BACKGROUND: Foot complications in diabetes are common and destructive, resulting in substantial healthcare costs and high rates of morbidity. Coastal areas have a significantly higher burden of disease. People with diabetes experience disproportionately high rates of psychological health issues, including anxiety, depression and diabetes distress. These can affect self-management and concordance with preventive measures and treatments of foot complications, negatively impacting on outcomes. Access to psychological health services is variable across the United Kingdom and there is a paucity of high-quality evidence for the effectiveness of treatments for diabetes distress. This study aimed to explore experiences of psychosocial burden and perceptions and experiences of psychosocial support, among patients with diabetes and foot complications living in a coastal area.
METHODS: Patients were eligible to participate if they had experienced diabetes-related foot complications (amputation, ulceration and/or Charcot neuroarthropathy) within the last 5 years and scored positive for diabetes distress on a validated screening tool (DDS2). Eligible patients completed cross-sectional questionnaires describing symptoms of diabetes distress (DDS17), anxiety (GAD-7) and depression (PHQ-9) and to take part in a face-to-face, semi-structured interview. Questionnaires were analysed using frequencies and interviews were analysed using reflexive thematic analysis.
RESULTS: A total of 183 patients completed the DDS2 screening questionnaire. Of these, 56 (30.6%) screened positive for diabetes distress. Twenty-seven patients completed DDS17, GAD-7 and PHQ-9 questionnaires. Eleven (40.7%) participants indicated high levels of diabetes distress and four (14.8%) indicated moderate distress. Seventeen participants (age range 52-81 years; 12 men) took part in an interview. Four key themes were identified: impact of living with foot problems; emotional consequences of foot problems; experiences and perceptions of psychological support; and strategies to cope with the emotional impact of foot problems.
CONCLUSIONS: Diabetes distress was prevalent among patients with diabetes-related foot complications. Foot problems impacted on participants\' daily activities, social lives and ability to work. Despite expressing feelings of ongoing fear, worry and depression relating to their foot problems, only one participant had accessed formal psychological support. Many participants relied on talking to podiatrists at routine appointments and described developing various strategies to cope. The psychosocial burden of living with foot complications in diabetes must not be overlooked by health professionals. Findings from this study can inform the design of future services and interventions.

OBJECTIVE: Delirium is an acute brain dysfunction associated with an increased risk of mortality and future dementia.
OBJECTIVE: To describe the prevalence of clinically documented delirium in the United States on World Delirium Awareness Day 2023.
METHODS: Sub-analysis of a prospective, cross-sectional, online, international survey.
METHODS: All healthcare settings were eligible with the exception of operating rooms and outpatient clinics.
METHODS: Healthcare clinicians, administrators, and researchers completed the survey.
METHODS: Prevalence of clinically documented delirium at 8:00 a.m. and 8:00 p.m. on March 15, 2023. Secondary outcomes were related to healthcare delivery. Descriptive statistics are reported. Differences between unit types (non-ICU vs ICU) were examined for all outcomes.
RESULTS: Ninety-one hospital units reported on 1,318/1,213 patients. The prevalence of clinically documented delirium was 16.4% (n=216/1,318) at 8:00 a.m., 17.9% (n=217/1,213) at 8:00 p.m. (p= 0.316) and significantly differed between age groups, reported discipline, unit, and hospital types. Significant differences were identified between non-ICU and ICU settings in the use of delirium-related protocols, non-pharmacologic and pharmacologic management, educational processes, and barriers to evidence-based delirium care.
CONCLUSIONS: To our knowledge, this is the first epidemiologic survey of clinically documented delirium across two time points in the U.S.. Delirium remains a significant burden and challenge for healthcare systems. The high percentage of units using delirium management protocols suggests administrator and clinician awareness of evidence-based strategies for its detection and mitigation. We provide recommendations for future studies and quality improvement projects to improve clinical recognition and management of delirium.

BACKGROUND: Inadequate pain relief with moderate to severe pain remains a challenge after cesarean section and may significantly impair postoperative recovery. However, detailed assessment on the timing of severe pain, opioid consumption, influence on activities such as mobilization, breastfeeding, and caring for the infant are difficult to conduct, especially after discharge. Short message services (SMS)-based questionnaires may offer a low-cost way of providing such data but with the risk of insufficient response rates. We assessed the feasibility of collecting detailed, prospective data on postoperative pain and recovery during the initial hours and days following cesarean section using SMS-based questionnaires.
METHODS: Prospective Danish single-center cohort study involving elective cesarean sections under spinal anesthesia with fentanyl and bupivacaine. The postoperative pain regimen consisted of paracetamol, NSAID and oral morphine by request. Patients received an SMS-based questionnaire at 6, 12, 18, 24, and 48 h postoperatively, as well as on days 7 and 30.
METHODS: Response rate and time from receiving the SMS to completion of the questionnaires.
RESULTS: Opioid consumption and Patient Reported Outcomes Measures on pain and recovery.
RESULTS: From December 2022 to June 2023; 100 patients were included. The response rate was 78% at 6 h postoperatively, decreasing to 63% at 24 h. The median response time from receiving to answering the SMS-based questionnaire at 6 h after cesarean section was 23 min (IQR 2-72), decreasing to 20 min (IQR 2-78) after 24 h. Severe pain, corresponding to a Numeric Rating Scale (NRS) score >6, was reported by 57% (95% CI 65-84) at 6 h, decreasing to 28% (95% CI 34-58) at 24 h. Median opioid consumption within the first 24 h was 30 mg (IQR 20-50).
CONCLUSIONS: SMS-based questionnaires on Patient Reported Outcome Measures are a feasible and cost-effective way of prospectively collecting frequent data with acceptable response rates, even shortly after cesarean section. Secondarily 66% of patients reported severe pain during the first 24 h following cesarean section, with the highest pain scores within the initial 12 h. Future studies should focus on optimizing pain-management within this timeframe.

The decision to vaccinate against COVID-19 is primarily a personal choice influenced by numerous factors. Vaccine acceptance and a positive attitude towards vaccination among nurses have an impact on patients\' willingness to vaccinate. To assess COVID-19 vaccination coverage among primary healthcare nurses and to associate socio-demographic factors, comorbidity, self-rated health, and unhealthy lifestyle with the decision to be vaccinated, we conducted an online cross-sectional study from March to May 2023 using a self-administrated questionnaire. Probability sampling was used to select 32 health centers and nurses were invited via email. Among the 560 participants who completed survey, 78.3% and 50.8% received the primary two-dose course and at least one booster dose of COVID-19 vaccine, respectively. Primary care nurses who were ≥41 years of age, physically less active, and those who were overweight opted statistically significantly more often for the primary vaccination scheme (p = 0.00, 0.015 and 0.017, respectively). Education and the living environments of primary care nurses did not significantly influence the decision to receive two primary COVID-19 doses. Likewise, good self-rated health and comorbidity did not contribute significantly to the vaccination decision. Nurses that were vaccinated with booster doses were significantly more often overweight (p = 0.034) and ≥41 year of age (p = 0.000).

The COVID-19 pandemic underscores the significance of vaccine hesitancy in shaping vaccination outcomes. Understanding the factors underpinning COVID-19 vaccination hesitancy is crucial for tailoring effective vaccination strategies. This cross-sectional study, conducted in three communities across the United States and Lebanon, employed surveys to assess respondents\' knowledge, attitudes, and perceptions regarding COVID-19 infection and vaccination. Among the 7196 participants, comprising 6775 from the US and 422 from Lebanon, vaccine hesitancy rates were comparable at 12.2% and 12.8%, respectively. Notably, a substantial proportion of respondents harbored misconceptions, such as attributing the potential to alter DNA (86.4%) or track individuals (92.8%) to COVID-19 vaccines and believing in the virus\'s artificial origins (81%). US participants had more misconceptions about the COVID-19 vaccine, such as altering DNA or causing infertility. Lebanese participants were more likely to question the origins of the virus and the speed of vaccine development. Additionally, US respondents were less worried about infection, while Lebanese respondents were more indecisive but less likely to outright reject the vaccine. Primary determinants of hesitancy included perceptions that the vaccine poses a greater risk than the infection itself (aOR = 8.7 and 9.4, respectively) and negative recommendations from healthcare providers (aOR = 6.5 and 5.4, respectively). Conversely, positive endorsements from healthcare providers were associated with reduced hesitancy (aOR = 0.02 and 0.4, respectively). Targeting healthcare providers to dispel misinformation and elucidate COVID-19 vaccine risks holds promise for enhancing vaccination uptake.

Rituximab (RTX) is a chimeric monoclonal antibody that targets the CD20 antigen on B cells and is used in various autoimmune disorders. In this study, we aimed to measure the awareness of pediatric rheumatologists about the use of RTX through a survey. Between February and March 2023, a 42-question survey was sent via email to pediatric rheumatology specialists in Turkey. The participants were questioned for which diagnoses and system involvement they preferred to use RTX, which routine tests they performed, vaccination policy, and adverse events that occurred during or after infusion. Forty-one pediatric rheumatologists answered the survey. They prescribed RTX most frequently for systemic lupus erythematosus (87.8%) and ANCA-associated vasculitis (9.8%). Prior to the administration of RTX, 95% of clinicians checked renal and liver function tests, as well as immunoglobulin levels. The most frequently tested hepatitis markers before treatment were HBsAg and anti-HBs antibody (97.6%), while 85.4% of rheumatologists checked for anti-HCV. Clinicians (31.4%) reported that they postpone RTX infusion 2 weeks following an inactivated vaccine. Sixty-one percent of rheumatologists reported starting RTX treatment 1 month after live vaccines, while 26.8% waited 6 months. The most frequent adverse events were an allergic reaction during RTX infusion (65.9%), hypogammaglobulinemia (46.3%), and rash (36.6%). In the event of hypogammaglobulinemia after RTX treatment, physicians reported that they frequently (58.5%) continued RTX after intravenous immunoglobulin administration.
CONCLUSIONS: RTX has become a common treatment option in pediatric rheumatology in recent years. Treatment management may vary between clinician such as vaccination and routine tests.
BACKGROUND: • During the course of rituximab therapy, clinicians should be attentive to specific considerations in pre-treatment, during administration, and in post-treatment patient monitoring.
BACKGROUND: • There are differences in practice among clinicians in the management of RTX therapy. These practice disparities have the potential to impact the optimal course of treatment. • This study highlights that standardized guidelines are needed for RTX treatment in pediatric rheumatology, particularly for vaccination policies and routine tests.

OBJECTIVE: To apply the 2019 joint American Academy of Neurology (AAN) and American Headache Society (AHS) quality measures for headache management to a cohort of neurology resident physicians and then assess outcomes related to guideline adherence.
BACKGROUND: The optimization of headache management is essential to reduce both the individual and systemic impact of these disorders. In 2014, the AAN developed 10 quality measures for evidence-based management of patients with headache. A workgroup updated and condensed its headache quality measures in 2019, narrowing the set to six measurements, four of which would primarily focus on the management of migraine and two of which would address the management of cluster headache.
METHODS: This quality improvement study was conducted using a pretest-posttest study design. A pre-intervention survey based on retrospective analysis of five clinic notes for adherence to the measures was designed and distributed to all neurology residents (n = 32) at a large, academic tertiary referral center. The intervention included the creation of an electronic medical record template to aid residents in following the measures during clinical encounters, as well as the provision of direct feedback based on pre-intervention results. Finally, a post-intervention survey was distributed for completion based on notes written during the intervention period. Analysis was limited to migraine, given the low percentage of cluster headache seen in clinic.
RESULTS: An increase in adherence was seen in three of the four migraine-related quality measures, with the Use of Abortive Medications for Migraine and Documentation of Counseling on Modifiable Lifestyle and Chronification Factors demonstrating statistically significant improvements (75.8% to 88.0% [p = 0.013] and 83.9% to 94.0% [p = 0.029] adherence, respectively). For secondary outcomes, the increase in the utilization of appropriate diagnostic criteria (82.6% to 93.2%, p = 0.018) was significant, and the self-assessed confidence rating for adherence to guidelines was significant (p < 0.001).
CONCLUSIONS: This study provides evidence that the quality improvement intervention led to increased adherence to the AAN and AHS migraine-related measures. It is anticipated that increased adherence may lead to improved patient outcomes.

BACKGROUND: Physicians and patient-facing caregivers have increasingly used mobile health (mHealth) technologies in the past several years, accelerating during the COVID-19 pandemic. However, barriers and feedback surrounding adoption remain relatively understudied and varied across health systems, particularly in rural areas.
OBJECTIVE: This study aims to identify provider adoption, attitudes, and barriers toward mHealth in a large, multisite, rural US health care system. We investigated (1) mHealth apps that providers use for their own benefit and (2) mHealth apps that a provider uses in conjunction with a patient.
METHODS: We surveyed all patient-seeing providers within the Marshfield Clinic Health System with a brief, 16-item, web-based survey assessing attitudes toward mHealth, adoption of these technologies, and perceived barriers faced by providers, their peers, and the institution. Survey results were summarized via descriptive statistics, with log-binomial regression and accompanying pairwise analyses, using Kruskal-Wallis and Jonckheere-Terpstra tests for significance, respectively. Respondents were grouped by reported clinical role and specialty.
RESULTS: We received a 38% (n/N=916/2410) response rate, with 60.7% (n=556) of those sufficiently complete for analyses. Roughly 54.1% (n=301) of respondents reported mHealth use, primarily around decision-making and supplemental information, with use differing based on provider role and years of experience. Self-reported barriers to using mHealth included a lack of knowledge and time to study mHealth technologies. Providers also reported concerns about patients\' internet access and the complexity of mHealth apps to adequately use mHealth technologies. Providers believed the health system\'s barriers were largely privacy, confidentiality, and legal review concerns.
CONCLUSIONS: These findings echo similar studies in other health systems, surrounding providers\' lack of time and concerns over privacy and confidentiality of patient data. Providers emphasized concerns over the complexity of these technologies for their patients and concerns over patients\' internet access to fully use mHealth in their delivery of care.

UNASSIGNED: Funding committees, comprising members with a range of knowledge, skills, and experience, are considered integral to the decision-making process of funding organisations for recommending or allocating research funding. However, there is limited research investigating the decision-making processes, the role of members and their social interactions during funding committee meetings conducted both virtually and face-to-face.
UNASSIGNED: Using a mixed-methods design and following netnography principles, the study observed nine National Institute for Health and Care Research programmes funding committee meetings conducted virtually during October 2020 to December 2021; complemented by interviews with committee chairs and members (18 interviews) and NIHR staff (12 interviews); an online survey (50 responses); and documentary analysis. Personal reflections through immersive journals also formed part of the analysis.
UNASSIGNED: Three main themes were identified from the observations, interviews, and online survey: efficiency of virtual committee meetings (importance of preparation, and the role of formality, process, and structure); understanding the effect of virtual committee meetings on well-being (effects of fatigue and apprehension, and the importance of work life balance); understanding social interactions and engagement (levels of engagement, contribution and inclusivity, awareness of unconscious bias and the value of social networking).
UNASSIGNED: Examining the decision-making practices of one funding organisation across several research programmes, across multiple committee meetings over one year has generated new insights around funding committee practices that previous studies have not been able to explore or investigate. Overall, it was observed that fair and transparent funding recommendations and outcomes can be achieved through virtual funding committees. However, whilst virtual funding committees have many benefits and opportunities, such as the potential to increase membership diversity and inclusivity, and be more environmentally sustainable, more evidence is needed to evaluate their effectiveness, with particular focus on issues of fatigue, engagement, and committee cohesion, especially when new committee members join.

Seamless study designs have the potential to accelerate clinical development. The use of innovative seamless designs has been increasing in the oncology area; however, while the concept of seamless designs becomes more popular and accepted, many challenges remain in both the design and conduct of these trials. This may be especially true when seamless designs are used in late phase development supporting regulatory decision-making. The Innovative Design Scientific Working Group (IDSWG) Oncology team conducted a survey to understand the current use of seamless study designs for registration purposes in oncology clinical development. The survey was designed to provide insights into the benefits and to identify the roadblocks. A total of 16 questions were included in the survey that was distributed using the ASA Biopharmaceutical Section and IDSWG email listings from August to September 2022. A total of 51 responses were received, with 39 (76%) respondents indicating that their organizations had seamless oncology studies in planning or implementation for registration purposes. Detailed survey results are presented in the manuscript. Overall, while seamless designs offer advantages in terms of timeline reduction and cost saving, they also present challenges related to additional complexity and the need for efficient surrogate clinical endpoints in oncology drug development.