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Nevin Manimala Statistics

Feasibility of the aktivplan Digital Health Intervention for Regular Physical Activity Following Phase II Rehabilitation: Protocol for a Mixed Method Randomized Controlled Pilot Study (ACTIVE-CaRe Pilot)

JMIR Res Protoc. 2025 Sep 15;14:e73704. doi: 10.2196/73704.

ABSTRACT

BACKGROUND: Patients with cardiovascular disease (CVD) often encounter challenges in establishing and maintaining heart-healthy physical activity habits, even after successfully completing a cardiac rehabilitation program. Digital health technologies hold promise to support long-term habit formation in the secondary prevention of CVD. The aktivplan digital health intervention has been developed to support patients with CVD in establishing long-term heart-healthy physical activity habits.

OBJECTIVE: The primary study aim is to pilot and assess the feasibility of a future randomized controlled trial design to investigate the effectiveness of the aktivplan intervention and to assess the usability, user experience, and acceptance of the aktivplan app. The secondary objective is to collect clinical and safety outcomes.

METHODS: This multicenter, mixed method, randomized controlled pilot study aims to recruit 40 patients with an established diagnosis of CVD or with increased risk of CVD (physically inactive along with 1 further CVD risk factor) who are undergoing phase II rehabilitation at 2 rehabilitation centers in Austria. Participants will be allocated to the intervention or standard care control group by stratified randomization and will be monitored for 10 weeks after discharge from phase II rehabilitation. Participants, health care professionals, and outcome assessors are not masked (blinded) to group allocation. Data collection will include recruitment and drop-out rate; data completeness; adherence to the intervention; usability, user experience, and user acceptance questionnaires; technical reliability of the intervention; clinical assessments (exercise capacity, physical activity behavior, and CVD risk factors); adverse events; self-reported outcome measures (health-related quality of life, exercise self-efficacy, depression and anxiety, and kinesiophobia); patient interviews, and focus groups with health care professionals. Quantitative data will be analyzed descriptively, and 95% CIs will be calculated for recruitment and drop-out rates and for data completeness. No confirmatory inferential statistical analysis or hypothesis testing will be conducted. Qualitative data will be analyzed thematically by framework analysis.

RESULTS: A total of 34 participants were recruited between October 2023 and May 2024. Data collection was completed in August 2024. Currently, the data are being analyzed and prepared for publication. The first publication of feasibility results is expected by summer 2025.

CONCLUSIONS: This pilot study is expected to generate valuable and comprehensive insights to inform the study design of a future definitive effectiveness trial of the aktivplan intervention, guide the need for further iteration of the aktivplan app before entering a definitive trial, and inform future implementation strategies for the intervention.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06025526; https://clinicaltrials.gov/study/NCT06025526.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73704.

PMID:40953438 | DOI:10.2196/73704

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Nevin Manimala Statistics

Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery: Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854.

ABSTRACT

BACKGROUND: Ultrasound-guided regional anesthesia in hip surgery has been shown to reduce the need for opioids and conventional analgesics, facilitate ambulation and early recovery, improve respiratory dynamics, and decrease the incidence of venous thrombosis and pneumonia. Lumbar erector spinae plane block (L-ESPB) has been proposed as a novel ultrasound-guided locoregional technique to relieve pain in hip surgery; however, the supporting evidence remains scarce.

OBJECTIVE: This study aims to provide evidence on the role of L-ESPB in perioperative pain management during hip surgery. We hypothesize that patients receiving L-ESPB compared to those without block will have lower opioid consumption and less pain after hip surgery. The primary outcome is the difference in pain intensity, measured using the visual analog scale, at 2 hours postoperatively between the L-ESPB group and the control group. We will compare postoperative analgesic needs and opioid consumption in both groups, assess the technical ease of performing L-ESPB, and record any side effects in both treatment arms. Finally, we will evaluate the level of patient satisfaction.

METHODS: This is a pragmatic, single-center, parallel-group randomized controlled trial. After patients provide informed consent, they will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided L-ESPB or conventional intravenous analgesia. A total of 180 patients (n=90, 50% in each group) will be enrolled. Data analysis will be performed using SPSS software.

RESULTS: This clinical trial was approved by the European Medicines Agency on May 27, 2024, following approval by the local ethics committee earlier that month. Patient recruitment took place between June 2024 and May 2025. Statistical analysis is currently ongoing, and final results are expected to be submitted for publication in early 2026.

CONCLUSIONS: This clinical trial will enable us to assess the analgesic effectiveness of L-ESPB in hip surgery. We will also evaluate its safety and potential adverse effects compared with conventional analgesia and opioid consumption.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06567522; https://www.clinicaltrials.gov/study/NCT06567522.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/75854.

PMID:40953436 | DOI:10.2196/75854

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Nevin Manimala Statistics

Adaptive Batch Size Time Evolving Stochastic Gradient Descent for Federated Learning

IEEE Trans Pattern Anal Mach Intell. 2025 Sep 15;PP. doi: 10.1109/TPAMI.2025.3610169. Online ahead of print.

ABSTRACT

Variance reduction has been shown to improve the performance of Stochastic Gradient Descent (SGD) in centralized machine learning. However, when it is extended to federated learning systems, many issues may arise, including (i) mega-batch size settings; (ii) additional noise introduced by the gradient difference between the current iteration and the snapshot point; and (iii) gradient (statistical) heterogeneity. In this paper, we propose a lightweight algorithm termed federated adaptive batch size time evolving variance reduction (FedATEVR) to tackle these issues, consisting of an adaptive batch size setting scheme and a time-evolving variance reduction gradient estimator. In particular, we use the historical gradient information to set an appropriate mega-batch size for each client, which can steadily accelerate the local SGD process and reduce the computation cost. The historical information involves both global and local gradient, which mitigates unstable varying in mega-batch size introduced by gradient heterogeneity among the clients. For each client, the gradient difference between the current iteration and the snapshot point is used to tune the time-evolving weight of the variance reduction term in the gradient estimator. This can avoid meaningless variance reduction caused by the out-of-date snapshot point gradient. We theoretically prove that our algorithm can achieve a linear speedup of of $mathcal {O}(frac{1}{sqrt{SKT}})$ for non-convex objective functions under partial client participation. Extensive experiments demonstrate that our proposed method can achieve higher test accuracy than the baselines and decrease communication rounds greatly.

PMID:40953432 | DOI:10.1109/TPAMI.2025.3610169

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Nevin Manimala Statistics

Statistical Thinking in Medicine, Part 6: Creating Evidence (or What to Know Before Visiting a Statistician)

WMJ. 2025;124(3):312-316.

NO ABSTRACT

PMID:40953402

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Nevin Manimala Statistics

A Silent Wave: Increases in Wisconsin’s Alcohol- Related Mortality During the COVID-19 Pandemic

WMJ. 2025;124(3):270-273.

ABSTRACT

BACKGROUND: Alcohol-related mortality is an increasing public health concern in the United States. To date, no study has considered trends in alcohol-related deaths during the full COVID-19 pandemic period.

METHODS: We analyzed deaths from Wisconsin vital statistics to explore the relationship between the pandemic period and any changes in alcohol-related mortality.

RESULTS: In Wisconsin, the pandemic period was associated with additional alcohol-related mortality above and beyond a previously reported upward trend.

DISCUSSION: We show that the COVID-19 pandemic was associated with exacerbated alcohol-related mortality in Wisconsin. Alcohol use may need to be considered as an additional public health risk in future pandemic scenarios.

PMID:40953391

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Nevin Manimala Statistics

A Novel Coach-Approach to Clinical Faculty Mentoring and the UW Department of Medicine Clinical Faculty Development Program

WMJ. 2025;124(3):249-257.

ABSTRACT

INTRODUCTION: Clinical faculty at academic health centers may benefit from specific mentorship and proficiencies that are distinct from those on research tracks. We describe the creation, activities, and 1-year impact of a faculty development program that included novel professional coaching training (the Clinical Faculty Mentoring Program), which was supplemented by skills- and knowledge-building activities (the Clinical Faculty Development Series).

METHODS: The goals and components of the Clinical Faculty Mentoring Program and Clinical Faculty Development Series are described in detail. A mixed methods evaluation plan guided collection of confidential survey and interview data before and after the first year of these activities. We used paired t tests to identify statistically significant changes.

RESULTS: The 43 clinical mentors reported significant gains in job satisfaction, teaching attitudes, knowledge of mentorship competencies, and confidence with coaching skills for mentorship (all P < 0.05). Of mentor respondents, 88% found the coach approach to mentoring program to be “very” or “somewhat” helpful. Coaching behavioral domains with the greatest evidence of improvement were supporting the mentee to integrate new awareness, insight, and learning into their worldview and behaviors (P = 0.0503) and managing time and focus of mentoring sessions (P = 0.022). All 37 mentees had at least 1 meeting with a mentor (100%). Over 9 months, 39 virtual Clinical Faculty Development Series sessions had an average participation of 38 participants (range 22-59). A majority of surveyed faculty (>55%) agreed or strongly agreed the sessions provided valuable opportunities for skills development with teaching, leadership, wellness, diversity, equity, inclusion, and promotion.

CONCLUSIONS: Among clinical mentors, our novel coach approach to clinical faculty mentoring and skill-building had favorable effects on job satisfaction, knowledge of mentorship competencies, and confidence in coaching skills. Outcomes from the Clinical Faculty Development series supported the mentoring program outcomes. Longitudinal follow-up is needed to determine how this program will impact mentees.

PMID:40953388

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Nevin Manimala Statistics

The Empty SmartLink Solution: A Quality Improvement Initiative to Improve History and Physical Notes Documentation Using Clinical Decision Support

WMJ. 2025;124(3):236-242.

ABSTRACT

INTRODUCTION: The use of structured documentation via auto-populated discrete fields is important to facilitate medical decision-making, research, and quality improvement. If these fields are not filed properly, they will appear “empty,” leaving behind incomplete documentation. Examples include past medical history (PMH), past surgical history (PSH), family history (FH), and active hospital problems (AHP).

OBJECTIVES: Our SMART aim was to decrease the incidence of “no PMH/PSH/FH/AHP on file” in history and physical notes (H&Ps) at our single children’s hospital from 7.9%, 18.7%, 8.3%, and 17.0%, respectively, to less than 5% over 4 months.

METHODS: A multidisciplinary team utilized quality improvement methodology. The population included all encounters admitted to pediatric hospital medicine. The outcome measure was percentage of H&Ps with “no PMH/PSH/FH/AHP on file.” The process measure was percentage of H&Ps using the proper template. Interventions included a clinical decision support tool in H&P templates to display a hard stop if “no PMH/SH/FH/AHP on file” appears and documentation education. Statistical process control charts were used to analyze measures.

RESULTS: “No PMH/PSH/FH/AHP on file” decreased from baseline to 1.2%, 2.2%, 2.9%, and 4.2%, respectively, showing special cause variation. H&P template use remained high at 87.2%.

CONCLUSIONS: The creation of a simple clinical decision support tool was associated with a decreased incidence of “no PMH/PSH/FH/AHP on file,” achieving our goal. Utilizing automatic clinical decision support reduced the need to rely on education to cause a change, an important element of our tool. Future steps include implementation of a hard stop in other required areas of discrete documentation and ongoing evaluation of sustained change.

PMID:40953386

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Nevin Manimala Statistics

Characteristics of Patients Disengaged From Pharmacist-Led Hypertension Management in Primary Care: An Observational Study

WMJ. 2025;124(3):230-235.

ABSTRACT

INTRODUCTION: Hypertension is a leading cause of morbidity and mortality worldwide. Although it is often asymptomatic, adequate blood pressure control can help decrease the risk of cardiovascular, renal, and neurologic diseases. Clinical pharmacists can play a critical role in blood pressure management and have been shown to help patients meet their goals. Despite this, patients often disengage from pharmacy services, and reasons for this are not well understood. This study sought to evaluate characteristics of patients who are referred but not engaged in a primary care pharmacy antihypertensive service and explore potential reasons for disengagement.

METHODS: Data from the 2023 fiscal year (July 1, 2022 – June 30, 2023) were collected from UW Health’s electronic health record. Inclusion criteria were prespecified to include adults referred by their primary care provider to pharmacy services but who did not engage in care. Retrospective chart reviews were performed to gather demographic information on this population, and descriptive statistics were used for data analysis.

RESULTS: Of the 168 individuals who met the inclusion criteria, 66.1% of participants were not currently at their blood pressure goal. The majority of patients did not engage in pharmacist services due to lack of patient interest (n = 114, 67.9%) or being managed by another health care member team (n = 36, 21.4%).

CONCLUSIONS: The majority of patients who did not engage with a pharmacist for hypertension medication management despite referral from their primary care provider are not achieving their blood pressure goal.

PMID:40953385

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Nevin Manimala Statistics

Epidemiological Analysis of Chlamydia and Gonorrhea Cases in La Crosse County, Wisconsin, 2001-2020

WMJ. 2025;124(3):216-222.

ABSTRACT

INTRODUCTION: Chlamydia trachomatis and Neisseria gonorrhoeae are the two most reported bacterial infections in the United States, with over 1.5 million and 500 000 cases reported in 2019, respectively. The number of infections continues to rise, with significant disparities at the national level in the rate of infection between age, race, and sex demographic classifications. Although the disparities in chlamydia and gonorrhea infections have been well described in the US, little research has been done on a smaller community scale, such as La Crosse County, Wisconsin.

METHODS: We accessed data from La Crosse County, Wisconsin; the State of Wisconsin; and the United States for gonorrhea and chlamydia cases from 2001 through 2020 and completed both descriptive analysis and inferential statistical analysis.

RESULTS: Gonorrhea and chlamydia rates have risen at the local, state, and national levels. Demographic analysis of the cases in La Crosse County conveyed that females and Black populations having higher rates of infection. Additionally, the 25- to 39-year age group had a marked increase in gonorrhea rates at the county and state levels.

CONCLUSIONS: We were able to show demographic differences in chlamydia and gonorrhea incidence rates. The authors recommend that the 25- to 39-year-old group should undergo more regular comprehensive screening for all sexually transmitted infections.

PMID:40953383

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Nevin Manimala Statistics

The Impact of Blinding on the Recruitment of Diverse Pediatric Residents

Acad Med. 2025 Sep 15. doi: 10.1097/ACM.0000000000006268. Online ahead of print.

ABSTRACT

PURPOSE: Blinding in pediatric residency recruitment and the influence of implicit biases have not been formally studied. This study examined whether blinding to race and/or gender influences the selection of candidates for pediatric residency interviews and assessed the role of respondent implicit bias.

METHOD: An electronic survey was sent to all U.S. pediatric residency program directors in spring 2023. Nonresponders were sent weekly reminders for 5 weeks (survey remained open for 6 weeks). Respondents rated 5 fictitious applicants, each randomly assigned a gender (male, female, or blinded) and race (Black, White, or blinded), and completed an Implicit Association Test (IAT) to assess unconscious attitudes about race. The survey then asked about current strategies to mitigate unconscious bias in residency recruitment.

RESULTS: Responses were received from 85 of 202 programs (42%). All 85 program leaders reported using implicit bias training, with 64 of 83 (77%) using blinding and 74 of 84 (88%) using standardized rubrics to score applications as strategies to mitigate bias. The IAT revealed no statistically significant difference in the proportion of respondents with a positive implicit attitude toward Black versus White people (W = 840, P = .20). Statistically significant main effects were found for applicant race and interaction between applicant race and respondent IAT score, with respondents rating applicants with unknown race lower by a mean (95% CI) of 0.61 (0.07-1.16) points on the 5-point scale than the same applicants presenting as White or Black (t222 = 2.2, P = .03) and respondents rating White or unknown race applicants lower when their implicit attitudes toward Black people were more positive (t207 = -4.0, P < .001 and t208 = -2.9, P = .004, respectively).

CONCLUSIONS: Blinding applicant race may adversely impact some applicants’ interview prospects, suggesting that caution be applied when considering blinding to address implicit bias.

PMID:40953379 | DOI:10.1097/ACM.0000000000006268