Evidence map›Paper›PMID 28425002›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2018

Beyond study participants: a framework for engaging patients in the selection or development of clinical outcome assessments for evaluating the benefits of treatment in medical product development.

Hilary Wilson, Ebony Dashiell-Aje, Milena Anatchkova, Karin Coyne, Asha Hareendran, Nancy Kline Leidy, Colleen A McHorney, Kathy Wyrwich

Abstract read
PubMed Publisher
In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

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

  1. Frameworks for supporting patient and public involvement in research: Systematic review and co-design pilot.Health expectations : an international journal of public participation in health care and health policy · 2019
    Pooled it
  2. Review
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  12. Patient-reported outcomes and patient-reported outcome measures in interstitial lung disease: where to go from here?European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  13. Including the patient voice in the development and implementation of patient-reported outcomes in cancer clinical trials.Health expectations : an international journal of public participation in health care and health policy · 2020
    Review
  14. Introduction to special section: measuring what matters.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018
    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

8 authors.

Hilary WilsonEvidera, Bethesda, MD, USA. hilary.wilson@evidera.com.ORCID 0000-0002-1102-6869
Ebony Dashiell-AjeEvidera, Bethesda, MD, USA.
Milena AnatchkovaEvidera, Bethesda, MD, USA.
Karin CoyneEvidera, Bethesda, MD, USA.
Asha HareendranEvidera, Bethesda, MD, USA.
Nancy Kline LeidyEvidera, Bethesda, MD, USA.
Colleen A McHorneyEvidera, Bethesda, MD, USA.
Kathy WyrwichEvidera, Bethesda, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients are participating more actively in health care decision-making with regard to their health, as well as in the broader realm of assessing the value of medical products and influencing decisions about their registration and reimbursement. There is an increasing trend to include patients' perspectives throughout the stages of medical product development by broadening the traditional study-participant role to that of an active partner throughout the process. Including patients in the selection and development of clinical outcome assessments (COAs) to evaluate the benefit of treatment is particularly important. Still, despite widespread enthusiasm, there is substantial uncertainty regarding how and when to engage patients in this process. PURPOSE: This manuscript proposes a methodological framework for engaging patients at varying levels in the selection and development of COAs for medical product development. FRAMEWORK: The framework builds on the Food and Drug Administration's roadmap for patient-focused COA. Methods for engaging patients across each stage in this roadmap are summarized by levels of engagement. Opportunities and examples of patient engagement (PE) in the selection and/or development of COAs are summarized, together with best practices and practical considerations.

conclusionThis paper offers a framework for understanding, planning, and implementing methods to advance PE in the selection and/or development of COAs for evaluating the benefit of medical products. The intent is to further this important discussion and enhance the process and outcome of PE in this context.

Indexed as

Equipment and SuppliesDecision MakingEquipment DesignHumansPatient ParticipationQuality of LifeClinical outcome assessmentDrug developmentMedical product developmentPatient centeredPatient engagementPatient focused

Identifiers

PMID28425002

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.