Joseph Cappelleri
Pfizer Inc, Statistics, Adjunct
ABSTRACTBackgroundEvidence on the impact of COVID-19 vaccination on symptoms, Health-Related Quality of Life (HRQoL), Work Productivity and Activity Impairment (WPAI) is scarce. We analyzed associations between bivalent BA.4/5 BNT162b2... more
ABSTRACTBackgroundEvidence on the impact of COVID-19 vaccination on symptoms, Health-Related Quality of Life (HRQoL), Work Productivity and Activity Impairment (WPAI) is scarce. We analyzed associations between bivalent BA.4/5 BNT162b2 and these patient-reported outcomes (PROs).MethodsSymptomatic US adults who tested positive for SARS-CoV-2 were recruited between 03/02-05/18/2023. PROs were assessed using a CDC-based symptom questionnaire, EQ-5D-5L, WPAI-GH, and PROMIS Fatigue, from pre-COVID to Week 4 following infection. Multivariable analysis using mixed models for repeated measures was conducted, adjusting for several covariates.ResultsThe study included 641 participants: 314 vaccinated with bivalent BA.4/5 BNT162b2 and 327 unvaccinated/not up-to-date. Mean (SD) age was 46.5 years (15.9), 71.2% were female, 44.2% reported prior infection, 25.7% had ≥1 comorbidity. The BA.4/5 BNT162b2 cohort reported fewer acute symptoms through Week 4, especially systemic and respiratory symptom...
BackgroundLongitudinal estimates of long COVID burden during Omicron remain limited. This study characterized long-term impacts of COVID-19 and booster vaccination on symptoms, Health-Related Quality of Life (HRQoL), and Work Productivity... more
BackgroundLongitudinal estimates of long COVID burden during Omicron remain limited. This study characterized long-term impacts of COVID-19 and booster vaccination on symptoms, Health-Related Quality of Life (HRQoL), and Work Productivity Activity Impairment (WPAI).MethodsOutpatients with ≥1 self-reported symptom and positive SARS-CoV-2 test at CVS Health United States test sites were recruited between 01/31-04/30/2022. Symptoms, EQ-5D and WPAI were collected via online surveys until 6 months following infection. Both observed and model-based estimates were analyzed. Effect sizes based on Cohen’s d quantified the magnitude of outcome changes over time, within and between vaccination groups. Mixed models for repeated measures were conducted for multivariable analyses, adjusting for covariates. Logistic regression assessed odds ratio (OR) of long COVID between vaccination groups.ResultsAt long COVID start (Week 4), 328 participants included 87 (27%) Boosted with BNT162b2, 86 (26%) wit...
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BackgroundThe impact of COVID-19 goes beyond the acute phase of infection. It is imperative to evaluate health related quality of life (HRQoL) pre-COVID-19, but there is currently no evidence of the retrospective application of the... more
BackgroundThe impact of COVID-19 goes beyond the acute phase of infection. It is imperative to evaluate health related quality of life (HRQoL) pre-COVID-19, but there is currently no evidence of the retrospective application of the EQ-5D-5L for COVID-19 studies.MethodsSubjects with ≥1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022-04/30/2022. On the day of enrollment which was around day 3 after testing positive, consented participants completed the EuroQol 5D-5L (EQ-5D-5L) questionnaire twice : a modified version where all the questions were past tense to retrospectively assess pre-COVID-19 baseline QoL, and the standard version in present tense to assess current HRQoL. Duncan’s new multiple range test was adopted for post analysis of variance pairwise comparisons of EQ-VAS means between problem levels for each of 5 domains. A linear mixed model was applied to check whether the relationship between EQ visual an...
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Background Although there is extensive literature on the clinical benefits of COVID-19 vaccination, data on humanistic effects are limited. This study evaluated the impact of SARS-CoV-2 infection on symptoms, Health-Related Quality of... more
Background Although there is extensive literature on the clinical benefits of COVID-19 vaccination, data on humanistic effects are limited. This study evaluated the impact of SARS-CoV-2 infection on symptoms, Health-Related Quality of Life (HRQoL) and Work Productivity and Impairment (WPAI) prior to and one month following infection between individuals vaccinated with BNT162b2 and those unvaccinated. Methods Subjects with ≥ 1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022 and 04/30/2022. Socio-demographics, clinical characteristics and vaccination status were evaluated. Self-reported symptoms, HRQoL, and WPAI outcomes were assessed using questionnaires and validated instruments (EQ-5D-5L, WPAI-GH) across acute COVID time points from pre-COVID to Week 4, and between vaccination groups. Mixed models for repeated measures were conducted for multivariable analyses, adjusting for several covariates. Effect size (ES) ...
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ABSTRACTBackgroundAlthough there is extensive literature on the clinical benefits of COVID-19 vaccination, data on humanistic effects are limited. This study evaluated the impact of SARS-CoV-2 infection on symptoms, Health Related Quality... more
ABSTRACTBackgroundAlthough there is extensive literature on the clinical benefits of COVID-19 vaccination, data on humanistic effects are limited. This study evaluated the impact of SARS-CoV-2 infection on symptoms, Health Related Quality of Life (HRQoL) and Work Productivity and Impairment (WPAI) prior to and one month following infection, and compared results between individuals vaccinated with BNT162b2 and those unvaccinated.MethodsSubjects with ≥1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022-04/30/2022. Socio-demographics, clinical characteristics and vaccination status were evaluated. Self-reported symptoms, HRQoL, and WPAI outcomes were assessed using questionnaires and validated instruments (EQ-5D-5L, WPAI-GH) across acute COVID time points from pre-COVID to Week 4, and between vaccination groups. Mixed models for repeated measures were conducted for multivariable analyses, adjusting for several covaria...
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Objective To examine pregabalin dose titration and its impact on treatment adherence and duration in patients with neuropathic pain (NeP). Methods MarketScan database (2009–2014) was used to extract a cohort of incident adult pregabalin... more
Objective To examine pregabalin dose titration and its impact on treatment adherence and duration in patients with neuropathic pain (NeP). Methods MarketScan database (2009–2014) was used to extract a cohort of incident adult pregabalin users with NeP who had at least 12 months of follow-up data. Any dose augmentation within 45 days following the first pregabalin claim was defined as dose titration. Adherence (measured by medication possession ratio/MPR) and persistence (measured as the duration of continuous treatment) were compared between the cohorts with and without dose titration. Logistic regressions and Cox proportional hazards models were used to identify the factors associated with adherence (MPR ≥ 0.8) and predictors of time to discontinuation. Results Among the 5,186 patients in the analysis, only 18% of patients had dose titration. Patients who had dose titration were approximately 2.6 times as likely to be adherent (MPR ≥ 0.8) (odds ratio = 2.59, P < 0.001) than thos...
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Research Interests: Medicine, Applied Economics, Humans, Cancer Therapy, kidney Cancer, and 15 moreFemale, Male, Functional Assessment, Rating Scale, Middle Aged, Questionnaires, Public health systems and services research, Economic Models, Rasch Model, Indexation, Elsevier, Antineoplastic Agents, Interferon Alpha, health status indicators, and item response models
Research Interests: Geography, European Union, Medicine, Humans, Internal Medicine, and 15 moreCancer Therapy, Health related Quality of Life, Female, Male, Functional Assessment, Cohort, Health Status, Aged, Middle Aged, Adult, Mixture Model, Indexation, Alpha Interferon, Interferon Alpha, and Metastatic Renal Cell Carcinoma
Research Interests: Australia, Quality of life, Brazil, Medicine, Canada, and 15 morePopulation, Humans, Internal Medicine, Europe, Female, Clinical, Male, Clinical oncology, Middle Aged, Questionnaires, Antineoplastic Agents, Interferon Alpha, health status indicators, Neoplasm metastasis, and Metastatic Renal Cell Carcinoma
The goal of the study was to determine the relationship of baseline Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI) scores with median progression-free survival (mPFS) and median overall survival (mOS) after... more
The goal of the study was to determine the relationship of baseline Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI) scores with median progression-free survival (mPFS) and median overall survival (mOS) after treatment with axitinib in patients with sorafenib-refractory metastatic renal cell carcinoma. As part of a multicenter, open-label, phase II study, patients (N = 62) reported symptoms at baseline using the FKSI, with higher scores indicating less severe symptoms. A Weibull (fully parametric) model was fit to time-to-event data to establish the relationship of baseline FKSI score with mPFS and mOS. Kaplan-Meier curves were obtained as sensitivity analyses. Longer progression-free and overall survivals were associated with higher (more favorable) baseline FKSI-15 and FKSI disease-related symptoms (FKSI-DRS) subscale specific to kidney cancer scores. For example, for FKSI-15 scores of 0 (most symptoms), 30, and 60 (no symptoms), the mPFS were 0.72, 3.83, and 20.43 months, respectively, and the mOS were 1.05, 6.27, and 37.53 months. Similar patterns and interpretations were observed for the FKSI-DRS scores. The results from the Kaplan-Meier analyses supported the parametric model. Baseline patient-reported kidney cancer symptoms are linked to mPFS and mOS in a clear and interpretable way. These results support the evaluation of patient-reported symptoms at baseline in clinical trials and in clinical practice to measure symptom severity and potentially predict progression-free and overall survival outcomes. The results provide a heightened opportunity to use patient data not only to assist in medical treatment planning but also to prepare patients, who have advanced disease and an already reduced expected lifespan, with an opportunity to deal with the psychosocial aspects of the dying process.
Research Interests: Clinical Trial, Cancer, Cancer Survivorship, Medicine, Clinical Practice, and 15 moreHumans, Internal Medicine, Cancer Therapy, kidney Cancer, Female, Male, Functional Assessment, Aged, Adult, Cancer Survivor, Indexation, Antineoplastic Agents, Axitinib, Medical Treatment, and Metastatic Renal Cell Carcinoma
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Background: Patients with ulcerative colitis (UC) often report impaired health-related quality of life (HRQoL). Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of UC. In addition to previous demonstrations... more
Background: Patients with ulcerative colitis (UC) often report impaired health-related quality of life (HRQoL). Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of UC. In addition to previous demonstrations of improved clinical measures (e.g., Mayo score), tofacitinib has been shown to improve HRQoL in patients with UC. This analysis explored the interrelationships among tofacitinib treatment, HRQoL, and disease activity (measured using Mayo subscores) using mediation modeling. Methods: Data were collected from two 8-week induction studies (OCTAVE Induction 1 and 2) in patients with moderate to severe UC treated with tofacitinib or placebo. Two mediation models were specified. First, Mayo subscores were mediators between the binary treatment variable (tofacitinib vs. placebo) and the eight Short Form-36 Health Survey (SF-36) domain scores as outcomes. Second, the four Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores served as outcomes. Both...
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Background Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis [UC]. We evaluated the relationship between Mayo/Inflammatory Bowel Disease Questionnaire [IBDQ] scores and Work Productivity... more
Background Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis [UC]. We evaluated the relationship between Mayo/Inflammatory Bowel Disease Questionnaire [IBDQ] scores and Work Productivity and Activity Impairment-UC [WPAI-UC] components in patients with UC. Methods All available pooled data from three Phase 3 tofacitinib studies [OCTAVE Induction 1 and 2 and OCTAVE Sustain] were included. Relationships were estimated using repeated measures regression models with Mayo score/subscores or IBDQ total/domain scores as a separate anchor predictor and WPAI-UC components as the outcome. Results Evidence for linear relationships was confirmed between Mayo/IBDQ scores and WPAI-UC components. Robust relationships between total Mayo score/IBDQ total score and WPAI-UC presenteeism, work productivity loss, and activity impairment were observed; relationships with absenteeism were weak. Total Mayo scores of 0 and 12 corresponded, on average, to WPA...
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Background:Osteoarthritis (OA) is a chronic joint disease associated with pain and impaired activity. With increasing obesity trends and an ageing population, the prevalence of OA is expected to rise in the future. This represents an... more
Background:Osteoarthritis (OA) is a chronic joint disease associated with pain and impaired activity. With increasing obesity trends and an ageing population, the prevalence of OA is expected to rise in the future. This represents an increasing societal problem which will lead to an increased burden on healthcare services.Objectives:To understand the pattern of healthcare resource utilisation (HCRU) across France, Germany, Italy, Spain and the UK, as OA disease severity increases.Methods:Data were drawn from the Adelphi OA Disease Specific Programme (2017-18), a point-in-time study of physicians and their OA patients. OA disease severity was reported by physicians, who categorised patients’ OA severity as mild, moderate or severe. Patients were excluded from the analyses if they suffered from back and neck OA only, and shoulder OA that had not been diagnosed by X-ray. Physicians provided information, on a patient record form, about OA-related visits to healthcare professionals (HCPs...
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Purpose To evaluate the relationship between self-reported concerns about becoming addicted to a medication and health-related quality of life (HRQoL) in patients with osteoarthritis (OA). Methods This real-world study used patient-level... more
Purpose To evaluate the relationship between self-reported concerns about becoming addicted to a medication and health-related quality of life (HRQoL) in patients with osteoarthritis (OA). Methods This real-world study used patient-level cross-sectional survey data collected from the US Adelphi Disease Specific Programme (DSP). The DSP for OA selected 153 physicians who collected de-identified data on their next nine adult patients with OA. Each patient completed a disease-relevant survey, which included the Likert-scale question, “I am concerned about becoming addicted to my medicine,” (CAA) with responses ranging from “completely disagree” [1] to “completely agree” [5]. HRQoL was measured by the EQ-5D-5L index value and the EQ Visual Analogue Scale (VAS). A set of ordinary least squares regressions using HRQoL measures as outcomes and CAA as a continuous predictor were estimated. Standardized effect size (ES) was used to gauge the magnitude of effects. Results A total of 866 patie...
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Background In psoriatic arthritis (PsA), further understanding of the relationships between clinical measures and patient-reported outcomes (PROs) is needed. This post hoc analysis evaluated associations between minimal disease activity... more
Background In psoriatic arthritis (PsA), further understanding of the relationships between clinical measures and patient-reported outcomes (PROs) is needed. This post hoc analysis evaluated associations between minimal disease activity (MDA) as a continuous outcome (termed ScoreMDA) or Psoriatic Arthritis Disease Activity Score (PASDAS) with selected PROs not included in the composite measures. Methods Data from two phase 3 studies of tofacitinib in PsA (OPAL Broaden [NCT01877668; N = 422]; OPAL Beyond [NCT01882439; N = 394]) were included. MDA (binary outcome) was defined as meeting ≥5/7 criteria. For ScoreMDA, each criterion was assigned a value (1 = true; 0 = false; score range, 0–7; scores ≥5 indicated MDA). For PASDAS (score range, 0–10), higher scores indicated worse disease activity. PROs analyzed included Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Patient’s Assessment of Arthritis Pain visual analog scale (Pain VAS), and EuroQoL-Five Dimensions-Thre...
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Ankylosing spondylitis (AS) can significantly impact quality of life. Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of adult patients (pts) with AS. The safety/efficacy (including pt-reported outcomes... more
Ankylosing spondylitis (AS) can significantly impact quality of life. Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of adult patients (pts) with AS. The safety/efficacy (including pt-reported outcomes [PROs]) of tofacitinib in pts with AS was assessed in a Phase 3 trial (NCT03502616).1To evaluate the effect of tofacitinib on pt-reported pain, fatigue, overall health and work productivity in pts with active AS enrolled in the Phase 3 trial.Pts with an inadequate clinical response or intolerance to ≥2 oral NSAIDs were randomised in a double-blind fashion to tofacitinib 5 mg twice daily (BID) or placebo (PBO) for 16 weeks. At Week (W)16, all pts received open-label tofacitinib 5 mg BID up to W48. Least squares (LS) mean changes from baseline (Δ) up to W48 are reported for the following outcomes: pt assessment of nocturnal spinal pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Short Form-36 Health Survey version 2 (SF-36v2;...
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Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared... more
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the reco...
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6529 Background: In an international, randomized phase 3 trial (Figlin et al, ASCO. 2008), sunitinib showed superior progression-free survival (the primary endpoint) and objective response rate over IFN-α (11 vs. 5 mo and 47% vs. 12%,... more
6529 Background: In an international, randomized phase 3 trial (Figlin et al, ASCO. 2008), sunitinib showed superior progression-free survival (the primary endpoint) and objective response rate over IFN-α (11 vs. 5 mo and 47% vs. 12%, respectively; p < 0.000001) as first-line mRCC therapy, with a median overall survival of more than 2 years. Here, we report the final health-related QOL results from this trial. Methods: 750 treatment-naïve mRCC patients were randomized 1:1 to receive sunitinib 50 mg orally once-daily in recurring cycles of 4 weeks on drug and 2 weeks off or IFN-α 9 MU subcutaneously thrice-weekly. QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G), which has 4 subscales, the FACT-Kidney Symptom Index-15 item (FKSI-15), which includes a Disease-Related Symptoms (FKSI-DRS) subscale, and the EQ-5D questionnaire's utility index (EQ-5D Index) and visual analog scale (EQ-VAS). The primary QOL endpoint was FKSI-DRS. Higher scores indicat...
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Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in... more
Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC. Methods Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 and 2 studies. The IBDQ was self-administered by patients at baseline, week 4, and week 8, with higher scores indicating better health-related quality of life (HRQoL). Change from baseline in IBDQ items was analyzed for 10 mg of tofacitinib twice daily (BID) vs placebo using a linear mixed-effects model, with no multiplicity adjustment performed. Effect sizes were calculated. Subgroup analyses by tumor necrosis factor inhibitor (TNFi) experience were performed. Results Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8. For the overall po...
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Research Interests: Oncology, Treatment Outcome, Risk assessment, Medicine, Humans, and 15 moreInternal Medicine, Renal cell Carcinoma, Risk factors, Time Factors, Proportional hazards model, Retrospective Studies, Risk Factors, Risk Assessment, Antineoplastic Agents, Sunitinib, Progression Free Survival, Interferon Alpha, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, and Disease Free Survival
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Research Interests: Cognitive Science, Psychometrics, Rasch Analysis, Medicine, Physical Therapy, and 15 moreIndependent Living, Humans, Differential Item Functioning, Neuropathic pain, Female, Male, Middle Aged, Adult, Medicine and Health Sciences, Cross Sectional Studies, Neurosciences, Pain Measurement, Outcome Measurement, Neuralgia, and PainDETECT
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Appendix 1: The FACIT-Fatigue scale. (DOCX 255 kb)
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Appendix 1. Work Productivity and Activity Impairment Questionnaire (WPAI). Appendix 2. Terms and Strings Used in Electronic Database Literature Searches. (DOCX 21 kb)
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A patient-reported outcome (PRO) is any report on the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. In this chapter methods of... more
A patient-reported outcome (PRO) is any report on the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. In this chapter methods of PRO interpretation are discussed, under the assumption that a PRO instrument has already evidenced validity and reliability, in order to lend meaning and import to PRO scores. Specifically, we focus on three ways to advance interpretation of PRO scores: anchor-based methods, distribution-based methods, and mediation models. Anchor-based approaches use a criterion measure that is clinically interpretable and appreciably correlated with the targeted PRO measure of interest. Distribution-based approaches use the statistical distribution of the data to gauge the meaning of PRO scores. Mediation models involve a multivariate approach to collectively and simultaneously examine the interrelationship of the PRO measure of interest with other variables. Throughout the chapter, concepts are illuminated with illustrative and real-life examples.
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Research Interests: Medicine, Applied Economics, Humans, Cancer Therapy, Female, and 15 moreRenal cell Carcinoma, Male, Functional Assessment, Rating Scale, Middle Aged, Questionnaires, Public health systems and services research, Economic Models, Rasch Model, Indexation, Elsevier, Antineoplastic Agents, Interferon Alpha, health status indicators, and item response models
In a randomized phase III trial, sunitinib was associated with significantly superior progression-free survival when compared with interferon alfa as first-line therapy in patients with metastatic renal cell carcinoma. This article... more
In a randomized phase III trial, sunitinib was associated with significantly superior progression-free survival when compared with interferon alfa as first-line therapy in patients with metastatic renal cell carcinoma. This article investigates whether baseline quality of life and demographic and clinical variables were predictive for progression-free survival.