Amy Grove

Aspirin for prophylactic use in the primary prevention of cardiovascular disease and cancer: a systematic review and overview of reviews

BACKGROUND Prophylactic aspirin has been considered to be beneficial in reducing the risks of heart disease and cancer. However, potential benefits must be balanced against the possible harm from side effects, such as bleeding and gastrointestinal (GI) symptoms. It is particularly important to know the risk of side effects when aspirin is used as primary prevention--that is when used by people as yet free of, but at risk of developing, cardiovascular disease (CVD) or cancer. In this report we aim to identify and re-analyse randomised controlled trials (RCTs), systematic reviews and meta-analyses to summarise the current scientific evidence with a focus on possible harms of prophylactic aspirin in primary prevention of CVD and cancer. OBJECTIVES To identify RCTs, systematic reviews and meta-analyses of RCTs of the prophylactic use of aspirin in primary prevention of CVD or cancer. To undertake a quality assessment of identified systematic reviews and meta-analyses using meta-analysis to investigate study-level effects on estimates of benefits and risks of adverse events; cumulative meta-analysis; exploratory multivariable meta-regression; and to quantify relative and absolute risks and benefits. METHODS We identified RCTs, meta-analyses and systematic reviews, and searched electronic bibliographic databases (from 2008 September 2012) including MEDLINE, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, NHS Centre for Reviews and Dissemination, and Science Citation Index. We limited searches to publications since 2008, based on timing of the most recent comprehensive systematic reviews. RESULTS In total, 2572 potentially relevant papers were identified and 27 met the inclusion criteria. Benefits of aspirin ranged from 6% reduction in relative risk (RR) for all-cause mortality [RR 0.94, 95% confidence interval (CI) 0.88 to 1.00] and 10% reduction in major cardiovascular events (MCEs) (RR 0.90, 95% CI 0.85 to 0.96) to a reduction in total coronary heart disease (CHD) of 15% (RR 0.85, 95% CI 0.69 to 1.06). Reported pooled odds ratios (ORs) for total cancer mortality ranged between 0.76 (95% CI 0.66 to 0.88) and 0.93 (95% CI 0.84 to 1.03). Inclusion of the Womens Health Study changed the estimated OR to 0.82 (95% CI 0.69 to 0.97). Aspirin reduced reported colorectal cancer (CRC) incidence (OR 0.66, 95% CI 0.90 to 1.02). However, including studies in which aspirin was given every other day raised the OR to 0.91 (95% CI 0.74 to 1.11). Reported cancer benefits appeared approximately 5 years from start of treatment. Calculation of absolute effects per 100,000 patient-years of follow-up showed reductions ranging from 33 to 46 deaths (all-cause mortality), 60-84 MCEs and 47-64 incidents of CHD and a possible avoidance of 34 deaths from CRC. Reported increased RRs of adverse events from aspirin use were 37% for GI bleeding (RR 1.37, 95% CI 1.15 to 1.62), between 54% (RR 1.54, 95% CI 1.30 to 1.82) and 62% (RR 1.62, 95% CI 1.31 to 2.00) for major bleeds, and between 32% (RR 1.32, 95% CI 1.00 to 1.74) and 38% (RR 1.38, 95% CI 1.01 to 1.82) for haemorrhagic stroke. Pooled estimates of increased RR for bleeding remained stable across trials conducted over several decades. Estimates of absolute rates of harm from aspirin use, per 100,000 patient-years of follow-up, were 99-178 for non-trivial bleeds, 46-49 for major bleeds, 68-117 for GI bleeds and 8-10 for haemorrhagic stroke. Meta-analyses aimed at judging risk of bleed according to sex and in individuals with diabetes were insufficiently powered for firm conclusions to be drawn. LIMITATIONS Searches were date limited to 2008 because of the intense interest that this subject has generated and the cataloguing of all primary research in so many previous systematic reviews. A further limitation was our potential over-reliance on study-level systematic reviews in which the person-years of follow-up were not accurately ascertainable. However, estimates of number of events averted or incurred through aspirin use calculated from data in study-level meta-analyses did not differ substantially from estimates based on individual patient data-level meta-analyses, for which person-years of follow-up were more accurate (although based on less-than-complete assemblies of currently available primary studies). CONCLUSIONS We have found that there is a fine balance between benefits and risks from regular aspirin use in primary prevention of CVD. Effects on cancer prevention have a long lead time and are at present reliant on post hoc analyses. All absolute effects are relatively small compared with the burden of these diseases. Several potentially relevant ongoing trials will be completed between 2013 and 2019, which may clarify the extent of benefit of aspirin in reducing cancer incidence and mortality. Future research considerations include expanding the use of IPD meta-analysis of RCTs by pooling data from available studies and investigating the impact of different dose regimens on cardiovascular and cancer outcomes. FUNDING The National Institute for Health Research Health Technology Assessment programme.

UK health visiting: challenges faced during lean implementation

Purpose – The purpose of this paper is to present the challenges identified during a lean implementation in a health visiting service within a large primary care trust in NHS UK.Design/methodology/approach – Following a series of lean workshops a triangulated approach to data collection was adopted in order to determine the root cause of the challenges that were faced during this lean implementation. The three methods that were selected for qualitative analysis included semi‐structured interviews, document analysis and researcher participant observation.Findings – Six key challenges were identified from the data analysis. These were: high process variability; a lack of understanding of lean; poor communication and leadership; target focused; problems defining waste; and difficulty in determining who is the customer and what do they value?Practical implications – Although this particular lean implantation had limited success, the research has highlighted a number of challenges which would have to be addres...

Classifying emergency 30-day readmissions in England using routine hospital data 2004–2010: what is the scope for reduction?

Background Many health systems across the globe have introduced arrangements to deny payment for patients readmitted to hospital as an emergency. The purpose of this study was to develop an exploratory categorisation based on likely causes of readmission, and then to assess the prevalence of these different types. Methods Retrospective analysis of 82 million routinely collected National Health Service hospital records in England (2004–2010) was undertaken using anonymised linkage of records at person-level. Numbers of 30-day readmissions were calculated. Exploratory categorisation of readmissions was applied using simple rules relating to International Classification of Diseases (ICD) diagnostic codes for both admission and readmission. Results There were 5 804 472 emergency 30-day readmissions over a 6-year period, equivalent to 7.0% of hospital discharges. Readmissions were grouped into hierarchically exclusive categories: potentially preventable readmission (1 739 519 (30.0% of readmissions)); anticipated but unpredictable readmission (patients with chronic disease or likely to need long-term care; 1 141 987 (19.7%)); preference-related readmission (53 718 (0.9%)); artefact of data collection (16 062 (0.3%)); readmission as a result of accident, coincidence or related to a different body system (1 101 818 (19.0%)); broadly related readmission (readmission related to the same body system (1 751 368 (30.2%)). Conclusions In this exploratory categorisation, a large minority of emergency readmissions (eg, those that are potentially preventable or due to data artefacts) fell into groups potentially amenable to immediate reduction. For other categories, a hospitals ability to reduce emergency readmission is less clear. Reduction strategies and payment incentives must be carefully tailored to achieve stated aims.

Do not attempt cardiopulmonary resuscitation (DNACPR) orders: a systematic review of the barriers and facilitators of decision-making and implementation.

UNLABELLED Most people who die in hospital do so with a DNACPR order in place, these orders are the focus of considerable debate. AIM To identify factors, facilitators and barriers involved in DNACPR decision-making and implementation. METHODS All study designs and interventions were eligible for inclusion. Studies were appraised guided by CASP tools. A qualitative analysis was undertaken. DATA SOURCES Included electronic databases: Medline, Embase, ASSIA, Cochrane library, CINAHL, PsycINFO, Web of Science, the Kings Fund Library and scanning reference lists of included studies. RESULTS Four key themes were identified: Considering the decision - by senior physicians, nursing staff, patients and relatives. Key triggers included older age, co-morbidities, adverse prognostic factors, quality of life and the likelihood of success of CPR. Discussing the decision - levels, and combinations, of physician and nursing skills, patient understanding and family involvement produced various outcomes. Implementing the decision - the lack of clear documentation resulted in a breakdown in communications within health teams. Staff knowledge and support of guidelines and local policies varied. Consequences of a DNACPR decision - inadequate understanding by staff resulted in suboptimal care, and incorrect withdrawal of treatment. CONCLUSION Significant variability was identified in DNACPR decision-making and implementation. The evidence base is weak but the absence of evidence does not indicate an absence of good practice. Issues are complex, and dependent on a number of factors. Misunderstandings and poor discussions can be overcome such as with an overall care plan to facilitate discussions and reduce negative impact of DNACPR orders on aspects of patient care.

Lean implementation in primary care health visiting services in National Health Service UK

Background This paper presents the findings of a 13-month lean implementation in National Health Service (NHS) primary care health visiting services from May 2008 to June 2009. Method Lean was chosen for this study because of its reported success in other healthcare organisations. Value-stream mapping was utilised to map out essential tasks for the participating health visiting service. Stakeholder mapping was conducted to determine the links between all relevant stakeholders. Waste processes were then identified through discussions with these stakeholders, and a redesigned future state process map was produced. Quantitative data were provided through a 10-day time-and-motion study of a selected number of staff within the service. This was analysed to provide an indication of waste activity that could be removed from the system following planned improvements. Results The value-stream map demonstrated that there were 67 processes in the original health visiting service studied. Analysis revealed that 65% of these processes were waste and could be removed in the redesigned process map. The baseline time-and-motion data demonstrate that clinical staff performed on average 15% waste activities, and the administrative support staff performed 46% waste activities. Conclusion Opportunities for significant waste reduction have been identified during the study using the lean tools of value-stream mapping and a time-and-motion study. These opportunities include simplification of standard tasks, reduction in paperwork and standardisation of processes. Successful implementation of these improvements will free up resources within the organisation which can be redirected towards providing better direct care to patients.

Total hip replacement and surface replacement for the treatment of pain and disability resulting from end-stage arthritis of the hip (review of technology appraisal guidance 2 and 44): systematic review and economic evaluation

BACKGROUND Total hip replacement (THR) involves the replacement of a damaged hip joint with an artificial hip prosthesis. Resurfacing arthroplasty (RS) involves replacement of the joint surface of the femoral head with a metal surface covering. OBJECTIVES To undertake clinical effectiveness and cost-effectiveness analysis of different types of THR and RS for the treatment of pain and disability in people with end-stage arthritis of the hip, in particular to compare the clinical effectiveness and cost-effectiveness of (1) different types of primary THR and RS for people in whom both procedures are suitable and (2) different types of primary THR for people who are not suitable for hip RS. DATA SOURCES Electronic databases including MEDLINE, EMBASE, The Cochrane Library, Current Controlled Trials and UK Clinical Research Network (UKCRN) Portfolio Database were searched in December 2012, with searches limited to publications from 2008 and sample sizes of ≥ 100 participants. Reference lists and websites of manufacturers and professional organisations were also screened. REVIEW METHODS Systematic reviews of the literature were undertaken to appraise the clinical effectiveness and cost-effectiveness of different types of THR and RS for people with end-stage arthritis of the hip. Included randomised controlled trials (RCTs) and systematic reviews were data extracted and risk of bias and methodological quality were independently assessed by two reviewers using the Cochrane Collaboration risk of bias tool and the Assessment of Multiple Systematic Reviews (AMSTAR) tool. A Markov multistate model was developed for the economic evaluation of the technologies. Sensitivity analyses stratified by sex and controlled for age were carried out to assess the robustness of the results. RESULTS A total of 2469 records were screened of which 37 were included, representing 16 RCTs and eight systematic reviews. The mean post-THR Harris Hip Score measured at different follow-up times (from 6 months to 10 years) did not differ between THR groups, including between cross-linked polyethylene and traditional polyethylene cup liners (pooled mean difference 2.29, 95% confidence interval -0.88 to 5.45). Five systematic reviews reported evidence on different types of THR (cemented vs. cementless cup fixation and implant articulation materials) but these reviews were inconclusive. Eleven cost-effectiveness studies were included; four provided relevant cost and utility data for the model. Thirty registry studies were included, with no studies reporting better implant survival for RS than for all types of THR. For all analyses, mean costs for RS were higher than those for THR and mean quality-adjusted life-years (QALYs) were lower. The incremental cost-effectiveness ratio for RS was dominated by THR, that is, THR was cheaper and more effective than RS (for a lifetime horizon in the base-case analysis, the incremental cost of RS was £11,284 and the incremental QALYs were -0.0879). For all age and sex groups RS remained clearly dominated by THR. Cost-effectiveness acceptability curves showed that, for all patients, THR was almost 100% cost-effective at any willingness-to-pay level. There were age and sex differences in the populations with different types of THR and variations in revision rates (from 1.6% to 3.5% at 9 years). For the base-case analysis, for all age and sex groups and a lifetime horizon, mean costs for category E (cemented components with a polyethylene-on-ceramic articulation) were slightly lower and mean QALYs for category E were slightly higher than those for all other THR categories in both deterministic and probabilistic analyses. Hence, category E dominated the other four categories. Sensitivity analysis using an age- and sex-adjusted log-normal model demonstrated that, over a lifetime horizon and at a willingness-to-pay threshold of £20,000 per QALY, categories A and E were equally likely (50%) to be cost-effective. LIMITATIONS A large proportion of the included studies were inconclusive because of poor reporting, missing data, inconsistent results and/or great uncertainty in the treatment effect estimates. This warrants cautious interpretation of the findings. The evidence on complications was scarce, which may be because of the absence or rarity of these events or because of under-reporting. The poor reporting meant that it was not possible to explore contextual factors that might have influenced study results and also reduced the applicability of the findings to routine clinical practice in the UK. The scope of the review was limited to evidence published in English in 2008 or later, which could be interpreted as a weakness; however, systematic reviews would provide summary evidence for studies published before 2008. CONCLUSIONS Compared with THR, revision rates for RS were higher, mean costs for RS were higher and mean QALYs gained were lower; RS was dominated by THR. Similar results were obtained in the deterministic and probabilistic analyses and for all age and sex groups THR was almost 100% cost-effective at any willingness-to-pay level. Revision rates for all types of THR were low. Category A THR (cemented components with a polyethylene-on-metal articulation) was more cost-effective for older age groups. However, across all age-sex groups combined, the mean cost for category E THR (cemented components with a polyethylene-on-ceramic articulation) was slightly lower and the mean QALYs gained were slightly higher. Category E therefore dominated the other four categories. Certain types of THR appeared to confer some benefit, including larger femoral head sizes, use of a cemented cup, use of a cross-linked polyethylene cup liner and a ceramic-on-ceramic as opposed to a metal-on-polyethylene articulation. Further RCTs with long-term follow-up are needed. STUDY REGISTRATION This study is registered as PROSPERO CRD42013003924. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Systematic review of interventions to improve appropriate use and outcomes associated with do-not-attempt-cardiopulmonary-resuscitation decisions.

BACKGROUND The treatment for a cardiac arrest, cardiopulmonary resuscitation (CPR), may be lifesaving following an acute, potentially reversible illness. Yet this treatment is unlikely to be effective if cardiac arrest occurs as part of the dying process towards the end of a persons natural life. Do not attempt CPR (DNACPR) decisions allow resuscitation to be withheld when it has little chance of success, or where the patient, or those close to the patient, indicate the burdens of CPR outweigh the benefits. This review sought to identify evidence for systems that improve the appropriate use of DNACPR decisions. METHODS Electronic databases were searched (Medline, CINAHL and Embase) for English language articles from 2001 to 2014. RESULTS 4090 citations were identified of which 37 studies were relevant. The overall quality of evidence was moderate to poor. Thematic synthesis identified key interventions which may improve DNACPR decision making. The most promising interventions involved structured discussion at the time of acute admission to hospital and review by specialist teams at the point of an acute deterioration. Linking DNACPR decisions to discussions about overall treatment plans provided greater clarity about goals of care, aided communication between clinicians and reduced harms. Standardised documentation proved helpful for improving the frequency and quality of recording DNACPR decisions. Patient and clinician education in isolation were associated with limited or no effects. CONCLUSION Relatively simple process changes may enhance the appropriate use of and outcomes associated with DNACPR decisions. Systematic review registration number: PROSPERO2012:CRD42012002669.

Setting benchmark revision rates for total hip replacement: analysis of registry evidence

Objective To compare 10 year revision rates for frequently used types of primary total hip replacement to inform setting of a new benchmark rate in England and Wales that will be of international relevance. Design Retrospective cohort study. Setting National Joint Registry. Participants 239 000 patient records. Main outcome measures Revision rates for five frequently used types of total hip replacement that differed according to bearing surface and fixation mode, encompassing 62% of all primary total hip replacements in the National Joint Registry for England and Wales. Revision rates were compared using Kaplan-Meier and competing risks analyses, and five and 10 year rates were estimated using well fitting parametric models. Results Estimated revision rates at 10 years were 4% or below for four of the five types of total hip replacement investigated. Rates differed little according to Kaplan-Meier or competing risks analysis, but differences between prosthesis types were more substantial. Cemented prostheses with ceramic-on-polyethylene bearing surfaces had the lowest revision rates (1.88-2.11% at 10 years depending on the method used), and cementless prostheses with ceramic-on-ceramic bearing surfaces had the highest revision rates (3.93-4.33%). Men were more likely to receive revision of total hip replacement than were women, and this difference was statistically significant for four of the five prosthesis types. Conclusions Ten year revision rate estimates were all less than 5%, and in some instances considerably less. The results suggest that the current revision rate benchmark should be at least halved from 10% to less than 5% at 10 years. This has implications for benchmarks internationally.

Neurolinguistic programming: a systematic review of the effects on health outcomes

BACKGROUND Neurolinguistic programming (NLP) in health care has captured the interest of doctors, healthcare professionals, and managers. AIM To evaluate the effects of NLP on health-related outcomes. DESIGN AND SETTING Systematic review of experimental studies. METHOD The following data sources were searched: MEDLINE, PsycINFO, ASSIA, AMED, CINAHL, Web of Knowledge, CENTRAL, NLP specialist databases, reference lists, review articles, and NLP professional associations, training providers, and research groups. RESULTS Searches revealed 1459 titles from which 10 experimental studies were included. Five studies were randomised controlled trials (RCTs) and five were pre-post studies. Targeted health conditions were anxiety disorders, weight maintenance, morning sickness, substance misuse, and claustrophobia during MRI scanning. NLP interventions were mainly delivered across 4-20 sessions although three were single session. Eighteen outcomes were reported and the RCT sample sizes ranged from 22 to 106. Four RCTs reported no significant between group differences with the fifth finding in favour of the NLP arm (F = 8.114, P<0.001). Three RCTs and five pre-post studies reported within group improvements. Risk of bias across all studies was high or uncertain. CONCLUSION There is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.

Total Hip Replacement for the Treatment of End Stage Arthritis of the Hip: A Systematic Review and Meta-Analysis

Background Evolvements in the design, fixation methods, size, and bearing surface of implants for total hip replacement (THR) have led to a variety of options for healthcare professionals to consider. The need to determine the most optimal combinations of THR implant is warranted. This systematic review evaluated the clinical effectiveness of different types of THR used for the treatment of end stage arthritis of the hip. Methods A comprehensive literature search was undertaken in major health databases. Randomised controlled trials (RCTs) and systematic reviews published from 2008 onwards comparing different types of primary THR in patients with end stage arthritis of the hip were included. Results Fourteen RCTs and five systematic reviews were included. Patients experienced significant post-THR improvements in Harris Hip scores, but this did not differ between impact types. There was a reduced risk of implant dislocation after receiving a larger femoral head size (36 mm vs. 28 mm; RR = 0.17, 95% CI: 0.04, 0.78) or cemented cup (vs. cementless cup; pooled odds ratio: 0.34, 95% CI: 0.13, 0.89). Recipients of cross-linked vs. conventional polyethylene cup liners experienced reduced femoral head penetration and revision. There was no impact of femoral stem fixation and cup shell design on implant survival rates. Evidence on mortality and complications (aseptic loosening, femoral fracture) was inconclusive. Conclusions The majority of evidence was inconclusive due to poor reporting, missing data, or uncertainty in treatment estimates. The findings warrant cautious interpretation given the risk of bias (blinding, attrition), methodological limitations (small sample size, low event counts, short follow-up), and poor reporting. Long-term pragmatic RCTs are needed to allow for more definitive conclusions. Authors are encouraged to specify the minimal clinically important difference and power calculation for their primary outcome(s) as well CONSORT, PRISMA and STROBE guidelines to ensure better reporting and more reliable production and assessment of evidence.