Patient Priorities, Decisional Comfort, and Satisfaction with Metformin versus Insulin for the Treatment of Gestational Diabetes Mellitus.

OBJECTIVE: We compared patient priorities, decisional comfort, and satisfaction with treating gestational diabetes mellitus (GDM) with metformin versus insulin among pregnant individuals with GDM requiring pharmacotherapy. STUDY DESIGN: We conducted a cross-sectional study of patients' perspectives about GDM pharmacotherapy in an integrated prenatal and diabetes care program from October 19, 2022, to August 24, 2023. The exposure was metformin versus insulin as the initial medication decision. Outcomes included standardized measures of patient priorities, decisional comfort, and satisfaction about their medication decision. RESULTS: Among 144 assessed individuals, 60.4% were prescribed metformin and 39.6% were prescribed insulin. Minoritized individuals were more likely to receive metformin compared with non-Hispanic White individuals (34.9 vs. 17.5%; p = 0.03). Individuals who were willing to participate in a GDM pharmacotherapy clinical trial were more likely to receive insulin than those who were unwilling (30.4 vs. 19.5%; p = 0.02). Individuals receiving metformin were more likely to report prioritizing avoiding injections (62.4 vs. 19.3%; adjusted odds ratio [aOR]: 2.83; 95% confidence interval [CI]: 1.10-7.31), wanting to take a medication no more than twice daily (56.0 vs. 30.4%; aOR: 3.67; 95% CI: 1.56-8.67), and believing that both medications can equally prevent adverse pregnancy outcomes (70.9 vs. 52.6%; aOR: 2.67; 95% CI: 1.19-6.03). Conversely, they were less likely to report prioritizing a medication that crosses the placenta (39.1 vs. 82.5%; aOR: 0.09; 95% CI: 0.03-0.25) and needing supplemental insulin to achieve glycemic control (21.2 vs. 47.4%; aOR: 0.36; 95% CI: 0.15-0.90). Individuals reported similarly high (mean score > 80%) levels of decisional comfort, personal satisfaction with medication decision-making, and satisfaction about their conversation with their provider about their medication decision with metformin and insulin (p ≥ 0.05 for all). CONCLUSION: Individuals with GDM requiring pharmacotherapy reported high levels of decision comfort and satisfaction with both metformin and insulin, although they expressed different priorities in medication decision-making. These results can inform future patient-centered GDM treatment strategies. KEY POINTS: · Pregnant individuals with GDM requiring pharmacotherapy expressed a high level of decisional comfort and satisfaction with medication decision making.. · Individuals placed different priorities on deciding to take metformin versus insulin.. · These results can inform interventions aimed at delivering person-centered diabetes care in pregnancy that integrates patient autonomy and knowledge about treatment options..

Comparative effectiveness trial of metformin versus insulin for the treatment of gestational diabetes in the USA: clinical trial protocol for the multicentre DECIDE study.

INTRODUCTION: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the affected pregnant individual and the infant exposed in utero. One in four individuals with GDM will require pharmacotherapy to achieve glycaemic control. Injectable insulin has been the mainstay of pharmacotherapy. Oral metformin is an alternative option increasingly used in clinical practice. Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterised, adequately powered study of a diverse US population remain lacking. Because metformin crosses the placenta, long-term safety data, in particular, the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remain to be characterised, including barriers to and facilitators of metformin versus insulin use. METHODS AND ANALYSIS: In a two-arm open-label, pragmatic comparative effectiveness randomised controlled trial, we will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. We plan to recruit 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites using consistent diagnostic and treatment criteria for oral metformin versus injectable insulin and follow them and their children through delivery to 2 years post partum. More information is available at www.decidestudy.org. ETHICS AND DISSEMINATION: The Institutional Review Board at The Ohio State University approved this study (IRB: 2024H0193; date: 7 December 2024). We plan to submit manuscripts describing the results of each study aim, including the pregnancy outcomes, the 2-year follow-up outcomes, and mixed-methods assessment of patient experiences for publication in peer-reviewed journals and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT06445946.

Public health nursing competency instrument: scale reduction and reliability of factors.

OBJECTIVES: To reduce the number of items of the Public Health Nursing Competency Instrument (PHNCI) and to report the psychometric properties of the abbreviated instrument. DESIGN AND SAMPLE: The 193-item PHNCI was administered via an online survey tool. A national sample of 2,269 public health nurses was recruited from 25 states. MEASURES: All items of the PHNCI scale were positively stated and participants were asked to rate their skill level via a 4-point Likert scale. RESULTS: A principal component exploratory factor analysis with oblique rotation and examination of scree plot resulted in a final abbreviated scale which included 81 items and six factors: (1) Evaluation Competencies, (2) Individual/Family/Community Competencies, (3) Systems' Competencies, (4) Partnership/Collaboration Competencies, (5) Planning Competencies, and (6) Assessment Competencies. The six factors in the resulting PHNCI Abbreviated (PHNCIa ) demonstrated acceptable internal consistency, ranging from 0.92 to 0.98. CONCLUSION: The six factors of the PHNCIa integrate important concepts of both the nursing process and the intervention wheel. The instrument can be used by educators, administrators, managers, and staff members to assess strengths and challenge areas, guide discussions on performance and expectations, and enhance professional development efforts. Next steps for future research are presented.

The Henry street consortium population-based competencies for educating public health nursing students.

The Henry Street Consortium, a collaboration of nurse educators from universities and colleges and public health nurses (PHNs) from government, school, and community agencies, developed 11 population-based competencies for educating nursing students and the novice PHN. Although many organizations have developed competency lists for experts, the Consortium developed a set of competencies that clearly define expectations for the beginning PHN. The competencies are utilized by both education and practice. They guide nurse educators and PHNs in the creation of learning experiences that develop population-based knowledge and skills for baccalaureate nursing students. Public health nursing leaders use the competencies to frame their expectations and orientations for nurses who are new to public health nursing. This paper explains the meaning of each of the 11 population-based competencies and provides examples of student projects that demonstrate competency development. Strategies are suggested for nurse educators and PHNs to promote effective population-based student projects in public health agencies.

A lidocaine-containing formulation of large-gel particle hyaluronic acid alleviates pain.

BACKGROUND: Effective pain management is an important component of aesthetic procedures. OBJECTIVE: To compare the pain relief and safety of large-gel particle hyaluronic acid (HA) plus 0.3% lidocaine (LGP-HA+L) with that of LGP-HA without lidocaine during correction of nasolabial folds (NLFs) and to assess filler safety in different skin types. METHODS AND MATERIALS: Sixty subjects were enrolled in a randomized, double-blind, split-face study of LGP-HA and LGP-HA+L for NLF correction. Subjects assessed pain on a 100-mm visual analog scale (VAS). The primary objective was to demonstrate that more than 50% of subjects experienced pain relief with LGP-HA+L, defined as a within-subject VAS difference of at least 10 mm at the end of injection. RESULTS: LGP-HA+L resulted in pain relief in 57 (95.0%, 95% confidence interval=86.1-99.0) subjects at the end of injection. The mean within-subject VAS difference was 34.4 mm. Injection-related adverse events occurred at similar frequencies with both products. Slightly higher adverse event rates were observed with Fitzpatrick skin type IV for both compounds. The safety profiles of LGP-HA and LGP-HA+L were similar to each other in all skin types. CONCLUSION: The addition of lidocaine substantially reduces the pain of LGP-HA injection without altering safety. LGP-HA and LGP-HA+L were generally well tolerated in all Fitzpatrick skin types.

Development of the public health nursing competency instrument.

This paper describes the development and initial testing of an instrument to measure population-based public health nursing competencies. Although multiple lists of public health competencies exist, literature review did not elicit a valid instrument that could measure changes in public health nursing competency over time. The public health nursing competency instrument, consisting of 195 measurable activities organized in the framework of the nursing process, was developed. Competency scores of practicing public health nurses significantly increased after a continuing education series, and the instrument was confirmed by experts to be a valid reflection of public health nursing practice. The time required for instrument development exceeded expectations because of the multiple stages of delineating competencies and validating data with national experts.

Identification of a 95 kDa putative adhesin from Actinomyces serovar WVA963 strain PK1259 that is distinct from type 2 fimbrial subunits.

The species Actinomyces serovar WVA963 is among the 20 bacteria most frequently isolated from human subgingival plaque. The interactions of this species with streptococci are inhibited by lactose, a function associated with type 2 fimbrial surface structures in Actinomyces naeslundii. Type 1 fimbriae mediate binding of cells to salivary proline-rich proteins. Specific polyclonal antisera against type 1 and type 2 fimbriae of A. naeslundii T14V revealed both types of fimbriae on Actinomyces serovar WVA963 strain PK1259. To investigate the role of type 2 fimbriae of strain PK1259 in Actinomyces-Streptococcus lactose-inhibitable coaggregations, spontaneous coaggregation-defective (Cog-) mutants that failed to coaggregate with streptococci were isolated; three were chosen for study. All three mutant strains synthesized type 1 fimbriae and a 59 kDa protein; mutant strains PK2415 and PK3092 synthesized type 2 fimbriae and a 57 kDa protein. In contrast, the Cog- strain PK2407 did not agglutinate with anti-type 2 antibodies or show the 57 kDa band, suggesting that the 57 kDa protein was the type 2 fimbrial subunit. Polyclonal antiserum raised against the Actinomyces serovar WVA963 strain PK2399, an antibiotic-resistant derivative of wild-type PK1259, blocked coaggregation between this strain and streptococci. Anti-PK2399 serum absorbed with mutant strain PK3092 bearing type 2 fimbriae retained its blocking ability. Surface sonicates of the parent and mutant strains were adsorbed to streptococcal cells and to lactose-agarose beads. Lactose eluates from both the streptococcal cells and the affinity beads were characterized by SDS-PAGE and corresponding immunoblots using anti-PK2399 serum absorbed with Cog- mutant PK3092. These blots revealed a 95 kDa putative adhesin in the parent strain PK2399 that was absent in the Cog- mutant strain PK3092. These results suggest the presence of a putative 95 kDa actinomyces adhesin distinct from the 57 kDa type 2 fimbrial subunit and that this adhesin mediates lactose-inhibitable coaggregation with streptococci.