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Nevin Manimala Statistics

Alternative Presentations of Overall and Statistical Uncertainty for Adults’ Understanding of the Results of a Randomized Trial of a Public Health Intervention: Parallel Web-Based Randomized Trials

JMIR Public Health Surveill. 2025 Mar 18;11:e62828. doi: 10.2196/62828.

ABSTRACT

BACKGROUND: Well-designed public health messages can help people make informed choices, while poorly designed messages or persuasive messages can confuse, lead to poorly informed decisions, and diminish trust in health authorities and research. Communicating uncertainties to the public about the results of health research is challenging, necessitating research on effective ways to disseminate this important aspect of randomized trials.

OBJECTIVE: This study aimed to evaluate people’s understanding of overall and statistical uncertainty when presented with alternative ways of expressing randomized trial results.

METHODS: Two parallel, web-based, individually randomized trials (3×2 factorial designs) were conducted in the United States and Norway. Participants were randomized to 1 of 6 versions of a text (summary) communicating results from a study examining the effects of wearing glasses to prevent COVID-19 infection. The summaries varied in how overall uncertainty (“Grading of Recommendations Assessment, Development and Evaluation [GRADE] language,” “plain language,” or “no explicit language”) and statistical uncertainty (whether a margin of error was shown or not) were presented. Participants completed a web-based questionnaire exploring 4 coprimary outcomes: 3 to measure understanding of overall uncertainty (benefits, harms, and sufficiency of evidence), and one to measure statistical uncertainty. Participants were adults who do not wear glasses recruited from web-based research panels in the United States and Norway. Results of the trials were analyzed separately and combined in a meta-analysis.

RESULTS: In the US and Norwegian trials, 730 and 497 individuals were randomized, respectively; data for 543 (74.4%) and 452 (90.9%) were analyzed. More participants had a correct understanding of uncertainty when presented with plain language (United States: 37/99, 37% and Norway: 40/76, 53%) than no explicit language (United States: 18/86, 21% and Norway: 34/80, 42%). Similar positive effect was seen for the GRADE language in the United States (26/79, 33%) but not in Norway (30/71, 42%). There were only small differences between groups for understanding the uncertainty of harms. Plain language improved correct understanding of evidence sufficiency (odds ratio 2.05, 95% CI 1.17-3.57), compared to no explicit language. The effect of GRADE language was inconclusive (odds ratio 1.34, 95% CI 0.79-2.28). The understanding of statistical uncertainty was improved when the participants were shown the margin of error compared to not being shown: Norway: 16/75, 21% to 24/71, 34% vs 1/71, 1% to 2/76, 3% and the United States: 21/101, 21% to 32/90, 36% vs 0/86, 0% to 3/79, 4%).

CONCLUSIONS: Plain language, but not GRADE language, was better than no explicit language in helping people understand overall uncertainty of benefits and harms. Reporting margin of error improved understanding of statistical uncertainty around the effect of wearing glasses, but only for a minority of participants.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05642754; https://tinyurl.com/4mhjsm7s.

PMID:40101228 | DOI:10.2196/62828

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Nevin Manimala Statistics

Penetrating Cardiac Injury: A 20-Year Retrospective Analysis at a High-Complexity University Center

Braz J Cardiovasc Surg. 2025 Mar 18;40(2):e20240049. doi: 10.21470/1678-9741-2024-0049.

ABSTRACT

INTRODUCTION: Penetrating cardiac injury, though infrequent, is associated with substantial mortality. In 2005, our research team conducted a comprehensive retrospective analysis of penetrating cardiac injuries managed at our facility from 1990 to 2003. Now, two decades later, we conducted the present study on penetrating cardiac injuries attended in our hospital over the last 20 years.

METHODS: This is a retrospective analysis of medical records and trauma database data, with a focus on survivors of penetrating cardiac trauma, excluding those deceased upon arrival.

RESULTS: Out of 1,093 cases, 25 had penetrating cardiac injuries with an overall mortality rate of 36%. Hemorrhage was the leading cause of death, and survival was correlated with higher systolic blood pressure upon admission and the level of consciousness.

CONCLUSION: The study highlights the need for rapid intervention and emphasizes the importance of managing bleeding and supporting hemodynamics. It also points to areas for improvement in emergency care and the benefits of interdisciplinary collaboration.

PMID:40101197 | DOI:10.21470/1678-9741-2024-0049

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The Effect of Prognostic Nutritional Index in Predicting Clinical Outcomes in Valve Replacement Patients

Braz J Cardiovasc Surg. 2025 Mar 18;40(2):e20230503. doi: 10.21470/1678-9741-2023-0503.

ABSTRACT

INTRODUCTION: Cardiopulmonary bypass is known to be a cause of systemic inflammatory response. The systemic inflammatory response affects albumin and lymphocyte levels and is associated with the development of complications. Serum albumin and lymphocyte concentrations have been used to create inflammation-based risk scores, which predict prognosis in different patient groups. One of these risk scores is called the Prognostic Nutritional Index (PNI). In this study, our objective was to examine how changes in PNI values, measured at different times before and after surgery, impact clinical outcomes and hospital mortality.

METHODS: One hundred and sixty-four patients were retrospectively scanned and included in the study. Patients were divided into aortic valve replacement (AVR) and mitral valve replacement (MVR) groups. The patient’s preoperative and postoperative PNI values were examined. Duration of cross-clamping, cardiopulmonary bypass time, length of hospital and intensive care unit stay, postoperative mortality, atrial fibrillation, and acute kidney injury (AKI) development were evaluated.

RESULTS: Preoperative and second PNI values were lower in the patients that developed AKI and non-survivors. The PNI cutoff value was ≤ 28.01 in non-survivors (P=0.001). In the MVR group, the decrease in PNI value over time was statistically significant (P<0.001). There was a negative correlation between preoperative PNI value and length of stay in intensive care unit, cross-clamping, and cardiopulmonary bypass duration (P<0.05, P<0.01).

CONCLUSION: A correlation was determined between the PNI value and development of postoperative AKI and mortality. PNI value, an easy method to use, can be used in the follow-up of these patients.

PMID:40101188 | DOI:10.21470/1678-9741-2023-0503

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Use of Antegrade Coronary Oxygen Persufflation as a Strategy for Donor Heart Preservation

Braz J Cardiovasc Surg. 2025 Mar 18;40(2):e20230469. doi: 10.21470/1678-9741-2023-0469.

ABSTRACT

OBJECTIVE: To assess the technical feasibility and functional, metabolic, and structural myocardial integrity of the donor heart after four hours of direct coronary oxygen persufflation (COP).

METHODS: This research was carried out on three-month-old minipig siblings weighing 23-36 kg. Cardiac arrest was achieved by administrating two liters of Bretschneider’s cardioplegic solution (histidine-tryptophan-ketoglutarate [HTK]) (Custodiol®, Germany) into the aortic root. Orthotopic heart transplantation was performed after three hours of cardiac arrest.

RESULTS: A statistically significant decrease in cardiac output was observed in both groups (from 3.36 ± 0.36 l/min and 3.72 ± 0.52 l/min in the HTK group and modified HTK + COP to 2.35 ± 0.52 l/min and 2.15 ± 0.34 l/min, respectively) (Р<0.05). Differences between both groups were insignificant (P>0.05). Cardiac output was 2.99 ± 0.45 l/min and 2.48 ± 0.58 l/min (Р>0.05) in both groups after 120 min of cardiac recovery. Lactate dehydrogenase, creatine phosphokinase-MB, and troponin I changes in coronary sinus blood were significantly higher in the early reperfusion period. Statistical insignificance was observed between both groups (P>0.05). Myocardial oxygen consumption was 8.2 [7.35; 9.35] ml-О2/min/100 g and 7.7 [6.75; 10.12] ml-О2/min/100g in both groups (P>0.05). Histological examinations demonstrate no significant myocardial ischemic injury in the persufflation group.

CONCLUSION: The study demonstrated technical feasibility and safety of direct coronary persufflation for four hours during ex vivo donor heart conditioning. However, no significant advantages of direct COP were observed over the standard cold preservation protocol.

PMID:40101187 | DOI:10.21470/1678-9741-2023-0469

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Payments by Drug and Medical Device Manufacturers to Society of Urologic Oncology (SUO) Fellowship Program Directors

Urol Pract. 2025 Mar 18:101097UPJ0000000000000814. doi: 10.1097/UPJ.0000000000000814. Online ahead of print.

ABSTRACT

PURPOSE: This study aims to characterize payments by drug and medical device manufacturers to current program directors (PD) of the Society of Urologic Oncology (SUO)-accredited fellowship programs in the United States (US).

METHODS: PDs were identified from SUO fellowship websites as of February 2024. Demographic data, educational background, and scholarly metrics were collected via an online search. Industry payments SUO PDs from 2014 to 2023 were extracted from the Open Payments database. Descriptive statistics were used to summarize PD characteristics and industry payment details. Univariable linear regression was used to assess the association of PD characteristics or scholarly metrics with payments.

RESULTS: Fifty-one PDs from 37 SUO fellowship programs were identified. PDs were predominantly men (94%) and mid-career. In aggregate, over the study period, PDs received $USD 18,963,555 in industry payments over ten years. Most payments were for associated research funding ($15,490,525, 81.6%; median [IQR] per PD recipient, $126,584 [$36,565-$706,516]; 1,262 payments). General payments accounted for a total of $3,473,030 (18.3%) (median [IQR] per PD, $10,345 [$2,196-$49,180]). SUO PDs received $120,763 (0.6%) for education fees. No association was found between PD characteristics or research metrics and industry payments.

CONCLUSIONS: PDs of SUO fellowships receive significant industry payments, surpassing those received by the average urologist. Most of these payments are allocated to research, with smaller proportions directed to general support and educational initiatives.

PMID:40101162 | DOI:10.1097/UPJ.0000000000000814

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Nevin Manimala Statistics

A Moderate-Intensity Interval Training Block Improves Endurance Performance in Well-Trained Cyclists

Med Sci Sports Exerc. 2025 Mar 18. doi: 10.1249/MSS.0000000000003706. Online ahead of print.

ABSTRACT

PURPOSE: This study compared the physiological effects of a moderate-intensity interval training (MIT) microcycle followed by an active recovery period (collectively termed MITblock) with a time-matched regular training period (REG) during the general preparation phase in well-trained cyclists.

METHODS: Using a randomized crossover design, 30 well-trained male cyclists (maximal oxygen consumption (VO2max), 70.5 (4.6) mL·min-1·kg-1) completed both MITblock and REG. The MIT microcycle involved six interval sessions over seven days with 5-7 × 10-14 min work intervals at a perceived exertion (RPE) of 14-15 on the Borg 6-20 scale. A six-day active recovery period followed before physiological testing. During REG, cyclists performed their regular preparatory-phase training routine, which primarily involved low-intensity exercise. Specific guidelines included completing either two MIT sessions or one MIT session and one high-intensity interval session per week. Endurance performance indicators assessed included changes in 15 min maximal average power output (PO15min), power output at 4 mmol·L-1 [blood lactate] (PO4mmol), 1 min peak power output during incremental testing (POVO2max), and VO2max.

RESULTS: Although the Training Impulse (TRIMP) score was not different between MITblock and REG (1944 (436) vs. 1800 (232), respectively; p = 0.27), MITblock resulted in significantly greater improvements than REG in PO4mmol (4.0 (4.4)% vs. -1.3 (3.7)%, p < 0.01), POVO2max (2.5 (4.5)% vs. -0.7 (3.9)%, p < 0.01) and VO2max (2.0 (3.9)% vs. 0.0 (3.5)%, p = 0.05). Changes in PO15min were not statistically different between MITblock and REG (3.9 (8.3)% vs. 0.2 (6.8)%, p = 0.14). During MIT intervals, RPE was 14.4 (0.3), corresponding to 66 (5)% of POVO2max, 85 (3)% of maximal heart rate, and 2.8 (1.1) mmol·L-1 [blood lactate].

CONCLUSIONS: Six moderate-intensity interval sessions over seven days, followed by a six-day active recovery period, induce improvements in endurance performance indicators compared to a time-matched regular training period in well-trained cyclists.

PMID:40101160 | DOI:10.1249/MSS.0000000000003706

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The Interactive Care Coordination and Navigation mHealth Intervention for People Experiencing Homelessness: Cost Analysis, Exploratory Financial Cost-Benefit Analysis, and Budget Impact Analysis

JMIR Form Res. 2025 Mar 18;9:e64973. doi: 10.2196/64973.

ABSTRACT

BACKGROUND: The Interactive Care Coordination and Navigation (iCAN) mobile health intervention aims to improve care coordination and reduce hospital and emergency department visits among people experiencing homelessness.

OBJECTIVE: This study aimed to conduct a three-part economic evaluation of iCAN, including a (1) cost analysis, (2) exploratory financial cost-benefit analysis, and (3) budget impact analysis (BIA).

METHODS: We collected cost and expenditure data from a randomized controlled trial of iCAN to conduct a cost analysis and exploratory financial cost-benefit analysis. Costs were classified as startup and recurring costs for participants and the program. Startup costs included participant supplies for each participant and SMS implementation costs. Recurring costs included the cost of recurring services, SMS text messaging platform maintenance, health information access fees, and personnel salaries. Using the per participant per year (PPPY) costs of iCAN, the minimum savings reduction in the average health care costs among people experiencing homelessness that would lead to a benefit-cost ratio >1 for iCAN was calculated. This savings threshold was calculated by dividing the PPPY cost of iCAN by the average health care costs among people experiencing homelessness multiplied by 100%. The benefit-cost ratio of iCAN was calculated under different savings thresholds from 0% (no savings) to 50%. Costs were calculated PPPY under different scenarios, and the results were used as inputs in a BIA. A probabilistic sensitivity analysis was conducted to incorporate uncertainty around cost estimates. Costs are in 2022 US $.

RESULTS: The total cost of iCAN was US $2865 PPPY, which was made up of US $265 in startup (9%) and US $2600 (91%) in recurring costs PPPY. The minimum savings threshold that would cause iCAN to have a positive return on investment is 7.8%. This means that if average health care costs (US $36,917) among people experiencing homelessness were reduced by more than 7.8% through iCAN, the financial benefits would outweigh the costs of the intervention. When health care costs are reduced by 25% ($9229/$36,917; equal to 56% [$9229/$16,609] of the average cost of an inpatient visit), the benefit-cost ratio is 3.22, which means that iCAN produces US $2.22 in health care savings per US $1 spent. The BIA estimated that implementing iCAN for 10,250 people experiencing homelessness over 5 years would have a financial cost of US $28.7 million, which could be reduced to US $2.2 million if at least 8% ($2880/$36,917) of average health care costs among people experiencing homelessness are reduced through the intervention.

CONCLUSIONS: If average costs of emergency department and hospital visits among people experiencing homelessness were reduced by more than 7.8% ($2880/$36,917) through iCAN, the financial benefits would outweigh the costs of the intervention. As the savings threshold increases, it results in a higher benefit-cost ratio.

PMID:40101159 | DOI:10.2196/64973

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The Relationship Between Ex Vivo Lung Perfusion Strategies and Transplantation Outcomes: Insights From the United Network for Organ Sharing Data

Transplantation. 2024 Nov 8. doi: 10.1097/TP.0000000000005259. Online ahead of print.

ABSTRACT

BACKGROUND: Ex vivo lung perfusion (EVLP) can increase the donor pool by allowing high-risk lungs to be further evaluated for transplant. Several EVLP platforms are currently in use. This study examines whether different EVLP platforms have any association with post-transplant outcomes.

METHODS: The United Network for Organ Sharing registry was queried from February 28, 2018, to March 31, 2024, for adult double lung transplant recipients with EVLP data. EVLP platform was categorized as hospital EVLP, EVLP facility, mobile EVLP, or No EVLP. Recipients of EVLP lungs were statistically matched to recipients of No EVLP lungs on donor characteristics.

RESULTS: After matching, the final cohort included 1542 in the No EVLP group and 771 who received EVLP. Lungs placed on EVLP had significantly longer ischemic time than No EVLP (P < 0.001). Patients who received EVLP lungs had significantly longer post-transplant length of stay (≥25 d versus 21 d No EVLP, P < 0.001). Ischemic time (OR = 1.04, P = 0.008) and being in the ICU at the time of transplant (OR = 2.22, P < 0.001) were associated with higher rates of primary graft dysfunction (PGD3). After adjusting for hospital status and ischemic time, there was no association between the EVLP modality and PGD3. Subgroup analysis showed that DCD recipients did not have worse short- or long-term outcomes.

CONCLUSIONS: There is no relationship between EVLP modality, PGD3, and post-transplant survival after matching donor quality and adjusting for ischemic time. Work should continue to focus on reducing ischemic times so EVLP can continue to increase the donor pool while limiting adverse effects.

PMID:40101107 | DOI:10.1097/TP.0000000000005259

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Temporal Patterns in Blood Pressure Management Before and After Recent Clinical Trials and Guideline Recommendations

J Clin Hypertens (Greenwich). 2025 Mar;27(3):e70030. doi: 10.1111/jch.70030.

ABSTRACT

We aimed to study trends in achieving blood pressure (BP) goals, antihypertensive prescribing, and whether clinician behavior changed in temporal relationship to the JNC-8 (October 1, 2014), SPRINT results (November 9, 2015), and the 2017 hypertension guideline (November 13, 2017). We used the National Cardiovascular Data Registry (NCDR) Practice INNovation and CLinical Excellence (PINNACLE) registry and studied patients with hypertension aged >65 years (n = 3 678 774). We found a statistically significant, albeit small and minimally relevant, increase from 2013 to 2018 in achieving office-based SBP.

PMID:40101103 | DOI:10.1111/jch.70030

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Causal associations of self-reported walking pace with respiratory diseases: A Mendelian randomization analysis

Medicine (Baltimore). 2025 Mar 14;104(11):e41746. doi: 10.1097/MD.0000000000041746.

ABSTRACT

Although studies have indicated causality between brisk walking and various diseases, the relationships between walking pace and respiratory diseases lack thorough investigation. The underlying relationships between walking pace and various respiratory diseases were examined through univariable Mendelian randomization (MR) analyses. Furthermore, we performed multivariable MR analyses to observe whether relationships between walking pace and respiratory diseases change after adjustment of body mass index (BMI). The genome-wide association study data of self-reported walking pace, BMI, and 42 respiratory diseases were retrieved from publicly available datasets. We employed the inverse-variance weighted, weighted median, and MR-Egger methods for MR analysis. Using the inverse-variance weighted method in univariable MR, we identified statistically significant negative causal associations between self-reported walking pace and 4 respiratory traits, including chronic lower respiratory diseases (odds ratio [OR], 0.27 [95% confidence interval [CI], 0.18-0.41]), asthma (OR, 0.23 [95% CI, 0.14-0.38]), chronic obstructive pulmonary disease (OR, 0.15 [95% CI, 0.08-0.30]), and diseases of the respiratory system (OR, 0.54 [95% CI, 0.41-0.70]). Similar results were observed with the MR-Egger and weighted median methods. These associations remained significant, though slightly attenuated, after adjusting for BMI. A brisk walking pace may significantly benefit respiratory health and aid in disease prevention and risk stratification.

PMID:40101097 | DOI:10.1097/MD.0000000000041746