scholarly journals The effectiveness and cost-effectiveness of erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating cancer treatment-induced anaemia (including review of technology appraisal no. 142): a systematic review and economic model

2016 ◽  
Vol 20 (13) ◽  
pp. 1-588 ◽  
Author(s):  
Louise Crathorne ◽  
Nicola Huxley ◽  
Marcela Haasova ◽  
Tristan Snowsill ◽  
Tracey Jones-Hughes ◽  
...  

BackgroundAnaemia is a common side effect of cancer treatments and can lead to a reduction in quality of life. Erythropoiesis-stimulating agents (ESAs) are licensed for use in conjunction with red blood cell transfusions to improve cancer treatment-induced anaemia (CIA).ObjectiveTo investigate the effectiveness and cost-effectiveness of ESAs in anaemia associated with cancer treatment (specifically chemotherapy).Data sourcesThe following databases were searched from 2004 to 2013: The Cochrane Library, MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Web of Science, Cumulative Index to Nursing and Allied Health Literature, British Nursing Index, Health Management Information Consortium, Current Controlled Trials and ClinicalTrials.gov. The US Food and Drug Administration and European Medicines Agency websites were also searched. Bibliographies of included papers were scrutinised for further potentially includable studies.Review methodsThe clinical effectiveness review followed principles published by the NHS Centre for Reviews and Dissemination. Randomised controlled trials (RCTs), or systematic reviews of RCTs, of ESAs (epoetin or darbepoetin) for treating people with CIA were eligible for inclusion in the review. Comparators were best supportive care, placebo or other ESAs. Anaemia- and malignancy-related outcomes, health-related quality of life (HRQoL) and adverse events (AEs) were evaluated. When appropriate, data were pooled using meta-analysis. An empirical health economic model was developed comparing ESA treatment with no ESA treatment. The model comprised two components: one evaluating short-term costs and quality-adjusted life-years (QALYs) (while patients are anaemic) and one evaluating long-term QALYs. Costs and benefits were discounted at 3.5% per annum. Probabilistic and univariate deterministic sensitivity analyses were performed.ResultsOf 1457 titles and abstracts screened, 23 studies assessing ESAs within their licensed indication (based on start dose administered) were included in the review. None of the RCTs were completely aligned with current European Union licenses. The results suggest a clinical benefit from ESAs for anaemia-related outcomes and an improvement in HRQoL scores. The impact of ESAs on AEs and survival remains highly uncertain, although point estimates are lower, confidence intervals are wide and not statistically significant. Base-case incremental cost-effectiveness ratios (ICERs) for ESA treatment compared with no ESA treatment ranged from £19,429 to £35,018 per QALY gained, but sensitivity and scenario analyses demonstrate considerable uncertainty in these ICERs, including the possibility of overall health disbenefit. All ICERs were sensitive to survival and cost.LimitationsThe relative effectiveness of ESAs was not addressed; all ESAs were assumed to have equivalent efficacy. No studies were completely aligned with their European labelling beyond the starting dose evaluated. There is questionable generalisability given that the included trials were published > 20 years ago and there have been many changes to chemotherapy as well as to the quality of supportive treatment. Trial quality was moderate or poor and there was considerable unexplained heterogeneity for a number of outcomes, particularly survival, and evidence of publication bias. Adjustments were not made to account for multiple testing.ConclusionsESAs could be cost-effective when used closer to licence, but there is considerable uncertainty, mainly because of unknown impacts on overall survival.Study registrationThis study is registered as PROSPERO CRD42013005812.FundingThe National Institute for Health Research Health Technology Assessment programme.

2002 ◽  
Vol 18 (3) ◽  
pp. 497-507 ◽  
Author(s):  
Andrew Clegg ◽  
Jackie Bryant ◽  
Tricia Nicholson ◽  
Linda McIntyre ◽  
Sofie De Broe ◽  
...  

Objectives: Systematic review of the clinical and cost-effectiveness of donepezil, rivastigmine, and galantamine for people suffering from Alzheimer's disease.Methods: Sixteen electronic databases (including MEDLINE, the Cochrane Library, and Embase) and bibliographies of related papers were searched for published/unpublished English language studies, and experts and pharmaceutical companies were consulted for additional information. Randomized controlled trials (RCTs) and economic studies were selected. Clinical effectiveness was assessed on measurement scales assessing progression of Alzheimer's disease on the person's global health, cognition, functional ability, behavior and mood, and quality of life. Cost-effectiveness was presented as incremental cost per year spent in a nonsevere state (by Mini Mental Health State Examination) or quality-adjusted life-year.Results: Twelve of 15 RCTs included were judged to be of good quality. Although donepezil had beneficial effects in Alzheimer's patients on global health and cognition, rivastigmine on global health, and galantamine on global health, cognition, and functional scales, these improvements were small and may not be clinically significant. Measures of quality of life and behavior and mood were rarely assessed. Adverse effects were usually mild and transient. Cost-effectiveness base case estimates ranged from £2,415 savings to £49,476 additional cost (1997 prices) per unit of effect for donepezil and a small savings for rivastigmine. Estimates were not considered robust or generalizable.Conclusions: Donepezil, rivastigmine, and galantamine appear to have some clinical effect for people with Alzheimer's disease, although the extent to which these translate into real differences in everyday life remains unclear. Due to the nature of current economic studies, cost-effectiveness remains uncertain and the impact on different care sectors has been inadequately investigated. Further research is needed to establish the actual benefits of acetylcholinesterase inhibitors (AChEls) for people with Alzheimer's disease and their caregivers, the relationship of these changes to clinical management, and careful prospective evaluation of resource and budgetary consequences.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mads G. Jørgensen ◽  
Navid M. Toyserkani ◽  
Frederik G. Hansen ◽  
Anette Bygum ◽  
Jens A. Sørensen

AbstractThe impact of breast cancer-related lymphedema (BCRL) on long-term quality of life is unknown. The aim of this study was to investigate the impact of BCRL on health-related quality of life (HRQoL) up to 10 years after breast cancer treatment. This regional population-based study enrolled patients treated for breast cancer with axillary lymph node dissection between January 1st 2007 and December 31th 2017. Follow up and assessments of the included patients were conducted between January 2019 and May 2020. The study outcome was HRQoL, evaluated with the Lymphedema Functioning, Disability and Health Questionnaire, the Disabilities of the Arm, Shoulder and Hand Questionnaire and the Short Form (36) Health Survey Questionnaire. Multivariate linear logistic regression models adjusted for confounders provided mean score differences (MDs) with 95% confidence intervals in each HRQoL scale and item. This study enrolled 244 patients with BCRL and 823 patients without BCRL. Patients with BCRL had significantly poorer HRQoL than patients without BCRL in 16 out of 18 HRQoL subscales, for example, in physical function (MDs 27, 95%CI: 24; 30), mental health (MDs 24, 95%CI: 21; 27) and social role functioning (MDs 20, 95%CI: 17; 23). Age, BMI, BCRL severity, hand and dominant arm affection had only minor impact on HRQoL (MDs < 5), suggesting a high degree of inter-individual variation in coping with lymphedema. This study showed that BCRL is associated with long-term impairments in HRQoL, especially affecting the physical and psychosocial domains. Surprisingly, BCRL diagnosis rather than clinical severity drove the largest impairments in HRQoL.


2021 ◽  
Vol 10 (11) ◽  
pp. 2354
Author(s):  
Francesca J. New ◽  
Sally J. Deverill ◽  
Bhaskar K. Somani

Background: Malignant ureteric obstruction occurs in a variety of cancers and has been typically associated with a poor prognosis. Percutaneous nephrostomy (PCN) can potentially help increase patient longevity by establishing urinary drainage and treating renal failure. Our aim was to look at the outcomes of PCN in patients with advanced cancer and the impact on the patients’ lifespan and quality of life. Materials and Methods: A literature review was carried out for articles from 2000 to 2020 on PCN in patients with advanced malignancies, using MEDLINE, EMBASE, Scopus, CINAHL, Cochrane Library, clinicaltrials.gov, and Google Scholar. All English-language articles reporting on a minimum of 20 patients who underwent PCN for malignancy-associated ureteric obstruction were included. Results: A total of 21 articles (1674 patients) met the inclusion criteria with a mean of 60.2 years (range: 21–102 years). PCN was performed for ureteric obstruction secondary to urological malignancies (n = −633, 37.8%), gynaecological malignancies (n = 437, 26.1%), colorectal and GI malignancies (n = 216, 12.9%), and other specified malignancies (n = 205, 12.2%). The reported mean survival times varied from 2 to 8.5 months post PCN insertion, with an average survival time of 5.6 months, which depended on the cancer type, stage, and previous treatment. Conclusions: Patients with advanced malignancies who need PCN tend to have a survival rate under 12 months and spend a large proportion of this time in the hospital. Although the advent of newer chemotherapy and immunotherapy options has changed the landscape of managing advanced cancer, decisions on nephrostomy must be balanced with their survival and quality of life, which must be discussed with the patient.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xin Ye ◽  
Dawei Zhu ◽  
Siyuan Chen ◽  
Xuefeng Shi ◽  
Rui Gong ◽  
...  

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.


2021 ◽  
pp. 1-13
Author(s):  
Ben-Max De Ruiter ◽  
Abel N. Keijzer ◽  
Maarten C.C.M. Hulshof ◽  
Adriaan D. Bins ◽  
Theo M. de Reijke ◽  
...  

BACKGROUND: Health related Quality of Life (HRQoL) is an important factor regarding treatment for localized Muscle Invasive Bladder Carcinoma (MIBC), as it may affect choice of treatment. The impact of chemoradiotherapy (CRT) for MIBC on HRQoL has not yet been well-established. OBJECTIVE: To systematically evaluate evidence regarding HRQoL as assessed by validated questionnaires after definitive treatment with CRT for localized MIBC. METHODS: We performed a critical review of PubMed/MEDLINE, EMBASE, and the Cochrane Library in October 2020. Two reviewers independently screened articles for eligibility and assessed the methodological quality of the included articles using Joanna Briggs Institute critical appraisal tools. A narrative synthesis was undertaken. RESULTS: Of 579 articles identified, 11 studies were eligible for inclusion, including three RCTs and 8 non-randomized studies, reporting on HRQoL data for 606 CRT patients. Global health declined at End of treatment (EoT), and recovered 3 months following treatment. Physical function declined from baseline at EoT and recovered between 3 and 24 months and was maintained at 5 years follow up. CRT had little effect on social and emotional function in the short-term, but HRQoL results in the long-term were lower compared to the general population. Urinary function declined from baseline at EoT, but returned to baseline at 6 months following CRT. After initial decline in bowel function, a complete return to baseline occurred 4 years following treatment. The majority of studies assessing sexual function showed no to little effect on sexual function. CONCLUSIONS: HRQoL recovers to baseline within 3 months to 2 years in almost all domains. The amount of available evidence regarding HRQoL following CRT for MIBC is limited and the quality of evidence is low.


Author(s):  
Thi Mai Nguyen ◽  
Thi Thanh Toan Do ◽  
Tho Nhi Tran ◽  
Jin Hee Kim

Menopausal symptoms are associated with deterioration in physical, mental, and sexual health, lowering women’s quality of life (QoL). Our study objective is to examine the effect of exercise on QoL in women with menopausal symptoms. After initially identifying 1306 studies published on PubMed, Web of Science, Scopus, and Cochrane Library before June 2020, two researchers independently selected nine randomized controlled trials (RCTs) in which any type of exercise was compared with no active treatment. We assessed the risk of bias in the included studies using the Cochrane risk-of-bias 2.0 tool for RCTs and computed the converged standardized mean difference with a 95% confidence interval. We found evidences for the positive effects of exercise on physical and psychological QoL scores in women with menopausal symptoms. However, there was no evidence for the effects of exercise on general, social, and menopause-specific QoL scores. The most common interventions for women with menopausal and urinary symptoms were yoga and pelvic floor muscle training (PFMT), respectively. In our meta-analyses, while yoga significantly improved physical QoL, its effects on general, psychological, sexual, and vasomotor symptoms QoL scores as well as the effect of PFMT on general QoL were not significant. Our findings suggest that well-designed studies are needed to confirm the effect of exercise on QoL in women with menopausal symptoms.


Author(s):  
Xiaohu Jin ◽  
Lin Wang ◽  
Shijie Liu ◽  
Lin Zhu ◽  
Paul Dinneen Loprinzi ◽  
...  

Purpose: To systematically evaluate the effects of mind-body exercises (Tai Chi, Yoga, and Health Qigong) on motor function (UPDRS, Timed-Up-and-Go, Balance), depressive symptoms, and quality of life (QoL) of Parkinson’s patients (PD). Methods: Through computer system search and manual retrieval, PubMed, Web of Science, The Cochrane Library, CNKI, Wanfang Database, and CQVIP were used. Articles were retrieved up to the published date of June 30, 2019. Following the Cochrane Collaboration System Evaluation Manual (version 5.1.0), two researchers independently evaluated the quality and bias risk of each article, including 22 evaluated articles. The Pedro quality score of 6 points or more was found for 86% (19/22) of these studies, of which 21 were randomized controlled trials with a total of 1199 subjects; and the trial intervention time ranged from 4 to 24 weeks. Interventions in the control group included no-intervention controls, placebo, waiting-lists, routine care, and non-sports controls. Meta-analysis was performed on the literature using RevMan 5.3 statistical software, and heterogeneity analysis was performed using Stata 14.0 software. Results: (1) Mind-body exercises significantly improved motor function in PD patients, including UPDRS (SMD = −0.61, p < 0.001), TUG (SMD = −1.47, p < 0.001) and balance function (SMD = 0.79, p < 0.001). (2) Mind-body exercises also had significant effects on depression (SMD = −1.61, p = 0.002) and QoL (SMD = 0.66, p < 0.001). (3) Among the indicators, UPDRS (I2 = 81%) and depression (I2 = 91%) had higher heterogeneity; according to the results of the separate combined effect sizes of TUG (I2 = 29%), Balance (I2 = 16%) and QoL (I2 = 35%), it shows that the heterogeneity is small; (4) After meta-regression analysis of the age limit and other possible confounding factors, further subgroup analysis showed that the reason for the heterogeneity of UPDRS motor function may be related to the sex of PD patients and severity of the disease; the outcome of depression was heterogeneous. The reason for this may be the use of specific drugs in the experiment and the duration of intervention in the trial. Conclusion: (1) Mind-body exercises were found to have significant improvements in motor function, depressive symptoms, and quality of life in patients with Parkinson’s disease, and can be used as an effective method for clinical exercise intervention in PD patients. (2) Future clinical intervention programs for PD patients need to fully consider specific factors such as gender, severity of disease, specific drug use, and intervention cycle to effectively control heterogeneity factors, so that the clinical exercise intervention program for PD patients is objective, scientific, and effective.


2001 ◽  
Vol 166 (5) ◽  
pp. 1804-1810 ◽  
Author(s):  
CONSTANCE G. BACON ◽  
EDWARD GIOVANNUCCI ◽  
MARCIA TESTA ◽  
ICHIRO KAWACHI

Medicines ◽  
2019 ◽  
Vol 6 (4) ◽  
pp. 112 ◽  
Author(s):  
Michela Iannone ◽  
Agata Janowska ◽  
Valentina Dini ◽  
Giulia Tonini ◽  
Teresa Oranges ◽  
...  

Background: The aims of this review are to analyze the current literature regarding the characteristics and pathophysiological mechanisms of itch in chronic wounds, to assess the impact on quality of life and delayed-healing, to focus on the best strategies of prevention and treatment, to highlight the importance of on-going research in order to fully understand the pathophysiology, and to improve the management of target therapies. Methods: A systematic literature review was performed using MEDLINE, PubMed, Embase, Scopus, ScienceDirect, and the Cochrane Library. We included a total of 11 articles written in English with relevant information on the pathophysiology of itch in chronic wounds and on management strategies. Results: Itch in chronic wounds was found to be correlated with xerosis, larger wound areas, necrotic tissue and amount of exudate, peripheral tissue edema, sclerosis, granulation tissue, contact dermatitis, and bacterial burden, as well as with lower quality of life. Conclusions: Although there are several aspecific pharmacological and non-pharmacological approaches, there appears to be no validated prevention or management strategy for itch in chronic wounds. Further studies are needed to clarify the association and pathophysiology of itch in chronic wounds, to evaluate the safety and efficacy of topical treatments on perilesional skin to reduce itch, to characterize multidimensional sensations of itch in chronic wounds, to identify specific cytokine and chemokine expressions that are correlated to a tailored-based approach, and to develop practical guidelines.


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