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Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.
Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.
Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.
Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p
In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.
To identify implementation strategies that effectively facilitate the adoption of social needs care coordination activities using enabling technologies among care management teams serving patients in community-based health centres.
Modified Delphi process.
Discrete, feasible implementation strategies were identified through literature review and semi-structured interviews with care management staff and subject matter experts in clinical informatics, workflow redesign, and product engineering. A modified Delphi was conducted with eight subject matter experts and nine health centre care management staff. Iterative rounds of online surveys were used to achieve consensus on the most relevant implementation strategies and their delivery methods.
The modified Delphi process achieved consensus on nine discrete implementation strategies needed to advance care management teams' ability to screen, refer and track social needs. Prioritised strategies included developing champions, enhancing quality improvement capacity, training staff on using enabling technologies and providing tailored technical assistance for workflow refinement. Consensus was also reached on a monthly cadence for most of the implementation strategies.
Consensus was reached on strategies to enhance care management teams' implementation of social needs screening, referrals and tracking using enabling technologies. These strategies will comprise an intervention to be pilot tested, refined and assessed in a cluster randomised clinical trial.
Findings from this study will inform the development of strategies to further the adoption of enabling technologies to support social needs care coordination.
This work is key to the design of a type 2 hybrid implementation-effectiveness trial that will assess whether user-informed, evidence-based implementation strategies can improve care management teams' adoption of enabling technologies to facilitate social needs care coordination for patients.
The research team includes a patient advisor with community-based nursing expertise and a nurse practitioner-clinical informaticist leader who was involved in data collection and interpretation of findings.
Trial registration: Clinicaltrials.gov registration # NCT06489002. Registered July 5, 2024, https://clinicaltrials.gov/study/NCT06489002?term=NCT06489002&rank=1.
Thromboangiitis obliterans (TAO) is a rare, tobacco-associated vasculitis that primarily affects the distal extremities of young males. In advanced stages, it often leads to chronic limb ischemia with ischemic ulceration, culminating in amputation. Data on risk factors for reamputation in this population remain limited. This study aimed to identify clinical, radiological and microbiological predictors of reamputation in patients with TAO-related foot ulcers undergoing amputation. A retrospective cohort study was conducted on 25 patients (31 limbs) with Fontaine stage IV TAO ulcers who underwent lower extremity amputation between January 2021 and December 2024. Patients were stratified into two groups based on whether they underwent repeat amputation (Group 1) or a single procedure (Group 2). Preoperative magnetic resonance imaging, intraoperative tissue cultures and laboratory data were evaluated. Smoking status, hospitalisation metrics and adjunctive therapies were recorded. Statistical analysis included Mann–Whitney U, Fisher's exact test, ROC curve analysis and multivariate logistic regression. Seventeen limbs required reamputation. Persistent smoking was observed in 100% of Group 1 compared with 58.4% of Group 2 (p = 0.015). Positive intraoperative cultures were significantly more frequent in Group 1 (64.7% vs. 21.4%; p = 0.029), with all multidrug-resistant organisms confined to this group. Length of hospital stay was significantly longer in Group 1 (25.2 ± 6.4 vs. 15.8 ± 5.3 days; p = 0.001). ROC analysis identified > 19 days of hospitalisation as a threshold for reamputation risk (AUC = 0.781; p = 0.018). Multivariate analysis identified three independent predictors of reamputation: persistent smoking (OR: 5.2, 95% CI: 1.2–22.8; p = 0.015), positive intraoperative culture (OR: 4.7, 95% CI: 1.1–20.1; p = 0.041), and hospitalisation longer than 19 days (OR: 6.5, 95% CI: 1.4–29.4; p = 0.018). Reamputation in advanced-stage TAO is strongly associated with modifiable factors, particularly ongoing tobacco use, Gram-negative infection and prolonged hospital stay. Early identification and targeted intervention addressing these variables may improve limb preservation outcomes in this high-risk population.
Prehospital notification by emergency medical services (EMS) can activate hospital resources before the patient arrives, which has been shown to improve in-hospital care for stroke patients. Optimising prehospital and handover processes in stroke care requires considering end-user perspectives to enhance acceptance and effectiveness of the developed solutions. The aim of this study was to identify current barriers in the preclinical-clinical phase of stroke care.
Within the investigator-initiated CAEHR project (CArdiovascular diseases—Enhancing Healthcare through cross-sectoral Routine data integration), an interface for transferring data from the electronic prenotification system to the hospital information system is implemented. A mixed-methods approach with semi-structured interviews as well as a cross-sectional online survey was used to gather feedback from healthcare professionals at a single stroke centre in Germany as well as from the participating EMS personnel. Data collection for the interviews was conducted between January and August 2023 and for the online survey between May and September 2023.
Interviews were conducted with 10 healthcare professionals, including seven from the neurological clinic and three from EMS. Additionally, 39 EMS employees took part in a cross-sectional online survey.
Challenges identified were educational and training aspects affecting preclinical processes and patient handover procedures, along with the opportunity for establishing more uniform protocols. Participants emphasised the importance of detailed patient information. Electronic prenotification was seen as an important step regarding structured information transmission, reducing the risk of information loss in stroke care.
The study highlights the importance of addressing organisational processes in addition to technical interfaces for implementing effective stroke care processes.
German Clinical Trials Register, DRKS00029103.
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