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.

Calnan, Michael .W. and Hashem, Ferhana and Brown, P (2017) Health and Care Excellence) as it regulates the provision of expensive new drugs within the English NHS on cost-effectiveness grounds. Ostensibly this is a highly rational process by which the regulatory mechanisms absorb uncertainty but in practice decision-making remains highly complex and uncertain. This paper draws on ethnographic data interviews with a range of stakeholders and decision-makers (n=41), observations of public and closed appraisal meetings, and documentary analysis regarding the decision-making processes involving three different pharmaceutical products. The study explores the various ways in which different forms of uncertainty are perceived and tackled within these Single Technology Appraisals (STAs). Difficulties of dealing with the various levels of uncertainty were manifest and often rendered straightforward decision-making problematic.Uncertainties associated with epistemology, procedures, interpersonal relations and technicality were particularly evident. The need to exercise discretion within a more formal institutional framework shaped a pragmatic combining of explicit and informal, collective and individual, strategies and tactics to navigate through the layers of complexity and uncertainty in making decisions.2

Background: We have undertaken a systematically searched literature review using a realist logic of analysis to help synthesise the diverse range of literature available on hospice at home services. Aim: To find out in the existing literature what features of hospice at home models work best, for whom and under what circumstances. Design: A realist logic of analysis was applied to synthesise the evidence focusing on mechanisms by which an intervention worked (or did not work). An initial programme theory was developed using the National Association for Hospice at Home standards, Normalisation Process Theory and through refinement using stakeholder engagement. Data sources: PubMed, Science Direct, AMED, BNI, CINAHL, EMBASE, Health Business Elite, HMIC, Medline, PsychINFO, SCOPUS, Web of Science, DARE, Google Scholar, NHS Evidence, NIHR CRN portfolio database, NIHR journal library of funded studies, including searches on websites of relevant professional bodies (August 2014, June 2017, June 2019). Results: Forty-nine papers were reviewed, of which 34 contributed evidence to at least one of the eight theory areas: marketing and referral, sustainable funding model, service responsiveness and availability, criteria for service admission, knowledge and skills of care providers, integration and coordination, anticipatory care, support directed at carers. Conclusions: Our literature review showed how it was possible to develop a coherent framework and test it against 34 published papers and abstracts. Central to this review was theory building, and as further evidence emerges, our programme theories can be refined and tested against any new empirical evidence.

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This article presents an ethnographic study of regulatory decision-making regarding the cost-effectiveness of expensive medicines at the National Institute for Health and Care Excellence (NICE) in England. We explored trust as one important mechanism by which problems of complexity and uncertainty were resolved. Existing studies note the salience of trust for regulatory decisions, by which the appraisal of people becomes a proxy for appraising technologies themselves. Although such (dis)trust in manufacturers was one important influence, we describe a more intricate web of (dis)trust relations also involving various expert advisors, fellow committee members and committee Chairs. Within these complex chains of relations, we found examples of both more blind-acquiescent and more critical-Investigative forms of trust as well as, at times, pronounced distrust. Difficulties in overcoming uncertainty through other means obliged trust in some contexts, although not in others. (Dis)trust was constructed through inferences involving abstract systems alongside actors' oral and written presentations-of-self. Systemic features and 'forced options' to trust indicate potential insidious processes of regulatory capture.