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Introduction: Despite widespread use of smokeless tobacco products by people within the Indian subcontinent, there is little awareness among Indians of its health hazards when compared with smoked tobacco. We hypothesise that mobile phone counselling will be feasible and effective for smokeless tobacco cessation intervention in India. This paper presents the protocol of the development and conduct of an exploratory trial before progression to a full randomised controlled trial., Methods and Analysis: An exploratory randomised controlled trial will be conducted in urban primary health centres in the state of Odisha, India. A total of 250 smokeless tobacco users will be recruited to the study (125 in each arm). Participants in the intervention arm will receive routine care together with a face-to-face counselling intervention followed by advice and reminder mobile messages. The control arm will receive routine care, delivered by a primary care physician based on 'Ask' and 'Advice'. All participants will be followed up for 3 months from the first counselling session. The primary outcome of this trial is to assess the feasibility to carry out a full randomised controlled trial., Ethics and Dissemination: Ethical approvals were obtained from the Institutional Ethics Committee of Public Health Foundation of India, Health Ministry's Screening Committee, Odisha State Ethics Board and also from University College London Research Ethics Committee, UK. The study findings will be published in a peer-reviewed scientific journal., Trial Registration Number: CTRI/2019/05/019484., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: In the UK, a compulsory '6-week hip check' is performed in primary care for the detection of developmental dysplasia of the hip (DDH). However, missed diagnoses and infants incorrectly labelled with DDH remain a problem, potentially leading to adverse consequences for infants, their families and the National Health Service. National policy states that infants should be referred to hospital if the 6-week check suggests DDH, though there is no available tool to aid examination or offer guidelines for referral. We developed standardised diagnostic criteria for DDH, based on international Delphi consensus, and a 9-item checklist that has the potential to enable non-experts to diagnose DDH in a manner approaching that of experts., Methods and Analysis: We will conduct a controlled trial randomised by practice that will compare a diagnostic aid against standard care for the hip check. The primary objective is to determine whether an aid to the diagnosis of DDH reduces the number of clinically insignificant referrals from primary care to hospital and the number of late diagnosed DDH. The trial will include a qualitative process evaluation, an assessment of professional behavioural change and a full health economic evaluation. We will recruit 152 general practitioner practices in England. These will be randomised to conduct the hip checks with use of the study diagnostic aid and/or as per usual practice. The total number of infants seen during a 15-month recruitment period will be 110 per practice. Two years after the 6-week hip check, we will measure the number of referred infants that are (1) clinically insignificant for DDH and (2) those that constitute appropriate referrals., Ethics and Dissemination: This study has approval from the Health Research Authority (16/1/2020) and the Confidentiality Advisory Group (18/2/2020). Results will be published in peer-reviewed academic journals, disseminated to patient organisations and the media., Trial Registration Number: NCT04101903; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objective: Ten Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service., Design: An economic evaluation was conducted alongside an individually randomised controlled trial., Setting: 14 general practitioner practices in England., Participants: All patients were aged ≥18 years, with body mass index ≥30 kg/m 2 . A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention., Outcomes Measures: Health service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation., Results: Over a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of -£36 (95% CI -£512 to £441) and a mean QALY difference of 0.001 (95% CI -0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI -£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold., Conclusions: Costs and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations., Trial Registration Number: ISRCTN16347068; Post-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care., Design: Cost-utility analysis alongside a randomised controlled trial., Setting: Community settings in Greater London, England., Participants: 174 young people with obesity aged 12-19 years., Interventions: Intervention participants received 12 one-to-one sessions across 6 months, addressing lifestyle behaviours and focusing on motivation to change and self-esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse-delivered session providing didactic weight-management advice., Main Outcome Measures: Mean costs and quality-adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC)., Results: Mean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI -0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120 630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20 000 or £30 000 per QALY gained., Conclusions: We did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective., Trial Registration Number: ISRCTN9984011., Competing Interests: Competing interests: AK is Director of International Public Health at Public Health England (PHE)., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To determine the cost-effectiveness of two bespoke severe mental illness (SMI)-specific risk algorithms compared with standard risk algorithms for primary cardiovascular disease (CVD) prevention in those with SMI., Setting: Primary care setting in the UK. The analysis was from the National Health Service perspective., Participants: 1000 individuals with SMI from The Health Improvement Network Database, aged 30-74 years and without existing CVD, populated the model., Interventions: Four cardiovascular risk algorithms were assessed: (1) general population lipid, (2) general population body mass index (BMI), (3) SMI-specific lipid and (4) SMI-specific BMI, compared against no algorithm. At baseline, each cardiovascular risk algorithm was applied and those considered high risk ( > 10%) were assumed to be prescribed statin therapy while others received usual care., Primary and Secondary Outcome Measures: Quality-adjusted life years (QALYs) and costs were accrued for each algorithm including no algorithm, and cost-effectiveness was calculated using the net monetary benefit (NMB) approach. Deterministic and probabilistic sensitivity analyses were performed to test assumptions made and uncertainty around parameter estimates., Results: The SMI-specific BMI algorithm had the highest NMB resulting in 15 additional QALYs and a cost saving of approximately £53 000 per 1000 patients with SMI over 10 years, followed by the general population lipid algorithm (13 additional QALYs and a cost saving of £46 000)., Conclusions: The general population lipid and SMI-specific BMI algorithms performed equally well. The ease and acceptability of use of an SMI-specific BMI algorithm (blood tests not required) makes it an attractive algorithm to implement in clinical settings., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Many people with dementia die in nursing homes, but quality of care may be suboptimal. We developed the theory-driven 'Compassion Intervention' to enhance end-of-life care in advanced dementia., Objectives: To (1) understand how the Intervention operated in nursing homes in different health economies; (2) collect preliminary outcome data and costs of an interdisciplinary care leader (ICL) to facilitate the Intervention; (3) check the Intervention caused no harm., Design: A naturalistic feasibility study of Intervention implementation for 6 months., Settings: Two nursing homes in northern London, UK., Participants: Thirty residents with advanced dementia were assessed of whom nine were recruited for data collection; four of these residents' family members were interviewed. Twenty-eight nursing home and external healthcare professionals participated in interviews at 7 (n=19), 11 (n=19) and 15 months (n=10)., Intervention: An ICL led two core Intervention components: (1) integrated, interdisciplinary assessment and care; (2) education and support for paid and family carers., Data Collected: Process and outcome data were collected. Symptoms were recorded monthly for recruited residents. Semistructured interviews were conducted at 7, 11 and 15 months with nursing home staff and external healthcare professionals and at 7 months with family carers. ICL hours were costed using Department of Health and Health Education England tariffs., Results: Contextual differences were identified between sites: nursing home 2 had lower involvement with external healthcare services. Core components were implemented at both sites but multidisciplinary meetings were only established in nursing home 1. The Intervention prompted improvements in advance care planning, pain management and person-centred care; we observed no harm. Six-month ICL costs were £18 255., Conclusions: Implementation was feasible to differing degrees across sites, dependent on context. Our data inform future testing to identify the Intervention's effectiveness in improving end-of-life care in advanced dementia., Trial Registration: ClinicalTrials.gov:NCT02840318: Results., Competing Interests: Competing interests: Authors had no competing interests, (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To investigate the rate of recording of premenstrual syndrome diagnoses in UK primary care and describe pharmacological treatments initiated following a premenstrual syndrome (PMS) diagnosis., Design: Retrospective cohort study., Setting: UK primary care., Participants: Women registered with a practice contributing to The Health Improvement Network primary care database between 1995 and 2013., Primary and Secondary Outcome Measures: The primary outcome was the rate of first premenstrual syndrome records per 1000 person years, stratified by calendar year and age. The secondary outcome was the proportions of women with a premenstrual syndrome record prescribed a selective serotonin reuptake inhibitor, progestogen, oestrogen, combined oral contraceptive, progestin only contraceptive, gonadotrophin-releasing hormone, danazol and vitamin B6., Results: The rate of recording of premenstrual syndrome diagnoses decreased over calendar time from 8.43 in 1995 to 1.72 in 2013. Of the 38,614 women without treatment in the 6 months prior to diagnosis, 54% received a potentially premenstrual syndrome-related prescription on the day of their first PMS record while 77% received a prescription in the 24 months after. Between 1995 and 1999, the majority of women were prescribed progestogens (23%) or vitamin B6 (20%) on the day of their first PMS record; after 1999, these figures fell to 3% for progestogen and vitamin B6 with the majority of women instead being prescribed a selective serotonin reuptake inhibitor (28%) or combined oral contraceptive (17%)., Conclusions: Recording of premenstrual syndrome diagnoses in UK primary care has declined substantially over time and preferred prescription treatment has changed from progestogen to selective serotonin reuptake inhibitor and combined oral contraceptives., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objective: To describe the characteristics of pregnant women with and without pregestational diabetes and to estimate the prevalence of pregestational diabetes in pregnant women recorded in a UK primary care database., Methods: The data source for this study is The Health Improvement Network (THIN) primary care database. Pregnant women with and without diabetes aged 16 years and over were identified using diagnostic Read codes and prescriptions for antidiabetics from medical records. Data were examined on: age, body mass index (BMI), social deprivation, smoking, ethnicity and glycaemic control. The prevalence of pregestational diabetes was calculated by diabetes type and calendar year between 1995 and 2012., Results: Data from 400,434 pregnancies suggests that women with pregestational diabetes were: older (median 29, 32 vs 29 years for type 1, type 2 and without diabetes, respectively), had higher BMI (median 25.0, 30.4 vs 23.9 k/m(2) for type 1, type 2 and without diabetes, respectively) and were registered with a general practice for longer than pregnant women without diabetes. The prevalence of type 1 diabetes in pregnancy increased from 1.56 to 4.09 per 1000 pregnancies between 1995 and 2015. For type 2 diabetes the increase was from 2.34 to 5.09 per 1000 pregnancies between 1995 and 2008 followed by a more rapid increase to 10.62 per 1000 pregnancies by 2012., Conclusions: Pregnant women with pregestational diabetes were older, had higher BMI and were registered for longer than women without diabetes. The prevalence of type 1 and type 2 diabetes increased in pregnancy. The prevalence of type 2 diabetes rose more rapidly with a marked increase after 2008., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objective: To investigate trends in incident and prevalent diagnoses of type 2 diabetes mellitus (T2DM) and its pharmacological treatment between 2000 and 2013., Design: Analysis of longitudinal electronic health records in The Health Improvement Network (THIN) primary care database., Setting: UK primary care., Participants: In total, we examined 8,838,031 individuals aged 0-99 years., Outcome Measures: The incidence and prevalence of T2DM between 2000 and 2013, and the effect of age, sex and social deprivation on these measures were examined. Changes in prescribing patterns of antidiabetic therapy between 2000 and 2013 were also investigated., Results: Overall, 406,344 individuals had a diagnosis of T2DM, of which 203,639 were newly diagnosed between 2000 and 2013. The incidence of T2DM rose from 3.69 per 1000 person-years at risk (PYAR) (95% CI 3.58 to 3.81) in 2000 to 3.99 per 1000 PYAR (95% CI 3.90 to 4.08) in 2013 among men; and from 3.06 per 1000 PYAR (95% CI 2.95 to 3.17) to 3.73 per 1000 PYAR (95% CI 3.65 to 3.82) among women. Prevalence of T2DM more than doubled from 2.39% (95% CI 2.37 to 2.41) in 2000 to 5.32% (95% CI 5.30 to 5.34) in 2013. Being male, older, and from a more socially deprived area was strongly associated with having T2DM, (p<0.001). Prescribing changes over time reflected emerging clinical guidance and novel treatments. In 2013, metformin prescribing peaked at 83.6% (95% CI 83.4% to 83.8%), while sulfonylureas prescribing reached a low of 41.4% (95% CI 41.1% to 41.7%). Both remained, however, the most commonly used pharmacological treatments as first-line agents and add-on therapy. Thiazolidinediones and incretin based therapies (gliptins and GLP-1 analogues) were also prescribed as alternate add-on therapy options, however were rarely used for first-line treatment in T2DM., Conclusions: Prevalent cases of T2DM more than doubled between 2000 and 2013, while the number of incident cases increased more steadily. Changes in prescribing patterns observed may reflect the impact of national policies and prescribing guidelines on UK primary care., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objective: To examine the recorded indication for antipsychotic prescriptions in UK primary care., Design: Cohort study., Setting: Primary care., Participants: Individuals prescribed antipsychotics between 2007 and 2011., Measures: The proportion of individuals prescribed antipsychotics with a diagnosis of (1) psychosis and bipolar disorder, (2) other diagnoses including depression, anxiety and dementia and (3) none of these diagnoses., Results: We identified 47,724 individuals prescribed antipsychotic agents. 13,941 received first-generation agents and 27,966 received second-generation agents. The rates of prescribing were higher in females (incidence rate ratio (IRR) 1.092 (95% CI 1.088 to 1.095), older people (80+ vs 40-49; IRR 2.234 (2.222 to 2.246)) and in those from the most deprived areas (most deprived vs least deprived IRR 3.487 (3.567 to 3.606). Of those receiving first-generation antipsychotics, less than 50% had a diagnosis of psychosis/bipolar disorder. For the second-generation agents, the numbers ranged from 4824 (36%) for quetiapine to 7094 (62%) for olanzapine. In patients without psychosis/bipolar disorder, common diagnoses included anxiety, depression, dementia, sleep and personality disorders. For example, in risperidone users, 14% had an anxiety code, 22% depression, 12% dementia, 11% sleep disorder and 4% personality disorder. The median daily doses and duration of treatment were greater in those with schizophrenia (eg, risperidone median daily dose 4 mg; IQR 2-6: median duration 1.2 years) than in those with non-psychotic/bipolar disorders such as depression or anxiety (eg, risperidone 1 mg; IQR 1-2: 0.6 years). A relatively large proportion (between 6% and 17%) of people receiving individual antipsychotics had none of the diagnoses stated above., Conclusions: In UK primary care, a large proportion of people prescribed antipsychotics have no record of psychotic or bipolar disorder. They are often older people with conditions including dementia, non-psychotic depression, anxiety and sleep disorders., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: To investigate how smoking status is recorded in UK primary care; to evaluate whether appropriate multiple imputation (MI) of smoking status yields results consistent with health surveys., Setting: UK primary care and a population survey conducted in the community., Participants: We identified 354 204 patients aged 16 or over in The Health Improvement Network (THIN) primary care database registered with their general practice 2008-2009 and 15 102 individuals aged 16 or over in the Health Survey for England (HSE)., Outcome Measures: Age-standardised and age-specific proportions of smokers, ex-smokers and non-smokers in THIN and the HSE before and after MI. Using information on time since quitting in the HSE, we estimated when ex-smokers are typically recorded as non-smokers in primary care records., Results: In THIN, smoking status was recorded for 84% of patients within 1 year of registration. Of these, 28% were smokers (21% in the HSE). After MI of missing smoking data, the proportion of smokers was 25% (missing at random) and 20% (missing not at random). With increasing age, more were identified as ex-smokers in the HSE than THIN. It appears that those who quit before age 30 were less likely to be recorded as an ex-smoker in primary care than people who quit later., Conclusions: Smoking status was relatively well recorded in primary care. Misclassification of ex-smokers as non-smokers is likely to occur in those quitting smoking at an early age and/or a long time ago. Those with no smoking status information are more likely to be ex-smokers or non-smokers than smokers.

Objectives: We aimed to examine the temporal association between selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressant (TCA) prescriptions and suicide-related events in children and adolescents., Design: Self-controlled case series., Setting: Electronic health records were used from 479 general practices in The Health Improvement Network (THIN) UK primary care database from 1995 to 2009., Participants: 81 young people aged 10-18 years with a record of completed suicide, 1496 who attempted suicide, 1178 with suicidal ideation and 2361 with intentional self-harm., Main Outcome Measures: Incidence Rate Ratios (IRRs) for completed and attempted suicide, suicidal ideation and intentional self-harm., Results: For non-fatal suicide-related behaviour, IRRs were similar for the time the person was prescribed either SSRIs or TCAs: IRRs increased during pre-exposure, peaked on prescription day, were stable up to the fourth prescription-week, and decreased after the prescriptions were stopped. For both types of antidepressants, IRRs were lower or similar to pre-exposure levels during the period of prescription. For SSRIs, there was an increase in the IRR for completed suicide on the day of prescription (N=5; IRR=42.5, 95% CI 4.5 to 403.4), and during the fourth week of SSRI prescription (N=2; IRR=11.3, 95% CI 1.1 to 115.6)., Conclusions: We found that a very small number of young people were prescribed antidepressants and that there was an absence of a sustained increase in rates of suicide-related events in this group. There were no systematic differences between the association of TCAs and SSRIs and the incidence risk ratios for attempted suicide, suicidal ideation or intentional self-harm and, apart from the day of prescription, rates did not exceed pre-exposure levels. The pattern of IRR for suicide for SSRIs was similar to that found in non-fatal suicide-related events. Our results warrant a re-evaluation of the current prescription of SSRIs in young people. We recommend the creation of a pragmatic registry for active pharmacovigilance.

Objective: To examine whether gender differences in primary care consultation rates (1) vary by age and deprivation status and (2) diminish when consultation for reproductive reasons or common underlying morbidities are accounted for., Design: Cross-sectional study of a cohort of patients registered with general practice., Setting: UK primary care., Subjects: Patients (1 869 149 men and 1 916 898 women) registered with 446 eligible practices in 2010., Primary Outcome Measures: Primary care consultation rate., Results: This study analyses routinely collected primary care consultation data. The crude consultation rate was 32% lower in men than women. The magnitude of gender difference varied across the life course, and there was no 'excess' female consulting in early and later life. The greatest gender gap in primary care consultations was seen among those aged between 16 and 60 years. Gender differences in consulting were higher in people from more deprived areas than among those from more affluent areas. Accounting for reproductive-related consultations diminished but did not eradicate the gender gap. However, consultation rates in men and women who had comparable underlying morbidities (as assessed by receipt of medication) were similar; men in receipt of antidepressant medication were only 8% less likely to consult than women in receipt of antidepressant medication (relative risk (RR) 0.916, 95% CI 0.913 to 0.918), and men in receipt of medication to treat cardiovascular disease were just 5% less likely to consult (RR=0.950, 95% CI 0.948 to 0.952) than women receiving similar medication. These small gender differences diminished further, particularly for depression (RR=0.950, 95% CI 0.947 to 0.953), after also taking account of reproductive consultations., Conclusions: Overall gender differences in consulting are most marked between the ages of 16 and 60 years; these differences are only partially accounted for by consultations for reproductive reasons. Differences in consultation rates between men and women were largely eradicated when comparing men and women in receipt of medication for similar underlying morbidities.

Objectives: To assess the safety of an AS03-adjuvanted split virion H1N1 (2009) vaccine (Pandemrix) in persons vaccinated during the national pandemic influenza vaccination campaign in the UK., Design: Prospective, cohort, observational, postauthorisation safety study., Setting: 87 general practices forming part of the Medical Research Council General Practice Research Framework and widely distributed throughout England., Participants: A cohort of 9143 individuals aged 7 months to 97 years who received at least one dose of the AS03-adjuvanted H1N1 pandemic vaccine during the national pandemic influenza vaccination campaign in the UK was enrolled. 94% completed the 6-month follow-up. Exclusion criteria were previous vaccination with other H1N1 pandemic vaccine and any child in care., Primary and Secondary Outcome Measures: Medically attended adverse events (MAEs) occurring within 31 days after any dose, serious adverse events (SAEs) and adverse events of special interest (AESIs) following vaccination were collected for all participants. Solicited adverse events (AEs) were assessed in a subset of participants., Results: MAEs were reported in 1219 participants and SAEs in 113 participants during the 31-day postvaccination period. The most frequently reported MAEs and SAEs were consistent with events expected to be reported during the winter season in this population: lower respiratory tract infections, asthma and pneumonia. The most commonly reported solicited AEs were irritability in young children aged <5 years (61.8%), muscle aches in children aged 5-17 years (61.9%) and adults (46.9%). 18 AESIs, experienced by 14 patients, met the criteria to be considered for the observed-to-expected analyses. AESIs above the expected number were neuritis (1 case within 31 days) and convulsions (8 cases within 181 days). There were 41 deaths during the 181-day period after vaccination, fewer than expected., Conclusions: Results indicate that the AS03-adjuvanted H1N1 pandemic vaccine showed a clinically acceptable reactogenicity and safety profile in all age and risk groups studied., Trial Registration: ClinicalTrials.gov, NCT00996853.