Evaluation study design – a pluralist approach to evidence

Fives, Allyn; Canavan, John; Dolan, Pat

doi:10.1080/1350293x.2016.1266227

Cited by 11 publications

(16 citation statements)

References 41 publications

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“…Pluralistic evidence as a methodological research approach can be used for clinical development programs where it is impossible, impractical, or unethical to follow a more traditional RCT-based approach (Tucker and Reed, 2008; Fives et al, 2017). In accordance with this, a pluralistic approach could therefore be applied when there is no commercial rationale for running a large randomized controlled clinical study to help establish causality for the efficacy of an off-label treatment in cancer.…”

Section: Creating An Evidence Base—pluralistic Evidence and Triangulamentioning

confidence: 99%

“…To develop a pluralistic evidence base, all available sources and types of data should be considered, including in silico bioinformatics, laboratory studies on mechanisms of action, in vitro experiments on human biopsies, in vivo animal models, quality of life data, clinical trials of off-label drug use, etc. (Liu et al, 2013; Fives et al, 2017). As illustrated in the glioblastoma multiforme (GBM) case study, the pluralistic approach involves designing studies and generating new data from a range of sources to support causality.…”

Section: Creating An Evidence Base—pluralistic Evidence and Triangulamentioning

confidence: 99%

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A New Method for Ethical and Efficient Evidence Generation for Off-Label Medication Use in Oncology (A Case Study in Glioblastoma)

Agrawal

Vamadevan²,

Mazibuko

et al. 2019

Front. Pharmacol.

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In oncology, preclinical and early clinical data increasingly support the use of a number of candidate “non-cancer” drugs in an off-label setting against multiple tumor types. In particular, metabolically targeted drugs show promise as adjuvant chemo and radiosensitizers, improving or restoring sensitivity to standard therapies. The time has come for large scale clinical studies of off-label drugs in this context. However, it is well recognized that high-cost randomized controlled trials may not be an economically viable option for studying patent-expired off-label drugs. In some cases, randomized trials could also be considered as ethically controversial. This perspective article presents a novel approach to generating additional clinical data of sufficient quality to support changes in clinical practice and relabeling of such drugs for use in oncology. Here, we suggest that a pluralistic evidence base and triangulation of evidence can support clinical trial data for off-label drug use in oncology. An example of an off-label drug protocol brought to the clinic for glioblastoma patients is presented, along with preliminary retrospective data from the METRICS study (NCT02201381). METRICS is a novel participant-funded, open-label, non-randomized, single-arm real-world study designed to gather high-quality evidence on the safety, tolerability, and effectiveness of four off-label metabolically targeted medicines as an adjunctive cancer treatment for glioblastoma patients.

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Section: Creating An Evidence Base—pluralistic Evidence and Triangulamentioning

confidence: 99%

Section: Creating An Evidence Base—pluralistic Evidence and Triangulamentioning

confidence: 99%

A New Method for Ethical and Efficient Evidence Generation for Off-Label Medication Use in Oncology (A Case Study in Glioblastoma)

Agrawal

Vamadevan²,

Mazibuko

et al. 2019

Front. Pharmacol.

View full text Add to dashboard Cite

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“…Moreover, in addition to being rigorous, evaluations also need to be useful, feasible, suitable, and accountable (Yarbrough et al, 2011). In sum, family support research needs to be practice-based, which requires a pluralist approach to evidence (Fives, Canavan, & Dolan, 2014). Agreement is also needed regarding the skills and qualifications of the family support workforce, in order to ensure quality performance when attending families (Durlak & DuPre, 2008).…”

Section: Con Clus Ionsmentioning

confidence: 99%

Family education and support for families at psychosocial risk in Europe: Evidence from a survey of international experts

García

Suárez

Lara

et al. 2018

Health Soc Care Community

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There is overwhelming consensus among policy makers, academics, and professionals about the need to support families in their childrearing tasks. Consequently, European countries have been encouraged to develop family support interventions aimed at guaranteeing children's rights, targeting particularly those children in situations of psychosocial risk. While a certain amount of evidence exists regarding how family support is generally delivered in certain European countries, with a particular focus on parenting initiatives, this paper aims to take existing evidence one step further by providing an updated review focusing on two core components of the Council of Europe's Recommendation on Positive Parenting: families at psychosocial risk as the target population, and family education and support initiatives as the delivery format. The scope of the study was therefore broad, in both geographical and conceptual terms. An online survey was conducted with experts from 19 European countries to gather information regarding how they perceive family education and support initiatives for families at psychosocial risk. Both quantitative and qualitative data were analysed by computing frequencies/percentages and by following a thematic synthesis method, respectively. The results revealed both similarities and disparities as regards provider profiles, intervention characteristics, and quality standards. Practical implications are discussed, such as the need to diversify initiatives for at‐risk families in accordance with the tenets of progressive universalism, the ongoing need for an evidence‐based, pluralistic approach to programmes, and the skills and qualifications required in the family support workforce. This study constitutes a first step towards building a common family support framework at a European level, which would encompass family support and parenting policies aimed at families at psychosocial risk.

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“…The evidence indicates that preventative, universal programmes work and are perceived by service providers and parents to be effective Fives et al, 2014). The evidence base also highlights positive outcomes for parents in particular contexts, including parents of adolescents (Nitsch et al, 2015); parents at risk of social exclusion and poverty (Belsky et al, 2006); low-income families (Cefai et al, 2010) and immigrant and minority parents Canavan, 2012, Dolan et al, 2013).…”

Section: Programmes and Practice In Parenting Supportmentioning

confidence: 99%

“…Professionals play a key role in working with families, in addition to utilising proven programmes as a key source of support. In this sense the practice wisdom of practitioners can complement programmatic work with parents (Fives et al, 2014). Tusla, the Child and Family Agency (2013a) recommend that the configuration of parenting support must consider all services, in addition to individual practice and programmatic approaches.…”

Section: Programmes and Practice In Parenting Supportmentioning

confidence: 99%

Parenting Support: Policy and Practice in the Irish Context

Connolly

Devaney

2017

Child Care in Practice

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Increasing government interest in parenting support (Broadhurst, 2009) has emerged in response to the increasingly diverse form of families, a growing emphasis on children's rights and a policy shift towards prevention and early intervention. This has contributed to a range of stakeholder activity in the area, with the notion that parenting is a set of skills that can be learned now widespread (Daly, 2011). The need to establish 'what works' in parenting support (Shulruf et al., 2009) has resulted in considerable research, with evidence supporting the provision of universally accessible supports for all parents which can be tailored for those with additional needs. Simultaneously, an increasing body of evaluation research has resulted in positive evidence-based outcomes for a range of parenting support programmes. This paper presents an overview of the policy and practice of parenting support, exploring the international and national literature on what works in improving parental capacity, and detailing the wide scale emergence of parenting as a policy imperative. The paper presents the Irish context, describing the diversity of the population, mapping the current service provision landscape, and detailing the strategic direction and emerging parenting support programme of work within Tusla, the statutory Child and Family Agency.

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Evaluation study design – a pluralist approach to evidence

Cited by 11 publications

References 41 publications

A New Method for Ethical and Efficient Evidence Generation for Off-Label Medication Use in Oncology (A Case Study in Glioblastoma)

A New Method for Ethical and Efficient Evidence Generation for Off-Label Medication Use in Oncology (A Case Study in Glioblastoma)

Family education and support for families at psychosocial risk in Europe: Evidence from a survey of international experts

Parenting Support: Policy and Practice in the Irish Context

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