Dennis A Revicki

Evidera, Maryland, United States

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Publications (249)1049.77 Total impact

  • Raymond C Rosen, Dennis A Revicki, Michael Sand
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    ABSTRACT: This invited commentary responds to recent criticisms of two validated and widely used sexual function questionnaires, the Female Sexual Function Index (FSFI) and the International Index of Erectile Function (IIEF) (Forbes, Baillie, & Schniering, 2014 ). We take issue with the conceptual arguments presented, selective review of published literature on both instruments, and conclusions drawn from methodologically flawed findings from an Internet-based study in a nonrepresentative group of Australian men and women. Alternative perspectives on the IIEF and FSFI are presented.
    The Journal of Sex Research 07/2014; 51(5):492-7. · 2.53 Impact Factor
  • Journal of Pain 04/2014; 15(4):S4. · 3.24 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 & Rheumatology. 03/2014; 66(S11).
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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(R) 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. · 2.27 Impact Factor
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    ABSTRACT: To describe the psychometric properties and identify the minimally important difference (MID) of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument. Chronic HCV infection and associated treatments negatively affect PROs of function and well-being. In a phase 2 trial, HCV-infected patients received direct-acting antivirals (DAAs) for 12 weeks with peg-interferon/ribavirin (peg-IFN/RBV) for 48 weeks, or placebo plus peg-IFN/RBV. The HCV-PRO total score, SF-36 PCS and MCS scores, EQ-5D-3L, and EQ VAS were measured at baseline, week 8, end of DAA treatment (EODT), end of peg-IFN/RBV treatment (EOT), and posttreatment week 24 (SVR24). Convergent validity of the HCV-PRO was assessed by Pearson's correlation coefficients. Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores (none vs. some) and presence/absence of depression or fatigue adverse events. MID was identified through effect size (ES) and receiver-operating characteristic (ROC) curve analyses (HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds). In 74 patients (22 % female; 81 % White; 51 % ≥50 years), correlations (0.64-0.96) between HCV-PRO total scores, SF-36 PCS/MCS scores, and EQ VAS scores at all time points supported convergent validity. HCV-PRO total scores were reduced to 10-30 points in patients impaired by depression, pain, or fatigue symptoms. Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time (EODT -0.76; EOT -0.93). ES and ROC curve analyses indicated an MID of -10 points. The HCV-PRO was valid and responsive in the population studied. An MID of -10 points represented a threshold of clinical significance for the HCV-PRO.
    Quality of Life Research 09/2013; · 2.86 Impact Factor
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    ABSTRACT: Chronic hepatitis C virus (HCV) infection is an important public health issue owing to its worldwide prevalence and its profound effects on patients' well-being and function. We developed a new patient self-report tool, the HCV patient-reported outcomes (HCV-PRO) instrument, to assess patients' function and well-being reflecting both HCV disease and treatment burdens. Items were developed through a qualitative phase including scientific literature review, expert appraisal, and semi-structured patient interviews. The item pool was initially psychometrically tested in 60 adult HCV patients, 18 years of age or older at a university hepatology clinic. A final psychometric test was conducted in 241 members of the online Harris International Panel to examine scale reliability, confirm factor structure, and assess convergent and discriminant validity. A single-factor 16-item HCV-PRO instrument demonstrated good model fit. The HCV-PRO items and total score (range 0-100) showed excellent item response (few floor and ceiling effects) and reliability (alpha > 0.90). Convergent validity was established from moderate to high (r > 0.50) correlation with symptom burden, life satisfaction (ladder of life), and SF-36v2 scales scores. Mean HCV-PRO scores differentiated between currently treated patients, those previously treated, and patients never treated (p < 0.01), suggesting strong known-groups validity. The results provide initial evidence that the HCV-PRO can yield reliable and valid measurement of the effects of HCV and its treatment on the well-being and function of HCV-infected patients.
    Quality of Life Research 09/2013; · 2.86 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; · 5.64 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; · 4.45 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; · 3.49 Impact Factor
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    ABSTRACT: OBJECTIVE: To evaluate the psychometric properties of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and Visual Function Questionnaire Utility Index (VFQ-UI) in patients with non-infectious intermediate and posterior uveitis. METHODS: Secondary analysis of pooled data from a 26-week, multicenter, masked, randomized, sham-controlled Phase 3 clinical trial. Health-related quality of life was assessed using the NEI VFQ-25, the EQ-5D, and SF-36. Internal consistency reliability, reproducibility, convergent validity, and known groups of BCVA and vitreous haze severity were assessed. Clinically significant difference was assessed using anchor-based and distribution-based methods. RESULTS: The study included 224 subjects with non-infectious intermediate (80.4 %) or posterior uveitis (19.6 %). The NEI VFQ-25 and the VFQ-UI demonstrated good internal consistency (Cronbach's alpha 0.87-0.94) and test-retest reliability (ICCs 0.58-0.88). Spearman's product-moment rank correlations between the NEI VFQ-25 and VFQ-UI scores and the SF-6D, EQ-5D, and BCVA ranged from small to moderate. There was a significant association between visual functioning and known groups of visual acuity (p < 0.05). Clinical significance, using the anchor-based method (difference between visual acuity groups ≥10-<15 letter better and no change), was 10.2 for change from baseline to week 26 for the NEI VFQ-25 composite score and 0.05 for the VFQ-UI. Using the distribution-based method, the clinical significance was 3.86 for the composite score and 0.04 for the VFQ-UI. CONCLUSION: The NEI VFQ-25 and the VFQ-UI are reliable and valid measures of vision-related functioning and preference-based status in patients with non-infectious intermediate and posterior uveitis.
    Quality of Life Research 05/2013; · 2.86 Impact Factor
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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; · 2.86 Impact Factor
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    ABSTRACT: The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized controlled trials (RCTs); however, it lacks guidance on the reporting of patient-reported outcomes (PROs), which are often inadequately reported in trials, thus limiting the value of these data. In this article, we describe the development of the CONSORT PRO extension based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points. These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract, that a description of the hypothesis of the PROs and relevant domains be provided (ie, if a multidimensional PRO tool has been used), that evidence of the PRO instrument's validity and reliability be provided or cited, that the statistical approaches for dealing with missing data be explicitly stated, and that PRO-specific limitations of study findings and generalizability of results to other populations and clinical practice be discussed. Examples and an updated CONSORT flow diagram with PRO items are provided. It is recommended that the CONSORT PRO guidance supplement the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes. Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care.
    JAMA The Journal of the American Medical Association 02/2013; 309(8):814-22. · 29.98 Impact Factor
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    ABSTRACT: OBJECTIVE To compare vision-related functioning and health-related quality of life of patients with noninfectious intermediate or posterior uveitis with those of the US general population and normal-vision reference groups. METHODS Secondary analysis of health-related quality of life measures administered at baseline to patients with noninfectious intermediate or posterior uveitis participating in the HURON trial, a 26-week, multicenter, masked, randomized, sham-controlled trial of a dexamethasone intravitreal implant (n = 224) was performed. Patient-reported outcome measures included the National Eye Institute Visual Function Questionnaire-25, the 36-Item Short-Form Health Survey, the Short Form-6 Dimensions, and the EuroQol-5D. The National Eye Institute Visual Function Questionnaire-25 scores from the HURON uveitis population were compared with published National Eye Institute Visual Function Questionnaire-25 scores from a normal-vision reference group (n = 122). The 36-Item Short-Form Health Survey, Short Form-6 Dimensions, and EuroQol-5D scores were compared with the US general population using data from the National Health Measurement Study (n = 3844) and the Medical Expenditure Panel Survey (n = 955). RESULTS Compared with a normal-vision population, the HURON uveitis population had clinically significant impairments across all National Eye Institute Visual Function Questionnaire-25 subscales and the composite score, with all subscale score differences exceeding 10 points (P < .001). The HURON uveitis population had significantly lower 36-Item Short-Form Health Survey mental component summary and Short Form-6 Dimensions scores compared with a US general population sample (P < .001). No significant differences were found for the 36-Item Short-Form Health Survey physical component summary and EuroQol-5D scores between the uveitis and US general population samples. CONCLUSIONS Compared with the US general population and normal-vision reference groups, noninfectious intermediate or posterior uveitis results in meaningful reductions in mental health outcomes, health-related quality of life, and vision-related functioning. TRIAL REGISTRATION clinicaltrials.gov Identifier:NCT00333814.
    Jama Ophthalmology 02/2013; 131(2):219-25. · 3.83 Impact Factor
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    ABSTRACT: We report health-related quality of life (HRQL) outcomes assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) among 167 RBC transfusion-dependent patients with IPSS Low-/Intermediate-1-risk del5q31 MDS treated with lenalidomide versus placebo in a randomized phase 3 clinical trial, MDS-004. Mean baseline to 12 week changes in FACT-An Total scores improved following treatment with lenalidomide 5 and 10mg (+5.7 and +5.7, respectively) versus placebo (-2.8) (both p<0.05). Clinically important changes in HRQL from baseline were observed at weeks 12, 24, 36, and 48 among RBC-TI≥26 week responders in both treatment groups. Lenalidomide treatment may be effective in improving HRQL outcomes.
    Leukemia research 12/2012; · 2.36 Impact Factor
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    ABSTRACT: BACKGROUND: The evaluation of asthma symptoms is a core outcome measure in asthma clinical research. The Asthma Symptom Utility Index (ASUI) was developed to assess the frequency and severity of asthma symptoms. The psychometric properties of the ASUI are not well characterized, and a minimal important difference (MID) is not established. OBJECTIVES: We assessed the reliability, validity, and responsiveness to change of the ASUI in a population of adult asthmatic patients. We also sought to determine the MID for the ASUI. METHODS: Adult asthmatic patients (n = 1648) from 2 previously completed multicenter randomized trials were included. Demographic information, spirometric results, ASUI scores, and other asthma questionnaire scores were obtained at baseline and during follow-up visits. Participants also kept a daily asthma diary. RESULTS: The internal consistency reliability of the ASUI was 0.74 (Cronbach α). Test-retest reliability was 0.76 (intraclass correlation). Construct validity was demonstrated by significant correlations between ASUI scores and Asthma Control Questionnaire scores (Spearman correlation r = -0.79; 95% CI, -0.85 to -0.75; P < .001) and Mini Asthma Quality of Life Questionnaire scores (r = 0.59; 95% CI, 0.51-0.61; P < .001). Responsiveness to change was demonstrated, with significant differences between mean changes in ASUI scores across groups of participants differing by 10% in percent predicted FEV(1) (P < .001) and by 0.5 points in Asthma Control Questionnaire scores (P < .001). Anchor-based and statistical methods support an MID for the ASUI of 0.09 points. CONCLUSIONS: The ASUI is reliable, valid, and responsive to changes in asthma control over time. The MID of the ASUI (range of scores, 0-1) is 0.09.
    The Journal of allergy and clinical immunology 09/2012; · 12.05 Impact Factor
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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; · 2.86 Impact Factor
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    ABSTRACT: Background and Aim: 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. · 2.27 Impact Factor
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    ABSTRACT: In an international, randomized Phase III trial ipilimumab demonstrated a significant overall survival benefit in previously treated advanced melanoma patients. This report summarizes health-related quality of life (HRQL) outcomes for ipilimumab with/without gp100 vaccine compared to gp100 alone during the clinical trial's 12 week treatment induction period. The Phase III clinical trial (MDX010-20) was a double-blind, fixed dose study in 676 previously treated advanced unresectable stage III or IV melanoma patients. Patients were randomized 3:1:1 to receive either ipilimumab (3 mg/kg q3w x 4 doses) + gp100 (peptide vaccine; 1 mg q3w x 4 doses; ipilimumab plus gp100, n = 403); gp100 vaccine + placebo (gp100 alone, n = 136); or ipilimumab + placebo (ipilimumab alone, n = 137). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assessed HRQL. Baseline to Week 12 changes in EORTC QLQ-C30 function, global health status, and symptom scores were analyzed for ipilimumab with/without gp100 vaccine compared to gp100 alone. Mean change in scores were categorized "no change" (0-5), "a little" (5-10 points), "moderate" (10-20 points), and "very much" (>20). In the ipilimumab plus gp100 and ipilimumab alone groups, mean changes from baseline to Week 12 generally indicated "no change" or "a little" impairment across EORTC QLQ-C30 global health status, function, and symptom subscales. Significant differences in constipation, favoring ipilimumab, were observed (p < 0.05). For ipilimumab alone arm, subscales with no or a little impairment were physical, emotional, cognitive, social function, global health, nausea, pain, dyspnea, constipation, and diarrhea subscales. For the gp100 alone group, the observed changes were moderate to large for global health, role function, fatigue, and for pain. Ipilimumab with/without gp100 vaccine does not have a significant negative HRQL impact during the treatment induction phase relative to gp100 alone in stage III or IV melanoma patients. Clinicaltrials.gov identification number NCT00094653.
    Health and Quality of Life Outcomes 06/2012; 10:66. · 2.27 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. · 1.84 Impact Factor
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    ABSTRACT: PURPOSE: The Fatigue Associated with Depression Questionnaire (FAsD) was developed to assess fatigue and its impact among patients with depression. The purpose of this study was to examine the questionnaire's responsiveness to change and identify a responder definition for interpretation of treatment-related changes. METHODS: Data were collected at baseline and at 6 weeks from patients with depression starting treatment with a new antidepressant. RESULTS: Of the 96 participants, 55.2% were women, with a mean age of 43.4 years. The total score and both subscales demonstrated statistically significant change with moderate to large effect sizes (absolute values ≥0.76). FAsD change scores were significantly correlated with change on the Brief Fatigue Inventory (r ≥ 0.73; p < 0.001). FAsD mean change scores discriminated among patient subgroups differing by degree of improvement in patient- and clinician-reported fatigue and depression. Responder definition for the two subscales and total score (0.67, 0.57, 0.62) was estimated primarily based on mean change among patients who reported a small but important improvement in fatigue. DISCUSSION: The FAsD was responsive to change, and the responder definition may be used when interpreting treatment-related change. Results add to previous findings suggesting the FAsD is a useful measure of fatigue among patients with depression.
    Quality of Life Research 03/2012; · 2.86 Impact Factor

Publication Stats

8k Citations
1,049.77 Total Impact Points

Institutions

  • 2014
    • Evidera
      Maryland, United States
  • 2013
    • Pennsylvania State University
      • Department of Public Health Sciences
      University Park, MD, United States
  • 2009–2013
    • Johnson & Johnson
      New Brunswick, New Jersey, United States
    • Emory University
      • Department of Health Policy and Management
      Atlanta, GA, United States
    • Johns Hopkins Bloomberg School of Public Health
      • Department of Health Policy and Management
      Baltimore, MD, United States
  • 2005–2013
    • United BioSource Corporation
      Maryland, United States
    • University of California, Irvine
      • Department of Psychiatry & Human Behavior
      Irvine, CA, United States
    • Group Health Cooperative
      • Group Health Research Institute
      Seattle, Washington, United States
    • Newcastle University
      • Centre for Oral Health Research
      Newcastle upon Tyne, ENG, United Kingdom
    • Covance
      Princeton, New Jersey, United States
  • 2012
    • DeltaQuest Foundation, Inc.
      Concord, Massachusetts, United States
  • 2011
    • Bristol-Myers Squibb
      New York City, New York, United States
    • Stanford University
      • Division of Rheumatology
      Palo Alto, CA, United States
    • Northwestern University
      • Department of Medical Social Sciences
      Evanston, IL, United States
    • Virginia Commonwealth University
      • Division of Gastroenterology, Hepatology and Nutrition
      Richmond, VA, United States
  • 2009–2010
    • University of California, Los Angeles
      • • Division of Digestive Diseases
      • • Department of Medicine
      Los Angeles, CA, United States
  • 2002–2008
    • Johns Hopkins University
      • Department of International Health
      Baltimore, Maryland, United States
    • University of Amsterdam
      • Faculty of Medicine AMC
      Amsterdam, North Holland, Netherlands
  • 2006
    • Pacific Neuropsychiatric Institute
      Seattle, Washington, United States
  • 1992–2005
    • University of Washington Seattle
      • Department of Pharmacy
      Seattle, Washington, United States
    • Precise Research Centers
      Mississippi, United States
  • 2003
    • University of Freiburg
      Freiburg, Baden-Württemberg, Germany
  • 2000
    • Case Western Reserve University
      • Department of Psychiatry (University Hospitals Case Medical Center)
      Cleveland, OH, United States
  • 1999–2000
    • West Virginia University
      • Department of Clinical Pharmacy
      Morgantown, WV, United States
  • 1998
    • University of Maryland, Baltimore
      • Department of Medicine
      Baltimore, MD, United States
  • 1994
    • RAND Corporation
      Santa Monica, California, United States
    • University of California, San Diego
      • Department of Family and Preventive Medicine
      San Diego, CA, United States
    • Washington DC VA Medical Center
      Washington, Washington, D.C., United States
  • 1990
    • Center for Medical Technology Policy
      Boston, Massachusetts, United States