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  • 1
    Online Resource
    Online Resource
    Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores
    Springer Science and Business Media LLC ; 2023
    In:  Journal of Patient-Reported Outcomes Vol. 7, No. 1 ( 2023-06-01)
    Details
    In: Journal of Patient-Reported Outcomes, Springer Science and Business Media LLC, Vol. 7, No. 1 ( 2023-06-01)
    Abstract: The Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) is a patient-reported outcome measure designed to assess symptoms and impacts of respiratory syncytial virus (RSV) infection. This study evaluated the construct validity, reliability, and responsiveness of the RiiQ™ Respiratory and Systemic Symptoms Scale scores. Methods Prospective data were analyzed from a total of 1795 participants, including from non-hospitalized patients with acute respiratory infection (ARI) and no coinfections enrolled in a Phase 2b RSV vaccine study (RSV-positive: n = 60; RSV-negative: n = 1615), and two observational studies of patients hospitalized with RSV (n = 20; n = 100). Descriptive statistics, confirmatory factor analysis (CFA), test–retest intraclass correlation coefficients (ICCs), construct validity correlations (between a clinician-assessed clinical questionnaire and the RiiQ™ symptoms scale), known-groups validity, and responsiveness (correlations of change scores) were evaluated. Results Mean patient age ranged from 66.5 to 71.5 years and the majority of patients were female. Initial assessments in the vaccine trial (ARI Day 1) were suggestive of less severe illness than in the observational studies with hospitalized patients. CFA loadings ( 〉  0.40) supported summary scores. ICCs exceeding the recommended threshold of 0.70 supported test–retest reliability for Respiratory and Systemic Symptoms, except in the small observational study. At the scale level, correlations were moderate to strong (| r | ≥ 0.3) and positive between the Respiratory Symptoms Scale and the related clinical questionnaire scores, reflecting measurement of similar symptoms in support of convergent validity. Correlations with change in Patient Global Impression of Severity  〉  0.30 supported responsiveness. Conclusions Psychometric tests applied to the RiiQ™ Symptoms scales provide evidence of its reliability, construct validity, discriminating ability, and responsiveness for use in clinical studies to assess the onset and severity of RSV symptoms.
    Type of Medium: Online Resource
    ISSN: 2509-8020
    URL: Article
    DOI: 10.1186/s41687-023-00593-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2906081-3
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  • 2
    Online Resource
    Online Resource
    Clinical Outcomes and Quantitative HBV Surface Antigen Levels in Diverse Chronic Hepatitis B Patients in Canada: A Retrospective Real-World Study of CHB in Canada (REVEAL-CANADA)
    MDPI AG ; 2022
    In:  Viruses Vol. 14, No. 12 ( 2022-11-29), p. 2668-
    Details
    In: Viruses, MDPI AG, Vol. 14, No. 12 ( 2022-11-29), p. 2668-
    Abstract: Background: Hepatitis B surface antigen (HBsAg) loss is associated with improved clinical outcomes for individuals with chronic hepatitis B (CHB); however, the effects of varying HBsAg levels on clinical outcomes in diverse cohorts are understudied. Methods: In this cross-sectional, multicentre, retrospective study, the data on adult subjects enrolled in the Canadian HBV Network with CHB seen from 1 January 2012 to 30 January 2021 with the treatment and virologic data within 1 year of HBsAg testing were analyzed. Patients were tested for HBsAg using qualitative (for HBsAg-negative samples) and/or commercial quantitative assays. Fibrosis or hepatic necroinflammation was determined by the liver stiffness measurement (LSM). The baseline data were summarized using descriptive statistics and compared by using univariable/multivariable analyses. Results: This study included 844 CHB patients, with a median age of 49.6 years (IQR 40.1–60.5), and 37% were female. In total, 751 patients (78.6%) had known ethnicity data, and 76.7% self-reported as Asian, 11.4% as Black, 6.8% as White, and 4.8% as other. Among the 844 patients, 237 (28.0%) were HBsAg (−) ( 〈 LLOQ), 190 (22.5%) had qHBsAg 1–100, 91 (10.8%) had qHBsAg 100–500, 54 (6.4%) had qHBsAg 500–1000, and 272 (32.2%) had qHBsAg 〉 1000 IU/mL. Overall, 80% (682) had known HBeAg status at the last follow-up, and the majority (87.0%) were HBeAg-negative. In addition, 54% (461/844) had prior antiviral therapy, 19.7% of which (16.3, 23.7, n = 91) were HBsAg (−). The treated patients had a lower risk of cirrhosis (16.46, 95% CI 1.89–143.39, p = 0.01) or HCC (8.23, 95% CI 1.01–67.39, p = 0.05) than the untreated patients. A lower proportion of the HBsAg-loss group had cirrhosis (5.7% vs. 10.9%, p = 0.021) and HCC (0.9% vs. 6.2%, p = 0.001). Conclusion: In this retrospective, ethnically diverse cohort study, CHB patients who received antiviral therapy and/or had HBsAg loss were less likely to develop cirrhosis and HCC, confirming the results of the studies in less diverse cohorts. No association was found between the qHBsAg level and fibrosis determined with LSM. Individuals who achieved HBsAg loss had low-level qHBsAg within 1 year of seroclearance.
    Type of Medium: Online Resource
    ISSN: 1999-4915
    URL: Article
    DOI: 10.3390/v14122668
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2516098-9
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  • 3
    Online Resource
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    Educating Nurses for Palliative Care : A Scoping Review
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Journal of Hospice & Palliative Nursing Vol. 16, No. 1 ( 2014-02), p. 47-54
    Details
    In: Journal of Hospice & Palliative Nursing, Ovid Technologies (Wolters Kluwer Health), Vol. 16, No. 1 ( 2014-02), p. 47-54
    Type of Medium: Online Resource
    ISSN: 1522-2179
    URL: Article
    DOI: 10.1097/NJH.0000000000000021
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 2070862-2
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  • 4
    Online Resource
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    Improvement of fatigue, physical functioning, and well-being among patients with severe impairment at baseline receiving ibrutinib in combination with bendamustine and rituximab for relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma in the HELIOS study
    Informa UK Limited ; 2018
    In:  Leukemia & Lymphoma Vol. 59, No. 9 ( 2018-09-02), p. 2075-2084
    Details
    In: Leukemia & Lymphoma, Informa UK Limited, Vol. 59, No. 9 ( 2018-09-02), p. 2075-2084
    Type of Medium: Online Resource
    ISSN: 1042-8194 , 1029-2403
    URL: Article
    DOI: 10.1080/10428194.2017.1416364
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2018
    detail.hit.zdb_id: 2030637-4
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  • 5
    Online Resource
    Online Resource
    1061. Evaluation of Measures for the Assessment of Covid-19 Signs and Symptoms in Children and Adolescents
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome (PRO) measure developed to assess the presence and severity of COVID-19 signs and symptoms in adults. To further facilitate the evaluation of new vaccines and treatments in development, similar tools are needed for use within pediatric populations. The objectives of this study were to support adolescent self-completion and create an adaptation of the measure for caregiver assessment of signs and symptoms in children aged & lt; 12 years (henceforth, the Pediatric SIC [PedSIC]). Methods After developing draft versions of the PedSIC and reference materials with definitions to facilitate accurate completion of both measures, iterative rounds of cognitive debriefing interviews were conducted from November 2020 through January 2021 to evaluate understanding of the SIC (in adolescents aged 12-17), and inform refinement of the PedSIC for caregivers of children aged & lt; 12. Recruitment quotas were employed to support sample diversity. Results Nine adolescents (mean [SD, range] age, 14 [1.76, 12-17] years, 56% female, 78% white; round 1, n=6; round 2, n=3) and 17 caregivers (mean [SD, range] age, 34 [6.28, 26-41] years, 59% female, 65% white; round 1, n=9; round 2, n=8) completed interviews. All adolescents understood and completed the adult version of the SIC without instrument modification. Ease and accuracy of self-completion was improved through the use of reference materials. Caregiver feedback resulted in modification of the PedSIC to include two sections: observable signs (ages & lt; 12), and symptoms assessed with input from children (ages ≥ 5- & lt; 12). Reference materials provided standardization of item intent. Conclusion Results support using the SIC, PedSIC, and their associated reference materials to assess the presence and severity of COVID-19 signs/symptoms in adolescents and children aged & lt; 12 years, respectively, who participate in vaccine and treatment clinical trials. Supported by Janssen Vaccines & Prevention B.V. Disclosures Carla Romano, MS, Janssen Pharmaceuticals: Grant/Research Support Margaret Mayorga, MS , MPH, Janssen Pharmaceuticals: Grant/Research Support Javier Ruiz-Guiñazu, MD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Géralyn C. Trudel, PhD, Janssen Pharmaceuticals: Stocks/Bonds Sheri Fehnel, PhD, Janssen Pharmaceuticals: Grant/Research Support Kelly McQuarrie, BSN, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Eric K. H. Chan, PhD, Janssen Global Services, LLC: Employee|Janssen Pharmaceuticals: Stocks/Bonds Eva G. Katz, PhD, MPH, RD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.902
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2757767-3
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  • 6
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    2321. Long-term immunogenicity of Ad26.RSV.preF/RSV preF protein vaccine against RSV in a phase 2b study by age and risk level
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Respiratory syncytial virus (RSV) can cause serious lower respiratory tract disease (LRTD) among older adults. There is no licensed RSV vaccine. In CYPRESS (a randomized, double-blind, placebo-controlled, phase 2b proof-of concept trial; NCT03982199), an Ad26.RSV.preF/RSV preF protein vaccine demonstrated 80.0% efficacy for prevention of RSV LRTD and 69.8% efficacy for prevention of any RSV acute respiratory infection in adults aged ≥65 years through the first RSV season. This study evaluated the durability of immune responses elicited by Ad26.RSV.preF/RSV preF protein after two RSV seasons (up to 1.5 years post-vaccination) in the overall study population and in groups of participants stratified by age and risk level for severe RSV LRTD. Methods Participants (N=5782) were randomized 1:1 to receive vaccine or placebo before the RSV season. The primary endpoint was first occurrence of RSV LRTD. RSV A2 virus neutralizing antibodies (VNAs; through Day 365), RSV preF binding antibodies (through Day 533), and RSV-F–specific IFN-γ enzyme-linked immune absorbent spot (ELISpot; through Day 533), were evaluated in an immunogenicity subset (n=195; ages 65–74 years: n=141; 75–84 years: n=47; ≥85 years: n=6; increased risk [chronic heart or lung disease]: n=48; non-increased risk: n=147). Results In the vaccine group of the immunogenicity subset, RSV A2 VNAs peaked at Day 15 and were maintained at 2.8-fold over baseline at 1 year. Similarly, RSV preF-specific binding antibodies peaked at Day 15 and were maintained at 2.1-fold above baseline at 1.5 years. Median RSV-F–specific IFN-γ T-cell frequency increased from 34 spot-forming cells (SFC)/106 peripheral blood mononuclear cells (PBMCs) at baseline to 143 SFC/106 PBMCs at 1.5 years. Comparable immune responses were observed in age/risk subgroups. No relevant changes were observed in the placebo group at any time point. Pre-existing Ad26 VNAs did not appear to impact RSV-specific immune response durability. Conclusion Ad26.RSV.preF/RSV preF protein vaccine was efficacious and elicited robust, durable (to at least 1.5 years) humoral and cellular immune responses in adults aged ≥65 years, older participants (≥75 years), and in participants with increased risk for severe RSV LRTD. Disclosures Christy A. Comeaux, MD, PhD, Janssen Vaccines & Prevention B.V.: Employee Ann R. Falsey, MD, BioFire Diagnostics: Grant/Research Support|Janssen: Grant/Research Support|Merck Sharp & Dohme: Grant/Research Support|Novavax: Advisor/Consultant|Pfizer: Grant/Research Support Kristi Williams, PhD, Janssen Research and Development: Employee John E. Ervin, MD, The Alliance for Multispecialty Research – KCM: Contractual agreement for conduct of study protocol Arangassery R. Bastian, PhD, Janssen Vaccines & Prevention BV: Employee Joris Menten, PhD, Janssen Infectious Diseases: Employee Els De Paepe, MSc, Janssen Infectious Diseases: employee Sjouke Vandenberghe, PhD, Janssen Infectious Diseases: Employee Eric K. H. Chan, PhD, Janssen Global Services, LLC: Employee Jerald Sadoff, MD, Janssen Vaccines & Prevention BV: Employee Macaya Douoguih, MD, MPH, Janssen Vaccines & Prevention B.V.: Employee Benoit Callendret, PhD, Janssen Vaccines & Prevention B.V.: Employee Esther Heijnen, MD, PhD, Janssen Vaccines & Prevention B.V.: Employee.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.152
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 7
    Online Resource
    Online Resource
    Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Patient-Reported Outcomes Vol. 6, No. 1 ( 2022-12)
    Details
    In: Journal of Patient-Reported Outcomes, Springer Science and Business Media LLC, Vol. 6, No. 1 ( 2022-12)
    Abstract: Given the urgent need for vaccines and treatments for coronavirus disease 2019 (COVID-19), the Symptoms of Infection with Coronavirus-19 (SIC), a comprehensive, patient-reported outcome (PRO) measure of signs and symptoms associated with COVID-19, was developed in full alignment with current US regulatory guidance to support evaluations of vaccines and treatments in development. Methods An initial version of the SIC was developed to address concepts identified through a targeted literature review and consultation with experts in infectious diseases and clinicians routinely managing COVID-19 in a hospital setting. A qualitative study was conducted in sites in the United States among 31 participants aged ≥ 18 years who were English-speaking and willing and able to provide informed consent and a self-reported history by telephone or online method. The measure was refined based on additional feedback from the clinicians and three iterative rounds of combined concept elicitation and cognitive debriefing interviews conducted with patients, caregivers, and healthy volunteers. Results Among 39 scientific articles identified in the literature review, 35 COVID-19 signs and symptoms were reported and confirmed during interviews with clinicians, patients, and caregivers. Patients and healthy participants suggested changes for refining the draft SIC to ensure consistent interpretation and endorsed both the 24-h recall period and use of an 11-point numeric rating scale (NRS) for capturing change in symptom severity. The final version of the SIC captures the daily presence or absence of 30 symptoms and a rating of severity for 25 of the 30 symptoms using an NRS for those symptoms reported as present. Conclusions The SIC comprehensively addresses observations described in the literature, by clinicians, and by patients, and captures patients’ experiences with COVID-19 in a manner that minimizes complexity and facilitates completion for both patients and healthy volunteers. This measure is thus appropriate for use in clinical trials of both therapeutics and vaccines for COVID-19.
    Type of Medium: Online Resource
    ISSN: 2509-8020
    URL: Article
    DOI: 10.1186/s41687-022-00471-w
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 8
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    Assessment of Illness Severity in Adults Hospitalized With Acute Respiratory Tract Infection due to Influenza, Respiratory Syncytial Virus, or Human Metapneumovirus
    Wiley ; 2024
    In:  Influenza and Other Respiratory Viruses Vol. 18, No. 5 ( 2024-05)
    Details
    In: Influenza and Other Respiratory Viruses, Wiley, Vol. 18, No. 5 ( 2024-05)
    Abstract: Influenza, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV) are common respiratory viruses causing similar symptoms. Optimal tools to assess illness severity for these viruses have not been defined. Using the Hospitalized Acute Respiratory Tract Infection (HARTI) study data, we report symptom severity by clinician‐rated clinical severity scores (CSS) in adults with influenza, RSV, or hMPV and correlations between CSS and patient‐reported outcomes (PROs). Methods HARTI was a global epidemiologic study in adults hospitalized with acute respiratory tract infections. Patients were assessed at enrollment within 24 h of admission with CSS and twice during hospitalization with CSS, Respiratory Infection Intensity and Impact Questionnaire™ (RiiQ™), and EQ‐5D‐5L. Data were summarized descriptively, stratified by pathogen and baseline and hospitalization characteristics. Domain (general, upper respiratory, and lower respiratory) and sign/symptom subscores are presented for CSS; sign/symptom subscores are presented for RiiQ™ results. Results Data from 635 patients with influenza, 248 with RSV, and 107 with hMPV were included. At enrollment, total CSS and general and lower respiratory signs/symptoms (LRS) scores were higher for RSV and hMPV than influenza. Between‐pathogen differences were greatest for LRS scores. Dyspnea, rales/rhonchi, wheezing, and shortness of breath scores trended higher for RSV and hMPV than influenza. RiiQ™ scores for cough, fatigue, and short of breath were strongly correlated with corresponding clinician‐rated symptoms. Conclusions These findings support the use of PROs (e.g., the RiiQ™) correlating with clinician assessments to gauge patient well‐being and aid patient management by accurately assessing respiratory illness severity due to RSV, hMPV, or influenza.
    Type of Medium: Online Resource
    ISSN: 1750-2640 , 1750-2659
    URL: Issue
    URL: Article
    DOI: 10.1111/irv.v18.5
    DOI: 10.1111/irv.13275
    Language: English
    Publisher: Wiley
    Publication Date: 2024
    detail.hit.zdb_id: 2272349-3
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  • 9
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    Long-term efficacy and immunogenicity of Ad26.RSV.preF–RSV preF protein vaccine (CYPRESS): a randomised, double-blind, placebo-controlled, phase 2b study
    Elsevier BV ; 2024
    In:  The Lancet Infectious Diseases ( 2024-5)
    Details
    In: The Lancet Infectious Diseases, Elsevier BV, ( 2024-5)
    Type of Medium: Online Resource
    ISSN: 1473-3099
    URL: Article
    DOI: 10.1016/S1473-3099(24)00226-3
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
    detail.hit.zdb_id: 2070985-7
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  • 10
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    1069. Psychometric Properties of the Symptoms of Infection with Coronavirus-19: A Patient-Reported Outcome Measure for COVID-19 Signs and Symptoms
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: The Symptoms of Infection with Coronavirus-19 (SIC), a patient reported outcome (PRO) measure, was developed to assess COVID-19 signs and symptoms. Qualitative and cross-sectional studies demonstrated its content validity and preliminary psychometric properties. This study provides additional evidence on the reliability, responsiveness, known-group validity, and meaningful change thresholds of the SIC using methods aligned with regulatory guidance and best practices. Methods Data were from ENSEMBLE-2, a multicenter, randomized, double-blind, placebo-controlled phase 3 trial to assess the efficacy and safety of Ad26.COV2.S for the prevention of SARS-CoV-2 infections in adults (aged 18+). The SIC was used in the trial to evaluate COVID-19 signs and symptoms and the Patient Global Impression of Severity (PGIS) was used as an anchor for validation. Intra-class correlations (ICCs) and Cronbach’s alphas were computed to evaluate the test-retest reliability and internal consistency, and analyses of variance (ANOVAs) were performed to assess the known-group validity of the SIC. Responsiveness was evaluated using PGIS as an anchor variable and a 1- or 2-point improvement in PGIS was used to estimate the meaningful change thresholds of the SIC. Results 183 participants with polymerase chain reaction (PCR) confirmed moderate to severe/critical COVID-19 were included (mean ± SD age: 51.5 ± 14.8 y; female: 44%; White 65%). ICCs showed strong test-retest reliabilities for most SIC domains (.60 and above). The internal consistency reliability of the SIC had a Cronbach’s alpha & gt; .70 for all but one domain (Neurological). Statistically significant differences (p values & lt; 0.05) for the different PGIS severity levels were found for all but one domain (Sensory), supporting known-group validity. All domains showed responsiveness based on changes (improvement and worsening) in PGIS, supporting the ability of the SIC to detect changes in COVID-19 signs and symptoms. Based on mean changes in the PGIS, estimated meaningful change thresholds for SIC domains ranged from -.36 to -2.11. Conclusion These results, based on data from ENSEMBLE-2, build upon prior cross-sectional analyses and provide additional supportive psychometric evidence on the SIC. Support: Janssen Vaccines & Prevention B.V. Disclosures Eric K. H. Chan, PhD, Janssen Global Services, LLC: Employee|Janssen Pharmaceuticals: Stocks/Bonds Jeffrey Stoddard, MD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Jerald Sadoff, MD, Janssen Vaccines & Prevention BV: Employee Yan Liu, PhD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Ilse van Dromme, PhD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Eva G. Katz, PhD, MPH, RD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Yi-hsuan Liu, PhD, MS, RD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Kelly McQuarrie, BSN, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.910
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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