Reporting of Harms in Randomized Controlled Trials Published in Urology Journals: An Updated Analysis.

PURPOSE: Harms are often overlooked, but important, outcomes of randomized controlled trial reporting. Our goal was to determine if harms reporting has improved in high-impact urology journals. MATERIALS AND METHODS: Randomized controlled trials published in The Journal of Urology®, Urology, European Urology, and BJU International in 2012 and 2020 were analyzed. Each randomized controlled trial was evaluated by 2 authors in a masked-duplicate fashion to evaluate for adherence to harms reporting guidelines recommended by the Consolidated Standards of Reporting Trials (CONSORT) group. RESULTS: One hundred and thirty-two published studies met inclusion criteria. Between 2012 and 2020, there was a statistically significant increase in the median number of harms criteria reported between 2012 and 2020 (5.3 vs 7.2; P = .01). Methods criteria demonstrating the greatest improvements included item #3 "which harms were assessed," item #4a "when harm information was collected," and item #4b "methods to attribute harm to intervention." Results sections with the most improvement in reporting include item #6 "reasons for patient withdrawal," item #8a "effect size for harms," and item #8b "stratified serious + minor harms." CONCLUSIONS: Reporting of adverse events in randomized trials published in several top urology journals has demonstrated marked improvement. Studies published in 2020 reported approximately 70% of CONSORT-Harms criteria-an increase of nearly 40% since 2004. While these improvements mark significant change, deficits remain present and should be addressed to provide clinicians with the most complete perspective possible.

A scoping review of health inequities in alcohol use disorder.

Background: Alcohol Use Disorder (AUD) poses a significant health burden on individuals. The burden occurs more frequently in the medically underserved, as well as racial and sexual minority populations. Ameliorating health inequities is vital to improving patient-centered care.Objectives: The objective of this scoping review is to chart the existing evidence on health inequities related to AUD and identify existing knowledge gaps to guide future equity-centered research.Methods: We performed a literature search using the Ovid (Embase) and MEDLINE (PubMed) databases for articles on AUD that were published in the 5-year period spanning from 2017 to 2021 and written in English. The frequencies of each health inequity examined were analyzed, and findings from each included study were summarized.Results: Our sample consisted of 55 studies for analysis. The most common inequity examined was by race/ethnicity followed by sex or gender. The least reported inequities examined were rural under-resourced areas and occupational status. Our findings indicate that significant research gaps exist in education, rural under-resourced populations, and LGBTQ+ communities with AUD.Conclusions: This scoping review highlights the gaps in research on inequities in AUD. To bridge the current gaps, we recommend research on the following: 1) triage screening tools and the use of telemedicine for rural, under-resourced populations; 2) interventions to increase treatment engagement and retention for women; and 3) community-based participatory methodologies for the LGBTQ+ communities.

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.

Harms-related data are poorly reported among randomized controlled trials underpinning the American Academy of Orthopaedic Surgeons clinical practice guideline recommendations for rotator cuff injuries.

BACKGROUND: Results produced from randomized controlled trials (RCTs) help guide clinical decision making and health policy. Therefore, it is essential that RCT outcomes- including harms (eg, adverse events)-are adequately reported such that clinicians, patients, and policy makers are equipped with all necessary information to complete risk-benefit assessment of the RCT's intervention. Here, we evaluated the quality of reporting of harms (eg, adverse events) in RCTs cited as supporting evidence for recommendations in the American Academy of Orthopaedic Surgeons (AAOS) Management of Rotator Cuff Injuries clinical practice guidelines (CPGs) using the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms Checklist. METHODS: To quantify adherence to CONSORT Extension for Harms items, each RCT was screened for pertinent information satisfying each checklist item. Screening of CPG reference sections for RCTs underpinning CPG recommendations, as well as data extraction from each of the included RCTs, was performed in a blind and duplicate manner. Descriptive statistics-including frequencies, percentages, and 95% confidence intervals-were used to summarize overall percent adherence to checklist items. A linear regression model assessed the relationship of CONSORT Harms reporting over time. RESULTS: Ninety-nine RCTs were included in our final sample. Fifty-seven RCTs (of 99; 57.6%) were conducted at a single center. Common funding sources included private (nonindustry) (17/99; 17.2%), private (industry) (8/99; 8.1%), and public (7/99; 7.1%) sources. Sample size for each trial most often consisted of <50 participants (29/99; 29.3%) or 51-100 participants (50/99; 50.5%). The average number of CONSORT Extension for Harms items adequately reported across all included RCTs was 5.7 (of 18; 31.7%). None of the included trials reported all 18 items. Twenty-six RCTs (of 99; 26.3%) adequately reported ≥50% of eligible checklist items. Fifty-nine RCTs (of 99; 59.6%) adequately reported ≤33% of eligible checklist items. Items with ≥50% adherence included item 2, item 7a, and item 8a. Items with ≤20% adherence included item 3b, item 4d, and item 5. Results from our linear regression demonstrated a slight, yet nonsignificant, improvement in adherence to the Harms Extension over time (R2 = 0.009; P = .407). CONCLUSIONS: Our results illustrate the poor state of harms reporting within RCTs cited as supporting evidence for the AAOS Management of Rotator Cuff Injuries CPG. Efforts to address these gaps in reporting are warranted, as complete knowledge of potential harms is critical to patients, clinicians, and health policy makers when determining best practice decisions in orthopedic surgery.

The non-medical out-of-pocket costs to attend a free anxiety disorders treatment clinic in Australia.

OBJECTIVE: Australia has high out-of-pocket costs for medical and non-medical treatments. The 'cost to attend' is seldom added to these estimates. METHOD: A sequence of 92 participants attending a free Anxiety Disorders Clinic at an inner city public hospital were surveyed about the costs to attend one appointment, including costs such as private /public transport costs and lost income. RESULTS: We found that these out-of-pocket costs were on average AUD$57 per person to attend an appointment at a free point-of-service clinic. Of the 45% who experienced financial burden from attending, the majority reported only slight burden. CONCLUSION: This level of 'cost to attend' a free outpatient treatment clinic is non-trivial given people with anxiety and depressive disorders, like many others with chronic disorders, will need at least 6-10 visits to complete a course of treatment.

The Current State of Health Inequities in COPD.

An understanding of the health inequities that surround the treatment and prevention of COPD is required to address the barriers that hinder improvement of care for underserved populations. This scoping review was conducted to identify the existing evidence of social factors that affect the health, health-care access, and health-care quality of patients with COPD within the United States, and to identify gaps in knowledge to help direct future research. We followed the guidelines from the Joanna Briggs Institute and Preferred Reporting Items for Systematic reviews and Meta Analyses Extension for Scoping Reviews. In July 2022, a literature search by using Ovid (Embase) and MEDLINE (PubMed) databases was conducted to identify articles on COPD, published between 2016 and 2021, written in English, and that investigated at least one health inequity as defined by the National Institutes of Health. All studies were screened for inclusion criteria and were extracted in a masked, duplicate manner. Each health inequity was investigated, extracted, and summarized. Thirty articles were screened in full text, and 19 were found to meet inclusion criteria. Common social factors investigated in the COPD literature included race/ethnicity, income, and education. Since the implementation of the National Institutes of Health's sex and gender minority category in 2016, only one study within our sample examined LGBTQ+ (lesbian, gay, bisexual, transgender, queer [or sometimes questioning], and others) patients with COPD. The least commonly investigated social factors that affect patients with COPD were rural/under-resourced (geography), sex and gender, and LGBTQ+ affiliation. In addition, occupational status was not investigated by any included studies in our sample. Our scoping review underlines the lack of research with regard to inequities that affect patients with COPD. We propose researching hormone replacement therapy's impact on lung function in transgender and nonbinary patients with COPD. Implementation science studies are suggested to enhance intervention for COPD medication adherence among racial/ethnic minority groups, given the intersectionalities of social factors that disproportionately affect this population. We, also recommend developing telemedicine pulmonary rehabilitation technology for rurally located patients with COPD.

Inadequate harms reporting among randomized controlled trials cited as supporting evidence in the AAOS management of hip fractures in older adults clinical practice guideline recommendations.

BACKGROUND: Recommendations within clinical practice guidelines (CPGs) are heavily influenced by results from randomized controlled trials (RCTs). Therefore, it is imperative that all RCT outcomes are reported thoroughly to ensure CPGs are created using accurate information. Here, we evaluate the quality of harms reporting using the CONSORT Extension for Harms in RCTs underpinning recommendations in the American Academy of Orthopedic Surgeons (AAOS) Management of Hip Fractures in Older Adults CPG. METHODS: Each RCT cited as evidence for recommendations in the AAOS Management of Hip Fractures in Older Adults CPG was evaluated using the CONSORT Extension for Harms to determine the quality of harms reporting. Descriptive statistics (frequencies, percentages, 95 % confidence intervals) were used to summarize adherence to CONSORT Harms items. A linear regression model was used to evaluate the CONSORT Harms influence on the quality of reporting over time. RESULTS: Among the 156 RCTs identified, there were a total of 31,848 participants. Most RCTs were conducted at a single center (137; 87.8 %) and in a single-blind manner (130; 83.3 %). Fifty-four (34.6 %) RCTs did not provide funding statements. Trials adequately reported an average of 6.65 out of 18 CONSORT Extension for Harms items (37.0 %). One RCT adequately reported all items, while five reported zero items. Forty-seven RCTs (30.1 %) reported ≥ 50 % of items and 73 (46.8 %) reported ≤ 33.3 % of items. The linear regression model demonstrated no significant increase in mean adherence over time (adjusted R2 = -0.006; p = 0.563). CONCLUSION: Our results highlight inadequate harms reporting among RCTs in the AAOS Management of Hip Fractures in Older Patients CPG. While the CONSORT Harms Extension was intended to enhance reporting, the linear regression model did not demonstrate significant improvements over time.

Inequities and Research Gaps in Ophthalmology: A Scoping Review.

Importance: Deficient ophthalmologic care is costly to patients, making the identification of groups not receiving adequate care of vital importance. The current landscape of equity in ophthalmic care has yet to be thoroughly investigated and is important to ensure inclusivity and patient-centered care. Objective: To perform a scoping review of the literature pertaining to health care inequities in the field of ophthalmology. Evidence Review: A comprehensive database search using MEDLINE (via PubMed) and Ovid Embase was done in July 2022. English-language articles published from 2016 to 2021 were included and encompassed all article types except commentaries or correspondence. The search modeled the National Institutes of Health list of designated US health inequity populations, which includes income, education level, occupational status, rural and underresourced area, sex and gender, lesbian, gay, bisexual, transgender, and queer (LGBTQ) identity, and race and ethnicity. A total of 8170 abstracts and titles were screened by 2 independent investigators, and 189 studies were assessed in full text for eligibility. For inclusion, articles needed to be an ophthalmic study discussing health inequities. In a masked, duplicate fashion, 2 independent investigators screened 75 full-text studies for data extraction using a pilot-tested form. Data extraction included general publication characteristics and health inequity data based on the National Institutes of Health's defined inequity groups. Findings: A total of 75 publications were included. Notable inequities were found among Black and Hispanic patients associated with negative ophthalmic outcomes and mixed associations regarding sex or gender. Overall, lower-income patients were more likely to have vision impairment, use eye care services less, and have lower adherence to eye examinations. No articles within our sample examined LGBTQ inequities among ophthalmology patients since the 2016 National Institutes of Health classification of sexual and gender minority populations. Substantial research gaps were observed within the ophthalmic literature pertaining to the LGBTQ community, race and ethnicity, and rural and underresourced areas. Conclusions and Relevance: This scoping review found substantial findings associated with the LGBTQ community, race and ethnicity, and the role of telemedicine in rural and underresourced areas. Because of the importance of ophthalmic care in overall patient health, it is vital to understand the various inequities present and strive to improve the current gaps in the literature. Future studies should (1) examine barriers to clinical study and medical trainee recruitment as well as patient values and preference studies and (2) investigate the implementation of telemedicine in underresourced areas.

What's in a P-Value? A Fragility Analysis of RCTs in the AUA Guidelines for Benign Prostatic Hyperplasia.

OBJECTIVE: To use the fragility index (FI) and fragility quotient (FQ) to assess the strength of statistically significant findings for randomized controlled trials (RCTs) cited in the American Urological Association (AUA) guidelines for benign prostatic hyperplasia. METHODS: Two investigators independently screened the AUA guidelines for management of benign prostatic hyperplasia for RCTs cited as evidence for recommendations. Investigators extracted data related to event rate per group and loss to follow-up which was compared against the FI. Stata 17.0 was used to calculate the FI and FQ which was then summarized and reported according to primary or secondary endpoints. RESULTS: Among the 373 citations in the AUA guidelines, 24 RCTs met inclusion criteria with 29 distinct outcomes analyzed. The median fragility index was 12 (IQR = 4-38), indicating that twelve alternative events to either study arm would nullify statistical significance. Six studies had a FI of ≤2, indicating that only 1-2 outcomes would need to be changed in order to render nonsignificance of results. In 10/24 RCTs, the number of patients lost to follow-up was greater than the FI. CONCLUSION: The AUA Clinical Practice Guidelines for management of benign prostatic hyperplasia cite RCTs with more robust findings when compared to previous studies assessing fragility in the field of Urology. While several included studies had high fragility, the median FI in our analysis was approximately 4-5 times higher than comparable studies of urologic RCTs. However, there are areas where improvement is necessary to support the highest quality of evidence-based medicine.

Inequities in Medically Assisted Reproduction: a Scoping Review.

Infertility has a high prevalence in the USA and health inequities play a large role in access to medically assisted reproduction (MAR). The aim of this study was to identify gaps in research pertaining to inequities in MAR and propose suggestions for future research directions. Searches were performed using MEDLINE and Ovid Embase. Articles that reported on MAR inequities, published between 2016 and 2021 in the USA, and written in English were included. The inequities investigated were adapted from the NIH-designated health disparities populations. Each article's inequity findings were extracted and reported, along with frequencies of inequities. Our sample included 66 studies. The majority of the studies investigated MAR outcomes by race/ethnicity and found that historically marginalized populations had poorer outcomes. LGBTQ + populations were less likely to use MAR or seek infertility care. Most studies found positive correlations with MAR use with income and education. The least commonly studied inequities in our sample were sex and/or gender and rural/under-resourced populations; findings showed that men and people from rural/under-resourced populations were less likely to access MAR. Studies that examined occupational status had varying findings. We suggest that future research be targeted toward: (1) standardizing and diversifying race/ethnicity reporting regarding MAR, (2) the use of community-based participatory research to increase data for LGBTQ + patients, and (3) increasing access to infertility care for men.

Analysis of the Evidence Underpinning the American Academy of Orthopedic Surgeons Knee Osteoarthritis Clinical Practice Guidelines.

CONTEXT: Clinical practice guidelines (CPGs) are vital to establishing a standardized and evidence-based approach in medicine. These guidelines rely on the use of methodologically sound clinical trials, and the subsequent reporting of their methodology. OBJECTIVE: To evaluate the completeness of randomized controlled trials (RCTs) underpinning CPGs published by the American Academy of Orthopedic Surgeons (AAOS) for management of osteoarthritis of the knee. DATA SOURCES: We searched the most recent AAOS CPGs for surgical and nonsurgical management of osteoarthritis of the knee for RCTs. To estimate the necessary sample size, we performed a power analysis using OpenEpi 3.0 (openepi.com). STUDY SELECTION: Two authors independently screened the reference sections of the included CPGs. Included studies met the definition of an RCT, were retrievable in the English language, and were cited in at least one of the included CPGs. STUDY DESIGN: Meta-Analysis. LEVEL OF EVIDENCE: Level 1a. DATA EXTRACTION: We performed double-blind screening and extraction of RCTs included in the AAOS CPGs. We evaluated each RCT for adherence to the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist. A multiple regression analysis was conducted to assess CONSORT adherence against characteristics of included studies (ie, type of intervention, funding source, etc). RESULTS: Our study included 179 RCTs. The overall adherence was 68.5% with significant differences between those published before and since the development of the 2010 CONSORT guidelines (P = 0.02). We found that RCTs receiving funding from industry/private sources as well as studies that included a conflict of interest statement showed more completeness than RCTs that reported receiving no funding (P < 0.01). CONCLUSION: We found suboptimal CONSORT adherence for RCTs cited in AAOS CGPs for management of osteoarthritis of the knee. Therefore, the CPGs are likely supported by outdated evidence and lack of high-quality reporting. It is important that evidence used to guide clinical decision making be of the highest quality in order to optimize patient outcomes. In order for clinicians to confer the greatest benefits to their patients, CPGs should provide the totality of evidence and emphasize emerging high-quality RCTs to ensure up-to-date, evidence-based clinical decision-making.

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.