Using the COM-B framework to elucidate facilitators and barriers to COVID-19 vaccine uptake in pregnant women: a qualitative study.

Since April 2021, COVID-19 vaccines have been recommended for pregnant women. Despite this, COVID-19 vaccine uptake in this group is low compared to the non-pregnant population of childbearing age. Our aim was to understand barriers and facilitators to COVID-19 vaccine uptake among pregnant women in Northern Ireland using the COM-B framework, and so to make recommendations for public health interventions. The COM-B proposes that human behaviour is influenced by the extent to which a person has the capability, opportunity, and motivation to enact that behaviour. Understanding the factors underpinning behaviour through this lens helps discern what needs to change to change behaviour, therefore supporting the development of targeted interventions.This study consisted of eight semi-structured interviews with new/expectant mothers who did not receive a COVID-19 vaccine dose while pregnant since April 2021, and a focus group with five participants who received at least one COVID-19 vaccine dose while pregnant. Interview and focus group data were analysed using semi-deductive reflexive thematic analysis framed by a subtle realist approach. The COM-B was used to categorise codes and subthemes were developed within each COM-B construct.Within Psychological Capability, subthemes captured the need for consistent and reliable COVID-19 vaccine information and access to balanced and jargon-free, risk-benefit information that is tailored to the pregnant individual. The behaviour/opinions of family, friends, and local healthcare providers had a powerful influence on COVID-19 vaccine decisions (Social Opportunity). Integrating the COVID-19 vaccine as part of routine antenatal pathways was believed to support access and sense of familiarity (Physical Opportunity). Participants valued health autonomy, however experienced internal conflict driven by concerns about long-term side effects for their baby (Reflective Motivation). Feelings of fear, lack of empathy from healthcare providers, and anticipated guilt commonly underpinned indecision as to whether to get the vaccine (Automatic Motivation).Our study highlighted that the choice to accept a vaccine during pregnancy generates internal conflict and worry. Several participants cited their concern was primarily around the safety for their baby. Healthcare professionals (HCPs) play a significant part when it comes to decision making about COVID-19 vaccines among pregnant women. HCPs and pregnant women should be involved in the development of interventions to improve the delivery and communication of information.

Methods for the drug effectiveness review project.

The Drug Effectiveness Review Project was initiated in 2003 in response to dramatic increases in the cost of pharmaceuticals, which lessened the purchasing power of state Medicaid budgets. A collaborative group of state Medicaid agencies and other organizations formed to commission high-quality comparative effectiveness reviews to inform evidence-based decisions about drugs that would be available to Medicaid recipients. The Project is coordinated by the Center for Evidence-based Policy (CEbP) at Oregon Health & Science University (OHSU), and the systematic reviews are undertaken by the Evidence-based Practice Centers (EPCs) at OHSU and at the University of North Carolina. The reviews adhere to high standards for comparative effectiveness reviews. Because the investigators have direct, regular communication with policy-makers, the reports have direct impact on policy and decision-making, unlike many systematic reviews. The Project was an innovator of methods to involve stakeholders and continues to develop its methods in conducting reviews that are highly relevant to policy-makers. The methods used for selecting topics, developing key questions, searching, determining eligibility of studies, assessing study quality, conducting qualitative and quantitative syntheses, rating the strength of evidence, and summarizing findings are described. In addition, our on-going interactions with the policy-makers that use the reports are described.

The clinical utility of neostigmine administration in the diagnosis of acquired myasthenia gravis.

OBJECTIVE: To assess the clinical utility of neostigmine methylsulfate administration in the diagnosis of suspected acquired myasthenia gravis (MG) in dogs and cats. DESIGN: Retrospective study (2017-2019). SETTING: Five university teaching hospitals and 2 private referral hospitals. ANIMALS: Twenty-two dogs and 3 cats. Criteria for inclusion were clinical signs consistent with acquired MG, performance of a neostigmine challenge and acetylcholine receptor antibody titers. INTERVENTIONS: None. MEASUREMENTS & MAIN RESULTS: The route of neostigmine administration was recorded. Response to neostigmine challenge was determined via sequential evaluation of muscle strength and ambulation following administration of neostigmine methylsulfate. Response to neostigmine challenge was compared to acetylcholine receptor antibody titers, which were used as the biochemical gold standard in this study. Sixteen out of 22 dogs were diagnosed with acquired MG. Thirteen of 16 had a strong positive response to neostigmine challenge whereas 3 of 16 had no response. Two out of 3 dogs with polymyositis also had a strong positive response to neostigmine challenge. Weak positive results were seen with intracranial neoplasia (n = 1) and a dog with dilated cardiomyopathy and coxofemoral joint disease (n = 1). One cat was diagnosed with acquired MG and had a positive response to neostigmine challenge. Two cats had no response to neostigmine challenge and were diagnosed with alternate conditions. Two cats were premedicated with glycopyrrolate, one of which had a mild adverse response to neostigmine challenge (sialorrhea and mild transient tremors). Three out of 22 dogs had minimal adverse effects (sialorrhea and 1 dog with muscle tremors). CONCLUSIONS: The neostigmine challenge appears to be safe and viable alternative to the previously utilized edrophonium challenge, particularly when weak positive responses are considered negative for acquired MG. Polymyositis cases may have a false positive response to neostigmine challenge.

Treatment-resistant depression.

Up to two thirds of patients with major unipolar depression will not respond to the first medication prescribed. Depression may be considered resistant to treatment when at least two trials with antidepressants from different pharmacologic classes (adequate in dose, duration, and compliance) fail to produce a significant clinical improvement. Evidence regarding the effectiveness of psychotherapy for treatment-resistant depression is limited. A recent high-quality trial found that patients who did not respond to citalopram and who received cognitive behavior therapy (with or without continued citalopram) had similar response and remission rates to those who received other medication regimens. Initial remission rates in that trial were 37 percent, and even after three additional trials of different drugs or cognitive behavior therapy, the cumulative remission rate was only 67 percent. In general, patients who require more treatment steps have higher relapse rates, and fewer than one half of patients achieve sustained remission. No treatment strategy appears to be better than another. Electroconvulsive therapy is effective as short-term therapy of treatment-resistant depression. There is no good-quality evidence that vagal nerve stimulation is an effective treatment for this condition.

Understanding Barriers to Early Intervention Services for Preterm Infants: Lessons From Two States.

OBJECTIVE: To explore existing barriers and challenges to Early Intervention (EI) referral, enrollment, and service provision for very low birth weight (VLBW; <1500 g) infants. METHODS: We conducted 10 focus groups with parents of VLBW children (n = 44) and 32 interviews with key informants from EI (n = 7), neonatal intensive care units (n = 17), and outpatient clinics (n = 8) at 6 sites in 2 states. We used grounded theory to identify themes about gaps in services. RESULTS: Both parents and providers found EI helpful. However, they also identified gaps in the current EI system at the levels of eligibility, referral, family receptivity, and service provision and coordination with medical care. Inadequate funding and variable procedures for evaluation may affect children's eligibility. Referrals can be missed as a result of simple oversight or communication failure among hospitals, EI, and families; referral outcomes often are not formally tracked. Families may not be receptive to services as a result of wariness of home visits, social stressors, denial about potential developmental delays, or lack of understanding of the benefits of EI. Once a child is deemed eligible, services may be delayed or terminated early, and EI providers may have little specialized training. Communication and coordination with the child's medical care team is often limited. CONCLUSIONS: Systemic barriers, including funding and staffing issues, state and federal regulations, and communication with families and medical providers, have led to gaps in the EI system. The chronic care model may serve as a framework for integrating community-based interventions like EI with medical care for VLBW children and other vulnerable populations.

Greatest impact of safe harbor rule may be to improve patient safety, not reduce liability claims paid by physicians.

"Safe harbor" legislation that provides liability protection to physicians when they follow designated guidelines is often proposed as a way to reform the malpractice system while improving patient safety. However, published evidence provides little policy guidance on implementing safe harbors. With the support of an Agency for Healthcare Research and Quality planning grant, we conducted an empirical analysis of closed liability claims in Oregon to determine the potential effects of hypothetical safe harbor legislation. We found that such legislation would have changed the liability outcome in favor of the physician defendant in only 1 percent of 266 claims from the period 2002-09 that we reviewed. Nevertheless, if safe harbors can induce greater physician adherence to care guidelines, they have the potential to improve patient safety. Implementing safe harbor legislation, however, requires overcoming a number of hurdles, including selecting and updating approved guidelines, obtaining broad stakeholder support, and withstanding challenges to the legal validity of the legislation. More experimentation with safe harbors is needed to determine their effects on the performance of the liability system and on health care quality and costs.

Improving preterm ophthalmologic care in the era of accountable care organizations.

OBJECTIVES To understand retinopathy of prematurity (ROP) follow-up care for preterm very low-birth-weight infants (VLBW; <1500 g) in the context of the chronic care model and identify opportunities for improvement under accountable care organizations. METHODS We conducted focus groups and interviews with parents (N = 47) of VLBW infants and interviews with neonatal intensive care unit and ophthalmologic providers (N = 28) at 6 sites in Massachusetts and South Carolina. Themes are reported according to consolidated criteria for reporting qualitative research guidelines. RESULTS Respondents perceived that legal liability and low reimbursement contributed to shortages of ROP providers. Some neonatal intensive care units offered subsidies to attract ophthalmologic providers or delayed transfers to institutions that could not provide ROP examinations and/or treatment. Sites used variable practices for coordinating ROP care. Even at sites with a tracking database and a dedicated ROP coordinator, significant time was required to ensure that examinations and treatment occurred as scheduled. Parents' ability to manage their children's health care was limited by parental understanding of ROP, feeling overwhelmed by the infant's care, and unmet needs for resources to address social stressors. CONCLUSIONS Under accountable care organizations, hospitals and ophthalmology practices should share responsibility for ensuring coordinated ROP care to mitigate liability concerns. To promote integrated care, reimbursement for ROP care should be bundled to include screening, diagnosis, treatment, and appropriate follow-up. Clinical information systems should be enhanced to increase efficiency and limit lapses in care. Self-management tools and connections to community resources could help promote families' attendance of follow-up appointments.

Quality-of-care indicators for children with sickle cell disease.

OBJECTIVE: To develop a set of quality-of-care indicators for the management of children with sickle cell disease (SCD) who are cared for in a variety of settings by addressing the broad spectrum of complications relevant to their illness. METHODS: We used the Rand/University of California Los Angeles appropriateness method, a modified Delphi method, to develop the indicators. The process included a comprehensive literature review with ratings of the evidence and 2 rounds of anonymous ratings by an expert panel (nominated by leaders of various US academic societies and the National Heart, Lung, and Blood Institute). The panelists met face-to-face to discuss each indicator in between the 2 rounds. RESULTS: The panel recommended 41 indicators that cover 18 topics; 17 indicators described routine health care maintenance, 15 described acute or subacute care, and 9 described chronic care. The panel identified 8 indicators most likely to have a large positive effect on improving quality of life and/or health outcomes for children with SCD, which covered 6 topics: timely assessment and treatment of pain and fever; comprehensive planning; penicillin prophylaxis; transfusion; and the transition to adult care. CONCLUSIONS: Children with SCD are at risk for serious morbidities and early mortality, yet efforts to assess and improve the quality of their care have been limited compared with other chronic childhood conditions. This set of 41 indicators can be used to assess quality of care and provide a starting point for quality-improvement efforts.

Communication of urgent public health messages to urban populations: lessons from the Massachusetts water main break.

OBJECTIVE: To study when and how an urgent public health message about a boil-water order reached an urban population after the Massachusetts water main break. METHODS: In-person surveys were conducted in waiting areas of clinics and emergency departments at a large urban safety net hospital within 1 week of the event. RESULTS: Of 533 respondents, 97% were aware of the order; 34% of those who lived in affected cities or towns were potentially exposed to contaminated water. Among those who were aware, 98% took action. Respondents first received the message through word of mouth (33%), television (25%), cellular telephone calls (20%), landline calls (10%), and other modes of communication (12%). In multivariate analyses, foreign-born respondents and those who lived outside the city of Boston had a higher risk of exposure to contaminated water. New modes (eg, cellular telephones) were used more commonly by females and younger individuals (ages 18 to 34). Individuals who did not speak English at home were more likely to receive the message through their personal networks. CONCLUSIONS: Given the increasing prevalence of cellular telephone use, public officials should encourage residents to register landline and cellular telephone for emergency alerts and must develop creative ways to reach immigrants and non-English-speaking groups quickly via personal networks.

Can state early intervention programs meet the increased demand of children suspected of having autism spectrum disorders?

OBJECTIVE: To determine whether Early Intervention programs have the capacity to accommodate the expected increase in referrals following the American Academy of Pediatrics' 2007 recommendation for universal screening of 18- and 24-month-old children for Autism Spectrum Disorders (ASD). METHOD: We conducted a telephone survey of all state and territory early. Intervention coordinators about the demand for ASD evaluations, services, and program capacity. We used multivariate models to examine state-level factors associated with the capacity to serve children with ASD. RESULTS: Fifty-two of the 57 coordinators (91%) responded to the survey. Most states reported an increase in demand for ASD-related evaluations (65%) and services (58%) since 2007. In addition, 46% reported that their current capacity poses a challenge to meeting the 45-day time limit for creating the Individualized Family Service Plan. Many states reported that they have shortages of ASD-related personnel, including behavioral therapists (89%), speech-language pathologists (82%), and occupational therapists (79%). Among states that reported the number of service hours (n = 34) 44% indicated that children with ASD receive 5 or fewer weekly service hours. Multivariate models showed that states with a higher percentage of African-American and Latino children were more likely to have provider shortages whereas states with higher population densities were more likely to offer a greater number of service hours. CONCLUSION: Many Early Intervention programs may not have the capability to address the expected increase in demand for ASD services. Early Intervention programs will likely need enhanced resources to provide all children with suspected ASD with appropriate evaluations and services.

Impact of the STAR*D trial from the perspective of the payer.

The authors discuss implications for private and public insurers of the STAR*D trial (Sequenced Treatment Alternatives to Relieve Depression), which found evidence that for second- and third-line treatment, no second-generation antidepressant was superior to another in terms of effectiveness or of the overall incidence of harmful effects. These findings have permitted payers to construct formulary coverage rules with more confidence and have highlighted the benefits of policies that improve access to care (for example, encouraging primary care treatment of depression) or promote treatment adherence (for example, implementing pay-for-performance initiatives).