Evidence map›Paper›PMID 28982824›Full record

Observational studyBMJ open2017

Are survival and mortality rates associated with recruitment to clinical trials in teenage and young adult patients with acute lymphoblastic leukaemia? A retrospective observational analysis in England.

Rachael Hough, Sabrina Sandhu, Maria Khan, Anthony Moran, Richard Feltbower, Charles Stiller, Mike C G Stevens, Clare Rowntree, Ajay Vora, Martin G McCabe

Abstract readComparative StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Trial
  2. Challenges to successful outcomes in AYAs with ALL and potential solutions.Hematology. American Society of Hematology. Education Program · 2023
    Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. 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

10 authors.

Rachael HoughUniversity College Hospital, London, UK.ORCID http://orcid.org/0000-0001-7616-443X
Sabrina SandhuNational Cancer Registration and Analysis Service, Public Health England, London, UK.
Maria KhanNational Cancer Registration and Analysis Service, Public Health England, London, UK.
Anthony MoranNational Cancer Registration and Analysis Service, Public Health England, London, UK.
Richard FeltbowerDivision of Epidemiology & Biostatistics, School of Medicine, University of Leeds, Leeds, UK.
Charles StillerNational Cancer Registration and Analysis Service, Public Health England, London, UK.
Mike C G StevensUniversity of Bristol, Bristol, UK.
Clare RowntreeUniversity Hospital of Wales, Cardiff, UK.
Ajay VoraSheffield Children's Hospital, Western Bank, London, UK.
Martin G McCabeDivision of Molecular and Clinical Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveParticipation rates in clinical trials are low in teenagers and young adults (TYA) with cancer. Whilst the importance of clinical trials in informing best practice is well established, data regarding individual patient benefit are scarce. We have investigated the association between overall survival and trial recruitment in TYA patients with acute lymphoblastic leukaemia (ALL).

designRetrospective.

settingNational (England) TYA patients treated for ALL.

participants511 patients aged 15-24 years diagnosed with ALL between 2004 and 2010 inclusive, of whom 239 (46.7%) participated in the UKALL2003 trial. OUTCOME MEASURES: Patients were identified using National Clinical Trial (UKALL2003) and Cancer Registry (National Cancer Data Repository, English National Cancer Online Registration Environment) Databases. Relative survival rates were calculated for trial and non-trial patients and observed differences were modelled using a multiple regression approach. The numbers and percentages of deaths in those patients included in the survival analysis were determined for each 3-month period, p values were calculated using the two-tailed z-test for difference between proportions and 95% CIs for percentage deaths were derived using the binomial distribution based on the Wilson Score method.

resultsPatients treated on the trial had a 17.9% better 2-year survival (85.4% vs 67.5%, p<0.001) and 8.9% better 1-year survival (90.8% vs 81.9%, p=0.004) than those not on the trial. 35 (14.6%) patients recruited to the trial died in the 2 years following diagnosis compared with 86 (32.6%) of those not recruited (p<0.001).

conclusionsTYA patients recruited to the clinical trial UKALL 2003 in England had a lower risk of mortality and a higher overall survival than contemporaneous non-trial patients. These data underline the potential for individual patient benefit in participating in a clinical trial and the importance of international efforts to increase trial participation in the TYA age group. TRIAL REGISTRATION NUMBER: ISRCTN07355119.

Indexed as

Patient SelectionAdolescentAge DistributionAntineoplastic Combined Chemotherapy ProtocolsEnglandFemaleHumansMalePrecursor Cell Lymphoblastic Leukemia-LymphomaRegistriesRetrospective StudiesSurvival AnalysisTime FactorsYoung Adultacute lymphoblastic leukaemiaclinical trialssurvivalteenage and young adult

Identifiers

PMID28982824
PMCPMC5639992

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.