An exploration and comparison of Shared Decision Making and Informed Consent in different clinical settings

Research Question: Shared Decision-making and Informed Consent in health care: An exploration and comparison of patient and health care professional experiences in primary and secondary care. Can implementation of each paradigm be informed and improved upon with reference to the other? Background Shared Decision-making (SDM) and Informed Consent (IC) purport to promote patient engagement in health care decisions. SDM has developed from patient engagement in medical research whilst IC has developed from case law in routine medical practice. It has been suggested that the paradigms are concordant, particularly in cases of elective surgery where risks may be high and there is more than one choice. Unilateral hip arthroplasty for osteoarthritis is one such case where potential adverse consequences can be severe, yet patients have the choice of not having surgery but continuing or increasing their analgesia. Patient decision aids have been developed as a tool to promote SDM and engage patients in decision-making. They are developed to cover medical decisions where there is more than one choice and the evidence is equivocal. These are described as preference sensitive decisions as they are dependent on patient values and preferences. One example is the consideration of insulin therapy in patients with Type 2 diabetes mellitus (T2DM) whose HbA1c is not controlled on maximum tolerated oral therapy. What has not been explored is whether these decision-making paradigms are actually concordant and whether techniques from each can inform improved implementation of the other. Methods One study (study 1) explored the implementation of SDM and a Patient Decision Aid (PDA) in a primary care setting by recruiting patients with T2DM who were considering insulin therapy and their corresponding health care professional (HCP). A second study (Study 2) explored the implementation of IC in relation to unilateral hip arthroplasty for osteoarthritis by recruiting patients undergoing the procedure and orthopaedic surgeons who regularly obtained consent for this operation. Participants from study 1 were recruited purposively from the intervention arm of The PANDAs study, a cluster Randomised Control trial in primary care. The PANDAs study was exploring the outcomes of using a PDA for patients with T2DM considering insulin therapy. Patients and their corresponding HCPs took part in semi-structured in-depth interviews after a consultation in which they had used the PDA. The consultation was audio-recorded and analysed, using the OPTIONs instrument, to assess the HCPs skill at engaging the patient in the decision-making process. Qualitative data from the interviews was triangulated with quantitative data from the consultation analysis. Patient participants for study 2 were recruited by two methods. Patients for semi-structured in-depth interviews were recruited prospectively from the list of one orthopaedic surgeon and interviewed once before surgery and once three months after surgery. A second cohort of patients were recruited retrospectively from the list of two different surgeons, having had surgery within the last six months. These patients participated in two focus groups to discuss their different experiences of the consenting process. Patient reported outcome measures (PROMs) in the form of the Oxford Hip Score were collected before surgery and 3 months after surgery. This quantitative data was used to inform the post-operative interview and triangulate patients expressed satisfaction with the surgery. Orthopaedic surgeons were recruited from one Orthopaedic Department and participated in semi-structured in-depth interviews on their techniques for obtaining IC. Interview and focus group were analysed using Thematic Framework Analysis, employing an iterative approach until data saturation was achieved. The main themes from each study were compared and synthesised into frameworks that could be used to encourage improved patient engagement in the decision-making process of either paradigm. Results Study 1. 8 patient- HCP dyads were recruited resulting in 8 audiotaped consultations, 8 patient interviews and 8 HCP interviews (3 general practitioner and 5 practice nurse interviews) Data analysis revealed several main themes relevant to how patients make decisions. Some of these factors were specific to the patient such as their pre-conceived ideas about T2DM complications and insulin; some were HCP specific such as the importance of discussion with a trusted professional; some patients found the information contained in the PDA influenced their decisions and in some cases greater knowledge about complications and outcomes altered patient decisions. Study 2. 16 patients were recruited for the before and after interviews and 8 patients were recruited for the two focus groups. 4 out of 7 orthopaedic surgeons who regularly took consent for hip arthroplasty at one department were interviewed. Patient and surgeon data were analysed separately but had common themes developed from different perspectives. Themes relating to the consultation included surgeon assumptions about patient understanding and patients feeling overwhelmed by information, but relief at being offered an operation. Patients valued many sources of information whilst surgeons accepted they were not the sole source of information but considered theirs was the most important for consent signing. Patients often appreciated the hospital process of information provision, although this was often dissociated from the consent obtaining process. Meta-themes created from the results synthesis Results from the two studies were synthesized in relation to “How do patients make decisions?” and four meta-themes were identified relevant to the comparison of SDM and IC: doctor-patient interactions, the presentation of information, external factors such as friends and family opinions and, the concepts and tools of Shared Decision Making. The doctor-patient interactions relate to the interpersonal skills of both participants in a consultation and skills and emotions in promoting decision-making. The presentation of information describes how different formats and combinations of information provision influence patient decisions. External factors can influence decision making and values attached to external influences such as friends or websites vary between patients and clinicians. The final meta-theme illustrates the extent to which the practical implementation of SDM techniques is used in each setting Conclusion Themes from SDM and IC are concordant when considering factors that influence how patients make healthcare decisions and, therefore, techniques from each paradigm are appropriate to consider in relation to the other. The novel findings from this thesis indicate that patient healthcare decision-making can be influenced by many factors including who initiates the process, emotions, interactions with the HCP, sources and presentation of information and hospital pathways. SDM and PDAs are one approach to engaging patients in preference-sensitive decisions which also have the potential to improve patient engagement in IC. However IC techniques also use multiple patient contacts with different clinicians which is often recommended in SDM theory but rarely implemented.