Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. Randomized controlled trials in pediatric surgery: could we do better? Comparison of registered and published primary outcomes in randomized controlled trials. Quality of reporting of randomized controlled trials in general endocrinology literature. Quality of reporting in randomized trials published in high-quality surgical journals. The reporting quality of randomised controlled trials in surgery: a systematic review. Undisclosed changes in outcomes in randomized controlled trials: an observational study. The quality of reporting of randomized controlled trials in solid organ transplantation. What is the quality of reporting in weight loss intervention studies? A systematic review of randomized controlled trials. Systematic review of symptom control and quality of life in studies on chemotherapy for advanced non-small cell lung cancer: how CONSORTed are the data? Identification and analysis of randomised controlled trials in nursing: a preliminary study. Examination of the analytic quality of behavioral health randomized clinical trials. Quality of randomized controlled trials reporting in the primary treatment of brain tumors. Evidence of improving quality of reporting of randomized controlled trials in subfertility. Evolution of the randomized controlled trial in oncology over three decades. Analysis of the quality of reporting of randomized controlled trials in acute and chronic myeloid leukemia, and myelodysplastic syndromes as governed by the CONSORT statement. Standards of reporting of randomized controlled trials in general surgery: can we do better? Publication bias and meta-analyses: a practical example. Improving the quality of reporting alcohol outcome studies: effects of the CONSORT statement. Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Reporting in randomized clinical trials improved after adoption of the CONSORT statement. Secular changes in the quality of published randomized clinical trials in rheumatology. Lessons learned: Outcomes and methodology of a coping skills intervention trial comparing individual and group formats for patients with cancer. Association between research sponsorship and study outcome in plastic surgery literature. Reporting of randomized controlled trials in Hodgkin lymphoma in biomedical journals. Prevalence study of the randomized controlled trials in the Journal of Intellectual Disability Research: 1957-1994. Abstracts of randomized controlled trials presented at the society for pediatric research meeting: an example of publication bias. Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Intention-to-treat analyses in behavioral medicine randomized clinical trials. Treatment success in cancer: new cancer treatment successes identified in phase 3 randomized controlled trials conducted by the National Cancer Institute-sponsored cooperative oncology groups, 1955 to 2006. A randomised controlled trial of the outcome of health assessment of people aged 75 years and over. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Quality of reporting of randomized controlled trials in polycystic ovary syndrome. Beyond Medline: reducing bias through extended systematic review search. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary intervention. Quality of reports on randomized controlled trials conducted in Japan: evaluation of adherence to the CONSORT statement. The quality of randomized controlled trials in major anesthesiology journals. The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China. CONSORT adoption and quality of reporting of randomized controlled trials: a systematic analysis in two dermatology journals. An investigation of the adequacy of MEDLINE searches for randomized controlled trials (RCTs) of the effects of mental health care. Implementing a guideline for the treatment of type 2 diabetics: results of a cluster-randomized controlled trial (C-RCT). In the dark: the reporting of blinding status in randomized controlled trials. Summary-of-findings tables in Cochrane reviews improved understanding and rapid retrieval of key information. Are leading medical journals following their own policies on CONSORT reporting? Quality and retrieval of obstetrical anaesthesia randomized controlled trials. Application of the CONSORT statement to randomized controlled trials comparing endoscopic and open carpal tunnel release. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Identification of randomized controlled trials from the emergency medicine literature: comparison of hand searching versus MEDLINE searching. Of consents and CONSORTs: reporting ethics, law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the "CONSORT" guidelines. Participation and successful patient recruitment in primary care. Randomized clinical trial of a quality improvement intervention in nursing homes. Randomized controlled trials in surgery. Promoting patient participation in consultations: a randomised controlled trial to evaluate the effectiveness of three patient-focused interventions. Assessment of risk of bias among pediatric randomized controlled trials. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial. Repetitive transcranial magnetic stimulation as an adjunct to constraint-induced therapy: an exploratory randomized controlled trial. Randomized clinical trials behind level A recommendations in obstetric practice bulletins: compliance with CONSORT statement. Patients with cancer holding their own records: a randomised controlled trial. Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists. Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Expanding patient involvement in care. Effects on patient outcomes. Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care. Outcomes and lessons from a pilot RCT of a community-based HIV prevention multi-session group intervention for gay men. Reporting randomised clinical trials of analgesics after traumatic or orthopaedic surgery is inadequate: a systematic review. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer.
                Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes.
                Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT.
                There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved. As of 2005, the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial's findings in member journals.
                To assess the proportion of registered trials with results recently published in journals with high impact factors; to compare the primary outcomes specified in trial registries with those reported in the published articles; and to determine whether primary outcome reporting bias favored significant outcomes.
                MEDLINE via PubMed was searched for reports of randomized controlled trials (RCTs) in 3 medical areas (cardiology, rheumatology, and gastroenterology) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors.
                For each included article, we obtained the trial registration information using a standardized data extraction form.
                Of the 323 included trials, 147 (45.5%) were adequately registered (ie, registered before the end of the trial, with the primary outcome clearly specified). Trial registration was lacking for 89 published reports (27.6%), 45 trials (13.9%) were registered after the completion of the study, 39 (12%) were registered with no or an unclear description of the primary outcome, and 3 (0.9%) were registered after the completion of the study and had an unclear description of the primary outcome. Among articles with trials adequately registered, 31% (46 of 147) showed some evidence of discrepancies between the outcomes registered and the outcomes published. The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6% (19 of 23).
                Comparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent. The reporting quality of randomized controlled trials (RCTs) is poor in general medicine and several areas of specialization but unknown in endocrinology.
                Our aim was to assess the reporting quality of RCTs in general endocrinology. A secondary objective was to identify predictors for better reporting quality.
                We systematically reviewed RCTs published in three general endocrinology journals between January 2005 and December 2006.
                We included parallel-design RCTs that addressed a question of treatment or prevention. Article selection and data abstraction were conducted by two reviewers independently, and disagreements were resolved by consensus.
                There were two main outcomes: 1) a 15-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials (CONSORT); and 2) a 3-point key score, based on allocation concealment, blinding, and use of intention-to-treat analysis.
                Eighty nine RCTs were included. The median OQS was 10 (interquartile range = 2). Allocation concealment, blinding, and analysis by intention to treat were reported in 10, 20, and 16 of the 89 RCTs, respectively. A multivariable regression analysis showed that complete industrial funding [incidence rate ratio (IRR) = 1.014; 95% confidence interval (CI), 1.010-1.018], journal of publication (IRR = 1.068; 95% CI, 1.007-1.132), and sample size (IRR = 1.048; 95% CI, 1.026-1.070) were significantly associated with a slightly better OQS.
                The quality of RCT reporting in general endocrine literature is suboptimal. We discuss our results, highlight the areas where improvements are needed, and provide some recommendations. Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements.
                We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event-related, and specific nonpharmacologic criteria.
                Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score > or = 3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event-related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively.
                Quality of reporting of generic methodologic, adverse-event-related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria. In order to examine the reporting quality of urological RCTs, the initial objectives of this study were to evaluate the degree to which RCTs involving urological surgical techniques (as the intervention) published in the years 2000-2003 complied with the CONSORT statement, and to assess trends and patterns of compliance. Following our initial findings in urology, we extended the methodology to a number of other specialties to assess whether our findings in urology could be generalised to other surgical disciplines.
                The Royal Society of Medicine (RSM) Library was commissioned to search the Medline and Cochrane databases for RCTs in compliance with the study inclusion criteria below. Additional analyses of five other specialties (non-urological trials: cardiovascular, gastrointestinal, hepatic, orthopaedic and vascular) were also made. For the non-urological trials, 15 English language trials (from each specialty) were randomly picked from a blast search conducted by the RSM for the year 2003. The RCTs were given a score out of 22, reflecting how many of the 22 CONSORT items were complied with (with each item being given equal weighting), this score was termed the "CONSORT score".
                Urology trials: In total 122 RCT abstracts were identified which met the inclusion criteria for this study. From these, 32 were excluded as they were follow-up studies, involved a virtual procedure or were a cost analysis, leaving 90 RCTs published across 35 different journals which were analysed (68.2%, 90/122). The average score of 11.1 for urological trials indicates that RCTs in our sample do not comply with the CONSORT statement. No trials reported how they implemented their randomisation process. Only 46% of RCTs stated that they had permission from an ethics review board, 20% had declared their sources of funding, 14% stated whether there were any conflicts of interest and only 1.1% stated their trial registry number. For non-urological studies, an average CONSORT score of 11.2 was obtained.
                Clinical research teams conducting RCTs in urology and other surgical disciplines demonstrate poor compliance with the CONSORT statement. We would recommend that trials should be registered at their outset and that urological and other surgical journals to consider supporting the CONSORT statement and to have compliance 'hard-wired' into their submission, editorial and peer-review processes. Since it seems the best researchers are unable to produce an RCT results which enable surgical techniques to be critically assessed, there is a need for education about the CONSORT statement and its importance at all levels of surgical training. We believe that an open debate is needed on the possible role of other research designs, such as tracker studies. Whether this study actually raises the question of how appropriate RCTs are to surgical techniques, we leave to the reader. We wanted to investigate the frequency of undisclosed changes in the outcomes of randomized controlled trials (RCTs) between trial registration and publication.
                Using a retrospective, nonrandom, cross-sectional study design, we investigated RCTs published in consecutive issues of 5 major medical journals during a 6-month period and their associated trials registry entries. Articles were excluded if they did not have an available trial registry entry, did not have analyzable outcomes, or were secondary publications. The primary outcome was the proportion of publications in which the primary outcome of the trial was, without disclosure, changed between that recorded in the trial registry and that reported in the final publication. The secondary outcome was the proportion of publications in which the secondary outcome was changed without disclosure.
                We reviewed 158 reports of RCTs and included 110 in the analysis. In 34 (31%), a primary outcome had been changed, and in 77 (70%), a secondary outcome had been changed.
                There are substantial and important undisclosed changes made to the outcomes of published RCTs between trial registration and publication. This finding has important implications for the interpretation of trial results. Disclosure and discussion of changes would improve transparency in the performance and reporting of trials. Randomized controlled trials (RCTs) of interventions provide the highest level of evidence about efficacy but their value either alone or within a meta-analysis is dependent on its methodological quality. For this reason recent RCTs in organ transplantation were assessed for quality. RCTs published between 2004 and 2006 (n = 332) were assessed, after excluding duplicate and nonEnglish reports. Quality was evaluated using the Jadad score plus allocation concealment and intention to treat analysis. We noted journal type, journal author instructions, funding source, sample size and number and location of study centres. Around one-third of RCTs had a Jadad score of 3 or greater (indication of a methodologically good quality trial) and the other two parameters were satisfied in just over one third. Although the majority of trials were published in speciality journals the quality of those published in general journals was superior. Commercially sponsored trials were of better quality as were multicentre trials in contrast to single centre trials. Overall quality of reporting of RCTs in organ transplantation is poor and as RCTs provide the highest level of evidence in evaluations of interventions there needs to be a concerted effort within the transplant community to improve the standards of RCTs. Despite the large number of randomized controlled trials (RCTs) assessing weight loss interventions, no study has assessed the quality of reporting in these trials.
                To assess the quality of reporting of RCTs of weight loss interventions and to identify predictors of reporting quality.
                The RCTs assessed were derived from a published systematic review of trials investigating the efficacy of weight loss interventions. For our study, two reviewers independently rated the quality of reporting in these trials, based on the Consolidated Standards for Reporting of Trials (CONSORT) Statement. We describe the quality of reporting using number (percent) of studies satisfying each of the 44 CONSORT criteria. We use generalized estimating equations (GEE) to fit a multivariable regression model to determine factors that are associated with the overall quality reporting score.
                We assessed 63 RCTs, of which 25 were dietary-lifestyle trials, 22 were pharmacological trials and 16 were behavior-cognitive, exercise-lifestyle, or surgical trials. Less than half (46%) of the trials defined the primary outcome of the study; about 10% provided the description of the method of allocation concealment. Multivariable GEE results showed that the sample size, type of intervention (non-pharmacologic trials having lower scores than pharmacologic trials), and publication time relative to the CONSORT Statement publication in 1996 (publications after 1996 having higher scores) were strong predictors of the quality reporting score. Reporting a statistically significant result on the primary outcome was not significantly associated with the quality score.
                While the overall quality in reporting seemed to have improved since the publication of the revised CONSORT Statement in 1996, the reporting of some key methodologic aspects, such as clear description of primary outcome and method of allocation concealment, still requires improvements. Factors that are significantly associated with the overall quality reporting score can be used as surrogates in the review of protocols to enhance the quality of the final reports. The effect of chemotherapy on survival of patients with advanced NSCLC is modest, therefore patient reported outcomes (PRO's) are of high interest in randomized controlled trials (RCTs). CONSORT (CONsolidated Standards On Reporting Trials) is a quality checklist of 22 items for the conduct and reporting of RCTs. The aim of this report was to analyse to what extent the different RCTs with information on PRO's adhere to the CONSORT statement.
                Systematic review of RCTs using PRO's either as primary or secondary endpoint. Compliance with the (revised) CONSORT statement was checked by 2 independent reviewers by making for each study the simple sum of the 22 CONSORT items, or a weighted score with a maximum rating of 31 points.
                The median weighted CONSORT score of the different RCTs was 25, with a remarkable difference from 12 till 30. There was no significant change over time, nor difference between academic and commercial studies, but a significant correlation between CONSORT agreement and journal type (P<0.0001). Adherence to CONSORT was similar for studies comparing chemotherapy with best supportive care alone, comparing different first-line chemotherapies with PRO either as primary or secondary endpoint, or studies looking at second-line chemotherapy. Benefit in PRO's was reported in all of these settings.
                The overall adherence of peer-reviewed RCTs to CONSORT is reasonable, with nonetheless major differences between journals, and with no clear sign of change over time. Apart from modest survival differences, benefits in PRO endpoints are present in all categories of studies we analysed. To describe preliminary work undertaken for development of a nursing contribution to the Cochrane Collaboration. To ascertain whether there are randomised controlled trials (RCTs) on nursing care which need to be identified for inclusion in systematic reviews of the effects of health care.
                Searches by Medline (1966-94) and by hand of 11 nursing research journals from inception to the end of 1994 to identify RCTs and systematic reviews; and a comparison of searches by hand and by Medline for three nursing research journals.
                Total number of RCTs identified and number of RCTs published in nursing journals; the sensitivity of Medline searches; and aspects of nursing care evaluated by RCT.
                The work is ongoing and 522 reports of RCTs and 20 systematic reviews of effectiveness have been identified so far. The sensitivity of Medline searches for RCTs in nursing journals is as low as 36% for one journal and the lack of reference to research design in the title or abstract was the main reason for the lack of sensitivity.
                There are RCTs that evaluate aspects of nursing care, and are published in nursing and non-nursing journals, and are largely undertaken by nurses. These must be reviewed in ongoing systematic reviews of the effects of health care (including those undertaken as part of the Cochrane Collaboration). Nursing journals must be hand searched to identify these studies as the lack of reference to study design in the titles and abstracts of nursing trials leads to poor indexing in electronic databases such as Medline. Adoption of evidence-based practice (EBP) policy has implications for clinicians and researchers alike. In fields that have already adopted EBP, evidence-based practice guidelines derive from systematic reviews of research evidence. Ultimately, such guidelines serve as tools used by practitioners. Systematic reviews of treatment efficacy and effectiveness reserve their strongest endorsements for treatments that are supported by high-quality randomized clinical trials (RCTs). It is unknown how well RCTs reported in behavioral science journals fare compared to quality standards set forth in fields that pioneered the evidence-based movement. We compared analytic quality features of all behavioral health RCTs (n = 73) published in three leading behavioral journals and two leading medical journals between January 2000 and July 2003. A behavioral health trial was operationalized as one employing a behavioral treatment modality to prevent or treat an acute or chronic physical disease or condition. Findings revealed areas of weakness in analytic aspects of the behavioral health RCTs reported in both sets of journals. Weaknesses were more pronounced in behavioral journals. The authors offer recommendations for improving the analytic quality of behavioral health RCTs to ensure that evidence about behavioral treatments is highly weighted in systematic reviews.
                (c) 2006 Wiley Periodicals, Inc. To assess the reporting quality of randomized controlled trials (RCTs) in the primary treatment of brain tumors and to identify significant predictors of quality.
                Two investigators searched MEDLINE, EMBASE, and bibliographies of retrieved articles for RCTs in the primary treatment of brain tumors published between January 1990 and December 2004. We assessed the quality of overall reporting and key methodologic factors reporting (allocation concealment, blinding, and intention to treat [ITT]). Two investigators also rated articles independently using items from the revised Consolidated Standards of Reporting Trials statement. A generalized estimated equation was used to generate regression models that identified significant factors associated with quality of reporting.
                We retrieved 74 relevant RCTs that randomly assigned 14,498 brain tumor patients. The quality of overall reporting has improved during the last 15 years, but eight of the 15 methodologic items were reported in less than 50% of trials. In the appraisal of the reporting quality of key methodologies, allocation concealment, blinding, and adherence to the ITT principle were reported in less than 30% of articles. Multivariable regression models revealed that an impact factor more than 1.66, publication after 1995, and sample size more than 280 were significant factors associated with better overall reporting, whereas complete industrial funding, impact factors more than 2.64, and positive primary outcomes were predictors of higher ratings of the three most important methodologic qualities.
                Despite improvement in general reporting quality, key methodologies that safeguard against biases may still benefit from better description. Significant factors associated with better reporting may act as surrogates for other characteristics. The quality of randomized controlled trials (RCTs) in subfertility and their suitability for inclusion in meta-analyses have been assessed in the past and found to be insufficient. Our aim was to assess whether this quality has improved over time, particularly since the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement, and to assess what proportion of trials could be included in the meta-analyses of pregnancy outcomes such as those included in Cochrane Reviews.
                A selection of subfertility trials published in 1990, 1996 and 2002 was collected from the Cochrane Menstrual Disorder and Subfertility Group (MDSG) database. Only trials published in English as full journal articles, claiming to be randomized and reporting on pregnancy outcomes, were included.
                One hundred and sixty-four trials met our inclusion criteria. Twenty-four (15%) were found not to be randomized, despite claims, and only 10 trials (6%) provided adequate details on the methods of randomization and allocation concealment. Of these, only three had sufficient details extractable to allow for an intention-to-treat analysis of the outcome 'live birth'.
                Although an improvement in some subfertility-specific issues was observed, the quality of reporting of RCTs still needs to improve to make them suitable for inclusion in meta-analyses such as those in the Cochrane Library. The randomized controlled trial (RCT) is the gold standard for establishing new therapies in clinical oncology. Here we document changes with time in design, sponsorship, and outcomes of oncology RCTs.
                Reports of RCTs evaluating systemic therapy for breast, colorectal (CRC), and non-small-cell lung cancer (NSCLC) published 1975 to 2004 in six major journals were reviewed. Two authors abstracted data regarding trial design, results, and conclusions. Conclusions of authors were graded using a 7-point Likert scale. For each study the effect size for the primary end point was converted to a summary measure.
                A total of 321 eligible RCTs were included (48% breast, 24% CRC, 28% NSCLC). Over time, the number and size of RCTs increased considerably. For-profit/mixed sponsorship increased substantially during the study period (4% to 57%; P < .001). There was increasing use of time-to-event measures (39% to 78%) and decreasing use of response rate (54% to 14%) as primary end point (P < .001). Effect size remained stable over the study period. Authors have become more likely to strongly endorse the experimental arm (P = .017). A significant P value for the primary end point and industry sponsorship were each independently associated with endorsement of the experimental agent (odds ratio [OR] = 19.6, 95% CI, 8.9 to 43.1, and OR = 3.5, 95% CI, 1.6 to 7.5, respectively).
                RCTs in oncology have become larger and are more likely to be sponsored by industry. Authors of modern RCTs are more likely to strongly endorse novel therapies. For-profit sponsorship and statistically significant results are independently associated with endorsement of the experimental arm. Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement is an evidence-based approach to improve the quality of RCTs. The aim of this study was to evaluate the reporting quality of published RCTs concerning myeloid hematologic malignancies according to the CONSORT statement.
                PubMed was searched for English-language RCTs involving patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML) and myelodysplastic syndromes (MDS). Trials were considered eligible when participants were randomly assigned to at least two treatment arms and included patients with AML, CML or MDS. Quality of reporting was assessed using a 24-item questionnaire based on the CONSORT checklist. Reporting was assessed in one pre-CONSORT (1988-1995) and one post-CONSORT (1996-2008) period. The effect of CONSORT statement in high- and low-ranked journals, according to their impact factor, has also been evaluated.
                The search identified 261 eligible articles for analysis. Only 13 of the 24 items of CONSORT statement were addressed in 75% or more of the studies. Most items concerning the methodological issues were reported by fewer than 50% of the studies. Significant improvements over time were seen for items that assessed the methodological quality, while RCTs published in high-ranked journals showed better quality of reporting.
                Quality of reporting in RCTs focusing on myeloid malignancies remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research. To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality.
                Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels.
                Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose.
                Of the 69 RCTs analyzed, only 37.7% had a Jadad score of > or =3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022).
                The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology. Publication bias is widely appreciated, but considerable time and effort are needed to locate and obtain data from unpublished randomized controlled trials (RCTs), those published in non-English language journals or those reported in the gray literature; for this publication, we will call this collection of trials the "gray+literature." However, excluding such trials from systematic reviews could introduce bias and give rise to misleading conclusions.
                We aimed to explore and quantify the impact of inclusion of gray+ literature on the results of all completed individual patient data (IPD) reviews coordinated by our group (13 meta-analyses). For each IPD review, results were calculated for RCTs fully published in English language journals and RCTs fully published in English language journals and the gray+literature.
                The IPD meta-analyses based only on RCTs that were fully published in English language journals tended to give more favorable results than those that included RCTs from the gray+literature. Although in most cases the addition of gray+data gave less encouraging results, moving the estimated treatment effect toward a null result, the direction of effect was not always predictable.
                We recommend that all systematic reviews should at least attempt to identify trials reported in the gray+literature and, where possible, obtain data from them. It is critical that the reporting of randomized controlled trials (RCTs) be transparent and comprehensive. The aim of this study was to examine if adopting standards of reporting, the Consolidated Standards 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.
                2010 Elsevier Ltd. All rights reserved. To evaluate the impact of an educational booklet on women's knowledge of and willingness to participate in a randomized clinical trial of treatment for breast cancer.
                Women undergoing surgery for newly diagnosed early stage breast cancer were randomized to receive, or not, an information booklet explaining the need for and manner in which randomized trials are conducted.
                Eighty-three women with newly diagnosed early stage breast cancer completed a questionnaire assessing attitudes to random clinical trials (RCTs) and were randomized to receive usual information treatment options provided from their oncologist, or the educational booklet in addition to usual information from their oncologist (42 usual information, 41 booklet). Fewer women who received the clinical trials booklet (40% versus 47%) would consider participating in the hypothetical clinical trial (P = 0.6). Mean knowledge scores increased for both groups; moreover, women who did not receive the booklet showed similar improvements to women who received the booklet [mean difference 0.09, 95% confidence interval (CI) -0.66 to 0.83]. In a multivariate analysis women who would consider participating in the clinical trial were more anxious [odds ratio (OR) 5.9, P = 0.02] had involved lymph nodes (OR 5.8, P = 0.02) and were less influenced by negative aspects of clinical trials (OR 7.7, P = 0.0001). After adjustment for these variables women who received the educational booklet were significantly less likely to consider trial participation (OR 0.22, P = 0.05).
                Educating women about clinical trials in this manner appears ineffective in improving recruitment to RCTs. Women appear to be more influenced by their perception of risk than understanding. This finding has ethical implications for communication of information about RCTs. To examine the extent to which the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines improved clinical trials reporting and subject attrition, which may undermine the credibility of published randomized clinical trials (RCTs).
                Published RCTs reported in two major medical journals before and after the CONSORT guidelines were systematically reviewed; one used the CONSORT statement (JAMA) and one did not (NEJM).
                The quality of RCT reporting improved for both journals, but JAMA showed more significant and consistent improvements in all aspects of RCT reporting. Subject attrition was better accounted for after the publication of CONSORT, although the attrition rates for various reasons actually increased. Attrition due to unknown reasons, as a percentage of total attrition, declined dramatically, from 68.7% pre-CONSORT to 13.0% post-CONSORT.
                Attrition of study subjects remains a serious problem in RCTs. Bias from selective attrition can undermine the presumptive scientific advantage of RCTs. The CONSORT guidelines improved RCT reporting when they were implemented but did not substantially improve reported attrition rates. To assess the quality of published randomized clinical trials (RCTs) in rheumatology and to determine whether there has been improvement in quality between 2 time periods, 1987-1988 and 1997-1998.
                Using MEDLINE and a hand search of selected rheumatology journals, we identified RCTs of adult rheumatic diseases published in English in 1987-1988 or 1997-1998. We examined trial quality with an expanded version of the Jadad scale, which assesses the adequacy of reported random sequence generation, allocation concealment, blinding, and analysis. All trials were read by 1 reviewer, with prior standardization using a random sample read by 2 reviewers. We also evaluated "high"- versus "low"-impact journals based on citation index.
                Two hundred forty RCTs (1987-1988 119 RCTs, 1997-1998 121 RCTs) were assessed. Results showed improvement in the quality of the trials, but the rates of reported random sequence generation, allocation concealment, power, and intent-to-treat analyses were persistently low. Low rates of reports of random sequence generation, allocation concealment, and intent-to-treat analyses were present even in the high-impact journals.
                There has been improvement in the quality of reporting of RCTs in rheumatology between 1987-1988 and 1997-1998. However, methodologic problems such as lack of allocation concealment, inadequate random sequence generation, lack of reporting of power, and lack of intent-to-treat analyses remain common. Many of these problems are established sources of bias in RCTs and are easily rectifiable. Nucare, a short-term psychoeducational coping skills training intervention was evaluated in a randomized controlled clinical trial (RCT) of 225 newly diagnosed breast and colon cancer patients.
                Measures of psychosocial distress, well being and optimism were evaluated every four months during a one-year period. Patients were randomized to one of four arms: Nucare presented in an individual basis; Nucare presented in a group format; a non-directive supportive group; and a no-intervention control. The interventions were provided in five sessions of ninety minutes each.
                Patients with breast cancer who received Nucare presented in an individual format showed more significant improvements in well-being over time compared to those in the control and group arms.
                We were unable to develop functioning groups within the RCT. Partial explanations for the latter finding include the structural limitations of the RCT: the groups were small, difficult to schedule and patients indicated that they would have preferred to choose whether or not to participate in a group. The positive changes in women with breast cancer who received Nucare persisted at 12 months. Financial and other competing interests have recently received increasing attention. In particular clinical research in plastic surgery attracts for-profit organizations, thus, explaining the increasing number of financial sponsorships. However, research articles often lack sufficient description of study design as well as disclosure of the source of funding. Furthermore, debate exists whether industry funding influences research findings and is leading to pro-industry results. A hand search was conducted identifying all randomized controlled (RCT) and controlled clinical trials (CCT) in 4 plastic surgery journals (Plastic and Reconstructive Surgery, British Journal of Plastic Surgery, Annals of Plastic Surgery, and Aesthetic Plastic Surgery) between 1990 and 2005. Subsequently, the influence of financial support on study outcome was analyzed. A total of 10,476 original articles were analyzed, resulting in the identification of 346 clinical trials which meet the Cochrane criteria for RCTs and CCTs. One hundred eighty-three trials and 163 studies were found to be RCTs and CCTs, respectively. Hereof, only 70 trials (20.2%) reported on grant support. Of these, 42 trials (60%) were supported by the industry. Depending on the topic addressed marked differences were detected regarding grant support. Studies with a focus on reconstructive plastic surgery were supported by the industry and by public institutions in almost equal shares (18 trials vs. 15 trials), whereas aesthetic surgical topics were predominantly funded by the industry (13 trials vs. 6 trials). Industry-funded trials reported more often statistically significant differences between treatment arms (28 trials vs. 16 trials). Authors' conclusions were found to be positively associated with financial competing interests. However, trial funding is rarely declared in the plastic surgery literature. Thus, the quality of reporting needs to be improved to be able to investigate these relationships in greater detail and draw more representative conclusions. Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The Consolidated Standards for Reporting Trials (CONSORT) statement was introduced in 1996 to improve reporting of RCTs. We aimed to determine the extent of ambiguity and reporting quality as assessed by adherence to the CONSORT statement in published reports of RCTs involving patients with Hodgkin lymphoma from 1966 through 2002.
                We analyzed 242 published full-text reports of RCTs in patients with Hodgkin lymphoma. Quality of reporting was assessed using a 14-item questionnaire based on the CONSORT checklist. Reporting was studied in two pre-CONSORT periods (1966-1988 and 1989-1995) and one post-CONSORT period (1996-2002).
                Only six of the 14 items were addressed in 75% or more of the studies in all three time periods. Most items that are necessary to assess the methodologic quality of a study were reported by fewer than 20% of the studies. Improvements over time were seen for some items, including the description of statistics methods used, reporting of primary research outcomes, performance of power calculations, method of randomization and concealment allocation, and having performed intention-to-treat analysis.
                Despite recent improvements, reporting levels of CONSORT items in RCTs involving patients with Hodgkin lymphoma remain unsatisfactory. Further concerted action by journal editors, learned societies, and medical schools is necessary to make authors even more aware of the need to improve the reporting RCTs in medical journals to allow assessment of validity of published clinical research. Systematic reviews of care are increasingly potent guides to clinical practice, and it is important that all relevant randomized controlled trials (RCTs) are identified by those within the speciality of learning disability who produce such works. All RCTs in the Journal of Intellectual Disability Research and its predecessor were identified by hand-searching (1957-1994), and the frequency, origin, intervention and quality of reporting of randomization were described. Electronic searches for the trials were undertaken for the years 1974-1994, and the quality of indexing was inspected and tested. These electronic searches were then compared to a 'gold standard' search. Fifty-six RCTs were identified. None contained the world 'randomized' in the title and only nine mentioned it in the abstract. Out of the 37 RCTs published between 1974 and 1994, 36 are in PsycLIT and 37 in MEDLINE. One MEDLINE record contained the wrong abstract. The methodological phrases used in the electronic records were poor, and thus, the precision of electronic searches, using both databases, was low. This international journal contains many relevant RCTs from around the world, involving several types of interventions. Unfortunately, these trials cannot be readily accessed electronically using methodological phrases designed to find RCTs. Improved quality of indexing would facilitate identification of RCTs and their dissemination. Publication bias toward studies that favor new therapies has been known to occur for the past 40 years, yet its implications are not well studied in child health. The increased interest in meta-analyses has highlighted the need to identify the totality of evidence when addressing treatment questions.
                To measure the percentage of randomized controlled trials (RCTs) presented at a major pediatric scientific meeting that were subsequently published as full-length articles, to investigate factors associated with publication, and to describe the variables that change from abstract to manuscript form.
                The scientific proceedings from the Society for Pediatric Research were hand searched for RCTs (1992-1995). Subsequent publication was ascertained through a search of various electronic databases. Quality of abstracts and manuscripts was measured, and data were extracted using a structured form.
                A total of 264 (59.1%) of 447 abstracts were subsequently published. Almost 64% of RCTs that were subsequently published favored new therapy compared with 43.5% of studies that were never published (P<.001). Mean effect size for published vs unpublished RCTs was 0.74 vs 0.05 (P<.001). Median sample size was larger in published (n = 45) vs unpublished (n = 34) RCTs (P =.02). Quality was significantly lower for abstracts vs published RCTs (P<.001). For 5% of abstracts that were subsequently published, the conclusion regarding treatment efficacy changed.
                Publication bias is a serious threat to assessing the effectiveness of interventions in child health, as little more than half of RCTs presented at a major scientific meeting are subsequently published. There is a need to institute an international registry of RCTs in children so that the totality of evidence can be accessed when assessing treatment effectiveness. Specific features of trial quality may be associated with exaggeration or shrinking of the observed treatment effect in randomized studies. Therefore, assessment of trial quality is often used in meta-analysis. However, the degree to which specific quality measures are associated with treatment effects has not been well established across a broad range of clinical areas.
                To determine if quality measures are associated with treatment effect size in randomized controlled trials (RCTs).
                Quality measures from published quality assessment scales were evaluated in RCTs included in meta-analyses from 4 medical areas (cardiovascular disease, infectious disease, pediatrics, and surgery). Included meta-analyses incorporated at least 6 RCTs, examined dichotomous outcomes, and demonstrated significant between-study heterogeneity in the odds ratio (OR) scale.
                Relative ORs comparing overall treatment effect (summary OR) of high vs low-quality studies, as determined by each quality measure, with relative ORs less than 1 indicating larger treatment effect in low-quality studies.
                Twenty-four quality measures were analyzed for 276 RCTs from 26 meta-analyses. Relative ORs of high vs low-quality studies for these quality measures ranged from 0.83 to 1.26; none was statistically significantly associated with treatment effect. The proportion of studies fulfilling specific quality measures varied widely in the 4 medical areas. In analyses limited to specific medical areas, placebo control, multicenter studies, study country, caregiver blinding, and statistical methods were significantly associated with treatment effect on 7 occasions. These relative ORs ranged from 0.40 to 1.74. However, the directions of these associations were not consistent.
                Individual quality measures are not reliably associated with the strength of treatment effect across studies and medical areas. Although use of specific quality measures may be appropriate in specific well-defined areas in which there is pertinent evidence, findings of associations with treatment effect cannot be generalized to all clinical areas or meta-analyses. The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal.
                To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs.
                Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator).
                Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument.
                Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8).
                Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs. To evaluate the reporting quality of key methodological items in randomized controlled trials (RCTs) in four general clinical ophthalmology journals.
                The reporting of 11 key methodological items in RCTs published in American Journal of Ophthalmology, Archives of Ophthalmology, British Journal of Ophthalmology and Ophthalmology in the year 2005 was assessed.
                Sixty-seven eligible RCTs were assessed and the mean number of items reported was 6.3 per RCT. No significant difference in the mean number of items reported was found between the four journals (P=0.20). The most frequently reported item was ethics approval and informed consent (97.0%), followed by masking status (85.1%), description of withdrawals (76.1%), adverse events (73.1%), and intention-to-treat analysis (71.6%). Details on sequence generation, randomization restriction, allocation concealment, allocation implementation, patient flow diagrams, and sample size calculation were reported in <50% of the RCTs assessed. Both sample size and page length of the RCTs correlated with the number of methodological items reported (P=0.024 and P=0.008, respectively).
                Similar to other specialties, rooms for improvement exist in the reporting of key methodological items of RCTs in clinical ophthalmic journals. Stricter adoption of the CONSORT statement might enhance the reporting quality of RCTs in ophthalmic journals. Intention-to-treat (ITT) is an analytic approach where all randomized participants are included in analyses and in their originally assigned condition, regardless of adherence or protocol deviation.
                The present study aimed to determine whether reporting and correct use of ITT in behavioral medicine randomized clinical trials (RCTs) published in behavioral journals has improved in recent years.
                ITT and related analytic conventions were examined in behavioral medicine RCTs (N = 87) published in Annals of Behavioral Medicine, Health Psychology, and the Journal of Consulting and Clinical Psychology in the years 2000-2003 and then again in 2006-2007. Logistic regression analyses tested whether ten indicators associated with ITT were being used increasingly over time. Also tested was whether reporting and correct use of ITT improved following the adoption of Consolidated Standards of Reporting Clinical Trials (CONSORT) statement.
                Results revealed that less than half of RCTs (42%) used ITT analyses correctly. Over time, reporting of sample size estimation and primary outcome as well as use of the term "ITT" to describe analyses improved; however, correct implementation of ITT did not. Improvement was not specifically attributable to CONSORT adoption.
                Investigators' claims of using ITT analyses have increased over time, but correct use of ITT has not. The evaluation of research output, such as estimation of the proportion of treatment successes, is of ethical, scientific, and public importance but has rarely been evaluated systematically. We assessed how often experimental cancer treatments that undergo testing in randomized clinical trials (RCTs) result in discovery of successful new interventions.
                We extracted data from all completed (published and unpublished) phase 3 RCTs conducted by the National Cancer Institute cooperative groups since their inception in 1955. Therapeutic successes were determined by (1) assessing the proportion of statistically significant trials favoring new or standard treatments, (2) determining the proportion of the trials in which new treatments were considered superior to standard treatments according to the original researchers, and (3) quantitatively synthesizing data for main clinical outcomes (overall and event-free survival).
                Data from 624 trials (781 randomized comparisons) involving 216 451 patients were analyzed. In all, 30% of trials had statistically significant results, of which new interventions were superior to established treatments in 80% of trials. The original researchers judged that the risk-benefit profile favored new treatments in 41% of comparisons (316 of 766). Hazard ratios for overall and event-free survival, available for 614 comparisons, were 0.95 (99% confidence interval [CI], 0.93-0.98) and 0.90 (99% CI, 0.87- 0.93), respectively, slightly favoring new treatments. Breakthrough interventions were discovered in 15% of trials.
                Approximately 25% to 50% of new cancer treatments that reach the stage of assessment in RCTs will prove successful. The pattern of successes has become more stable over time. The results are consistent with the hypothesis that the ethical principle of equipoise defines limits of discoverability in clinical research and ultimately drives therapeutic advances in clinical medicine. To measure the outcomes of a health assessment, conducted by a nurse, of people aged 75 years and older (75+HA) living independently in their own homes.
                Randomised controlled trial (RCT).
                A convenience sample of six general practices within the Adelaide Western Division of General Practice (AWDGP). A random sample of 100 participants was drawn from practice age-sex registers. Data were collected in initial visits between 1 August 1998 and February 1999, then in follow-up visits one year later.
                Participants were aged 75 years and over on 1 August 1998 and living independently in the community. 145 eligible patients were invited to join the study, and 100 of these consented to enrol (69%).
                A 75+HA conducted in the participant's home by a nurse and reported to their usual general practitioner.
                Primary: number of problems in each group; number of participants with problems; and mortality. Secondary: physical function; psychological (including cognitive) function; falls; and admission to institution.
                There were no significant differences between the control and intervention groups at follow-up in the number of problems, the number of participants with problems, or mortality. In the intervention group, there was significant improvement in self-rated health, geriatric depression score (GDS 15), and number of falls.
                This RCT has not demonstrated improvement in health status of the intervention group which received a 75+HA compared with a control group left to usual care. The "Consolidated Standards of Reporting Trials" (CONSORT) was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). However, little is known about the quality of reporting since this publication. We undertook an observational study to determine the quality of reporting key methodological factors in RCTs since the publication of the CONSORT statement and if a journal policy to promote adherence to the CONSORT checklist was associated with superior reporting. We recorded the reporting of 11 key methodological factors in 105 RCTs from 29 medical journals published subsequent to the CONSORT statement. We examined the quality of reporting in relation to whether a journal was a "CONSORT promoter" as defined by inclusion of the CONSORT checklist in a journal's "information to authors" section or a requirement that authors, manuscript reviewers, or copy editors complete the CONSORT checklist. Multivariate analysis controlled for journal impact factor, study outcome, and time of publication. Six of the 11 methodological factors were reported <50% of the time. The number of methodological factors reported was greater in CONSORT promoters than in journals not promoting CONSORT in both unadjusted (6.0 and 5.1, respectively, p-value = 0.03) and adjusted (6.4 and 4.8 of the 11 methodological factors, respectively, p-value = 0.0001) analyses. While journals that promote CONSORT demonstrate superior reporting of RCTs, persistent inadequacies in reporting remain. Until these inadequacies are resolved health-care providers will remain limited in their ability to make informed inferences about the validity of the studies upon which they base their clinical practice. Inadequate reporting of randomized controlled trials (RCTs) is associated with biased estimates of treatment effects. The reporting quality of RCTs involving patients with polycystic ovary syndrome (PCOS) is unknown. The purpose of this study was to assess the reporting quality of RCTs involving patients with PCOS using a standardized tool based on the Consolidated Standards of Reporting Trials (CONSORT) statement.
                We searched PubMed database for English-language RCTs involving patients with PCOS. Quality of reporting was assessed using a 24-item questionnaire based on the revised CONSORT checklist. Reporting was evaluated overall, and for pre- and post-CONSORT periods. RCTs on PCOS associated with fertility and non-fertility disturbances were also evaluated separately.
                Nine of the 24 items were reported in less than 50% of the studies, while a significant improvement (P < 0.05) was detected in 12 of 24 items (50%) over the two CONSORT periods. The RCTs on PCOS with reference to fertility seem to have adhered better to CONSORT statement than RCTs not associated to fertility.
                There is empirical evidence of suboptimal reporting quality of RCTs in PCOS. Endorsement of the CONSORT statement may optimize the reporting quality and enhance the validity of research. To evaluate the sensitivity and precision of various extended search methods in identifying randomized controlled trials (RCTs) for systematic reviews.
                Prospective analysis of extended search methods (specialized databases or trial registries, reference lists, hand-searching, personal communication, and Internet) used in two systematic reviews of RCTs. The gold standard was the total number of RCTs identified by major databases (MEDLINE, EMBASE, etc.) and extended search strategies combined. Sensitivity was the proportion of all known RCTs identified by any extended search method. Precision reflected the proportion of all items uncovered by any extended search method that actually were RCTs.
                The extended search identified 94 additional RCTs for the systematic reviews beyond those identified with the major databases. Specialized databases and trial registries had the highest sensitivity and precision for the lipid-lowering project (13.6% and 52.7%, respectively; p < .05) followed by scanning of reference lists (7.2% sensitivity and 41.9% precision; p <.05). Hand-searching was more effective than personal communication and Internet searching (1.7% sensitivity and 12.2% precision; p < .05). The acupuncture project had slightly different results, with the specialized databases and trial registries tied with the review of reference lists for highest sensitivity (14.2%). The precision followed the same trend as the lipid-lowering project (17.6% specialized databases; 8.3% reference lists; p < .05). A post-hoc analysis showed that 75 of the 94 RCTs were indexed in the major databases but missed by the major database search.
                Extended searching identified additional RCTs for the systematic reviews beyond those found in major databases. Specialized databases and trial registries were most effective. An important number of RCTs were missed by the major database search. Timing and accuracy of indexing may explain this finding. The definitive measure, whether there is an association between the method used to uncover RCTs, the quality of the items uncovered and their impact on systematic review results, is yet to be determined. Applicability of randomized controlled clinical trial (RCT) results to 'real world' situations is dependent on the comparability of trial participants to general patient populations. A full disclosure of criteria employed for trial enrollment is necessary for clinicians to assess generalizability. We sought to assess both the impact on generalizability and the disclosure rate of enrollment criteria for 32 major HIV RCTs in the AIDS Clinical Trial Group (ACTG) and Community Programs for Clinical Research on AIDS (CPCRA) trial networks.
                Eligibility criteria were compared in complete protocols to criteria listed in publications from these 32 NIH-funded HIV RCTs. We then applied these criteria to the Women's Interagency HIV Study (WIHS), the largest cohort study of HIV-infected women in the US.
                When applied to WIHS, eligibility criteria from protocols excluded 0-67.6% (median 42%) of WIHS participants (50.6% excluded from ACTG trials). Eligibility criteria in publications excluded 0-62% (median 19.6%) of WIHS (21.2% excluded from ACTG trials). The number of women in WIHS seemingly ineligible for trial participation per enrollment criteria listed in publications averaged only 60% of those actually excluded based on the protocols.
                We found that HIV RCT eligibility criteria excluded a large proportion of a representative cohort of HIV-infected women from trial participation. Furthermore, trial publications are not fully reflective of protocols in terms of disclosing eligibility criteria. Standardization and full disclosure of trial methodology will allow clinicians and researchers to more fully assess the generalizability of findings to their patient populations. Studies investigating means of recruiting participants to randomized controlled trials (RCTs) are sparse. We investigated the effects of telephone reminders as a recruitment strategy.
                Sick-listed employees received a written invitation to participate in a study comparing standard treatments with a solution-focused follow-up and were randomly allocated to an intervention or control group (n=703). Those who did not respond within 2 weeks received either 'no reminder' (n=242) or 'attempted telephone reminder' (n=256). Outcome was enrollment to the RCT.
                An intention to recruit analysis revealed no significant differences between the groups (P=.229). An intention to phone analysis among nonresponders revealed significant differences between 'no reminder' (recruited 4.5%) and 'attempted telephone reminder' (recruited 12.1%) (P=.003, odds ratio 2.89, 95% confidence interval [CI] 1.42-5.90). An analysis of numbers needed to phone showed that to recruit one more person in this group of nonresponders, we needed to phone 13 persons (95% CI=8-33).
                Systematic use of telephone calls can increase the recruitment rate among nonresponders in RCTs. Stents are commonly used to treat patients with coronary artery disease. However, the quality of reporting internal and external validity data in published reports of randomised controlled trials (RCTs) of stents has never been assessed.The objective of our study was to evaluate the quality of reporting internal and external validity data in published reports of RCTs assessing the stents for percutaneous coronary interventions.
                A systematic literature review was conducted. Reports of RCTs assessing stents for percutaneous coronary interventions indexed in MEDLINE and the Cochrane Central Register of Controlled Trials and published between January 2003 and September 2008 were selected. A standardized abstraction form was used to extract data. All analyses were adjusted for the effect of clustering articles by journal.
                132 articles were analyzed. The generation of the allocation sequence was adequate in 58.3% of the reports; treatment allocation was concealed in 34.8%. Adequate blinding was reported in one-fifth of the reports. An intention-to-treat analysis was described in 79.5%. The main outcome was a surrogate angiographic endpoint in 47.0%. The volume of interventions per center was described in two reports. Operator expertise was described in five (3.8%) reports. The quality of reporting was better in journals with high impact factors and in journals endorsing the CONSORT statement.
                The current reporting of results of RCTs testing stents needs to be improved to allow readers to appraise the risk of bias and the applicability of the results. The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to improve the quality of randomized controlled trial (RCT) reports. We assessed the quality of current Japanese RCT reports by conducting a cross-sectional study to examine the extent to which they adhere to the CONSORT statement.
                Reports of RCTs conducted in Japan that were published in medical journals between January and March 2004 were sampled from MEDLINE. The proportion of adherence to each item in the CONSORT checklist was evaluated for each report. Additionally, information on ethics reporting and funding sources was collected.
                A total of 98 RCT reports from Japan were evaluated, and adherence to the CONSORT statement was found to be suboptimal. Only 6 of 29 items in the checklist were described in more than 80% of reports. Adherence to key methodological items of the CONSORT statement was as follows: 23% for sample size determination, 39% for random sequence generation, 17% for allocation concealment, 29% for blinding, 53% for numbers analyzed, and 6% for inclusion of a flow diagram. Adherence to additional items was 82% for ethics committee approval, 92% for receiving informed consent, and 20% for disclosing funding sources.
                Our study on adherence of recent RCT reports from Japan to the CONSORT statement reveals that there is a significant need for improvement. Further investigation on the quality of RCT reports and ways to improve reporting quality is required. Increased attention has been directed at the quality of randomized controlled trials (RCTs) and how they are being reported. We examined leading anesthesiology journals to identify if there were specific areas for improvement in the design and analysis of published clinical studies. All RCTs that appeared between January 2000 and December 2000 in leading anesthesiology journals (Anesthesiology,Anesthesia & Analgesia,Anaesthesia, and Canadian Journal of Anaesthesia) were retrieved by a MEDLINE search. We used a previously validated assessment tool, including 14 items associated with study quality, to determine a quality score for each article. The overall mean weighted quality score was 44% +/- 16%. Overall average scores were relatively high for appropriate controls (77% +/- 7%) and discussions of side effects (67% +/- 6%). Scores were very low for randomization blinding (5% +/- 2%), blinding observers to results (1% +/- 1%), and post-beta estimates (16% +/- 13%). Important pretreatment clinical predictors were absent in 32% of all studies. Significant improvement in the reporting and conduct of RCTs is required and should focus on randomization methodology, the blinding of investigators, and sample size estimates. Repeat assessments of the literature may improve the adoption of guidelines for the improvement of the quality of randomized controlled trials. The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. Objective: This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004.
                Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus.
                Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%).
                The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor. CONSORT (Consolidated Standards for Reporting Trials) guidelines were constructed to ensure optimal reporting quality of randomized controlled trials (RCTs).
                To determine the effect of the adoption of CONSORT on the reporting quality of RCTs, we performed a systematic evaluation of RCTs published in two dermatology journals pre- and post-CONSORT adoption.
                The journals selected for the study were the Journal of the American Academy of Dermatology and the British Journal of Dermatology. We selected RCTs published in 1997 and 2006 using both Medline and hand searching. The following critical CONSORT criteria were recorded: sample size, type of disease studied, type of control, single-centre or multicentre study, type of funding, blinding, methods and type of randomization, definition of a primary endpoint, justification for sample size selection and power calculation, population for analysis, and adequacy of group comparison. A multivariable analysis was conducted to determine factors associated with optimal reporting quality.
                In total, 98 studies were included. Improvement in reporting quality was evident for the specification of the randomization method (20% in 1997 vs. 45% in 2006, P < 0.01) and for the justification of sample size (22% in 1997 vs. 43% in 2006, P = 0.027). The percentage of studies with optimal reporting quality increased from 11% in 1997 to 28% in 2006 (P = 0.03). Factors significantly associated with a good methodological quality were pharmaceutical industry funding and publication in 2006 vs. 1997.
                There is a need to improve the reporting quality of RCTs published in dermatology journals. Valid reviews of the effects of mental health care depend on identifying as high a proportion as possible of relevant randomized controlled trials (RCTs). To investigate the sensitivity and precision both of MEDLINE and of hand-searching for RCTs in mental health, 12 journals specializing in mental health and indexed by the National Library of Medicine (NLM) for MEDLINE were searched for the years 1971, 1976, 1981, 1986 and 1991. The sensitivity of the hand-search was 94% (95% Confidence Interval (CI) 93-95%), but it had a precision of only 7% (CI 6-8%). The optimal MEDLINE search had a sensitivity of only 52% (CI 48-56%) and a precision of 59% (CI 55-63%). Of the reports of RCTs identified by the hand-search, 9% (CI 7-11%) were not included in MEDLINE at all. Authors had included methodological descriptions in 84% (CI 80-88%) of RCTs found by the hand-search but missed by the MEDLINE search. Systematic reviews of mental health care which are based solely on MEDLINE searches of the literature will miss a large proportion of the relevant RCTs, and are thus liable to random error and bias. A register of mental health RCTs is urgently required. In Italy many diabetics still lack adequate care in general practice. We assessed the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes among General Practitioners (GPs) of Lazio region.
                Three-arm cluster-randomised controlled trial with GPs as units of randomisation (clusters). 252 GPs were randomised either to an active strategy (training module with administration of the guideline), or to a passive dissemination (administration of the guideline only), or to usual care (control). Data on prescriptions of tests and drugs were collected by existing information systems, whereas patients' data came from GPs' databases. Process outcomes were measured at the cluster level one year after the intervention. Primary outcomes concerned the measurement of glycosilated haemoglobin and the commissioning of micro- and macrovascular complications assessment tests. In order to assess the physicians' drug prescribing behaviour secondary outcomes were also calculated.
                GPs identified 6395 uncomplicated type 2 patients with a high prevalence of cardiovascular risk factors. Data on GPs baseline performance show low proportions of glycosilated haemoglobin assessments. Results of the C-RCT analysis indicate that the active implementation strategy was ineffective relating to all primary outcomes (respectively, OR 1.06 [95% IC: 0.76-1.46]; OR 1.07 [95% IC: 0.80-1.43]; OR 1.4 [95% IC:0.91-2.16]. Similarly, passive dissemination of the guideline showed no effect.
                In our region compliance of GPs with guidelines was not enhanced by a structured learning programme. Implementation through organizational measures appears to be essential to induce behavioural changes.
                ISRCTN80116232. To determine the quality of reporting of blinding in randomized controlled trials (RCTs), we evaluated 40 consecutive RCTs published in each of five leading journals. We noted whether authors reported the blinding status of participants, health care providers, data collectors, judicial assessors of outcomes, data analysts, and manuscript writers. Explicit reporting of blinding status occurred in <25% of RCTs for all groups. Eighty-three RCTs, reported as double-blind, provided eight combinations of blinded groups. In conclusion, prestigious journals do not currently report blinding status optimally. To do so, journals should abandon the term "double blind" and explicitly report the blinding status of the groups involved in RCTs. Until such reporting occurs, clinicians will be left with uncertainty about the validity of RCTs that guide their clinical practice. To measure the effects of a summary-of-findings (SoF) table on user satisfaction, understanding, and time spent finding key results in a Cochrane review.
                We randomized participants in an evidence-based practice workshop (randomized controlled trial [RCT] I) and a Cochrane Collaboration entities meeting (RCT II) to receive a Cochrane review with or without an SoF table. In RCT I, we measured user satisfaction. In RCT II, we measured correct comprehension and time spent finding key results.
                RCT I: Participants with the SoF table (n=47) were more likely to "agree" or "strongly agree" that it was easy to find results for important outcomes than (n=25) participants without the SoF table-68% vs. 40% (P=0.021). RCT II: Participants with the SoF table (n=18) were more likely to correctly answer two questions regarding results than (n=15) those without the SoF table: 93% vs. 44% (P=0.003) and 87% vs. 11% (P<0.001). Participants with the SoF table spent an average of 90 seconds to find key information compared with 4 minutes for participants without the SoF table (P=0.002).
                In two small trials, we found that inclusion of an SoF table in a review improved understanding and rapid retrieval of key findings compared with reviews with no SoF table. The revised Consolidated Standards of Reporting Trials (CONSORT) statement recognizes the importance of including data so that readers are able to judge the reliability or relevance of randomized controlled trial (RCT) findings. However, it is unclear whether journals consistently report the pre-randomization information necessary to assess the general applicability of trial results. The objective of this study was to assess the extent of adherence to pre-randomization data reporting in 4 leading general medicine journals, as recommended by the revised CONSORT statement over a specific time frame. A total of 480 RCTs met the eligibility criteria for review. In 2004, 138 of 246 (56%) articles reported the full CONSORT pre-randomization information, of which 121 (88%) presented this information in diagram form. In 2006, 136 of 234 (58%) reported the full information, of which 127 (93%) presented the information in a diagram. These numbers indicate no improvement in the reporting of pre-randomization information. In conclusion, reporting of the full CONSORT data remains inconsistent. We recommend that journals continue to support the CONSORT statement and ensure that adequate information is provided upon submission before commencing the peer review process. The presentation of clear, precise data will ensure that readers are able to better interpret the applicability of findings. Randomized controlled trials (RCTs) are suitable for meta-analysis and systematic reviews provided they are of high quality and are easy to retrieve. We determined these attributes of RCTs in obstetrical anaesthesia in a sample of available journals that are indexed in MEDLINE.
                Randomized controlled trials published between January 1985 and December 1994 in seven anaesthetic and three obstetric journals were identified by a MEDLINE search, and by handsearch of the same journals. Each RCT was assigned a quality score by a blinded rater using a reliable and validated scaled. The quality of each RCT was described and compared over time and by journal. The comparative yield of MEDLINE and hand-search was evaluated.
                Three hundred and forty RCTs were retrieved by MEDLINE and handsearch. Two hundred and twenty seven (65%) were identified by the MEDLINE search and 333 by the handsearch (98%). The median quality score was 3/5. There was no difference in score over time. Anesthesiology had the highest median score, Anaesthesia had the lowest (P < 0.05).
                Care must be taken when reviewing obstetrical anaesthesia research. Strategies in addition to a MEDLINE search must be used to identify RCTs since more than one third were missed using MEDLINE alone. Poor quality RCTs are more likely to be biased in favour of a new treatment. Therefore, to increase the validity of reviews sensitivity analyses based on quality should be done. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed by a group of clinical trialists, biostatisticians, epidemiologists and biomedical editors as a means to improve the quality of reports of randomized controlled trials (RCTs). The purpose of the present study is to assess the reporting quality of published RCTs that compare endoscopic carpal tunnel release (ECTR) with open carpal tunnel release (OCTR) using the CONSORT statement.
                A computerized literature search was conducted to identify all RCTs published from January 1989 to November 2004 that compared ECTR with OCTR. Foreign language studies were also included, and translated versions of these studies were obtained. Two investigators independently reviewed each eligible article and determined whether the authors reported on each of the 22 items of the CONSORT statement. Disagreements were resolved by consensus. The mean scores for studies published before the introduction of the CONSORT statement and those published afterward were compared. Similarly, a comparison was made between foreign language studies and those published in English.
                Eighteen RCTs comparing ECTR with OCTR met the inclusion criteria. The total scores on the CONSORT checklist ranged from 3 to 20, with a mean score of 9.83+/-3.79 (the maximum possible score was 22). The six studies published in foreign language journals had a statistically significantly lower mean score than the studies published in English language journals (7.00+/-2.76 versus 11.25+/-3.49, respectively; P<0.05). The mean score was higher for studies published after 1996 than for those published in 1996 or earlier (12.14+/-3.80 versus 8.36+/-3.11, respectively; P<0.05).
                The quality of reporting improved over time, but no study met all 22 criteria of the CONSORT statement. The CONSORT scores were higher for studies published after 1996 and for studies published in English language journals. Despite the improvement after 1996, most of these RCTs only reported one-half of the items listed on the CONSORT statement. Future investigators of surgical RCTs should make an effort to comply with the CONSORT checklist. It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed. As part of an ongoing project to identify all the randomized controlled trials (RCTs) in the emergency medicine literature, in association with the Cochrane Collaboration, 2 discrete studies were undertaken; the first, to compare motives for active participation in hand searching of the literature by emergency medicine professionals, and the second, to compare hand searching with MEDLINE searching of a number of emergency medicine journals.
                All listed members of the British Association for Emergency Medicine (BAEM) and the Society for Academic Emergency Medicine (SAEM) received a standard letter outlining the objectives of the project, with 1 of 3 headings assigned on an alternate basis. Recruited volunteers hand searched journals prioritized from the emergency medicine literature. Each issue of each journal was hand searched for RCTs. In addition, a comprehensive MEDLINE search was conducted for each journal. The yields of RCTs from the 2 searching methods were compared for all journals and for each journal individually.
                No clear motivation for participation in this work could be ascertained because of the low response rates from BAEM and SAEM (10.1% and 1.8%, respectively). Only 18 (29.0%) of the 62 journals identified were indexed by MEDLINE. In the 14 journals indexed by MEDLINE for which hand searching was completed, a total of 710 RCTs were identified by a combination of the 2 approaches; of these, 592 (83.4%) were identified by hand searching alone and 483 (68.0%) by MEDLINE searching alone. Both methods identified 365 (51. 4%) RCTs; hand searching revealed an additional 227 (32.0%) that were not identified by MEDLINE searching, and MEDLINE searching found 118 (16.6%) that were not identified by hand searching. The difference between the proportions identified by hand searching and by MEDLINE searching (15.4%; 95% confidence interval [CI], 12.7% to 17.9%) was statistically significant (McNemar's chi2 test, 1 df, 33. 8; P <.0001). This difference was not significant for 8 of the journals.
                The response rates from mailing to members of the relevant professional organizations letters requesting participation in this work were very low and suggested that such an approach was not cost-effective. However, no formal costing exercise was undertaken. Searching results showed that, in the 14 emergency medicine journals indexed by MEDLINE for which hand searching was completed, hand searching led to identification of additional RCTs (primary articles) not found through MEDLINE searching. However, hand searching, although statistically significantly better than MEDLINE searching, failed to identify some of the RCTs found by MEDLINE searching, suggesting that hand searching is not a "gold standard" method and that the dual approach, promoted by the Cochrane Collaboration, may be the optimal approach for journals indexed by MEDLINE. Randomized controlled trials (RCTs) of therapeutic interventions in acute drug overdose present a significant challenge for ethical, legal, and human rights protections of research subjects, particularly when healthy volunteers are involved. The CONSORT statement on the uniform reporting of clinical trials was published in 1996 with the overall aim of improving the reporting of RCTs, both individually and to facilitate their inclusion into systematic reviews. In CONSORT, reporting of ethical, legal, and human rights protections, including prior evaluation of the study by an ethics committee and provision of informed consent, was largely an implicit requirement. Those drafting CONSORT may have assumed such protections and the rights of study subjects were secured by existing doctor-patient relationships. Alternatively, CONSORT may have been viewed as likely to indirectly enhance such protections, as a flow-on effect of improved RCT design and reporting. We wished to examine whether such assumptions were justified by examining the reporting of RCTs of simulated overdose in healthy volunteers. We reviewed all reported RCTs involving activated charcoal in healthy human volunteersfor three years before the CONSORT statement (1989, 1990, and 1991) and three years afterwards (1999, 2000, 2001). Presence of documentation of inclusion and exclusion criteria, stopping rules, protocol deviations, information sheets, consent documentation, ethical approvals, conflicts of interest, understanding, refusal, inducements and coercion were recorded. We found a very poor level of reporting of some key ethical, legal, and human rights protections for healthy volunteers in toxicological RCTs. Reporting did not improve with the publication of CONSORT even in relation to requirements specifically included in the guidelines. The demand for family physicians (FPs) to participate in research is growing. The delicate balance between research participation and the daily practice routine might explain the often-disappointing number of patients recruited. We analyzed practice and physician characteristics associated with successful patient recruitment.
                We used a survey to conduct this study.
                There was a total of 165 FPs who participated in a combined randomized clinical trial/cohort study on drug treatment of dyspepsia in the Netherlands.
                We surveyed FPs about personal and practice characteristics and their motivation for participation in the project. These data were then related to the number of patients recruited. Univariate associations were calculated; relevant factors were entered into a logistic model that predicted patient recruitment.
                Data on 128 FPs could be analyzed (80% response rate); these FPs recruited 793 patients in the cohort study (mean = 6.3 per FP) and 527 in the clinical trial (mean = 4.2 per FP). The main reasons for participation were the research topic (59%) and the participation of an academic research group in the study (63%). Many FPs felt that participation was a professional obligation (39%); the financial incentive played a minor role (15%). The number of recruited patients was only independently associated with the participation of an academic research group.
                Successful patient recruitment in primary care research is determined more by motivation driven by the research group than by financial incentives, the research topic, or research experience. The purpose of the study was to determine if simply providing nursing facilities with comparative quality performance information and education about quality improvement would improve clinical practices and subsequently improve resident outcomes, or if a stronger intervention, expert clinical consultation with nursing facility staff, is needed.
                Nursing facilities (n = 113) were randomly assigned to one of three groups: workshop and feedback reports only, workshop and feedback reports with clinical consultation, and control. Minimum Data Set (MDS) Quality Indicator (QI) feedback reports were prepared and sent quarterly to each facility in intervention groups for a year. Clinical consultation by a gerontological clinical nurse specialist (GCNS) was offered to those in the second group.
                With the exception of MDS QI 27 (little or no activity), no significant differences in resident assessment measures were detected between the groups of facilities. However, outcomes of residents in nursing homes that actually took advantage of the clinical consultation of the GCNS demonstrated trends in improvements in QIs measuring falls, behavioral symptoms, little or no activity, and pressure ulcers (overall and for low-risk residents).
                Simply providing comparative performance feedback is not enough to improve resident outcomes. It appears that only those nursing homes that sought the additional intensive support of the GCNS were able to effect enough change in clinical practice to improve resident outcomes significantly. The objective was to determine the number of randomized controlled trials (RCT) performed by surgeons, published in surgical journals, or comprising a surgical arm and to assess their characteristics and overall quality.
                RCT in general surgery (including gastrointestinal, breast, surgical oncology, vascular, critical care, and trauma) published in 1990 were retrieved by MEDLINE and analyzed to determine the funding agency, type of therapy, area of surgery, journal published, country of origin, number of centers, and whether a surgeon was the principal author. The completeness of the MEDLINE search was compared to a manual search of the literature. All RCT were assessed with Chalmers' qualitative score.
                MEDLINE retrieved 202 surgical RCT (46% of those retrieved by a manual search) with a mean score of 0.40 +/- 0.13. However, surgical RCT were performed by surgeons in only one third of trials, compared surgical therapies in only one quarter of trials, and were published in surgical journals in less than one third of trials. Only 22% of surgical RCT were funded by peer reviewed granting agencies. The strongest variables determining the quality of surgical RCT were the type of therapy tested (p = 0.0001), the type of journal published (p = 0.006), and the area of general surgery (p = 0.007).
                Although surgical RCT are being performed, there are a relatively low proportion and standard of RCT performed by surgeons as the principal author, published in surgical journals, and comparing surgical therapies. This may reflect a lack of expertise by surgeons in clinical trials, lack of funding for surgical trials, methodologic problems peculiar to surgical trials, or a need for adoption of other research designs to assess surgical therapies. The aim of this experimental study was to evaluate the effectiveness of three patient-focused interventions designed to increase patient question asking in clinical consultations. Patients were randomly allocated to one of five conditions to receive either one of three interventions or to serve as an attention control group or a control group. The primary outcome measure was question asking by the patient of their physician. Participants in the intervention groups did not ask more questions than participants in the control groups. Immediately after the consultation participants in the intervention groups had higher levels of self-efficacy in asking questions. Three months after the index visit patients in the intervention groups were significantly more likely to be satisfied to some degree than patients in the control group. There was no difference in diabetic control. These results suggest that simple brief patient-focused interventions do not change patient behaviour in medical outpatient consultations. The goal was to assess the risk of bias among pediatric, randomized, controlled trials (RCTs) reported in 8 high-impact journals.
                We searched PubMed for all pediatric RCTs reported between July 1, 2007, and June 30, 2008, in 8 journals with high impact factors. Using Cochrane Collaboration methods for risk assessment, we evaluated all reports for risk of bias according to domain (ie, randomized sequence generation, allocation concealment, masking, incomplete outcome data, selective outcome reporting, and other). We used multiple logistic regression to test for associations between the presence of a high risk of bias according to domain and funding source, intervention type, trial registration, and multicenter status.
                Industry-funded RCTs were more likely to show a high risk of bias for sequence generation, compared with government-funded RCTs (adjusted odds ratio [aOR]: 6.1 [95% confidence interval [CI]: 1.70- 21.89]), and behavioral/educational trials were more likely to show a high risk of bias for sequence generation (aOR: 2.8 [95% CI: 1.06-7.36]) and allocation concealment (aOR: 4.09 [95% CI: 1.69-9.90]), compared with drug trials. Registered trials were less likely to have a high risk of bias for sequence generation, compared with nonregistered trials (aOR: 0.33 [95% CI: 0.15-0.71]).
                Overall, we found a large proportion of pediatric RCT reports with a high risk of bias for sequence generation and allocation concealment. Factors associated with a high risk of bias included industry funding and assessment of behavioral/educational interventions, whereas trial registration was associated with a lower risk of bias. Patient-centred depression care approaches should better address barriers of insufficient patient information and involvement in the treatment decision process. Additional research is needed to test the effect of increased patient participation on outcomes. The aim of this study was to assess, if patient participation in decision-making via a shared decision-making intervention leads to improved treatment adherence, satisfaction, and clinical outcome without increasing consultation time.
                Cluster-randomized controlled intervention study based on physician training and patient-centered decision aid compared to usual care in primary care settings in Südbaden region of Germany. Twenty-three primary care physicians treating 405 patients with newly diagnosed depression were enrolled. Patient involvement was measured with the patient perceived involvement in care scale (PICS) and a patient participation scale (MSH-scale). Patient satisfaction was measured by the CSQ-8 questionnaire. Treatment adherence was evaluated by patient and provider self-report. Depression severity and remission outcomes were assessed with the Brief PHQ-D.
                Physician facilitation of patient participation improved significantly and to a greater extent in the intervention compared to the control group. There was no intervention effect for depression severity reduction. Doctor facilitation of patient participation, patient-rated involvement, and physician assessment of adherence improved only in the intervention group. Patient satisfaction at post-intervention was higher in the intervention group compared to the control group. The consultation time did not differ between groups.
                A shared decision-making intervention was better than usual care for improving patient participation in treatment decision-making, and patient satisfaction without increasing consultation time. Additional research is needed to model causal linkages in the decision-making process in regard to outcomes.
                The study results encourage the implementation of patient participation in primary care of depression. To test the potential adjuvant effect of repetitive transcranial magnetic stimulation (rTMS) on motor learning in a group of stroke survivors undergoing constraint-induced therapy (CIT) for upper-limb hemiparesis.
                This was a prospective randomized, double-blind, sham-controlled, parallel group study. Nineteen individuals, one or more years poststroke, were randomized to either a rTMS + CIT (n = 9) or a sham rTMS + CIT (n = 10) group and participated in the 2-wk intervention.
                Regardless of group assignment, participants demonstrated significant gains on the primary outcome measures: the Wolf Motor Function Test (WMFT) and the Motor Activity Log (MAL)--Amount of Use, and on secondary outcome measures including the Box and Block Test (BBT) and the MAL--How Well. Participants receiving rTMS failed to show differential improvement on either primary outcome measure.
                Although this study provided further evidence that even relatively brief sessions of CIT can have a substantial effect, it provided no support for adjuvant use of rTMS. We appraised the compliance of randomized clinical trials (RCTs) cited for level A recommendations in obstetric practice bulletins (OPBs) and published after the CONSORT (Consolidated Standards of Reporting Trials, published 1996) statement. From the CONSORT checklist, we identified 50 separate items the RCTs should describe in the article and assigned 1 point if present; 0, if absent. The CONSORT score was the total points, expressed as a percentage. From 1998 to 2006, American College of Obstetricians and Gynecologists published 68 level A obstetric recommendations, and 20 (29%) are supported by > or = 1 RCT published after 1997. The median CONSORT score for the 32 RCTs published after the statement was 73% (range 30 to 100%). Only four RCTs complied with 90% of the CONSORT statement. RCTs supporting level A recommendations in OPB have variable compliance with CONSORT. Recommendations that lack quality RCTs should prompt further studies into the topic. The burden of cancer care in general practice is increasing. Patient-held records may facilitate effective, coordinated care, but no randomised controlled trials of their use in cancer care have been conducted, and concerns about possible negative effects remain.
                To evaluate the use of a supplementary patient-held record in cancer care.
                Six hundred and fifty radiotherapy outpatients with any form of cancer were randomised either to hold a supplementary record or to receive normal care. It was explained to record holders that the supplementary record was intended to improve communication with health professionals and act as an aide memoire. After three months, patients' satisfaction with communication and with participation in their own care were assessed. Global health status, emotional functioning, and cognitive functioning were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire.
                There were no significant differences between groups in any of the outcome measures. Patients in both groups expressed a high level of satisfaction with communication and participation in their care. Mean (SD) scores in the intervention and control groups were: global health status, 66.8 (24.2) and 65.3 (23.7); emotional functioning, 75.0 (24.6) and 77.4 (22.8); cognitive functioning, 84.5 (21.0) and 84.0 (21.3).
                A supplementary patient-held record for radiotherapy outpatients appears to have no effect on satisfaction with communication, participation in care, or quality of life. To improve understanding of physicians' reluctance to refer patients to clinical trials.
                This study was conducted in a large metropolitan region from 1993 to 1995 using a two-staged population-based sampling strategy. A total of 147 physicians discussed 245 patient cases and their own knowledge, attitudes, and practices toward clinical trials.
                Ninety-three patients (38. 0%) were offered a trial, and 49 (52.7%) of them agreed to participate. Forty-five patients (18.4%) actually received their adjuvant therapy on trial. Older patients and those with a poorer prognosis were less likely to be referred. Patients who delayed their decision were more than three times as likely to participate in a trial and more than eight times as likely to participate when they were reported to be actively involved in making the decision. Generally, physicians in university settings and who had formal support from a cooperative group were more likely to refer patients to trials. More specifically, surgeons referred more patients to trials when they felt comfortable explaining trials or believed that treatment should not stray from protocol. Oncologists were less likely to make referrals if they perceived the paperwork to be onerous or entry requirements to be too stringent. Surgeons' participation in recommending adjuvant therapy to patients resulted in more trial referrals unless they treated their patients with tamoxifen.
                (1) Physicians still need to overcome attitudinal and practical barriers to trial participation, (2) more support for physicians is needed, (3) surgeons may play a pivotal role in the recruitment of patients to adjuvant therapy trials, and (4) garnering patient enthusiasm for trial participation and involving them in the choice of adjuvant therapy may be key components to increasing trial enrollment. A consulting method known as 'shared decision making' (SDM) has been described and operationalized in terms of several 'competences'. One of these competences concerns the discussion of the risks and benefits of treatment or care options-'risk communication'. Few data exist on clinicians' ability to acquire skills and implement the competences of SDM or risk communication in consultations with patients.
                The aims of this study were to evaluate the effects of skill development workshops for SDM and the use of risk communication aids on the process of consultations.
                A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. Half the consultations were randomly selected for audio-taping, of which 352 patients attended and were audio-taped successfully. After baseline, participating doctors were randomized to receive training in (i) SDM skills or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were allocated randomly to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations were audio-taped from each phase. Raters (independent, trained and blinded to study phase) assessed the audio-tapes using a validated scale to assess levels of patient involvement (OPTION: observing patient involvement), and to analyse the nature of risk information discussed. Clinicians completed questionnaires after each consultation, assessing perceived clinician-patient agreement and level of patient involvement in decisions. Multilevel modelling was carried out with the OPTION score as the dependent variable, and rater, consultation and clinician levels of data, standardized by rater within clinician.
                Following each of the interventions, the clinicians significantly increased their involvement of patients in decision making (OPTION score increased by 10.6 following risk communication training [95% confidence interval (CI) 7.9 -13.3; P < 0.001] and by 12.9 after SDM skill development (95% CI 10 -15.8, P < 0.001), a moderate effect size. The level of involvement achieved by the risk communication aids was significantly increased by the subsequent introduction of the skill development workshops (7.7 increase in OPTION score, 95% CI 3.4-12; P < 0.001). The alternative sequence (skills followed by risk communication aids) did not achieve this effect. The use of most risk information formats increased after the provision of specific risk communication aids (P < 0.001). Clinicians using the risk communication tools perceived significantly higher patient and clinician agreement on treatment (P < 0.001), patient satisfaction with information (P < 0.01), clinician satisfaction with decision (P < 0.01) and general overall satisfaction with the consultation (P < 0.001) than those who were exposed to SDM skill development workshops.
                These clinicians were able to acquire the skills to implement SDM competences and to use risk communication aids. Each intervention provided independent effects. Further progress towards greater patient involvement in health care decision making is possible, and skill development in this area should be incorporated into postgraduate professional development programmes. Few meta-analyses of randomised trials assess the quality of the studies included. Yet there is increasing evidence that trial quality can affect estimates of intervention efficacy. We investigated whether different methods of quality assessment provide different estimates of intervention efficacy evaluated in randomised controlled trials (RCTs).
                We randomly selected 11 meta-analyses that involved 127 RCTs on the efficacy of interventions used for circulatory and digestive diseases, mental health, and pregnancy and childbirth. We replicated all the meta-analyses using published data from the primary studies. The quality of reporting of all 127 clinical trials was assessed by means of component and scale approaches. To explore the effects of quality on the quantitative results, we examined the effects of different methods of incorporating quality scores (sensitivity analysis and quality weights) on the results of the meta-analyses.
                The quality of trials was low. Masked assessments provided significantly higher scores than unmasked assessments (mean 2.74 [SD 1.10] vs 2.55 [1.20]). Low-quality trials (score < or = 2), compared with high-quality trials (score > 2), were associated with an increased estimate of benefit of 34% (ratio of odds ratios [ROR] 0.66 [95% CI 0.52-0.83]). Trials that used inadequate allocation concealment, compared with those that used adequate methods, were also associated with an increased estimate of benefit (37%; ROR=0.63 [0.45-0.88]). The average treatment benefit was 39% (odds ratio [OR] 0.61 [0.57-0.65]) for all trials, 52% (OR 0.48 [0.43-0.54]) for low-quality trials, and 29% (OR 0.71 [0.65-0.77]) for high-quality trials. Use of all the trial scores as quality weights reduced the effects to 35% (OR 0.65 [0.59-0.71]) and resulted in the least statistical heterogeneity.
                Studies of low methodological quality in which the estimate of quality is incorporated into the meta-analyses can alter the interpretation of the benefit of intervention, whether a scale or component approach is used in the assessment of trial quality. Shared decision-making (SDM) between professionals and patients is increasingly advocated from ethical principles. Some data are accruing about the effects of such approaches on health or other patient-based outcomes. These effects often vary substantially between studies.
                Our aim was to evaluate the effects of training GPs in SDM, and the use of simple risk communication aids in general practice, on patient-based outcomes.
                A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. After baseline, participating doctors were randomized to receive training in (i) SDM skills; or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were randomly allocated to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations took place in 'research clinics' to evaluate the effects of more time for consultations, compared with usual surgery time. Patient-based outcomes were assessed at exit from consultation and 1 month follow-up. These were: COMRADE instrument (principal measures; subscales of risk communication and confidence in decision), and a range of secondary measures (anxiety, patient enablement, intention to adhere to chosen treatment, satisfaction with decision, support in decision making and SF-12 health status measure). Multilevel modelling was carried out with outcome score as the dependent variable, and follow-up point (i.e. exit or 1 month later for each patient), patient and doctor levels of explanatory variables.
                No statistically significant changes in patient-based outcomes due to the training interventions were found: COMRADE risk communication score increased 0.7 [95% confidence interval (CI) -0.92 to 2.32] after risk communication training and 0.9 (95% CI -0.89 to 2.35) after SDM training; and COMRADE satisfaction with communication score increased by 1.0 (95% CI -1.1 to 3.1) after risk communication, and decreased by 0.6 (95% CI 2.7 to -1.5) after SDM training. Patients' confidence in the decision (2.1 increase, 95% CI 0.7-3.5, P < 0.01) and expectation to adhere to chosen treatments (0.7 increase, 95% CI 0.04-1.36, P < 0.05) were significantly greater among patients seen in the research clinics (when more time was available) compared with usual surgery time. Most outcomes deteriorated between exit and 1 month later. There was no interaction between intervention effects.
                Patients can be more involved in treatment decisions, and risks and benefits of treatment options can be explained in more detail, without adversely affecting patient-based outcomes. SDM and risk communication may be advocated from values and ethical principles even without evidence of health gain or improvement in patient-based outcomes, but the resources required to enhance these professional skills must also be taken into consideration. These data also indicate the benefits of extra consultation time. An intervention was developed to increase patient involvement in care. Using a treatment algorithm as a guide, patients were helped to read their medical record and coached to ask questions and negotiate medical decisions with their physicians during a 20-minute session before their regularly scheduled visit. In a randomized controlled trial we compared this intervention with a standard educational session of equal length in a clinic for patients with ulcer disease. Six to eight weeks after the trial, patients in the experimental group reported fewer limitations in physical and role-related activities (p less than 0.05), preferred a more active role in medical decision-making, and were as satisfied with their care as the control group. Analysis of audiotapes of physician-patient interactions showed that patients in the experimental group were twice as effective as control patients in obtaining information from physicians (p less than 0.05). Results of the intervention included increased involvement in the interaction with the physician, fewer limitations imposed by the disease on patients' functional ability, and increased preference for active involvement in medical decision-making. Cumulative meta-analysis of clinical trials (a Bayesian interpretation for accumulating evidence) will profoundly affect medical care by summarizing evidence in the assessment of technology innovations. Application of the technique to the randomized control trials (RCTs) of streptokinase treatment of acute myocardial infarction, reduction of peri-operative mortality by antibiotic prophylaxis, and prevention of death from bleeding peptic ulcers has revealed efficacy years before it was suspected by any other means. Arrangement of the trials according to event rate in the controls, effect sizes, quality of the trials or according to covariables of interest has supplied unique information. If carried out prospectively the technique supplies invaluable information regarding indications for another trial, the number of patients necessary to determine the validity of past trends, and the type of patients who might be benefitted. Careful examination in a cumulative manner of the prior trials can reduce the need for future large trials. This paper presents the first outcome evaluation of multi-session groupwork for HIV prevention among gay men in the UK. This community-based RCT recruited 50 men, of whom 42% were HIV-positive or untested, and 32% reported status unknown or serodiscordant UAI in the previous 12 months. No knowledge, skills, attitudinal or behavioural differences were detected between intervention and control at baseline. At eight weeks, those attending the group reported significant gains over their control in making sexual choices, physical safety, HIV and STI transmission knowledge, and sexual negotiation skills. At 20 weeks, significant differences remained for HIV and STI transmission knowledge and comfort with sexual choices. Although no behavioural differences were detected, the aims of the National Prevention Strategy were met. This pilot RCT is appraised in the light of modest sample size and attrition, and recommendations for establishing behavioural outcomes are presented. This study has demonstrated that high-risk community samples can be recruited to multi-session interventions, and has provided feasibility data for future rigorous evaluation designs. Several randomised clinical trials (RCTs) of analgesics in postoperative pain after traumatic or orthopaedic surgery (TOS) have been published, but no studies have assessed the quality of these reports. We aimed to examine the quality of reporting RCTs on analgesics for postoperative pain after TOS.
                Reports of RCTs assessing analgesics in postoperative pain after TOS were systematically searched from electronic databases. The quality of reports was assessed using the CONSORT checklist (scoring range from 0 to 22). The quality was considered poor when scoring was 12 or lesser. The publication year and the impact factor of journals were recorded.
                A total of 92 reports of RCTs were identified and 69 (75%) scored 12 or lesser in CONSORT checklist (range 5-17). The mean (SD) CONSORT score of all reports was 10.6 (2.7). Missing CONSORT items included primary and secondary outcome measures (11%), the specific objectives and hypothesis definition (12%), the sample size calculation (12%), the dates defining the periods of recruitment (12%), the discussion of external validity of findings (14%), the allocation sequence generation (24%), and the interpretation of potential bias or imprecision of results (25%). There was a little improvement in CONSORT scores over time (r = 0.62; p < 0.001) and with impact factor of journals (r = 0.30; p < 0.001).
                Quality of reporting RCTs on analgesics after TOS is poor. Reporting of those RCTs should be improved according to methodological standard checklists in the next years. Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected, but direct evidence of such bias is currently limited to case reports.
                To study empirically the extent and nature of outcome reporting bias in a cohort of randomized trials.
                Cohort study using protocols and published reports of randomized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg, Denmark, in 1994-1995. The number and characteristics of reported and unreported trial outcomes were recorded from protocols, journal articles, and a survey of trialists. An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta-analysis. Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias. Protocols and published articles were also compared to identify discrepancies in primary outcomes.
                Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes; consistency between primary outcomes defined in the most recent protocols and those defined in published articles.
                One hundred two trials with 122 published journal articles and 3736 outcomes were identified. Overall, 50% of efficacy and 65% of harm outcomes per trial were incompletely reported. Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy (pooled odds ratio, 2.4; 95% confidence interval [CI], 1.4-4.0) and harm (pooled odds ratio, 4.7; 95% CI, 1.8-12.0) data. In comparing published articles with protocols, 62% of trials had at least 1 primary outcome that was changed, introduced, or omitted. Eighty-six percent of survey responders (42/49) denied the existence of unreported outcomes despite clear evidence to the contrary.
                The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols. Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention. To ensure transparency, planned trials should be registered and protocols should be made publicly available prior to trial completion.
This review indicates that participation in RCTs is associated with similar outcomes to receiving the same treatment outside RCTs. These results challenge the assertion that the results of RCTs are not applicable to usual practice.