Abstract

BACKGROUND: Stroke is a significant burden in Saudi Arabia and the Saudi Ministry of Health's stroke committee has identified an urgent need to improve care.

AIM: The purpose of this study was to undertake a health-economic analysis to quantify the impact of developing stroke care in the country.

METHODS: An economic model was developed to assess the costs and clinical outcomes associated with an ischemic stroke care development program compared with current stroke care. Based on Saudi epidemiological data, cohorts of ischemic stroke patients enter the model each year for the first 10 years based on increasing incidence. Four treatment options were modeled including reperfusion and non-reperfusion treatments. The development scenario estimates the impact of gradually increasing uptake of more effective treatments over 10 years. Changes in the stroke care organization are considered along with resources required to increase capacity, allowing more patients to be admitted to stroke hospitals and access effective treatments.

RESULTS: The stroke care development program is associated with an increase in functionally independent patients and a decrease in disabling strokes compared with current stroke care. Additionally, the development program is associated with estimated cost savings of $602 million over 15 years ($255 million direct costs, $348 million indirect costs).

CONCLUSIONS: The model predicts that the stroke care development program is associated with improved patient outcomes and lower overall costs compared with the current stroke care program.

Abstract

OBJECTIVES: Transferability of economic evaluations to low- and middle-income countries through adaptation of models is important; however, several methodological and practical challenges remain. Given its significant costs and the quality-of-life burden to patients, adjuvant treatment of early breast cancer was identified as a priority intervention by the South African National Department of Health. This study assessed the cost-effectiveness of docetaxel and paclitaxel-containing chemotherapy regimens (taxanes) compared with standard (non-taxane) treatments.

METHODS: A cost-utility analysis was undertaken based on a UK 6-health-state Markov model adapted for South Africa using the Mullins checklist. The analysis assumed a 35-year time horizon. The model was populated with clinical effectiveness data (hazard ratios, recurrence rates, and adverse events) using direct comparisons from clinical trials. Resource use patterns and unit costs for estimating cost parameters (drugs, diagnostics, consumables, personnel) were obtained from South Africa. Uncertainty was assessed using probabilistic and deterministic sensitivity analyses.

RESULTS: The incremental cost per patient for the docetaxel regimen compared with standard treatment was R6774. The incremental quality-adjusted life years (QALYs) were 0.24, generating an incremental cost-effectiveness ratio of R28430 per QALY. The cost of the paclitaxel regimen compared with standard treatment was estimated as -R578 and -R1512, producing an additional 0.03 and 0.025 QALYs, based on 2 trials. Paclitaxel, therefore, appears to be a dominant intervention. The base case results were robust to all sensitivity analyses.

CONCLUSIONS: Based on the adapted model, docetaxel and paclitaxel are predicted to be cost-effective as adjuvant treatment for early breast cancer in South Africa.

Abstract

Research synthesis is the practice of systematically distilling and integrating data from many studies in order to draw more reliable conclusions about a given research issue. When the first edition of The Handbook of Research Synthesis and Meta-Analysis was published in 1994, it quickly became the definitive reference for conducting meta-analyses in both the social and behavioral sciences. In the third edition, editors Harris Cooper, Larry Hedges, and Jeff Valentine present updated versions of classic chapters and add new sections that evaluate cutting-edge developments in the field.

The Handbook of Research Synthesis and Meta-Analysis draws upon groundbreaking advances that have transformed research synthesis from a narrative craft into an important scientific process in its own right. The editors and leading scholars guide the reader through every stage of the research synthesis process-problem formulation, literature search and evaluation, statistical integration, and report preparation. The Handbook incorporates state-of-the-art techniques from all quantitative synthesis traditions and distills a vast literature to explain the most effective solutions to the problems of quantitative data integration. Among the statistical issues addressed are the synthesis of non-independent data sets, fixed and random effects methods, the performance of sensitivity analyses and model assessments, the development of machine-based abstract screening, the increased use of meta-regression and the problems of missing data. The Handbook also addresses the non-statistical aspects of research synthesis, including searching the literature and developing schemes for gathering information from study reports. Those engaged in research synthesis will find useful advice on how tables, graphs, and narration can foster communication of the results of research syntheses.

The third edition of the Handbook provides comprehensive instruction in the skills necessary to conduct research syntheses and represents the premier text on research synthesis.

Abstract

BACKGROUND: Colonoscopies are carried out for a range of reasons including for the detection of colon cancer and investigation of abdominal and bowel related symptoms. Inadequate preparation can increase the burden of repeat procedures.

METHODS: A systematic review aimed to identify the rate of repeat colonoscopies due to inadequate bowel preparation in France, Germany, Italy, Spain and the United Kingdom. The information obtained populated a decision analytic model to estimate the cost implications of inadequate bowel cleansing in the same five countries. The model explored scenarios by comparing one and two-litre polyethylene glycol-based bowel preparation.

RESULTS: The systematic review identified 14 eligible studies reporting on the proportion of patients with inadequate bowel cleansing indicated for a repeat procedure. Data were available for Italy (27.5%-35.9%), Spain (63%) and the UK (24.5%) only. The decision analytic model demonstrates that improving the proportion of adequate bowel cleansing at first colonoscopy is likely to generate cost savings.

CONCLUSIONS: Based on the available evidence, increasing the proportion of people who have adequate bowel cleansing at index colonoscopy will likely have financial benefits in Italy, Spain and the UK. A paucity of data, for France and Germany, limits the robustness of conclusions in these countries.

Abstract

OBJECTIVE: A randomised controlled trial (RCT) recruited women undergoing caesarean section (CS) in Poland. The aim of the trial was to assess the efficacy of a dialkylcarbamoyl chloride (DACC)-impregnated surgical dressing (bacterial-binding dressings) compared with standard of care (SoC) in preventing surgical site infection (SSI). The aim of the present analysis was to evaluate the cost-effectiveness of the bacterial-binding dressings in the context of the UK National Health Service (NHS).

METHOD: The clinical trial randomised patients to a bacterial-binding dressing (n=272) or a standard surgical dressing (n=271). The study recorded the presence of SSI and associated resource use up to 14 days postoperatively. To generalise results to the NHS, UK unit costs were applied to resource use recorded in the trial. An alternative approach applied a single UK-specific episode cost per SSI.

RESULTS: There were 543 women recruited to the trial. SSI rates were 5/272 (1.8%) and 14/271 (5.2%) for bacterial-binding dressings and SoC, respectively (p=0.04). Patients in the bacterial-binding dressing group had six fewer outpatient visits and 33 fewer hospital bed-days. The mean length of SSI-attributable hospitalisation was 2.36 days. Applying UK unit costs at 2017 prices to resource use recorded in the trial, costs of SSI prophylaxis and treatment were £48.97 and £24.69 per patient in the SoC and bacterial-binding dressing groups respectively, a difference of £24.27 (49.6%) per patient. The alternative costing approach produced a cost saving of £119 (57.6%) per patient with the bacterial-binding dressing.

CONCLUSION: Use of bacterial-binding dressings following CS has the potential to reduce the incidence of SSI and costs to the NHS.

Abstract

Guidance of the Panel on Genetically Modified Organisms (GMOs) of the European Food Safety Authority (EFSA) assists applicants in the preparation and presentation of their market registration applications by describing elements and information/data requirements for the risk assessment and monitoring of GMOs. This explanatory note to the guidance: (1) clarifies the scope and methodology for literature searching performed in the context of applications for market authorisation of GMOs submitted under Regulation (EC) No 1829/2003 before and after the Implementing Regulation (EU) No 503/2013 entered into force; annual post-market environmental monitoring reports on GMOs authorised in the EU market; and GMO applications for the renewed market authorisation of GM food/feed authorised under Regulation (EC) No 1829/2003; and (2) provides detailed recommendations on how to conduct and report systematic/extensive literature searches, and present the results of any scoping reviews.

Abstract

Mepilex Border Sacrum and Heel dressings are self-adherent, multilayer foam dressings designed for use on the heel and sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention. The National Institute for Health and Care Excellence (NICE) selected Mepilex Border Sacrum and Heel dressings for evaluation. The External Assessment Centre (EAC) critiqued the company's submission. Thirteen studies (four randomised controlled trials and nine nonrandomised comparative studies) were included. The majority of studies compared Mepilex Border Sacrum dressings (plus standard care) with standard care alone. Comparative evidence for Mepilex Border Heel dressings was limited. A meta-analysis indicated a non-statistically significant difference in favour of Mepilex Border Sacrum dressings for pressure ulcer incidence [RR 0.51 (95% CI 0.22-1.18)]. The company produced a de novo cost model, which was critiqued by the EAC. After the EAC updated input parameters, cost savings of £19 per patient compared with standard care alone for pressure ulcer prevention were estimated with Mepilex Border dressings predicted to be cost saving in 57% of iterations. The Medical Technologies Advisory Committee reviewed the evidence and judged that, although Mepilex Border Heel and Sacrum dressings have potential to prevent pressure ulcers in people who are considered to be at risk in acute care settings, further evidence is required to address uncertainties around the claimed benefits of the dressings and the incidence of pressure ulcers in an NHS acute-care setting. After a public consultation, NICE published this as Medical Technology Guidance 40.