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Effect of Carbamazepine on the Pharmacokinetics of Erdafitinib in Healthy Participants

Clin Pharmacol Drug Dev. 2024 May 13. doi: 10.1002/cpdd.1412. Online ahead of print.

ABSTRACT

Erdafitinib, a selective and potent oral pan-FGFR inhibitor, is metabolized mainly through CYP2C9 and CYP3A4 enzymes. This phase 1, open-label, single-sequence, drug-drug interaction study evaluated the pharmacokinetics, safety, and tolerability of a single oral dose of erdafitinib alone and when co-administered with steady state oral carbamazepine, a dual inducer of CYP3A4 and CYP2C9, in 13 healthy adult participants (NCT04330248). Compared with erdafitinib administration alone, carbamazepine co-administration decreased total and free maximum plasma concentrations of erdafitinib (Cmax) by 35% (95% CI 30%-39%) and 22% (95% CI 17%-27%), respectively. The areas under the concentration-time curve over the time interval from 0 to 168 hours, to the last quantifiable data point, and to time infinity (AUC168h, AUClast, AUCinf), were markedly decreased for both total erdafitinib (56%-62%) and free erdafitinib (48%-55%). The safety profile of erdafitinib was consistent with previous clinical studies in healthy participants, with no new safety concerns when administered with or without carbamazepine. Co-administration with carbamazepine may reduce the activity of erdafitinib due to reduced exposure. Concomitant use of strong CYP3A4 inducers with erdafitinib should be avoided.

PMID:38740493 | DOI:10.1002/cpdd.1412

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Inappropriate Ordering of Multitarget Stool DNA Tests for Colon Cancer Screening

J Am Board Fam Med. 2024 Mar-Apr;37(2):328-331. doi: 10.3122/jabfm.2023.230164R2.

ABSTRACT

BACKGROUND: CRC screening is recommended for adults aged 45-75. Mt-sDNA is indicated for asymptomatic individuals between the ages of 45 and 85, but not for those with rectal bleeding, iron deficiency anemia, adenomatous polyps, previous colonoscopy within 10 years, family history of CRC, positive results from CRC screening tests within the past 6 months, or age less than 45 and greater than 85. We aimed to determine the prevalence of mt-sDNA use when not indicated and factors associated with inappropriate testing.

METHODS: 7,345 patients underwent mt-sDNA testing and were randomized using EMERSE. Charts for the first 500 patients were reviewed to determine whether mt-sDNA was ordered appropriately according to the USPSTF criteria. Seven patients were excluded due to having more than one inappropriate ordering for mt-sDNA.

RESULTS: Of 500 patients, 22.2% had an inappropriately ordered mt-sDNA test. The most common reason for inappropriate ordering was having a previous colonoscopy done within the past 10 years. Rates of inappropriate testing significantly varied by race and the specialty of the ordering provider, with internal medicine providers ordering the most mt-sDNA tests. Rates of inappropriate testing did not significantly vary by sex or type of insurance.

DISCUSSION: Our study suggests that providers may not be familiar with guidelines for the indicated use of mtsDNA, leading to inappropriate referrals and increased costs. Patients at increased CRC risk would benefit from a more sensitive procedure such as a colonoscopy. Future studies could understand the motivation to order testing outside approved indications through provider surveys and interviews.

PMID:38740492 | DOI:10.3122/jabfm.2023.230164R2

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The Ability of Primary Care Practices to Measure and Report on Care Quality

J Am Board Fam Med. 2024 Mar-Apr;37(2):316-320. doi: 10.3122/jabfm.2023.230116R1.

ABSTRACT

BACKGROUND: Creating useful clinical quality measure (CQM) reports in a busy primary care practice is known to depend on the capability of the electronic health record (EHR). Two other domains may also contribute: supportive leadership to prioritize the work and commit the necessary resources, and individuals with the necessary health information technology (IT) skills to do so. Here we describe the results of an assessment of the above 3 domains and their associations with successful CQM reporting during an initiative to improve smaller primary care practices’ cardiovascular disease CQMs.

METHODS: The study took place within an AHRQ EvidenceNOW initiative of external support for smaller practices across Washington, Oregon and Idaho. Practice facilitators who provided this support completed an assessment of the 3 domains previously described for each of their assigned practices. Practices submitted 3 CQMs to the study team: appropriate aspirin prescribing, use of statins when indicated, blood pressure control, and tobacco screening/cessation.

RESULTS: Practices with advanced EHR reporting capability were more likely to report 2 or more CQMs. Only one-third of practices were “advanced” in this domain, and this domain had the highest proportion of practices (39.1%) assessed as “basic.” The presence of advanced leadership or advanced skills did not appreciably increase the proportion of practices that reported 2 or more CQMs.

CONCLUSIONS: Our findings support previous reports of limited EHR reporting capabilities within smaller practices but extend these findings by demonstrating that practices with advanced capabilities in this domain are more likely to produce CQM reports.

PMID:38740491 | DOI:10.3122/jabfm.2023.230116R1

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Self-Management Support Improves Diabetes Outcomes Without Exacerbating Inequities

J Am Board Fam Med. 2024 Mar-Apr;37(2):303-308. doi: 10.3122/jabfm.2023.230324R1.

ABSTRACT

INTRODUCTION: Previous research has found an association between low health literacy and poor clinical outcomes in type 2 Diabetes Mellitus (T2DM) patients. We sought to determine if this association can be mitigated by a self-management support (SMS) program provided by trained health workers using a technology assisted menu driven program, called Connection to Health (CTH).

METHODS: This study is a secondary analysis from a randomized trial of 2 similar versions of CTH implemented in 12 Northern California community health centers. As part of this, each participant completed a single validated question to assess health literacy. We used unadjusted and adjusted linear regression analyses to determine the extent to which baseline health literacy was predictive of prepost changes in hemoglobin A1c (HbA1c).

RESULTS: Of 365 participants for whom prepost HbA1c data were available, HbA1c concentrations declined by an average of 0.76% (from 9.9% to 9.2%, 95% CI (0.53%-1.0%). Almost 114 (31.2%) of the participants had low health literacy, but there was no significant association between health literacy and the reduction in HbA1c concentrations in either the unadjusted or adjusted models, nor did baseline health literacy predict prepost changes in body mass index, medication adherence, exercise, or diet.

DISCUSSION: The study found that implementing the CTH program in 2 versions via a randomized clinical trial improved HbA1c concentrations without increasing disparities between participants with high and low health literacy. This suggests CTH-like programs can enhance diabetes outcomes in community health centers without exacerbating inequities for those with low health literacy.

PMID:38740490 | DOI:10.3122/jabfm.2023.230324R1

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Prospective Validation of a Simple Risk Score to Predict Hospitalization during the Omicron Phase of COVID-19

J Am Board Fam Med. 2024 Mar-Apr;37(2):324-327. doi: 10.3122/jabfm.2023.230208R1.

ABSTRACT

INTRODUCTION: We previously developed a simple risk score with 3 items (age, patient report of dyspnea, and any relevant comorbidity), and in this report validate it in a prospective sample of patients, stratified by vaccination status.

METHODS: Data were abstracted from a structured electronic health record of primary care and urgent care 8 patients with COVID-19 in the Lehigh Valley Health Network from 11/21/2021 and 10/31/2022 9 (Omicron variant). Our previously derived risk score was calculated for each of 19,456 patients, 10 and the likelihood of hospitalization was determined. Area under the ROC curve was calculated.

RESULTS: We were able to place 13,239 patients (68%) in a low-risk group with only a 0.16% risk of 13 hospitalization. The moderate risk group with 5622 patients had a 2.2% risk of hospitalization 14 and might benefit from close outpatient follow-up, whereas the high-risk group with only 574 15 patients (2.9% of all patients) had an 8.9% risk of hospitalization and may require further 16 evaluation. Area under the curve was 0.844.

DISCUSSION: We prospectively validated a simple risk score for primary and urgent care patients with COVID1919 that can support outpatient triage decisions around COVID-19.

PMID:38740489 | DOI:10.3122/jabfm.2023.230208R1

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Missed Opportunities for HIV Prevention in a Large County Safety Net Health System

J Am Board Fam Med. 2024 Mar-Apr;37(2):261-269. doi: 10.3122/jabfm.2023.230297R2.

ABSTRACT

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is effective at reducing HIV transmission. However, PrEP uptake is low for racial and ethnic minorities and women, especially in the Southern US Health care clinicians should be prepared to identify all patients eligible for PrEP, provide counseling, and prescribe PrEP.

METHODS: Retrospective analysis of persons newly diagnosed with HIV was conducted at a large public health system from January 2015 to June 2021. Interactions with the health system in the 5 years preceding HIV diagnosis were analyzed, and missed opportunities for HIV prevention interventions, including PrEP and condom use counseling, were identified.

RESULTS: We identified 454 patients with a new HIV diagnosis with previous health system interactions. 166(36.6%) had at least 1 identifiable indication for PrEP: 42(9.3%) bacterial STI, 63(13.9%) inconsistent condom use, or 82(18%) injection drug use before HIV diagnosis. Only 7(1.5%) of patients were counseled on PrEP. Most patients (308; 67.8%) had no documented condom use history in the EHR before diagnosis, a surrogate marker for obtaining a sexual history. Patients who exclusively interacted with the emergency care setting did not receive PrEP education and were less likely to receive condom use counseling.

CONCLUSION: Missed opportunities to offer HIV prevention before diagnosis were common among patients newly diagnosed with HIV. Most patients did not have sexual history documented in the chart before their HIV diagnosis. Educational interventions are needed to ensure that clinicians are prepared to identify those eligible and discuss the benefits of PrEP.

PMID:38740488 | DOI:10.3122/jabfm.2023.230297R2

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Variable Impact of Medical Scribes on Physician Electronic Health Record Documentation Practices: A Quantitative Analysis Across a Large, Integrated Health-System

J Am Board Fam Med. 2024 Mar-Apr;37(2):228-241. doi: 10.3122/jabfm.2023.230211R2.

ABSTRACT

BACKGROUND: Medical scribes have been utilized to reduce electronic health record (EHR) associated documentation burden. Although evidence suggests benefits to scribes, no large-scale studies have quantitatively evaluated scribe impact on physician documentation across clinical settings. This study aimed to evaluate the effect of scribes on physician EHR documentation behaviors and performance.

METHODS: This retrospective cohort study used EHR audit log data from a large academic health system to evaluate clinical documentation for all ambulatory encounters between January 2014 and December 2019 to evaluate the effect of scribes on physician documentation behaviors. Scribe services were provided on a first-come, first-served basis on physician request. Based on a physician’s scribe use, encounters were grouped into 3 categories: never using a scribe, prescribe (before scribe use), or using a scribe. Outcomes included chart closure time, the proportion of delinquent charts, and charts closed after-hours.

RESULTS: Three hundred ninety-five physicians (23% scribe users) across 29 medical subspecialties, encompassing 1,132,487 encounters, were included in the analysis. At baseline, scribe users had higher chart closure time, delinquent charts, and after-hours documentation than physicians who never used scribes. Among scribe users, the difference in outcome measures postscribe compared with baseline varied, and using a scribe rarely resulted in outcome measures approaching a range similar to the performance levels of nonusing physicians. In addition, there was variability in outcome measures across medical specialties and within similar subspecialties.

CONCLUSION: Although scribes may improve documentation efficiency among some physicians, not all will improve EHR-related documentation practices. Different strategies may help to optimize documentation behaviors of physician-scribe dyads and maximize outcomes of scribe implementation.

PMID:38740487 | DOI:10.3122/jabfm.2023.230211R2

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Family Medicine Clinician Screening and Barriers to Communication on Food Insecurity: A CERA General Membership Survey

J Am Board Fam Med. 2024 Mar-Apr;37(2):196-205. doi: 10.3122/jabfm.2023.230319R1.

ABSTRACT

PURPOSE: Food insecurity (FI) is a hidden epidemic associated with worsening health outcomes affecting 33.8 million people in the US in 2021. Although studies demonstrate the importance of health care clinician assessment of a patient’s food insecurity, little is known about whether Family Medicine clinicians (FMC) discuss FI with patients and what barriers influence their ability to communicate about FI. This study evaluated FM clinicians’ food insecurity screening practices to evaluate screening disparities and identify barriers that influence the decision to communicate about FI.

METHODS: Data were gathered and analyzed as part of the 2022 Council of Academic Family Medicine’s Educational Research Alliance survey of Family Medicine general membership.

RESULTS: The majority of respondents reported (66.9%) that their practice has a screening system for food insecurity, and most practices used a verbal screen with staff other than the clinician (41%) at specific visits (63.8%). Clinicians reported “rarely or never asking about FI” 40% of the time and only asking “always or frequently” 6.7% of the time. Inadequate time during appointments (44.5%) and other medical issues taking priority (29.4%) were identified as the most common barriers. The lack of resources available in the community was a significant barrier for clinicians who worked in rural areas.

CONCLUSIONS: This survey provides insight into food insecurity screening disparities and identifies obstacles to FMC screening, such as time constraints, lack of resources, and knowledge of available resources. Understanding current communication practices could create opportunities for interventions to identify food insecurity and impact “Food as Medicine.”

PMID:38740486 | DOI:10.3122/jabfm.2023.230319R1

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Data Disaggregation of Asian-American Family Physicians

J Am Board Fam Med. 2024 Mar-Apr;37(2):349-350. doi: 10.3122/jabfm.2023.230326R1.

ABSTRACT

The singular label of “Asian” obscures socioeconomic differences between Asian ethnic groups that affect matriculation into the field of medicine. Using data from American Board of Family Medicine Examination candidates in 2023, we found that compared to the US population, among Asian-American family physicians, Indians were present at higher rates, while Chinese and Filipinos were underrepresented, suggesting the importance of continued disaggregation of Asian ethnicities in medicine.

PMID:38740485 | DOI:10.3122/jabfm.2023.230326R1

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The Gender Wage Gap Among Early-Career Family Physicians

J Am Board Fam Med. 2024 Mar-Apr;37(2):270-278. doi: 10.3122/jabfm.2023.230218R1.

ABSTRACT

PURPOSE: Numerous studies have documented salary differences between male and female physicians. For many specialties, this wage gap has been explored by controlling for measurable factors that influence pay such as productivity, work-life balance, and practice patterns. In family medicine where practice activities differ widely between physicians, it is important to understand what measurable factors may be contributing to the gender wage gap, so that employers and policymakers and can address unjust disparities.

METHODS: We used data from the 2017 to 2020 American Board of Family Medicine (ABFM) National Graduate Survey (NGS) which is administered to family physicians 3 years after residency (n = 8608; response rate = 63.9%, 56.2% female). The survey collects clinical income and practice patterns. Multiple linear regression analysis was performed, which included variables on hours worked, degree type, principal professional activity, rural/urban, and region.

RESULTS: Although early-career family physician incomes averaged $225,278, female respondents reported incomes that were $43,566 (17%) lower than those of male respondents (P = .001). Generally, female respondents tended toward lower-earning principal professional activities and US regions; worked fewer hours (2.9 per week); and tended to work more frequently in urban settings. However, in adjusted models, this gap in income only fell to $31,804 (13% lower than male respondents, P = .001).

CONCLUSION: Even after controlling for measurable factors such as hours worked, degree type, principal professional activity, population density, and region, a significant wage gap persists. Interventions should be taken to eliminate gender bias in wage determinations for family physicians.

PMID:38740481 | DOI:10.3122/jabfm.2023.230218R1