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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
Ideas, Concerns, Expectations and Effects on life (ICEE) in GP consultations: an observational study using video-recorded UK consultations.
BACKGROUND: Eliciting patients' Ideas, Concerns, Expectations, and whether a problem has an Effect on their life (ICEE), is a widely recommended communication technique. However, it is not known how frequently ICEE components are raised in UK GP consultations. AIM: Assess the frequency of ICEE in routine GP consultations with adult patients and explore variables associated with ICEE. DESIGN AND SETTING: Secondary analysis of face-to-face video-recorded GP consultations archive. METHOD: Observational coding of 92 consultations. Associations were assessed using binomial and ordered logistic regression. RESULTS: Most consultations included at least one ICEE component (90.2%). The most common ICEE component per consultation was patient ideas (79.3%), followed by concerns (55.4%), expectations (51.1%) and then effects on life (42.4%). For all ICEE components, patients more commonly initiated the ICEE dialogue and in only three consultations (3.3%) GPs directly asked patients about their expectations.Problems that were acute (OR 2.98, 95% confidence interval [CI]=1.36-6.53, P=0.007) or assessed by GPs ≥50 years (OR 2.10, CI =1.07-4.13, P=0.030) were associated with more ICEE components. Problems assessed later in the consultation (OR 0.60 per problem order increase, CI =0.41-0.87, P=0.007), by patients ≥75 years (OR 0.40, CI =0.16-0.98, P=0.046) and from the most deprived cohort were associated with fewer ICEE components (OR 0.39, CI =0.17-0.92, P=0.032). Patient ideas were associated with more patients being 'very satisfied' post-consultation (OR 10.74, CI =1.60-72.0, P=0.014) and the opposite was true of concerns (OR 0.14, CI =0.02-0.86, P=0.034). CONCLUSION: ICEE components were associated with patient satisfaction and demographic variables. Further research is required to assess if the way ICEE are communicated affects these associations and other potential confounders.
Negotiation of collective and individual candidacy for long Covid healthcare in the early phases of the Covid-19 pandemic: Validated, diverted and rejected candidacy
This analysis of people's accounts of establishing their need and experiences of healthcare for long Covid (LC) symptoms draws on interview data from five countries (UK, US, Netherlands, Canada, Australia) during the first ∼18 months of the Covid-19 pandemic when LC was an emerging, sometimes contested, condition with scant scientific or lay knowledge to guide patients and professionals in their sense-making of often bewildering constellations of symptoms. We extend the construct of candidacy to explore positive and (more often) negative experiences that patients reported in their quest to understand their symptoms and seek appropriate care. Candidacy usually considers how individuals negotiate healthcare access. We argue a crucial step preceding individual claims to candidacy is recognition of their condition through generation of collective candidacy. “Vanguard patients” collectively identified, named and fought for recognition of long Covid in the context of limited scientific knowledge and no established treatment pathways. This process was technologically accelerated via social media use. Patients commonly experienced “rejected” candidacy (feeling disbelieved, discounted/uncounted and abandoned, and that their suffering was invisible to the medical gaze and society). Patients who felt their candidacy was “validated” had more positive experiences; they appreciated being believed and recognition of their changed lives/bodies and uncertain futures. More positive healthcare encounters were described as a process of “co-experting” through which patient and healthcare professional collaborated in a joint quest towards a pathway to recovery. The findings underpin the importance of believing and learning from patient experience, particularly vanguard patients with new and emerging illnesses.
An external validation of the QCOVID3 risk prediction algorithm for risk of hospitalisation and death from COVID-19: An observational, prospective cohort study of 1.66m vaccinated adults in Wales, UK
Introduction At the start of the COVID-19 pandemic there was an urgent need to identify individuals at highest risk of severe outcomes, such as hospitalisation and death following infection. The QCOVID risk prediction algorithms emerged as key tools in facilitating this which were further developed during the second wave of the COVID-19 pandemic to identify groups of people at highest risk of severe COVID-19 related outcomes following one or two doses of vaccine. Objectives To externally validate the QCOVID3 algorithm based on primary and secondary care records for Wales, UK. Methods We conducted an observational, prospective cohort based on electronic health care records for 1.66m vaccinated adults living in Wales on 8th December 2020, with follow-up until 15th June 2021. Follow-up started from day 14 post vaccination to allow the full effect of the vaccine. Results The scores produced by the QCOVID3 risk algorithm showed high levels of discrimination for both COVID-19 related deaths and hospital admissions and good calibration (Harrell C statistic: ≥ 0.828). Conclusion This validation of the updated QCOVID3 risk algorithms in the adult vaccinated Welsh population has shown that the algorithms are valid for use in the Welsh population, and applicable on a population independent of the original study, which has not been previously reported. This study provides further evidence that the QCOVID algorithms can help inform public health risk management on the ongoing surveillance and intervention to manage COVID-19 related risks.
Economic Evaluation of Integrated Care
The complexity of integrated care and the substantial resources needed to collect reliable data appears to have challenged health economists to evaluate the cost-effectiveness of integrated care to date. On the health services research side, health economists were not involved in many evaluation studies so far, which presumably resulted in low quality evidence on cost-effectiveness. Economic evaluations are frequently piggy back tailed in the effectiveness evaluation of integrated care but this needs to be changed because there is a clear need for better understanding and communication between health economists, researchers from other disciplines, clinicians, payers and decision-makers during the set-up of an evaluation study.
Evaluating Complex Interventions
There is an increasing interest in evaluating complex interventions as epidemiological changes increasingly call for composite interventions to address patients’ needs and preferences. It is also because such interventions increasingly require explicit reimbursement decisions. That was not the case in the past, when these interventions often entered the benefit package automatically, once they were considered standard medical practice. Nowadays, payers as well as care providers are intrigued to know not just if a health care intervention works but also when, for whom, how, and under which circumstances. In addition, there is broad recognition in the research community that evaluating complex interventions is a challenging task that requires adequate methods and scientific approaches.
Optimizing a digital intervention for managing blood pressure in stroke patients using a diverse sample: Integrating the person-based approach and patient and public involvement
Background: Having a stroke or transient ischaemic attack increases the risk of a subsequent one, especially with high blood pressure (BP). Home-based BP management can be effective at maintaining optimal BP. Objective: To describe the optimization of a digital intervention for stroke patients and the value of participant diversity, using the person-based approach (PBA) and integral patient and public involvement (PPI). Setting and participants: Stroke patients recruited from primary care and community settings, and health-care professionals in primary care, in England and Ireland. Design: Three linked qualitative studies conducted iteratively to develop an intervention using the PBA, with integral PPI. Intervention: The BP: Together intervention, adapted from existing BP self-monitoring interventions, is delivered via mobile phone or web interface to support self-monitoring of BP at home. It alerts patients and their clinicians when a change in antihypertensive medication is needed. Findings: Feedback from a diverse range of participants identified potential barriers, which were addressed to improve the intervention accessibility, feasibility and persuasiveness. Easy-to-read materials were developed to improve usability for patients with aphasia and lower literacy. The importance of including family members who support patient care was also highlighted. Feedback messages regarding medication change were refined to ensure usefulness for patients and clinicians. Discussion: Input from PPI alongside qualitative research with a diverse study sample allowed the creation of a simple and equitable BP management intervention for stroke patients. Patient involvement: Two PPI co-investigators contributed to design, conduct of study, data interpretation and manuscript preparation; community PPI sessions informed early planning. Study participants were stroke patients and family members.
Public involvement in the governance of population-level biomedical research: Unresolved questions and future directions
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.
SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial
Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy. Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods. Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03968952.
A core outcome set for pre-eclampsia research: an international consensus development study
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists Objective: To develop a core outcome set for pre-eclampsia. Design: Consensus development study. Setting: International. Population: Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods: Modified Delphi method and Modified Nominal Group Technique. Results: A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support. Conclusions: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies. Tweetable abstract: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.].
Supporting patients with female genital mutilation in primary care: A qualitative study exploring the perspectives of GPS' working in England
© British Journal of General Practice Background Female genital mutilation (FGM) includes all procedures that intentionally harm or alter female genitalia for non-medical reasons. In 2015, reporting duties were introduced, applicable to GPs working in England including a mandatory reporting duty and FGM Enhanced Dataset. Our patient and public involvement work identified the exploration of potential impacts of these duties as a research priority. Aim To explore the perspectives of GPs working in England on potential challenges and resource needs when supporting women and families affected by FGM. Design and setting Qualitative study with GPs working in English primary care. Method Semi-structured interviews focused around a fictional scenario of managing FGM in primary care. The authors spoke to 17 GPs from five English cities, including those who saw women who have experienced FGM often, rarely, or never. Interviews were audio recorded and transcribed verbatim for thematic analysis. Lipsky's theory of street-level bureaucracy was drawn on to support analysis. Results Managing women with FGM was experienced as complex. Challenges included knowing how and when to speak about FGM, balancing care of women and their family's potential care and safeguarding needs, and managing the mandated reporting and recording requirements. GPs described strategies to manage these tensions that helped them balance maintaining patient-doctor relationships with reporting requirements. This was facilitated by access to FGM holistic services. Conclusion FGM reporting requirements complicate consultations. The potential consequences on trust between women affected by FGM and their GP are clear. The tensions that GPs experience in supporting women affected by FGM can be understood through the theoretical lens of street-level bureaucracy. This is likely to be relevant to other areas of proposed mandated reporting.
“You Probably Won’t Notice Any Symptoms”: Blood Pressure in Pregnancy—Discourses of Contested Expertise in an Era of Self-Care and Responsibilization
Pregnancy is not a disease or illness, but requires clinical surveillance as life-threatening complications can develop. Preeclampsia, one such potentially serious complication, puts both mother and baby at risk. Self-monitoring blood pressure in the general population is well established, and its potential in pregnancy is currently being explored. In the context of self-monitoring, the information and guidance given to women regarding hypertension, and the literature they themselves seek out during pregnancy, are vital to perceptions of disease risk and subsequent responses to, and management of, any symptoms. Drawing on online, offline, official, and unofficial sources of information, discourses are examined to provide analysis of how self-responsibilization is reflected in contemporary information, advice, and guidance drawn from multiple sources. A paradox emerges between the paternalistic and lay discourses that seek to challenge and regain control. Findings are discussed in the context of Foucault’s governmentality and medical power.
Navigating possible endometriosis in primary care: A qualitative study of GP perspectives
Background Endometriosis affects approximately 6-10% of women, with well documented delays between initial presentation with symptoms and diagnosis. In England, women typically seek help first in primary care, making this setting pivotal in women's pathways to diagnosis and treatment. English GP perspectives on managing possible endometriosis have not been previously reported. Aim To explore what GPs identify as important considerations when caring for women with symptoms that raise the possibility of endometriosis. Design and setting Qualitative study in English primary care. Method Semi-structured scenario-based telephone interviews with 42 GPs from April 2019 to January 2020, based around a fictional scenario of a woman presenting to primary care with symptoms suggesting possible endometriosis. Interviews were thematically coded and analysed. Results Managing possible endometriosis in primary care brings challenges. While knowledge and awareness were prerequisites for considering endometriosis, other important considerations were raised. Symptoms suggestive of endometriosis are non-specific, making endometriosis one possible consideration of many. GPs move through a diagnostic hierarchy to exclude sinister causes and utilise trials of treatment as both therapeutic interventions and diagnostic tools; processes which take time. An endometriosis label or diagnosis has advantages and risks. GPs reported sharing decisions about investigation and referral while holding women's priorities as pivotal. These conversations were underpinned by their knowledge of uncertainties and unknowns, including the wide spectrum and unpredictability of endometriosis. Conclusion GPs considerations are more complex than simply lacking awareness. The unknowns surrounding endometriosis matter to GPs. Further research and tailored resources for primary care, where women present with undifferentiated symptoms, are needed.
Intervention planning and modification of the BUMP intervention: A digital intervention for the early detection of raised blood pressure in pregnancy
© 2019 The Author(s). Background: Hypertensive disorders in pregnancy, particularly pre-eclampsia, pose a substantial health risk for both maternal and foetal outcomes. The BUMP (Blood Pressure Self-Monitoring in Pregnancy) interventions are being tested in a trial. They aim to facilitate the early detection of raised blood pressure through self-monitoring. This article outlines how the self-monitoring interventions in the BUMP trial were developed and modified using the person-based approach to promote engagement and adherence. Methods: Key behavioural challenges associated with blood pressure self-monitoring in pregnancy were identified through synthesising qualitative pilot data and existing evidence, which informed guiding principles for the development process. Social cognitive theory was identified as an appropriate theoretical framework. A testable logic model was developed to illustrate the hypothesised processes of change associated with the intervention. Iterative qualitative feedback from women and staff informed modifications to the participant materials. Results: The evidence synthesis suggested women face challenges integrating self-monitoring into their lives and that adherence is challenging at certain time points in pregnancy (for example, starting maternity leave). Intervention modification included strategies to address adherence but also focussed on modifying outcome expectancies, by providing messages explaining pre-eclampsia and outlining the potential benefits of self-monitoring. Conclusions: With an in-depth understanding of the target population, several methods and approaches to plan and develop interventions specifically relevant to pregnant women were successfully integrated, to address barriers to behaviour change while ensuring they are easy to engage with, persuasive and acceptable.
Self-monitoring of blood pressure in pregnancy: A mixed methods evaluation of a national roll-out in the context of a pandemic
Objective: To evaluate how English maternity units implemented self-monitoring of blood pressure (SMBP) in pregnancy in response to the COVID-19 pandemic. Design: Mixed methods including surveys, anonymised patient data and in-depth interviews with women. Setting: Maternity units across England. Participants: 45 maternity units completed a survey about the implementation of SMBP (supported by the provision of guidance and blood pressure monitors) during the pandemic, 166 women completed a survey about their experiences of SMBP, and 23 women took part in in-depth interviews. Clinical data from 627 women undertaking SMBP were available from 13 maternity units. Results: SMBP was predominantly used to provide additional BP monitoring for hypertensive or high-risk pregnant women. Overall maternity units and women were positive about its use in terms of reducing the need for additional face-to-face contacts and giving women more control and insight into their own BP. However, there were challenges in setting up SMBP services rapidly and embedding them within existing care pathways, particularly around interpreting readings and managing the provision of monitors. Conclusions: A considerable proportion of maternity units in England commenced a SMBP service for hypertensive or high-risk women from March 2020. There is a need for further research into appropriate care pathways, including guidance around white coat or masked hypertension and the use of SMBP postnatally.
Exploring the potential for introducing home monitoring of blood pressure during pregnancy into maternity care: Current views and experiences of staff-a qualitative study
Objective One in 20 women are affected by pre-eclampsia, a major cause of maternal and perinatal morbidity, death and premature birth worldwide. Diagnosis is made from monitoring blood pressure (BP) and urine and symptoms at antenatal visits after 20 weeks of pregnancy. There are no randomised data from contemporary trials to guide the efficacy of self-monitoring of BP (SMBP) in pregnancy. We explored the perspectives of maternity staff to understand the context and health system challenges to introducing and implementing SMBP in maternity care, ahead of undertaking a trial. Design Exploratory study using a qualitative approach. Setting Eight hospitals, English National Health Service. Participants Obstetricians, community and hospital midwives, pharmacists, trainee doctors (n=147). Methods Semi-structured interviews with site research team members and clinicians, interviews and focus group discussions. Rapid content and thematic analysis undertaken. Results The main themes to emerge around SMBP include (1) different BP changes in pregnancy, (2) reliability and accuracy of BP monitoring, (3) anticipated impact of SMBP on women, (4) anticipated impact of SMBP on the antenatal care system, (5) caution, uncertainty and evidence, (6) concerns over action/inaction and patient safety. Conclusions The potential impact of SMBP on maternity services is profound although nuanced. While introducing SMBP does not reduce the responsibility clinicians have for women's health, it may enhance the responsibilities and agency of pregnant women, and introduces a new set of relationships into maternity care. This is a new space for reconfiguration of roles, mutual expectations and the relationships between and responsibilities of healthcare providers and women. Trial registration number NCT03334149.