scholarly journals Real-world data of the association between quality of life using the EuroQol 5 Dimension 5 Level utility value and adverse events for outpatient cancer chemotherapy

2020 ◽  
Vol 28 (12) ◽  
pp. 5943-5952
Author(s):  
Chiemi Hirose ◽  
Hironori Fujii ◽  
Hirotoshi Iihara ◽  
Masashi Ishihara ◽  
Minako Nawa-Nishigaki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Logistic Regression ◽  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Cancer Chemotherapy ◽  
Proportional Odds ◽  
Utility Value ◽  
Serious Adverse Events ◽  
Outpatient Chemotherapy

Abstract Background Outpatient cancer chemotherapy may lead to improved quality of life (QOL) by allowing treatment to continue without impairing the social lives of patients compared with hospitalization. However, the occurrence of serious adverse events may cause a decline in QOL. We investigated the relationship between outpatient chemotherapy–induced adverse events and QOL. Methods A single-center retrospective descriptive study was conducted in patients who received outpatient chemotherapy at Gifu University Hospital (Gifu, Japan) between September 2017 and December 2018. The utility values of QOL, type and severity of adverse events, type of cancer, chemotherapy regimen, and other patient demographics were analyzed. Adverse events were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. QOL was evaluated using the Japanese version of the EuroQol 5 Dimension 5 Level (EQ-5D-5L). Associations between the EQ-5D-5L utility value and serious adverse events were assessed using adjusted (age and sex) odds ratios obtained with a proportional odds logistic regression model. Results Data from 1008 patients who received 4695 chemotherapy cycles were analyzed. According to proportional odds logistic regression, the adverse events that significantly correlated with a decreased EQ-5D-5L utility value were malaise, edema of the limbs, peripheral neuropathy, pruritus, and dry skin. Based on the proportional odds logistic analysis, neither cancer type nor anticancer drugs were significantly correlated with the EQ-5D-5L utility value in patients who received chemotherapy. Pharmaceutical care for peripheral neuropathy significantly improved patients’ EQ-5D-5L utility value from 0.747 to 0.776 (P < 0.01). Conclusions Adverse events (i.e., peripheral neuropathy, malaise, and edema of the limbs) are significantly correlated with a decrease in QOL, regardless of the type of cancer or anticancer drugs used. Pharmaceutical care provided by pharmacists in collaboration with physicians may improve QOL.

scholarly journals Anorexia, pain and peripheral neuropathy are associated with a decrease in quality of life in patients with advanced pancreatic cancer receiving outpatient chemotherapy — a retrospective observational study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Hironori Fujii ◽  
Maaya Koda ◽  
Shiori Sadaka ◽  
Koichi Ohata ◽  
Hiroko Kato-Hayashi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Logistic Regression ◽  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Advanced Pancreatic Cancer ◽  
Utility Value ◽  
Pharmaceutical Intervention ◽  
Outpatient Chemotherapy

Abstract Background Cancer chemotherapy usually improves clinical outcomes in patients with advanced pancreatic cancer (APC), but can also cause moderate-to-severe adverse events (AEs). We investigated the relationship between moderate-to-severe AEs and quality of life (QOL) in patients with APC who received outpatient chemotherapy. Methods We recruited APC patients who received outpatient chemotherapy in Gifu University Hospital between September 2017 and December 2018. Adverse events related to chemotherapy were assessed by a pharmacist collaborating with a physician using common terminology criteria for AEs (CTCAE) ver 4.0, and QOL of patients was self-assessed by patients using the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L Japanese edition 2). Associations between the EQ-5D-5L utility value and serious AEs were assessed using proportional odds logistic regression. Results A total of 59 patients who received 475 chemotherapy cycles were included. The proportional odds logistic regression indicated that grade ≥ 2 anorexia, pain and peripheral neuropathy were significantly correlated with a decreased EQ-5D-5L utility value. Pharmaceutical intervention for these AEs significantly improved the patients’ EQ-5D-5L utility value. Conclusions Anorexia, pain and peripheral neuropathy were significantly associated with a decrease in QOL. It is assumed that appropriate pharmaceutical intervention with particular emphasis on these AEs can improve the QOL of pancreatic cancer patients receiving outpatient chemotherapy.

scholarly journals Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea

2019 ◽  
Vol 55 (1) ◽  
pp. 1901320 ◽  
Author(s):  
Peter R. Eastwood ◽  
Maree Barnes ◽  
Stuart G. MacKay ◽  
John R. Wheatley ◽  
David R. Hillman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Nerve Stimulation ◽  
Hypoglossal Nerve ◽  
Sleep Apnoea ◽  
Serious Adverse Events ◽  
Obstructive Sleep ◽  
Device Use ◽  
Post Implantation

Background and aimHypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.MethodsThis prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea–hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604.Results22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m−2) completed the protocol. At 6 months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1 events·h−1, a mean change of 10.8 events·h−1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h−1, a mean change of 9.3 events·h−1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.ConclusionsBilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.

scholarly journals Innovative Approach for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Pilot Study With the Hilotherm Device, the Poliambulanza Hospital Experience

2020 ◽  
Vol 19 ◽  
pp. 153473542094328
Author(s):  
Ester Oneda ◽  
Fausto Meriggi ◽  
Laura Zanotti ◽  
Elisabetta Zaina ◽  
Sara Bighè ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Negative Impact ◽  
Life Questionnaire ◽  
European Organization ◽  
Effective Prevention ◽  
The Common ◽  
Hands And Feet

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse event of taxanes, with no effective prevention or treatment available and a highly negative impact on patient quality of life. The aim of this study is to asses that the constant application of cooled cuffs on the hands and feet prevent and mitigate CIPN. Methods: Patients with breast, gynecologic, and pancreatic cancer who received weekly paclitaxel (PTX), PTX/carboplatin, and nab-paclitaxel (nab-PTX)/gemcitabine for any indication at the therapeutic scheduled dosage were included in this prospective study. Hilotherm Chemo care device forms a closed-loop system with cuffs and tubes through which a coolant flows at a temperature of 10 °C. CIPN was monitored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (edition 3.0), and the tolerability and side effects were scored by using the Common Terminology Criteria for Adverse Events (T4.03 2017). Results: To date, we have enrolled 64 patients. Of these, 54 (84%) completed all cooling cycles. Continuous cooling was well tolerated by all patients. No patients had grade >2 CIPN or had serious or lasting adverse events as a result of Hilotherapy. The median time to CIPN onset was 77 days for the entire population. Conclusion: Hilotherapy has good effectiveness and tolerability and seems to be able to prevent or reduce the symptoms of CIPN. We are still recruiting patients to obtain more data and to collect data at 3 months after the end of chemotherapy. Prospective studies seem to be warranted.

scholarly journals Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events

Cancers ◽  
2017 ◽  
Vol 9 (12) ◽  
pp. 73 ◽  
Author(s):  
Sidra Anwar ◽  
Wei Tan ◽  
Chi-Chen Hong ◽  
Sonal Admane ◽  
Askia Dozier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Solid Tumors ◽  
Phase 1 ◽  
Advanced Solid Tumors ◽  
Serious Adverse Events ◽  
Phase 1 Trial

scholarly journals Safety of Denervation Following Targeted Lung Denervation Therapy for COPD: AIRFLOW-1 Three-year Outcomes

2020 ◽  
Author(s):  
Christophe Pison ◽  
Pallav Shah ◽  
Dirk-Jan Slebos ◽  
Vincent Ninane ◽  
Wim Janssens ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Adverse Events ◽  
Late Onset ◽  
Open Label ◽  
Serious Adverse Events ◽  
Copd Exacerbations ◽  
Clinical Consequences

Abstract Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over three years of follow up.Methods: TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at one, two, and three years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results: Three-year follow-up data were available for 73.9% of patients (n=34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over three years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion: TLD in COPD patients demonstrated a positive safety profile out to three years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over three years of follow up.

scholarly journals The effectiveness of combination of 7% hypertonic saline and 0.1% natrii hyaluronas in patients with chronic obstructive pulmonary disease who have suffered a new coronavirus infection

2021 ◽  
pp. 85-91
Author(s):  
O. N. Titova ◽  
N. A. Kuzubova ◽  
D. B. Skliarova ◽  
A. L. Aleksandrov ◽  
N. V. Egorova
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Hypertonic Saline ◽  
Chronic Obstructive ◽  
Hypertonic Solution ◽  
Shortness Of Breath ◽  
Serious Adverse Events ◽  
Obstructive Pulmonary Disease ◽  
Coronavirus Infection

Introduction. New coronavirus infection (COVID-19) contributes to the aggravation of respiratory symptoms in patients with COPD, including affecting the intensity and nature of cough. Hypertonic solution (HS) has a positive effect on the rheological properties of sputum and mucociliary clearance. However, there are no studies in the available literature on the use of HS in patients who have undergone COVID-19.Goal. To evaluate the effect of the combination of 7% hypertonic saline and 0.1% natrii hyaluronas on the intensity and productive nature of cough in patients with COPD who have undergone a new coronavirus infection and the safety of its use in this cohort of patients.Materials and methods. 50 patients with severe COPD in remission who suffered a new coronavirus infection were examined. The rehabilitation stage of treatment was carried out in the conditions of the pulmonology department. From the moment of receiving the last negative PCR result for SARS-CoV-2 to admission to the hospital for rehabilitation, it took from 2 to 3 weeks. The duration of follow-up of patients was 10 days. The patients were divided into two groups: group 1 (n = 25) – patients who received combination of 7% hypertonic saline and 0.1% natrii hyaluronas 7% by inhalation through a nebulizer; group 2 (n = 25) – patients who did not receive combination of 7% hypertonic saline and 0.1% natrii hyaluronas. The severity of cough was assessed (cough severity scale; shortness of breath, cough and sputum scale), clinical and biochemical blood tests, ECG, spirometry.Results. In patients treated with combination of 7% hypertonic saline and 0.1% natrii hyaluronas, a significant decrease in the severity of cough, the amount of sputum was revealed. The tendency to reduce shortness of breath and improve the quality of life is determined. No serious adverse events were detected when using the drug.Conclusions. The use of the combination of 7% hypertonic saline and 0.1% natrii hyaluronas in patients with COPD who have suffered a new coronavirus infection at the rehabilitation stage leads to a decrease in the intensity of cough and improved sputum discharge, which helps to reduce the severity of shortness of breath and improve the quality of life. The use of the drug is safe and does not lead to clinically significant adverse events.

scholarly journals Ordinal logistic regression models: application in quality of life studies

2008 ◽  
Vol 24 (suppl 4) ◽  
pp. s581-s591 ◽  
Author(s):  
Mery Natali Silva Abreu ◽  
Arminda Lucia Siqueira ◽  
Clareci Silva Cardoso ◽  
Waleska Teixeira Caiaffa
Keyword(s):  
Quality Of Life ◽  
Logistic Regression ◽  
Regression Models ◽  
Goodness Of Fit ◽  
Ordinal Logistic Regression ◽  
Proportional Odds Model ◽  
Outcome Variable ◽  
Proportional Odds ◽  
Logistic Regression Models

Quality of life has been increasingly emphasized in public health research in recent years. Typically, the results of quality of life are measured by means of ordinal scales. In these situations, specific statistical methods are necessary because procedures such as either dichotomization or misinformation on the distribution of the outcome variable may complicate the inferential process. Ordinal logistic regression models are appropriate in many of these situations. This article presents a review of the proportional odds model, partial proportional odds model, continuation ratio model, and stereotype model. The fit, statistical inference, and comparisons between models are illustrated with data from a study on quality of life in 273 patients with schizophrenia. All tested models showed good fit, but the proportional odds or partial proportional odds models proved to be the best choice due to the nature of the data and ease of interpretation of the results. Ordinal logistic models perform differently depending on categorization of outcome, adequacy in relation to assumptions, goodness-of-fit, and parsimony.

scholarly journals Glucocorticosteroids for people with alcoholic hepatitis (Cochrane review)

2019 ◽  
Vol 91 (8) ◽  
pp. 52-66
Author(s):  
Chavdar S Pavlov ◽  
Daria L Varganova ◽  
Giovanni Casazza ◽  
Emmanuel Tsochatzis ◽  
Dimitrinka Nikolova ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Alcoholic Hepatitis ◽  
Health Related Quality ◽  
Serious Adverse Events ◽  
Adult Participants ◽  
All Cause Mortality ◽  
Related Quality ◽  
Health Related

Alcoholic hepatitis (AH) is a form of alcoholic liver disease. Glucocorticosteroids (GCS) are used as anti - inflammatory drugs for people with alcoholic hepatitis. Aim. To assess the benefits and harms of GCS in people with AH. Material and methods. We identified trials through electronic searches in Cochrane Hepato-Biliary's (CHB) Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, and Science Citation Index Expanded. We considered for inclusion randomised clinical trials (RCTs) assessing GCS versus placebo/no intervention in adult participants with AH. We allowed co - interventions in the trial groups if they were similar. We followed Cochrane methodology, CHB Group methodology using Review Manager 5 and Trial Sequential Analysis(TSA) to perform meta - analysis (M-A), assessed bias risk of the trials, certainty of evidence using GRADE. Results and discussion. Sixteen trials fulfilled the inclusion criteria. Fifteen trials provided data for analysis (927 participants received GCS, 934 - placebo/no intervention). The GCS were administered to adult participants at different stages of AH orally or parenterally for a median of 28 days. There was no evidence of effect of GCCs on our primary outcomes all - cause mortality up to 3 months following randomisation (RR 0.90, 95% CI 0.70-1.15; n=1861), on health - related quality of life (MD - 0.04 points; 95% CI -0.11-0.03; n=377; trial = 1) (EQ-5D-3L scale), on the occurrence of serious adverse events during treatment (RR 1.05, 95% CI 0.85-1.29; n=1861). We found no evidence of a difference between the intervention groups. The risk of bias was high in all the trials except one. The certainty of evidence was very low or low. One of the trials seems to be not industry - funded. Conclusion. We found no evidence of a difference between GCS and placebo or no intervention on all - cause mortality, health - related quality of life, and serious adverse events during treatment. We cannot exclude increases in adverse events and cannot rule out significant benefits and harms of GCSs. Future trials ought to report depersonalised individual participant data.

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