Publications by authors named "Stephen A Bremner"

27 Publications

  • Page 1 of 1

Antenatal and perinatal factors influencing neonatal blood pressure: a systematic review.

J Perinatol 2021 Sep 7;41(9):2317-2329. Epub 2021 Aug 7.

British Columbia Children´s Hospital, Vancouver, BC, Canada.

Objective: A comprehensive understanding of the factors contributing to perinatal blood pressure is vital to ensure optimal postnatal hemodynamic support. The objective of this study was to review existing literature on maternal and perinatal factors influencing blood pressure in neonates up to 3 months corrected age.

Methods: A systematic search of published literature in OVID Medline, OVID Embase and the COCHRANE library identified publications relating to maternal factors affecting blood pressure of neonates up to corrected age of 3 months. Summary data were extracted and compared (PROSPERO CRD42018092886).

Results: Of the 3683 non-duplicate publications identified, 44 were eligible for inclusion in this review. Topics elicited were sociodemographic factors, maternal health status, medications, smoking during pregnancy, and cord management at birth. Limited data were available for each factor. Results regarding the impact of these factors on neonatal blood pressure were inconsistent across studies.

Conclusions: There is insufficient evidence to draw definitive conclusions regarding the impact of various maternal and perinatal factors on neonatal blood pressure. Future investigations of neonatal cardiovascular therapies should account for these factors in their study design. Similarly, studies on maternal diseases and perinatal interventions should include neonatal blood pressure as part of their primary or secondary analyses.
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September 2021

EnDPoINT: protocol for an implementation research study to integrate a holistic package of physical health, mental health and psychosocial care for podoconiosis, lymphatic filariasis and leprosy into routine health services in Ethiopia.

BMJ Open 2020 10 15;10(10):e037675. Epub 2020 Oct 15.

Centre for Global Health Research, Brighton and Sussex Medical School, Brighton, UK.

Introduction: Neglected tropical diseases (NTDs) causing lower limb lymphoedema such as podoconiosis, lymphatic filariasis (LF) and leprosy are common in Ethiopia. Routine health services for morbidity management and disability prevention (MMDP) of lymphoedema caused by these conditions are still lacking, even though it imposes a huge burden on affected individuals and their communities in terms of physical and mental health, and psychosocial and economic outcomes. This calls for an integrated, holistic approach to MMDP across these three diseases.

Methods And Analysis: The 'Excellence in Disability Prevention Integrated across NTDs' (EnDPoINT) implementation research study aims to assess the integration and scale-up of a holistic package of care-including physical health, mental health and psychosocial care-into routine health services for people with lymphoedema caused by podoconiosis, LF and leprosy in selected districts in Awi zone in the North-West of Ethiopia. The study is being carried out over three phases using a wide range of mixed methodologies. Phase 1 involves the development of a comprehensive holistic care package and strategies for its integration into the routine health services across the three diseases, and to examine the factors that influence integration and the roles of key health system actors. Phase 2 involves a pilot study conducted in one subdistrict in Awi zone, to establish the care package's adoption, feasibility, acceptability, fidelity, potential effectiveness, its readiness for scale-up, costs of the interventions and the suitability of the training and training materials. Phase 3 involves scale-up of the care package in three whole districts, as well as its evaluation in regard to coverage, implementation, clinical (physical health, mental health and psychosocial) and economic outcomes.

Ethics And Dissemination: Ethics approval for the study has been obtained in the UK and Ethiopia. The results will be disseminated through publications in scientific journals, conference presentations, policy briefs and workshops.
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October 2020

Method of Blood Pressure Measurement in Neonates and Infants: A Systematic Review and Analysis.

J Pediatr 2020 06;221:23-31.e5

Critical Path Institute (C-Path) International Neonatal Consortium (INC), Denver, CO.

Objectives: To determine the recommended blood pressure (BP) measurement methods in neonates after systematically analyzing the literature regarding proper BP cuff size and measurement location and method.

Study Design: A literature search was conducted in MEDLINE, PubMed, Embase, Cochrane Library, and CINAHL from 1946 to 2017 on BP in neonates <3 months of age (PROSPERO ID CRD42018092886). Study data were extracted and analyzed with separate analysis of Bland-Altman studies comparing measurement methods.

Results: Of 3587 nonduplicate publications identified, 34 were appropriate for inclusion in the analysis. Four studies evaluating BP cuff size support a recommendation for a cuff width to arm circumference ratio of approximately 0.5. Studies investigating measurement location identified the upper arm as the most accurate and least variable location for oscillometric BP measurement. Analysis of studies using Bland-Altman methods for comparison of intra-arterial to oscillometric BP measurement show that the 2 methods correlate best for mean arterial pressure, whereas systolic BP by the oscillometric method tends to overestimate intra-arterial systolic BP. Compared with intra-arterial methods, systolic BP, diastolic BP, and mean arterial pressure by oscillometric methods are less accurate and precise, especially in neonates with a mean arterial pressure <30 mm Hg.

Conclusions: Proper BP measurement is critical in neonates with naturally lower BP and attention to BP cuff size, location, and method of measurement are essential. With decreasing use of intra-arterial catheters for long-term BP monitoring in neonates, further studies are urgently needed to validate and develop oscillometric methodology with enhanced accuracy.
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June 2020

Filaggrin gene defects are associated with eczema, wheeze, and nasal disease during infancy: Prospective study.

J Allergy Clin Immunol 2020 09 27;146(3):681-682. Epub 2020 Apr 27.

Academic Department of Paediatrics, Royal Alexandra Children's Hospital, Brighton and Sussex Medical School, Brighton, United Kingdom; Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom.

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September 2020

A protocol paper: community engagement interventions for cardiovascular disease prevention in socially disadvantaged populations in the UK: an implementation research study.

Glob Health Res Policy 2020 12;5:12. Epub 2020 Mar 12.

5Department of Primary and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.

Background: Cardiovascular disorders (CVD) are the single greatest cause of mortality worldwide. In the UK, the National Health Service (NHS) has launched an initiative of health checks over and above current care to tackle CVD. However, the uptake of Health Checks is poor in disadvantaged communities. This protocol paper sets out a UK-based study (Sussex and Nottingham) aiming to co-produce a community delivered CVD risk assessment and coaching intervention to support community members to reduce their risk of CVD.The overall aim of the project is to implement a tailored-to-context community engagement (CE) intervention on awareness of CVD risks in vulnerable populations in high, middle and low-income countries. The specific objectives of the study are to enhance stakeholder' engagement; to implement lifestyle interventions for cardiovascular primary prevention, in disadvantaged populations and motivate uptake of NHS health checks.

Methods: This study uses both qualitative and quantitative methods in three phases of evaluation, including pre-, per- and post-implementation. To ensure contextual appropriateness the 'Scaling-up Packages of Interventions for Cardiovascular disease prevention in selected sites in Europe and Sub-Saharan Africa: An implementation research' (SPICES) project will organize a multi-component community-engagement intervention. For the qualitative component, the pre-implementation phase will involve a contextual assessment and stakeholder mapping, exploring potentials for CVD risk profiling strategies and led by trained Community Health Volunteers (CHV) to identify accessibility and acceptability. The per-implementation phase will involve healthy lifestyle counselling provided by CHVs and evaluation of the outcome to identify fidelity and scalability. The post-implementation phase will involve developing sustainable community-based strategies for CVD risk reduction. All three components will include a process evaluation. A stepped wedge cluster randomised trial of the roll out will focus on implementation outcomes including uptake and engagement and changes in risk profiles. The quantitative component includes pre and post-intervention surveys. The theory of the socio-ecological framework will be applied to analyse the community engagement approach.

Discussion: Based on the results ultimately a sustainable community engagement-based strategy for the primary prevention of CVD risk will be developed to enhance the performance of NHS health care in the UK. The Trial Registration number is ISRCTN68334579.
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August 2021

Determining the accuracy of zero-flux and ingestible thermometers in the peri-operative setting.

J Clin Monit Comput 2019 Dec 8;33(6):1113-1118. Epub 2019 Jan 8.

Brighton and Sussex University Hospitals Trust, Royal Sussex County Hospital, Eastern Road, Brighton, East Sussex, BN2 5BE, UK.

Accurately monitoring peri-operative core temperature is a cornerstone of good practice. Relatively invasive devices such as oesophageal temperature probes and pulmonary artery catheters facilitate this, but are inappropriate for many patients. There remains a need for accurate monitors of core temperature that can be used in awake patients. This study compared the accuracy of two core temperature thermometers that can be used for this purpose: the 3M Bair Hugger™ Temperature Monitoring System Zero Flux Thermometer and the CorTempR™ Wireless Ingestible Temperature Sensor. Readings were compared with the oesophageal probe, the current intraoperative standard. Thirty patients undergoing elective surgical procedures under general anaesthesia were recruited. The ingestible sensor was ingested prior to induction of anaethesia, and post induction, the zero-flux electrode attached above the right eyebrow and oesophageal probe inserted. During surgery, the temperature on each device was recorded every minute. Measurements were compared using Bland-Altman analysis. The ingestible sensor experienced interference from use of diathermy and fluoroscopy in the operating theatre, rendering 39% of its readings unusable. These were removed from analysis. With remaining readings the bias compared with oesophageal probe was + 0.42 °C, with 95% limits of agreement - 2.4 °C to 3.2 °C. 75.4% of readings were within ± 0.5 °C of the OTP reading. The bias for the zero flux electrode compared to oesophageal probe was + 0.02 °C with 95% limits of agreement - 0.5 °C to 0.5 °C. 97.7% of readings were within ± 0.5 °C of the oesophageal probe. The study findings suggest the zero-flux thermometer is sufficiently accurate for clinical use, whereas the ingestible sensor is not.Trial registration The study was registered at , NCT Number: NCT02121574.
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December 2019

Impact of London's low emission zone on air quality and children's respiratory health: a sequential annual cross-sectional study.

Lancet Public Health 2019 01 15;4(1):e28-e40. Epub 2018 Nov 15.

Asthma UK Centre for Applied Research, Barts Institute of Population Health Sciences, Queen Mary University of London, London, UK; MRC and Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, London, UK. Electronic address:

Background: Low emission zones (LEZ) are an increasingly common, but unevaluated, intervention aimed at improving urban air quality and public health. We investigated the impact of London's LEZ on air quality and children's respiratory health.

Methods: We did a sequential annual cross-sectional study of 2164 children aged 8-9 years attending primary schools between 2009-10 and 2013-14 in central London, UK, following the introduction of London's LEZ in February, 2008. We examined the association between modelled pollutant exposures of nitrogen oxides (including nitrogen dioxide [NO]) and particulate matter with a diameter of less than 2·5 μm (PM) and less than 10 μm (PM) and lung function: postbronchodilator forced expiratory volume in 1 s (FEV, primary outcome), forced vital capacity (FVC), and respiratory or allergic symptoms. We assigned annual exposures by each child's home and school address, as well as spatially resolved estimates for the 3 h (0600-0900 h), 24 h, and 7 days before each child's assessment, to isolate long-term from short-term effects.

Findings: The percentage of children living at addresses exceeding the EU limit value for annual NO (40 μg/m) fell from 99% (444/450) in 2009 to 34% (150/441) in 2013. Over this period, we identified a reduction in NO at both roadside (median -1·35 μg/m per year; 95% CI -2·09 to -0·61; p=0·0004) and background locations (-0·97; -1·56 to -0·38; p=0·0013), but not for PM. The effect on PM was equivocal. We found no association between postbronchodilator FEV and annual residential pollutant attributions. By contrast, FVC was inversely correlated with annual NO (-0·0023 L/μg per m; -0·0044 to -0·0002; p=0·033) and PM (-0·0090 L/μg per m; -0·0175 to -0·0005; p=0·038).

Interpretation: Within London's LEZ, a smaller lung volume in children was associated with higher annual air pollutant exposures. We found no evidence of a reduction in the proportion of children with small lungs over this period, despite small improvements in air quality in highly polluted urban areas during the implementation of London's LEZ. Interventions that deliver larger reductions in emissions might yield improvements in children's health.

Funding: National Institute for Health Research Biomedical Research Centre at Guy's and St Thomas' National Health Service (NHS) Foundation Trust and King's College London, NHS Hackney, Lee Him donation, and Felicity Wilde Charitable Trust.
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January 2019

Caring for Caregivers (C4C): study protocol for a pilot feasibility randomised control trial of Positive Written Disclosure for older adult caregivers of people with psychosis.

Pilot Feasibility Stud 2017 21;3:63. Epub 2017 Nov 21.

Department of Primary Care and Public Health, Brighton and Sussex Medical School, Mayfield House, Village Way, Falmer, BN1 9PH UK.

Background: The caregivers of people who experience psychosis are themselves at risk of developing physical and mental health problems. This risk is increased for older adult caregivers who also have to manage the lifestyle and health changes associated with ageing. As a consequence, older adult caregivers are in particular need of support; we propose a Written Emotional Disclosure (WED) intervention, called Positive Written Disclosure (PWD).

Methods/design: This is a pilot randomised controlled trial of PWD compared to a neutral writing control and a no writing condition. We aim to recruit 60 participants, 20 in each arm. This study will utilise a mixed-methods approach and collect quantitative (questionnaires) and qualitative (interviews) data. Quantitative data will be collected at baseline and 1, 3, and 6 months post baseline. Participants who complete a writing task (PWD or neutral writing control) will be invited to complete an exit interview to discuss their experiences of the intervention and study. The study is supported by a patient and public involvement group.

Discussion: The results of this trial will determine whether a definitive trial is justified. If so, the quantitative and qualitative findings will be used to refine the intervention and study protocols.

Trial Registration: ISRCTN, ISRCTN79116352. Registered on 23 January 2017.
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November 2017

Financial incentives to improve adherence to antipsychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial.

Health Technol Assess 2016 09;20(70):1-122

Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.

Background: Poor adherence to long-term antipsychotic injectable (LAI) medication in patients with psychotic disorders is associated with a range of negative outcomes. No psychosocial intervention has been found to be consistently effective in improving adherence.

Objectives: To test whether or not offering financial incentives is effective and cost-effective in improving adherence and to explore patient and clinician experiences with such incentives.

Design: A cluster randomised controlled trial with economic and nested qualitative evaluation. The intervention period lasted for 12 months with 24 months' follow-up. The unit of randomisation was mental health teams in the community.

Setting: Community teams in secondary mental health care.

Participants: Patients with a diagnosis of schizophrenia, schizoaffective psychosis or bipolar illness, receiving ≤ 75% of their prescribed LAI medication. In total, 73 teams with 141 patients (intervention n = 78 and control n = 63) were included.

Interventions: Participants in the intervention group received £15 for each LAI medication. Patients in the control group received treatment as usual.

Main Outcome Measures:

Primary Outcome: adherence to LAI medication (the percentage of received out of those prescribed).

Secondary Outcomes: percentage of patients with at least 95% adherence; clinical global improvement; subjective quality of life; satisfaction with medication; hospitalisation; adverse events; and costs. Qualitative evaluation: semistructured interviews with patients in the intervention group and their clinicians.


Primary Outcome: outcome data were available for 131 patients. Baseline adherence was 69% in the intervention group and 67% in the control group. During the intervention period, adherence was significantly higher in the intervention group than in the control group (85% vs. 71%) [adjusted mean difference 11.5%, 95% confidence interval (CI) 3.9% to 19.0%; p = 0.003]. Secondary outcome: patients in the intervention group showed statistically significant improvement in adherence of at least 95% (adjusted odds ratio 8.21, 95% CI 2.00 to 33.67; p = 0.003) and subjective quality of life (difference in means 0.71, 95% CI 0.26 to 1.15; p = 0.002). Follow-ups: after incentives stopped, adherence did not differ significantly between groups, neither during the first 6 months (adjusted difference in means -7.4%, 95% CI -17.0% to 2.1%; p = 0.175) nor during the period from month 7 to month 24 (difference in means -5.7%, 95% CI -13.1% to 1.7%; p = 0.130). Cost-effectiveness: the average costs of the financial incentives was £303. Overall costs per patient were somewhat higher in the intervention group, but the difference was not significant. Semistructured interviews: the majority of patients and clinicians reported positive experiences with the incentives beyond their monetary value. These included improvement in the therapeutic relationship. The majority of both patients and clinicians perceived no negative impact after the intervention was stopped after 1 year.

Conclusions: Financial incentives are effective in improving adherence to LAI medication. Health-care costs (including costs of the financial incentive) are unlikely to be increased substantially by this intervention. Once the incentives stop, the advantage is not maintained. The experiences of both patients and clinicians are largely, but not exclusively, positive. Whether or not financial incentives are effective for patients with more favourable background, those on oral mediation or for shorter or longer time periods remains unknown.

Trial Registration: Current Controlled Trials ISRCTN77769281.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 70. See the NIHR Journals Library website for further project information.
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September 2016

Discontinuing financial incentives for adherence to antipsychotic depot medication: long-term outcomes of a cluster randomised controlled trial.

BMJ Open 2016 Sep 21;6(9):e011673. Epub 2016 Sep 21.

Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Service Development), Queen Mary University London, London, UK.

Objectives: In a cluster randomised controlled trial, offering financial incentives improved adherence to antipsychotic depot medication over a 1-year period. Yet, it is unknown whether this positive effect is sustained once the incentives stop.

Methods And Analyses: Patients in the intervention and control group were followed up for 2 years after the intervention. Primary and secondary outcomes were assessed at 6 months and 24 months post intervention. Assessments were conducted between September 2011 and November 2014.

Results: After the intervention period, intervention and control groups did not show any statistically significant differences in adherence, neither in the first 6 months (71% and 77%, respectively) nor in the following 18 months (68%, 74%). There were no statistically significant differences in secondary outcomes, that is, adherence ≥95% and untoward incidents either.

Conclusions: It may be concluded that incentives to improve adherence to antipsychotic maintenance medication are effective only for as long as they are provided. Once they are stopped, adherence returns to approximately baseline level with no sustained benefit.

Trial Registration Number: ISRCTN77769281; Results.
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September 2016

Nanoflow-Nanospray Mass Spectrometry Metabolomics Reveals Disruption of the Urinary Metabolite Profiles of HIV-Positive Patients on Combination Antiretroviral Therapy.

J Acquir Immune Defic Syndr 2017 Feb;74(2):e45-e53

*School of Life Sciences, University of Sussex, Brighton, United Kingdom; †Brighton and Sussex Medical School, Brighton, United Kingdom; ‡Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; and §The Royal Melbourne Hospital, The University of Melbourne, Victoria, Australia.

Background: The use of combination antiretroviral therapy (cART) has substantially improved the outlook for patients with HIV infection. However, lifelong exposure to cART is also associated with adverse metabolic changes and an enhanced risk of renal, hepatic, and cardiovascular dysfunction. This study investigated disruptions of the urinary metabolome of cART-exposed patients, thereby furthering our understanding of some of the side effects of pharmaceutical intervention.

Methods: HIV-positive patients were recruited from an HIV clinic and divided into cART-naive and cART-exposed groups. HIV-negative patients were recruited from a sexual health clinic. All 89 subjects were white males. Targeted biochemistry analyses were performed on plasma samples. Urine samples were collected after an overnight fast and analyzed with a highly sensitive untargeted metabolomic method using nanoflow/nanospray liquid chromatography-time-of-flight mass spectrometry. Data sets were analyzed using projection modeling to detect metabolite markers of cART exposure.

Results: Metabolites or parent compounds of all cART drugs were detected in urine extracts of all but one of the cART-exposed patients confirming adherence to the pharmaceutical regimen. Analysis of urine samples from patients on cART revealed significant reductions in selected bile acids, lipid, nucleoside, and androgen metabolites. However, plasma concentrations of free or conjugated testosterone remained unchanged indicating possible disruption of androgen transport or excretion in urine of patients on cART.

Conclusions: Discovery-based metabolomics reveals the potential to identify novel markers of cART intervention and metabolite disruption in HIV-positive patients, which may enable investigation of the efficacy, compliance, and side effects of these pharmaceutical mixtures to be investigated.
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February 2017

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial).

Health Technol Assess 2015 Sep;19(77):1-164

National Centre for Bowel Research and Surgical Innovation, Blizard Institute, Queen Mary University of London, London, UK.

Background: Faecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life. When conservative strategies fail, treatment options are limited. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive outpatient treatment, shown in preliminary case series to have significant effectiveness; however, no randomised controlled trial has been conducted.

Objectives: To assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed.

Design: Multicentre, parallel-arm, double-blind randomised (1 : 1) controlled trial.

Setting: Eighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders.

Participants: Participants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention.

Interventions: PTNS was delivered via the Urgent(®) PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturer's protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation.

Main Outcome Measures: Outcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved ≥ 50% reduction in weekly faecal incontinence episodes (FIEs).

Results: In total, 227 patients were randomised from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: seven from the PTNS arm and five from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a ≥ 50% reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38%) compared with 32 in the sham arm (31%) [odds ratio 1.28, 95% confidence interval (CI) 0.72 to 2.28; p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta -2.3, 95% CI -4.2 to -0.3; p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Mark's Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported.

Conclusions: PTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50% reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied. Further research will concentrate on particular subgroups of patients, for example those with pure urge FI.

Trial Registration: Current Controlled Trials ISRCTN88559475.

Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.
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September 2015

The effect of financial incentives on adherence to antipsychotic depot medication: does it change over time?

J Clin Psychiatry 2015 08;76(8):e1029-34

Unit for Social and Community Psychiatry, Newham Centre for Mental Health, London, United Kingdom E13 8SP

Objective: A recent cluster-randomized controlled trial found that offering financial incentives improves adherence to long-acting injectable antipsychotics (LAIs). The present study investigates whether the impact of incentives diminishes over time and whether the improvement in adherence is linked to the amount of incentives offered.

Method: Seventy-three teams with 141 patients with psychotic disorders (using ICD-10) were randomized to the intervention or control group. Over 1 year, patients in the intervention group received £15 (US $23) for each LAI, while control patients received treatment as usual. Adherence levels, ie, the percentage of prescribed LAIs that were received, were calculated for quarterly intervals. The amount of incentives offered was calculated from the treatment cycle at baseline. Multilevel models were used to examine the time course of the effect of incentives and the effect of the amount of incentives offered on adherence.

Results: Adherence increased in both the intervention and the control group over time by an average of 4.2% per quarterly interval (95% CI, 2.8%-5.6%; P < .001). Despite this general increase, adherence in the intervention group remained improved compared to the control group by between 11% and 14% per quarterly interval. There was no interaction effect between time and treatment group. Further, a higher total amount of incentives was associated with poorer adherence (βbootstrapped = -0.11; 95% CIbootstrapped, -0.20 to -0.01; P = .023).

Conclusions: A substantial effect of financial incentives on adherence to LAIs occurs within the first 3 months of the intervention and is sustained over 1 year. A higher total amount of incentives does not increase the effect.

Trial Registration: identifier: ISRCTN77769281 and identifier: 7033.
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August 2015

Effects of Air Pollution and the Introduction of the London Low Emission Zone on the Prevalence of Respiratory and Allergic Symptoms in Schoolchildren in East London: A Sequential Cross-Sectional Study.

PLoS One 2015 21;10(8):e0109121. Epub 2015 Aug 21.

Asthma UK Centre for Applied Asthma Research, Centre for Primary Care and Public Health, Blizard Institute, Queen Mary University of London, London, United Kingdom.

The adverse effects of traffic-related air pollution on children's respiratory health have been widely reported, but few studies have evaluated the impact of traffic-control policies designed to reduce urban air pollution. We assessed associations between traffic-related air pollutants and respiratory/allergic symptoms amongst 8-9 year-old schoolchildren living within the London Low Emission Zone (LEZ). Information on respiratory/allergic symptoms was obtained using a parent-completed questionnaire and linked to modelled annual air pollutant concentrations based on the residential address of each child, using a multivariable mixed effects logistic regression analysis. Exposure to traffic-related air pollutants was associated with current rhinitis: NOx (OR 1.01, 95% CI 1.00-1.02), NO2 (1.03, 1.00-1.06), PM10 (1.16, 1.04-1.28) and PM2.5 (1.38, 1.08-1.78), all per μg/m3 of pollutant, but not with other respiratory/allergic symptoms. The LEZ did not reduce ambient air pollution levels, or affect the prevalence of respiratory/allergic symptoms over the period studied. These data confirm the previous association between traffic-related air pollutant exposures and symptoms of current rhinitis. Importantly, the London LEZ has not significantly improved air quality within the city, or the respiratory health of the resident population in its first three years of operation. This highlights the need for more robust measures to reduce traffic emissions.
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May 2016

Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial.

Lancet 2015 Oct 18;386(10004):1640-8. Epub 2015 Aug 18.

Pragmatic Clinical Trials Unit, Blizard Institute, Queen Mary University of London, London, UK.

Background: Percutaneous tibial nerve stimulation (PTNS) is a new ambulatory therapy for faecal incontinence. Data from case series suggest it has beneficial outcomes in 50-80% patients; however its effectiveness against sham electrical stimulation has not been investigated. We therefore aimed to assess the short-term efficacy of PTNS against sham electrical stimulation in adults with faecal incontinence.

Methods: We did a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial (CONtrol of Faecal Incontinence using Distal NeuromodulaTion [CONFIDeNT]) in 17 specialist hospital units in the UK that had the skills to manage patients with faecal incontinence. Eligible participants aged 18 years or older with substantial faecal incontinence for whom conservative treatments (such as dietary changes and pelvic floor exercises) had not worked, were randomly assigned (1:1) to receive either PTNS (via the Urgent PC neuromodulation system) or sham stimulation (via a transcutaneous electrical nerve stimulation machine to the lateral forefoot) once per week for 12 weeks. Randomisation was done with permuted block sizes of two, four, and six, and was stratified by sex and then by centre for women. Patients and outcome assessors were both masked to treatment allocation for the 14-week duration of the trial (but investigators giving the treatment were not masked). The primary outcome was a clinical response to treatment, which we defined as a 50% or greater reduction in episodes of faecal incontinence per week. We assessed this outcome after 12 treatment sessions, using data from patients' bowel diaries. Analysis was by intention to treat, and missing data were multiply imputed. This trial is registered with the ISRCTN registry, number 88559475, and is closed to new participants.

Findings: Between Jan 23, 2012, and Oct 31, 2013, we randomly assigned 227 eligible patients (of 373 screened) to receive either PTNS (n=115) or sham stimulation (n=112). 12 patients withdrew from the trial: seven from the PTNS group and five from the sham group (mainly because they could not commit to receiving treatment every week). Two patients (one in each group) withdrew because of an adverse event that was unrelated to treatment (exacerbation of fibromyalgia and rectal bleeding). 39 (38%) of 103 patients with full data from bowel diaries in the PTNS group had a 50% or greater reduction in the number of episodes of faecal incontinence per week compared with 32 (31%) of 102 patients in the sham group (adjusted odds ratio 1·28, 95% CI 0·72-2·28; p=0·396). No serious adverse events related to treatment were reported in the trial. Seven mild, related adverse events were reported in each treatment group, mainly pain at the needle site (four in PTNS, three in sham).

Interpretation: PTNS given for 12 weeks did not confer significant clinical benefit over sham electrical stimulation in the treatment of adults with faecal incontinence. Further studies are warranted to determine its efficacy in the long term, and in patient subgroups (ie, those with urgency).

Funding: National Institute for Health Research.
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October 2015

Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial.

Trials 2014 Feb 15;15:59. Epub 2014 Feb 15.

Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, London E1 2AB, UK.

Background: The Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS) trial assessed whether a group-based self-management course is effective in reducing pain-related disability in participants with chronic musculoskeletal pain. This article describes the statistical analysis plan for the COPERS trial.

Methods And Design: COPERS was a pragmatic, multicentre, unmasked, parallel group, randomised controlled trial. This article describes (a) the overall analysis principles (including which participants will be included in each analysis, how results will be presented, which covariates will be adjusted for, and how we will account for clustering in the intervention group); (b) the primary and secondary outcomes, and how each outcome will be analysed; (c) sensitivity analyses; (d) subgroup analyses; and (e) adherence-adjusted analyses.

Trial Registration: ISRCTN24426731.
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February 2014

Cascade diagrams for depicting complex interventions in randomised trials.

BMJ 2013 Nov 15;347:f6681. Epub 2013 Nov 15.

Centre for Primary Care and Public Health, Blizard Institute, Queen Mary University of London, London E1 2AT, UK.

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November 2013

Prevalence and impact of chronic widespread pain in the Bangladeshi and White populations of Tower Hamlets, East London.

Clin Rheumatol 2013 Sep 30;32(9):1375-82. Epub 2013 May 30.

Barts and The London School of Medicine and Dentistry, Centre for Primary Care and Public Health, 58 Turner Street, London, E1 2AB, UK.

The prevalence and impact of chronic pain differ between ethnic groups. We report a study of the comparative prevalence and impact of chronic pain in Bangladeshi, British Bangladeshi and White British/Irish people. We posted a short questionnaire to a random sample of 4,480 patients registered with 16 general practices in the London Borough of Tower Hamlets and conducted a longer questionnaire with patients in the waiting areas at those practices. We distinguished between Bangladeshi participants who were born in the UK or had arrived in the UK at the age of 14 or under (British Bangladeshi) and those who arrived in UK at the age of over 14 (Bangladeshi). We obtained 1,223/4,480 (27 %) responses to the short survey and 600/637 (94 %) to the long survey. From the former, the prevalence of chronic pain in the White, British Bangladeshi and Bangladeshi groups was 55, 54 and 72 %, respectively. The corresponding figures from the long survey were 49, 45 and 70 %. Chronic widespread pain was commoner in the Bangladeshi (16 %) than in the White (10 %) or British Bangladeshi (9 %) groups. People with chronic pain experienced poorer quality of life (odds ratio for scoring best possible health vs. good health (or good vs. poor health) 5.6 (95 % confidence interval 3.4 to 9.8)), but we found no evidence of differences between ethnic groups in the impact of chronic pain on the quality of life. Chronic pain is commoner and, of greater severity, in Bangladeshis than in Whites. On most measures in this study, British Bangladeshis resembled the Whites more than the Bangladeshis.
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September 2013

Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial.

Lancet 2013 Jul 2;382(9886):41-9. Epub 2013 May 2.

Warwick Clinical Trials Unit, Warwick Medical School, The University of Warwick, Coventry, UK.

Background: Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes.

Methods: We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ≥32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277.

Findings: Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI -0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI -0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group.

Interpretation: This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required.

Funding: National Institute for Health Research Health Technology Assessment.
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July 2013

Self-management support for moderate-to-severe chronic obstructive pulmonary disease: a pilot randomised controlled trial.

Br J Gen Pract 2012 Oct;62(603):e687-95

Queen Mary University of London, Barts and The London School of Medicine and Dentistry, London, UK.

Background: Better self management could improve quality of life (QoL) and reduce hospital admissions in chronic obstructive pulmonary disease (COPD), but the best way to promote it remains unclear.

Aim: To explore the feasibility, effectiveness and cost effectiveness of a novel, layperson-led, theoretically driven COPD self-management support programme.

Design And Setting: Pilot randomised controlled trial in one UK primary care trust area.

Method: Patients with moderate to severe COPD were identified through primary care and randomised 2:1 to the 7-week-long, group intervention or usual care. Outcomes at baseline, 2, and 6 months included self-reported health, St George's Respiratory Questionnaire (SGRQ), EuroQol, and exercise.

Results: Forty-four per cent responded to GP invitation, 116 were randomised: mean (standard deviation [SD]) age 69.5 (9.8) years, 46% male, 78% had unscheduled COPD care in the previous year. Forty per cent of intervention patients completed the course; 35% attended no sessions; and 78% participants completed the 6-month follow-up questionnaire. Results suggest that the intervention may increase both QoL (mean EQ-5D change 0.12 (95% confidence interval [CI] = -0.02 to 0.26) higher, intervention versus control) and exercise levels, but not SGRQ score. Economic analyses suggested that with thresholds of £20 000 per quality-adjusted life-year gained, the intervention is likely to be cost-effective.

Conclusion: This intervention has good potential to meet the UK National Institute for Health and Clinical Excellence criteria for cost effectiveness, and further research is warranted. However, to make a substantial impact on COPD self-management, it will also be necessary to explore other ways to enable patients to access self-management education.
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October 2012

Outdoor air pollution and respiratory health in patients with COPD.

Thorax 2011 Jul 1;66(7):591-6. Epub 2011 Apr 1.

Department of Primary Care and Public Health Sciences, King's College London, 7th Floor Capital House, 42 Weston Street, London SE1 3QD, UK.

Objectives: Time series studies have shown adverse effects of outdoor air pollution on mortality and hospital admissions in patients with chronic obstructive pulmonary disease (COPD) but panel studies have been inconsistent. This study investigates short-term effects of outdoor nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM(10)) and black smoke on exacerbations, respiratory symptoms and lung function in 94 patients with COPD in east London.

Methods: Patients were recruited from an outpatient clinic and were asked to complete daily diary cards (median follow-up 518 days) recording exacerbations, symptoms and lung function, and the amount of time spent outdoors. Outdoor air pollution exposure (lag 1 day) was obtained from local background monitoring stations.

Results: Symptoms but not lung function showed associations with raised pollution levels. Dyspnoea was significantly associated with PM(10) (increase in odds for an IQR change in pollutant: 13% (95% CI 4% to 23%)) and this association remained after adjustment for other the pollutants measured. An IQR increase in nitrogen dioxide was associated with a 6% (0-13%) increase in the odds of a symptomatic fall in peak flow rate. The corresponding effect sizes for PM(10) and black smoke were 12% (2-25%) and 7% (1-13%), respectively.

Conclusion: It is concluded that outdoor air pollution is associated with important adverse effects on symptoms in patients with COPD living in London.
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July 2011

Can we identify how programmes aimed at promoting self-management in musculoskeletal pain work and who benefits? A systematic review of sub-group analysis within RCTs.

Eur J Pain 2011 Sep 26;15(8):775.e1-11. Epub 2011 Feb 26.

Royal Holloway University of London, Department of Psychology, Egham, Surrey TW20 0EX, UK.

Background: There are now several systematic reviews of RCTs testing self-management for those with chronic musculoskeletal pain. Evidence for the effectiveness of self-management interventions in chronic musculoskeletal pain is equivocal and it is not clear for which sub-groups of patients SM is optimally effective.

Aims: To systematically review randomized controlled trials of self-management for chronic musculoskeletal pain that reported predictors, i.e., 'baseline factors that predict outcome independent of any treatment effect'; moderators, i.e., 'baseline factors which predict benefit from a particular treatment'; or mediators i.e., 'factors measured during treatment that impact on outcome' of outcome.

Method: We searched relevant electronic databases. We assessed the evidence according to the methodological strengths of the studies. We did meta-regression analyses for age and gender, as potential moderators.

Results: Although the methodological quality of primary trials was good, there were few relevant studies; most were compromised by lack of power for moderator and mediator analyses. We found strong evidence that self-efficacy and depression at baseline predict outcome and strong evidence that pain catastrophizing and physical activity can mediate outcome from self-management. There was insufficient data on moderators of treatment.

Conclusions: The current evidence suggests four factors that relate to outcome as predictors/mediators, but there is no evidence for effect moderators. Future studies of mediation and moderation should be designed with 'a priori' hypotheses and adequate statistical power.
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September 2011

Inpatient mental healthcare in England and Wales: patterns in NHS and independent healthcare providers.

J R Soc Med 2008 Nov;101(11):544-51

Healthcare Commission, London, UK.

Objectives: Independent healthcare, most of it NHS-funded, provides a significant and growing proportion of inpatient mental healthcare in the UK, but information about patients in these providers is limited. This paper examines differences in the profiles of mental health inpatients in NHS and independent providers in England and Wales, and assesses whether current information systems are adequate for monitoring patient flows and care, given the plurality of service provision. DESIGN DATA: from the national censuses of inpatients in mental health services in England and Wales in 2006 and 2007 were analysed to examine differences in demographic and other characteristics between inpatients in NHS and independent providers.

Setting: All NHS and independent providers of inpatient mental health services in England and Wales in 2006 and 2007.

Main Outcome Measures: Patients in independent providers were younger, 60% were on low/medium secure wards (compared with 16% in the NHS), they were 44% more likely to be detained and referrals were predominantly from NHS inpatient services. For all ethnic groups, ratios of detention on admission were higher in independent providers.

Conclusions: This analysis highlights differences between inpatients in NHS and independent providers of mental health services. We also highlight the inadequacy of current information systems for monitoring care, and the urgent need for standardized data across all NHS-commissioned mental healthcare, irrespective of whether it is publicly or privately provided. This is especially important in view of the increases in independent sector provision, and the specialist nature of their services. Such information is critical for commissioners, regulators of health and social care, and other audiences for monitoring patient flows, the quality of care provided, usage of the Mental Health Act 2007 and compliance with equality legislation.
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November 2008

Patient safety indicators for England from hospital administrative data: case-control analysis and comparison with US data.

BMJ 2008 Oct 17;337:a1702. Epub 2008 Oct 17.

Healthcare Commission, London EC1Y 8TG.

Objective: To assess the feasibility of deriving patient safety indicators for England from routine hospital data and whether they can indicate adverse outcomes for patients.

Design: Nine patient safety indicators developed by the United States Agency for Healthcare Research and Quality (AHRQ) were derived using hospital episode statistics for England for 2003-4, 2004-5, and 2005-6. A case-control analysis was undertaken to compare length of stay and mortality between cases (patients experiencing the particular safety event measured by an indicator) and controls matched for age, sex, health resource group (standard groupings of clinically similar treatments that use similar levels of healthcare resource), main specialty, and trust. Comparisons were undertaken with US data.

Setting: All NHS trusts in England.

Participants: Inpatients in NHS trusts.

Results: There was fair consistency in national rates for the nine indicators across three years. For all but one indicator, hospital stays were longer in cases than in matched controls (range 0.2-17.1 days, P<0.001). Mortality in cases was also higher than in controls (5.7-27.1%, P<0.001), except for the obstetric trauma indicators. Excess length of stay and mortality in cases was greatest for postoperative hip fracture and sepsis. England's rates were lower than US rates for these indicators. Increased length of stay in cases was generally greater in England than in the US. Excess mortality was also higher in England than in the US, except for the obstetric trauma indicators where there were few deaths in both countries. Differences between England and the US in excess length of stay and mortality were most marked for postoperative hip fracture.

Conclusions: Hospital administrative data provide a potentially useful low burden, low cost source of information on safety events. Indicators can be derived with English data and show that cases have poorer outcomes than matched controls. These data therefore have potential for monitoring safety events. Further validation, for example, of individual cases, is needed and levels of event recording need to improve. Differences between England and the US might reflect differences in the depth of event coding and in health systems and patterns of healthcare provision.
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October 2008

[Hospital admissions and mortality: association with air pollution in São Paulo, Brazil, 1993 to 1997].

Rev Saude Publica 2004 Dec 10;38(6):751-7. Epub 2004 Dec 10.

Centro de Vigilância Epidemiológica, Secretaria de Estado da Saúde de São Paulo, São Paulo, SP, Brazil.

Objective: To investigate short-term effects of air pollution on respiratory morbidity of children under 15 and elderly mortality.

Methods: The study was carried out in the city of São Paulo, Brazil. Daily hospital admissions due to respiratory conditions in children under 15 and mortality of adults over 64 years of age were obtained for the period ranging from 1993 to 1997. Daily levels of PM10, CO and O3 were collected for the same period. Poisson regression analysis was used in generalized additive models, which were adjusted for temporal trends, seasonality, day of the week, temperature and relative humidity as well as serial autocorrelation.

Results: A 10th to 90th percentile variation of pollutants was significantly associated with respiratory admissions of children and PM10 (%RR=10.0), CO (%RR=6.1), and O3 (%RR=2.5). Similar results were observed for mortality in elderly people and PM10 (%RR=8.1) and CO (%RR=7.9).

Conclusions: The study results are consistent with other studies showing an association of short-term variations of air pollution and increase of morbidity and mortality in large urban centers.
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December 2004

Developing a large electronic primary care database (Doctors' Independent Network) for research.

Int J Med Inform 2004 Jun;73(5):443-53

Department of Community Health Sciences, St George's Hospital Medical School, Cranmer Terrace, London SW17 0RE, UK.

Background And Objectives: Primary care databases form a unique source of population-based clinical information on the prevalence and management of diagnosed disorders. Historically such databases have lacked individual level socio-economic markers. We describe the development of the Doctors' Independent Network (DIN) database for epidemiological and health services research. DIN includes a socio-economic marker (ACORN) based on postcode linkage at individual patient level. The validity of DIN is assessed against the General Practice Research Database (GPRD).

Methods: External validity is assessed by comparing the demographic structure and prevalence rates for treated ischemic heart disease (IHD) and treated hay fever with those from the GPRD. We assess the utility of a socio-economic measure (ACORN) based on postcode-linkage at individual patient level by examining the trend in prevalence rates of IHD and hay fever by ACORN index.

Results: 142 practices providing high quality data were selected, with 1827361 fully registered patients contributing data between 1992 and 2001, representing an identical age-sex structure to that for England & Wales and GPRD. Regionally adjusted prevalence of treated IHD (7.29 and 5.37%, respectively for men and women aged 35+ in 1998) in DIN was highly comparable to GPRD (7.27 and 5.42%). In DIN, the odds ratio of IHD was 1.37 (95% CI 1.30-1.44) in subjects living in "striving" compared to "thriving" areas. The prevalence of treated hay fever prevalence was similar across databases, with inverse associations seen with ACORN in DIN (higher rates in "thriving" areas).

Conclusions: DIN provides comparable period prevalence rates to GPRD for two common conditions, with social trends as expected. Primary care databases such as these have the potential to replace the decennial national morbidity surveys carried out in UK general practices, with DIN having the important advantage of including a socio-economic index.
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June 2004

Implications of the problem orientated medical record (POMR) for research using electronic GP databases: a comparison of the Doctors Independent Network Database (DIN) and the General Practice Research Database (GPRD).

BMC Fam Pract 2003 Sep 30;4:14. Epub 2003 Sep 30.

Department of Community Health Sciences, St George's Hospital Medical School, Cranmer Terrace, London SW17 0RE.

Background: The General Practice Research Database (GPRD) and Doctor's Independent Network Database (DIN), are large electronic primary care databases compiled in the UK during the 1990s. They provide a valuable resource for epidemiological and health services research. GPRD (based on VAMP) presents notes as a series of discrete episodes, whereas DIN is based on a system (MEDITEL) that used a Problem Orientated Medical Record (POMR) which links prescriptions to diagnostic problems. We have examined the implications for research of these different underlying philosophies.

Methods: Records of 40,183 children from 141 practices in DIN and 76,310 from 464 practices in GRPD who were followed to age 5 were used to compare the volume of recording of prescribing and diagnostic codes in the two databases. To assess the importance and additional value of the POMR within DIN, the appropriateness of diagnostic linking to skin emollient prescriptions was investigated.

Results: Variation between practices for both the number of days on which prescriptions were issued and diagnoses were recorded was marked in both databases. Mean number of "prescription days" during the first 5 years of life was similar in DIN (19.5) and in GPRD (19.8), but the average number of "diagnostic days" was lower in DIN (15.8) than in GPRD (22.9). Adjustment for linkage increased the average "diagnostic days" to 23.1 in DIN. 32.7% of emollient prescriptions in GPRD appeared with an eczema diagnosis on the same day compared to only 19.4% in DIN; however, 86.4% of prescriptions in DIN were linked to an earlier eczema diagnosis. More specifically 83% of emollient prescriptions appeared under a problem heading of eczema in the 121 practices that were using problem headings satisfactorily.

Conclusion: Prescribing records in DIN and GPRD are very similar, but the usage of diagnostic codes is more parsimonious in DIN because of its POMR structure. Period prevalence rates will be underestimated in DIN unless this structure is taken into account. The advantage of the POMR is that in 121 of 141 practices using problem headings as intended, most prescriptions can be linked to a problem heading providing a specific reason for their issue.
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September 2003