Dataset Information

Experiences of trial participants and site staff of participating in and running a large randomised trial within fertility (the endometrial scratch trial): a qualitative interview study.

ABSTRACT:

Objectives

To explore the experiences of endometrial scratch (ES) trial participants and site staff of trial recruitment and participation, in order to improve the experience of participants in future trials.

Design

Qualitative study of a subset of participants in the ES randomised controlled trial and a subset of trial site staff.

Setting

A purposeful sample of 9 of the 16 UK Fertility Units that participated in the trial.

Participants

A purposeful sample of 27 trial participants and 7 site staff.

Results

Participants were largely happy with the recruitment practices, however, some were overwhelmed with the amount of information received. Interviewees had positive preconceptions regarding the possible effect of the ES on the outcome of their in vitro fertilisation (IVF) cycle, which often originated from their own internet research and seemed to be exacerbated by how site staff described the intervention. Some participants appeared to not understand that receiving the ES could potentially reduce their chances of a successful IVF outcome. Those randomised to the control arm discussed feeling discontent; site staff developed mechanisms of dealing with this.

Conclusions

A lack of equipoise in both study participants and the recruiting site staff led to trial participants having positive preconceptions of the potential impact of the ES on their upcoming IVF cycle. Trial participants may not have understood the potential harms of participating in a randomised trial. The trial information sheet did not clearly state this; further research should assess how such information should be presented to potential participants, to proportionately present the level of risk, but to not unduly discourage participation. The amount of information fertility patients require about a research study should also be investigated, in order to avoid participants feeling overwhelmed by the amount of information they receive prior to starting IVF.

Trial registration number

ISRCTN23800982.

SUBMITTER: Chatters R

PROVIDER: S-EPMC8449983 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Purpose:To describe the experiences of non-medical discipline staff of difficulties and possibilities in inter-professional communication within the radiology department and remitting departments. Materials and Methods:Three focus group interviews were conducted with 16 non-medical discipline staff in a radiology department at a university hospital in Sweden. Data were analysed using qualitative content analysis. Results:The experiences of inter-professional communication by non-medical discipline staff within the radiology department and with remitting departments can be described in three categories, and six sub categories. The informants experienced difficulties in both oral and written inter-professional communication. Inadequate structures, incorrect information and unclear language in the referral forms, lack of feedback from clinicians and radiologists, and reduced face-to-face communication were described as factors that negatively influenced communication. Other difficulties were time shortage, inadequate routines and economy issues. The possibilities described were use of face-to-face communication, interpreters, and clear and well-structured referral forms. Conclusion:Non-medical staff experience that quality in inter-professional communication has a significant impact on health outcomes and patient safety. They expressed a number of difficulties in both written and oral inter-professional communication. For example inadequate written and oral communication, as well as practical issues such as routine could negatively influence the quality of the outcome of inter-professional communication. Lack of feedback from clinicians and radiologists and reduced face-to-face communication were also mentioned as factors that influence oral communication. Possibilities described to improve inter-professional communication quality and thus patient safety were professional contact on both professional and personal levels, use of interpreters, and clear and well-structured referral forms. The results of this study add to our knowledge of the difficulties and possibilities in non-medical inter-professional communication, which may enhance both safety and health outcomes for patients if implemented. Future studies in interprofessional communication is needed.

Project description:ObjectiveTo examine the experiences of patients, health professionals and screeners; their interactions with and understandings of diabetic retinopathy screening (DRS); and how these influence uptake.DesignPurposive, qualitative design using multiperspectival, semistructured interviews and thematic analysis.SettingThree UK Screening Programme regions with different service-delivery modes, minority ethnic and deprivation levels across rural, urban and inner-city areas, in general practitioner practices and patients' homes.Participants62 including 38 patients (22 regular-screening attenders, 16 non-regular attenders) and 24 professionals (15 primary care professionals and 9 screeners).ResultsAntecedents to attendance included knowledge about diabetic retinopathy and screening; antecedents to non-attendance included psychological, pragmatic and social factors. Confusion between photographs taken at routine eye tests and DRS photographs was identified. The differing regional invitation methods and screening locations were discussed, with convenience and transport safety being over-riding considerations for patients. Some patients mentioned significant pain and visual disturbance from mydriasis drops as a deterrent to attendance.ConclusionsIn this, the first study to consider multiperspectival experiential accounts, we identified that proactive coordination of care involving patients, primary care and screening programmes, prior to, during and after screening is required. Multiple factors, prior to, during and after screening, are involved in the attendance and non-attendance for DRS. Further research is needed to establish whether patient self-management educational interventions and the pharmacological reformulation of shorter acting mydriasis drops, may improve uptake of DRS. This might, in turn, reduce preventable vision loss and its associated costs to individuals and their families, and to health and social care providers, reducing current inequalities.

Project description:ObjectivesTo improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention.SettingThe interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options.ParticipantsThe sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes.OutcomesWe asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires.ResultsInterviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item.ConclusionsElderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in 'missing' or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an intervention is a subjective experience, it seems important to create a method by which participants can convey their personal experiences. These could be nested qualitative studies.Trial registration numberISRCTN77108101807.