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
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
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 .