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CONTEXT: The use of telemedicine strategies has been increasing in the United States for more than a decade, with physicians taking advantage of this new tool to reach more patients. Determining the specific demographics of physicians utilizing telemedicine most in their practice can inform recommendations for expanded telemedicine use among all physicians and aid in mitigating the need for local physicians in urban and rural populations. OBJECTIVES: This study aims to assess the use of telemedicine by physicians in 2021, based on four demographics utilizing the National Electronic Health Record Survey (NEHRS): physician age, sex, specialty, and training. METHODS: We performed a cross-sectional study of the 2021 NEHRS to determine the relationship between physician characteristics and telemedicine practices. Differences between groups were measured through design-based chi-square tests. RESULTS: Compared to male physicians, female physicians were more likely to utilize telemedicine services (X 2=8.0; p=0.005). Compared to younger physicians, those over the age of 50 were less likely to utilize telemedicine services (X 2=4.1; p=0.04). Compared to primary care physicians, medical and surgical specialty physicians were less likely to utilize telemedicine services, with surgical specialty physicians being the least likely overall (X 2=11.5; p<0.001). We found no significant differences in telemedicine use based on degree (Osteopathic and Allopathic). CONCLUSIONS: Our results showed a statistically significant difference between physician's age, sex, and specialty on telemedicine use in practice during 2021. Efforts to increase telemedicine use among physicians may be needed to provide more accessible care to patients. Thus, by increasing physician education on the importance of telemedicine for modern patients, more physicians may decide to utilize telemedicine services in practice.
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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.
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Osteoartritis de la Cadera , Osteoartritis de la Rodilla , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Estudios Transversales , Calidad de Vida , Evaluación de Resultado en la Atención de SaludRESUMEN
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.
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Pruebas Neuropsicológicas , Trastornos Relacionados con Sustancias , Humanos , Trastornos Relacionados con Sustancias/diagnóstico , Femenino , Masculino , Pruebas Neuropsicológicas/estadística & datos numéricos , Factores SexualesRESUMEN
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.
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Púrpura Trombocitopénica Idiopática , Humanos , Estudios Transversales , Evaluación de Resultado en la Atención de Salud , Recuento de Plaquetas , Púrpura Trombocitopénica Idiopática/tratamiento farmacológico , Sistema de Registros , Ensayos Clínicos como AsuntoRESUMEN
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 3.7â¯% (n=2991) of high school athletes reported previous steroid use and that 20.7â¯% (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 (7.2â¯%) among American Indian/Alaska Natives (AI/AN). A significantly higher prevalence of steroid use occurred in athletes who were males (4.7â¯%) than females (2.5â¯%) and in athletes with a BMI>95â¯% (5.2â¯%) compared with those with a BMI between 85 and 95â¯% (3.9â¯%) and <85â¯% (3.5â¯%) (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 3.4â¯% in 1999 to 1.9â¯% in 2019, with the most drastic drop occurring between 2015 and 2019-declining 1.9â¯%. Whereas 19.6â¯% of athletes reported a concussion without steroid use, 54.6â¯% of steroid-utilizing athletes reported having experienced a concussion-a statistically significant finding (adjusted odds ratio [AOR]=4.3; 95â¯% 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; 95â¯% 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.
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Traumatismos en Atletas , Conmoción Encefálica , Masculino , Femenino , Humanos , Adolescente , Estudios Transversales , Traumatismos en Atletas/epidemiología , Conmoción Encefálica/epidemiología , Atletas , Esteroides , Asunción de RiesgosRESUMEN
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.
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Nacimiento Prematuro , Recién Nacido , Femenino , Humanos , Nacimiento Prematuro/prevención & control , Estudios Transversales , Evaluación de Resultado en la Atención de Salud , Análisis de Series de Tiempo Interrumpido , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
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.
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Enfermedad de Parkinson , Humanos , Enfermedad de Parkinson/diagnóstico , Enfermedad de Parkinson/complicaciones , Ensayos Clínicos Controlados Aleatorios como Asunto , Evaluación de Resultado en la Atención de SaludRESUMEN
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.
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Inequidades en Salud , Diálisis Renal , HumanosRESUMEN
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.
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Sobredosis de Droga , Trastornos Relacionados con Opioides , Humanos , Tratamiento de Sustitución de Opiáceos/métodos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Sobredosis de Droga/tratamiento farmacológico , Atención Dirigida al PacienteRESUMEN
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.
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Trastornos por Estrés Postraumático , Veteranos , Humanos , Publicaciones , Proyectos de Investigación , Preparaciones FarmacéuticasRESUMEN
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.