Evidence map›Paper›PMID 32641097›Full record

Trial reportTrials2020

The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial.

Rebecca Lewis, Rachel Todd, Michelle Newton, Robert J Jones, Caroline Wilson, Jenny L Donovan, Richard T Bryan, Alison Birtle, Emma Hall, POUT Trial Management Group

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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. Trial
  2. Trial
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

10 authors.

Rebecca LewisClinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK. Rebecca.Lewis@icr.ac.uk.ORCID http://orcid.org/0000-0001-9222-5263
Rachel ToddClinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.
Michelle NewtonClinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.
Robert J JonesInstitute of Cancer Sciences, Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.
Caroline WilsonPopulation Health Sciences, Bristol Medical School, Bristol, UK.
Jenny L DonovanPopulation Health Sciences, Bristol Medical School, Bristol, UK.
Richard T BryanInstitute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.
Alison BirtleRoyal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.
Emma HallClinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.
POUT Trial Management Group

Funding

Cancer Research UK 13324Cancer Research UK 16781Cancer Research UK CRUK/11/027Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

backgroundThe utility of patient screening logs and their impact on improving trial recruitment rates are unclear. We conducted a retrospective exploratory analysis of screening data collected within a multicentre randomised controlled trial investigating chemotherapy for upper tract urothelial carcinoma.

methodsParticipating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC). Sites recorded the number of patients ineligible, not approached, declined and randomised. The CTC monitored proportions of eligible patients, approach rate (proportion of eligible patients approached) and acceptance rate (proportion recruited of those approached). Data were retrospectively analysed to identify patterns of screening activity and correlation with recruitment.

resultsData were collected between May 2012 and August 2016, during which time 71 sites were activated-a recruitment period of 2768 centre months. A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received. A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation. The approach rate was 91% (344/380), and the acceptance rate was 40% (137/344); these rates remained consistent throughout the data collection. The main reason patients provided for declining (99/207, 48%) was not wanting to receive chemotherapy. There was a moderately strong correlation (r = 0.47) between the number reported on screening logs and the number recruited per site. Considerable variation in data between centres was observed, and 54/191 trial participants (28%) enrolled during this period were not reported on logs.

conclusionsCentral collection of screening logs can identify reasons for patients declining trial participation and help monitor trial activity at sites; however, obtaining complete data can be challenging. There was a correlation between the number of patients reported on logs and recruitment; however, this was likely confounded by sites' available patient population. The use of screening logs may not be appropriate for all trials, and their use should be carefully considered in relation to the associated workload. No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.

trial registrationISRCTN98387754 . Registered on 31 January 2012.

Indexed as

Clinical Decision-MakingPatient SelectionCarcinomaEligibility DeterminationHumansRetrospective StudiesSample SizeUrologic NeoplasmsPatient screening logsRare cancerTrial recruitment

Identifiers

PMID32641097
PMCPMC7346417

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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.