Methods
Design
A qualitative study using an interpretive phenomenological analysis (IPA) approach. Ethical approval for the study was granted by NRES committee North East - Northern and Yorkshire (ref no: 12/NE/0052) and included obtaining written consent from participants for the publication of their data.
Participants
Potentially eligible patients were identified by the UKUFF trial team. The inclusion criteria for the UKUFF trial specified patients with full thickness degenerative tears, without trauma, were eligible for inclusion. No patient had an isolated subscapularis tear.
Data collected upon trial entry were used to invite participants with a range of Oxford Shoulder Scores, trial arm allocations, treatments and outcomes. UKUFF participants are English speaking patients aged over 50 with a rotator cuff tear (diagnosed by ultrasound or MRI scanning). Potential participants were posted an invitation by their local UKUFF site principal investigator. Interested patients contacted the study team directly by pre-paid reply slip, telephone or email (their preference) to discuss the study and, if willing, arrange an interview. Written informed consent was obtained pre- interview. Participant characteristics are presented (Table 1).
Sample Size
The sample size needed to be sufficiently large to enable relevant data to be obtained, without being so overly large that detailed analysis is subsequently prevented. 20 participants (from 46 people approached) provided a rich insight into the experience of the intervention and recruitment was ceased at this point
Interviews
A preliminary semi-structured interview guide was developed, following a literature review, by the researchers and an ex-shoulder patient (Table 2). Participants were invited to participate in in-depth semi-structured interviews at a time and venue of their choice. 18/20 interviews were held at participants home and two at conference meeting rooms between September 2012-April 2013. Participants were from across England and Wales, achieving a wide geographical and urban/rural spread. Visits ranged from 50 minutes to two and a half hours in duration, with taped interviews ranging from 28–101 minutes (average 45 minutes). Time was spent after the interviews in everyday conversation, allowing the interviewer (CML) to check the well being of the interviewee; interviews did not cause obvious distress. Interviews were digitally audio recorded and transcribed. Field notes, memos and a reflexive diary were recorded throughout. Participants were posted a summary of their transcript, providing opportunity to check quotations and views and remove anything with which they did not feel comfortable (member checking). No participant withdrew information, several added additional update comments or something they had remembered post-interview.
Data Analysis
Audio recordings were listened to and transcripts read until they become familiar. Data was coded in accordance with IPA. CML broke down interview data into discrete units and wrote these in the right hand margins of transcripts, making concerted efforts to remain close to the data and continually explore meaning. Units found to be conceptually similar were grouped together under more abstract categories and these written in the left hand transcript margins. NVIVO 9 software was used to assist data management. The process of constantly comparing data, codes and categories occurred throughout all analyses. The first three interviews were considered a pilot phase and the analyses discussed by all authors. The sampling approach was discussed at this point, and again after nine interviews. No changes in approach were considered necessary since a wide range of Oxford Shoulder scores, degree of tear and outcomes were being provided by participants. Further strategies to promote rigour, including peer review, code-recode audits, constant comparison of data, codes and categories occurred throughout. KB assisted in the peer review of emerging codes and categories; including independently coding a sample of the interview data (n = 8 full transcripts, including the pilot 3). Literature searches, to promote rich interpretation of the data, were incorporated in the analyses and writing up.