The Reporting and Methodological Quality of Systematic Reviews Underpinning Clinical Practice Guidelines Focused on the Management of Cutaneous Melanoma: Cross-Sectional Analysis.

BACKGROUND: Clinical practice guidelines (CPGs) inform evidence-based decision-making in the clinical setting; however, systematic reviews (SRs) that inform these CPGs may vary in terms of reporting and methodological quality, which affects confidence in summary effect estimates. OBJECTIVE: Our objective was to appraise the methodological and reporting quality of the SRs used in CPGs for cutaneous melanoma and evaluate differences in these outcomes between Cochrane and non-Cochrane reviews. METHODS: We conducted a cross-sectional analysis by searching PubMed for cutaneous melanoma guidelines published between January 1, 2015, and May 21, 2021. Next, we extracted SRs composing these guidelines and appraised their reporting and methodological rigor using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (A Measurement Tool to Assess Systematic Reviews) checklists. Lastly, we compared these outcomes between Cochrane and non-Cochrane SRs. All screening and data extraction occurred in a masked, duplicate fashion. RESULTS: Of the SRs appraised, the mean completion rate was 66.5% (SD 12.29%) for the PRISMA checklist and 44.5% (SD 21.05%) for AMSTAR. The majority of SRs (19/50, 53%) were of critically low methodological quality, with no SRs being appraised as high quality. There was a statistically significant association (P<.001) between AMSTAR and PRISMA checklists. Cochrane SRs had higher PRISMA mean completion rates and higher methodological quality than non-Cochrane SRs. CONCLUSIONS: SRs supporting CPGs focused on the management of cutaneous melanoma vary in reporting and methodological quality, with the majority of SRs being of low quality. Increasing adherence to PRISMA and AMSTAR checklists will likely increase the quality of SRs, thereby increasing the level of evidence supporting cutaneous melanoma CPGs.

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.

Obesity, stigma, and person-centered language: A serial cross-sectional analysis of scientific literature.

OBJECTIVE: Language can influence societal perceptions of medical conditions. The employment of person-centered language (PCL) in health care is reflected in many scientific publications; however, the extent of this adaptation in reference to obesity is unknown. METHODS: This cross-sectional analysis included a systematic search of PubMed obesity-related articles across four cohorts spanning January 2004 through December 2006; January 2008 through December 2010; January 2015 through December 2018; and January 2019 through May 2020, respectively. Approximately 1971 publications were screened and examined for prespecified, non-PCL terminology set forth by the American Medical Association Manual of Style and the International Committee of Medical Journal Editors, of which 991 were retained. Statistical analysis demonstrating PCL and non-PCL findings was then performed. Incidence rates and cohort classifications were reported. RESULTS: Of the 991 articles examined, it was found that 24.02% of publications adhered to PCL. Similar adherence was observed across obesity-specific, general medicine, and nutrition journals. PCL adherence increased over time. The most common non-PCL label was "obese," occurring in 75.48% of articles. CONCLUSIONS: This investigation showed that non-PCL in reference to obesity is widely evident in weight-focused journals despite recommendations for adherence to PCL guidelines. Continued use of non-PCL in reference to obesity in research may inadvertently perpetuate weight-based stigma and health disparities in future generations.

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 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).

Assessment of Spin in the Abstracts of Systematic Reviews and Meta-analyses on Platelet-Rich Plasma Treatment in Orthopaedics: A Cross-sectional Analysis.

Background: Systematic reviews on the use of platelet-rich plasma (PRP) in orthopaedic surgery are abundant in current published literature. However, a beautification of results (referred to as spin) has been noted in abstracts across various aspects of medicine. Purpose: To determine the prevalence of spin in systematic reviews of PRP-related orthopaedic surgery abstracts. Study Design: Cross-sectional study. Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Murad and Wang guidelines, we conducted a search in Medline, Embase, and the Cochrane Database for reviews on PRP-related orthopaedic surgery. The search included studies published from inception until June 30, 2021. Included were systematic reviews written in English that involved the use of PRP in the treatment of orthopaedic injuries in human participants. The abstracts of the included reviews were evaluated for the top 9 types of spin as described by Yavchitz et al in 2016. We determined the relationship between spin and study characteristics using odds ratios. Results: Of an initial 1560 studies, 176 were included. We found that 50 studies (28.4%) contained at least 1 form of spin. The 2 most common forms of spin found in our sample were type 5 ("Conclusion claims the beneficial effect of treatment despite high risk of bias"; n = 27 [15.3%]) and type 3 ("Selective reporting or overemphasis of efficacy in outcomes favoring beneficial effect of intervention"; n = 18 [10.2%]). No statistical significance was found between study characteristics and the presence of spin. Conclusion: Spin was present in 28% of the systematic reviews that covered PRP-related orthopaedic treatments. Spin was not associated with general study characteristics, including adherence to PRISMA guidelines or funding. Journals and authors should be aware of spin in articles and avoid its usage.

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.

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.

Underreporting of patient-reported outcomes in cystic fibrosis randomized controlled trials using CONSORT-PRO and RoB 2.0.

BACKGROUND: Patient-reported outcomes (PROs) are increasingly used in randomized controlled trials (RCTs) to foster patient-centered healthcare. The aim of this investigation was to assess the completeness of reporting of PROs in RCTs pertaining to cystic fibrosis (CF). METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for RCTs concerning CF that included PROs as a primary or secondary outcome. The RCTs were assessed by 2 independent investigators using an adaptation of the Consolidated Standards of Reporting Trials for Patient-Reported Outcomes (CONSORT-PRO) and the Cochrane Risk of Bias (RoB) 2.0 assessment. We calculated the mean completion percentage of adherence to the CONSORT-PRO adaptation and used bivariate regression models to evaluate for associations with particular trial characteristics. RESULTS: Our systematic search returned 2302 potential studies. Fifty-nine eligible RCTs were included after full-text screening. The RCT mean completeness of reporting was 38.38% (SD = 12.74). We found the following associations between trial characteristics and completeness of PRO reporting: (1) significantly higher reporting completeness for RCTs published in journals requiring adherence to the CONSORT guideline (p-value = 0.049), (2) improved reporting completeness in studies with 'some concerns' of RoB versus 'high' RoB (p-value = 0.042), and (3) significantly better reporting completeness when the PRO is the primary outcome of a RCT (p-value = 0.006). CONCLUSION: Inadequate PRO reporting exists within RCTs focused on CF. Given that CF has substantial effects on quality of life, PROs are imperative to understand patients' experiences. We believe greater adherence to CONSORT-PRO will promote the standardization of PRO reporting and will facilitate comprehension of PROs by stakeholders, patients, and clinicians.

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.

Examining the Public's Most Frequently Asked Questions About Carpal Tunnel Syndrome and Appraising Online Information About Treatment.

BACKGROUND: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy. Patients often search online for health information regarding common musculoskeletal complaints. Thus, the purpose of this study was to use language processing information from Google to assess the content of CTS frequently asked questions (FAQs) searched online and the transparency and quality of online CTS information. METHODS: On March 11, 2021, we searched Google for 3 terms "carpal tunnel syndrome treatment," "carpal tunnel syndrome surgical treatment," and "carpal tunnel syndrome non-surgical treatment" until a minimum of 100 FAQs and their answer links were extracted from each search. We used Rothwell classification to categorize the FAQs. The Journal of the American Medical Association's benchmark criteria were used to assess information transparency. Information quality was assessed using the Brief DISCERN tool. RESULTS: Our Google search returned 124 unique FAQs. Fifty-six (45.2%) were value based and most were related to the evaluation of treatment options (45/56, 80.4%). The most common source type was medical practices (26.6%). Nearly half of the answer sources (45.9%) were found to be lacking in transparency. One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores among the 5 source types, F(4, 119) = 5.93, P = .0002, with medical practices averaging the worst score (13.73/30). CONCLUSIONS: Patients are most commonly searching Google to gain information regarding CTS treatment options. Online sources such as medical practices should use widely accepted rubrics for ensuring transparency and quality prior to publishing CTS information.

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.

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 presence of spin in systematic reviews focused on diabetic neuropathy: A cross-sectional analysis.

BACKGROUND: Spin-the misrepresentation of a study's actual results-has the potential to alter a clinician's interpretation of the study's findings and therefore could affect patient care. Studies have shown spin frequently occurs in abstracts of systematic reviews from a variety of other medical disorders and specialties. AIMS: Our primary aim was to evaluate whether the nine most severe types of spin occurred in systematic review abstracts' concerning diabetic neuropathy treatments. Secondly, we aimed to determine whether spin presence was associated with the methodological quality of a systematic review. METHODS: A search of MEDLINE and Embase collected 1297 articles focused on diabetic neuropathy treatments, of which we included 114 systematic reviews for spin assessment. Each included study was evaluated for the nine most severe types of spin as defined by Yachitz et al. The methodological quality of a systematic review was determined by using the AMSTAR-2 instrument. All screening and data extraction were conducted in a masked, duplicate fashion. Since the final sample size of 114 was not sufficiently powered to do multivariable logistic regression, we calculated unadjusted odds ratios which evaluated relationships between spin presence within abstracts and study characteristics. RESULTS: From the 114 articles reviewed, spin was present in 7.9% of the studies (9/114), with spin type 5: "conclusion claims the beneficial effect of the experimental treatment despite the high risk of bias in the included primary studies" as the most frequent in our study. Spin types 1, 2, 6, and 8 were not identified. No association was observed between the study characteristics and spin presence, including the methodological quality of a systematic review. CONCLUSIONS: Overall, spin is infrequently observed in abstracts of systematic reviews covering diabetic neuropathy treatments. When comparing our results to other fields of medicine, the field of diabetic neuropathy research publishes systematic reviews whose abstracts mostly portray the findings of the review's full-text to reflect the results adequately.

Spin within systematic review abstracts on antiplatelet therapies after acute coronary syndrome: a cross-sectional study.

OBJECTIVES: Spin is a reporting practice in which study results are misrepresented by overestimating efficacy or underestimating harm. Prevalence of spin varies between clinical specialties, and estimates are based almost entirely on clinical trials. Little is known about spin in systematic reviews. DESIGN: We performed a cross-sectional analysis searching MEDLINE and Embase for systematic reviews and meta-analyses pertaining to antiplatelet therapies following acute coronary syndrome on 2 June 2020. Data were extracted evaluating the presence of spin and study characteristics, including methodological quality as rated by A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2). All data extraction was conducted in a masked, duplicate manner from 2 June 2020 to 26 June 2020. PARTICIPANTS AND SETTING: Not applicable. PRIMARY AND SECONDARY OUTCOME MEASURES: We assessed abstracts of systematic reviews on antiplatelet therapy following acute coronary syndrome and evaluated the prevalence of the nine most severe types of spin. We additionally explored associations between spin and certain study characteristics, including quality. RESULTS: Our searches returned 15 263 articles, and 185 systematic reviews met inclusion criteria. Of these 185 reviews, 31.9% (59/185) contained some form of spin in the abstract. Seven forms of spin (1, 2, 3, 4, 5, 7 and 9) among the nine most severe were identified. No instances of types 6 or 8 were found. There were no statistically significant relationships between spin and the evaluated study characteristics or AMSTAR-2 appraisals. CONCLUSIONS: Spin was present in abstracts for systematic reviews and meta-analyses; subsequent studies are needed to identify correlations between spin and specific study characteristics. There were no statistically significant associations between spin and study characteristics or AMSTAR-2 ratings; however, implementing changes will ensure that spin is reduced in the field of cardiology as well as other fields of medicine.

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.

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization.

Purpose: To evaluate the completeness of patient-reported outcomes (PROs) reporting using Consolidated Standards of Reporting Trials Patient-Reported Outcome (CONSORT-PRO) in randomized controlled trials (RCTs) involving rotator cuff injuries. Methods: We performed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on rotator cuff injuries that included at least one PRO measure. We included RCTs published from 2006 to 2020. Investigators extracted data from RCTs using the CONSORT-PRO and evaluated each RCT using the Cochrane Risk of Bias 2.0 tool. Our primary objective was to evaluate the mean completion percentage of CONSORT-PRO. Our secondary objective used bivariate regression analyses to explore the relationship between trial characteristics and completeness of reporting. Results: The initial search returned 467 results, with 33 published RCTs meeting the prespecified inclusion criteria. The mean CONSORT-PRO completeness across all included RCTs was 49.7% (standard deviation 15.43). An increase in sample size was associated with an increase in mean completeness of reporting (t = 2.31; P = .028). The Risk of Bias assessment found 29 (of 33, 87.88%) RCTs had "some concerns" for bias. We did not find any additional significant associations between completeness of reporting and trial characteristics. Conclusions: Randomized controlled trials involving rotator cuff injuries frequently use PRO measures as primary outcomes. Reporting of these PRO measures is suboptimal and may benefit from rigorous standardization. Clinical Relevance: PRO measures are increasingly incorporated as primary or secondary outcomes of RCTs. Appropriate reporting and use of state-of-the-art PRO measures may improve the dissemination of clinical knowledge from RCTs to guide treatment and determine intervention effectiveness. With increased adoption of Patient-Reported Outcome Measure Information System and adherence to CONSORT-PRO, orthopaedic literature may improve PRO reporting to optimize the interpretability of PROs and facilitate patient-centered care.

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.

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.

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.