Evidence map›Paper›PMID 29284407›Full record

ReviewBMC family practice2017

Clinical drug trials in general practice: how well are external validity issues reported?

Anja Maria Brænd, Jørund Straand, Atle Klovning

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMC family practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Understanding the nature and scope of clinical research commentaries in PubMed.Journal of the American Medical Informatics Association : JAMIA · 2020
    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

3 authors.

Anja Maria BrændDepartment of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, Postbox 1130 Blindern, N-0318, Oslo, Norway. ambraend@medisin.uio.no.ORCID 0000-0003-0940-7555
Jørund StraandDepartment of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, Postbox 1130 Blindern, N-0318, Oslo, Norway.
Atle KlovningDepartment of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, Postbox 1130 Blindern, N-0318, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhen reading a report of a clinical trial, it should be possible to judge whether the results are relevant for your patients. Issues affecting the external validity or generalizability of a trial should therefore be reported. Our aim was to determine whether articles with published results from a complete cohort of drug trials conducted entirely or partly in general practice reported sufficient information about the trials to consider the external validity.

methodsA cohort of 196 drug trials in Norwegian general practice was previously identified from the Norwegian Medicines Agency archive with year of application for approval 1998-2007. After comprehensive literature searches, 134 journal articles reporting results published from 2000 to 2015 were identified. In these articles, we considered the reporting of the following issues relevant for external validity: reporting of the clinical setting; selection of patients before inclusion in a trial; reporting of patients' co-morbidity, co-medication or ethnicity; choice of primary outcome; and reporting of adverse events.

resultsOf these 134 articles, only 30 (22%) reported the clinical setting of the trial. The number of patients screened before enrolment was reported in 61 articles (46%). The primary outcome of the trial was a surrogate outcome for 60 trials (45%), a clinical outcome for 39 (29%) and a patient-reported outcome for 25 (19%). Clinical details of adverse events were reported in 124 (93%) articles. Co-morbidity of included participants was reported in 54 trials (40%), co-medication in 27 (20%) and race/ethnicity in 78 (58%).

conclusionsThe clinical setting of the trials, the selection of patients before enrolment, and co-morbidity or co-medication of participants was most commonly not reported, limiting the possibility to consider the generalizability of a trial. It may therefore be difficult for readers to judge whether drug trial results are applicable to clinical decision-making in general practice or when developing clinical guidelines.

Indexed as

Clinical Trials as TopicDrug TherapyGeneral PracticeComorbidityDrug-Related Side Effects and Adverse ReactionsDrug Therapy, CombinationEthnicityHumansPatient Reported Outcome MeasuresPatient SelectionResearch DesignResearch ReportTranslational Research, BiomedicalTreatment OutcomeApplicabilityClinical trialsEligibility determinationExternal validityGeneralizabilityGeneral practice

Identifiers

PMID29284407
PMCPMC5746953

What OpenQuestion holds

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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.