Introduction Failure to provide adequate information for valid informed consent may impact negatively on patient satisfaction and trust, and is a common cause of medical litigation. Some professional societies produce standardised consent forms in an attempt to reduce variation in quality of consent. There is no published national guideline standard for consent for medical thoracoscopy. We reviewed the quality of consents for medical thoracoscopy in a unit performing an average of 40 medical thoracoscopies per year.
Methods Case records of 80 patients who had undergone medical thoracoscopy were retrospectively reviewed. Consent forms were assessed for mention of potential complications, and grade and competency at thoracoscopy of consent-takers. We analysed the consistency between consents taken by the same individuals at different times, and numbers of patients experiencing complications for which they were not consented.
Results Consent was taken by 19 individuals. Consultant thoracoscopists took 54% of consents; non-thoracoscopist consultants took 15% and trainees 31%. Potential complications consented for were: bleeding (100%), ‘infection’ (99%), persistent pneumothorax/trapped lung (81%), pain (73%), Empyema (46%), damage to underlying organs (28%), respiratory distress (28%), non-diagnostic procedure (20%), (talc related) fever (16%), cardiac complications (15%) and haemothorax (10%).
Consultant thoracoscopists were significantly more likely than all other consent-takers to consent patients for empyema; 72% vs 16% of consents, p < 0.001, and pain; 93% vs 49%, p < 0.001.
Consistency with which consent-takers omitted or mentioned complications varied by individual and complication. For example, those individuals who consented at least once for empyema (7/19 consent-takers) did so collectively on 80% of their consents (individual range 25%-100%), whereas those who took consent for damage to underlying organs (10/19 consent-takers) did so on only 35% of their consents (range 5%-100%).
Empyema occurred in 5% of patients, all of whom had been consented for this complication. 38/80 patients (48%) experienced significant pain, of whom 34% were not consented for this.
Conclusion Information provided on thoracoscopy consent forms is inconsistent, both for common minor and serious complications. Even experienced thoracoscopists may fail to clarify significant complications. Introduction of a standardised consent form could reduce variation and consequent potential for patient distress and medico-legal risk.