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The Spectra Optia® automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.
BACKGROUND: This paper provides guidance about how to plan, prepare, conduct, report, amend or update a systematic search. It aims to contribute to a new version of the Collaboration for Environmental Evidence (CEE) Guidelines for Systematic Reviews in Environmental Management, and the methods we describe are likely to be broadly applicable across a wider range of topics. In evidence synthesis, searches are expected to be repeatable, ft for purpose, with
minimum biases, and to collate a maximum number of relevant articles. Failing to include relevant information in an evidence synthesis may lead to inaccurate or skewed conclusions and/or changes in conclusions as soon as the omitted information is added.
METHOD: The paper takes into account similar documents produced by the Cochrane Collaboration and the Campbell Collaboration, including necessary adjustments for environmental policy and management, and the current version of the CEE Guidelines (version 4.2, 2013). Where possible this guidance is based on evidence from research, and in its absence on expert opinion and experience.
RESULTS: Here we aim to provide guidance on the optimal search structure as the basis on which any evidence synthesis should be built.
CONCLUSION: It is aimed at all those who intend to conduct systematic evidence synthesis, including reviews and Ph.D. thesis.
BACKGROUND: A patient-engagement and pathway-management program for patients undergoing primary total hip and knee replacement was evaluated. Health-service and multimedia features supported by technology were integrated with existing enhanced recovery after surgery (ERAS) practices. The primary objective was to demonstrate the impact on length of stay. The secondary objective was to assess the impact on clinical, patient-focused, and financial outcomes.
METHODS: Two thousand and eighty consecutive patients undergoing primary total hip replacement (n = 1,034) and total knee replacement (n = 1,046) were classified into "pre-program" (retrospectively assessed [n = 1,038]) and "program" (prospectively assessed [n = 1,042]) cohorts. Patients in the program cohort were subdivided according to those who were eligible for criteria-based outreach support (OS) (n = 401) and those who were ineligible for this service (NOS) (n = 641). Clinical outcomes were assessed for all patients, and patient-focused outcomes were assessed for a subset (n = 223).
RESULTS: The mean reduction in length of stay ranged from 20% (1.2 days) to 42% (2.5 days) following total hip replacement and from 9% (0.6 day) to 31% (2 days) following total knee replacement (p < 0.001). Clinical outcomes (readmissions, complications, emergency department re-attendance rates) were not significantly negatively impacted. The Oxford Hip Score had numerically larger improvement after total hip replacement in the OS group than in the pre-program group (4.1-point increase), and the Oxford Knee Score had numerically larger improvement after total knee replacement in the NOS group than in the pre-program group (0.8-point increase). The patients in the program cohort (either OS or NOS) rated overall health gain as higher than those in the pre-program cohort (gain in numerical rating scale, 1.4 points for patients managed with total hip replacement, 0.6 points for patients managed with total knee replacement). Older patients and those with higher comorbidity indices benefited most with respect to length of stay and multiple clinical outcomes. Patient experience was significantly improved across domains (p < 0.001 to p = 0.003). Potential savings for patients managed with total hip replacement (£401.64 [$267.76] per patient) exceeded estimated program charges of £50 [$33.33] to £60 [$40] per patient, whereas the potential savings for patients managed with total knee replacement (£76.67 [$51.11] per patient) were sufficient to achieve a reduction of total system costs. CONCLUSIONS: Technology-enabled programs may deliver enhanced care at lower costs for patients undergoing lower-limb arthroplasty. Shorter durations of inpatient stay without a negative impact on clinical outcomes and improved patient-focused outcomes and experience can deliver substantial value that can be especially beneficial for older patients and those with greater medical complexity.
AIM: The aim was to evaluate the cost-effectiveness of endoscopic eradication therapy (EET) with combined endoscopic mucosal resection and radiofrequency ablation for the treatment of high-grade dysplasia (HGD) arising in patients with Barrett's esophagus compared with endoscopic surveillance alone in the UK.
MATERIALS AND METHODS: The cost-effectiveness model consisted of a decision tree and modified Markov model. A lifetime time horizon was adopted with the perspective of the UK healthcare system.
RESULTS: The base case analysis estimates that EET for the treatment of HGD is cost-effective at a GB£20,000 cost-effectiveness threshold compared with providing surveillance alone for HGD patients (incremental cost-effectiveness ratio: GB£1272).
CONCLUSION: EET is likely to be a cost-effective treatment strategy compared with surveillance alone in patients with HGD arising in Barrett's esophagus in the UK.
The XprESS multi-sinus dilation system (XprESS) is a minimally invasive alternative to functional endoscopic sinus surgery (FESS) used in the treatment of people with chronic or recurrent acute sinusitis refractory to medical treatment. The manufacturer of XprESS, Entellus Medical, claims the technology is as effective as FESS in improving quality of life and is associated with quicker recovery times and reduced costs. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected XprESS for evaluation. Nine trials published in 13 papers were correctly identified by the company as relevant to the decision problem, including one randomised controlled trial (REMODEL study). From this evidence, the company concluded that XprESS is as beneficial as FESS for a range of clinical endpoints. The External Assessment Centre (EAC) agreed with the company's conclusion in a subgroup of patients, but judged that the evidence did not generalise to patients within the NHS fully. The company constructed a de novo costing model. XprESS generated cost-savings of £1302 per patient compared with FESS. The EAC critiqued and updated the model's inputs, with differences in results driven by changes in assumptions on procedure duration, length of hospital stay and the proportion of procedures undertaken in an outpatient setting under local anaesthetic. Although cost-incurring in the base case, XprESS generated cost savings under certain scenarios. The MTAC reviewed the evidence and supported the case for adoption, issuing positive draft recommendations. After public consultation NICE published this as Medical Technologies Guidance 30.
International and national guidelines on the treatment of chronic nonhypovolaemic hypotonic hyponatraemia differ; therefore, we have undertaken this systematic review and meta-analysis to investigate the efficacy and safety of interventions for the treatment of chronic nonhypovolaemic hypotonic hyponatraemia. Following registration of the review protocol with PROSPERO, systematic literature searches were conducted to identify randomized and quasi-randomized controlled trials assessing any degree of fluid restriction or any drug treatment with the aim of increasing serum sodium concentration in patients with chronic nonhypovolaemic hypotonic hyponatraemia. Where appropriate, outcome data were synthesized in a meta-analysis. A total of 45 716 bibliographic records were identified from the searches and 18 trials (assessing conivaptan, lixivaptan, tolvaptan and satavaptan) met the eligibility criteria. Results suggest that all four vasopressin receptor agonists ("vaptans") significantly improve serum sodium concentration. Lixivaptan, satavaptan and tolvaptan were associated with greater rates of response versus placebo. There was no evidence of a difference between each of the vaptans compared with placebo for mortality, discontinuation and rates of hypernatraemia. No RCT evidence of treatments other than the vaptans for hyponatraemia such as oral urea, salt tablets, mannitol, loop diuretics demeclocycline or lithium was identified. Vaptans demonstrated superiority over placebo for outcomes relating to serum sodium correction. Few trials documented the potential benefit of vaptans on change in health-related quality of life as a result of treatment. There was also a lack of high-quality RCT evidence on the comparative efficacy of the vaptans and other treatment strategies for the treatment of chronic nonhypovolaemic hypotonic hyponatraemia.
OBJECTIVE: The objective of this review was to update a systematic review of associations between living near an animal feeding operation (AFO) and human health.
METHODS: The MEDLINE® and MEDLINE® In-Process, Centre for Agricultural Biosciences Abstracts, and Science Citation Index databases were searched. Reference lists of included articles were hand-searched. Eligible studies reported exposure to an AFO and an individual-level human health outcome. Two reviewers performed study selection and data extraction.
RESULTS: The search returned 3702 citations. Sixteen articles consisting of 10 study populations were included in the analysis. The health outcomes were lower and upper respiratory tracts, MRSA, other infectious disease, neurological, psychological, dermatological, otologic, ocular, gastrointestinal, stress and mood, and other non-infectious health outcomes. Most studies were observational and used prevalence measures of outcome. An association between Q fever risk and proximity to goat production was reported. Other associations were unclear. Risk of bias was serious or critical for most exposure-outcome associations. Multiplicity (i.e., a large number of potentially correlated outcomes and exposures assessed on the same study subjects) was common in the evidence base.
CONCLUSIONS: Few studies reported an association between surrogate clinical outcomes and AFO proximity for respiratory tract-related outcomes. There were no consistent dose-response relationships between surrogate clinical outcome and AFO proximity. A new finding was that Q fever in goats is likely associated with an increased Q fever risk in community members. The review results for the non-respiratory health outcomes were inconclusive because only a small number of studies were available or the between-study results were inconsistent.
