Assessing the degree to which randomized controlled trials align with the core outcome set for osteoarthritis of knee and hip: A cross-sectional analysis.

OBJECTIVE: To assess the degree of core outcome set alignment and identify issues with alignment to the 2019 COS among clinical trial registrations focused on knee and/or hip osteoarthritis (OA). METHODS: Our search was performed on registered knee and hip OA randomized controlled trials (RCTs) available on ClinicalTrials.gov and WHO International Clinical Trials Registry Platform. The screening process considered trials registered between 8/2014 and 6/2023. We extracted data on general trial characteristics and the five trial endpoints detailed in the COS (pain, physical function, quality of life, patient global assessment, and adverse events), in a masked and duplicate manner. The frequencies of COS alignment were assessed over time prior to and after COS publication. RESULTS: Of the 10,718 RCTs screened, 481 met inclusion criteria. Most were phase 3 (368/481, 76.51%) and heavily university-funded (184/481, 38.25%). Despite the 2019 COS, no marked enhancement in overall alignment was noted. The outcome 'Pain' exhibited the highest degree of COS alignment (455/481, 94.59%), whereas 'adverse events' lagged behind (89/481, 18.50%). Additionally, trial factors such as 'Continent', 'Funding Type', and 'Recruitment Status' displayed no significant influence on COS alignment. CONCLUSIONS: Despite the acknowledged advantages of using COS in RCTs and the availability of an updated COS, the alignment to these outcomes remains notably low. Significant efforts are needed to encourage broader adoption in future studies on knee and hip OA, with the aim of improving research quality and patient care.

Gender disparities in neuropsychological assessment research in drug abuse populations: A systematic review.

Objective: To systematically review the literature on the neurocognitive effects of drug use to determine if there are significant gender differences. Methods: In April 2023, we conducted a broad search in MEDLINE (via PubMed), PsycINFO, and Embase for original research studies that used objective neuropsychological assessment to evaluate neurocognition in persons with drug use. Data extraction was performed in a masked, duplicate fashion. Results: Our initial search returned 22,430 records, of which 273 articles were included in our analysis. We found significant underrepresentation of women as participants in the studies. Twenty-one percent of studies had exclusively male participants; when women were included, they averaged only 23% of the sample. Only 49 studies sufficiently documented an analysis of their results by gender; due to the heterogeneity in study characteristics, no conclusions about cognitive differences between women and men could be made. Conclusions: Women are significantly underrepresented in the research on cognition in drug use. Increased efforts to include more women participants and consistent analysis and reporting of data for potential gender differences will be required to close this gap in knowledge, which may lead to improved substance abuse treatment approaches for women.

Assessing the uptake of the type 1 diabetes core outcome set in randomized controlled trials: A Cross-Sectional study.

AIMS: This study analyzed uptake of the core outcome set (COS) for type 1 diabetes (T1D) and trends in its use before and after its development in December 2017. METHODS: On June 26, 2023, ClinicalTrials.gov was systematically searched for T1D randomized controlled trials. The Core Outcome Measures in Effectiveness Trials (COMET) database provided a COS of eight key outcomes for analysis. Included trials were analyzed for COS uptake before and after its release in December 2017 in a masked, duplicate fashion by independent reviewers. We also calculated the proportion of trials that measured the complete COS and assessed the most frequently reported COS outcomes. RESULTS: Of 3,792 originally screened articles, 144 RCTs were included in the final sample. Following COS publication, its use steadily decreased. Within the COS, HbA1c and severe hypoglycemia were most frequently implemented as endpoints; other recommended outcomes were rarely used in the published trials. CONCLUSION: Despite the 2017 T1D COS publication, use has decreased over time. This inconsistency negatively influences evidence-based practices and care. Educating researchers on COS and promoting uptake is crucial. Wider COS adoption in T1D trials could enhance clinical research overall. Further study of barriers and facilitators influencing uptake is essential to support consistent use and reporting.

Assessing uptake of the core outcome set in clinical trials for immune thrombocytopenia: A cross-sectional analysis.

INTRODUCTION: Clinical trials (CTs) guide clinical practice, but inconsistent outcome reporting presents challenges. To increase comparability, a core outcome set (COS) was created for primary Immune thrombocytopenia (ITP) in 2009 to standardize outcome measurements. We aimed to evaluate uptake of the primary ITP COS in CT registries. MATERIALS & METHODS: Our cross-sectional analysis employed a search string on ClinicalTrials.gov and ICTRP for phase III/IV CTs in June 2023. Inclusion criteria consisted of subjects with primary ITP, study was registered five years before COS publication to June 26, 2023, and assessed effectiveness of interventions. Two investigators extracted data in a masked, duplicate manner. Interrupted time series analysis, ANOVAs, and correlation analyses were conducted to assess the main outcome of COS uptake pre/post COS publication. RESULTS: The search identified 131 eligible trials for data extraction. Altogether, 38.2 % (50/131) followed IWG platelet response guidelines. An alternative platelet count measurement was 50,000 × 109 L, with 46.56 % (61/131) of trials reporting it. The most measured outcome was adverse events (106/131, 80.9 %). Remaining secondary outcomes were measured in <50 % of studies. After COS publication, there was a statistically non-significant 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) increase in the monthly trend of COS-defined outcomes. CONCLUSION: We found a non-significant increase in uptake of the ITP COS since its publication and highlighted the lack of standardization among endpoints within ITP clinical trials. Our analysis highlights the need for heightened awareness and a COS update that acknowledges the variability in clinical trials.

Taking a chance on outcome standardisation: A cross-sectional analysis assessing the uptake of the prevention of preterm birth core outcome set in randomised controlled trials.

OBJECTIVE: Analyse uptake of the core outcome set (COS) within preterm birth (PTB) clinical trials. DESIGN: On 26 June 2023, we conducted a systematic search of phase III/IV trial registry entries regarding PTB interventions via ClinicalTrials.gov and the International Clinical Trial Registry Platform. These trials were analysed for the outcomes measured. SETTING: N/A. SAMPLE: After searching the two databases, 5257 randomised controlled trials (RCTs) were screened, resulting in 92 RCTs for analysis. METHODS: Inclusion criteria were the following: subjects were patients receiving an intervention for PTB, study enrolment began within 5 years prior to publication of PTB COS to 26 June 2023, and evaluated the efficacy of interventions. Authors screened and extracted data in masked, duplicate fashion, then performed an interrupted time series analysis, analysis of variance and correlation analysis. MAIN OUTCOME MEASURES: We extracted outcomes measured by each clinical trial in our sample. Trials were analysed for the percentage of adopted outcomes from PTB COS. RESULTS: After COS publication, there was no significant change in percentage of COS outcomes measured. The most measured outcome was 'offspring mortality' (54.34%, 50/92) and the least measured outcome was 'late neonatal neurodevelopment morbidity' (3.26%, 3/92). Additionally, 22.83% (21/92) of trials measured zero outcomes related to the PTB COS. CONCLUSION: Our results demonstrated no significant change in outcome measurement before or after PTB COS publication. We recommend focusing on both the measurement of outcomes and the assessments that are used.

Association between steroid use and concussions among high school athletes: a cross-sectional analysis of the Youth Risk Behavior Surveillance System.

CONTEXT: In 2017, there were almost 2.5 million high school students who experienced a concussion while playing a sport, raising concern for the neurologic problems that they could face. Some of these athletes may seek to gain a competitive advantage in their sport by utilizing substances like steroids. However, steroid use can cause increased aggression and body mass index (BMI), which might lead to heightened risk for concussions. Despite extensive research, we found no previous evidence linking these two factors. OBJECTIVES: This analysis aims to investigate steroid use trends in high school athletes and to determine whether there is an association between steroid use and concussions in these athletes. METHODS: We conducted a cross-sectional analysis of the cumulative Youth Risk Behavior Surveillance System (YRBSS). Respondents were added if they participated in sports and answered the steroid and concussion prompts. Demographic variables were assessed including age, grade, BMI, gender, and race/ethnicity. RESULTS: We found that 3.7 % (n=2991) of high school athletes reported previous steroid use and that 20.7 % (n=2273) reported having sustained a concussion. There was a statistically significant difference in steroid use by race/ethnicity (p<0.001), with the highest rate of use (7.2 %) among American Indian/Alaska Natives (AI/AN). A significantly higher prevalence of steroid use occurred in athletes who were males (4.7 %) than females (2.5 %) and in athletes with a BMI>95 % (5.2 %) compared with those with a BMI between 85 and 95 % (3.9 %) and <85 % (3.5 %) (χ2=135.1, p<0.001 and χ2=16.3, p<0.001, respectively). Further, our results showed that the prevalence of steroid use among high school athletes decreased from 3.4 % in 1999 to 1.9 % in 2019, with the most drastic drop occurring between 2015 and 2019-declining 1.9 %. Whereas 19.6 % of athletes reported a concussion without steroid use, 54.6 % of steroid-utilizing athletes reported having experienced a concussion-a statistically significant finding (adjusted odds ratio [AOR]=4.3; 95 % CI: 3.2-5.9). Finally, compared with White athletes, we found that AI/AN athletes were significantly more likely to have sustained a concussion (AOR=2.3; 95 % CI=1.2-4.3). CONCLUSIONS: Although our study found decreasing rates of steroid use among high school athletes from 1999 through 2019, our results also show that steroid use is significantly associated with sustaining a concussion. Additionally, the data from YRBSS also demonstrates that AI/AN high school athletes are more likely to utilize steroids and sustain a concussion. Given the long-term consequences of traumatic brain injuries, we recommend that coaches should be aware of potential steroid use among players, and that coaches, athletic trainers, and physicians should all be aware of concussion protocols and remove players from games for evaluation when a concussion is suspected.

Comorbidities associated with symptoms of subjective cognitive decline in individuals aged 45-64.

CONTEXT: Early-stage cognitive decline occurs when an individual experiences memory loss or other cognitive impairment but does not meet the criteria for Alzheimer's disease (AD) or other dementias. After diagnosis of mild cognitive impairment (MCI), approximately 5-15 % of cases progress to dementia per year. AD and many other causes of dementia are presently incurable. Early recognition of cognitive decline can allow healthcare providers to reduce the risk of disease progression. Literature is scarce on factors that can increase the incidence of cognitive decline, especially in early ages; this is further exacerbated by difficulty tracking the prevalence of mild cognitive symptoms. OBJECTIVES: This analysis aims to determine demographic and comorbid factors that predispose individuals to higher rates of early-stage subjective cognitive impairment in order to determine which individuals should be screened at earlier stages. METHODS: We conducted a cross-sectional analysis of data from the Subjective Cognitive Decline module of the 2017-2021 Behavioral Risk Factor Surveillance System (BRFSS). Applying survey design and sampling weights, we constructed binary logistic regression models to assess associations, via odds ratios (OR), between comorbidities and subjective cognitive decline (SCD). Alpha was set at 0.05 and confidence intervals (CIs) are reported at 95 %. RESULTS: Our sample included 110,305 participants representing 13.4 million US adults aged 45-64 years. Results showed that individuals with diabetes (OR: 2.29, CI: 2.09-2.51), hypertension (OR: 1.98, CI: 1.81-2.17), stroke (OR: 4.61, CI: 4.07-5.22), myocardial infarction (MI [OR: 3.09, CI: 2.73-3.49]), coronary heart disease (CHD [OR: 3.26, CI: 2.88-3.69]), depression (OR: 5.65, CI: 5.21-6.11), and chronic kidney disease (CKD [OR: 3.08, CI: 2.66-3.58]) experienced higher rates of SCD. Further, there were higher rates of SCD among individuals who identified as American Indian/Alaskan Native (AI/AN), those with low educational attainment, and those with lower incomes. CONCLUSIONS: Our findings show that all comorbidities listed were correlated with higher rates of memory loss or confusion. Investigation of factors that are associated with an increased risk of developing new or worsening cognitive decline allows healthcare professionals to properly screen and treat these individuals early, before progressing to conditions that are currently incurable. Future studies into the mechanisms of these diseases in contributing to cognitive decline can illuminate specific effective treatment options.

Assessing uptake of the core outcome set in randomized controlled trials for Parkinson's disease: A systematic review.

BACKGROUND: Parkinson's Disease (PD) affects more than 10 million individuals, with increasing incidence worldwide. As PD's incidence rises, research funding is increasing substantially. PD's core outcome set (COS) provides standardization for PD clinical trial outcomes, improves research quality, and study comparability. Our study aimed to analyze COS uptake rate before and after the PD COS publication. METHODS: We searched ClinicalTrials.gov to retrieve phase III/IV adult PD trials published between 2013 and 2023. Screening for inclusion and data extraction occurred in a masked, duplicate fashion. Trial characteristics and COS uptake rate were extracted from this sample. RESULTS: In our 111 included trials, the COS uptake rate was highest for the 'Walking and Balance' outcome and lowest for the 'Hospital Admissions' outcome. Overall, there was a non-significant monthly increase of 0.26 % (P = 0.266, CI = [-0.20, 0.72]) in "COS-defined outcome" measurement when comparing pre- and post-COS publication. CONCLUSION: Our study found no significant increase in COS uptake in PD clinical trials. We found multiple outcomes to be vastly unmeasured and heterogeneity among the measurement instruments used. These findings complicate standardizing and comparing RCT outcomes. Overcoming these barriers is vital to improving the usefulness of PD research.

Health inequities in dialysis care: A scoping review.

MAIN PROBLEM: We aim to look at potential gaps in current dialysis literature on inequities and explore future research that could contribute to more equitable care. METHODS: Following guidelines from the Joanna Briggs Institute (JBI) and the Preferred Reporting Items for Systematic reviews and Meta Analyses extension for Scoping Reviews (PRISMA-ScR), we conducted a scoping review of health inequities in dialysis. PubMed and Ovid Embase were searched in July 2022 for articles published between 2016 and 2022 that examined at least one of the following NIH defined health inequities: race/ethnicity, sex/gender, LGBTQ+ identity, underserved rural populations, education level, income, and occupation status. Frequencies of each health inequity as well as trends over time of the four most examined inequities were analyzed. RESULTS: In our sample of 69 included studies, gaps were identified in LGBTQ+ identity and patient education. Inequities pertaining to race/ethnicity, sex/gender, underserved rural populations, and income were sufficiently reported. No trends between inequities investigated over time were identified. CONCLUSIONS: Our scoping review examined current literature on health inequities pertaining to dialysis and found gaps concerning LGBTQ+ and patients with lower levels of education. To help fill these gaps, and possibly alleviate additional burden to these patients, we recommend cultural competency training for providers and dialysis center staff as well as community-based educational programs to improve dialysis patients' health literacy.

Prevalence of depression among caregivers based on the condition and relationship of care recipient.

BACKGROUND: Caregiver distress is the strain experienced by individuals providing care for people with chronic conditions which limit their self-sufficiency for tasks of daily living. Over 1 in 5 Americans are caregivers-a number expected to increase with an aging population. METHODS: We performed a cross-sectional analysis using the 2021 Behavioral Risk Factor Surveillance System (BRFSS) conducted by the Centers for Disease Control and Prevention (CDC) to determine rates of depressive disorders among caregivers and associations between demographic and relational aspects of the care recipient. RESULTS: The included sample size for analysis was 32,676, representing 17,274,935 US caregivers. We found that caregivers who were female, American Indian/Alaskan Native, race-not-listed, earning less than $15,000 a year, or did not complete high school, had higher rates of depression diagnosis. The rates of depression were higher among caregivers if the recipient had a mental or chronic respiratory condition, or if the recipient was their live-in partner. Rates of depression were lower for caregivers of their mother-in-law or spouse. LIMITATIONS: Results were based on self-reported survey data, which are susceptible to social desirability bias. Diagnoses of depression may also be over or under reported across several demographic variables, which may confound results. CONCLUSION: Our findings add to previous research showing that specific groups of caregivers are at higher risk for caregiver stress. Future qualitative research may elucidate underlying causes of depression among caregivers. Analysis into the risk factors for depression among caregivers is vital in providing effective therapeutic options for the caregiver.

Inequities in the treatment of opioid use disorder: A scoping review.

BACKGROUND: Given the lack of access to evidenced-based OUD treatment and the corresponding overdose crisis, researchers must evaluate and report health care inequities involving the treatment of OUD. Additionally, clinicians should be aware of these inequities in the treatment of patients. METHODS: We carried out a scoping review of the literature regarding health inequities in treatment for OUD in July 2022. The study team retrieved articles published between 2016 and 2021 from MEDLINE and Ovid Embase. After authors received training, screening and data extraction were performed in masked, duplicate fashion. The team screened a total of 3673 titles and abstracts, followed by 172 articles for full-text review. The inequities that we examined were race/ethnicity, sex or gender, income, under-resourced/rural, occupational status, education level, and LGBTQ+. We used Stata 17.0 (StataCorp, LLC, College Station, TX) to summarize data and statistics of the studies within our sample. RESULTS: A total of 44 studies evaluating inequities in OUD treatment met inclusion criteria. The most common inequity that studies examined was race/ethnicity (34/44 [77.27 %] studies), followed by under-resourced/rural (19/44 [43.18 %] studies), and sex or gender (18/44 [40.91 %] studies). LGBTQ+ (0/44 [0.0 %] studies) was not reported in the included studies. Our results indicate that many historically marginalized populations experience inequities related to access and outcomes in OUD treatment. The included studies in our scoping review occasionally demonstrated inconsistent findings. CONCLUSIONS: Gaps exist within the literature on health inequities in treatment for OUD. The most examined inequities were race/ethnicity, under-resourced/rural and sex or gender, while studies did not examine LGBTQ+ status. Future research should aim to advance and supplement literature investigating health inequities in OUD treatment to ensure inclusive, patient-centered care.

Discontinuation and nonpublication of clinical trials for the pharmacologic treatment of posttraumatic stress disorder among military veterans.

Failures by researchers and clinicians to overcome barriers in veteran health-related research may result in clinical trial (CT) discontinuation and nonpublication. Such outcomes are a waste of limited academic resources. To determine rates of discontinuation and nonpublication among CTs for posttraumatic stress disorder (PTSD) with pharmaceutical interventions specific to the veteran population, we performed a systematic search of registered trials in ClinicalTrials.gov for pharmaceutical interventions for the treatment of PTSD. Extracted study characteristics included sample size, study design, trial status, phase, and funding source. Studies were classified as completed or discontinued based on the status listed in ClinicalTrials.gov. Descriptive statistics of trials were reported, and associations of trial termination and nonpublication were assessed using logistic regression. The final sample included 54 CTs, 15 of which (27.8%) had not been published within the FDA's required timeframe, and 11 (20.4%) were discontinued. The total number of trial participants was 3,463, with a median of 37 (interquartile range: 15-92). Of the 54 trials, 12 (22.2%) were nonrandomized, and 42 (77.8%) were randomized. There were 25 (46.3%) trials that were in either Phase 3 or Phase 4, and 39 (72.2%) were government-funded. We found high rates of CT discontinuation and nonpublication among PTSD pharmaceutical intervention studies in veterans, as has been shown in other fields of research.

Health inequities in human papillomavirus prevention, diagnostics and clinical care in the USA: a scoping review.

BACKGROUND: Human papillomavirus (HPV) represents the most common STI in the USA. HPV inequities in prevention, diagnostics and clinical care persist. We define inequities as systematic, avoidable and unfair differences in health outcomes. OBJECTIVES: The objectives of this scoping review are to chart existing data on HPV-related inequities, identify gaps in existing literature and guide future research to reduce these inequities. METHODS: We completed a scoping review following guidelines from the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses scoping reviews extension. We performed a literature search on PubMed and Ovid Embase in July 2022 for articles pertaining to HPV and evaluating populations within the USA. We included English language publications from 2018 to 2022 evaluating at least one health inequity outlined by the National Institutes of Health. General publication characteristics and health inequity data were charted in a masked, duplicate fashion using a pilot-tested Google Form. We analysed frequencies of health inequities and summarised main findings from included studies. RESULTS: Our final sample included 170 publications. The most common inequities examined were race/ethnicity (140 studies), sex or gender (97 studies), and income (69 studies). Many historically marginalised racial/ethnic groups had lower rates of HPV-related knowledge, vaccination and worse overall outcomes related to HPV. Compared with women, men had lower rates of HPV vaccination and provider recommendation, and higher rates of HPV-infection. Results regarding income were largely conflicting. CONCLUSION: Findings from our review demonstrate clear gaps in HPV-related inequity research. Vaccine completion, provider recommendation and intersectionality should continue to be evaluated to implement targeted interventions.

Rates of discontinuation and non-publication of trials for the pharmacologic treatment of alcohol use disorder.

Objective: With approximately 15 million individuals in the United States meeting criteria for Alcohol Use Disorder (AUD), advancing effective medication-assisted treatment options is crucial. This advancement stems from the publication of clinical trial (CT) results. The primary objective of this study was to assess the rates of discontinuation and non-publication of results in CTs focused on the pharmacologic treatment of AUD and to assess associated factors. Design: A cross-sectional study was completed after acquiring trials focused on AUD within the ClinicalTrials.gov database. Inclusion criteria for CTs were the use of a pharmaceutical intervention with an outcome measure of alcohol intake or craving, conducted between October 2008 through September 2018. The primary outcome measures were the frequency of trial discontinuation and non-publication. Discontinuation was assessed as the listed status on ClinicalTrials.gov. Publications were identified through verification of listings on ClinicalTrials.gov, or via searches of PubMed, Embase, and Google Scholar. If publications were not found, correspondence to trial contacts were sent. Data analysis occurred on December 5th, 2020. Results: Of 235 trials returned from the search, 87 met inclusion criteria. Our study found that 12.6% (11) of CTs involving pharmaceutical treatments for AUD were prematurely terminated, and 39.1% (34) had no published results. Recruitment and lower cutoff of targeted age groups were significantly associated with discontinuation and non-publication, respectively. Conclusions: Scientific evidence advances faster when all results are known-furthering the progress of positive studies, while avoiding duplicative efforts to test the same hypotheses with the same methods, thereby reducing scientific waste. Given the number of unpublished AUD trials, potentially useful information regarding treatment for individuals with AUD may be inaccessible to clinicians while also adding to the abundance of research waste.Key pointsQuestion: What are the rates of discontinuation or non-publication of clinical trials for pharmacological treatments for AUD and associated factors?Findings: Among 87 trials, 11 (12.6%) were prematurely terminated and 34 (39.1%) did not reach publication, with trials that included participants 21 years and older more likely to reach publication than those with younger participants.Meaning: Low publication rates of CTs for pharmacological treatments of AUD may (1) stunt the advancement of AUD research, (2) decrease the value in funding AUD research from government entities, and (3) needlessly expose participants to potentially harmful interventions.

Evaluation of spin in the abstracts of systematic reviews and meta-analyses of treatments and interventions for smoking cessation.

INTRODUCTION: Smoking cessation treatments and available evidence continue to evolve. To stay current with the latest research, physicians often refer to abstracts of systematic reviews. Because abstracts of systematic reviews may have direct effects on patient care, the information within them should be free of 'spin'. Spin is a specific way of reporting, intentional or not, to highlight that the beneficial effect of the experimental treatment in terms of efficacy or safety is greater than that shown by the results (i.e. overstate efficacy and/or understate harm). METHODS: We searched systematic reviews and meta-analyses focused on interventions and treatments for smoking cessation. Full-text screening, data extraction, evaluation of spin, and quality assessment were conducted in masked, duplicate fashion. Study and journal characteristics were also recorded to determine whether they were associated with the presence of spin. RESULTS: A total of 200 systematic reviews that met inclusion criteria were included in the final analyses. Spin occurred in 3.5% (7/200) of the systematic review abstracts included in our sample. No study characteristics were significantly associated with spin. CONCLUSIONS: Of the reviewed abstracts in systematic reviews and meta-analyses, 96.5% of those that focused on smoking cessation were free of spin. However, the existence of spin warrants further steps to improve the scientific accuracy of abstracts on smoking cessation treatments. By identifying and acknowledging the presence of spin in systematic reviews, we hope to increase awareness about reporting practices in an ultimate effort to improve the integrity of scientific research as a whole.