Neck pain is a common issue among the working-age population, with a high recurrence rate and one of the highest healthcare costs globally. Exercise is proposed as one of the key components in managing this condition, and electrotherapy is established as a safe and proven analgesic measure. Telemedicine improves access to healthcare by removing geographical barriers and reducing costs, allowing consultations from any location and supporting the work-life balance of the patient.
The aim of this study is to compare the efficacy of e-Health versus a face-to-face programme in the therapeutic management of non-specific neck pain through exercise and analgesic electrotherapy.
A randomised clinical trial with 100 participants suffering from non-specific neck pain will be conducted. Participants will be evenly divided into two groups to receive analgesic electrotherapy combined with a cervical exercise programme delivered either via an e-Health programme or face-to-face programme. A total of 24 sessions will be administered over 8 weeks. Data collected will include demographic and clinical information, disability, pain intensity, fear of movement, sleep quality, catastrophising, quality of life and range of motion. Assessments will be conducted at the start of the study (baseline), at 8 weeks (post-treatment), and 2 months after completing the intervention (follow-up).
This protocol has been approved by the Andalusian Biomedical Research Ethics Coordinating Committee (SICEIA) with number register (SICEIA-2024-000820) on 25 September 2024. Findings will be disseminated through publications in peer-reviewed journals and presentations at international and national conferences.
ClinicalTrials.gov (NCT06842381).
To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.
Preimplementation qualitative study using semistructured interviews.
Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.
36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.
Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.
This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.
Split-thickness skin autografts are commonly used to treat extensive cutaneous defects. However, donor site morbidity, including pain, bleeding, and delayed epithelialization, remains a major clinical challenge. This study evaluates whether applying autologous platelet-rich plasma (PRP) to the donor site improves healing outcomes. A prospective cohort study was conducted at a tertiary-level academic hospital in Colombia. The study protocol was approved by the local Institutional Ethics Committee. Adult patients (> 18 years) undergoing split-thickness skin grafts for trauma, burns, oncologic resections, or chronic ulcers were included. Two groups were compared: the PRP group, in which autologous platelet-rich plasma was applied to the donor site, and the control group, which received standard wound care. The primary outcome was the quality of epithelialization at the donor site, while pain, assessed using the Numeric Rating Scale, was evaluated as a secondary outcome at multiple postoperative time points. Data were analysed using descriptive statistics and linear mixed-effects models adjusted for potential confounders, with statistical significance set at p < 0.05. A total of 46 patients were included (16 in the PRP group and 30 in the control group), with no significant demographic differences between groups. The PRP group demonstrated improved epithelialization quality, with lower Vancouver Scar Scale scores on postoperative days 7 and 14 (p < 0.05). Patients treated with PRP also reported a reduction of up to 50% in postoperative pain during early assessments (p < 0.001). These effects were maintained throughout the follow-up period, suggesting a sustained benefit of PRP on both healing quality and pain control. These findings suggest that autologous PRP application at split-thickness skin graft donor sites may enhance early epithelialization quality and reduce postoperative pain compared with standard wound care. PRP appears to be safe and may represent a useful adjunct to promote improved wound healing and patient recovery in reconstructive surgery. However, larger randomised controlled trials are required to confirm these findings and to establish the clinical effectiveness of autologous PRP in this setting.
Community support for individuals with mental health problems is a global public health issue. Poor mental health literacy and high levels of stigmatising attitudes among the general population can hinder both help-seeking behaviours and limit the capacity of community members to provide support to people experiencing mental health challenges. The Mental Health First Aid (MHFA) training course was created to educate community members to provide initial help towards a person developing a mental health problem. MHFA training has spread to high-income countries, but there is relatively little research on cultural adaptation to lower-resource settings. This study aims to fill that gap and is the first cluster randomised controlled trial (cRCT) assessing the effectiveness of MHFA training in Chile and Argentina.
The study involves a two-arm wait-list cRCT with 240 participants (120 in each country). The study will be conducted in three settings in each of Chile and Argentina (eg, universities, health services and workplaces). Two clusters per setting in each country will be paired and randomly allocated to the intervention (the MHFA training for Chile and Argentina) or the wait-list control group. Participants in the intervention arm will be asked to complete questionnaires at baseline (T1), after training completion (T2) and 6 months after completion (T3), with control arm participants completing data collection at corresponding time points. The primary outcome will be intended support towards someone experiencing a mental health problem or experiencing a mental health crisis. Secondary outcome measures will include the ability to recognise depression and psychosis in vignettes; beliefs about the helpfulness of different types of interventions and helping actions, confidence in providing MHFA and stigmatising attitudes towards a person with depression or psychosis. Findings will demonstrate whether the culturally adapted MHFA training for Chile and Argentina can effectively enhance intended support, knowledge, attitudes and supportive actions towards other individuals within the community.
Ethics approval has been granted by the Human Research Ethics Committee at the University of Melbourne (Australia), Proyecto Suma (Argentina) and the University of Chile (Chile). Dissemination will be via academic publications and conference presentations. These will also be made available to participants and other interested parties on request.
This study aims to evaluate a structured nurse-led follow-up programme coordinated by an advanced practice nurse (APN) as an alternative to conventional postdischarge care for patients with heart failure (HF). The main objective is to assess the clinical effectiveness and economic efficiency of the programme using quality-adjusted life years and healthcare costs related to resource use as outcome measures.
A quasiexperimental multicentre study will be conducted including an intervention group and a comparison group of patients discharged with HF from three public hospitals in the province of Málaga, Spain. The intervention group will be followed by an APN using a structured follow-up model, while the comparison group will receive standard care. Sociodemographic, clinical, quality of life, self-care, therapeutic adherence and healthcare resource utilisation data will be collected. The economic evaluation will be conducted from the perspective of the public healthcare system through a cost-utility analysis.
The study protocol has been approved by the corresponding Research Ethics Committee. All participants will provide written informed consent prior to inclusion. The results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences.
Clinical trials have produced inconclusive results regarding the optimal glucose range for a patient with sepsis in the intensive care unit (ICU) receiving insulin treatment.
To investigate the optimal glucose range in patients with sepsis in the ICU independent of confounding covariates.
Targeted trial emulation of glucose ranges using causal inference targeted maximum likelihood estimation and longitudinal mixed-effects models combined with survival models.
Single-centre, academic referral hospital in Boston, Massachusetts, USA.
Adults fulfilling sepsis 3 criteria with at least three glucose readings and insulin treatment from the Medical Information Mart for Intensive Care (MIMIC)-IV database (2008–2019).
Five predefined glucose distributions with means at 100, 130, 160 (baseline), 190 and 220 mg/dL mimicking current guidelines’ recommendations (140–180 mg/dL).
The primary outcome was in-hospital mortality. Modified counterfactual treatment-policy risks across distinct time-weighted glucose ranges were estimated.
Of 73 181 eligible patients, 8002 patients with a median age of 66 years (41% women, 67% white ethnicity, 57% diabetes) were included. There was a U-shaped curve between glucose range and mortality in patients without diabetes, but overall, this association was not significant (mean glucose at 100 mg/dL with 21% mortality and mean glucose at 220 mg/dL with 26% mortality, p-for-trend 0.26). Mortality was lowest at 17%, with mean glucose between 130 and 160 mg/dL. Hypoglycaemic events (
Our data suggest a U-shaped association of glucose and mortality with an optimal average glucose between 160 and 190 mg/dL. These results confirm current guideline recommendations. Together with recent results from randomised controlled trials, intensivists should aim for a liberal glucose range in most patients.
Population ageing is a global phenomenon that has resulted in an increase in the number of patients with chronic diseases and geriatric syndromes. Frailty, sarcopenia and neurocognitive disorders are among the most prevalent conditions affecting older adults and have a direct effect on their quality of life, and can impact the burden and budgets of health systems. Recently, the oral microbiome has gained attention as it may be a factor that potentially influences the onset and progression of these syndromes. However, this is still a new line of research that has not been deeply explored. This scoping review protocol aims to explore how the oral microbiome may be associated with the onset of prevalent geriatric syndromes, frailty, sarcopenia and neurocognitive disorders, providing a picture of the current evidence and potential gaps for future research.
The scoping review will follow the Johanna Briggs Institute (JBI) methodology and will be reported accordit to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines (PRISMA-ScR). Searches will be conducted in Medline, Embase, Cochrane Central, CINAHL, LILACS and Epistemonikos from inception to December 2025. Independent reviewers will perform the study selection and data extraction. A descriptive analysis of information will be conducted, highlighting oral microorganisms associated with these syndromes and emerging trends in the evidence. Original research studies in any language will be included. We will include randomised controlled trials, cohort studies, case–control studies and other relevant designs if they investigate the oral microbiome and its relation to geriatric syndromes in adults aged 65 or older, regardless of geographic location or setting.
Ethics approval is not required.
by Deborah Baron, Nisha Gottfredson O’Shea, Alexandra Lightfoot, Caroline Kuo, Sheri Lippman, F. Xavier Gómez-Olivé, Kathleen Kahn, Audrey Pettifor, Suzanne Maman
BackgroundSouth African women are disproportionately impacted by HIV. Among these women, adverse childhood experiences (ACEs) are common and have been linked to HIV risk behaviors, including transactional sex (TS). Resilience—or multi-level processes related to overcoming adversity—provides a strengths-based lens that may buffer effects between ACEs and TS.
MethodsWe conducted a convergent mixed methods study among women aged 18–25 years in Mpumalanga, South Africa. We used logistic regression to assess the association between ACEs and TS; and tested moderation effects of five resilience scales across social-ecological levels hypothesized to dampen the effect of ACEs on TS. In parallel, we conducted a photovoice study that utilized participant-generated images and narratives, and thematic and sequence analysis to explore how women exposed to ACEs perceive and use resilience to navigate TS relationships.
ResultsOur analysis included 1,222 women aged 18–25 years, of whom 714 (58.43%) reported ACE exposure, with 519 (42.47%) reporting 1–2 ACEs and 195 (15.96%) reporting ≥3 ACEs; 340 (27.82%) reported TS. Women reporting ACE exposure had increased odds of TS compared to those without ACE exposure, controlling for confounders (AOR = 1.52, 95% CI: 1.17–1.99, P = 0.002). Among women with histories of ACEs, women with ≥3 ACES had 2.55 times the odds of TS than those reporting 1–2 ACEs (95% CI: 1.79–3.63, P= Conclusion
We examined the interplay between resilience, ACEs, and TS. Although quantitative results showed resilience did not buffer negative effects of ACEs on TS, the photovoice findings suggest resilience was salient and influential in women’s lives. Future research should explore resilience measures and interventions that address the complex gender and power dynamics that exacerbate women’s exposure to TS and HIV.
by Andrés Castellanos-Chacón, Daniela Arias-Otero, Valeria Uribe-Jaramillo, Juan David Leongómez, Milena Vásquez-Amézquita
The attentional system tends to prioritize negative stimuli in the early stages of processing, favoring threat detection. However, it is unclear whether this bias is maintained or reversed toward positive stimuli at later stages. In this study, we used a free-viewing paradigm with eye tracking to examine early and late attentional biases toward negative, positive, and neutral stimuli (humans in emotionally unloaded activities) versus control stimuli (inanimate objects) in 122 participants without affective disorders (64 men, 58 women). We fitted generalized linear mixed models with random intercepts for stimuli and random intercepts and slopes for participants, and used non-parametric bootstrap resampling to obtain robust estimates and confidence intervals. Additionally, the number of first fixations was analyzed with a COM-Poisson. Results showed that participants fixated faster (χ2(3) = 97.55, p 2(3) = 337.45, p χ2(3) = 200.24, p χ2(3) = 207.02, pThe digital transformation of healthcare has created an urgent need for primary care physicians (PCPs) to acquire competencies in digital health. However, the structure and scope of postgraduate training programmes remain poorly defined and unevenly implemented worldwide, and no scoping review has yet synthesised the evidence. This review aims to map existing postgraduate digital health training programmes for PCPs, including their content, structure and delivery approaches.
This scoping review will follow the Joanna Briggs Institute methodology and adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A systematic search will be conducted across five databases (PubMed, Scopus, Cochrane Library, ScienceDirect and Web of Science) and relevant grey literature, covering publications from January 2019 to June 2025. Studies describing postgraduate digital health training programmes for PCPs will be eligible for inclusion. Data will be extracted and synthesised descriptively and thematically using an inductive approach.
As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through a peer-reviewed publication and conference presentations and will inform future curriculum development and policy in digital health education for PCPs. The results may also inform national curriculum reforms and accreditation standards, supporting more consistent and competency-based digital health education globally.
This scoping review protocol has been registered with the Open Science Framework.
by Fezile Wagner, Unathi Kolanisi, Ryan G. Wagner, Lerato P. Makuapane, Mxolisi Masango, Francesc Xavier Gómez-Olivé
The COVID-19 pandemic exacerbated hunger levels in South Africa, with an increase from 10% pre-pandemic to 23% during the pandemic. Pre-pandemic national and global research identified university students to be more vulnerable to hunger compared to the general population. This elevated risk is commonly associated with prevalent financial mismanagement in this group. However, research investigating the prevalence of hunger during the pandemic among this at-risk group is limited. This cross-sectional study aimed to assess the prevalence and determinants of hunger among students at a South African university during the COVID-19 lockdown, with particular focus on the effect of returning home. An online, self-administered survey produced a sample of 596 students. The Household Hunger Scale (HHS) was used to assess hunger. Most students (84%) who resided in on- or off-campus residences before the lockdown returned home during the lockdown. The weighted prevalence of hunger during lockdown was 16.4% (95%CI 13.6%, 19.6%). Bivariate analyses found living alone to be significantly associated with hunger, while multivariate analyses found that first-generation students (adjusted odds ratio (aOR) = 1.78; 95%CI: 1.04, 3.07, p = 0.015), financial aid recipients (aOR = 2.69; 95%CI: 1.47, 4.91, p = 0.001), and those experiencing financial stress/worry (aOR = 3.38; 95%CI: 1.85, 6.18, pTo determine the survival rate and prognostic factors associated with tuberculosis (TB) mortality in Medellín between 2018 and 2023.
Quantitative observational analytical study of a retrospective cohort.
Based on notifications made to the Public Health Surveillance System and managed by the Secretary of Health of Medellín—Colombia between 2018 and 2023.
A total of 11 202 individuals diagnosed with TB, aged between 1 and 103 years.
The Kaplan-Meier method was employed to determine survival and risk functions, as well as median survival. Crude HRs and adjusted HRs (aHRs) were estimated using Cox proportional hazards regression models.
A median overall survival of 1410 days (3.86 years) and an adjusted mortality rate of 40 cases per 100 000 population were estimated for the study period (6 years). Factors associated with TB mortality were age (>59 years) (aHR 5.53; 95% CI 3.17 to 9.65), renal disease (aHR 2.98; 95% CI 2.27 to 3.90), HIV infection (aHR 2.82; 95% CI 1.39 to 3.32) and cancer (aHR 2.56; 95% CI 1.95 to 3.34).
TB survival is influenced by age and comorbidities, indicating the need for targeted strategies to protect high-risk groups. Strengthening comprehensive TB control through timely diagnosis, integrated management of chronic conditions and patient-centred care is essential to reduce preventable deaths. Furthermore, improving case notification and follow-up through integrated information platforms will contribute to more effective public health interventions.
Despite a lack of evidence relating to effectiveness and safety, the use of apps in the field of mental health is increasing due to their ease of use and accessibility. The aim of the EvalDepApps project is to develop and validate an assessment tool for evaluating depression management apps based on scientific evidence, expert judgement and end-user needs.
The purpose of this study was to determine the most relevant criteria for evaluating apps intended to manage depression through consensus-based assessment.
A total of 43 individuals were invited to participate in an online modified Delphi study of 51 criteria identified from the literature. In Round 1, participants rated criteria according to relevance and three levels of consensus were defined: high level when ≥80% of respondents scored the criterion at 5 or 6; medium when 60%–79% of respondents scored the criterion at 5 or 6 and low when
The response rate was 59.0% (26/43) in Round 1 and 53.4% (23/43) in Round 2. In Round 1, 24 criteria (47.1%) attained the maximum level of consensus, 20 (39.2%) the medium level and 7 (13.7%) the lowest level. In Round 2, 4 out of 20 criteria (20.0%) attained the maximum consensus. Participant comments reinforced the relevance of the selected criteria. The final list consisted of 28 criteria, the majority relating to Safety and Privacy and Clinical Effectiveness (25.0% each), followed by Usability and Functionality (17.9%).
By prioritising criteria relating to data safety and clinical effectiveness, participants in this study emphasised that the assessment of apps for depression management must take both these aspects into full consideration. Despite some limitations of the study (eg, lack of participant sociodemographic data and its implications for generalisation, not face-to-face inter-round), the results of this study will enable the EvalDepApps project to develop an assessment tool for depression management apps that incorporates the most relevant criteria.
EvalDepApps will support healthcare professionals and users in identifying safe, effective and user-friendly depression management apps.
This study aimed to investigate the factors influencing health-related quality of life (HRQoL) in patients undergoing haemodialysis, focusing on the association between HRQoL dimensions and sociodemographic variables, clinical parameters, mental health status and biochemical indicators.
A multicentre cross-sectional study conducted over 30 months.
The study was carried out in secondary care centres across multiple locations in the Community of Extremadura, Spain.
A total of 150 patients undergoing haemodialysis were recruited between March 2022 and September 2023. Inclusion criteria required patients to be diagnosed with chronic kidney disease (CKD) and undergoing haemodialysis. Patients unable to provide informed consent or with severe cognitive impairment were excluded.
HRQoL was assessed using the Kidney Disease Quality of Life 36-item Short Form scale. Mental health parameters, specifically anxiety and depression, were evaluated using the Hospital Anxiety and Depression Scale. Biochemical markers such as haemoglobin and haematocrit levels, as well as sociodemographic and clinical data, were analysed for their influence on HRQoL.
Symptoms of anxiety and depression were prevalent among patients undergoing haemodialysis. Anxiety had the greatest negative effect on HRQoL, being significantly associated with lower scores in the mental component summary (MCS) (β = –2.06; 95% CI –2.78 to –1.33; R² = 0.106; p
Depression and anxiety, along with older age, were identified as key factors negatively affecting HRQoL of patients undergoing haemodialysis. Management of mental health, alongside optimisation of clinical care to minimise complications, could enhance the HRQoL in this patient population. Further research is recommended to develop targeted interventions addressing anxiety and other modifiable factors influencing HRQoL in haemodialysis patients.
Safety culture is essential to improving healthcare quality. Paediatric emergency departments are high-risk environments where evaluating safety culture helps identify areas for improvement. This study aimed to analyse the safety culture among professionals in paediatric emergency departments, according to job category and gender.
Multicentre cross-sectional study using the Hospital Survey on Patient Safety Culture (HSOPSC).
19 paediatric emergency departments, covering all levels of care.
1843 healthcare professionals were invited to participate; the response rate was 63.8%, and 33% of respondents were nurses. All clinical staff in paediatric emergency departments were eligible. Professionals from other specialties and non-clinical staff were excluded.
The primary outcome was the assessment of patient safety culture using the HSOPSC, following the methodology of the Agency for Healthcare Research and Quality. Secondary outcomes included comparisons by job category and gender, and an exploratory cluster analysis.
In terms of patient safety, the main strength was ‘teamwork within units’ (83.65% positive), while the main weakness was ‘staffing’ (61.92% negative). Patient safety was rated with an average score of 7.21 by the participants. Paediatricians rated ‘manager expectations’ significantly higher than nurses (p=0.023) and residents (p=0.026). Paediatricians gave more positive responses overall, with significant differences in ‘communication openness’, ‘feedback and communication’, ‘non-punitive response’ and ‘teamwork across units’, though none were classified as strengths. Cluster analysis showed that the group with more paediatricians identified more strengths and no weaknesses, while the group with more nurses and nursing assistants showed no strengths and significant weaknesses in ‘overall safety perception’, ‘staffing’ and ‘management support’.
Safety culture in paediatric emergency departments is acceptable, but still far from excellent, indicating ample room for improvement. Differences between professional categories, especially between paediatricians and nurses, highlight the need for targeted safety strategies and leadership involvement.
In deprived urban areas of South America, young people face heightened risks of mental disorders. Research suggests an association exists between social media engagement (SME), depression and anxiety.
This study explored the associations of SME with symptoms of depression, anxiety and subjective quality of life among young people from South American deprived urban areas.
Our cross-sectional survey study used an adapted version of the Multidimensional Facebook Intensity Scale to categorise 2399 participants into four SME groups: low, moderate, high and very high. Symptoms of depression (Patient Health Questionnaire-8), anxiety (Generalised Anxiety Disorder-7) and quality of life (Manchester Short Assessment) were assessed and compared using F and Tukey tests.
Each step of increased SME was associated with more symptoms of depression and anxiety and poorer quality of life. Statistically significant differences were observed across all groups (p
The findings suggest an association exists between SME, increased mental distress and lower quality of life in young people from deprived South American urban areas. This influence seems to apply across the spectrum of engagement levels, not only to extremes. However, due to the cross-sectional nature of the study, causal relationships cannot be established.
SME should be explored in clinical settings, as lower levels are associated with lower symptom levels and better quality of life. Policies addressing youth SME should be developed and evaluated in the challenging contexts of deprived urban areas.
Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.
This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.
We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).
All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.
Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.
This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.
This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.
Migraine is a primary headache showing a multifactorial component that includes altered pain processing, psychological/emotional problems, neurocognitive and executive function deficits, all with a possible genetic association. The aim of the current study will be to evaluate the association between sensitisation, psychological/emotional, neurocognitive and genetic profile on conditioned pain modulation (CPM) in women with migraine from a multidisciplinary perspective.
A cross-sectional observational case–control study including 90 women with chronic migraine, 90 women with episodic migraine and 90 women without migraine (as controls) will be conducted. Clinical variables (disability, pain), processing (sensitisation-associated, neuropathic-like symptoms), psychological/emotional (anxiety, depression, sleep quality, catastrophising), neurocognitive (attention), executive functions (memory, mental inhibition, speed processing) and genetics (Val158Met polymorphism rs4680 gene) will be assessed in all subjects by healthcare professionals. Subsequently, CPM will be evaluated with the cold-pressor test paradigm by assessing changes obtained in mechanical and thermal stimuli. The association of each group of variables on CPM will be analysed with multivariate analyses (OMNIBUS analysis of variance). A network model will also be created to identify those variables showing the greatest key measure of centrality with the rest of the severity indicators (strength, intermediation and closeness) to establish the potentially therapeutic targets in patients with migraine from a multidisciplinary point of view.
The protocol of the current study has been approved by the Ethics Committee of all involved institutions (Hospital Universitario Fundación Alcorcón 24–117, Universidad Rey Juan Carlos 010220240912024). All procedures will be conducted following the Declaration of Helsinki. Participants will be informed of the aims and procedures of the study and will receive the informed written consent which should be signed before their inclusion. Study results will be disseminated through peer-reviewed publications and presentations at scientific meetings.
The needs of patients in palliative care (PC) are multiple and changing. Several tools assess them, but there is a lack of homogeneity among them. A specific diagnostic tool to assess complexity in PC (IDC-Pal: Instrumento Diagnóstico de la Complejidad en Cuidados Paliativos, in Spanish) was created in community and hospital settings with 36 items to diagnose PC complexity, but its application in primary care is difficult.
(1) To generate an adapted version to primary care of the IDC-Pal tool to identify and stratify PC complexity in the adult population. (2) To determine face, content, criterion and construct validity and reliability of the new instrument.
There are three phases of clinimetric cross-sectional observational validation study: Phase 0: Review of the original tool structure suitability for its use in primary care setting by a committee (researchers and the original developer team). Phase 1: Expert consensus phase by Delphi technique with physicians, nurses and social workers from primary care and PC. Phase 2: Empirical validation of the resulting tool in primary care using a cross-sectional descriptive design involving physicians and case manager nurses from across Andalucia, who will recruit adult patients with PC needs from healthcare centres that accept to participate in the study. Reliability (Cronbach’s alpha, McDonald’s omega, interclass correlation coefficient) and construct validity (exploratory factor analysis) analysis will be carried out; convergent criterion validity will be assessed with the NEC-PAL (Necesidades Paliativas Questionnaire, in Spanish) instrument. Differences by gender, type of professional and place where it is administered will be explored. Interobserver reliability analyses will be carried out using intraclass correlation coefficient, Bland-Altman plots and concordance analysis. Phase 0–1 results were expected by 2025 and Phase 2 results by 2026. Reporting method: CRISP checklist. This protocol was conducted without patient or public participation.
This study evaluates a novel, co-designed tool to diagnose PC complexity to inform practice recommendations for a more efficient allocation of resources that may be included in future clinical practice guidelines. The study has been approved by the Provincial Research Ethics Committee of Málaga as of July 2023 and will be conducted in accordance with the principles established in the Declaration of Helsinki, the Council of Europe Convention on Human Rights and Biomedicine, and the requirements established in Spanish legislation. The study conforms to the norms of good clinical practice. All participants in the Delphi study must express their agreement to participate in the survey by providing informed consent (IC) before beginning the questionnaire. For the development of Phase 2, the primary care professionals who agree to participate will sign a researcher commitment, and the patients included in the study will sign a written IC before the data collection. Dissemination of the results will inform future research on the appropriate diagnosis of PC complexity in the primary care setting, which is of paramount importance due to its gatekeeper position. Dissemination will be aimed at academics and healthcare professionals through publications, presentations and training workshops on the use of the diagnostic tool.