gms | German Medical Science

Background: Midwifery usually seeks research answers through qualitative data gathering to try and understand women’s/people’s experiences of pregnancy, birth and the postnatal period. Treatment and interventions usually gather research data via quantitative methods. Commonly randomised controlled trials (RCT) are used to obtain data to answer a treatment question. The long-held debate around effective and meaningful research methods continuous.

Midwives are concerned with knowing what an effective treatment is for an individual woman/person rather with what happens on average. Double-blind randomised N-of-1 (N – Number of 1 – one) trials may be ideal for determining effectiveness and suitability of individual treatment effects. Informally many midwives use this research method already when advising different treatment option for women/people, for example, pain relief for Symphysis Pubis Dysfunction (SPD). Which pain relief works best for the individual woman e.g. positioning, paracetamol, using crutches? This design that have been widely used in psychology, education, and social work.

Aim/research question: The presentation aims to introduce the N-of-1 research methodology identifying how it may provide an objective basis of the best treatment for the individual pregnant or postpartum woman/person.

What is the research method N-of-1 and how does it work?

Methods and results: In an N-of-1 trial the woman (blinded) would be her own control, and receives the experimental and the control treatment during several periods of time in random order. She is able to diary her lived experience of the treatment as well as providing quantitative data of the treatment effect.

Relevancy: Published reports of N-of-1 trials are still relatively infrequent and the research methodology is not as firmly established as that of RCTs. It is hoped that this presentation will encourage midwives to consider the use of N-of-1 as it may well be a useful tool for enhancing therapeutic precision and answering questions for individual women/people when there is doubt regarding the effectiveness and suitability of a treatment.

Recommendations/conclusion: The N-of-1 trial method can be useful for an individual rigorous treatment option or for a pilot study prior to commencing a larger trial. Understanding published results of N-of-1 trials enables midwives to decide if the results could be applicable to their practice.

Ethics and conflicts of interest: A vote on ethics was not necessary. The research was financed by own resources. There are no conflicts of interest.