ContextThe National Institute for Health and Care Excellence (NICE) has an explicit mandate to include patient and public involvement in the appraisal of medicines to be available for funding on the NHS. NICE involves an appraisal committee who are required to take on board experiential evidence from patient experts alongside population‐based evidence on clinical and cost‐effectiveness when making a decision whether to fund a drug.ObjectiveThis paper considers how NICE Single Technological Appraisal (STA) committees attempt to incorporate the views of patients in making decisions about funding medicines on the NHS.MethodsA prospective design was employed to follow three pharmaceutical products involving three different appraisal committees. Three data collection methods were used: analysis of documentary evidence sent by NICE, non‐participant unstructured observations of the open and closed sessions of meetings and qualitative interviews.Settings and participantsUnstructured non‐participant observations were carried out at nine STA meetings, and 41 semi‐structured interviews were undertaken with committee members from NICE's STA committees, patient experts, analysts from NICE's project team and drug manufacturers.ResultsOur analysis showed how the committees displayed a preference for an ideal‐type of patient representative, disagreement among the committee when weighing‐up patient statements in the STA process and more pre‐preparation support for patient involvement.ConclusionsAlthough NICE has attempted to adopt an approach flexible to patients and carers through formal decision‐making arrangements that incorporate patient views, nonetheless, the processes of the STAs can in fact undermine the very evidence collected from patient representatives.

BackgroundA patient research internship (Patient and Community Engagement Research program—PaCER) was created to support a provincial commitment by Alberta Health Services’ Strategic Clinical Networks™ to find new ways to engage patients in a new interdisciplinary organization to support evidence‐informed improvements in clinical outcomes across the health system.ObjectiveImplement and test a new research method and training curriculum to build patient capacity for engagement in health through peer‐to‐peer research.DesignProgramme evaluation using Outcome Mapping and the grounded theory method.Setting and ParticipantsTwenty‐one patients with various chronic conditions completed one year of training in adapted qualitative research methods, including an internship where they designed and conducted five peer‐to‐peer inquiries into a range of health experiences.Main Outcome MeasuresOutcomes were continually monitored and evaluated using an Outcome Mapping framework, in combination with grounded theory analysis, based on data from focus groups, observation, documentation review and semi‐structured interviews (21 patient researchers, 15 professional collaborators).ResultsKey stakeholders indicated the increased capacity of patients to engage in health‐care research and planning, and the introduction and acceptance of new, collaborative roles for patients in health research. The uptake of new patient roles in health‐care planning began to impact attitudes and practices.ConclusionsPatient researchers become “part of the team” through cultural and relationship changes that occur in two convergent directions: (i) building the capacity of patients to engage confidently in a dialogue with clinicians and decision makers, and (ii) increasing the readiness for patient engagement uptake within targeted organizations.

ObjectivePatient‐reported outcome measure (PROM) conceived to enable description of treatment‐related effects, from the patient perspective, bring the potential to improve in clinical research, and to provide patients with accurate information. Therefore, the aim of this study was to develop a patient‐centred peptic ulcer patient‐reported outcome measure (PU‐PROM) and evaluate its reliability, validity, differential item functioning (DIF) and feasibility.MethodTo develop a conceptual framework and item pool for the PU‐PROM, we performed a literature review and consulted other measures created in China and other countries. Beyond that, we interviewed 10 patients with peptic ulcers, and consulted six key experts to ensure that all germane parameters were included. In the first item selection phase, classical test theory and item response theory were used to select and adjust items to shape the preliminary measure completed by 130 patients and 50 controls. In the next phase, the measure was evaluated used the same methods with 492 patients and 124 controls. Finally, we used the same population in the second item reselection to assess the reliability, validity, DIF and feasibility of the final measure.ResultsThe final peptic ulcer PRO measure comprised four domains (physiology, psychology, society and treatment), with 11 subdomains, and 54 items. The Cronbach's α coefficient of each subdomain for the measure was >0.800. Confirmatory factory analysis indicated that the construct validity fulfilled expectations. Model fit indices, such as RMR, RMSEA, NFI, NNFI, CFI and IFI, showed acceptable fit. The measure showed a good response rate.ConclusionsThe peptic ulcer PRO measure had good reliability, validity, DIF and feasibility, and can be used as a clinical research evaluation instrument with patients with peptic ulcers to assess their condition focus on treatment. This measure may also be applied in other health areas, especially in clinical trials of new drugs, and may be helpful in clinical decision making.

BackgroundEvidence suggests that patients can meaningfully feed back to healthcare providers about the safety of their care. The PRASE (Patient Reporting and Action for a Safe Environment) intervention provides a way to systematically collect feedback from patients to support service improvement. The intervention is being implemented in acute care settings with patient feedback collected by hospital volunteers for the first time.ObjectiveTo undertake a formative evaluation which explores the feasibility and acceptability of the PRASE intervention delivered in collaboration with hospital volunteers from the perspectives of key stakeholders.DesignA qualitative evaluation design was adopted across two acute NHS trusts in the UK between July 2014 and November 2015. We conducted five focus groups with hospital volunteers (n=15), voluntary services and patient experience staff (n=3) and semi‐structured interviews with ward staff (n=5). Data were interpreted using framework analysis.ResultsAll stakeholders were positive about the PRASE intervention as a way to support service improvement, and the benefits of involving volunteers. Volunteers felt adequate training and support would be essential for retention. Staff concentrated on the infrastructure needed for implementation and raised concerns around sustainability. Findings were fed back to the implementation team to support revisions to the intervention moving into the subsequent summative evaluation phase.ConclusionAlthough there are concerns regarding sustainability in practice, the PRASE intervention delivered in collaboration with hospital volunteers is a promising approach to collect patient feedback for service improvement.

BackgroundThere is a growing interest in redesigning health‐care systems to better manage the increasing numbers of people with multimorbidity. Knowing how patients experience health‐care delivery and what they need from the health‐care system are critical pieces of evidence that can be used to guide health system reforms.ObjectiveThe purpose of this study was to understand the challenges patients with multimorbidity face in accessing care in the community, and the implications for patients and their families.MethodsA secondary analysis of qualitative data was conducted on semi‐structured interviews with 116 patients who were receiving care in an urban rehabilitation facility in 2011. Exploratory interpretive analysis was used to identify themes about access to care.ResultsChallenges occurred at two levels: at the health system level and at the individual (patient) level. Issues at the health system level fell into two broad categories: availability of services (failing to qualify, coping with wait times, struggling with scarcity and negotiating the location of care) and service delivery (unreliable care, unmet needs, incongruent care and inflexible care). Challenges at the patient level fell into the themes of logistics of accessing care and financial strain. Patients interacted and responded to these challenges by: managing the system, making personal sacrifices, substituting with informal care, and resigning to system constraints.ConclusionIdentifying the barriers patients encounter and the lengths they go to in order to access care highlights areas where policy initiatives can focus to develop appropriate and supportive services that are more person and family‐centred.

BackgroundOlder people are sometimes challenged in maintaining a healthy diet but, because of age and disadvantage, are also more vulnerable to the adverse health consequences of poor nutrition. It has been claimed that older adults have low levels of health literacy regarding food and struggle to discern which foods are healthy from the vast range available in developed counties. However, nutrition and eating behaviour are modifiable risk factors for health in old age and health benefits can accrue from promoting healthy eating later in life. In order to achieve these health benefits, it is necessary to understand more about the capabilities and vulnerabilities of older people in terms of acquiring and maintaining a healthy diet.ObjectiveTo understand the potential for issues around food vulnerability to arise in that group and to characterize that vulnerability, if present.DesignNarrative interviews were conducted to collect the data. An interpretative thematic approach to analysis was utilized.ParticipantsTwenty older, bereaved men from two communities in the North of England.FindingsFive overarching themes were identified: financial security, social networks, cooking skills, food and routine and single servings.DiscussionOur findings suggest that some older men experience cumulative benefit from resources at their disposal, which contributes towards their capabilities to avoid food vulnerability.

I’m writing in response to a recent article published in HEX: Wiering et al.1 I read this article with great deal of interest, given the title and my interest in patient involvement in research and PROMs. However, I felt a little concerned that the article seemed to combine ‘patient involvement’ in the form of qualitative research to develop PROMs and, to a lesser scale, patient involvement as active involvement in research2 working alongside the PROM development team. However, little detail was provided in the article on the latter other than a few studies with ‘patient involvement in developing the domains or framework’ (although it is unclear exactly what this involvement entailed). The authors are correct to state that the views of patients are key to developing PROMs and rightly cited the FDA regulatory requirement for qualitative research with patients to develop PROMs for medical product development and regulatory claims.3 This guideline advocates the use of (i) open-ended concept elicitation interviews to establish the key concepts important and relevant to patients for inclusion in a conceptual model and framework forming the basis of the PROM content, and (ii) cognitive interviews with patients to confirm the face and content validity of a draft PROM. However, there is a key role for patients to be involved in the research and PROM development process that seems to be missing from this paper, or at least not emphasized enough. For PROM development, patients can have parallel, but notably different roles: (i) as participants in qualitative research to establish the content and confirm the content/face validity of PROMs and (ii) as active members of the research team working collaboratively in all aspects of the PROM development to ‘enhance the quality, relevance and acceptability of PROMs’.4 The second role may include involvement in a whole range of activities, such as: In summary, I think this article is well intended and, although it might be a matter of semantics, the role of true patient involvement in PROM development is important and it seems to have been underemphasized.

BackgroundPhysician associates are new to English general practice and set to expand in numbers.ObjectiveTo investigate the patients’ perspective on consulting with physician associates in general practice.DesignA qualitative study, using semi‐structured interviews, with thematic analysis.Setting and participantsThirty volunteer patients of 430 who had consulted physician associates for a same‐day appointment and had returned a satisfaction survey, in six general practices employing physician associates in England.FindingsSome participants only consulted once with a physician associate and others more frequently. The conditions consulted for ranged from minor illnesses to those requiring immediate hospital admission. Understanding the role of the physician associate varied from ‘certain and correct’ to ‘uncertain’, to ‘certain and incorrect’, where the patient believed the physician associate to be a doctor. Most, but not all, reported positive experiences and outcomes of their consultation, with some choosing to consult the physician. Those with negative experiences described problems when the limits of the role were reached, requiring additional GP consultations or prescription delay. Trust and confidence in the physician associate was derived from trust in the NHS, the general practice and the individual physician associate. Willingness to consult a physician associate was contingent on the patient's assessment of the severity or complexity of the problem and the desire for provider continuity.ConclusionPatients saw physician associates as an appropriate general practitioner substitute. Patients’ experience could inform delivery redesign.