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Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.
The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.
Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.
This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.
Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.
Current guideline-recommended antibiotic treatment durations for ventilator-associated pneumonia (VAP) are largely standardised, with limited consideration of individual patient characteristics, pathogens or clinical context. This one-size-fits-all approach risks both overtreatment—promoting antimicrobial resistance and adverse drug events—as well as undertreatment, increasing the likelihood of pneumonia recurrence and sepsis-related complications. There is a critical need for VAP-specific biomarkers to enable individualised treatment strategies. The Ventilator-associated pneumonia Biomarker Evaluation (VIBE) study aims to identify a dynamic alveolar biomarker signature associated with treatment response, with the goal of informing personalised antibiotic duration in future clinical trials.
VIBE is a prospective, observational, case-cohort study of 125 adult patients with VAP in Michigan Medicine University Hospital intensive care units. Study subjects will undergo non-bronchoscopic bronchoalveolar lavage on the day of VAP diagnosis (Day 1) and then on Days 3 and 5. Alveolar biomarkers (quantitative respiratory culture bioburden, alveolar neutrophil percentage and pathogen genomic load assessed via BioFire FilmArray polymerase chain reaction) will be assessed. An expert panel of intensivists, blinded to biomarker data, will adjudicate each patient’s Day 10 outcome as VAP clinical cure (control) or treatment failure (case). Absolute biomarker levels and mean-fold changes in biomarker levels will be compared between groups. Data will be used to derive a composite temporal alveolar biomarker signature predictive of VAP treatment failure.
Ethical approval was obtained from the University of Michigan Institutional Review Board (IRB #HUM00251780). Informed consent will be obtained from all study participants or their legally authorised representatives. Findings will be disseminated through peer-reviewed publications, conferences and feedback into clinical guidelines committees.
To assess the feasibility of conducting a definitive randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a tailored exercise intervention compared with usual care for people aged 80 years and older with hip and/or knee osteoarthritis (OA) and comorbidities.
Two-arm, parallel-design, multicentre, pragmatic, feasibility RCT.
Four National Health Service outpatient physiotherapy services across England.
Adults aged 80 years and over with clinical hip and/or knee OA and ≥1 comorbidity.
Participants were randomised 1:1 via a central web-based system to be offered: (1) a 12-week tailored exercise programme or (2) usual care. Participants and outcome assessors were not blinded to treatment allocation.
(1) Ability to screen and recruit participants; (2) retention of participants at 14-week follow-up; (3) intervention fidelity (proportion of participants who received ≥4 intervention sessions as per protocol) and (4) participant engagement (assessed by home exercise adherence).
Between 12 May 2022 and 26 January 2023, 133 potential participants were screened, of whom 94 were eligible. The main reasons for ineligibility were symptoms not consistent with hip or knee OA (10/39, 25.6%) or already having had a physiotherapy appointment (8/39, 20.5%). 51 of 94 (54%) eligible participants were recruited. Participants had a mean age of 84 years (SD 3.5), 31 (60.8%) were female and 96.1% reported their ethnicity as White British (n=49/51). 45 of 51 participants (88%) provided outcome data at the 14-week follow-up time point. Four or more intervention sessions were attended by 13/25 (52%) participants. Home exercise log completion declined over time: 6/23 participants (26.1%) returned completed exercise logs for all 12 weeks. The median number of days home exercises were recorded each week was 5 (range 0–7).
This study demonstrated that a definitive trial would be feasible. Before proceeding, modifications to ensure recruitment of a diverse population and intervention fidelity should be addressed.
Background
Chinese American immigrants have been underrepresented in health research partly due to challenges in recruitment.
Objectives
This study aims to describe recruitment and retention strategies and report adherence in a 7-day observational physical activity study of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic.
Methods
Foreign-born Chinese women aged 18–45 years, with a gestational diabetes index pregnancy of 0.5–5 years, who were not pregnant and had no current diabetes diagnosis were recruited. They wore an accelerometer for 7 consecutive days and completed an online survey. Multiple recruitment strategies were used: (a) culturally and linguistically tailored flyers, (b) social media platforms (e.g., WeChat [a popular Chinese platform] and Facebook), (c) near-peer recruitment and snowball sampling, and (d) a study website. Retention strategies included flexible scheduling and accommodation, rapid communications, and incentives. Adherence strategies included a paper diary and/or automated daily text reminders with a daily log for device wearing, daily email reminders for the online survey, close monitoring, and timely problem-solving.
Results
Participants were recruited from 17 states; 108 were enrolled from August 2020 to August 2021. There were 2,479 visits to the study webpage, 194 screening entries, and 149 inquiries about the study. Their mean age was 34.3 years, and the mean length of U.S. stay was 9.2 years. Despite community outreach, participants were mainly recruited from social media (e.g., WeChat). The majority were recruited via near-peer recruitment and snowball sampling. The retention rate was 96.3%; about 99% had valid actigraphy data, and 81.7% wore the device for 7 days. The majority of devices were successfully returned, and the majority completed the online survey on time.
Discussion
We demonstrated the feasibility of recruiting and retaining a geographically diverse sample of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic. Recruiting Chinese immigrants via social media (e.g., WeChat) is a viable approach. Nonetheless, more inclusive recruitment strategies are needed to ensure broad representation from diverse socioeconomic groups of immigrants. Background
The prevalence of short sleep duration is rising and is linked to chronic comorbidities, such as metabolic syndrome (MetS). Sleep extension interventions in adults with MetS comorbidities and short sleep duration are limited and vary widely in terms of approach and duration.
Objectives
This pilot study aimed to test the feasibility and acceptability of a personalized 12-week systematic sleep time extension intervention on post-intervention sleep outcomes in middle-aged adults at risk for MetS with actigraphy-estimated short sleep duration.
Methods
A single-arm, 12-week, 12-session systematic sleep time extension intervention was delivered weekly via videoconferencing. Feasibility and acceptability were assessed using retention rates and mean sleep diary completions. Sleep was estimated for 14 consecutive days prior to and immediately following the 12-week intervention using wrist actigraphy. Daytime sleepiness was assessed using the Epworth Sleepiness Scale. Paired sample t-tests modeled changes in study outcomes.
Results
Study participants (N = 41) had a mean age of 52 years and were mostly female and White; 86% attended >80% of sessions, and mean sleep diary completion was 6.7 diaries/week. Significant improvements in sleep from pre- to post-intervention included increased total sleep time, earlier sleep onsets, more regular sleep onsets, a higher sleep regularity index, and reduced daytime sleepiness. Extending sleep, as well as improving sleep timing and regularity in middle-aged adults with actigraphy-estimated short sleep duration and at risk for MetS, is feasible and acceptable.
Discussion
Behavioral sleep characteristics may be modifiable and present a novel behavioral paradigm for mitigating MetS risk. This pilot study provides a proof of concept for the feasibility, acceptability, and preliminary effectiveness of a systematic sleep time extension for middle-aged adults at risk for MetS with actigraphy-estimated short sleep duration. To generate, test and refine programme theories that emerged from a rapid realist review investigating practising UK Nurses' and Midwives' experiences of effective leadership strategies during the COVID-19 pandemic.
The realist review of literature generated six tentative theories of healthful leadership practices reflecting, working with people's beliefs and values; being facilitative; multiple means of communication and; practical support. The review yielded little insight into the actual impact of the leadership approaches advocated.
A realist study, informed by person-centredness using mixed-methods. Online survey (n = 328) and semi-structured interviews (n = 14) of nurses and midwives across the UK in different career positions/specialities. Quantitative data analysed using descriptive statistics and exploratory factor analysis. Framework analysis for qualitative data using context (C), mechanism (M), outcome (O) configurations of the tentative theories.
Three refined theories were identified concerning: Visibility and availability; embodying values and; knowing self. Healthful leadership practices are only achievable within organisational cultures that privilege well-being.
Leaders should intentionally adopt practices that promote well-being. ‘Knowing self’ as a leader, coaching and mentoring practice development is important for leadership development.
Nurses who feel valued, heard, cared for and safe are more likely to remain in clinical practice. Job satisfaction and being motivated to practice with confidence and competence will impact positively on patient outcomes.
The study addresses the role of leadership in developing healthful workplace cultures. The main findings were six leadership practices that promote healthful cultures. The research will have an impact on strategic and clinical leaders, nurses and midwives.
This study used EQUATOR checklist, RAMASES II as reporting standards for realist evaluations.
No patient or public contribution.
Background
Engagement with self-monitoring of blood pressure (BP) declines, on average, over time but may vary substantially by individual.
Objectives
We aimed to describe different 1-year patterns (groups) of self-monitoring of BP behaviors, identify predictors of those groups, and examine the association of self-monitoring of BP groups with BP levels over time.
Methods
We analyzed device-recorded BP measurements collected by the Health eHeart Study—an ongoing prospective eCohort study—from participants with a wireless consumer-purchased device that transmitted date- and time-stamped BP data to the study through a full 12 months of observation starting from the first day they used the device. Participants received no instruction on device use. We applied clustering analysis to identify 1-year self-monitoring, of BP patterns.
Results
Participants had a mean age of 52 years and were male and White. Using clustering algorithms, we found that a model with three groups fit the data well: persistent daily use (9.1% of participants), persistent weekly use (21.2%), and sporadic use only (69.7%). Persistent daily use was more common among older participants who had higher Week 1 self-monitoring of BP frequency and was associated with lower BP levels than the persistent weekly use or sporadic use groups throughout the year.
Conclusion
We identified three distinct self-monitoring of BP groups, with nearly 10% sustaining a daily use pattern associated with lower BP levels. 
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