Personalization: a new political arithmetic?

Scholarship on the history of political arithmetic highlights its significance for classical liberalism, a political philosophy in which subjects perceive themselves as autonomous individuals in an abstract system called society. This society and its component individuals became intelligible and governable in a deluge of printed numbers, assisted by the development of statistics, the emergence of a common space of measurement, and the calculation of probabilities. Our proposal is that the categories, numbers, and norms of this political arithmetic have changed in a ubiquitous culture of personalization. Today's political arithmetic, we suggest, produces a different kind of society, what Facebook CEO Mark Zuckerberg calls the 'default social'. We address this new social as a 'vague whole' and propose that it is characterized by a continuous present, the contemporary form of simultaneity or way of being together that Benedict Anderson argued is fundamental to any kind of imagined community. Like the society imagined in the earlier arithmetic, this vague whole is an abstraction that obscures forms of stratification and discrimination.

"I'd rather wait and see what's around the corner": A multi-perspective qualitative study of treatment escalation planning in frailty.

INTRODUCTION: People living with frailty risk adverse outcomes following even minor illnesses. Admission to hospital or the intensive care unit is associated with potentially burdensome interventions and poor outcomes. Decision-making during an emergency is fraught with complexity and potential for conflict between patients, carers and clinicians. Advance care planning is a process of shared decision-making which aims to ensure patients are treated in line with their wishes. However, planning for future care is challenging and those living with frailty are rarely given the opportunity to discuss their preferences. The aim of the ProsPECT (Prospective Planning for Escalation of Care and Treatment) study was to explore perspectives on planning for treatment escalation in the context of frailty. We spoke to people living with frailty, their carers and clinicians across primary and secondary care. METHODS: In-depth online or telephone interviews and online focus groups. The topic guide explored frailty, acute decision-making and planning for the future. Data were thematically analysed using the Framework Method. Preliminary findings were presented to a sample of study participants for feedback in two online workshops. RESULTS: We spoke to 44 participants (9 patients, 11 carers and 24 clinicians). Four main themes were identified: frailty is absent from treatment escalation discussions, planning for an uncertain future, escalation in an acute crisis is 'the path of least resistance', and approaches to facilitating treatment escalation planning in frailty. CONCLUSION: Barriers to treatment escalation planning include a lack of shared understanding of frailty and uncertainty about the future. Emergency decision-making is focussed on survival or risk aversion and patient preferences are rarely considered. To improve planning discussions, we recommend frailty training for non-specialist clinicians, multi-disciplinary support, collaborative working between patients, carers and clinicians as well as broader public engagement.

'In the picture': perspectives on living and working with cancer.

We explored working and living with cancer at a large research-intensive National Health Service hospital breast cancer service and adjoining non-governmental organisation (NGO). The project had three elements that were largely autonomous in practice but conceptually integrated through a focus on personalised cancer medicine. Di Sherlock held conversations with staff and patients from which she produced a collection of poems, Written Portraits At the same time, we conducted interviews and observation in the hospital, and hosted a public series of science cafés in the NGO. The trajectory of this project was not predetermined, but we found that the poetry residency provided a context for viewing participation in experimental cancer care and vice versa. Taking themes from the poetry practice, we show how they revealed categories of relevance to participants and illuminated others that circulated in the hospital and NGO. Reciprocally, turning to findings from long-term ethnographic research with patients, we show that their observations were not only representations but also tools for navigating life in waiting with cancer. The categories that we discovered and assembled about living and working with cancer do not readily combine into an encompassing picture, we argue, but instead provide alternating perspectives. Through analysis of different forms of research participation, we hope to contribute to an understanding of how categories are made, recognised and inhabited through situated comparisons. In personalised medicine, category-making is enabled if not dependent on increasingly intensive computation and so the practices seem far removed from mundane processes of interaction. Yet, we emphasise connections with everyday practices, in which people categorise themselves and others routinely according to what they like and resemble.

Personalising clinical pathways in a London breast cancer service.

Using interview and observational data from a busy and research-intensive breast cancer service in the United Kingdom, we discuss recent developments in personalised medicine. Specifically, we show how clinical and research practices meet in clinical pathways that are reconfigured in response to changing approaches of diagnosing, monitoring, treating and understanding cancers. Clinical pathways are increasingly sensitive to changes in evidence deduced through new technologies and therapies as well as decisions based on intensive, iterative analysis of data collected across a range of platforms. We contribute to existing research by showing how the organisation of clinical pathways both maintains established clinical practices and responds to new research evidence, managing a threshold between evidence-based and experimental medicine. Finally, we invite comparisons with other forms of personalisation to understand how they depend on the 'real time' collection, analysis and application of data.

A bacterial stimulation assay for bronchoalveolar lavage immune cells from young children with cystic fibrosis.

Cystic Fibrosis (CF) is primarily a progressive lung disease, characterized by chronic pulmonary infections with opportunistic pathogens. Such infections typically commence early in life, producing an inflammatory response marked by IL-8 chemokine production and neutrophilic infiltration, major contributory factors in CF progression. Studying this inflammation, especially early in life, is critical for developing new strategies for preventing or slowing disruption to the structural integrity of the CF airways. However, evaluating the immune responses of bronchoalveolar lavage (BAL) cells from children with CF faces technical challenges, including contamination carried from the lung due to pre-existing infections and low cell number availability. Here, we describe a technique for preparing BAL cells from young children with CF and using those cells in a bacterial stimulation assay. Initial antibiotic treatment proved essential for preventing resident bacteria from overgrowing BAL cell cultures, or non-specifically activating the cells. ACTB, identified as an optimal reference gene, was validated for accurate analysis of gene expression in these cells. Pseudomonas aeruginosa and Staphylococcus aureus were used as bacterial stimulants to evaluate the immune response of BAL cells from young children with CF. Addition of gentamicin prevented bacterial overgrowth, although if added after 3 hours of culture an extremely variable response resulted, with the bacteria causing a suppressive effect in some cultures. Addition of gentamicin after 1 hour of culture completely prevented this suppressive effect. This technique was then able to reproducibly measure the IL-8 response to stimulation with S. aureus and P. aeruginosa, including co-stimulation with both bacteria.

The reported impact of public involvement in biobanks: A scoping review.

BACKGROUND: Biobanks increasingly employ public involvement and engagement strategies, though few studies have explored their impact. This review aims to (a) investigate how the impact of public involvement in biobanks is reported and conceptualized by study authors; in order to (b) suggest how the research community might re-conceptualize the impact of public involvement in biobanks. METHODS: A systematic literature search of three electronic databases and the INVOLVE Evidence Library in January 2019. Studies commenting on the impact of public involvement in a biobank were included, and a narrative review was conducted. RESULTS AND DISCUSSION: Forty-one studies covering thirty-one biobanks were included, with varying degrees of public involvement. Impact was categorized according to where it was seen: 'the biobank', 'people involved' and 'the wider research community'. Most studies reported involvement in a 'functional' way, in relation to improved rates of participation in the biobank. Broader forms of impact were reported but were vaguely defined and measured. This review highlights a lack of clarity of purpose and varied researcher conceptualizations of involvement. We pose three areas for further research and consideration by biobank researchers and public involvement practitioners. CONCLUSIONS: Functional approaches to public involvement in biobanking limit impact. This conceptualization of involvement emerges from an entrenched technical understanding that ignores its political nature, complicated by long-standing disagreement about the values of public involvement. This study urges a re-imagination of impact, re-conceptualized as a two-way learning process. More support will help researchers and members of the public to undergo such reflective exercises.

Experience of primary care for people with HIV: a mixed-method analysis.

BACKGROUND: Advances in treatment have transformed HIV into a long-term condition (LTC), presenting fresh challenges for health services, HIV specialists, and GPs. AIM: To explore the experience of people living with HIV (PLHIV) regarding consulting their GPs. DESIGN & SETTING: A mixed-method analysis using data from two sources: a nationally-representative survey of PLHIV and a qualitative study with London-based PLHIV. METHOD: Univariate logistic regression was used for quantitative data and framework analysis for qualitative data. RESULTS: The survey had 4422 participants; the qualitative study included 52 participants. In both studies, registration with a GP and HIV status disclosure were high. Similar to general population trends, recent GP use was associated with poor self-rated health status, comorbidities, older age, and lower socioeconomic status. Two-thirds reported a good experience with GPs; a lower proportion felt comfortable asking HIV-related questions. Actual or perceived HIV stigma were consistently associated with poor satisfaction. In the interviews, participants with additional LTCs valued sensitive and consistent support from GPs. Some anticipated, and sometimes experienced, problems relating to HIV status, as well as GPs' limited experience and time to manage their complex needs. Sometimes they took their own initiative to facilitate coordination and communication. For PLHIV, a 'good' GP offered continuity and took time to know and accept them without judgment. CONCLUSION: The authors suggest clarification of roles and provision of relevant support to build the confidence of PLHIV in GPs and primary care staff to care for them. As the PLHIV population ages, there is a strong need to develop trusting patient-GP relationships and HIV-friendly GP practices.

Cephamycins inhibit pathogen sporulation and effectively treat recurrent Clostridioides difficile infection.

Spore-forming bacteria encompass a diverse range of genera and species, including important human and animal pathogens, and food contaminants. Clostridioides difficile is one such bacterium and is a global health threat because it is the leading cause of antibiotic-associated diarrhoea in hospitals. A crucial mediator of C. difficile disease initiation, dissemination and re-infection is the formation of spores that are resistant to current therapeutics, which do not target sporulation. Here, we show that cephamycin antibiotics inhibit C. difficile sporulation by targeting spore-specific penicillin-binding proteins. Using a mouse disease model, we show that combined treatment with the current standard-of-care antibiotic, vancomycin, and a cephamycin prevents disease recurrence. Cephamycins were found to have broad applicability as an anti-sporulation strategy, as they inhibited sporulation in other spore-forming pathogens, including the food contaminant Bacillus cereus. This study could directly and immediately affect treatment of C. difficile infection and advance drug development to control other important spore-forming bacteria that are problematic in the food industry (B. cereus), are potential bioterrorism agents (Bacillus anthracis) and cause other animal and human infections.

From activism to secrecy: Contemporary experiences of living with HIV in London in people diagnosed from 1986 to 2014.

BACKGROUND: Successes in biomedicine have transformed HIV from a debilitating and frequently fatal infection to a chronic, manageable condition. OBJECTIVE: To explore how the contemporary metanarrative of HIV as a chronic condition is understood by patients and how it varies depending on when they were diagnosed. DESIGN: Qualitative interviews with 52 people living with HIV who were diagnosed during different phases in the history of the epidemic. SETTING AND PARTICIPANTS: Participants were recruited from two HIV clinics in London to include four "HIV generations": generation 1 were those who had been diagnosed pre-1997 (pre-ART), generation 2 from 1997 to 2005 (complex ART), generation 3 from 2006 to 2012 (simpler ART) and generation 4 diagnosed in the year before the study (2013-2014). RESULTS: Participants in all HIV generations took their medication as prescribed, attended clinic appointments and were well informed about their immunological biomarkers. While the pre-treatment generation had been engaged in community endeavours such as activism, public education and use of support groups, those more recently diagnosed had little experience of collective activities and their HIV was essentially a private matter, separate from their social identity. These strategies worked for some; however, those experiencing clinical or social problems related to HIV or wider issues often relied exclusively on their HIV clinic for wider support. CONCLUSION: The loss of public conversation around HIV, the imperative for patients to take on greater individual responsibility for HIV management and the streamlining of HIV services alongside reductions in ancillary support services may expose some people to suboptimal health outcomes.

Patient perspectives on the HIV continuum of care in London: a qualitative study of people diagnosed between 1986 and 2014.

OBJECTIVES: To describe the experiences of the HIV treatment cascade of diagnosis, engagement with care and initiation of treatment from the perspective of patients; we explored whether this differed according to the year of their diagnosis, for example, whether they had experienced HIV care in the pretreatment era. DESIGN: Qualitative interview study with framework analysis. SETTING: Two large HIV adult outpatient clinics in central London. PARTICIPANTS: 52 HIV-positive individuals, 41 men, 11 women, purposively sampled to include people who had been diagnosed at different stages in the history of the epidemic classified as four 'generations': pre-1996 (preantiretroviral therapy (ART)), 1997-2005 (complex ARTs), 2006-2012 (simpler ARTs) and 2013 onwards (recent diagnoses). RESULTS: Some important differences were identified; for earlier generations, the visible illness and deaths from AIDS made it harder to engage with care following diagnosis. Subsequent decisions about starting treatment were deeply influenced by the fear of severe side effects from early ART. However, despite improvements in ART and life expectancy over the epidemic, we found a striking similarity across participants' accounts of the key stages of the care continuum, regardless of when they were diagnosed. Diagnosis was a major traumatic life event for almost everyone. Fear of testing positive or having low self-perceived risk affected the timing of testing and diagnosis. Engaging with care was facilitated by a flexible approach from services/clinicians. Initiating treatment was a major life decision. CONCLUSION: We found patients' experiences are influenced by when they were diagnosed, with earliest cohorts facing substantial challenges. However, being diagnosed with HIV and starting treatment continue to be significant life-altering events even in the era of effective, simple treatments. Despite the advances of biomedical treatment, services should continue to recognise the needs of patients for whom the diagnosis and treatment remain significant challenges.

"They made me feel comfortable": a comparison of methods to measure patient experience in a sexual health clinic.

BACKGROUND: High quality sexual health services are needed to improve both individual and public health outcomes. This study set out to explore what is important to patients who visit a sexual health clinic, and examine their understanding of standard survey questions, in order to inform the collection and interpretation of patient experience data that are used to improve services. METHODS: We conducted a cross-sectional, qualitative study. In the first part of the interview, we used "discovery interviews" to explore patients' experiences of attending a central London walk-in sexual health clinic. In the second part, we asked patients how they would respond to eight standard patient experience survey questions and to provide an explanation for each of their responses. We conducted a thematic analysis of the interview data. RESULTS: We interviewed seventeen participants (nine women, eight men) of different ethnicities and backgrounds. All interviewees were positive about their experience. They described how staff had made them feel "comfortable", and talked about how staff spent time, listened and did not rush them, despite being a very busy clinic. In response to the survey questions, fourteen patients rated their as care excellent or very good overall. However, survey questions were interpreted in different ways and were not always easily understood. CONCLUSIONS: The open-ended "discovery interviews" provided new insights into aspects of care that were most valued or could improve. Standard patient experience questions provide a rating but little elucidation of the experiences that lie behind patients' responses. They do not always measure aspects of care valued by patients or identify areas for improvement. They are not uniformly understood and necessarily collapse a wide range of experiences and views into categories that may seem inappropriate. Qualitative methods have a key role in measuring patient experience and involving patients in service improvement.

Stratified, precision or personalised medicine? Cancer services in the 'real world' of a London hospital.

We conducted ethnographic research in collaboration with a large, research-intensive London breast cancer service in 2013-2014 so as to understand the practices and potential effects of stratified medicine. Stratified medicine is often seen as a synonym for both personalised and precision medicine but these three terms, we found, also related to distinct facets of treatment and care. Personalised medicine is the term adopted for the developing 2016 NHS England Strategy, in which breast cancer care is considered a prime example of improved biological precision and better patient outcomes. We asked how this biologically stratified medicine affected wider relations of care and treatment. We interviewed formally 33 patients and 23 of their carers, including healthcare workers; attended meetings associated with service improvements, medical decision-making, public engagement, and scientific developments as well as following patients through waiting rooms, clinical consultations and other settings. We found that the translation of new protocols based on biological research introduced further complications into an already-complex patient pathway. Combinations of new and historic forms of stratification had an impact on almost all patients, carers and staff, resulting in care that often felt less rather than more personal.

Nurse handover: patient and staff experiences.

AIM AND OBJECTIVES: to understand the purpose, impact and experience of nurse handover from patient and staff perspectives. BACKGROUND: poor communication is increasingly recognised as a major factor in healthcare errors. Handover is a key risk point. Little consensus exists regarding the practice in nursing but the trend is towards bedside handover. Research on patient and staff experiences of handover is limited. DESIGN: a qualitative and observational study on two acute wards in a large urban hospital in the UK. METHODS: interviews conducted with patients and staff and observation of handovers, ward rounds and patient-staff interactions. RESULTS: diverse forms of nurse handover were found, used in combination: office based (whole nursing team), nurse in charge (NIC) to NIC, and bedside. Patients' and nurses' views concurred on the purpose of bedside handover--transference of information about the patient between two nurses--and about the medical ward round, which was seen as a discussion with the patient. Views diverged regarding the purpose and value of office handover. Bedside handover differed in style, content, and place of delivery, often driven by concerns regarding confidentiality and talking over patients, and there were varied views on the benefits of patient involvement in bedside handover. Nurses worked beyond their shift end to complete handover. Communication problems within the clinical team were identified by staff and patients. CONCLUSIONS: while it is important to agree the purpose of handover and develop appropriate structure, content and style, it need not be a uniform process in all clinical areas. Nurse training to deliver bedside handover and patient information on the purpose of handover and the patient's role would be beneficial.

Process evaluation of the impact and acceptability of a polypill for prevention of cardiovascular disease.

IMPORTANCE: The Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial has shown improved adherence with the use of a polypill strategy when compared with usual medications for cardiovascular disease (CVD) prevention. To advance from efficacy to impact, we need a better understanding of why and how such a strategy might be deployed in complex health systems. OBJECTIVE: To understand, from the perspective of UMPIRE trial participants and professionals, how and why a polypill strategy improves adherence compared with usual care, why improvement is greater in some subgroups, and to explore the acceptability of a polypill strategy among trial participants and healthcare professionals. DESIGN, SETTING AND PARTICIPANTS: A preplanned process evaluation, based on qualitative interviews, was conducted with a subsample of 102 trial participants and 41 healthcare professionals at the end of the UMPIRE trial in India and Europe. RESULTS: Most patients contrasted the simplicity of the polypill with usual medications that they found complex and, for many in India, expensive. Patients with low baseline adherence struggled most with complex medication lists, and those without established disease described less motivation to adhere when compared with people who had already been diagnosed with CVD; people in the latter group had already undertaken self-directed measures to adhere to CVD preventive medicines prior to entering the trial. Taking medication was one of many adaptations described by patients; these included dietary changes, stopping smoking and maintaining exercise. Most patients liked the polypill strategy, although some participants and health professionals were concerned that it would provide less tailored therapy for individual needs. CONCLUSIONS: Adherence to treatment lists with multiple medications is complex and influenced by several factors. Simplifying medication by using a once-daily polypill is one approach to CVD prevention that may enhance adherence. Prescribers should also consider the wide variety of adjustments that individuals need to make to cope with daily medication.

Exploring research participation among cancer patients: analysis of a national survey and an in-depth interview study.

BACKGROUND: Inequalities in cancer research participation are thought to exist with certain groups under-represented in research populations; however, much of the evidence is based on small-scale studies. The aim of this study was to explore data from in-depth interviews with cancer patients and a large national survey to investigate variation in who is asked to participate in research and who takes part. METHODS: Factors associated with research discussion and participation were explored in National Cancer Patient Experience Survey data using multivariate logistic regression and during in-depth interviews with 25 breast cancer patients. RESULTS: Survey data were available for 66,953 cancer patients; 30.4% reported having discussions about, and 18.9% took part in, research. Barriers to participation at staff, patient and trust level were evident; for example, staff were less likely to discuss research with older patients, Asian and black patients were less likely to take part and patients treated at specialist or teaching trusts had higher levels of discussion and participation. Interviews showed that patients' willingness to participate changed over time and was not synonymous with participation as some were ineligible. CONCLUSION: Some patient groups were less likely to have discussions about or participate in research. Analysis of this variation vis-à-vis the composition of the patient population may be useful to ensure that there is equity regarding the potential benefits of research participation and that research findings are applicable to target populations in the translational model.

Inequalities in the care experiences of patients with cancer: analysis of data from the National Cancer Patient Experience Survey 2011-2012.

OBJECTIVES: To explore inequalities in the care experiences of of patients with cancer by patient, clinical and trust-level factors [corrected]. DESIGN: Secondary analysis of data from the National Cancer Patient Experience Survey 2011-2012. SETTING AND PARTICIPANTS: Adult patients with a primary diagnosis of cancer who attended an acute or specialist National Health Service (NHS) trust in England. OUTCOME MEASURE: OR of a patient rating their overall care positively, adjusting for other patient, clinical and trust-level factors. METHODS: Using cross-sectional data from 71 793 patients with cancer who completed the National Cancer Patient Experience Survey 2011-2012, we examined associations between patient, clinical and trust-level factors and a summary measure of patient experience, namely overall rating of care. Multivariate logistic regression was used to investigate variation by sociodemographic characteristics adjusting for other patient, clinical and trust-level factors. RESULTS: Female, non-white and younger patients were less likely to rate their overall care as excellent or very good. Patients with long-standing conditions, particularly those with learning disabilities or mental health conditions, also reported poorer overall care. This variation persisted when other patient, clinical and trust-level factors were controlled for, indicating that there are real differences in experiences among patients with cancer by sociodemographic characteristics. CONCLUSIONS: There is evidence of inequalities in the experiences of patients with cancer in the UK by sociodemographic characteristics such as gender, age, ethnicity and disability. Quality cancer care services must strive to meet the needs of a diverse patient population equally; this study identifies patient groups for whom it appears cancer care services are in greatest need of improvement.

Bioanalytical and chemical assessment of the disinfection by-product formation potential: role of organic matter.

Disinfection by-products (DBP) formed from natural organic matter and disinfectants like chlorine and chloramine may cause adverse health effects. Here, we evaluate how the quantity and quality of natural organic matter and other precursors influence the formation of DBPs during chlorination and chloramination using a comprehensive approach including chemical analysis of regulated and emerging DBPs, total organic halogen quantification, organic matter characterisation and bioanalytical tools. In vitro bioassays allow us to assess the hazard potential of DBPs early in the chain of cellular events, when the DBPs react with their molecular target(s) and activate stress response and defence mechanisms. Given the reactive properties of known DBPs, a suite of bioassays targeting reactive modes of toxic action including genotoxicity and sensitive early warning endpoints such as protein damage and oxidative stress were evaluated in addition to cytotoxicity. Coagulated surface water was collected from three different drinking water treatment plants, along with reverse osmosis permeate from a desalination plant, and DBP formation potential was assessed after chlorination and chloramination. While effects were low or below the limit of detection before disinfection, the observed effects and DBP levels increased after disinfection and were generally higher after chlorination than after chloramination, indicating that chlorination forms higher concentrations of DBPs or more potent DBPs in the studied waters. Bacterial cytotoxicity, assessed using the bioluminescence inhibition assay, and induction of the oxidative stress response were the most sensitive endpoints, followed by genotoxicity. Source waters with higher dissolved organic carbon levels induced increased DBP formation and caused greater effects in the endpoints related to DNA damage repair, glutathione conjugation/protein damage and the Nrf2 oxidative stress response pathway after disinfection. Fractionation studies indicated that all molecular weight fractions of organic carbon contributed to the DBP formation potential, with the humic rich fractions forming the greatest amount of DBPs, while the low molecular weight fractions formed more brominated DBPs due to the high bromide to organic carbon ratio. The presence of higher bromide concentrations also led to a higher fraction of brominated DBPs as well as proportionally higher effects. This study demonstrates how a suite of analytical and bioanalytical tools can be used to effectively characterise the precursors and formation potential of DBPs.

An approach to hyperolactone C and analogues using late stage conjugate addition on an oxonium ylide-derived spirofuranone.

A stereocontrolled synthesis of norphenyl hyperolactone C together with its utility as a direct precursor to the anti-HIV agent hyperolactone C and analogues by addition of organolithiums, are described. Preliminary studies to access this key building block in a catalytic enantioselective manner are also reported.

INterpreting the Processes of the UMPIRE Trial (INPUT): protocol for a qualitative process evaluation study of a fixed-dose combination (FDC) strategy to improve adherence to cardiovascular medications.

INTRODUCTION: This paper describes a planned process evaluation of the Use of a Multidrug Pill In Reducing Cardiovascular Events (UMPIRE) trial, one of several randomised clinical trials taking place globally to assess the potential of cardiovascular drugs as a fixed-dose combination (polypill) in cardiovascular disease prevention. A fixed-dose combination may be a promising strategy for promoting adherence to medication; alleviating pill burden through simplifying regimens and reducing cost. This process evaluation will complement the UMPIRE trial by using qualitative research methods to inform understanding of the complex interplay of factors that underpin trial outcomes. METHODS: A series of semistructured, in-depth interviews with local health professionals and UMPIRE trial participants in India and the UK will be undertaken. The aim is to understand their views and experiences of the trial context and of day-to-day use of medications more generally. The grounded theory approach will be used to analyse data and help inform the processes of the UMPIRE trial. ETHICS AND DISSEMINATION: The study has received ethical approval for all sites in the UK and India where trial participant interviews will be undertaken. The process evaluation will help inform and enhance the understanding of the UMPIRE trial results and its applicability to clinical practice as well as shaping policy regarding strategies for improving cardiovascular medication adherence.