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2.3 Components of the study

2.3.1 Research instruments development

Two main objectives are established to develop three research instruments. First, the quantitative element aims to investigate the extent and nature of the relationship between psychological factors and expectation with pain and functioning on quality of life.

A literature review was undertaken to review the relevant psychological factors and expectations of pain and function. A wide range of psychological factors and outcomes were selected to develop a single questionnaire built from carefully selected validated questionnaires and designed to explore their quantitative relationships. Additional questions were also constructed to collect relevant characteristics and other factors with respect to the participants, and to enable screening against the inclusion criteria.

Regarding reviews of previous qualitative studies, they reported pain perspective and experience through THR and the recovery process. Therefore, pain experience was

Recruitment

concerned to explore the perspective of patients in pain with relevant psychological factors throughout the patient’s treatment and recovery journey. This may explain the quantitative relationship that was conducted concurrently. A diary was considered the most appropriate method to capture pain experience and daily views of patients over a short period127. The diary was mailed to participants following confirmation of THR and a face to face interview was then conducted after analysis of the diary to confirm, explore, and expand upon critical points from the diary.

2.3.1.1 Rationale of questionnaire development

Validated questionnaires were selected through psychometric properties. Inclusion criteria were set up to screen several questionnaires, which consisted of content validity, construct validity, internal consistency, test-retest reliability and responsiveness2,3. Two other characteristics were included in the criteria. They were duration of self-completion and number of studies using the questionnaire in patients undergoing THR because of covering various psychological factors and outcomes, and the purpose of this study.

Following the selection, combining validated tools can impact on their validity from the previous reports. Consequently, in order to minimise the impact of re-design, two additional validation steps were included in the development phase for the questionnaire, whereby the amalgamated questionnaire was first iteratively developed by expert review and secondly subject to extensive piloting by cognitive interviews. This aimed to evaluate any errors in the responses to the questionnaire, and explore any items that posed particular problems130 from the process of thinking and interpreting the questions131 to assess the content validity. It has been utilised in the developmental process of high quality and robust questionnaires in many areas such as dietary survey132, education133, and health134 that was classified as two main techniques: think-aloud and verbal probing techniques. Think-aloud technique required participants to read out loud and independently reflect their thoughts with at least involvement of researcher. The other technique was probing to ask further questions depending on their responses130,135.

2.3.1.1.1 Cognitive interview schedule

To guide the cognitive interview, an interview schedule was developed (Appendix 13).

There are four parts to this schedule which comprised of introduction, warming up, actual interview and closing session. First, an introduction part was used to introduce the researcher and explain details of the interview. Following this, the researcher prepared the participant to become familiar with the think-aloud process within one question. Next, the participant started reading the question out loud and answered some questions, the verbal probing technique. Finally, the closing session was that the interviewer asked other opinions about the questionnaire.

2.3.1.1.2 Data collection of cognitive interviews

Purposive sampling was utilised to invite participants via pain psychology research panel.

Participants, who either suffered from pain in their hip or had experience of hip surgery, were over 18 years old, and comprehended English, were received an email of invitation to interview with the patient information sheet (Appendix 10) and the participation form (Appendix 11). Prior to the interview, each participant completed a consent form giving consent to take part and allow the interview to be recorded (Appendix 12). The researcher also had the role of the interviewer and noted down important points during interview for further analysis. This was summarised with the recorded information in order to identify errors in the questionnaire so that the questionnaire could be revised and finalised to use in the questionnaire survey. Two rounds of interviews took place. The second round was arranged to confirm that issues had been adequately addressed following implementation of changes from the first round. Full details of questionnaire development have been described in chapter 3.

2.3.1.2 Rationale of diary and interview schedule development

Diary questions were constructed from previous literatures110,136. Structure and format were subject to iterative review by the research team and other expert opinions to assess content and face validity. The purpose of the final design was to elicit a broad range of experiences and opinions from participants. Following on from this, the diary was returned and analysed, face-to-face basis interviews were conducted to expand upon critical points and to explore incomplete issues from the analysis of the diary137. Four relevant topics of

this development rationale comprised reflective techniques, critical incident technique, diary, and interview schedule.

Reflective techniques were applied in developing the diary and reflecting significant events from the diary in the interview part. This technique was selected to mainly develop knowledge in health education, teaching and learning areas. A few reports were found from the perspective of patients or caregivers. As a result of a Canadian study on Alzheimer’s caregivers, the most important type of diary used was the reflective diaries. A reflective diary provided precise details in experience of caregivers such as daily life, feelings and significant events and that was also a benefit in the therapeutic writing of emotional support for caregivers138.

Moreover, critical incident technique is one type of reflective technique that was utilised to reflect the participant’s feelings, while interviewing is based on the critical events in the diary. Critical incident technique was applied to many areas such as organisational psychology, nurse, and education137 including health care139. This technique was applied to explore the critical incidents from diary entry prior to face-to-face interview.

A solicited diary was utilised to capture pain experiences and views from participants without possible bias140 in their own words141. It was a daily record of participants specifically in the open-ended question designed142. In addition, this approach was useful in that it ably recorded the transition of life experience, especially in recovery from surgery, and emphasises changes110. The diary was also a vehicle used to address situations that the researcher was not able to observe122 in particular with day-to-day activities in an appropriate period - a range of one or two weeks136. In the qualitative element, a two week period was selected to be an appropriate length of time to balance between deep enough data and less overloaded tiredness136. However, there were some disadvantages of the diary approach such as the possibility of over or under-reporting141, accuracy and verifiability, dropout, and need for literacy ability143. These disadvantages were considered and prevented by using interviews following the diary being returned in order to confirm data in the diary entry. In addition, follow-up diary with interview possibly maximised

recruitment due to frequently contacting participants. Full details of diary development were described in chapter 3.

Moreover, the interview schedule was dependent upon the content of individual diaries and was responsive to the comments made therein. It was constructed in three parts:

introduction, probes, and closing session to guide semi-structured interview. The introduction part explained the aim of the element and the participants’ role during the interview. Next, the probes part consisted of exploring, reflection of and expanding critical points from data in the returned diary. In the closing session, participants were asked about comments in the diary and interviews as well as any views that they had.