Evidence map›Paper›PMID 38598132›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2024

Patient adherence and response time in electronic patient-reported outcomes: insights from three longitudinal clinical trials.

Andrzej Nowojewski, Erik Bark, Vivian H Shih, Richard Dearden

3 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03347279 phase3completednot on this map

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

TypeinterventionalSponsorAstraZenecaRan2017 to 2020Enrolled1,061ConditionsAsthmaArmsExperimental: Tezepelumab, Placebo
NCT03401229 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis

TypeinterventionalSponsorAstraZenecaRan2018 to 2020Enrolled413ConditionsNasal PolyposisArmsBenralizumab 30 mg SC + Mometasone Furoate, Matching placebo SC + Mometasone Furoate
NCT03406078 phase3completednot on this map

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE)

TypeinterventionalSponsorAstraZenecaRan2018 to 2020Enrolled150ConditionsAsthmaArmsTezepelumab, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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.

Andrzej NowojewskiImaging & Data Analytics, Clinical Pharmacology & Safety Sciences, AstraZeneca, R&D BioPharmaceuticals, Cambridge, UK. andrzej.nowojewski@astrazeneca.com.ORCID http://orcid.org/0009-0005-7729-8452
Erik BarkBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Vivian H ShihBioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0003-0853-4210
Richard DeardenImaging & Data Analytics, Clinical Pharmacology & Safety Sciences, AstraZeneca, R&D BioPharmaceuticals, Cambridge, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePatient-reported outcome measures (PROMs) are used to collect data on disease symptoms in support of clinical trial endpoints. Clinical studies can last a year or more, and the patients' adherence and response time to daily at-home questionnaires may vary significantly over time. The aim of this study was to understand patterns and changes in patients' completion of daily PROMs during longitudinal clinical studies.

methodsData were collected from 1342 patients randomized into three respiratory clinical trials (NCT03401229, NCT03347279, and NCT03406078). PROMs were completed by patients using electronic handheld devices that collected the starting and completion times. A Bayesian generalized linear mixed-effects model was used to identify unbiased coefficients associated with PROM adherence and response time using patient, site, and calendar features as covariates.

resultsAdherence decreased over time after randomization, and the rate of decrease was higher in younger patients. The 14-day pre-randomization adherence was correlated with adherence throughout the study. Patients were also more adherent during working days compared to non-working days. Oldest patients took twice as long to complete PROMs throughout the study; however, the response time for all patients decreased during the first month of the study regardless of age. Response time increased 7 days before and after the date of a scheduled clinic visit and when a patient-reported higher symptom burden.

conclusionDetailed analyses of adherence and response time for daily PROMs in clinical trials can provide significant insights about trends of patient behavior in longitudinal clinical studies with high baseline adherence.

Indexed as

Patient CompliancePatient Reported Outcome MeasuresAdultAgedBayes TheoremFemaleHumansLongitudinal StudiesMaleMiddle AgedSurveys and QuestionnairesTime FactorsAdherenceClinical outcome assessmentCOAComplianceeCOAElectronic clinical outcome assessmentePROePROMPatient burdenPatient-reported outcome measuresPatient-reported outcomesPROPROMResponse time

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.