Evidence map›Paper›PMID 34407860›Full record

Trial reportTrials2021

Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study.

Emily Day, A Toby Prevost, Matthew R Sydes, Deepika Reddy, Taimur T Shah, Mathias Winkler, Tim Dudderidge, John Staffurth, Stuart McCracken, Vincent Khoo and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2021. 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
0.3field-weighted citation impact, top 40% of its field
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, 2 citations in OpenAlex.

  1. Article
  2. Review
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

15 authors at 9 institutions in 1 country.

Emily DayImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
A Toby PrevostNightingale-Saunders Unit, King's Clinical Trials Unit, King's College London, London, UK.
Matthew R SydesMRC Clinical Trials Unit at UCL, University College London, London, UK.
Deepika ReddyImperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Taimur T ShahImperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Mathias WinklerImperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Tim DudderidgeDepartment of Urology, University Hospital Southampton NHS Trust, Southampton, UK.
John StaffurthSchool of Medicine, Cardiff University, Cardiff, UK.
Stuart McCrackenDepartment of Urology, Sunderland Royal Hospital, Sunderland, UK.
Vincent KhooDepartment of Oncology, The Royal Marsden NHS Foundation and Institute of Cancer Research, London, UK.
Puja JadavImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
Natalia Klimowska-NassarImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
Thiagarajah SasikaranImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
Hashim U AhmedImperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Francesca FiorentinoImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK. f.fiorentino@imperial.ac.uk.ORCID http://orcid.org/0000-0001-9817-6634
Imperial College Healthcare NHS Trust · GBImperial College London · GBSt Mary's Hospital · GBCardiff University · GBKing's College London · GBMRC Clinical Trials Unit at UCL · GBRoyal Marsden NHS Foundation Trust · GBSunderland Royal Hospital · GBUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

Medical Research Council MC_UU_00004/08Medical Research Council MC_UU_12023/24
6 · The paper itself

Abstract

backgroundRandomised controlled trials (RCTs) for surgical interventions have often proven difficult with calls for innovative approaches. The Imperial Prostate (IP4) Comparative Health Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS) study aims to deliver level 1 evidence on outcomes following focal therapy which involves treating just the tumour rather than whole-gland surgery or radiotherapy. Our aim is to test the feasibility of two parallel RCTs within an overarching strategy that fits with existing patient and physician equipoise and maximises the chances of success and potential benefit to patients and healthcare services. METHODS AND

designIP4-CHRONOS is a randomised, unblinded multi-centre study, including two parallel randomised controlled trials targeting the same patient population: IP4-CHRONOS-A and IP4-CHRONOS-B. IP4-CHRONOS-A is a 1:1 RCT and the other is a multi-arm, multi-stage (MAMS) RCT starting with three arms and a 1:1:1 randomisation. The two linked RCTs are discussed with patients at the time of consent and the choice of A or B is dependent on physician and patient equipoise. The primary outcome is the feasibility of recruitment, acceptance of randomisation and compliance to allocated arm.

resultsThis paper describes the statistical analysis plan (SAP) for the feasibility study within IP4-CHRONOS given its innovative approach. Version 1.0 of the SAP has been reviewed by the Trial Steering Committee (TSC), Chief Investigator (CI), Senior Statistician and Trial Statistician and signed off. The study is ongoing and recruiting. Recruitment is scheduled to finish later in 2021. The SAP documents approved methods and analyses that will be conducted. Since this is written in advance of the analysis, we avoid bias arising from prior knowledge of the study data and findings. DISCUSSION: Our feasibility analysis will demonstrate if IP4-CHRONOS is feasible in terms of recruitment, randomisation and compliance, and whether to continue both A and B or just one to the main stage.

trial registrationISRCTN ISRCTN17796995 . Registered on 08 October 2019.

Indexed as

Prostatic NeoplasmsFeasibility StudiesHumansMaleTreatment OutcomeComplianceFeasibilityFocal therapyMulti-centre multi-armRandomised controlled trialRecruitment

Identifiers

PMID34407860
PMCPMC8371592
OpenAlexW3194863353

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.