Evidence map›Paper›PMID 32610811›Full record

ArticleInternational journal of health policy and management2022

A Process for Evaluating Quality Decision-Making Practices During the Development, Review and Reimbursement of Medicines.

Magdalena Bujar, Neil McAuslane, Stuart Walker, Sam Salek

Abstract read
In one paragraph

Article in International journal of health policy and management, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Magdalena BujarDepartment of Clinical and Pharmaceutical Sciences, School of Life & Medical Sciences, University of Hertfordshire, Hatfield, UK.ORCID 0000-0001-8579-2163
Neil McAuslaneDepartment of Clinical and Pharmaceutical Sciences, School of Life & Medical Sciences, University of Hertfordshire, Hatfield, UK.
Stuart WalkerDepartment of Clinical and Pharmaceutical Sciences, School of Life & Medical Sciences, University of Hertfordshire, Hatfield, UK.
Sam SalekCentre for Innovation in Regulatory Science (CIRS), London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe development of a medicine is not only underpinned by good science but also by Quality DecisionMaking Practices (QDMPs). Indeed, it is important to ensure that all organisations involved in the lifecycle of medicines are aligning their practices in decision-making to the QDMPs to ensure quality, transparent and consistent decisionmaking processes.

methodsThe aim of this study was to evaluate the practicality of QoDoS (Quality of Decision-Making Orientation Scheme) in assessing the incorporation of ten QDMPs during the development, review and reimbursement of medicines, illustrated by case studies with a pharmaceutical company, a regulatory authority and a health technology assessment (HTA) agency. Individuals from each organisation completed the 47-item QoDoS questionnaire.

resultsThe results demonstrate the applicability of QoDoS in identifying favourable and unfavourable practices and in assessing the consistency and transparency of the QDMPs within each organisation, as well as across the different stakeholders. Furthermore, the study established the value of the methodology in raising awareness of the biases and best practices in decision-making, as well as having a basis for discussion for differences within and across stakeholders to promote consistency and alignment in decision-making. Finally, the QoDoS demonstrated the need for improvement across a number of decision-making practices for the 3 organisations such as the evaluation of alternatives and of the decision impact.

conclusionThe QoDoS can be used to benchmark organisations' decision-making practices to provide a basis for discussion to ultimately encourage a level of trust across and within organisations and helping to identify areas for improvement.

Indexed as

BenchmarkingTechnology Assessment, BiomedicalHumansHealth Technology AssessmentMedicines DevelopmentQoDoSQuality Decision-MakingRegulatory Review

Identifiers

PMID32610811
PMCPMC9278608

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.