scholarly journals Validation of Surrogate Endpoints in Advanced Solid Tumours: Systematic Review of Statistical Methods, Results, and Implications for Policy Makers

2013 ◽  
Vol 16 (7) ◽  
pp. A327 ◽  
Author(s):  
O. Ciani ◽  
S. Davis ◽  
P. Tappenden ◽  
R. Garside ◽  
K. Stein ◽  
...  
Keyword(s):  
Systematic Review ◽  
Statistical Methods ◽  
Solid Tumours ◽  
Surrogate Endpoints ◽  
Policy Makers

scholarly journals VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMORS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS

2014 ◽  
Vol 30 (3) ◽  
pp. 312-324 ◽  
Author(s):  
Oriana Ciani ◽  
Sarah Davis ◽  
Paul Tappenden ◽  
Ruth Garside ◽  
Ken Stein ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Statistical Methods ◽  
Surrogate Endpoint ◽  
Cytotoxic Agents ◽  
Surrogate Endpoints ◽  
Treatment Level ◽  
Cancer Type ◽  
Policy Makers ◽  
New Therapies ◽  
Advanced Tumor

Objectives: Licensing of, and coverage decisions on, new therapies should rely on evidence from patient-relevant endpoints such as overall survival (OS). Nevertheless, evidence from surrogate endpoints may also be useful, as it may not only expedite the regulatory approval of new therapies but also inform coverage decisions. It is, therefore, essential that candidate surrogate endpoints be properly validated. However, there is no consensus on statistical methods for such validation and on how the evidence thus derived should be applied by policy makers.Methods: We review current statistical approaches to surrogate-endpoint validation based on meta-analysis in various advanced-tumor settings. We assessed the suitability of two surrogates (progression-free survival [PFS] and time-to-progression [TTP]) using three current validation frameworks: Elston and Taylor's framework, the German Institute of Quality and Efficiency in Health Care's (IQWiG) framework and the Biomarker-Surrogacy Evaluation Schema (BSES3).Results: A wide variety of statistical methods have been used to assess surrogacy. The strength of the association between the two surrogates and OS was generally low. The level of evidence (observation-level versus treatment-level) available varied considerably by cancer type, by evaluation tools and was not always consistent even within one specific cancer type.Conclusions: Not in all solid tumors the treatment-level association between PFS or TTP and OS has been investigated. According to IQWiG's framework, only PFS achieved acceptable evidence of surrogacy in metastatic colorectal and ovarian cancer treated with cytotoxic agents. Our study emphasizes the challenges of surrogate-endpoint validation and the importance of building consensus on the development of evaluation frameworks.

The role of radiotherapy in patients with solid tumours after solid organ transplantation: a systematic review

2021 ◽  
Vol 22 (3) ◽  
pp. e93-e104
Author(s):  
Rosario Mazzola ◽  
Francesco Cuccia ◽  
Alessandro Bertani ◽  
Slavisa Tubin ◽  
Pier Giulio Conaldi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Organ Transplantation ◽  
Solid Organ Transplantation ◽  
Solid Tumours ◽  
Solid Organ

scholarly journals Systematic review of statistical methods used in molecular marker studies in cancer

Cancer ◽  
2008 ◽  
Vol 112 (8) ◽  
pp. 1862-1868 ◽  
Author(s):  
Andrew J. Vickers ◽  
Kwang Jang ◽  
Daniel Sargent ◽  
Hans Lilja ◽  
Michael W. Kattan
Keyword(s):  
Systematic Review ◽  
Molecular Marker ◽  
Statistical Methods ◽  
Marker Studies

scholarly journals Prevalence, incidence and bothersomeness of urinary incontinence in pregnancy: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Heidi F. A. Moossdorff-Steinhauser ◽  
Bary C. M. Berghmans ◽  
Marc E. A. Spaanderman ◽  
Esther M. J. Bols
Keyword(s):  
Systematic Review ◽  
Urinary Incontinence ◽  
Pregnant Women ◽  
Health Care Providers ◽  
Meta Analysis ◽  
Care Providers ◽  
Case Definitions ◽  
Monthly Basis ◽  
Policy Makers ◽  
In Pregnancy

Abstract Introduction and hypothesis Urinary incontinence (UI) is a common and embarrassing complaint for pregnant women. Reported prevalence and incidence figures show a large range, due to varying case definitions, recruited population and study methodology. Precise prevalence and incidence figures on (bothersome) UI are of relevance for health care providers, policy makers and researchers. Therefore, we conducted a systematic review and meta-analysis to investigate the prevalence and incidence of UI in pregnancy in the general population for relevant subgroups and assessed experienced bother. Methods All observational studies published between January 1998 and October 2018 reporting on prevalence and/or incidence of UI during pregnancy were included. All women, regardless of weeks of gestation and type of UI presented in all settings, were of interest. A random-effects model was used. Subgroup analyses were conducted by parity, trimester and subtype of UI. Results The mean (weighted) prevalence based on 44 included studies, containing a total of 88.305 women, was 41.0% (range of 9–75%). Stress urinary incontinence (63%) is the most prevalent type of UI; 26% of the women reported daily loss, whereas 40% reported loss on a monthly basis. Bother was experienced as mild to moderate. Conclusions UI is very prevalent and rising with the weeks of gestation in pregnancy. SUI is the most common type and in most cases it was a small amount. Bother for UI is heterogeneously assessed and experienced as mild to moderate by pregnant women.

scholarly journals Cost-effectiveness of treatment optimisation with biomarkers for immunotherapy in solid tumours: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e048141
Author(s):  
Sara Mucherino ◽  
Valentina Lorenzoni ◽  
Valentina Orlando ◽  
Isotta Triulzi ◽  
Marzia Del Re ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Immune Checkpoint ◽  
Cost Utility ◽  
Solid Tumours ◽  
Economic Evaluations ◽  
Monetary Benefit ◽  
The Cost ◽  
Net Monetary Benefit

IntroductionThe combination of biomarkers and drugs is the subject of growing interest both from regulators, physicians and companies. This study protocol of a systematic review is aimed to describe available literature evidences about the cost-effectiveness, cost-utility or net-monetary benefit of the use of biomarkers in solid tumour as tools for customising immunotherapy to identify what further research needs.Methods and analysisA systematic review of the literature will be carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed and Embase will be queried from June 2010 to June 2021. The PICOS model will be applied: target population (P) will be patients with solid tumours treated with immune checkpoint inhibitors (ICIs); the interventions (I) will be test of the immune checkpoint predictive biomarkers; the comparator (C) will be any other targeted or non-targeted therapy; outcomes (O) evaluated will be health economic and clinical implications assessed in terms of incremental cost-effectiveness ratio, net health benefit, net monetary benefit, life years gained, quality of life, etc; study (S) considered will be economic evaluations reporting cost-effectiveness analysis, cost-utility analysis, net-monetary benefit. The quality of the evidence will be graded according to Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis systematic review will assess the cost-effectiveness implications of using biomarkers in the immunotherapy with ICIs, which may help to understand whether this approach is widespread in real clinical practice. This research is exempt from ethics approval because the work is carried out on published documents. We will disseminate this protocol in a related peer-reviewed journal.PROSPERO registration numberCRD42020201549.

scholarly journals Quality of life of elderly patients with solid tumours undergoing adjuvant cancer therapy: a systematic review

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e018101 ◽  
Author(s):  
Karis Kin-Fong Cheng ◽  
Ethel Yee-Ting Lim ◽  
Ravindran Kanesvaran
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Elderly Patients ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Risk Of Bias ◽  
Solid Tumours

ObjectivesThe measurement of quality of life (QoL) in elderly cancer population is increasingly being recognised as an important element of clinical decision-making and the evaluation of treatment outcome. This systematic review aimed to summarise the evidence of QoL during and after adjuvant therapy in elderly patients with cancer.MethodsA systematic search was conducted of studies published in CINAHL plus, CENTRAL, PubMed, PsycINFO and Web of Science from the inception of these databases to December 2016. Eligible studies included RCTs and non-RCTs in which QoL was measured in elderly patients (aged 65 years or above) with stage I–III solid tumours who were undergoing adjuvant chemotherapy and/or radiotherapy. Because of the heterogeneity and the insufficient data among the included studies, the results were synthesised narratively.ResultsWe included 4 RCTs and 14 non-RCTs on 1785 participants. In all four RCTs, the risk of bias was low or unclear for most items but high for detection. Of the 14 non-RCTs, 5 studies were judged to have a low or moderate risk of bias for all domains, and the other 9 studies had a serious risk of bias in at least one domain. The bias was observed mainly in the confounding and in the selection of participants for the study. For most elderly patients with breast cancer, the non-significant negative change in the QoL was transient. A significant increase in the QoL during the course of temozolomide in elderly patients with glioblastoma but a decreasing trend in QoL after radiotherapy was shown. This review also shows a uniform trend of stable or improved QoL during adjuvant therapy and at follow-up evaluations across the studies with prostate, colon or cervical cancer population.ConclusionsThis review suggests that adjuvant chemotherapy and radiotherapy may not have detrimental effects on QoL in most elderly patients with solid tumours.

A Systematic Review of Gamification Within E-Learning

2022 ◽  
pp. 123-140
Author(s):  
Samuel Muthee Kamunya ◽  
Robert Obwocha Oboko ◽  
Elizaphan Muuro Maina ◽  
Evans Kirimi Miriti
Keyword(s):  
Systematic Review ◽  
Literature Review ◽  
Systematic Reviews ◽  
Policy Makers ◽  
Learning Platform ◽  
E Learning ◽  
Learning Platforms ◽  
Meta Analyses ◽  
Enhanced Learning ◽  
User Motivation

The focus of this study was to review and evaluate the effectiveness of gamification within e-learning platforms. The study deployed systematic literature review methodology to evaluate how effective gamification has been used within e-learning platforms. The study used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Approach (PRISMA), starting with 366 articles, shifting to a final 34 articles for consideration. It was established that gamification positively influences and enhances learning within the e-learning platform. Therefore, the study recommends policy makers, designers, and implementers of e-learning platforms to consider incorporating gamification elements in order to increase user motivation and engagement for enhanced learning.

A Call for Evaluation of Restorative Justice Programs

2019 ◽  
Vol 22 (1) ◽  
pp. 186-190 ◽  
Author(s):  
Daye Gang ◽  
Bebe Loff ◽  
Bronwyn Naylor ◽  
Maggie Kirkman
Keyword(s):  
Systematic Review ◽  
Sexual Violence ◽  
Family Violence ◽  
Restorative Justice ◽  
Eligible Study ◽  
Policy Makers

Restorative justice as a response to sexual violence continues to be subject to significant criticism. To assess the evidence, we sought to appraise and synthesize evaluations of restorative justice programs for sexual and family violence offences by conducting a systematic review of peer-reviewed literature. However, our rigorous search identified only one eligible study. This dearth of evidence leaves us unable to identify how best to achieve the aims for which programs were established and poses difficulties for policy makers determining whether it is justified to introduce restorative justice programs for sexual and family violence. We recommend that evaluations of restorative justice programs that accept sexual and family violence cases be conducted as a matter of urgency.

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