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Background: Cochrane’s mission is to promote evidence-informed health decision making by producing high-quality, relevant, accessible systematic reviews. But Cochrane Reviews are long and complex, posing difficulties for both review users and review producers. Goal 2 in the Cochrane Strategy to 2020 is to make Cochrane evidence accessible and useful to everybody, everywhere in the world. For Cochrane intervention reviews to be accessible to people making decisions, users need to be able to quickly find the information they need and to understand that information. What we did: From October 2017 to December 2018, we developed a prototype of a new interactive format for intervention reviews that would make them easier to navigate and understand for both expert and non-expert target audiences, as well as less time consuming for authors and editors to write and peer review. We reviewed evidence about presenting findings from systematic reviews and drew on our own experience. We used a human-centred design approach, which entailed cycles of prototype development, feedback collection, and analysis, and idea-generation. We collected feedback from a wide range of stakeholders, through queries to an Advisory Group, individual user-test interviews, and meetings at Cochrane events where we presented and discussed prototypes. Acknowledgements This project was initiated by Sasha Sheppard and Simon Lewin from the EPOC satellite in Norway, and funded by the Norwegian Institute of Public Health. The following working group from EPOC managed and carried out the project: Sarah Rosenbaum, Andy Oxman, Newton Opiyo, Simon Lewin, Claire Glenton and Sasha Sheppard. Nandi Siefried re-wrote four example reviews. Appendices 4, 5, 6, 7, and 13 are excel files. They are available on request to the corresponding author (saro@fhi.no)

Introduction To help students think critically about health information and decisions, we developed the Informed Health Choices (IHC) secondary school intervention. We are evaluating the intervention in cluster-randomised trials, and linked process evaluations, in Kenya, Rwanda, and Uganda. The study planned herein is a qualitative evidence synthesis (QES), using data about experiences and views of adverse effects from all three process evaluations. The QES overlaps with the process evaluations. The QES will allow us to comprehensively explore, report, and discuss experiences and views of potential adverse effects, and potential mechanisms. The findings are intended to help inform decisions about whether or how to redevelop, re-evaluate, or implement the intervention. The methods and findings might also be helpful to developing, evaluating, or implementing other educational interventions—especially interventions intended to improve critical thinking, within health or other fields. Objective Explore participants’ and investigators’ experiences and views of potential adverse effects of the IHC secondary school intervention, and potential mechanisms of those effects. Methods An independent researcher will assess methodological limitations of the included studies, based on a list of domains used by the Cochrane Effective Practice and Organisation of Care (EPOC) group. We will merge and modify framework analysis as outlined by Ritchie and Spencer, framework synthesis as described by Barnett-Page et al., and “best fit” framework synthesis as outlined by Carrol et al. All three are pragmatic approaches with a deductive analysis using an a priori framework, followed by an inductive thematic analysis. We will note possible differences in how participants generally conceptualise adverse effects of educational interventions, compared to the study team, and possible differences in adverse effects across trial settings, for the purposes of future research. To assess confidence in the synthesis findings, we will apply the Grading of Recommendations Assessment, Development and Evaluation Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) approach, using the interactive Summary of Qualitative Findings (iSoQ) tool. We will produce a Qualitative Evidence Profile, and Summary of Qualitative Findings Tables. Discussion The QES and the process evaluations overlapping and being part of the same project has methodological implications that amount to both strengths and limitations. Like in prospective meta-analyses, when planning the process evaluations, we harmonised the objectives, facilitating synthesis, while investigators in each setting still had autonomy to explore phenomena specifically for their study. Like individual patient data (IDP) meta-analyses, this study will be based on data from the process evaluations, facilitating more reliable analysis and synthesis than if it was only based on reported findings. As far as we are aware, this QES will be the first of its kind methodologically, and first empirical study of its size and rigour focusing on potential adverse effects of an educational intervention. The QES and process evaluations overlapping and being part of the same project also introduces risk of bias. Another challenge is that we are including the study team’s experiences and views. In general, to address these challenges, we will be transparent, and apply reflexivity throughout.

Well-informed choices about how to intervene to improve health outcomes de-pend on access to reliable information, including research evidence. Many peo-ple (not only the public, but health professionals and policymakers too) have problems understanding some of the terminology used in describing evalua-tions of treatments. We have developed a glossary to provide plain language ex-planations and illustrations of 242 commonly used terms. The glossary is freely available at http://getitglossary.org and can be incorporated into documents providing support for evidence-informed healthcare decisions, and embedded in other websites serving a wide variety of functions.

This study will allow us to refine the development of key components of the health messages lab and gain new knowledge about the effects of alternative formats to communicate uncertainty on participants beliefs, decisions, and behaviours. The objectives of therandomized trial are: To compare the effects of three ways of communicating the overall uncertainty of the effects of wearing glasses to reduce the chance of getting COVID and To compare the effects of including the margin of error (confidence interval) compared to not including it. The primary outcome for all 6 summary versions tested is understanding of the uncertainty. For the 3 summary versions that include the margin of error (compared to those that do not), there is an additional co-primary outcome, assessing understanding of statistical uncertainty (i.e., precision of the effect estimates). &nbsp

Background During the Covid-19 pandemic, governments and health authorities have had to make difficult decisions about infection prevention and control measures such as social distancing, face masks, travel restrictions, self-isolation, quarantines, lockdowns, and vaccination. Judgments underlying those decisions require democratic input, as well as expert input. Objective To systematically review examples of participatory democracy in decisions about how to control the Covid-19 pandemic, including the level or degree of participation, inclusion of marginalised groups, the methods used for participation, the decision-making process, support for understanding and applying relevant concepts for making well-informed decisions, and evaluation of the effects of participation. Methods We will include reports that describe public participation in deliberations or decisions by a government, public health authority, or international agency about infection prevention and control measures during the Covid-19 pandemic, including case reports and any type of qualitative or quantitative evaluation. We will search Participedia, MEDLINE, Embase, IPSA, Sociological Abstracts, ProQuest Politics Collection, CPSI-S, CPSI-SSH, Web of Science Core Collection, Clarivate Analytics, Citationchaser, and relevant websites, including Open Government Partnership, the International Observatory on Participatory Democracy, and Involve. Two review authors will independently read the titles and abstracts resulting from the search process and eliminate any obviously irrelevant reports. We will retrieve the full text of potentially relevant reports. Two review authors will then assess each retrieved report for inclusion. One review author will extract data from each included report using a standard data-extraction form. A second review author will check the extracted data against the full report. If possible and warranted, we will contact report authors to collect information that is missing from reports. For formal evaluations that report effects of participation on an outcome), we will use the “Risk of Bias In Non-randomised Studies - of Interventions” (ROBINS-I) tool to assess the risk of bias. We will undertake a structured synthesis.

Background During the Covid-19 pandemic, governments and health authorities have had to make difficult decisions about infection prevention and control measures such as social distancing, face masks, travel restrictions, self-isolation, quarantines, lockdowns, and vaccination. Judgments underlying those decisions require democratic input, as well as expert input. Objective To systematically review examples of participatory democracy in decisions about how to control the Covid-19 pandemic, including the level or degree of participation, inclusion of marginalised groups, the methods used for participation, the decision-making process, support for understanding and applying relevant concepts for making well-informed decisions, and evaluation of the effects of participation. Methods We will include reports that describe public participation in deliberations or decisions by a government, public health authority, or international agency about infection prevention and control measures during the Covid-19 pandemic, including case reports and any type of qualitative or quantitative evaluation. We will search Participedia, MEDLINE, Embase, IPSA, Sociological Abstracts, ProQuest Politics Collection, CPSI-S, CPSI-SSH, Web of Science Core Collection, Clarivate Analytics, Citationchaser, and relevant websites, including Open Government Partnership, the International Observatory on Participatory Democracy, and Involve. Two review authors will independently read the titles and abstracts resulting from the search process and eliminate any obviously irrelevant reports. We will retrieve the full text of potentially relevant reports. Two review authors will then assess each retrieved report for inclusion. One review author will extract data from each included report using a standard data-extraction form. A second review author will check the extracted data against the full report. If possible and warranted, we will contact report authors to collect information that is missing from reports. For formal evaluations that report effects of participation on an outcome), we will use the “Risk of Bias In Non-randomised Studies - of Interventions” (ROBINS-I) tool to assess the risk of bias. We will undertake a structured synthesis.

Background We designed the “Be smart about your health” digital resources to teach lower secondary school students how to assess the trustworthiness of claims about the effects of treatments. We shall evaluate effects of using these resources in a randomised trial in Uganda. This paper describes the process evaluation that will be conducted alongside this trial. The aim is to identify factors affecting the implementation, fidelity, effects, and scaling up use of the Be smart about your health teaching resources in Uganda and potential adverse and beneficial effects of the intervention. Methods Forty teachers from 40 schools in the intervention arm of the trial will complete a lesson evaluation questionnaire after each of the 10 lessons and at the end of the term. We will conduct structured classroom observations at all 40 schools. We will purposively select eight schools where we will conduct focus group discussions with teachers and students. We also will conduct key informant interviews among education officers (that visit the schools to monitor the implementation), teachers, head teachers, learners, and their parents. We will use a framework analysis approach to analyse the data. Expected results We anticipate that the findings from this evaluation will provide insights into factors that may impact the effectiveness of using the Be smart about your health resources, factors that can inhibit or facilitate scaling up use of the resources, and potential effects that were not measured quantitatively after the intervention, including transfer of what was learned to other contexts and adverse effects.

Background: People frequently make decisions about what can improve their health. They do this based on large amounts of information that they get from different sources, which include claims about what harms or improves health. People therefore need skills to assess the trustworthiness of health claims. The Informed Health Choices (IHC) Key Concepts framework was used to develop the ‘Be Smart about your Health’ secondary school resources to help students in lower secondary to assess health claims about the effects of treatments. We are evaluating these resources in a cluster randomized trial in 80 lower secondary schools in Kenya. This protocol is for a process evaluation that will be conducted alongside the trial. The objective of this evaluation is to explore the extent to which the intervention was delivered as planned; understand factors that facilitated or hindered the delivery and impact of the resources; and antici-pated and unanticipated effects. Study design: We will employ a mixed-methods design using quantitative and qualita-tive data. We will collect quantitative data from all schools (n=40) allocated to the in-tervention arm using lesson evaluation forms. Our qualitative data collection will in-clude: (a) structured classroom observations in all schools (n=40), with at least one lesson observed in each school. In a sample of eight schools, we shall observe more than one lesson. (b) We will conduct focus group discussions (with students (n=4), teachers (n=1) and parents (n=4). (c) Key informant interviews with policymakers in education (n=5), teachers (n=8), and with school principals (n=8)). We will purposively select these schools based on location (urban and rural) and ownership (private and public). Data analysis: We will use framework analysis to analyze qualitative data and descrip-tive analysis to analyze quantitative data. We will summarize and appraise the confi-dence of the key findings from the qualitative data using a modified version of the GRADE-CERQual approach.

We are developing an online education programme called Informed Health Choices-Cancer (IHC-C) based on theInformed Health Choices (IHC) initiativeKey Concepts. We will provide those impacted by cancer with the knowledge and skills necessary to think critically about the reliability of health information and claims and make informed choices. TheIHC-C protocoldescribes the methods we will use to identify the IHC Key Concepts we will include in the IHC-C programme and prioritise the order in which the Key Concepts will be addressed.The appendixes for this protocol are: Appendix 1: patient and public involvement (PPI) panel recruitment.pdf Appendix 2: Informed Health Choices-Cancer judgement form.pdf

There are endless claims about treatments in the mass media, advertisements, and everyday personal communication. Some are true and some are false. Many are unsubstantiated: we do not know whether they are true or false. Unsubstantiated claims about the effects of treatments often turn out to be wrong. Consequently, people who believe and act on these claims suffer unnecessarily and waste resources by doing things that do not help and might be harmful, and by not doing things that do help. In response to these challenges, we developed the Informed Health Choices Key Concepts as the first step in the Informed Health Choices (IHC) project, an initiative supported by the Research Council of Norway. The aim of the IHC project and ongoing work by the IHC Network is to help people make informed health choices. In this document, we use the term “treatment” to include any intervention (action) intended to improve health, including preventive, therapeutic and rehabilitative interventions, and public health or health system interventions. Although we have developed and framed the Key Concepts to address treatment claims, people in other disciplines may find them relevant; for example, for assessing claims about the effects of educational interventions or environmental measures. The Informed Health Choices (IHC) Key Concepts serve as the basis for developing learning resources to help people understand and apply the concepts when claims about the effects of treatments (and other interventions) are made, and when they make health choices. They are also the basis for an item bank of multiple-choice questions (the Claim Evaluation Tools item bank) that can be used for assessing people’s ability to apply the IHC Key Concepts. The concepts are principles for evaluating the trustworthiness of treatment claims, comparisons, and choices. The concepts can help people to: Recognise when a claim about the effects of treatments has an untrustworthy basis Recognise when evidence from comparisons of treatments is trustworthy and when it is not Make well-informed choices about treatments They can help anyone, not just researchers, to think critically about whether to believe a treatment claim and what to do. This is sometimes referred to as critical health literacy. The Key Concepts are intended for people using research, not for doing research. In this update, we started with the explanations and implications from the 2019 version of the IHC Key Concepts. For each concept, we have provided one or more examples to illustrate each explanation, and the basis for each concept, drawing on relevant research that informed the development of the IHC Key Concepts. We have received only a few suggestions since the 2019 version was published and did not publish a new version of the Key Concepts in 2020 or 2021. We have decided that the version presented here will be the last revision made by us. This does not mean that this list of concepts cannot be further improved, but we will leave any further development of the IHC Key Concepts to others.