Madeline Brennan is GP Research Registrar at the Department of General Practice and Primary Care and Centre of Public Health, Queen’s University, Belfast
Margaret Cupples is a general practitioner and professor at the Department of General Practice and Primary Care, Centre of Public Health and UKCRC Centre of Excellence for Public Health, Queen’s University Belfast, UK.
Editor’s note: This post is based on a presentation to the Association of University Departments of General Practice in Ireland, at Queen’s University, Belfast.
As a GP research registrar embarking on developing my first research project, I didn’t think I was going to change the world, but I hoped that I could, perhaps, influence a few. Obesity is a major global problem and maternal obesity is rising in addition to that of the general population. My aim was to change the health behaviour of the expectant mother.
The initial booking visit seemed a prime opportunity to offer health promotion and physical activity advice. As both the National Institute for Health and Care Excellence (NICE) guidelines and a Cochrane meta-analysis called for further research to aid weight management during pregnancy, I thought I would tackle this issue. My feasibility study aimed to recruit 30 women to be randomly allocated into either a pedometer-based physical activity intervention or to a control group. So far, so good.
Recruitment was a failure. Despite the enthusiasm of the recruiting GPs, midwives and myself, just six women across four practices agreed to take part over the five-month recruitment period. We had difficulty contacting potential participants because GP records did not always have up-to-date telephone numbers. Often, there was no answer to my calls or response to my voicemails. When I did speak to women on the phone, their reasons for non-participation or their failure to attend arranged meetings included lack of time, broken down cars and sick children.
Of the six women that we recruited, two dropped out; one, understandably, because of family issues, and one did not respond to my calls. Of the four women enrolled, one woman from the control group made it to the final hurdle. One of three women who completed the intervention didn’t make the final visit because she had gone into labour, another accidentally put her pedometer in the washing machine, and the third dropped her pedometer down the toilet!
To salvage my project from the same untimely “death by toilet,” I decided to conduct some semi-structured interviews with pregnant women attending their antenatal clinic appointments in their GP surgery and with those GPs and midwives involved in recruitment. Every cloud has a silver lining, and these interviews were most definitely my silver lining and may help research in the future: Everyone recognized the need for advice, and the general consensus from women was that they were open to advice on physical activity but were anxious that exercise could cause harm.
So, what have I learned? Feasibility studies are simply that — small studies to determine whether a project is doable, the intervention is acceptable and recruitment is possible. In its current format, this project is a no-goer. Perhaps we got it wrong. The qualitative interviews suggested that the next step would be to develop a group-based antenatal exercise program that GPs and midwives could signpost to women. This program could incorporate an educational component advising women about safe exercise during pregnancy and help to dispel age-old myths that exercise is harmful. To be continued……
Well written! Indeed a glorious failure, and in terms of a feasibility study very much a success! Successful in informing researchers that a larger trial to answer your research question is not feasible in this setting or with these participants. It appears that expectant mothers are a hard to reach population for us researchers – we will need to think outside the box for future studies, and heed the findings of your very important qualitative work. This really highlights the importance of feasibility studies, and of patient involvement in study design.
This glorious failure adds a lot to what we knew before you embarked, thus success!
Centre for Public Health, QUB
This is a very interesting read, which has been excellently written.
Well done and best wishes for the future,
GP Research Registrar QUB
Well done Madeline. I’d say nearly every researcher out there has had their failures – not all perhaps as glorious as yours. However, you’d never know that from reading the research literature. We are all, perhaps, a bit ashamed of perceived failure even when the failure is not our fault. And yet research is inherently a risk venture – for some research to succeed it is inevitable that other research must fail. Otherwise we would all end up doing anodyne research proving what is already quite well known or established. Indeed, it is arguable that there is already too much research which is of this risk averse kind. I sincerely hope that your considerable endeavour is recognised and that your funding and other support continues in spite of this apparent failure so that you may yet go on to glorious success.