Evidence map›Paper›PMID 27733414›Full record

SynthesisBMJ open2016

Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion.

Rianne A Weersink, Margriet Bouma, David M Burger, Joost P H Drenth, Nicole G M Hunfeld, Minke Kranenborg, Margje H Monster-Simons, Sandra A W van Putten, Herold J Metselaar, Katja Taxis and 1 more

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 16% of its field
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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Guideline
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  10. Impact of Pharmacogenomics in Clinical Practice.Pharmaceuticals (Basel, Switzerland) · 2023
    Review
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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

11 authors at 8 institutions in 1 country.

Rianne A WeersinkHealth Base Foundation, Houten, The Netherlands Department of Pharmacy, Unit of Pharmacotherapy, -Epidemiology & -Economics, University of Groningen, Groningen, The Netherlands.
Margriet BoumaDepartment of Guideline Development, Dutch College of General Practice, Utrecht, The Netherlands.
David M BurgerDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
Joost P H DrenthDepartment of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands.
Nicole G M HunfeldDepartment of Pharmacy and Department of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.
Minke KranenborgCentre for Information on Medicines, Royal Dutch Pharmacists Association (KNMP), The Hague, The Netherlands.
Margje H Monster-SimonsDutch Medicines Evaluation Board, Utrecht, The Netherlands.
Sandra A W van PuttenDe Brug Pharmacy, Almere, The Netherlands.
Herold J MetselaarDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Katja TaxisDepartment of Pharmacy, Unit of Pharmacotherapy, -Epidemiology & -Economics, University of Groningen, Groningen, The Netherlands.
Sander D BorgsteedeHealth Base Foundation, Houten, The Netherlands SIR Institute for Pharmacy Practice and Policy, Leiden, The Netherlands.
Erasmus MC · NLUniversity of Groningen · NLDutch College of General Practitioners · NLMedicines Evaluation Board · NLRadboud University Medical Center · NLRadboud University Nijmegen · NLRoyal Dutch Pharmacists Association · NLSIR Institute for Pharmacy Practice and Policy · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLiver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. METHODS AND ANALYSIS: For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of) liver cirrhosis, and (B) drugs frequently prescribed to the general population. ETHICS AND DISSEMINATION: Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings.

Indexed as

Chemical and Drug Induced Liver InjuryDrug InteractionsHumansLiver CirrhosisNetherlandsPatient SafetyPharmaceutical PreparationsPractice Guidelines as TopicPrescription DrugsPharmaceutical PreparationsPrescription Drugsdrug safetyexpert opinionliterature reviewliver cirrhosispractice guideline

Identifiers

PMID27733414
PMCPMC5073492
OpenAlexW2530757797

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.