Skip to main content

Trinity College Dublin, The University of Dublin

Trinity Menu Trinity Search

School of Nursing & Midwifery

You are here Research > Methodological Research

Methodological Research 

Introduction

Methodological research is the systematic study of the methods applied to research designs. It has often been referred to as ‘research on research’, involving the study and evaluation of how research is being done. Methodological research is not research that describes or discusses research approaches, methods or designs, rather it involves rigorous scientific evaluation of the efficacy of research designs or their discrete components to identify how these can be improved or better organised to ensure that the research processes are optimally efficient and effective for research enquiry.

 

Examples of Methodological Research within the School of Nursing and Midwifery.

Study Within A Trial (SWAT)

A SWAT is a self-contained research study that has been embedded within a host trial with the aim of evaluating or exploring alternative ways of delivering or organising a particular trial process (e.g. recruiting participants, informing people about the trial, taking consent, or reporting the findings of a trial) to provide evidence about how to improve the process. The SWAT programme has a repository for people to log their SWAT and to upload their findings https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/Repositories/SWATStore/

SWAT Projects:

  • Prioritising key motivators and challenges influencing informal caregivers’ decisions for participating in randomised trials (Study Within A Trial: SWAT-55). Smith V, Devane D, Treweek S, Corry M, Comiskey C, Grylska-Bach S, Hunter A, Healy P. Funding: HRB-TMRN-2017-SWAT Awards.

SWAT Publications:

  • Smith V. Clarke M, Begley C, Devane D. (2015). SWAT-1: The effectiveness of a 'site visit' intervention on recruitment rates in a multicentre randomised trials. Trials, 16:211.
  • Smith V, Clarke M, Devane D, Begley C, Shorter G, Maguire L. (2013) SWAT 1: What effects do site visits by the principal investigator have on recruitment in a multi-centre randomised trial? Journal of Evidence-Based Medicine 6, 136-137.

Core Outcome Sets(COS)


A COS represents the minimum that should be measured and reported in all clinical trials, and systematic reviews, of a specific condition, and is also suitable for use in clinical audit or practice. The existence or use of a COS does not imply that outcomes in a particular trial should be restricted to those in the relevant core outcome set, rather, there is an expectation that the core outcomes will be collected and reported, making it easier for the results of trials to be compared, contrasted and combined as appropriate; while researchers continue to explore other outcomes as well. Examples of current COS, and guidance on COS development can be found at http://www.comet-initiative.org/

COS Projects:

  • Development of a core outcome set for Pelvic Girdle Pain; a systematic review, qualitative interviews and Delphi consensus study. Wuytack F, Gutke A, Stuge B, Mørkved S, Olsson C, Stendal Robinson H, Vøllestad NK, Öberg B, Nilsson Wikmar L, Saldaña Mena JJ, Smith V. Funding: €80,303 by the European Centre for Chiropractic Research Excellence (ECCRE).
  • Development of salutogenic intrapartum core outcome sets (SIPCOS). Smith V, Daly D, Lundgren I, Schaur-Eri T, Gross M, Alfirevic Z, Downe S, Devane D. Conducted as part of an international collaboration within an EU COST Action (No: ISO907): Childbirth cultures, concerns and consequences

COS Publications:

  • Gargon E, Gorst SL, Harman NL, Smith V, Matvienko-Sikar K, Williamson PR. (2018) Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research. PLoS One Dec 28, 13(12): e0209869.
  • Wuytack F, Gutke A, Stuge B, Mørkved S, Olsson C, Robinson HS, Vøllestad NK, Öberg B, Nilsson Wikmar L, Saldaña Mena JJ, Smith V. (2018) Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study. BMC Medical Research Methodology, 18:158.
  • Davis K, Gorst SL, Harman N, Smith V, Gargon E, Altman DG, et al. (2018) Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries. PLoS ONE 13(2): e0190695. https://doi.org/10.1371/journal.pone.0190695
  • Smith V, Daly D, Lungren I, Eri T, Begley C, Gross MM, Downe S, Alfirevic A, Devane D. (2017) Protocol for the development of a salutogenic intrapartum core outcome set (SIPCOS). BMC Medical Research Methodology, 17:61
  • Egan A, G Sander, Maresh MJA, Loeken MR, Napoli A, Anastasiou E, Noctor E, de Valk HW, van Poppel M, Todd M, Smith V, Devane D, Dunne FP. (2017) A core outcome set for studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes. Diabetologia DOI 10.1007/s00125-017-4277-4.
  • Gorst SL, Gargon E, Clarke M, Smith V, Williamson PR. (2016) Choosing important health outcomes for comparative effectiveness research: an updated review and identification of gaps. PLoS ONE, 11(12): Art-No. e0168403
  • Egan AM, Smith V, Devane D, Dunne FP. (2015) Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey. Trials, 16:356, 1-7
  • Wuytack F, Smith V, Clarke M, Williamson P, Gargon E. (2015). Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews. Systematic Reviews, 4:73.
  • Smith V, Clarke M, Williamson P, Gargon E. (2015) Survey of new 2007 and 2011 Cochrane reviews found 37% of pre-specified outcomes not reported. Journal of Clinical Epidemiology, 68:3, 237-245.
  • Smith V, Daly D, Lundgren I, Eri T, Benstoem C, Devane D. (2014) Salutogenically focused outcomes in systematic reviews of intrapartum interventions: A systematic review of systematic reviews, Midwifery 30, e151-e156

Trial Recruitment research

Randomised trials are considered the gold standard for testing the effectiveness of interventions. A major challenge however, often encountered by trial researchers is slow or low recruitment, with reports suggesting that less than half of trials reach their original recruitment targets or require an extension to the trial in order to do so. While trial extensions are costly, and where recruitment targets are not met then often the research question is unanswered, wasting money and participants’ time. Many strategies are implemented to improve recruitment rates such as incentives to participate or tailored recruitment materials, however, as highlighted by Treweek et al. (2018) there is limited evidence and uncertainty remains as to on whether particular recruitment strategies are effective. To address this uncertainty, research on trial recruitment processes is recommended.

Trial Recruitment Projects

  • How are clinical care pathways being utilised for recruitment to randomised trials in the acute care setting: case study and document analysis. Smith V, Hennessy M, Emmanuelle G (PhD Scholar). Funded by the HRB-TMRN-2 PhD Scholarship.
  • Education and training for recruiters to trials: a pilot embedded randomised trial. Smith V, Devane D, Galvin S, Treweek S, Gamble C, Delaney H. Funded by the HRB-TMRN-2017-1-Pilot.
  • Priority setting in uncertainties in trial recruitment methodology (the PRioRiTy study). Devane D, Treweek S, Mitchel D, Glavin S, Broder A, McAuliffe E, Clarke M, Eustace J, O’Donnell M, Daly L, O’Shea E, Gill M, Whelton H, Smith V. Funded by the HRB-Knowledge Exchange and Dissemination Scheme (KEDS-2015-1618).
  • Methods to influence the completeness of response to self-administered questionnaires. Healy P, Smith V, Edwards P, Murphy E, Newell J, Burke E, Meskell P, Galvin S, Devane D. Funded by the HRB-Cochrane Training Fellowships 2015.

Trial Recruitment Publications:

  • Delaney H, Devane D, Hunter A, Hennessy M, Parker A, Murphy L, Cronin P, Smith V. (2019) Limited evidence exists on the effectiveness of education and training interventions on trial recruitment: a systematic review. Journal Clinical Epidemiology, available online 22-May at https://doi.org/10.1016/j.jclinepi.2019.05.013
  • Healy P, Galvin S, Williamson P.R, Treweek S, Whiting C, Maeso B, Bray C, Brocklehurst P, Clarke Moloney M, Douiri A, Gamble C, Gardner H, Mitchell D, Stewart D, Jordan J, O’Donnell M, Clarke M, Pavitt SH, Woodford Guegan E, Blatch-Jones A, Smith V, Reay H, Devane D. (2018) Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – The PRioRiTy (Prioritising Recruitment in Randomised Trials) Study. Trials, 19:147.
  • Healy P, Edwards PJ, Smith V, Murphy E, Newell J, Burke E, Meskell P, Galvin S, Lynn P, Stovold E, McCarthy B, Biesty LM, Devane D. (2018) Design-based methods to influence the completeness of response to self-administered questionnaires (Protocol). Cochrane Database of Systematic Reviews, Issue 7. Art. No.: MR000048. DOI: 10.1002/14651858.MR000048.
  • Smith V. Clarke M, Begley C, Devane D. (2015). SWAT-1: The effectiveness of a 'site visit' intervention on recruitment rates in a multicentre randomised trials. Trials, 16:211.