Assessment of Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Interventions of Post-Traumatic Stress Disorder.

BACKGROUND: Post-traumatic stress disorder (PTSD) has debilitating effects on quality of life. Patient-reported outcomes (PROs) assess changes in quality of life and serve as subjective measurements of patient experience. The aim of this study is to assess the completeness of PRO reporting within randomized controlled trials with interventions pertaining to PTSD. METHODS: This cross-sectional, meta-epidemiological study assessed the completeness of PRO reporting in RCTs investigating PTSD interventions. We searched multiple databases for published RCTs of PTSD interventions that used PROs as a primary or secondary outcome. We assessed PRO completeness using the PRO adaptation of the Consolidated Standards of Reporting Trial (CONSORT). We used a bivariate regression model to determine the association between trial characteristics and the completeness of reporting. RESULTS: After an initial screening of 5906 articles, our final sample of RCTs for inclusion was 43. The mean completeness of reporting of PROs was 58.4% (SD = 14.50). We found no significant associations between trial characteristics and completeness of the CONSORT-PRO adaptation. CONCLUSION: Reporting of PROs was often incomplete among RCTs focused on PTSD. We believe that adherence to CONSORT-PRO will improve both PRO reporting and implementation into clinical practice to improve assessment of quality of life.

Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials.

Esophageal motility disorders (EMD) can have significant effects on quality of life. Patient-reported outcomes (PROs) provide valuable insight into the patient's perspective on their treatment and are becoming increasingly used in randomized controlled trials (RCTs). Thus, our investigation aims to evaluate the completeness of reporting of PROs in RCTs pertaining to EMDs. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on EMDs. Included RCTs were published between 2006 and 2020, reported a primary outcome related to an EMDs, and listed at least one PRO measure as a primary or secondary outcome. Investigators screened and extracted data in a masked, duplicate fashion. Data extraction was carried out using both the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias 2.0 tool. We assessed overall mean percent completion of the CONSORT-PRO adaptation and a bivariate regression analysis was used to assess relationships between trial characteristics and completeness of reporting. The overall mean percent completion of the CONSORT-PRO checklist adaptation was 43.86% (SD = 17.03). RCTs with a primary PRO had a mean completeness of 47.73% (SD = 17.32) and RCTs with a secondary PRO was 35.36% (SD = 13.52). RCTs with a conflict of interest statement were 18.15% (SE = 6.5) more complete (t = 2.79, P = .009) than trials lacking a statement. No additional significant associations between trial characteristics and completeness of reporting were found. PRO reporting completeness in RCTs focused on EMDs was inadequate. We urge EMD researchers to prioritize complete PRO reporting to foster patient-centered research for future RCTs on EMDs.

An Evaluation of Spin in the Abstracts of Systematic Reviews and Meta-analyses on the Treatment of Psoriasis: A Cross-sectional Analysis.

Spin is a way of reporting that distorts the true findings; we sought to investigate the prevalence of spin in systematic review abstracts on psoriasis treatments and whether study characteristics were associated with spin. We searched MEDLINE and Embase to obtain our sample. Screening and data extraction were performed in a masked duplicate fashion. Each included study was evaluated for the 9 most severe types of spin and other study characteristics. The methodological quality was assessed to explore potential relationships between spin and study quality. Search queries returned 3200 articles, which included 173 systematic reviews. Spin was present in systematic review abstracts. Preventing spin is essential for improving future systematic reviews.

Evaluating the underreporting of patient-reported outcomes in carpal tunnel syndrome randomized controlled trials.

CONTEXT: In recent years, patient-centered healthcare has become a primary concern for researchers and healthcare professionals. When included in randomized controlled trials (RCTs), patient-reported outcome (PRO) measures serve a critical role in supplementing efficacy outcomes with a patient perspective. OBJECTIVES: The goals of this study are to evaluate the reporting completeness of PROs within literature concerning carpal tunnel syndrome (CTS) utilizing the Consolidated Standards of Reporting Trials Patient-Reported Outcomes (CONSORT-PRO) extension. METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for published RCTs relating to CTS with at least one PRO measure from 2006 to 2020. Two investigators screened all RCTs for inclusion utilizing Rayyan (https://rayyan.qcri.org/), a systematic review screening platform. In an independent, masked fashion, investigators then evaluated all RCTs utilizing the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Bivariate regression analyses were utilized to assess relationships between trial characteristics and completeness of reporting. RESULTS: Our search returned 374 publications, yet only 31 unique RCTs met the inclusion criteria. The mean overall percent of adherence for CONSORT-PRO was 41%. Our secondary outcome-assessing study characteristics-indicated significantly higher completeness of reporting in the absence of a conflict of interest statement (p<0.05), 'some concerns' for bias (p<0.005), and when journals required the use of the CONSORT statement (p<0.005). The RoB assessment determined overall suspicion for bias among included RCTs, with 35% (n=11/31) being labeled as 'high,' 58% (n=18/31) as 'some concerns,' and 7% (n=2/31) as 'low.' CONCLUSIONS: Our study indicated that the completeness of CONSORT-PRO reporting was deficient within CTS trials. Because of the importance placed on PROs in clinical practice, we recommend adherence to CONSORT-PRO prior to publication of RCTs to increase the understanding of various interventions on patients' quality of life (QoL).

Reporting of patient-reported outcomes in trials on alcohol use disorder: a meta-epidemiological study.

OBJECTIVES: Currently, limited research exists to assess the extent of patient-reported outcome (PRO) reporting among randomised controlled trials (RCTs) evaluating alcohol use disorder (AUD). We sought to investigate the completeness of reporting of PROs using the Consolidated Standards of Reporting Trials-PRO (CONSORT-PRO) extension in AUD RCTs. DESIGN SETTING: Meta-epidemiological study. METHODS: We searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) on 29 June 2021 for published RCTs focused on AUD. Following these searches, title and abstract screening, and full-text screening were performed by two investigators. To be included, a study must have employed a randomised trial design, published in English, focused on treatment of AUD and included at least one PRO. Trials meeting inclusion criteria were evaluated for completeness of reporting using the CONSORT-PRO extension adaptation. These trials were also evaluated for risk of bias (RoB) using the Cochrane RoB V.2.0 tool. Additionally, an exploratory analysis of each RCT's therapeutic area was extracted using the Mapi Research Trust's ePROVIDE platform. Screening and data collection were all performed in masked, duplicate fashion. MAIN OUTCOME MEASURES: PRO completeness of reporting, identification of factors associated with completeness of reporting and PRO measures used in RCTs to evaluate patients with AUD. RESULTS: Nineteen RCTs were evaluated in our analysis. Our primary outcome, the mean completion score for CONSORT-PRO, was 40.8%. Our secondary outcome-the identification of factors associated with completeness of reporting-found that trials published after 2014 (ie, 1 year after the publication of the CONSORT-PRO extension) were 15.0% more complete than trials published before 2014. We found no additional associations with better reporting. CONCLUSIONS: We found that the completeness of PRO reporting in RCTs involving AUD was deficient. Complete reporting of PROs is instrumental in understanding the effects of interventions, encourages patient participation in their treatment and may increase clinician confidence in the value of PROs. High quality treatment strategies for AUD require properly reported PROs.

Evaluating reporting of patient-reported outcomes in randomized controlled trials regarding inflammatory bowel disease: a methodological study.

Patient-reported outcomes (PROs) in randomized controlled trials pertaining to inflammatory bowel disease are important in identifying patients' perspective of treatment. Incompletely reported PROs within trials could misrepresent information for clinicians and may contribute to treatment which lacks accommodation of patient input. Our study evaluates completeness of reporting of PROs and risk of bias (RoB) to identify how well trialists are adhering to known resources for trials. We used MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify eligible trials from 2006 to 2020 with at least 1 PRO measure related to inflammatory bowel disease. The trials were screened in duplicate using Rayyan. We then compared trial completion of reporting to the Consolidated Standards of Reporting Trials (CONSORT)-PRO adaptation, and assessed RoB using the Cochrane Collaboration RoB 2.0 tool. To measure trial and reporting characteristics, we performed bivariate regression analyses. Among a sample of 29 trials, the mean completion percentage for CONSORT-PRO was 46.77%. We found PROs as a secondary outcome had significantly lower CONSORT-PRO reporting (p<0.05). In addition, per cent completeness of reporting was significantly higher with both a 'therapy' intervention, and trials published following the development of CONSORT-PRO (p<0.05). Incomplete PRO reporting is common in trials focused on inflammatory bowel disease. This suboptimal reporting indicates the need for adherence to reporting guidelines. Trialists should use the CONSORT-PRO checklist, as endorsed by Patient-Reported Outcomes Tools: Engaging Users and Stakeholders, to assess their studies in order to enhance reporting adherence.

Evaluating reporting of patient-reported outcomes in peptic ulcer disease: a meta-epidemiological study of randomized controlled trials.

OBJECTIVES: Peptic ulcer disease (PUD) can significantly affect quality of life (QoL). These QoL outcomes are often patient-reported, and their inclusion in clinical trials supplements efficacy outcomes to provide the patients' perspective. This assese existing literature for completeness of PRO reporting across randomized controlled trials (RCTs) evaluating PUD. METHODS: This meta-epidemiological, cross-sectional study that assessed completeness of reporting among RCTs addressing management of PUD. We conducted a comprehensive literature search] to identify RCTs with a PRO as a primary or secondary outcome. These RCTs were assessed for completion of reporting according to the PRO adaptation of CONSORT checklist. RCTs were also assessed for Risk of Bias (RoB) using the Cochrane RoB 2.0 tool. RESULTS: Masked, duplicate screening of 829 results = yielded a final sample of 35 RCTs. The average completeness of reporting was 32.9% according to the CONSORT-PRO adaptation. Twenty-one (of 35; 60%) of the RCTs were assessed as having 'high' risk of bias and nine (of 35; 25.71%) were assessed as having 'some concerns' for risk of bias. Bivariate regression found completeness of reporting to be positively associated with increased PRO follow-up duration, sample size, and studies with conflicts of interest. CONCLUSION: RCTs examining the treatment and prevention of PUD with PROs as an outcome measure have deficient reporting and 'high' risk of bias according to the CONSORT-PRO and Cochrane RoB guidelines.

The evaluation of reporting of patient-reported outcomes in MDD: A meta-epidemiological study of clinical trials.

Major depressive disorder (MDD) is a multifaceted disease that profoundly affects quality of life. Patient reported outcomes (PROs) are used in randomized controlled trials (RCTs) to better understand patient perspectives on interventions. Therefore, we sought to assess the completeness of reporting PROs in RCTs addressing MDD. We identified RCTs evaluating MDD containing a PRO measure published between 2016 and 2020 from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Inclusion of studies was performed in duplicate. The completion of reporting of RCTs was assessed using the Consolidated Standards of Reporting Trials (CONSORT-PRO) adaptation. Bivariate regression analyses were used to evaluate reporting completeness and trial characteristics. A total of 49 RCTs were included in our analysis, with a mean CONSORT-PRO completion score of 56.7% (SD = 17.3).Our findings show a significant association with completeness of reporting and the following: secondary PRO trials were less completely reported as compared to primary PRO trials (t = -3.19, p = .003); studies with a follow-up period between six months and year were more completely reported as compared to three months or less (6 months to a year, t = 2.34, p = .024); and increased trial sample size was associated with more completeness of reporting (t = 3.17, p = .003). As compared to brain stimulation, the intervention types classified as combination, other, and psychotherapy had greater completeness of reporting (combination, t = 2.35, p = .024; other, t = 3.13, p = .003; psychotherapy, t = 3.41, p = .001). There were no other significant findings. Our study found the completeness of PRO reporting to be inconsistent in RCTs regarding MDD. Moreover, we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with MDD and facilitate training on the application of PRO data.

Incomplete reporting of patient-reported outcomes in multiple sclerosis: A meta-epidemiological study of randomized controlled trials.

BACKGROUND: Multiple Sclerosis significantly affects quality of life, which is often measured by patient-reported outcomes. The incorporation of patient-reported outcomes within clinical trials supplements the efficacy of outcomes in order to provide a patient's perspective for clinicians. Our objective was to evaluate current literature for completeness of reporting of PROs in randomized controlled trials (RCTs) for the management of MS. METHODS: We used MEDLINE, Embase, and Cochrane Central Register of Controlled Trials to search for RCT publications investigating the management of MS. After duplicate screening via Rayyan, RCTs fitting our inclusion criteria were abstracted employing the Consolidated Standards of Reporting Trials - Patient-Reported Outcome (CONSORT-PRO) adaptation and the Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Mean percent completion of an adaptation of CONSORT-PRO was calculated to address completeness of reporting. In addition, bivariate regression models were used to evaluate relationships between trial characteristics and completeness of reporting. RESULTS: Our search returned 3,966 results and 92 RCTs were included for data abstraction and analysis. We found an overall completion of 48.68% (SD=19.03). Sixty-five (of 92; 70.65%) of the RCTs were evaluated as having 'high' RoB. There were significant associations between completeness of reporting and the following: mention of CONSORT within published RCTs (t=2.55, p=.013), length of PRO follow-up (t=2.9, p=.005; t=2.14, p=.035), and sample size (t=3.12, p=.002). No other significant associations were found. CONCLUSION: Our study found incomplete adherence to the CONSORT-PRO adaptation among RCTs pertaining to MS. Of the most underreported items, the failure to report a hypothesis and define an approach to missing data threaten the validity of the evidence acquired from RCTs. Furthermore, PROs provide an opportunity to supplement trial outcomes with the patient's perspective. Thus, trialists of future RCTs may improve PRO reporting with increased adherence to the CONSORT-PRO adaptation.

Association between author conflicts of interest and industry-sponsorship with the favorability of outcomes of systematic reviews focusing on treatments of erectile dysfunction.

BACKGROUND: Authors' conflicts of interest and industry sponsorship have been shown to influence study outcomes. OBJECTIVE: We aimed to determine whether author conflicts of interest and industry sponsorship influenced the nature of results and conclusions of systematic reviews focusing on treatment interventions for erectile dysfunction. MATERIALS AND METHODS: We searched PubMed and Embase for systematic reviews and meta-analyses focusing on erectile dysfunction treatments published between September 1, 2016, and June 2, 2020. Authors' conflicts of interest were collected from the systematic reviews' disclosure statements. These disclosures were verified using the information provided by the Open Payments, Dollars for Profs, Google Patents, and US Patent and Trademark Office databases and from previously published disclosure statements. RESULTS: Our study included 24 systematic reviews authored by 138 authors. Nineteen authors (13.8%) were found to have conflicts of interest (disclosed, undisclosed, or both). No authors completely disclosed all conflicts. Nine reviews (37.5%) contained at least one author with conflicts of interest; of which eight reported narrative results favoring the treatment group, and seven reported conclusions favoring the treatment group. Of the 15 (62.5%) reviews without a conflicted author, 11 reported results favoring the treatment group, and 12 reported conclusions favoring the treatment group. DISCUSSION: The results and conclusions of systematic reviews for erectile dysfunction treatments did not appear to be influenced by authors who reported conflicts of interest. However, our search algorithm relied on the US-based Open Payments database and a large percentage of reviews in our study were produced by authors with international affiliations. Our study results underscore the difficulties in conducting such analyses. CONCLUSION: Although we found that undisclosed conflicts of interest (COI) were problematic among systematic reviews of erectile dysfunction treatment, only 14% of authors in our sample possessed them and these COI did not appear to influence the favorability of systematic review outcomes.

Financial Conflicts of Interest Among Systematic Review Authors Investigating Interventions for Achilles Tendon Ruptures.

BACKGROUND: The primary aim of our study was to evaluate the effects of undisclosed financial conflicts of interest in Achilles tendon rupture repair-focused systematic reviews. METHODS: Following a cross-sectional study design, we searched MEDLINE and Embase for Achilles tendon rupture repair systematic reviews. We performed screening and data extraction in a blind, triplicate fashion. Each systematic review was evaluated on the individual characteristics of the study, presence of undisclosed and disclosed conflicts of interest, favorability of results and conclusions, and the relationship between conflicts of interest and the favorability of results and conclusions. RESULTS: Our search produced 172 total systematic reviews pertaining to Achilles tendon rupture repair; of those, only 12 were included in our study. Undisclosed conflicts of interest were found in half (6/12) of the included reviews. However, no significant association was found between conflict of interest and the favorability of results and conclusions. CONCLUSION: Undisclosed conflicts of interests were discovered in a large percentage of our sample. This lack of disclosure did not appear to increase the likelihood of the systematic review results or conclusions reporting favorability of the intervention being investigated. LEVEL OF EVIDENCE: Level II.