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.

Evaluation of spin in the abstracts of systematic reviews and meta-analyses relating to postoperative nausea and vomiting.

INTRODUCTION: Spin - the beautification of study results to emphasise benefits or minimise harms - is a deceptive reporting strategy with the potential to affect clinical decision-making adversely. Few studies have investigated the extent of spin in systematic reviews. Here, we sought to address this gap by evaluating the presence of the nine most severe forms of spin in the abstracts of systematic reviews on treatments for postoperative nausea and vomiting (PONV). PONV has the potential to increase hospital costs and patient burden, adversely affecting outcomes. METHODS: We developed search strategies for MEDLINE and Embase to identify systematic reviews focused on PONV. Following title and abstract screening of the reviews identified during the initial search, those that met inclusion criteria were evaluated for the presence of spin and received a revised AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews) appraisal by two investigators in a masked, duplicate manner. Study characteristics for each review were also extracted in duplicate. RESULTS: Our systematic search returned 3513 studies, of which 130 systematic reviews and meta-analyses were eligible for data extraction. We found that 29.2% of included systematic reviews contained spin (38/130). Eight of the nine types of spin were identified, with spin type 3 ('selective reporting of or overemphasis on efficacy outcomes or analysis favouring the beneficial effect of the experimental intervention') being the most common. Associations were found between spin and funding source. Spin was more likely in the abstracts of privately funded than nonfunded studies, odds ratio (OR) 2.81 [95% confidence interval (CI), 0.66 to 11.98]. In the abstracts of studies not mentioning funding spin was also more likely than in nonfunded studies, OR 2.30 (95% CI, 0.61 to 8.70). Neither of these results were statistically significant. Significance was found in the association between the presence of spin and AMSTAR-2 ratings: 'low' quality studies were less likely to contain spin than 'high' quality, OR 0.24 (95% CI, 0.07 to 0.88): 'critically low' studies were also less likely to contain spin than 'high' quality studies, OR 0.21 (95% CI, 0.07 to 0.65). There were no other associations between spin and the remaining extracted study characteristics or AMSTAR-2 ratings. CONCLUSION: Spin was present in greater than 29% of abstracts of systematic reviews and meta-analyses regarding PONV. Various stakeholders must take steps to improve the reporting quality of abstracts on PONV.

Sickle Cell Disease and Quality of Life: An Evaluation of Reporting of Patient-Reported Outcomes in Randomized Controlled Trials.

Sickle cell disease significantly impacts one's quality of life (QOL); thus, randomized controlled trials (RCTs) have integrated patient-reported outcomes (PROs) to assess patients' health from their perspective. We aim to evaluate the completeness of reporting of PROs included in sickle cell disease RCTs. We searched MEDLINE, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) for published sickle cell disease RCTs with at least one PRO measure from 2006 to 2021. In a masked, duplicate fashion, two investigators evaluated RCTs using the Consolidated Standards of Reporting in Trials (CONSORT)-PRO adaptation and Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. The primary objective was mean percent completeness of the CONSORT-PRO adaptation. Additional relationships between trial characteristics and completeness of reporting were evaluated. Mean completeness of reporting of RCTs was 41.49% (SD = 20.90). Randomized controlled trials with primary outcomes were more complete (57.50%, SD = 8.33) than RCTs with secondary PROs (33.48%, SD = 20.91). We did not find a significant difference in completion between trials with primary PROs and secondary PROs (t1 = 2.07; p = 0.06). Our secondary objectives included factors that may be associated with completeness of PRO reporting. Of the 12 included studies, five were considered to be overall 'high' RoB (41.67%). In each of the five domains, the majority of studies received 'low' RoB evaluations. Incomplete PRO reporting was common within sickle cell RCTs. Therefore, we recommend future RCTs including PROs should take measures to increase completeness of reporting.

Superlatives in news articles reporting non-FDA approved indications for use of cannabis and cannabis products with a focus on psychiatric disorders: a cross-sectional analysis.

The exaggerated language used in news articles to describe the benefits of cannabis for conditions without FDA indications may mislead the public and healthcare providers. Thus, this study's objective was to investigate the use of exaggerated language in news articles focused on cannabis and cannabis-derived products. Using a cross-sectional study design, we searched Google News from March 3, 2020, and September 3, 2019 for 11 prespecified superlative terms along with the search terms "cannabis," "cannabidiol," "pot," "marijuana," "weed," and "CBD." Articles were evaluated for these exaggerative terms describing cannabis and cannabis-derived products along with additional news article characteristics. Screening and data extraction occurred in a masked, duplicate fashion. We identified 612 superlative terms in 374 different news articles focused on cannabis and cannabis-derived products from 262 news outlets. Only 26 (of 374, 7.0%) news articles provided clinical data. In total, superlative terms were used to describe cannabis and cannabis-derived products for the treatment of 91 medical conditions, of which only 2 are FDA approved. The most common psychiatric disorder indicated was anxiety disorder appearing in 88 news articles. Superlatives in news articles covering the treatment of psychiatric illnesses with cannabis and cannabis-derived products are common.

Spin Infrequently Occurs in Abstracts of Systematic Reviews For The Pharmacological Treatment of Type 2 Diabetes Mellitus.

AIMS: Currently, there is a growing body of research demonstrating that spin - the misinterpretation and distortion of a study's findings - is common in different fields of medicine. To our knowledge, no study has investigated its presence in systematic reviews focused on diabetic therapies. METHODS: We performed a cross-sectional study by searching MEDLINE and Embase for systematic reviews focused on pharmacologic treatments for type 2 diabetes mellitus. Our search retrieved 26,490 records, from which 199 studies were extracted in a masked, duplicate fashion. Each study was evaluated for the nine most severe types of spin and other study design parameters. Spin was presented as frequencies and odds ratios to identify associations between study characteristics. RESULTS: Spin was identified in the abstracts of 15 systematic reviews (15/199, 7.5%). Spin type 5 was the most common type identified (7/199, 3.5%). Spin types 1, 2, 4, and 8 were not identified. In the last 5 years (2016-2021), 7 systematic reviews contained spin within their abstract. There was no association between spins presence and any extracted study characteristic . CONCLUSIONS: Our findings show that spin infrequently occurs in abstracts of systematic reviews focused on pharmacologic therapies for type 2 diabetes mellitus. However, any amount of spin can lead to the distortion of a reader's interpretation of the study's findings. Thus, we provide recommendations with rationale to prevent spin in future systematic reviews.

Methodological quality of systematic reviews comprising clinical practice guidelines for cardiovascular risk assessment and management for noncardiac surgery.

BACKGROUND: Cardiac assessment in noncardiac surgery clinical practice guidelines should be supported by the highest-quality evidence such as that offered by systematic reviews. Currently, the methodological and reporting quality of these studies remains unknown. METHODS: We used PubMed to search for all clinical practice guidelines related to perioperative cardiovascular patients undergoing noncardiac surgery from 2010 to 2021. The included clinical practice guidelines were analysed for all systematic reviews and meta-analyses. The primary objective of this study was to determine reporting and methodological quality using the PRISMA (Preferred Reporting Instrument for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews-2) instruments. Our secondary objective was to compare systematic reviews conducted by the Cochrane Collaboration with non-Cochrane studies. RESULTS: Three clinical practice guidelines were included in our study. Within these, 78 systematic reviews were included. PRISMA completion ranged from 34.8% to 100.0% with a mean of 76.9%. AMSTAR-2 completion ranged from 15.6% to 96.9% with a mean of 58.0%. Fifty-four systematic reviews underpinned a clinical practice guidelines recommendation, of which 25 were rated 'critically low' by AMSTAR-2 appraisal. Cochrane systematic reviews typically performed better than non-Cochrane studies, but were a minority of the included studies (10/78). CONCLUSION: We found deficiencies in several key areas regarding the methodological and reporting qualities of systematic reviews included in cardiac assessment in noncardiac surgery clinical practice guidelines. As these clinical practice guidelines are instrumental to clinical decision-making and patient care in cardiac assessment in noncardiac surgery, we advocate for improved reporting quality among systematic reviews cited as supportive evidence for these recommendations.

Evaluation of Spin in the Abstracts of Systematic Reviews and Meta-Analyses of Atopic Dermatitis Treatments and Interventions.

BACKGROUND: Spin - the misrepresentation of a study's results - has been identified in abstracts of studies focused on a variety of disorders from multiple fields of medicine. OBJECTIVES: This study's primary objective was to evaluate the abstracts of systematic reviews and meta-analyses focused on the treatment of atopic dermatitis for the nine most severe forms of spin. METHODS: We systematically searched Embase and MEDLINE for systematic reviews of atopic dermatitis therapies. Screening and data extraction occurred in a masked, duplicate fashion. Each included study was evaluated for the nine most severe types of spin and other study characteristics. RESULTS: Our searches retrieved 2,456 studies, of which 113 were included for data extraction. Spin was found in 74.3% of our included studies (84/113). Spin type 6 occurred most frequently (68/113, 60.2%). Spin types 1, 2, and 9 were not identified. All industry-funded systematic reviews contained spin in their abstract. The presence of spin was not associated with any specific study characteristics, including the methodological quality of the study. CONCLUSIONS: Severe forms of spin were found in the majority of abstracts for systematic reviews of atopic dermatitis treatments. Steps should be taken to prevent spin to improve the quality of reporting in abstracts.

Over 30% of Systematic Reviews and Meta-analyses Focused on Rotator Cuff Tear Treatments Contained Spin in the Abstract.

PURPOSE: The purpose of this study is to determine the prevalence of spin in the abstracts of systematic reviews and meta-analyses on treatments for rotator cuff tears and whether various study and publishing journal characteristics were associated with the presence of spin. METHODS: A search strategy was developed for Ovid MEDLINE and Ovid Embase to retrieve systematic reviews focused on treatments for rotator cuff tears. For an article to be included, it must meet the following criteria: (1) the article must be a systematic review with or without a meta-analysis, (2) the article must pertain to the treatment of rotator cuff tears, (3) the article must only contain human subjects, and (4) the article must be accessible in English. Systematic reviews were analyzed for spin using a previously developed classification scheme in a masked, duplicate manner. Binary logistic regression was used to examine independent associations via unadjusted odds ratios and 95% confidence intervals between the presence of spin and study characteristics. RESULTS: Search queries returned 932 articles, of which 121 systematic reviews and meta-analyses were eligible. A total of 36.4% (44/121) of systematic reviews contained spin. Among the general characteristics evaluated, there were no correlations with spin. CONCLUSIONS: Spin was present in more than one-third of systematic reviews and meta-analyses covering rotator cuff tear treatments. Spin was not associated with any general study or journal characteristics, which indicates that clinicians must be aware of the potential presence of spin in all such abstracts. CLINICAL RELEVANCE: Clinicians rely on systematic reviews and meta-analyses, especially abstracts of these articles, to provide succinct guidance on best practices in patient care. The presence of spin could adversely affect patient care; thus, steps should be taken to improve the reporting quality of abstracts on rotator cuff tear treatment.

Evaluation of spin in the abstracts of systematic reviews and meta-analyses focused on treatments of alcohol use disorder.

Background: With 14.4 million U.S. adults diagnosed with alcohol use disorder (AUD) annually, effective treatments for combatting this condition are essential. Clinicians are often guided by systematic reviews and meta-analyses - considered the gold standard of research. Spin, a biased way of reporting results, may lead to misinterpretation of research findings, resulting in suboptimal patient care.Objective: Our primary objective was to investigate the presence of spin in the abstracts of systematic reviews of AUD treatments.Methods: After systematically searching MEDLINE and Embase for systematic reviews of AUD treatments, abstracts were evaluated for the nine most severe types of spin. Additional article characteristics were concurrently extracted and study quality was evaluated. Descriptive statistics of spin were calculated and associations between spin and study characteristics were determined through Fisher's exact and logistic regression.Results: Among 79 included systematic reviews, 44 instances of spin were identified spanning 43% of our sample (34/79). Of the nine forms of spin, eight were found with a majority of instances being "selective reporting of or overemphasis on efficacy outcomes" (13/44, 29.5% of cases). The majority of articles were rated as critically low quality (51/79, 64.6%). No association was found between the presence of spin and extracted study characteristics.Conclusions: Spin was found in more than 40% of systematic review abstracts that evaluated pharmacotherapies in the treatment of AUD. Coupled with the finding that the majority of systematic reviews on the subject were of low quality, increased awareness of spin among physicians may be warranted.

Evaluation of spin in the abstracts of systematic reviews and meta-analyses of studies on opioid use disorder.

BACKGROUND: Spin, or the inappropriate formatting of information to emphasize certain outcomes, should not be present in research. This study focuses on identifying and characterizing the presence of spin in systematic review and meta-analysis abstracts that focus on the treatment of opioid use disorder. Methods: Search strategies were developed to identify studies pertaining to the treatment of opioid use disorder. The studies were then screened by two authors. These qualifying studies were then evaluated for the presence of spin within their abstracts by two trained authors. These studies were also evaluated by the AMSTAR-2 standards to evaluate the quality of the qualifying systematic reviews by two trained reviewers. Results: The sample in this study included 113 systematic reviews and meta-analyses. Spin was present in 20 of these studies (20/113, 17.7%). The most common spin form was spin type 3 (6/20, 30%), followed by types 5 and 9 (both 4/20, 20%), type 6 (3/20, 15%), type 7 (2/20, 10%), and type 8 (1/20, 5%). The remaining spin types 1, 2, and 4 were not present in the sample. Of the 113 included studies, the most common intervention type was pharmacologic (93/113, 82%). No significant association was found between the quality of a systematic review and the presence of spin. Conclusions: Findings in this study show positive trends in prevalence of five forms of spin evaluated in abstracts of systematic reviews and meta-analyses looking at treatments for opioid use disorder. However, study quality had no significant association with the presence of spin. Misrepresentation of results, or spin, may alter a clinician's perceptions about treatment efficacies. Therefore, increasing physician awareness of spin may improve clinical decision-making.

Evaluating spin in the abstracts of systematic reviews and meta-analyses on cannabis use disorder.

BACKGROUND: Clinicians rely upon abstracts to provide them quick synopses of research findings that may apply to their practice. Spin can exist within these abstracts that distorts or misrepresents the findings. Our goal was to evaluate the level of spin within systematic reviews (SRs) focused on the treatment of cannabis use disorder (CUD). Methods: A systematic search was conducted in May 2020. To meet inclusion criteria, publications had to be either an SR or meta-analysis related to the treatment of cannabis use. Screening and data extraction was performed in a duplicate and masked fashion. Study quality was assessed using AMSTAR-2 Results: 16/24 SRs (66.7%) contained at least one form of spin in the abstract. The most common forms of spin identified were type 3-selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention (45.8%)-and type 8-the review's findings from a surrogate marker or a specific outcome to the global improvement of the disease (37.5%). No significant association between spin and intervention type, PRISMA requirements, or funding source was identified. Weak positive correlations were found between the presence of spin and abstract word count (r =.217) and between spin and AMSTAR-2 rating (r = 0.143). "Moderate" was the most common AMSTAR-2 rating (9/24, 37.5%), followed by "low" (7/24, 29.2%) and "critically low" (7/24, 29.2%). One systematic review received an AMSTAR-2 rating of "high" (1/24, 4.2%). Conclusions: Spin was common among abstracts from the SRs focused on the treatments for CUD. Higher quality studies may help reduce the overall rate as well as standardizing treatment outcomes. To facilitate this, we encourage all authors, peer-reviewers, and editors to be more aware of the various types of spin as they can help reduce the overall amount of spin seen within the literature.

Evaluation of spin in the abstracts of systematic reviews and meta-analyses related to the treatment of proximal humerus fractures.

BACKGROUND: Research has shown that many physicians rely solely on abstracts to make clinical decisions. However, many abstracts have been shown to be misleading. The primary objective of this study was to identify the prevalence of spin - bias towards particular results - within the abstracts of systematic reviews and meta-analyses pertaining to the treatment of proximal humerus fractures, one of the most common osteoporotic fractures among elderly patients. METHODS: We systematically searched MEDLINE and Embase databases to identify systematic reviews and meta-analyses examining the treatment of proximal humerus fractures. Screening and data extraction occurred in a masked, duplicate fashion. The nine most severe types of spin that occur within abstracts were extracted along with study characteristics, including journal recommendations to adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and year in which the review was performed, to identify potential associations. We subsequently explored the association between spin and the methodological quality of a systematic review using the revised A MeaSurement Tool to Assess systematic Reviews (AMSTAR 2) appraisal instrument. RESULTS: Our search retrieved 505 articles, of which 73 systematic reviews met inclusion criteria. We found that 34.2% (25/73) of the included systematic reviews contained spin. Spin type 3 (selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention) was the most common type identified (12/73, 16.4%). Three spin types were not identified in any of the abstracts. Spin was 3.2 (OR 3.2; 95% CI, 1.02-10.02) times more likely to be present in systematic reviews published in journals recommending adherence to PRISMA. Furthermore, the odds of an abstract containing spin was 1.25 (OR 1.25; 95% CI, 1.02-1.52) times more likely to be present in systematic reviews for each year after 2000. No other study characteristics were associated with spin. The methodological quality of 24 studies were rated as "critically low" (32.9%), 14 were "low" (19.2%), 28 were "moderate" (38.4%), and 7 were "high" (9.6%), but these findings were not associated with spin. CONCLUSION: Spin was present in systematic review abstracts regarding treatment of proximal humerus fractures. Measures such as education on the subject of spin and improved reporting standards should be implemented to increase awareness and reduce incidence of spin in abstracts. LEVEL OF EVIDENCE OF THE STUDY PERFORMED: Basic Science Study; Research Methodology.

Assessing the Reporting of Harms in Systematic Reviews Focused on the Therapeutic and Cosmetic Uses of Botulinum Toxin.

BACKGROUND AND OBJECTIVE: The expanding use of botulinum toxin (BoNT) in medical practice demonstrates the need to highlight whether there is adequate information regarding its safety profile. The aim of our study was to identify completeness of harms reporting for BoNT treatment within systematic reviews (SRs), assess quality of SRs using the AMSTAR-2 tool, and determine the degree of overlap among primary studies within each SR. METHODS: On May 31, 2022, we searched Embase, Epistemonikos, MEDLINE, and the Cochrane Database of Systematic Reviews for SRs on BoNT therapy. Screening and data extraction were performed in a masked, duplicate fashion. AMSTAR-2 was used to evaluate the methodological quality of included SRs. Corrected covered area (CCA) was calculated for SR dyads. RESULTS: Of the 90 included SRs, we found that 70 completed less than 50% of harms items. The most reported items were BoNT as a favorable intervention (73/90, 81.1%) and harms as a primary outcome (72/90, 80.0%). The least reported items were grades and severity scales used to classify harms (8/90, 8.9%) and number of treatment discontinuations in each arm (10/90, 11.1%). Eighty-three SRs were rated "critically low" (83/90, 92.2%), while 5 SRs were rated "high" (5/90, 5.6%) via AMSTAR-2 tool. Significant associations were found between completion of harms reporting and: (1) a "critically low" appraisal on AMSTAR-2 tool (p = 0.0060) and (2) whether harms was reported as a primary outcome (p = 0.0001). The total CCA overlap was determined to be 0.8%. CONCLUSION: Our results demonstrate that harms are underreported within BoNT SRs. Because healthcare professionals often refer to SRs to guide clinical decision making, it is important to continue to explore shortcomings among BoNT literature in future studies.

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 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).

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 Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials.

BACKGROUND: Stress urinary incontinence (SUI) significantly reduces women's quality of life (QoL). Use of patient-reported outcomes (PROs) is increasing in randomized controlled trials (RCTs), thus standardization is important to ensure reporting completeness. We aim to evaluate completeness of reporting of RCTs for surgical management of SUI in women based on an adaptation of the Consolidated Standards of Reporting Trials statement with PRO extension (CONSORT-PRO). STUDY DESIGN: A literature search was conducted and all RCTs meeting inclusion criteria were evaluated using the CONSORT-PRO adapted checklist and the Cochrane Collaboration risk of bias assessment tool (RoB). We calculated a completion percentage score for each trial's adherence to the CONSORT-PRO adapted checklist and used bivariate regression analysis to examine associations between trial characteristics and completion percentage scores. RESULTS: Forty-three RCTs underwent data extraction and analysis. Mean completion percentage of the CONSORT-PRO was 50.53% (SD = 15.63). A total of 38 (of 43; 88.37%) RCTs received an RoB 2.0 rating of "some concern." RCTs with follow-up longer than 3 months had statistically significantly higher CONSORT-PRO completion: 3-6 months (p = .049), 6-12 months (p = .009), more than 12 months (p = .021). Compared with studies without a conflict of interest statement, studies reporting a conflict of interest (p < .001) or reporting no conflict of interest (p = .048) had higher reporting completeness. CONCLUSIONS: Our results suggest many RCTs addressing surgical management of SUI in women have poor adherence to CONSORT-PRO reporting guidelines. Improving reporting completeness through adherence to the CONSORT-PRO checklist can better inform clinical decision making and improve QoL.