Sales and regulatory status of fixed dose combination psychotropic drugs in India: a retrospective longitudinal study.

Background: There is limited evidence to support use of fixed dose combination (FDC) drugs in the treatment of psychiatric disorders. This study aimed to examine the sales and regulatory status of psychotropic FDCs in India, in the context of two government regulatory initiatives.

Methods: Official documents were searched to establish an account of the initiatives and measures targeting psychotropic FDCs.

Preparing for responsive management versus preparing for renal dialysis in multimorbid older people with advanced chronic kidney disease (Prepare for Kidney Care): Study protocol for a randomised controlled trial.

Background: Chronic kidney disease (CKD) prevalence is steadily increasing, in part due to increased multimorbidity in our aging global population. When progression to kidney failure cannot be avoided, people need unbiased information to inform decisions about whether to start dialysis, if or when indicated, or continue with holistic person-centred care without dialysis (conservative kidney management). Comparisons suggest that while there may be some survival benefit from dialysis over conservative kidney management, in people aged 80 years and over, or with multiple health problems or frailty, this may be at the expense of quality of life, hospitalisations, symptom burden and preferred place of death.

Private sector expansion and the widening NHS treatment gap between rich and poor in England: Admissions for NHS-funded elective primary hip and knee replacements between 1997/98 and 2018/19.

Parliament has imposed duties on the government and NHS in England aimed at reducing health inequalities. AIM: to understand the effect on inequalities of government policies, which require the NHS in England to outsource elective surgery to the private sector. We analysed the numbers of admissions for hip and knee replacement surgery from the least and most deprived population quintiles in three time periods: before the introduction of the policies (1997/98-2002/03); following the implementation of the independent sector treatment centre programme (2003/04-2006/07); and after the extension of 'choice at referral' (2007/08-2018/19).

Liver Fibrosis Assessed Via Noninvasive Tests Is Associated With Incident Heart Failure in a General Population Cohort.

Background & Aims: The aim of this study was to determine whether liver fibrosis is associated with heart failure in a general population cohort, and if genetic polymorphisms (PNPLA3 rs738409; TM6SF2 rs58542926), linked to increased risk of liver fibrosis and decreased risk of coronary artery disease, modify this association.

Methods: Using UK Biobank data, we prospectively examined the relationship between noninvasive fibrosis markers (nonalcoholic fatty liver disease [NAFLD] fibrosis score [NFS], Fibrosis-4 [FIB-4] and aspartate transaminase [AST] to platelet ratio index [APRI]) and incident hospitalization/death from heart failure (n = 413,860). Cox-regression estimated hazard ratios (HRs) for incident heart failure.

Primary and secondary care service use and costs associated with frailty in an ageing population: longitudinal analysis of an English primary care cohort of adults aged 50 and over, 2006-2017.

Background: Frailty becomes more prevalent and healthcare needs increase with age. Information on the impact of frailty on population level use of health services and associated costs is needed to plan for ageing populations.

Aim: To describe primary and secondary care service use and associated costs by electronic Frailty Index (eFI) category.

Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics.

Background: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whether they have been sufficient to remove centrally unapproved systemic antibiotic FDCs from the market.

Methods: Information was extracted from documents published by the central regulator and the ministry of health, including the National List of Essential Medicines (NLEM), and court judgments, and analysed alongside sales volume data for 2008-2020 using PharmaTrac market dataset.

Alternative cascade-testing protocols for identifying and managing patients with familial hypercholesterolaemia: systematic reviews, qualitative study and cost-effectiveness analysis.

Background: Cascade testing the relatives of people with familial hypercholesterolaemia is an efficient approach to identifying familial hypercholesterolaemia. The cascade-testing protocol starts with identifying an index patient with familial hypercholesterolaemia, followed by one of three approaches to contact other relatives: indirect approach, whereby index patients contact their relatives; direct approach, whereby the specialist contacts the relatives; or a combination of both direct and indirect approaches. However, it is unclear which protocol may be most effective.

Mixed methods feasibility and usability testing of a childhood obesity risk estimation tool.

Background: A Childhood Obesity Risk Estimation tool (SLOPE CORE) has been developed based on prediction models using routinely available maternity and early childhood data to estimate risk of childhood obesity at 4-5 years. This study aims to test the feasibility, acceptability and usability of SLOPE CORE within an enhanced health visiting (EHV) service in the UK, as one context in which this tool could be utilised.

Methods: A mixed methods approach was used to assess feasibility of implementing SLOPE CORE.

Clustering by multiple long-term conditions and social care needs: a cross-sectional study among 10 026 older adults in England.

BACKGROUND   : People with multiple long-term conditions (MLTC) face health and social care challenges. This study aimed to classify people by MLTC and social care needs (SCN) into distinct clusters and quantify the association between derived clusters and care outcomes. METHODS : A cross-sectional study was conducted using the English Longitudinal Study of Ageing, including people with up to 10 MLTC.

Prediction of childhood overweight and obesity at age 10-11: findings from the Studying Lifecourse Obesity PrEdictors and the Born in Bradford cohorts.

Background: In England, 41% of children aged 10-11 years live with overweight or obesity. Identifying children at risk of developing overweight or obesity may help target early prevention interventions. We aimed to develop and externally validate prediction models of childhood overweight and obesity at age 10-11 years using routinely collected weight and height measurements at age 4-5 years and maternal and early-life health data.

Associations with age and glomerular filtration rate in a referred population with chronic kidney disease: methods and baseline data from a UK multicentre cohort study (NURTuRE-CKD).

Background: Chronic kidney disease (CKD) is common but heterogenous and is associated with multiple adverse outcomes. The National Unified Renal Translational Research Enterprise (NURTuRE)-CKD cohort was established to investigate risk factors for clinically important outcomes in persons with CKD referred to secondary care.

Methods: Eligible participants with CKD stages G3-4 or stages G1-2 plus albuminuria >30 mg/mmol were enrolled from 16 nephrology centres in England, Scotland and Wales from 2017 to 2019.

The impact of non-alcoholic fatty liver disease and liver fibrosis on adverse clinical outcomes and mortality in patients with chronic kidney disease: a prospective cohort study using the UK Biobank.

Background: Chronic kidney disease (CKD) and non-alcoholic fatty liver disease (NAFLD) frequently co-exist. We assess the impact of having NAFLD on adverse clinical outcomes and all-cause mortality for people with CKD.

Methods: A total of 18,073 UK Biobank participants identified to have CKD (eGFR < 60 ml/min/1.

Frailty transitions and prevalence in an ageing population: longitudinal analysis of primary care data from an open cohort of adults aged 50 and over in England, 2006-2017.

Introduction: frailty is common in older adults and is associated with increased health and social care use. Longitudinal information is needed on population-level incidence, prevalence and frailty progression to plan services to meet future population needs.

Methods: retrospective open cohort study using electronic health records of adults aged ≥50 from primary care in England, 2006-2017.

Childhood overweight and obesity at the start of primary school: External validation of pregnancy and early-life prediction models.

Tackling the childhood obesity epidemic can potentially be facilitated by risk-stratifying families at an early-stage to receive prevention interventions and extra support. Using data from the Born in Bradford (BiB) cohort, this analysis aimed to externally validate prediction models for childhood overweight and obesity developed as part of the Studying Lifecourse Obesity PrEdictors (SLOPE) study in Hampshire. BiB is a longitudinal multi-ethnic birth cohort study which recruited women at around 28 weeks gestation between 2007 and 2010 in Bradford.

Role of foetal kidney size on kidney function in childhood: the born in bradford cohort renal study.

Background: Foetal and early childhood development contributes to the risk of adult non-communicable diseases such as hypertension and cardiovascular disease. We aimed to investigate whether kidney size at birth is associated with markers of kidney function at 7-11 years.

Methods: Foetal kidney dimensions were measured using ultrasound scans at 34 weeks gestation and used to derive kidney volume (cm) in 1802 participants in the Born in Bradford (BiB) birth cohort.

Household food insecurity risk indices for English neighbourhoods: Measures to support local policy decisions.

Background: In England, the responsibility to address food insecurity lies with local government, yet the prevalence of this social inequality is unknown in small subnational areas. In 2018 an index of small-area household food insecurity risk was developed and utilised by public and third sector organisations to target interventions; this measure needed updating to better support decisions in different settings, such as urban and rural areas where pressures on food security differ.

Methods: We held interviews with stakeholders (n = 14) and completed a scoping review to identify appropriate variables to create an updated risk measure.

Change in treatment burden among people with multimorbidity: a follow-up survey.

Background: Treatment burden is the effort required of patients to look after their health and the impact this has on their functioning and wellbeing. Little is known about change in treatment burden over time for people with multimorbidity.

Aim: To quantify change in treatment burden, determine factors associated with this change, and evaluate a revised single-item measure for high treatment burden in older adults with multimorbidity.

Systemic antibiotic sales and WHO recommendations, India.

Objective: To analyse sales of fixed-dose combination and single antibiotics in India in relation to World Health Organization (WHO) recommendations and national regulatory efforts to control antibiotic sales.

Methods: We extracted data on sales volumes of systemic antibiotics in India from a market research company sales database. We compared the market share of antibiotic sales in 2020 by WHO AWaRe (Access, Watch and Reserve) category and for those under additional national regulatory controls.

Dismantling the National Health Service in England.

The National Health Service was established in the United Kingdom in 1948 as a universal, comprehensive service free at the point of delivery, which is publicly provided, funded, and accountable. Market incrementalism in England has eroded this system over three decades. The recently enacted Health and Care Act will erode it further.

Understanding social care need through primary care big data: a rapid scoping review.

Background: A more comprehensive understanding and measurement of adult social care need could contribute to efforts to develop more effective, holistic personalised care, particularly for those with multiple long-term conditions (MLTC). Progress in this area faces the challenge of a lack of clarity in the literature relating to how social care need is assessed and coded within variables included in primary care databases.

Aim: To explore how social care need is assessed and coded within variables included in primary care databases.

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.