Efficacy and safety of an algorithm using C-reactive protein to guide antibiotic therapy applied through a digital clinical decision support system: a study protocol for a randomised controlled clinical trial

Introduction
The escalating resistance of microorganisms to antimicrobials poses a significant public health threat. Strategies that use biomarkers to guide antimicrobial therapy—most notably Procalcitonin (PCT) and C-reactive protein (CRP)—show promise in safely reducing patient antibiotic exposure. While CRP is less studied, it offers advantages such as lower cost and broader availability compared with PCT.

Methods and analysis
This randomised clinical trial aims to evaluate a novel algorithm for non-critically ill adult patients. The algorithm incorporates key clinical variables and CRP behaviour. It will be applied through a mobile application as a digital clinical decision support system. The primary goal will be to assess the algorithm’s effectiveness in reducing treatment duration compared with standard care based on current guidelines, while ensuring patient safety by monitoring the occurrence of adverse events.

Ethics and dissemination
Only patients who agree to participate in the study after reading the informed consent form will be included. This project was submitted for consideration to the Research Ethics Committee of the Federal University of Minas Gerais (COEP-UFMG) and received approval (Approval Number: 5.905.290). Collection of clinical and laboratory data from 200 patients is expected, extracted from electronic medical records and laboratory systems, along with serum samples stored for potential future analyses. Data will be preserved using the Research Electronic Data Capture platform, and serum samples will be stored in a regulated biorepository at UFMG. Access will be controlled via credentials, with privacy protections and anonymisation prior to sharing, which will occur during scientific publications.

Trial registration number
This trial was registered on ClinicalTrials.gov (NCT05841875) and was last updated on 5 December 2024 at 12:49.

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Gennaio 2025

How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol

Introduction
Current care plans for stroke survivors typically focus on acute management, resulting in many stroke survivors being discharged to their communities without adequate follow-up, despite their often experiencing significant post-stroke complications, such as post-stroke spasticity (PSS). While studies have explored the incidence and prevalence of PSS, little is known about how early PSS develops and how many stroke survivors develop ‘problematic’ PSS that would benefit from pharmacological treatment.

Methods and analysis
EPITOME is a prospective, international, observational, epidemiological study of participants (aged 18–90 years) who develop paresis within days 3–14 of a first-ever stroke that occurred within the past 4 weeks. Participants at sites across seven different countries are monitored remotely at 2 weeks and 1, 2, 3, 6, 9 and 12 months post-stroke to detect the possible onset of PSS using the Post-stroke Spasticity Monitoring Questionnaire (PSMQ). If the PSMQ indicates the possible presence of PSS, participants undergo a full in-clinic assessment to confirm the presence of PSS. For participants with confirmed PSS, the severity and distribution of spasticity is documented, and the investigator assesses whether the participant has spasticity that could benefit from pharmacological therapy. Participants without clinically confirmed PSS return to remote monitoring.

Ethics and dissemination
Ethics approval was obtained in all seven participating countries. Results will be published at international meetings and in an international peer-reviewed journal. Lay summaries will be prepared to accompany the primary paper and will also be provided to study participants.

Trial registration number
ClinicalTrials.gov NCT06055725.

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Gennaio 2025

Nation-wide cohort of device-measured sedentary time and physical activity in the USA–the Cancer Prevention Study-3 (CPS-3) Accelerometry Substudy: cohort profile

Purpose
This paper describes the data collection and management methods for the Cancer Prevention Study-3 (CPS-3) Accelerometry Substudy, a nested cohort of device-based physical activity and sedentary time data.

Participants
US-based CPS-3 participants (initially enrolled 2006–2013) who completed the 2018 follow-up survey and had a valid email address were invited to the Accelerometry Substudy (n=109 780). Among the 23 111 participants who registered and were shipped an ActiGraph GT3X+ accelerometer, 21 219 participants returned the device with a complete wear log (91.8%) and 20 950 (90.6%) provided at least three adherent days of data (eg, days with at least 10 hours of wear).

Findings to date
Participants with ≥3 adherent days were predominantly female (n=16 187, 77.3%), non-Latino white (n=17 977, 85.8%) and had an average age of 58 years (SD=9.8). The median daily wear time was 15.3 hours, which did not vary considerably by wear day. The median time spent in moderate-intensity aerobic physical activity was 29 min/day (IQR=36), and the median time in vigorous physical activity was 3 min/day (IQR=13). Participants were sedentary for 9.4 hours (564 min, IQR=171 min) and accumulated a median of 6474 steps per day (IQR=5348).

Future plans
The full CPS-3 cohort will be linked with the National Death Index and state cancer registries biennially. Participants will be sent triennial surveys for the next two decades. Future analyses within the CPS-3 Accelerometry Substudy more specifically aim to identify relationships between physical activity, sedentary time and health outcomes, primarily cancer incidence, survival and survivorship.

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Gennaio 2025

'Do they care?: a qualitative examination of patient perspectives on primary care clinician communication related to opioids in the USA

Objectives
This substudy’s objectives were to (1) examine the transferability of a four archetype framework (simplified pattern of prototypical features) for patients at high risk for opioid use disorder (OUD) developed from a previous study with a similar population; (2) explore how patient preferences for terminology can inform clinician communication strategies for patients with OUD across archetypes and (3) explore how patient perceptions of opioid risks can inform clinician communication strategies across patient archetypes.

Design
This qualitative study collected data via semistructured phone interviews with patients about views on opioid-related discussions with primary care clinicians. Qualitative data were coded using the Rigorous and Accelerated Data Reduction technique and analysed via iterative inductive/deductive thematic analysis.

Setting
40 primary care clinics affiliated with two health systems (site1=Pennsylvania; site2=Minnesota, Wisconsin and North Dakota).

Participants
40 adults meeting one of the following: OUD diagnosis; taking medication for OUD (MOUD) and ≥3 opioid prescriptions in the previous year.

Results
The aforementioned four archetype framework transferred well to the study sample and hinted at archetype differences in participant OUD-terminology preferences and opioid risk perceptions. Two additional archetypes of ‘in treatment/recovery for OUD and not taking MOUD’ and ‘in treatment/recovery for OUD and taking MOUD’ were identified. Participants best fitting archetypes 1–4 preferred clinicians to refrain from using addiction terminology to describe their relationship with opioids, finding the term ‘dependence’ as more appropriate and a signal that clinicians cared for patients. Participants who best first archetypes 5–6 felt ‘addiction’ was an appropriate, direct term that accurately described their condition, often using it themselves. Patients in all archetypes recognised risks of harm from using opioids, especially participants fitting archetypes 2, 5 and 6 who conveyed the greatest concern.

Conclusion
The modified six archetype framework may help clinicians tailor their communication and care for patients diagnosed with or at high risk for OUD.

Trial registration number
NCT04198428.

Leggi
Gennaio 2025

Gender-affirming care education in pharmacy: a scoping review protocol of practices in Canada and the USA

Introduction
Gender-affirming care refers to a range of social, psychological, medical and/or surgical interventions provided to affirm one’s gender. Pharmacists play a key role in gender-affirming care and are involved with choosing optimal treatments, monitoring progress/side-effects and providing education. However, it is currently unknown what gender-affirming care education is provided to pharmacy students and pharmacists according to information available in published literature. This is important to identify potential education gaps in pharmacy curricula and an understanding of the current state of gender-affirming care education in pharmacy.

Methods and analysis
This scoping review protocol follows guidance from Arksey and O’Malley and Levac and colleagues. The population, concept and context framework are used to specify the research question and subsequently the search strategy. Database searching will occur across four databases: Medline, Embase, APA PsycINFO and Scopus; with the search date ranging from inception to 1 January 2025. Eligible studies will include pharmacy students or pharmacists, and examine the presence of gender-affirming care pharmacy education in Canada and the USA. There are no restrictions to date. Article screening and extraction will occur independently and in duplicate. Educational interventions, gender-affirming care content and recommendations extracted from each article will be narratively synthesised. This work is undertaken with patients and public involvement.

Ethics and dissemination
Ethical approval is not required as this is a review of published studies and does not collect any human data. Results will be disseminated through a peer-reviewed publication and conference presentations.

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Gennaio 2025