Publications by authors named "John P New"

33 Publications

Comment on: Clinical significance of diabetes control before metabolic surgery.

Surg Obes Relat Dis 2021 Jul 24. Epub 2021 Jul 24.

Department of Diabetes, Endocrinology & Obesity Medicine, Salford Royal NHS Foundation & University Teaching Trust, Salford, UK; Division of Informatics, Imaging & Data Sciences, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.

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http://dx.doi.org/10.1016/j.soard.2021.07.008DOI Listing
July 2021

Safety data in randomised real-world evidence studies: Salford Lung Study learnings.

ERJ Open Res 2021 Apr 31;7(2). Epub 2021 May 31.

GlaxoSmithKline plc, Uxbridge, Middlesex, UK.

Evidence to support clinical decision making must be based on safety data that have been captured, analysed and interpreted in a robust and reliable way. Randomised real-world evidence (RRWE) studies provide the opportunity to evaluate the use of medicines in patients and settings representative of routine clinical practice. However, elements that underpin the design of RRWE studies can have a significant impact upon the analysis, interpretation and implications of safety data. In this narrative review, we use data from the Salford Lung Study; two prospective, 12-month, open-label, parallel-group, phase III randomised controlled trials conducted in primary care in the UK; to highlight the importance of capturing treatment modifications when attempting to evaluate safety events according to actual treatment exposure. We demonstrate that analysing safety data by actual treatment received ( accounting for the treatment modifications that occur routinely in the primary care setting) provides additional insight beyond analysing according to randomised treatment strategy only. It is therefore proposed that understanding of safety data from RRWE trials can be optimised by analysing both by randomised group and by actual treatment received.
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http://dx.doi.org/10.1183/23120541.00966-2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8165374PMC
April 2021

Weight loss and metabolic outcomes in women with or without polycystic ovarian syndrome after Roux-en-Y gastric bypass: A case-matched study.

Surgeon 2021 Apr 13. Epub 2021 Apr 13.

The University of Manchester, Oxford Road, Manchester, M13 9PL, UK; Department of Diabetes and Endocrinology, Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK. Electronic address:

Background And Objectives: Weight loss is the mainstay of management for women with polycystic ovarian syndrome (PCOS). However, lifestyle and dietary modifications, and gastric banding have generally poor long-term efficacy. We aimed to investigate whether gastric bypass is equally efficacious in women with or without PCOS.

Methods: We performed a matched case-control study of primary Roux-en-Y gastric bypass surgery in women with PCOS (cases, n = 30) compared to women without PCOS (controls, n = 60) matched for baseline age, body mass index (BMI) and presence or absence of type 2 diabetes (T2D). Data shown represent mean values.

Results: At 24 months after surgery the 90 participants (age 36.1 years) experienced significant reductions in BMI (53.4 vs. 34.9 kg/m, p < 0.0001), glycated haemoglobin (HbA1c) in 21 women with T2D (68.2 vs. 38.7 mmol/mol, p < 0.0001) and blood pressure (BP) in 29 women with hypertension (144/91 vs. 129/83 mmHg, p < 0.01), while obstructive sleep apnoea (OSA) resolved in 88.0% of the 25 affected patients. Women with PCOS compared to women without PCOS achieved equivalent reductions in percentage total weight loss (32.6% vs. 32.6% at 12 months and 34.8% vs. 36.1% at 24 months) and HbA1c (T2D subgroup; 38.3 vs. 41.6 mmol/mol at 12 months and 37.0 vs. 39.6 mmol/mol at 24 months) and comparable improvement in BP (hypertension subgroup) and resolution of OSA (87.5% vs. 88.2% at 24 months).

Conclusion: In women with PCOS with morbid obesity, gastric bypass resulted in significant weight loss and metabolic outcomes similar to women without PCOS.
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http://dx.doi.org/10.1016/j.surge.2021.02.012DOI Listing
April 2021

The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease.

Ther Adv Respir Dis 2021 Jan-Dec;15:17534666211001013

Department of Respiratory Medicine, Salford Royal NHS Foundation Trust, Salford, UK.

Aim: The Salford Lung Study (SLS) in chronic obstructive pulmonary disease (COPD) was a randomised controlled trial evaluating the effectiveness and safety of initiating fluticasone furoate/vilanterol (FF/VI) 100/25 µg continuing usual care (UC) in patients with COPD and a history of exacerbations. Here, we investigate the impact of initiating FF/VI on healthcare resource utilisation (HRU) in SLS COPD.

Methods: HRU and interventions were determined from patients' electronic health records. Annual rates of on-treatment all-cause and COPD-related secondary care contacts (SCCs) and primary care contacts (PCCs) for FF/VI UC were analysed using a general linear model. Costs were derived from national data sources.

Results: Least-squares (LS) mean annual rates of all-cause (9.81 9.36) and COPD-related (1.57 1.48) SCCs were similar for FF/VI and UC, as were rates of all-cause hospitalisations (0.87 0.82). Mean duration of hospital stay/patient was 4.5 and 4.2 days, respectively. COPD-related SCC mean total cost/patient was £484 FF/VI and £475 UC. LS mean annual rates of all-cause PCCs were significantly higher for FF/VI (21.20 18.88 UC;  < 0.001). LS mean annual rates of COPD-related PCCs were similar for FF/VI and UC (2.42 2.46). All-cause PCC mean total cost/patient was £900 FF/VI £811 UC, but COPD-related PCC costs were similar (£116 £114). Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806 £963 UC;  < 0.001).

Discussion: In patients with COPD and exacerbation history, FF/VI may represent a less costly alternative to current therapies.GlaxoSmithKline plc. study HZC115151; ClinicalTrials.gov NCT01551758.
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http://dx.doi.org/10.1177/17534666211001013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8013671PMC
November 2021

Implications of COVID-19 labour market shocks for inequality in financial wellbeing.

J Popul Econ 2021 Jan 4:1-35. Epub 2021 Jan 4.

Melbourne Institute: Applied Economic & Social Research, University of Melbourne, 111 Barry Street, Carlton, VIC 3053 Australia.

Australia's economy abruptly entered into a recession due to the COVID-19 pandemic of 2020. Related labour market shocks on Australian residents have been substantial due to business closures and social distancing restrictions. Government measures are in place to reduce flow-on effects to people's financial situations, but the extent to which Australian residents suffering these shocks experience lower levels of financial wellbeing, including associated implications for inequality, is unknown. Using novel data we collected from 2078 Australian residents during April to July 2020, we show that experiencing a labour market shock during the pandemic is associated with a 29% lower level of perceived financial wellbeing, on average. Unconditional quantile regressions indicate that lower levels of financial wellbeing are present across the entire distribution, except at the very top. Distribution analyses indicate that the labour market shocks are also associated with higher levels of inequality in financial wellbeing. Financial counselling and support targeted at people who experience labour market shocks could help them to manage financial commitments and regain financial control during periods of economic uncertainty.
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http://dx.doi.org/10.1007/s00148-020-00821-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779333PMC
January 2021

Haemoglobin and Hematinic Status Before and After Bariatric Surgery over 4 years of Follow-Up.

Obes Surg 2021 Feb 1;31(2):682-693. Epub 2020 Sep 1.

Salford Royal NHS Foundation Trust, Salford, UK.

Purpose: Bariatric surgery is associated with deficiencies of vitamins and minerals, and patients are routinely advised supplements postoperatively. We studied prevalence of vitamin B, folate and iron deficiencies and anaemia before and after bariatric surgery over 4 years of follow-up.

Materials And Methods: We performed a retrospective cohort analysis of 353 people with obesity, including 257 (72.8%) women, who underwent gastric bypass (252, 71.4%) or sleeve gastrectomy (101, 28.6%) at our National Health Service bariatric centre in Northwest England.

Results: At baseline, mean (standard error) age was 46.0 (0.6) years, body mass index 53.1 (0.4) kg/m, serum vitamin B 400.2 (16.4) pg/L, folate 7.7 (0.2) μg/L, iron 12.0 (0.3) μmol/L, ferritin 118.3 (8.4) μg/L and haemoglobin 137.9 (0.8) g/L. Frequency of low vitamin B levels reduced from 7.5% preoperatively to 2.3% at 48 months (P < 0.038). Mean folate levels increased from baseline to 48 months by 5.3 μg/L (P < 0.001) but frequency of low folate levels increased from 4.7% preoperatively to 10.3% (P < 0.048). Ferritin levels increased from baseline to 48 months by 51.3 μg/L (P < 0.009). Frequency of low ferritin levels was greater in women (39.1%) than in men (8.9%) at baseline (P < 0.001) and throughout the study period. Haemoglobin was low in 4.6% of all patients at baseline with no significant change over the study period.

Conclusion: There were notable rates of haematinic insufficiencies in bariatric surgical candidates preoperatively. Our study lends further support to regular supplementation with vitamin B, folic acid, and iron in people undergoing bariatric surgery.
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http://dx.doi.org/10.1007/s11695-020-04943-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7847875PMC
February 2021

Vitamin D Status After Gastric Bypass or Sleeve Gastrectomy over 4 Years of Follow-up.

Obes Surg 2020 Apr;30(4):1473-1481

Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.

Background: Bariatric surgery for severe obesity can lead to micronutrient/vitamin deficiencies.

Aims: To study baseline and post-surgical prevalence of vitamin D deficiency in patients undergoing bariatric surgery.

Participants And Setting: Patients undergoing bariatric surgery in a university teaching hospital in North West England.

Methods: We performed an observational cohort analysis of longitudinal data on vitamin D and related parameters in patients who underwent bariatric surgery. Patients were routinely recommended daily combined calcium and vitamin D supplementation post-surgery.

Results: We studied 460 patients who had completed at least 12 months post-operatively; mean (standard deviation) age was 48.0 (10.5) years, weight 144.7 (27.3) kg and body mass index 50.0 (7.6) kg/m; 292 (63.5%) underwent gastric bypass and 168 (36.5%) sleeve gastrectomy. Vitamin D level was 33.1 (23.9) nmol/L at baseline, rising to 57.1 (23.1) nmol/L at 12 months post-surgery. Whereas 43.2% had vitamin D deficiency and 34.7% insufficiency preoperatively, 8.9% and 26.7% had deficiency and insufficiency, respectively, at 12 months with similar trends up to 4 years of follow-up. There were no significant differences between procedures or sexes in vitamin D levels or sufficiency rates.

Conclusion: Vitamin D deficiency and insufficiency were prevalent pre-surgery and reduced significantly with routine supplementation post-surgery.
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http://dx.doi.org/10.1007/s11695-019-04318-0DOI Listing
April 2020

Bariatric surgery as a model to explore the basis and consequences of the Reaven hypothesis: Small, dense low-density lipoprotein and interleukin-6.

Diab Vasc Dis Res 2019 03;16(2):144-152

1 Cardiovascular Research Group, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

Background: Reaven originally described the clustering of insulin resistance/hyperinsulinaemia, obesity (particularly visceral), altered cytokine levels, glucose intolerance, hypertriglyceridaemia and low high-density lipoprotein cholesterol. Subsequently, a potentially highly atherogenic small, dense low-density lipoprotein was also reported. We have studied the effect of bariatric surgery on this and other risk factors for atherosclerosis.

Methods: Forty patients (20 with type 2 diabetes mellitus) undergoing bariatric surgery were studied before and 1 year after bariatric surgery.

Results: Twelve months after bariatric surgery, median body mass index had decreased from 49.5 to 36.5 kg/m, fasting insulin from 21.3 to 7.8 mU/L and insulin resistance (homeostatic model assessment of insulin resistance) from 5.9 to 1.8 (all p < 0.001). Thirteen out of 20 patients had remission from type 2 diabetes mellitus. Highly sensitive C-reactive protein, interleukin-6, fasting triglycerides ( p < 0.001) and small, dense low-density lipoprotein ( p < 0.001) decreased, while high-density lipoprotein cholesterol increased ( p < 0.001) significantly, irrespective of having type 2 diabetes mellitus and/or being treated with statin therapy before surgery.

Conclusion: The association between marked weight loss and change in insulin resistance and hyperinsulinaemia with the change in small, dense low-density lipoprotein and interleukin-6 warrants further investigation. Bariatric surgery provides a model for investigating the mechanisms linking insulin resistance/hyperinsulinaemia to atherosclerosis.
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http://dx.doi.org/10.1177/1479164119826479DOI Listing
March 2019

Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups.

Respir Med 2019 02 10;147:58-65. Epub 2019 Jan 10.

Global Respiratory Franchise, GlaxoSmithKline plc., 980 Great West Rd, Brentford, Middlesex, TW8 9GS, UK. Electronic address:

Background: SLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups.

Methods: Patients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months' follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed.

Results: Lower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0% [0.1, 15.4]), except in patients without baseline airflow limitation (-0.5% [-29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6% [3.4, 26.3]), and with baseline CAT score <10 (25.3% [-0.4, 44.4]). Pneumonia SAESI rates were similar for FF/VI versus UC across all subgroups/strata, except the LABA, LAMA or LABA + LAMA stratum (incidence ratio 2.8 [0.9, 8.5]). SAESI rates were not increased for FF/VI versus other ICS + LABA.

Conclusions: Initiating FF/VI versus continuing UC reduced exacerbation rates without increased pneumonia SAESI risk compared to other ICS-containing regimens and in various patient subgroups, consistent with primary study findings. FF/VI may be a therapeutic option for a broad population of COPD patients, including those with more severe disease.
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http://dx.doi.org/10.1016/j.rmed.2018.12.016DOI Listing
February 2019

Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford Lung Study.

J Asthma 2019 07 16;56(7):748-757. Epub 2018 Oct 16.

g Global Respiratory Franchise, GSK , Brentford , Middlesex , UK.

Objective: The Asthma Salford Lung Study demonstrated the effectiveness of initiating once-daily fluticasone furoate/vilanterol (FF/VI) versus continuing usual care in asthma patients in UK primary care [ 1 ]. Here, we report a secondary analysis in a subset of patients with fluticasone propionate/salmeterol (FP/Salm) as their baseline intended maintenance therapy, to evaluate the relative effectiveness of initiating FF/VI versus continuing FP/Salm.

Methods: Adults with symptomatic asthma were randomised to initiate FF/VI 100[200]/25 µg or continue FP/Salm. The Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), Work Productivity and Activity Impairment Asthma questionnaire, severe exacerbations, salbutamol inhaler prescriptions and serious adverse events (SAEs) were recorded throughout the 12-month treatment period.

Results: One thousand two hundred and sixty-four patients (FF/VI 646; FP/Salm 618) were included in this subset analysis; 978 had baseline ACT score <20 and were included in the primary effectiveness analysis (PEA) population. At week 24, odds of patients being ACT responders (total score ≥20 and/or improvement from baseline ≥3) were significantly higher with FF/VI versus FP/Salm (71% vs. 56%; odds ratio 2.03 [95% CI: 1.53, 2.68]; p < 0.001 [PEA]). Significant benefit with FF/VI versus FP/Salm was also observed for AQLQ responders, activity impairment due to asthma, exacerbation rates, and salbutamol inhalers prescribed. No significant between-group differences were observed for impairment while working or work absenteeism due to asthma.

Conclusions: For patients in primary care, initiating FF/VI was significantly better than continuing with FP/Salm for improving asthma control and quality of life, and reducing asthma exacerbations, with no notable difference in SAEs. ClinicalTrials.gov: NCT01706198.
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http://dx.doi.org/10.1080/02770903.2018.1490751DOI Listing
July 2019

Putting patients in control of data from electronic health records.

BMJ 2018 01 2;360:j5554. Epub 2018 Jan 2.

Salford Royal NHS Foundation Trust, Salford, UK.

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http://dx.doi.org/10.1136/bmj.j5554DOI Listing
January 2018

Effect of Roux-en-Y Bariatric Surgery on Lipoproteins, Insulin Resistance, and Systemic and Vascular Inflammation in Obesity and Diabetes.

Front Immunol 2017 15;8:1512. Epub 2017 Nov 15.

Cardiovascular Research Group, Core Technologies Facility, The University of Manchester, Manchester, United Kingdom.

Purpose: Obesity is a major modifiable risk factor for cardiovascular disease. Bariatric surgery is considered to be the most effective treatment option for weight reduction in obese patients with and without type 2 diabetes (T2DM).

Objective: To evaluate changes in lipoproteins, insulin resistance, mediators of systemic and vascular inflammation, and endothelial dysfunction following Roux-en-Y bariatric surgery in obese patients with and without diabetes.

Materials And Methods: Lipoproteins, insulin resistance, mediators of systemic and vascular inflammation, and endothelial dysfunction were measured in 37 obese patients with ( = 17) and without ( = 20) T2DM, before and 6 and 12 months after Roux-en-Y bariatric surgery. Two way between subject ANOVA was carried out to study the interaction between independent variables ( and ) and all dependent variables.

Results: There was a significant effect of on (large effect size) weight, body mass index (BMI), waist circumference, triglycerides (TG), small-dense LDL apolipoprotein B (sdLDL ApoB), HOMA-IR, CRP, MCP-1, ICAM-1, E-selectin, P-selectin, leptin, and adiponectin. BMI and waist circumference had the largest impact of . The effect of was noticed mostly in the first 6 months. Absence of diabetes led to a significantly greater reduction in total cholesterol, low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol although the effect size was small to medium. There was a greater reduction in TG and HOMA-IR in patients with diabetes with a small effect size. No patients were lost to follow up.

Conclusion: Lipoproteins, insulin resistance, mediators of systemic and vascular inflammation, and endothelial dysfunction improve mostly 6 months after bariatric surgery in obese patients with and without diabetes.

Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02169518. https://clinicaltrials.gov/ct2/show/NCT02169518?term=paraoxonase&cntry1=EU%3AGB&rank=1.
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http://dx.doi.org/10.3389/fimmu.2017.01512DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5694757PMC
November 2017

Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

Pharmacoepidemiol Drug Saf 2017 Mar 1;26(3):344-352. Epub 2016 Nov 1.

Global Respiratory Franchise, GlaxoSmithKline UK Ltd, Uxbridge, UK.

Background: The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records.

Objective: The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications.

Achievements: The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected.

Conclusion: Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
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http://dx.doi.org/10.1002/pds.4118DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5347861PMC
March 2017

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma.

BMC Pulm Med 2015 Dec 10;15:160. Epub 2015 Dec 10.

GSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, UK.

Background: Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings.

Methods/design: The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors.

Primary Endpoint: Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data.

Discussion: The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings.

Trial Registration: Clinicaltrials.gov, NCT01706198; 04 October 2012.
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http://dx.doi.org/10.1186/s12890-015-0150-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4676141PMC
December 2015

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease.

Respir Res 2015 Sep 4;16:101. Epub 2015 Sep 4.

Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.

Background: New treatments need to be evaluated in real-world clinical practice to account for co-morbidities, adherence and polypharmacy.

Methods: Patients with chronic obstructive pulmonary disease (COPD), ≥ 40 years old, with exacerbation in the previous 3 years are randomised 1:1 to once-daily fluticasone furoate 100 μg/vilanterol 25 μg in a novel dry-powder inhaler versus continuing their existing therapy. The primary endpoint is the mean annual rate of COPD exacerbations; an electronic medical record allows real-time collection and monitoring of endpoint and safety data.

Conclusions: The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in COPD.

Trial Registration: Clinicaltrials.gov identifier NCT01551758.
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http://dx.doi.org/10.1186/s12931-015-0267-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4558879PMC
September 2015

Using an electronic medical record (EMR) to conduct clinical trials: Salford Lung Study feasibility.

BMC Med Inform Decis Mak 2015 Feb 7;15. Epub 2015 Feb 7.

Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.

Background: Real-world data on the benefit/risk profile of medicines is needed, particularly in patients who are ineligible for randomised controlled trials conducted for registration purposes. This paper describes the methodology and source data verification which enables the conduct of pre-licensing clinical trials of COPD and asthma in the community using the electronic medical record (EMR), NorthWest EHealth linked database (NWEH-LDB) and alert systems.

Methods: Dual verification of extracts into NWEH-LDB was performed using two independent data sources (Salford Integrated Record [SIR] and Apollo database) from one primary care practice in Salford (N = 3504). A feasibility study was conducted to test the reliability of the NWEH-LDB to support longitudinal data analysis and pragmatic clinical trials in asthma and COPD. This involved a retrospective extraction of data from all registered practices in Salford to identify a cohort of patients with a diagnosis of asthma (aged ≥18) and/or COPD (aged ≥40) and ≥2 prescriptions for inhaled bronchodilators during 2008. Health care resource utilisation (HRU) outcomes during 2009 were assessed. Exacerbations were defined as: prescription for oral corticosteroids (OCS) in asthma and prescription of OCS or antibiotics in COPD; and/or hospitalisation for a respiratory cause.

Results: Dual verification demonstrated consistency between SIR and Apollo data sources: 3453 (98.6%) patients were common to both systems; 99.9% of prescription records were matched and of 29,830 diagnosis records, one record was missing from Apollo and 272 (0.9%) from SIR. Identified COPD patients were also highly concordant (Kappa coefficient = 0.98). A total of 7981 asthma patients and 4478 COPD patients were identified within the NWEH-LDB. Cohort analyses enumerated the most commonly prescribed respiratory medication classes to be: inhaled corticosteroids (ICS) (42%) and ICS plus long-acting β2-agonist (LABA) (40%) in asthma; ICS plus LABA (55%) and long-acting muscarinic antagonists (36%) in COPD. During 2009 HRU was greater in the COPD versus asthma cohorts, and exacerbation rates in 2009 were higher in patients who had ≥2 exacerbations versus ≤1 exacerbation in 2008 for both asthma (137.5 vs. 20.3 per 100 person-years, respectively) and COPD (144.6 vs. 41.0, respectively).

Conclusion: Apollo and SIR data extracts into NWEH-LDB showed a high level of concordance for asthma and COPD patients. Longitudinal data analysis characterized the COPD and asthma populations in Salford including medications prescribed and health care utilisation outcomes suitable for clinical trial planning.
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http://dx.doi.org/10.1186/s12911-015-0132-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4331140PMC
February 2015

Obtaining real-world evidence: the Salford Lung Study.

Thorax 2014 Dec 6;69(12):1152-4. Epub 2014 Mar 6.

Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.

Unlabelled: We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can facilitate concurrent safety monitoring and data collection without direct patient contact for large randomised study populations in pRCTs. The Salford Lung Study is the world's first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomise over 7000 patients. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention.

Glaxosmithkline Protocol: HZC115151 ASTHMA STUDY CLINICALTRIALSGOV REGISTRATION: NCT01706198 COPD STUDY CLINICALTRIALSGOV REGISTRATION: NCT01551758.
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http://dx.doi.org/10.1136/thoraxjnl-2014-205259DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4251297PMC
December 2014

Liraglutide therapy in obese people with type 2 diabetes - experience of a weight management centre.

Eur J Intern Med 2014 Mar 10;25(3):e38-9. Epub 2014 Jan 10.

Obesity Medicine and Endocrinology, Salford Royal NHS Foundation Trust and University Teaching Hospital, Salford, UK; Faculty of Medical and Human Sciences, The University of Manchester, Manchester, UK.

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http://dx.doi.org/10.1016/j.ejim.2013.12.009DOI Listing
March 2014

The languages of health in general practice electronic patient records: a Zipf's law analysis.

J Biomed Semantics 2014 Jan 10;5(1). Epub 2014 Jan 10.

School Of Computer Science, University of Manchester, Oxford Road, Manchester M13 9PL, UK.

Background: Natural human languages show a power law behaviour in which word frequency (in any large enough corpus) is inversely proportional to word rank - Zipf's law. We have therefore asked whether similar power law behaviours could be seen in data from electronic patient records.

Results: In order to examine this question, anonymised data were obtained from all general practices in Salford covering a seven year period and captured in the form of Read codes. It was found that data for patient diagnoses and procedures followed Zipf's law. However, the medication data behaved very differently, looking much more like a referential index. We also observed differences in the statistical behaviour of the language used to describe patient diagnosis as a function of an anonymised GP practice identifier.

Conclusions: This works demonstrate that data from electronic patient records does follow Zipf's law. We also found significant differences in Zipf's law behaviour in data from different GP practices. This suggests that computational linguistic techniques could become a useful additional tool to help understand and monitor the data quality of health records.
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http://dx.doi.org/10.1186/2041-1480-5-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3944945PMC
January 2014

Metabolic outcomes 1 year after gastric bypass surgery in obese people with type 2 diabetes.

Med Princ Pract 2012 20;21(2):125-8. Epub 2011 Oct 20.

Department of Obesity Medicine, Endocrinology and Diabetes, Salford Royal NHS Foundation Trust and University Teaching Hospital, Salford, UK.

Objective: To assess metabolic outcomes in obese people with type 2 diabetes (T2D) in the first year following gastric bypass surgery.

Subjects And Methods: Forty-nine obese patients with T2D who had undergone gastric bypass surgery 12 or more months previously were identified. Body weight and glycosylated haemoglobin (HbA(1c)) pre-operatively and 3, 6 and 12 months postoperatively, changes to glucose-lowering therapies, and blood pressure (BP) and total and high-density lipoprotein (HDL) cholesterol pre-operatively and 12 months postoperatively were recorded. The primary outcome measure was change in HbA(1c); secondary outcomes included changes in BP and lipid profile.

Results: The mean pre-operative body weight was 141.4 kg, the body mass index 49.4 and HbA(1c) 8.1%. The mean postoperative percentage of excess body weight loss at 3, 6 and 12 months was 39.0, 53.9 and 71.1 with reduction in HbA(1c) to 6.6, 6.2 and 5.8%, respectively (p < 0.0001). Remission of diabetes (HbA(1c) <6.5%) occurred in 12 of 18 patients (67%) at 3 months, 20 of 27 (74%) at 6 months and 21 of 25 (84%) at 12 months; of 41 patients under glucose-lowering treatment, 26 (63%) achieved complete withdrawal of treatment and 7 (17%) had their doses reduced. The mean of differences between baseline and 12-month measurements of systolic BP was 10.5 mm Hg (p = 0.021) and the total-to-HDL cholesterol ratio 0.9 (p < 0.002).

Conclusion: Our study confirmed the finding of previous studies that gastric bypass surgery in obese people with T2D results in significant weight loss, and improved glycaemic, BP and lipid profiles. Bariatric surgery should be regarded as an effective therapeutic intervention in this patient population.
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http://dx.doi.org/10.1159/000331793DOI Listing
June 2012

Patient perceptions of treatment and illness when prescribed multiple medicines for co-morbid type 2 diabetes.

Diabetes Metab Syndr Obes 2011 11;4:127-35. Epub 2011 Apr 11.

Sandwell and West Birmingham NHS Trust and University of Birmingham, Birmingham, UK;

Illness and treatment perceptions are vital for people self-managing co-morbid conditions with associated cardiovascular disease, such as type 2 diabetes (T2D). However, perceptions of a co-morbid condition and the use of multiple medicines have yet to be researched. This study investigated the illness and treatment perceptions of people with co-morbid T2D. The Brief Illness Perception Questionnaire (repeated for T2D, hypertension, and hyperlipidemia) and the Beliefs about Medicines Questionnaire Specific Concerns Scales (repeated for Oral hypoglycemic agents, anti-hypertensive medicines, and statins) were sent to 480 people managing co-morbid T2D. Data on the number of medicines prescribed were collected from medical records. Significantly different perceptions were found across the illnesses. The strongest effect was for personal control; the greatest control reported for T2D. Illness perceptions of T2D differed significantly from perceptions about hyperlipidemia. Furthermore, illness perceptions of T2D also differed from perceptions of hypertension with the exception of perceptions of illness severity. Hypertension and hyperlipidemia shared similar perceptions about comprehensibility, concerns, personal control, and timeline. Significant differences were found for beliefs about treatment necessity, but no difference was found for treatment concerns. When the number of medicines was taken as a between-subjects factor, only intentional non-adherence, treatment necessity beliefs, and perceptions of illness timeline were accounted for. Co-morbid illness and treatment perceptions are complex, often vary between illnesses, and can be influenced by the number of medicines prescribed. Further research should investigate relationships between co-morbid illness and treatment perception structures and self-management practices.
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http://dx.doi.org/10.2147/DMSO.S17444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3138144PMC
October 2012

Effect of patient age on airway response by paramedics: frailty or futility?

Prehosp Emerg Care 2011 Jul-Sep;15(3):351-8

Department of Emergency Medicine, Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, USA.

Objective: We studied patterns related to patient age and indication for airway interventions delivered by paramedics from 2000 through 2004.

Methods: The study population included patients ≥ 15 years old managed by paramedics. Outcomes were the frequencies of definitive airway, ventilatory techniques, and oxygenation techniques. Independent variables were patient age, gender, race, hospital drive time, do-not-resuscitate status, and two trauma indicators of the American College of Surgeons Committee on Trauma (anatomic injury and mechanism of injury). Subset analysis was performed with the presence or absence of a set of recorded conditions.

Results: A total of 827,772 paramedic transports were studied; 233,470 were identified with at least one indication for airway intervention. Patients older than 65 years were, when compared with patients 65 years old or younger, 1) less likely to receive ventilatory interventions with any indication; 2) more likely to receive ventilatory intervention without an indication; and 3) more likely to receive oxygenation interventions whether indications were present or not. We considered age in five-year intervals and noted a consistent biphasic pattern for all interventions, regardless of indications. The odds ratios for interventions for patients in each block compared with those for 15- to 29-year-old patients increased with age until about 70 years of age, then gradually declined.

Conclusions: Patterns of age-related variations in airway interventions cannot be explained by the application of protocols. The reason for the peak rate of interventions at age 70 years is unknown. Explanations need to consider the influence on paramedic behavior of a number of factors, including frailty and futility. Additional paramedic training may be needed to change these patterns.
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http://dx.doi.org/10.3109/10903127.2011.561402DOI Listing
September 2011

The use of eGFR and ACR to predict decline in renal function in people with diabetes.

Nephrol Dial Transplant 2011 Mar 13;26(3):887-92. Epub 2010 Sep 13.

The University of Manchester, Manchester Academic Health Sciences Centre, Vascular Research Group, Salford Royal Hospital Foundation Trust, UK.

Background: There have been few attempts to estimate progression of kidney disease in people with diabetes in a single large population with predictive modelling. The aim of this study was to investigate the rate of progression of chronic kidney disease in people with diabetes according to their estimated glomerular filtration rate (eGFR) and presence of albuminuria.

Methods: Data were collected on all people with diabetes in Salford, UK, where an eGFR could be calculated using the four-variable MDRD formula and urinary albumin-creatinine ratio (uACR) was available. All data between 2001 and 2007 were used in the model. Classification of albuminuria status was based on the average of their first two uACR measurements. A longitudinal mixed effect dynamic regression model was fitted to the data. Parameters were estimated by maximum likelihood.

Results: For the analysis of the population, average progression of eGFR, uACR and drug prescribing were available in 3431 people. The regression model showed that in people with diabetes and macroalbuminuria, eGFR declined at 5.7% per annum, while the eGFR of those with microalbuminuria or without albuminuria declined at 1.5% and 0.3% per annum, respectively, independently of age (P < 0.0001).

Conclusions: The longitudinal effect of time on eGFR showed that people with diabetes and macroalbuminuria have an estimated 19 times more rapid decline in renal function compared with those without albuminuria. This study demonstrates that the progression of kidney disease in diabetic people without albuminuria is relatively benign compared with those with albuminuria.
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http://dx.doi.org/10.1093/ndt/gfq526DOI Listing
March 2011

Factors associated with kidney disease progression and mortality in a referred CKD population.

Am J Kidney Dis 2010 Dec 8;56(6):1072-81. Epub 2010 Aug 8.

Vascular Research Group, University of Manchester, Manchester Academic Health Sciences Centre, Salford Royal Hospital Foundation Trust, Salford, UK.

Background: Knowing how kidney disease progresses is important for decision making in patients with chronic kidney disease (CKD) and for designing clinical services.

Study Design: Prospective cohort study.

Setting & Participants: We examined renal function trajectories in CRISIS (Chronic Renal Insufficiency Standards Implementation Study), in which 1,325 patients with CKD stages 3-5 and mean age of 65.1 years were followed up prospectively for a median of 26 months after referral to a regional nephrology center in the United Kingdom. By protocol, estimated glomerular filtration rate was determined every 12 months.

Predictors: CKD stage defined as estimated glomerular filtration rate ≥ 45 (stage 3a), 30-44 (3b), 15-29 (4), and < 15 (5) mL/min/1.73 m².

Outcomes: Onset of renal replacement therapy (RRT), death, the composite end point of RRT or death, or decreasing CKD stage.

Results: During a median follow-up of 26 months, 13% reached the end point of RRT (5.1 events/100 patient-years), 20% died (9.6 deaths/100 patient-years), and 33% reached the combined end point of RRT or death (14.7 events/100 patient-years). For stage 3a, baseline prevalence and annual probabilities of decreasing CKD stage, RRT, and death were 18.0%, 0.41, 0.01, and 0.02, respectively. Corresponding values for stage 3b were 32.5%, 0.22, < 0.01, and 0.06; for stage 4, 36.5%, 0.17, 0.03, and 0.10; and for stage 5, 13.2%, zero (by definition), 0.31, and 0.08, respectively. Markov model projections suggested a steady decrease for proportions with stages 3a, 3b, and 4; a steady increase for death and RRT; and a biphasic pattern for (non-RRT) stage 5, with a plateau in the first 2 years followed by a steady decrease.

Limitations: Single-center observational study.

Conclusion: This study suggests that death and RRT are the dominant outcomes in patients referred for management of CKD and that most patients spend comparatively little time in late stages without RRT.
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http://dx.doi.org/10.1053/j.ajkd.2010.06.010DOI Listing
December 2010

Type 2 diabetes whole-genome association study in four populations: the DiaGen consortium.

Am J Hum Genet 2007 Aug 26;81(2):338-45. Epub 2007 Jun 26.

Oy Jurilab, and Research Institute of Public Health, University of Kuopio, Kuopio, Finland, and Hope Hospital, Salford, UK.

Type 2 diabetes (T2D) is a common, polygenic chronic disease with high heritability. The purpose of this whole-genome association study was to discover novel T2D-associated genes. We genotyped 500 familial cases and 497 controls with >300,000 HapMap-derived tagging single-nucleotide-polymorphism (SNP) markers. When a stringent statistical correction for multiple testing was used, the only significant SNP was at TCF7L2, which has already been discovered and confirmed as a T2D-susceptibility gene. For a replication study, we selected 10 SNPs in six chromosomal regions with the strongest association (singly or as part of a haplotype) for retesting in an independent case-control set including 2,573 T2D cases and 2,776 controls. The most significant replicated result was found at the AHI1-LOC441171 gene region.
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http://dx.doi.org/10.1086/520599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1950819PMC
August 2007

Derivation and validation of a prediction score for major coronary heart disease events in a U.K. type 2 diabetic population.

Diabetes Care 2006 Jun;29(6):1231-6

Tayside Centre for General Practice, Health Informatics Centre, Community Health Sciences, University of Dundee, Mckenzie Building, Dundee DD2 4BF, U.K.

Objective: To derive and validate an absolute risk algorithm for major coronary heart disease (CHD) events in the U.K. population with type 2 diabetes.

Research Design And Methods: A population cohort with type 2 diabetes was constructed in Tayside, Scotland, U.K., and longitudinally followed-up to June 2004. Participants were all people with type 2 diabetes registered with general practices and the Diabetes Audit and Research in Tayside, Scotland, database (97% sensitive) with no previous CHD event and with complete measurements (n = 4,569). The main outcome measure was risk of CHD defined as fatal or nonfatal myocardial infarction or CHD death, derived from the Weibull accelerated failure-time model. Validation of the algorithm was performed on an independent dataset from Salford, England, U.K.

Results: There were a total of 243 subjects (5.3%) with a fatal or nonfatal myocardial infarction or CHD death over the follow-up period from 1 January 1995 to 30 June 2004 (maximum follow-up 9.5 years). The final Weibull model included the significant predictors of age at diagnosis, duration of diabetes, HbA(1c), smoking (current, past, never), sex, systolic blood pressure, treated hypertension, total cholesterol, and height. Assessment of discrimination and calibration in the Salford validation dataset demonstrated a good fit (c = 0.71 [95% CI 0.63-0.79]).

Conclusions: This study provides the first validated, population-derived model for prediction of absolute risk of CHD in people with type 2 diabetes. It provides a useful additional decision aid for the clinician treating type 2 diabetes by indicating appropriate early action to decrease the risk of adverse outcomes.
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http://dx.doi.org/10.2337/dc05-1911DOI Listing
June 2006

Polymorphisms in IGF-binding protein 1 are associated with impaired renal function in type 2 diabetes.

Diabetes 2005 Dec;54(12):3547-53

Vascular Research Group, Hope Hospital, Salford, UK.

The dysregulation of the IGF system has been implicated in the pathogenesis of obesity, diabetes, and diabetes complications such as nephropathy, but little is known about the genomics of the IGF system in health and disease. We genotyped 13 single nucleotide polymorphisms (SNPs) in IGFBP1 gene in 732 representative type 2 diabetic patients from the Salford Diabetes Register. Of the 13 SNPs, 8 were polymorphic and 7 of those had minor allele frequencies >0.1, one of which was in the gene promoter and one of which was nonsynonymous in exon 4. The minor alleles of these SNPs and two others were associated with a reduced prevalence of diabetic nephropathy. Haplotype analysis revealed that 97% of the genetic variation for IGFBP1 in the population sample could be accounted for using two of the "reno-protective" SNPs, with other SNPs adding little extra information. One of these two SNPs was the nonsynonymous mutation in exon 4, lying close to the integrin-binding RGD motif, which is thought to affect tissue delivery of IGF-I by IGF-binding protein 1 (IGFBP-1), possibly suggesting a "reno-protective" effect via altered IGFBP-1 binding. In conclusion, we have described the first genomic markers to be associated with diabetic microvascular complications within the human IGFBP1 gene.
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http://dx.doi.org/10.2337/diabetes.54.12.3547DOI Listing
December 2005

The unrecognized prevalence of chronic kidney disease in diabetes.

Nephrol Dial Transplant 2006 Jan 12;21(1):88-92. Epub 2005 Oct 12.

Department of Renal Medicine, Hope Hospital, Stott Lane, Salford M6 8HD, UK, and Chronic Disease Research Group and University of Minnesota, Minneapolis, USA.

Background: Diabetes mellitus and chronic kidney disease (CKD) are common and exhibit synergistic associations with premature mortality. Current diabetes guidelines in the UK recommend annual urinary albumin and serum creatinine determinations to screen for diabetic kidney disease. The aim of this study was to estimate the burden of CKD in patients with diabetes and examine the ability of serum creatinine and albuminuria to detect clinically meaningful CKD compared with estimated glomerular filtration rate (eGFR).

Methods: All adults known to have diabetes in primary and secondary care in Salford, UK, alive with independent renal function on 1 January 2004 were included in this observational study (n=7596). Demographic and laboratory parameters were obtained from the Electronic Patient Record. eGFR was determined using the 4-variable modification of diet in renal disease (MDRD) formula. Clinically meaningful CKD was defined as an eGFR <60 ml/min/1.73 m(2).

Results: Creatinine and albuminuria were measured in the preceding 2 years in 82.3 and 55.2% of subjects, respectively. In patients with CKD, normoalbuminuria was present in 48.8%, and serum creatinine was normal (or=120 micromol/l) had a sensitivity and specificity of 45.3 and 100%, respectively, to identify CKD. The combination of abnormal creatinine and albuminuria had an improved performance but still failed to detect a large number with CKD (sensitivity 82.4%, specificity 75.4%). Serum creatinine failed to identify CKD more often in females (OR 8.22, CI 6.56-10.29).

Conclusions: Undiagnosed CKD is common in diabetes. Current screening strategies, based on creatinine or albuminuria, fail to identify a considerable number of subjects with CKD. Incorporating eGFR into screening for CKD would identify individuals earlier in the natural history of the disease and enable early effective treatment to delay progression of CKD.
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http://dx.doi.org/10.1093/ndt/gfi163DOI Listing
January 2006

Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial.

Diabetes Care 2005 Feb;28(2):278-82

Diabetes & Endocrinology, Hope Hospital, Salford M6 8HD, UK.

Objective: To determine whether Pro-Active Call Center Treatment Support (PACCTS), using trained nonmedical telephonists supported by specially designed software and a diabetes nurse, can effectively improve glycemic control in type 2 diabetes.

Research Design And Methods: A randomized controlled implementation trial of 1-year duration was conducted in Salford, U.K. The trial comprised 591 randomly selected individuals with type 2 diabetes. By random allocation, 197 individuals were assigned to the usual care (control) group and 394 to the PACCTS (intervention) group. Lifestyle advice and drug treatment in both groups followed local guidelines. PACCTS patients were telephoned according to a protocol with the frequency of calls proportional to the last HbA(1c) level. The primary outcome was absolute reduction in HbA(1c), and the secondary outcome was the proportion of patients reducing HbA(1c) by at least 1%.

Results: A total of 332 patients (84%) in the PACCTS group and 176 patients (89%) in the control group completed the study. Final HbA(1c) values were available in 374 patients (95%) in the PACCTS group and 180 patients (92%) in the usual care group. Compared with usual care, HbA(1c) improved by 0.31% (95% CI 0.11-0.52, P = 0.003) overall in the PACCTS patients. For patients with baseline HbA(1c) >7%, the improvement increased to 0.49% (0.21-0.77, P < 0.001), whereas in patients with baseline HbA(1c) <7% there was no change. The difference in the proportions of patients achieving a >/=1% reduction in HbA(1c) significantly favored the PACCTS intervention: 10% (4-16, P < 0.001) overall and 15% (7-24, P < 0.001) for patients with baseline HbA(1c) >7%.

Conclusions: In an urban Caucasian trial population with blood glucose HbA(1c) >7%, PACCTS facilitated significant improvement in glycemic control. Further research should extend the validity of findings to rural communities and other ethnic groups, as well as to smoking and lipid and blood pressure control.
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http://dx.doi.org/10.2337/diacare.28.2.278DOI Listing
February 2005
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