Evidence map›Paper›PMID 30582066›Full record

ArticleContemporary clinical trials communications2019

Item banking and computer-adaptive testing in clinical trials: Standing in sight of the PROMISed land.

Adam B Smith, Andria Hanbury, Jenny Retzler

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06396702 (Emotion And Symptom-focused Engagement), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

NCT06396702 nanot yet recruitingnot on this mapstarted 2024, after this paper: background citation

Emotion And Symptom-focused Engagement (EASE) Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study

TypeinterventionalSponsorUniversity Health Network, TorontoRan2024 to 2027Enrolled120ConditionsTransplant, Failure,Kidney, Transplant, Failure, HeartArmsEASE-SOT
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. A visual analog scale for patient-reported voice outcomes: The VAS voice.Laryngoscope investigative otolaryngology · 2020
    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

3 authors.

Adam B SmithYork Health Economics Consortium, Enterprise House, University of York, Hesling, York, YO105NQ, UK.
Andria HanburyYork Health Economics Consortium, Enterprise House, University of York, Hesling, York, YO105NQ, UK.
Jenny RetzlerYork Health Economics Consortium, Enterprise House, University of York, Hesling, York, YO105NQ, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The use of patient-reported outcome instruments (PRO) in clinical trials in order to capture the impacts of treatment on patients is widespread. However, regulatory agencies have over the past decade highlighted the need for PROs that are fit for purpose and target relevant aspects of the patient's condition. Many legacy PROs were developed with little patient input, are lengthy, and may lack relevance having not been modified or adapted as medical treatments have advanced. Computer-adaptive test (CAT) systems provide the possibility of targeted approaches to capturing patient-centric data, while minimising patient burden. Coupled with greater patient input in the development of PROs, CAT offers the opportunity of overcoming the shortcomings of the previous generation of PROs. This paper describes the some of the issues facing legacy PROs, current regulatory guidance, and initiatives, such as the Patient-Reported Outcome Measurement Information System (PROMIS), as well as the early signs of use of CAT to capture PRO data in clinical trials.

Identifiers

PMID30582066
PMCPMC6299156

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.