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Background: The term ‘safeguarding’ refers to measures designed to protect health, wellbeing and human rights, allowing people (especially children, young people and vulnerable adults) to live without fear of abuse, harm or neglect. The Children Act 2004 placed a responsibility on key agencies, including those in health and social care, to have regard to the need to safeguard children and promote their welfare. Objectives: To address the question ‘What interventions are feasible/acceptable, effective and cost effective in: • improving health and social care practitioners' recognition of children or young people who are at risk of abuse? • improving recognition of co-occurring forms of abuse where relevant? • preventing abuse in these groups?‘ Data sources: Fourteen health and social care databases were searched from 2004 (date of Children Act) to October 2019. Methods: This mapping review included an extensive literature search, independent study selection, extraction of study data and quality assessment of study design features. The research was carried out in two stages. We systematically retrieved and coded UK research and policy documents to gain a contemporary picture of safeguarding issues and practice. We also identified systematic reviews or narrative reviews that reported safeguarding practice from other high-income countries. Studies were summarised using narrative synthesis in four pre-defined groupings. A further grouping of policy/guidance documents was added based on examination of the evidence retrieved. Results: The review included 179 papers (Strategies=15; Policy/Guidance=36; Cultural/Organisational=31; Initiatives=69 and Reviews=28). There were four empirical evaluations of strategies (‘what to do’) and 54 of initiatives (‘how to do it’). Most initiatives fell into three categories: training, service development and use of data. Promising initiatives included liaison nurses; assessment clinics; secondment; joint protocols; and a ‘hub and spoke’ model. Approaches using routinely collected data also appeared promising. However, the evidence base comprised mainly cross-sectional or before/after studies with no control group, providing little hard evidence of effectiveness. Barriers to effective implementation of safeguarding strategies were identified at all levels of the health and care system. Limitations: We used a number of methods to abbreviate the review process. Limitations of the evidence base included lack of long-term follow-up, control groups and data on service relevant outcomes. Conclusions: The UK and international literature documents increased awareness and activity in relation to safeguarding. A limited number of types of interventions have been reported and generally these lack rigorous evaluation. In particular, the user voice is muted in relation to experience of different interventions or services. Taken as a whole the topic of child safeguarding seems to be lacking a whole system approach which would facilitate a more joined-up approach. Future work: Future research questions centre on the need to balance multi-agency training and development initiatives with the specific needs of individual health and social care professional groups.

Background Reconfiguration of urgent and emergency care services often increases travel time/distance for patients to reach an appropriate facility. Evidence of the effects of reconfiguration is important for local communities and commissioners and providers of health services. Methods We performed a systematic review of the evidence regarding effects of service reconfigurations that increase the time/distance for some patients to reach an urgent and emergency care (UEC) facility. We searched seven bibliographic databases from 2000 to February 2019 and used citation tracking and reference lists to identify additional studies. We included studies of any design that compared outcomes for people with conditions requiring emergency treatment before and after service reconfiguration with an associated change in travel time/distance to access UEC. Studies had to be conducted in the UK or other developed countries. Data extraction and quality assessment (using the Joanna Briggs Institute checklist for quasi-experimental studies) were undertaken by a single reviewer with a sample checked for accuracy and consistency. We performed a narrative synthesis of the included studies. Overall strength of evidence was assessed using a previously published method that considers volume, quality and consistency. Results We included 12 studies, of which six were conducted in the USA, two in the UK and four in other European countries. The studies used a variety of observational designs, with before–after and cohort designs being most common. Only two studies included an independent control site/sites where no reconfiguration had taken place. The reconfigurations evaluated in these studies reported relatively small effects on average travel times/distance. Discussion For studies of general UEC populations, there was no convincing evidence as to whether reconfiguration affected mortality risk. However, evidence of increased risk was identified from studies of patients with acute myocardial infarction, particularly 1 to 4 years after reconfiguration. Evidence for other conditions was inconsistent or very limited. Conclusions We found insufficient evidence to determine whether increased distance to UEC increases mortality risk for the general population of people requiring UEC, although this conclusion may not extend to people with specific conditions.

ObjectivesIn England, the NHS111 service provides assessment and triage by telephone for urgent health problems. A digital version of this service has recently been introduced. We aimed to systematically review the evidence on digital and online symptom checkers and similar services.DesignSystematic review.Data sourcesWe searched Medline, Embase, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Management Information Consortium, Web of Science and ACM Digital Library up to April 2018, supplemented by phrase searches for known symptom checkers and citation searching of key studies.Eligibility criteriaStudies of any design that evaluated a digital or online symptom checker or health assessment service for people seeking advice about an urgent health problem.Data extraction and synthesisData extraction and quality assessment (using the Cochrane Collaboration version of QUADAS for diagnostic accuracy studies and the National Heart, Lung and Blood Institute tool for observational studies) were done by one reviewer with a sample checked for accuracy and consistency. We performed a narrative synthesis of the included studies structured around pre-defined research questions and key outcomes.ResultsWe included 29 publications (27 studies). Evidence on patient safety was weak. Diagnostic accuracy varied between different systems but was generally low. Algorithm-based triage tended to be more risk averse than that of health professionals. There was very limited evidence on patients’ compliance with online triage advice. Study participants generally expressed high levels of satisfaction, although in mainly uncontrolled studies. Younger and more highly educated people were more likely to use these services.ConclusionsThe English ‘digital 111’ service has been implemented against a background of uncertainty around the likely impact on important outcomes. The health system may need to respond to short-term changes and/or shifts in demand. The popularity of online and digital services with younger and more educated people has implications for health equity.PROSPERO registration numberCRD42018093564.

Background There have been calls for greater consideration of applicability and transferability in systematic reviews, to improve their usefulness in informing policy and practice. Understanding how evidence is, or is not applicable and transferable to varying local situations and contexts, is a key challenge for systematic review synthesis in healthcare. Assessing applicability and transferability in systematic reviews is reported to be difficult, particularly in reviews of complex interventions. There is a need for exploration of factors perceived to be important by policy-makers, and for further guidance on which items should be reported. In this paper we focus on the process of development of a framework that can be used by systematic reviewers to identify and report data across studies relating to applicability and transferability. Methods The framework was developed by scrutinising existing literature on applicability and transferability, examining data during a systematic review of highly complex changes to health service delivery, and was informed by stakeholder engagement. The items of the framework were thus grounded in both data identified during a real review, and stakeholder input. The paper describes examples of data identified using the framework during a review of integrated care interventions, and outlines how it informed analysis and reporting of the review findings. Results The Framework for Implementation Transferability Applicability Reporting (FITAR) comprises 44 items which can be used to structure analysis and reporting across studies during systematic reviews of complex interventions. The framework prompts detailed consideration of contextual data during extraction and reporting, within areas of: patient type and populations; type of organisations and systems; financial and commissioning processes; systems leadership elements; features of services; features of the workforce; and finally elements of the interventions/initiatives. Conclusions Use of the framework during our review of complex healthcare interventions helped the review team to surface contextual data, which may not be commonly extracted, analysed and reported. Further exploration and evaluation of systems for identifying and reporting these factors during reviews is required. Electronic supplementary material The online version of this article (10.1186/s12874-019-0723-y) contains supplementary material, which is available to authorized users.

Background Healthcare systems around the world have been responding to the demand for better integrated models of service delivery. However, there is a need for further clarity regarding the effects of these new models of integration, and exploration regarding whether models introduced in other care systems may achieve similar outcomes in a UK national health service context. Methods The study aimed to carry out a systematic review of the effects of integration or co-ordination between healthcare services, or between health and social care on service delivery outcomes including effectiveness, efficiency and quality of care. Electronic databases including MEDLINE; Embase; PsycINFO; CINAHL; Science and Social Science Citation Indices; and the Cochrane Library were searched for relevant literature published between 2006 to March 2017. Online sources were searched for UK grey literature, and citation searching, and manual reference list screening were also carried out. Quantitative primary studies and systematic reviews, reporting actual or perceived effects on service delivery following the introduction of models of integration or co-ordination, in healthcare or health and social care settings in developed countries were eligible for inclusion. Strength of evidence for each outcome reported was analysed and synthesised using a four point comparative rating system of stronger, weaker, inconsistent or limited evidence. Results One hundred sixty seven studies were eligible for inclusion. Analysis indicated evidence of perceived improved quality of care, evidence of increased patient satisfaction, and evidence of improved access to care. Evidence was rated as either inconsistent or limited regarding all other outcomes reported, including system-wide impacts on primary care, secondary care, and health care costs. There were limited differences between outcomes reported by UK and international studies, and overall the literature had a limited consideration of effects on service users. Conclusions Models of integrated care may enhance patient satisfaction, increase perceived quality of care, and enable access to services, although the evidence for other outcomes including service costs remains unclear. Indications of improved access may have important implications for services struggling to cope with increasing demand. Trial registration Prospero registration number: 42016037725. Electronic supplementary material The online version of this article (10.1186/s12913-018-3161-3) contains supplementary material, which is available to authorized users.

As part of its Single Technology Appraisal Process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of degarelix (Ferring Pharmaceuticals) to submit evidence for the clinical and cost effectiveness of degarelix for the treatment of advanced hormone-dependent prostate cancer. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence contained within the company’s submission to NICE. The evidence, which included a randomised controlled trial (RCT) of degarelix versus leuprorelin, found that degarelix was non-inferior to leuprorelin for reduction of testosterone levels and that degarelix achieved a more rapid suppression of prostate-specific antigen levels and subsequently decreased incidences of testosterone flare associated with luteinising hormone releasing-hormone (LHRH) agonists. However, protection against testosterone flare for the comparators in the clinical trials was not employed in line with UK clinical practice. Further claims surrounding overall survival, cardiovascular adverse events and clinical equivalence of the comparator drugs from six RCTs of degarelix should be regarded with caution because of flaws and inconsistencies in the pooling of trial data to draw conclusions. The cost-effectiveness evidence included a de novo economic model. Based on the ERG’s preferred base case, the deterministic incremental cost-effectiveness analysis (ICER) for degarelix versus 3-monthly triptorelin was £14,798 per quality-adjusted life-year (QALY) gained. Additional scenario analyses undertaken by the ERG resulted in ICERs for degarelix versus 3-monthly triptorelin ranging from £17,067 to £35,589 per QALY gained. Subgroup analyses undertaken using the Appraisal Committee’s preferred assumptions suggested that degarelix was not cost effective for the subgroup with metastatic disease but could be cost effective for the subgroup with spinal metastases. The company submitted further evidence to NICE following an initial negative Appraisal Committee decision. Further analyses from the Decision Support Unit found that that, whilst some evidence indicated that degarelix could be cost effective for a small subgroup of people with spinal cord compression (SCC), data on the potential size of this subgroup and the rate of SCC were insufficient to estimate an ICER based on the evidence submitted by the company and a separately commissioned systematic review. NICE recommended degarelix as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the UK NHS in June 2016.

Background The rate of elective Caesarean Section (CS) is rising in many countries. Many obstetric units in the UK have either introduced or are planning to introduce enhanced recovery (ER) as a means of reducing length of stay for planned CS. However, to date there has been very little evidence produced regarding the necessary components of ER for the obstetric population. We conducted a rapid review of the composition of published ER pathways for elective CS and undertook an umbrella review of systematic reviews evaluating ER components and pathways in any surgical setting. Methods Pathways were identified using MEDLINE, EMBASE and the National Guideline Clearing House, appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool and their components tabulated. Systematic reviews were identified using the Cochrane Library and Database of Abstracts of Reviews of Effects (DARE) and appraised using The Grading of Recommendations Assessment, Development and Evaluation (GRADE). Two reviewers aggregated summaries of findings for Length of Stay (LoS). Results Five clinical protocols were identified, involving a total of 25 clinical components; 3/25 components were common to all five pathways (early oral intake, mobilization and removal of urinary catheter). AGREE II scores were generally low. Systematic reviews of single components found that minimally invasive Joel-Cohen surgical technique, early catheter removal and post-operative antibiotic prophylaxis reduced LoS after CS most significantly by around half to 1 and a half days. Ten meta-analyses of multi-component Enhanced Recovery after Surgery (ERAS) packages demonstrated reductions in LoS of between 1 and 4 days. The quality of evidence was mostly low or moderate. Conclusions Further research is needed to develop, using formal methods, and evaluate pathways for enhanced recovery in elective CS. Appropriate quality improvement packages are needed to optimise their implementation. Electronic supplementary material The online version of this article (doi:10.1186/s12884-017-1265-0) contains supplementary material, which is available to authorized users.

As part of its Single Technology Appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of evolocumab (Amgen) to submit evidence on the clinical and cost effectiveness of evolocumab. The appraisal assessed evolocumab as monotherapy or in combination with a statin (HMG-CoA reductase inhibitor) with or without ezetimibe, or in combination with ezetimibe (without statin therapy), in adult patients with primary hypercholesterolaemia (which includes mixed dyslipidaemia), for whom statins do not provide optimal control of their low-density lipoprotein cholesterol (LDL-C) levels and/or for whom statins are contraindicated or not tolerated. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology, based on the company's submission to NICE. The evidence was derived mainly from four randomised controlled trials comparing evolocumab either with ezetimibe or placebo in adults with primary familial or non-familial hypercholesterolaemia, who were either able to take statins or who were statin-intolerant. The clinical effectiveness review found that evolocumab is efficacious at lowering LDL-C but that there was uncertainty regarding its impact on cardiovascular disease outcomes. In response to the ERG's critique of the submitted health economic model, the company submitted an amended model, which also included a Patient Access Scheme (PAS). Based on this, the deterministic incremental cost-effectiveness ratios (ICERs) for evolocumab against ezetimibe were above £74,000 and £45,000 per quality-adjusted life-year (QALY) gained within the non-familial primary and secondary prevention population, respectively, whilst the ICERs within the heterozygous familial hypercholesterolaemia population were approximately £23,000 per QALY gained. The final determination was that evolocumab would be a clinically and cost effective use of UK National Health Service resources in certain patient subgroups.

BackgroundThe Health and Social Care Act mandated research use as a core consideration ofhealth service commissioning arrangements in England. We undertook a controlled before and after study to evaluate whether access to a demand-led evidence briefing service improved use of research evidence by commissioners compared with less intensive and less targeted alternatives.MethodsNine Clinical Commissioning Groups (CCGs) in the North of England received one of three interventions: A) access to an evidence briefing service; B) contact plus an unsolicited push of non-tailored evidence; or C) unsolicited push of non-tailored evidence. Data for the primary outcome measure were collected at baseline and 12 months using a survey instrument devised to assess an organisations' ability to acquire, assess, adapt and apply research evidence to support decision-making.Documentary and observational evidence of the use of the outputs of the service were sought and interviews with CCG participants were undertaken.ResultsOver the course of the study the service addressed 24 topics raised by participating CCGs. At 12 months, the evidence briefing service was not associated with increases in CCG capacity to acquire, assess, adapt and apply research evidence to support decision making, individual intentions to use research findings or perceptions of CCG relationships with researchers. Regardless of intervention received, participating CCGs indicated that they remained inconsistent in their research seeking behaviours and in their capacity to acquire research. The informal nature of decision making processes meant that there was little traceability of the use of evidence. Low baseline and followup response rates and missing data limit the reliability of the findings.ConclusionsAccess to a demand-led evidence briefing service did not improve the uptake and use of research evidence by NHS commissioners compared with less intensive and less targeted alternatives. Commissioners appear well intentioned but ad hoc users of research. Further research is required on the effects of interventions and strategies to build individual and organisational capacity to use research.

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology based upon the company's submission to NICE. Clinical evidence for cabazitaxel was derived from a multinational randomised open-label phase III trial (TROPIC) of cabazitaxel plus prednisone or prednisolone compared with mitoxantrone plus prednisone or prednisolone, which was assumed to represent best supportive care. The NICE final scope identified a further three comparators: abiraterone in combination with prednisone or prednisolone; enzalutamide; and radium-223 dichloride for the subgroup of people with bone metastasis only (no visceral metastasis). The company did not consider radium-223 dichloride to be a relevant comparator. Neither abiraterone nor enzalutamide has been directly compared in a trial with cabazitaxel. Instead, clinical evidence was synthesised within a network meta-analysis (NMA). Results from TROPIC showed that cabazitaxel was associated with a statistically significant improvement in both overall survival and progression-free survival compared with mitoxantrone. Results from a random-effects NMA, as conducted by the company and updated by the ERG, indicated that there was no statistically significant difference between the three active treatments for both overall survival and progression-free survival. Utility data were not collected as part of the TROPIC trial, and were instead taken from the company's UK early access programme. Evidence on resource use came from the TROPIC trial, supplemented by both expert clinical opinion and a UK clinical audit. List prices were used for mitoxantrone, abiraterone and enzalutamide as directed by NICE, although commercial in-confidence patient-access schemes (PASs) are in place for abiraterone and enzalutamide. The confidential PAS was used for cabazitaxel. Sequential use of the advanced hormonal therapies (abiraterone and enzalutamide) does not usually occur in clinical practice in the UK. Hence, cabazitaxel could be used within two pathways of care: either when an advanced hormonal therapy was used pre-docetaxel, or when one was used post-docetaxel. The company believed that the former pathway was more likely to represent standard National Health Service (NHS) practice, and so their main comparison was between cabazitaxel and mitoxantrone, with effectiveness data from the TROPIC trial. Results of the company's updated cost-effectiveness analysis estimated a probabilistic incremental cost-effectiveness ratio (ICER) of £45,982 per quality-adjusted life-year (QALY) gained, which the committee considered to be the most plausible value for this comparison. Cabazitaxel was estimated to be both cheaper and more effective than abiraterone. Cabazitaxel was estimated to be cheaper but less effective than enzalutamide, resulting in an ICER of £212,038 per QALY gained for enzalutamide compared with cabazitaxel. The ERG noted that radium-223 is a valid comparator (for the indicated sub-group), and that it may be used in either of the two care pathways. Hence, its exclusion leads to uncertainty in the cost-effectiveness results. In addition, the company assumed that there would be no drug wastage when cabazitaxel was used, with cost-effectiveness results being sensitive to this assumption: modelling drug wastage increased the ICER comparing cabazitaxel with mitoxantrone to over £55,000 per QALY gained. The ERG updated the company's NMA and used a random effects model to perform a fully incremental analysis between cabazitaxel, abiraterone, enzalutamide and best supportive care using PASs for abiraterone and enzalutamide. Results showed that both cabazitaxel and abiraterone were extendedly dominated by the combination of best supportive care and enzalutamide. Preliminary guidance from the committee, which included wastage of cabazitaxel, did not recommend its use. In response, the company provided both a further discount to the confidential PAS for cabazitaxel and confirmation from NHS England that it is appropriate to supply and purchase cabazitaxel in pre-prepared intravenous-infusion bags, which would remove the cost of drug wastage. As a result, the committee recommended use of cabazitaxel as a treatment option in people with an Eastern Cooperative Oncology Group performance status of 0 or 1 whose disease had progressed during or after treatment with at least 225 mg/m(2) of docetaxel, as long as it was provided at the discount agreed in the PAS and purchased in either pre-prepared intravenous-infusion bags or in vials at a reduced price to reflect the average per-patient drug wastage.

Sugammadex 16 mg kg⁻¹ can be used for the immediate reversal of neuromuscular block 3 min after administration of rocuronium and could be used in place of succinylcholine for emergency intubation. We have systematically reviewed the efficacy and cost-effectiveness and made an economic assessment of sugammadex for immediate reversal. The economic assessment investigated whether sugammadex appears cost-effective under various assumptions about the value of any reduction in recovery time with sugammadex, the likelihood of a 'can't intubate, can't ventilate' (CICV) event, the age of the patient, and the length of the procedure. Three trials were included in the efficacy review. Sugammadex administered 3 or 5 min after rocuronium produced markedly faster recovery than placebo or spontaneous recovery from succinylcholine-induced block. No published economic evaluations were found. Our economic analyses showed that sugammadex appears more cost-effective, where the value of any reduction in recovery time is greater, where the reduction in mortality compared with succinylcholine is greater, and where the patient is younger, for lower probabilities of a CICV event and for long procedures which do not require profound block throughout. Because of the lack of evidence, the value of some parameters remains unknown, which makes it difficult to provide a definitive assessment of the cost-effectiveness of sugammadex in practice. The use of sugammadex in combination with high-dose rocuronium is efficacious. Further research is needed to clarify key parameters in the analysis and to allow a fuller economic assessment.

Patients receive prophylactic antibiotics against surgical site infections (SSIs) before or during many procedures. Glycopeptide antibiotics are effective against most strains of methicillin-resistant Staphylococcus aureus (MRSA), but their wider use risks increasing resistance. Our objective was to review the evidence for clinical effectiveness that might help to determine whether there is a threshold of MRSA prevalence at which switching from non-glycopeptide to glycopeptide antibiotic prophylaxis might be justified.We performed a systematic review of randomized trials comparing a glycopeptide with an alternative antibiotic regimen for SSI prophylaxis in adults undergoing clean or clean-contaminated surgical procedures. The evidence was used to inform development of a decision-analytic model. We subsequently updated the review to May 2008.Fourteen studies were identified that provided evidence concerning clinical effectiveness. The studies were too heterogeneous clinically for meta-analysis. Only one of 12 trials found that glycopeptides reduced SSIs significantly at 30 days compared with non-glycopeptide antibiotics. Of the two trials that reported on MRSA infection, neither found a significant difference between glycopeptide and comparator drugs.This systematic review did not find any evidence to support the use of glycopeptides in preference to other antibiotics for the prevention of MRSA infections and SSIs. The limitations of the evidence make it difficult to identify a threshold at which a switch from non-glycopeptide to glycopeptide prophylaxis should be recommended. Given the difficulties of addressing this issue through randomized trials, further research should focus on hospital infection control policies, MRSA screening, and the isolation and treatment of anyone infected with MRSA prior to surgery.

Surgical site infection is commonly caused by Staphylococcus aureus. The multiresistant strains (MRSA) are resistant to most antibiotic prophylaxis regimens. Our aim was to explore whether there is a threshold of MRSA prevalence at which switching to routine glycopeptide-based antibiotic prophylaxis becomes cost-effective. An indicative model was designed to explore the cost-effectiveness of vancomycin, cephalosporin or a combination, in patients undergoing primary hip arthroplasty. If the MRSA infection rate is equal to or above 0.25% and the rate of other infections with cephalosporin prophylaxis is equal to or above 0.2%, use of the combination antibiotic prophylaxis is optimal. Modelling the cost-effectiveness of interventions for MRSA prevention is complex due to uncertainty around resistance and effectiveness of glycopeptides. The indicative model provides a framework for evaluation. More work is needed to understand the impact of antibiotic resistance over time in these currently effective antibiotics.

Objective: To assess the cost-effectiveness of radiofrequency catheter ablation (RFCA) compared with anti-arrhythmic drug (AAD) therapy for the treatment of atrial fibrillation (AF) from the perspective of the UK NHS. Design: Bayesian evidence synthesis and decision analytical model. Methods: A systematic review and meta-analysis was conducted and Bayesian statistical methods used to synthesise the effectiveness evidence from randomised control trials. A decision analytical model was developed to assess the costs and consequences associated with the primary outcome of the trials over a lifetime time horizon. Main outcome measure: Costs from a health service perspective and outcomes measured as quality-adjusted life years (QALYs). Results: The incremental cost-effectiveness ratio of RFCA varied between £7763 and £7910 for each additional QALY according to baseline risk of stroke, with a probability of being cost-effective from 0.98 to 0.99 for a cost-effectiveness threshold of £20 000. Results were sensitive to the duration of quality of life benefits from treatment. Conclusions: RFCA is potentially cost-effective for the treatment of paroxysmal AF in patients’ predominantly refractory to AAD therapy provided the quality-of-life benefits from treatment are maintained for more than 5 years. These findings remain subject to limitations in the existing evidence regarding the nature of life benefits and the prognostic importance of restoring normal sinus rhythm conferred using RFCA.

Objective To assess what is known about effective patient and public engagement in health service reconfiguration processes and identify implications for further research and health care practice. Methods Rapid systematic review of published and grey literature to identify methods or approaches to engagement in decisions about health service reconfiguration; and to examine how engagement has worked or not worked in specific examples of system change. Following a search for literature published in English from 2000 to March 2014, eight systematic reviews, seven primary studies and 24 case studies (of which 6 were exemplars) were included. We undertook a narrative synthesis to consider five aspects of engagement with health service reconfiguration. Results Engagement varied in nature and intensity, and efforts generally involved multiple methods. There was no evidence on the isolated impact of any particular engagement method or collection of methods. In general, engagement was most likely to be successful when started early, when led and supported by clinicians, and when it offered opportunities for genuine interaction. The impact of engagement was variably measured and demonstrated, and frequently defined as process measures rather than the outcomes of proposals for service reconfiguration. Little was reported on the potential negative impact of service user engagement. Conclusions Patients and the public can be engaged through various methods. Problems often arise because decision-makers paid insufficient attention to issues considered important by patients and the public. Guidance setting out the stages of reconfiguration and opportunities for service user input could be a helpful practical framework for future engagement activity. Future evaluation and explicit reporting of engagement and impact is needed.

Background Clinical Commissioning Groups (CCGs) are mandated to use research evidence effectively to ensure optimum use of resources by the National Health Service (NHS), both in accelerating innovation and in stopping the use of less effective practices and models of service delivery. We intend to evaluate whether access to a demand-led evidence service improves uptake and use of research evidence by NHS commissioners compared with less intensive and less targeted alternatives. Methods/design This is a controlled before and after study involving CCGs in the North of England. Participating CCGs will receive one of three interventions to support the use of research evidence in their decision-making: 1) consulting plus responsive push of tailored evidence; 2) consulting plus an unsolicited push of non-tailored evidence; or 3) standard service unsolicited push of non-tailored evidence. Our primary outcome will be changed at 12 months from baseline of a CCGs ability to acquire, assess, adapt and apply research evidence to support decision-making. Secondary outcomes will measure individual clinical leads and managers’ intentions to use research evidence in decision making. Documentary evidence of the use of the outputs of the service will be sought. A process evaluation will evaluate the nature and success of the interactions both within the sites and between commissioners and researchers delivering the service. Discussion The proposed research will generate new knowledge of direct relevance and value to the NHS. The findings will help to clarify which elements of the service are of value in promoting the use of research evidence. Those involved in NHS commissioning will be able to use the results to inform how best to build the infrastructure they need to acquire, assess, adapt and apply research evidence to support decision-making and to fulfil their statutory duties under the Health and Social Care Act. Electronic supplementary material The online version of this article (doi:10.1186/s13012-014-0199-4) contains supplementary material, which is available to authorized users.

Objectives To assess the evidence on the impact of enhanced recovery programmes for patients undergoing elective surgery in acute hospital settings in the UK. Design Rapid evidence synthesis. Eight databases were searched from 1990 to March 2013 without language restrictions. Relevant reports and guidelines, websites and reference lists of retrieved articles were scanned to identify additional studies. Systematic reviews, RCTs not included in the systematic reviews, economic evaluations and UK NHS cost analysis, implementation case studies and surveys of patient experience in a UK setting were eligible for inclusion. Primary and secondary outcome measures We assessed the impact of enhanced recovery programmes on health or cost-related outcomes, and assessed implementation case studies and patient experience in UK settings. Studies were quality assessed where appropriate using the Centre for Reviews and Dissemination Database of Abstracts of Reviews of Effects critical appraisal process. Results 17 systematic reviews and 12 additional RCTs were included. Ten relevant economic evaluations were included. No cost analysis studies were identified. Most of the evidence focused on colorectal surgery. 14 innovation case studies and 15 implementation case studies undertaken in National Health Service settings described factors critical to the success of an enhanced recovery programme. Evidence for colorectal surgery suggests that enhanced recovery programmes may reduce hospital stays by 0.5–3.5 days compared with conventional care. There were no significant differences in reported readmission rates. Other surgical specialties showed greater variation in reductions in length of stay reflecting the limited evidence identified. Findings relating to other outcomes were hampered by a lack of robust evidence and poor reporting. Conclusions There is consistent, albeit limited, evidence that enhanced recovery programmes can reduce length of patient hospital stay without increasing readmission rates. The extent to which managers and clinicians considering implementing enhanced recovery programmes in UK settings can realise savings will depend on length of stay achieved under their existing care pathway.

Background Exploring barriers to the uptake of research based recommendations into practice is an important part of the development of implementation programmes. Techniques to identify barriers can include use of theory-informed questionnaires and qualitative interviews. Conceptualising and measuring theory-informed factors, and engaging health professionals’ to uncover all potential barriers, can be a difficult task. This paper presents a case study of the process of trying to identify, systematically, the key factors influencing health professionals’ referrals for women diagnosed with mild to moderate postnatal depression for psychological treatment. The paper illustrates how the factors were conceptualised and measured and explores the real world challenges experienced, with implications for future implementation studies. Methods Theory-informed factors were conceptualised and measured using a questionnaire and interviews. The questionnaire was piloted, before being administered to general practitioners, practice nurses and health visitors working in general practices in one area of the UK NHS. The interviews were conducted with a small sample of general practitioners who had not completed the questionnaire, further exploring factors influencing their referral decisions in the local context. Results The response rate to the questionnaire was low (19%), despite selecting the recommendation to target through engagement with local stakeholders and surveying local health professionals, and despite using two reminders, an incentive prize, and phone calls to practice managers to bolster response rates. Conclusions Two significant challenges to achieving higher response rates and successfully exploring local context were identified: the difficulties of developing a robust- but feasible- questionnaire to explore theory-informed factors, and targeting recommendations that are important to policy makers, but which health professionals view as unimportant. This case study highlights the “trade-off” between scientifically rigorous collection of data against the pragmatism and flexibility requirements of “real world” implementation. Future implementation studies should explore different ways of identifying factors influencing the adoption of recommendations to bridge this gulf.

Background: In an era of scarce and competing priorities for implementation, choosing what to implement is a key decision point for many behavioural change projects. The values and attitudes of the professionals and managers involved inevitably impact the priority attached to decision options. Reliably capturing such values is challenging. Methods: This paper presents an approach for capturing and incorporating professional values into the prioritization of healthcare innovations being considered for adoption. Conjoint Analysis (CA) was used in a single UK Primary Care Trust to measure the priorities of healthcare professionals working with women with postnatal depression. Rating-based CA data was gathered using a questionnaire and then mapped onto 12 interventions being considered as a means of improving the management of postnatal depression. Results: The ‘impact on patient care’ and the ‘quality of supporting evidence’ associated with the potential innovations were the most influential in shaping priorities. Professionals were least influenced by whether an innovation was an existing national or local priority, or whether current practice in the Trust was meeting minimum standards. Ranking the 12 innovations by the preferences of potential adopters revealed ‘guided self help’ was the top priority for implementation and ‘screening questions for post natal depression’ the least. When other factors were considered (such as the presence of routine data or planned implementation activity elsewhere in the Trust), the project team chose to combine the eight related treatments and implement these as a single innovation referred to as ‘psychological therapies’. Conclusions: Using Conjoint Analysis to prioritise potential innovation implementation options is a feasible means of capturing the utility of stakeholders and thus increasing the chances of an innovation being adopted. There are some practical barriers to overcome such as increasing response rates to conjoint surveys before routine and unevaluated use of this technique should be considered.

Background We have developed a framework for translating existing sources of synthesized and quality-assessed evidence, primarily systematic reviews, into actionable messages in the form of short accessible briefings. The service aims to address real-life problems in response to requests from decision-makers. Development of the framework was based on a scoping review of existing resources and our initial experience with two briefing topics, including models of service provision for young people with eating disorders. We also drew on previous experience in dissemination research and practice. Where appropriate, we made use of the SUPporting POlicy relevant Reviews and Trials (SUPPORT) tools for evidence-informed policymaking. Findings To produce a product that it is fit for this purpose it has been necessary to go beyond a traditional summary of the available evidence relating to effectiveness. Briefings have, therefore, included consideration of cost effectiveness, local applicability, implications relating to local service delivery, budgets, implementation and equity. Our first evidence briefings produced under this framework cover diagnostic endoscopy by specialist nurses and integrated care pathways in mental healthcare settings. Conclusions The framework will enable researchers to present and contextualize evidence from systematic reviews and other sources of synthesized and quality-assessed evidence. The approach is designed to address the wide range of questions of interest to decision-makers, especially those commissioning services or managing service delivery and organization in primary or secondary care. Evaluation of the use and usefulness of the evidence briefings we produce is an integral part of the framework and will help to fill a gap in the literature.

BackgroundSocial network analysis (SNA) has been widely used across a range of disciplines but is most commonly applied to help improve the effectiveness and efficiency of decision making processes in commercial organisations. We are utilising SNA to inform the development and implementation of tailored behaviour-change interventions to improve the uptake of evidence into practice in the English National Health Service. To inform this work, we conducted a systematic scoping review to identify and evaluate the use of SNA as part of an intervention to support the implementation of change in healthcare settings.Methods and findingsWe searched ten bibliographic databases to October 2011. We also searched reference lists, hand searched selected journals and websites, and contacted experts in the field. To be eligible for the review, studies had to describe and report the results of an SNA performed with healthcare professionals (e.g. doctors, nurses, pharmacists, radiographers etc.) and others involved in their professional social networks. We included 52 completed studies, reported in 62 publications. Almost all of the studies were limited to cross sectional descriptions of networks; only one involved using the results of the SNA as part of an intervention to change practice.ConclusionsWe found very little evidence for the potential of SNA being realised in healthcare settings. However, it seems unlikely that networks are less important in healthcare than other settings. Future research should seek to go beyond the merely descriptive to implement and evaluate SNA-based interventions.

Summary The cost-effectiveness of sugammadex for the routine reversal of muscle relaxation produced by rocuronium or vecuronium in UK practice is uncertain. We performed a systematic review of randomized controlled trials of sugammadex compared with neostigmine/glycopyrrolate and an economic assessment of sugammadex for the reversal of moderate or profound neuromuscular block (NMB) produced by rocuronium or vecuronium. The economic assessment aimed to establish the reduction in recovery time and the ‘value of time saved' which would be necessary for sugammadex to be potentially cost-effective compared with existing practice. Three trials indicated that sugammadex 2 mg kg−1 (4 mg kg−1) produces more rapid recovery from moderate (profound) NMB than neostigmine/glycopyrrolate. The economic assessment indicated that if the reductions in recovery time associated with sugammadex in the trials are replicated in routine practice, sugammadex would be cost-effective if those reductions are achieved in the operating theatre (assumed value of staff time, £4.44 per minute), but not if they are achieved in the recovery room (assumed value of staff time, £0.33 per minute). However, there is considerable uncertainty in these results. Sugammadex has the potential to be cost-effective compared with neostigmine/glycopyrrolate for the reversal of rocuronium-induced moderate or profound NMB, provided that the time savings observed in trials can be achieved and put to productive use in clinical practice. Further research is required to evaluate the effects of sugammadex on patient safety, predictability of recovery from NMB, patient outcomes, and efficient use of resources.

Background Sugammadex (Bridion®) is a newly developed agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium. Sugammadex can reverse profound blockade and can be given for immediate reversal and its use would avoid the potentially serious adverse effects of the currently used agent, succinylcholine. Also, sugammadex can reverse NMB more quickly and predictably than existing agents. Objectives To determine the clinical effectiveness and cost-effectiveness of sugammadex for the reversal of muscle relaxation after general anaesthesia in UK practice following routine or rapid induction of NMB. Data sources Medical databases [including MEDLINE, EMBASE, CINAHL, Science Citation Index, BIOSIS and Cochrane Central Register of Controlled Trials (CENTRAL), conference proceedings, internet sites and clinical trials registers] were searched to identify published and unpublished studies. The main searches were carried out in May 2008 and supplemented by current awareness updates up until November 2008. Review methods For the clinical effectiveness review, randomised controlled trials of sugammadex against placebo or an active comparator (neostigmine + glycopyrrolate) for the reversal of moderate or profound NMB and for immediate reversal (spontaneous recovery from succinylcholine-induced blockade) were included. The primary effectiveness outcome was speed of recovery from NMB, as measured by objective monitoring of neuromuscular function. For the cost-effectiveness review, a de novo economic assessment considered the routine induction of NMB and the rapid induction and/or reversal of NMB, and threshold analyses were carried out on a series of pairwise comparisons to establish how effective sugammadex needs to be to justify its cost. Results The review of clinical effectiveness included four randomised active-control trials of sugammadex, nine randomised placebo-controlled trials and five studies in special populations. A total of 2132 titles and abstracts and 265 full-text publications were screened. The included trials indicated that sugammadex produces more rapid recovery from moderate or profound NMB than placebo or neostigmine. Median time to recovery from moderate blockade was 1.3–1.7 minutes for rocuronium + sugammadex, 21–86 minutes for rocuronium + placebo and 17.6 minutes for rocuronium + neostigmine. In profound blockade, median time to recovery was 2.7 minutes for rocuronium + sugammadex, 30 to > 90 minutes for rocuronium + placebo, and 49 minutes for rocuronium + neostigmine. Results for vecuronium were similar. In addition, recovery from NMB was faster with rocuronium reversed by sugammadex 16 mg/kg after 3 minutes (immediate reversal) than with succinylcholine followed by spontaneous recovery (median time to primary outcome 4.2 versus 7.1 minutes). The evidence base for modelling cost-effectiveness is very limited. However, assuming that the reductions in recovery times seen in the trials can be achieved in routine practice and can be used productively, sugammadex [2 mg/kg (4 mg/kg)] is potentially cost-effective at its current list price for the routine reversal of rocuronium-induced moderate (profound) blockade, if each minute of recovery time saved can be valued at approximately £2.40 (£1.75) or more. This is more likely to be achieved if any reductions in recovery time are in the operating room (estimated value of £4.44 per minute saved) rather than the recovery room (estimated value of £0.33 per minute saved). The results were broadly similar for rocuronium- and vecuronium-induced blockade. For rapid reversal of NMB it appeared that any reduction in morbidity from adopting sugammadex is unlikely to result in significant cost savings. Limitations The evidence base was not large and many of the published trials were dose-finding and safety studies with very small sample sizes. Also, some relevant outcomes, in particular patient experience/quality of life and resources/costs used, were either not investigated or not reported. In addition, it is likely that the patients included in the efficacy trials were relatively young and in good general health compared with the overall surgical population. Regarding the economic evaluation, there appears to be no evidence linking measures of clinical efficacy to patients’ health-related quality of life and mortality risks. Conclusions Sugammadex may be a cost-effective option compared with neostigmine + glycopyrrolate for reversal of moderate NMB and also provides the facility to recover patients from profound blockade. Rocuronium + sugammadex could be considered as a replacement for succinylcholine for rapid induction (and reversal) of NMB, although this may not be a cost-effective option in some types of patient at current list prices for sugammadex. Considerable uncertainties remain about whether the full benefits of sugammadex can be realised in clinical practice.

Objective Case series can influence clinical practice but are often omitted from systematic reviews. We evaluated the contribution of case series to a systematic review of radiofrequency catheter ablation (RFCA) for treatment of atrial fibrillation (AF). Study Design and Setting Analysis of the results of a systematic review based on a search of 25 electronic databases and Internet sources. Results We included eight controlled trials and 53 case series. Case series provided most patients longest follow-up and data on adverse events and complications. Rates of freedom from arrhythmia were comparable between case series, RFCA arms of controlled trials, and a survey of RFCA centers. Conclusion In the case of RFCA for AF, the case series make a useful contribution to the systematic review. Inclusion of case series can increase the evidence base and strengthen the credibility of a review of an emerging health technology. These advantages must be balanced against the risk of bias associated with the lack of a control group, potential publication bias, overrepresentation of results from specialist centers, and overlap of patients across series. Specification in the review protocol of inclusion criteria for outcomes and quality criteria is recommended to make optimum use of case series.

OBJECTIVES: To determine whether there is a level of methicillin-resistant Staphylococcus aureus (MRSA) prevalence at which a switch from non-glycopeptide to glycopeptide antibiotics for routine prophylaxis is indicated in surgical environments with a high risk of MRSA infection. DATA SOURCES: Major electronic databases were searched up to September 2005. REVIEW METHODS: The effectiveness review included controlled clinical trials comparing a glycopeptide with an alternative antibiotic regimen that reported effectiveness and/or adverse events. Controlled observational studies were also included for adverse events. The cost-effectiveness review included economic evaluations comparing glycopeptide prophylaxis with any alternative comparator. Study validity was assessed using standard checklists. The supplementary economic reviews assessed evaluations of non-glycopeptide antibiotic prophylaxis; evaluations where antibiotic resistance is a problem; methods of modelling resistance in infectious diseases; and developing a conceptual framework. An indicative decision analytic model was developed to compare vancomycin with a cephalosporin and with a combination of vancomycin and cephalosporin, using hip arthroplasty as an exemplar. Available data on, for example, surgical site infection (SSI) rates, MRSA rates, effectiveness of the antibiotics, were incorporated into the model. Costs were estimated from the perspective of the NHS. RESULTS: The effectiveness review included 16 randomised controlled trials, with a further three studies included for adverse events only. There was no evidence that glycopeptides were more effective than non-glycopeptides in preventing SSIs. Most of the trials did not report either the baseline prevalence of MRSA at the participating surgical units or MRSA infections as an outcome. The cost-effectiveness review included five economic evaluations of glycopeptide prophylaxis. Only one study incorporated health-related quality of life and undertook a cost-utility analysis. None of the studies was undertaken in the UK and none explicitly modelled antibiotic resistance. The supplementary reviews provided few insights into how to assess cost-effectiveness in the context of resistance. No studies modelled cost-effectiveness alongside epidemiological models of resistance. There was little information regarding the impact of surgical infections on costs post-discharge and patient quality of life. The lack of available clinical evidence limited the development of the cost-effectiveness model and meant that the modelling could only be indicative in nature. The model can be used to show the threshold baseline risk at which the use of vancomycin as prophylaxis might be cost-effective (the model did not include teicoplanin). The indicative model suggests that the baseline risk of MRSA can be fairly modest at below the national average and it would still appear cost-effective to use glycopeptide prophylaxis. The model indicates that the use of glycopeptides as a form of prophylaxis in addition to a treatment for MRSA infections is unlikely to decrease the total usage and hence reduce the risk of future problems with glycopeptide-resistant bacteria. CONCLUSIONS: There is insufficient evidence to determine whether there is a threshold prevalence of MRSA at which switching from non-glycopeptide to glycopeptide antibiotic prophylaxis might be clinically effective and cost-effective. Future research needs to address the complexities of decision-making relating to the prevention of MRSA and infection control in general. Research including evidence synthesis and decision modelling comparing a full range of interventions for infection control, which extends to other infections, not just MRSA, is needed. A long-term research programme to predict the pattern of drug resistance and its implications for future costs and health is also needed.

BackgroundThe aetiology of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is still unknown. The identification of risk factors for CFS/ME is of great importance to practitioners.MethodA systematic scoping review was conducted to locate studies that analysed risk factors for CFS/ME using multiple predictors. We searched for published and unpublished literature in 11 electronic databases, reference lists of retrieved articles and guideline stakeholder submissions in conjunction with the development of a forthcoming national UK guideline. Risk factors and findings were extracted in a concise tabular overview and studies synthesized narratively.ResultsEleven studies were identified that met inclusion criteria: two case-control studies, four cohort studies, three studies combining a cohort with a case-control study design, one case-control and twin study and one cross-sectional survey. The studies looked at a variety of demographic, medical, psychological, social and environmental factors to predict the development of CFS/ME. The existing body of evidence is characterized by factors that were analysed in several studies but without replication of a significant association in more than two studies, and by studies demonstrating significant associations of specific factors that were not assessed in other studies. None of the identified factors appear suitable for the timely identification of patients at risk of developing CFS/ME within clinical practice.ConclusionsVarious potential risk factors for the development of CFS/ME have been assessed but definitive evidence that appears meaningful for clinicians is lacking.

Objective To summarise evidence on the effectiveness of behaviour change interventions to encourage prescribing of generic forms of prescription drugs where clinically appropriate in the UK National Health Service (NHS) and similar settings. Design Systematic review. Search strategy We conducted a rapid evidence synthesis in two stages: First, we searched databases, such as the Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE), for systematic reviews of interventions that reported outcomes related to utilisation of generic drugs. In the second stage, we searched several databases including MEDLINE and EMBASE to identify primary studies of any interventions not covered by systematic reviews. Data extraction and quality assessment Data were extracted into a standardised data extraction form. Standardised quality assessment tools were used to assess study quality. Two reviewers were involved in data extraction and quality assessment. Results 10 reviews were included for the initial evidence synthesis, but most were of limited usefulness to our focused review question. One review evaluated the effect of prescribing policies using financial incentives and showed an increase in generic prescribing. Thirteen primary studies of other interventions were included for the rapid review. Two studies showed an increase in percentage of overall generic prescribing with an educational intervention; two studies showed an improvement in generic prescribing rates when physicians collaborated with pharmacists, though in one study this was not statistically significant; two US studies showed improvements in generic prescribing with electronic prescribing. Five out of seven studies showed positive results with multifaceted interventions. Conclusions The existing evidence remains insufficient to determine which behaviour change intervention or combination of interventions is most effective due to methodological weaknesses and conflicting results. Based on the evidence, financial incentives with educational intervention and audit/feedback look promising but decision-makers should take into account the practicality and costs of the interventions before implementation.

Objectives To identify and critically assess the extent to which systematic reviews of enhanced recovery programmes for patients undergoing colorectal surgery differ in their methodology and reported estimates of effect. Design Review of published systematic reviews. We searched the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA) Database from 1990 to March 2013. Systematic reviews of enhanced recovery programmes for patients undergoing colorectal surgery were eligible for inclusion. Primary and secondary outcome measures The primary outcome was length of hospital stay. We assessed changes in pooled estimates of treatment effect over time and how these might have been influenced by decisions taken by researchers as well as by the availability of new trials. The quality of systematic reviews was assessed using the Centre for Reviews and Dissemination (CRD) DARE critical appraisal process. Results 10 systematic reviews were included. Systematic reviews of randomised controlled trials have consistently shown a reduction in length of hospital stay with enhanced recovery compared with traditional care. The estimated effect tended to increase from 2006 to 2010 as more trials were published but has not altered significantly in the most recent review, despite the inclusion of several unique trials. The best estimate appears to be an average reduction of around 2.5 days in primary postoperative length of stay. Differences between reviews reflected differences in interpretation of inclusion criteria, searching and analytical methods or software. Conclusions Systematic reviews of enhanced recovery programmes show a high level of research waste, with multiple reviews covering identical or very similar groups of trials. Where multiple reviews exist on a topic, interpretation may require careful attention to apparently minor differences between reviews. Researchers can help readers by acknowledging existing reviews and through clear reporting of key decisions, especially on inclusion/exclusion and on statistical pooling.

Objective To determine the clinical effectiveness and cost-effectiveness of endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) in patients at varying levels of risk. Data sources The following bibliographic databases were searched (2005-February 2007): BIOSIS Previews, CINAHL, Cochrane Central Register of Controlled Trials, EMBASE, ISI Proceedings, MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Science Citation Index and Zetoc Conferences. Review methods A systematic review of the clinical effectiveness of EVAR was performed using standard methods. Meta-analysis was employed to estimate a summary measure of treatment effect on relevant outcomes based on intention to treat analyses. A second systematic review was undertaken to identify existing cost-effectiveness analyses of EVAR compared with open surgery and non-surgical interventions. Two new decision models were developed to inform the review. Results Six RCTs were included in the clinical effectiveness review. Thirty-four studies evaluated the role of patients' baseline characteristics in predicting risks of particular outcomes after EVAR. The majority were based on data relating to devices in current use from the EUROSTAR registry. Compared with open repair EVAR reduces operative mortality (odds ratio 0.35, 95% CI 0.19 to 0.63) and medium-term aneurysm-related mortality (hazard ratio 0.49, 95% CI 0.29 to 0.83) but offers no significant difference in all-cause mortality. EVAR is associated with increased rates of complications and reinterventions, which are not offset by any increase in health-related quality of life. EVAR trial 2 comparing EVAR with non-surgical management in patients unfit for open repair found no differences in mortality between groups; however, substantial numbers of patients randomised to non-surgical management crossed over to receive surgical repair of their aneurysm. The cost-effectiveness systematic review identified six published decision models. Both models considered relevant for the decision in the UK concluded that EVAR was not cost-effective on average compared with open repair at a threshold of 20,000 pounds per quality-adjusted life-year (QALY). Another model concluded that EVAR would be on average more cost-effective than no surgical intervention in unfit patients at this threshold. The Medtronic model concluded that EVAR was more cost-effective than open repair for fit patients at this threshold. The York economic evaluations found that EVAR is not cost-effective compared with open repair on average at a threshold of 30,000 pounds per QALY, with the results very sensitive to model assumptions and the baseline risk of operative mortality. Exploratory analysis to evaluate management options in patients unsuitable for open surgery suggested that the cost-effectiveness of EVAR may be sensitive to aneurysm size and patient's age at operation. Indicative modelling suggests that EVAR may be cost-effective for small aneurysms in some patient groups. Ongoing RCTs will provide further evidence relating to these patients. Conclusion Open repair is more likely to be cost-effective than EVAR on average in patients considered fit for open surgery. EVAR is likely to be more cost-effective than open repair for a subgroup of patients at higher risk of operative mortality. These results are based on extrapolation of mid-term results of clinical trials. Evidence does not currently support EVAR for the treatment of ruptured aneurysms. Further follow-up of the existing UK trials should be undertaken and the relative costs of procedures and devices should be investigated further.

Background Detailed intervention descriptions and robust evaluations that test intervention impact—and explore reasons for impact—are an essential part of progressing implementation science. Time series designs enable the impact and sustainability of intervention effects to be tested. When combined with time series designs, qualitative methods can provide insight into intervention effectiveness and help identify areas for improvement for future interventions. This paper describes the development, delivery, and evaluation of a tailored intervention designed to increase primary health care professionals’ adoption of a national recommendation that women with mild to moderate postnatal depression (PND) are referred for psychological therapy as a first stage treatment. Methods Three factors influencing referral for psychological treatment were targeted using three related intervention components: a tailored educational meeting, a tailored educational leaflet, and changes to an electronic system data template used by health professionals during consultations for PND. Evaluation comprised time series analysis of monthly audit data on percentage referral rates and monthly first prescription rates for anti-depressants. Interviews were conducted with a sample of health professionals to explore their perceptions of the intervention components and to identify possible factors influencing intervention effectiveness. Results The intervention was associated with a significant, immediate, positive effect upon percentage referral rates for psychological treatments. This effect was not sustained over the ten month follow-on period. Monthly rates of anti-depressant prescriptions remained consistently high after the intervention. Qualitative interview findings suggest key messages received from the intervention concerned what appropriate antidepressant prescribing is, suggesting this to underlie the lack of impact upon prescribing rates. However, an understanding that psychological treatment can have long-term benefits was also cited. Barriers to referral identified before intervention were cited again after the intervention, suggesting the intervention had not successfully tackled the barriers targeted. Conclusion A time series design allowed the initial and sustained impact of our intervention to be tested. Combined with qualitative interviews, this provided insight into intervention effectiveness. Future research should test factors influencing intervention sustainability, and promote adoption of the targeted behavior and dis-adoption of competing behaviors where appropriate.

Objective To assess whether limitations of randomised controlled trials (RCTs) of endovascular aneurysm repair (EVAR) can be addressed by evidence from non-randomised studies. Design Analysis of data from a systematic review. Methods We conducted a review of EVAR versus open repair or non-surgical management of abdominal aortic aneurysms. In addition to RCTs, we included pre-specified registries of EVAR and open repair. Results The six included RCTs randomised patients in 2003 and earlier. Of the three registries included, one contributed data on a large (>8000) sample of patients treated with newer generation EVAR devices and followed up for up to 8 years. However, treatment dates of these patients overlapped with those of the RCTs. The other registries were of limited usefulness. A large (>45,000) controlled observational study published while the review was in progress broadly supported the findings of RCTs comparing EVAR with open surgery. A comparison of outcomes across all studies did not support the hypothesis that the findings of the RCTs are no longer representative of clinical practice. Conclusions Both randomised and non-randomised sources of evidence have strengths and weaknesses for assessing the effectiveness of EVAR. Further research should explore the optimum use of registry data, including patient-level analyses.