Trial reportThe Australian and New Zealand journal of surgery1998
Informed consent: how much information is enough?
Trial report in The Australian and New Zealand journal of surgery, 1998. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 4 of them syntheses that pooled 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.
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.
Who cites it
36 citing papers in PubMed, 4 syntheses or guidelines pooled it, 130 citations in OpenAlex.
- Informational video on preoperative anxiety and postoperative satisfaction prior to elective cesarean delivery: a systematic review and meta-analysis.BMC psychology · 2024Pooled it
- Risks and medico-legal aspects of endoscopic sinus surgery: a review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2014Pooled it
- Audio-visual presentation of information for informed consent for participation in clinical trials.The Cochrane database of systematic reviews · 2014Pooled it
- Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.The Cochrane database of systematic reviews · 2013Pooled it
- How could multimedia information about dental implant surgery effects patients' anxiety level?Medicina oral, patologia oral y cirugia bucal · 2017Trial
- A randomised trial of conventional versus BAUS procedure-specific consent forms for transurethral resection of prostate.Annals of the Royal College of Surgeons of England · 2009Trial
- Effects of presentation method on the understanding of informed consent.The British journal of ophthalmology · 2006Trial
- The impact of animations to improve health-information recall in patients with lower back pain: a quasi-experimental study.BMC public health · 2026Article
- Improving consenting practice in trauma and orthopaedics: A single centre original mixed methods study.Surgery in practice and science · 2025Article
- Reduced Returns to ED With Post-Tonsillectomy and Adenoidectomy Chat Program: Outcomes and Costs.The Laryngoscope · 2025Article
- Effect of Supplementary Video Information on Patient Anxiety Before Urodynamic Testing: A Randomized Controlled Study.International neurourology journal · 2025Article
- The effect of video-animated information on the anxiety of male patients before flexible cystoscopy performed under local anesthesia.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2025Article
- Using panoramic radiographs to assess the probability of causing oroantral communication following tooth removal. A retrospective cross-sectional study.Clinical oral investigations · 2025Article
- A Randomized-Controlled Trial Evaluating the Impact of a Web Tutorial on Perceptions and Usage of Opioids Post-Carpal Tunnel Release Surgery.Journal of hand surgery global online · 2024Article
- Effectiveness of educational videos on patient's preparation for diagnostic procedures: Systematic review and Meta-Analysis.Preventive medicine reports · 2022Review
- Understanding Immunotherapy Terminology: An Analysis of Provider-Patient Conversations.Immunomedicine · 2021Article
- Improving Surgical Informed Consent: Unanswered Questions.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2021Review
- Informed consent in veterinary medicine: Ethical implications for the profession and the animal 'patient'.Food ethics · 2018Article
- Poor patient-reported outcome after hip replacement, related to poor perception of perioperative information, commoner in immigrants than in non-immigrants.Acta orthopaedica · 2016Article
- The effect of video-based education on patient anxiety in men undergoing transrectal prostate biopsy.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2014Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecent judicial decisions involving informed consent have led to some medical practitioners altering the way they obtain consent. The aim of this study was to determine the degree to which patients understood the risks associated with a surgical procedure after giving routine consent and whether providing additional detailed verbal and/or written information improved their understanding. It was further determined whether the provision of more extensive information altered patients' anxiety levels.
methodsPatients undergoing femoral popliteal bypass or carotid surgery were randomized to obtain either routine consent only or routine consent with verbal or written or verbal and written consent. Patients undertook a pre-operative risk and complication questionnaire, a pre- and postoperative anxiety and depression evaluation and a follow-up questionnaire 6 weeks after discharge.
resultsThirty-two patients were included in the trial. The comprehension questionnaire resulted in a correct percentage response of 48% for the routine information only, 59% with added verbal information, 59% with added written information and 55% with added written and verbal information. Twenty-five per cent of patients stated that they had a poor understanding of the risks and complications of the procedure.
conclusionsAdditional written or verbal information did not improve a patient's understanding of risks and complications of the procedure. It also did not improve patients' perceived understanding of the operation or its complications. Patients' anxiety levels were unaltered by the increase in the information they were given. The information provided to patients should be simple, easy to understand and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure.
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What OpenQuestion holds
Registered trials
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.