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Clinical practice guidelines support evidence-based care and aim to reduce unwarranted variation in healthcare. Despite evidence that guideline-adherent physiotherapy is associated with reduced healthcare utilisation, adherence among physiotherapists remains inconsistent. This scoping review aimed to synthesise evidence on determinants of guideline adherence and implementation strategies in physiotherapy and to identify research gaps relevant to guideline implementation.
Scoping review.
MEDLINE (PubMed), EMBASE, the Cochrane Library, PEDro and CINAHL were searched from database inception to July 2023 and updated in July 2025. Grey literature sources, including Grey Literature Report, OpenGrey and Web of Science Conference Proceedings, were also searched. Reference lists of included studies were screened.
Studies were eligible if they examined determinants of guideline adherence and/or implementation strategies in physiotherapy. Studies involving physiotherapists across all clinical fields and settings were included. Only studies published in English or German were considered.
Determinants were analysed using qualitative content analysis and mapped to the Consolidated Framework for Implementation Research (CFIR). Implementation strategies were summarised using Proctor’s reporting recommendations.
Fifty-eight studies were included: 29 examined determinants, 25 implementation strategies and four both. Determinants were identified across all CFIR domains, with most relating to the Inner Setting and Characteristics of Individuals. Implementation strategies primarily targeted individual-level change, such as education, reminders and feedback, whereas few addressed system-level factors, including organisational leadership or reimbursement structures.
Guideline implementation in physiotherapy is shaped by determinants across individual, organisational and system levels, yet current strategies predominantly focus on individual clinicians. This individual-level focus may contribute to the responsibilisation of clinicians for care quality, while organisational and system-level strategies that have shown promise in other fields remain underutilised in physiotherapy. Future implementation initiatives should adopt broader, system-oriented approaches to enhance long-term implementation success.
Open Science Framework (https://osf.io/g5cpt/).
To estimate the relative effectiveness of vaccination (0, 1, 2, ≥3 doses) and prior infection, in combination, on risk of SARS-CoV-2 infection/reinfection.
Prospective cohort study.
We recruited participants for the Aegis Study from nine clinics across five US states. Participants must have been 18 years or older, had a history of a positive PCR for SARS-CoV-2, SARS-CoV-2 antigen or antibody test for SARS-CoV-2 with documentation or had no suspected or documented prior SARS-CoV-2 infection, intended to remain in study area for the next 12 months, and had elevated risk of future SARS-CoV-2 exposure. Exclusion criteria included acute illness, contraindication to phlebotomy, use of immunosuppressants or receipt of systemic immunoglobulins.
We used extended Cox regression with robust standard errors to estimate the association between time-varying number of vaccine doses and baseline prior infection on risk of infection/reinfection among a prospective cohort of US adults between February 2021 and January 2023, accounting for censoring using inverse probability of censoring weights. Additionally, to quantify possible exposure misclassification of prior infection by comparing prior infection operationalised as (1) documented/self-reported prior infection and (2) documented/self-reported prior infection plus nucleocapsid antibody indication of prior infection.
Of n=2178 who completed enrolment, n=1887 adults (63% female; 65% non-Latino White) contributed 366 905 days of observation. Participants contributed an average of 7.2 months of follow-up between February 2021 and January 2023. 28% (n=533) of individuals were infected or reinfected during the study period. Similar relative effectiveness was observed between the two different operationalisations of prior infection. After correction for prior infection status in the nearly 16% of those without study documentation of prior infection who had nucleocapsid antibody levels comparable to documented cases, relative to the unvaccinated with no prior infection, estimated effectiveness generally increased with increasing vaccine doses and prior infection (without prior infection: one (17%, 95% CI –31% to 47%), two (49%, 95% CI 31% to 63%), ≥three (71%, 95% CI 58% to 80%) vaccine doses; with prior infection: none (56%, 95% CI 30% to 72%), one (71%, 95% CI 42% to 86%), two (65%, 95% CI 49% to 76%), ≥three (80%, 95% CI 68% to 88%) vaccine doses). Pairwise comparisons at each vaccine dose (ref: no prior infection) revealed that prior infection provided additional protection, with stronger relationships for no and one dose (none: 56% (95% CI 30% to 72%), one: 66% (95% CI 28% to 84%), two: 31% (95% CI 7% to 49%), ≥three 31% (95% CI 0% to 53%)). There was a marked decrease in the protection offered by vaccination, prior infection, or both in the Omicron period versus pre-Omicron period.
In our real-world observational sample, vaccination (with two and ≥three vaccine doses of any Food and Drug Administration Emergency Use Authorization approved vaccine) and prior infection conferred benefits for protection against infection/reinfection. Re-classification of prior infection status based on antibody levels had little effect on results.
Socioeconomic inequalities exist in infectious diseases and sepsis in high-income countries. We investigated the association between income and mortality among patients with sepsis, overall and among those treated in the intensive care unit (ICU) versus general wards.
A retrospective register-based cohort study.
The Region of Southern Denmark (RSD).
All adult patients with an unplanned contact with a hospital in the RSD from 1 January 2016 to 20 March 2018. Patients with sepsis were identified based on the following criteria: (1) blood culture(s) performed within 48 hours of arrival, (2) antibiotic(s) administered within 48 hours of arrival, (3) a discharge diagnosis of infection and (4) a SOFA (Sequential Organ Failure Assessment) score of ≥2. The cohort was divided into quartiles according to household income.
Cox proportional hazards models were used to estimate the association between income groups and mortality. The primary outcome was 90-day mortality with 7-day and 365-day mortality as secondary outcomes. All outcomes were calculated overall and stratified by general ward treatment only and ICU admission.
We identified 7813 first-time visits with community-acquired sepsis, including 886 ICU admissions (11.3%). Among patients in the lowest income group, sepsis was associated with a HR of 1.16 (95% CI 1.01 to 1.34) for 90-day mortality compared with the highest income group. This association was particularly pronounced at 365-day follow-up: HR=1.24 (95% CI 1.10 to 1.39). No difference was observed in 7-day all-cause mortality, HR=1.13 (95% CI 0.89 to 1.45). The association was not observed among patients admitted to the ICU.
Low income was associated with increased mortality in patients with sepsis, particularly during long-term follow-up. The impact of income disparities was not observed among patient admitted to the ICU.
Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.
A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.
This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.
The aims of this study were (1) to develop and validate the interactive CLAIM Test (iCLAIM Test) to measure children’s ability to assess claims about treatment effects and make informed health choices and (2) to measure this ability in Spanish primary school children using the developed test.
We followed a multistep process including (1) definition of the test scope, (2) selection of the questions, (3) translation process, (4) design and development of the online test, (5) external review with experts, (6) user-test with children and (7) cross-sectional validation study with Rasch analysis.
Spanish primary schools.
Twelve experts (75% women) participated in the review, 11 children (45% girls) participated in the user-test and 480 Spanish primary school children (46.5% girls) from fourth to sixth grades (9–12 years old) participated in the cross-sectional validation study.
The iCLAIM Test is an online, interactive and user-friendly test in Spanish that measures children’s ability to understand and apply key concepts of the informed health choices (IHC) Project when assessing claims about treatment effects and making IHCs. The test includes 30 questions: six demographic questions and 24 questions from the Claim Evaluation Tools item bank. Less than 40% of the students who participated in the cross-sectional validation study showed basic knowledge of the IHC Key Concepts and how to apply them, and less than 4% showed a clear knowledge. The test showed a good fit to the Rasch model and was acceptable to the target audience.
The iCLAIM Test is the first instrument validated for measuring children’s ability to assess treatment claims in Spain. In the future, we can tailor IHC education interventions and improve critical thinking skills about the health of Spanish children.
To understand the political, economic, social and technological facilitators and barriers in obtaining an HIV diagnosis to inform implementation strategies for HIV diagnostics in the Dominican Republic (DR).
In-depth, semi-structured qualitative interviews.
A high complexity public hospital in Santiago de los Caballeros, DR.
A convenience and purposive sample of 36 internal medicine physicians and laboratory personnel involved in sample collection, sample analysis or oversight of biological sample analysis.
Using the Social Ecological Model, our results highlighted several interrelated barriers and facilitators to sample analysis at the individual (patient), interpersonal (interactions between laboratory personnel, physicians and patients), organisational (the hospital), community (Santiago de Los Caballeros) and societal (the DR) levels. Some key findings include the importance of psychological support in receiving an HIV diagnosis, how spoken language can be a barrier to care, how inconsistent access to laboratory supplies is a barrier for patients, laboratory personnel and clinicians, and the importance of government public health investment.
Employing qualitative methods to investigate a bioengineering challenge yielded rich data on the sociotechnical implementation context of HIV diagnostics in the DR. Several context-relevant suggestions were developed for HIV diagnostic developers which include incorporating psychological support into the diagnosis workflow, delivering information in multiple languages (ie, Haitian Creole and Spanish) and with non-stigmatising phrasing, working with the public sector to develop and implement technologies, and reducing the supply chain reliance on high-income countries to lessen delays in care. These findings can apply to other types of health technologies and settings and demonstrate the importance of utilizing human-centered design to understand implementation context and promote global health equity in health technology development and adoption.
Childhood overweight and obesity pose a growing public health problem with increasing prevalence both in Europe and globally. Reasons can be found in behavioural factors such as a sedentary lifestyle, eating habits or low exercise levels and to a lesser extent in a genetic predisposition or a metabolic disorder. Preventing children with obesity and overweight to grow into obese teenagers is therefore of high importance. However, there are currently no established care and prevention programmes in Germany for the early reduction of overweight and prevention of obesity in children aged 3–6 years. fruehstArt aims to close this gap with a cross-sector outreach and family-centred personal counselling approach, where parents receive support from paediatricians and trained coaches who conduct consultations in the home of the family. The main research question is whether the fruehstArt programme reduces overweight and obesity in children aged 3–6 years within 12 months, as measured by the body mass index-standard deviation score (BMI-SDS).
fruehstArt has been developed as a new form of care, which includes a family intervention with motivational interviews provided by paediatricians and individual home-based counselling provided by a trained coach on eating behaviour, exercising, sleeping behaviour and age-appropriate use of electronic devices. fruehstArt will be accompanied by an efficacy study (summative evaluation of change in BMI-SDS). In addition to German, the project is also offered in Turkish in order to reach families with a migration background and language barriers. 812 children with overweight or obesity and their families in the region North Rhine will be included and observed over 12 months. Recruitment of children occurred from December 2023 to April 2025 with the final visits scheduled for April 2026. The study is conducted as a randomised controlled trial with a social-ecological intervention approach, considering children in their living environment and conditions. Moreover, a formative evaluation at the process level, and the system level will be carried out and complemented by a health economic analysis. Those are carried out to provide information about the intervention’s success and relevant costs. Thus, fruehstArt is realised in the form of an effectiveness–implementation hybrid design that combines the analysis of effectiveness with an evaluation of the implementation process.
The study received ethics approval in a coordinated procedure from the ethics committee of the Medical Faculty University hospital of Cologne and the ethics committee of the North Rhine Medical Association. For all collected data, the relevant national and European data protection regulations will be considered. All personal data (contact details) will be removed for the data analysis in order to ensure pseudonymisation. Dissemination strategies include reports and quality workshops for organisations, peer-reviewed publications and the presentation of results at conferences.
The aim of the unique form of care fruehstArt is to improve the care of preschool children with overweight or obesity through innovative home-based counselling, cross-sectoral service integration and to address the cultural needs of Turkish families.
DRKS00030749 (29-09-2023)
The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.
To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.
We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.
We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.
This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).
34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.
SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.
Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.
This study aims to develop a robust, targeted measure of patient experiences of person-centred care (PCC), informed by the lived experiences of patients with chronic illness using the psychometric theory of Rasch measurement.
The Rasch measurement model was used to analyse the psychometric functioning of 57 candidate items and select appropriate items for a targeted measure.
Participants were recruited from Prolific.com, having experience of both chronic or long-term illness and first-hand experience of primary or secondary care in the UK healthcare setting and completed a survey containing PCC items and descriptors of healthcare experience.
Data from 501 adult persons (49.5% men and 49.7% women) with different types of long-term conditions recruited from the prolific web panel.
For an initial analysis of all 57 candidate items, there were several indicators of misfit, such as signs of local dependence and multidimensionality. The response options worked as intended according to threshold ordering. After removal of misfitting items and refinement for the best spread of locations, a 14-item solution showed good fit to the Rasch model in this UK sample.
The results support a unidimensional measurement of patients’ experiences of PCC, once the local dependency was accommodated. The present work thus offers a 14-item measure of PCC experience. The present work also contains a robust item bank for the further development of dynamic computerised adaptive testing.
The UK Health Security Agency and the National Health Service England (NHSE) led a hepatitis C virus (HCV) patient re-engagement exercise beginning in 2018, which entailed sharing public health surveillance data with NHSE Operational Delivery Networks (ODNs) in England. The ODNs used the data to contact and offer testing and treatment to people historically diagnosed with HCV, but who did not have evidence of successfully clearing the virus. A quantitative evaluation found that of 55 329 individuals whose details were shared with ODNs, around 13% had treatment after the exercise commenced. This qualitative evaluation aims to identify the barriers and facilitators to the re-engagement exercise as reported by ODN staff.
Semistructured interviews. The topic guide and analysis were guided by the Theoretical Domains Framework, using a combined deductive framework and inductive thematic analysis approach.
21 staff from 13 ODNs. The sampling frame was designed to capture participants from all regions of England and with varied outcomes from the re-engagement exercise.
Interviewees reported the most barriers in environmental context and resources (including staffing limitations, interruptions during COVID-19, restricted laboratory access), and social influences (with limited responses from general practitioners and patients). Interviewees discussed whether it was appropriate for ODNs and individual staff to be assigned the data validation work and reported some stress and memory/attention barriers due to the volume of the exercise. They had varied beliefs about the consequences of the exercise, with most believing it was worthwhile due to treatment yield, lessons learnt and confirmation that some people had cleared the virus. Further facilitators included the ODN goals fitting with the exercise, and regional resources such as patient databases. Interviewees also reported adaptations to the exercise that facilitated patient contact, and their ongoing work to re-engage patients emphasised outreach partnerships and peer support.
The evaluation revealed insights into methods for re-engaging patients and of sharing and using public health data to support clinical practice. Government support and funding provision for regionally tailored holistic re-engagement approaches, alongside enhancements to health surveillance data, could enable barriers to re-engagement to be overcome.
To explore participants’ experiences of potential adverse effects of the Informed Health Choices secondary school intervention across three trial sites and to revise a framework of potential adverse effects of interventions to improve critical thinking about health choices.
This was a qualitative study. We extracted and analysed relevant data from separate process evaluations in each country. Data came from surveying teachers, observing lessons and group and individual interviews with students, teachers and other stakeholders. We modified and applied framework analysis, including five stages: (1) development of an initial framework of potential adverse effects, (2) familiarisation with the data, (3) indexing, (4) abstraction and synthesis and (5) revising the framework. We applied reflexive strategies individually and as a team.
Lower secondary school in five randomly sampled subcounties of Kisumu County in Kenya, districts representing all five provinces in Rwanda, and six districts in the central region of Uganda, between 2022 and 2024.
Students and teachers in the intervention arms of the trials, parents of students in the intervention arms and administrators at intervention schools, as well as curriculum developers and policy-makers.
The intervention involved providing teachers with a 2–3-day training workshop, and digital classroom resources, including lesson plans for 10 lessons to be delivered over the course of one semester.
We generated findings about potential increases in adverse misunderstandings, anxiety related to transfer of learning, adversely experienced cognitive dissonance, work or schoolwork-related stress, inequity, conflicts and waste. The revised framework includes the same categories of potential adverse effects as our initial framework: decision-making harms, psychological harms, equity harms, group and social harms, waste and other harms. We revised other elements of the framework, including definitions of the categories and its structure.
This study provides insight into the potential adverse effects of interventions to improve critical thinking about health choices. The findings complement those of the trials and country-level process evaluations.
Cardiac rehabilitation has traditionally been administered through face-to-face consultations with a specialised team of nurses, medical doctors and physiotherapists. However, the healthcare system is undergoing a significant digital transformation, which may lead to telemedicine (TM) becoming a cornerstone of healthcare. However, successful TM requires digital competencies among both patients and health professionals. This trial will examine the best methods of onboarding patients to TM by way of a co-designed cardiac telerehabilitation model with a family-focused approach.
The aim is to investigate how patients and family members could benefit from using TM, including video consultations and home monitoring, for cardiac rehabilitation. We ask how patients’ health literacy, digital health literacy, health-related quality of life and family support would be affected by a shift to TM.
The primary outcome is the Health Literacy Questionnaire, and secondary outcomes are the eHealth Literacy Questionnaire, European Quality of Life—Five Dimensions Scale, and the Iceland—Family Perceived Support Questionnaire. The sample size is 73 patients in each group. Data will be analysed with 2 or Fisher’s exact tests, a t-test or a Wilcoxon signed-rank test, depending on the distribution.
Approval for this trial was obtained from the Danish Data Protection Agency (P-2023-65) and the National Committee on Health Research Ethics (F-23075094). The trial will be conducted in compliance with the Declaration of Helsinki. The trial results—whether positive, neutral or negative—will be submitted for publication. The trial has been registered at ClinicalTrials.gov (NCT06320652).
(NCT06320652).
Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.
The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.
As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.
The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).
The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.
The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.
clinicaltrials.gov (NCT06021288).
This study examined the patterns and persistence of SARS-CoV-2 seropositivity among college students from March to November 2020. Using data from a sample of students at Indiana University, we assessed (1) the duration and seropositivity following reverse transcription-PCR (RT-PCR)-confirmed SARS-CoV-2 infection and (2) persistence of seropositivity over 10 weeks between two laboratory antibody test visits.
The longitudinal study was conducted at Indiana University from September to November 2020, with two laboratory antibody tests, and included self-reported RT-PCR results before the observational period from as early as 20 March 2020. This 6–9 month period contributes to our understanding of seropositivity dynamics. The study included 172 college students who had previously tested positive for SARS-CoV-2 and measured their seropositivity.
Our results showed a notable decline (66.7%) in antibody positivity over the observed period. Additionally, 12 weeks postinfection, most students with a SARS-CoV-2 infection history (75%) were no longer seropositive.
These findings reveal a nuanced picture of antibody dynamics, highlighting the complex interplay of factors among college students. The study underscores the need for continued research on antibody levels among young adults to better understand the drivers of variations in antibody persistence.
Blue light (peak wavelength 442 nm) has been shown to modulate the immune response in preclinical models of intra-abdominal sepsis and pneumonia. In vivo pathways involve optic nerve stimulation with transmission to the central nervous system, activation of parasympathetic pathways terminating at the spleen, and downstream immune effects including decreased inflammatory tissue damage and improved pathogen clearance. Related effects on pain mediators including proinflammatory cytokines (interleukin 6, TNF- α) and autonomic tone (increased parasympathetic outflow) suggest possible analgesic properties that would be highly relevant to a trauma population.
This is a randomised controlled trial in which adult trauma inpatients (
Full ethical approval for this trial has been granted by the University of Pittsburgh Institutional Review Board. On study completion, results will be published in the peer-reviewed literature and at ClinicalTrials.gov.
Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.
This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.
The collected data will be used in two substudies with the overall aims of:
Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.
Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.
Endpoints will include CGM metrics, alarm data and PROs.
The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.
ClinicalTrials.gov (NCT06453434).
Sleep is a biological necessity with vital effects on all tissues and organs of the body. Preoperative sleep disturbance is associated with increased postoperative pain intensity and opioid consumption. Given that insomnia is a potentially modifiable risk factor, interventions targeting sleep prior to surgery may improve postoperative pain control and enhance key outcomes of recovery.
Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) is a randomised, parallel group, two arm, controlled trial evaluating the effects of preoperative sleep-promotion on postoperative pain control, brain health and physical recovery. The main objective is to investigate whether preoperative insomnia treatment in patients scheduled to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA) may improve acute postoperative pain control. 100 adults with insomnia disorder (Insomnia Severity Index score >10 and confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for persistent insomnia disorder), scheduled to undergo primary TKA or THA, will be randomised to preoperative cognitive behavioural therapy for insomnia (CBT-I) or an active comparator control intervention, sleep education therapy (SET). Both interventions will be delivered over 4 weeks in hybrid format through a digital self-guided platform in combination with weekly telehealth video sessions with a psychologist (CBT-I) or research nurse (SET). A video-assisted booster session will be provided 1–2 weeks postoperatively. The primary outcome measure is acute postoperative pain intensity, averaged over the first 7 postoperative days (POD). Secondary outcome measures include long-term postoperative pain control, changes in quantitative sensory testing variables (eg, temporal summation, conditioned pain modulation), sleep, cognition (eg, attention, memory, processing speed, executive function), mental health, health-related function, physical activity, quality of life and blood biomarkers. Participants will undergo on-site evaluation preoperative (preintervention and postintervention) and 6 months postoperative. Additional remote assessments will take place during POD1–7, 3 and 12 months postoperative.
The Swedish Ethical Review Authority has approved the PROSAP-A trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.
Elder neglect by both informal and formal caregivers is common, particularly among persons with dementia, and has serious health consequences but is under-recognised and under-reported. Persons with dementia are often unable to report neglect due to memory and language impairments, increasing their vulnerability. Screening for elder mistreatment and initiation of intervention in primary care clinics may be helpful, but few evidence-based tools or strategies exist. We plan to: (1) develop a novel primary care screening tool to identify elder neglect in persons with dementia, (2) develop an innovative technology-driven intervention for caregivers and (3) pilot both for feasibility and acceptability in primary care.
We will use a multistep process to develop a screening tool, including a modified Delphi approach with experts, and multivariable analysis comparing confirmed cases of neglect in patients with dementia from the existing data registry to non-neglected controls. We will develop an evidence-based, technology-driven caregiving intervention for neglect with an expert panel and iterative beta testing. Following the development of the protocol for implementation of the tool and intervention with associated training, we will pilot test both the tool and intervention in older adult patients and caregivers. We will conduct provider focus groups and interviews with patients and caregivers to assess usability and will modify the tool and intervention. These studies are in preparation for a future randomised trial.
Initial phases of this project have been reviewed and approved by the Weill Cornell Medicine Institutional Review Board, protocol #22-06024967, with initial approval on 1 July 2022. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.
FreshRSS 