Dennis Revicki

University of Florida, Gainesville, Florida, United States

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Publications (169)813.24 Total impact

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    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.
    Osteoporosis International 07/2015; DOI:10.1007/s00198-015-3215-x · 4.17 Impact Factor
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    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.
    PharmacoEconomics 05/2015; DOI:10.1007/s40273-015-0292-9 · 3.34 Impact Factor
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    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).
    European journal of pain (London, England) 05/2015; DOI:10.1002/ejp.727 · 3.22 Impact Factor
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    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.
    2014 ACR/ARHP Annual Meeting; 11/2014
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    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.
    2014 ACR/ARHP Annual Meeting; 11/2014
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    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).
    Annual European Congress of Rheumatology EULAR 2014; 06/2014
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    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).
    Annual European Congress of Rheumatology EULAR 2014; 06/2014
  • D. Revicki · W. Chen · E. Morgan-DeWitt · C. Nowinski · D. Cella
    Journal of Pain 04/2014; 15(4):S4. DOI:10.1016/j.jpain.2014.01.018 · 4.22 Impact Factor
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    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.
    Arthritis and Rheumatology 03/2014; 66(S11). DOI:10.1002/art.38590
  • D. Revicki · M. A. Cifaldi · S. Safikhani · N. Chen · A. Ganguli
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    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.
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A867-A867. DOI:10.1136/annrheumdis-2013-eular.2588 · 10.38 Impact Factor
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    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.
    Health and Quality of Life Outcomes 12/2013; 11(1):210. DOI:10.1186/1477-7525-11-210 · 2.10 Impact Factor
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    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.
    Pain 08/2013; 154(12). DOI:10.1016/j.pain.2013.08.024 · 5.84 Impact Factor
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    ABSTRACT: To systematically evaluate available health-related quality of life (HRQL) instruments for use in patients with heart failure (HF). Seven HF-specific HRQL questionnaires and associated studies of their metric properties were identified by systematic review: the Chronic Heart Failure Assessment Tool, the Cardiac Health Profile congestive heart failure, the Chronic Heart Failure Questionnaire (CHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Left Ventricular Disease Questionnaire (LVDQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Quality of Life in Severe Heart Failure Questionnaire. Each instrument was assessed by four experts using a standardized tool for evaluating patient-reported outcomes (EMPRO; scores from 0 to 100). Four questionnaires were given adequate scores (median >50) for the attribute "conceptual model." The LVDQ had the highest rated median for "reliability" (72.8). The CHFQ, the KCCQ, and the MLHFQ all got reasonable scores for "validity" (from 54.4 to 76.4). The reviewers rated the KCCQ the highest in terms of "sensitivity to change" (median 94.4). Only the CHFQ (50.0) and the KCCQ (72.2) received adequate scores for the "interpretability" attribute. The most highly rated instruments based on the overall EMPRO score were the KCCQ (64.4) and the MLHFQ (60.7), followed by the CHFQ (59.2). Based on the first systematic and reliable expert-based evaluation of available HF-specific HRQL questionnaires, the evidence seems to support the choice of the KCCQ, the MLHFQ, and the CHFQ over the others, which require further research on metric properties.
    Heart Failure Reviews 05/2013; 19(3). DOI:10.1007/s10741-013-9394-7 · 3.99 Impact Factor
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    ABSTRACT: OBJECTIVES: We aimed to examine the relationships between asthma control, daytime sleepiness, and asthma-specific health-related quality of life (HRQOL) among children with asthma. Path analyses were conducted to test if daytime sleepiness can mediate the effect of asthma control status on asthma-specific HRQOL. METHODS: 160 dyads (pairs) of asthmatic children and their parents were collected for analyses. The Asthma Control and Communication Instrument (ACCI) was used to categorize adequate and poor asthma control status. The Cleveland Adolescent Sleepiness Questionnaire (CASQ) was used to measure children's daytime sleepiness, including sleep in school, awake in school, sleep in evening, and sleep during transport. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale was used to measure asthma-specific HRQOL. RESULTS: Poorly controlled asthma was associated with daytime sleepiness and impaired asthma-specific HRQOL. Asthma control status was directly associated with asthma-specific HRQOL (P<.05), whereas sleep in school and sleep in evening domains of daytime sleepiness significantly mediated the relationship between poor asthma control and impaired HRQOL (P<.01). CONCLUSIONS: Asthma control status was associated with pediatric asthma-specific HRQOL, and the association was significantly mediated by daytime sleepiness. Healthcare providers need to address pediatric sleep needs related to poor asthma control to reduce the negative impact on HRQOL.
    Sleep Medicine 05/2013; 14(7). DOI:10.1016/j.sleep.2013.04.002 · 3.10 Impact Factor
  • Donald W Robinson · Ning Zhao · Fitzroy Dawkins · Ming Qi · Dennis Revicki
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    ABSTRACT: PURPOSE: To compare pain assessment questionnaires commonly used in advanced prostate cancer trials and to determine the psychometric characteristics and longitudinal relationships by contrasting questionnaire data from two international phase 2 trials. METHODS: Scores from the Present Pain Intensity (PPI) question of the McGill Pain Questionnaire, the pain intensity scale of the Brief Pain Inventory (BPI), and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) were analyzed using Pearson correlation, intraclass correlation coefficient, and Cronbach's α, respectively. Concordance was evaluated with Cohen's kappa coefficient and McNemar test at baseline (n = 224) and two subsequent observations. RESULTS: PPI and FACT-P scores were associated with the BPI score at baseline for Trials 1 and 2: PPI r = 0.66 and 0.80, respectively (P < 0.001); FACT-P (pain scale) r = -0.76 and -0.82, respectively (P < 0.001). However, concordance analysis revealed that the BPI identified pain (score > 0) at higher rates than the PPI: at baseline, BPI: 89 % (64/72) and 77 % (95/124), PPI: 68 % (49/72) and 64 % (79/124) [Trials 1 and 2, respectively; McNemar test (P < 0.001) for both studies]. The FACT-P pain scale identified pain similarly to the BPI pain intensity scale; longitudinal analysis produced comparable findings. All pain scales met standard psychometric acceptability criteria, but the BPI and FACT-P performed better than the PPI. CONCLUSIONS: Data suggest the BPI pain intensity and FACT-P pain scales are better than the PPI question at capturing the pain experience among patients with advanced prostate cancer. Additional comparative research is needed in larger population samples.
    Quality of Life Research 04/2013; 22(10). DOI:10.1007/s11136-013-0411-z · 2.86 Impact Factor
  • Arthritis Rheum; 01/2013
  •  Revicki D. · Cifaldi M · Safikhani S · Chen · Ganguli A
    ISOQOL 20th Annual Conference, Maimi, Florida; 01/2013
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    ABSTRACT: Purpose To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs. Methods A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance. Results Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either ‘essential’ or ‘desirable’ when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors. Conclusions ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.
    Quality of Life Research 09/2012; 22(6). DOI:10.1007/s11136-012-0252-1 · 2.86 Impact Factor
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    ABSTRACT: Background Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design. Methods A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest. Results This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations. Conclusions This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to ensure that CHC clinical trials evaluate concepts that are important to patients and include measures that have evidence supporting content validity, reliability, construct validity, and responsiveness.
    Health and Quality of Life Outcomes 08/2012; 10(1):92. DOI:10.1186/1477-7525-10-92 · 2.10 Impact Factor
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    ABSTRACT: Children with life-threatening illnesses have unique physical and psychosocial needs that pediatric palliative care programs can address. Integrated programs strive to address these needs from the point of diagnosis through death, if needed, at the same time that curative care is provided. To better understand the variation in these needs, we assessed the health status and health-related quality of life (HRQOL) of children enrolled in an integrated pediatric palliative care program. A telephone survey was conducted with 98 parents whose children were enrolled in an integrated pediatric palliative care program in Florida. The Health Utilities Index (HUI) system was used to assess health status and HRQOL. HUI2 attribute levels show that children have the greatest impairment with moderate-to-severe burdens related to self-care, mobility, and sensation, and the least impairment with emotion. HUI3 attribute levels show that children have the greatest impairment with moderate-to-severe burdens related to ambulation and cognition and the least impairment with hearing and emotional functioning. Mean overall HUI2 and HUI3 utility scores are 0.37 and 0.15, respectively. Children with life-threatening illnesses in our sample had a high level of morbidity compared with those found in other HUI studies of children with acute or chronic health conditions. Not only do our results highlight severely impaired HRQOL, they also demonstrate the wide variety of health states and needs for children in integrated palliative care programs. This information can help develop strategies to encourage more providers to participate in integrated pediatric palliative care programs.
    Journal of palliative medicine 06/2012; 15(7):790-7. DOI:10.1089/jpm.2011.0504 · 2.06 Impact Factor

Publication Stats

8k Citations
813.24 Total Impact Points

Institutions

  • 2014
    • University of Florida
      Gainesville, Florida, United States
    • Evidera
      Maryland, United States
  • 2007–2013
    • United BioSource Corporation
      Maryland, United States
  • 2011
    • Georgetown University
      • Department of Psychiatry
      Washington, Washington, D.C., United States
  • 2005
    • Mayo Clinic - Rochester
      Рочестер, Minnesota, United States
  • 2002
    • University of Washington Seattle
      Seattle, Washington, United States
    • Johns Hopkins University
      • Department of International Health
      Baltimore, MD, United States
  • 1999–2000
    • West Virginia University
      • Department of Clinical Pharmacy
      Morgantown, WV, United States
  • 1998
    • University of North Carolina at Chapel Hill
      North Carolina, United States
    • University of Maryland, Baltimore
      • Department of Medicine
      Baltimore, Maryland, United States
  • 1996–1997
    • Eli Lilly
      • Lilly Research Laboratories
      Indianapolis, Indiana, United States
  • 1994
    • Battelle Memorial Institute
      Columbus, Ohio, United States