Developing a Digital Marketplace for Family Planning: Pilot Randomized Encouragement Trial.

BACKGROUND: Family planning is an effective tool for preventing death among women who do not want to become pregnant and has been shown to improve newborn health outcomes, advance women's empowerment, and bring socioeconomic benefits through reductions in fertility and population growth. Yet among the populations that would benefit the most from family planning, uptake remains too low. The emergence of digital health tools has created new opportunities to strengthen health systems and promote behavior change. In this study, women with an unmet need for family planning in Western Kenya were randomized to receive an encouragement to try an automated investigational digital health intervention that promoted the uptake of family planning. OBJECTIVE: The objectives of the pilot study were to explore the feasibility of a full-scale trial-in particular, the recruitment, encouragement, and follow-up data collection procedures-and to examine the preliminary effect of the intervention on contraception uptake. METHODS: This pilot study tested the procedures for a randomized encouragement trial. We recruited 112 women with an unmet need for family planning from local markets in Western Kenya, conducted an eligibility screening, and randomized half of the women to receive an encouragement to try the investigational intervention. Four months after encouraging the treatment group, we conducted a follow-up survey with enrolled participants via short message service (SMS) text message. RESULTS: The encouragement sent via SMS text messages to the treatment group led to differential rates of intervention uptake between the treatment and control groups; however, uptake by the treatment group was lower than anticipated (19/56, 33.9% vs 1/56, 1.8%, in the control group). Study attrition was also substantial. We obtained follow-up data from 44.6% (50/112) of enrolled participants. Among those in the treatment group who tried the intervention, the instrumental variables estimate of the local average treatment effect was an increase in the probability of contraceptive uptake of 41.0 percentage points (95% uncertainty interval -0.03 to 0.85). CONCLUSIONS: This randomized encouragement design and study protocol is feasible but requires modifications to the recruitment, encouragement, and follow-up data collection procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT03224390; https://clinicaltrials.gov/ct2/show/NCT03224390 (Archived by WebCite at http://www.webcitation.org/70yitdJu8).

Racial and Ethnic Disparities in Providing Guideline-Concordant Care After Hip Fracture Surgery.

Importance: Institutions have adopted protocol-driven standardized hip fracture programs (SHFPs). However, concerns persist regarding bias in adherence to guideline-concordant care leading to disparities in implementing high-quality care for patients recovering from surgery for hip fracture. Objective: To assess disparities in the implementation of guideline-concordant care for patients after hip fracture surgery in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Targeted Hip Fracture (THF) Database. Design, Setting, and Participants: This cross-sectional study was conducted using the ACS-NSQIP THF database from 2016 to 2021 for patients aged 65 years and older with hip fractures undergoing surgical fixation. Care outcomes of racial and ethnic minority patients (including American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, or multiple races and Hispanic ethnicity) were compared with non-Hispanic White patients via risk difference, stratified by care institution SHFP status. Modified Poisson regression was used to measure interactions. Statistical analysis was performed from November 2022 to June 2024. Main Outcomes and Measures: The primary outcomes of interest encompassed weight-bearing as tolerated (WBAT) on postoperative day 1 (POD1), venous thromboembolism (VTE) prophylaxis, bone-protective medication, and the presence of SHFP at the institution. Results: Among 62 194 patients (mean [SD] age, 82.4 [7.3] years; 43 356 [69.7%] female) who met inclusion criteria and after multiple imputation, 11.2% (95% CI, 10.8%-11.5%) were racial and ethnic minority patients, 3.3% (95% CI, 3.1%-3.4%) were Hispanic patients, and 92.0% (95% CI, 91.7%-92.2%) were White. Receiving care at an institution with an SHFP was associated with improved likelihood of receiving guideline-concordant care for all patients to varying degrees across care outcomes. SHFP was associated with higher probability of being WBAT-POD1 (risk difference for racial and ethnic minority patients, 0.030 [95% CI, 0.004-0.056]; risk difference for non-Hispanic White patients, 0.037 [95% CI, 0.029-0.45]) and being prescribed VTE prophylaxis (risk difference for racial and ethnic minority patients, 0.066 [95% CI, 0.040-0.093]; risk difference for non-Hispanic White patients, 0.080 [95% CI, 0.071-0.089]), but SHFP was associated with the largest improvements in receipt of bone-protective medications (risk difference for racial and ethnic minority patients, 0.149 [95% CI, 0.121-0.178]; risk difference for non-Hispanic White patients, 0.181 [95% CI, 0.173-0.190]). While receiving care at an SHFP was associated with improved probability of receiving guideline-concordant care in both race and ethnicity groups, greater improvements were seen among non-Hispanic White patients compared with racial and ethnic minority patients. Conclusions and Relevance: Older adults who received care at an institution with an SHFP were more likely to receive guideline-concordant care (bone-protective medication, WBAT-POD1, and VTE prophylaxis), regardless of race and ethnicity. However, the probability of receiving guideline-concordant care at an institution with an SHFP increased more for non-Hispanic White patients than racial and ethnic minority patients.

Addressing meniscal deficiency part 2: An umbrella review of systematic reviews and meta-analyses on meniscal scaffold-based approaches.

Purpose: Meniscal injuries are common in knee surgery and often require preservation techniques to prevent secondary osteoarthritis. Despite advancements in repair techniques, some patients undergo partial meniscectomy, which can lead to postmeniscectomy syndrome. To address these challenges, meniscal substitution techniques like scaffolds have been developed. However, a comprehensive synthesis of the existing evidence through an umbrella review is lacking. Methods: A comprehensive search was conducted in the MEDLINE, Embase and Scopus databases to identify relevant systematic reviews and meta-analyses. Studies were screened based on predefined inclusion and exclusion criteria. The quality of included studies was assessed using the AMSTAR-2 tool. Results: A total of 17 studies met the inclusion criteria and were included in the review. Most studies focused on the use of collagen-based scaffolds, with fewer studies evaluating synthetic scaffolds. The majority of studies (52.9%) were rated as having 'Critically Low' overall confidence, with only one study (5.9%) rated as 'High' confidence and most studies exhibiting methodological limitations, such as small sample sizes and lack of long-term follow-up. Despite these limitations, the majority of studies reported positive short-term outcomes, including pain relief and functional improvement, following scaffold implantation. However, some studies noted a relatively high failure rate. Radiographically, outcomes also varied, with some studies reporting morphological deterioration of the implant seen on MRI, while others noted possible chondroprotective effects. Conclusions: Meniscal scaffold-based approaches show promise in the management of meniscal deficiency; however, the current evidence is limited by methodological shortcomings. One notable gap in the literature is the lack of clear guidelines for patient selection and surgical technique. Future research should focus on conducting well-designed randomized controlled trials with long-term follow-up to further elucidate the benefits and indications of these techniques in clinical practice. Additionally, efforts should be made to develop consensus guidelines to standardize the use of meniscal scaffolds and improve patient outcomes. Despite limited availability, synthesizing the literature on meniscal scaffold-based approaches is crucial for understanding research, guiding clinical decisions and informing future directions. Level of Evidence: Level IV.

The Effect of Social Drivers of Health on 90-Day Readmission Rates and Costs After Primary Total Hip and Total Knee Arthroplasty.

INTRODUCTION: The effect of social drivers of health (SDOH) on readmissions and costs after total hip arthroplasty (THA) and total knee arthroplasty (TKA) is poorly understood. Policies such as the Hospital Readmissions Reduction Program have targeted overall readmission reduction, using value-based strategies to improve healthcare quality. However, the implications of SDOH on these outcomes are not yet understood. We hypothesized that the area deprivation index (ADI) as a surrogate for SDOH would markedly influence readmission rates and healthcare costs in the 90-day postprocedural period for THA and TKA. METHODS: We used the 100% US fee-for-service Medicare claims data from 2019 to 2021. Patients were identified using diagnosis-related groups. Our primary outcomes included 90-day unplanned readmission after hospital discharge and cost of care, treated as "high cost" if > 1 standard deviation above the mean. The relationships between ADI and primary outcomes were estimated with logistic regression models. RESULTS: A total of 628,399 patients were included in this study. The mean age of patients was 75.6, 64% were female, and 7.8% were dually eligible for Medicaid. After full covariate adjustment, readmission was higher for patients in more deprived areas (high Area Deprivation Index (ADI)) (low socioeconomic status (SES) group OR: 1.30 [95% confidence intervals 1.23, 1.38]). ADI was associated with high cost before adjustment (low SES group odds ratio 1.08 [95% confidence intervals 1.04, 1.11], P < 0.001), although, after adjustment, this association was lost. DISCUSSION: This analysis highlights the effect of SDOH on readmission rates after THA and TKA. A nuanced understanding of neighborhood-level disparities may facilitate targeted strategies to reduce avoidable readmissions in orthopaedic surgery. Regarding cost, although there is some association between ADI and cost, this study may illustrate that ADI for THA and TKA is not sufficiently granular to identify the contribution of social drivers to elevated costs.

Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology.

BACKGROUND: Single patient Investigational New Drug (IND) applications are one mechanism through which experimental therapies are accessed for children with cancer. The landscape of use, outcomes, and toxicity from single patient INDs remains unknown in pediatric oncology. METHODS: We performed a retrospective analysis of all single patient INDs requested and prescribed at a single institution between 1/1/2007 and 5/1/2019. We report aggregate data from the US Food and Drug Administration (FDA) on single patient IND applications over the final two years of the study (2017-2019). We report an overview of all IND applications, as well as clinical descriptions of patients, treatments, outcomes, and toxicity. RESULTS: Over the 2-year period, the FDA approved all 171 submitted single patient IND requests for pediatric oncology. We identified 56 requests from our center during the 12-year study period, and all were approved (median time from FDA submission to approval: 1 day (range 0-12)). 71% of requests were based on disease histology. Lack of pediatric clinical trial (65%) was the most common reason for use. 48 approved requests were ultimately administered. The median duration of treatment was 84 days (range: 4-1590), with 3 patients remaining on treatment at time of analysis. Only 7% discontinued treatment due to toxicity. Three-year overall survival was 50% (95% CI, 35-64). CONCLUSIONS: Single patient INDs in pediatric oncology were universally approved in our national and single-center analysis. In our cohort, single patient INDs were primarily utilized based on disease histology, rather than genomics, for agents that lacked a clinical trial.