Vichithranie Madurasinghe

Maternal and fetal risk factors for stillbirth: population based study

Objective To assess the main risk factors associated with stillbirth in a multiethnic English maternity population. Design Cohort study. Setting National Health Service region in England. Population 92 218 normally formed singletons including 389 stillbirths from 24 weeks of gestation, delivered during 2009-11. Main outcome measure Risk of stillbirth. Results Multivariable analysis identified a significant risk of stillbirth for parity (para 0 and para ≥3), ethnicity (African, African-Caribbean, Indian, and Pakistani), maternal obesity (body mass index ≥30), smoking, pre-existing diabetes, and history of mental health problems, antepartum haemorrhage, and fetal growth restriction (birth weight below 10th customised birthweight centile). As potentially modifiable risk factors, maternal obesity, smoking in pregnancy, and fetal growth restriction together accounted for 56.1% of the stillbirths. Presence of fetal growth restriction constituted the highest risk, and this applied to pregnancies where mothers did not smoke (adjusted relative risk 7.8, 95% confidence interval 6.6 to 10.9), did smoke (5.7, 3.6 to 10.9), and were exposed to passive smoke only (10.0, 6.6 to 15.8). Fetal growth restriction also had the largest population attributable risk for stillbirth and was fivefold greater if it was not detected antenatally than when it was (32.0% v 6.2%). In total, 195 of the 389 stillbirths in this cohort had fetal growth restriction, but in 160 (82%) it had not been detected antenatally. Antenatal recognition of fetal growth restriction resulted in delivery 10 days earlier than when it was not detected: median 270 (interquartile range 261-279) days v 280 (interquartile range 273-287) days. The overall stillbirth rate (per 1000 births) was 4.2, but only 2.4 in pregnancies without fetal growth restriction, increasing to 9.7 with antenatally detected fetal growth restriction and 19.8 when it was not detected. Conclusion Most normally formed singleton stillbirths are potentially avoidable. The single largest risk factor is unrecognised fetal growth restriction, and preventive strategies need to focus on improving antenatal detection.

Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis.

Summary Objective To compare the effectiveness of acupuncture with other relevant physical treatments for alleviating pain due to knee osteoarthritis. Design Systematic review with network meta-analysis, to allow comparison of treatments within a coherent framework. Comprehensive searches were undertaken up to January 2013 to identify randomised controlled trials in patients with osteoarthritis of the knee, which reported pain. Results Of 156 eligible studies, 114 trials (covering 22 treatments and 9,709 patients) provided data suitable for analysis. Most trials studied short-term effects and many were classed as being of poor quality with high risk of bias, commonly associated with lack of blinding (which was sometimes impossible to achieve). End of treatment results showed that eight interventions: interferential therapy, acupuncture, TENS, pulsed electrical stimulation, balneotherapy, aerobic exercise, sham acupuncture, and muscle-strengthening exercise produced a statistically significant reduction in pain when compared with standard care. In a sensitivity analysis of satisfactory and good quality studies, most studies were of acupuncture (11 trials) or muscle-strengthening exercise (9 trials); both interventions were statistically significantly better than standard care, with acupuncture being statistically significantly better than muscle-strengthening exercise (standardised mean difference: 0.49, 95% credible interval 0.00–0.98). Conclusions As a summary of the current available research, the network meta-analysis results indicate that acupuncture can be considered as one of the more effective physical treatments for alleviating osteoarthritis knee pain in the short-term. However, much of the evidence in this area of research is of poor quality, meaning there is uncertainty about the efficacy of many physical treatments.

The NHS Health Check in England: an evaluation of the first 4 years.

Objectives To describe implementation of a new national preventive programme to reduce cardiovascular morbidity. Design Observational study over 4 years (April 2009—March 2013). Setting 655 general practices across England from the QResearch database. Participants Eligible adults aged 40–74 years including attendees at a National Health Service (NHS) Health Check. Intervention NHS Health Check: routine structured cardiovascular check with support for behavioural change and in those at highest risk, treatment of risk factors and newly identified comorbidity. Results Of 1.68 million people eligible for an NHS Health Check, 214 295 attended in the period 2009–12. Attendance quadrupled as the programme progressed; 5.8% in 2010 to 30.1% in 2012. Attendance was relatively higher among older people, of whom 19.6% of those eligible at age 60–74 years attended and 9.0% at age 40–59 years. Attendance by population groups at higher cardiovascular disease (CVD) risk, such as the more socially disadvantaged 14.9%, was higher than that of the more affluent 12.3%. Among attendees 7844 new cases of hypertension (38/1000 Checks), 1934 new cases of type 2 diabetes (9/1000 Checks) and 807 new cases of chronic kidney disease (4/1000 Checks) were identified. Of the 27 624 people found to be at high CVD risk (20% or more 10-year risk) when attending an NHS Health Check, 19.3% (5325) were newly prescribed statins and 8.8% (2438) were newly prescribed antihypertensive therapy. Conclusions NHS Health Check coverage was lower than expected but showed year-on-year improvement. Newly identified comorbidities were an important feature of the NHS Health Checks. Statin treatment at national scale for 1 in 5 attendees at highest CVD risk is likely to have contributed to important reductions in their CVD events.

Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials.

BackgroundRandomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts.Methods/DesignThe Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies.DiscussionSuccessful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention.Trial registrationThe START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.

Guidelines for reporting embedded recruitment trials

BackgroundRecruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials.MethodsWe followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines.ResultsWe developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial.ConclusionsImplementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.

The NHS Health Check programme: implementation in east London 2009-2011

Objectives To describe implementation and results from the National Health Service (NHS) Health Check programme. Design Three-year observational open cohort study: 2009–2011. Participants People of age 40–74 years eligible for an NHS Health Check. Setting 139/143 general practices in three east London primary care trusts (PCTs) serving an ethnically diverse and socially disadvantaged population. Method Implementation was supported with education, IT support and performance reports. Tower Hamlets PCT additionally used managed practice networks and prior-stratification to call people at higher cardiovascular (CVD) risk first. Main outcomes measures Attendance, proportion of high-risk population on statins and comorbidities identified. Results Coverage 2009, 2010, 2011 was 33.9% (31 878/10 805), 60.6% (30 757/18 652) and 73.4% (21 194/28 890), respectively. Older people were more likely to attend than younger people. Attendance was similar across deprivation quintiles and was in accordance with population distributions of black African/Caribbean, South Asian and White ethnic groups. 1 in 10 attendees were at high-CVD risk (20% or more 10-year risk). In the two PCTs stratifying risk, 14.3% and 9.4% of attendees were at high-CVD risk compared to 8.6% in the PCT using an unselected invitation strategy. Statin prescription to people at high-CVD risk was higher in Tower Hamlets 48.9%, than in City and Hackney 23.1% or Newham 20.2%. In the 6 months following an NHS Health Check, 1349 new cases of hypertension, 638 new cases of diabetes and 89 new cases of chronic kidney disease (CKD) were diagnosed. This represents 1 new case of hypertension per 38 Checks, 1 new case of diabetes per 80 Checks and 1 new case of CKD per 568 Checks. Conclusions Implementation of the NHS Health Check programme in these localities demonstrates limited success. Coverage and treatment of those at high-CVD risk could be improved. Targeting invitations to people at high-CVD risk and managed practice networks in Tower Hamlets improved performance.

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

BackgroundRandomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial.MethodsA three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial.ResultsSix thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77–1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71–1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65–1.31, p = 0.65)).ConclusionsThis embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study.Trial registrationInternational Standard Randomised Controlled Trials Number registry, ISRCTN68240461. Registered on 01 July 2011.

NHS Health Check comorbidity and management: an observational matched study in primary care.

BACKGROUND The NHS Health Check programme completed its first 5 years in 2014, identifying those at highest risk of cardiovascular disease and new comorbidities, and offering behavioural change support and treatment. AIM To describe the coverage and impact of this programme on cardiovascular risk management and identification of new comorbidities. DESIGN AND SETTING Observational 5-year study from April 2009 to March 2014, in 139 of 143 general practices in three clinical commissioning groups (CCGs) in east London. METHOD A matched analysis compared comorbidity in NHS Health Check attendees and non-attendees. RESULTS A total of 252 259 adults aged 40-74 years were eligible for an NHS Health Check and, of these, 85 122 attended in 5 years. Attendance increased from 7.3% (10 900/149 867) in 2009 to 17.0% (18 459/108 525) in 2013 to 2014, representing increasing coverage from 36.4% to 85.0%. Attendance was higher in the more deprived quintiles and among South Asians. Statins were prescribed to 11.5% of attendees and 8.2% of non-attendees. In a matched analysis, newly-diagnosed comorbidity was more likely in attendees than non-attendees, with odds ratios for new diabetes 1.30 (95% confidence interval [CI] = 1.21 to 1.39), hypertension 1.50 (95% CI = 1.43 to 1.57), and chronic kidney disease 1.83 (95% CI = 1.52 to 2.21). CONCLUSION The NHS Health Check programme provision in these CCGs was equitable, with recent coverage of 85%. Statins were 40% more likely to be prescribed to attendees than non-attendees, providing estimated absolute benefits of public health importance. More new cases of diabetes, hypertension, and chronic kidney disease were identified among attendees than a matched group of non-attendees.

PTU-004 Asking about bowel control problems in IBD: results of face-to-face screening versus self-reporting

Introduction Patients with IBD have difficulty revealing concerns about bowel control problems to clinicians,1 who do not actively ask about this symptom2 despite clinical guidelines recommending active-case finding in high-risk populations.3 With no available evidence to advise clinicians on how to ask, we aimed to determine the results of face-to-face or self-reported screening to identify faecal incontinence (FI) in IBD patients. We also asked about patients’ desire for interventions to improve continence. FI was defined in this study as: ‘ever having accidental passing of stool, faeces, poo into your underclothes, that you are either unaware of at the time, or unable to control’. Methods This cross-sectional survey used a study-specific questionnaire to screen participants at either face-to-face interview (by clinician/researcher) or anonymously (participant self-completed). Eligibility criteria: 18 to 80 years of age, confirmed diagnosis of IBD, no current fistula, no stoma, any level of disease activity. Disease activity was measured using the Harvey Bradshaw Index or the Simple Clinical Colitis Activity Index. Results Of 1336 participants, 48% were male; mean age 43 years (range 18–80); 55% had Crohn’s Disease (CD), 41% ulcerative colitis (UC), 4% IBD unclassified. FI (occurring ever) was reported by 63% of 772 screened face-to-face and 56% of 564 self-report participants (p=0.012). A total of 38.7% of all respondents expressed interest in an intervention for FI. Patients with CD were more likely to report FI than those with UC (p≤0.05). FI was reported by 49% of participants in remission, and by 59%, 83% and 93% of participants with mild, moderate and severe relapse of IBD respectively (p≤0.001). Conclusions Bowel control problems are very common in patients with IBD (including in remission) and these symptoms can be identified by face-to-face interview and postal screening. Interest in interventions for FI is expressed by 38.7 of patients with IBD. References . Dibley L, Norton C. Experience of fecal incontinence in people with inflammatory bowel disease: self-reported experiences among a community sample. Inflammatory Bowel Diseases2013;19(7):1450–62. . Dibley L, Norton C. Help-seeking for fecal incontinence among people with inflammatory bowel disease. JWOCN 2013;40(6):631–638. . National Institute for Health and Clinical Excellence. Management of faecal incontinence in adults. London: NICE;2007. Report No.: CG 49.

Sequence balance minimisation: minimising with unequal treatment allocations

BackgroundMinimisation ensures excellent balance between groups for several prognostic factors, even in small samples. However, its use with unequal allocation ratios has been problematic. This paper describes a new minimisation scheme named sequence balance minimisation for unequal treatment allocations.MethodsTreatment- and factor-balancing properties were assessed in simulation studies for two- and three-arm trials with 1:2 and 1:2:3 allocation ratios. Sample sizes were set 30, 60 and 120. The number of prognostic factors on which to achieve balance was ranged from zero (treatment totals only) to ten with two levels occurring in equal probabilities. Random elements were set at 0.95, 0.9, 0.85, 0.80, 0.7, 0.6 and 0.5. Characteristics of the randomisation distributions and the impact of changing the block size while maintaining the allocation ratio were also examined.ResultsSequence balance minimisation has good treatment- and factor-balancing capabilities, and the randomisation distribution was centred at zero for all scenarios. The mean and median number of allocations achieved were the same as the number expected in most scenarios, and including additional factors (up to ten) in the minimisation scheme had little impact on treatment balance. Treatment balance tended to depart from the target as the random element was lowered. The variability in allocations achieved increased slightly as the number of factors increased, as the random element was decreased and as the sample size increased. The mean and median factor imbalance remained tightly around zero even when the chosen factor was not included in the minimisation scheme, though the variability was greater. The variability in factor imbalance increased slightly as the random element decreased, as well as when the number of prognostic factors and sample size increased. Increasing block size while maintaining the allocation ratio improved treatment balance notably with little impact on factor imbalance.ConclusionsSequence balance minimisation has good treatment- and factor-balancing properties and is particularly useful for small trials seeking to achieve balance across several prognostic factors.