Evidence map›Paper›PMID 33715267›Full record

SynthesisPharmacoepidemiology and drug safety2021

Control yourself: ISPE-endorsed guidance in the application of self-controlled study designs in pharmacoepidemiology.

Suzanne M Cadarette, Malcolm Maclure, J A Chris Delaney, Heather J Whitaker, Kaleen N Hayes, Shirley V Wang, Mina Tadrous, Joshua J Gagne, Giulia P Consiglio, Jesper Hallas

Abstract readSystematic Review
In one paragraph

Synthesis in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 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

39 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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.

Suzanne M CadaretteLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-8584-9649
Malcolm MaclureDepartment of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada.
J A Chris DelaneyCollege of Pharmacy, University of Manitoba, Winnipeg, Manitoba, Canada.ORCID 0000-0003-1771-1776
Heather J WhitakerDepartment of Mathematic and Statistics, The Open University, Milton Keynes, UK.ORCID 0000-0001-5833-1863
Kaleen N HayesDalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-1122-0071
Shirley V WangBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-7761-7090
Mina TadrousLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0003-1911-6129
Joshua J GagneBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-5428-9733
Giulia P ConsiglioLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Jesper HallasClinical Pharmacology and Pharmacy, IST, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-8097-8708

Funding

Medical Research Council MR/L009005/1
6 · The paper itself

Abstract

purposeConsensus is needed on conceptual foundations, terminology and relationships among the various self-controlled "trigger" study designs that control for time-invariant confounding factors and target the association between transient exposures (potential triggers) and abrupt outcomes. The International Society for Pharmacoepidemiology (ISPE) funded a working group of ISPE members to develop guidance material for the application and reporting of self-controlled study designs, similar to Standards of Reporting Observational Epidemiology (STROBE). This first paper focuses on navigation between the types of self-controlled designs to permit a foundational understanding with guiding principles.

methodsWe leveraged a systematic review of applications of these designs, that we term Self-controlled Crossover Observational PharmacoEpidemiologic (SCOPE) studies. Starting from first principles and using case examples, we reviewed outcome-anchored (case-crossover [CCO], case-time control [CTC], case-case-time control [CCTC]) and exposure-anchored (self-controlled case-series [SCCS]) study designs.

resultsKey methodological features related to exposure, outcome and time-related concerns were clarified, and a common language and worksheet to facilitate the design of SCOPE studies is introduced.

conclusionsConsensus on conceptual foundations, terminology and relationships among SCOPE designs will facilitate understanding and critical appraisal of published studies, as well as help in the design, analysis and review of new SCOPE studies. This manuscript is endorsed by ISPE.

Indexed as

PharmacoepidemiologyResearch DesignCase-Control StudiesCross-Over StudiesHumansTime Factorsdesignpharmacoepidemiologyresearchself-controlled

Identifiers

PMID33715267
PMCPMC8251635

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.