Ala Szczepura

Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised controlled trial

BACKGROUND Delivery of high-quality, evidence-based health care to deprived sectors of the community is a major goal for society. We investigated the effectiveness of a culturally sensitive, enhanced care package in UK general practices for improvement of cardiovascular risk factors in patients of south Asian origin with type 2 diabetes. METHODS In this cluster randomised controlled trial, 21 inner-city practices in the UK were assigned by simple randomisation to intervention (enhanced care including additional time with practice nurse and support from a link worker and diabetes-specialist nurse [nine practices; n=868]) or control (standard care [12 practices; n=618]) groups. All adult patients of south Asian origin with type 2 diabetes were eligible. Prescribing algorithms with clearly defined targets were provided for all practices. Primary outcomes were changes in blood pressure, total cholesterol, and glycaemic control (haemoglobin A1c) after 2 years. Analysis was by intention to treat. This trial is registered, number ISRCTN 38297969. FINDINGS We recorded significant differences between treatment groups in diastolic blood pressure (1.91 [95% CI -2.88 to -0.94] mm Hg, p=0.0001) and mean arterial pressure (1.36 [-2.49 to -0.23] mm Hg, p=0.0180), after adjustment for confounders and clustering. We noted no significant differences between groups for total cholesterol (0.03 [-0.04 to 0.11] mmol/L), systolic blood pressure (-0.33 [-2.41 to 1.75] mm Hg), or HbA1c (-0.15% [-0.33 to 0.03]). Economic analysis suggests that the nurse-led intervention was not cost effective (incremental cost-effectiveness ratio pound28 933 per QALY gained). Across the whole study population over the 2 years of the trial, systolic blood pressure, diastolic blood pressure, and cholesterol decreased significantly by 4.9 (95% CI 4.0-5.9) mm Hg, 3.8 (3.2-4.4) mm Hg, and 0.45 (0.40-0.51) mmol/L, respectively, and we recorded a small and non-significant increase for haemoglobin A1c (0.04% [-0.04 to 0.13]), p=0.290). INTERPRETATION We recorded additional, although small, benefits from our culturally tailored care package that were greater than the secular changes achieved in the UK in recent years. Stricter targets in general practice and further measures to motivate patients are needed to achieve best possible health-care outcomes in south Asian patients with diabetes.

Breast and bowel cancer screening uptake patterns over 15 years for UK south Asian ethnic minority populations, corrected for differences in socio-demographic characteristics.

AbstractBackgroundA number of studies have reported low uptake of cancer screening programmes by South Asian populations in the UK. However, studies to date have not adjusted findings for differences in demographics and socio-economic status of these populations.MethodsSubjects: All residents in Coventry and Warwickshire, UK, eligible for screening. Uptakes compared for round 1 (2000–02) and round 2 (2003–05) of a national bowel cancer screening pilot, and for rounds 1, 2 and 5 of the established NHS breast cancer screening programme (commenced 1989). Data: Bowel screening data were analysed for 123,367 invitees in round 1 and 116,773 in round 2 (total 240,140 cases). Breast screening data were analysed for 61,934, 62,829 and 86,749 invitees in rounds 1, 2 and 5 respectively (total 211,512 cases). Analysis: Screening uptake was compared for two broad meta-categories (South Asian and non-Asian) and for five Asian subgroups (Hindu-Gujarati; Hindu-Other; Muslim; Sikh; South Asian Other). Univariate and multivariate analyses examined screening uptake and various demographic attributes of invitees, including age, gender, deprivation and ethnic group.ResultsSouth Asians demonstrated significantly lower (p < 0.001) unadjusted bowel screening uptake; 32.8% vs. 61.3% for non-Asians (round 1). Rates were particularly low for the Muslim subgroup: 26.1% (round 1), 21.5% (round 2). For breast screening, a smaller difference was observed between South Asians and non-Asians; initially 60.8% vs. 75.4% (round 1) and later 66.8% vs. 77.7% (round 5). Thus, the disparity reduced gradually over time, alongside an overall trend of increased uptake. However, figures remained consistently low for Muslims (51% in rounds 1 and 5). After adjusting for age, deprivation (and gender), bowel screening uptake remained significantly lower for all South Asian subgroups. After similar adjustments, breast screening uptake remained lower for all subgroups except Hindu-Gujaratis.For Muslims registered with an Asian (vs. non-Asian) GP, bowel screening uptake was significantly lower (p < 0.001). However, breast screening uptake for Muslims with an Asian (vs. non-Asian) GP showed no difference (p = 0.12) in the same period.Colonoscopy and breast assessment uptakes were similar for both meta-categories, but Asian response time appeared slower for colonoscopy. The percentage of abnormal FOBT results was significantly higher for South Asian invitees. A slight increase in abnormal mammograms was observed for Muslims over time (2.7% to 4.2% in rounds 1 and 5 respectively).ConclusionThe lower cancer screening uptakes observed for the South Asian population cannot be attributed to socio-economic, age or gender population differences. Although breast screening disparities have reduced over time, significant differences remain. We conclude that both programmes need to implement and assess interventions to reduce such differences.

Evaluation of delivery of enhanced diabetes care to patients of South Asian ethnicity : the United Kingdom Asian Diabetes Study (UKADS)

Aims  We tested the hypothesis that enhanced care for diabetes, tailored to the needs of the South Asian community with Type 2 diabetes, would improve risk factors for diabetic vascular complications and ultimately reduce morbidity and mortality.

A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain : the back skills training (BeST) trial

OBJECTIVES To estimate the clinical effectiveness of active management (AM) in general practice versus AM plus a group-based, professionally led cognitive behavioural approach (CBA) for subacute and chronic low back pain (LBP) and to measure the cost of each strategy over a period of 12 months and estimate cost-effectiveness. DESIGN Pragmatic multicentred randomised controlled trial with investigator-blinded assessment of outcomes. SETTING Fifty-six general practices from seven English regions. PARTICIPANTS People with subacute and chronic LBP who were experiencing symptoms that were at least moderately troublesome. INTERVENTIONS Participants were randomised (in a ratio of 2:1) to receive either AM+CBA or AM alone. MAIN OUTCOME MEASURES Primary outcomes were the Roland Morris Disability Questionnaire (RMQ) and the Modified Von Korff Scale (MVK), which measure LBP and disability. Secondary outcomes included mental and physical health-related quality of life (Short Form 12-item health survey), health status, fear avoidance beliefs and pain self-efficacy. Cost-utility of CBA was considered from both the UK NHS perspective and a broader health-care perspective, including both NHS costs and costs of privately purchased goods and services related to LBP. Quality-adjusted life-years (QALYs) were calculated from the five-item EuroQoL. RESULTS Between April 2005 and April 2007, 701 participants were randomised: 233 to AM and 468 to AM+CBA. Of these, 420 were female. The mean age of participants was 54 years and mean baseline RMQ was 8.7. Outcome data were obtained for 85% of participants at 12 months. Benefits were seen across a range of outcome measures in favour of CBA with no evidence of group or therapist effects. CBA resulted in at least twice as much improvement as AM. Mean additional improvement in the CBA arm was 1.1 [95% confidence interval (CI) 0.4 to 1.7], 1.4 (95% CI 0.7 to 2.1) and 1.3 (95% CI 0.6 to 2.1) change points in the RMQ at 3, 6 and 12 months respectively. Additional improvement in MVK pain was 6.8 (95% CI 3.5 to 10.2), 8.0 (95% CI 4.3 to 11.7) and 7.0 (95% CI 3.2 to 10.7) points, and in MVK disability was 4.3 (95% CI 0.4 to 8.2), 8.1 (95% CI 4.1 to 12.0) and 8.4 (95% CI 4.4 to 12.4) points at 3, 6 and 12 months respectively. At 12 months, 60% of the AM+CBA arm and 31% of the AM arm reported some or complete recovery. Mean cost of attending a CBA course was 187 pounds per participant with an additional benefit in QALYs of 0.099 and an additional cost of 178.06 pounds. Incremental cost-effectiveness ratio was 1786.00 pounds. Probability of CBA being cost-effective reached 90% at about 3000 pounds and remained at that level or above; at a cost-effectiveness threshold of 20,000 pounds the CBA group had an almost 100% probability of being considered cost-effective. User perspectives on the acceptability of group treatments were sought through semi-structured interviews. Most were familiar with key messages of AM; most who had attended any group sessions had retained key messages from the sessions and two-thirds talked about a reduction in fear avoidance and changes in their behaviour. Group sessions appeared to provide reassurance, lessen isolation and enable participants to learn strategies from each other. CONCLUSIONS Long-term effectiveness and cost-effectiveness of CBA in treating subacute and chronic LBP was shown, making this intervention attractive to patients, clinicians and purchasers. Short-term (3-month) clinical effects were similar to those found in high-quality studies of other therapies and benefits were maintained and increased over the long term (12 months). Cost per QALY was about half that of competing interventions for LBP and because the intervention can be delivered by existing NHS staff following brief training, the back skills training programme could be implemented within the NHS with relative ease. TRIAL REGISTRATION Current Controlled Trials ISRCTN37807450. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Reduction in the rate of methicillin‐resistant Staphylococcus aureus acquisition in surgical wards by rapid screening for colonization: a prospective, cross‐over study

Identification of patients colonized with methicillin-resistant Staphylococcus aureus (MRSA) and subsequent isolation and decolonization is pivotal to the control of cross infection in hospitals. The aim of this study was to establish if early identification of colonized patients using rapid methods alone reduces transmission. A prospective, cluster, two-period cross-over design was used. Seven surgical wards at a large hospital were allocated to two groups, and for the first 8 months four wards used rapid MRSA screening and three wards used a standard culture method. The groups were reversed for the second 8 months. Regardless of the method of detection, all patients were screened for nasal carriage on admission and then every 4 days. MRSA control measures remained constant. Results were analysed using a log linear Poisson regression model. A total of 12 682/13 952 patient ward episodes (PWE) were included in the study. Admission screening identified 453 (3.6%) MRSA-positive patient ward episodes, with a further 268 (2.2%) acquiring MRSA. After adjusting for other variables, rapid screening was shown to statistically reduce MRSA acquisition, with patients being 1.49 times (p 0.007) more likely to acquire MRSA in wards where they were screened using the culture method. Screening of surgical patients using rapid testing resulted in a statistically significant reduction in MRSA acquisition. This result was achieved in a routine surgical service with high bed occupancy and low availability of isolation rooms, making it applicable to the majority of health-care systems worldwide.

Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450]

BackgroundThe optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs.Methods/designSix hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions.DiscussionThis paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Treatment of severe ankle sprain: a pragmatic randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of three types of mechanical ankle support with tubular bandage. The CAST trial.

OBJECTIVE To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN A randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING Eight emergency departments in England. PARTICIPANTS Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS 584 participants were randomised to one of four treatment arms: tubular bandage, below knee cast, Aircast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS When adjusted for age, sex and baseline scores, the below knee cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the Aircast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the Aircast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the Aircast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS The below knee cast and the Aircast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

Medication administration errors for older people in long-term residential care

BackgroundOlder people in long-term residential care are at increased risk of medication prescribing and administration errors. The main aim of this study was to measure the incidence of medication administration errors in nursing and residential homes using a barcode medication administration (BCMA) system.MethodsA prospective study was conducted in 13 care homes (9 residential and 4 nursing). Data on all medication administrations for a cohort of 345 older residents were recorded in real-time using a disguised observation technique. Every attempt by social care and nursing staff to administer medication over a 3-month observation period was analysed using BCMA records to determine the incidence and types of potential medication administration errors (MAEs) and whether errors were averted. Error classifications included attempts to administer medication at the wrong time, to the wrong person or discontinued medication. Further analysis compared data for residential and nursing homes. In addition, staff were surveyed prior to BCMA system implementation to assess their awareness of administration errors.ResultsA total of 188,249 medication administration attempts were analysed using BCMA data. Typically each resident was receiving nine different drugs and was exposed to 206 medication administration episodes every month. During the observation period, 2,289 potential MAEs were recorded for the 345 residents; 90% of residents were exposed to at least one error. The most common (n = 1,021, 45% of errors) was attempting to give medication at the wrong time. Over the 3-month observation period, half (52%) of residents were exposed to a serious error such as attempting to give medication to the wrong resident. Error incidence rates were 1.43 as high (95% CI 1.32-1.56 p < 0.001) in nursing homes as in residential homes. The level of non-compliance with system alerts was very low in both settings (0.075% of administrations). The pre-study survey revealed that only 12/41 staff administering drugs reported they were aware of potential administration errors in their care home.ConclusionsThe incidence of medication administration errors is high in long-term residential care. A barcode medication administration system can capture medication administration errors and prevent these from occurring.

Non-invasive fetal RHD genotyping tests: A systematic review of the quality of reporting of diagnostic accuracy in published studies

Articles reporting the diagnostic accuracy of non-invasive prenatal diagnostic (NIPD) tests for RHD genotyping using fetal material extracted from maternal blood have been published steadily for over a decade. Health care providers in Europe have started to use this technology for management of the small number of sensitised pregnancies (ca. 220-600 per annum in the Netherlands, Germany, France and the UK). Scientists and clinicians are also advocating widespread implementation for the far larger number of non-sensitised RhD-negative pregnancies (ca. 34,000-125,000 per annum in the same countries). Large-scale, prospective trials are only now underway. Estimates of the technical performance of these tests are currently based on results from small-scale studies, together with formal meta-analysis. The issue of early assessment of test performance is one faced by many new genetic tests. As part of a wider study we have investigated the quality of reporting of diagnostic accuracy in publications and produced guidelines for future studies. A systematic search of the literature identified 27 papers which met predefined inclusion criteria. All 27 papers were, first, assessed against an international quality (STARD) checklist for reporting of diagnostic accuracy and, second, against our own in-house NIPD proforma to assess the implications of the quality of reporting specifically for the RhD NIPD test. Authors were found to generally present an optimistic view of NIPD, bearing in mind weaknesses identified in reporting and conduct of their studies and the analysis of results, as evidenced by the low STARD scores. The NIPD proforma identified that specific biases were potentially introduced through selective population sampling and/or failure to report the make-up of the population tested, omission of inconclusive results, inconsistencies in the handling of repeat results on a sample, and lack of adequate controls. These factors would inevitably affect the validity of diagnostic accuracy as reported in individual publications, as well as any subsequent meta-analyses. Together, published reports to date may provide a biased picture of the actual potential of NIPD testing for fetal RHD genotyping. Generalisation of the available evidence on diagnostic accuracy, especially to large-scale implementation of NIPD testing of non-sensitised women, will also require that decision makers consider further aspects such as test reliability and cost of routine testing in clinical practice. It is recommended that all studies of diagnostic accuracy of NIPD tests adhere to the STARD quality checklist in order to improve reporting, thereby, minimising bias and increasing the comparability of studies. Researchers should also consider specific shortcomings for NIPD and avoid selective participant sampling; report population characteristics; report handling of replicate sampling as well as their failure rates; and include controls for genotypes tested in the study. Furthermore, meta-analyses should consider the quality, as well as the sample size, of NIPD studies in their analysis. Larger trials, required to produce results that are valid and meaningful for clinical practice, must also adhere to these reporting standards.

Comparison of breast and bowel cancer screening uptake patterns in a common cohort of South Asian women in England

BackgroundInequalities in uptake of cancer screening by ethnic minority populations are well documented in a number of international studies. However, most studies to date have explored screening uptake for a single cancer only. This paper compares breast and bowel cancer screening uptake for a cohort of South Asian women invited to undertake both, and similarly investigates these womens breast cancer screening behaviour over a period of fifteen years.MethodsScreening data for rounds 1, 2 and 5 (1989-2004) of the NHS breast cancer screening programme and for round 1 of the NHS bowel screening pilot (2000-2002) were obtained for women aged 50-69 resident in the English bowel screening pilot site, Coventry and Warwickshire, who had been invited to undertake breast and bowel cancer screening in the period 2000-2002. Breast and bowel cancer screening uptake levels were calculated and compared using the chi-squared test.Results72,566 women were invited to breast and bowel cancer screening after exclusions. Of these, 3,539 were South Asian and 69,027 non-Asian; 18,730 had been invited to mammography over the previous fifteen years (rounds 1 to 5). South Asian women were significantly less likely to undertake both breast and bowel cancer screening; 29.9% (n = 1,057) compared to 59.4% (n = 40,969) for non-Asians (p < 0.001). Women in both groups who consistently chose to undertake breast cancer screening in rounds 1, 2 and 5 were more likely to complete round 1 bowel cancer screening. However, the likelihood of completion of bowel cancer screening was still significantly lower for South Asians; 49.5% vs. 82.3% for non-Asians, p < 0.001. South Asian women who undertook breast cancer screening in only one round were no more likely to complete bowel cancer screening than those who decided against breast cancer screening in all three rounds. In contrast, similar women in the non-Asian population had an increased likelihood of completing the new bowel cancer screening test. The likelihood of continued uptake of mammography after undertaking screening in round 1 differed between South Asian religio-linguistic groups. Noticeably, women in the Muslim population were less likely to continue to participate in mammography than those in other South Asian groups.ConclusionsCulturally appropriate targeted interventions are required to reduce observed disparities in cancer screening uptakes.