Driving up the Quality and Relevance of Research Through the Use of Agreed Core Outcomes Replication in Prevention Science Bias in Systematic Reviews? Allergen immunotherapy for the treatment of allergic rhinitis and/or asthma: an umbrella review. A systematic review of randomized controlled trials on curative and health enhancement effects of forest therapy Gynaecologic surgery from uncertainty to science: evidence-based surgery is no passing fad. A Systematic Review of Randomized Controlled Interventions for Parents' Distress in Pediatric Leukemia The nuts and bolts of PROSPERO: an international prospective register of systematic reviews A systematic review of anxiety interventions in stroke and acquired brain injury: Efficacy and trial design The Effects of Exercise on Memory Function Among Young to Middle-Aged Adults: Systematic Review and Recommendations for Future Research Digital Games, Design, and Learning Unpacking Resident-Led Code Status Discussions: Results from a Mixed Methods Study Psychosocial interventions for people with dementia: An overview and commentary on recent developments Adherence to Enhanced Recovery after Surgery Protocols across a High-Volume Gastrointestinal Surgical Service Research Design Options for Intervention Studies CONSORT-EHEALTH: Implementation of a Checklist for Authors and Editors to Improve Reporting of Web-Based and Mobile Randomized Controlled Trials The Melbourne Family Support Program: evidence-based strategies that prepare family caregivers for supporting palliative care patients A Guide for applying a revised version of the PARIHS framework for implementation Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers NICE guidance on long-term sickness and incapacity. Living Legends: Effectiveness of a Program to Enhance Sense of Purpose and Meaning in Life Among Community-Dwelling Older Adults. Best Practice in Systematic Reviews: The Importance of Protocols and Registration Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review
There is a growing recognition that insufficient attention has been paid to the selection of the outcomes to measure in clinical trials and clinical audit . Outcomes need to be relevant to patients , clinicians , purchasers and policy-makers if the findings of research are to influence practice and future research . In addition , st and ardization of outcomes is needed to combine data from different studies to allow evidence synthesis and to compare data sets . Inconsistent choice of outcome measures means that many meta-analyses are unable to include data from all the relevant studies . For example , the five most accessed Cochrane review s in 2009 , together with the top cited review in that year , all described inconsistencies in the outcomes reported in eligible trials . A call for the st and ardization of outcomes is a regular conclusion of systematic review s. Furthermore , outcome reporting bias , defined as the bias arising from selecting outcomes for publication based on the results , affects many r and omized trials and ‘ is an under-recognized problem that affects the conclusions in a substantial proportion of Cochrane review s ’ . That bias is likely to affect systematic review s more widely as well as affecting individual studies when considered on their own . Similar problems occur with clinical audit , highlighting the importance of establishing national audits that use and report the same outcomes for all participants . All these issues could be addressed with the development and application of agreed st and ardized sets of outcomes that have been termed ‘ core outcome sets ’ . These should be measured and reported , as a minimum , in all relevant clinical trials and national clinical audits for a specific condition . Adopting a core outcome set does not imply that a particular study , review or audit should be restricted to only those outcomes . Rather , the expectation is that , as a minimum , core outcomes will always be collected and reported to allow the results of trials to be compared , contrasted and combined as appropriate . The adoption of core outcomes would have implication s across all areas of research in health and health care , reduce heterogeneity between trials , and lead to research that is more likely to have measured relevant outcomes . Importantly , they would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information . In addition , they will increase the efficiency and value of research . An important rationale for core outcome sets is that outcomes currently reported for trials do not consistently reflect endpoints that are meaningful for patients . Examples exist where trials failed to include all outcomes important to patients and where involvement of patients has identified an outcome that might not have been considered by practitioners on their own . Despite increasing recognition of the importance of incorporating patients ’ opinions , their involvement has been limited . Recent regulatory guidance in the USA requires documented evidence of patient input during the development of instruments to measure  patient reported outcomes ( PROs ) . However , measurement of PROs in clinical trials is hampered by the multiplicity and heterogeneity of tools currently available . Many generic , disease and domain-specific instruments have been developed and vali date d , each containing multiple scales and items . As a result , synthesis of PRO data from trials is difficult and review s aim ing to summarize treatment effect according to PROs may fail . There is synergy between the development of core outcome sets for trials and work to select up to seven outcomes that are important to patients for inclusion in Summary of Findings tables in systematic review s. Developed by the GRADE group ( http://www . grade workinggroup.org ) , Cochrane review s have featured such tables since 2008 , and they play a key role in presenting research in guidelines , such as those produced by the World Health Organization ( WHO ) . The development of core outcome sets needs to be accelerated and undertaken in ways that maximize efficiency . The COMET ( Core Outcome Measures in Effectiveness Trials , http://www.comet-initiative.org ) Initiative in the UK brings together research ers interested in the development and application of core outcome sets . These include key participants in a collaboration of research ers in rheumatology who have done the most notable work to date in this area . The COMET Initiative was launched in January 2010 , with a second meeting in July 2011 . Attendees included trialists , systematic review ers , patients , clinicians , journal editors , research funders , policy-makers , people responsible for trials registries and regulators . Data on individual studies , both published and ongoing , are being included in a free , publically available internet-based re source . This will be up date d periodically , to minimize the risk of duplication . Seventy-eight published or ongoing studies have already been entered into the repository . In addition , published review s of outcomes used in clinical trials or studies examining patients ’ views , will be entered Replication research is essential for the advancement of any scientific field . In this paper , we argue that prevention science will be better positioned to help improve public health if ( a ) more replications are conducted ; ( b ) those replications are systematic , thoughtful , and conducted with full knowledge of the trials that have preceded them ; and ( c ) state-of-the art techniques are used to summarize the body of evidence on the effects of the interventions . Under real-world dem and s it is often not feasible to wait for multiple replications to accumulate before making decisions about intervention adoption . To help individuals and agencies make better decisions about intervention utility , we outline strategies that can be used to help underst and the likely direction , size , and range of intervention effects as suggested by the current knowledge base . We also suggest structural changes that could increase the amount and quality of replication research , such as the provision of incentives and a more vigorous pursuit of prospect i ve research registers . Finally , we discuss methods for integrating replications into the roll-out of a program and suggest that strong partnerships with local decision makers are a key component of success in replication research . Our hope is that this paper can highlight the importance of replication and stimulate more discussion of the important elements of the replication process . We are confident that , armed with more and better replications and state-of-the-art review methods , prevention science will be in a better position to positively impact public health At an orthodontic meeting in recent years , a colleague recounted to me that when a presenter had finished their presentation on a systematic review , the person beside leaned over and said to my colleague ‘ not another systematic review where it ’s not possible to draw any firm conclusions ’ . So an element of frustration was clear based on the screening of a large volume of evidence to arrive at such a low point for a conclusion . This , however , is now a familiar outcome for many orthodontic systematic review s. In this short editorial , I have attempted to give a brief outline of the proposed benefits of systematic review s but more importantly , to highlight , some issues we all need to bear in mind in their regard . The increasing focus on evidence -based healthcare , including orthodontics , has shunned the narrative review and spawned the systematic review . Aim ing to identify , evaluate and summarize the findings of all relevant studies on a specific topic , its exacting systematic approach should minimize bias and provide conclusions based on reliable findings . Meta-analyses of r and omized clinical trials with low risk of bias are considered the highest level of evidence available for evaluating the effects of an intervention . Systematic review s are also important tools in setting the research agenda via their recommendations for future research and authors can alert research ers to the most pertinent outcomes in clinical practice . But systematic review s like any other study type are not without their variability , both in dentistry in general and specifically in orthodontics . Large differences have also been observed in the quality of reporting of several characteristics between Cochrane and non-Cochrane systematic review s. A key question that must be asked when looking at all Cochrane review s is whether the review has been undertaken in a way to avoid bias and whether the data and results from the included studies are valid . Conclusions may be distorted if bias is introduced to the review process at any stage . For example , incomplete search ing for all relevant studies may lead to publication bias ; there is strong association between publication and studies reporting significant or positive findings in medicine and also within orthodontics . With regard to studies included within the review , these need to be assessed to ensure that they are undertaken and reported in a manner that is free of bias ( systematic error ) . Outcome reporting bias ( ORB ) may also be relevant , e.g. in a study identified as relevant to a review , where data exist on the outcome of interest but only selected findings have been given based on the results . Although systematic review s have emphasized ‘ assessment of method ological quality ’ of included studies , the Cochrane h and book recommends a focus on ‘ risk of bias assessment ’ instead . The justifications are four-fold : it targets whether the results of included studies should be credible ; despite being carried out to the highest st and ards , a study may have risk of bias due to , e.g. impracticality/impossibility of blinding of participants / study personnel ; some quality markers , e.g. a power calculation is unlikely to directly affect risk of bias ; it overcomes ambiguity between quality of reporting and quality of the underlying research BACKGROUND Allergic rhinitis and asthma are important public health concerns , yet there is no consensus about the benefits and harms of allergen-specific immunotherapy to treat these conditions . We performed an umbrella review of systematic review s summarizing the current evidence for the benefits and harms of subcutaneous immunotherapy ( SCIT ) and sublingual immunotherapy ( SLIT ) . METHODS We search ed MEDLINE , Embase , the Cochrane Library and the grey literature from Jan. 1 , 2010 to Nov. 20 , 2016 for systematic review s of r and omized controlled trials or prospect ively controlled studies involving children or adults with allergic rhinitis or asthma . Outcomes were summarized narratively ( benefits : total combined symptom-medication score , symptom score , medication score , disease-specific quality of life , adherence ; harms : anaphylaxis , death , local and systemic reactions ) . RESULTS Twenty-three systematic review s were included . SCIT and SLIT were more effective than placebo for most outcomes . SCIT was better than SLIT at improving medication and symptom scores , with no differences in quality of life ; however , data were limited for this comparison . Anaphylaxis and death were infrequently reported . Few review s assessed benefits or harms among children . INTERPRETATION Allergen immunotherapy appears to be effective among patients with allergic rhinitis and asthma . The safety of allergen immunotherapy is not conclusively established , although death and anaphylaxis appear to be rare . PROSPERO no. : CRD42015024590 Objective To summarize the evidence for curative and health enhancement effects through  forest therapy  and to assess the quality of studies based on a review of r and omized controlled trials ( RCTs ) . Study design A systematic review based on RCTs . Methods Studies were eligible if they were RCTs . Studies included one treatment group in which forest therapy was applied .  The following data bases – from 1990 to November 9 , 2010 – were search ed : MEDLINE via PubMed , CINAHL , Web of Science , and Ichushi- Web . All Cochrane data bases and Campbell Systematic Review s were also search ed up to November 9 , 2010 . Results Two trials met all inclusion criteria . No specific diseases were evaluated , and both studies reported significant effectiveness in one or more outcomes for health enhancement . However , the results of evaluations with the CONSORT ( Consoli date d St and ards of Reporting Trials ) 2010 and CLEAR NPT ( A Checklist to Evaluate a Report of a Nonpharmacological Trial ) checklists generally showed a remarkable lack of description in the studies . Furthermore , there was a problem of heterogeneity , thus a meta- analysis was unable to be performed . Conclusion Because there was insufficient evidence on forest therapy due to poor method ological and reporting quality and heterogeneity of RCTs , it was not possible to offer any conclusions about the effects of this intervention . However , it was possible to identify problems with current RCTs of forest therapy , and to propose a strategy for strengthening study quality and stressing the importance of study feasibility and original check items based on characteristics of forest therapy as a future research agenda BACKGROUND The r and omized controlled trial ( RCT ) is the least biased measure of the effectiveness of interventions , including surgical interventions . The aim was to review the available evidence base in gynaecologic surgery , to assess what progress has been made and to determine gaps in the evidence for clinical decision-making . METHODS Systematic review s involving gynaecological surgery interventions were extracted from the Cochrane Data base of Systematic Review s ( Issue 2 , 2007 ) and data were extracted for key primary outcomes from each of the r and omized trials in the review s. The review s were categorized as to whether they had provided evidence of effectiveness for pre-defined outcomes of most relevance to patients . RESULTS Of 371 review s or protocol s published on the Cochrane Data base of Systematic Review s ( Issue 2 , 2007 ) , only 30 were completed review s assessing surgical interventions . Seven review s concluded there was evidence of a significant effect ( whether beneficial or harmful ) of the interventions studied for pre-defined primary outcomes ; 11 review s concluded there was some evidence of significant effects for primary outcomes along with some gaps for primary outcomes ; 12 review s concluded insufficient evidence of effectiveness . Common themes of unique method ological challenges and pitfalls with trials of surgical interventions were apparent . CONCLUSIONS Cochrane review s have gone a long way to establishing a sound evidence base in gynaecologic surgery : some gaps in the evidence have been eliminated and others highlighted . In general , gynaecology has been a specialty where surgical interventions have been well exposed to the scrutiny of RCTs compared with other surgical specialties Objective . This review aims to summarize the existing evidence concerning interventions towards reducing stress in parents with a child with leukemia and their effect in child and family wellbeing . Methods . A systematic review strategy was conducted using MEDLINE covering the period January 1980 to June 2010 . Results . Seven r and omized controlled trials met the inclusion criteria including in total 1045 parents participants . A variety of cognitive-behavioral interventions problem-solving skills training programs have been used for managing distress in parents and children . Outcome measures are assessed by self-report , observer report , behavioral/psychological , and physiological measures . The most prominent method ological problems were the marked heterogeneity in stress measurement and the relative absence of proper measurement and adjustment of moderating and mediating factors . The largest effect has been obtained by combined cognitive-behavioral interventions with promising but limited evidence for several other psychological interventions . Conclusions . Recommendations for future RCTs are provided , and particular attention to the quality of trial design and reporting is highlighted Background Following publication of the PRISMA statement , the UK Centre for Review s and Dissemination ( CRD ) at the University of York in Engl and began to develop an international prospect i ve register of systematic review s with health-related outcomes . The objectives were to reduce unplanned duplication of review s and provide transparency in the review process , with the aim of minimizing reporting bias . Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality . This article describes the development of the register , now called PROSPERO , and the process of registration . Results PROSPERO offers free registration and free public access to a unique prospect i ve register of systematic review s across all areas of health from all around the world . The dedicated web-based interface is electronically search able and available to all prospect i ve registrants . At the moment , inclusion in PROSPERO is restricted to systematic review s of the effects of interventions and strategies to prevent , diagnose , treat , and monitor health conditions , for which there is a health-related outcome .Ideally , registration should take place before the research ers have started formal screening against inclusion criteria but review s are eligible as long as they have not progressed beyond the point of completing data extraction .The required data set captures the key attributes of review design as well as the administrative details necessary for registration .Su bmi tted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register , rejected , or returned to the applicant for clarification . The public records include an audit trail of major changes to planned methods , details of when the review has been completed , and links to result ing publications when provided by the authors . Conclusions There has been international support and an enthusiastic response to the principle of prospect i ve registration of protocol s for systematic review s and to the development of PROSPERO .In October 2011 , PROSPERO contained 200 records of systematic review s being undertaken in 26 countries around the world on a diverse range of interventions Objective There is little r and omized controlled trial ( RCT ) evidence to guide treatment for anxiety after stroke . We systematic ally review ed RCTs of anxiety interventions in acquired brain injury ( ABI ) conditions including stroke and traumatic brain injury ( TBI ) in order to summarize efficacy and key aspects of trial design to help guide future RCTs . Methods We search ed the Cochrane trial register , Medline , Embase , PsychInfo and CINAHL systematic ally up to August 2017 . Two independent review ers systematic ally selected studies and extracted data . We summarized the effect size , key study characteristics and sources of potential bias in trial design . Results 14 studies ( 12 stroke ; one stroke & TBI ; one TBI ) with 928 participants were included . Meta- analysis of five psychotherapy comparisons favoured intervention over control ( st and ardized mean difference ( SMD ) : − 0.41 [ − 0.79 , − 0.03 ] , I2 = 28 % ) ; Overall effect size of pharmacotherapy comparisons favoured intervention over control ( SMD : − 2.12 [ − 3.05 , − 1.18 ] , I2 = 89 % ) . One comparison of mixed pharmacotherapy and psychotherapy favoured intervention over usual care ( SMD : − 4.79 [ − 5.87 , − 3.71 ] ) . One comparison favoured  forest therapy versus urban control ( SMD : − 2.00 [ − 2.59 , − 1.41 ] ) . All positive studies carried high or unclear risk of bias . Sample sizes were small in all included studies . Conclusions There is low quality evidence to suggest that psychotherapy and pharmacotherapy may be effective interventions in the treatment of anxiety after stroke based on underpowered studies that carried high risk of bias . Large-scale well- design ed definitive trials are needed to establish whether pharmacological or psychotherapy works . Our review highlighted key considerations for investigators wishing to design high quality trials to evaluate treatments for anxiety after stroke Objective : To systematic ally summarize the experimental effects of exercise on cognitive-related memory function among young to middle-aged adults , which has yet to be done in the literature . Data Source : PubMed . Study Inclusion and Exclusion Criteria : Studies were included if they were published in the English language , indexed in PubMed , employed an experimental study design ( eg , traditional parallel group r and omized controlled trial : either acute intervention or chronic/training intervention study ) , and conducted among human adults . Studies were excluded if nonhumans ( ie , animal models ) were studied , if children/adolescents ( < 18 years ) or older adults ( > 50 years ) were evaluated , and if select chronic diseases ( eg , diabetes and dementia ) were present . Data Extraction : A systematic review approach was employed . Data Synthesis : An extraction table was created synthesizing the key results , and recommendations for future research are emphasized . Results : Among the 17 evaluated studies , 2 were published before the year 2000 ( ie , 1998 and 1999 ) , 2 were published in 2007 , and the remaining 13 were published in the years 2011 and beyond . This highlights the emergence of this research topic within this age-group ( young to middle-aged adults ) . Among the 17 evaluated studies , 14 were conducted among healthy sample s , with 3 conducted among those with a diagnosis of depression . Among the 17 studies , 4 employed a chronic training protocol , with 13 utilizing an acute exercise protocol . Among the 3 experimental studies in the depressed population , all demonstrated a favorable effect of exercise on memory function . Among the 14 trials in the nondepressed population , 10 ( 71 % ) demonstrated a favorable effect of exercise on some aspect of memory function . Conclusion : Acute and chronic exercise appears to play a pronounced effect on memory function  among young to middle-aged adults . Implication s and recommendations for future research are outlined in this systematic review In this meta- analysis , we systematic ally review ed research on digital games and learning for K–16 students . We synthesized comparisons of game versus nongame conditions ( i.e. , media comparisons ) and comparisons of augmented games versus st and ard game design s ( i.e. , value-added comparisons ) . We used r and om-effects meta-regression models with robust variance estimates to summarize overall effects and explore potential moderator effects . Results from media comparisons indicated that digital games significantly enhanced student learning relative to nongame conditions ( g ¯ = 0.33 , 95 % confidence interval [ 0.19 , 0.48 ] , k = 57 , n = 209 ) . Results from value-added comparisons indicated significant learning benefits associated with augmented game design s ( g ¯ = 0.34 , 95 % confidence interval [ 0.17 , 0.51 ] , k = 20 , n = 40 ) . Moderator analyses demonstrated that effects varied across various game mechanics characteristics , visual and narrative characteristics , and research quality characteristics . Taken together , the results highlight the affordances of games for learning as well as the key role of design beyond medium ABSTRACT BACKGROUND The quality of code status discussion s ( CSDs ) is suboptimal as physicians often fail to discuss patients ’ goals of care and resuscitation outcomes . We previously demonstrated that internal medicine residents r and omized to a communication skills intervention  scored higher than controls on a CSD checklist using a st and ardized patient . However , the impact of this training on CSD content is unknown . OBJECTIVE Compare CSD content between intervention and control residents . DESIGN We conducted qualitative analysis of simulated CSDs . Augmenting a priori codes with constant comparative analysis , we identified key themes associated with resident determination of code status . We dichotomized each theme as present or absent . We used chi-square tests to evaluate the association between training and presence of each theme . PARTICIPANTS Fifty-six residents rotating on the internal medicine service in July 2010 were r and omized to intervention ( n = 25 ) or  control ( n = 31).INTERVENTIONIntervention residents completed CSD skills training ( lectures , deliberate practice , and self- study ) . Six months later , all 56 residents completed a simulated CSD.MAIN MEASUREComparison of key themes identified in CSDs among intervention and controls . KEY RESULTS Fifty-one transcripts were recorded and review ed . Themes identified included : exploration of patient values/ goals , framing code status as a patient decision , discussion of resuscitation outcomes and quality of life , and making a recommendation regarding code status . Intervention residents were more likely than controls to explore patient values/ goals ( p = 0.002 ) and make a recommendation ( p < 0.001 ) ; and less likely to frame the decision as one solely to be made by the patient ( p = 0.01 ) . Less than one-third of residents discussed resuscitation outcomes or quality of life . CONCLUSION Training positively influenced CSD content in key domains , including exploration of patient values/ goals , making a recommendation regarding code status , and not framing code status as solely a patient decision . However , despite the intervention , residents infrequently discussed resuscitation outcomes and quality of life An influential review in 2010 concluded that non-pharmacological multi-component interventions have positive effects on cognitive functioning , activities of daily living , behaviour and mood of people with dementia . Our aim here is to provide an up-to- date overview of research into psychosocial interventions and their impact on psychosocial outcomes . We focused on r and omised controlled trials , controlled studies and review s published between October 2008 and August 2015 , since the earlier review . The search of PsychInfo , Medline and the Cochrane data base of systematic review s yielded 61 relevant articles , organised into four themes echoing key phases of the care pathway : Living at home with dementia ( five review s , eight studies ) , carer interventions ( three review s , four studies ) , interventions in residential care ( 16 review s , 12 studies ) and end-of-life care ( three review s , two studies ) , along with an additional group spanning community and institutional setting s ( six review s , two studies ) . Community findings suggested that appointment of dementia specialists and attention to case management can produce positive outcomes ;  physical therapies , cognitive training and modified cognitive behaviour therapy also had a range of benefits . There was more limited evidence of positive benefits for people with dementia through interventions with family carers . Thirty-two articles focused on the management of ‘ behavioural symptoms ’ through a range of interventions all of which had some evidence of benefit . Also a range of multi-component and specific interventions had benefits for cognitive , emotional and behavioural well-being of people with dementia in residential setting s , as well as for quality of life . Overall , interventions tended to be short term with impact only measured in the short term . We recommend further research on interventions to promote living well in the community post-diagnosis and to address end-of-life care . Development of psychosocial interventions would benefit from moving beyond the focus on control of behaviours to focus on wider aspects of life for people with dementia Background and Aims : Enhanced recovery after surgery ( ERAS ) has been shown to improve outcomes for patients following gastrointestinal surgery . Data on protocol adherence and how this impacts on outcome are limited . This study examines how protocol adherence changes over time and determines how this impacts on outcome across a large-volume gastrointestinal surgical service . Material s and Methods : A prospect i ve review of patients eligible for colorectal , liver and oesophagogastric ERAS over two 3-month periods in 2010 and 2011 was performed . End points included : length of stay ( LOS ) , overall protocol adherence , individual modality adherence , reason for pathway deviation and patient outcomes . Results : 172 patients ( 110 colorectal , 31 liver and 31 oesophagogastric ) were evaluated . For each sub-speciality , the introduction of ERAS led to significant reductions in LOS that were sustained for the duration of the study . Adherence was achieved across 60 % ( colorectal ) , 75 % ( liver ) and 88 % ( oesophagogastric ) of individual pathway modalities . The major causes of pathway deviation were : post-operative nausea and vomiting ( colorectal ) , pain ( liver ) and pulmonary complications ( oesophagogastric ) . Conclusions : Large-scale implementation of ERAS at a high-volume centre is feasible and offers many of the benefits demonstrated in controlled trials , but adherence may diminish over time Purpose : To review research design s for rehabilitation . Summary of Key Points : Single-case , observational , and qualitative design s are highlighted in terms of recent advances and ability to answer important scientific questions about rehabilitation . Statement of Conclusions : Single-case , observational , and qualitative design s can be conducted in a systematic and rigorous manner that provides important information that can not be acquired using more common design s , such as r and omized controlled trials . These less commonly used design s may be more feasible and effective in answering many research questions in the field of rehabilitation . Recommendations for Clinical Practice : Research ers should consider these design s when selecting the optimal design to answer their research questions . We should improve education about the advantages and disadvantages of existing research design s to enable more critical analysis of the scientific literature we read and review to avoid undervaluing studies not within more commonly used categories BACKGROUND R and omized trials of web-based and mobile interventions pose very specific issues and challenges . A set of best practice s on how to conduct and report such trials was recently summarized in the CONSORT-EHEALTH statement ( Consoli date d St and ards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth ) , published in August 2011 as draft and in December 2011 as journal article ( V1.6.1 ) . The purpose of this presentation is to review the results of the pilot implementation at the Journal of Medical Internet Research ( JMIR ) , a leading eHealth journal , where reporting of trials in accordance with CONSORT-EHEALTH became m and atory in late 2011 . METHODS Authors of all r and omized trials su bmi tted to JMIR were asked to complete an electronic question naire , which involved copying pertinent manuscript sections into a CONSORT EHEALTH data base form , were asked to score the importance of CONSORT EHEALTH items , and were asked to provide narrative feedback on the value of the process . RESULTS Between August 2011 and November 2012 , 67 r and omized trials were su bmi tted , of which 61 were intended for publication in JMIR . Authors reported that it took between 1 and 16 hours to complete the checklist including making required changes to their manuscripts . 72 % ( 48/67 ) of authors reported they made minor changes to the manuscript , 6 % ( 4/67 ) made major changes . Most authors felt it was a useful process that improved their manuscripts : 63 % ( 42/67 ) said it improved their manuscript , 13 % ( 9/67 ) said it did not , 12 % ( 8/67 ) indicated that it had improved a little . CONCLUSIONS The CONSORT EHEALTH statement and checklist appeared successful in improving the quality of reporting . The checklist should be endorsed and used by authors and editors of other journals Background A key component of palliative care is support for family caregivers . Although some family caregivers identify positive aspects , the impact is typically burdensome ; they are prone to physical and psychological morbidity , financial disadvantage and social isolation . Outcomes of systematic review s have highlighted the importance of investment in  family caregiver intervention research . Purpose To provide an overview of the development , evaluation and outcomes arising from of a programme of research ( The Melbourne Family Support Program ( FSP ) ) , which focused on reducing the psychosocial burden of family caregivers . Methods Developmental work involved a systematic literature review ; focus groups with family caregivers and health professionals ; and identification of a conceptual framework . Following a pilot r and omised controlled trial ( RCT ) , a programme of psychoeducational intervention studies was developed and tested ; one via RCT , the others via prepost test . Results Four psychoeducational interventions , incorporating one-to-one and group format delivery , conducted in both the home and inpatient hospital/hospice were evaluated . Statistically significant outcomes included improvements in family caregivers ’ preparedness , competence , positive emotions , more favourable levels of psychological wellbeing and a reduction in unmet needs . Internationally endorsed guidelines for the psychosocial support of family caregivers were produced and several re sources were constructed . Fifteen publications in international peer- review ed journals have arisen from this programme . Conclusions The interventions and re sources from the Melbourne FSP provide several evidence d-based and clinical ly relevant approaches that focus on reducing the psychosocial burden of the caregiving role . In several instances , however , more rigorous method ological testing is advocated Background Based on a critical synthesis of literature on use of the Promoting Action on Research Implementation in Health Services ( PARIHS ) framework , revisions and a companion Guide were developed by a group of research ers independent of the original PARIHS team . The purpose of the Guide is to enhance and optimize efforts of research ers using PARIHS in implementation trials and evaluations . Methods Authors used a planned , structured process to organize and synthesize critiques , discussion s , and potential recommendations for refinements of the PARIHS framework arising from a systematic review . Using a templated form , each author independently recorded key components for each review ed paper ; that is , study definitions , perceived strengths/ limitations of PARIHS , other observations regarding key issues and recommendations regarding needed refinements . After reaching consensus on these key components , the authors summarized the information and developed the Guide . Results A number of revisions , perceived as consistent with the PARIHS framework 's general nature and intent , are proposed . The related Guide is composed of a set of reference tools , provided in Additional files . Its core content is built upon the basic elements of PARIHS and current implementation science . Conclusions We invite research ers using PARIHS for targeted evidence -based practice ( EBP ) implementations with a strong task-orientation to use this Guide as a companion and to apply the revised framework prospect ively and comprehensively . Research ers also are encouraged to evaluate its use relative to perceived strengths and issues . Such evaluations and critical reflections regarding PARIHS and our Guide could thereby promote the framework 's continued evolution In recognition of the benefits of transparent reporting , many peer- review ed journals require that their authors be prepared to share their raw , unprocessed data with other scientists and /or state the availability of raw data in published articles . But little information on how data should be prepared for publication - or sharing - has emerged . In clinical research patient privacy and consent for use of personal health information are key considerations , but agreed-upon definitions of what constitutes anonymised patient information do not appear to have been established . We aim to address this issue by providing practical guidance for those involved in the publication process , by proposing a minimum st and ard for de-identifying data sets for the purpose s of publication in a peer- review ed biomedical journal , or sharing with other research ers . Basic advice on file preparation is provided along with procedural guidance on prospect i ve and retrospective publication of raw data , with an emphasis on r and omised controlled trials . In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal web sites Long-term  sickness absence and incapacity benefits ( disability pension ) rates have increased across industrialised countries . Effective measures are needed to support return to work . The recommendations of this guidance were informed by the most appropriate available evidence of effectiveness and cost-effectiveness . Public health evidence was provided by research using a variety of study design s that attempted to determine the outcome of a particular intervention by evaluating status before and after the intervention had been effected , and was not limited to r and omised control trials . Where the evidence base was depleted or underdeveloped , expert witnesses were called to give their opinion on the best available evidence and emerging interventions . The process enabled challenge and contestability from stakeholder groups at different points as the guidance was developed . Forty-five heterogeneous studies were included in the review of interventions to reduce long-term sickness absence and transitions from short-term to long-term absence ( mainly covering the former and also mainly examining musculoskeletal conditions ) . The analysis of evidence was restricted to descriptive synthesis . Three general themes emerged from an analysis of the studies that were more likely to report positive results : early interventions ; multidisciplinary approaches ; and interventions with a workplace component . Two further review s were undertaken , one on interventions to reduce the re-occurrence of sickness absence , which identified seven studies on lower back pain , and concluded that early intervention and direct workplace input are important factors . The final evidence review focused on six studies of interventions for those in receipt of incapacity benefit . The evidence was that work-focused interviews coupled with access to tailored support are effective and cost-effective interventions . Practitioners should consider the impact of interventions and management options on work ability for patients of working age . Work ability should be considered a key outcome for future intervention studies OBJECTIVE We investigated the therapeutic benefits ( i.e. , sense of purpose and meaning in life ) of the Living Legends program , which includes life review writing and an intergenerational exchange , compared with life review writing alone , for community-dwelling older adults . METHOD This study was a r and omized controlled trial with a connected qualitative component . We analyzed quantitative data using independent- sample s t tests and written descriptions of program experiences using Collaizi 's qualitative methodology ; we then used a triangulation protocol to integrate the qualitative and quantitative data . RESULTS For participants in the writing workshop plus intergenerational exchange , sense of purpose and meaning in life increased significantly ( p<.0001 ) compared with those in the writing workshop alone . Qualitative themes revealed additional program benefits . CONCLUSION Living Legends enhanced participants ' sense of purpose and meaning in life , a factor known to prevent cognitive loss and disability , compared with life review writing alone It is now just over six years [ 1 ] since many medical journals began requiring that trials be registered before considering the trial report for publication . Such a policy was set up explicitly to reduce what was considered to be widespread bias in favor of publication of ‘ ‘ positive ’ ’ trials and to ensure that all clinical trials be made public prior to participant enrollment . Given the importance of clinical trials for estimating the efficacy and safety of interventions , and their role in approval of new drugs and devices , such a policy seemed uncontroversial . Although it is known that some trials still go unregistered , there are strong incentives ( such as journal publication ) and , in some countries legally enforceable m and ates , for authors to register these studies before enrolling patients . The existence and widespread uptake of trial registration helps research ers , patients , and funders underst and how many trials are being undertaken and which interventions are being evaluated . It also allows studies to be traced from inception through to completion and publication [ 2 ] . However , well-conducted systematic review s — overviews of health care interventions that use a predefined , explicit methodology to find and synthesize all the relevant evidence —are generally considered higher-caliber evidence than are individual trials in decision-making for clinical practice and health policy . The superiority given to such review s derives from key aspects inherent to the process of carrying out a systematic review . This study type , if done properly , allows the review to come closer to estimating the true effect of an intervention than any single study can , for two main reasons . First , such review s collect and synthesize all relevant studies ; second , review s appraise each included study for risk of bias . However , there is increasing evidence of the existence of publication bias for systematic review s. A recent survey [ 3 ] indicates that nonpublication of completed studies may be as much of a problem for systematic review s as it is for trials . Other analyses [ 4,5 ] point to the existence of discrepancies between systematic review protocol s and the published report , with one study [ 5 ] showing that the outcomes included in published systematic review s may be biased toward ‘ ‘ positive ’ ’ findings . It is crucially important , therefore , that if the evidence from these studies is to be incorporated into clinical practice , the review is as rigorous and as fully reported as possible . For example , it should be obvious to readers whether there was a prespecified protocol for the review , that deviations are noted , and whether outcomes from the review are reported according to the original study plan . Increased clarity surrounding systematic review conduct and reporting would be possible if the protocol s for systematic review s , just like those for trials , were registered [ 6,7 ] . Systematic review s conducted under the auspices of the Cochrane Collaboration are registered early , at the protocol development stage . This registration helps minimize bias in the conduct and reporting of the review , reduce duplication of effort between groups , and keep systematic review s up date d. However , until now no overarching registry open to all research ers , worldwide , has existed for recording the existence and development of systematic review s from inception through to completion . This month , the Centre for Review s and Dissemination ( University of York , UK ) , supported by the UK National Institutes of Health Research and in collaboration with an international advisory group , announces PROSPERO , its international Prospect i ve Register of Ongoing Systematic Review s. Following months of public consultation , with many hundreds of respondents from 34 countries providing input on the proposed registration process and minimum data set , PROSPERO is now open for business [ 8 ] . Registration is free , is available to anyone around the world , and generates a unique identifying number for each registered systematic review , which can ( and should ) be reported in any publications that arise from the study . Investigators should use the registry to record the existence of the protocol for a planned or ongoing systematic review of health care interventions even before screening studies for inclusion in the systematic review . A minimum data set specifies the key items that are required for a systematic review to be meaningfully registered . Key data items include a statement of the research question , patients and population , study intervention(s ) and outcomes ; criteria for inclusion and exclusion of studies in the systematic review ; outline of search strategy ; and methods to assess risk of bias and for analysis of studies included in the systematic review . With a clear system in place for registration of new and ongoing systematic review s , PLoS Medicine announces its support for this initiative . The journal wishes to promote best practice in the conduct and reporting of systematic review s. Best practice includes registration during the protocol phase in PROSPERO or other appropriate registry , conduct of the review in accordance with a fully developed protocol , and reporting in line with the PRISMA guidelines [ 9 ] . PLoS Medicine and other PLoS journals will now start Background Poor recruitment to r and omised controlled trials ( RCTs ) is a widespread problem . Provision of interventions aim ed at supporting or incentivising clinicians may improve recruitment to RCTs . Objectives To quantify the effects of strategies aim ed at improving the recruitment activity of clinicians in RCTs , complemented with a synthesis of qualitative evidence related to clinicians ' attitudes towards recruiting to RCTs . Data sources A systematic review of English and non-English articles identified from : The Cochrane Library , Ovid MEDLINE , Ovid EMBASE , Ovid PsycINFO , Ebsco CINAHL , Index to Theses and Open SIGLE from 2001 to March 2011 . Additional reports were identified through citation search es of included articles . Study eligibility criteria Quantitative studies were included if they evaluated interventions aim ed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians . Information about host trial , study design , participants , interventions , outcomes and host RCT was extracted by one research er and checked by another . Studies that met the inclusion criteria were assessed for quality using a st and ardised tool , the Effective Public Health Practice Project tool . Qualitative studies were included if they investigated clinicians ' attitudes to recruiting patients to RCTs . All results / findings were extracted , and content analysis was carried out . Overarching themes were abstract ed , followed by a meta summary analysis . Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist . Data extraction Data extraction was carried out by one research er using predefined data fields , including study quality indicators , and verified by another . Results Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians . One study was rated as strong , one as moderate and the remaining six as weak when assessed for quality using the Effective Public Health Practice Project tool . Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment , reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time . Eleven qualitative studies were identified , and eight themes were abstract ed from the data : underst and ing of research , communication , perceived patient barriers , patient – clinician relationship , effect on patients , effect on clinical practice , individual benefits for clinicians and methods associated with successful recruitment . Meta summary analysis identified the most frequently reported subthemes to be : difficulty communicating trial methods , poor underst and ing of research and priority given to patient well-being . Overall , the qualitative studies were found to be of good quality when assessed using the Critical Appraisal Skills Programme checklist . Conclusions There were few high- quality trials that tested interventions to improve  clinicians ' recruitment activity in RCTs . The most promising intervention was the use of qualitative methods to identify and overcome barriers to  clinician recruitment activity . More good quality studies of interventions are needed to add to the evidence base . The meta summary of qualitative findings identified underst and ing and communicating RCT methods as a key target for future interventions to improve recruitment . Reinforcement of the potential benefits , both for clinicians and for their patients , could also be a successful factor in improving recruitment . A bias was found towards investigating barriers to recruitment , so future work should also encompass a focus on successfully recruiting trials
The majority of this literature derives from the study of patients undergoing colorectal surgery , but increasingly enhanced recovery is spreading to other surgical specialties .
The combination of reduced length of hospital stay ( a surrogate for morbidity ) with no increase in readmissions to hospital suggests that morbidity is reduced with enhanced recovery .
Inconsistency in morbidity reporting limits the value of pooling data between studies , but within study comparisons in general support this conclusion .
Patients adhering to an  enhanced recovery programme  return to normal function faster than those following traditional care pathways .
PURPOSE OF REVIEW The aim of this review is to summarize important publications in  enhanced recovery during 2010 - 2011 and to highlight key themes .