Evidence map›Paper›PMID 24914059›Full record

SynthesisJournal of nuclear medicine : official publication, Society of Nuclear Medicine2014

The move from accuracy studies to randomized trials in PET: current status and future directions.

Bettina Siepe, Poul Flemming Hoilund-Carlsen, Oke Gerke, Wolfgang A Weber, Edith Motschall, Werner Vach

Abstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Journal of nuclear medicine : official publication, Society of Nuclear Medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. FDG PET/CT in cancer: comparison of actual use with literature-based recommendations.European journal of nuclear medicine and molecular imaging · 2016
    Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Impact ofJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022
    Article
  6. Review
  7. Review
  8. Article
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  11. Demonstrating the benefits of clinical nuclear imaging: is it time to add economic analysis?European journal of nuclear medicine and molecular imaging · 2014
    Article
  12. A flexible, multifaceted approach is needed in health technology assessment of PET.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2014
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Bettina SiepeDepartment of Anesthesiology, Freiburg University Medical Center, Freiburg, Germany wv@imbi.uni-freiburg.de bettina.schnitter@uniklinik-freiburg.de.
Poul Flemming Hoilund-CarlsenDepartment of Nuclear Medicine, Odense University Hospital, Odense, Denmark.
Oke GerkeDepartment of Nuclear Medicine, Odense University Hospital, Odense, Denmark Department of Business and Economics, Centre of Health Economics Research, University of Southern Denmark, Odense, Denmark.
Wolfgang A WeberMemorial Sloan-Kettering Cancer Center, New York, New York.
Edith MotschallDepartment of Medical Biometry and Medical Informatics, Freiburg University Medical Center, Freiburg, Germany; and.
Werner VachClinical Epidemiology, Department of Medical Biometry and Medical Informatics Freiburg University Medical Center, Freiburg, Germany wv@imbi.uni-freiburg.de bettina.schnitter@uniklinik-freiburg.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledSince the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play an important role in informing guideline developers and policy makers. Our aim was to investigate how far the nuclear medicine community has come on its way from accuracy studies to RCTs and which issues we have to take into account in planning future studies.

methodsWe conducted a systematic review of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome, sufficient sample size, and current standard as comparator.

resultsFourteen published and 15 planned studies were identified. Five of the published studies and 12 of the planned studies did not use a patient-important outcome. Sample sizes were often so small that a significant result could be expected only under the assumption of a substantial reduction in the event rate. Comparators typically reflected the current standard.

conclusionIf we consider the traditional areas of primary diagnosis, staging, and follow-up, then the number and quality of RCTs on PET is currently not sufficient to provide a major source for evidence-based decisions on the clinical benefit of PET. There will also be a future need in these traditional areas to deduce the clinical benefit of PET from the results of accuracy studies. The situation may be more favorable for the areas of treatment planning and response evaluation. Choice of patient-important outcomes and sufficient sample sizes are crucial issues in planning RCTs to demonstrate the clinical benefit of using PET.

Indexed as

HumansPositron-Emission TomographyRandomized Controlled Trials as TopicSensitivity and Specificitydiagnostic randomized controlled trialpatient-important outcomepositron emission tomographysystematic review

Identifiers

What OpenQuestion holds

Textmetadata
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.