Recruitment & consent

3.6 Recruitment & consent

Access to participants was through GP practices and gynaecology clinics participating in the ECLIPSE trial. Once ethical approval had been granted for the interview study, each of the 134 ECLIPSE Trial collaborating GPs and Gynaecologists was visited by a member of the ECLIPSE Trial Management Team to deliver up-to-date trial and qualitative study documentation and to teach collaborators about the interview study recruitment process. This was facilitated by means of posters (see Appendix III on page 257) and one to one training relating to the documentation specific to the interview study. Practitioners identified potential participants at the time that interest in participation in the ECLIPSE trial was discussed, and trial participation accepted or declined.

Permission was sought to pass contact details to the study researcher (part of the trial research team) by the use of the Consent to Contact form (see Appendix V on page 263). The qualitative study was rolled out in the final year of the recruitment phase of the ECLIPSE Trial (RCT), when more than 80% recruitment to the RCT had been achieved. There were approximately

one hundred women recruited to the ECLIPSE Trial during the qualitative study recruitment process. It is not known how many women were asked about participating in the interview study, as records were not kept of women who declined to complete the Consent to Contact form. All collaborators were trained to ask women about the interview study, but the returned Consent to Contact forms indicated that some collaborators made more effort to recruit than others. This was also the case when recruiting to the RCT.

There were advantages and disadvantages to nesting this qualitative study within the ongoing ECLIPSE Trial. The major advantage was access to the established framework of GPs and gynaecologists who where ECLIPSE Trial collaborators. This provided a network of doctors that were interested in understanding heavy menstrual bleeding and motivated to identify potential study participants via the Consent to Contact form. The ECLIPSE Trial collaborators covered a very large geographical area and so were able to identify potential study participants from diverse backgrounds with different demographic characteristics. The framework of the ECLIPSE Trial also gave this study credibility and support with administrative tasks such as printing of study documentation.

There was only one major disadvantage to nesting this study within the ECLIPSE Trial and that related to the recruitment of women from a variety of ethnic backgrounds. Recruitment to the study was restricted to women who presented to the ECLIPSE Trial collaborators requesting treatment for heavy menstrual bleeding. Fewer women from ethnic minority backgrounds presented seeking treatment, which in turn reduced the ethnic diversity captured in this study sample population. As this study was nested within the ECLIPSE Trial the researcher could not use snowballing or other targeted techniques to specifically recruit women of diverse ethnicity. This

then limited the amount of data relating to the effect of ethnicity on womenÕs experiences of heavy menstrual bleeding.

A total of fifty-two Consent to Contact forms were received and all of these women were contacted to discuss their participation in the interview study.

One woman was ineligible, as within one month of her consultation she had undergone a hysterectomy as a private patient. During the first three months of the recruitment process six women declined to participate in the interview study, as they had not fully understood what participation in the study would mean to them. This identified a retraining need in two of the GP practices and one of the secondary care clinics from which the potential study participants were drawn. Following retraining of these collaborators this problem ceased to occur and the remaining forty-five women who signed the Consent to Contact form were all willing to be interviewed. From the forty-five, twenty-seven were finally selected according to the criteria outlined above. The other women were all telephoned and thanked for their interest.

The study researcher sent study information via a patient information letter and verbal consent was obtained to visit the participant in order to conduct an interview. Text was found to be a useful means of communication with several women and email was also popular but most contact to arrange the interviews was conducted by telephone. Discretion was always maintained with the women being offered a more convenient or appropriate time for telephone contact. Over the course of the study period most telephone contact was conducted in the evenings or at weekends as the majority of the women worked during office hours.

On arrival at the participants home time was allowed for questions and conversation to establish the womenÕs understanding of the research process and study participation. Only if both researcher and participant

were satisfied with each otherÕs understanding of general research process and specifically the interview process was written consent to participate obtained using the Consent Form (Appendix VI on page 264). On one occasion the interview had to be rescheduled as the potential interviewee had taken prescription medication (analgesia) following knee surgery and the researcher felt that true informed consent was not achievable due to the slight drowsiness of the potential participant. An alternative date was agreed for one month later and this woman was then able to give full informed consent.