Meaning behind measurement : self-comparisons affect responses to health related quality of life questionnaires

Purpose The subjective nature of quality of life is particularly pertinent to the domain of health-related quality of life (HRQOL) research. The extent to which participants’ responses are affected by subjective information and personal reference frames is unknown. This study investigated how an elderly population living with a chronic metabolic bone disorder evaluated self-reported quality of life. Methods Participants (n = 1,331) in a multi-centre randomised controlled trial for the treatment of Paget’s disease completed annual HRQOL questionnaires, including the SF-36, EQ-5D and HAQ. Supplementary questions were added to reveal implicit reference frames used when making HRQOL evaluations. Twenty-one participants (11 male, 10 female, aged 59–91 years) were interviewed retrospectively about their responses to the supplementary questions, using cognitive interviewing techniques and semi-structured topic guides. Results The interviews revealed that participants used complex and interconnected reference frames to promote response shift when making quality of life evaluations. The choice of reference frame often reflected external factors unrelated to individual health. Many participants also stated that they were unclear whether to report general or disease-related HRQOL. Conclusions It is important, especially in clinical trials, to provide instructions clarifying whether ‘quality of life’ refers to disease-related HRQOL. Information on selfcomparison reference frames is necessary for the interpretation of responses to questions about HRQOL.The Chief Scientist Office of the Scottish Government Health Directorates, The PRISM funding bodies (the Arthritis Research Campaign, the National Association for the Relief of Paget’s disease and the Alliance for Better Bone Health)Peer reviewedAuthor final versio

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.

National Coordinating Centre for Research Methodology; Medical Research Council, UK Department of Health; Chief Scientist OfficeNot peer reviewedPublisher PD

The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study

Background: In trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in self-monitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT). Methods: Educators’ views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method. Results: Educators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG. Conclusions: The findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers’ awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT

Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT

Abstract Background Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed. Methods We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT) to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres. Results Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice. Conclusion The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians) may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic design is not considered a design fault. We conclude that it does matter if clinicians do not understand the rationale for the trial if, as we have shown here, their perception of the trial aims and methods adversely affects who they recruit; if their views affect what the patients are told; and if they mistakenly view the results as unscientific, unreliable and ultimately irrelevant to their practice

The Contribution of Social Networks to the Health and Self-Management of Patients with Long-Term Conditions: A Longitudinal Study

Evidence for the effectiveness of patient education programmes in changing individual self-management behaviour is equivocal. More distal elements of personal social relationships and the availability of social capital at the community level may be key to the mobilisation of resources needed for long-term condition self-management to be effective. Aim: To determine how the social networks of people with long-term conditions (diabetes and heart disease) are associated with health-related outcomes and changes in outcomes over time. Methods: Patients with chronic heart disease (CHD) or diabetes (n = 300) randomly selected from the disease registers of 19 GP practices in the North West of England. Data on personal social networks collected using a postal questionnaire, alongside face-to-face interviewing. Follow-up at 12 months via postal questionnaire using a self-report grid for network members identified at baseline. Analysis: Multiple regression analysis of relationships between health status, self-management and health economics outcomes, and characteristics of patients’ social networks. Results: Findings indicated that: (1) social involvement with a wider variety of people and groups supports personal self-management and physical and mental well-being; (2) support work undertaken by personal networks expands in accordance with health needs helping people to cope with their condition; (3) network support substitutes for formal care and can produce substantial saving in traditional health service utilisation costs. Health service costs were significantly (p0.01) reduced for patients receiving greater levels of illness work through their networks. Conclusions: Support for self-management which achieves desirable policy outcomes should be construed less as an individualised set of actions and behaviour and more as a social network phenomenon. This study shows the need for a greater focus on harnessing and sustaining the capacity of networks and the importance of social involvement with community groups and resources for producing a more desirable and cost-effective way of supporting long term illness management

Receptionists' role in new approaches to consultations in primary care: a focused ethnographic study

Background The receptionist is pivotal to the smooth running of general practice in the UK, communicating with patients and booking appointments. Aim The authors aimed to explore the role of the receptionist in the implementation of new approaches to consultations in primary care. Design and setting The authors conducted a team-based focused ethnography. Three researchers observed eight general practices across England and Scotland between June 2015 and May 2016. Method Interviews were conducted with 39 patients and 45 staff in the practices, all of which had adopted one or more methods (telephone, email, e-consultation, or internet video) for providing an alternative to face-to-face consultation. Results Receptionists have a key role in facilitating patient awareness regarding new approaches to consultations in primary care, while at the same time ensuring that patients receive a consultation appropriate to their needs. In this study, receptionists’ involvement in implementation and planning for the introduction of alternative approaches to faceto-face consultations was minimal, despite the expectation that they would be involved in delivery. Conclusion A shared understanding within practices of the potential difficulties and extra work that might ensue for reception staff was lacking. This might contribute to the low uptake by patients of potentially important innovations in service delivery. Involvement of the wider practice team in planning and piloting changes, supporting team members through service reconfiguration, and providing an opportunity to discuss and contribute to modifications of any new system would ensure that reception staff are suitably prepared to support the introduction of a new approach to consultations

General Practitioner use of online resources during medical visits: Managing the boundary between inside and outside the clinic

In an increasingly connected world, information about health can be exchanged at any time, in any location or direction, and is no longer dominated by traditional authoritative sources. We consider the ways information and advice given in consultations by doctors transcends the boundary between the clinic and the home. We explore how information that is widely accessible outside the consultation is transformed by General Practitioners (GPs) into a medical offering. Data comprise 18 consultations identified from 144 consultations between unselected patients and five GPs. We use conversation analytic methods to explore four ways in which GPs used online resources; (i) to check information; (ii) as an explanatory tool; (iii) to provide information for patients for outside the consultation; (iv) to signpost further explanation and self‐help. We demonstrate the interactional delicacy with which resources from the Internet are introduced and discussed, developing and extending Nettleton's (2004) idea of ‘e‐scaped medicine’ to argue that Internet resources may be ‘recaptured’ by GPs, with information transformed and translated into a medical offering so as to maintain the asymmetry between patients and practitioners necessary for the successful functioning of medical practice

Unintended consequences of patient online access to health records: a qualitative study in UK primary care

Background: Health systems around the world are seeking to harness digital tools to promote patient autonomy and increase the efficiency of care. One example of this policy in England is online patient access to full medical records in primary care. Since April 2019, all NHS England patients have had the right to access their full medical record prospectively, and full record access has been the “default position” since April 2020. / Aim: To identify and understand the unintended consequences of online patient access their medical record. / Design and Setting: Qualitative interview study in 10 general practices in South West and North West England. / Method: Semi-structured individual interviews with 13 patients and 16 general practice staff with experience of patient online access to health records. / Results: Online access generated unintended consequences that negatively impacted patients’ understanding of their health care, for example patients discovering surprising information or information that was difficult to interpret. Online access impacted GPs’ documentation practices, such as when GPs pre-emptively attempted to minimise potential misunderstandings to aid patient understanding of their health care, in other cases, negatively impacting the quality of the records and patient safety when GPs avoided documenting their speculations or concerns. Contrary to assumptions that practice workload would be reduced, online access introduced extra work, such as managing and monitoring access and taking measures to prevent possible harm to patients. / Conclusion: The unintended consequences described by both staff and patients show that to achieve the intended consequences set out in NHS policy additional work is necessary to prepare records for sharing and prepare patients about what to expect. It is crucial that practices are adequately supported and resourced to manage the unintended consequences of online access now that it is the default position

Using online patient feedback to improve NHS services: The INQUIRE multimethod study

Background People are increasingly able and willing to use the internet to give their views on products and services, and health care is no exception. This research aimed to find out what this online feedback from patients represents, how it is viewed by NHS staff and patients, and how it can be used by the NHS to improve the quality of its services. Methods We used a mixture of approaches. We talked to experts and examined previous research to find out about current practice in this area. We used a questionnaire to find out who the people who read and write online feedback are, and the reasons they choose to comment on health services in this way. We also interviewed patients about their experiences of giving feedback to the NHS. We used another questionnaire to find out the views and experiences of doctors and nurses. Finally, we spent time in four NHS trusts to learn more about the approaches that NHS organisations take to receiving and dealing with online feedback from patients. Key findings Many people use the internet to read feedback from other patients. Fewer people go online to write feedback, but when they do one of their main reasons is to give praise. Most online feedback is positive in its tone and people describe caring about the NHS and wanting to support it. They also want their feedback to form part of a conversation. However, many professionals are cautious about online patient feedback and rarely encourage it. NHS trusts do not monitor all feedback routes and staff are often unsure where the responsibility to respond lies. Maintaining patient confidentiality can be a challenge. It is important that NHS staff have the ability to respond, and can do so in a timely and visible way