Exploring the impact of ineligibility on individuals expressing interest in a trial aimed at improving daily functioning regarding perceptions of self, research and likelihood of future participation

Christopher P Dwyer, Helen McAneney, Fionnuala M Rogers, Robert Joyce, Sinéad M Hynes

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Abstract

BACKGROUND: Eligibility guidelines in research trials are necessary to minimise confounds and reduce bias in the interpretation of potential treatment effects. There is limited extant research investigating how being deemed ineligible for such trials might impact patients' perceptions of themselves and of research. Better understanding of the impact of patient ineligibility could enhance design and implementation of future research studies.

METHODS: Eight semi-structured telephone interviews were conducted to explore the impact of ineligibility on self-perceptions; perceptions regarding the nature of research; and the likelihood of expressing interest in future research. Data were collected and analysed thematically through inductive, interpretive phenomenological analysis (IPA).

RESULTS: Five themes emerged regarding the experience of being deemed ineligible: (1) Being deemed ineligible is emotion and reaction evoking; (2) 'Doing your bit': Helping others and increasing the value of research; (3) Communication of ineligibility; (4) Appreciation for those who express interest; and (5) Subsequent perceptions and attitudes towards research.

CONCLUSIONS: The results suggest that being deemed ineligible can elicit negative emotional outcomes but is not likely to change perceptions of or attitudes towards research, possibly due to a desire to help similar others. Ineligibility can impact future participation in some cases, thus reducing the recruitment pool for subsequent research studies. Recommendations are provided to help minimise this risk. Advising of ineligibility in a personal way is recommended: with enhanced clarity regarding the reasoning behind the decision; providing opportunities to ask questions; and ensuring that appreciation for the patient's time and interest are communicated.

Original languageEnglish
Article number264 (2021)
Number of pages12
JournalBMC Medical Research Methodology
Volume21
Early online date27 Nov 2021
DOIs
Publication statusPublished online - 27 Nov 2021

Bibliographical note

This study-within-a-trial was conducted within research funded by the Health
Research Board (Ireland) under a Definitive Interventions and Feasibility Award
(DIFA-FA-2018-027). No further funding was associated with the study-within-a-trial.
© 2021. The Author(s).

Keywords

  • Communication
  • Emotions
  • Humans
  • Probability
  • Qualitative Research

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