31 research outputs found
Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)
Get PDFIntroduction: Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.
Methods and analysis: Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.
Ethics and dissemination: UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.
Trial registration number: ISRCTN registration number 73041168
Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK:a multi-centre, assessor-blind, randomised controlled trial-THRIVE trial
Get PDFINTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective.METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression.ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences.TRIAL REGISTRATION NUMBER: ISRCTN18501431.</p
The combination of bedsharing and maternal smoking leads to a greatly increased risk of sudden unexpected death in infancy:the New Zealand Nationwide SUDI case control study
Get PDFCollaborating with front-line healthcare professionals: the clinical and cost effectiveness of a theory based approach to the implementation of a national guideline
Get PDFBackground
Clinical guidelines are an integral part of healthcare. Whilst much progress has been made in ensuring that guidelines are well developed and disseminated, the gap between routine clinical practice and current guidelines often remains wide. A key reason for this gap is that implementation of guidelines typically requires a change in the behaviour of healthcare professionals – but the behaviour change component is often overlooked. We adopted the Theoretical Domains Framework Implementation (TDFI) approach for supporting behaviour change required for the uptake of a national patient safety guideline to reduce the risk of feeding through misplaced nasogastric tubes.
Methods
The TDFI approach was used in a pre-post study in three NHS hospitals with a fourth acting as a control (with usual care and no TDFI). The target behavior identified for change was to increase the use of pH testing as the first line method for checking the position of a nasogastric tube. Repeat audits were undertaken in each hospital following intervention implementation. We used Zou’s modified Poisson regression approach with robust standard errors to estimate risk ratios for the use of pH testing. The projected return on investment (ROI) was also calculated.
Results
Following intervention implementation, the use of pH first line increased significantly across intervention hospitals [risk ratio (95% CI) ranged from 3.1 (1.14 to8.43) p < .05, to 8.14 (3.06 to21.67) p < .001] compared to the control hospital, which remained unchanged [risk ratio (CI) = .77 (.47-1.26) p = .296]. The estimated savings and costs in the first year were £2.56 million and £1.41 respectively, giving an ROI of 82%, and this was projected to increase to 270% over five years.
Conclusion
The TDFI approach improved the uptake of a patient safety guideline across three hospitals. The TDFI approach is clinically and cost effective in comparison to the usual practice
Going to sleep in the supine position is a modifiable risk factor for late pregnancy stillbirth; findings from the New Zealand multicentre stillbirth case-control study
Get PDFObjective: Our objective was to test the primary hypothesis that maternal non-left, in particular supine going-to-sleep position, would be a risk factor for late stillbirth (≥28 weeks of gestation). Methods: A multicentre case-control study was conducted in seven New Zealand health regions, between February 2012 and December 2015. Cases (n=164) were women with singleton pregnancies and late stillbirth, without congenital abnormality. Controls (n=569) were women with on-going singleton pregnancies, randomly selected and frequency matched for health region and gestation. The primary outcome was adjusted odds of late stillbirth associated with self-reported going-to-sleep position, on the last night. The last night was the night before the late stillbirth was thought to have occurred or the night before interview for controls. Going to- sleep position on the last night was categorised as: supine, left-side, right-side, propped or restless. Multivariable logistic regression adjusted for known confounders. Results: Supine going-to-sleep position on the last night was associated with increased late stillbirth risk (adjusted odds ratios (aOR) 3.67, 95% confidence interval (CI) 1.74 to 7.78) with a population attributable risk of 9.4%. Other independent risk factors for late stillbirth (aOR, 95% CI) were: BMI (1.04, 1.01 to 1.08) per unit, maternal age ≥40 (2.88, 1.31 to 6.32), birthweight <10th customised centile (2.76, 1.59 to 4.80), and <6 hours sleep on the last night (1.81, 1.14 to 2.88). The risk associated with supine-going-to sleep position was greater for term (aOR 10.26, 3.00 to 35.04) than preterm stillbirths (aOR 3.12, 0.97 to 10.05). Conclusions: Supine going-to-sleep position is associated with a 3.7 fold increase in overall late stillbirth risk, independent of other common risk factors. A public health campaign encouraging women not to go-to-sleep supine in the third trimester has potential to reduce late stillbirth by approximately 9%
Designing out Medical Error: An Interdisciplinary Approach to the Design of Healthcare Equipment
Get PDFMedical error is an internationally recognised problem, with major financial and human costs (Gray; 2003, de Vries; et.al. 2008). The design of hospital equipment, devices and environments can contribute to the problem. Clinical staff often have to cope with confusing interfaces and equipment, making their tasks difficult and potentially dangerous.
There are calls to rethink the approach to design in healthcare. Design should acknowledge the real world issues users face in the hospital environment. A collaborative approach is required to understand these issues, (Karsh & Scanlon, 2007).
This paper outlines the methodologies used in two interdisciplinary case study projects, revealing the importance of a clear set of working methods and detailing the approach taken at each point. The resulting designs aim to better support healthcare processes, reducing the instance of medical error and ultimately saving lives
Peri-Abortion Contraceptive Choices of Migrant Chinese Women: A Retrospective Review of Medical Records
Get PDFBACKGROUND: Migrant Asian women reportedly have low levels of contraceptive use and high rates of abortion in New Zealand. Chinese make up the largest proportion of migrant Asian in New Zealand. This study aimed to describe the contraceptive choices of Chinese women seeking abortion; to examine method choice in relation to demographic characteristics (including length of stay) and to determine whether Chinese women were over-represented among abortion clinic attendees. METHODS: Retrospective review of medical records at a public hospital abortion clinic involving 305 Chinese women. Previously collected data for European (n = 277) and Maori women (n = 128) were used for comparative analyses. Regression analyses explored correlates of contraceptive method choice. Population census data were used to calculate rates of clinic attendance across ethnic groups. RESULTS: Chinese women were not over-represented among clinic attendees, and had similar rates of contraceptive non-use pre-abortion as women in comparison groups. Use of the oral contraceptive pill by Chinese was lower pre-abortion than for other ethnic groups, but choice of this method post-abortion was similar for Chinese (46.9%, 95% CI 41-52.7) and European women (43.7%, 95% CI 37.8-49.7). Post-abortion choice of an intrauterine device did not differ significantly between Chinese (28.9%, 95% CI 23.8-34.3) and Maori women (37%, 95% CI 28.4-45.7), but was higher than uptake of this method by European women (21.7%, 95% CI 17-27.0). Age, parity and previous abortion were significant predictors of post-abortion method choice by Chinese women (p<0.05). CONCLUSIONS: Following contraceptive counseling at the clinic, Chinese women chose more effective contraceptive methods for use post-abortion than they had used previously. As the population of migrant Chinese in New Zealand continues to increase, strategies are urgently needed to provide new arrivals with appropriate information and advice about contraception and where to access it, so women can be better prepared to avoid unplanned pregnancy
The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design
Get PDF<p>Abstract</p> <p>Background</p> <p>Physical inactivity is an independent risk factor for diabetes and heart disease. There is evidence that increasing physical activity can reduce the risk of developing these chronic diseases, but less evidence about effective ways to increase adherence to physical activity. Interventions are therefore needed that produce sustained increases in adherence to physical activity, are cost-effective and improve clinical endpoints.</p> <p>Methods</p> <p>The Women's Lifestyle Study is a two year randomized controlled trial involving a nurse-led intervention to increase physical activity in 40–74 year old physically inactive women recruited from primary care. Baseline measures were assessed in a face-to-face interview with a primary care nurse. The intervention involved delivery of a 'Lifestyle script' by a primary care nurse followed by telephone counselling for nine months and a face-to-face nurse visit at six months. Outcome measurements are assessed at 12 and 24 months. The primary outcome is physical activity measured using a validated physical activity questionnaire. Secondary outcomes include blood pressure, weight, waist circumference, physical fitness (step test), serum HbA1c, fasting glucose, lipids, insulin, and quality of life (SF36). Costs were measured prospectively to allow a subsequent cost-effectiveness evaluation if the trial is positive.</p> <p>Discussion</p> <p>Due to report in 2008, the Women's Lifestyle Study tests the effectiveness of an enhanced low-cost, evidence-based intervention in increasing physical activity, and improving cardiovascular and diabetes risk indicators over two years. If successful in demonstrating improvements in health outcomes, this randomized controlled trial will be the first to demonstrate long-term cardiovascular and diabetes risk health benefit, in addition to improvements in physical activity, from a sustainable physical activity intervention based in primary care.</p> <p>Trial Registration</p> <p>Australian Clinical Trials Registry (ACTR), ACTRN012605000490673.</p
Falls Assessment Clinical Trial (FACT): design, interventions, recruitment strategies and participant characteristics
Get PDF<p>Abstract</p> <p>Background</p> <p>Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care.</p> <p>Methods</p> <p>Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used – waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels.</p> <p>Results</p> <p>312 participants were recruited (69% women). Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05). Mean age of all participants was 81 years (SD 5). On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics) with a median of 2 falls (interquartile range 1, 3) in the previous year.</p> <p>Conclusion</p> <p>The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a 'real life' setting is important.</p> <p>Trial registration</p> <p>Australian Clinical Trials Register ID 12605000054617.</p
