Categories
Nevin Manimala Statistics

Statistical Methods for Comparing Predictive Values in Medical Diagnosis

Korean J Radiol. 2024 Jul;25(7):656-661. doi: 10.3348/kjr.2024.0049.

ABSTRACT

Evaluating the performance of a binary diagnostic test, including artificial intelligence classification algorithms, involves measuring sensitivity, specificity, positive predictive value, and negative predictive value. Particularly when comparing the performance of two diagnostic tests applied on the same set of patients, these metrics are crucial for identifying the more accurate test. However, comparing predictive values presents statistical challenges because their denominators depend on the test outcomes, unlike the comparison of sensitivities and specificities. This paper reviews existing methods for comparing predictive values and proposes using the permutation test. The permutation test is an intuitive, non-parametric method suitable for datasets with small sample sizes. We demonstrate each method using a dataset from MRI and combined modality of mammography and ultrasound in diagnosing breast cancer.

PMID:38942459 | DOI:10.3348/kjr.2024.0049

Categories
Nevin Manimala Statistics

Diagnostic Efficacy and Safety of Low-Contrast-Dose Dual-Energy CT in Patients With Renal Impairment Undergoing Transcatheter Aortic Valve Replacement

Korean J Radiol. 2024 Jul;25(7):634-643. doi: 10.3348/kjr.2023.1207.

ABSTRACT

OBJECTIVE: This study aimed to evaluate the diagnostic efficacy and safety of low-contrast-dose, dual-source dual-energy CT before transcatheter aortic valve replacement (TAVR) in patients with compromised renal function.

MATERIALS AND METHODS: A total of 54 consecutive patients (female:male, 26:38; 81.9 ± 7.3 years) with reduced renal function underwent pre-TAVR dual-energy CT with a 30-mL contrast agent between June 2022 and March 2023. Monochromatic (40- and 50-keV) and conventional (120-kVp) images were reconstructed and analyzed. The subjective quality score, vascular attenuation, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR) were compared among the imaging techniques using the Friedman test and post-hoc analysis. Interobserver reliability for aortic annular measurement was assessed using the intraclass correlation coefficient (ICC) and Bland-Altman analysis. The procedural outcomes and incidence of post-contrast acute kidney injury (AKI) were assessed.

RESULTS: Monochromatic images achieved diagnostic quality in all patients. The 50-keV images achieved superior vascular attenuation and CNR (P < 0.001 in all) while maintaining a similar SNR compared to conventional CT. For aortic annular measurement, the 50-keV images showed higher interobserver reliability compared to conventional CT: ICC, 0.98 vs. 0.90 for area and 0.97 vs. 0.95 for perimeter; 95% limits of agreement width, 0.63 cm² vs. 0.92 cm² for area and 5.78 mm vs. 8.50 mm for perimeter. The size of the implanted device matched CT-measured values in all patients, achieving a procedural success rate of 92.6%. No patient experienced a serum creatinine increase of ≥ 1.5 times baseline in the 48-72 hours following CT. However, one patient had a procedural delay due to gradual renal function deterioration.

CONCLUSION: Low-contrast-dose imaging with 50-keV reconstruction enables precise pre-TAVR evaluation with improved image quality and minimal risk of post-contrast AKI. This approach may be an effective and safe option for pre-TAVR evaluation in patients with compromised renal function.

PMID:38942457 | DOI:10.3348/kjr.2023.1207

Categories
Nevin Manimala Statistics

Opioid Dose Reductions by Sex and Race in a Cohort of Patients in a Family Medicine Clinic

J Am Board Fam Med. 2024 Jun 28:jabfm.2023.230220R2. doi: 10.3122/jabfm.2023.230220R2. Online ahead of print.

ABSTRACT

BACKGROUND: The 2022 Centers for Disease Control’s “Clinical Practice Guidelines for Prescribing Opioids for Pain in United States” called for attention and action toward reducing disparities in untreated and undertreated pain among Black and Latino patients. There is growing evidence for controlled substance safety committees (CSSC) to change prescribing culture, but few have been examined through the lens of health equity. We examined the impact of a primary care CSSC on opioid prescribing, including by patients’ race and sex.

METHODS: We conducted a retrospective cohort study. Our primary outcome was a change in prescribed morphine milligram equivalents (MME) at baseline (2017) and follow-up (2021). We compared the differences in MME by race and sex. We also examined potential intersectional disparities. We used paired t test to compare changes in mean MME’s and logistic regression to determine associations between patient characteristics and MME changes.

RESULTS: Our cohort included 93 patients. The mean opioid dose decreased from nearly 200 MME to 136.1 MME, P < .0001. Thirty percent of patients had their dose reduced to under 90 MME by follow-up. The reduction rates by race or sex alone were not statistically significant. There was evidence of intersectional disparities at baseline. Black women were prescribed 88.5 fewer MME’s at baseline compared with their White men counterparts, P = .04.

DISCUSSION: Our findings add to the previously documented success of CSSCs in reducing opioid doses for chronic nonmalignant pain to safer levels. We highlight an opportunity for primary care based CSSCs to lead the efforts to identify and address chronic pain management inequities.

PMID:38942449 | DOI:10.3122/jabfm.2023.230220R2

Categories
Nevin Manimala Statistics

Adjusting Clinical Plans Based on Social Context

J Am Board Fam Med. 2024 Jun 28:jabfm.2023.230289R1. doi: 10.3122/jabfm.2023.230289R1. Online ahead of print.

ABSTRACT

BACKGROUND: Social risk data collection is expanding in community health centers (CHCs). We explored clinicians’ practices of adjusting medical care based on their awareness of patients’ social risk factors-that is, changes they make to care plans to mitigate the potential impacts of social risk factors on their patients’ care and health outcomes-in a set of Texas CHCs.

METHODS: Convergent mixed methods. Surveys/interviews explored clinician perspectives on adjusting medical care based on patient social risk factors. Survey data were analyzed with descriptive statistics; interviews were analyzed using thematic analysis and inductive coding.

RESULTS: Across 4 CHCs, we conducted 15 clinician interviews and collected 97 surveys. Interviews and surveys overall indicated support for adjustment activities. Two main themes emerged: 1) clinicians reported making frequent adjustments to patient care plans based on their awareness of patients’ social contexts, while simultaneously expressing concerns about adjustment; and 2) awareness of patients’ social risk factors, and clinician time, training, and experience all influenced clinician adjustments.

CONCLUSIONS: Clinicians at participating CHCs described routinely adjusting patient care plans based on their patients’ social contexts. These adjustments were being made without specific guidelines or training. Standardization of adjustments may facilitate the contextualization of patient care through shared decision making to improve outcomes.

PMID:38942447 | DOI:10.3122/jabfm.2023.230289R1

Categories
Nevin Manimala Statistics

Commentary Pharmacokinetic Theory Must Consider Published Experimental Data

Drug Metab Dispos. 2024 Jun 28:DMD-MR-2024-001735. doi: 10.1124/dmd.124.001735. Online ahead of print.

ABSTRACT

Recently, we have proposed simple methodology to derive clearance and rate constant equations, independent of differential equations, based on Kirchhoff’s Laws, a common methodology from physics used to describe rate-defining processes either in series or parallel. Our approach has been challenged in three recent publications, two published in this journal, but notably what is lacking is that none evaluate experimental pharmacokinetic data. As reviewed here, manuscripts from our laboratory have evaluated published experimental data, demonstrating that the Kirchhoff’s Laws approach explains (1) why all of the experimental perfused liver clearance data appear to fit the equation that was previously believed to be the well-stirred model, (2) why linear pharmacokinetic systemic bioavailability determinations can be greater than 1, (3) why renal clearance can be a function of drug input processes, and (4) why statistically different bioavailability measures may be found for urinary excretion versus systemic concentration measurements. Our most recent paper demonstrates (5) how the universally accepted steady-state clearance approach utilized by the field for the past 50 years leads to unrealistic outcomes concerning the relationship between liver-to-blood Kpuu and hepatic availability FH , highlighting the potential for errors in pharmacokinetic evaluations based on differential equations. The Kirchhoff’s Laws approach is applicable to all pharmacokinetic analyses of quality experimental data, those that were previously adequately explained with present pharmacokinetic theory, and those that were not. The publications that have attempted to rebut our position do not address unexplained experimental data, and we show here why their analyses are not valid. Significance Statement The Kirchhoff’s Laws approach to deriving clearance equations for linear systems in parallel or in series, independent of differential equations, successfully describes published pharmacokinetic data that has previously been unexplained. Three recent publications claim to refute our proposed methodology; these publications only make theoretical arguments, do not evaluate experimental data; never demonstrate that the Kirchhoff methodology provides incorrect interpretations of experimental pharmacokinetic data, including statistically significant data not explained by present pharmacokinetic theory. We demonstrate why these analyses are invalid.

PMID:38942444 | DOI:10.1124/dmd.124.001735

Categories
Nevin Manimala Statistics

Frontline nursing staff’s perceptions of intravenous medication administration: the first step toward safer infusion processes-a qualitative study

BMJ Open Qual. 2024 Jun 27;13(2):e002809. doi: 10.1136/bmjoq-2024-002809.

ABSTRACT

OBJECTIVES: Intravenous medication errors continue to significantly impact patient safety and outcomes. This study sought to clarify the complexity and risks of the intravenous administration process.

DESIGN: A qualitative focus group interview study.

SETTING: Focused interviews were conducted using process mapping with frontline nurses responsible for medication administration in September 2020.

PARTICIPANTS: Front line experiened nurses from a Japanese tertiary teaching hospital.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was to identify the mental models frontline nurses used during intravenous medication administration, which influence their interactions with patients, and secondarily, to examine the medication process gaps between the mental models nurses perceive and the actual defined medication administration process.

RESULTS: We found gaps between the perceived clinical administration process and the real process challenges with an emphasis on the importance of verifying to see if the drug was ordered for the patient immediately before its administration.

CONCLUSIONS: This novel and applied improvement approach can help nurses and managers better understand the process vulnerability of the infusion process and develop a deeper understanding of the administration steps useful for reliably improving the safety of intravenous medications.

PMID:38942437 | DOI:10.1136/bmjoq-2024-002809

Categories
Nevin Manimala Statistics

Decreasing incidence of admission neonatal hypothermia in Gandhi Memorial Hospital, Addis Ababa, Ethiopia: quality improvement project

BMJ Open Qual. 2024 Jun 27;13(2):e002656. doi: 10.1136/bmjoq-2023-002656.

ABSTRACT

BACKGROUND: WHO reported that neonatal hypothermia accounts for about 27% of newborn deaths worldwide. It is a serious concern in Ethiopia and other parts of sub-Saharan Africa; it poses a serious threat to global health, increasing morbidity and mortality. Hypothermic neonates are more likely to experience respiratory distress, infections and other issues that could result in longer hospital stays and delayed development. The objective of this quality improvement project was to minimise intensive medical treatments, maximise resource usage and enhance overall health outcomes for newborns at Gandhi Memorial Hospital by reducing neonatal hypothermia.

METHODS: Over 10 months (from 1 March 2021 to 30 January 2022), neonatal hypothermia incidence was assessed using Quality Supervision Mentoring Team and Health Management Information System data. Root cause analysis and literature review led to evidence-based interventions in a change bundle. After team training and neonatal intensive care unit (NICU) relocation, Plan-Do-Study-Act cycles tested the bundle. Close temperature monitoring and data collection occurred. Run charts evaluated intervention success against baseline data, informing conclusions about effectiveness.

RESULT: The quality improvement project reduced neonatal hypothermia in NICU admissions from a baseline median of 80.6% to a performance median of 30%.

CONCLUSION AND RECOMMENDATION: The quality improvement project at Gandhi Memorial Hospital effectively reduced neonatal hypothermia through interventions such as the temperature management bundle and NICU relocation, leading to improved patient care, fewer hypothermic neonates and enhanced body temperature management. Continuous monitoring, adherence to best practices, sharing success and outcome assessment are crucial for enhancing the project’s effectiveness and sustaining positive impacts on neonatal hypothermia reduction and patient outcomes.

PMID:38942436 | DOI:10.1136/bmjoq-2023-002656

Categories
Nevin Manimala Statistics

Infant deaths increased after Texas banned early abortions, study finds

BMJ. 2024 Jun 28;385:q1447. doi: 10.1136/bmj.q1447.

NO ABSTRACT

PMID:38942430 | DOI:10.1136/bmj.q1447

Categories
Nevin Manimala Statistics

Emotional and psychosocial function after dorsal column spinal cord stimulator implantation: a systematic review and meta-analysis

Reg Anesth Pain Med. 2024 Jun 27:rapm-2024-105523. doi: 10.1136/rapm-2024-105523. Online ahead of print.

ABSTRACT

BACKGROUND: The efficacy of spinal cord stimulation (SCS) in chronic pain studies is traditionally assessed by pain scores, which do not reflect the multidimensional nature of pain perception. Despite the evidence of SCS’s influence on emotional functioning comprehensive assessments of its effect remain lacking.

OBJECTIVE: To assess changes in emotional and psychosocial functioning in patients who underwent SCS implantation for chronic pain.

EVIDENCE REVIEW: Ovid MEDLINE, EMBASE, PsychINFO, Cochrane CENTRAL and Scopus databases were searched for original peer-reviewed publications reporting emotional functioning after SCS. The primary outcomes were a pooled mean difference (MD) in anxiety, depression, global functioning, mental well-being and pain catastrophizing at 12 months. The Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) was used to determine the quality of evidence.

FINDINGS: Thirty-two studies were included in the primary analysis. Statistically significant improvements were observed in anxiety (MD -2.16; 95% CI -2.84 to -1.49; p<0.001), depression (MD -4.66; 95% CI -6.26 to -3.06; p<0.001), global functioning (MD 20.30; 95% CI 14.69 to 25.90; p<0.001), mental well-being (MD 4.95; 95% CI 3.60 to 6.31; p<0.001), and pain catastrophizing (MD -12.09; 95% CI -14.94 to -9.23; p<0.001). Subgroup analyses revealed differences in Global Assessment of Functioning and mental well-being based on study design and in depression based on waveform paradigm.

CONCLUSION: The results highlight the statistically and clinically significant improvements in emotional and psychosocial outcomes in patients with chronic pain undergoing SCS therapy. However, these results need to be interpreted with caution due to the very low certainty of evidence per the GRADE criteria.

PROSPERO REGISTRATION: CRD42023446326.

PMID:38942426 | DOI:10.1136/rapm-2024-105523

Categories
Nevin Manimala Statistics

A Single Injection of Platelet-Rich Plasma Injection for the Treatment of Stress Urinary Incontinence in Females: A Randomized Placebo-Controlled Trial

Urology. 2024 Jun 26:S0090-4295(24)00499-0. doi: 10.1016/j.urology.2024.06.047. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the efficacy of a single injection of platelet-rich plasma into the anterior vaginal wall at the mid-urethra compared to placebo, as there is emerging evidence that platelet-rich plasma may help treat female stress urinary incontinence.

METHODS: This was a single-blind, randomized, placebo-controlled clinical trial at a single institution. Females with bothersome, demonstrable stress-predominant urinary incontinence were enrolled. Participants were randomized to either injection of 5 mL autologous platelet-rich plasma or saline at the anterior vaginal wall at the mid-urethra. The primary outcome was composite treatment success at six months, defined as a negative cough stress test and an answer of “much better” or “very much better” on the Patient’s Global Impression of Improvement.

RESULTS: Fifty patients were enrolled in the study and randomized to the platelet-rich plasma group (n = 25) or the saline placebo group (n = 25). There was no statistically significant difference in the primary outcome between the two groups. Adverse events were minor, and the rate of adverse events was similar between both groups.

CONCLUSIONS: In this randomized placebo-controlled study, we were unable to demonstrate a difference in stress urinary incontinence treatment success between platelet-rich plasma and saline injections. At this time, there is insufficient evidence to offer a one-time platelet-rich plasma injection into the anterior vaginal wall for treatment of female stress urinary incontinence.

PMID:38942391 | DOI:10.1016/j.urology.2024.06.047