Dennis Revicki

Evidera, Maryland, United States

Are you Dennis Revicki?

Claim your profile

Publications (177)778.52 Total impact

  • [Show abstract] [Hide abstract] ABSTRACT: Objective: The objective was to evaluate the psychometric properties of the Rheumatoid Arthritis-Work Instability Scale (RA-WIS) in a clinical trial setting. Methods: Secondary analyses were conducted using data from a 56-week, randomized controlled trial of patients with early rheumatoid arthritis (RA). Patient-reported outcome measures included the RA-WIS, the Health Assessment Questionnaire (HAQ), the Rheumatoid Arthritis Quality of Life Questionnaire, and the Global Assessment of Disease Activity and Pain, data for which were collected at baseline and at weeks 12, 16, 24, and 56. Data were analyzed for reliability, validity, and responsiveness. Results: Among 148 patients whose data were analyzed, more than half were women (56.1%) with a mean age of 46.8 years. On average, patients experienced RA symptoms for 8.7 months; the mean 28-Joint Disease Activity Score (DAS28) was 5.9, and the mean HAQ - Disability Index was 1.3. The RA-WIS demonstrated excellent internal consistency and test-retest reliability (α = 0.89 and intraclass correlation coefficient = 0.91, respectively). At baseline and week 24, moderate to strong correlations were seen between RA-WIS total scores and the HAQ, the Global Assessment of Disease Activity, and the Pain Rheumatoid Arthritis Quality of Life Questionnaire, ranging from 0.47 to 0.81 (all P < 0.0001). Mean RA-WIS total scores and work disability risk levels discriminated between clinical severity scores on the DAS28, the HAQ - Disability Index, and the Physician Global Assessment of Disease Activity (all P < 0.05). Mean baseline to week 24 RA-WIS total change scores were significantly different among American College of Rheumatology responder groups (P ≤ 0.0001) and between DAS28 remission status groups (P < 0.001). Conclusions: These findings provide evidence supporting the reliability, validity, and responsiveness of the RA-WIS for evaluating work disability in patients with RA in a clinical trial setting. © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
    No preview · Article · Nov 2015 · Value in Health
  • No preview · Article · Oct 2015 · Quality of Life Research
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: The Dutch-Flemish PROMIS Group translated the adult PROMIS Pain Interference item bank into Dutch-Flemish. The aims of the current study were to calibrate the parameters of these items using an item response theory (IRT) model, to evaluate the cross-cultural validity of the Dutch-Flemish translations compared to the original English items, and to evaluate their reliability and construct validity. The 40 items in the bank were completed by 1085 Dutch chronic pain patients. Before calibrating the items, IRT model assumptions were evaluated using confirmatory factor analysis (CFA). Items were calibrated using the graded response model (GRM), an IRT model appropriate for items with more than two response options. To evaluate cross-cultural validity, differential item functioning (DIF) for language (Dutch vs. English) was examined. Reliability was evaluated based on standard errors and Cronbach's alpha. To evaluate construct validity correlations with scores on legacy instruments (e.g., the Disabilities of the Arm, Shoulder and Hand Questionnaire) were calculated. Unidimensionality of the Dutch-Flemish PROMIS Pain Interference item bank was supported by CFA tests of model fit (CFI = 0.986, TLI = 0.986). Furthermore, the data fit the GRM and showed good coverage across the pain interference continuum (threshold-parameters range: -3.04 to 3.44). The Dutch-Flemish PROMIS Pain Interference item bank has good cross-cultural validity (only two out of 40 items showing DIF), good reliability (Cronbach's alpha = 0.98), and good construct validity (Pearson correlations between 0.62 and 0.75). A computer adaptive test (CAT) and Dutch-Flemish PROMIS short forms of the Dutch-Flemish PROMIS Pain Interference item bank can now be developed.
    Full-text · Article · Jul 2015 · PLoS ONE
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: Two comorbidity indices were adapted for use in the FREEDOM trial and significantly correlated with the number of medications and impaired health status at baseline. The indices have applications for the analysis of clinical trial data and would allow for the appropriate adjustment of comorbidities when evaluating clinical trial outcomes. The purpose of this study is to adapt two published comorbidity indices for use with the FREEDOM clinical trial evaluating postmenopausal women with osteoporosis. FREEDOM enrolled women aged 60-90 years with a bone mineral density T-score <-2.5 at the lumbar spine or total hip and ≥-4.0 at both sites. Comorbidity indices were calculated using methods described by Sangha (Arthritis Rheum 49:156-163, 2003) and Wolfe (J Rheumatol 37:305-315, 2010) following modification. The adapted Sangha index included 12 conditions with a summary score of 0-12; the adapted Wolfe index included 7 conditions with a weighted summary score of 0-8. Higher scores indicated greater comorbidity. A panel of clinicians independently reviewed subjects' medical histories using a systematic process based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms to map specified comorbid conditions. Spearman correlations between the adapted indices and baseline subject characteristics expected to be associated with comorbidities were examined. Of the 7808 subjects in this study, 74 % had ≥1 comorbidities based on the adapted Sangha or Wolfe comorbidity indices. The mean (SD) adapted Sangha and Wolfe comorbidity indices were 1.4 (1.2) and 1.4 (1.3), respectively. Both indices correlated positively with age, body mass index, and the number of medications (r = 0.54 to 0.55) at baseline and inversely correlated with health-related quality of life (r = -0.22 to -0.30) (all P < 0.0001). Further, when either the adapted Sangha or Wolfe index was included as a covariate for assessing mortality over 36 months in the FREEDOM population, the hazard ratio of the comorbidity index indicated that the mortality risk increased by 27 or 28 %, respectively, for each unit increase in the adapted index (both P < 0.0001). Our work suggests these comorbidity indices may be adapted for use with clinical trial data, thereby allowing for the appropriate adjustment and reporting of covariates in the evaluation of clinical trial outcomes in an osteoporotic population.
    Preview · Article · Jul 2015 · Osteoporosis International
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: Multi-attribute utility-based instruments (MAUIs) assess health status and provide an index score on the full health-dead scale, and are widely used to support reimbursement decisions for new healthcare interventions worldwide. A valuation study is a key part of the development of MAUIs, with the primary goal of developing a scoring algorithm through eliciting societal preferences. We developed the 21-item Checklist for REporting VAluaTion StudiEs (CREATE) by following a modified two-round Delphi panel approach plus an email survey. CREATE is intended to promote good reporting practice as well as guiding developers to thoroughly and carefully think through key methodological elements in designing valuation studies. Electronic supplementary material The online version of this article (doi:10.1007/s40273-015-0292-9) contains supplementary material, which is available to authorized users.
    Full-text · Article · May 2015 · PharmacoEconomics
  • [Show abstract] [Hide abstract] ABSTRACT: Background The aims of the current study were to calibrate the item parameters of the Dutch-Flemish PROMIS Pain Behavior item bank using a sample of Dutch patients with chronic pain and to evaluate cross-cultural validity between the Dutch-Flemish and the US PROMIS Pain Behavior item banks. Furthermore, reliability and construct validity of the Dutch-Flemish PROMIS Pain Behavior item bank were evaluated.Methods The 39 items in the bank were completed by 1042 Dutch patients with chronic pain. To evaluate unidimensionality, a one-factor confirmatory factor analysis (CFA) was performed. A graded response model (GRM) was used to calibrate the items. To evaluate cross-cultural validity, Differential item functioning (DIF) for language (Dutch vs. English) was evaluated. Reliability of the item bank was also examined and construct validity was studied using several legacy instruments, e.g. the Roland Morris Disability Questionnaire.ResultsCFA supported the unidimensionality of the Dutch-Flemish PROMIS Pain Behavior item bank (CFI = 0.960, TLI = 0.958), the data also fit the GRM, and demonstrated good coverage across the pain behavior construct (threshold parameters range: −3.42 to 3.54). Analysis showed good cross-cultural validity (only six DIF items), reliability (Cronbach's α = 0.95) and construct validity (all correlations ≥0.53).Conclusions The Dutch-Flemish PROMIS Pain Behavior item bank was found to have good cross-cultural validity, reliability and construct validity. The development of the Dutch-Flemish PROMIS Pain Behavior item bank will serve as the basis for Dutch-Flemish PROMIS short forms and computer adaptive testing (CAT).
    No preview · Article · May 2015 · European journal of pain (London, England)
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: Background/Purpose: In the assessment of chronic pain patients it is important to measure physical functioning. The National Institutes of Health’s Patient-Reported Outcomes Measurement Information System (PROMIS) initiative developed an item bank for measuring physical functioning. This PROMIS physical functioning item bank was translated into Dutch-Flemish language according to the FACIT methodology. The aim of current study was to validate the Dutch-Flemish translation of the PROMIS physical functioning item bank (DF-PROMIS-PF) in patients with chronic pain. Methods: A paper-and-pencil or web-based survey including the full DF-PROMIS-PF (121 items), was completed by 857 chronic pain patients (77% female, mean age 49y) satisfying the ACR classification criteria of chronic pain and referred to an outpatient secondary care center for rheumatology and rehabilitation in the Netherlands. One-dimensionality was evaluated by one-factor confirmatory factor analysis. With the future strategy to develop computer adaptive tests (CAT), item response theory (IRT) models were used to evaluate the item characteristics of the two item banks. A graded item response model (GRM) was fitted and Differential Item Functioning (DIF) was evaluated for e.g. language (Dutch vs. English), by ordinal regression models. Furthermore, construct validity was studied. Results: Through computer technical limitation, the item bank was separated during statistical analysis into DF-PROMIS-PFA (50 PFA-items) and DF-PROMIS-PFBC (45 PFB- and 26 PFC-items). These interim analysis showed that the DF-PROMIS-PFA and DF-PROMIS-PFBC demonstrated good fit to a one-dimensional model (both CFI=0.976 and TLI=0.975). The first factor accounted for 57% of the questionnaire variance. The results showed acceptable test information (SE<0.3) for theta between -2.3 and 3.8 for DF-PROMIS-PFA and between -1.6 and 4 for DF-PROMIS-PFBC. The items demonstrated no DIF with respect to survey version. DIF was present with respect to gender (2 items), age (4 items) and language (11 items). However, the impact of DIF on the total item scores was minimal. The analyses of the full DF-PROMIS-PF are in progress and will be presented at the ACR conference. Conclusion: The first results indicate that the DF-PROMIS-PF fits a GRM and demonstrates good coverage across the range of the physical functioning domain. Nearly all Dutch item parameters match the American item parameters and likely Dutch-specific item calibrations are not needed. The DF-PROMIS-PF can be used to develop a CAT.
    Full-text · Conference Paper · Nov 2014
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: Background/Purpose: In the assessment of chronic pain patients it is important to measure pain behavior and pain interference. The National Institutes of Health’s Patient-Reported Outcomes Measurement Information System (PROMIS) initiative developed item banks for measuring pain behavior and pain interference. These PROMIS item banks were translated into Dutch-Flemish language according to the FACIT methodology. The aim of current study was to validate the Dutch-Flemish translation of the PROMIS pain behavior item bank (DF-PROMIS-PB) and the Dutch-Flemish PROMIS pain interference item bank (DF-PROMIS-PI) in patients with chronic pain. Methods: A paper-and-pencil or web-based survey, including the full DF-PROMIS-PB (39 items, 6-point Likert scale) and DF-PROMIS-PI (41 items, 5-point Likert scale), was completed by 1042 chronic pain patients satisfying the ACR classification criteria of chronic pain and referred to an outpatient secondary care center for rheumatology and rehabilitation in the Netherlands. One-dimensionality was evaluated by one-factor confirmatory factor analysis. With the future strategy to develop computer adaptive tests (CAT), item response theory (IRT) models were used to evaluate the item characteristics of the two item banks. A graded item response model (GRM) was fitted and Differential Item Functioning (DIF) was evaluated for e.g. language (Dutch vs. English), by ordinal regression models. Furthermore, construct validity was studied. Results: DF-PROMIS-PB and DF-PROMIS-PI demonstrated good fit to a one-dimensional model (CFI=0.960; 0.988 resp. and TLI=0.958; 0.987 resp). The first factor accounted for 42% (DF-PROMIS-PB) and 66% (DF-PROMIS-PI) of the questionnaire variance. The results showed acceptable testinformation (SE<0.3) for theta between -1.9 and 3.6 for DF-PROMIS-PB and between -3.3 and 2.8 for DF-PROMIS-PI. 14 out of 741 (1.9%) DF-PROMIS-PB item pairs and 62 out of 820 (7.6%) DF-PROMIS-PI item pairs were marked as possibly locally dependent. The items demonstrated no DIF with respect to age, gender, and survey version. DIF with respect to language was present for 6 DF-PROMIS-PB items and 2 DF-PROMIS-PI items. However, the impact of DIF on the total item scores was minimal. Conclusion: The DF-PROMIS-PB and the DF-PROMIS-PI fit a GRM and demonstrate good coverage across the range of the pain behavior and pain interference domain. Nearly all Dutch item parameters match the American item parameters and likely Dutch-specific item calibrations are not needed. The DF-PROMIS-PB and DF-PROMIS-PI can be used to develop a CAT.
    Full-text · Conference Paper · Nov 2014
  • No preview · Article · Oct 2014 · Quality of Life Research
  • No preview · Article · Oct 2014 · Quality of Life Research
  • [Show abstract] [Hide abstract] ABSTRACT: Background: In the assessment of chronic pain patients it is important to measure physical functioning. The National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS) initiative developed an item bank for measuring physical functioning. This PROMIS physical functioning item bank was translated into Dutch-Flemish language according to the FACIT methodology1. Objectives: The aim of current study was to validate the Dutch-Flemish translation of the PROMIS physical functioning item bank (DF-PROMIS-PF) in patients with chronic pain. Methods: A paper-and-pencil or web-based survey including the full DF-PROMIS-PF (124 items), was completed by 857 chronic pain patients (77% female, mean age 49y) referred to an outpatient secondary care center for rheumatology and rehabilitation in the Netherlands. One-dimensionality was evaluated by one-factor confirmatory factor analysis. With the future strategy to develop computer adaptive tests (CAT), item response theory (IRT) models were used to evaluate the item characteristics of the two item banks. A graded item response model (GRM) was fitted and Differential Item Functioning (DIF) was evaluated for e.g. language (Dutch vs. English), by ordinal regression models. Furthermore, construct validity was studied. Results: Through computer technical limitation, the item bank was separated during statistical analysis into DF-PROMIS-PFA (51 PFA-items) and DF-PROMIS-PFBC (45 PFB- and 28 PFC-items). These interim analysis showed that the DF-PROMIS-PFA and DF-PROMIS-PFBC demonstrated good fit to a one-dimensional model (both CFI=0.976 and TLI=0.975). The first factor accounted for 57% of the questionnaire variance. The results showed acceptable testinformation (SE<0.3) for theta between -2.3 and 3.8 for DF-PROMIS-PFA and between -1.6 and 4 for DF-PROMIS-PFBC. 103 out of 1275 (8%) DF-PROMIS-PFA item pairs and 130 out of 1431 (9%) DF-PROMIS-PFBC item pairs were marked as possibly locally dependent. The items demonstrated no DIF with respect to survey version. DIF was present with respect to gender (2 items), age (4 items) and language (11 items). However, the impact of DIF on the total item scores was minimal. Conclusions: The first results indicate that the DF-PROMIS-PF fits a GRM and demonstrates good coverage across the range of the physical functioning domain. Nearly all Dutch item parameters match the American item parameters and likely Dutch-specific item calibrations are not needed. The DF-PROMIS-PF can be used to develop a CAT. References: Terwee CB, Roorda LD, de Vet HCW, Dekker J, Westhovens R, van Leeuwen J, Cella D, Correia H, Arnold B, Perez B, Boers M. Dutch-Flemish translation of 17 item banks from the Patient Reported Outcomes Measurement Information System (PROMIS).
    No preview · Conference Paper · Jun 2014
  • [Show abstract] [Hide abstract] ABSTRACT: Background: In the assessment of chronic pain patients it is important to measure pain behavior and pain interference. The National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS) initiative developed item banks for measuring pain behavior and pain interference. These PROMIS item banks were translated into Dutch-Flemish language according to the FACIT methodology1. Objectives: The aim of current study was to validate the Dutch-Flemish translation of the PROMIS pain behavior item bank (DF-PROMIS-PB) and the Dutch-Flemish PROMIS pain interference item bank (DF-PROMIS-PI) in patients with chronic pain. Methods: A paper-and-pencil or web-based survey, including the full DF-PROMIS-PB (39 items, 6-point Likert scale) and DF-PROMIS-PI (41 items, 5-point Likert scale), was completed by 1046 chronic pain patients referred to an outpatient secondary care center for rheumatology and rehabilitation in the Netherlands. One-dimensionality was evaluated by one-factor confirmatory factor analysis. With the future strategy to develop computer adaptive tests (CAT), item response theory (IRT) models were used to evaluate the item characteristics of the two item banks. A graded item response model (GRM) was fitted and Differential Item Functioning (DIF) was evaluated for e.g. language (Dutch vs. English), by ordinal regression models. Furthermore, construct validity was studied. Results: DF-PROMIS-PB and DF-PROMIS-PI demonstrated good fit to a one-dimensional model (CFI=0.963; 0.988 resp. and TLI=0.961; 0.987 resp). The first factor accounted for 42% (DF-PROMIS-PB) and 66% (DF-PROMIS-PI) of the questionnaire variance. The results showed acceptable testinformation (SE<0.3) for theta between -1.9 and 3.6 for DF-PROMIS-PB and between -3.3 and 2.8 for DF-PROMIS-PI. 23 out of 741 (3%) DF-PROMIS-PB item pairs and 62 out of 820 (7.6%) DF-PROMIS-PI item pairs were marked as possibly locally dependent. The items demonstrated no DIF with respect to age, gender, and survey version. DIF with respect to language was present for 6 DF-PROMIS-PB items and 2 DF-PROMIS-PI items. However, the impact of DIF on the total item scores was minimal. Conclusions: The DF-PROMIS-PB and the DF-PROMIS-PI fit a GRM and demonstrate good coverage across the range of the pain behavior and pain interference domain. Nearly all Dutch item parameters match the American item parameters and likely Dutch-specific item calibrations are not needed. The DF-PROMIS-PB and DF-PROMIS-PI can be used to develop a CAT. References: Terwee CB, Roorda LD, de Vet HCW, Dekker J, Westhovens R, van Leeuwen J, Cella D, Correia H, Arnold B, Perez B, Boers M. Dutch-Flemish translation of 17 item banks from the Patient Reported Outcomes Measurement Information System (PROMIS).
    No preview · Conference Paper · Jun 2014
  • No preview · Article · Apr 2014 · Journal of Pain
  • [Show abstract] [Hide abstract] ABSTRACT: Background/Purpose:The NIH Patient Reported Outcomes Measurement Information System (PROMIS) has created publicly available patient reported outcomes measures in several domains of physical, social and emotional health. Measurement of pediatric pain in PROMIS is currently limited to pain interference. Pain behaviors are observable actions orreactions that communicate pain including verbal, nonverbal and pain reducing behaviors. Numerous validated parent/provider-rating scales of pain behavior in children exist but there are currently no validated self-report measures of pain behavior in school-age children and adolescents. Such measures could be useful in establishing targets for treatment and assessing outcomes. The aim of this study is to enhance PROMIS pediatric pain assessment by developing and testing pediatric pain behavior item banks for self- and proxy-report.Methods:Candidate items were developed through a qualitative item review process, and were in the format, “In the past 7 days, when I was in pain …” Patients ages 8 to 17 years, or parents/guardians of children, with a chronic painful condition (fibromyalgia, juvenile idiopathic arthritis, sickle cell disease) were recruited through outpatient clinics at 3 centers. Child participants completed approximately 100 PROMIS items concerning their pain (including 47 candidate pain behavior items), physical function, fatigue, and psychosocial well/being. Proxies responded to sociodemographic and health history items and 51 new candidate proxy-report pain behavior items were collected. A confirmatory factor analysis (CFA) was performed on the child and guardian pain behavior data, with model fit assessed by the comparative fit index (CFI) and root mean square error of approximation (RMSEA). Item response theory (IRT) analysis was performed on the pain behavior items based on the graded response model. Differential item functioning (DIF) was assessed by age group and disease group.Results:450 children (71% female, Mage 13.54), and 232 proxies participated. CFA indicated unidimensionality in the child (CFI = 0.962; RMSEA = 0.079) and proxy pain behavior responses (CFI = 0.970; RMSEA = 0.080). The responses for the child and proxy data had good IRT model fit and were free of local dependence. Slopes for the pediatric responses ranged from 1.81 (“rubbed body where hurt”) to 4.40 (“moved slower”), and thresholds ranged from −2.00 to 4.95. For the proxy data, slopes ranged from 1.51 (“think of something fun”) to 3.48 (“tried not to move”), and thresholds ranged from −3.02 to 2.43. Items performed well across disease groups and age. There was little DIF either by age group (8–12, 13–18) or by sample (child vs. proxy). Child and proxy scores were correlated at 0.70. Correlations between pain behavior and pain intensity were 0.60 in children and 0.65 in proxy sample.Conclusion:The PROMIS pediatric pain behavior item-banks for self and proxy report are suitable for use in non-adaptive format as short forms or in dynamic format as computerized adaptive tests in clinical research with the potential for adoption into clinical care.
    No preview · Article · Mar 2014 · Arthritis and Rheumatology
  • D. Revicki · M. A. Cifaldi · S. Safikhani · N. Chen · A. Ganguli
    [Show abstract] [Hide abstract] ABSTRACT: Background Within 2 to 3 years of disease, approximately 20 to 30% of patients with early rheumatoid arthritis (RA) become permanently work disabled (Allaire, 2008). Disability-associated ‘work instability’ defined as the mismatch between their functional capabilities and job demands, is a risk factor for loss of employment. The RA-WIS was developed to assess the level of risk for work disability in RA patients; however there is limited information on its responsiveness and minimal important difference (MID). Objectives The objective of this study was to evaluate the responsiveness and MID of the RA-WIS in patients with early RA. Methods A secondary analysis was conducted using data from PROWD study, a 56-week, randomized, and controlled trial of patients with early RA (Bejarano, 2008). Clinical measures included American College of Rheumatology (ACR) response and Disease Activity Score-28 (DAS28), and patient-reported outcomes included the RA-WIS and Health Assessment Questionnaire Disability Index (HAQ-DI), which were collected at Baseline and at Weeks 12, 16, 24 and 56. Responsiveness of the RA-WIS was evaluated at Weeks 24 and 56 based on DAS28 (<3.2 vs. >3.2) and ACR response criteria (<20% vs. 20% to <50%;) using analysis of covariance, adjusting for age, gender and baseline RA-WIS scores. MID estimates were derived from these analyses. Results A total of 148 patients were included in the analysis sample, and was 56% female, with a mean age of 46.8 years. Patients experienced RA symptoms for a mean 8.7 months with mean DAS scores of 5.9 and mean HAQ-DI scores of 1.3. Mean Baseline to Week 24 RA-WIS Total change scores were significantly different among ACR responder groups (P≤0.0001) and between DAS28 remission status groups (P<0.001). There was a -5.3 to -7.7 point RA-WIS score change associated with an improvement of 20% to <50% in ACR from baseline to 24 or 56 weeks. There was a -5.4 to -6.1 point RA-WIS point change associated with a moderate response for DAS28 at 24 or 56 weeks. Conclusions These findings provide evidence on the responsiveness of the RA-WIS for evaluating work disability in RA patients. The MID for the RA-WIS is estimated at 5 to 7 points. Disclosure of Interest D. Revicki Consultant for: AbbVie, M. Cifaldi Shareholder of: AbbVie, Employee of: AbbVie. The design, study conduct, and financial support for the study/trial was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract., S. Safikhani Consultant for: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie. The design, study conduct, and financial support for the study/trial was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract., A. Ganguli Shareholder of: AbbVie, Employee of: AbbVie. The design, study conduct, and financial support for the study/trial was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract.
    No preview · Article · Jan 2014 · Annals of the Rheumatic Diseases
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network. PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making. The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context. IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed.
    Full-text · Article · Dec 2013 · Health and Quality of Life Outcomes
  • Dennis Revicki · Mary A. Cifaldi · Shima Safikhani · Chen · Ganguli A
    No preview · Conference Paper · Oct 2013
  • No preview · Article · Oct 2013 · Quality of Life Research
  • No preview · Article · Oct 2013 · Quality of Life Research
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: Pain behaviors that are maintained beyond the acute stage post-injury can contribute to subsequent psychosocial and physical disability. Critical to the study of pain behaviors is the availability of psychometrically sound pain behavior measures. In this study we developed a self-report measure of pain behaviors, the Pain Behaviors Self Report (PaB-SR). PaB-SR scores were developed using item response theory and evaluated using a rigorous, multiple-witness approach to validity testing. Participants included: a) 661 survey participants with chronic pain and with multiple sclerosis (MS), back pain, or arthritis; b) 618 survey participants who were significant others of a chronic pain participant; and c) 86 participants in a videotaped pain behavior observation protocol. Scores on the PaB-SR were found to be measurement invariant with respect to clinical condition. PaB-SR scores, observer-reports, and the video-taped protocol yielded distinct, but convergent views of pain behavior, supporting the validity of the new measure. The PaB-SR is expected to be of substantial utility to researchers wishing to explore the relationship between pain behaviors and constructs such as pain intensity, pain interference, and disability.
    Full-text · Article · Aug 2013 · Pain

Publication Stats

9k Citations
778.52 Total Impact Points

Institutions

  • 2014
    • Evidera
      Maryland, United States
    • University of Florida
      Gainesville, Florida, United States
  • 2008
    • United BioSource Corporation
      Maryland, United States
  • 1998-2002
    • University of Washington Seattle
      Seattle, Washington, United States
  • 1999
    • West Virginia University
      • Department of Clinical Pharmacy
      Morgantown, WV, United States
  • 1996-1997
    • Eli Lilly
      • Lilly Research Laboratories
      Indianapolis, Indiana, United States