SYSTEMATIC REVIEW OF THE ROLE OF KAVA IN MOTOR VEHICLE CRASH INJURY

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CHAPTER 5: DEVELOPMENT AND PILOT OF A QUESTIONNAIRE TO MEASURE HEALTH  OUTCOMES FOLLOWING MOTOR VEHICLE CRASH INJURY IN FIJI

INTRODUCTION

Drawing on the findings from the literature review in Chapter 4, this chapter presents the methods and results of the development and pilot of a questionnaire to measure long-term health outcomes following serious, injury-involved motor vehicle crashes (MVCs) in drivers in Fiji (Study 1).

AIMS AND OBJECTIVES

The aims of this pilot study were to: i) develop and pre-test a questionnaire to measure long term health outcomes following serious injury-involved MVCs; ii) to describe issues relating to the questionnaire and the methods; and iii) describe revisions made to the questionnaire as a result of the pre-test findings prior to its use in the Fiji Car Crash Disability (FCCD) Study.

METHODS
STUDY DESIGN AND SETTING

A pilot study was conducted in Suva, Fiji, over a two month period (20 January to 20 March 2016) on a purposive sample of people with acquired disabilities due to injury or other causes. The pilot was designed to pre-test a questionnaire developed to measure health outcomes, particularly, disability and HRQoL following serious injury-involved MVCs, trial the methods of recruitment and interview, and revise the questionnaire and methods based on the findings of the pilot.

THE HEALTH OUTCOMES QUESTIONNAIRE

The Health Outcomes questionnaire development was guided by the findings of the literature (Chapter 4), which identified commonly used generic measures of HRQoL, the quality of these studies in relation to pre-defined criteria, and the breadth of capture of content relevant to injury and Pacific well-being. However, the review revealed that most studies employed generic HRQOL instruments to measure injury outcomes, with only one study located that had used a health status measure and none that had used a generic functional outcome/disability measure. Discussions with study stakeholders, (in particular the Fiji National Council of Disabled Persons (FNCDP) and the Ministry of Health, Wellness division) during this time helped identify aspects of disability that were important for measurement and reporting for a Fiji context. As a result, a Health Outcomes Questionnaire was developed that included validated instruments such as the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), 12-item version for the assessment of functional outcomes/disability;²²⁸ the EQ-5D, a generic HRQoL measure of health status,^{229, 230} and the Short-screen scale for post-traumatic stress disorder (PTSD).²³¹ Other questions came from the TRIP study (described in detail in section 3.5.1) to allow for comparison (e.g. marital status, income level, health status, lifestyle) with baseline characteristics. Questions from previous injury studies²³² (e.g. supplement income or compensation); items on spirituality and family support (relevant to Pacific health and well-being), alongside novel ones (e.g. impacts of RTI on the family and support) were also included. The questionnaire contained 79 items in total organised into seven sections: demographic information, health status, functional ability, lifestyle, emotional health, impact on family and support and personal information (see Appendix E). The questionnaire included a combination of closed ended questions, statements with dichotomous or multiple choice options, Likert scale-type options, and open-ended questions. The questionnaire was administered in a face-to-face interview.

RECRUITMENT

A convenience sample of 20 adults aged ≥18 years and older, living with an acquired disability, was sought in the greater Suva urban area. Excluded individuals were those who had participated in the TRIP study.²³³ Respondents were recruited through convenience sampling using the study’s stakeholder network. Initial contact was made with the FNCDP, the national co-ordinating body for disability development in Fiji.²³⁴ As one of three stakeholders in the proposed FCCD study, this organisation played an important role in the development of the questionnaire and the recruitment process. Through the FNCDP Director, contact was established with the Spinal Injury Association and Counterstroke-Fiji as potential avenues for participant recruitment. The Spinal Injury Association provided a list of names and phone contacts of potential respondents for the candidate to approach. These people were provided with a brief overview of the study and invited to participate. If they agreed, the candidate established a convenient day, time and venue for the interview. Those that requested time to think about participation were asked to give a day and time to be re-contacted. A maximum of three phone attempts was made to contact people to ascertain their interest in participating. Recruitment via Counterstroke-Fiji was done in a series of face-to-face meetings with stroke survivors who attend weekly “talk shop” social gatherings at the FNCDP complex. Some of those who consented to participate opted to have the interview at the complex soon after the “talk shop” session; others provided the candidate with a suitable venue, day and time to be contacted again. Respondents were advised that other family members were welcome to be present and to participate in the interview. This was encouraged because not only is this culturally appropriate, it also can alleviate interview anxiety and in some situations they could act as interpreters.

THE INTERVIEW

Prior to the interview, the candidate explained the objectives of the study using the participant information sheet (see Appendix C). Verbal agreement to participate was obtained prior to the interview commencing and written consent on completion of the interview (Appendix D). This approach was taken because some respondents felt uncomfortable signing documents until rapport was established. Unless a translator was requested, all interviews were conducted in English. In addition to undertaking all interviews, the candidate took the role of the Fijian translator. A Hindi translator was also available when required. There were two distinct phases to each interview. In the cognitive interviewing phase, the interviewer encouraged respondents to comment or ‘think aloud’ about the questions they were answering, including the meanings of words, the clarity of the words, highlighting items that were not easy to answer or those that did not capture their ideas. During this phase, the interviewer assessed participant responses to questionnaire items according to pre-defined criteria of the Conrad and Blair, five-category classification,^{35, 235} to look for the following specific issues: Lexical problems relate to the respondent’s understanding of the meaning and Temporal problems relate to difficulties encountered by respondents when asked about events in relation to time periods. Inclusion/exclusion problems relate to the categories used in a question. Problems can arise when respondents may have answers that are outside of the response options provided, so that they are forced to choose among the options that do not apply to the respondent (misclassification) or not answer the question at all (non-response). Logical problems can involve presuppositions where the question asked is not relevant to the respondent or is perceived as repetitive (tautology). Computational problems include other issues that do not fall into any of the other categories (i – iv). The conventional pre-testing phase involved the candidate’s (as interviewer) assessment of the overall experience of administering the questionnaire. Issues important to this phase included item formatting, looking out for redundant questions, sequencing, questionnaire length and time taken to complete an interview, as some of the issues. An awareness of the cultural context in the conduct of this research was considered in the design of the study questionnaire and the methods. The study adhered to the principles of cultural awareness similar to that described by Pacific research methodologies,^{179, 236} and the Health Research Council of New Zealand guidelines²²⁸ to ensure that the methods demonstrated respect, establishing of relationships and reciprocity.

ANALYSIS

Issues identified in the cognitive interviewing phase and conventional pre-testing phase informed amendments to the questionnaire. A general inductive approach was used to classify questionnaire feedback to identify common themes or categories that emerged and these were presented in tabular format.²³⁷

ETHICAL CONSIDERATIONS

This study was approved by the Fiji National Research Ethics Review Committee of Health (Ref No. 2015.70.MP) and the University of Auckland Human Participants Ethics Committee (Ref No. 013973). All potential respondents received an information brochure outlining the purpose and requirements of the study. Those who were interested in participating provided written informed consent or a thumbprint in accordance with Fiji laws.²³⁸ Respondents were informed that they could withdraw from the study at any time. All research data, both electronic and paper-based are stored securely at the University of Auckland.
 

RESULTS
SAMPLE CHARACTERISTICS

During the two-month pilot phase, 16 adults were approached. Of these, two declined participation and two were not contactable. Of the 12 respondents, aged between 26 to 78 years, over half (n=8) were males and the majority (n=8) were Fijians (Table 15). The acquired disabilities experienced by the respondents were related to injury (n=5), stroke (n=6) and infection (n=1). The average years living with a disability was 13 years (range: 6-23 years). The median WHODAS simple score for respondents was 6, suggestive of moderate levels of disability.^{239, 240} Most of the interviews was conducted at home (n=6), three were conducted at the workplace, two at the ‘Talk shop’ meeting, and one at a sports training site. Each interview took between 75 to 90 minutes to complete. All respondents completed the questionnaire in English. In five interviews, family members were present and in one interview, a family member assisted with completion of the questionnaire.

CHAPTER 1: INTRODUCTION
1.1 ROAD TRAFFIC INJURIES: A GLOBAL PUBLIC HEALTH ISSUE
1.2 ROAD TRAFFIC INJURIES: A PACIFIC PERSPECTIVE
1.3 RISK FACTORS FOR ROAD TRAFFIC INJURIES: AN OVERVIEW
1.4 RISK FACTORS FOR ROAD TRAFFIC INJURIES: A PACIFIC PERSPECTIVE
1.5 ROAD TRAFFIC INJURY PREVENTION
1.6 THE NON-FATAL OUTCOMES OF ROAD TRAFFIC INJURIES
1.7 FIJI – THE STUDY SETTING
1.8 THESIS AIMS AND OBJECTIVES
1.9 THE CANDIDATE’S ROLE
1.10 PERSONAL STATEMENT
1.11 STRUCTURE OF THE THESIS
CHAPTER 2: SYSTEMATIC REVIEW OF THE ROLE OF KAVA IN MOTOR VEHICLE CRASH INJURY
2.1 INTRODUCTION
2.2 KAVA USE AND RATIONALE FOR A SYSTEMATIC REVIEW
2.3 METHODS
2.4 RESULTS
2.5 CHAPTER SUMMARY
CHAPTER 3: CASE CONTROL STUDY AND THE ROLE OF KAVA IN MOTOR VEHICLE CRASH INJURY
3.1 INTRODUCTION
3.2 STUDY OBJECTIVE AND HYPOTHESIS
3.3 STUDY DESIGN AND RATIONALE
3.4 SELECTION OF THE STUDY BASE
3.5 RESULTS
3.6 CHAPTER SUMMARY
CHAPTER 4: MEASURING LONG-TERM HEALTH OUTCOMES FOLLOWING INJURY IN LOW- AND MIDDLE-INCOME COUNTRIES: A REVIEW OF
MEASURES AND CONCEPTS
4.1 INTRODUCTION
4.2 HEALTH RELATED QUALITY OF LIFE
4.3 A LITERATURE REVIEW OF HEALTH RELATED QUALITY OF LIFE MEASURES USED IN LOW-AND MIDDLE-INCOME COUNTRIES TO ASSESS QUALITY OF LIFE FOLLOWING INJURY
4.4 CHAPTER SUMMARY
CHAPTER 5: DEVELOPMENT AND PILOT OF A QUESTIONNAIRE TO MEASURE HEALTH OUTCOMES FOLLOWING MOTOR VEHICLE CRASH
INJURY IN FIJI
5.1 INTRODUCTION
5.2 AIMS AND OBJECTIVES
5.3 METHODS
5.4 ETHICAL CONSIDERATIONS
5.5 RESULTS
5.6 CHAPTER SUMMARY
CHAPTER 6: THE FIJI CAR CRASH DISABILITY STUDY – AIMS AND METHODS
6.1 INTRODUCTION
6.2 STUDY OBJECTIVES
6.3 METHODS
6.4 ETHICAL CONSIDERATIONS
CHAPTER 7: FIJI CAR CRASH DISABILITY STUDY – RESULTS
7.1 INTRODUCTION
7.2 STUDY NUMBERS AND RESPONSE RATES
7.3 MEASURING HEALTH STATUS AND DISABILITY IN CRASH PARTICIPANTS (PART 1)
7.4 PERCEPTIONS OF PARTICIPANTS ON PERCEIVED IMPACTS OF SERIOUS INJURYINVOLVED CAR CRASH (PART 2)
7.5 ALIGNMENT OF QUANTITATIVE MEASURES OF HEALTH OUTCOMES WITH OPENENDED RESPONSES
7.6 CHAPTER SUMMARY
CHAPTER 8: DISCUSSION AND CONCLUSION
8.1 INTRODUCTION
8.2 WHAT IS ALREADY KNOWN ABOUT KAVA’S EFFECT ON MOTOR VEHICLE CRASHES, ROAD TRAFFIC INJURIES, OR DRIVING PERFORMANCE?
8.3 IS THERE AN ASSOCIATION BETWEEN KAVA USE AND THE RISK OF FOUR WHEEL MOTOR VEHICLE CRASH INJURIES IN FIJI?
8.4 THE CONSEQUENCES OF MOTOR VEHICLE CRASHES IN FIJI
8.5 IMPLICATIONS FOR POLICY, PRACTICE AND FUTURE RESEARCH
8.6 CONCLUSION
APPENDICES
APPENDIX A: GATE-LITETM CRITICAL APPRAISAL CHECKLISTS
APPENDIX B: TRIP STUDY QUESTIONNAIRE
APPENDIX C: PARTICIPANT INFORMATION SHEETS – PILOT & MAIN (FCCD) STUDIES
APPENDIX D: CONSENT FORMS – PILOT AND FCCD STUDIES
APPENDIX E: STUDY QUESTIONNAIRE – PILOT STUDY
APPENDIX F: STUDY QUESTIONNAIRE (REVISED) – FCCD STUDY

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A thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy, The University of Auckland, 2017