Tag: statistics

JAMA Netw Open. 2025 May 1;8(5):e259481. doi: 10.1001/jamanetworkopen.2025.9481.

ABSTRACT

IMPORTANCE: Patient-staff interactions in clinical trials may influence future enrollment decisions among racial and ethnic minority patients, who remain underrepresented in clinical research. A scale that measures common patient-staff interactions encountered by racial and ethnic minority patients in clinical trials may help improve patient experience and enrollment outcomes.

OBJECTIVE: To develop and validate a scale that measures common interactions encountered by racial and ethnic minority patients in clinical trials.

DESIGN, SETTING, AND PARTICIPANTS: This mixed-methods survey study involved interviews and online surveys for data collection between April 1, 2023, and June 30, 2024. Adult (aged ≥18 years) racial and ethnic minority patients were interviewed to identify common interactions with research staff. The survey was validated across potential clinical trial participants and among former clinical trial participants.

MAIN OUTCOMES AND MEASURES: Fit statistics for exploratory factor analysis and confirmatory factor analysis were used to confirm the validity of the scale. Structural equation modeling coefficients were used to assess the validity of the scale for measuring patients’ trust toward the research staff and willingness to participate in future studies.

RESULTS: The sample include 1113 participants. The scale item derivation cohort comprised 16 racial and ethnic minority participants with clinical trial experience (mean [SD] age, 44.9 [12.9] years; 10 female [62.5%]; 3 identifying as Asian or Pacific Islander [18.8%], 9 as Black [56.3%], 3 as Latino [18.8%], and 1 as multiracial [6.3%]). The scale structure validation cohort of potential clinical trial participants comprised 479 survey respondents (mean [SD] age, 35.5 [11.9] years; 219 women [45.7%]; 1 identifying as American Indian [0.2%], 59 as Asian or Pacific Islander [12.3%], 266 as Black [55.5%], 59 as Latino [12.3%], and 86 as multiracial [19.7%]). The concurrent validation cohort included 618 participants (mean [SD] age, 45.3 [16.3] years; 53% male; 63 identifying as Asian or Pacific Islander [10.2%], 228 as Black [36.9%], 75 as Latino [12.1%], 223 as White [36.1%], and 29 as multiracial [4.7%]). The 22-item Clinical Research Interaction Scale had high reliability (α = 0.96) and validity (comparative fit index, 0.92; Tucker-Lewis index, 0.91; root mean square error of approximation, 0.08). Patient experience of frequent low-quality interactions was significantly associated with lowered trust toward research staff (β, -0.56; 95% CI, -0.74 to -0.37), which in turn significantly lowered patients’ willingness to return to the site for future studies (β, 0.80; 95% CI, 0.70-0.90).

CONCLUSIONS AND RELEVANCE: These findings suggest that low-quality interactions with research staff may reduce racial and ethnic minority patients’ willingness to return for future studies, mediated by lowered trust toward the staff. The Clinical Research Interaction Scale may be a useful tool to improve the experience and enrollment outcomes for racial and ethnic minorities in clinical trials.

PMID:40358951 | DOI:10.1001/jamanetworkopen.2025.9481

JAMA Netw Open. 2025 May 1;8(5):e259599. doi: 10.1001/jamanetworkopen.2025.9599.

ABSTRACT

IMPORTANCE: Language used in clinical documentation can reflect biases, potentially contributing to health disparities. Understanding associations between patient race and ethnicity and documentation of stigmatizing and positive language in clinical notes is crucial for addressing health disparities and improving patient care.

OBJECTIVE: To examine associations of race and ethnicity with stigmatizing and positive language documentation in clinical notes from hospital birth admission.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included birthing patients at 2 metropolitan hospitals in the Northeastern US between 2017 and 2019. Eligible participants were admitted for labor and birth and had at least 1 free-text clinical note. Analysis was conducted using natural language processing. Data were analyzed between March and December 2024.

EXPOSURES: Patient race and ethnicity, categorized into mutually exclusive groups of Asian or Pacific Islander, Black, Hispanic, and White.

MAIN OUTCOME AND MEASURES: Presence of 4 stigmatizing language categories (marginalized language or identities, difficult patient, unilateral or authoritarian decisions, and questioning patient credibility) and 2 positive language categories (preferred and/or autonomy, power and/or privilege).

RESULTS: Among the 18 646 patients included in the study (mean [SD] age, 30.5 [6.2] years), 2121 were Black (11.4%), 11 078 were Hispanic (59.4%), and 4270 were White (22.9%). The majority (10 559 patients [56.6%]) were insured by Medicaid. Compared with White patients, Black patients had higher odds of having any stigmatizing language (model 2: odds ratio [OR], 1.25; 95% CI, 1.05-1.49; P < .001), after adjustment for demographic characteristics. Black patients also had higher odds of any positive language documented (model 2: OR, 1.18; 95% CI, 1.05-1.32; P = .006). Hispanic patients had lower odds of documented positive language (model 2: OR, 0.90; 95% CI, 0.82-0.99; P = .03). Asian or Pacific Islander patients had lower odds of language documented in the power and/or privilege category (model 2: OR, 0.71; 95% CI, 0.57-0.88; P = .002).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study examining clinical notes of 18 646 patients admitted for labor and birth, there were notable disparities in how stigmatizing and positive language was documented across racial and ethnic groups. This underscores the necessity for improving documentation and communication practices to reduce the use of stigmatizing language.

PMID:40358949 | DOI:10.1001/jamanetworkopen.2025.9599

JAMA Netw Open. 2025 May 1;8(5):e259852. doi: 10.1001/jamanetworkopen.2025.9852.

ABSTRACT

IMPORTANCE: Value-based health care increasingly requires electronic patient-reported outcome-based remote symptom monitoring (RSM) to improve health care utilization in patients with cancer. However, data on the impact of RSM in clinical practice are lacking.

OBJECTIVE: To evaluate the association of RSM with 3- and 6-month health care utilization among patients receiving systemic cancer treatment.

DESIGN, SETTING, AND PARTICIPANTS: This nonrandomized controlled trial used a hybrid, type 2 implementation-effectiveness design. Participants were patients with cancer at 2 Alabama-based academic institutions receiving chemotherapy, targeted therapy, or immunotherapy; the exposure group received standard-of-care delivered RSM from 2021 to 2024, and historical controls were patients who received cancer treatment prior to RSM implementation from 2017 to 2021. Data were analyzed from May to October 2024.

EXPOSURE: RSM using electronic patient-reported outcomes.

MAIN OUTCOMES AND MEASURES: Health care utilization at 3 and 6 months after RSM enrollment (intensive care unit [ICU] admissions, hospitalizations, emergency department [ED] visits). Adjusted modified Poisson models estimated the relative risk (RR) and 95% CI of health care utilization overall. Penalized logistic regression was used for stratified analyses by patient race, residence, neighborhood deprivation, insurance type, and comorbid conditions.

RESULTS: A total of 5949 patients were assessed. From May 2021 to May 2024, 1392 patients (median [IQR] age at index date, 61 [51-69] years; 933 [67%] female) were enrolled in RSM, including 378 Black patients (27%) and 922 White patients (66%), with 262 patients (19%) living in rural areas and 372 patients (27%) living in areas with high neighborhood disadvantage; RSM patients were compared with 4557 controls (median [IQR] age at index date, 62 [53-69] years; 2654 [58%] female), including 1177 Black patients (26%) and 3151 White patients (69%), with 1012 patients (22%) living in rural areas, and 1281 patients (28%) living in areas with high neighborhood disadvantage. Compared with historical controls, hospitalizations among patients receiving RSM were 19% lower at 3 months (RR, 0.81; 95% CI, 0.73-0.91) and 13% lower at 6 months (RR, 0.87; 95% CI, 0.80-0.96). ICU admissions were not significantly different among the RSM populations compared with controls (3 months: RR, 0.82; 95% CI, 0.59-1.13; 6 months: RR, 0.83; 95% CI, 0.65-1.06). ED visits were similar for both groups (3 months: RR, 1.02; 95% CI, 0.89-1.16; 6 months: RR, 1.03; 95% CI, 0.92-1.15). Subset analyses showed similar patterns in 3- and 6-month RR for hospitalizations, ED visits, and ICU admissions.

CONCLUSIONS AND RELEVANCE: In this nonrandomized controlled trial, RSM implementation was associated with reduced risk of hospitalizations for patients with cancer, supporting the need to expand implementation nationally.

PMID:40358948 | DOI:10.1001/jamanetworkopen.2025.9852

JAMA Netw Open. 2025 May 1;8(5):e2510016. doi: 10.1001/jamanetworkopen.2025.10016.

ABSTRACT

IMPORTANCE: Although structural and social determinants of health (SSDH) have been consistently associated with health disparities, percentage African genetic ancestry (AGA) has been suggested as a risk factor associated with common diseases in Black populations. Appropriate use and interpretation of percentage AGA in understanding health disparities has been complicated by the fact that percentage AGA is correlated with genetic and nongenetic factors.

OBJECTIVE: To evaluate associations of SSDH with mortality in the context of percentage AGA and how percentage AGA is correlated with SSDH.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study investigated data from the Multiethnic Cohort (MEC) Study, in which participants were enrolled from 1993 through 1996 and followed up until death or censoring on December 31, 2019. Participant data were analyzed between March and June 2023. The population-based sample was predominantly from Los Angeles County, California, consisting of self-identified Black adults aged 45 to 75 years who enrolled into the MEC Study; completed a baseline demographic, clinical, and lifestyle questionnaire; and provided biospecimens.

EXPOSURES: The Index of Concentration at the Extremes (ICE), capturing social polarization based on income and racial composition, and a neighborhood socioeconomic status (NSES) index were computed from the 1990 Census, scaled to county-specific quintiles, and linked to residential census tracts at study enrollment. Percentage AGA was estimated using 21 431 single-nucleotide variations based on similarity with African continental referent data.

MAIN OUTCOMES AND MEASURES: Multivariable hazard ratios (HRs) for all-cause mortality were estimated from Cox models. Correlation of percentage AGA with SSDH measures was described.

RESULTS: After exclusions, 9685 participants were included (mean [SD] age, 61.0 [8.9] years; 5593 female [57.7%]), with a mean (SD) percentage AGA of 75.0% (14.0%). There were 5504 deaths over 204 463 person-years of follow-up. Comparing the most with least advantaged quintile, income ICE (adjusted HR [aHR], 1.30; 95% CI, 1.16-1.45) and NSES (aHR, 1.37, 95% CI, 1.20-1.56) were associated with lower all-cause mortality. Minimal changes were observed after adjusting for percentage AGA; for example, comparing the most with least advantaged quintile, NSES (aHR, 1.36; 95% CI, 1.19-1.55) remained associated with lower all-cause mortality. There was no association between percentage AGA and mortality after adjustment (aHR per 10-percentage point change in percentage AGA, 1.01; 95% CI, 0.99-1.03).

CONCLUSIONS AND RELEVANCE: In this study, associations of SSDH with mortality persisted with adjustment for percentage AGA. Findings support the hypothesis that SSDH should be the primary factors to consider for eliminating health disparities.

PMID:40358946 | DOI:10.1001/jamanetworkopen.2025.10016

JAMA Netw Open. 2025 May 1;8(5):e2510077. doi: 10.1001/jamanetworkopen.2025.10077.

ABSTRACT

IMPORTANCE: Illegal fentanyl is driving overdose mortality, and fentanyl test strips (FTS) can be used to test drugs for fentanyl at the point of consumption. Evidence on whether FTS use is associated with overdose risk reduction behaviors is encouraging, but largely limited to smaller, single-site studies.

OBJECTIVE: To determine whether self-reported baseline FTS use among people who use drugs (PWUD) was associated with overdose risk reduction behaviors and nonfatal overdose over a 28-day follow-up.

DESIGN, SETTING, AND PARTICIPANTS: Multisite, observational cohort study of PWUD conducted from May to December 2023 as an ancillary study of the HEALing Communities Study, which consists of fixed and mobile direct service provision sites in 14 community partner organizations distributing FTS. Participants lived in Kentucky, New York, or Ohio and reported using heroin, fentanyl, cocaine, methamphetamine, or nonprescribed opioids, benzodiazepines, or stimulants within 30 days before baseline. Participants were followed up for a maximum of 37 days.

EXPOSURE: Baseline FTS use.

MAIN OUTCOME AND MEASURES: The primary outcome was a composite score measuring the self-reported number and frequency of using 8 overdose risk reduction behaviors. Secondary outcomes included multiple measures (eg, self-reported nonfatal overdose).

RESULTS: The study included 732 participants (median [IQR] age, 41 [34.0-48.0] years; 369 [50.4%] male; 64 [8.9%] Black or African American, 587 [81.3%] White, and 71 [9.8%] other races); 414 reported baseline FTS use and 318 did not. Compared with nonusers, a higher percentage of baseline FTS users were from Ohio and White, while a lower percentage were from New York and Hispanic and/or Black. In adjusted analyses, PWUD who used FTS had a mean daily composite score for overdose risk reduction behaviors that was 0.86 (95% CI, 0.34-1.38) units higher across follow-up compared with nonusers (score for FTS users, 7.37; nonusers, 6.51). There was no difference in self-reported nonfatal overdoses between the 2 groups (mean daily risk for FTS users, 0.02; nonusers, 0.02; risk ratio, 1.20; 95% CI, 0.70-2.06).

CONCLUSIONS AND RELEVANCE: In this cohort study, baseline FTS use was associated with greater engagement in overdose risk reduction behaviors during follow-up, but not with the risk of nonfatal overdose during follow-up, suggesting PWUD who use FTS may also engage in a broader set of harm reduction strategies.

PMID:40358945 | DOI:10.1001/jamanetworkopen.2025.10077

JAMA Netw Open. 2025 May 1;8(5):e2510083. doi: 10.1001/jamanetworkopen.2025.10083.

ABSTRACT

IMPORTANCE: School-based health centers (SBHCs) provide students with convenient access to physical, mental, and dental health services, which is particularly important in rural areas with long travel distances and limited availability of primary care.

OBJECTIVE: To examine the association between SBHCs and school attendance in a rural region.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study compared attendance rates among students in school districts with and without SBHCs in rural upstate New York. Student attendance data from the 2015 to 2016 through the 2018 to 2019 school years were obtained for 52 schools in 32 districts within a regional education service area. Analysis included students in kindergarten through 12th grade from 18 schools in 14 districts with SBHCs and 34 schools in 18 districts without SBHCs. Multivariable logistic regression was used to model the association between SBHC access and risk of chronic absenteeism. Statistical analysis was performed from May 2024 to February 2025.

EXPOSURE: Access vs no access to an SBHC based on which district a student was enrolled in. In districts with SBHCs, all schools had SBHCs.

MAIN OUTCOMES AND MEASURES: Absenteeism was calculated as the number of days absent divided by the total days enrolled and classified by federal and state chronic absenteeism categories: not at risk (0%-4.99% absent), at risk of chronic absenteeism (5%-9.99% absent), and chronically absent (≥10% absent).

RESULTS: Attendance data were available for 66 303 students (kindergarten through 12th grade; 49.4% female) during 4 years: 30 046 from SBHC districts and 36 257 from non-SBHC districts. Across all but 1 school year, non-SBHC students were significantly more likely than SBHC students to be classified as chronically absent or at risk for chronic absenteeism. Students in SBHC districts had 12% greater odds of being not at risk for chronic absenteeism after accounting for grade, sex, school year, economic disadvantage, and community characteristics of wealth and district size (odds ratio, 1.12; 95% CI, 1.08-1.16). Evidence of a stronger association was found between SBHC access and reduced absenteeism among elementary school students and among children attending schools with higher student poverty and higher community wealth.

CONCLUSIONS AND RELEVANCE: This cross-sectional study of rural students in kindergarten through 12th grade found that students in SBHC districts had significantly fewer absences than students in non-SBHC districts in the same region. These findings suggest that by providing primary care services at school, SBHCs may help decrease absenteeism among students in rural communities.

PMID:40358944 | DOI:10.1001/jamanetworkopen.2025.10083

Neurol Ther. 2025 May 13. doi: 10.1007/s40120-025-00759-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Neuromodulation therapies (including non-invasive and invasive neuromodulation) are being used to treat painful diabetic neuropathy (PDN).

METHODS: A systematic search of the PubMed, Embase, Cochrane Library, Web of Science, and Scopus databases was conducted, from their inception until 1 October 2024, to identify randomized controlled trials (RCTs) on neuromodulation therapies for PDN. Data were collected on pain intensity of various adjunctive therapies for PDN, including transcutaneous electrical nerve stimulation (TENS), percutaneous electrical nerve stimulation, repetitive transcranial magnetic stimulation, pulsed electromagnetic field therapy, spinal cord stimulation (SCS), transcranial direct current stimulation, frequency rhythmic electrical modulation system, mesodiencephalic modulation, and sham.

RESULTS: The data from an aggregate of 12 separate studies, comprising a total sample size of 922 participants, was subject to analysis. All seven neuromodulation therapies exhibited better outcomes in pain intensity compared to the Sham intervention, with TENS achieving the highest ranking, followed by SCS. At the final follow-up time point, statistically significant reductions in pain intensity (vs. Sham) was only observed for SCS.

CONCLUSION: The results of this network meta-analysis should facilitate the development of clinical guidance and enhance the decision-making process for both patients and healthcare professionals, thereby identifying the most appropriate PDN treatment options.

TRIAL REGISTRATION: PROSPERO: CRD42024597208.

PMID:40358907 | DOI:10.1007/s40120-025-00759-1

Adv Ther. 2025 May 13. doi: 10.1007/s12325-025-03200-z. Online ahead of print.

ABSTRACT

INTRODUCTION: Physical inactivity contributes to non-communicable disease (NCD) health burden, making it essential to study and address this issue at a population level. The present research aims to explore the patterns of physical activity (PA) in Haryana through a subgroup analysis of the national Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study.

METHODS: This study was conducted between December 2018 and July 2019 in Haryana and included 3918 adult participants. Physical activity was assessed using the validated MDRF Physical Activity Questionnaire (MPAQ), which has domain-wise assessments of PA. Weighted prevalence was estimated using state-specific sampling weights, and associations between PA, anthropometric and biochemical profiles were assessed using bivariate analysis done using Student’s unpaired t tests, one-way analysis of variance (ANOVA), or chi-square tests. Factors describing the likelihood of being active were ascertained using a multivariable nominal regression analysis.

RESULTS: About 73% of the study participants were physically inactive, and only 27% were moderately to vigorously active. The time spent in different PA domains varied significantly across sociodemographic variables, including sex, education, region, occupation, and socioeconomic status. Participants from the middle socioeconomic class spent more time in work-related PA, compared to low and upper-class participants who spent more time in general and transport-related PA. There were significant statistical differences between active and non-active groups concerning their mean blood glucose levels, body mass index, waist circumference and systolic blood pressure, but the differences in the lipid profile were non-significant. However, regression analysis showed higher odds of being physically active among younger participants, men, residents in rural areas, and those having fewer years of education.

CONCLUSION: We highlight the alarmingly high prevalence of physical inactivity across different segments of society in Haryana with significant sociodemographic disparities. Considering the increasing prevalence of NCDs, it is high time to prioritise health promotion measures and inculcate more physical activity amongst the population to achieve health-related sustainable development goals.

PMID:40358896 | DOI:10.1007/s12325-025-03200-z

Biochem Genet. 2025 May 13. doi: 10.1007/s10528-025-11131-1. Online ahead of print.

ABSTRACT

This study aimed to identify differentially expressed long non-coding RNAs (lncRNAs) and messenger RNAs (mRNAs) in damaged cartilage (DC) and un-damaged cartilage (UDC) in human osteoarthritis (OA), exploring their roles in disease progression through bioinformatics analysis and ceRNA network construction. Cartilage samples from 5 OA patients undergoing total knee arthroplasty were analyzed. RNA sequencing was used to detect the expression of lncRNAs and mRNAs in DC and UDC samples. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses were performed to investigate biological processes. A ceRNA network was constructed, and differentially expressed RNAs were validated by quantitative real-time polymerase chain reaction (qRT-PCR). In the damaged cartilage (DC) samples, 5 lncRNAs were significantly upregulated, and 15 were significantly downregulated, while 8 mRNAs were upregulated, and 8 were downregulated. The differential expression of lncRNAs, including LINC01411, AL596087.2, PCDH20, LRFN2, and AL583785.1, was confirmed using qRT-PCR, with p-values for all results showing statistical significance (p < 0.05). GO/KEGG enrichment analysis revealed key pathways such as Ras, PI3K-Akt, and MAPK that were significantly involved in OA pathogenesis. The ceRNA network construction highlighted crucial miRNA interactions, identifying potential regulators of cartilage-related biological processes. Differentially expressed lncRNAs and mRNAs are involved in critical signaling pathways in OA cartilage, suggesting their potential as biomarkers or therapeutic targets for OA treatment. Further functional studies are needed to fully elucidate their roles in OA pathogenesis.

PMID:40358893 | DOI:10.1007/s10528-025-11131-1

Spine Deform. 2025 May 13. doi: 10.1007/s43390-025-01106-y. Online ahead of print.

ABSTRACT

PURPOSE: Surgical invasiveness indices have been used in adult spine surgery to characterize the invasiveness of complex procedures and for risk stratification. This has not been studied in the pediatric population. The purpose of this study was to develop and validate a surgical invasiveness index for pediatric spinal deformity surgery.

METHODS: The National Surgical Quality Improvement Program (NSQIP) Pediatric database was queried between the years 2016-2022. Patients were included if they were <18 years of age, received posterior or anterior-posterior spinal fusion surgery, and had a diagnosis of spinal deformity. The study cohort was divided into a derivation cohort and a validation cohort. A multivariable linear regression analysis was performed to identify surgical components associated with operative time. Surgical components of interest included number of posterior fusion levels, number of anterior fusion levels, pelvic instrumentation, posterior column osteotomies, three-column osteotomies, and prior spinal deformity surgery. Statistically significant variables were used to establish a pediatric spinal deformity surgical invasiveness index. The score was assessed and validated using linear and logistic regression analysis and receiver operating characteristic curve analysis on operative time and allogeneic transfusion.

RESULTS: There were 37,658 patients included (Derivation cohort: 26,372; Validation cohort: 11,286). In the linear regression analysis, more posterior fusion levels (7-12 levels: 0.54, p<0.001;>12 levels: 1.40, p<0.001), anterior fusion 1-3 levels (2.42, p<0.001), anterior fusion ≥4 levels (2.93, p<0.001), pelvic instrumentation (0.79, p<0.001), and previous spinal deformity surgery (0.44, p<0.001) were associated with longer operative time. Each level of posterior column osteotomy (0.13, p<0.001) and three-column osteotomy (0.61, p<0.001) were associated with increased operative time. Points were assigned to each surgical component: 7-12 posterior fusion levels (4 pts), >12 posterior fusion levels (11 pts), anterior fusion 1-3 levels (19 pts), anterior fusion ≥4 levels (23 pts), pelvic instrumentation (6 pts), previous spinal deformity surgery (3 pts), posterior column osteotomy (1 pt per level), and three-column osteotomy (5 pts per level). In the derivation cohort, each point was associated with an increase in operative time by 0.13 hours (R²=0.16, p<0.001). In the validation cohort, each point was associated with an increase in operative time by 0.12 hours (R²=0.15, p<0.001). In the derivation cohort, the area under the curve (AUC) for operative time ≥8 hours and allogeneic transfusion were 0.74 and 0.71, respectively. In the validation cohort, the AUC for operative time ≥8 hours and allogeneic transfusion were 0.74 and 0.70, respectively.

CONCLUSION: A pediatric spinal deformity surgical invasiveness index was created and predictive of prolonged operative time and allogeneic transfusion. This is the first quantitative tool to measure the extent of surgical interventions in pediatric spine surgery.

PMID:40358891 | DOI:10.1007/s43390-025-01106-y