qMOLI phase - formal qualitative evaluation
MH, RA
RECRUITMENT, IOL
A formal qualitative element of the whole MOLI RCT was undertaken to assess the priorities, experiences, and acceptability of IOL for women in the MOLI study. It also covered the researchers’ and clinicians’ views of the feasibility, usability, acceptability, and barriers to implementation of the study. The qMOLI process and results reported here date from September to December 2021, when Covid restrictions had been lifted; thus while the women taking part in the qMOLI interviews had all completed the PaGES Index, and had given birth in the same two hospitals, they are not the same women whose PaGES responses are reported here. The interviews included a review of the PaGES Index administration, and this is reported here. Women were eligible for inclusion in the qMOLI study if they were recruited to the MOLI RCT and provided informed consent. Research Assistants (RAs) who administered the PaGES Index forms were interviewed; in addition, clinicians involved in screening, recruiting, randomising, and consenting participants to MOLI RCT were also eligible. Full recruitment details can be found in the registered qMOLI protocol at ClinicalTrials.gov (NCT04037683).Before recruitment, a sampling frame was outlined to specify key characteristics such as parity, mode of birth, induction methods for women and cadres of staff from the recruitment team. One-to-one interviews were conducted in the language of the patient’s choice (Hindi/Marathi), by a trained RA with a background in clinical research and Homeopathic medicine; these continued until data saturation was met. Two focus groups were conducted pre-trial in 2019 and a further six mid-trial in September – December 2021 by a senior qualitative researcher and clinician. Interview schedules were devised by the research group and reviewed throughout the project. FGDs were planned to capture data both before and during trial, in order to understand anticipated versus lived experiences amongst the research team.Interviews and focus group discussions were audio recorded and transcribed verbatim, including any observations noted. Interviews were translated into English by the interviewer and reviewed by a research team member. Researchers familiarised themselves with the data through post-interview meetings, note-keeping, re-reading, and detailed memo writing. Codes were generated using a primarily inductive approach through open coding of the data. Working independently, two researchers (KL and CK) initially devised separate coding frameworks. These were then merged through consensus. The wider trial management group reviewed a selection of transcripts (interview 16, 21 and focus group 1) before finalising the initial coding framework. Codes were clustered into categories with “other” categories to avoid missing important data.NVivo 12 software was used to code to the analytical framework before charting the data into matrices using summaries and illustrative quotes (KL, MH, LH). The data were thoroughly reviewed for common patterns to generate overall themes. Any differences in the data were examined for causality, and comparisons were explored between the different groups.