Papers by Joseph Cappelleri
27560 Interpreting the relationship between pruritus, sleep, and work productivity: Results from JADE MONO-2
Journal of The American Academy of Dermatology, Sep 1, 2021
BJUI, Sep 27, 2012
What ' s known on the subject? and What does the study add? Studies on erectile dysfunction (ED) ... more What ' s known on the subject? and What does the study add? Studies on erectile dysfunction (ED) therapies rely heavily on patient-reported outcomes (PROs) to measure effi cacy on treatment response. A challenge when using PROs is interpretation of the clinical meaning of changes in scores. A responder analysis provides a threshold score to indicate whether a change in score qualifi es a patient as a responder. However, a major consideration with responder analysis is the sometimes arbitrary nature of defi ning the threshold for a response. By contrast, cumulative response curves (CRCs) display patient response rates over a continuum of possible thresholds, thus eliminating problems with a rigid threshold defi nition, allowing for a variety of response thresholds to be examined simultaneously, and encompassing all data. With respect to the psychosocial factors addressed in the Self-Esteem And Relationship questionnaire in ED, CRCs clearly, distinctly, and meaningfully highlighted the favourable profi les of responses to sildenafi l compared with placebo. CRCs for PROs in urology can provide a clear, transparent and meaningful visual depiction of effi cacy data that can supplement and complement other analyses.
International Journal of Obesity, Jun 9, 2009
Background: The Power of Food Scale (PFS) was developed to assess the psychological impact of tod... more Background: The Power of Food Scale (PFS) was developed to assess the psychological impact of today's food-abundant environments. Objective: To evaluate the structure of the PFS in diverse populations of obese and nonobese individuals. Design: Data were obtained from obese adults in a clinical trial for a weight management drug (n ¼ 1741), and overweight, obese and normal weight adults in a Web-based survey (n ¼ 1275). Exploratory and confirmatory factor analyses were used to investigate the PFS structure using the clinical data. The model developed was then tested using the Web-based data. Relationships between PFS domains and body mass index (BMI) were examined. Logistic regression was used in the Web-based survey to evaluate the association between obesity status and PFS scores. Results: Clinical data indicated that the scale was best represented by a 15-item version with three subscale domains and an aggregate domain (average of three domains); this was confirmed with data from the Web-based survey (Comparative Fit Index: 0.95 and 0.94 for the clinical and Web-based studies, respectively). Cronbach's a for both data sets was high, ranging from 0.81 to 0.91. The relationships between BMI and each domain were weak (and approximately linear). A full category increase in PFS domain score (range 1-5) increased the odds of being obese 1.6-2.3 times. Conclusions: The 15-item PFS is best represented by three domains and an aggregate domain. The PFS may provide a useful tool to evaluate the effects of obesity treatments on feelings of being controlled by food in an obesogenic food environment.
Opioids for Osteoarthritis: Cross-Sectional Survey of Patient Perspectives and Satisfaction
Journal of Clinical Medicine, Apr 6, 2023
Délai d’amélioration de la fatigue chez les patients atteints de spondylarthrite ankylosante dans une étude sur le tofacitinib
Revue du Rhumatisme, Dec 1, 2022
27582 Abrocitinib improves work productivity through improvement in pruritus and sleep: Results from the JADE MONO-2 study in patients with moderate-to-severe atopic dermatitis (AD)
Journal of The American Academy of Dermatology, Sep 1, 2021
PMS72 A Comparison of Characteristics of Patients with Osteoarthritis of the HIP or Knee Willing or NOT to Undergo TOTAL Joint Replacement Surgery
Value in Health, Dec 1, 2020
PDG2 Evaluating the Severity of Atopic Dermatitis (AD) in Children and Adults: Mapping of Investigator's Static Global Assessment (ISGA) to Eczema Area and Severity INDEX (EASI) in Phase 3 Studies of Crisaborole, 2%
Value in Health, Dec 1, 2020
Patient-Reported Outcomes: Development and Validation
Value in Health, May 1, 2011
We used multi-attribute theory to develop a utility elicitation instrument for people with glauco... more We used multi-attribute theory to develop a utility elicitation instrument for people with glaucoma based on the National Eye Institute-Visual Functioning Questionnaire (NEI-VFQ), a vision specific quality of life instrument frequently used in clinical trials. METHODS: NEI-VFQ responses for 1677 people enrolled in glaucoma prevention trials were analyzed to identify items responsive to differences in vision status. We then constructed a conjoint interview administered to 48 people with glaucoma and identified the 6 items of greatest importance to people with glaucoma. Using these results, we constructed a web-based interview using standard gamble (SG) and visual analog scales(VAS) administered to a community sample of 404 people. RESULTS: The five attributes most important to people with glaucoma (and responsive to change in disease status) were: ability to read, driving at night, ability to leave home, needing help with activities and ability to accomplish tasks. We added a sixth attribute, peripheral vision, even though it was not rated highly by the participants as this is an important function lost early in the disease process. Final utility estimates were made using a method similar to that employed in the Health Utility Index. The results had excellent face validity and we note the range of utility loss from mild loss of function to severe difficulty: 1) Ability to read (0.011-0.039); 2) Driving at night (0.011-0.037); 3) Leaving home (0.014-0.056); 4) Needing help with activities (0.027-0.063); 5) Ability to accomplish tasks (0.016-0.046); and 6) Peripheral vision (0.008-0.032). CONCLUSIONS: We have developed an instrument that can be used to estimate the utility loss in people with glaucoma based upon the NEI-VFQ. When used in clinical trials, the instrument will provide an estimate of the utility loss associated with the progression of glaucoma. Further work will be required to refine and validate these estimates.
International Urogynecology Journal, Apr 4, 2017
Objectives: The prevalence of urinary incontinence (UI) in women in Slovakia is about 240 000 cas... more Objectives: The prevalence of urinary incontinence (UI) in women in Slovakia is about 240 000 cases and has an increasing trend. Only 5 % of them were diagnosed by visiting urology or gynecology outpatient department. The objective of this paper was to find out the level of QoL in women with UI in Slovakia. MethOds: The primary method used for the analysis of QoL was the combined questionnaire consisting of 6 parts: A. Demography (9 items), B. Clinical part (B1-International Consultation on Incontinence (ICIQ-SF): 4 items, B2-characteristics of UI: 23 items), C. Quality of life with dominant numeric scale (13 items), D. Socio-economic part (9 items), E. EQ-5D (5 items), F. Symptoms of disease (9 items). There were 112 patients in the examined group from the160 asked to fill the questionnaire. The average age was 61 years. Results: Present level of QoL was identified as 6,60 on the scale from 1 to 10 (1-the worst,10 -the best), while in the time of the UI diagnosis it was 5,10. QoL was 8,10 in the time without UI and 9,40 in the total optimal state of health. Comparative to the QoL was examined the ability to work (AW), too. Present level of AW was identified as 6,50, while in the time of the BC diagnosis it was 5,50. AW was 8.20 in the time without UI and 9,40 in the total optimal state of health. The impact of treatment on QoL was 7,60 and the disease had impact 7,40 on family QoL. The average income was 465,04 € and the willingness to pay for 1 month of complete health was in average 391,06 € . cOnclusiOns: The disease had a significant impact on patients´s QoL. The treatment of UI had a significant impact on increasing QoL of patients.
Estimating the economic benefits of positive shifts in fibromyalgia severity: an exploratory analysis based on modeling of clinical trial data of pregabalin
Journal of Medical Economics, Sep 17, 2012
To estimate the annualized differences in direct medical and indirect costs associated with impro... more To estimate the annualized differences in direct medical and indirect costs associated with improvement in fibromyalgia (FM) severity among pregabalin-treated patients. Data from three clinical trials of pregabalin in patients with FM were modeled; efficacy results were extrapolated. Mean annual costs (direct and indirect) were assigned based on FM severity levels (mild: $10,219; moderate: $26,217; severe: $42,456). FM severity levels were defined using established cut-points on the Fibromyalgia Impact Questionnaire (FIQ). Mean annualized costs at end-point were estimated for all patients within each cohort and the mean differences in costs were compared using a regression model. Relative to placebo, there was a significantly higher proportion of subjects with mild FM at end-point with pregabalin 450 mg and a significantly lower proportion of subjects with severe FM. Mean total costs were lower with pregabalin (300 mg, $25,721; 450 mg, $24,103) than placebo ($26,162). The difference in mean annual costs was $2059 lower for pregabalin 450 mg (p = 0.003) and $441 lower for pregabalin 300 mg (p = 0.52). Mean direct medical costs were higher with pregabalin (300 mg, $4962; 450 mg, $4820) than placebo ($4364). The difference in mean annual direct medical costs was significantly higher for pregabalin 450 mg by $456 (p < 0.0001) and by $599 for pregabalin 300 mg (p < 0.0001). Mean indirect costs for pregabalin (300 mg, $20,783; 450 mg, $19,306) were lower than placebo ($21,735). The difference in mean annual indirect costs for pregabalin 450 mg was lower by $2429 (p < 0.0001); pregabalin 300 mg was lower by $951 (p = 0.12). Use of 13-week end-point data from clinical trials to extrapolate to annual costs and an assumption of continuous therapy over the course of 1 year. Improvements in FM severity were associated with overall reductions in cost. Reductions in indirect costs may offset the costs of treatment with pregabalin.
Itch, Jun 1, 2018
Introduction: Pruritus is an essential feature of atopic dermatitis (AD) and is widely considered... more Introduction: Pruritus is an essential feature of atopic dermatitis (AD) and is widely considered the most distressing symptom. Crisaborole ointment is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate AD. The efficacy of crisaborole for AD-associated pruritus was assessed in 2 phase 3 trials using the Severity of Pruritus Scale (SPS). Post hoc validation of the SPS identified that 1 SPS observation provided inadequate test-retest reliability. Therefore, extended analyses were conducted using at least 2 SPS observations for robust assessment of pruritus in the phase 3 crisaborole trials. Methods: Data were analyzed from 2 identically designed, vehicle-controlled, double-blind, phase 3 trials designed to investigate the efficacy and safety of crisaborole in AD patients aged 2 years and above (AD-301: NCT02118766; AD-302: NCT02118792). At least 2 SPS observations were averaged for acceptable test-retest reliability. Results: At least 2 baseline observations were available for 569 patients in AD-301 and 561 patients in AD-302. Median time to pruritus improvement (SPS score ≤ 1 with at least 1-point improvement from baseline) was shorter with crisaborole than with vehicle (AD-301: 5.0 vs. 10.0 d, P = 0.0003; AD-302: 6.0 vs. 9.0 d, P = 0.0087). At week 4, more crisaborole-treated patients than vehicletreated patients experienced pruritus improvement (AD-301: 37% vs. 21%, P < 0.0001; AD-302: 34% vs. 21%, P = 0.0006), mean pruritus scores were lower with crisaborole than with vehicle (AD-301: 0.97 vs. 1.28, P < 0.0001; AD-302: 1.08 vs. 1.35, P < 0.0001), and more crisaborole-treated patients than vehicle-treated patients experienced a clinically important pruritus response (AD-301: 75% vs. 57%, P < 0.0001; AD-302: 72% vs. 64%, P = 0.0828). Conclusions: These extended analyses show that patients treated with crisaborole experienced rapid and clinically relevant improvement in AD-associated pruritus.
Postgraduate Medicine, Dec 4, 2020
Objective: To evaluate healthcare resource utilization (HCRU) by osteoarthritis (OA) pain severit... more Objective: To evaluate healthcare resource utilization (HCRU) by osteoarthritis (OA) pain severity. Methods: Cross-sectional surveys of US physicians and their patients were conducted between February and May 2017. Using the Numeric Rating Scale, patients were classified by self-reported pain intensity in the last week into mild (0-3), moderate (4-6), and severe (7-10) cohorts. Parameters assessed included clinical characteristics, HCRU, and current caregiver support. Descriptive statistics were obtained, and analysis of variance and chi-square tests were performed. Results: Patients (n = 841) were mostly female (60.9%) and white (77.8%), with mean age of 64.6 years. Patients reported mild (45.4%), moderate (35.9%), and severe (18.7%) OA pain. Mean number of affected joints varied by pain severity (range mild: 2.7 to severe: 3.6; p < 0.0001). Pain severity was associated with an increased number of physician-reported and patient-reported overall healthcare provider visits (HCPs; both p < 0.001). As pain increased, patients reported an increased need for mobility aids, accessibility modifications to homes, and help with daily activities due to functional disability. The number of imaging tests used to diagnose OA was similar across pain severity but varied when used for monitoring (X-rays: p < 0.0001; computerized tomography scans: p < 0.0447). Hospitalization rates for OA were low but were significantly associated with pain severity (mild: 4.9%; severe: 11.5%). Emergency department visits were infrequent but increasing pain severity was associated with more prior and planned surgeries. Conclusion: Greater current pain was associated with more prior HCRU including imaging for monitoring progression, HCP visits including more specialty care, hospitalizations, surgery/planned surgery, and loss of independence due to functional disability. Yet rates of hospitalizations and X-ray use were still sizable even among patients with mild pain. These cross-sectional findings warrant longitudinal assessment to further elucidate the impact of pain on HCRU.
Osteoarthritis and Cartilage, Sep 1, 2020
Objective: To quantify preferences for attributes of potential analgesic treatments for moderate-... more Objective: To quantify preferences for attributes of potential analgesic treatments for moderate-to-severe pain associated with osteoarthritis (OA) and/or chronic low back pain (CLBP) as relevant to injectable nerve growth factor (NGF)einhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. Methods: We used a discrete-choice experiment (DCE) to elicit preferences for attributes of OA and CLBP pharmaceutical treatments, and a best-worst scaling (BWS) exercise to further characterize the relative importance of treatment-related side-effect risks. The survey was completed online by 602 US residents with self-reported chronic, moderate-to-severe OA pain and/or CLBP who had tried, had contraindications for, or were unwilling to take currently available pharmaceutical therapies. In the DCE, respondents repeatedly chose between two hypothetical treatments defined by six attributes (symptom control; treatment-related risks of (1) severe joint problems, (2) heart attack, and (3) physical dependence; mode/frequency of administration; and cost). In the BWS exercise, respondents evaluated ten side-effect risks. Random-parameters logit models were estimated; conditional relative attribute importance, maximum acceptable risks, and willingness to pay were calculated. Results: The most important DCE attributes were improving symptom control (scaled conditional relative importance, 10.00) and reducing risk of physical dependence (6.99). The three most important BWS attributes were, in rank order, risks of stroke, physical dependence, and heart attack. Respondents were willing to accept a > 4% treatment-related risk of severe joint problems for even modest symptom improvement. Conclusion: A pharmaceutical treatment with a risk of severe joint problems was viewed as an acceptable alternative to other treatments with comparable efficacy but risks associated with NSAIDs or opioids.
Application of the Itch Severity Score in patients with moderate-to-severe plaque psoriasis: Clinically important difference and responder analyses
Journal of Dermatological Treatment, Apr 10, 2014
Abstract The Itch Severity Score (ISS), a 0-10 numeric rating scale, was used to assess pruritus ... more Abstract The Itch Severity Score (ISS), a 0-10 numeric rating scale, was used to assess pruritus due to psoriasis in a Phase 2 b trial of tofacitinib, a novel oral Janus kinase inhibitor. 197 patients with moderate-to-severe plaque psoriasis were randomized to tofacitinib 2, 5 or 15 mg twice daily, or placebo. The ISS was recorded daily from baseline to week 2 and at study visits. Following good and recommended research practice, we performed analyses to examine the clinically important differences (CID) (between-group difference or within-group difference) and clinically important responders (CIR) (within-patient change) for the ISS. The CID and CIR were defined using Patient Global Assessment of psoriasis as an anchor and were estimated with a longitudinal model. A CID on the ISS was 1.64 and, by day 10, the mean changes from baseline in ISS values for the tofacitinib doses (placebo-adjusted) exceeded CID. A CIR on the ISS was a 30% improvement from baseline and, at week 12, 87.2% to 100% of patients receiving tofacitinib reached ≥30% improvement versus 29.4% of patients receiving placebo (p &amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.0001). Overall, the CID and CIR analyses play vital roles in the interpretation of the treatment effects measured by ISS.
Psychometric validation of the physician global assessment scale for assessing severity of psoriasis disease activity
Quality of Life Research, Nov 1, 2013
The Physician Global Assessment (PGA) is a key measure of psoriasis frequently used in clinical t... more The Physician Global Assessment (PGA) is a key measure of psoriasis frequently used in clinical trials. A psychometric validation of a three-item (erythema, induration, and scaling) PGA scale was performed using Phase 2 data. Confirmatory factor analysis (CFA) tested the PGA measurement model and appropriateness of equal weighting of the items. PGA test-retest reliability was assessed by estimating the intraclass correlation coefficient (ICC). Internal consistency reliability was gauged by calculating Cronbach&#39;s coefficient α (CCα). Clinically important difference (CID) was defined using the repeated measures model to estimate the relationship between PGA and Patient Global Assessment (PtGA). Known-group, convergent, and divergent validity for the PGA were also assessed. 197 patients with psoriasis were randomized to tofacitinib 2, 5, 15 mg twice daily, or placebo. CFA demonstrated that the PGA measurement model fitted the data using equal weighting of the PGA items. The PGA scale demonstrated good test-retest reliability (ICC &gt; 0.7) and internal consistency reliability (CCα &gt; 0.8). The CID for PGA was estimated at 0.52 (95 % confidence interval: 0.47, 0.56). A robust monotonic relationship between PGA and Psoriasis Area and Severity Index (PASI) data substantiated known-group validity. Relatively high correlations of PGA with PASI and PtGA data (all correlations &gt;0.5 except at baseline) supported convergent validity; relatively low correlations of PGA with the Pain/Discomfort Assessment and the Ocular Comfort Index supported divergent validity. The three-item PGA scale has sound psychometric properties with respect to reliability and validity, with equal weighting of the items being appropriate.
The Journal of Sexual Medicine, Oct 1, 2008
Introduction. The Erection Hardness Score (EHS), recently validated, was developed in 1998 as a s... more Introduction. The Erection Hardness Score (EHS), recently validated, was developed in 1998 as a simple (one-item) method to quantify erection outcome data. Although it is intuitive that erection hardness and successful sexual intercourse (SSI) are related, the link has not been directly established. Objective. To evaluate the relationship between erection hardness (assessed by EHS) and SSI, establishing the EHS as a clinically useful tool. Methods. The data set (N = 307) was from a multinational, double-blind, placebo-controlled trial (with open-label extension) of sildenafil citrate in men with erectile dysfunction. Main Outcome Measures. Event-based modeling used every intercourse attempt and the EHS to estimate the odds ratio of SSI between adjacent EHS categories. Mean-based modeling used mean EHS per patient to determine its relationship to percentage of SSI. Mediation-based modeling used mean EHS and mean percentage of SSI over the double-blind phase to estimate the direct effect of sildenafil treatment on SSI and the indirect effect of sildenafil treatment on SSI via erection hardness. Results. The odds of SSI for EHS 3 (hard enough for penetration but not completely hard) were 41.9 times (95% confidence interval [CI], 33.0-53.2; P < 0.0001) that for EHS 2 (hard but not hard enough for penetration), and the odds of SSI for EHS 4 (completely hard and fully rigid) were 23.7 times (95% CI, 19.5-28.9; P < 0.0001) that for EHS 3. The percentage of SSI increased approximately curvilinearly with the increase in mean EHS, from almost 60% at EHS 3 to 78.5% at EHS 3.5 and to 93.1% at EHS 4. The indirect effect of sildenafil treatment on SSI via erection hardness accounted for almost 90% of the total effect on SSI (P < 0.0001). The close and direct relationship between erection hardness and SSI supports the broader use of the EHS-a simple, valid, reliable, and responsive measure-in clinical practice. Goldstein I, Mulhall JP, Bushmakin AG, Cappelleri JC, Hvidsten K, and Symonds T. The erection hardness score and its relationship to successful sexual intercourse.
Examining the Relationships Among Treatment, Pain, and Physical Function in Patients With Osteoarthritis
The Clinical Journal of Pain, Feb 7, 2023
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Papers by Joseph Cappelleri