The impact of herpes zoster and post-herpetic neuralgia on quality of life: patient-reported outcomes in six European countries

Introduction: A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). Objective: The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. Methods: This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. Results: During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (p < 0.0001), effects of kidney disease (p < 0.0001), and burden of kidney disease (p < 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (p < 0.0001). No significant differences in the number of symptoms (DSI, p = 0.1) were observed, although their severity decreased (p = 0.009). Conclusions: In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

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Gastrointestinal Symptoms of and Psychosocial Changes in Inflammatory Bowel Disease: A Nursing-Led Cross-Sectional Study of Patients in Clinical Remission

Medicina ◽

10.3390/medicina56010045 ◽

2020 ◽

Vol 56 (1) ◽

pp. 45 ◽

Cited By ~ 4

Author(s):

Rosellina Margherita Mancina ◽

Raffaele Pagnotta ◽

Caterina Pagliuso ◽

Vincenzo Albi ◽

Daniela Bruno ◽

...

Keyword(s):

Quality Of Life ◽

Patient Reported Outcomes ◽

Gastrointestinal Symptoms ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Patient Reported ◽

Inflammatory Bowel ◽

The Impact

Background and Objectives: Nursing management in Inflammatory Bowel Disease (IBD) is focused on global patient care. Starting from basic knowledge of diagnostic and therapeutic management, nurses can assess the impact of IBD on patients’ quality of life not only at the physical level, but also at the psychological, social, and emotional levels. The aim of this study was to evaluate the impact of gastrointestinal symptoms on psychosocial changes in IBD patients in remission through nursing-led Patient-Reported Outcomes. Materials and Methods: We performed a cross-sectional study of 109 IBD patients in clinical and endoscopic remission. Specialist nurses invited patients to complete questionnaires on gastrointestinal symptoms and quality of life through the Patient-Reported Outcomes Measurement Information System (PROMIS). Results: We found that the gastrointestinal symptoms that the patients reported had a significant impact on the analyzed aspects of health. More specifically, belly pain, diarrhea, and bloating were associated with depressive symptoms (p < 0.001), anxiety (p < 0.001), fatigue (p < 0.001), and sleep disturbances (p < 0.001). Moreover, these symptoms also significantly affected patients’ social dimension in terms of satisfaction with participation in social roles (p < 0.001, p < 0.05, and p < 0.001 for belly pain, diarrhea, and bloating, respectively) and physical functions (p < 0.001). The results were virtually the same in a multivariable analysis adjusted by age, gender, body mass index (BMI), and disease duration. Conclusions: Even during remission, gastrointestinal symptoms are the main factors that influence quality of life in IBD patients. This exploratory study highlights the need to adopt validated questionnaires in clinical practice, and demonstrates that PROMIS is a valid, objective, and standardized instrument that can help nursing staff to better define the consequences of the disease in a patient’s daily life.

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The impact of herpes zoster and post-herpetic neuralgia on quality-of-life

BMC Medicine ◽

10.1186/1741-7015-8-37 ◽

2010 ◽

Vol 8 (1) ◽

Cited By ~ 175

Author(s):

Robert W Johnson ◽

Didier Bouhassira ◽

George Kassianos ◽

Alain Leplège ◽

Kenneth E Schmader ◽

...

Keyword(s):

Quality Of Life ◽

Herpes Zoster ◽

Post Herpetic Neuralgia ◽

The Impact

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Healthcare utilization, quality of life and patient-reported outcomes during two years of GH replacement therapy in GH-deficient adults – comparison between Sweden, The Netherlands and Germany

Acta Endocrinologica ◽

10.1530/eje.1.02149 ◽

2006 ◽

Vol 154 (6) ◽

pp. 843-850 ◽

Cited By ~ 30

Author(s):

Bernhard Saller ◽

Anders F Mattsson ◽

Peter H Kann ◽

Hans P Koppeschaar ◽

Johan Svensson ◽

...

Keyword(s):

Quality Of Life ◽

Growth Hormone ◽

Replacement Therapy ◽

Healthcare Utilization ◽

Patient Reported Outcomes ◽

Gh Deficiency ◽

European Countries ◽

Gh Replacement ◽

Patient Reported

Objective: This study set out to determine the change in quality of life (QoL) and healthcare utilization during 2 years of growth hormone (GH) replacement therapy in adults with GH deficiency. Data were compared from three European countries. Design: Analysis was made from KIMS, the Pfizer International Metabolic Database on adult GH deficiency. Methods: QoL and healthcare utilization were measured at baseline and after 1 and 2 years of GH replacement in patient cohorts from Sweden (n = 302), The Netherlands (n = 103) and Germany (n = 98). QoL was assessed by the QoL-Assessment in Growth Hormone Deficient Adults (QoL-AGHDA) questionnaire, and the KIMS Patient Life Situation Form was used to evaluate healthcare utilization. Results: QoL improved significantly (P < 0.0001) and comparably in all three cohorts. The improvement was seen during the first year of treatment and QoL remained improved during the second year. The number of days in hospital was reduced by 83% (P < 0.0001) during GH replacement. There were no country-specific differences either at baseline or during follow-up. The same was true for the number of days of sick leave (reduction of 63%; P = 0.0004). Significant reductions were recorded in the number of doctor visits in each of the three cohorts after 2 years of GH replacement (P < 0.05). Conclusions: This study provides a detailed comparative analysis of GH replacement therapy in GHD patients in three European countries. Despite some differences in treatment strategies, the beneficial effects on QoL, patient-reported outcomes and healthcare utilization are essentially similar in the healthcare environment of Western European countries.

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Identifying Patient-Reported Outcomes in Rheumatoid Arthritis: The Impact of Foot Symptoms on Self-Perceived Quality of Life

Musculoskeletal Care ◽

10.1002/msc.1001 ◽

2012 ◽

Vol 10 (2) ◽

pp. 65-75 ◽

Cited By ~ 13

Author(s):

S. J. Otter ◽

K. Lucas ◽

K. Springett ◽

A. Moore ◽

K. Davies ◽

...

Keyword(s):

Quality Of Life ◽

Rheumatoid Arthritis ◽

Patient Reported Outcomes ◽

Perceived Quality ◽

Perceived Quality Of Life ◽

Patient Reported ◽

The Impact

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The Impact of Asthma on Quality-of-Life (QoL) and Other Patient-Reported Outcomes: The Patient's Perspective

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2005.12.1067 ◽

2006 ◽

Vol 117 (2) ◽

pp. S270

Author(s):

S.P. McKenna ◽

D.M. Meads ◽

K.M. Beusterien ◽

R. Flood ◽

H. Lau ◽

...

Keyword(s):

Quality Of Life ◽

Patient Reported Outcomes ◽

Patient’S Perspective ◽

Patient Reported ◽

The Impact

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Health-related quality of life/patient-reported outcomes in relapsed ovarian cancer: Results from a randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.5526 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 5526-5526

Author(s):

C. N. Krasner ◽

A. Poveda ◽

T. Herzog ◽

J. Vermorken ◽

B. Monk ◽

...

Keyword(s):

Quality Of Life ◽

Ovarian Cancer ◽

Health Status ◽

Patient Reported Outcomes ◽

Phase Iii ◽

Gi Symptoms ◽

Patient Reported ◽

Phase Iii Study ◽

The Impact

5526 Background: In an open-label, multicenter, randomized phase III study comparing the combination of trabectedin and PLD to PLD alone in patients with relapsed ovarian cancer, the combination demonstrated significantly improved progression free survival and response rates, manageable non-cumulative toxicity, and fewer PLD-associated adverse events. We studied the impact of the combination of trabectedin with PLD on the quality of life (QoL)/patient-reported outcomes (PRO) evaluated as part of the trial. Methods: QoL/PRO questionnaires, EORTC-QLQ C30, OV28, and EQ-5D were completed by patients at screening and on Day 1 of every other treatment cycle starting with Cycle 1, and at the end-of-treatment visit. Global health status/QoL, fatigue, rain subscales from QLQ C30, and abdominal pain/GI symptoms scale from OV28 were chosen a priori for primary analyses. Other scales of the three questionnaires were analyzed on a supportive basis. Results: A total of 672 patients were randomized. 663 (98%) completed at least the baseline questionnaires. Median cycles of treatment was 6 (131 days) for the combination arm and 5 (143 days) for the monotherapy arm. Mixed effects models (using a covariance structure of AR[1]) predicting the score at baseline and follow-up scores as a function of treatment, days after baseline, and interaction between treatment and days after baseline showed no significant differences between the treatment arms for any of the prespecified scales. Similar analyses of other scales, including EQ-5D Health Index scores and Health State on the Visual Analog Scale, support the findings. Conclusions: The addition of trabectedin to PLD results in superior efficacy in patients with relapsed ovarian cancer, with no added decrement to overall health status as assessed by PRO. [Table: see text]

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TOUCH® Patient Reported Outcomes Study: The Impact of Natalizumab on Common Measures of Quality of Life in CD patients

Inflammatory Bowel Diseases ◽

10.1097/00054725-201212001-00097 ◽

2012 ◽

Vol 18 ◽

pp. S41-S42

Author(s):

Sunanda Kane ◽

Arpita Nag ◽

Lori Taylor ◽

Gary Hogge ◽

Jean-Frédéric Colombel ◽

...

Keyword(s):

Quality Of Life ◽

Patient Reported Outcomes ◽

Patient Reported ◽

Outcomes Study ◽

The Impact

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The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

Journal of Clinical Oncology ◽

10.1200/jco.2007.13.3439 ◽

2008 ◽

Vol 26 (8) ◽

pp. 1355-1363 ◽

Cited By ~ 378

Author(s):

Carolyn C. Gotay ◽

Crissy T. Kawamoto ◽

Andrew Bottomley ◽

Fabio Efficace

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Patient Reported Outcomes ◽

Prognostic Significance ◽

Cancer Clinical Trials ◽

Life Questionnaire ◽

European Organization ◽

Patient Reported ◽

The Impact

Purpose Patient-reported outcomes (PROs), routinely collected as a part of cancer clinical trials, have been linked with survival in numerous clinical studies, but a comprehensive critical review has not been reported. This study systematically assessed the impact of PROs on patient survival after a cancer diagnosis within the context of clinical trials. Design Cancer clinical trials that assessed baseline PROs and mortality were identified through MEDLINE (through December 2006) supplemented by the Cochrane database, American Society of Clinical Oncology/European Society for Medical Oncology abstracts and hand searches. Inclusion criteria were publication in English language and use of multivariate analyses of PROs that controlled for one or more clinical factors. Two raters reviewed each study, abstracted data, and assessed study quality; two additional raters verified abstractions. Results In 36 of 39 studies (N = 13,874), at least one PRO was significantly associated with survival (P < .05) in multivariate analysis, with varying effect sizes. Studies of lung (n = 12) and breast cancer (n = 8) were most prevalent. The most commonly assessed PRO was quality of life, measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 in 56% of studies. Clinical variables adjusted for included performance status (PS), treatment arm, stage, weight loss, and serum markers. Results indicated that PROs provide distinct prognostic information beyond standard clinical measures in cancer clinical trials. Conclusion PROs might be considered for stratification purposes in future trials, as they were often better predictors of survival than PS. Studies are needed to determine whether interventions that improve PROs also increase survival and to identify explanatory mechanisms through which PROs relate to survival.

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