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      Item banking and computer-adaptive testing in clinical trials: Standing in sight of the PROMISed land

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      Journal: Contemporary Clinical Trials Communications
      Publisher: Elsevier

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          Abstract

          The use of patient-reported outcome instruments (PRO) in clinical trials in order to capture the impacts of treatment on patients is widespread. However, regulatory agencies have over the past decade highlighted the need for PROs that are fit for purpose and target relevant aspects of the patient's condition. Many legacy PROs were developed with little patient input, are lengthy, and may lack relevance having not been modified or adapted as medical treatments have advanced. Computer-adaptive test (CAT) systems provide the possibility of targeted approaches to capturing patient-centric data, while minimising patient burden. Coupled with greater patient input in the development of PROs, CAT offers the opportunity of overcoming the shortcomings of the previous generation of PROs. This paper describes the some of the issues facing legacy PROs, current regulatory guidance, and initiatives, such as the Patient-Reported Outcome Measurement Information System (PROMIS), as well as the early signs of use of CAT to capture PRO data in clinical trials.

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          Health status assessment for the twenty-first century: item response theory, item banking and computer adaptive testing.

          D A Revicki, D Cella (1997)
          Health status assessment is frequently used to evaluate the combined impact of human immunodeficiency virus (HIV) disease and its treatment on functioning and well-being from the patient's perspective. No single health status measure can efficiently cover the range of problems in functioning and well-being experienced across HIV disease stages. Item response theory (IRT), item banking and computer adaptive testing (CAT) provide a solution to measuring health-related quality of life (HRQoL) across different stages of HIV disease. IRT allows us to examine the response characteristics of individual items and the relationship between responses to individual items and the responses to each other item in a domain. With information on the response characteristics of a large number of items covering a HRQoL domain (e.g. physical function, and psychological well-being), and information on the interrelationships between all pairs of these items and the total scale, we can construct more efficient scales. Item banks consist of large sets of questions representing various levels of a HRQoL domain that can be used to develop brief, efficient scales for measuring the domain. CAT is the application of IRT and item banks to the tailored assessment of HRQoL domains specific to individual patients. Given the results of IRT analyses and computer-assisted test administration, more efficient and brief scales can be used to measure multiple domains of HRQoL for clinical trials and longitudinal observational studies.
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            Defining patient centricity with patients for patients and caregivers: a collaborative endeavour

            Guy Yeoman, Patricia Furlong, Michael Seres … (2017)
            Background Patient engagement is an essential aspect in the research/development of biopharmaceutical products and disease management. Improving the lives of patients requires a deep understanding of their medical conditions, experiences, needs and priorities. However, a consistent definition of patient centricity is lacking. A series of initiatives was conducted to define patient centricity and its important principles impacting the biopharmaceutical industry. Methods Interviews, questionnaires and literature reviews were conducted involving key stakeholders to initially identify issues of importance to patients, healthcare providers and payers. Subsequently, two identical workshops which included 22 patients/carers created a definition of patient centricity and the healthcare values important to patients/caregivers. Outputs were tested in a validation exercise involving patients in predominantly US (n=470) and European (n=703) patient forums. Results Initial research provided deeper understanding of patient needs and key topics of interest that were used to cocreate a definition of patient centricity and 10 associated principles of importance to the biopharmaceutical industry. Wider testing of these outputs among predominantly US/European patient communities confirmed their validity. Patient centricity should be defined as ‘Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family’. Important principles for patients focused on education/information, cocreation, access and transparency. Conclusions The development of a consistent definition of patient centricity and its associated principles provides an opportunity for biopharmaceutical companies to adopt and use these as a reference point for consistent patient engagement throughout the product life cycle.
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              Applications of computerized adaptive testing (CAT) to the assessment of headache impact.

              John E Ware, Mark Kosinski, Jakob Bjorner … (2003)
              To evaluate the feasibility of computerized adaptive testing (CAT) and the reliability and validity of CAT-based estimates of headache impact scores in comparison with 'static' surveys. Responses to the 54-item Headache Impact Test (HIT) were re-analyzed for recent headache sufferers (n = 1016) who completed telephone interviews during the National Survey of Headache Impact (NSHI). Item response theory (IRT) calibrations and the computerized dynamic health assessment (DYNHA) software were used to simulate CAT assessments by selecting the most informative items for each person and estimating impact scores according to pre-set precision standards (CAT-HIT). Results were compared with IRT estimates based on all items (total-HIT), computerized 6-item dynamic estimates (CAT-HIT-6), and a developmental version of a 'static' 6-item form (HIT-6-D). Analyses focused on: respondent burden (survey length and administration time), score distributions ('ceiling' and 'floor' effects), reliability and standard errors, and clinical validity (diagnosis, level of severity). A random sample (n = 245) was re-assessed to test responsiveness. A second study (n = 1103) compared actual CAT surveys and an improved 'static' HIT-6 among current headache sufferers sampled on the Internet. Respondents completed measures from the first study and the generic SF-8 Health Survey; some (n = 540) were re-tested on the Internet after 2 weeks. In the first study, simulated CAT-HIT and total-HIT scores were highly correlated (r = 0.92) without 'ceiling' or 'floor' effects and with a substantial reduction (90.8%) in respondent burden. Six of the 54 items accounted for the great majority of item administrations (3603/5028, 77.6%). CAT-HIT reliability estimates were very high (0.975-0.992) in the range where 95% of respondents scored, and relative validity (RV) coefficients were high for diagnosis (RV = 0.87) and severity (RV = 0.89); patient-level classifications were accurate 91.3% for a diagnosis of migraine. For all three criteria of change, CAT-HIT scores were more responsive than all other measures. In the second study, estimates of respondent burden, item usage, reliability and clinical validity were replicated. The test-retest reliability of CAT-HIT was 0.79 and alternate forms coefficients ranged from 0.85 to 0.91. All correlations with the generic SF-8 were negative. CAT-based administrations of headache impact items achieved very large reductions in respondent burden without compromising validity for purposes of patient screening or monitoring changes in headache impact over time. IRT models and CAT-based dynamic health assessments warrant testing among patients with other conditions.
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                Author and article information

                Contributors
                Adam B. Smith
                Journal
                Journal ID (nlm-ta): Contemp Clin Trials Commun
                Journal ID (iso-abbrev): Contemp Clin Trials Commun
                Title: Contemporary Clinical Trials Communications
                Publisher: Elsevier
                ISSN (Electronic): 2451-8654
                Publication date PMC-release: 17 November 2018
                Publication date Collection: March 2019
                Publication date (Electronic): 17 November 2018
                Volume: 13
                Page: 005
                Affiliations
                [1]York Health Economics Consortium, Enterprise House, University of York, Hesling, York, YO105NQ, UK
                Author notes
                [∗ ]Corresponding author. adam.smith@ 123456york.ac.uk
                Article
                Publisher ID: S2451-8654(18)30115-7 Publisher ID: 100306
                DOI: 10.1016/j.conctc.2018.11.005
                PMC ID: 6299156
                PubMed ID: 30582066
                SO-VID: 0a37ddd1-2d2a-4f50-8595-e528ea00ba88
                Copyright © © 2018 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 8 August 2018
                Date revision received : 7 November 2018
                Date accepted : 9 November 2018
                Categories
                Subject: Article

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