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The Article Alert for the week of April 13, 2015 (sample articles)
Ioannidis JP, Horbar JD, Ovelman CM, Brosseau Y, Thorlund K, Buus-Frank ME, Mills EJ, Soll RF. Completeness of main outcomes across randomized trials in entire discipline: survey of chronic lung disease outcomes in preterm infants. BMJ. 2015 Jan 26;350:h72. PMID: 25623087.
Objective: To map the availability of information on a major clinical outcome--chronic lung disease--across the randomized controlled trials in systematic reviews of an entire specialty, specifically interventions in preterm infants.
Design: Survey of systematic reviews.
Data Sources: Cochrane Database of Systematic Reviews.
Study Selection and Methods: All Cochrane systematic reviews (as of November 2013) that had evaluated interventions in preterm infants. We identified how many of those systematic reviews had looked for information on chronic lung disease, how many reported on chronic lung disease, and how many of the randomized controlled trials included in the systematic reviews reported on chronic lung disease. We also randomly selected 10 systematic reviews that did not report on chronic lung disease and 10 that reported on any such outcomes and identified whether any information on chronic lung disease appeared in the primary reports of the randomized controlled trials but not in the systematic reviews.
Main Outdome Measures: Whether availability of chronic lung disease outcomes differed by type of population and intervention and whether additional non-extracted data might have been available in trial reports.
Results: 174 systematic reviews with 1041 trials exclusively concerned preterm infants. Of those, 105 reviews looked for chronic lung disease outcomes, and 79 reported on these outcomes. Of the 1041 included trials, 202 reported on chronic lung disease at 28 days and 200 at 36 weeks postmenstrual; 320 reported on chronic lung disease with any definition. The proportion of systematic reviews that looked for or reported on chronic lung disease and the proportion of trials that reported on chronic lung disease was larger in preterm infants with respiratory distress or support than others (P<0.001) and differed across interventions (P<0.001). Even for trials on children with ventilation interventions, only 56% (48/86) reported on chronic lung disease. In the random sample, 45 of 84 trials (54%) had no outcomes on chronic lung disease in the systematic reviews, and only 9/45 (20%) had such information in the primary trial reports.
Conclusions: Most trials included in systematic reviews of interventions on preterm infants are missing information on one of the most common serious outcomes in this population. Use of standardized clinical outcomes that would have to be collected and reported by default in all trials in a given specialty should be considered.
© Ioannidis et al 2015.
- FREE FULL TEXT: http://www.bmj.com/content/350/bmj.h72.full.pdf+html
- DOI: http://dx.doi.org/10.1136/bmj.h72
- PubMed: http://www.ncbi.nlm.nih.gov/pubmed/25623087
Schriger DL, Cooper RJ, Lopez-O'Sullivan A, Wystrach C, Altman DG. Is the relationship among outcome variables shown in randomized trials? Trials. 2015 Dec;16(1):584
Background: Randomized controlled trials (RCTs) often have more than one primary outcome and frequently have secondary and harm outcomes. Comparison of outcomes between study arms is the primary focus of RCTs, but there are times when the relation between outcomes is important, such as determining whether an intermediate outcome and a clinical outcome have a strong association. We sought to determine how often reports of RCTs depict the relations among outcomes at the individual patient level and, for those studies that use composite outcomes, how often the relations between component elements are depicted.
Methods: We selected 20 general, specialty and subspecialty medical journals with high impact factors that publish original clinical research. We identified every RCT in the 2011 and 2012 issues and randomly selected 10 articles per journal. For each article we recorded the number of outcomes, the number of composite outcomes and how often the relations between outcomes or elements of composite outcomes were portrayed.
Results: All but 16 of the 200 RCTs had more than one outcome. Thus, outcomes could have been related in 92% of studies, but such relations were only reported in 2 (1%). A total of 33 (17%) investigations measured a composite outcome, 32 of which showed data for each component. None, however, showed cross-tabulation of the components.
Conclusions: Readers are rarely shown the relation between outcomes. Mandatory posting of datasets or requirements for detailed appendices would allow readers to see these cross-tabulations, helping future investigators know which outcomes are redundant, which provide unique information and which are most responsive to changes in the independent variables. While not every relationship between outcomes requires depiction, at present such information is seldom portrayed.
- FREE FULL TEXT: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4374175/pdf/13063_2015_Article_584.pdf
- DOI: http://dx.doi.org/10.1186/s13063-015-0584-6
- PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4374175/
Mohiuddin S, Fenwick E, Payne K. Use of value of information in UK health technology assessments. Int.J.Technol.Assess.Health Care. 2014 Dec;30(6):553-70. PMID: 25816821.
Objectives: The aim of this study was to identify and critically appraise the use of Value of Information (VOI) analyses undertaken as part of health technology assessment (HTA) reports in England and Wales.
Methods: A systematic review of National Institute for Health Research (NIHR) funded HTA reports published between 2004 and 2013 identified the use of VOI methods and key analytical details in terms of: (i) types of VOI methodology used; (ii) parameters and key assumptions; and (iii) conclusions drawn in terms of the need for further research.
Results: A total of 512 HTA reports were published during the relevant timeframe. Of these, 203 reported systematic review and economic modeling studies and 25 of these had used VOI method(s). Over half of the twenty-five studies (n = 13) conducted both EVPI (Expected Value of Perfect Information) and EVPPI (Expected Value of Partial Perfect Information) analyses. Eight studies conducted EVPI analysis, three studies conducted EVPI, EVPPI, and EVSI (Expected Value of Sampling Information) analyses and one study conducted EVSI analysis only. The level of detail reporting the methods used to conduct the VOI analyses varied.
Conclusions: This review has shown that the frequency of the use of VOI methods is increasing at a slower pace compared with the published volume of HTA reports. This review also suggests that analysts reporting VOI method(s) in HTA reports should aim to describe the method(s) in sufficient detail to enable and encourage decision-makers guiding research prioritization decisions to use the potentially valuable outputs from quantitative VOI analyses.