scholarly journals Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older

2018 ◽  
Vol 74 (8) ◽  
pp. 1231-1238 ◽  
Author(s):  
Desmond Curran ◽  
Lidia Oostvogels ◽  
Thomas Heineman ◽  
Sean Matthews ◽  
Janet McElhaney ◽  
...  

Abstract Background To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life. Methods The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined. Results The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset. Conclusions Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients’ utility loss.

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S980-S981
Author(s):  
Kenneth E Schmader ◽  
Myron J Levin ◽  
Michael Chen ◽  
Sean Matthews ◽  
Megan Riley ◽  
...  

Abstract Background The adjuvanted recombinant zoster vaccine (RZV) is efficacious in preventing herpes zoster in adults ≥ 50 years. The current study investigates whether the vaccinees’ quality of life (QoL) and physical functioning (PF) are impacted by local and systemic reactions due to RZV. In a previous report of this phase III, open-label, multicenter study (NCT02979639), overall PF and QoL were not significantly affected by a first RZV dose. [1] Here we report the results from the same study after a second RZV dose and safety results from dose 1 up to study end. Methods Adults aged ≥ 50 years were to receive 2 doses of RZV 2 months apart. Changes in mean Short Form health survey (SF-36) PF score between pre- and post-each RZV dose for 7 days, QoL, reactogenicity and safety were assessed. Results 401 adults received dose 1 and 391 received dose 2 of RZV. Post-second RZV dose, the reported solicited local symptoms were pain (75.1%), erythema (22.4%) and swelling (13.9%), and the most frequent solicited systemic symptoms were fatigue (46.3%), headache (37.5%) and myalgia (32.9%). Grade 3 solicited symptoms were reported by 7.2% (local) and 11.1% (general) of participants, and 5 (1.2%) participants reported reactogenicity triggering medical attention post-second RZV dose. From first dose up to study end, 14 (3.5%) participants reported 21 serious adverse events, none related to RZV. In days 1–2, post-second RZV dose, a transient, clinically-important decrease in SF-36 PF score (table) was seen in those reporting grade 3 solicited symptoms, which impacted activities such as walking and climbing stairs. Overall, during the 7 days post-second RZV dose, a mean change of −0.4 points was observed from the mean baseline score, indicating the PF was not clinically meaningfully impacted. No overall quality-adjusted-life-year loss was recorded. Conclusion Overall, the QoL and PF of adults ≥ 50 years were not affected post-second RZV dose; a transient impact was observed in adults with grade 3 reactogenicity. These results and the observed reactogenicity and safety profile are consistent with first RZV dose results, as well as that of previous studies with the RZV vaccine in adults of similar age. Funding: GlaxoSmithKline Biologicals SA. 1. Schmader et al., Abstract 2488, IDWeek 2018 Disclosures All authors: No reported disclosures.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S3-S4
Author(s):  
Joon Hyung Kim ◽  
Robert Johnson ◽  
Martina Kovac ◽  
Anthony L Cunningham ◽  
Srikanth Emmadi ◽  
...  

Abstract Background Older and immunocompromised adults are at increased risk for herpes zoster (HZ) and often experience persistent, severe HZ-related pain, impacting their quality of life and activities of daily living. High vaccine efficacy (VE) of the adjuvanted recombinant zoster vaccine (RZV) in preventing HZ and reducing severe and clinically significant HZ-related pain has been shown in adults ≥ 50 years of age (YOA; ZOE-50 study; NCT01165177), ≥ 70 YOA (ZOE-70; NCT01165229) and ≥ 18 YOA undergoing autologous hematopoietic stem cell transplantation (ZOE-HSCT; NCT01610414). Methods In patients with confirmed HZ from the above phase III, randomized, placebo-controlled studies, we analyzed VE of RZV in reducing the duration of clinically significant HZ-related pain and in reducing the use and duration of HZ-related pain medication. Pain was assessed by the Zoster Brief Pain Inventory (ZBPI). Use of all HZ-related medication was recorded. Results VE in reducing the duration of clinically significant HZ-related pain (ZBPI pain score ≥3) during HZ episodes was 38.5% (p-value: 0.0099) in RZV-vaccinated patients from the ZOE-HSCT study compared to placebo. A similar trend (not statistically significant) was observed in the ZOE-50 (VE: 26.9%; p-value: 0.4318) and ZOE-70 (VE: 28.4%; p-value: 0.1877) studies. VE in reducing the use (Table 1) and duration (Table 2) of HZ-related pain medication was 39.6% (p-value: 0.0083) and 49.3%(p-value: 0.0404), respectively, in the ZOE-70 study; corresponding positive VE estimates were also seen in the ZOE-50 and ZOE-HSCT studies. Non-opioids were used by 61.2%, 44.3% and 22.1% of patients in the ZOE-50, ZOE-70 and ZOE-HSCT studies, respectively; weak opioids by 18.6%, 13.0% and 10.8% of patients, and strong opioids by 8.0%, 2.0% and 5.3% of patients (Table 3). Table 1. Reduction in the use of HZ-related pain medication in patients with confirmed HZ Table 2. Reduction in the duration of HZ-related pain medication use in patients with confirmed HZ Table 3. HZ-related medication types in patients with confirmed HZ Conclusion In addition to a high VE in preventing HZ in these studies, we also observed an attenuation of HZ-related pain, and thus lower use and duration of pain medication in breakthrough cases after RZV vaccination, thereby potentially improving patient quality of life. Funding: GlaxoSmithKline Biologicals SA Acknowledgment: Kristel Vercauteren/Sander Hulsmans (Modis c/o GSK) provided medical writing/editorial support Disclosures Joon Hyung Kim, MD, GSK (Employee, Shareholder) Robert Johnson, MD, FRCA, GSK (Other Financial or Material Support, I accept no fees but have had expense reimbursement in the past.) Martina Kovac, MD, GSK (Other Financial or Material Support, I was an employee of GSK at the time of the study) Anthony L. Cunningham, MBBS, MD, FRACP, FRCPA, GSK (Consultant) Srikanth Emmadi, MSc, GSK (Employee) Keith Sullivan, MD, FASTCT, GSK (Consultant) Alemnew F. Dagnew, MD, GSK group of companies (Employee, Shareholder) Desmond Curran, PhD, GSK (Employee, Shareholder) Anne Schuind, MD, GSK (Employee, Other Financial or Material Support, own GSK stock options or restricted shares as part of renumeration)


Author(s):  
Wei Yu ◽  
Jie Tong ◽  
Xirong Sun ◽  
Fazhan Chen ◽  
Jie Zhang ◽  
...  

Background: Factors related to medication adherence in patients with schizophrenia have always been key to the treatment and rehabilitation of these patients. However, the treatment modes in different countries are not the same, and there is no research on the factors influencing medication adherence under different mental health service modes. Objectives: The purpose of this study was to explore medication adherence and its influencing factors in patients with schizophrenia in the Chinese institutional environment. Methods: We conducted a cross-sectional study of hospitalized persons living with schizophrenia from November 2018 to January 2019. A systematic sampling method was used to select 217 hospitalized persons living with schizophrenia. The Medication Adherence Rating Scale (MARS), Positive and Negative Syndrome Scale (PANSS), General Self-Efficacy Scale (GSES), Schizophrenia Quality of Life Scale (SQLS), and Scale of Social Skills for Psychiatric Inpatients (SSPI) were used to explore medication compliance and its influencing factors in the Chinese institutional environment. Results: The descriptive analysis and ANOVA showed that there were no significant differences in medication adherence when assessed by demographic characteristics such as sex, marital status, and education level (p > 0.05). A correlation analysis showed that there was no significant correlation between medication adherence and mental symptoms (p > 0.05) but that there was a positive correlation with self-efficacy, quality of life, and activities of daily living (p < 0.01). The linear regression analysis showed that self-efficacy, psychosocial factors, symptoms/side effects, and activities of daily living had significant effects on medication adherence (F = 30.210, p < 0.001). Conclusions: Our findings show that the self-efficacy, quality of life, and social function of patients with schizophrenia are important self-factors influencing medication adherence in the Chinese institutional environment.


2021 ◽  
pp. 026921552199517
Author(s):  
Runze Li ◽  
Yanran Zhang ◽  
Yunxia Jiang ◽  
Mengyao Wang ◽  
Wei How Darryl Ang ◽  
...  

Objective: To examine the effectiveness of rehabilitation training based on virtual reality in improving balance, quality of life, activities of daily living, and depressive symptoms of patients with Parkinson’s disease. Data sources: PubMed, EMBASE, CINAHL, Scopus, Cochrane Library, PsycINFO, ProQuest, Physiotherapy Evidence Database, IEEE Xplore, China National Knowledge Infrastructure, Wanfang, and VIP Information databases were searched from their inception to October 15, 2020. Trial registries, gray literature, and target journals were also searched. Methods: Eligible randomized controlled trials included studies with patients with Parkinson’s disease in rehabilitation training based on virtual reality. Comprehensive Meta-Analysis 3.0 software was used. Physiotherapy Evidence Database Scale and the Grading of Recommendation, Assessment, Development, and Evaluation system were used to assess the methodological quality of individual trials and the overall quality of the evidence, respectively. Results: A total of 22 randomized controlled trials with 836 patients were included. Meta-analysis revealed that training significantly improved balance ( g = 0.66, P < 0.001), quality of life ( g = 0.28, P = 0.015), activities of daily living ( g = 0.62, P < 0.001), and depressive symptoms ( g = 0.67, P = 0.021) compared to the control group. Subgroup analysis indicated that training should utilize video game consoles. Meta-regression analyses showed that age, sessions, and frequency of training had statistically significant impacts on balance scores. Quality of individual trials was high and overall evidence ranged from very low to low. Conclusion: Virtual rehabilitation training could be adopted in healthcare institutions as supplementary training for patients with Parkinson’s disease.


2014 ◽  
Vol 51 (1) ◽  
pp. 25-28 ◽  
Author(s):  
Denis PAJECKI ◽  
Marco Aurélio SANTO ◽  
Ana Lumi KANAGI ◽  
Daniel RICCIOPPO ◽  
Roberto de CLEVA ◽  
...  

Context Obesity in the elderly is associated with exacerbation of functional decline (dependency), that occurs with aging, because of decreased muscle mass and strength, and increased joint dysfunction. Consequently, there is progressive loss of independence, autonomy, chronic pain and impaired quality of life. The weight loss can bring benefits in all these aspects, especially when accompanied by exercises. Elderly patients with morbid obesity may be submitted to surgical treatment, taking into account that the massive weight loss, eventually caused by bariatric surgery, may exacerbate the loss of muscle mass and nutritional complications that may bring harm to the overall health and quality of life of these patients. The functional assessment of elderly patients, candidates for bariatric surgery and the extent to which surgery can bring benefits to the patients, in the field of functionality, has still to be determined. Objective To describe profile functionality in obese elderly referred to a bariatric surgery program. Methods Patients with age ≥60 and BMI ≥35 underwent comprehensive geriatric assessment that evaluates co morbidities, medication use, ability to perform basic activities of daily living and instrumental activities of daily living, and the “Timedupandgo” test to evaluate mobility, whose cut-off point was ≤10 seconds. Statistical analysis was performed in order to see if there is a positive correlation of dependency with BMI and age (over or under 65 years). Results Forty subjects have completed evaluation. The mean age was 64.1 years (60-72) and 75% were women. They had an average weight of 121.1 kg (72.7-204) and a mean BMI of 47.2 kg/m2 (35.8-68.9). 16 patients (40%) have shown dependency for activities of daily living, 19 (47,5%) for instrumental activities of daily living and 20 patients (50%) had a “Timedupandgo” test over 10 seconds. Statistical analysis (t-Student, Mann-Whitney, Binary Logistic Regression) has shown positive correlation of dependency in activities of daily living for BMI >49 kg/m2, dependency in instrumental activities of daily living for BMI >46,5 kg/m2, and “Timedupandgo” test greater than 10 seconds for BMI >51 kg/m2 (P<0,05). No dependency difference was observed for patients over or under 65 years age. Conclusions Functional decline is observed in almost half of the morbid obese patients over 60 years old. It is related to increasing BMI (BMI >46,5 kg/m2) but not related to age (60 to 65 years or over 65 years). Functional decline should be considered a co-morbidity in the elderly obese patients and should be assessed before bariatric surgery in this population.


2014 ◽  
Vol 26 (8) ◽  
pp. 1283-1293 ◽  
Author(s):  
Clarissa M. Giebel ◽  
Caroline Sutcliffe ◽  
Minna Stolt ◽  
Staffan Karlsson ◽  
Anna Renom-Guiteras ◽  
...  

ABSTRACTBackground:Performing basic activities of daily living (ADLs) is one of the major difficulties encountered in dementia, which can have considerable negative impacts on the quality of life (QoL) of people with dementia (PwD). However, the extent to which basic ADL performance deteriorates across mild, moderate, and severe dementia is little examined and its impact, together with depression and neuropsychiatric behavior, upon QoL, is of considerable relevance across European countries.Methods:Data were drawn from people living in the community who were participants in a large-scale European study on transition from community living to care homes of PwD. PwD completed measures on cognitive functioning and QoL, and informal carers reported upon QoL, depressive symptomatology, psychopathology, and functional ability of the PwD.Results:ADL performance deteriorated differently for each activity. In particular, toileting, transfer, and feeding remained relatively intact throughout, whereas performance on bathing and dressing deteriorated to a greater extent from mild to severe dementia. It appears that continence was not affected by the stage of dementia with similar levels of impairment. Basic ADL performance impacted to different degrees on QoL across dementia stages and countries.Conclusions:Interventions aimed at maintaining independence or QoL need to target different ADLs across different dementia stages and perhaps also tailor interventions to the context of different countries. Findings contribute to the development of non-pharmaceutical interventions and governmental pledges to promote independence in dementia.


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