Nevin Manimala

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

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

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 Kp_uu and hepatic availability F_H , 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

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

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

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

NO ABSTRACT

PMID:38942430 | DOI:10.1136/bmj.q1447

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

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

Urology. 2024 Jun 26:S0090-4295(24)00505-3. doi: 10.1016/j.urology.2024.06.046. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the outcomes of Ventral inlay buccal mucosal graft urethroplasty (VIBMGU) with dorsal onlay buccal mucosal graft urethroplasty (DOBMGU) for the treatment of Female urethral stricture (FUS).

MATERIAL AND METHODS: This study included women who underwent either VIBMGU or DOBMGU between January 2016 and June 2023. The preoperative AUA symptom scores, maximal urinary flow rate (Qmax), post-void residual volume (PVR) on ultrasonography, and length and location of the stricture were obtained from a prospectively maintained electronic database. The data obtained from the patient’s last visit was compared with the preoperative values for this study. The primary outcome was the success rate. The secondary outcomes were changes in AUA score, PVR, and Qmax. The patient’s last follow-up visit was considered for the duration of the follow-up.

RESULTS: Seventy-three patients were treated for BMGU for FUS. Forty-six patients underwent VIBMGU, and 27 patients underwent DOBMGU. The median duration of follow-up was 27.5 11.00-55.00) versus 14 (7.00-17.00) months respectively. The success rates of VIBMGU and DOBMGU were 89.13% and 88.89% respectively. There was a reduction in AUA scores and PVR and an improvement in Qmax postoperatively in both groups. The difference in the reduction in AUA scores between the VIBMGU and DOBMGU groups was statistically significant. The difference was not statistically significant in terms of reduction in PVR and improvement in Qmax between the two groups.

CONCLUSION: The ventral inlay technique can provide equal results to the dorsal technique with the added advantage of vaginal sparing. This is the single largest series in the literature on female urethral stricture with the largest follow-up period of 90 months.

PMID:38942390 | DOI:10.1016/j.urology.2024.06.046

F S Sci. 2024 Jun 26:S2666-335X(24)00034-X. doi: 10.1016/j.xfss.2024.06.005. Online ahead of print.

ABSTRACT

OBJECTIVE: To study the identification of rare genetic variants in the PCDH genetic family in a cohort of transgender women and their potential role in gender identity.

DESIGN: Exome sequencing and functional ontology analysis.

SETTING: Augusta University, including the Equality Clinic of Augusta and the Reproductive Medicine and Infertility Associates Clinic.

PATIENTS: 24 transgender women and 22 cisgender men.

INTERVENTIONS: Exome sequencing followed by variant confirmation through Sanger sequencing and functional classification analysis using the Database for Annotation, Visualization and Integrated Discovery (DAVID) tool.

MAIN OUTCOME MEASURES: Identification of rare, functionally significant genetic variants in the PCDH gene family and their prevalence in transgender women compared to cisgender men.

RESULTS: Exome sequencing revealed 38,524 genetic variants, of which 2441 were rare and predicted to be functionally significant. DAVID analysis demonstrated a statistically enriched functional group, “homophilic cell adhesion via plasma membrane adhesion molecules” (Benjamini corrected p-value 1.5 x 10-11), containing 55 genes, including 18 PCDH gene family members. A total of 37 rare variants in 21 PCDH genes were identified, with 36 confirmed by Sanger sequencing. A statistically significant increase in these variants was observed in transgender women compared to cisgender men (Z = 2.08905, p= 0.037).

CONCLUSIONS: Transgender women exhibited a greater than 3-fold increase in functionally significant PCDH gene variants compared to cisgender men. These findings suggest that the PCDH family may play a role in the genetic pathways associated with gender identity in transgender women.

PMID:38942387 | DOI:10.1016/j.xfss.2024.06.005