Developing technical support and strategic dialogue at the country level to achieve Primary Health Care-based health systems beyond the COVID-19 era

Background The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. Methods There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. Results Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six ‘core elements’ that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. Limitations The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. Conclusions This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as ‘events in systems’ that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. Future work We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. Funding This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).

It has been 30 years since the Declaration of Alma Ata. During that time, primary care has been the central strategy for expanding health services in many low- and middle-income countries. The recent global calls to redouble support for primary care highlighted it as a pathway to reaching the health Millennium Development Goals. In this systematic review we described and assessed the contributions of major primary care initiatives implemented in low- and middle-income countries in the past 30 years to a broad range of health system goals. The scope of the programs reviewed was substantial, with several interventions implemented on a national scale. We found that the majority of primary care programs had multiple components from health service delivery to financing reform to building community demand for health care. Although given this integration and the variable quality of the available research it was difficult to attribute effects to the primary care component alone, we found that primary care-focused health initiatives in low- and middle-income countries have improved access to health care, including among the poor, at reasonably low cost. There is also evidence that primary care programs have reduced child mortality and, in some cases, wealth-based disparities in mortality. Lastly, primary care has proven to be an effective platform for health system strengthening in several countries. Future research should focus on understanding how to optimize the delivery of primary care to improve health and achieve other health system objectives (e.g., responsiveness, efficiency) and to what extent models of care can be exported to different settings. Copyright 2010 Elsevier Ltd. All rights reserved.