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.

Validación de un cuestionario para medir la habilidad de la población general para evaluar afirmaciones acerca de tratamientos médicos.

INTRODUCCIÓN: Todos los días, las personas se enfrentan a afirmaciones acerca de tratamientos en medios de comunicación, redes sociales o por viva voz. OBJETIVO: Validar un cuestionario en español para medir las habilidades de un individuo para evaluar afirmaciones acerca de tratamientos. MÉTODO: Veintidós preguntas de opción múltiple de la base de datos Claim Evaluation Tools fueron traducidas y aplicadas a 172 niños y 268 adultos. Mediante un modelo Rasch se exploró el ajuste promedio e individual por reactivo, el potencial comportamiento diferencial del reactivo (basado en el género, edad y modo de aplicación), la multidimensionalidad y la independencia local. RESULTADOS: El ajuste promedio por reactivo fue apropiado. Cuatro preguntas de opción múltiple mostraron pobre ajuste. La fiabilidad del cuestionario fue satisfactoria, con un índice de separación de 0.7. Las preguntas de opción múltiple fueron unidimensionales, y no hubo dependencia específica. CONCLUSIÓN: Se obtuvo un conjunto de 18 preguntas de opción múltiple con ajuste satisfactorio. El cuestionario es el primero disponible y validado en español para medir las habilidades de los individuos para evaluar afirmaciones acerca de tratamientos. INTRODUCTION: Every day, people are faced with claims about treatment effects through mass media, social media, or by word of mouth. OBJECTIVE: To validate a Spanish-language questionnaire to measure the ability of an individual to assess claims about treatments effects. METHOD: A set of 22 multiple choice questions taken from the claim evaluation tools database were translated and applied to 172 children and 268 adults. Using a Rasch model, overall and individual item-person fit was explored, as well as the potential item differential functioning (based on gender, age and mode of administration), multidimensionality and local independence. RESULTS: Overall item-person fit was appropriate. Four multiple-choice questions showed a poor fit. Reliability of the questionnaire was satisfactory with a person separation index of 0.7. Multiple-choice questions were unidimensional, and there was no specific dependency. CONCLUSION: A set of 18 multiple-choice questions with satisfactory fit was obtained. This is the first available questionnaire validated in Spanish to measure individuals' ability to assess claims about treatment effects.

[Patient volume and quality in surgery for abdominal aortic aneurysm]. / Pasientvolum og kvalitet ved kirurgi for abdominale aortaaneurismer.

BACKGROUND Patient volume is assumed to affect quality, whereby complex procedures are best performed by those who perform them frequently. We have conducted a systematic review of the research on the association between patient volume and quality of vascular surgery. In this article we describe the outcomes for abdominal aortic aneurysm surgery.MATERIAL AND METHOD We undertook systematic searches in relevant databases. We searched for systematic reviews, and randomised and observational studies. The search was concluded in December 2015. We have summarised the results descriptively and assessed the overall quality of the evidence.RESULTS Forty-six observational studies fulfilled our inclusion criteria. We found a possible association for both hospital and surgeon volume. Higher patient volume may possibly be associated with lower 30-day mortality and lower hospital mortality for both open and endovascular surgery. Although the association appears to apply to both elective and acute hospitalisations, there is greater uncertainty with regard to the most ill patients. For hospital volume there may also be fewer complications for open and endovascular surgery, as well as for all surgery assessed as a whole. We considered the evidence base to be medium to very low quality.INTERPRETATION We found a possible correlation between patient volume and quality indicators such as mortality and complications. It may be advantageous to allocate planned procedures to institutions and surgeons with high volume, while this is less certain with regard to acute hospitalisations.

A case study of the organisation of research knowledge by systematic reviews within the mental health care field.

BACKGROUND: Our aim was to explore how systematic reviews of the effects of complex interventions within the field of organisation of mental health care organised research knowledge. METHODS: We looked up references included in 14 mental health care reviews in the database Epistemonikos to examine overlap between reviews. We classified topic concordance between study reports and reviews as similar, narrower, broader or other topic to indicate how well the research knowledge was organised. FINDINGS: We examined 182 comparisons between the theme of study reports and reviews. In 100 (55%) of the 182 comparisons, the review had a broader theme, 18 (10%) narrower, 34 (19%) similar and in 30 (16%), the review's theme was classified as 'other'. The content analysis indicated that there existed (inconsistent) overlapping of study reports between different topics. CONCLUSIONS: Within the field organisation of mental health care, there exists some unclear and inconsistent organisation of current knowledge. This may diminish the validity and reliability of systematic reviews. It is important that review authors take care in defining the review question precisely, conduct thorough literature searches, consider each study's hypothesis, disciplinary tradition and context, and if necessary, examine which other reviews have included a study in question.

Interventions aimed at communities to inform and/or educate about early childhood vaccination.

BACKGROUND: A range of strategies are used to communicate with parents, caregivers and communities regarding child vaccination in order to inform decisions and improve vaccination uptake. These strategies include interventions in which information is aimed at larger groups in the community, for instance at public meetings, through radio or through leaflets. This is one of two reviews on communication interventions for childhood vaccination. The companion review focuses on face-to-face interventions for informing or educating parents. OBJECTIVES: To assess the effects of interventions aimed at communities to inform and/or educate people about vaccination in children six years and younger. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE and five other databases up to July 2012. We searched for grey literature in the Grey Literature Report and OpenGrey. We also contacted authors of included studies and experts in the field. There were no language, date or settings restrictions. SELECTION CRITERIA: Individual or cluster-randomised and quasi-randomised controlled trials, interrupted time series (ITS) and repeated measures studies, and controlled before-and-after (CBA) studies. We included interventions aimed at communities and intended to inform and/or educate about vaccination in children six years and younger, conducted in any setting. We defined interventions aimed at communities as those directed at a geographic area, and/or interventions directed to groups of people who share at least one common social or cultural characteristic. Primary outcomes were: knowledge among participants of vaccines or vaccine-preventable diseases and of vaccine service delivery; child immunisation status; and unintended adverse effects. Secondary outcomes were: participants' attitudes towards vaccination; involvement in decision-making regarding vaccination; confidence in the decision made; and resource use or cost of intervention. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed the references to identify studies for inclusion. We extracted data and assessed risk of bias in all included studies. MAIN RESULTS: We included two cluster-randomised trials that compared interventions aimed at communities to routine immunisation practices. In one study from India, families, teachers, children and village leaders were encouraged to attend information meetings where they received information about childhood vaccination and could ask questions. In the second study from Pakistan, people who were considered to be trusted in the community were invited to meetings to discuss vaccine coverage rates in their community and the costs and benefits of childhood vaccination. They were asked to develop local action plans and to share the information they had been given and continue the discussions in their communities.The trials show low certainty evidence that interventions aimed at communities to inform and educate about childhood vaccination may improve knowledge of vaccines or vaccine-preventable diseases among intervention participants (adjusted mean difference 0.121, 95% confidence interval (CI) 0.055 to 0.189). These interventions probably increase the number of children who are vaccinated. The study from India showed that the intervention probably increased the number of children who received vaccinations (risk ratio (RR) 1.67, 95% CI 1.21 to 2.31; moderate certainty evidence). The study from Pakistan showed that there is probably an increase in the uptake of both measles (RR 1.63, 95% CI 1.03 to 2.58) and DPT (diptheria, pertussis and tetanus) (RR 2.17, 95% CI 1.43 to 3.29) vaccines (both moderate certainty evidence), but there may be little or no difference in the number of children who received polio vaccine (RR 1.01, 95% CI 0.97 to 1.05; low certainty evidence). There is also low certainty evidence that these interventions may change attitudes in favour of vaccination among parents with young children (adjusted mean difference 0.054, 95% CI 0.013 to 0.105), but they may make little or no difference to the involvement of mothers in decision-making regarding childhood vaccination (adjusted mean difference 0.043, 95% CI -0.009 to 0.097).The studies did not assess knowledge among participants of vaccine service delivery; participant confidence in the vaccination decision; intervention costs; or any unintended harms as a consequence of the intervention. We did not identify any studies that compared interventions aimed at communities to inform and/or educate with interventions directed to individual parents or caregivers, or studies that compared two interventions aimed at communities to inform and/or educate about childhood vaccination. AUTHORS' CONCLUSIONS: This review provides limited evidence that interventions aimed at communities to inform and educate about early childhood vaccination may improve attitudes towards vaccination and probably increase vaccination uptake under some circumstances. However, some of these interventions may be resource intensive when implemented on a large scale and further rigorous evaluations are needed. These interventions may achieve most benefit when targeted to areas or groups that have low childhood vaccination rates.'

Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies.

BACKGROUND: Pharmaceuticals are important interventions that could improve people's health. Pharmaceutical pricing and purchasing policies are used as cost-containment measures to determine or affect the prices that are paid for drugs. Internal reference pricing establishes a benchmark or reference price within a country which is the maximum level of reimbursement for a group of drugs. Other policies include price controls, maximum prices, index pricing, price negotiations and volume-based pricing. OBJECTIVES: To determine the effects of pharmaceutical pricing and purchasing policies on health outcomes, healthcare utilisation, drug expenditures and drug use. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library (including the Effective Practice and Organisation of Care Group Register) (searched 22/10/2012); MEDLINE In-Process & Other Non-Indexed Citations and MEDLINE, Ovid (searched 22/10/2012); EconLit, ProQuest (searched 22/10/2012); PAIS International, ProQuest (searched 22/10/2012); World Wide Political Science Abstracts, ProQuest (searched 22/10/2012); INRUD Bibliography (searched 22/10/2012); Embase, Ovid (searched 14/12/2010); NHSEED, part of The Cochrane Library (searched 08/12/2010); LILACS, VHL (searched 14/12/2010); International Political Science Abstracts (IPSA), Ebsco (searched (17/12/2010); OpenSIGLE (searched 21/12/10); WHOLIS, WHO (searched 17/12/2010); World Bank (Documents and Reports) (searched 21/12/2010); Jolis (searched 09/10/2011); Global Jolis (searched 09/10/2011) ; OECD (searched 30/08/2005); OECD iLibrary (searched 30/08/2005); World Bank eLibrary (searched 21/12/2010); WHO - The Essential Drugs and Medicines web site (browsed 21/12/2010). SELECTION CRITERIA: Policies in this review were defined as laws; rules; financial and administrative orders made by governments, non-government organisations or private insurers. To be included a study had to include an objective measure of at least one of the following outcomes: drug use, healthcare utilisation and health outcomes or costs (expenditures); the study had to be a randomised trial, non-randomised trial, interrupted time series (ITS), repeated measures (RM) study or a controlled before-after study of a pharmaceutical pricing or purchasing policy for a large jurisdiction or system of care. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Results were summarised in tables. There were too few comparisons with similar outcomes across studies to allow for meta-analysis or meaningful exploration of heterogeneity. MAIN RESULTS: We included 18 studies (seven identified in the update): 17 of reference pricing, one of which also assessed maximum prices, and one of index pricing. None of the studies were trials. All included studies used ITS or RM analyses. The quality of the evidence was low or very low for all outcomes. Three reference pricing studies reported cumulative drug expenditures at one year after the transition period. Two studies reported the median relative insurer's cumulative expenditures, on both reference drugs and cost share drugs, of -18%, ranging from -36% to 3%. The third study reported relative insurer's cumulative expenditures on total market of -1.5%. Four reference pricing studies reported median relative insurer's expenditures on both reference drugs and cost share drugs of -10%, ranging from -53% to 4% at one year after the transition period. Four reference pricing studies reported a median relative change of 15% in reference drugs prescriptions at one year (range -14% to 166%). Three reference pricing studies reported a median relative change of -39% in cost share drugs prescriptions at one year (range -87% to -17%). One study of index pricing reported a relative change of 55% (95% CI 11% to 98%) in the use of generic drugs and -43% relative change (95% CI -67% to -18%) in brand drugs at six months after the transition period. The same study reported a price change of -5.3% and -1.1% for generic and brand drugs respectively six months after the start of the policy. One study of maximum prices reported a relative change in monthly sales volume of all statins of 21% (95% CI 19% to 24%) after one year of the introduction of this policy. Four studies reported effects on mortality and healthcare utilisation, however they were excluded because of study design limitations. AUTHORS' CONCLUSIONS: The majority of the studies of pricing and purchasing policies that met our inclusion criteria evaluated reference pricing. We found that internal reference pricing may reduce expenditures in the short term by shifting drug use from cost share drugs to reference drugs. Reference pricing may reduce related expenditures with effects on reference drugs but the effect on expenditures of cost share drugs is uncertain. Reference pricing may increase the use of reference drugs and may reduce the use of cost share drugs. The analysis and reporting of the effects on patients' drug expenditures were limited in the included studies and administration costs were not reported. Reference pricing effects on health are uncertain due to lack of evidence. The effects of other purchasing and pricing policies are until now uncertain due to sparse evidence. However, index pricing may reduce the use of brand drugs, increase the use of generic drugs, and may also slightly reduce the price of the generic drug when compared with no intervention.

Development of a complex intervention to improve health literacy skills.

BACKGROUND: Providing insight into the developmental processes involved in building interventions is an important way to ensure methodological transparency and inform future research efforts. The objective of this study was to describe the development of a web portal designed to improve health literacy skills among the public. METHODS: The web portal was tailored to address three key barriers to obtaining information, using the conceptual frameworks of shared decision-making and evidence-based practice and based on explicit criteria for selecting the content and form of the intervention. RESULTS: The web portal targeted the general public and took the form of structured sets of tools. Content included: an introduction to research methods, help on how to find evidence-based health information efficiently based on the steps of evidence-based practice, an introduction to critical appraisal, information about patient participation rights in decision-making, and a decision aid for consultations. CONCLUSIONS: The web portal was designed in a systematic and transparent way and address key barriers to obtaining and acting upon reliable health information. The web portal provides open access to the tools and can be used independently by health care users, or during consultations with health professionals.

Public health nurses' barriers and facilitators to the use of research in consultations about childhood vaccinations.

The aim of this study was to describe sources of information, as well as barriers and facilitators to the use of research during consultations by public health nurses concerning childhood vaccinations. The study was conducted using semi-structured focus group interviews in a grounded theory approach. Overall 16 public health nurses participated into three focus groups conducted in 2008. We found that the public health nurses' most important sources of information were the National guidelines and other information issued by the National Institute of Public Health. Although they argued that research was important for being able to base practice on solid information, for their own professional development and for meeting parents' demands, they were reluctant to search for such information themselves. This was explained by beliefs about their own role, limited critical appraisal skills and perceived capacity. We conclude with that insight into how knowledge is produced and how to obtain such information is not only a necessity for good quality health care and professional development, but is also a way to address challenges such as time, overload of information and the ability to answer questions parents may have. More emphasis should be given to empowering public health nurses so they can find and critically appraise research, and this should be an integrated part of practice.

Cognitive factors predicting intentions to search for health information: an application of the theory of planned behaviour.

BACKGROUND: Peoples' ability to obtain health information is a precondition for their effective participation in decision making about health. However, there is limited evidence describing which cognitive factors can predict the intention of people to search for health information. OBJECTIVES: To test the utility of a questionnaire in predicting intentions to search for health information, and to identify important predictors associated with this intention such that these could be targeted in an Intervention. METHOD: A questionnaire was developed based on the Theory of Planned Behaviour and tested on both a mixed population sample (n=30) and a sample of parents (n = 45). The questionnaire was explored by testing for internal consistency, calculating inter-correlations between theoretically-related constructs, and by using multiple regression analysis. RESULTS: The reliability and validity of the questionnaire were found to be satisfactory and consistent across the two samples. The questionnaires' direct measures prediction of intention was high and accounted for 47% and 55% of the variance in behavioural intentions. Attitudes and perceived behavioural control were identified as important predictors to intention for search for health information. CONCLUSION: The questionnaire may be a useful tool for understanding and evaluating behavioural intentions and beliefs related to searches for health information.

What informs parents' decision-making about childhood vaccinations?

AIM: This paper is a report of a study conducted to identify parents' decision-making processes in relation to childhood vaccinations, including barriers and facilitators to searching for information. BACKGROUND: Decision-making about childhood vaccinations is complex. Access to the best available evidence and the ability to obtain and understand such information are necessary for effective participation in decision-making. METHODS: A grounded theory approach was used, with semi-structured interviews and focus groups with parents (n = 10) and public health nurses (n = 16) conducted in 2008. Data were derived through incident-to-incident and axial coding. FINDINGS: Being positive towards vaccination and being decided were found to be main barriers to participation and obtaining information; other factors were perceptions about own abilities and capacity. Public health nurses were the parents' most important source of information, but tended to inform to facilitate vaccinations. Issues related to this and being inadequately informed were that some parents expressed low confidence about the decision they had made and uncertainty about their rights and responsibilities in decision-making. CONCLUSION: Information delivered by public health nurses should not facilitate a specific choice but rather be balanced, explaining the benefits and harms, and accompanied by a qualified recommendation. Useful tools to improve practice may include checklists for shared decision-making and guidelines about trustworthy websites.

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 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.

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.

The James Lind Initiative: books, websites and databases to promote critical thinking about treatment claims, 2003 to 2018.

BACKGROUND: The James Lind Initiative (JLI) was a work programme inaugurated by Iain Chalmers and Patricia Atkinson to press for better research for better health care. It ran between 2003 and 2018, when Iain Chalmers retired. During the 15 years of its existence, the JLI developed three strands of work in collaboration with the authors of this paper, and with others. WORK THEMES: The first work strand involved developing a process for use by patients, carers and clinicians to identify shared priorities for research - the James Lind Alliance. The second strand was a series of articles, meetings, prizes and other developments to raise awareness of the massive amounts of avoidable waste in research, and of ways of reducing it. The third strand involved using a variety of approaches to promote better public and professional understanding of the importance of research in clinical practice and public health. JLI work on the first two themes has been addressed in previously published reports. This paper summarises JLI involvement during the 15 years of its existence in giving talks, convening workshops, writing books, and creating websites and databases to promote critical thinking about treatment claims. CONCLUSION: During its 15-year life, the James Lind Initiative worked collaboratively with others to create free teaching and learning resources to help children and adults learn how to recognise untrustworthy claims about the effects of treatments. These resources have been translated in more than twenty languages, but much more could be done to support their uptake and wider use.

Evaluating people's ability to assess treatment claims: Validating a test in Mandarin from Claim Evaluation Tools database.

OBJECTIVE: To describe the psychometric testing using Rasch analysis of a test in Mandarin developed from the Claim Evaluation Tools database. METHODS: We translated selected MCQs from the IHC Claim Evaluation Tools database to Mandarin and created a test including 24 MCQs covering 11 key concepts. We used purposeful sampling and surveyed children and adults in the Lanzhou area. In total 389 responses were entered into the analysis. We evaluated the psychometric properties of the test using Rasch analysis and the RUMM2030 software, testing for internal construct validity (multidimensionality), invariance of the items (item-person interaction), and item bias (differential item functioning). RESULTS: Overall, the psychometric properties of the test were found to be satisfactory. Based on findings from the Rasch analysis, we deleted three MCQs with suboptimal fit. CONCLUSIONS: The resulting test includes 21 MCQs and can be used in school and other teaching settings, in randomized trials evaluating outcomes of educational interventions, or in cross-sectional studies in Mandarin-speaking populations in China.

Informed Health Choices media intervention for improving people's ability to critically appraise the trustworthiness of claims about treatment effects: a mixed-methods process evaluation of a randomised trial in Uganda.

We developed the Informed Health Choices podcast to improve people's ability to assess claims about the effects of treatments. We evaluated the effects of the podcast in a randomised trial. OBJECTIVES: We conducted this process evaluation to assess the fidelity of the intervention, identify factors that affected the implementation and impact of the intervention and could affect scaling up, and identify potential adverse and beneficial effects. SETTING: The study was conducted in central Uganda in rural, periurban and urban settings. PARTICIPANTS: We collected data on parents who were in the intervention arm of the Informed Health Choices study that evaluated an intervention to improve parents' ability to assess treatment effects. PROCEDURES: We conducted 84 semistructured interviews during the intervention, 19 in-depth interviews shortly after, two focus group discussions with parents, one focus group discussion with research assistants and two in-depth interviews with the principal investigators. We used framework analysis to manage qualitative data, assessed the certainty of the findings using the GRADE-CERQual (Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative Research) approach, and organised findings in a logic model. OUTCOMES: Proportion of participants listening to all episodes; factors influencing the implementation of the podcast; ways to scale up and any adverse and beneficial effects. RESULTS: All participants who completed the study listened to the podcast as intended, perhaps because of the explanatory design and recruitment of parents with a positive attitude. This was also likely facilitated by the podcast being delivered by research assistants, and providing the participants with MP3 players. The podcast was reportedly clear, understandable, credible and entertaining, which motivated them to listen and eased implementation. No additional adverse effects were reported. CONCLUSIONS: Participants experienced the podcast positively and were motivated to engage with it. These findings help to explain the short-term effectiveness of the intervention, but not the decrease in effectiveness over the following year.

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.

"A waste of time without patients": The views of patient representatives attending a workshop in evidence-based practice.

BACKGROUND: Shared decision-making is a central element of evidence-based practice (EBP). Training in EBP has traditionally focused on providers, but there is an increasing interest in developing such educational resources for patients. The aim of this study is to explore the views of patient representatives attending a workshop in EBP. METHODS: We conducted three focus groups with participants attending EBP workshops in 2013, 2014, and 2015. We used the framework method for content analysis. We reviewed the transcribed interviews independently and assigned initial codes and final categories to the transcriptions. We created an analytical framework and a flow diagram to visualize the category hierarchy and the relationship between categories. RESULTS: We identified two main themes; "How to facilitate training in evidence-based practice for patients," and "Outputs of training in evidence based practice for patients." Training in EBP for patient representatives "should reflect the principles EBP," and include interaction with both health professionals and other representatives. The educational needs of representatives are much the same as those of health professionals, and the training should therefore be "on a par with professionals." The relevance of such training may depend on the representatives' mandate, and costs might be an important barrier. Important outputs of such training include "becoming a knowledge manager," "enabling participation and informed decisions" and "re-defining the patient representatives' role." CONCLUSIONS: The findings of this study suggest that training in EBP is attractive to patient representatives with outputs perceived important. Organizers should consider the principles of EBP when planning such training.