Methodological quality and completeness of reporting in clinical trials conducted in livestock species. CONSORT adoption and quality of reporting of randomized controlled trials: a systematic analysis in two dermatology journals Improving the quality of reporting in randomised controlled trials. Improving the quality of reporting alcohol outcome studies: effects of the CONSORT statement. Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis. A Standard Set of Outcome Measures for the Comprehensive Appraisal of Cleft Care Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. Quality of patient‐reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient‐reported outcome extension: A pooled analysis of 557 trials Effectiveness of Conservative, Surgical, and Postsurgical Interventions for Trigger Finger, Dupuytren Disease, and De Quervain Disease: A Systematic Review. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey How study design affects outcomes in comparisons of therapy. II: Surgical. Reporting number needed to treat and absolute risk reduction in randomized controlled trials. Applying the CONSORT and STROBE statements to evaluate the reporting quality of neovascular age-related macular degeneration studies. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations.
R and omized controlled trials ( RCTs ) are the gold st and ard for evaluating efficacy of treatments under real world conditions and , as such , it is important that they are conducted with method ological rigour to prevent biased results . Many medical journals have adopted a st and ard checklist for reporting of RCTs , the CONSORT statement . The objective of this study was to evaluate clinical trials in livestock population s to assess method ological quality and completeness of reporting and to investigate the association between these criteria and treatment effects . A total of 100 clinical trials published between 2006 and 2008 in the English language were r and omly selected . For each trial , 2 review ers independently completed a checklist based on the CONSORT statement and a different 2 review ers completed a st and ard template describing the outcomes used and the statistical significance of all reported treatment effects . Disagreements among review ers were resolved by consensus . The results showed that there were substantive deficiencies in the reporting of many of trial features , both related to method ological quality and completeness of reporting . Details on key features such as r and omization , double blinding , and the number of subjects lost to follow-up were reported in only 67 , 4 , and 62 % of trials , respectively . Reporting of r and om allocation to treatment group was associated with a lower proportion of positive treatments effects within trials , as was reporting of inclusion /exclusion criteria for study subjects , details on the intervention , animal signalment , significance tests of baseline differences for at least one variable , and the methods used to measure all outcomes . The results suggest that there are deficiencies in the current reporting of important features of RCTs conducted in livestock species and that these deficiencies may be associated with biased treatment effects . The creation and adoption of st and ards for trial reporting in livestock could aid authors , review ers , and editors in ensuring that necessary trial details are reported in all published trials Background CONSORT ( Consoli date d St and ards for Reporting Trials ) guidelines were constructed to ensure optimal reporting quality of r and omized controlled trials ( RCTs ) . Wound-care journals contain abundant reports of trials , but not all report a satisfactory methodology . Systematic review s of wound-care trials have highlighted many areas for improvement , and the National Institute for Clinical Excellence ( NICE ) guidelines recommend that primary research in the field of pressure ulcer prevention should adhere more closely to current method ological st and ards in terms of conduct and reporting . The CONSORT tool was developed to help achieve these improvements in the design and reporting of r and omised controlled trials ( RCTs ) It is critical that the reporting of r and omized controlled trials ( RCTs ) be transparent and comprehensive . The aim of this study was to examine if adopting st and ards of reporting , the Consoli date d St and ards of Reporting Trials ( CONSORT ) , improved the quality of reporting of alcohol treatment outcome studies . RCTs were identified from eight journals publishing a substantial number of alcohol treatment outcome studies ( n=127 RCTs ) and coded for the quality of reporting according to the CONSORT guidelines . Both CONSORT adopter and non-adopter journals showed significant improvements in the quality of reporting of alcohol treatment outcome studies over time . While overall results suggested a non-significant trend for more improvement over time in the quality of reporting for adopter compared to non-adopter journals , comparison of effects sizes suggested that specific areas of reporting did significantly improve for the adopter journals . Results suggest that efforts to improve reporting such as the CONSORT guidelines can be useful and influential Abstract Background Patient-reported outcomes ( PROs ) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions . However , variability in st and ards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice . Methods We systematic ally investigated a cohort of r and omized controlled cancer trials that included a primary or secondary PRO . For each trial , an evaluation of protocol and reporting quality was undertaken using st and ard checklists . General patterns of reporting where also explored . Results Protocol s ( 101 source d , 44.3 % ) included a mean ( SD ) of 10 ( 4 ) of 33 ( range = 2–19 ) PRO protocol checklist items . Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data . Of 160 trials with published results , 61 ( 38.1 % , 95 % confidence interval = 30.6 % to 45.7 % ) failed to include their PRO findings in any publication ( mean 6.43-year follow-up ) ; these trials included 49 568 participants . Although two-thirds of included trials published PRO findings , reporting st and ards were often inadequate according to international guidelines ( mean [ SD ] inclusion of 3 [ 3 ] of 14 [ range = 0–11 ] ) CONSORT PRO Extension checklist items ) . More than one-half of trials publishing PRO results in a secondary publication ( 12 of 22 , 54.5 % ) took 4 or more years to do so following trial closure , with eight ( 36.4 % ) taking 5–8 years and one trial publishing after 14 years . Conclusions PRO protocol content is frequently inadequate , and nonreporting of PRO findings is widespread , meaning patient-important information may not be available to benefit patients , clinicians , and regulators . Even where PRO data are published , there is often considerable delay and reporting quality is suboptimal . This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future BACKGROUND Recent r and omized controlled trials ( RCTs ) in rheumatoid arthritis ( RA ) have used patient- and physician-reported outcomes , ESR and /or CRP as components of ACR response criteria to assess efficacy . OBJECTIVES Mean changes from baseline in patient- and physician-reported outcome measures , ESR and CRP were compared in two RCTs in patients with active RA . Comparisons between active and placebo treatment used mean percentage improvements and st and ard effect sizes ( SESs ) . RESULTS In both protocol s , patient-reported assessment s of disease activity , pain and physical function reflected little or no improvement with placebo , best discriminating between active and placebo therapy , as did ESR and CRP . CONCLUSION Improvements in signs and symptoms of active RA in placebo RCTs appear to be best reflected by patient-reported measures of physical function , as long as reported changes in global assessment s of disease activity and /or pain reflect similar benefit . Patient-reported outcome measures should be considered objective ; treatment-associated changes are congruent with measures of inflammation , and appear less susceptible to the placebo response Care of the patient with cleft lip and /or palate remains complex . Prior attempts at aggregating data to study the effectiveness of specific interventions or overall treatment protocol s have been hindered by a lack of data st and ards . There exists a critical need to better define the outcomes - particularly those that matter most to patients and their families- and to st and ardize the methods by which these outcomes will be measured . This report summarizes the recommendations of an international , multidisciplinary working group with regard to which outcomes a typical cleft team could track , how those outcomes could be measured and recorded , and what strategies may be employed to sustainably implement a system for prospect i ve data collection . It is only by agreeing on a common , st and ard set of outcome measures for the comprehensive appraisal of cleft care that intercenter comparisons can become possible . This is important for quality -improvement endeavors , comparative effectiveness research , and value-based health-care reform The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care As practitioners strive to improve the delivery of patient care , it is increasingly important that they find it easier to identify studies with the highest level of evidence . Once found , there must be some assurance that the studies were carried out satisfactorily and the methodology was sound . To assist in meeting this challenge , the Consoli date d St and ards of Reporting Trials ( CONSORT ) guidelines were developed by a team of dedicated journal editors , epidemiologists , and statisticians . They determined the st and ards for authors reporting the findings of controlled clinical trials . CONSORT comprises a checklist and a flow diagram ( Figs 1 and 2 ) to help improve the quality of reports of r and omized controlled trials ( RCTs ) . It offers a st and ard way for research ers to report their findings . The checklist includes items , based on evidence , that should be addressed in the report ; the flow diagram gives readers a clear picture of the progress of all participants in the trial , from the time they are r and omized until the end of their involvement . The intent is to make the experimental process transparent , flawed or not , so that users of the data can more appropriately evaluate the validity for their purpose s. The key elements start when the research er su bmi ts an article for review and completes the st and ardized forms . The completed checklist should accompany the manuscript through the review process and identify the page on which each item is addressed . The completed flow diagram should appear as a figure in the manuscript . Nearly a year ago , the AJO-DO m and ated a structured abstract with each su bmi ssion ; this is one of the first items on the CONSORT checklist . There are good reasons for this change and for all other requests listed . According to Sharma and Harrison , “ the quality of information provided in journals with structured abstract s is greater than in those with nonstructured abstract s. ” These authors concluded that the quality of information in an abstract improves when a journal changes to a structured format . THE R AND OMIZED controlled trial ( RCT ) , more than any other methodology , can have a powerful and immediate impact on patient care . Ideally , the report of such an evaluation needs to convey to the reader relevant information concerning the design , conduct , analysis , and generalizability of the trial . This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial . Accurate and complete reporting also benefits editors and review ers in their deliberations regarding su bmi tted manuscripts . For RCTs to ultimately benefit patients , the published report should be of the highest possible st and ard The main objectives of this study were to identify the number of r and omized controlled trials ( RCTs ) including a patient‐reported outcome ( PRO ) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consoli date d St and ards of Reporting Trials ( CONSORT ) PRO extension OBJECTIVES To provide an evidence -based overview of the effectiveness of conservative and (post)surgical interventions for trigger finger , Dupuytren disease , and De Quervain disease . DATA SOURCES Cochrane Library , Physiotherapy Evidence Data base , PubMed , Embase , and CINAHL were search ed to identify relevant systematic review s and r and omized controlled trials ( RCTs ) . DATA SELECTION Two review ers independently applied the inclusion criteria to select potential studies . DATA EXTRACTION Two review ers independently extracted the data and assessed the method ologic quality . DATA SYNTHESIS A best- evidence synthesis was performed to summarize the results . Two review s ( trigger finger and De Quervain disease ) and 37 r and omized controlled trials ( RCTs ) ( trigger finger : n=8 ; Dupuytren disease : n=14 , and De Quervain disease : n=15 ) were included . The trials reported on oral medication ( Dupuytren disease ) , physiotherapy ( De Quervain disease ) , injections and surgical treatment ( trigger finger , Dupuytren disease , and De Quervain disease ) , and other conservative ( De Qervain disease ) and postsurgical treatment ( Dupuytren disease ) . Moderate evidence was found for the effect of corticosteroid injection  on the very short term for trigger finger , De Quervain disease , and for injections with collagenase ( 30d ) when looking at all joints , and no evidence was found when looking at the PIP joint for Dupuytren disease . A thumb splint as additive to a corticosteroid injection seems to be effective ( moderate evidence ) for De Quervain disease ( short term and midterm ) . For Dupuytren disease , use of a corticosteroid injection within a percutaneous needle aponeurotomy in the midterm and tamoxifen versus a placebo before or after a fasciectomy seems to promising ( moderate evidence ) . We also found moderate evidence for splinting after Dupuytren surgery in the short term . CONCLUSIONS In recent years , more and more RCTs have been conducted to study treatment of the aforementioned h and disorders . However , more high- quality RCTs are still needed to further stimulate evidence -based practice for patients with trigger finger , Dupuytren disease , and De Quervain disease Introduction Crohn ’s disease ( CD ) and ulcerative colitis ( UC ) , the main forms of inflammatory bowel disease ( IBD ) , are chronic , progressive and disabling disorders of the gastrointestinal tract . Although data from r and omised controlled trials ( RCTs ) provide the foundation of evidence that vali date s medical therapy for IBD , considerable heterogeneity exists in the measured outcomes used in these studies . Furthermore , in recent years , there has been a paradigm shift in IBD treatment targets , moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance , inflammatory biomarkers and histological and radiographic end points . The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development . Accordingly , there exists a need to harmonise measures used in clinical trials through the development of a core outcome set ( COS ) . Methods and analysis The development of an IBD-specific COS includes four steps . First , a systematic literature review is performed to identify outcomes previously used in IBD RCTs . Second , semistructured qualitative interviews are conducted with key stakeholders , including patients , clinicians , research ers , pharmaceutical industry representatives , healthcare payers and regulators to identify additional outcomes of importance . Using the outcomes generated from literature review and stakeholder interviews , an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS . Finally , a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials . Ethics and dissemination Given that over 30 novel therapeutic compounds are in development for IBD treatment , the design of robust clinical trials measuring relevant and st and ardised outcomes is crucial . St and ardising outcomes through a COS will reduce heterogeneity in trial reporting , facilitate valid comparisons of new therapies and improve clinical trial quality We analysed the results of 221 comparisons of an innovation with a st and ard treatment in surgery published in six leading surgery journals in 1983 to relate features of study design to the magnitude of gain . For each comparison we measured the gain attributed to the innovation over the st and ard therapy by the Mann-Whitney statistic and the difference in proportion of treatment successes . For primary treatments ( aim ed at curing or ameliorating a patient 's principal disease ) , an average gain of 0.56 was produced by 20 r and omized controlled trials . This was less than the 0.62 average for four non-r and omized controlled trials , 0.63 for 19 externally controlled trials , and 0.57 for 73 record review s ( 0.50 represents a toss-up between innovation and st and ard ) . For secondary therapies ( used to prevent or treat complications of therapy ) , the average gain was 0.53 for 61 r and omized controlled trials , 0.58 for eleven non-r and omized controlled trials , 0.54 for eight externally controlled trials , and 0.55 for 18 record review s. Readers of studies evaluating new treatments , particularly for primary treatments , may consider adjustment of the gain according to the study type CONTEXT Ongoing efforts to improve the quality of reporting for r and omized controlled trials ( RCTs ) include the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement . We examined the frequency of explicit reporting of the number needed to treat ( NNT ) and the absolute risk reduction ( ARR ) in RCTs . METHODS Five frequently cited journals were investigated : Annals of Internal Medicine , BMJ , JAMA , The Lancet , and the New Engl and Journal of Medicine . For each journal , 4 years were evaluated : 1989 , 1992 , 1995 , and 1998 . All issues of each journal for each year were review ed manually . Eligible articles were those in which an RCT was conducted on the use of a medication showing a significant treatment effect . Elements abstract ed from each eligible article were the condition investigated , event being treated or prevented , intervention , study results , and reporting methods ( relative risk reduction , NNT , and ARR ) . RESULTS Of 359 eligible articles , NNT was reported in 8 articles . Six of the 8 studies were from 1998 . Absolute risk reduction was reported in 18 articles , 10 of which were from 1998 . CONCLUSIONS Despite CONSORT recommendations , few authors expressed their findings in terms of NNT or ARR . Consideration should be given to including these values in reports of RCTs PURPOSE To evaluate the quality of reporting in the neovascular age-related macular degeneration ( nvAMD ) literature by applying the Consoli date d St and ards for Reporting Trials ( CONSORT ) and Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) statement writing st and ards . DESIGN CONSORT and STROBE impact analysis ; literature review . PARTICIPANTS Phase III r and omized controlled trials ( RCTs ) of verteporfin photodynamic therapy , pegaptanib , and ranibizumab , and interventional case studies of bevacizumab for nvAMD .  METHODS A literature search identified eligible articles published before October 31 , 2007 . We assessed the report quality of Phase III RCTs using the CONSORT statement and case series publications using the STROBE statement , both with indicators relevant to nvAMD . MAIN OUTCOME MEASURES Presence or absence of CONSORT or STROBE statement indicators . RESULTS Seven publications of Phase III RCTs and 29 publications on bevacizumab interventional case studies for nvAMD met our inclusion criteria . Of 37 possible CONSORT writing guideline items , the mean report quality for RCTs was 30.6 ( 83 % ) , with a range from 23 to 35 ( 65%-95 % ) . Of 35 possible STROBE writing guideline items , the mean report quality grade for intravitreal bevacizumab case series was 23 ( 70 % ) , with a range from 16 to 31 ( 46%-94 % ) . Among the bevacizumab studies , more than 90 % reported scientific background , drug dose and administration , baseline characteristics , unadjusted results , and adverse events . Fewer than 20 % reported study size calculations , h and ling of missing data , or a discussion of bias . CONCLUSIONS Since the adoption of the CONSORT st and ards by Ophthalmology and other journals in 1996 , the reporting quality for RCTs has further improved among this cohort of nvAMD articles . On the other h and , no reporting st and ards for case series have existed until the recent publication of the STROBE statement . In this first application of the STROBE st and ards to ophthalmology , we found that the small interventional studies in our series had an average reporting score lower than the RCTs , but also that some individual scores were higher than the RCTs . This outcome demonstrates that good , useful articles can be written about small studies . Although not a direct measure of the quality of a study , good reporting allows a reader to assess the validity and applicability of the study 's findings . FINANCIAL DISCLOSURE(S ) Proprietary or commercial disclosure may be found after the references Acupuncture treatment and control group interventions in parallel-group r and omised trials of acupuncture are not always precisely reported . In an attempt to improve st and ards , an international group of experienced acupuncturists and research ers devised a set of recommendations , design ating them STRICTA : ST and ards for Reporting Interventions in Controlled Trials of Acupuncture . In a further consensus-building round , the editors of several journals helped redraft the recommendations . These follow the Consoli date d St and ards for Reporting Trials ( CONSORT ) format , acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies . Participating journals are publishing the STRICTA recommendations and requesting prospect i ve authors to adhere to them when preparing reports for publication . Other journals are invited to adopt these recommendations . The intended outcome is that interventions in controlled trials of acupuncture  will be more adequately reported , thereby facilitating an improvement in critical appraisal , analysis and replication of trials
Outcomes , such as range of motion , recurrence , and clinical success , were frequently defined , however many different definitions were used .
This systematic review summarizes the outcome reporting st and ards in Dupuytren ’s disease treatment research .