Abstract

BACKGROUND: Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures.

METHODS: A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index – Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed.

RESULTS: From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes.

CONCLUSIONS: The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.

Abstract

PURPOSE: The aim of this study was to evaluate the cost effectiveness of ranibizumab compared with verteporfin photodynamic therapy (vPDT) or no treatment (observation) in patients with visual impairment due to myopic choroidal neovascularization (CNV).

METHODS: A Markov model with health states defined by best-corrected visual acuity and a 3-month cycle length was developed. It had a healthcare provider (UK National Health Service and personal social services) perspective, a lifetime time horizon, and was based on 2011 prices; future costs and health outcomes were discounted at 3.5 % per annum. Baseline characteristics were based on the phase III RADIANCE (Ranibizumab and vPDT Evaluation in Myopic CNV) study, and year 1 health-state transitions were based on this and the VIP (Verteporfin in Photodynamic Therapy) study. Extensive sensitivity analyses tested the robustness of the model.

RESULTS: The lifetime cost of treating myopic CNV with ranibizumab was £12,866, whereas vPDT and observation were associated with total costs of £14,421 and £8,163, respectively. Ranibizumab treatment produced higher cumulative quality-adjusted life-years (QALYs; 12.99) than vPDT (12.60) or observation (12.45). Ranibizumab treatment was therefore dominant, with greater health gains and lower overall costs than vPDT. Ranibizumab was cost effective compared with observation, with an incremental cost-effectiveness ratio of £8,778/QALY. In the probabilistic sensitivity analysis, ranibizumab had a 100 % and 88 % probability of being cost effective compared with vPDT and observation, respectively, at a willingness-to-pay threshold of £20,000/QALY.

CONCLUSION: This study indicates that ranibizumab therapy is dominant over vPDT for the treatment of visual impairment due to CNV secondary to pathologic myopia in the UK healthcare setting and cost effective compared with observation.

Abstract

OBJECTIVE: The aim of this paper is to provide new insights into the psychometrics of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire, originally developed for longer-term survivors 5 + years post-diagnosis. Specifically, to examine the classic psychometric properties of QLACS in a sample of shorter-term survivors, and to undertake Rasch analysis to explore the extent to which the Generic and Cancer-Specific summary scales (and separately-analysed Benefits of cancer domain) are unidimensional, with linear measurement properties and no differential item functioning (DIF).

METHODS: Patients with potentially curable breast, colorectal or prostate cancer completed QLACS 15 months post-diagnosis (N = 407). Score distributions, floor and ceiling effects, internal reliability, and feasibility (completion time and missing data) were examined. Rasch analysis included examination of item fit, DIF and unidimensionality.

RESULTS: The QLACS domains and summary scales had very similar score distributions and classic psychometric properties (no ceiling effects, majority no floor effects, acceptable reliability) to those found in development work with longer-term survivors. Median completion time was 10 min and total missing data 2.3%. The Generic summary scale contained several misfitting items and exhibited multidimensionality. The Cancer-Specific summary scale and Benefits domain showed fit to the Rasch model and demonstrated unidimensionality and no DIF, with just one or no item modifications respectively.

CONCLUSION: QLACS demonstrates similarly good classic psychometric properties among shorter-term as among longer-term survivors, and has good feasibility. The Cancer-Specific summary scale and Benefits domain showed an impressive degree of fit to the Rasch model, although the validity of computing the Generic summary score was not supported.

Abstract

BACKGROUND: There is evidence to suggest that component randomized controlled trials (RCTs) within systematic reviews may be biased. It is important that these reviews are identified to prevent erroneous conclusions influencing health care policies and decisions.

PURPOSE: To assess the likelihood of bias in trials in 12 meta-analyses.

DESIGN: A review of 12 systematic reviews.

DATA SOURCES: Twelve recently published systematic reviews with 503 component randomized trials, published in the British Medical Journal, The Lancet, Journal of the American Medical Association, and The Annals of Internal Medicine before May 2012.

STUDY SELECTION AND DATA EXTRACTION: Systematic reviews were eligible for inclusion if they included only RCTs. We obtained the full text for the component RCTs of the 12 systematic reviews (in English only). We extracted summary data on age, number of participants in each treatment group, and the method of allocation concealment for each RCT.

DATA SYNTHESIS: Five of the 12 meta-analyses exhibited heterogeneity in age differences (I2 > 0.30), when there should have been none. In two meta-analyses, the age of the intervention group was significantly greater than that of the control group. Inadequate allocation concealment was a statistically significant predictor of heterogeneity in one trial as observed by a metaregression.

CONCLUSIONS: Most of the sample of recent meta-analyses showed that there were signs of imbalance and/or heterogeneity in ages between treatment groups, when there should have been none. Systematic reviewers might consider using the techniques described here to assess the validity of their findings.

Abstract

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

Abstract

BACKGROUND: Livestock and poultry operations that feed large numbers of animals are common. Facility capacity varies, but it is not uncommon for facilities to house 1,000 swine with multiple barns at a single site, feedlots to house 50,000 cattle, and poultry houses to house 250,000 hens. There is primary research that suggests livestock facilities that confine animals indoors for feeding can represent a health hazard for surrounding communities. In this protocol, we describe a review about the association between proximity to animal-feeding operations (AFOs) and the health of individuals in nearby communities. A systematic review of the topic was published by some members of our group in 2010. The purpose of this review is to update that review.

METHODS/DESIGN
The populations of interest are people living in communities near livestock production facilities. Outcomes of interest are any health outcome measured in humans such as respiratory disease, gastrointestinal disease, and mental health. Measures of antibiotic resistance in people from the communities compared to measures of resistance found in animals and the environment on animal-feeding operations will also be summarized. The exposure of interest will be exposure to livestock production using a variety of metrics such as distance from facilities, endotoxin levels, and measures of odor. Electronic searches will be conducted using MEDLINE and MEDLINE In-Process (via OvidSP), CAB Abstracts (via Web of Knowledge), and Science Citation Index (via Web of Knowledge). No language or date restriction will be applied. We will access the risk of bias using a pilot version of a tool developed by the Methods Groups of the Cochrane Collaboration for non-randomized interventions. We propose to conduct a meta-analysis for each health metric (e.g., combining all respiratory disease outcomes, combining all gastrointestinal outcomes). A planned subgroup analysis will be based on the domains of the risk of bias.

DISCUSSION: This systematic review will provide synthesis of current evidence reporting the association between living near an animal-feeding operation and human health.

Abstract

No abstract available.