lists of articles retrieved and of core dementia , geriatric and psycho geriatric journals was undertaken . ASSESSMENT OF QUALITY Method ological quality of each of the articles was assessed by two independent review ers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Review s and Dissemination . DATA COLLECTION AND ANALYSIS St and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each included study reported in the meta- analysis . Results from comparable groups of studies were pooled in statistical meta- analysis using Review Manager Software from the Cochrane Collaboration . Heterogeneity between combined studies was tested using st and ard chi-square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . RESULTS A comprehensive search of relevant data bases , h and search ing and cross referencing found 685 articles that were assessed for relevance to the review . Eighty-five papers appeared to meet the inclusion criteria based on title and abstract , and the full paper was retrieved . Of the 85 full papers review ed , 40 were accepted for inclusion , three were systematic review s , three were meta- analysis , and the remaining 34 were r and omised controlled trials . For the r and omised controlled trials that were able to be included in a meta- analysis , st and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each . Results from comparable groups of studies were pooled in statistical meta- analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi-square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . The results are discussed in two main sections . Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression , health , subjective well-being , self-efficacy and burden . Secondly , results are reported by main outcome category . For each of these sections , meta- analysis was conducted where it was possible ; otherwise , a narrative summary describes the findings . EFFECTIVENESS OF INTERVENTION TYPE Four categories of intervention were included in the review - psycho-educational , support , multi-component and other . Psycho-educational Thirteen studies used  psycho-educational interventions  , and all but one showed positive results across a range of outcomes . Eight studies were entered in a meta- analysis . No significant impact of psycho-educational interventions was found for the outcome categories of subjective well-being , self-efficacy or health . However , small but significant results were found for the categories of depression and burden . Support Seven studies discussed support only interventions and two of these showed significant results . These two studies were suitable for meta- analysis and demonstrated a small but significant improvement on caregiver burden . Multi-component Twelve of the studies report multi-component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self-efficacy , depression , subjective well-being and burden . Unfortunately because of the heterogeneity of study design s and outcome measures , no meta- analysis was possible . Other interventions Other interventions included the use of exercise or nutrition which result ed in improvements in psychological distress and health benefits . Case management and a computer aided support intervention provided mixed results . One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour . EFFECTIVENESS OF INTERVENTIONS USING SPECIFIC OUTCOME CATEGORIES In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies . In particular the impact of interventions on caregiver depression was available for meta- analysis from eight studies . This indicated that multi-component and psycho-educational interventions showed a small but significant positive effect on caregiver depression . Five studies using the outcome category of caregiver burden  were entered into a meta- analysis and findings indicated that there were no significant effects of any of interventions . No meta- analysis was possible for the outcome categories of health , self-efficacy or subjective well-being . IMPLICATION S FOR PRACTICE From this review there is evidence to support the use of well- design ed psycho-educational or multi-component interventions for caregivers of people with dementia who live in the community . Factors that appear to positively contribute to effective interventions are those which : Factors which do not appear to have benefit in interventions are those which Introduction Unscheduled hospital admissions are an increasing burden on health systems worldwide . To date , initiatives to reduce admissions have had limited success as it is unclear which strategies effectively reduce admissions and are supported by a strong evidence -base . Therefore , we will conduct an overview to find , assess and summarise all published peer- review ed systematic review s of r and omised controlled trials that examine the effect of an intervention on  unplanned admissions among adults . Methods and analysis This is a protocol for a systematic overview of review s. We will search four data bases : Ovid MEDLINE , PubMed , Cochrane Data base of Systematic Review s and the Cochrane Data base of Abstract s of Review s of Effects . We will consider systematic review s and meta-analyses of r and omised controlled trials in adults ( ≥16 years old ) evaluating the effect of any intervention on unscheduled hospital admissions including those to treat , monitor , diagnose or prevent a health problem . We will only include review s that identified unscheduled hospitalisations as a prespecified outcome . Two authors will independently screen articles for inclusion using a priori criteria . We will assess the quality of included review s and extract ratings of the quality of evidence from within each review . We will create a hierarchical list of interventions based on estimates of absolute admission reductions and the quality of the evidence . Presentation of results will align with guidelines in the Cochrane H and book of Systematic Review s of Interventions and the Preferred Reporting Items for Systematic Review s and Meta- Analysis statement . Ethics and dissemination Ethics approval is not required . We will su bmi t the results of this study for peer- review publication . The results will inform future research and could be used by healthcare managers , administrators and policymakers to guide re source allocation decisions and inform local implementation and optimisation of interventions to reduce unscheduled hospital admissions OBJECTIVES To propose methods for mixed treatment comparisons ( MTC ) based on pooled summaries of the type produced in overviews of review s. STUDY DESIGN AND SETTING Overviews of review s ( umbrella review s ) summarize the results of multiple systematic review s into a single document . They report the summary estimates from the original pairwise meta-analyses and discuss them in narrative form , with the intention of identifying the most effective treatment . We present methods for MTC synthesis , tailored for use with overviews of review s. These generate a single internally consistent summary of all the relative treatment effects and assessment s of whether the summary is consistent with the data . These methods are applied to a published overview of treatments for childhood nocturnal enuresis . We apply the methods to both fixed-effect ( FE ) and r and om-effects ( RE ) meta-analyses of the original trials . RESULTS The summary relative risks based on FE meta-analyses , as originally published , were highly inconsistent . Those based on RE meta-analyses were consistent and could , given st and ard assumptions on comparability of treatment effects in meta- analysis , form a basis for coherent decision making . CONCLUSION Along with the summaries from systematic review s , MTC methods should be used in overviews to provide a single coherent analysis of all treatment comparisons and to check for evidence consistency 2011 ; 14 : 371–380 . 6 . Senn S , Gavini F , Magrez D , Scheen A. Issues in performing a network meta analysis . Statistical Methods in Medical Research 2013 ; 22 : 169–89 . 7 . Salanti G , Higgins JP , Ades A , Ioannidis JP . Evaluation of networks of r and omized trials . Statistical Methods in Medical Research 2008 ; 17 : 279– 301 . 8 . Song F , Clark A , Bachmann MO , Maas J. Simulation evaluation of statistical properties  of methods for indirect and mixed treatment comparisons . BMC Medical Research Methodology 2012 ; 12 : 1–14 . 9 . Jansen JP , Naci H. Is network meta- analysis as valid as st and ard pairwise meta- analysis ? It all depends on the distribution of effect modifers . BMC Medicine 2013 ; 11 : 1 . 10 . The Guidelines Manual . London : National Institute for Health and Clinical Excellence . 2012 . https://www . nice.org.uk/process/pmg6/chapter/6 review ing-the- evidence ( accessed 27/ 05/2017 ) . 11 . Kanters S , Ford N , Druyts E , et al. Use of network meta- analysis  in clinical guidelines . Bulletin of the World Health Organization 2016 ; 94 : 782–4 . 12 . Kiefer C , Sturtz S , Bender R. Indirect comparisons and network meta-analyses : estimation of effects in the absence of head-to-head trials . Deutsches € Arzteblatt International 2015 ; 112 : 803–8 . 13 . Imberger G , Gluud C , Boylan J , Wetterslev J. Systematic review s of anesthesiologic interventions reported as statistically significant : problems with power , precision , and type 1 error protection . Anesthesia and Analgesia 2015 ; 121 : 1611–22 . 14 . Afshari A , Wetterslev J , Smith AF . Can systematic review s with sparse data be trusted ? Anaesthesia 2017 ; 72 : 12–6 . 15 . Jakobsen JC , Wetterslev J , Lange T , Gluud C. Viewpoint : taking into account risks of r and om errors when analysing multiple outcomes in systematic review s. Cochrane Data base of Systematic Review s 2016 ; 3 : ED000111 . 16 . Jakobsen JC , Wetterslev J , Winkel P , Lange T , Gluud C. Thresholds for statistical and clinical significance in systematic review s with meta-analytic methods . BMC Medical Research Methodology 2014 ; 14 : 120 . 17 . Wetterslev J , Jakobsen JC , Gluud C. Trial Sequential Analysis in systematic review s with meta- analysis . BMC Medical Research Methodology 2017 ; 17 : 39 . 18 . Smith AF , Carlisle JC . Review s , systematic review s and Anaesthesia . Anaesthesia 2015 ; 70 : 644–70 . 19 . Cook TM , Kelly FE . The Difficult Airway Society 2015 guidelines and the sacred cows of routine airway management . Anaesthesia 2016 ; 71 : 466–7 . 20 . Schmitz S , Adams R , Walsh C. Incorporating data from various trial design s into a mixed treatment comparison model . Statistics in Medicine 2013 ; 32 : 2935–49 . 21 . Marshall SD , P and it JJ . Radical evolution : the 2015 Difficult Airway Society guidelines for managing unanticipated difficult or failed tracheal intubation . Anaesthesia 2016 ; 71 : 131–7 . 22 . Black AE , Flynn PE , Smith HL , Thomas ML , Wilkinson KA . Association of Pediatric Anaesthetists of Great Britain and Irel and . Development of a guideline for the management of the unanticipated difficult airway in pediatric practice . Pediatric Anaesthesia 2015 ; 25 : 346–62 . 23 . Hagberg CA , Gabel JC , Connis RT . Difficult Airway Society 2015 guidelines for the management of unanticipated difficult intubation in adults : not just another algorithm . British Journal of Anaesthesia 2015 ; 115 : 812–4 . 24 . Martin-Castro C , Montero A.  Flexible laryngeal mask as an alternative to reinforced tracheal tube for upper chest , head and neck oncoplastic surgery . European Journal of Anaesthesiology 2008 ; 25 : 261–6 . 25 . Maclennan A , Smith AF . An analysis of critical incidents relevant to paediatric anaesthesia reported to the UK National Reporting and Learning System , 2006 - 2008 . Pediatric Anesthesia 2011 ; 21 : 841–7 . 26 . P and it JJ , Popat MT , Cook TM , et al. The Difficult Airway Society ‘ ADEPT ’ Guidance on selecting airway devices : the basis of a strategy for equipment evaluation . Anaesthesia 2011 ; 66 : 726–37 Introduction : The aim of this quantitative systematic review /meta- analysis was to compare the treatment outcomes of mineral trioxide aggregate ( MTA ) and calcium hydroxide ( CH ) in pulpotomy of human primary molars . The focused PICO question was “ in case of pulp exposure in vital primary molars , how does MTA pulpotomy compare to CH in terms of clinical /radiographic success ? ” Methods and Material s : We retrieved published r and omized clinical trials ( RCTs ) of at least 6-month duration ; our search included articles published up to March 2013 in five following data bases : PubMed ( Medline ) , Cochrane data base of systematic review s , Science Citation Index , EMBASE , and Google Scholar . Mantel Haenszel and Inverse Variance-weighted methods were applied by STATA ; the relative risk ( RR ) was calculated with 95 % confidence intervals ( CI ) . Results : A total of 282 English articles were collected . Two authors independently screened the articles and five RCTs were selected ; data extraction and quality assessment were then carried out . Four RCTs were appropriate for meta- analysis according to their follow-up times by Mantel Haenszel method . Statistically significant difference was found between success rate of MTA compared to CH , with RR=0.08 ( 95 % CI , 0.02 - 0.39 ) , RR=0.19 ( 95 % CI , 0.08 - 0.46 ) , and RR=0.38 ( 95 % CI , 0.21 - 0.68 ) for 6- , 12- , and 24-month follow-ups , respectively . A significant difference was also observed for all included RCTs after analyses using the Inverse Variance-weighted method ( RR=0.44 ; 95 % CI , 0.27 - 0.72 ) . Conclusions : Systematic review /meta- analysis of included RCTs revealed that for pulpotomy of vital primary molars , MTA has better treatment outcomes compared to CH Objectives The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . Inclusion criteria Types of participants Adult caregivers who provide support for people with dementia living in the community ( non‐institutional care ) . Types of interventions Interventions design ed to support caregivers in their role such as skills training , education to assist in caring for a person living with dementia and support groups/programs . Interventions of formal approaches to care design ed to support caregivers in their role , care planning , case management and specially design ated members of the healthcare team ‐ for example dementia nurse specialist or volunteers trained in caring for someone with dementia . Types of studies This review considered any meta‐analyses , systematic review s , r and omised control trials , quasi‐experimental studies , cohort studies , case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . Search strategy The search sought to identify published studies from 2000 to 2005 through the use of electronic data bases . Only studies in English were considered for inclusion . The initial search was conducted of the data bases , CINAHL , MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group . A second more extensive search was then conducted using the appropriate Medical Subject Headings ( MeSH ) and keywords for other available data bases . Finally , h and search ing of reference lists of articles retrieved and of core dementia , geriatric and psycho geriatric journals was undertaken . Assessment of quality Method ological quality of each of the articles was assessed by two independent review ers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Review s and Dissemination . Data collection and analysis St and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each included study reported in the meta‐ analysis . Results from comparable groups of studies were pooled in statistical meta‐ analysis using Review Manager Software from the Cochrane Collaboration . Heterogeneity between combined studies was tested using st and ard chi‐square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . Results A comprehensive search of relevant data bases , h and search ing and cross referencing found 685 articles that were assessed for relevance to the review . Eighty‐five papers appeared to meet the inclusion criteria based on title and abstract , and the full paper was retrieved . Of the 85 full papers review ed , 40 were accepted for inclusion , three were systematic review s , three were meta‐ analysis , and the remaining 34 were r and omised controlled trials . For the r and omised controlled trials that were able to be included in a meta‐ analysis , st and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each . Results from comparable groups of studies were pooled in statistical meta‐ analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi‐square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . The results are discussed in two main sections . Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression , health , subjective well‐being , self‐efficacy and burden . Secondly , results are reported by main outcome category . For each of these sections , meta‐ analysis was conducted where it was possible ; otherwise , a narrative summary describes the findings . Effectiveness of intervention type Four categories of intervention were included in the review ‐ psycho‐educational , support , multi‐component and other . Psycho‐educational Thirteen studies used  psycho‐educational interventions , and all but one showed positive results across a range of outcomes . Eight studies were entered in a meta‐ analysis . No significant impact of psycho‐educational interventions was found for the outcome categories of subjective well‐being , self‐efficacy or health . However , small but significant results were found for the categories of depression and burden . Support Seven studies discussed support only interventions and two of these showed significant results . These two studies were suitable for meta‐ analysis and demonstrated a small but significant improvement on caregiver burden . Multi‐component Twelve of the studies report multi‐component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self‐efficacy , depression , subjective well‐being and burden . Unfortunately because of the heterogeneity of study design s and outcome measures , no meta‐ analysis was possible . Other interventions Other interventions included the use of exercise or nutrition which result ed in improvements in psychological distress and health benefits .  Case management and a computer aided support intervention provided mixed results . One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour . Effectiveness of interventions using specific outcome categories In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies . In particular the impact of interventions on  caregiver depression was available for meta‐ analysis from eight studies . This indicated that multi‐component and psycho‐educational interventions showed a small but significant positive effect on caregiver depression . Five studies using the outcome category of caregiver burden  were entered into a meta‐ analysis and findings indicated that there were no significant effects of any of interventions . No meta‐ analysis was possible for the outcome categories of health , self‐efficacy or subjective well‐being . Implication s for practice From this review there is evidence to support the use of well‐ design ed psycho‐educational or multi‐component interventions for caregivers of people with dementia who live in the community . Factors that appear to positively contribute to effective interventions are those which : Provide opportunities within the intervention for the person with dementia as well as the caregiver to be involved Encourage active participation in educational interventions for caregivers Offer individualised programs rather than group sessions Provide information on an ongoing basis , with specific information about services and coaching regarding their new role Target the care recipient particularly by reduction in behaviours Factors which do not appear to have benefit in interventions are those which : Simply refer caregivers to support groups Only provide self help material s Only offer peer UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis  BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes . BACKGROUND Diabetes is a serious chronic condition affecting millions of people worldwide and is the sixth leading cause of death in Canada . In 2005 , an estimated 8.8 % of Ontario 's population had diabetes , representing more than 816,000 Ontarians . The direct health care cost of diabetes was $ 1.76 billion in the year 2000 and is projected to rise to a total cost of $ 3.14 billion by 2016 . Much of this cost arises from the serious long-term complications associated with the disease including : coronary heart disease , stroke , adult blindness , limb amputations and kidney disease . Type 2 diabetes accounts for 90 - 95 % of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older , prevalence in younger population s is increasing due to a rise in obesity and physical inactivity in children . Data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics . Despite physicians ' and patients ' knowledge of the importance of glycemic control , Canadian data has shown that only 38 % of patients with diabetes have HbA1C levels in the optimal range of 7 % or less . This statistic highlights the complexities involved in the management of diabetes , which is characterized by extensive patient involvement in addition to the support provided by physicians . An enormous dem and is , therefore , placed on patients to self-manage the physical , emotional and psychological aspects of living with a chronic illness . Despite differences in individual needs to cope with diabetes , there is general agreement for the necessity of supportive programs for patient self-management . While traditional programs were didactic models with the goal of improving patients ' knowledge of their disease , current models focus on behavioural approaches aim ed at providing patients with the skills and strategies required to promote and change their behaviour . Several meta-analyses and systematic review s have demonstrated improved health outcomes with  self-management support programs in type 2 diabetics . They have all , however , either looked at a specific component of self-management support programs ( i.e. self-management education ) or have been conducted in specific population s. Most review s are also qualitative and do not clearly define the interventions of interest , making findings difficult to interpret . Moreover , heterogeneity in the interventions has led to conflicting evidence on the components of effective programs . There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers . EVIDENCE -BASED ANALYSIS OF EFFECTIVENESS : RESEARCH QUESTIONS Are behavioural interventions  effective in improving glycemic control in adults with type 2 diabetes?Is the effectiveness of the intervention impacted by intervention characteristics ( e.g. delivery of intervention , length of intervention , mode of instruction , interventionist etc . ) ? INCLUSION CRITERIA English Language Published between January 1996 to August 2008 Type 2 diabetic adult population ( > 18 years)R and omized controlled trials ( RCTs ) Systematic review s , or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control ( HbA1c ) with extractable data Studies with a minimum of 6-month follow up EXCLUSION CRITERIA Studies with a control group other than usual care Studies with a sample size < 30 Studies without a clearly defined intervention OUTCOMES OF INTEREST PRIMARY OUTCOME glycemic control ( HbA1c ) SECONDARY OUTCOMES systolic blood pressure ( SBP ) control , lipid control , change in smoking status , weight change , quality of life , knowledge , self-efficacy , managing psychosocial aspects of diabetes , assessing dissatisfaction and readiness to change , and setting and achieving diabetes goals . SEARCH STRATEGY A search was performed in OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , The Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1996 and August 2008 . Abstract s were review ed by a single author and studies meeting the inclusion criteria outlined above were obtained . Data on population characteristics , glycemic control outcomes , and study design were extracted . Reference lists were also checked for relevant studies . The quality of the evidence was assessed as being either high , moderate , low , or very low according to the GRADE methodology . SUMMARY OF FINDINGS The search identified 638 citations published between 1996 and August 2008 , of which 12 met the inclusion criteria and one was a meta- analysis ( Gary et al. 2003 ) . The remaining 11 studies were RCTs ( 9 were used in the meta- analysis ) and only one was defined as small ( total sample size N=47 ) . SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES : A total of 2,549 participants were included in the 11 identified studies . The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years . Most studies reported gender with a mean percentage of females of approximately 67 % . Of the eleven studies , two focused only on women and four included only Hispanic individuals . All studies evaluated type 2 diabetes patients exclusively . STUDY CHARACTERISTICS : The studies were conducted between 2002 and 2008 . Approximately six of 11 studies were carried out within the USA , with the remaining studies conducted in the UK , Sweden , and Israel ( sample size ranged from 47 to 824 participants ) . The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality ( based on the Consort Checklist ) . Differences in quality were mainly due to method ological issues such as inadequate description of r and omization , sample size calculation allocation concealment , blinding and uncertainty of the use of intention-to-treat ( ITT ) analysis . Patients were recruited from several setting s : six studies from primary or general medical practice s , three studies from the community ( e.g. via advertisements ) , and two from outpatient diabetes clinics . A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group . INTERVENTION CHARACTERISTICS : All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide . The interventions most often focused on problem solving , goal setting and encouraging participants to engage in activities that protect and promote health ( e.g. modifying behaviour , change in diet , and increase physical activity ) . All of the studies examined comprehensive interventions targeted at least two self-care topics ( e.g. diet , physical activity , blood glucose monitoring , foot care , etc . ) . Despite the homogeneity in the aims of the interventions , there was substantial clinical heterogeneity in other intervention characteristics such as duration , intensity , setting , mode of delivery ( group vs. individual ) , interventionist , and outcomes of interest ( discussed below ) . DURATION , INTENSITY AND MODE OF DELIVERY : Intervention duration s ranged from 2 days to 1 year , with many falling into the range of 6 to 10 weeks . The rest of the interventions fell into categories of ≤ 2 weeks ( 2 studies ) , 6 months ( 2 studies ) , or 1 year ( 3 studies ) . Intensity of the interventions varied widely from 6 hours over 2 days , to 52 hours over 1 year ; however , the majority consisted of interventions of 6 to 15 hours . Both individual and group sessions were used to deliver interventions . Group counselling was used in five studies as a mode of instruction , three studies used both individual and group sessions , and one study used individual sessions as its sole mode of instruction . ( ABSTRACT UNLABELLED In July 2009 , the Medical Advisory Secretariat ( MAS ) began work on Non-Invasive Cardiac Imaging Technologies for the Diagnosis of Coronary Artery Disease ( CAD ) , an evidence -based review of the literature surrounding different cardiac imaging modalities to ensure that appropriate technologies are accessed by patients suspected of having CAD . This project came about when the Health Services Branch at the Ministry of Health and Long-Term Care asked MAS to provide an evidentiary platform on effectiveness and cost-effectiveness of non-invasive cardiac imaging modalities . After an initial review of the strategy and consultation with experts , MAS identified five key non-invasive cardiac imaging technologies for the diagnosis of CAD . Evidence -based analyses have been prepared for each of these five imaging modalities : cardiac magnetic resonance imaging , single photon emission computed tomography , 64-slice computed tomographic angiography , stress echocardiography , and stress echocardiography with contrast . For each technology , an economic analysis was also completed ( where appropriate ) . A summary decision analytic model was then developed to encapsulate the data from each of these reports ( available on the OHTAC and MAS website).The Non-Invasive Cardiac Imaging Technologies for the Diagnosis of Coronary Artery Disease series is made up of the following reports , which can be publicly accessed at the MAS website at : www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlSINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE : An Evidence -Based Analysis STRESS ECHOCARDIOGRAPHY FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE : An Evidence -Based Analysis STRESS ECHOCARDIOGRAPHY WITH CONTRAST FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE : An Evidence -Based Analysis 64-Slice Computed Tomographic Angiography for the Diagnosis of Coronary Artery Disease : An Evidence -Based Analysis CARDIAC MAGNETIC RESONANCE IMAGING FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE : An Evidence -Based Analysis Pease note that two related evidence -based analyses of non-invasive cardiac imaging technologies for the assessment of myocardial viability are also available on the MAS website : POSITRON EMISSION TOMOGRAPHY FOR THE ASSESSMENT OF MYOCARDIAL VIABILITY : An Evidence -Based Analysis MAGNETIC RESONANCE IMAGING FOR THE ASSESSMENT OF MYOCARDIAL VIABILITY : an Evidence -Based Analysis The Toronto Health Economics and Technology Assessment Collaborative has also produced an associated economic report entitled : The Relative Cost-effectiveness of Five Non-invasive Cardiac Imaging Technologies for Diagnosing Coronary Artery Disease in Ontario [ Internet ] . Available from : http://theta.utoronto.ca/reports/?id=7 OBJECTIVE The objective of the analysis is to determine the diagnostic accuracy of single photon emission tomography ( SPECT ) in the diagnosis of coronary artery disease ( CAD ) compared to the reference st and ard of coronary angiography ( CA ) . The analysis is primarily meant to allow for indirect comparisons between non-invasive strategies for the diagnosis of CAD , using CA as a reference st and ard . SPECT : Cardiac SPECT , or myocardial perfusion scintigraphy ( MPS ) , is a widely used nuclear , non-invasive image acquisition technique for investigating ischemic heart disease . SPECT is currently appropriate for all aspects of detecting and managing ischemic heart disease including diagnosis , risk assessment /stratification , assessment of myocardial viability , and the evaluation of left ventricular function . Myocardial perfusion scintigraphy was originally developed as a two-dimensional planar imaging technique , but SPECT acquisition has since become the clinical st and ard in current practice . Cardiac SPECT for the diagnosis of CAD uses an intravenously administered radiopharmaceutical tracer to evaluate regional coronary blood flow usually at rest and after stress . The radioactive tracers thallium ( 201Tl ) or technetium-99 m ( 99mTc ) , or both , may be used to visualize the SPECT acquisition . Exercise or a pharmacologic agent is used to achieve stress . After the administration of the tracer , its distribution within the myocardium ( which is dependent on myocardial blood flow ) is imaged using a gamma camera . In SPECT imaging , the gamma camera rotates around the patients for 10 to 20 minutes so that multiple two-dimensional projections are acquired from various angles . The raw data are then processed using computational algorithms to obtain three-dimensional tomographic images . Since its inception , SPECT has evolved and its techniques/applications have become increasingly more complex and numerous . Accordingly , new techniques such as attenuation correction and ECG gating have been developed to correct for attenuation due to motion or soft-tissue artifact and to improve overall image clarity . RESEARCH QUESTIONS What is the diagnostic accuracy of SPECT for the diagnosis of CAD compared to the reference st and ard of CA?Is  SPECT cost-effective compared to other non-invasive cardiac imaging modalities for the diagnosis of CAD?What are the major safety concerns with SPECT when used for the diagnosis of CAD ? METHODS A preliminary literature search was performed across OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for all systematic review s/meta- analysis published between January 1 , 2004 and August 22 , 2009 . A comprehensive systematic review was identified from this search and used as a basis for an up date d search . A second comprehensive literature search was then performed on October 30 , 2009 across the same data bases for studies published between January 1 , 2002 and October 30 , 2009 . Abstract s were review ed by a single review er and , for those studies meeting the eligibility criteria , full-text articles were obtained . Reference lists were also h and - search ed for any additional studies . Inclusion Criteria Exclusion Criteria Systematic review s , meta-analyses , controlled clinical trials , and observational studies Minimum sample size of 20 patients who completed coronary angiographyUse of CA as a reference st and ard for the diagnosis of CAD Data available to calculate true positives ( TP ) , false positives ( FP ) , false negatives ( FN ) and true negatives (TN)Accuracy data reported by patient not by segmentEnglish language Non- systematic review s , case reportsGrey literature and abstract sTrials using planar imaging onlyTrials conducted in patients with non-ischemic heart disease Studies done exclusively in special population s ( e.g. , patients with left branch bundle block , diabetics , minority population s ) unless insufficient data available SUMMARY OF FINDINGS Eighty-four observational studies , one non-r and omized , single arm controlled clinical trial , and one poorly reported trial that appeared to be a r and omized controlled trial ( RCT ) met the inclusion criteria for this review . All studies assessed the diagnostic accuracy of myocardial perfusion SPECT  for the diagnosis of CAD using CA as a reference st and ard . Based on the results of these studies the following conclusions were made : According to very low quality evidence , the addition of attenuation correction to traditional or ECG-gated SPECT greatly improves the specificity of SPECT  for the diagnosis of CAD although this improvement is not statistically significant . A trend towards improvement of specificity was also observed with the addition of ECG gating to traditional SPECT.According to very low quality evidence , neither the choice of stress agent ( exercise or pharmacologic ) nor the choice of radioactive tracer ( technetium vs. thallium ) significantly affect the diagnostic accuracy of SPECT  for the diagnosis of CAD although a trend towards accuracy improvement was observed with the use of pharmacologic stress over exercise stress and technetium over thallium . Considerably heterogeneity was observed both within and between trials . This heterogeneity may explain why some of the differences observed between accuracy estimates for various subgroups were not statistically significant . More complex analytic techniques such as meta-regression may help to better underst and which study characteristics significantly influence the diagnostic accuracy of SPECT BACKGROUND Systematic review s may be compromised by selective inclusion and reporting of outcomes and analyses . Selective inclusion occurs when there are multiple effect estimates in a trial report that could be included in a particular meta- analysis ( e.g. from multiple measurement scales and time points ) and the choice of effect estimate to include in the meta- analysis is based on the results ( e.g. statistical significance , magnitude or direction of effect ) . Selective reporting occurs when the reporting of a subset of outcomes and analyses in the systematic review is based on the results ( e.g. a protocol -defined outcome is omitted from the published systematic review ) . OBJECTIVES To summarise the characteristics and synthesis e the results of empirical studies that have investigated the prevalence of selective inclusion or reporting in systematic review s of r and omised controlled trials ( RCTs ) , investigated the factors ( e.g. statistical significance or direction of effect ) associated with the prevalence and quantified the bias . SEARCH METHODS We search ed the Cochrane Methodology Register ( to July 2012 ) , Ovid MEDLINE , Ovid EMBASE , Ovid PsycINFO and ISI Web of Science ( each up to May 2013 ) , and the US Agency for Healthcare Research and Quality ( AHRQ ) Effective Healthcare Program 's Scientific Re source Center ( SRC ) Methods Library ( to June 2013 ) . We also search ed the abstract books of the 2011 and 2012 Cochrane Colloquia and the article alerts for method ological work in research synthesis published from 2009 to 2011 and compiled in Research Synthesis Methods . SELECTION CRITERIA We included both published and unpublished empirical studies that investigated the prevalence and factors associated with selective inclusion or reporting , or both , in systematic review s of RCTs of healthcare interventions . We included empirical studies assessing any type of selective inclusion or reporting , such as investigations of how frequently RCT outcome data is selectively included in systematic review s based on the results , outcomes and analyses are discrepant between protocol and published review or non-significant outcomes are partially reported in the full text or summary within systematic review s. DATA COLLECTION AND ANALYSIS Two review authors independently selected empirical studies for inclusion , extracted the data and performed a risk of bias assessment . A third review author resolved any disagreements about inclusion or exclusion of empirical studies , data extraction and risk of bias . We contacted authors of included studies for additional unpublished data . Primary outcomes included overall prevalence of selective inclusion or reporting , association between selective inclusion or reporting and the statistical significance of the effect estimate , and association between selective inclusion or reporting and the direction of the effect estimate . We combined prevalence estimates and risk ratios ( RRs ) using a r and om-effects meta- analysis model . MAIN RESULTS Seven studies met the inclusion criteria . No studies had investigated selective inclusion of results in systematic review s , or discrepancies in outcomes and analyses between systematic review registry entries and published systematic review s. Based on a meta- analysis of four studies ( including 485 Cochrane Review s ) , 38 % ( 95 % confidence interval ( CI ) 23 % to 54 % ) of systematic review s added , omitted , up grade d or down grade d at least one outcome between the protocol and published systematic review . The association between statistical significance and discrepant outcome reporting between protocol and published systematic review was uncertain . The meta-analytic estimate suggested an increased risk of adding or upgrading ( i.e. changing a secondary outcome to primary ) when the outcome was statistically significant , although the 95 % CI included no association and a decreased risk as plausible estimates ( RR 1.43 , 95 % CI 0.71 to 2.85 ; two studies , n = 552 meta-analyses ) . Also , the meta-analytic estimate suggested an increased risk of downgrading ( i.e. changing a primary outcome to secondary ) when the outcome was statistically significant , although the 95 % CI included no association and a decreased risk as plausible estimates ( RR 1.26 , 95 % CI 0.60 to 2.62 ; two studies , n = 484 meta-analyses ) . None of the included studies had investigated whether the association between statistical significance and adding , upgrading or downgrading of outcomes was modified by the type of comparison , direction of effect or type of outcome ; or whether there is an association between direction of the effect estimate and discrepant outcome reporting . Several secondary outcomes were reported in the included studies . Two studies found that reasons for discrepant outcome reporting were infrequently reported in published systematic review s ( 6 % in one study and 22 % in the other ) . One study ( including 62 Cochrane Review s ) found that 32 % ( 95 % CI 21 % to 45 % ) of systematic review s did not report all primary outcomes in the abstract . Another study ( including 64 Cochrane and 118 non-Cochrane review s ) found that statistically significant primary outcomes were more likely to be completely reported in the systematic review abstract than non-significant primary outcomes ( RR 2.66 , 95 % CI 1.81 to 3.90 ) . None of the studies included systematic review s published after 2009 when reporting st and ards for systematic review s ( Preferred Reporting Items for Systematic review s and Meta-Analyses ( PRISMA ) Statement , and Method ological Expectations of Cochrane Intervention Review s ( MECIR ) ) were disseminated , so the results might not be generalisable to more recent systematic review s. AUTHORS ' CONCLUSIONS Discrepant outcome reporting between the protocol and published systematic review is fairly common , although the association between statistical significance and discrepant outcome reporting is uncertain . Complete reporting of outcomes in systematic review abstract s is associated with statistical significance of the results for those outcomes . Systematic review outcomes and analysis plans should be specified prior to seeing the results of included studies to minimise post-hoc decisions that may be based on the observed results . Modifications that occur once the review has commenced , along with their justification , should be clearly reported . Effect estimates and CIs should be reported for all systematic review outcomes regardless of the results . The lack of research on selective inclusion of results in systematic review s needs to be addressed and studies that avoid the method ological weaknesses of existing research are also needed UNLABELLED In August 2008 , the Medical Advisory Secretariat ( MAS ) presented a vignette to the Ontario Health Technology Advisory Committee ( OHTAC ) on a proposed targeted health care delivery model for chronic care . The proposed model was defined as multidisciplinary , ambulatory , community-based care that bridged the gap between primary and tertiary care , and was intended for individuals with a chronic disease who were at risk of a hospital admission or emergency department visit . The goals of this care model were thought to include : the prevention of emergency department visits , a reduction in hospital admissions and re-admissions , facilitation of earlier hospital discharge , a reduction or delay in long-term care admissions , and an improvement in mortality and other disease-specific patient outcomes .OHTAC approved the development of an evidence -based assessment to determine the effectiveness of specialized community based care for the management of  heart failure , Type 2 diabetes and chronic wounds .  PLEASE VISIT THE MEDICAL ADVISORY SECRETARIAT WEB SITE AT : www.health.gov.on.ca/ohtas to review the following reports associated with the Specialized Multidisciplinary Community-Based care series . Specialized multidisciplinary community-based care series : a summary of evidence -based analysesCommunity-based care for the specialized management of heart failure : an evidence -based analysis Community-based care for chronic wound management : an evidence -based analysis Please note that the evidence -based analysis of specialized community-based care for the management of diabetes titled : " Community-based care for the management of type 2 diabetes : an evidence -based analysis " has been published as part of the Diabetes Strategy Evidence Platform at this URL : http://www.health.gov.on.ca/english/providers/program/mas/tech/ohtas/tech_diabetes_20091020.htmlPLEASE VISIT THE TORONTO HEALTH ECONOMICS AND TECHNOLOGY ASSESSMENT COLLABORATIVE WEB SITE AT : http://theta.utoronto.ca/papers/MAS_CHF_Clinics_Report.pdf to review the following economic project associated with this series : Community-based Care for the specialized management of heart failure : a cost-effectiveness and budget impact analysis . OBJECTIVE The objective of this evidence -based review is to determine the effectiveness of a multidisciplinary wound care team for the management of chronic wounds . CLINICAL NEED CONDITION AND TARGET POPULATION Chronic wounds develop from various aetiologies including pressure , diabetes , venous pathology , and surgery . A pressure ulcer is defined as a localized injury to the skin/ and or underlying tissue occurring most often over a bony prominence and caused , alone or in combination , by pressure , shear , or friction . Up to three fifths of venous leg ulcers are due to venous aetiology . Approximately 1.5 million Ontarians will sustain a pressure ulcer , 111,000 will develop a diabetic foot ulcer , and between 80,000 and 130,000 will develop a venous leg ulcer . Up to 65 % of those afflicted by chronic leg ulcers report experiencing decreased quality of life , restricted mobility , anxiety , depression , and /or severe or continuous pain . MULTIDISCIPLINARY WOUND CARE TEAMS : The term ' multidisciplinary ' refers to multiple disciplines on a team and ' interdisciplinary ' to such a team functioning in a coordinated and collaborative manner . There is general consensus that a group of multidisciplinary professionals is necessary for optimum specialist management of chronic wounds stemming from all aetiologies . However , there is little evidence to guide the decision of which professionals might be needed form an optimal wound care team . EVIDENCE -BASED ANALYSIS METHODS LITERATURE SEARCH A literature search was performed on July 7 , 2009 using OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , OVID EMBASE , Wiley Cochrane , Centre for Review s and Dissemination/International Agency for Health Technology Assessment , and on July 13 , 2009 using the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , and the International Agency for Health Technology Assessment ( INAHTA ) for studies pertaining to leg and foot ulcers . A similar literature search was conducted on July 29 ' 2009 for studies pertaining to pressure ulcers . Abstract s were review ed by a single review er and , for those studies meeting the eligibility criteria , full-text articles were obtained . Reference lists were also examined for any additional relevant studies not identified through the search . Articles with an unknown eligibility were review ed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established . INCLUSION CRITERIA R and omized controlled trials and Controlled clinical Trials ( CCT ) Systematic review with meta analysis Population includes persons with pressure ulcers ( anywhere ) and /or leg and foot ulcersThe intervention includes a multidisciplinary ( two or more disciplines ) wound care team . The control group does not receive care by a wound care team Studies published in the English language between 2004 and 2009 EXCLUSION CRITERIA : Single centre retrospective observational studies OUTCOMES OF INTEREST Proportion of persons and /or wounds completely healedTime to complete healing Quality of LifePain assessment SUMMARY OF FINDINGS Two studies met the inclusion and exclusion criteria , one a r and omized controlled trial ( RCT ) , the other a CCT using a before and after study design . There was variation in the setting , composition of the wound care team , outcome measures , and follow up periods between the studies . In both studies , however , the wound care team members received training in wound care management and followed a wound care management protocol . In the RCT , Vu et al. reported a non-significant difference between the proportion of wounds healed in 6 months using a univariate analysis ( 61.7 % for treatment vs. 52.5 % for control ; p=0.074 , RR=1.19 ) There was also a non-significant difference in the mean time to healing in days ( 82 for treatment vs. 101 for control ; p=0.095 ) . More persons in the intervention group had a Brief Pain Inventory ( BPI ) score equal to zero ( better pain control ) at 6 months when compared with the control group ( 38.6 % for intervention vs. 24.4 % for control ; p=0.017 , RR=1.58 ) . By multivariate analysis a statistically significant hazard ratio was reported in the intervention group ( 1.73 , 95 % CI 1.20 - 1.50 ; p=0.003 ) . In the CCT , Harrison et al. reported a statistically significant difference in healing rates between the pre ( control ) and post ( intervention ) phases of the study . Of patients in the pre phase , 23 % had healed ulcers 3 months after study enrolment , whereas 56 % were healed in the post phase ( P<0.001 , OR=4.17 ) ( Figure 3 ) . Furthermore , 27 % of patients were treated daily or more often in the pre phase whereas only 6 % were treated at this frequency in the post phase ( P<0.001 ) , equal to a 34 % relative risk reduction in frequency of daily treatments . The authors did not report the results of pain relief assessment . The body of evidence was assessed using the GRADE methodology for 4 outcomes : proportion of wounds healed , proportion of persons with healed wounds , wound associated pain relief , and proportion of persons needing daily wound treatments . In general , the evidence was found to be low to very low quality . CONCLUSION The evidence supports that managing chronic wounds with a multidisciplinary wound care team significantly increases wound healing and reduces the severity of wound-associated pain and the required daily wound treatments compared to persons not managed by a wound care team . The quality of evidence supporting these outcomes is low to very low meaning that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Background The ideal evidence to answer a question about the effectiveness of treatment is a systematic review . However , for many clinical questions a systematic review will not be available , or may not be up to date . One option could be to use the evidence from an individual trial to answer the question ? Methods We assessed how often ( a ) the estimated effect and ( b ) the p-value in the most precise single trial in a meta- analysis agreed with the whole meta- analysis . For a r and om sample of 200 completed Cochrane Review s ( January , 2005 ) we identified a primary outcome and extracted : the number of trials , the statistical weight of the most precise trial , the estimate and confidence interval for both the highest weighted trial and the meta- analysis overall . We calculated the p-value for the most precise trial and meta- analysis . Results Of 200 review s , only 132 provided a meta- analysis of 2 or more trials , with a further 35 effect estimates based on single trials . The average number of trials was 7.3 , with the most precise trial contributing , on average , 51 % of the statistical weight to the summary estimate from the whole meta- analysis . The estimates of effect from the most precise trial and the overall meta-analyses were highly correlated ( rank correlation of 0.90).There was an 81 % agreement in statistical conclusions . Results from the most precise trial were statistically significant in 60 of the 167 evaluable review s , with 55 of the corresponding systematic review s also being statistically significant . The five discrepant results were not strikingly different with respect to their estimates of effect , but showed considerable statistical heterogeneity between trials in these meta-analyses . However , among the 101 cases in which the most precise trial was not statistically significant , the corresponding meta-analyses yielded 31 statistically significant results . Conclusions Single most precise trials provided similar estimates of effects to those of the meta-analyses to which they contributed , and statistically significant results are generally in agreement . However , " negative " results were less reliable , as may be expected from single underpowered trials . For systematic review ers we suggest that : ( 1 ) key trial(s ) in a review deserve greater attention ( 2 ) systematic review ers should check agreement of the most precise trial and the meta analysis . For clinicians using trials we suggest that when a meta- analysis is not available , a focus on the most precise trial is reasonable provided it is adequately powered Background Computerized clinical decision support systems are information technology-based systems design ed to improve clinical decision-making . As with any healthcare intervention with cl aims to improve process of care or patient outcomes , decision support systems should be rigorously evaluated before widespread dissemination into clinical practice . Engaging healthcare providers and managers in the review process may facilitate knowledge translation and uptake . The objective of this research was to form a partnership of healthcare providers , managers , and research ers to review r and omized controlled trials assessing the effects of computerized decision support for six clinical application areas : primary preventive care , therapeutic drug monitoring and dosing , drug prescribing , chronic disease management , diagnostic test ordering and interpretation , and acute care management ; and to identify study characteristics that predict benefit . Methods The review was undertaken by the Health Information Research Unit , McMaster University , in partnership with Hamilton Health Sciences , the Hamilton , Niagara , Haldim and , and Brant Local Health Integration Network , and pertinent healthcare service teams . Following agreement on information needs and interests with decision-makers , our earlier systematic review was up date d by search ing Medline , EMBASE , EBM Review data bases , and Inspec , and review ing reference lists through 6 January 2010 . Data extraction items were exp and ed according to input from decision-makers . Authors of primary studies were contacted to confirm data and to provide additional information . Eligible trials were organized according to clinical area of application . We included r and omized controlled trials that evaluated the effect on practitioner performance or patient outcomes of patient care provided with a  computerized clinical decision support system compared with patient care without such a system . Results Data will be summarized using descriptive summary measures , including proportions for categorical variables and means for continuous variables . Univariable and multivariable logistic regression models will be used to investigate associations between outcomes of interest and study specific covariates . When reporting results from individual studies , we will cite the measures of association and p-values reported in the studies . If appropriate for groups of studies with similar features , we will conduct meta-analyses . Conclusion A decision-maker- research er partnership provides a model for systematic review s that may foster knowledge translation and uptake Introduction Systematic review er authors intending to include all r and omized participants in their meta-analyses need to make assumptions about the outcomes of participants with missing data . Objective The objective of this paper is to provide systematic review er authors with a relatively simple guidance for addressing dichotomous data for participants excluded from analyses of r and omized trials . Methods This guide is based on a review of the Cochrane h and book and published method ological research . The guide deals with participants excluded from the analysis who were considered ‘ non-adherent to the protocol ’ but for whom data are available , and participants with missing data . Results Systematic review er authors should include data from ‘ non-adherent ’ participants excluded from the primary study authors ' analysis but for whom data are available . For missing , unavailable participant data , authors may conduct a complete case analysis ( excluding those with missing data ) as the primary analysis . Alternatively , they may conduct a primary analysis that makes plausible assumptions about the outcomes of participants with missing data . When the primary analysis suggests important benefit , sensitivity meta-analyses using relatively extreme assumptions that may vary in plausibility can inform the extent to which risk of bias impacts the confidence in the results of the primary analysis . The more plausible assumptions draw on the outcome event rates within the trial or in all trials included in the meta- analysis . The proposed guide does not take into account the uncertainty associated with assumed events . Conclusions This guide proposes methods for h and ling participants excluded from analyses of r and omized trials . These methods can help in establishing the extent to which risk of bias impacts meta- analysis results OBJECTIVES To assess the type of evidence that supported our management of surgical patients . DESIGN Retrospective audit . SETTING Teaching hospital , Republic of Irel and . PATIENTS All 222 patients admitted by two surgical teams during one month . Patients admitted for diagnostic procedures were included if they were treated as a result . MAIN OUTCOME MEASURES Diagnosis and treatment were established from the notes . Evidence for each intervention was then sought in MEDLINE 1986 - 1999 , Best Evidence 1991 - 1999 , and the Cochrane Data base of Systematic Review s Issue 3 , 1999 , and grade d into one of five categories : systematic review , meta- analysis , r and omised controlled trial , prospect i ve study , or retrospective study . RESULTS Treatment was supported by systematic review in 14 , by meta- analysis in 12 , by r and omised controlled trial in 75 , by prospect i ve studies in 55 , by retrospective studies in 58 , and by no evidence in 8 . CONCLUSIONS Everyday surgical practice in our unit is supported by good quality evidence from recent publications In many areas of medicine the amount of published information is increasing at an exponential rate , making it difficult for the clinician to condense the data to a manageable amount of valuable and useful information . Systematic review s have been suggested as a remedy for this information overload . Such review s are regarded as the highest level of evidence . Certain statistical methods , e.g. , meta- analysis , have also been introduced for the calculation of a more comprehensive summation of the compiled results from studies with small sample sizes . These findings would then serve as an authoritarian guide for evidence -based practice . Endodontists have lately jumped on the b and wagon of systematic review s and meta-analyses , and papers on various topics are being published . Well done , such comprehensive information would be very useful and authoritative for the practitioner . Alarmingly , the quality of these recent publications is negatively correlated to the frequency . This can have serious consequences in the clinical arena if spurious information is given a seal of approval when communicated as facts in refereed journals . A systematic literature review is design ed to focus on a single question and to synthesize all high- quality research reports relevant to the question . In these studies , however , sources of bias are often not controlled . Therefore , even the best review and meta- analysis becomes useless if it is based on poorly design ed research . Furthermore , these review s are mostly based on published data which are too often biased toward studies that show significant differences in results and /or outcome . “ Uninteresting ” conclusions tend not to be published . Endodontic literature , thus far , is short on well design ed and executed r and omized clinical trials . Furthermore , clinical protocol s often have many important “ proprietary ” modifications that make comparison difficult . This makes it very hard to undertake a systematic review to answer a narrow question . Such GIGO ( garbage in , garbage out ) can easily lead to biased conclusions and reinforce already existing biased comclusions . An example of such bias can be illustrated by a meta- analysis recently published . The study focused on assessing if there were differences in outcome between 1 and 2 treatment visits when treating teeth with apical periodontitis . Relevant publications on this topic are rare , and with the narrow inclusion criteria only 3 investigations were available for the review . However , the only factors connecting these 3 studies was the words “ single ” and “ two visits ” in the title . Beyond that , the selected studies are too different and inadequate for the study . Only 1 study is somewhat demonstrably r and omized , and outcome assessment s are based on 3 vastly different criteria . Two of the studies use calcium hydroxide as intracanal dressing , whereas the third uses no intervisit medication . Complexity of initial pathology and healing time are also clearly factors of great importance but not controlled . In addition , sample sizes in the component studies as well as the final cohort are all too small for the conclusions that there was no significant difference between 1or 2-visit treatment protocol s. To undertake and publish a meta- analysis on such an incomplete sample is counterproductive . Although the publication noted its numerous limitations , it will still communicate erroneous conclusions with a poor scientific foundation to the less informed reader . There are other examples of recently published systematic review s that are very ambiguous and tend to communicate spurious facts . One of these studies looks at the effect of smear-layer removal on sealing ability of root canal obturation . The study is entirely limited to laboratory experiments , with the majority of evaluations using dye leakage which is generally considered to be unreliable . This is an example of review ers lacking content expertise . The authors draw the conclusion , using defective review material , that removal of smear layer enhances the seal of the root filling . We may generally believe that this is the truth We introduce the series of 7 tutorial papers on  evidence synthesis methods for decision making , based on the Technical Support Documents in Evidence Synthesis prepared for the National Institute for Health and Clinical Excellence ( NICE ) Decision Support Unit . Although oriented to NICE ’s Technology Appraisal process , which examines new pharmaceutical products in a cost-effectiveness framework , the methods presented throughout the tutorials are equally relevant to clinical guideline development and to comparisons between medical devices , or public health interventions . Detailed guidance is given on how to use the other tutorials in the series , which propose a single evidence synthesis framework that covers fixed and r and om effects models , pairwise meta- analysis , indirect comparisons , and network meta- analysis , and where outcomes expressed in several different reporting formats can be analyzed without recourse to normal approximations . We describe the principles of evidence synthesis required by the 2008 revision of the NICE Guide to the Methods of Technology Appraisal and explain how the approach proposed in these tutorials was design ed to conform to those requirements . We finish with some suggestions on how to present the evidence , the synthesis methods , and the results Background Twelve r and omised controlled trials ( RCTs ) comparing mechanical thrombectomy against traditional treatment options for patients experiencing acute ischaemic stroke ( AIS ) have been published . Aims To evaluate whether this technology is more effective and /or safer than traditional treatment options and to assess the potential for implementation of this technology as a treatment strategy for acute ischaemic stroke in Irel and . Methods RCTs published up to February 2017 were included . Meta- analysis was performed for two primary ( mortality at 90 days , mRS at 90 days ) and four secondary outcomes . Cumulative meta- analysis was used to investigate the point at which a consistent treatment effect was observed for outcomes that had a statistically significant pooled effect . Results Mechanical thrombectomy was associated with higher likelihood of being independent ( mRS , p < 0.01 ; Barthel index , p < 0.01 ) at 90 days post-AIS ( p < 0.001 ) . Cumulative meta- analysis demonstrated a consistent treatment effect in favour of mechanical thrombectomy after each trial was added to the analysis . There was no evidence of a difference in mortality rates ( p = 0.21 ) or rates of SICH ( p = 0.71 ) between patients r and omised to intervention and control arms . Although the intervention appears to be associated with higher rates of any cerebral haemorrhage ( p < 0.01 ) and recurrent ischaemic stroke ( p = 0.03 ) , considerable uncertainty remains as to these treatment effects . Conclusions The trials published most recently have acted as a ‘ watershed ’ for mechanical thrombectomy , and while there are significant caveats , the data suggests that mechanical thrombectomy needs to be factored into the planning and delivery of services for the management of patients with acute ischaemic stroke in Irel and BACKGROUND Innovators have piloted improvements in communication , changed patterns of practice and patient empowerment from online access to electronic health records ( EHR ) . International studies of online services , such as prescription ordering , online appointment booking and secure communications with primary care , show good uptake of email consultations , accessing test results and booking appointments ; when technologies and business process are in place . Online access and transactional services are due to be rolled out across Engl and by 2015 ; this review seeks to explore the impact of online access to health records and other online services on the quality and safety of primary health care . OBJECTIVE To assess the factors that may affect the provision of  online patient access to their EHR and transactional services , and the impact of such access on the quality and safety of health care . METHOD Two review ers independently search ed 11 international data bases during the period 1999 - 2012 . A range of papers including descriptive studies using qualitative or quantitative methods , hypothesis-testing studies and systematic review s were included . A detailed eligibility criterion will be used to shape study inclusion . A team of experts will review these papers for eligibility , extract data using a customised extraction form and use the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) instrument to determine the quality of the evidence and the strengths of any recommendation . Data will then be descriptively summarised and thematically synthesis ed . Where feasible , we will perform a quantitative meta- analysis . Prospero ( International Prospect i ve Register of Systematic Review s ) registration number : crd42012003091 Background Bruxism is a disorder of jaw-muscle activity characterised by repetitive clenching or grinding of the teeth which results in discomfort and damage to dentition . The two clinical manifestations of the condition ( sleep and awake bruxism ) are thought to have unrelated aetiologies but are palliated using similar techniques . The lack of a definitive treatment has prompted renewed interest in biofeedback , a behaviour change method that uses electronic detection to provide a stimulus whenever bruxism occurs . This systematic review aims to provide a comprehensive overview of the state of research into biofeedback for bruxism ; to assess the efficacy and acceptability of  biofeedback therapy in management of awake bruxism and , separately , sleep bruxism in adults ; and to compare findings between the two variants . Methods A systematic review of published literature examining biofeedback as an intervention directed at controlling primary bruxism in adults . We will search electronic data bases and the grey literature using a predefined search strategy to identify r and omised and non-r and omised studies , technical reports and patents . Search es will not be restricted by language or date and will be exp and ed through contact with authors and experts , and by following up reference lists and citations . Two authors , working independently , will conduct screening of search results , study selection , data extraction and quality assessment and a third will resolve any disagreements . The primary outcomes of acceptability and effectiveness will be assessed using only r and omised studies , segregated by bruxism subtype . A meta- analysis of these data will be conducted only if pre-defined conditions for quality and heterogeneity are met , otherwise the data will be summarized in narrative form . Data from non-r and omised studies will be used to augment a narrative synthesis of the state of technical developments and any safety-related issues . PROSPERO registration number : CRD42013006880 . Discussion Biofeedback is not new , but its place in the clinical management of bruxism remains unclear . New research , and the availability of miniaturized consumer- grade devices , makes a systematic review timely to guide treatment decisions and inform future research 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 Study design : Prospect i ve study . Study rationale : A recurrent phenomenon , the lifetime prevalence of low back pain has been reported as 54%–80 % , while annual prevalence ranges from 15%–45%.1 It is also associated with enormous economic , societal , and health impact.2 India , being a developing country , has its problem compounded by the occupational compulsions in parts of the rural areas .3 For some interventional therapies , like epidural steroid injections , utilization rates have increased dramatically.4,5,6,7,8,9 They have become one of the most commonly performed interventions in the United States for low back pain with radiculopathy.10 Clinical question : Multiple systematic review s,11 a meta- analysis , 12 several guidelines , 13 health technology assessment s by insurers , and local medical review policies and coverage decisions have been published . However , controversy continues regarding the effectiveness of epidural steroid injections . In addition three types of epidurals , namely interlaminar , transforaminal , and caudal , with variable results complicate the picture for practice of interventional pain management . The underlying mechanism of action of epidurally administered steroid and local anesthetic injections is still not well understood and compounds the problem.14 Objective : To evaluate and up date the effects of caudal epidural injection in the management of chronic low back pain and sciatica .  Final Class of evidence -treatment Yes Study design : RCT • Cohort Case control Case series Methods Concealed allocation ( RCT ) • Intention to treat ( RCT ) • Blinded/independent evaluation of primary outcome • F/U ≥ 85 % • Adequate sample size • Control for confounding Overall class of evidence II The definiton of the different classes of evidence is available here Background Many preventable behaviors contribute to adolescent mortality and morbidity . Non-adherence to preventive measures represents a challenge and has been associated with worse health outcomes in this population . The widespread use of electronic communication technologies by adolescents , particularly the use of text messaging ( short message service , SMS ) and mobile phones , presents new opportunities to intervene on risk and preventive risk behavior , but little is known about their efficacy . Objective This study aim ed to systematic ally evaluate evidence for the efficacy of text messaging and mobile phone app interventions to improve adherence to preventive behavior among adolescents and describe intervention approaches to inform intervention development . Methods This review covers literature published between 1995 and 2015 . Search es included PubMed , Embase , CENTRAL , PsycINFO , CINAHL , INSPEC , Web of Science , Google Scholar , and additional data bases . The search strategy sought articles on text messaging and mobile phone apps combined with adherence or compliance , and adolescents and youth . An additional h and search of related themes in the Journal of Medical Internet Research was also conducted . Two review ers independently screened titles and abstract s , assessed full-text articles , and extracted data from articles that met inclusion criteria . Included studies reflect original research —experimental or preexperimental design s with text messaging or mobile phone app interventions —targeting adherence to preventive behavior among adolescents ( 12 - 24 years old ) . The preferred reporting items of systematic review s and meta-analyses ( PRISMA ) guidelines were followed for reporting results , and findings were critically appraised against the Oxford Centre for Evidence -based Medicine criteria . Results Of 1454 records , 19 met inclusion criteria , including text messaging ( n=15 ) and mobile phone apps ( n=4 ) . Studies targeted clinic attendance , contraceptive use , oral health , physical activity and weight management , sun protection , human papillomavirus ( HPV ) vaccination , smoking cessation , and sexual health .  Most studies were performed in the United States ( 47 % , 9/19 ) , included younger adolescents ( 63 % , 12/19 ) , and had sample size < 100 ( 63 % , 12/19 ) . Although most studies were r and omized controlled trials ( RCTs ; 58 % , 11/19 ) , only 5 followed an intent-to-treat analysis . Only 6 of 19 studies ( 32 % ) incorporated a theoretical framework in their design . Most studies reported good feasibility with high acceptability and satisfaction . About half of the included studies ( 42 % , 8/19 ) demonstrated significant improvement in preventive behavior with moderate st and ardized mean differences . As early efforts in this field to establish feasibility and initial efficacy , most studies were low to moderate in quality . Studies varied in sample size and methods of preventive behavior adherence or outcome assessment , which prohibited performing a meta- analysis . Conclusions Despite the promising feasibility and acceptability of text messaging and mobile phone apps in improving preventive behavior among adolescents , overall findings were modest in terms of efficacy . Further research evaluating the efficacy , effectiveness , and cost-effectiveness of these intervention approaches in promoting preventive behavior among adolescents is needed Background In Australia , diabetes was identified as a national health priority area in 1996 ; nevertheless the prevalence of type 2 diabetes has increased dramatically since then . Nurses have been working within Australian general practice s for several decades but only in recent years has the role of the practice nurse in primary health care increased . Objectives This review aims to identify the effectiveness of nurse‐led care in general practice as compared to general practitioner care on clinical outcomes in adults with type 2 diabetes . Inclusion criteria Types of participants Participants were adults ( aged > 18 years ) , with diabetes type 2 attending a general/family practice . Types of intervention Interventions of interest include nurse‐led care in general practice in which the nurse is identified as taking a lead role in the care of patients with type 2 diabetes compared to general practitioner‐led care . Types of studies To evaluate the effectiveness of nurse‐led diabetes care in general practice , this review sought r and omised controlled trials as the study design of choice . Other research design s such as controlled clinical trials , interrupted time series and controlled before and after design s were also considered . Types of outcomes The outcomes of interest were clinical outcomes including changes in systolic and diastolic blood pressure , body mass index , cholesterol levels , HbA1c ( glycated haemoglobin ) and fasting blood glucose . Search strategy A three step literature search was conducted for English language articles from January 1990 to December 2011 . Method ological quality Quantitative papers selected for retrieval were assessed by two independent review ers for method ological validity prior to inclusion in the review using st and ardised critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument . Data collection Quantitative data was extracted from papers included in the review using the st and ardised data extraction tool from the Joanna Briggs Institute . The data extracted included specific details about the interventions , population s , study methods and outcomes of significance to the review question and specific objectives . Data synthesis Data from quantitative papers , where possible , were pooled in statistical meta‐ analysis using the Meta‐ Analysis of Statistics Assessment and Review Instrument . Additionally , RevMan 5 was used for presenting forest plots of the meta‐ analysis . Results The electronic search yielded 804 potentially relevant papers of which 49 papers appeared to satisfy the criteria for inclusion and full texts of these papers were assessed against the inclusion criteria by two independent review ers . From these papers , five were included in the review , four r and omised control trials and one quasi‐experimental study . These articles provided evidence that nurse‐led care improves blood pressure and cholesterol levels for patients with type 2 diabetes attending a general practice . Conclusions There is some evidence to support the use of nurse‐led care in general practice for patients with type 2 diabetes . Implication s for Practice If nurse‐led care is implemented in the care of people with type 2 diabetes consideration needs to be given to the use of clinical algorithms , goal setting , individualised care plans , self management and follow up of lifestyle risk factors . Implication for Research More r and omised controlled trials are required to assess the efficacy of nurse‐led care including cost effectiveness 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 The aim of this paper was to provide reliable evidence by performing a systematic review and meta- analysis for evaluating the role of acupuncture in assisted reproductive technology . All r and omized controlled trials that evaluated the effects of acupuncture , including manual , electrical , and laser acupuncture ( LA ) techniques , on the clinical pregnancy rate ( CPR ) and live birth rate ( LBR ) of in vitro fertilization ( IVF ) or artificial insemination were included . The controlled groups consisted of no acupuncture and sham acupuncture groups . The sham acupuncture included sham acupuncture at acupoints , sham acupuncture at non- or inappropriate points , sham LA , and adhesive tapes .  Twenty-three trials ( a total of 5598 participants ) were included in this paper . The pooled CPR from all acupuncture groups was significantly higher than that from all controlled groups , whereas the LBR was not significantly different between the two groups . However , the results were quite distinct when the type of control and /or different acupuncture times were examined in a sensitivity analysis . The results mainly indicate that acupuncture , especially around the time of the controlled ovarian hyperstimulation , improves pregnancy outcomes in women undergoing IVF . More positive effects from acupuncture in IVF can be expected if a more individualized acupuncture programs are used CONTEXT The relative merits of various study design s and their placement in hierarchies of evidence are often discussed . However , there is limited knowledge about the relative citation impact of articles using various study design s. OBJECTIVE To determine whether the type of study design affects the rate of citation in subsequent articles . DESIGN AND SETTING We measured the citation impact of articles using various study design s -- including meta-analyses , r and omized controlled trials , cohort studies , case-control studies , case reports , non systematic review s , and decision analysis or cost-effectiveness analysis --published in 1991 and in 2001 for a sample of 2646 articles . MAIN OUTCOME MEASURE The citation count through the end of the second year after the year of publication and the total received citations . RESULTS Meta-analyses received more citations than any other study design both in 1991 ( P<.05 for all comparisons ) and in 2001 ( P<.001 for all comparisons ) and both in the first 2 years and in the longer term . More than 10 citations in the first 2 years were received by 32.4 % of meta-analyses published in 1991 and 43.6 % of meta-analyses published in 2001 . R and omized controlled trials did not differ significantly from epidemiological studies and non systematic review articles in 1991 but clearly became the second-cited study design in 2001 . Epidemiological studies , non systematic review articles , and decision and cost-effectiveness analyses had relatively similar impact ; case reports received negligible citations . Meta-analyses were cited significantly more often than all other design s after adjusting for year of publication , high journal impact factor , and country of origin . When limited to studies addressing treatment effects , meta-analyses received more citations than r and omized trials . CONCLUSION Overall , the citation impact of various study design s is commensurate with most proposed hierarchies of evidence R and omised controlled trials ( RCTs ) of acupuncture often find equivalent responses to real and placebo acupuncture despite both appearing superior to no treatment . This raises questions regarding the mechanisms of acupuncture , especially the contribution of patient expectancies . We systematic ally review ed previous research assessing the relationship between expectancy and treatment responses following acupuncture , whether real or placebo . To be included , studies needed to assess and /or manipulate expectancies about acupuncture and relate these to at least one health-relevant outcome . Nine such independent studies were identified through systematic search es of Medline , PsycInfo , PubMed , and Cochrane Clinical Trials Register . The methodology and reporting of these studies were quite heterogeneous , meaning that meta- analysis was not possible . A descriptive review revealed that five studies found statistically significant effects of expectancy on a least one outcome , with three also finding evidence suggestive of an interaction between expectancy and type of acupuncture ( real or placebo ) . While there were some trends in significant effects in terms of study characteristics , their generality is limited by the heterogeneity of study design s. The differences in design across studies highlight some important method ological considerations for future research in this area , particularly regarding whether to assess or manipulate expectancies and how best to assess expectancies Background The production of high quality systematic review s requires rigorous methods that are time-consuming and re source intensive . Citation screening is a key step in the systematic review process . An opportunity to improve the efficiency of systematic review production involves the use of non-expert groups and new technologies for citation screening . We performed a pilot study of citation screening by medical students using four screening methods and compared students ’ performance to experienced review authors . Methods The aims of this pilot r and omised controlled trial were to provide preliminary data on the accuracy of title and abstract screening by medical students , and on the effect of screening modality on screening accuracy and efficiency . Medical students were r and omly allocated to title and abstract screening using one of the four modalities and required to screen 650 citations from a single systematic review up date . The four screening modalities were a reference management software program ( EndNote ) , Paper , a web-based systematic review workflow platform ( ReGroup ) and a mobile screening application ( Screen2Go ) .  Screening sensitivity and specificity were analysed in a complete case analysis using a chi-squared test and Kruskal-Wallis rank sum test according to screening modality and compared to a final set of included citations selected by expert review authors . Results Sensitivity of medical students ’ screening decisions ranged from 46.7 % to 66.7 % , with students using the web-based platform performing significantly better than the paper-based group . Specificity ranged from 93.2 % to 97.4 % with the lowest specificity seen with the web-based platform . There was no significant difference in performance between the other three modalities . Conclusions Medical students are a feasible population to engage in citation screening . Future studies should investigate the effect of incentive systems , training and support and analytical methods on screening performance . Systematic review registration Cochrane Data base BACKGROUND There is increasing interest from review authors about including  non-r and omized studies  ( NRS ) in their systematic review s of health care interventions . This series from the Ottawa Non-R and omized Studies Workshop consists of six papers identifying method ological issues when doing this . AIM To format the guidance from the preceding papers on study design and bias , confounding and meta- analysis , selective reporting , and applicability/directness into checklists of issues for review authors to consider when including NRS in a systematic review . CHECKLISTS Checklists were devised providing frameworks to describe/assess : ( 1 ) study design s based on study design features ; ( 2 ) risk of residual confounding and when to consider meta-analysing data from NRS ; ( 3 ) risk of selective reporting based on the Cochrane framework for detecting selective outcome reporting in trials but extended to selective reporting of analyses ; and ( 4 ) directness of evidence contributed by a study to aid integration of NRS findings into summary of findings tables . SUMMARY The checklists described will allow review groups to operationalize the inclusion of NRS in systematic review s in a more consistent way . The next major step is extending the existing Cochrane Risk of Bias tool so that it can assess the risk of bias to NRS included in a review . Copyright © 2013 John Wiley & Sons , Background Violence during pregnancy is a global problem , associated with serious health risks for both the mother and baby . Evaluation of interventions targeted for reducing or controlling domestic violence ( DV ) is still in its infancy , and the majority of findings are primarily from high-income countries ( HICs ) . Therefore , there is an urgent need for generating evidence of DV interventions among pregnant women in low- and middle-income countries ( LMICs ) . Methods Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines will be employed to structure the review . A comprehensive search will be carried out via electronic data bases including MEDLINE , CINAHL , Scopus , Embase , Web of Science , PsycINFO , and The Cochrane library . Gray literature will also be scrutinized for potential articles . An optimal search strategy has been developed following consultations with subject-matter experts and librarians . This search strategy will be adapted to the different data bases . Experimental studies evaluating DV interventions among pregnant women from LMICs will be included in the review . The review will only include literature written in English . Two review ers will independently screen and assess studies for inclusion in the review . A third author will resolve any discrepancies between the review ers . Risk of bias will be assessed based on the Cochrane risk of bias assessment tool , and overall quality of the evidence will be judged using Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) criteria . Findings will be presented with the narrative synthesis , and if applicable , they will be further quantified using r and om-effects meta- analysis . Effect size , risk ratio for dichotomous variables , and st and ardized mean differences for continuous variables will be calculated for each outcome using Review Manager 5.3 . Discussion Systematic review s to evaluate the efficacy of interventions to address DV within the perinatal context have been limited . Hence , no one intervention has emerged as substantially effective towards addressing perinatal DV and associated health consequences . The evidence generated from this systematic review will inform research ers and policy makers about the effectiveness of existing DV interventions among pregnant women in LMICs and provide recommendations for future research in this area . This in turn will contribute towards violence prevention in LMICs . Systematic review registration PROSPERO Objective To create a data base of long-term r and omised controlled trials ( RCTs ) comparing higher with lower omega-3 , omega-6 or total polyunsaturated fatty acid ( PUFA ) , regardless of reported outcomes , and to develop methods to assess effects of increasing omega-6 , alpha-linolenic acid ( ALA ) , long-chain omega-3 ( LCn3 ) and total PUFA on health outcomes . Design Systematic review search , methodology and meta-analyses . Data sources Medline , Embase , CENTRAL , WHO International Clinical Trials Registry Platform , Clinical trials.gov and trials in relevant systematic review s. Eligibility criteria RCTs of ≥24 weeks ' duration assessing effects of increasing ALA , LCn3 , omega-6 or total PUFAs , regardless of outcomes reported . Data synthesis Methods included r and om-effects meta-analyses and sensitivity analyses . Funnel plots were examined , and subgrouping assessed effects of intervention type , replacement , baseline diabetes risk and use of diabetic medications , trial duration and dose . Quality of evidence was assessed using Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) . Results Electronic search es generated 37 810 hits , de-duplicated to 19 772 titles and abstract s. We assessed 2155 full-text papers , conference abstract s and trials registry entries independently in duplicate . Included studies were grouped into 363 RCTs comparing higher with lower omega-3 , omega-6 and /or total PUFA intake of at least 6 months ’ duration —the Data base . Of these 363 included RCTs , 216 RCTs were included in at least one of our review s of health outcomes , data extracted and risk of bias assessed in duplicate . Ninety five RCTs were included in the Data base but not included in our current review s. Of these 311 completed trials , 27 altered ALA intake , 221 altered LCn3 intake and 16 trials altered omega-3 intake without specifying whether ALA or LCn3 . Forty one trials altered omega-6 and 59 total PUFA.The remaining 52 trials are ongoing though 13 ( 25 % ) appear to be outst and ing , or constitute missing data . Conclusions This extensive data base of trials is available to allow assessment of further health outcomes Traditional clinical review articles , also known as up date s , differ from systematic review s and meta-analyses . Up date s selectively review the medical literature while discussing a topic broadly . Non-quantitative systematic review s comprehensively examine the medical literature , seeking to identify and synthesize all relevant information to formulate the best approach to diagnosis or treatment . Meta-analyses ( quantitative systematic review s ) seek to answer a focused clinical question , using rigorous statistical analysis of pooled research studies . This article presents guidelines for writing an evidence -based clinical review article for American Family Physician . First , the topic should be of common interest and relevance to family practice . Include a table of the continuing medical education objectives of the review . State how the literature search was done and include several sources of evidence -based review s , such as the Cochrane Collaboration , BMJ 's Clinical Evidence , or the InfoRetriever Web site . Where possible , use evidence based on clinical outcomes relating to morbidity , mortality , or quality of life , and studies of primary care population s. In articles su bmi tted to American Family Physician , rate the level of evidence for key recommendations according to the following scale : level A ( r and omized controlled trial [ RCT ] , meta- analysis ) ; level B ( other evidence ) ; level C ( consensus/expert opinion ) . Finally , provide a table of key summary points 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 AIMS Oesophageal cancer is an aggressive disease and the optimal therapy for patients with resectable tumours remains unclear . A systematic review and companion practice guideline were published in 2004 ; however , new evidence has become available since the publication of the original report . An up date of the literature search and a revision of the recommendations were undertaken to incorporate the new data . The following research question was addressed : should patients with resectable oesophageal cancer receive preoperative or postoperative therapy together with surgery ? The outcomes of interest were survival , adverse effects and quality of life . MATERIAL S AND METHODS The literature search of the original systematic review was up date d to April 2007 . MEDLINE , EMBASE , Cochrane Library and abstract s from the American Society of Clinical Oncology and the American Society for Therapeutic Radiology and Oncology were search ed for reports of r and omised controlled trials and meta-analyses comparing preoperative or postoperative therapy with surgery alone or other preoperative or postoperative therapy . After the completion of the draft systematic review and practice guideline , the report was distributed through a mailed survey to 133 health care providers in Ontario for review and feedback . RESULTS The up date d literature search yielded eight new r and omised controlled trial reports and seven new meta- analysis reports for consideration , together with the evidence review ed in the original review publication . Of the 31 practitioners who responded to the mailed survey , 80 % agreed with the draft recommendations as stated , 83 % agreed that the report should be approved as a practice guideline and 86 % indicated that they would probably use the guideline in their own practice . CONCLUSIONS Preoperative cisplatin-based chemotherapy plus radiotherapy is recommended as the preferred modality for the management of surgically resectable patients with oesophageal cancer .  Preoperative cisplatin-based chemotherapy alone is an alternative choice for the management of these patients OBJECTIVE This study assessed the impact of systematic review and data extraction experience on the accuracy and efficiency of data extraction in systematic review s. STUDY DESIGN AND SETTING We conducted a prospect i ve cross-sectional study from October to December 2006 . Participants were classified as having minimal , moderate , or substantial experience in systematic review s and data extraction . Three studies on insomnia treatment were extracted . Our primary outcome was the accuracy of data extraction . Data sets of each experience level were analyzed for errors in data extraction and results of meta-analyses . Additionally , the time required for completion of data extraction was compared . RESULTS Error rates were similar across the various levels of experience and ranged from 28.3 % to 31.2 % . Mean rates for errors of omission ( 11.3 - 16.4 % ) were generally lower than those for errors of inaccuracy ( 13.9 - 17.9 % ) . There were no significant differences in error rates or accuracy of meta- analysis results between groups . Time required approached significance , with minimally experienced participants requiring the most time . CONCLUSION Overall , there were high error rates by participants at all experience levels ; however , time required for extraction tended to decrease with experience . These results illustrate the need to develop strategies aim ed at mastery of data extraction , rather than reliance on previous data extraction experience alone BACKGROUND The National Institute for Health and Clinical Excellence has issued guidelines on the treatment of non-small cell lung cancer ( NSCLC ) and recommends that patients with stage IIIA-IIIB disease who are not amenable to surgery be treated with potentially curative chemoradiation ( CTX-RT ) . This review was conducted as part of a larger systematic review of all first-line chemotherapy ( CTX ) and CTX-RT treatments for patients with locally advanced or metastatic NSCLC . However , it was considered that patients with potentially curable disease ( e.g. stage IIIA ) are different from those with advanced disease , who are suitable for palliative treatment only , and therefore the results should be reported separately . OBJECTIVE To evaluate the clinical effectiveness of first-line CTX in addition to radiotherapy ( RT ) ( CTX-RT vs CTX-RT ) for adult patients with locally advanced NSCLC who are suitable for potentially curative treatment . DATA SOURCES Three electronic data bases ( MEDLINE , EMBASE and The Cochrane Library ) were search ed from January 1990 to September 2010 . REVIEW METHODS Inclusion criteria comprised adult patients with locally advanced NSCLC , trials that compared any first-line CTX-RT therapy ( induction , sequential , concurrent and consolidation ) and outcomes of overall survival ( OS ) and /or progression-free survival ( PFS ) . The results of clinical data extraction and quality assessment were summarised in tables and with narrative description . Direct meta-analyses using OS data were undertaken where possible : sequential CTX-RT compared with concurrent CTX-RT ; sequential CTX-RT compared with concurrent/consolidation CTX-RT ; and sequential CTX-RT compared with concurrent CTX-RT with or without consolidation . There were not sufficient data to perform meta- analysis on PFS . RESULTS Of the 240 potentially relevant studies that were published post 2000 , 19 met the inclusion criteria and compared CTX-RT with CTX-RT . The results from the OS meta- analysis comparing sequential CTX-RT with concurrent CTX-RT appear to show an OS advantage for concurrent CTX-RT arms over sequential arms ; this result is not statistically significant [ hazard ratio ( HR ) 0.79 ; 95 % confidence interval ( CI ) 0.50 to 1.25 ) ] . The results from the OS meta- analysis comparing sequential CTX-RT with concurrent/consolidation CTX-RT appear to show a statistically significant OS advantage for concurrent/consolidation CTX-RT treatment over sequential treatment ( HR 0.68 ; 95 % CI 0.55 to 0.83 ) . The results from the OS meta- analysis comparing sequential CTX-RT with concurrent CTX-RT with or without consolidation appear to show a statistically significant OS advantage for concurrent CTX-RT with or without consolidation over sequential treatment ( HR 0.72 ; 95 % CI 0.61 to 0.84 ) . LIMITATIONS This report provides a summary and critical appraisal of a comprehensive evidence base of CTX-RT trials ; however , it is possible that additional trials have been reported since our last literature search . It is disappointing that the quality of the research in this area does not meet the accepted quality st and ards regarding trial design and reporting . CONCLUSIONS This review identified that the research conducted in the area of CTX-RT was generally of poor quality and suffered from a lack of reporting of all important clinical findings , including OS . The 19 trials included in the systematic review were too disparate to form any conclusions as to the effectiveness of individual CTX agents or types of RT . The focus of primary research should be good method ological quality ; appropriate allocation of concealment and r and omisation , and comprehensive reporting of key outcomes , will enable meaningful synthesis and conclusions to be drawn . FUNDING The National Institute for Health Research Health Technology Assessment programme Prognostic markers help to stratify patients for treatment by identifying patients with different risks of outcome ( e.g. recurrence of disease ) , and are important tools in the management of cancer and many other diseases . Systematic review and meta-analytical approaches to identifying the most valuable prognostic markers are needed because ( sometimes conflicting ) evidence relating to markers is often published across a number of studies . To investigate the practicality of this approach , an empirical investigation of a systematic review of  tumour markers for neuroblastoma was performed ; 260 studies of prognostic markers were identified , which considered 130 different markers . The reporting of these studies was often inadequate , in terms of both statistical analysis and presentation , and there was considerable heterogeneity for many important clinical /statistical factors . These problems restricted both the extraction of data and the meta- analysis of results from the primary studies , limiting feasibility of the evidence -based approach . Guidelines for reporting the results of primary prognostic marker studies in cancer , and other diseases , are given in order to facilitate both the interpretation of individual studies and the undertaking of systematic review s , meta- analysis and , ultimately , evidence -based practice . General availability of full individual patient data is a necessary step forward and would overcome the majority of problems encountered , including poorly reported summary statistics and variability in cutoff level , outcome assessed and adjustment factors used . It would also limit the problem of reporting bias , although publication bias will remain a concern until studies are prospect ively registered . Such changes in practice would help important evidence -based review s to be conducted in order to establish the most appropriate prognostic markers for clinical use , which should ultimately improve patient care Objectives The objective of this study was to perform a meta- analysis of all r and omised controlled trials ( RCTs ) comparing surgical and non-surgical management of fractures of the proximal humerus , and to determine whether further analyses based on complexity of fracture , or the type of surgical intervention , produced disparate findings on patient outcomes . Methods A systematic review of the literature was performed identifying all RCTs that compared surgical and non-surgical management of fractures of the proximal humerus . Meta- analysis of clinical outcomes was performed where possible . Subgroup analysis based on the type of fracture , and a sensitivity analysis based on the type of surgical intervention , were also performed . Results Seven studies including 528 patients were included . The overall meta- analysis found that there was no difference in clinical outcomes . However , subgroup and sensitivity analyses found improved patient outcomes for more complex fractures managed surgically . Four-part fractures that underwent surgery had improved long-term health utility scores ( mean difference , MD 95 % CI 0.04 to 0.28 ; p = 0.007 ) . They were also less likely to result in osteoarthritis , osteonecrosis and non/malunion ( OR 7.38 , 95 % CI 1.97 to 27.60 ; p = 0.003 ) . Another significant subgroup finding was that secondary surgery was more common for patients that underwent internal fixation compared with conservative management within the studies with predominantly three-part fractures ( OR 0.15 , 95 % CI 0.04 to 0.63 ; p = 0.009 ) . Conclusion This meta- analysis has demonstrated that differences in the type of fracture and surgical treatment result in outcomes that are distinct from those generated from analysis of all types of fracture and surgical treatments grouped together . This has important implication s for clinical decision making and should highlight the need for future trials to adopt more specific inclusion criteria . Cite this article : S. Sabharwal , N. K. Patel , D. Griffiths , T. Athanasiou , C. M. Gupte , P. Reilly . Trials based on specific fracture configuration and surgical procedures likely to be more relevant for decision making in the management of fractures of the proximal humerus : Findings of a meta- analysis Bone Joint Res 2016;5:470–480 . DOI : 10.1302/2046 - 3758.510.2000638 Background Across the developed world , we are witnessing an increasing emphasis on the need for more closely coordinated forms of health and social care provision . Integrated care pathways ( ICPs ) have emerged as a response to this aspiration and are believed by many to address the factors which contribute to service integration . ICPs map out a patient 's journey , providing coordination of services for users . They aim to have : ' the right people , doing the right things , in the right order , at the right time , in the right place , with the right outcome ' . The value for ICPs in supporting the delivery of care across organisational boundaries , providing greater consistency in practice , improving service continuity and increasing collaboration has been advocated by many . However , there is little evidence to support their use , and the need for systematic evaluations in order to measure their effectiveness has been widely identified . A recent Cochrane review assessed the effects of ICPs on functional outcome , process of care , quality of life and hospitalisation costs of in patients with acute stroke , but did not specifically focus on service integration or its derivatives . To the best of our knowledge , no such systematic review of the literature exists . Objectives To systematic ally review all high‐ quality studies which have evaluated the impact of care pathway technologies on ' service integration ' and its derivatives in stroke care To examine how elements of service integration are defined in such studies To examine the type of evidence utilised to measure service integration To analyse the weight of evidence used to support cl aims about the effectiveness of ICPs on improving service integration To produce recommendations for ICP developers , users and evaluators . Inclusion criteria Types of participants The review focused on the care of adult patients who had suffered a stroke . It included the full spectrum of services ‐ acute care , rehabilitation and long‐term support ‐ in hospital and community setting s. Types of intervention(s)/phenomena of interest Integrated care pathways were the intervention of interest , defined for the purpose of this review as ' a multidisciplinary tool to improve the quality and efficiency of evidence based care and is used as a communication tool between professionals to manage and st and ardise the outcome orientated care ' . Here ' multidisciplinary ' is taken to refer to the involvement of two or more disciplines . Types of outcomes Service integration ' was the outcome of interest however , this was defined and measured in the selected studies . Types of studies This review was concerned with how ' service integration ' was defined in evaluations of ICPs ; the type of evidence utilised in measuring the impact of the intervention and the weight of evidence to support the effectiveness of care pathway technologies on ' service integration ' . Studies that made an explicit link between ICPs and service integration were included in the review . Evidence generated from r and omised controlled trials , quasi‐experimental , qualitative and health economics research was sought . The search was limited to publications after 1980 , coinciding with the emergence of ICPs in the healthcare context . Assessment for inclusion of foreign papers was based on the English‐ language abstract , where available . These were included only if an English translation was available . Exclusion criteria This review excluded studies that : focused only on a single aspect of stroke care ( e.g. dysphasia ) evaluated ICPs as part of a wider program of service development did not make an explicit link between ICPs and service integration did not meet the definition of ICP utilised for the purpose s of the review focused exclusively on the outcomes of variance analysis Search strategy In order to avoid replication , the Joanna Briggs Institute for Evidence Based Nursing and Midwifery Data base and the Cochrane Library were search ed to establish that no systematic review s existed and none were in progress . A three‐stage search strategy was then used to identify both published and unpublished studies ( see Appendix III ) . Data collection Our search strategy located 2123 papers , of which 39 were retrieved for further evaluation . We critically appraised seven papers , representing five studies . These were all evaluation studies and , as is typical in this field , comprised a range of study design s and data collection methods . Owing to the diversity of the study types included in the review , we developed a single‐ appraisal checklist and data ‐ extraction tool which could be applied to all research design s.32 The tool drew on the Joanna Briggs Institute ( JBI ) appraisal checklists for experimental studies and interpretive and critical research , and also incorporated specific information and issues which were relevant for our purpose s ( see Appendix VI ) . This extends the thinking outlined in Lyne et al.31 in which , drawing on Campbell and Stanley 's classic paper , the case is made for developing an appraisal tool which is applicable to all types of evaluation , irrespective of study design . In assessing the quality of the papers , we were sympathetic to the method ological challenges of evaluating complex interventions such as ICPs . We were also cognisant of the very real constraints in which service evaluations are frequently undertaken in healthcare context s. In accordance with the aims of this particular review , we have included studies , which are method ologically weaker than is typical of many systematic review s because , in our view , in the absence of stronger evidence , they yield useful information . Data synthesis Given the heterogeneity of the included studies , meta‐ analysis and /or qualitative synthesis was not possible . A narrative summary of the study findings is presented . Results ICPs can be effective in ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner , although these improvements may reflect better documentation rather than actual changes in practice . ICPs can be effective in improving the documentation of rehabilitation goals , documentation of communication with patients , carers ( diagnosis , prognosis and follow‐up arrangements ) and documentation of notification of primary care physicians of discharge . However , this can create additional burdens of work for staff . Early studies of  ICP‐managed care in the acute stroke context have demonstrated reduced length of stay without any associated adverse effects on discharge destination , morbidity or mortality . These effects do not reach statistical significance , however , and may reflect wider changes in service provision and a general trend towards reduced length of hospital stay . While later studies in the acute and rehabilitation context s do not reveal any significant reduction in length of stay , they do report greater documented use of certain clinical interventions and assessment s , suggesting that ICPs can be effective in mobilising hospital re sources around the patient . ICPs implemented in the context of acute stroke care can be effective in reducing the occurrence of urinary tract infections , although we do not know whether this can be attributed to improved service integration . ICP management in stroke rehabilitation may not be flexible enough to meet diverse patient needs and can result in insufficient attention to higher‐level functioning and carer needs influencing perceptions of quality of life . ICP management may assist in clarifying role boundaries and a shared underst and ing of the work , but this can result in some members of the disciplinary team perceiving that their contribution is not appropriately reflected in the documentation . There is some evidence that ICPs may be effective in changing professional behaviours in the desired direction where there is scope for improvement , but in situations in which multidisciplinary working is effective , their positive effects may be limited . Furthermore , it is far from clear what the active ingredients of ICPs actually are . Kwan et al. suggest that it was the process of ICP development that had most impact on behaviours rather than the use of the artefact per se.20 None of the studies assessed the balance of costs and benefits of ICP use . Therefore , we do not know whether the costs of ICP development and implementation are justified by any of the reported benefits . Conclusions Implication s for practice There is some evidence that ICPs may support certain elements of service integration in the context of stroke care . This seems to be as a result of their ability to support the timely implementation of clinical interventions and the mobilisation of re sources around the patient without incurring additional increases in length of stay . ICPs appear to be most successful in improving service coordination in the acute stroke context where patient care trajectories are predictable . Their value in the context of rehabilitation setting s in which recovery pathways are more variable is less clear . There is some evidence that ICPs may be effective in bringing about behavioural changes in context s where deficiencies in service provision have been identified . Their value in context s where inter‐professional working is well established is less clear . While earlier before and after studies show a reduction in length of stay in ICP‐managed care , this may reflect wider healthcare trends , and the failure of later studies to demonstrate further reductions suggests that there may be limits as to how far this can continue to be reduced . There is some evidence to suggest that ICPs bring about improvements in documentation , but we do not know how far documented practice reflects actual practice . It is unclear how ICPs have their effects and the relative importance of the process of development and the artefact in use . As none of the studies review ed included an economic evaluation , moreover , it remains unclear whether the benefits of ICPs UNLABELLED EXECUTIVE SUMMARY : BACKGROUND Across the developed world , we are witnessing an increasing emphasis on the need for more closely coordinated forms of health and social care provision . Integrated care pathways ( ICPs ) have emerged as a response to this aspiration and are believed by many to address the factors which contribute to service integration . ICPs map out a patient 's journey , providing coordination of services for users . They aim to have : ' the right people , doing the right things , in the right order , at the right time , in the right place , with the right outcome ' . The value for ICPs in supporting the delivery of care across organisational boundaries , providing greater consistency in practice , improving service continuity and increasing collaboration has been advocated by many . However , there is little evidence to support their use , and the need for systematic evaluations in order to measure their effectiveness has been widely identified . A recent Cochrane review assessed the effects of ICPs on functional outcome , process of care , quality of life and hospitalisation costs of in patients with acute stroke , but did not specifically focus on service integration or its derivatives . To the best of our knowledge , no such systematic review of the literature exists . OBJECTIVES • To systematic ally review all high- quality studies which have evaluated the impact of care pathway technologies on ' service integration ' and its derivatives in stroke care • To examine how elements of service integration are defined in such studies • To examine the type of evidence utilised to measure service integration • To analyse the weight of evidence used to support cl aims about the effectiveness of ICPs on improving service integration • To produce recommendations for ICP developers , users and evaluators . INCLUSION CRITERIA Types of participants The review focused on the care of adult patients who had suffered a stroke . It included the full spectrum of services - acute care , rehabilitation and long-term support - in hospital and community setting s. Types of intervention(s)/phenomena of interest Integrated care pathways were the intervention of interest , defined for the purpose of this review as ' a multidisciplinary tool to improve the quality and efficiency of evidence based care and is used as a communication tool between professionals to manage and st and ardise the outcome orientated care ' Here ' multidisciplinary ' is taken to refer to the involvement of two or more disciplines . Types of outcomes ' Service integration ' was the outcome of interest however , this was defined and measured in the selected studies . Types of studies This review was concerned with how ' service integration ' was defined in evaluations of ICPs ; the type of evidence utilised in measuring the impact of the intervention and the weight of evidence to support the effectiveness of care pathway technologies on ' service integration ' . Studies that made an explicit link between ICPs and service integration were included in the review . Evidence generated from r and omised controlled trials , quasi-experimental , qualitative and health economics research was sought . The search was limited to publications after 1980 , coinciding with the emergence of ICPs in the healthcare context . Assessment for inclusion of foreign papers was based on the English- language abstract , where available . These were included only if an English translation was available . EXCLUSION CRITERIA This review excluded studies that : • focused only on a single aspect of stroke care ( e.g. dysphasia ) • evaluated ICPs as part of a wider program of service development • did not make an explicit link between ICPs and service integration • did not meet the definition of ICP utilised for the purpose s of the review • focused exclusively on the outcomes of variance analysis SEARCH STRATEGY In order to avoid replication , the Joanna Briggs Institute for Evidence Based Nursing and Midwifery Data base and the Cochrane Library were search ed to establish that no systematic review s existed and none were in progress . A three-stage search strategy was then used to identify both published and unpublished studies ( see Appendix III ) . DATA COLLECTION Our search strategy located 2123 papers , of which 39 were retrieved for further evaluation . We critically appraised seven papers , representing five studies . These were all evaluation studies and , as is typical in this field , comprised a range of study design s and data collection methods . Owing to the diversity of the study types included in the review , we developed a single- appraisal checklist and data - extraction tool which could be applied to all research design s.(32 ) The tool drew on the Joanna Briggs Institute ( JBI ) appraisal checklists for experimental studies and interpretive and critical research , and also incorporated specific information and issues which were relevant for our purpose s ( see Appendix VI ) . This extends the thinking outlined in Lyne et al.(31 ) in which , drawing on Campbell and Stanley 's classic paper , the case is made for developing an appraisal tool which is applicable to all types of evaluation , irrespective of study design . In assessing the quality of the papers , we were sympathetic to the method ological challenges of evaluating complex interventions such as ICPs . We were also cognisant of the very real constraints in which service evaluations are frequently undertaken in healthcare context s. In accordance with the aims of this particular review , we have included studies , which are method ologically weaker than is typical of many systematic review s because , in our view , in the absence of stronger evidence , they yield useful information . DATA SYNTHESIS Given the heterogeneity of the included studies , meta- analysis and /or qualitative synthesis was not possible . A narrative summary of the study findings is presented . RESULTS 1 ICPs can be effective in ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner , although these improvements may reflect better documentation rather than actual changes in practice . 2 ICPs can be effective in improving the documentation of rehabilitation goals , documentation of communication with patients , carers ( diagnosis , prognosis and follow-up arrangements ) and documentation of notification of primary care physicians of discharge . However , this can create additional burdens of work for staff . 3 Early studies of ICP-managed care in the acute stroke context have demonstrated reduced length of stay without any associated adverse effects on discharge destination , morbidity or mortality . These effects do not reach statistical significance , however , and may reflect wider changes in service provision and a general trend towards reduced length of hospital stay . While later studies in the acute and rehabilitation context s do not reveal any significant reduction in length of stay , they do report greater documented use of certain clinical interventions and assessment s , suggesting that ICPs can be effective in mobilising hospital re sources around the patient . 4 ICPs implemented in the context of acute stroke care can be effective in reducing the occurrence of urinary tract infections , although we do not know whether this can be attributed to improved service integration . 5 ICP management in stroke rehabilitation may not be flexible enough to meet diverse patient needs and can result in insufficient attention to higher-level functioning and carer needs influencing perceptions of quality of life . 6 ICP management may assist in clarifying role boundaries and a shared underst and ing of the work , but this can result in some members of the disciplinary team perceiving that their contribution is not appropriately reflected in the documentation . 7 There is some evidence that ICPs may be effective in changing professional behaviours in the desired direction where there is scope for improvement , but in situations in which multidisciplinary working is effective , their positive effects may be limited . Furthermore , it is far from clear what the active ingredients of ICPs actually are . Kwan et al. suggest that it was the process of ICP development that had most impact on behaviours rather than the use of the artefact per se.(20 ) 8 None of the studies assessed the balance of costs and benefits of ICP  use . Therefore , we do not know whether the costs of ICP development and implementation are justified by any of the reported benefits . CONCLUSIONS Implication s for practice There is some evidence that ICPs may support certain elements of service integration in the context of stroke care . This seems to be as a result of their ability to support the timely implementation of clinical interventions and the mobilisation of re sources around the patient without incurring additional increases in length of stay .  ICPs appear to be most successful in improving service coordination in the acute stroke context where patient care trajectories are predictable . Their value in the context of rehabilitation setting s in which recovery pathways are more variable is less clear . There is some evidence that ICPs may be effective in bringing about behavioural changes in context s where deficiencies in service provision have been identified . Their value in context s where inter-professional working is well established is less clear . While earlier before and after studies show a reduction in length of stay in ICP-managed care , this may reflect wider healthcare trends , and the failure of later studies to demonstrate further reductions suggests that there may be limits as to how far this can continue to be reduced . There is some evidence to suggest that ICPs bring about improvements in documentation , but we do not know how far documented practice reflects actual practice . It is unclear how ICPs have their effects and the relative importance of the process of development and the artefact in use . ( ABSTRACT TRUNCATED Background Dysmenorrhea is a common gynecological complaint in adolescent and young females . The purpose of this study is to assess the efficacy of Shaofu Zhuyu ( SFZY ) decoctions as treatments for primary dysmenorrhea . Methods / design Fifteen ( four English , seven Korean , three Chinese , and one Japanese ) data bases will be search ed from their inception without a language restriction . These include PubMed , AMED , EMBASE , The Cochrane Library , seven Korean Medical Data bases ( Korean Studies Information , DBPIA , Oriental Medicine Advanced Search ing Integrated System , Research Information Service System , KoreaMed , The Town Society of Science Technology , and the Korean National Assembly Library ) , three Chinese Medical Data bases [ the Chinese Medical Data base ( CNKI ) , Chongqing VIP Chinese Science and Technology Periodical Data base ( VIP ) , and WanFang Data base ] , and one Japanese Data base ( J global ) . R and omized clinical trials ( RCTs ) included those that examined an SFZY decoction or a modified SFZY decoction . The control groups include no treatment , placebo , and medication . Trials testing a combination of SFZY decoction and medication compare to the same medication alone will be also included . Data extraction and risk of bias assessment s will be performed by two independent review ers . All statistical analyses will be conducted using Review Manager software ( RevMan V.5.3.0 ) . Method ological quality will be assessed with the Cochrane risk of bias tool . Discussion This systematic review will provide a detailed summary of the available evidence testing the effects of SFZY decoctions for the treatment of primary dysmenorrhea . The review will benefit patients and practitioners in the fields of traditional and complementary medicine . Systematic review registration PROSPERO registration number : Background Diabetic retinopathy ( DR ) is a common microvascular complication of diabetes mellitus , and more than 75 % of patients who have had diabetes for more than 20 years will have some degree of DR . This disease is highly destructive to self-esteem and puts a high burden on public health and pension systems due to the effects that it has on people of working age . The current mainstay of treatment is laser photocoagulation , which causes impairment of vision and discomfort to patients . Thus , finding a systemic drug that could act on all microcirculation and prevent direct manipulation of the eyes would be highly desirable . Objective To assess the efficacy and safety of the drugs in the statin and /or fibrate groups for the prevention and treatment of DR . Methods In this systematic review , we will select r and omized controlled trials of fibrates or statins used for the treatment or prevention of DR . Our search strategy will include free text terms and controlled vocabulary ( eg , MeSH , Emtree ) for , “ diabetic retinopathy ” , “ statins ” , “ fibrates ” , “ hypolipidemic agents ” , and for drugs from both groups . Data bases that will be used include Medical Literature Analysis and Retrieval System/ PubMed , Embase , Cochrane Central Register of Controlled Trials , Latin American and Caribbean Center on Health Sciences Information , Clinical trials.gov , World Health Organization International Clinical Trials Registry Platform , and OpenGrey , and we will not have language or date limits . Two review authors will independently select eligible studies and assess the risk of bias using the Cochrane Collaboration ’s tool . We will report structured summaries of the included studies and , if possible , conduct meta-analyses . Results This is a protocol for a systematic review , therefore results are not available . We registered a short version of this protocol before progressing in the review and we are currently in the process of selecting the studies for inclusion . Conclusions Intensive glucose control and lowering blood pressure and lipids are mechanisms that protect macrocirculation in diabetic patients . Both macrovascular and microvascular events in diabetic patients appear to have a common pathway , starting with endothelial injury . Thus , prevention and treatment of microvascular events may benefit from the same interventions . In the review for which we have written this protocol , we will assess whether the use of lipid-lowering oral drugs of the statin and /or fibrate groups may prevent and /or retard progression of DR , with the added benefit of preserving visual acuity . Trial Registration PROSPERO Differences in disease prevalence , clinical manifestations , and health outcomes exist between men and women . Sources for this variation range from biological differentiation at the cellular level to behavioral differences influenced by societal gender norms . Typically , biologically based differences between men and women are called sex differences , whereas gender differences describe health differences related , at least in part , to societal constructs of gender ( 13 ) . For example , biological events unique to women , such as pregnancy and menopause , are probably associated with sex differences in occurrence of certain conditions or in response to some medical therapies ( 48 ) . Gender differences probably exist in health-related perceptions and behaviors for women and men with medical conditions that are prevalent for both sexes ( for example , heart disease and chronic pain ) ( 9 –16 ) . Although sex and gender differences are theoretically distinct , they remain difficult to disentangle when differences between men and women in health outcomes and treatment effectiveness are being examined . For this reason , and for brevity , we hereafter refer to sex and gender differences collectively as sex effects . In the past 2 decades , recognition of the importance of sex effects for health outcomes and treatment heterogeneity has been growing . Beginning in 1993 , the National Institutes of Health has issued policies requiring the inclusion of women and minorities in all clinical research and trial design s with valid analysis of sex effects or differences between racial and ethnic groups ( 17 , 18 ) . Since then , the inclusion of women in clinical trials has increased ( 19 , 20 ) , and sex effects have been identified for medications , such as nicotine replacement therapy , analgesics , and aspirin ( 13 , 14 , 21 ) . Recently , sex effects in adverse reactions led to sex-specific dosage recommendations for a widely used sedative ( 7 ) . Despite this progress , representation of women in clinical studies remains inadequate for many conditions ( 22 ) . Further , published clinical trials infrequently report sex effects or discuss the appropriateness of sex-specific analyses ( 19 , 20 , 23 ) . To advance the clinical evidence base and improve health outcomes for women , clinical research must include adequate numbers of women , appropriately conduct sex-specific analyses , and consistently report sex effects . Systematic review s ( SRs ) are a key source of information for clinicians , research ers , and guideline panels . By synthesizing the overall body of evidence for key clinical and research questions , SRs could potentially make a unique contribution to the evaluation of sex effects . To our knowledge , however , the reporting of sex effects by SRs has not been previously examined . Here , we use evidence mapping to systematic ally evaluate the reporting of sex effects by SRs examining a diverse set of interventions for chronic conditions common to women ( that is , depression , diabetes , and chronic pain ) . Evidence mapping is an emerging approach that describes key characteristics of studies for a broad area of medicine ( 2426 ) . Our evidence map addresses the volume and characteristics of eligible SRs , including the representation of women in primary studies , whether and how review s reported sex effects , and findings about sex effects . Methods This work was part of a larger report for the Veterans Health Administration ( VHA ) Evidence -based Synthesis Program ( ESP ) . The complete technical report is available online ( www.hsrd . research .va.gov/publications/esp ) and includes additional information on our methods . We focused on SRs to determine the reporting of sex effects , provide high-level information about the volume of current clinical evidence , and summarize information about actual sex effects . Prioritization of Conditions for Inclusion We used forced-ranking prioritization ( 27 ) with our VHA stakeholders to determine our conditions of interest . These stakeholders included representatives from the Health Services Research & Development Center for the Study of Healthcare Innovation , Implementation and Policy ; Health Services Research & Development Women 's Health Research Network ; Women 's Health Research in the Office of Research & Development ; Women 's Health Services ; and Mental Health Services . We initially selected 34 conditions ( Appendix Table 1 ) based on disease prevalence in women , disease burden in women , availability and breadth of effective treatments for men or women , and women veterans ' priorities for gender-specific care . Stakeholders ranked this initial set of conditions , discussed the rankings , and reranked conditions that initially received intermediate priority rankings . After 2 rounds of iterative prioritization , the following conditions were selected : depressive disorders , type 2 diabetes mellitus , and chronic pain ( that is , chronic low back pain , fibromyalgia , and chronic knee pain due to osteoarthritis ) . Appendix Table 1 . Conditions Presented to Stakeholders for Prioritization * Data Sources and Search es In collaboration with an expert reference librarian , we search ed PubMed and Cochrane Data base of Systematic Review s to identify eligible SRs published after 1 October 2009 through 31 October 2014 for depression , 13 February 2015 for diabetes , and 27 February 2015 for chronic pain . Search strategies used Medical Subject Headings and free-text terms for the conditions of interest , eligible interventions , and SRs ( Appendix Table 2 ) . We restricted the search to the past 6 years because SRs are typically out date d within 5 years of publication ( 28 ) , and our goal was to describe the current state of the clinical literature . In addition to electronic search ing , we screened published review s of review s for eligible articles . Appendix Table 2 . Search Strategies Study Selection and Quality Assessment Eligible SRs evaluated interventions in several broad categories ( that is , medications , behavioral interventions , supervised exercise , and quality improvement or organizational interventions ) . We also included condition-specific interventions , such as bariatric surgery for diabetes . Review s that evaluated mixed conditions or multiple interventions must have reported results separately for at least 1 eligible condition or intervention . We included review s of interventions in any setting , with any type of active or inactive comparator , and with any duration of follow-up . Detailed inclusion and exclusion criteria are provided in Appendix Table 3 . Appendix Table 3 . Detailed Inclusion and Exclusion Criteria for Review Eligibility Two investigators screened citations for eligibility , and citations that were considered to be relevant by either person were retained for full-text review . Full-text articles were review ed by 2 investigators , and disagreements were resolved through discussion or adjudicated by a third person . Formal assessment of review quality was beyond the scope of this project . However , we noted whether review s originated from organizations known for high- quality review s ( that is , Cochrane Collaboration , Agency for Healthcare Research and Quality Evidence -based Practice Centers , and VHA ESP ) . For review s reporting sex effects , we also assessed industry funding and whether statistical power was considered . Data Abstract ion Data were abstract ed by 1 investigator and review ed by a second person . Disagreements were resolved by discussion or by a third review er . Abstract ed data included the analysis method ( that is , qualitative synthesis , meta- analysis , network meta- analysis , or individual-patient data [ IPD ] meta- analysis ) ; clinical conditions ; interventions ; main outcomes ; number and design of primary studies ( for example , r and omized , controlled trials [ RCTs ] or observational cohorts ) ; proportion of women in the included primary studies ; and if sex effects were part of the study aims , analysis plan , or results . For review s reporting sex effects , we also recorded the number of primary studies used for sex-specific analyses , effect estimates , and the method used ( for example , metaregression , subgroup analysis , or IPD meta- analysis ) . All eligible review s on depressive disorders and chronic pain conditions were fully abstract ed . All diabetes review s of nonpharmacologic interventions were also fully abstract ed . For eligible diabetes medication review s ( n= 120 ) , we applied an additional prioritization procedure before full abstract ion . We prioritized review s that examined multiple classes of medications or evaluated a single class of medications when 6 or fewer eligible review s were identified . For SRs evaluating a single class ( > 6 eligible review s were identified ) , we used additional prioritization criteria ( for example , the most recent review published in a high-impact journal or work done by an organization known for high- quality review s ) . The remaining unselected but eligible review s ( n= 58 ) had a keyword text search for sex effects and were fully abstract ed only when this search yielded positive results ( n= 13 ) . Data Synthesis and Analysis of SRs We grouped eligible review s by intervention category and described the overall volume of clinical literature for interventions addressing each condition of interest . We also determined the number of review s reporting sex effects and summarized these results . Time trends for the proportion of these review s were examined for depression and diabetes . Examination of Primary RCTs for Selected Interventions We anticipated that some interventions for each condition would have few or no eligible SRs that addressed sex effects . Thus , for a subset of interventions for each condition , we evaluated primary RCTs to determine the feasibility of conducting a future review to evaluate sex effects . Specifically , we examined  quality improvement interventions and psychotherapy for depression ; diet , physical activity , and culturally tailored psychoeducation for diabetes ; behavioral interventions for chronic low back pain ; and exercise interventions Objectives To identify ways to improve the usefulness of systematic review s for health care managers and policy-makers that could then be evaluated prospect ively . Methods We systematic ally review ed studies of decision-making by health care managers and policy-makers , conducted interviews with a purposive sample of them in Canada and the United Kingdom ( n=29 ) , and review ed the websites of research funders , producers/purveyors of research , and journals that include them among their target audiences ( n=45 ) . Results Our systematic review identified that factors such as interactions between research ers and health care policy-makers and timing/timeliness appear to increase the prospect s for research use among policy-makers . Our interviews with health care managers and policy-makers suggest that they would benefit from having information that is relevant for decisions highlighted for them ( e.g. context ual factors that affect a review 's local applicability and information about the benefits , harms/risks and costs of interventions ) and having review s presented in a way that allows for rapid scanning for relevance and then grade d entry ( such as one page of take-home messages , a three-page executive summary and a 25-page report ) . Managers and policy-makers have mixed views about the helpfulness of recommendations . Our analysis of websites found that context ual factors were rarely highlighted , recommendations were often provided and grade d entry formats were rarely used . Conclusions Research ers could help to ensure that the future flow of systematic review s will better inform health care management and policy-making by involving health care managers and policy-makers in their production and better highlighting information that is relevant for decisions . Research funders could help to ensure that the global stock of systematic review s will better inform health care management and policy-making by supporting and evaluating local adaptation processes such as developing and making available online more user-friendly ‘ front ends ’ for potentially relevant systematic review Background There are increasing numbers of r and omised trials and systematic review s examining the efficacy of interventions design ed to bring about a change in clinical practice . The findings of this research are being used to guide strategies to increase the uptake of evidence into clinical practice . Knowledge of the outcomes measured by these trials is vital not only for the interpretation and application of the work done to date , but also to inform future research in this exp and ing area of endeavour and to assist in collation of results in systematic review s and meta-analyses . Methods The objective of this review was to identify methods used to measure change in the clinical practice s of health professionals following an intervention aim ed at increasing the uptake of evidence into practice . All published trials included in a recent , comprehensive Health Technology Assessment of interventions to implement clinical practice guidelines and change clinical practice ( n = 228 ) formed the sample for this study . Using a st and ardised data extraction form , one review er ( SH ) , extracted the relevant information from the methods and /or results sections of the trials . Results Measures of a change of health practitioner behaviour were the most common , with 88.8 % of trials using these as outcome measures . Measures that assessed change at a patient level , either actual measures of change or surrogate measures of change , were used in 28.8 % and 36.7 % of studies ( respectively ) . Health practitioners ' knowledge and attitudes were assessed in 22.8 % of the studies and changes at an organisational level were assessed in 17.6 % . Conclusion Most trials of interventions aim ed at changing clinical practice measured the effect of the intervention at the level of the practitioner , i.e. did the practitioner change what they do , or has their knowledge of and /or attitude toward that practice changed ? Less than one-third of the trials measured , whether or not any change in practice , result ed in a change in the ultimate end-point of patient health status Context Clinicians rely on systematic review s for current , evidence -based information . Contribution This survival analysis of 100 meta-analyses indexed in ACP Journal Club from 1995 to 2005 found that new evidence that substantively changed conclusions about the effectiveness or harms of therapies arose frequently and within relatively short time periods . The median survival time without substantive new evidence for the meta-analyses was 5.5 years . Significant new evidence was already available for 7 % of the review s at the time of publication and became available for 23 % within 2 years . Implication Clinical ly important evidence that alters conclusions about the effectiveness and harms of treatments can accumulate rapidly . The Editors Systematic review s have become increasingly common in recent years ( 1 ) and are recommended by many as the best sources of evidence to guide both clinical decisions ( 2 ) and health care policy ( 3 ) . For systematic review s to fulfill these roles , their findings must remain relatively stable for at least several years or effective mechanisms must exist for alerting end users to important changes in evidence . Yet , surprisingly little research has assessed the extent to which systematic review s become out of date or the rate at which this occurs ( 47 ) . Some organizations , such as the Cochrane Collaboration , recommend updating systematic review s every 2 years , but few empirical data guide this or other recommendations about updating . We sought to determine how quickly systematic review s meet explicitly defined criteria for changes in evidence of sufficient importance to warrant updating . We also sought to identify predictors of survival time , the time to such important changes in evidence . Survival time might vary depending on many factors , including the type of question posed by the original review ( for example , therapeutic or diagnostic ) , the types of studies included ( for example , r and omized trials or observational studies ) , and whether the systematic review provided quantitative synthesis . To limit such variation , we focused on systematic review s of r and omized , controlled trials that evaluated therapeutic benefit or harm by providing quantitative synthesis ( meta- analysis ) for at least 1 outcome . Methods Study Design and Sample We used a quasi-r and om process ( alphabetical sort order by author ) to select 100 systematic review s that were indexed in ACP Journal Club with an accompanying commentary between January 1995 and December 2005 ( with a search date no later than 31 December 2004 to ensure at least 1 full year for new evidence to appear ) . We chose this sampling frame because ACP Journal Club selects systematic review s that meet explicit quality st and ards and are deemed directly relevant to clinical practice ( 8) . We regarded the sample size of 100 as sufficiently large to achieve suitably narrow confidence intervals and to permit evaluation of up to 5 potential predictors of survival . Eligibility Criteria Eligible review s evaluated the benefit or harm of a specific drug , class of drug , device , or procedure ( invasive procedure or surgery ) and included r and omized or quasi-r and omized , controlled trials . We excluded evaluations of alternative and complementary medicines because the stability of review s of such therapies might differ substantially from review s of conventional therapies . We required that review s provide a point estimate and 95 % confidence interval for at least 1 outcome in the form of a relative risk , odds ratio , or absolute risk difference for binary outcomes and weighted mean differences for continuous outcomes . We excluded meta-analyses of individual-patient data , meta-regressions , and indirect meta-analyses because of the difficulty of determining whether new data would alter previous quantitative results . Two team members independently assessed eligibility , with disagreements resolved by consensus involving a third review er . When more than 1 review on the same topic was identified , only the earliest was included . Search ing For each review , search es for new trials included identifying new systematic review s on the same topic , su bmi tting relevant content terms to the Clinical Queries function in Ovid , applying the Related Articles function in PubMed to the 3 largest and the 3 most recent trials in the original review ( up to 6 trials in total ) , and using Scopus ( www . scopus .com/ scopus /home.url ) to identify new r and omized trials that cited the original review . When these search strategies yielded no eligible new trials , we conducted more comprehensive electronic search es and review ed relevant chapters in such sources as Clinical Evidence and UpTo Date to ensure that we had not missed new trials . Team members who had background s in both medicine and clinical research screened citations retrieved by the preceding methods to identify trials that would have met the inclusion criteria in the original review . Retrieved articles were screened in chronological order to ascertain quantitative or qualitative signals for the need for updating . The review protocol stopped when any criteria for updating were met . Each systematic review was discussed in detail , with the final statussignal for updating was or was not detectedadjudicated by consensus ( Figure 1 ) . Figure 1 . Overall process for determining updating status . ACP Journal Club Signals for the Need to Up date Systematic Review s In design ing criteria for comparing new findings with those in a previous review , we adapted methods used by other investigators to address similar problems with comparing 2 sets of results relating to the same question ( 913 ) , such as r and omized and nonr and omized studies of the same intervention . These investigators identified conflicting findings among different publications using a combination of quantitative thresholds for differences in effect magnitude and qualitative judgments about the language used to describe the results . We have similarly conceptualized quantitative and qualitative signals of potential changes in evidence that are sufficiently important to warrant updating previous systematic review s. Quantitative Signals Quantitative signals consisted of a change in statistical significance or relative change in effect magnitude of at least 50 % . We restricted these changes to those involving 1 of the primary outcomes of the original review or any mortality outcome . We also ignored trivial changes in statistical significance when the original and up date d meta-analytic results both had P values between 0.04 and 0.06so that quantitative signals of changes in evidence would represent robust indicators of the need to up date previous review s. Quantitative signals were detected by combining data from eligible new trials with the previous results using a fixed-effects approach . Use of fixed-effect models allowed pooling of the new trials with the previous meta-analytic result , as opposed to having to obtain original data from all of the included trials in each of 100 systematic review s. Although r and om-effects models are usually preferred to avoid spurious precision in the face of heterogeneity , our goal was to detect potential changes in evidence that would warrant a formal up date , not produce exact estimates of the up date d results . Qualitative Signals Qualitative signals included new information about harm sufficient to affect clinical decision making , important caveats to the original results , emergence of a superior alternate therapy , and important changes in certainty or direction of effect . Qualitative signals were detected by using explicit criteria for comparing the language in the original review with descriptions of findings in new systematic review s that addressed the same topic , pivotal trials , clinical practice guidelines , or recent editions of major textbooks ( for example , UpTo Date ) . Pivotal trials were defined as trials that had a sample size at least 3 times larger than that of the previous largest trial or were published in 1 of the 5 highest-impact general medical journals ( The New Engl and Journal of Medicine , Lancet , Journal of the American Medical Association , Annals of Internal Medicine , and the British Medical Journal ) . We defined 2 levels of importance for qualitative signals : potentially invalidating changes in evidence , which would make one no longer want clinicians or policymakers to base decisions on the original findings ( such as a pivotal trial that characterized treatment effectiveness in terms opposite of those in the original systematic review ) , and major changes in evidence , which would affect clinical decision making in important ways without invalidating the previous results ( such as the identification of patient population s for whom treatment is more or less beneficial ) . Major changes also included differing characterizations of effectiveness that were less extreme than those for potentially invalidating signals but that would still affect clinical decision making ( for example , a change from possibly beneficial to definitely beneficial ) . Of importance , such characterizations as possibly effective , probably effective , and promising , were all categorized as possibly effective . Thus , qualitative signals for changes in evidence captured substantive differences in the characterization of treatment effects , not merely semantic differences . Full definitions for each of the specific signals can be found at www.ohri.ca/UpdatingSystRevs . Data Collection For each review , we characterized the clinical content area , eligibility criteria for included trials , definitions of reported outcomes , number of included trials and participants , meta-analytic result for each outcome , identification of statistical heterogeneity , and excerpted quotations of the authors ' characterizations of the main results . We also abstract ed whether a given outcome was explicitly identified as 1 of the primary or main outcomes . We discounted identification of more than 3 such outcomes as inconsistent with the Introduction In 2008 , the UK National Osteoporosis Guideline Group ( NOGG ) produced a guideline on the prevention and treatment of osteoporosis , with an up date in 2013 . This paper presents a major up date of the guideline , the scope of which is to review the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal women and men age 50 years or over . Methods Where available , systematic review s , meta-analyses and r and omised controlled trials were used to provide the evidence base . Conclusions and recommendations were systematic ally grade d according to the strength of the available evidence . Results Review of the evidence and recommendations are provided for the diagnosis of osteoporosis , fracture-risk assessment , lifestyle measures and pharmacological interventions , duration and monitoring of bisphosphonate therapy , glucocorticoid-induced osteoporosis , osteoporosis in men , postfracture care and intervention thresholds . Conclusion The guideline , which has received accreditation from the National Institute of Health and Care Excellence ( NICE ) , provides a comprehensive overview of the assessment and management of osteoporosis for all healthcare professionals who are involved in its management For decades , exercise has been considered a cornerstone of diabetes management , along with diet and medication . However , high- quality evidence on the importance of exercise and fitness in diabetes was lacking until recent years . The present document summarizes the most clinical ly relevant recent advances related to people with type 2 diabetes and the recommendations that follow from these . Our recently published technical review on physical activity/exercise and type 2 diabetes ( 1 ) includes greater detail on individual studies , on prevention of diabetes , and on the physiology of exercise . The present statement focuses on type 2 diabetes . Issues primarily germane to type 1 diabetes will be covered in a subsequent technical review and ADA Statement . The levels of evidence used are defined by the ADA in ref . 2 . Two r and omized trials each found that lifestyle interventions including ∼150 min/week of physical activity and  diet-induced weight loss of 5–7 % reduced the risk of progression from impaired glucose tolerance ( IGT ) to type 2 diabetes by 58 % ( 3,4 ) . A cluster-r and omized trial found that diet alone , exercise alone , and combined diet and exercise were equally effective in reducting the progression from IGT to diabetes ( 5 ) . Therefore , there is firm and consistent evidence that programs of increased physical activity  and modest weight loss reduce the incidence of type 2 diabetes in individuals with IGT . Boule et al. ( 6 ) undertook a systematic review and meta- analysis on the effects of structured exercise interventions in clinical trials of ≥8 weeks duration on HbA1c ( A1C ) and body mass in people with type 2 diabetes . Postintervention A1C was significantly lower in exercise than control groups ( 7.65 vs. 8.31 % , weighted mean difference −0.66 % ; P < 0.001 ) . In contrast , postintervention body weight did not differ between the exercise and control groups . Meta-regression confirmed that the beneficial effect of exercise on A1C Background The prevalence of overweight and obesity is high amongst healthcare professionals and there is growing interest in delivering weight loss interventions in the workplace . We conducted a systematic review to ( i ) examine the effectiveness of workplace-based diet and /or physical activity interventions aim ed at healthcare professionals and to ( ii ) identify and describe key components of effective interventions . Seven electronic data bases were systematic ally search ed . Results Thirteen r and omised controlled trials met the inclusion criteria , of which seven had data available for meta- analysis . Where meta- analysis was possible , studies were grouped according to length of follow-up ( < 12 months and ≥12 months ) and behavioural target ( diet only , physical activity only or diet and physical activity ) , with outcome data pooled using a weighted r and om effects model . Nine studies reported statistically significant ( between-group ) differences . Four studies reported being informed by a behaviour change theory . Meta- analysis of all trials reporting weight data demonstrated healthcare professionals allocated to dietary and physical activity interventions lost significantly more body weight ( −3.95 Kg , [ 95 % CI −4.96 to- 2.95 Kg ] ) than controls up to 12 months follow up . Conclusions Workplace diet and /or physical activity interventions targeting healthcare professionals are limited in number and are heterogeneous . To improve the evidence base , we recommend additional evaluations of theory-based interventions and adequate reporting of intervention content Background Community pharmacists can deliver health care advice at an opportunistic level , related to prescription or non-prescription medicines and as part of focused services design ed to reduce specific risks to health . Obesity , smoking and excessive alcohol intake are three of the most significant modifiable risk factors for morbidity and mortality in the UK , and interventions led by community pharmacists , aim ed at these three risk factors , have been identified by the government as public health priorities . In 2008 , the Department of Health for Engl and stated that ‘ a sound evidence base that demonstrates how pharmacy delivers effective , high quality and value for money services is needed ’ ; this systematic review aims to respond to this requirement . Methods / design We will search the data bases MEDLINE , Embase , CINAHL , PsycINFO , Social Sciences Citation Index , ASSIA , IBSS , Sociological Abstract s , Scopus and NHS Economic Evaluation Data base for studies that have evaluated interventions based on community pharmacies that aim to target weight management , smoking cessation and alcohol misuse . We will include all r and omised controlled trials ( RCTs ) , non-r and omised controlled trials ( N RCTs ) , controlled before-after studies ( CBAs ) and interrupted time series ( ITS ) and repeated measures studies . Data from included studies will be extracted by two independent review ers and will include study details methods , results , intervention implementation/costs and method ological quality . Meta- analysis will be conducted if appropriate ; if not , the synthesis will be restricted to a narrative overview of individual studies looking at the same question . Discussion The review aims to summarise the evidence base on the effectiveness of community pharmacy interventions on health and health behaviours in relation to weight management , smoking cessation and alcohol misuse . It will also explore if , and how , socio-economic status , gender , ethnicity and age moderate the effect of the interventions and will describe how the interventions included in the review have been organised , implemented and delivered , since context is an important factor governing the success of public health interventions . The findings from this review will have an impact on the commissioning of public health services aim ing to promote healthy weight , smoking cessation and prevent excessive alcohol consumption . Systematic review registration The review has been registered with PROSPERO ( registration no. CRD42013005943 ) . Available at : http://www.crd.york.ac.uk/ prospero /display_record.asp?ID = CRD42013005943 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 Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged This article describes approaches for planning , dealing , and analyzing heterogeneity in a systematic review of complex interventions . Approaches aim to generate a priori hypotheses of the mechanism of action of a complex intervention to identify the key variables that might contribute to variation among studies and guide statistical analysis . In addition to characteristics related to the population , intervention , and outcomes , we describe study -related variables , such as the way the interventions have been implemented and the context and conduct of studies . These approaches will guide review ers planning a meta- analysis and provide a rationale for not meta-analyzing data if there is too much variability . Potential difficulties in applying meta-analytical techniques to examine statistical association among study results and sources of potential heterogeneity are described ; these include the selection of a fixed or r and om-effects model , the risk of multiple testing and confounding when studies include different aspects of a complex intervention or different sub sample s of the intended participant pool Objective : This systematic review examines experimental studies that test the effectiveness of strategies intended to integrate empirically supported mental health interventions  into routine care setting s. Our goal was to characterize the state of the literature and to provide direction for future implementation studies . Method : A literature search was conducted using electronic data bases and a manual search . Results : Eleven studies were identified that tested implementation strategies with a r and omized ( n = 10 ) or controlled clinical trial design ( n = 1 ) . The wide range of clinical interventions , implementation strategies , and outcomes evaluated precluded meta- analysis . However , the majority of studies ( n = 7 ; 64 % ) found a statistically significant effect in the hypothesized direction for at least one implementation or clinical outcome . Conclusion : There is a clear need for more rigorous research on the effectiveness of implementation strategies , and we provide several suggestions that could improve this research area Objectives . Overview the quality , direction , and characteristics of yoga interventions for treatment of acute and chronic health conditions in adult population s. Methods . We search ed for systematic review s in 10 online data bases , bibliographic references , and h and - search es in  yoga-related  journals . Included review s satisfy Oxman criteria and specify yoga as a primary intervention in one or more r and omized controlled trials for treatment in adults . The AMSTAR tool and GRADE approach evaluated the method ological quality of review s and quality of evidence . Results . We identified 2202 titles , of which 41 full-text articles were assessed for eligibility and 26 systematic review s satisfied inclusion criteria . Thirteen systematic review s include quantitative data and six papers include meta- analysis . The quality of evidence is generally low . Sixteen different types of health conditions are included . Eleven review s show tendency towards positive effects of yoga intervention , 15 review s report unclear results , and no , review s report adverse effects of yoga . Yoga appears most effective for reducing symptoms in anxiety , depression , and pain . Conclusion . Although the quality of systematic review s is high , the quality of supporting evidence is low . Significant heterogeneity and variability in reporting interventions by type of yoga , setting s , and population characteristics limit the generalizability of results PURPOSE Health interventions based on theory may be more effective than those that are not . This review of review s synthesizes all published r and omized controlled trial ( RCT ) meta-analytic evidence from the last decade to examine whether theory-based interventions were found to be associated with more effective  adult health behaviour change interventions . METHODS Systematic review s including meta-analyses were identified by search ing Medline , CINAHL , PsycINFO , and CDSR . A narrative synthesis was used to summarize and analyse the evidence . Only review s including RCTs of health behaviour change interventions with adults aged 18 + published from 2007 to 2017 were included . RESULTS Of 8,659 articles , nine systematic review s met inclusion criteria . The majority of review s ( n = 8) suggested no increased effectiveness for theory-based compared to non-theory-based interventions for effectiveness of outcomes relating to health behaviour . Less than half of the RCTs included in the review s reported the use of theory ( 85/183 ) . Two review s suggested interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Method ological and reporting issues limit the conclusions . CONCLUSIONS Theory-based interventions as currently operationalized in systematic review s were not found to be more effective than non-theory-based interventions . Method ological and reporting issues at study and review level may not reflect the true utility of theory use within health behaviour interventions . The promotion of theory use may benefit from using a multifaceted argument , rather than a narrow focus of increased effectiveness . Statement of contribution What is already known on this subject ? Theory use is regularly promoted by cl aim ing that it will lead to more effective behaviour change interventions . Theory use has been frequently linked to effectiveness within systematic review s of behaviour change interventions . The theory-effectiveness hypothesis has not been systematic ally examined at the systematic review level . What does this study add ? Theory use as operationalized by systematic review authors was not associated with increased effectiveness within systematic review s examining r and omized controlled trials of behaviour change interventions in adults . Interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Theory use should be promoted using a multifaceted argument , and assertions for increased effectiveness of theory-based interventions should only be used in domains where specific evidence exists to support this cl aim
The narrative synthesis provided mixed effects of CHITs on other clinical , psychosocial , behavioral , and knowledge outcomes .
Conclusions The use of CHITs appears to be more effective than usual care in improving glycemic control for patients with diabetes .
However , their effectiveness did not remain consistent over time and in other patient outcomes .
Objective To reveal the effects of consumer-oriented health information technologies ( CHITs ) on patient outcomes in diabetes management over time through systematic review and meta- analysis .