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Nevin Manimala Statistics

Maternal positional therapy for fetal growth and customised birth weight centile benefit in a Bayesian reanalysis of a double-blind, sham-controlled, randomised clinical trial

BMJ Open. 2024 Apr 28;14(4):e078315. doi: 10.1136/bmjopen-2023-078315.

ABSTRACT

OBJECTIVES: To update the Ghana PrenaBelt Trial’s (GPT) primary outcome data with the latest fetal growth standard and reanalyse it. To estimate the posterior probability, under various clinically relevant prior probabilities, of maternal nightly positional therapy (PT) throughout the third-trimester having a beneficial effect on customised birth weight centile (CBWC) using Bayesian analyses.

DESIGN: A reanalysis of a double-blind, sham-controlled, randomised clinical trial.

SETTING: A single, tertiary-level centre in Accra, Ghana.

PARTICIPANTS: Two-hundred participants entered, 181 completed and 167 were included in the final analysis. Participants were Ghanaian, healthy, aged 18-35 years, with low-risk, singleton pregnancies in their third-trimester, with Body Mass Index<35 kg/m2 at the first antenatal appointment for the index pregnancy and without known fetal abnormalities, pregnancy complications or medical conditions complicating sleep.

INTERVENTIONS: Participants were randomised to receive treatment with either a PT or sham-PT device.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the CBWC using the latest Perinatal Institute, Gestation-Related Optimal Weight calculator. Using Bayesian methods, posterior probabilities of achieving a greater than 0%, 5% and 10% benefit in CBWC with PT were estimated. There was no secondary outcome.

RESULTS: The median (IQR) CBWC was 42% (15-71) and 28% (9-52) in the PT and sham-PT groups, respectively (difference 8.4%; 95% CI -0.30 to 18.2; p=0.06). For achieving a >0%, >5% and >10% gain in CBWC with PT, the posterior probabilities were highly probable, probable and unlikely, respectively, given a range of prior probabilities reflecting varying degrees of pre-existing enthusiasm and scepticism.

CONCLUSIONS: Maternal nightly PT throughout the third-trimester did not have a statistically significant effect on CBWC on a frequentist analysis using the latest fetal growth standard. However, from a Bayesian analysis, clinicians can infer that PT is likely to benefit fetal growth but with a modest effect size.

TRIAL REGISTRATION NUMBER: NCT02379728.

PMID:38684260 | DOI:10.1136/bmjopen-2023-078315

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Healthcare and economic cost burden of emergency medical services treated non-traumatic shock using a population-based cohort in Victoria, Australia

BMJ Open. 2024 Apr 28;14(4):e078435. doi: 10.1136/bmjopen-2023-078435.

ABSTRACT

OBJECTIVES: We aimed to assess the healthcare costs and impact on the economy at large arising from emergency medical services (EMS) treated non-traumatic shock.

DESIGN: We conducted a population-based cohort study, where EMS-treated patients were individually linked to hospital-wide and state-wide administrative datasets. Direct healthcare costs (Australian dollars, AUD) were estimated for each element of care using a casemix funding method. The impact on productivity was assessed using a Markov state-transition model with a 3-year horizon.

SETTING: Patients older than 18 years of age with shock not related to trauma who received care by EMS (1 January 2015-30 June 2019) in Victoria, Australia were included in the analysis.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome assessed was the total healthcare expenditure. Secondary outcomes included healthcare expenditure stratified by shock aetiology, years of life lived (YLL), productivity-adjusted life-years (PALYs) and productivity losses.

RESULTS: A total of 21 334 patients (mean age 65.9 (±19.1) years, and 9641 (45.2%) females were treated by EMS with non-traumatic shock with an average healthcare-related cost of $A11 031 per episode of care and total cost of $A280 million. Annual costs remained stable throughout the study period, but average costs per episode of care increased (Ptrend=0.05). Among patients who survived to hospital, the average cost per episode of care was stratified by aetiology with cardiogenic shock costing $A24 382, $A21 254 for septic shock, $A19 915 for hypovolaemic shock and $A28 057 for obstructive shock. Modelling demonstrated that over a 3-year horizon the cohort lost 24 355 YLLs and 5059 PALYs. Lost human capital due to premature mortality led to productivity-related losses of $A374 million. When extrapolated to the entire Australian population, productivity losses approached $A1.5 billion ($A326 million annually).

CONCLUSION: The direct healthcare costs and indirect loss of productivity among patients with non-traumatic shock are high. Targeted public health measures that seek to reduce the incidence of shock and improve systems of care are needed to reduce the financial burden of this syndrome.

PMID:38684259 | DOI:10.1136/bmjopen-2023-078435

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Novel foam dressing with through holes and negative pressure wound therapy with instillation and dwell time: a retrospective cohort study

Wounds. 2024 Mar;36(3):67-72.

ABSTRACT

BACKGROUND: NPWTi-d of a topical wound solution has been shown to benefit healing in a variety of wound types. This therapy has traditionally been applied via a standard ROCF-V. In 2017, a new ROCF-CC was introduced at the practice of the authors of the current manuscript for adjunctive management of patients with wounds with thick exudate and/or nonviable tissue and in cases in which surgical debridement is not available or not appropriate.

OBJECTIVE: To compare the efficacy of NPWTi-d with ROCF-CC dressing (treatment) vs NPWTi-d with ROCF-V dressing (control).

MATERIALS AND METHODS: An observational retrospective cohort study of hospital records of patients with VLUs treated with NPWTi-d who received ROCF-CC dressings (n = 11) vs standard ROCF-V dressings (n = 11) was conducted. NPWTi-d was chosen to promote wound healing in VLUs that were not fully responsive to advanced dressings and/or compression bandage. Solution dwell time was 10 minutes, followed by 2.5-hour NPWT cycles at -125 mm Hg. Dressings were changed every 72 hours.

RESULTS: Overall, mean ± SD duration of therapy and hospital length of stay were shorter in the treatment group vs the control group (duration of therapy, 8.63 days ± 7.05 vs 11.72 days ± 17.41, respectively; P = .05, and length of stay, 9.9 days ± 2.98 vs 12.81 days ± 4.26, respectively; P = .08), but these differences were not statistically significant. Mean wound area reduction was greater in the treatment group than in the control group (14.63 cm2 ± 13.24 and 10.72 cm2 ± 14.06, respectively; P = .51), but this was not significant.

CONCLUSION: ROCF-CC dressings were a useful tool in assisting wound bed preparation and reducing time to skin graft closure in this series of complex VLUs.

PMID:38684120

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The Benefits and Risks of Receiving Investigational Solid Tumor Drugs in Randomized Trials : A Systematic Review and Meta-analysis

Ann Intern Med. 2024 Apr 30. doi: 10.7326/M23-2515. Online ahead of print.

ABSTRACT

BACKGROUND: Many patients participate in cancer trials to access new therapies. The extent to which new treatments produce clinical benefit for trial participants is unclear.

PURPOSE: To estimate the progression-free survival (PFS) and overall survival (OS) advantage of assignment to experimental groups in randomized trials for 6 solid tumors.

DATA SOURCES: ClinicalTrials.gov was searched for trials of investigational drugs with results posted between 2017 and 2021.

STUDY SELECTION: Investigational drugs were defined as those not yet having full approval from the U.S. Food and Drug Administration for the study indication. Trials were included if they were randomized and tested drugs or biologics.

DATA EXTRACTION: Data extraction was completed by 2 independent reviewers. Data were pooled using a random-effects model.

DATA SYNTHESIS: The sample included 128 trials comprising 141 comparisons of a new drug and a comparator. These comparisons included 47 050 patients. The pooled hazard ratio for PFS was 0.80 (95% CI, 0.75 to 0.85), indicating statistically significant benefit for patients in experimental groups. This corresponded to a median PFS advantage of 1.25 months (CI, 0.80 to 1.68 months). The pooled hazard ratio for OS was 0.92 (CI, 0.88 to 0.95), corresponding to a survival gain of 1.18 months (CI, 0.72 to 1.71 months). The absolute risk for a serious adverse event for comparator group patients was 29.56% (CI, 26.64% to 32.65%), with an increase in risk of 7.40% (CI, 5.66% to 9.14%) for patients in experimental groups.

LIMITATIONS: Trials in this sample were heterogeneous. Comparator group interventions were assumed to reflect standard of care.

CONCLUSION: Assignment to experimental groups produces statistically significant survival gains. However, the absolute survival gain is small, and toxicity is statistically significantly greater. The findings of this review provide reassuring evidence that patients are not meaningfully disadvantaged by assignment to comparator groups.

PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research.

PMID:38684102 | DOI:10.7326/M23-2515

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An Analysis of Lesbian, Gay, Bisexual, Transgender, and Queer Curricula Inclusion: A National Study of Physician Assistant Programs

J Physician Assist Educ. 2024 Apr 30. doi: 10.1097/JPA.0000000000000584. Online ahead of print.

ABSTRACT

INTRODUCTION: The health professions education literature shows an increased focus on inclusion of lesbian, gay, bisexual, transgender, and queer (LGBTQ) content in curricula; however, it does not address hours of content or methods for content delivery. The purpose of this study was to describe the delivery of LGBTQ content in physician assistant (PA) education through a national survey of PA programs.

METHODS: In 2021, a national program survey was sent to all US-accredited PA Programs (n = 284) and had a completion rate of 71.8% (n = 204). Descriptive statistics were conducted to describe trends and make comparisons in the delivery of LGBTQ content.

RESULTS: Most PA programs are incorporating LGBTQ content into preclinical phases of PA education (81%) and describe that LGBTQ curricula align with institutional values (82%). Most report 1 to 3 hours of preclinical education for all LGBTQ population groups and cite medical interviewing courses as the most frequently used course to address LGTBQ care. Many programs (43%) do not provide instructional hours on LGBTQ content in the clinical phase, and the majority do not offer clinical rotations focused on this care. The results show variability in the level of preparedness that programs report on their students caring for LGBTQ populations.

DISCUSSION: Physician assistant programs are generally integrating the content throughout their didactic curricula; however, few offer clinical experiences focused on caring for patients who are LGBTQ. Offering clinical experiences and assessing student competencies are areas of growth in health professions education as related to LGBTQ health.

PMID:38684096 | DOI:10.1097/JPA.0000000000000584

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Assessing Student-Reported Perceptions of Prerequisite Usefulness in Preparation for Didactic Physician Assistant Education

J Physician Assist Educ. 2024 Apr 30. doi: 10.1097/JPA.0000000000000589. Online ahead of print.

ABSTRACT

INTRODUCTION: To gain admittance to a physician assistant (PA) school, applicants must complete program-specific prerequisite courses and experiences. The lack of standardization contributes to complexity, expense, and limits diversity. This research assessed current didactic PA students’ perceptions of prerequisite courses, course delivery methods, and direct patient care (DPC) experiences to determine which were perceived as the most useful in preparation for didactic PA education.

METHODS: An online cross-sectional survey was sent to eligible PA students across the United States. The survey collected opinions on the usefulness of commonly required prerequisite courses, course delivery methods, and DPC experiences. Collected data underwent statistical analysis and qualitative analysis for open-response questions.

RESULTS: A total of 527 students completed the survey. Greater than 50% reported prerequisite courses in science and psychology as well as speech, ethics, cardiopulmonary resuscitation (CPR), medical ethics, medical terminology, and nutrition “prepared them well” or “extremely well.” The most frequently recommended educational delivery method was “in person.” The DPC experiences reported to best prepare students were Medical Assistant, Certified Nursing Assistant, and Scribe. The reported recommended number of DPC hours was 1000 to 1499. Chi-square tests for courses that prepared students “well” and “extremely well” revealed that in-person delivery had a statistically significant association with anatomy, physiology, ethics, CPR, medical ethics, and Spanish.

DISCUSSION: These significant findings should be considered by PA programs when evaluating their requirements for admission. Furthermore, PA education associations should consider universal requirements to reduce applicant barriers, complexity, and expense, which may lead to improved diversity.

PMID:38684092 | DOI:10.1097/JPA.0000000000000589

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The Applications of Artificial Intelligence for Assessing Fall Risk: Systematic Review

J Med Internet Res. 2024 Apr 29;26:e54934. doi: 10.2196/54934.

ABSTRACT

BACKGROUND: Falls and their consequences are a serious public health problem worldwide. Each year, 37.3 million falls requiring medical attention occur. Therefore, the analysis of fall risk is of great importance for prevention. Artificial intelligence (AI) represents an innovative tool for creating predictive statistical models of fall risk through data analysis.

OBJECTIVE: The aim of this review was to analyze the available evidence on the applications of AI in the analysis of data related to postural control and fall risk.

METHODS: A literature search was conducted in 6 databases with the following inclusion criteria: the articles had to be published within the last 5 years (from 2018 to 2024), they had to apply some method of AI, AI analyses had to be applied to data from samples consisting of humans, and the analyzed sample had to consist of individuals with independent walking with or without the assistance of external orthopedic devices.

RESULTS: We obtained a total of 3858 articles, of which 22 were finally selected. Data extraction for subsequent analysis varied in the different studies: 82% (18/22) of them extracted data through tests or functional assessments, and the remaining 18% (4/22) of them extracted through existing medical records. Different AI techniques were used throughout the articles. All the research included in the review obtained accuracy values of >70% in the predictive models obtained through AI.

CONCLUSIONS: The use of AI proves to be a valuable tool for creating predictive models of fall risk. The use of this tool could have a significant socioeconomic impact as it enables the development of low-cost predictive models with a high level of accuracy.

TRIAL REGISTRATION: PROSPERO CRD42023443277; https://tinyurl.com/4sb72ssv.

PMID:38684088 | DOI:10.2196/54934

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Acceptance, Satisfaction, and Preference With Telemedicine During the COVID-19 Pandemic in 2021-2022: Survey Among Patients With Chronic Pain

JMIR Form Res. 2024 Apr 29;8:e53154. doi: 10.2196/53154.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has forced many health care providers to make changes in their treatment, with telemedicine being expanded on a large scale. An earlier study investigated the acceptance of telephone calls but did not record satisfaction with treatment or patients’ preferences. This warranted a follow-up study to investigate acceptance, satisfaction, and preferences regarding telemedicine, comprising of phone consultations, among health care recipients.

OBJECTIVE: The primary aim was to assess the acceptance and satisfaction of telemedicine during the subsequent months of 2021-2022, after the initial wave of the COVID-19 pandemic in Switzerland. Furthermore, we aimed to assess patients’ preferences and whether these differed in patients who had already experienced telemedicine in the past, as well as correlations between acceptance and satisfaction, pain intensity, general condition, perception of telemedicine, and catastrophizing. Finally, we aimed to investigate whether more governmental restrictions were correlated with higher acceptance.

METHODS: An anonymous cross-sectional web-based survey was conducted between January 27, 2021, and February 4, 2022, enrolling patients undergoing outpatient pain therapy in a tertiary university clinic. We conducted a descriptive analysis of acceptance and satisfaction with telemedicine and investigated patients’ preferences. Further, we conducted a descriptive and correlational analysis of the COVID-19 stringency index. Spearman correlation analysis and a chi-square test for categorical data were used with Cramer V statistic to assess effect sizes.

RESULTS: Our survey was completed by 60 patients. Telemedicine acceptance and satisfaction were high, with an average score of 7.6 (SD 3.3; on an 11-point Numeric Rating Scale from 0=not at all to 10=completely), and 8.8 (SD 1.8), respectively. Respondents generally preferred on-site consultations to telemedicine (n=35, 58% vs n=24, 40%). A subgroup analysis revealed that respondents who already had received phone consultation, showed a higher preference for telemedicine (n/N=21/42, 50% vs n/N=3/18, 17%; χ22 [N=60]=7.5, P=.02, Cramer V=0.354), as well as those who had been treated for more than 3 months (n/N=17/31, 55% vs n/N=7/29, 24%; χ22 [N=60]=6.5, P=.04, Cramer V=0.329). Acceptance of telemedicine showed a moderate positive correlation with satisfaction (rs{58}=0.41, P<.05), but there were no correlations between the COVID-19 stringency index and the other variables.

CONCLUSIONS: Despite high acceptance of and satisfaction with telemedicine, patients preferred on-site consultations. Preference for telemedicine was markedly higher in patients who had already received phone consultations or had been treated for longer than 3 months. This highlights the need to convey knowledge of eHealth services to patients and the value of building meaningful relationships with patients at the beginning of treatment. During the COVID-19 pandemic, the modality of patient care should be discussed individually.

PMID:38684086 | DOI:10.2196/53154

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Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial

JMIR Res Protoc. 2024 Apr 29;13:e57878. doi: 10.2196/57878.

ABSTRACT

BACKGROUND: Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources.

OBJECTIVE: This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety.

METHODS: The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients’ self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits.

RESULTS: The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024.

CONCLUSIONS: This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57878.

PMID:38684080 | DOI:10.2196/57878

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Predicting the onset of myopia in children by age, sex, and ethnicity: Results from the CLEERE Study

Optom Vis Sci. 2024 Apr 1;101(4):179-186. doi: 10.1097/OPX.0000000000002127.

ABSTRACT

SIGNIFICANCE: Clinicians and researchers would benefit from being able to predict the onset of myopia for an individual child. This report provides a model for calculating the probability of myopia onset, year-by-year and cumulatively, based on results from the largest, most ethnically diverse study of myopia onset in the United States.

PURPOSE: This study aimed to model the probability of the onset of myopia in previously nonmyopic school-aged children.

METHODS: Children aged 6 years to less than 14 years of age at baseline participating in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study who were nonmyopic and less hyperopic than +3.00 D (spherical equivalent) were followed up for 1 to 7 years through eighth grade. Annual measurements included cycloplegic autorefraction, keratometry, ultrasound axial dimensions, and parental report of children’s near work and time spent in outdoor and/or sports activities. The onset of myopia was defined as the first visit with at least -0.75 D of myopia in each principal meridian. The predictive model was built using discrete time survival analysis and evaluated with C statistics.

RESULTS: The model of the probability of the onset of myopia included cycloplegic spherical equivalent refractive error, the horizontal/vertical component of astigmatism (J0), age, sex, and race/ethnicity. Onset of myopia was more likely with lower amounts of hyperopia and less positive/more negative values of J0. Younger Asian American females had the highest eventual probability of onset, whereas older White males had the lowest. Model performance increased with older baseline age, with C statistics ranging from 0.83 at 6 years of age to 0.92 at 13 years.

CONCLUSIONS: The probability of the onset of myopia can be estimated for children in the major racial/ethnic groups within the United States on a year-by-year and cumulative basis up to age 14 years based on a simple set of refractive error and demographic variables.

PMID:38684060 | DOI:10.1097/OPX.0000000000002127