Potential adverse effects of an educational intervention: Development of a framework

Background Researchers often overlook potential adverse effects of educational and public health interventions (increases in adverse outcomes, or decreases in beneficial outcomes, attributed to the intervention). To help us identify potential adverse effects of an educational intervention intended to improve critical thinking about health choices, we developed a framework. We also did a preliminary prioritisation of outcomes in the framework for randomised trials of the intervention, and associated process evaluations. Methods Based on relevant evidence and theory, we developed an initial framework. For feedback on the initial framework, we sent a survey to 70 external experts. We conducted a thematic analysis of the qualitative survey data. After revising the framework based on the survey findings, we interviewed teachers in the context where we are evaluating the intervention, to help identify any effects still missing from the framework, and preliminarily prioritise potential outcomes for the evaluation. Results We received responses from 38 of the 70 external experts (54%), including researchers and others with a variety of expertise within health, education, and design. Overall, the responses were positive. However, they also included critical feedback that led to substantial revisions of the framework’s content and presentation. The revised framework has six categories of potential adverse effects: decision-making harms, psychological harms, equity harms, group and social harms, waste, and other harms. We interviewed three teachers, who did not suggest any missing outcomes. Based on the interview findings, we prioritised three outcomes for the evaluation of the intervention: work-related stress; wasted time or resources; and conflict, in particular between students and family. Discussion As far as we are aware, the framework presented in this article is the first tool of its kind in education research. The framework is a “living” tool, which can be improved upon, as well as adapted. We have used it to inform the development of interview and observation guides, and we are using it to inform the development of outcome measures. Important limitations of the framework include limits to its comprehensiveness, and the use of terminology with different meanings or interpretations depending on the context. Our approach to identifying and evaluating potential adverse effects of an educational intervention can have value to other researchers. Conclusion Rigorous evaluations of potential adverse effects of educational and public health interventions can be time and resource-intensive. However, that cost might be small compared to the cost of implementing harmful interventions. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The study was funded by the Research Council of Norway (https://www.forskningsradet.no/en/), as part of the project ‘Enabling sustainable public engagement in improving health and health equity’, project number 284683, grant number 69006. The funder had no role in in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Norwegian Institute of health (NIPH) is the project’s lead partner. As required by NIPH—to comply with the European General Data Protection Regulation—we have completed a data privacy impact assessment (DPIA) for the entire development stage of the project, including this study. The Data Protection and Chief Information Security Officers at the Norwegian Institute of Public Health (NIPH) provided feedback on the DPIA, and the relevant senior advisor at NIPH approved it. Furthermore, as required by RCN, we have created a data management plan for the entire project, which we are updating continuously and will submit to RCN at the end of the project. Since the project will not generate new knowledge about health and disease, it falls outside the remit of the Regional Committee for Medical Research Ethics, in Norway, which the committee has confirmed (reference number 30713). In Kenya, we obtained ethics approval from Masinde Muliro University of Science and Technology Institutional Ethics Review Committee and the Kenya National Commission of Science and Technology Institute (licence number NACOSTI/P/19/1986), as well as approval from the Ministry of Education and the Teachers Service Commission, nationally and at the county-level. In Rwanda, we obtained ethics approval from the Rwandan National Ethics Committee. In Uganda, we obtained ethics approval from the School of Medicine research ethics committee at the Makerere University College of Health Sciences, and from the Uganda National Council for Science and Technology. 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