Conceptual frameworks and key dimensions to support coverage decisions for vaccines

González-Lorenzo, Marién; Piatti, Alessandra; Cóppola, Liliana; Gramegna, Maria; Demicheli, Vittorio; Melegaro, Alessia; Tirani, Marcello; Parmelli, Elena; Auxilia, F.; Moja, Lorenzo

doi:10.1016/j.vaccine.2014.12.020

Cited by 19 publications

(14 citation statements)

References 32 publications

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“…However, other frameworks frequently fail to consider key factors and do not transparently use evidence to inform judgements about each key factor. For example, an overview of existing frameworks to support coverage decisions for vaccines highlighted differences in the taxonomy used by different frameworks, and that key factors were not consistently considered (29). The EtD frameworks provides a way for organizations to monitor their decisions, and they can facilitate sharing, comparing and learning across organizations that make coverage decisions.…”

Section: Discussionmentioning

confidence: 99%

GRADE EVIDENCE TO DECISION (EtD) FRAMEWORK FOR COVERAGE DECISIONS

Parmelli

Amato

Oxman

et al. 2017

Int J Technol Assess Health Care

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Objectives: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones. Methods: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. Results: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. Conclusions: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence. Coverage decisions are decisions by third party payers (public or private health insurers) about whether and how much to pay for drugs, tests, devices, or services and under what conditions. These decisions are made at national, regional, or local levels, depending on the type of interventions and the way health services are paid for in a country. Often, committees or panels that may include policy makers, managers, clinicians, from the Italian Ministry of Health ( Keywords: GRADE, Coverage decisions

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Section: Discussionmentioning

confidence: 99%

GRADE EVIDENCE TO DECISION (EtD) FRAMEWORK FOR COVERAGE DECISIONS

Parmelli

Amato

Oxman

et al. 2017

Int J Technol Assess Health Care

Self Cite

View full text Add to dashboard Cite

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“…The reviews on women’s values and preferences and economic evidence were, however, limited to English and for the last ten years and Medline only, and results would have been more robust if such reviews were carried out with a broader scope. Moreover, the suggestion for less intensive follow-up was built by using the EtD: this is a new approach in the clinical oncology field, but has been previously used already in breast cancer screening [ 53 ], colon cancer screening [ 54 ], as well as in other contexts [ 55 ]. The EtD explicitly takes into account factors related, among others, to the quality of evidence, desirable and undesirable effects, values, resources and feasibility, that altogether constitute a comprehensive approach to a decision-making exercise.…”

Section: Discussionmentioning

confidence: 99%

Intensive follow-up for women with breast cancer: review of clinical, economic and patient’s preference domains through evidence to decision framework

Lafranconi

Pylkkänen

Deandrea

et al. 2017

Health Qual Life Outcomes

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BackgroundWomen treated for breast cancer are followed-up for monitoring of treatment effectiveness and for detecting recurrences at an early stage. The type of follow-up received may affect women’s reassurance and impact on their quality of life. Anxiety and depression among women with breast cancer has been described, but little is known about how the intensity of the follow-up can affect women’s psychological status. This study was undertaken to evaluate the effects of intensive vs. less-intensive follow-up on different health outcomes, to determine what are women’s preferences and values regarding the follow-up received, and also assess the costs of these different types of follow-up.MethodsA systematic review following standard Cochrane Collaboration methods was carried out to assess the efficacy of intensive follow-up versus non-intensive follow-up in breast cancer patients. Two additional reviews on women’s preferences and economic evidence were also carried out. The search was performed up to January 2016 in: MEDLINE, EMBASE, PDQ, McMaster Health Systems Evidence, CENTRAL, and NHS EED (through The Cochrane Library). The quality of evidence was assessed by GRADE (for quantitative studies) and CerQUAL (for qualitative studies). Several outcomes including mortality, breast cancer recurrences, quality of life, and patient satisfaction were evaluated.ResultsSix randomised trials (corresponding to 3534 women) were included for the evaluation of health outcomes; three studies were included for women’s values and preferences and four for an economic assessment. There is moderate certainty of evidence showing that intensive follow-up, including more frequent diagnostic tests or visits, does not have effects on 5- or 10-year overall mortality and recurrences in women with breast cancer, compared with less intensive follow-up. Regarding women’s preferences and values, there was important variability among studies and within studies (low confidence due to risk of bias and inconsistency). Furthermore, intensive follow-up, as opposed to less intensive follow-up, is not likely to be cost-effective.ConclusionsLess intensive follow-up appears to be justified and can be recommended over intensive follow-up. Resources could thus be mobilised to other aspects of breast cancer care, or other areas of healthcare.Electronic supplementary materialThe online version of this article (10.1186/s12955-017-0779-5) contains supplementary material, which is available to authorized users.

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“…Sie ähneln Kriterien, die bereits von vielen Organisationen genutzt werden, und ähneln den Kriterien der GRADE-Arbeitsgruppe für klinische Empfehlungen [10][11][12][13]15,16]. Andere Ansätze berücksichtigen jedoch häufig nicht alle wichtigen Faktoren und stellen nicht sicher, dass Evidenz auf transparente Weise als Bewertungsgrundlage für jeden wichtigen Faktor herangezogen wird [32]. Zum Beispiel hob ein Übersichtsartikel zu existierenden Ansätzen, die Entscheidungen zur Erstattung von Impfungen unterstützen, die Unterschiede in den Klassifizierungen der verschiedenen Ansätze hervor und betonte, dass wichtige Faktoren nicht konsistent berücksichtigt wurden.…”

Section: Finanzielle Förderungunclassified