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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?

ABSTRACT: 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.Secondary care hospitals in Denmark.Patient information leaflets from all hospitals that used misoprostol as an induction agent by June 2015 (N=13).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.Women's involvement in decision-making, information on benefits and harms associated with the treatment, other justifiable treatment options, and non-registered treatment.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.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.

SUBMITTER: Clausen JA

PROVIDER: S-EPMC4885466 | biostudies-other | 2016

REPOSITORIES: biostudies-other

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Project description:BackgroundInformed consent (IC) is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions.MethodsAdult postsurgical patients in nine general hospitals of Italy's Campania Region were interviewed via a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire.ResultsThe written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients (age???60) and patients with higher levels of education were more likely to read the written IC form.ConclusionsThe written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients' needs. To improve the quality of communication we suggest enhancing physicians' communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures.

Project description:AimsPragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US.MethodsThe study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives.ResultsA total of 2008 adults sampled from a probability-based online panel responded to the web-based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7-37.1%) than the alternative of verbal consent (12.7-14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent.ConclusionsThe results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low-risk pRCTs.

Project description:BackgroundTotal knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients' information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice.MethodsWe chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis.ResultsWe conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information.ConclusionsWe were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.

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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?

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