Development and Validation of Population Clusters for Integrating Health and Social Care: Protocol for a Mixed Methods Study in Multiple Long-Term Conditions (Cluster-Artificial Intelligence for Multiple Long-Term Conditions).

BACKGROUND: Multiple long-term health conditions (multimorbidity) (MLTC-M) are increasingly prevalent and associated with high rates of morbidity, mortality, and health care expenditure. Strategies to address this have primarily focused on the biological aspects of disease, but MLTC-M also result from and are associated with additional psychosocial, economic, and environmental barriers. A shift toward more personalized, holistic, and integrated care could be effective. This could be made more efficient by identifying groups of populations based on their health and social needs. In turn, these will contribute to evidence-based solutions supporting delivery of interventions tailored to address the needs pertinent to each cluster. Evidence is needed on how to generate clusters based on health and social needs and quantify the impact of clusters on long-term health and costs. OBJECTIVE: We intend to develop and validate population clusters that consider determinants of health and social care needs for people with MLTC-M using data-driven machine learning (ML) methods compared to expert-driven approaches within primary care national databases, followed by evaluation of cluster trajectories and their association with health outcomes and costs. METHODS: The mixed methods program of work with parallel work streams include the following: (1) qualitative semistructured interview studies exploring patient, caregiver, and professional views on clinical and socioeconomic factors influencing experiences of living with or seeking care in MLTC-M; (2) modified Delphi with relevant stakeholders to generate variables on health and social (wider) determinants and to examine the feasibility of including these variables within existing primary care databases; and (3) cohort study with expert-driven segmentation, alongside data-driven algorithms. Outputs will be compared, clusters characterized, and trajectories over time examined to quantify associations with mortality, additional long-term conditions, worsening frailty, disease severity, and 10-year health and social care costs. RESULTS: The study will commence in October 2021 and is expected to be completed by October 2023. CONCLUSIONS: By studying MLTC-M clusters, we will assess how more personalized care can be developed, how accurate costs can be provided, and how to better understand the personal and medical profiles and environment of individuals within each cluster. Integrated care that considers "whole persons" and their environment is essential in addressing the complex, diverse, and individual needs of people living with MLTC-M. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/34405.

Qualitative Review on Domains of Quality of Life Important for Patients, Social Care Users, and Informal Carers to Inform the Development of the EQ-HWB.

OBJECTIVES: To identify the themes to inform the content of a new generic measure, the EQ-HWB (EQ Health and Wellbeing), that can be used in economic evaluation across health, social care, and public health, based on the views of users and beneficiaries of these services including informal carers. METHODS: A qualitative review was undertaken. Systematic and citation searches were undertaken focusing on qualitative evidence of the impact on quality of life from reviews for selected health conditions, informal carers, social care users, and primary qualitative work used in the development of selected measures. A subset of studies was included in the review. Framework analysis and synthesis were undertaken based on a conceptual model. RESULTS: A total of 42 reviews and 24 primary studies were selected for inclusion in the review. Extraction and synthesis resulted in 7 high-level themes (with subthemes): (1) feelings and emotions (sadness, anxiety, hope, frustration, safety, guilt/shame); (2) cognition (concentration, memory, confusion, thinking clearly); (3) self-identity (dignity/respect, self-esteem); (4) "coping, autonomy, and control" relationships; (5) social connections (loneliness, social engagement, stigma, support, friendship, belonging, burden); (6) physical sensations (pain, discomfort, sleep, fatigue); and (7) activity (self-care, meaningful activities, mobility, communication, hearing, vision). Apart from physical sensations, most of the other themes and subthemes were relevant across both health and social care, including for informal carers. CONCLUSIONS: The findings from this broad review identified themes that go beyond health and that are relevant to patients, informal carers, and social care users. The themes and subthemes informed the domains for the EQ-HWB.

What is the best approach to adopt for identifying the domains for a new measure of health, social care and carer-related quality of life to measure quality-adjusted life years? Application to the development of the EQ-HWB?

Economic evaluation combines costs and benefits to support decision-making when assessing new interventions using preference-based measures to measure and value benefits in health or health-related quality of life. These health-focused instruments have limited ability to capture wider impacts on informal carers or outcomes in other sectors such as social care. Sector-specific instruments can be used but this is problematic when the impact of an intervention straddles different sectors.An alternative approach is to develop a generic preference-based measure that is sufficiently broad to capture important cross-sector outcomes. We consider the options for the selection of domains for a cross-sector generic measure including how to identify domains, who should provide information on the domains and how this should be framed. Beyond domain identification, considerations of criteria and stakeholder needs are also identified.This paper sets out the case for an approach that relies on the voice of patients, social care users and informal carers as the main source of domains and describes how the approach was operationalised in the 'Extending the QALY' project which developed the new measure, the EQ-HWB (EQ health and wellbeing instrument). We conclude by discussing the strengths and limitations of this approach. The new measure should be sufficiently generic to be used to consistently evaluate health and social care interventions, yet also sensitive enough to pick up important changes in quality of life in patients, social care users and carers.

Trends in Internal Medicine Faculty by Sex and Race/Ethnicity, 1980-2018.

Importance: Increasing diversity in the physician workforce is a fulcrum for reducing health disparities. Efforts to increase the diversity in the internal medicine (IM) workforce may improve health equity among an increasingly diverse population with increasing prevalence of chronic disease. Objectives: To assess diversity trends in the academic IM workforce and evaluate how well these trends reflected medical student diversity and the changing demographic composition of the general population. Design, Setting, and Participants: This secondary analysis of a cross-sectional study analyzed data from January 1, 1980, to December 31, 2018, from the Association of American Medical Colleges Faculty Roster and Applicant Matriculant File, which capture full-time US medical school faculty and matriculants, respectively, and population data through 2017 from the US Census Bureau. Main Outcomes and Measures: The study calculated the proportions of women and individuals from racial/ethnic groups that are traditionally underrepresented in medicine (URM) among IM faculty and faculty in all other clinical departments. These data were compared with the proportions of female and URM matriculants in US medical schools and the proportions of women and individuals from underrepresented racial/ethnic groups in the population. The analysis was stratified by sex, race/ethnicity, and intersections of sex and race/ethnicity. Results: From 1980 to 2018, the absolute number of full-time IM faculty increased from 10 964 to 42 547. Although IM was the department classification with the most women faculty, in 2018 it continued to have a lower proportion of women (n = 17 165 [40.3%]) compared with all other clinical departments (n = 48 936 [43.2%]). Among IM faculty, the percentage of URM faculty members more than doubled during the study period (from 4.1% to 9.7%) but still made up only a small portion of faculty members. The percentage of female matriculants among medical school matriculants increased steadily (from 28.7% in 1980 to 51.6% in 2018) and was nearly identical to their population representation in 2017 (50.7% compared with 50.8%). Although the percentage of URM matriculants had nearly doubled since 1980 (from 11.3% to 18.1%), it still lagged far behind the proportion of individuals in the US population who are members of underrepresented racial/ethnic groups (18.1% vs 31.5% in 2017). Conclusions and Relevance: This cross-sectional study found that progress has been made in diversifying academic IM faculty; however, it does not yet reflect the diversity of medical students or the US population. Continued efforts to increase the diversity of the academic IM workforce are needed.

Role of endogenous glucagon-like peptide-1 enhanced by vildagliptin in the glycaemic and energy expenditure responses to intraduodenal fat infusion in type 2 diabetes.

AIM: To evaluate the effects of the dipeptidyl peptidase-4 (DPP-4) inhibitor vildagliptin on glycaemic and energy expenditure responses during intraduodenal fat infusion, as well as the contribution of endogenous glucagon-like peptide-1 (GLP-1) signalling, in people with type 2 diabetes (T2DM). METHODS: A total of 15 people with T2DM managed by diet and/or metformin (glycated haemoglobin 49.3 ± 2.1 mmol/mol) were studied on three occasions (two with vildagliptin and one with placebo) in a double-blind, randomized, crossover fashion. On each day, vildagliptin 50 mg or placebo was given orally, followed by intravenous exendin (9-39) 600 pmol/kg/min, on one of the two vildagliptin treatment days, or 0.9% saline over 180 minutes. At between 0 and 120 minutes, a fat emulsion was infused intraduodenally at 2 kcal/min. Energy expenditure, plasma glucose and glucose-regulatory hormones were evaluated. RESULTS: Intraduodenal fat increased plasma GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), insulin and glucagon, and energy expenditure, and decreased plasma glucose (all P < 0.05). On the two intravenous saline days, plasma glucose and glucagon were lower, plasma intact GLP-1 was higher (all P < 0.05), and energy expenditure tended to be lower after vildagliptin (P = 0.08) than placebo. On the two vildagliptin days, plasma glucose, glucagon and GLP-1 (both total and intact), and energy expenditure were higher during intravenous exendin (9-39) than saline (all P < 0.05). CONCLUSIONS: In well-controlled T2DM during intraduodenal fat infusion, vildagliptin lowered plasma glucose and glucagon, and tended to decrease energy expenditure, effects that were mediated by endogenous GLP-1.

Gastrointestinal Symptoms in Diabetes: Prevalence, Assessment, Pathogenesis, and Management.

If you haven't measured something, you really don't know much about it.-Karl Pearson (attributed)Gastrointestinal (GI) symptoms represent an important and often unappreciated cause of morbidity in diabetes, although the significance of this burden across the spectrum of patients and the underlying pathophysiology, including the relationship of symptoms with glycemic control, remain poorly defined. The relevance of GI symptoms and the necessity for their accurate assessment have increased with the greater focus on the gut as a therapeutic target for glucose lowering. This review addresses the prevalence, assessment, pathogenesis, and management of GI symptoms in diabetes, beginning with broad principles and then focusing on specific segments of the GI tract. We initially performed a literature search of PubMed by using synonyms and combinations of the following search terms: "gastrointestinal symptoms", "diabetes", "prevalence", "pathogenesis", "diagnosis", and "management". We restricted the search results to English only. Review papers and meta-analyses are presented as the highest level of evidence where possible followed by randomized controlled trials, uncontrolled trials, retrospective and observational data, and expert opinion.

Implementing personal health budgets in England: a user-led approach to substance misuse.

Personal health budgets (PHBs) in England have been viewed as a vehicle for developing a personalised patient-based strategy within the substance misuse care pathway. In 2009, the Department of Health announced a 3-year pilot programme of PHBs to explore opportunities offered by this new initiative across a number of long-term health conditions, and commissioned an independent evaluation to run alongside as well as a separate study involving two pilot sites that were implementing PHBs within the substance misuse service. The study included a quantitative and qualitative strand. The qualitative strand involved 20 semi-structured interviews among organisational representatives at two time points (10 at each time point) between 2011 and 2012 which are the focus for this current paper. Overall, organisational representatives believed that PHBs had a positive impact on budget-holders with a drug and/or alcohol misuse problem, their families and the health and social care system. However, a number of concerns were discussed, many of which seemed to stem from the initial change management process during the early implementation stage of the pilot programme. This study provides guidance on how to implement and offer PHBs within the substance misuse care pathway: individuals potentially would benefit from receiving their PHB post-detox rather than at a crisis point; PHBs have the potential to improve the link to after-care services, and direct payments can provide greater choice and control, but sufficient protocols are required.

Personalization in the health care system: do personal health budgets have an impact on outcomes and cost?

OBJECTIVES: In England's National Health Service, personal health budgets are part of a growing trend to give patients more choice and control over how health care services are managed and delivered. The personal health budget programme was launched by the Department of Health in 2009, and a three-year independent evaluation was commissioned with the aim of identifying whether the initiative ensured better health- and care-related outcomes and at what cost when compared to conventional service delivery. METHODS: The evaluation used a pragmatic controlled trial design to compare the outcomes and costs of patients selected to receive a personal health budget with those continuing with conventional support arrangements (control group). Just over 1000 individuals were recruited into the personal health budget group and 1000 into the control group in order to ensure sufficient statistical power, and followed for 12 months. RESULTS: The use of personal health budgets was associated with significant improvement in patients' care-related quality of life and psychological wellbeing at 12 months. Personal health budgets did not appear to have an impact on health status, mortality rates, health-related quality of life or costs over the same period. With net benefits measured in terms of care-related quality of life on the adult social care outcome toolkit measure, personal health budgets were cost-effective: that is, budget holders experienced greater benefits than people receiving conventional services, and the budgets were worth the cost. CONCLUSION: The evaluation provides support for the planned wider roll-out of personal health budgets in the English NHS after 2014 in so far as the localities in the pilot sample are representative of the whole country.

Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes.

AIMS: Liraglutide reduces bodyweight in patients with type 2 diabetes mellitus (T2DM). This study aimed to investigate the mechanisms underlying this effect. METHODS: The comparative effects of liraglutide, glimepiride and placebo on energy intake, appetite, nausea, gastric emptying, antral distension, bodyweight, gastrointestinal hormones, fasting plasma glucose and resting energy expenditure (REE), were assessed in subjects with T2DM randomised to treatment A (liraglutide-placebo), B (placebo-glimepiride) or C (glimepiride-liraglutide). Assessments were performed at the end of each 4-week treatment period. RESULTS: Energy intake was less (NS) with liraglutide vs placebo and glimepiride, and 24-h REE was higher (NS) with liraglutide vs placebo and glimepiride. Fasting hunger was less (p=0.01) with liraglutide vs placebo and glimepiride, and meal duration was shorter with liraglutide (p=0.002) vs placebo. Paracetamol AUC(0-60 min) and C(max) were less (p<0.01) and fasting peptide YY was lower (p ≤ 0.001) after liraglutide vs placebo and glimepiride. Bodyweight reductions of 1.3 and 2.0 kg were observed with liraglutide vs placebo and glimepiride (p<0.001). There were no differences on antral distension, nausea, or other gastro-intestinal hormones. CONCLUSION: Liraglutide caused decreased gastric emptying and increased reduction in bodyweight. The mechanisms of the liraglutide-induced weight-loss may involve a combined effect on energy intake and energy expenditure.

A quality improvement framework for equity in cardiovascular care: results of a national collaborative.

Disparities in the quality of cardiovascular care provided to minorities have been well documented, but less is known about the use of quality improvement methods to eliminate these disparities. Measurement is also often impeded by a lack of reliable patient demographic data. The objective of this study was to assess the ability of hospitals with large minority populations to measure and improve the care rendered to Black and Hispanic patients. The Expecting Success: Excellence in Cardiac Care project utilized the standardized collection of self-reported patient race, ethnicity, and language data to generate stratified performance measures for cardiac care coupled with evidence-based practice tools in a national competitively selected sample of 10 hospitals with high cardiac volumes and largely minority patient populations. Main outcomes included changes in nationally recognized measures of acute myocardial infarction and heart failure quality of care and 2 composite measures, stratified by patient demographic characteristics. Quality improved significantly at 7 of the 10 hospitals as gauged by composite measures (p < .05), and improvements exceeded those observed nationally for all hospitals. Three of 10 hospitals found racial or ethnic disparities which were eliminated in the course of the project. Clinicians and institutions were able to join the standardized collection of self-reported patient demographic data to evidence-based measures and quality improvement tools to improve the care of minorities and eliminate disparities in care. This framework may be replicable to ensure equity in other clinical areas.

Impact of the University of Colorado's Advanced Clinical Training and Service (ACTS) Program on dental students' clinical experience and cognitive skills, 1994-2006.

The University of Colorado Denver School of Dental Medicine has operated a community-based dental education program for all of its students since 1985. A database of student productivity has been maintained in a standardized format, capable of multiyear compilation, since 1994. This study utilizes twelve years of these data to profile the type and amount of clinical treatment that can be provided by a typical fourth-year dental student during a 100-day community-based training experience. Between 1994 and 2006, the school's 423 graduates provided a mean of 922 treatment procedures per student at a mean of 498 patient visits per student. During a typical four-week clinical affiliation, each student provided a mean of approximately twenty-seven restorations on permanent teeth, sixteen restorations on primary teeth, and twenty-four oral surgery procedures (extractions). Students also gained considerable experience in periodontics, fixed and removable prosthodontics, and endodontics. Self-assessed competency ratings tended to increase after completing the program, as did willingness to treat underserved populations after graduation. About 16 percent of graduates reported planning to practice in the public sector after completing dental school. A community-based experience such as this appears to offer an opportunity to substantially augment dental students' clinical training experiences.

Deprivation of liberty safeguards: how prepared are we?

The Mental Health Act 2007 introduced Deprivation of Liberty safeguards into the Mental Capacity Act 2005 with potentially far reaching resource implications. There appears to be no scientific data regarding the prevalence of deprivation of liberty in clinical settings such as hospitals and nursing homes. We examined how many patients across a whole Trust area in Wales were subject to some lack of capacity, how well documented this was and how many were potentially deprived of their liberty. We found that no patient was deprived of their liberty, but 8% lacked capacity to make either basic or complex decisions; another 5% lacked capacity to make complex decisions. Documentation was good in mental health and community directorates, but there were gaps in documentation (not practice) in the medical and surgical directorates. Routine collection of data improved documentation regarding deprivation of liberty criteria. There is a high likelihood that senior nursing staff underestimate the number of patients who lack capacity.

The costs of change: a case study of the process of implementing individual budgets across pilot local authorities in England.

Individual budgets form a key element in the objective of the English Government to promote independence among people with needs for social care support. The initiative was designed to provide greater user control but the wider consequences, in terms of the implications for local authorities and their other responsibilities, remain to be addressed. An evaluation of the implementation of individual budgets in 13 local authorities was funded by the Department of Health, using a mixed methods approach to explore the impact of individual budgets both in terms of service user experiences and the implications for the local authority social services. One aspect of the evaluation concentrated on the cost implications of implementing individual budgets for the local authorities. All pilot local authorities were invited to take part in an interview designed to obtain the resources required to implement individual budget. Twelve of the 13 local authorities were part of the study reported in this article. All quantitative analysis was carried out using SPSS 13. Excluding all expenses that might be at least in part associated with the pilot process, in the first year, the estimated mean average cost was 290,000 pounds (median 270,000 pounds). This article will describe the initial approach adopted in estimating set-up costs, followed by a description of the findings for the first year of implementation and likely subsequent set-up costs. We also identify the range of factors that might affect reported costs.

Improving adult immunization rates in primary care clinics.

The goal of this effort was to improve adult immunization rates within a large urban health care system. To measure improvement efforts, we calculated each month the percentage of adults 65 years and older who leave clinic visits with up-to-date pneumococcal vaccination were calculated. This was accomplished through the development of three key aspects: standing orders, an immunization registry, and an algorithm to recommend vaccinations based on age and past vaccination history, but also on health history and risk factors for specific diseases.