Ethical approval was granted by the Biomedical & Scientific Research Ethics Committee (BSREC) at the University of Warwick for the studies as indicated in table 3.8:
Study BSREC Reference Approval
Letter Patient Preferences for Sexually
Transmitted Infection Testing & Treatment – Pilot Phase
REGO-2014-694 Appendix 2
Patient Preferences for Sexually Transmitted Infection Testing & Treatment – Final DCE
REGO-2015-1647 Appendix 3 Identification of pathways, costs and
performance monitoring data for Chlamydia Testing and Treatment
REGO-2015-1497 Appendix 4
Table 3.8 - Summary of Ethical Approval
3.7.1.1 Consent
Informed consent was recorded for all focus group, cognitive interview and costing study participants. A statement of consent was included at the start of the online DCE questionnaire which made it clear that by continuing participants were consenting for their response to be used as outlined in the participant
Specific consideration was given to the issues regarding consent of 16-18 year olds. The guidance provided by the MRC states that for research covered by the clinical trials regulations a minor is defined as someone under the age of 16 and “where common law applies – all situations not covered by the Regulations – the law states that the age of majority is 18. Whilst not considered to have fully reached adulthood, young people between the age of 16 and 18 are presumed to be competent to give consent” (Medical Research Council, 2007:23).
Young people are considered competent to consent to have sex at age 16 and they can choose to access NHS STI testing and treatment services (including ordering postal chlamydia testing kits from the NCSP) without their parents being informed or requiring their consent. As the research involved talking to 16-18 year olds about their preferences for STI testing and treatment services, and within the context of the MRC guidance, parental consent was not required in addition to participant consent for this study.
3.7.1.2 Sensitivity of Topic
For participants in the focus groups and cognitive testing interviews the only potential risk identified was that participants may regard the topic of STI testing and treatment to be embarrassing or sensitive. Participants were made aware of the topic in advance and that discussion centred on the attributes of testing and treatment services, and what may influence their decision to use them. Participants were also reminded during the introduction to the focus group and interviews that if they were not comfortable with answering a question or taking part in the discussion they did not have to. For participants completing the DCE online the same issue exists however they had the option to drop out of the questionnaire at any point prior to completion.
For participants in the costing study, no sensitive issues were identified as their participation related directly to their job role.
3.7.1.3 Expenses & Payments
Participants in the focus groups and cognitive interviews were offered a £10 shopping voucher in recognition of their time commitment. Participants in the final online DCE were offered reimbursement in accordance with the predefined criteria used by Youthsight of 1 point (equivalent to £1) for completion of a survey of up to 20 minutes in length. Points are then exchanged for Amazon Vouchers. No participant in the costing study was offered reimbursement as their participation was linked directly to their job role.
3.8
Summary
This chapter has introduced HTA, specifically eHTA as the overarching framework for the consideration of the research questions explored in this thesis. Whilst the methods used for undertaking HTA at the end of the technology development process (at the point of market access) are well defined and utilised by agencies such as NICE, published research on the methods and application of eHTA are limited, particularly in respect of telemedicine, eHealth and mHealth. It is important to recognise that the research presented addresses some, but not all aspects of eHTA, with the safety and clinical effectiveness of the OCCP and self-test being developed being assessed by other researchers within the eSTI2 consortium.
The technology being considered in this thesis has been situated in the appropriate stage of technology development to inform the selection of methods to address the research questions. This chapter has provided an overview of the key considerations for the selection of the methods to answer the research questions within the context of eHTA. As outlined, both the DCE and economic evaluation are comprised of a number of component pieces of research which are presented in the following chapters, each chapter includes a detailed outline of the methods selected and the justification of the choices made. The next chapter, Chapter 4, introduces the two literature reviews undertaken to understand patient preferences for and acceptability of STI testing and treatment and to identify the ‘long list’ of attributes for consideration in the DCE.
4
CHAPTER 4 – LITERATURE REVIEWS TO INFORM
SELECTION OF POTENTIAL ATTRIBUTES FOR THE DCE
4.1
Introduction
This chapter describes two separate literature reviews that were undertaken to inform the DCE study design and the selection of a ‘long list’ of potential attributes for the DCE:
i. a review of the use of stated preference studies for STI testing and treatment services adopting a systematic review approach
ii. a scoping review of other studies exploring the preferences and acceptability of STI testing and treatment services.
The literature reviews had different objectives. The objective of the first literature review was to identify and appraise published studies in order to inform the methods used for the design and development of the proposed DCE and to explore evidence on which attributes influence patient and clinician preferences for the testing and treatment of STIs. The desired outcomes would both contribute to a ‘long list’ of potential attributes and inform the development of the planned DCE. The objective of the second literature review was to identify which factors influence individuals’ decisions to access testing and treatment services for STIs. The desired outcome of this literature review was solely to contribute to the ‘long list’ of potential attributes for the DCE.
Consideration was given to the methods for undertaking the literature reviews using Grant & Booth’s typology of reviews (Grant and Booth, 2009). For the first review a systematic review approach was adopted, which conformed to the methods outlined in the Cochrane Handbook for the Systematic Review of Interventions (Higgins and Green, 2011) where possible.
For the second review a scoping review was undertaken. This is defined by Grant and Booth as “a preliminary assessment of the potential size and scope of available research literature. It aims to identify the nature and extent of research evidence (usually including ongoing research)” (Grant and Booth, 2009:101). A weakness of this approach is that it does not include an assessment of the quality of studies which may lead to bias, however since the aim of this second review was to add to the ‘long list’ of potential attributes, the quality of a study was less relevant. The overall aim was to produce a comprehensive list of potential attributes to form the framework for focus group discussion.
Adapting the approach in the Cochrane Handbook and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement (Moher et al., 2009), review processes consisted of the following stages:
• defining the review question and formulating the criteria for including studies;
• literature searches;
• selection of studies to include in the review;
• data extraction;
• quality assessment;
• synthesis.
Quality assessment was undertaken for the first review only, recognising the aim was to learn from the application of stated preference methods to inform the design and development of the planned DCE as well as the creation of a ‘long list’ of potential attributes.