Global Health Methodology Research and SWATs (Studies Within A Trial)
Randomised controlled trials, and other health research studies, are key to reducing uncertainty about which the best health intervention are. One of the key goals of The Global Health Network is to share knowledge, tools and resources to create and support research capacity, especially in low- and middle-income countries. A really important and interesting approach that has been receiving more attention is doing research not only on interventions and health practises, but also to do research on the best ways to do studies. This falls into a branch of research called methodology research. On The Global Health Network, the Global Health Methodology area (http://globalhealthmethodologyresearch.org) has been set up to address this directly, and to support groups that are interested in conducting studies in parallel to the trials that they may be conducting.
Over the past couple of decades, there have been many hundreds of thousands of randomised controlled trials, which have added significantly to our understanding of how best to improve health outcomes. In spite of this, very little research has been done on how to improve the way in which these trials are done. One approach, called SWATs, or Studies Within A Trial, has been proposed as a way to improve the situation. Basically this involves building into big trials smaller studies that specifically try to find out better ways to do the research studies, which will improve the way in which studies are conducted. For example, one key challenge in doing multi-centred trials is that there is significant uncertainty about the best way to ensure good recruitment rates at different sites. Sometimes Principal Investigators take the view that a visit to the site to review processes would improve recruitment at sites at which recruitment has dropped. A SWAT approach would be to conduct a small study on the recruitment rates at sites that do, or do not, receive such visits, to collect evidence on whether or not this approach actually improves recruitment rates. Other approaches to improve recruitment sometimes use social media to promote study participation, but very little evidence exists to support this approach. A SWAT could be done to test whether or not social media can improve study recruitment.
Another example comes from research into adherence to antiretroviral therapy (ART) for HIV infection. Taken as prescribed, and regularly with good adherence levels, ART is an excellent treatment for HIV that can lead to control of infection and a long and healthy life for patients. Many studies have been conducted into ways to improve adherence, but it could be that the way in which adherence is measured in the study (either objectively or by self-report) could actually change the adherence behaviour of patients. So, for example, regularly asking patients to report on their adherence may cause them to be more aware of the importance of adherence and so cause them to actually take their medicines more regularly. In addition to this, being asked regularly about their adherence may lead patients to see that the clinic staff are interested in their medication-taking behaviour, and also improve adherence. Some ways of asking about adherence, and the frequency with which these measures are done, could impact on adherence in different ways and studies within a trial could be done to measure the impact of this so that it can be controlled in future studies of adherence to treatment.
There are initiatives currently underway in developed countries to do this kind of research, but it also presents a great opportunity for researchers in low- and middle-income countries to contribute significantly to the conduct of health research. This is particularly true of researchers who are taking part in large multi-centred trials as this presents an opportunity to do work that is relevant to local conditions, increases the body of scientific knowledge, and can create opportunities for locally-led and conceptualised studies that lead to publication in high calibre international academic journals. The Global Health Network is especially interested in hearing from you. What kinds of SWATs have you done previously, or what kinds of questions can you see as being answered through this approach? Post up in the comments here to tell the community about what you have previously done, but also to stimulate discussion about a list of possible research questions. Use the facilities on The Global Health Network to support new research studies, and let the community know about how this has helped you.
This article was prepared for the Global Health Methodology Research Site (http://globalhealthmethodologyresearch.org), and was posted up there initially. Visit the site to learn more about methodology research in health. All resources on the Global Health Methodology Research site are free to use and adapt as you like. If you do adapt a tool or template for use at your site, please could you post up your improvements back to the site so that other members of the community can benefit from your modifications. If the work you do using our tools and templates leads to published reports or papers, please could you support the utility of these tools by including an acknowledgement: "This work used free to use tools and/or templates from the Global Health Methodology Research Site (http://globalhealthmethodologyresearch.org), part of The Global Health Network (http://www.tghn.org).