راهنمای گزارش دهی برای اجرا و پژوهش عملیاتی (OR)

ABSTRACT Reporting guidelines for implementation and operational research

Implementation and operational research are growing in importance and recognition. Major donors, including the Canadian Institutes of Health Research, the European & Developing Countries Clinical Trials Partnership, the United States of America’s National Institutes of Health and the Wellcome Trust are increasing funding support for this research area and leading scientifc journals have established sections promoting the publication of such research. Implementation research contributes a growing part of the evidence base used by the World Health Organization (WHO), which promotes, supports, publishes and evaluates such research. Te combined results of basic, clinical and implementation research have made it possible to reach millions of people with life-saving treatments and effective prevention measures.

For example, the global scale-up of antiretroviral drugs for human immunodefciency virus (HIV) has brought the number of people on treatment to 13.6 million from 800 000 in 20031 and reduced deaths from 2.4 million in 2005 to 1.5 million in 2013.2 As another example, tuberculosis is declining rapidly. However, to sustain these gains and reach elimination targets for tuberculosis, new drugs and vaccines are needed, along with the implementation research that shows how these can be delivered where they are needed and in a form that works. Deaths from malaria have decreased by 58% between 2000 and 2015,1 in part because malaria control measures, including indoor residual spraying, long-lasting insecticidal nets, pointof-care diagnostic tests and artemisinin-based combination therapies have been delivered effectively to communities.

Operational research uses an existing resource – the data routinely collected by programmes – to provide ways of improving programme operations and thereby delivering more effective, efcient and equitable care. Implementation and operational research are usually carried out in close collaboration between researchers and public health practitioners. Operational research is typically very specifc to a single programme or activity. Te costs are generally modest, yet these studies have the potential for a huge magnifer effect, in extending the impact of health interventions.3

Implementation research can help answer questions about why effective interventions are not reaching the people who could beneft from them.4,5 Implementation research is also useful in understanding how health system failures create barriers to the delivery of policies or programmes. For example, the non-adherence of providers to service delivery guidelines based on evidence may result from a lack of monitoring and feedback mechanisms within the system. It could also result from the time allocated per visit which limits what providers are able to achieve. A broad understanding of systems failures and their relationship to implementation barriers is a key aspect of much implementation research. Resolving barriers such as non-adherence to treatment guidelines may have less to do with training providers and more to do with changing the system to allow more time or by establishing better feedback mechanisms. As the range of applications of implementation research is very broad, a wide range of different research methods may be used depending on the type of problem studied (Table 1).

Existing guidelines and their extensions cover some – but not all – of the required reporting areas. Tese gaps can make it difcult for researchers, implementers and journal editors to ensure that studies are reported in sufcient detail to allow replication. A further difculty is that the success of implementation, particularly for complex interventions, is ofen highly dependent on the context. Te traditional structure of a scientifc research article may not provide a good framework for reporting important contextual issues.

For the past 10 years, the Bulletin of the World Health Organization has published many examples of implementation research in a section called Lessons from the Field.6 The papers in this section have described actions taken in response to a wide variety of public health problems in many different settings, but we have found that authors often needed to be prompted to provide sufficient detail on local context, details of interventions and measures of impact.

Here we describe the development of reporting guidelines for implementation and operational research (Table 2). In future, authors submitting relevant research articles to the Bulletin will be asked to follow the new reporting guidelines. Te guidelines are the result of collaboration between WHO, the Alliance for Health Policy & Systems Research (AHPSR) and the Special Programme for Research and Training in Tropical Diseases (TDR), journal editors, researchers and funders. Our intention is to provide a useful reference for all involved in implementation and operational research, and to revise these guidelines, as required, afer a frst year’s trial period.