Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

ArticleinJournal of Medical Systems 35(6):1521-30 · December 2011with10 Reads
DOI: 10.1007/s10916-010-9429-8 · Source: PubMed
Abstract
New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.
    • "The primary focus was on the measurement of generic health domains that are important for children across a variety of illnesses [10][11][12][13][14][15]. It is expected that PROMIS will be implemented worldwide , and that PROMIS instruments will rapidly replace existing PROMs [16][17][18] . In 2011, the Dutch–Flemish pediatric PROMIS Group was established with the aim to implement pediatric PROMIS instruments in the Netherlands and Flanders (northern Belgium). "
    [Show abstract] [Hide abstract] ABSTRACT: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children. It has the potential to be more valid, reliable, and responsive than existing PROMs. The items banks are designed to be self-reported and completed by children aged 8-18 years. The PROMIS items can be administered in short forms or through computerized adaptive testing. This paper describes the translation and cultural adaption of nine PROMIS item banks (151 items) for children in Dutch-Flemish. The translation was performed by FACITtrans using standardized PROMIS methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three independent reviews (at least two Dutch, one Flemish), and pretesting in 24 children from the Netherlands and Flanders. For some items, it was necessary to have separate translations for Dutch and Flemish: physical function-mobility (three items), anger (one item), pain interference (two items), and asthma impact (one item). Challenges faced in the translation process included scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items, or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items. The Dutch-Flemish PROMIS items are linguistically equivalent to the original USA version. Short forms are now available for use, and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders.
    Full-text · Article · Mar 2015
    • "After each question, the person's latent trait or domain level (the score on the instrument) is estimated, and when the estimation reaches a pre-defined precision (usually this happens after about 5–7 items), the computer stops asking questions. It is expected that PROMIS will be implemented worldwide and that PROMIS instruments will experience rapid adoption, once their cross-cultural validity is docu- mented181920. A Spanish translation of 21 items banks for adults and 9 item banks for children was performed by FACITtrans for use in the US and in Spanish-speaking countries. "
    [Show abstract] [Hide abstract] ABSTRACT: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children that has the potential to be more valid, reliable and responsive than existing PROMs. The PROMIS items can be administered in short forms or, more efficiently, through computerized adaptive testing. This paper describes the translation of 563 items from 17 PROMIS item banks (domains) for adults from the English source into Dutch-Flemish. The translation was performed by FACITtrans using standardized methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three to five independent reviews (at least two Dutch, one Flemish) and pre-testing in 70 adults (age range 20-77) from the Netherlands and Flanders. A small number of items required separate translations for Dutch and Flemish: physical function (five items), pain behaviour (two items), pain interference (one item), social isolation (one item) and global health (one item). Challenges faced in the translation process included: scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items. The methodology used and experience gained in this study can be used as an example for researchers in other countries interested in translating PROMIS. The Dutch-Flemish PROMIS items are linguistically equivalent. Short forms will soon be available for use and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders.
    Full-text · Article · Jan 2014
    • "If the definitions of error and true score under CTT do hold, then a reliability coefficient for any given test can be calculated and interpreted, and measurement ''error'' can be estimated as (1- reliability) (among other formulae; see [15], pp 69–70; [16]). If the CTT definitions do not hold, more complex theoretical and modeling approaches to reliability are available (see [17]; see also [5] and [6]), although these models are not widely used outside of formal psychometric contexts (although see [18] for a new application of modern/formal measurement theory to widely available tests for clinical research). ''Reliability'' under CTT is a widely used construct across many disciplines, but to compute and interpret it assumes that the distribution of error associated with a test is identical for all respondents and that the error is independent of the respondent's true score. "
    [Show abstract] [Hide abstract] ABSTRACT: We used a Guttman model to represent responses to test items over time as an approximation of what is often referred to as "points lost" in studies of cognitive decline or interventions. To capture this meaning of "point loss", over four successive assessments, we assumed that once an item is incorrect, it cannot be correct at a later visit. If the loss of a point represents actual decline, then failure of an item to fit the Guttman model over time can be considered measurement error. This representation and definition of measurement error also permits testing the hypotheses that measurement error is constant for items in a test, and that error is independent of "true score", which are two key consequences of the definition of "measurement error"--and thereby, reliability--under Classical Test Theory. We tested the hypotheses by fitting our model to, and comparing our results from, four consecutive annual evaluations in three groups of elderly persons: a) cognitively normal (NC, N = 149); b) diagnosed with possible or probable AD (N = 78); and c) cognitively normal initially and a later diagnosis of AD (converters, N = 133). Of 16 items that converged, error-free measurement of "cognitive loss" was observed for 10 items in NC, eight in converters, and two in AD. We found that measurement error, as we defined it, was inconsistent over time and across cognitive functioning levels, violating the theory underlying reliability and other psychometric characteristics, and key regression assumptions.
    Full-text · Article · Feb 2012
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