1 Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia 5000, Louise.Wiles@unisa.edu.au
2 Health Consumer Advocate/Representative, Adelaide, South Australia, Australia 5000, Debra@debrakay.com.au
3 Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia 5000, Julie.Luker@unisa.edu.au
4 Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia, 5000. Anthea.Worley@unisa.edu.au
5 Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia 5000, Susan.Hillier@unisa.edu.au
Engaging consumers in decision-making aims to ensure participative democracy, accountability and transparency in areas of public interest. Thus, consumer engagement in health care policy, research and services is widely recognised as important to generating approaches that are acceptable, accessible, high-quality and clinically relevant. A systematic review of randomised-controlled trials (RCTs) was undertaken (2009-2020) to assess the effects of consumer engagement in health care policy, research and services. The protocol was developed in partnership with a stakeholder advisory group (including ten consumers) to enhance the review’s relevance and currency. The International Association for Public Participation, Spectrum of Public Participation was used to identify, describe, compare and analyse consumer engagement. Outcome measures were effects on people; effects on the policy/research/health care services; or process outcomes. 23 RCTs with a moderate-high risk of bias were included, involving 136,265 participants. Most consumer engagement strategies adopted a consultative approach during the development of interventions, targeted to health services. The most compelling evidence exists in health care service development and delivery, where engaging consumers resulted in reduced rates of adverse health outcomes (e.g., neonatal mortality), and patient information material that was more relevant, readable, and understandable. Investigations of consumer engagement in health policy were less prevalent (e.g., collaborating with consumers in health priority-setting) with little exploration of effects in policy decision-making. Consumer engagement in health research was limited to process indicators (e.g., recruitment, adherence, information and satisfaction) with no trials investigating the effects of consumers being engaged in research agenda or methodology development. PROSPERO CRD42018102595.