Effectiveness and Cost-Effectiveness of Self-Management Interventions for Adults Living with Heart Failure to Improve Patient-Important Outcomes: An Evidence Map of Randomized Controlled Trials.

Self-management interventions (SMIs) may enhance heart failure (HF) outcomes and address challenges associated with disease management. This study aims to review randomized evidence and identify knowledge gaps in SMIs for adult HF patients. Within the COMPAR-EU project, from 2010 to 2018, we conducted searches in the databases MEDLINE, CINAHL, Embase, Cochrane, and PsycINFO. We performed a descriptive analysis using predefined categories and developed an evidence map of randomized controlled trials (RCTs). We found 282 RCTs examining SMIs for HF patients, comparing two to four interventions, primarily targeting individual patients (97%) globally (34 countries, only 31% from an European country). These interventions involved support techniques such as information sharing (95%) and self-monitoring (62%), often through a mix of in-person and remote sessions (43%). Commonly assessed outcomes included quality of life, hospital admissions, mortality, exercise capacity, and self-efficacy. Few studies have focused on lower socio-economic or minority groups. Nurses (68%) and physicians (30%) were the primary providers, and most studies were at low risk of bias in generating a random sequence for participant allocation; however, the reporting was noticeably unclear of methods used to conceal the allocation process. Our analysis has revealed prevalent support techniques and delivery methods while highlighting methodological challenges. These findings provide valuable insights for researchers, clinicians, and policymakers striving to optimize SMIs for individuals living with HF.

Self-Management Interventions for Adults Living with Type II Diabetes to Improve Patient-Important Outcomes: An Evidence Map.

Self-management interventions (SMIs) may be promising in the treatment of Diabetes Mellitus Type 2 (T2DM). However, accurate comparisons of their relative effectiveness are challenging, partly due to a lack of clarity and detail regarding the intervention content being evaluated. This study summarizes intervention components and characteristics in randomized controlled trials (RCTs) related to T2DM using a taxonomy for SMIs as a framework and identifies components that are insufficiently incorporated into the design of the intervention or insufficiently reported. Following evidence mapping methodology, we searched MEDLINE, CINAHL, Embase, Cochrane, and PsycINFO from 2010 to 2018 for randomized controlled trials (RCTs) on SMIs for T2DM. We used the terms 'self-management', 'adult' and 'T2DM' for content. For data extraction, we used an online platform based on the taxonomy for SMIs. Two independent reviewers assessed eligible references; one reviewer extracted data, and a second checked accuracy. We identified 665 RCTs for SMIs (34% US, 21% Europe) including 164,437 (median 123, range 10-14,559) adults with T2DM. SMIs highly differed in design and content, and characteristics such as mode of delivery, intensity, location and providers involved were poorly described. The majority of interventions aimed to improve clinical outcomes like HbA1c (83%), weight (53%), lipid profile (45%) or blood pressure (42%); 27% (also) targeted quality of life. Improved knowledge, health literacy, patient activation or satisfaction with care were hardly used as outcomes (<16%). SMIs most often used education (98%), self-monitoring (56%), goal-setting (48%) and skills training (42%) to improve outcomes. Management of emotions (17%) and shared decision-making (5%) were almost never mentioned. Although diabetes is highly prevalent in some minority groups, in only 13% of the SMIs, these groups were included. Our findings highlight the large heterogeneity that exists in the design of SMIs for T2DM and the way studies are reported, making accurate comparisons of their relative effectiveness challenging. In addition, SMIs pay limited attention to outcomes other than clinical, despite the importance attached to these outcomes by patients. More standardized and streamlined research is needed to better understand the effectiveness and cost-effectiveness of SMIs of T2DM and benefit patient care.

The role of low health literacy in shared treatment decision-making in patients with kidney failure.

The classic paternalist medicine in nephrology has been modified to a shared decision-making model that clearly offers a benefit in patients with kidney disease. One of the cornerstones of shared treatment decision in patients with kidney failure is the understanding of kidney disease. As kidney disease is silent until advanced stages and is also an entity with a complex pathophysiology with little knowledge in the general population, its presence and understanding are difficult for most people. Health literacy (HL) plays a crucial role in the care of patients with kidney disease and the shared treatment decision. Limited HL has been associated with inefficient use of health services, non-compliance of medications, worse quality of life and increased mortality. In this review, we will address the importance of low HL in nephrology in terms of diagnosis, measurement, its effect on shared decision-making and how to increase it in people with kidney disease.

Piloting the informed health choices resources in Barcelona primary schools: A mixed methods study.

INTRODUCTION: The main objective of the Informed Health Choices (IHC) project is to teach people to assess treatment claims and make informed health choices. For this purpose, the IHC learning resources were developed for primary school children. The aim of this study is to explore students' and teachers' experience when using the IHC resources in primary schools in Barcelona (Spain). METHODS: We conducted a mixed methods study for piloting the IHC resources in a convenience sample of primary schools in Barcelona. The intervention included a workshop with teachers, and nine lessons with students. We collected data using multiple approaches. We performed quantitative and qualitative analyses, and integrated the findings in a joint display. Finally, we formulated recommendations for using the IHC resources in this setting. RESULTS: Two schools, with a total of 143 students in 4th and 5th grade and six teachers, participated in the study. One school followed the suggested IHC teaching plan and competed all the lessons; the other school modified the plan substantially and did not complete all the lessons. Overall, students and teachers from both schools understood, were interested in, and were able to apply the content of the lessons. During the lessons, the textbook was useful for students; nevertheless, for the teachers, the usefulness of the IHC resources was variable. Teachers adapted the IHC resources to increase student participation and used Information and Communications Technologies tools. We observed more facilitators than barriers to teach the lessons. The teachers suggested some ideas to improve the lessons based on activities they developed and implemented. The integration analysis showed great convergence of the quantitative and qualitative findings. We propose seven recommendations for using the IHC resources in this setting. CONCLUSIONS: Students and teachers from primary schools in Barcelona showed a positive experience when using IHC resources; however, these resources should be adapted to promote classroom participation.

Self-management interventions for adults living with obesity to improve patient-relevant outcomes: An evidence map.

OBJECTIVES: To conduct an evidence map on self-management interventions and patient-relevant outcomes for adults living with overweight/obesity. METHODS: Following Arksey and O'Malley methodology, we searched in five electronical databases including randomized controlled trials (RCTs) on SMIs for overweight/obesity. We used the terms "self-management", "adult" and "obesity" for content. Two independent reviewers assessed eligible references; one reviewer extracted data, a second checked accuracy. RESULTS: We identified 497 RCTs (58% US, 20% Europe) including 99,741 (median 112, range 11-5145) adults living with overweight/obesity. Most research evaluated clinical outcomes (617, 55%) and behaviors adherence (255, 23%). Empowerment skills, quality of life and satisfaction were less targeted (8%, 7%, 0.2%, respectively). The most frequent techniques included sharing information (858, 99%), goal setting (619, 72%) and self-monitoring training (614, 71%), provided face-to-face (386, 45%) or in combination with remote techniques (256, 30%). Emotional management, social support and shared-decision were less frequent (18%, 26%, 4%). Socio-economic status, minorities or health literacy were seldom reported. CONCLUSION: There is a need of widening the scope of research by focusing on outcomes important to patients, assessing emotional/social/share-decision support, exploring remote techniques and including vulnerable populations.

Systemic Oncological Treatments versus Supportive Care for Patients with Advanced Hepatobiliary Cancers: An Overview of Systematic Reviews.

BACKGROUND: The trade-off between systemic oncological treatments (SOTs) and UPSC in patients with primary advanced hepatobiliary cancers (HBCs) is not clear in terms of patient-centred outcomes beyond survival. This overview aims to assess the effectiveness of SOTs (chemotherapy, immunotherapy and targeted/biological therapies) versus UPSC in advanced HBCs. METHODS: We searched for systematic reviews (SRs) in PubMed, EMBASE, the Cochrane Library, Epistemonikos and PROSPERO. Two authors assessed eligibility independently and performed data extraction. We estimated the quality of SRs and the overlap of primary studies, performed de novo meta-analyses and assessed the certainty of evidence for each outcome. RESULTS: We included 18 SRs, most of which were of low quality and highly overlapped. For advanced hepatocellular carcinoma, SOTs showed better overall survival (HR = 0.62, 95% CI 0.55-0.77, high certainty for first-line therapy; HR = 0.85, 95% CI 0.79-0.92, moderate certainty for second-line therapy) with higher toxicity (RR = 1.18, 95% CI 0.87-1.60, very low certainty for first-line therapy; RR = 1.58, 95% CI 1.28-1.96, low certainty for second-line therapy). Survival was also better for SOTs in advanced gallbladder cancer. No outcomes beyond survival and toxicity could be meta-analysed. CONCLUSION: SOTs in advanced HBCs tend to improve survival at the expense of greater toxicity. Future research should inform other patient-important outcomes to guide clinical decision making.

Effectiveness of nonpharmacological interventions to prevent adverse events in the intensive care unit: A review of systematic reviews.

BACKGROUND: Different types of interventions have been assessed for the prevention of adverse events. However, determining which patient-safety practice is most effective can be challenging when there is no systematised evidence synthesis. An overview following the best methodological standards can provide the best reliable integrative evidence. OBJECTIVES: The objective of this study was to provide an overview of effectiveness nonpharmacological interventions aimed at preventing adverse events in the intensive care unit. METHODS: A review of systematic reviews (SRs) was conducted according to the Cochrane Handbook and PRISMA recommendations. PubMed, CINAHL, and Cochrane Library were searched for SRs published until March 2022. Two reviewers independently assessed the study's quality, using AMSTAR-2, and extracted data on intervention characteristics and effect on prevention of adverse events. RESULTS: Thirty-seven SRs were included, and 27 nonpharmacological interventions were identified to prevent 11 adverse events. Most of the reviews had critically low methodological quality. Among all the identified interventions, subglottic secretion drainage, semirecumbent position, and kinetic bed therapy were effective in preventing ventilator-associated pneumonia; the use of earplugs, early mobilisation, family participation, and music in reducing delirium; physical rehabilitation in improving muscle strength; use of respiratory support in preventing reintubation; the use of a computerised physician order entry system in reducing risk of medication errors; and the use of heated water humidifier was effective in reducing artificial airway occlusion. CONCLUSIONS: Some nonpharmacological interventions reduced adverse events in the intensive care setting. These findings should be interpreted carefully due to the low methodological quality. SRs on preventing adverse events in the intensive care unit should adhere to quality assessment tools so that best evidence can be used in decision-making.

Using a Taxonomy to Systematically Identify and Describe Self-Management Interventions Components in Randomized Trials for COPD.

Self-management interventions (SMIs) may improve outcomes in Chronic Obstructive Pulmonary Disease (COPD). However, accurate comparisons of their relative effectiveness are challenging, partly due to a lack of clarity and detail regarding the intervention content being evaluated. This study systematically describes intervention components and characteristics in randomized controlled trials (RCTs) related to COPD self-management using the COMPAR-EU taxonomy as a framework, identifying components that are insufficiently incorporated into the design of the intervention or insufficiently reported. Overall, 235 RCTs published between 2010 and 2018, from a systematic review were coded using the taxonomy, which includes 132 components across four domains: intervention characteristics, expected patient (or caregiver) self-management behaviours, patient relevant outcomes, and target population characteristics. Risk of bias was also assessed. Interventions mainly focused on physical activity (67.4%), and condition-specific behaviours like breathing exercise (63.5%), self-monitoring (50.8%), and medication use (33.9%). Support techniques like education and skills-training, self-monitoring, and goal setting (over 35% of the RCTs) were mostly used for this. Emotional-based techniques, problem-solving, and shared decision-making were less frequently reported (less than 15% of the studies). Numerous SMIs components were insufficiently incorporated into the design of COPD SMIs or insufficiently reported. Characteristics like mode of delivery, intensity, location, and providers involved were often not described. Only 8% of the interventions were tailored to the target population's characteristics. Outcomes that are considered important by patients were hardly taken into account. There is still a lot to improve in both the design and description of SMIs for COPD. Using a framework such as the COMPAR-EU SMI taxonomy may contribute to better reporting and to better informing of replication efforts. In addition, prospective use of the taxonomy for developing and reporting intervention content would further aid in building a cumulative science of effective SMIs in COPD.

Appropriateness of the dialysis modality selection process: A cross-sectional study.

Studies that specifically quantify the appropriateness of the process of dialysis modality selection are lacking. Peritoneal dialysis (PD) offers clinical and social advantages over hemodialysis (HD), but may be underused. We aimed to determine the appropriateness of the process of dialysis modality selection and quantify the percentage of patients who could potentially have been PD candidates. We performed a cross-sectional study that included adult patients from a hospital Nephrology Department in Barcelona who started dialysis between 2014 and 2015. We assessed the appropriateness of dialysis modalities selection by defining 3 sequential domains based on 3 critical steps in choosing a dialysis modality: eligibility for either treatment, information about modalities, and shared decision-making. We obtained data using medical records and a patient questionnaire. The dialysis modality selection process was considered appropriate when patients had no contraindications for the selected option, received complete information about both modalities, and voluntarily chose the selected option. A total of 141 patients were included in this study. The median age was 72 years (interquartile range 63-82 years), and 65% of the patients were men. The dialysis modality selection process was potentially inappropriate in 22% of the participants because of problems related to information about dialysis modalities (15%) or shared decision-making (7%). Appropriate PD use can potentially increase from 17% to 38%. Patient age and lack of information regarding dialysis options were independently associated with the potential degree of inappropriate dialysis modality selection. Our findings indicate areas for improvement in the selection of dialysis modalities. With better education and shared decision-making, the number of patients with PD could potentially double. The analysis of appropriateness is a helpful approach for studying renal replacement treatment patterns and identifying strategies to optimize their use.

Recommendations of high-quality clinical practice guidelines related to the process of starting dialysis: A systematic review.

BACKGROUND: The optimal time for initiation of dialysis and which modality to choose as the starting therapy is currently unclear. This systematic review aimed to assess the recommendations across high-quality clinical practice guidelines (CPGs) related to the start of dialysis. METHODS: We systematically searched MEDLINE, EMBASE, Web of Science, LILACS, and databases of organisations that develop CPGs between September 2008 to August 2021 for CPGs that addressed recommendations on the timing of initiation of dialysis, selection of dialysis modality, and interventions to support the decision-making process to select a dialysis modality. We used the Appraisal of Guidelines for Research and Evaluation instrument to assess the methodological quality of the CPGs and included only high-quality CPGs. This study is registered in PROSPERO, number CRD42018110325. RESULTS: We included 12 high-quality CPGs. Six CPGs addressed recommendations related to the timing of initiating dialysis, and all agreed on starting dialysis in the presence of symptoms or signs. Six CPGs addressed recommendations related to the selection of modality but varied greatly in their content. Nine CPGs addressed recommendations related to interventions to support the decision-making process. Eight CPGs agreed on recommended educational programs that include information about dialysis options. One CPG considered using patient decision aids a strong recommendation. LIMITATIONS: We could have missed potentially relevant guidelines since we limited our search to CPGs published from 2008, and we set up a cut-off point of 60% in domains of the rigour of development and editorial independence. CONCLUSION: High-quality CPGs related to the process of starting dialysis were consistent in initiating dialysis in the presence of symptoms or signs and offering patients education at the point of decision-making. There was variability in how CPGs addressed the issue of dialysis modality selection. CPGs should improve strategies on putting recommendations into practice and the quality of evidence to aid decision-making for patients. REGISTRATION: The protocol of this systematic review has been registered in the international prospective register of systematic reviews (PROSPERO) under the registration number: CRD CRD42018110325. https://clinicaltrials.gov/ct2/show/CRD42018110325.

Efficacy of systemic oncological treatments in patients with advanced pancreatic cancer at high risk of dying in the short or medium-term: overview of systematic reviews.

BACKGROUND: Patients with advanced pancreatic cancer (PC) have a high risk of dying in the short or medium-term. This overview aimed to assess the evidence regarding systemic oncological treatments (SOT) versus supportive care for advanced PC. METHODS: We searched for systematic reviews (SRs) in MEDLINE, Embase, The Cochrane Library, Epistemonikos, and PROSPERO. Two authors assessed eligibility independently. Data extraction and methodological quality assessment were conducted by one author and cross-checked by another one. We evaluated the overlap of primary studies, performed a de novo meta-analysis, and assessed the certainty of evidence. Primary outcomes were overall survival (OS), quality of life (QoL), functional status (FS), and toxicity. RESULTS: We identified three SRs that assessed SOT versus supportive care in patients with advanced PC. All SRs had critically low methodological quality. At 12 months, OS improved with chemotherapy, radiotherapy followed by chemotherapy, and immunotherapy, but the certainty of the evidence supporting these findings is very low. The evidence on chemotherapy is very uncertain about its effects on QoL; it suggests a slight increase in toxicity and little to no difference in FS. The evidence on immunotherapy is very uncertain about its effects in toxicity. CONCLUSIONS: The identified evidence is very uncertain about the benefits of oncological treatments on OS and QoL in patients with advanced PC with a high risk of dying in the short or medium-term, so its use should be proposed only to selected patients. Further studies that include a thorough assessment of patient-centred outcomes are needed.

Patient decision aids for adults with advanced chronic kidney disease with a medical recommendation to start dialysis: a scoping review protocol.

OBJECTIVE: This review will identify and describe the content and assess the quality of available decision aids aimed at adults with advanced chronic kidney disease with medical indication to start dialysis who need to choose one of the two dialysis modalities. INTRODUCTION: The lack of evidence regarding the superiority of the different options for dialysis, hemodialysis, and peritoneal dialysis, indicated in advanced chronic kidney disease, makes the shared decision-making process especially important. INCLUSION CRITERIA: We will include decision aids from published studies and non-published material aimed at adults with advanced chronic kidney disease. METHODS: We will perform searches in MEDLINE, CINAHL, Embase, PsycINFO, the Cochrane Library, and Epistemonikos. In addition, we will search unpublished studies in OpenGrey, ClinicalTrials.gov, and Open Access Theses and Dissertations. We will also identify decision aids through a specific search in Google and by searching websites of nephrology societies or associations. We will include decision aids in English or Spanish aimed at adults with advanced chronic kidney disease with medical indication to start dialysis. Two independent reviewers will screen, select, and extract the data. General aspects and attributes of the decision aids will be collected. Their quality will be evaluated, and their recommendations for implementation in clinical practice will be analyzed.

The Perspectives of Patients with Chronic Diseases and Their Caregivers on Self-Management Interventions: A Scoping Review of Reviews.

BACKGROUND: Self-management (SM) interventions are supportive interventions systematically provided by healthcare professionals, peers, or laypersons to increase the skills and confidence of patients in their ability to manage chronic diseases. We had two objectives: (1) to summarise the preferences and experiences of patients and their caregivers (informal caregivers and healthcare professionals) with SM in four chronic diseases and (2) to identify and describe the relevant outcomes for SM interventions from these perspectives. METHODS: We conducted a mixed-methods scoping review of reviews. We searched three databases until December 2020 for quantitative, qualitative, or mixed-methods reviews exploring patients' and caregivers' preferences or experiences with SM in type 2 diabetes mellitus (T2DM), obesity, chronic obstructive pulmonary disease (COPD), and heart failure (HF). Quantitative data were narratively synthesised, and qualitative data followed a three-step descriptive thematic synthesis. Identified themes were categorised into outcomes or modifiable factors of SM interventions. RESULTS: We included 148 reviews covering T2DM (n = 53 [35.8%]), obesity (n = 20 [13.5%]), COPD (n = 32 [21.6%]), HF (n = 38 [25.7%]), and those with more than one disease (n = 5 [3.4%]). We identified 12 main themes. Eight described the process of SM (disease progression, SM behaviours, social support, interaction with healthcare professionals, access to healthcare, costs for patients, culturally defined roles and perceptions, and health knowledge), and four described their experiences with SM interventions (the perceived benefit of the intervention, individualised care, sense of community with peers, and usability of equipment). Most themes and subthemes were categorised as outcomes of SM interventions. CONCLUSION: The process of SM shaped the perspectives of patients and their caregivers on SM interventions. Their perspectives were influenced by the perceived benefit of the intervention, the sense of community with peers, the intervention's usability, and the level of individualised care. Our findings can inform the selection of patient-important outcomes, decision-making processes, including the formulation of recommendations, and the design and implementation of SM interventions.

Opinión de los especialistas de medicina preventiva y salud pública acerca de las recomendaciones sobre las prácticas de bajo valor: encuesta piloto / Preventive medicine and public health specialists' opinion about recommendations of low-value practices: a pilot survey

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A survey to assess awareness and opinion of initiatives and recommendations on low-value diagnostic practices.

BACKGROUND: The need to reduce healthcare practices that provide no value has led to the development of initiatives that generate and publish recommendations to improve the appropriateness of clinical practice by identifying potentially inappropriate services, making recommendations, and proposing improvements. DianaHealth (www.dianahealth.com) identifies, classifies, and publishes recommendations from numerous scientific societies. The purpose of this study was to determine the awareness and perceived usefulness and applicability of published recommendations on low-value diagnostic measures, as judged by physicians who are recognised clinical leaders in their respective centres. METHODS: We designed a questionnaire on the diagnostic recommendations considered relevant for each medical specialty and made it available, until September 2016, on DianaHealth. The survey was administered online to clinical leaders from 25 Spanish healthcare centres (hospitals and primary care centres). RESULTS: A total of 413 (40.0%) physicians from 34 different specialties participated. The participation rate varied between centres (range 21.1%-100.0%) and specialties (range 12.5%-78.9%). Do Not Do (57.1%) was the most widely-known initiative. Most participants (82.6%; IQR 77.9%-94.9%) stated that they knew at least one of the 12 initiatives that identify non-recommended practices, and on average they were aware of four initiatives (range 1-12). The initiatives were perceived useful by 82.4% (IQR 73.3%-90.4%), and perceived applicable by 75.6% (IQR 67.4%-86.8%). A total of 531 recommendations were assessed. Sixty-three percent (IQR 53.6%-77.5%) of participants reported they were aware of the recommendations for their corresponding specialty. A total of 84.5% (IQR 75.0%-90.0%) stated they agreed with the recommendations and 84.5% (IQR 75.0%-90.0%) considered them useful. Among those who agreed with their respective recommendations, a median of 51.5% (IQR 41.4%-60.9%) perceived the guidelines as being fully implemented, 40.1% (IQR 31.9%-46.8%) considered them partially implemented, and 7.1% (IQR 3.7%-12.9%), not implemented. CONCLUSIONS: Clinical leaders' awareness of initiatives that generate and publish recommendations to improve clinical appropriateness remains low, although they did consider them useful. In general, participants were familiar with their speciality-specific diagnostic recommendations, agreed with them, and perceived them as useful and implemented in their centres. More needs to be done to raise awareness among professionals who do not know of or apply these recommendations.

The perspectives of patients and their caregivers on self-management interventions for chronic conditions: a protocol for a mixed-methods overview.

Introduction: Self-management (SM) interventions are complex interventions and one of the main components of high-quality chronic disease care for which the incorporation of the perspectives of patients and their informal caregivers is crucial. We aim to identify, appraise and synthesise the evidence exploring patients' and caregivers' perspectives on SM interventions. More precisely, we aim to 1) describe how they value the importance of outcomes of SM interventions, and 2) identify the factors that might impact on acceptability and feasibility of SM interventions based on their preferences and experiences. Methods and analysis: We will conduct four mixed-methods overviews as part of COMPAR-EU, a European Union (EU) funded project aimed to identify the most effective and cost-effective SM interventions for chronic obstructive pulmonary disease (COPD), heart failure (HF), obesity, and type 2 diabetes mellitus (T2DM). We will search in MEDLINE, CINAHL, and PsycINFO for systematic reviews of studies addressing patients' preferences on outcomes, or their experiences with SM alongside their disease trajectory or with SM interventions, published in English. Selection of studies and data extraction will be conducted in pairs. We will assess the overlap of studies and methodological quality. We will follow a three-step synthesis process: 1) narrative synthesis for quantitative evidence, 2) thematic synthesis for qualitative evidence, and 3) integration of findings in the interpretation phase. Additionally, we will consult on the relevance of findings with patients and their caregivers. Systematic review registration: PROSPERO CRD42019117867.

Learning to make informed health choices: Protocol for a pilot study in schools in Barcelona.

Introduction: The Informed Health Choices (IHC) project has developed learning resources to teach primary school children (10 to 12-year-olds) to assess treatment claims and make informed health choices. The aim of our study is to explore both the students' and teachers' experience when using these resources in the context of Barcelona (Spain). Methods: During the 2019-2020 school year, we will conduct a pilot study with 4 th and 5 th-year primary school students (9 to 11-year-olds) from three schools in Barcelona. The intervention in the schools will include: 1) a workshop with the teachers, and 2) lessons to the students. The data collection will include: 1) assessment of the IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment by the students at the end of the lessons, and 6) assessment of the IHC resources by the teachers at the end of the lessons. We will use ad hoc questionnaires and guides to register the data. We will perform a quantitative and qualitative analysis of the data to explore understandability, desirability, suitability, usefulness, facilitators and barriers of the resources. The most relevant results will be discussed and some recommendations on how to use, how to adapt (if needed), and how to implement the IHC resources to this context will be agreed. The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use. Ethical considerations: The study protocol has obtained an approval exemption from the Ethics Committee of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain).