ArticleBMJ open2016
Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?
Article in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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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.
The trial behind it
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Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Effects of induction of labor prior to post-term in low-risk pregnancies: a systematic review.JBI database of systematic reviews and implementation reports · 2019Pooled it
- Co-Developing Patient-Centered Information: A Focus Group Study of Asthma Patients' Preferences and Attitudes towards New Medical Treatment Guidelines.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Factors that Facilitate and Hinder the Comprehension of Patient Information Leaflets (PILs): A Brief Scoping Review.Frontiers in pharmacology · 2021Article
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe need for thorough patient information is increasing as maternity care becomes more medicalised. The aim was to assess the quality of written patient information on labour induction. In most Danish hospitals, misoprostol is the first-choice drug for induction in low-risk pregnancies. Misoprostol has been associated with adverse side effects and severe outcomes for mother and child and is not registered for obstetric use in Denmark.
settingSecondary care hospitals in Denmark. DATA: Patient information leaflets from all hospitals that used misoprostol as an induction agent by June 2015 (N=13).
designPatient leaflets were evaluated according to a validated scoring tool (International Patient Decision Aid Standards instrument, IPDAS), core elements in the Danish Health Act, and items regarding off-label use and non-registered medication. Two of the authors scored all leaflets independently. OUTCOME MEASURES: Women's involvement in decision-making, information on benefits and harms associated with the treatment, other justifiable treatment options, and non-registered treatment.
resultsGenerally, the hospitals scored low on the IPDAS checklist. No hospitals encouraged women to consider their preferences. Information on side effects and adverse outcomes was poorly covered and varied substantially between hospitals. Few hospitals informed about precautions regarding outpatient inductions, and none informed about the lack of evidence on the safety of this procedure. None informed that misoprostol is not registered for induction or explained the meaning of off-label use or use of non-registered medication. Elements such as interprofessional consensus, long-term experience, and health authorities' approval were used to add credibility to the use of misoprostol.
conclusionsCentral criteria for patient involvement and informed consent were not met, and the patient leaflets did not inform according to current evidence on misoprostol-induced labour. Our findings indicate that patients receive very different, sometimes contradictory, information with potential ethical implications. Concerns should be given to outpatient inductions, where precise written information is of particular importance.
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