Intensive care units (ICUs) can be a particularly challenging environment for patients who are mentally vulnerable. In addition to the physical stress associated with critical illness and its management, there are physiological and psychosocial factors that can negatively impact a patient’s mental health. Approximately half of ICU survivors will experience post-intensive care syndrome, a set of emotional, neuropsychological and physical sequelae that can significantly affect patients’ functionality and quality of life, both in the short and long term. The main objective of this study is to investigate whether the ICU Recovery Answers (ICURA) digital follow-up platform can effectively detect emotional and cognitive problems in critically ill patients and its impact on functionality and health-related quality of life during the first year after ICU discharge.

Multicentre longitudinal prospective study involving ICU adult patients, with randomised follow-up comparing a telemedicine monitoring programme versus usual medical care during 1 year after discharge. A total of 360 participants will be recruited during their ICU admission in two hospitals in Spain. Efficacy outcomes will focus on participants’ level of functioning, assessed with the WHO Short Disability Assessment Schedule, and quality of life, measured with the 12-Item Short Form Survey at 1, 6 and 12 months after ICU discharge. Emotional state and cognitive impairment will be evaluated using the Patient Health Questionnaire-9, Generalised Anxiety Disorder-7 and Treatment-Outcome Post-Traumatic Stress Disorder Scale and the Montreal Cognitive Assessment by telephone at 1, 3, 6, 9 and 12 months after ICU discharge.

The implementation of this project is expected to have a direct impact on the satisfaction of ICU survivors, improving their well-being, personalised follow-up and quality of life. Results from this study will be disseminated at various scientific conferences, national and international meetings, and will be shared with the general public and other relevant parties. The dissemination of these results will occur through scientific publications, allowing the medical and scientific community to benefit from the study’s findings. Ethics approval from the Ethics Board of Parc Taulí Foundation and Balearic Islands with reference numbers 2022/3031 and IB 5072/22 PI: Protocol version 1 of 18 November 2022.

NCT06504979.

A qualitative study was conducted in Catalonia (Spain), incorporating the views and opinions of relatives, healthcare professionals and patients on what they considered a ‘good death’. This study aimed to describe barriers, facilitators and unmet needs related to the achievement of a good death.

We recruited adult patients with advanced or chronic conditions, relatives and health and social care professionals involved in end-of-life processes of care, management or strategic planning. All participants took part in a qualitative study. The study was informed by phenomenological, hermeneutical and social constructivist perspectives and included 23 in-depth interviews and three focus group discussions with a total of 31 participants. Fieldwork was conducted between February and April 2022. Data were transcribed and analysed using qualitative thematic content and discourse analysis.

Six main themes were identified, comprising 17 subthemes. Facilitators and barriers related to achieving ‘a good death’ were categorised according to whether they occurred before death or during the dying process. Key facilitators include high-quality palliative care, open communication about death and the ability to choose the place of death. Key barriers included bureaucratic delays, inadequate resources, insufficient professional training and lack of respect for patients’ preferences and wishes.

Our study highlights the need to understand factors that facilitate or hinder the achievement of a good death and the quality of the dying process. Specifically, understanding individual preferences and unmet needs, enhancing communication, increasing awareness, reducing bureaucratic barriers and ensuring adequate resources are essential to support a more dignified end-of-life experience for patients, caregivers and healthcare professionals.

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.

ISRCTN63724445.

Severe pectus excavatum (PE) may impair cardiopulmonary and physical function. The effectiveness of surgical treatment to correct PE and restore physical function is widely debated due to a lack of high-quality comparative evidence. The RESTORE trial aims to determine the clinical and cost-effectiveness of corrective surgery for severe PE compared with conservative management for the first time in a randomised controlled trial (RCT).

RESTORE is a pragmatic, multicentre, RCT with an embedded observational cohort. 200 participants aged ≥12 years with severe PE will be recruited at around 12 National Health Service cardiothoracic surgical centres in England. Participants will be randomised 1:1 to receive either surgery within 3 months of randomisation (intervention arm) or no surgery until after the primary outcome measurement at 1 year (comparator arm). The primary outcome is change in physical functioning from baseline to 1 year as measured by the Short Form Health Survey (SF-36v2) physical function score. The primary economic outcome is cost-effectiveness. The key secondary outcome is change in % predicted VO_2peak at 1 year measured by cardiopulmonary exercise test (CPET). Outcomes will be assessed at 1 year post-randomisation in the comparator arm and 1 year post-surgery in the intervention arm. The primary analyses will be undertaken on an intention-to-treat population using a linear mixed-effects model, adjusted for stratification variables via a binary covariate. Other secondary outcomes will include change from baseline of cardiopulmonary function (CPET and spirometry), health-related quality of life using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) and SF-36v2 questionnaires, Hospital Anxiety and Depression Scale and disease specific symptoms (Phoenix Comprehensive Assessment for Pectus Excavatum Symptoms and Pectus Excavatum Evaluation Questionnaire). Adverse events, complications from surgery and operative technical success (Haller and Compression Indices from preoperative and postoperative CT scans) will also be assessed. Health economic analysis will estimate the incremental cost per quality adjusted life year at 1 year.

The trial was approved by East of Scotland Research and Ethics Service (24/ES/0034). Participants who are ≥16 years of age will be required to provide written informed consent. For participants

ISRCTN11359779.

To examine how cultural health brokers, as trusted intermediaries between formal systems and diverse ethnocultural communities, help navigate decisional conflict and misinformation regarding COVID-19 vaccination and to identify how their work contributes to system resilience in crisis contexts.

A community-based participatory action sensemaking research project to capture the real-time work of cultural health brokers in helping people navigate decisional conflict for vaccination.

Multicultural Health Broker Cooperative in Edmonton, Alberta where brokers speak 54 languages and serve more than 10 000 people from diverse ethnolinguistic communities. 28 cultural health brokers (9 male; experience 4–25 years) contributed to data collection and analysis between 16 September 2021 and 16 December 2021.

The brokers captured real-time reflections and self-interpretations in the SenseMaker platform through a theoretically informed, codesigned, mixed-method data collection tool. The team engaged in 13 weekly, 90 minute, audio-recorded and transcribed sessions: seven focused on understanding and action planning and five reflecting on the SenseMaker data, the focus of the thematic analysis. Data were managed in NVivo (QSR International, Version 12, 2018).

Brokers collected 277 narratives and conducted 13 sensemaking sessions. Understanding and purpose were identified in 68% of narratives as key to achieving coherence; 81% of narratives highlighted trust as crucial to what was needed for action; 62% of narratives reflected on a potential risk, with loss of trust a concern in 70% of them. A rich understanding of the sources of decisional conflict and misinformation was achieved and managed through outreach. There were four entwined components to navigation of the evolving complexity of COVID-19 vaccination: (1) building and sustaining trust; (2) strengthening relationships; (3) creating safe spaces for collective sensemaking and solution finding; and (4) leveraging cultural and social capital to address barriers. Through these mechanisms, brokers reduced decisional conflict and misinformation, supporting informed, values-congruent decisions.

Cultural health brokers, embedded within communities and linked to formal systems, play a critical role in crisis response by fostering trust, mobilising resources and enabling collective sensemaking. This study demonstrates how these intermediaries’ contextually and culturally attuned work provides a model for building system resilience for future crisis response.

Deaths related to drug overdose and suicide in the USA have increased 500% and 35%, respectively, over the last two decades. The human and economic costs to society associated with these ‘deaths of despair’ are immense. Great efforts and substantial investments have been made in treatment and prevention, yet these efforts have not abated these increasing trajectories of deaths over time. The COVID-19 pandemic has exacerbated and highlighted these problems. Notably, some geographical areas (eg, Appalachia, farmland) and some communities (eg, low-income persons, ‘essential workers’, minoritised populations) have been disproportionately affected. Risk factors have been identified for substance use and suicide deaths: forms of adversity, neglect, opportunity indexes and trauma. Yet, the biological, psychological and social mechanisms driving risk are not uniform. Notably, most people exposed to risk factors do not become symptomatic and could broadly be considered resilient. Achieving a better understanding of biological, psychological and social mechanisms underlying both pathology and resilience will be crucial for improving approaches for prevention and treatment and creating precision medicine approaches for more efficient and effective treatment.

The State of Ohio Adversity and Resilience (SOAR) study is a prospective, longitudinal, multimodal, integrated familial study designed to identify biological, psychological and social risk and resilience factors and processes leading to mental health disorders, substance use disorders, substance overdose, suicide and associated psychological/medical comorbidities which reduce life expectancy and quality of life. It includes two nested longitudinal samples: (1) WD Survey: an address-based random population epidemiological sample of 15 000 individuals (unique households) representative of the state of Ohio assessed for psychosocial, psychiatric, behavioural health and substance use factors and (2) Brain Health Study: a family-based, multimodal, deep-phenotyping study conducted in 1200 families (up to 3600 persons aged 12–72 years) including MRI, electroencephalography, blood biomarkers and psychiatric diagnostic interviews, as well as neuropsychological, psychosocial functioning and family/community history, dynamics and support assessments. SOAR is designed to discover, develop and deploy advanced predictive analytics and interventions to transform mental health prevention, diagnosis, treatment and recovery.

All participants will provide written informed consent (or parental permission and assent for minors). The study was approved by The Ohio State University Institutional Review Board (study numbers 2023H0316 (Brain Health) and 2023H0350 (Wellness Survey). The Brain Health study was also approved by institutional review boards at each partnering institution involved in conducting participant assessments. Findings will be disseminated to academic peers, clinicians and healthcare consumers, policymakers and the general public, using local and international academic channels (academic journals, evidence briefs and conferences) and outreach (workshops and seminars).

Intervention adaptation is likely to occur to some extent when implementing interventions in new implementation contexts. Using systematic frameworks can guide intentional and effective adaptation processes. Intervention Mapping for Adaptation (IM-ADAPT) is a framework that offers step-by-step guidance for systematic, theory-based intervention adaptation. Despite the increasing use of IM-ADAPT, there is limited understanding of the contexts in which it has been applied and how effectively it is used and reported. Addressing this knowledge gap can improve current adaptation practices and inform future enhancements of the IM-ADAPT framework and the broader science of intervention adaptation. This review aims to (1) determine the context in which IM-ADAPT is used, (2) assess how studies apply IM-ADAPT tasks and (3) evaluate how these studies report their IM-ADAPT findings.

This protocol followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The eligibility criteria include original peer-reviewed English articles that used Intervention Mapping or IM-ADAPT to adapt interventions. We searched PubMed/Medline, Web of Science, Embase and the Intervention Mapping literature library, and conducted forward citation searches using two landmark articles from inception to 19 July 2024. At least two independent coders will screen the records to determine eligibility and extract data from the included articles. Any discrepancies will be resolved through regular co-author meetings or in consultation with a senior author. The study protocol was registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/D5TCP).

As this systematic review only used published data, no ethics approval was required. We will disseminate the findings of this review through open-access channels and journals.

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.

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

NCT04897516.

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by ² tests or the Kruskal-Wallis test.

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

NCT06916598 (clinicaltrials.gov).

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.

Women with recurrent urinary tract infections (UTIs) often undergo intensive antibiotic exposure, especially with suppressive therapies. Suppressive therapy is recommended for women with three UTIs in the past year or two in the last 6 months. However, the collateral long-term effects of this have been poorly studied.

To assess whether suppressive therapy for recurrent UTIs increases the incidence and severity of future infections compared with episodic UTI treatment.

Retrospective cohort study.

The study was conducted using data from the Information System for Research in Primary Care database, including 5.8 million people in Catalonia. Two groups of women with recurrent UTIs (≥3 episodes/year) were compared: those on suppressive antibiotic therapy for ≥6 months and those treated episodically. Primary outcomes were hospitalisations due to pyelonephritis, septicaemia, COVID-19, influenza, pneumonia and mortality by these infections, over a 100-month follow-up period.

Among 36 170 women, 2898 (8%) were treated with continuous suppressive therapy. Overall, 6.9% of the population experienced severe infections, with a higher incidence in women on suppressive therapy (12.6%) compared with those without (6.4%), with a HR of 1.50 (95% CI 1.33 to 1.68). Pyelonephritis presented the greatest difference (HR, 1.95 (95% CI 1.64 to 2.33)), followed by septicaemia (HR, 1.34 (95% CI 1.13 to 1.59)) and COVID-19 (HR 1.23 (95% CI 1.01 to 1.50)).

Suppressive antibiotic therapy in women with recurrent UTIs is associated with a higher incidence and severity of future infections. Future research should focus on clarifying causal relationships and identifying the potential mechanisms involved.

Indigenous Mayan-Yucatecan communities in Mexico have a high prevalence of chronic non-communicable diseases (NCDs) such as diabetes, hypertension, obesity and rheumatic diseases (RMDs). According to the syndemic theory, these diseases combined with social, economic and cultural factors affect the quality of life. The aim of this protocol is to describe the methodological process to create, implement and evaluate a Syndemic-Based Care Model (SCM), using a Community Based-Participatory Research (CBPR) strategy in three Mayan-Yucatecan communities.

This is a convergent mixed-methods protocol. The quantitative component is a before-after study, and the qualitative component is an ethnographic study. The intervention will be a SCM co-constructed with Mayan communities based on their particular needs and aiming for reduction of the negative impact of NCD/RMD through a multidisciplinary approach. We will follow four phases of the CBPR: (1) situational analysis, through community censuses and semistructured interviews to understand the prevalence of NCDs and the syndemics in these communities; (2) co-construction of the elements of a SCM based on the health priorities identified by researchers, community members and healthcare workers; (3) implementation of this SCM and (4) evaluation of the SCM through (1) statistical analyses involving the construction of a syndemic index through stepwise logistic regression of the normalised and standardised key clinical, social and economic variables; interval and ratio variables will be normalised by their z-score and categorical variables will be one-hot encoded; similarity and social networks analysis with clustering to identify syndemic subpopulations; and cost-effectiveness and cost-utility analyses using Markov modelling and (2) narrative and thematic qualitative analysis of the SCM’s implementation and impact on community members’ health, function and quality of life.

Research ethics boards of participant institutions approved this research protocol. This project will be presented to municipal authorities, community meetings and community leaders for observation and acceptance. For people who wish to participate, informed consent will be provided written and verbally in Spanish or Mayan-Yucatecan according to the participant preferences, and it can be signed by either autograph or fingerprint. The results of this research will be disseminated to various groups: (a) local and regional authorities of the Mexican health system and municipal authorities; (b) the participating communities will be informed in an assembly of the results and (c) academic dissemination will be done through publications in public science journals and institutional press releases and will also be presented at national and international congresses or symposia.

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.