Showing papers by "Matthew J. Grainge published in 2014"

The SNAP trial: a randomised placebo-controlled trial of nicotine replacement therapy in pregnancy – clinical effectiveness and safety until 2 years after delivery, with economic evaluation

Abstract: Background: Smoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine replacement therapy (NRT) is effective for cessation outside pregnancy but efficacy and safety in pregnancy are unknown. We hypothesised that NRT would increase smoking cessation in pregnancy without adversely affecting infants. Objectives: To compare (1) at delivery, the clinical effectiveness and cost-effectiveness for achieving biochemically validated smoking cessation of NRT patches with placebo patches in pregnancy and (2) in infants at 2 years of age, the effects of maternal NRT patch use with placebo patch use in pregnancy on behaviour, development and disability. Design: Randomised, placebo-controlled, parallel-group trial and economic evaluation with follow-up at 4 weeks after randomisation, delivery and until infants were 2 years old. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1: 1 ratio. Participants, site pharmacies and all study staff were blind to treatment allocation. Setting: Seven antenatal hospitals in the Midlands and north-west England. Participants: Women between 12 and 24 weeks' gestation who smoked ≥ 10 cigarettes a day before and ≥ 5 during pregnancy, with an exhaled carbon monoxide (CO) reading of ≥ 8 parts per million (p.p.m.). Interventions: NRT patches (15 mg per 16 hours) or matched placebo as an 8-week course issued in two equal batches. A second batch was dispensed at 4 weeks to those abstinent from smoking. Main outcome measures: Participants: self-reported, prolonged abstinence from smoking between a quit date and childbirth, validated at delivery by CO measurement and/or salivary cotinine (COT) (primary outcome). Infants, at 2 years: absence of impairment, defined as no disability or problems with behaviour and development. Economic: cost per 'quitter'. Results: One thousand and fifty women enrolled (521 NRT, 529 placebo). There were 1010 live singleton births and 12 participants had live twins, while there were 14 fetal deaths and no birth data for 14 participants. Numbers of adverse pregnancy and birth outcomes were similar in trial groups, except for a greater number of caesarean deliveries in the NRT group. Smoking: all participants were included in the intention-to-treat (ITT) analyses; those lost to follow-up (7% for primary outcome) were assumed to be smoking. At 1 month after randomisation, the validated cessation rate was higher in the NRT group {21.3% vs. 11.7%, odds ratio [OR], [95% confidence interval (CI)] for cessation with NRT, 2.05 [1.46 to 2.88]}. At delivery, there was no difference between groups' smoking cessation rates: 9.4% in the NRT and 7.6% in the placebo group [OR (95% CI), 1.26 (0.82 to 1.96)]. Infants: at 2 years, analyses were based on data from 888 out of 1010 (87.9%) singleton infants (including four postnatal infant deaths) [445/503 (88.5%) NRT, 443/507 (87.4%) placebo] and used multiple imputation. In the NRT group, 72.6% (323/445) had no impairment compared with 65.5% (290/443) in placebo (OR 1.40, 95% CI 1.05 to 1.86). The incremental cost-effectiveness ratio for NRT use was £4156 per quitter (£4926 including twins), but there was substantial uncertainty around these estimates. Conclusions: Nicotine replacement therapy patches had no enduring, significant effect on smoking in pregnancy; however, 2-year-olds born to women who used NRT were more likely to have survived without any developmental impairment. Further studies should investigate the clinical effectiveness and safety of higher doses of NRT. Trial registration: Current Controlled Trials ISRCTN07249128. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 54. See the NIHR Journals Library programme website for further project information. © Queen's Printer and Controller of HMSO 2014.

REFINE (REducing Falls in In-patieNt Elderly) using bed and bedside chair pressure sensors linked to radio-pagers in acute hospital care: a randomised controlled trial

Abstract: Background: falls in hospitals are a major problem and contribute to substantial healthcare burden. Advances in sensor technology afford innovative approaches to reducing falls in acute hospital care. However, whether these are clinically effective and cost effective in the UK setting has not been evaluated. Methods: pragmatic, parallel-arm, individual randomised controlled trial of bed and bedside chair pressure sensors using radiopagers (intervention group) compared with standard care (control group) in elderly patients admitted to acute, general medical wards, in a large UK teaching hospital. Primary outcome measure number of in-patient bedside falls per 1,000 bed days. Results: 1,839 participants were randomised (918 to the intervention group and 921 to the control group). There were 85 bedside falls (65 fallers) in the intervention group, falls rate 8.71 per 1,000 bed days compared with 83 bedside falls (64 fallers) in the control group, falls rate 9.84 per 1,000 bed days (adjusted incidence rate ratio, 0.90; 95% confidence interval [CI], 0.66–1.22; P= 0.51). There was no significant difference between the two groups with respect to time to first bedside fall (adjusted hazard ratio (HR), 0.95; 95% CI: 0.67–1.34; P= 0.12). The mean cost per patient in the intervention group was £7199 compared with £6400 in the control group, mean difference in QALYs per patient, 0.0001 (95% CI: −0.0006–0.0004, P=0.67). Conclusions: bed and bedside chair pressure sensors as a single intervention strategy do not reduce in-patient bedside falls, time to first bedside fall and are not cost-effective in elderly patients in acute, general medical wards in the UK. Trial registration: isrctn.org identifier: ISRCTN44972300.

Eligibility for and prescription of urate-lowering treatment in patients with incident gout in England.

Abstract: Gout is caused by urate crystal deposition secondary to persistent hyperuricemia. Current guidelines recommend urate-lowering treatment to prevent crystal deposition and encourage crystal dissolution for patients with more severe gout or concomitant conditions.1,2 However, after the first diagnosis, it remains unclear when such treatment is appropriate. We investigated the timing of eligibility for and prescription of urate-lowering treatment following first gout diagnosis and factors associated with prescription.

Factors Associated With Smoking Cessation in Early and Late Pregnancy in the Smoking, Nicotine, and Pregnancy Trial: A Trial of Nicotine Replacement Therapy

Abstract: Introduction: Previous studies have found partners’ smoking status, multiparity, and nicotine dependence to be associated with smoking cessation in pregnancy. However, no studies have investigated influences on cessation among women using nicotine replacement therapy (NRT). We analyzed data from a trial of NRT in pregnancy to determine factors associated with shorter- and longer-term cessation. Methods: Data were collected at baseline, 1 month, and delivery from 1,050 pregnant women. Two multivariable logistic models for validated cessation at 1 month and delivery were created with a systematic strategy for selection of included factors. Results: All findings are from multivariable analyses. At 1 month, odds of cessation were greater among those who completed full time education at >16 years of age (odds ratio [OR] = 1.82, 95% confidence interval CI = 1.24–2.67, p = .002) but they were lower in women with higher baseline cotinine levels (OR = 0.93, 95% CI = 0.90–0.95, p 16 years of age (OR = 1.89, 95% CI = 1.16–3.07, p = 0.010) but were inversely associated with higher baseline cotinine levels (OR = 0.96, 95% CI = 0.92–0.99, p = .010). Conclusions: Women who are better educated and have lower pretreatment cotinine concentrations had higher odds of stopping smoking and factors associated with shorter and longer term cessation were similar.

Risk of First Venous Thromboembolism in Pregnant Women in Hospital: Population-based Cohort Study From England

Abstract: Objective: To examine the potential for preventing venous thromboembolism during and after antepartum hospital admissions in pregnant women. Design: Cohort study using linked primary (Clinical Practice Research Datalink) and secondary (Hospital Episode statistics) care records. Setting: Primary and secondary care centres, England. Participants: 206 785 women aged 15-44 who had one or more pregnancies from 1997 up to 2010. Main outcome measure: Risk of first venous thromboembolism in pregnant women admitted to hospital for one or more days for reasons other than delivery or venous thromboembolism. Risk was assessed by calculating the absolute rate of venous thromboembolism and comparing these rates with those observed during follow-up time not associated with hospital admission using a Poisson regression model to estimate incidence rate ratios. Results: Admission to hospital in pregnancy was associated with an increased risk of venous thromboembolism(absolute rate 1752/100000 person years; incidence rate ratio 17.5, 95% confidence interval 7.69 to 40.0) compared with time outside hospital. The rate of venous thromboembolism was also high during the 28 days after discharge(absolute rate 676; 6.27, 3.74 to 10.5). The rate during and after admission combined was highest in the third trimester (961; 5.57, 3.32 to 9.34) and in those aged ≥35 years (1756; 21.7, 9.62 to 49.0). While the absolute rate in the combined period was highest for those with three or more days in hospital (1511; 12.2, 6.65 to 22.7), there was also a fourfold increase (558; 4.05, 2.23 to 7.38) in the risk of venous thromboembolism for those admitted to hospital for less than three days. Conclusion: The overall risk of first venous thromboembolism in pregnant women increased during admissions to hospital not related to delivery,and remained significantly higher in the 28 days after discharge. During these periods need for thromboprophylaxis should receive careful consideration.

SAT0503 Eligibility for Urate-Lowering Treatment around the Time of Diagnosis in Gout Patients: A Nationwide Population Study

Abstract: Background Current guidelines and recommendations [1-3] recommend urate-lowering treatment (ULT) only for patients with more severe disease or with other concomitant conditions that merit earlier ULT. However, when in the course of gout ULT should be initiated is not explicitly discussed and currently there is no suggestion that ULT should be considered and discussed with the patient when they first receive information on gout at or close to the time of first diagnosis. Objectives To determine the time at which people diagnosed with clinical gout in the UK are eligible for urate lowering therapy (ULT). Methods We identified incident gout patients from 1997 to 2010 using the Clinical Practice Research Datalink (CPRD). From time of diagnosis, cumulative probabilities of prescription of ULT and meeting currently recommended eligibility criteria for ULT (defined as having (1) multiple acute attacks; (2) tophi; (3) chronic kidney disease or renal function impairment; (4) urolithiasis or (5) use of diuretic) were both estimated using the method of Kaplan-Meier plot. Results A total of 52,164 incident gout patients (men: 38,272; 73.37%) were identified. Women tended to be older at time of gout diagnosis than men (mean age at diagnosis 69.2±14.2 years and 60.1±14.9 years respectively; p Conclusions Most gout patients appear eligible for ULT early in the clinical course of their disease, 44% being eligible at time of diagnosis. However, the timing of ULT initiation lags behind eligibility and many apparently eligible people do not receive ULT. These data support the growing case for full information and discussion of ULT close to the time of first diagnosis and involvement of the patients in management decisions. References Zhang W, Doherty M, Bardin T, Pascual E, Barskova V, Conaghan P, et al. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006;65:1312-1324. Khanna D, Fitzgerald JD, Khanna PP, Bae S, Singh MK, Neogi T, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res (Hoboken). 2012;64:1431-1446. Jordan KM, Cameron JS, Snaith M, Zhang W, Doherty M, Seckl J, et al. British Society for Rheumatology and British Health Professionals in Rheumatology guideline for the management of gout. Rheumatology (Oxford). 2007;46:1372-1374. Acknowledgements This work was funded the National Science Council of Taiwan (project NSC 102-2314-B-182A-104) and Chang Gung Memorial Hospital (project CMRPG3B1671) Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.1070