Toward a core outcome set for faecal incontinence-A systematic review of outcomes reported in the literature.

AIM: Faecal incontinence (FI) is a prevalent issue which can have a detrimental impact on the patient's quality of life. Current international guidelines lack strong treatment recommendations due to few studies in the field, in combination with the heterogeneity in outcome reporting. To address this, a core outcome set (COS) is proposed to standardize outcome reporting in FI studies, facilitating meta-analyses and enhancing therapeutic recommendations. Through several steps outlined by COMET 'what' to measure will be determined prior to determining 'how' to measure these outcomes. This systematic review aims to identify 'what' outcomes have been used in FI intervention studies so far in adult patients as a starting phase for the development of a future COS for FI. METHOD: Medline, Embase and the Cochrane library were searched to identify all outcomes reported in comparative effectiveness trials assessing one or more treatment option in adult patients suffering from FI. The outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to standardize outcome terminology, assess completeness, and inform subsequent steps in COS development. RESULTS: A total of 109 studies were included, which revealed 51 unique outcomes classified into 38 domains within four core areas. On average four outcomes were reported per study (range 1-11). The most commonly reported outcomes were "severity of FI" (83%), "quality of life" (64%), "number of FI episodes" (40%), "anorectal motor function" (39%), and "frequency of bowel movements" (16%). CONCLUSION: This systematic review offers an overview of outcomes reported in FI studies, highlighting the heterogeneity between studies. This heterogeneity emphasizes the need for standardizing outcome reporting which can be established through the creation of a COS.

Perioperative Demographic and Laboratory Characteristics of Failed Debridement, Antibiotics, and Implant Retention: Can We Determine Which Patients Will Fail?

BACKGROUND: Debridement, antibiotics, and implant retention (DAIR) are the mainstays surgical treatment for acute periprosthetic joint infection (PJI). However, reoperation following DAIR is common and the risk factors for DAIR failure remain unclear. This study aimed to assess the perioperative characteristics of patients who failed initial DAIR treatment. METHODS: A retrospective review was conducted on 83 patients who underwent DAIR for acute PJI within 3 months following index surgery from 2011 to 2022, with a minimum one-year follow-up. Surgical outcomes were categorized using the Musculoskeletal Infection Society outcome reporting tool (Tiers 1 to 4). Patient demographics, laboratory data, and perioperative outcomes were compared between patients who had failed (Tiers 3 and 4) (n = 32) and successful (Tiers 1 and 2) (n = 51) DAIR treatment. Logistic regression was also performed. RESULTS: After logistic regression, Charlson Comorbidity Index (odds ratio [OR]: 1.57; P = .003), preoperative C-reactive protein (OR: 1.06; P = .014), synovial white blood cell (OR: 1.14; P = .008), and polymorphonuclear cell (PMN%) counts (OR: 1.05; P = .015) were independently associated with failed DAIR. Compared with total hip arthroplasty, total knee arthroplasty patients (OR: 6.08; P = .001) were at increased risk of DAIR failure. The type of organism and time from primary surgery were not correlated with DAIR failure. CONCLUSIONS: Patients who had failed initial DAIR tended to have significantly higher Charlson Comorbidity Index, C-reactive protein, synovial white blood cell, and PMN%. The total knee arthroplasty DAIRs were more likely to fail than the total hip arthroplasty DAIRs. These characteristics should be considered when planning acute PJI management, as certain patients may be at higher risk for DAIR failure and may benefit from other surgical treatments. LEVEL OF EVIDENCE: III.

Correcting for outcome reporting bias in a meta-analysis: A meta-regression approach.

Outcome reporting bias (ORB) refers to the biasing effect caused by researchers selectively reporting outcomes within a study based on their statistical significance. ORB leads to inflated effect size estimates in meta-analysis if only the outcome with the largest effect size is reported due to ORB. We propose a new method (CORB) to correct for ORB that includes an estimate of the variability of the outcomes' effect size as a moderator in a meta-regression model. An estimate of the variability of the outcomes' effect size can be computed by assuming a correlation among the outcomes. Results of a Monte-Carlo simulation study showed that the effect size in meta-analyses may be severely overestimated without correcting for ORB. Estimates of CORB are close to the true effect size when overestimation caused by ORB is the largest. Applying the method to a meta-analysis on the effect of playing violent video games on aggression showed that the effect size estimate decreased when correcting for ORB. We recommend to routinely apply methods to correct for ORB in any meta-analysis. We provide annotated R code and functions to help researchers apply the CORB method.

Inconsistent Outcome Reporting in Heart Failure Randomized Controlled Trials.

BACKGROUND: Randomized controlled trials (RCTs) may report outcomes different from those prespecified on trial-registration websites, protocols and statistical analysis plans (SAPs). This study sought to investigate the prevalence and characteristics of heart failure (HF) RCTs that report outcomes different from those prespecified. METHODS AND RESULTS: MEDLINE via PubMed was searched to include phase II-IV HF RCTs in 9 high-impact journals from 2010 to 2020. Outcomes reported in trial publications were compared with prespecified outcomes in protocols, registration websites and SAPs. We used the χ2 or Fisher exact test to analyze correlations between trial characteristics and inconsistencies. Among 216 trials, 32 inconsistencies were observed in 28 trials (13.0%). Among 32 inconsistencies, 2 (6.3%) pertained to omission of prespecified primary outcomes, 4 (12.5%) to omission of prespecified secondary outcomes, 2 (6.3%) to changing prespecified primary outcomes to secondary outcomes, and 2 (6.3%) to changing prespecified secondary outcomes to primary outcomes. Of the inconsistencies, 3 (9.4%) pertained to addition of new primary outcomes, 17 (53.1%) to addition of new secondary outcomes, and 2 (6.3%,) to changes in the timing of assessment of primary outcomes. The majority of the inconsistencies favored statistically significant findings; 78 (36.1%) were registered retrospectively. Single-center recruitment was associated with outcome inconsistencies (ß = -0.14; 95% CI, -0.22 - -0.01; P = 0.035). CONCLUSIONS: More than 1 in 10 trials reported outcomes inconsistent with those specified in trial registration websites, SAPs and protocols. An action plan is warranted to minimize selective reporting and improve transparency.

Single and partial tooth replacement with fixed dental prostheses supported by dental implants: A systematic review of outcomes and outcome measures used in clinical trials in the last 10 years.

AIM: To evaluate outcome measures, methods of assessment, and analysis in clinical studies on fixed single- and multiple-unit implant restorations. MATERIALS AND METHODS: Three independent electronic database searches (MEDLINE, EMBASE, and Cochrane) were done to identify prospective and retrospective clinical studies published from January 2011 up to June 2021 with ≥20 patients and minimum 1-year follow-up period on technical and clinical outcomes of implant-supported single crowns (SCs) and partial fixed dental prostheses (P-FDPs). An entire data extraction was performed to identify primarily the most reported outcome measures and later to define the choice of assessment methods of those outcome measures. The outcomes were analysed descriptively, and the strength of association was evaluated using the Pearson chi-square test (p ≤ .05). RESULTS: In a total 531 studies, 368 on SCs (69.3%), 70 on P-FDPs (13.1%), and 93 on both restoration types (17.5%) were included; 56.3% of all studies did not clearly define a primary outcome. The most frequent primary outcome was marginal bone level (MBL) (55.2%) followed by implant survival (5.3%), professional aesthetic evaluation (3.4%), and technical complications (2.1%). Peri-implant indices were the most reported secondary outcome (55.1%), followed by implant survival (39.9%), MBL (36%), and implant success (26.4%). Prosthetic failure (seven studies [3.9%]) was one of the least reported outcome measures. CONCLUSIONS: Outcome measures and their assessment methods showed high heterogeneity among studies. Primary outcomes were not often defined clearly, and the most frequently selected primary outcome was marginal bone loss. Prosthetic outcomes, implant survival, and patient-related outcomes were only infrequently reported.

Single and partial tooth replacement with fixed dental prostheses supported by dental implants: A systematic review of outcomes and outcome measures used in clinical trials in the last 10 years.

AIM: To evaluate outcome measures, methods of assessment, and analysis in clinical studies on fixed single- and multiple-unit implant restorations. MATERIALS AND METHODS: Three independent electronic database searches (MEDLINE, EMBASE, and Cochrane) were done to identify prospective and retrospective clinical studies published from January 2011 up to June 2021 with ≥20 patients and minimum 1-year follow-up period on technical and clinical outcomes of implant-supported single crowns (SCs) and partial fixed dental prostheses (P-FDPs). An entire data extraction was performed to identify primarily the most reported outcome measures and later to define the choice of assessment methods of those outcome measures. The outcomes were analysed descriptively, and the strength of association was evaluated using the Pearson chi-square test (p ≤ .05). RESULTS: In a total 531 studies, 368 on SCs (69.3%), 70 on P-FDPs (13.1%), and 93 on both restoration types (17.5%) were included; 56.3% of all studies did not clearly define a primary outcome. The most frequent primary outcome was marginal bone level (MBL) (55.2%) followed by implant survival (5.3%), professional aesthetic evaluation (3.4%), and technical complications (2.1%). Peri-implant indices were the most reported secondary outcome (55.1%), followed by implant survival (39.9%), MBL (36%), and implant success (26.4%). Prosthetic failure (seven studies [3.9%]) was one of the least reported outcome measures. CONCLUSIONS: Outcome measures and their assessment methods showed high heterogeneity among studies. Primary outcomes were not often defined clearly, and the most frequently selected primary outcome was marginal bone loss. Prosthetic outcomes, implant survival, and patient-related outcomes were only infrequently reported.

Consideration of Sex, Gender, or Age on Outcomes of Digital Technologies for Treatment and Monitoring of Chronic Obstructive Pulmonary Disease: Overview of Systematic Reviews.

BACKGROUND: Several systematic reviews have addressed digital technology use for treatment and monitoring of chronic obstructive pulmonary disease (COPD). OBJECTIVE: This study aimed to assess if systematic reviews considered the effects of sex, gender, or age on the outcomes of digital technologies for treatment and monitoring of COPD through an overview of such systematic reviews. The objectives of this overview were to (1) describe the definitions of sex or gender used in reviews; (2) determine whether the consideration of sex, gender, or age was planned in reviews; (3) determine whether sex, gender, or age was reported in review results; (4) determine whether sex, gender, or age was incorporated in implications for clinical practice in reviews; and (5) create an evidence map for development of individualized clinical recommendations for COPD based on sex, gender, or age diversity. METHODS: MEDLINE, the Cochrane Library, Epistemonikos, Web of Science, and the bibliographies of the included systematic reviews were searched to June 2022. Inclusion was based on the PICOS framework: (1) population (COPD), (2) intervention (any digital technology), (3) comparison (any), (4) outcome (any), and (5) study type (systematic review). Studies were independently selected by 2 authors based on title and abstract and full-text screening. Data were extracted by 1 author and checked by another author. Data items included systematic review characteristics; PICOS criteria; and variables related to sex, gender, or age. Systematic reviews were appraised using A Measurement Tool to Assess Systematic Reviews, version 2 (AMSTAR 2). Data were synthesized using descriptive statistics. RESULTS: Of 1439 records, 30 systematic reviews published between 2010 and 2022 were included in this overview. The confidence in the results of 25 of the 30 (83%) reviews was critically low according to AMSTAR 2. The reviews focused on user outcomes that potentially depend on sex, gender, or age, such as efficacy or effectiveness (25/30, 83%) and acceptance, satisfaction, or adherence (3/30, 10%) to digital technologies for COPD. Reviews reported sex or gender (19/30 systematic reviews) or age (25/30 systematic reviews) among primary study characteristics. However, only 1 of 30 reviews included age in a subgroup analysis, and 3 of 30 reviews identified the effects of sex, gender, or age as evidence gaps. CONCLUSIONS: This overview shows that the effects of sex, gender, or age were rarely considered in 30 systematic reviews of digital technologies for COPD treatment and monitoring. Furthermore, systematic reviews did not incorporate sex, gender, nor age in their implications for clinical practice. We recommend that future systematic reviews should (1) evaluate the effects of sex, gender, or age on the outcomes of digital technologies for treatment and monitoring of COPD and (2) better adhere to reporting guidelines to improve the confidence in review results. TRIAL REGISTRATION: PROSPERO CRD42022322924; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=322924. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/40538.

Survey of New Zealand Arthroplasty Surgeons on Surgeon-Level Outcome Reporting.

BACKGROUND: Surgeon-specific outcome monitoring has become increasingly prevalent over the last 3 decades. The New Zealand Orthopaedic Association monitors individual surgeon performance through 2 mechanisms: arthroplasty revision rates derived from the New Zealand Joint Registry and a practice visit program. Despite remaining confidential, surgeon-level outcome reporting remains contentious. The purpose of this survey was to evaluate the opinions of hip and knee arthroplasty surgeons in New Zealand on the perceived importance of outcome monitoring, current methods used to evaluate surgeon-specific outcomes, and potential improvements identified through literature review and discussion with other registries. METHODS: The survey consisted of 9 questions on surgeon-specific outcome reporting, using a five-point Likert scale, and 5 demographic questions. It was distributed to all current hip and knee arthroplasty surgeons. There were 151 hip and knee arthroplasty surgeons who completed the survey, a response rate of 50%. RESULTS: Respondents agreed that monitoring arthroplasty outcomes is important and that revision rates are an acceptable measure of performance. Reporting risk-adjusted revision rates and more recent timeframes were supported, as was including patient-reported outcomes when monitoring performance. Surgeons did not support public reporting of surgeon-level or hospital-level outcomes. CONCLUSION: The findings of this survey support the use of revision rates to confidentially monitor surgeon-level arthroplasty outcomes and suggest that concurrent use of patient-reported outcome measures would be acceptable.

Assessment of consistency between peer-reviewed publications and clinical trial registrations in nursing journals.

BACKGROUND: The inconsistencies between randomized clinical trials (RCTs) registrations and peer-reviewed publications may distort trial results and threaten the validity of evidence-based medicine. Previous studies have found many inconsistencies between RCTs registrations and peer-reviewed publications, and outcome reporting bias is prevalent. AIMS: The aims of this review were to assess whether the primary outcomes and other data reported in publications and registered records in RCTs of nursing journals were consistent and whether discrepancies in the reporting of primary outcomes favored statistically significant results. Moreover, we reviewed the proportion of RCTs for prospective registration. METHODS: We systematically searched PubMed for RCTs published in the top 10 nursing journals between March 5, 2020, and March 5, 2022. Registration numbers were extracted from the publications, and registered records were identified from the registration platforms. The publications and registered records were compared to identify consistency. Inconsistencies were subdivided into discrepancies and omissions. RESULTS: A total of 70 RCTs published in seven journals were included. The inconsistencies involved sample size estimation (71.4%), random sequence generation (75.7%), allocation concealment (97.1%), blinding (82.9%), primary outcomes (60.0%) and secondary outcomes (84.3%). Among the inconsistencies in the primary outcomes, 21.4% were due to discrepancies and 38.6% resulted from omissions. Fifty-three percent (8/15) presented discrepancies in the primary outcomes that favored statistically significant results. Additionally, although only 40.0% of the studies were prospective registrations, the number of prospectively registered trials has trended upward over time. LINKING EVIDENCE TO ACTION: While not including all RCTs in the nursing field, our sample reflected a general trend: inconsistencies between publications and trial registrations were prevalent in the included nursing journals. Our research helps to provide a way to improve the transparency of research reports. Ensuring that clinical practice has access to transparent and reliable research results are essential to achieve the best possible evidence-based medicine.

Fractures of the posterior malleolus: a systematic review and analysis of patient-reported outcome scale selection.

PURPOSE: Despite the extensive use of PROs in ankle fracture research, no study has quantified which PROs are most commonly used for assessing outcomes of patients who sustain fractures of the posterior malleolus. The purpose of this study was therefore to quantify which PROs are most commonly used for outcome research after posterior malleolus fractures. METHODS: A systematic search was performed using the preferred reporting items for systematic reviews and meta-analyses guidelines. Articles were identified through Pubmed, EMBASE, Web of Science, and cochrane central register of controlled trials through May of 2021. Included articles were analyzed for the primary outcome of the most commonly reported PRO. RESULTS: The American orthopedic foot and ankle ankle-hindfoot score (AOFAS) was the most commonly used PRO for assessment of posterior malleolus fracture outcomes, used in 37 of 72 studies (51.4%). The second and third most common were the olerud-molander ankle score (OMAS) (22 studies, 30.6%) and the visual analogue score (VAS) (21 studies, 29.2%). Eleven different PROs were used only once. Quality of evidence was graded as low given the percentage of studies that were observational or case series (68 of 72 studies, 94.4%). CONCLUSION: Investigators have used many different PROs to assess outcomes for posterior malleolus fractures, the most common of which are the AOFAS, OMAS, and VAS. Future investigators should attempt to unify outcome reporting for these injuries.

Transparency and reporting characteristics of COVID-19 randomized controlled trials.

BACKGROUND: In the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether reporting improves after the peer review process for all preprints subsequently published in peer-reviewed journals. METHODS: We searched the Cochrane COVID-19 Study Register and L·OVE COVID-19 platform to identify all reports of RCTs assessing pharmacological treatments of COVID-19, up to May 2021. We extracted indicators of transparency (e.g., trial registration, data sharing intentions) and assessed the completeness of reporting (i.e., some important CONSORT items, conflict of interest, ethical approval) using a standardized data extraction form. We also identified paired reports published in preprint and peer-reviewed publications. RESULTS: We identified 251 trial reports: 121 (48%) were first published in peer-reviewed journals, and 130 (52%) were first published as preprints. Transparency was poor. About half of trials were prospectively registered (n = 140, 56%); 38% (n = 95) made their full protocols available, and 29% (n = 72) provided access to their statistical analysis plan report. A data sharing statement was reported in 68% (n = 170) of the reports of which 91% stated their willingness to share. Completeness of reporting was low: only 32% (n = 81) of trials completely defined the pre-specified primary outcome measures; 57% (n = 143) reported the process of allocation concealment. Overall, 51% (n = 127) adequately reported the results for the primary outcomes while only 14% (n = 36) of trials adequately described harms. Primary outcome(s) reported in trial registries and published reports were inconsistent in 49% (n = 104) of trials; of them, only 15% (n = 16) disclosed outcome switching in the report. There were no major differences between preprints and peer-reviewed publications. Of the 130 RCTs published as preprints, 78 were subsequently published in a peer-reviewed journal. There was no major improvement after the journal peer review process for most items. CONCLUSIONS: Transparency, completeness, and consistency of reporting of COVID-19 clinical trials were insufficient both in preprints and peer-reviewed publications. A comparison of paired reports published in preprint and peer-reviewed publication did not indicate major improvement.

Approaches to Assessing and Adjusting for Selective Outcome Reporting in Meta-analysis.

BACKGROUND: Selective or non-reporting of study outcomes results in outcome reporting bias. OBJECTIVE: We sought to develop and assess tools for detecting and adjusting for outcome reporting bias. DESIGN: Using data from a previously published systematic review, we abstracted whether outcomes were reported as collected, whether outcomes were statistically significant, and whether statistically significant outcomes were more likely to be reported. We proposed and tested a model to adjust for unreported outcomes and compared our model to three other methods (Copas, Frosi, trim and fill). Our approach assumes that unreported outcomes had a null intervention effect with variance imputed based on the published outcomes. We further compared our approach to these models using simulation, and by varying levels of missing data and study sizes. RESULTS: There were 286 outcomes reported as collected from 47 included trials: 142 (48%) had the data provided and 144 (52%) did not. Reported outcomes were more likely to be statistically significant than those collected but for which data were unreported and for which non-significance was reported (RR, 2.4; 95% CI, 1.9 to 3.0). Our model and the Copas model provided similar decreases in the pooled effect sizes in both the meta-analytic data and simulation studies. The Frosi and trim and fill methods performed poorly. LIMITATIONS: Single intervention of a single disease with only randomized controlled trials; approach may overestimate outcome reporting bias impact. CONCLUSION: There was evidence of selective outcome reporting. Statistically significant outcomes were more likely to be published than non-significant ones. Our simple approach provided a quick estimate of the impact of unreported outcomes on the estimated effect. This approach could be used as a quick assessment of the potential impact of unreported outcomes.

Reporting and grading of complications for intracorporeal robot-assisted radical cystectomy: an in-depth short-term morbidity assessment using the novel Comprehensive Complication Index®.

OBJECTIVE: To assess suitability of Comprehensive Complication Index (CCI®) vs. Clavien-Dindo classification (CDC) to capture 30-day morbidity after robot-assisted radical cystectomy (RARC). MATERIALS AND METHODS: A total of 128 patients with bladder cancer (BCa) undergoing intracorporeal RARC with pelvic lymph node dissection between 2015 and 2021 were included in a retrospective bi-institutional study, which adhered to standardized reporting criteria. Thirty-day complications were captured according to a procedure-specific catalog. Each complication was graded by the CDC and the CCI®. Multivariable linear regression (MVA) was used to identify predictors of higher morbidity. RESULTS: 381 complications were identified in 118 patients (92%). 55 (43%), 43 (34%), and 20 (16%) suffered from CDC grade I-II, IIIa, and ≥ IIIb complications, respectively. 16 (13%), 27 (21%), and 2 patients (1.6%) were reoperated, readmitted, and died within 30 days, respectively. 31 patients (24%) were upgraded to most severe complication (CCI® ≥ 33.7) when calculating morbidity burden compared to corresponding CDC grade accounting only for the highest complication. In MVA, only age was a positive estimate (0.44; 95% CI = 0.03-0.86; p = 0.04) for increased cumulative morbidity. CONCLUSION: The CCI® estimates of 30-day morbidity after RARC were substantially higher compared to CDC alone. These measurements are a prerequisite to tailor patient counseling regarding surgical approach, urinary diversion, and comparability of results between institutions.

Registration and primary outcome reporting in behavioral health trials.

BACKGROUND: Registration of research studies is designed to lock investigators into a data collection and analysis plan before a study starts and thereby limit their ability to engage in flexible data analysis and selective outcome reporting. Studies of registered clinical trials show that one- to two-thirds are registered after the study has started and that non-adherence to important design and analytic features, such as reporting data pertaining to all primary outcomes, remains high. Less is known about the effects of registration on research transparency and integrity outside of clinical trials. To address this gap in knowledge, the current study examined the effects of registration on the reporting of research findings in a sample of behavioral health trials published in BMC Public Health. METHODS: Registered trials published in the BMC Public Health section "Health Behavior, Health Promotion and Society" between 2011 and 2015 were included in the study. For each trial, we reviewed associated online submissions from 13 different registration sites. For those determined to have been prospectively registered, we used the trial registry, MEDLINE (Pubmed), PsychINFO, Web of Science and e-mails to investigators to identify subsequent publications from the study that reported results pertaining to primary outcomes. The two investigators then independently reviewed the outcome publication(s) and compared the primary outcomes reported in these to the registered primary outcomes. RESULTS: The final analytic sample comprised 136 locatable, registered trials with an identifiable start date. Sixty-eight of the 136 were prospectively registered. Among these prospectively registered trials, only 16 published manuscripts reported outcomes and methods that were concordant with their registrations. CONCLUSIONS: Retrospective submission of protocols for publication and retrospective registration remain common in public health research, and adherence to prespecified outcomes is rare. In its current form, registration of behavioral and health promotion trials is likely to have minimal effect on preventing selective outcome reporting in publications, and the pervasiveness of vague and incomplete registry entries means that registries will have limited utility in terms of facilitating replication studies.

Registry versus publication: discrepancy of primary outcomes and possible outcome reporting bias in child and adolescent mental health.

Outcome reporting bias is one of the fundamental forms of publication bias. It implies publishing only outcomes that have positive results. The aim of this observational study was to explore primary outcome discrepancies between registry of clinical trials and their corresponding publications, since these can indicate outcome reporting bias in child mental health. Data were extracted from completed interventional clinical trials from ClinicalTrial.gov registry and its Archive site. Trials were registered under "Behaviours and Mental Disorders" category, and conducted on underage participants (0-17 years). Their primary outcomes were compared to those published in publication which had a corresponding NCT number stated in the text. Sixteen percent of trials did not have the minimum information on primary outcome stated in the registry-neither the measure used nor the measurement time points; 38.9% of trials had the minimum information stated to describe primary outcome, while only 3.3% of trials had all the necessary elements stated in the registry. Most of the publication in our sample had positive results (66.4%). Half of the trials registered before completion had non-matching primary outcomes in the registry and publication; 85.4% of trials with non-matching outcomes indicated possible outcome reporting bias for some of the primary outcome. Middle-sized trials and industry-funded trials were related with higher quality of primary outcome registration. Industry funding was related with positive findings in publication. Non-industry funding proved to be the only significant predictor of discrepancy between registered and published primary outcomes, and possible outcome reporting bias. Journal impact factor was not related with any of the outcome measures. The main limitation of the study is that it primarily offers an insight into discrepancy of registered and published outcomes. The methodology does not imply an access to results of unpublished outcomes - therefore, it was not possible to determine the presence of the bias with sufficient certainty in large number of trials. Further research should be done with improved methodology and additional data.

ROB-MEN: a tool to assess risk of bias due to missing evidence in network meta-analysis.

BACKGROUND: Selective outcome reporting and publication bias threaten the validity of systematic reviews and meta-analyses and can affect clinical decision-making. A rigorous method to evaluate the impact of this bias on the results of network meta-analyses of interventions is lacking. We present a tool to assess the Risk Of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN). METHODS: ROB-MEN first evaluates the risk of bias due to missing evidence for each of the possible pairwise comparison that can be made between the interventions in the network. This step considers possible bias due to the presence of studies with unavailable results (within-study assessment of bias) and the potential for unpublished studies (across-study assessment of bias). The second step combines the judgements about the risk of bias due to missing evidence in pairwise comparisons with (i) the contribution of direct comparisons to the network meta-analysis estimates, (ii) possible small-study effects evaluated by network meta-regression, and (iii) any bias from unobserved comparisons. Then, a level of "low risk", "some concerns", or "high risk" for the bias due to missing evidence is assigned to each estimate, which is our tool's final output. RESULTS: We describe the methodology of ROB-MEN step-by-step using an illustrative example from a published NMA of non-diagnostic modalities for the detection of coronary artery disease in patients with low risk acute coronary syndrome. We also report a full application of the tool on a larger and more complex published network of 18 drugs from head-to-head studies for the acute treatment of adults with major depressive disorder. CONCLUSIONS: ROB-MEN is the first tool for evaluating the risk of bias due to missing evidence in network meta-analysis and applies to networks of all sizes and geometry. The use of ROB-MEN is facilitated by an R Shiny web application that produces the Pairwise Comparisons and ROB-MEN Table and is incorporated in the reporting bias domain of the CINeMA framework and software.

Effects of selective outcome reporting on risk perception.

The current study aimed to investigate how selective reporting of study results indicating increased health effects will influence its receiver's risk perception. Using the example of the Interphone Study from 2010 on mobile phone usage and cancer, an online experiment was conducted separating respondents into two groups. One group of subjects was informed selectively about a relationship between heavy mobile phone use and an elevated risk of glioma (brain cancer) only. The other group of subjects was informed about the full results of the analyses of glioma risk by cumulative call time, which suggests that other than for the heavy users, there were no statistically significant elevated risks related to mobile phone use. The results showed that selective reporting of risk information increased risk perception when compared to receiving the full information. Additionally, the selectively informed subjects revealed a stronger tendency towards overgeneralization of the 'elevated brain cancer risk' to all mobile phone users, although this did not extend to an overgeneralization to other electromagnetic field sources or differences in the perception of a usage time dependency for possible health risks. These results indicate that reporting of full results is an important factor in effective risk communication.

A tool for assessing the comprehensiveness of outcome reporting within clinical trials in pregnancy.

INTRODUCTION: Clinical trials provide fundamental evidence used to inform healthcare decisions at patient- and population levels and it is thus important that trials consider outcomes relevant to both patients and stakeholders. Although validated tools assessing other aspects of trial integrity exist, there is no tool for assessing the breadth and completeness of outcomes measured. Our objective was to develop a comprehensiveness of outcome reporting (COR) tool to assess this within trials in pregnancy. MATERIAL AND METHODS: We developed a tool that aids in visualizing outcome reporting through the automatic generation of a heatmap, enabling assessment of the range of maternal and fetal/neonatal outcomes included in clinical trials. Outcome reporting and measurement of each study is compared to a context-specific, user-determined, ideal standard set of outcomes, created by initially considering all domains within five core outcome areas. These include mortality, morbidity, functioning/life-impact, resource-use, and adverse events, as identified by the most recent taxonomy for outcomes in medical research. We tested the tool's functionality using trials previously identified as studies on obesity in pregnant patients, and further compared the utility of the COR Tool against Cochrane's Risk of Bias 2.0 Tool using correlational analysis. RESULTS: The pilot heatmap using clinical trials studying obesity in pregnancy (n = 15), illustrated a lack of comprehensiveness of reported outcomes in the majority of studies. Included trials were found to readily report physiological/clinical outcome but consistently neglected outcome areas related to functioning, delivery of care, resource-use, and adverse events. Outcome areas reported and measured were done so with largely varying degrees of quality. When the COR Tool was compared with Cochrane's RoB 2.0 Tool on a scatter plot, only a weak correlation was found (R = 0.2936, R2  = 0.0862) CONCLUSIONS: The COR Tool will promote transparency in clarifying what outcomes a trial's conclusions are based on, encourage trialists to consider outcomes related to all aspects of maternal and fetal/neonatal health, and support reviewers in appraising outcome reporting and measurement in the assessment of trial integrity. Used in tandem with RoB tools and core outcome sets, we hope the COR Tool will meaningfully contribute to improving maternal-infant health.

A systematic review of pain outcomes reported by randomised trials of hip and knee arthroplasty.

It is difficult to pool results from randomised clinical trials that report different outcomes. We want to develop a core set of pain-related outcomes after total hip or knee arthroplasty, the first stage of which is to systematically review published outcomes. We searched PubMed, Embase and CENTRAL for relevant trials to January 2020. We identified 165 outcomes from 565 trials with 50,668 participants, which we categorised into six domains: pain; analgesic consumption; quality of care; adverse events; mobility; and patient-reported outcome measures. The outcome in each domain reported by most trials was: visual analogue score for pain, 401 (71%); morphine consumption, 212 (38%); length of hospital stay, 166 (29%); nausea or vomiting, 425 (75%); range of motion, 173 (31%); and patient satisfaction score, 181 (32%). A primary outcome was reported in 281 (50%) trials: 101 (18%) trials reported consumption of rescue analgesics and 95 (17%) trials reported pain. We plan to publish a consensus on outcomes that should be reported in postoperative pain trials after hip or knee arthroplasty.

Trial registration and selective outcome reporting in 585 clinical trials investigating drugs for prevention of postoperative nausea and vomiting.

BACKGROUND: Selective outcome reporting in clinical trials introduces bias in the body of evidence distorting clinical decision making. Trial registration aims to prevent this bias and is suggested by the International Committee of Medical Journal Editors (ICMJE) since 2004. METHODS: The 585 randomized controlled trials (RCTs) published between 1965 and 2017 that were included in a recently published Cochrane review on antiemetic drugs for prevention of postoperative nausea and vomiting were selected. In a retrospective study, we assessed trial registration and selective outcome reporting by comparing study publications with their registered protocols according to the 'Cochrane Risk of bias' assessment tool 1.0. RESULTS: In the Cochrane review, the first study which referred to a registered trial protocol was published in 2004. Of all 585 trials included in the Cochrane review, 334 RCTs were published in 2004 or later, of which only 22% (75/334) were registered. Among the registered trials, 36% (27/75) were pro- and 64% (48/75) were retrospectively registered. 41% (11/27) of the prospectively registered trials were free of selective outcome reporting bias, 22% (6/27) were incompletely registered and assessed as unclear risk, and 37% (10/27) were assessed as high risk. Major outcome discrepancies between registered and published high risk trials were a change from the registered primary to a published secondary outcome (32%), a new primary outcome (26%), and different outcome assessment times (26%). Among trials with high risk of selective outcome reporting 80% favoured at least one statistically significant result. Registered trials were assessed more often as 'overall low risk of bias' compared to non-registered trials (64% vs 28%). CONCLUSIONS: In 2017, 13 years after the ICMJE declared prospective protocol registration a necessity for reliable clinical studies, the frequency and quality of trial registration in the field of PONV is very poor. Selective outcome reporting reduces trustworthiness in findings of clinical trials. Investigators and clinicians should be aware that only following a properly registered protocol and transparently reporting of predefined outcomes, regardless of the direction and significance of the result, will ultimately strengthen the body of evidence in the field of PONV research in the future.