Evidence map›Paper›PMID 30962244›Full record

ArticleBMJ open2019

Identification of potential carcinogenic and chemopreventive effects of prescription drugs: a protocol for a Norwegian registry-based study.

Bettina Kulle Andreassen, Nathalie C Støer, Jan Ivar Martinsen, Giske Ursin, Elisabete Weiderpass, G Hege Thoresen, Karen Boldingh Debernard, Øystein Karlstad, Anton Pottegard, Søren Friis

Abstract read
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

10 authors.

Bettina Kulle AndreassenDepartment of Research, Cancer Registry of Norway, Oslo, Norway.
Nathalie C StøerNorwegian National Advisory Unit on Women's Health, Women's Clinic, Oslo University Hospital, Oslo, Norway.
Jan Ivar MartinsenCancer Registry of Norway, Oslo, Norway.
Giske UrsinCancer Registry of Norway, Oslo, Norway.
Elisabete WeiderpassDepartment of Research, Cancer Registry of Norway, Oslo, Norway.
G Hege ThoresenDepartment of Pharmacology, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Karen Boldingh DebernardRegional Medicines Information and Pharmacovigilance Centre (RELIS), Department of Pharmacology, Oslo University Hospital, Oslo, Norway.
Øystein KarlstadDepartment of Chronic Diseases and Aging, Nasjonalt folkehelseinstitutt, Oslo, Norway.
Anton PottegardClinical Pharmacology and Pharmacy, Department ofPublic Health, University of Southern Denmark, Odense, Denmark.
Søren FriisDanish Cancer Society Research Center, Danish Cancer Society, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSurveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations. METHODS AND ANALYSIS: The main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case-control design including all adult (~200 000) incident cancer cases within the age-range 18-85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions' daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use-cancer-risk associations. ETHICS AND DISSEMINATION: The study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsCase-Control StudiesFemaleHumansInformation Storage and RetrievalMaleMiddle AgedPharmacoepidemiologyProduct Surveillance, PostmarketingYoung AdultAntineoplastic Agentscancer riskdrug safetypharmacoepidemiology

Identifiers

PMID30962244
PMCPMC6500356

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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.