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BACKGROUND: REGEN-COV is a non-Food and Drug Adminstration approved monoclonal antibody combination of casirivimab/imdevimab. Casirivimab/imdevimab was previously used for the treatment of SARS-CoV-2 infection (COVID-19), under an emergency use authorization, and has demonstrated a reduction in hospitalizations and death. With the ability to administer this monoclonal antibody combination subcutaneously in an outpatient setting, limited community pharmacies became a treatment location for patients. OBJECTIVES: The objective of this study was to describe an innovative service and evaluate the safety of administering REGEN-COV, a monoclonal antibody combination of casirivimab and imdevimab, in a community pharmacy setting as treatment for COVID-19. PRACTICE DESCRIPTION: This study was conducted in a community pharmacy during traditional business hours. PRACTICE INNOVATION: A novel service of monoclonal antibody administration for the treatment of COVID-19 was implemented in a community pharmacy in response to community needs during the pandemic. EVALUATION METHODS: A retrospective, observational study was conducted from September 1, 2021 to December 31, 2021. Patients were required to have a positive SARS-CoV-2 test and meet all inclusion and exclusion criteria. Patients were assessed for adverse drug reactions at the time of monoclonal antibody administration and 60-minutes after administration. Patients were contacted by phone to complete a survey to assess patient reported adverse drug reactions post administration, number of patients hospitalized, and number of patients able to return to normal daily activities. RESULTS: Of the 93 patients included in this study, adverse effects were reported in 4.3% of patients at administration and 9.7% at follow-up. Included patients receiving this service generated $32,688.68 in revenue for the community pharmacy. CONCLUSION: Community pharmacists can administer casirivimab/imdevimab safely and effectively in an outpatient setting with low adverse events. This innovative monoclonal antibody administration service should be used as an example for a Call to Action of expansion of pharmacist scope of practice.

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The 15-day Jumpstart was developed as an evidence-based, affordable, standardized, replicable, and scalable program, designed to demonstrate quickly to patients that changing what they eat can improve their health. The program was designed using the principles of the self-determination theory of motivation and personality. Patients were instructed to eat an Esselstyn-compliant, whole-food plant-based diet consisting of vegetables, fruits, whole grains, and legumes. Of the 389 participants in the program from September 2018 to February 2020, average weight loss was 5.8 pounds (7.3 for those whose body mass index was >30), average systolic blood pressure drop was 6.8 points (16.8 points for those with systolic blood pressure >140), average drop in cholesterol was 26 points (44 points for those with a cholesterol >200), average drop in low-density lipoprotein was 19 points (33 points for those with a low-density lipoprotein >100), and average drop in fasting blood sugar was 5.1 points (28.4 points for those starting in the diabetic range); P value was <.005 for fasting blood sugar and <.001 for all other comparisons. A 15-day program that helps patients adopt an Esselstyn-style whole-food plant-based diet, through education, individualized medical feedback, social support, and facilitated small group work, rapidly improves health.

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Patients with chronic conditions are at higher risk of complications and mortality if they get COVID-19. Approximately half of American adults have at least 1 condition that increases their risk of complications if they become infected. The medical and public health communities need to send a clear message about the impact of lifestyle on health, particularly in the time of this pandemic. We need to communicate with patients and the public, to let them know how rapidly major lifestyle changes can improve health. This communication is urgent; the timeline for self-care and lifestyle medicine interventions has been telescoped, so that chronic diseases are now acute risk factors.

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A semi-structured, web-based questionnaire was developed to survey midwives (n = 241) employed by NHS Tayside, UK, to identify current practice and views on weight management of obese women during pregnancy and the puerperium. A total of 78 (32%) midwives submitted responses following email invitation. Most respondents (79%) reported always calculating women's body mass index (BMI) at booking, with 73% routinely explaining the BMI category. In terms of future practice for obese women, although few respondents (15%) currently offer personalised advice regarding weight management based on a woman's diet and physical activity levels, 77% of respondents thought such advice would be appropriate and 69% thought it could possibly be feasible to offer such advice. The respondents viewed weight management to be of importance and felt that universal advice is appropriate, but confidence in discussing weight management and knowledge of the subject was low. Strategies to improve midwife confidence and weight management services should include training, ongoing support and definition of the midwife's role within the multidisciplinary team to support practice in the future.

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BACKGROUND: The latent phase of labor can vary greatly in duration, and many women are uncertain about when to contact the maternity unit. The aim of this study was to elicit and value women's preferences for some aspects of labor management. METHODS: A questionnaire was sent to 1,251 women who had recently given birth to their first child at one of 14 maternity units in Scotland. Discrete choice questions were used to measure women's preferences for five attributes of care: number of visits (assessments) before admission to the labor ward, time spent on the labor ward before delivery, mobility during labor, pain relief required, and mode of delivery. Responses were analyzed for the sample as a whole and for subgroups defined by recent experiences of labor. RESULTS: A total of 730 (58.4%) questionnaires were returned and analyzed. Women expressed a preference for fewer visits before admission, shorter times on the labor ward before delivery, mobility during labor, normal vaginal deliveries, and moderate forms of pain relief (Entonox and opiates). Subgroup analysis suggests that women's preferences for pain relief are influenced by their recent labor experience. The elicited preference values provide a means for estimating the tradeoffs women are willing to make between attributes of labor management. CONCLUSIONS: Women appear to dislike being turned away from the labor ward before admission for delivery. Extra visits before admission only appear to be a price worth paying if they result in reductions in the duration of time spent on the labor ward, reductions in the chance of being immobilized in hospital during labor, or a lower chance of requiring an instrumental or operative delivery.

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As the discipline of health services research has developed so methods of evaluation have become increasingly sophisticated; where once a 'simple' randomized controlled trial would have been considered the gold standard, now terms such as 'complex interventions' and the 'cluster randomized controlled trial' are hot topics for discussion. The challenges involved in carrying out such studies are rarely presented. In this paper we discuss some of these challenges in relation to ethical and statistical considerations, and illustrate them using a recently completed cluster randomized controlled trial of a decision tool for early labour.

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OBJECTIVE: To compare the effectiveness of an algorithm for diagnosis of active labour in primiparous women with standard care in terms of maternal and neonatal outcomes. DESIGN: Cluster randomised trial. SETTING: Maternity units in Scotland with at least 800 annual births. PARTICIPANTS: 4503 women giving birth for the first time, in 14 maternity units. Seven experimental clusters collected data from a baseline sample of 1029 women and a post-implementation sample of 896 women. The seven control clusters had a baseline sample of 1291 women and a post-implementation sample of 1287 women. INTERVENTION: Use of an algorithm by midwives to assist their diagnosis of active labour, compared with standard care. Main outcomes Primary outcome: use of oxytocin for augmentation of labour. SECONDARY OUTCOMES: medical interventions in labour, admission management, and birth outcome. RESULTS: No significant difference was found between groups in percentage use of oxytocin for augmentation of labour (experimental minus control, difference=0.3, 95% confidence interval -9.2 to 9.8; P=0.9) or in the use of medical interventions in labour. Women in the algorithm group were more likely to be discharged from the labour suite after their first labour assessment (difference=-19.2, -29.9 to -8.6; P=0.002) and to have more pre-labour admissions (0.29, 0.04 to 0.55; P=0.03). CONCLUSIONS: Use of an algorithm to assist midwives with the diagnosis of active labour in primiparous women did not result in a reduction in oxytocin use or in medical intervention in spontaneous labour. Significantly more women in the experimental group were discharged home after their first labour ward assessment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN00522952.

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CONTEXT: Transient hypothyroxinemia is common in infants less than 30 wk gestation and is associated with neurodevelopmental deficits; it has no consensus definition. We previously suggested that appropriate ranges for postnatal serum T4 values are at least cord levels corrected to an equivalent gestational age if the fetuses had remained in utero. OBJECTIVE: The study objective is to investigate the contribution of prenatal and intrapartum factors (n = 27) to the variations in cord levels of iodothyronines, T4-binding globulin, and TSH, and to provide an appropriate definition of transient hypothyroxinemia. DESIGN: The study design is a cohort study (n = 620) in 11 Scottish neonatal intensive care units. PATIENTS: Infants were delivered at 23- to 42-wk gestation and recruited between January 1998 and September 2001. RESULTS: Using -2 SD of adjusted T4 cord levels applied to postnatal d-7 values of equivalent gestational age, 14% of the 23- to 27-wk group, 1% of the 28- to 30-wk group, and 3% of the 31- to 34-wk group are hypothyroxinemic; using -1 SD, the respective figures are 41, 23, and 12%. CONCLUSIONS: In the absence of neurodevelopmental follow-up studies to quantify transient hypothyroxinemia, a pragmatic criterion is necessary for selection of extreme preterm infants into clinical trials of T4 supplementation. We suggest the use of serum T4 levels on postnatal d 7 that are below -1 SD of adjusted cord T4 levels of equivalent gestational age. This criterion avoids over-recruitment of the more mature infants in whom universal T4 supplementation is detrimental to neurodevelopmental outcome, but still allows selection of the least mature entrants on whom universal T4 supplementation is beneficial.

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