Development of the informed health choices resources in four countries to teach primary school children to assess claims about treatment effects: a qualitative study employing a user-centred approach.

BACKGROUND: People of all ages are flooded with health claims about treatment effects (benefits and harms of treatments). Many of these are not reliable, and many people lack skills to assess their reliability. Primary school is the ideal time to begin to teach these skills, to lay a foundation for continued learning and enable children to make well-informed health choices, as they grow older. However, these skills are rarely being taught and yet there are no rigorously developed and evaluated resources for teaching these skills. OBJECTIVES: To develop the Informed Health Choices (IHC) resources (for learning and teaching people to assess claims about the effects of treatments) for primary school children and teachers. METHODS: We prototyped, piloted, and user-tested resources in four settings that included Uganda, Kenya, Rwanda, and Norway. We employed a user-centred approach to designing IHC resources which entailed multiple iterative cycles of development (determining content scope, generating ideas, prototyping, testing, analysing and refining) based on continuous close collaboration with teachers and children. RESULTS: We identified 24 Key Concepts that are important for children to learn. We developed a comic book and a separate exercise book to introduce and explain the Key Concepts to the children, combining lessons with exercises and classroom activities. We developed a teachers' guide to supplement the resources for children. CONCLUSION: By employing a user-centred approach to designing resources to teach primary children to think critically about treatment claims and choices, we developed learning resources that end users experienced as useful, easy to use and well-suited to use in diverse classroom settings.

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about treatment effects: one-year follow up of a randomised trial.

INTRODUCTION: Earlier, we designed and evaluated an educational mass media intervention for improving people's ability to think more critically and to assess the trustworthiness of claims (assertions) about the benefits and harms (effects) of treatments. The overall aims of this follow-up study were to evaluate the impact of our intervention 1 year after it was administered, and to assess retention of learning and behaviour regarding claims about treatments. METHODS: We randomly allocated consenting parents to listen to either the Informed Health Choices podcast (intervention) or typical public service announcements about health issues (control) over 7-10 weeks. Each intervention episode explained how the trustworthiness of treatment claims can be assessed by using relevant key concepts of evidence-informed decision-making. Participants listened to two episodes per week, delivered by research assistants. We evaluated outcomes immediately, and a year after the intervention. Primary outcomes were mean score and the proportion with a score indicating a basic ability to apply the key concepts (> 11 out of 18 correct answers) on a tool measuring people's ability to critically appraise the trustworthiness of treatment claims. Skills decay/retention was estimated by calculating the relative difference between the follow-up and initial results in the intervention group, adjusting for chance. Statistical analyses were performed using R (R Core Team, Vienna, Austria; version 3.4.3). RESULTS: After 1 year, the mean score for parents in the intervention group was 58.9% correct answers, compared to 52.6% in the control (adjusted mean difference of 6.7% (95% CI 3.3% to 10.1%)). In the intervention group, 47.2% of 267 parents had a score indicating a basic ability to assess treatment claims compared to 39.5% of 256 parents in the control (adjusted difference of 9.8% more parents (95% CI 0.9% to 18.9%). These represent relative reductions of 29% in the mean scores and 33% in the proportion of parents with a score indicating a basic ability to assess the trustworthiness of claims about treatment effects. CONCLUSIONS: Although listening to the Informed Health Choices podcast initially led to a large improvement in the ability of parents to assess claims about the effects of treatments, our findings show that these skills decreased substantially over 1 year. More active practice could address the substantial skills decay observed over 1 year. TRIAL REGISTRATION: Pan African Clinical Trial Registry (www.pactr.org), PACTR201606001676150. Registered on 12 June 2016.

Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, 1-year follow-up: a cluster-randomised trial.

INTRODUCTION: We evaluated an intervention designed to teach 10- to 12-year-old primary school children to assess claims about the effects of treatments (any action intended to maintain or improve health). We report outcomes measured 1 year after the intervention. METHODS: In this cluster-randomised trial, we included primary schools in the central region of Uganda that taught year 5 children (aged 10 to 12 years). We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books and a teachers' guide). The primary outcomes, measured at the end of the school term and again after 1 year, were the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores. RESULTS: We assessed 2960 schools for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n = 60 schools; 76 teachers and 6383 children) or the control group (n = 60 schools; 67 teachers and 4430 children). After 1 year, the mean score in the multiple-choice test for the intervention schools was 68.7% compared with 53.0% for the control schools (adjusted mean difference 16.7%; 95% CI, 13.9 to 19.5; P < 0.00001). In the intervention schools, 3160 (80.1%) of 3943 children who completed the test after 1 year achieved a predetermined passing score (≥ 13 of 24 correct answers) compared with 1464 (51.5%) of 2844 children in the control schools (adjusted difference, 39.5%; 95% CI, 29.9 to 47.5). CONCLUSION: Use of the learning resources led to a large improvement in the ability of children to assess claims, which was sustained for at least 1 year. TRIAL REGISTRATION: Pan African Clinical Trial Registry (www.pactr.org), PACTR201606001679337. Registered on 13 June 2016.

Development of mass media resources to improve the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about the effects of treatments: a human-centred design approach.

BACKGROUND: Claims about what we need to do to improve our health are everywhere. Most interventions simply tell people what to do, and do not empower them to critically assess health information. Our objective was to design mass media resources to enable the public to critically appraise the trustworthiness of claims about the benefits and harms of treatments and make informed health choices. METHODS: Research was conducted between 2013 and 2016 across multiple iterative phases. Participants included researchers, journalists, parents, other members of the public. First, we developed a list of 32 key concepts that people need to understand to be able to assess the trustworthiness of claims about treatment effects. Next, we used a human-centred design approach, to generate ideas for resources for teaching the key concepts, and developed and user-tested prototypes through qualitative interviews. We addressed identified problems and repeated this process until we had a product that was deemed relevant and desirable by our target audience, and feasible to implement. RESULTS: We generated over 160 ideas, mostly radio-based. After prototyping some of these, we found that a podcast produced collaboratively by health researchers and journalists was the most promising approach. We developed eight episodes of the Informed Health Choices podcast, a song on critical thinking about treatments and a reminder checklist. Early versions of the podcast were reportedly too long, boring and confusing. We shortened the episodes, included one key concept per episode, and changed to story-telling with skits. The final version of the podcast was found to be useful, understandable, credible and desirable. CONCLUSION: We found many problems with various prototypes of mass media resources. Using a human-centred design approach, we overcame those problems. We have developed a guide to help others prepare similar podcasts.

The GRADE Evidence to Decision (EtD) framework for health system and public health decisions.

OBJECTIVE: To describe a framework for people making and using evidence-informed health system and public health recommendations and decisions. BACKGROUND: We developed the GRADE Evidence to Decision (EtD) framework for health system and public health decisions as part of the DECIDE project, in which we simultaneously developed frameworks for these and other types of healthcare decisions, including clinical recommendations, coverage decisions and decisions about diagnostic tests. DEVELOPING THE FRAMEWORK: Building on GRADE EtD tables, we used an iterative approach, including brainstorming, consultation of the literature and with stakeholders, and an international survey of policy-makers. We applied the framework to diverse examples, conducted workshops and user testing with health system and public health guideline developers and policy-makers, and observed and tested its use in real-life guideline panels. FINDINGS: All the GRADE EtD frameworks share the same basic structure, including sections for formulating the question, making an assessment and drawing conclusions. Criteria listed in the assessment section of the health system and public health framework cover the important factors for making these types of decisions; in addition to the effects and economic impact of an option, the priority of the problem, the impact of the option on equity, and its acceptability and feasibility are important considerations that can inform both whether and how to implement an option. Because health system and public health interventions are often complex, detailed implementation considerations should be made when making a decision. The certainty of the evidence is often low or very low, but decision-makers must still act. Monitoring and evaluation are therefore often important considerations for these types of decisions. We illustrate the different components of the EtD framework for health system and public health decisions by presenting their application in a framework adapted from a real-life guideline. DISCUSSION: This framework provides a structured and transparent approach to support policy-making informed by the best available research evidence, while making the basis for decisions accessible to those whom they will affect. The health system and public health EtD framework can also be used to facilitate dissemination of recommendations and enable decision-makers to adopt, and adapt, recommendations or decisions.

Marcos GRADE de la evidencia a la decisión (EtD): un enfoque sistemático y transparente para tomar decisiones sanitarias bien informadas. 1: Introducción / GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction

Los médicos y quienes elaboran guías y políticas a veces pasan por alto criterios importantes, les dan un peso indebido o no usan la mejor evidencia disponible para informar sus juicios. Los sistemas explícitos y transparentes para la toma de decisiones pueden ayudar a garantizar que se consideren todos los criterios importantes, y que las decisiones estén basadas en la mejor evidencia disponible. El grupo de trabajo GRADE ha desarrollado marcos «de la evidencia a la decisión» (EtD) para los diferentes tipos de recomendaciones o decisiones. El objetivo de los marcos EtD es ayudar a los paneles a usar la evidencia de una manera estructurada y transparente para informar las decisiones respecto de las recomendaciones clínicas, decisiones de cobertura sanitaria y recomendaciones o decisiones sobre el sistema sanitario o sobre salud pública. Los marcos EtD tienen una estructura común: formulación de una pregunta, evaluación de la evidencia y conclusiones. No obstante, existen diferencias entre los marcos para cada tipo de decisión. Los marcos EtD informan a los usuarios sobre los juicios que se han hecho y la evidencia que los apoya dotando de transparencia la base para las decisiones de los que tienen que tomarlas. Los marcos EtD también facilitan la diseminación de las recomendaciones y permiten a los decisores de otros ámbitos adoptar recomendaciones o decisiones, o adaptarlas a su contexto. El siguiente artículo es una traducción del artículo original publicado en British Medical Journal. Los marcos EtD se utilizan actualmente en el marco del Programa de Guías de Práctica Clínica en el Sistema Nacional de Salud, coordinado por GuíaSalud (AU)

Clinicians, guideline developers, and policymakers sometimes neglect important criteria, give undue weight to criteria, and do not use the best available evidence to inform their judgments. Explicit and transparent systems for decision making can help to ensure that all important criteria are considered and that decisions are informed by the best available research evidence. The GRADE Working Group has developed Evidence to Decision (EtD) frameworks for the different type of recommendations or decisions. The purpose of EtD frameworks is to help people use evidence in a structured and transparent way to inform decisions in the context of clinical recommendations, coverage decisions, and health system or public health recommendations and decisions. EtD frameworks have a common structure that includes formulation of the question, an assessment of the evidence, and drawing conclusions, though there are some differences between frameworks for each type of decision. EtD frameworks inform users about the judgments that were made and the evidence supporting those judgments by making the basis for decisions transparent to target audiences. EtD frameworks also facilitate dissemination of recommendations and enable decision makers in other jurisdictions to adopt recommendations or decisions, or adapt them to their context. This article is a translation of the original article published in British Medical Journal. The EtD frameworks are currently used in the Clinical Practice Guideline Programme of the Spanish National Health System, co-ordinated by GuíaSalud (AU)

[GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction]. / Marcos GRADE de la evidencia a la decisión (EtD): un enfoque sistemático y transparente para tomar decisiones sanitarias bien informadas. 1: Introducción.

Clinicians, guideline developers, and policymakers sometimes neglect important criteria, give undue weight to criteria, and do not use the best available evidence to inform their judgments. Explicit and transparent systems for decision making can help to ensure that all important criteria are considered and that decisions are informed by the best available research evidence. The GRADE Working Group has developed Evidence to Decision (EtD) frameworks for the different type of recommendations or decisions. The purpose of EtD frameworks is to help people use evidence in a structured and transparent way to inform decisions in the context of clinical recommendations, coverage decisions, and health system or public health recommendations and decisions. EtD frameworks have a common structure that includes formulation of the question, an assessment of the evidence, and drawing conclusions, though there are some differences between frameworks for each type of decision. EtD frameworks inform users about the judgments that were made and the evidence supporting those judgments by making the basis for decisions transparent to target audiences. EtD frameworks also facilitate dissemination of recommendations and enable decision makers in other jurisdictions to adopt recommendations or decisions, or adapt them to their context. This article is a translation of the original article published in British Medical Journal. The EtD frameworks are currently used in the Clinical Practice Guideline Programme of the Spanish National Health System, co-ordinated by GuíaSalud.

Developing Evidence to Decision Frameworks and an Interactive Evidence to Decision Tool for Making and Using Decisions and Recommendations in Health Care.

Evidence-informed health care decisions and recommendations need to be made systematically and transparently. Mediating technology can help manage boundaries between groups making decisions and target audiences, enhancing salience, credibility, and legitimacy for all. This article describes the development of the Evidence to Decision (EtD) framework and an interactive tool to create and use frameworks (iEtD) to support communication in decision making. Methods: Using a human-centered design approach, we created prototypes employing a broad range of methods to iteratively develop EtD framework content and iEtD tool functionality. Results: We developed tailored EtD frameworks for making evidence-informed decisions and recommendations about clinical practice interventions, diagnostic and screening tests, coverage, and health system and public health options. The iEtD tool provides functionality for preparing frameworks, using them in group discussions, and publishing output for implementation or adaption. EtD and iEtD are intuitive and useful for producers and users of frameworks, and flexible for use across different types of topics, decisions, and organizations. They bring valued structure to panel discussions and transparency to published output. Conclusion: EtD and iEtD can resolve some of the challenges inherent in multicriteria, multistakeholder decision systems. They are freely available online for all to use at https://ietd.epistemonikos.org/ and https://gradepro.org.

Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects: a cluster-randomised controlled trial.

BACKGROUND: Claims about what improves or harms our health are ubiquitous. People need to be able to assess the reliability of these claims. We aimed to evaluate an intervention designed to teach primary school children to assess claims about the effects of treatments (ie, any action intended to maintain or improve health). METHODS: In this cluster-randomised controlled trial, we included primary schools in the central region of Uganda that taught year-5 children (aged 10-12 years). We excluded international schools, special needs schools for children with auditory and visual impairments, schools that had participated in user-testing and piloting of the resources, infant and nursery schools, adult education schools, and schools that were difficult for us to access in terms of travel time. We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books, and a teachers' guide). Teachers attended a 2 day introductory workshop and gave nine 80 min lessons during one school term. The lessons addressed 12 concepts essential to assessing claims about treatment effects and making informed health choices. We did not intervene in the control schools. The primary outcome, measured at the end of the school term, was the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores on the same test. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201606001679337. FINDINGS: Between April 11, 2016, and June 8, 2016, 2960 schools were assessed for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n=60, 76 teachers and 6383 children) or control group (n=60, 67 teachers and 4430 children). The mean score in the multiple-choice test for the intervention schools was 62·4% (SD 18·8) compared with 43·1% (15·2) for the control schools (adjusted mean difference 20·0%, 95% CI 17·3-22·7; p<0·00001). In the intervention schools, 3967 (69%) of 5753 children achieved a predetermined passing score (≥13 of 24 correct answers) compared with 1186 (27%) of 4430 children in the control schools (adjusted difference 50%, 95% CI 44-55). The intervention was effective for children with different levels of reading skills, but was more effective for children with better reading skills. INTERPRETATION: The use of the Informed Health Choices primary school learning resources, after an introductory workshop for the teachers, led to a large improvement in the ability of children to assess claims about the effects of treatments. The results show that it is possible to teach primary school children to think critically in schools with large student to teacher ratios and few resources. Future studies should address how to scale up use of the resources, long-term effects, including effects on actual health choices, transferability to other countries, and how to build on this programme with additional primary and secondary school learning resources. FUNDING: Research Council of Norway.

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess claims about treatment effects: a randomised controlled trial.

BACKGROUND: As part of the Informed Health Choices project, we developed a podcast called The Health Choices Programme to help improve the ability of people to assess claims about the benefits and harms of treatments. We aimed to evaluate the effects of the podcast on the ability of parents of primary school children in Uganda to assess claims about the effects of treatments. METHODS: We did this randomised controlled trial in central Uganda. We recruited parents of children aged 10-12 years who were in their fifth year of school at 35 schools that were participating in a linked trial of the Informed Health Choices primary school resources. The parents were randomly allocated (1:1), via a web-based random number generator with block sizes of four and six, to listen to either the Informed Health Choices podcast (intervention group) or typical public service announcements about health issues (control group). Randomisation was stratified by parents' highest level of formal education attained (primary school, secondary school, or tertiary education) and the allocation of their children's school in the trial of the primary school resources (intervention vs control). The primary outcome, measured after listening to the entire podcast, was the mean score and the proportion of parents with passing scores on a test with two multiple choice questions for each of nine key concepts essential to assessing claims about treatments (18 questions in total). We did intention-to-treat analyses. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201606001676150. FINDINGS: We recruited parents between July 21, 2016, and Oct 7, 2016. We randomly assigned 675 parents to the podcast group (n=334) or the public service announcement group (n=341); 561 (83%) participants completed follow-up. The mean score for parents in the podcast group was 67·8% (SD 19·6) compared with 52·4% (17·6) in the control group (adjusted mean difference 15·5%, 95% CI 12·5-18·6; p<0·0001). In the podcast group, 203 (71%) of 288 parents had a predetermined passing score (≥11 of 18 correct answers) compared with 103 (38%) of 273 parents in the control group (adjusted difference 34%, 95% CI 26-41; p<0·0001). No adverse events were reported. INTERPRETATION: Listening to the Informed Health Choices podcast led to a large improvement in the ability of parents to assess claims about the effects of treatments. Future studies should assess the long-term effects of use of the podcast, the effects on actual health choices and outcomes, and how transferable our findings are to other countries. FUNDING: Research Council of Norway.

Key concepts that people need to understand to assess claims about treatment effects.

OBJECTIVE: People are confronted with claims about the effects of treatments and health policies daily. Our objective was to develop a list of concepts that may be important for people to understand when assessing claims about treatment effects. METHODS: An initial list of concepts was generated by the project team by identifying key concepts in literature and tools written for the general public, journalists, and health professionals, and consideration of concepts related to assessing the certainty of evidence for treatment effects. We invited key researchers, journalists, teachers and others with expertise in health literacy and teaching or communicating evidence-based health care to patients to act as the project's advisory group. RESULTS: Twenty-nine members of the advisory group provided feedback on the list of concepts and judged the list to be sufficiently complete and organised appropriately. The list includes 32 concepts divided into six groups: (i) Recognising the need for systematic reviews of fair tests, (ii) Judging whether a comparison of treatments is fair comparison, (iii) Understanding the role of chance, (iv) Considering all the relevant fair comparisons, (v) Understanding the results of fair comparisons of treatments, (vi) Judging whether fair comparisons of treatments are relevant. CONCLUSION: The concept list provides a starting point for developing and evaluating resources to improve people's ability to assess treatment effects. The concepts are considered to be universally relevant, and include considerations that can help people assess claims about the effects of treatments, including claims that are found in mass media reports, in advertisements and in personal communication.