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Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?

Authors : Jette Aaroe Clausen, Mette Juhl, Eva Rydahl

Abstract

Objectives

The 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.

Setting Secondary care hospitals in Denmark.

Data Patient information leaflets from all hospitals that used misoprostol as an induction agent by June 2015 (N=13).

Design Patient 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.

Results

Generally, 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.

Conclusions

Central 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.

Citation: Jette Aaroe Clausen, Mette Juhl, Eva Rydahl Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?  
BMJ Open 2016;6:e011333 doi:10.1136/bmjopen-2016-011333

Received: 29 January 2016 Revised: 21 April 2016 Accepted: 6 May 2016 Published: 27 May 2016

Copyright: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Contributors

JAC and ER conceptualised the idea of the study. JAC, ER and MJ contributed considerably to the design of the work; and to the acquisition, analysis and interpretation of the data. They also contributed considerably to the drafting and revision of the paper; and to important intellectual discussions forming the final submitted version. All authors have approved the submitted version and agree to be accountable for all aspects of the work.

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

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