___________________________________________________________________________ Risk Management
Informational resources in a variety of media may be help- ful as a supplement to the discussion. These resources help emphasize realistic expectations and address different learning preferences; as such, they have been shown to enhance under- standing, especially for patients with low educational levels [72; 136; 137]. A systematic review of 55 trials on decision aids indicated that they increase patients’ involvement and are more likely to lead to informed values-based decisions, but the size of this effect has varied across studies [138]. An updated review that included 105 trials indicated that decision aids are more likely to lead to improved patient knowledge and improved perception of the risks involved [139]. If time allows, it is reasonable to let patients consider a decision made after signing an informed consent form [36]. Giving a patient 24 to 48 hours to think about the risks and benefits can reinforce the validity of the informed consent [36]. If a patient withdraws consent, it should be documented in the medical record, with the date and time of withdrawal. Documenting the informed consent discussion in the patient’s record and including the signed informed consent form in the record decreases the probability of a successful malpractice case against the physician [36]. A signed informed consent form is not automatic protection; patients can argue that the risks were discussed by a healthcare professional other than the physician who performed the treatment or that they did not understand the risks.
DISCUSSION POINTS FOR INFORMED CONSENT Diagnosis (if known) Nature and purpose of treatment or procedure Potential risks of proposed treatment Expected benefits of proposed treatment Probability of a good outcome with the proposed treatment Potential problems during recovery Estimated time to return to normal activities Availability of alternative treatment options Risks and benefits of alternative treatment options
(including no treatment or procedure) Likely results if no treatment is given Source: [40; 133]
Table 5
Essential elements of the informed consent conversation include the diagnosis, the proposed procedure or treatment plan and its potential risks and expected benefits, the risks and benefits of any alternative treatment options, the typical recov- ery process, and the expected long-term and short-term effects ( Table 5 ) [40; 133]. In addition, physicians should tailor the informed consent discussion to a patient’s unique situation, noting risks that may be applicable to a patient because of his or her medical history or current comorbidities [41]. In a study to assess the levels of knowledge of patients, more than 80% of patients were satisfied with an informed consent discussion about pending surgery and considered themselves to be fully informed, but more than half could not list a single potential complication related to the surgery [134]. A patient’s dissatisfaction with an informed consent discussion is most likely to surface only if an adverse event occurs after the treatment was given. Because of the gap between what is told and what is remembered, a patient may think that an adverse event is the result of inadequate informed consent or negligent care [135]. Given the challenge of knowing whether a patient has under- stood the informed consent discussion, physicians should take several efforts to enhance understanding. Asking the patient to read a section of the informed consent form aloud enables the physician to assess the patient’s literacy level [41]. Physi- cians should plan sufficient time to speak with the patient and should present information in easy-to-understand language. Patients should be encouraged to ask questions and to take an active role in decision making [135]. Lastly, the patient should be asked to describe a section or sections of the form in his or her own words to demonstrate the level of understanding. Physicians should have consent forms translated into languages spoken by any large percentage of their patient population [41].
APPROPRIATE AND COMPLETE DOCUMENTATION
The patient’s medical record is a legal document that reflects the care provided to a patient, and it serves as the basis of defense against malpractice claims and other types of law- suits [9]. As such, it is crucial for physicians to document all encounters and patient information carefully and accurately [9]. Experts indicate that no amount of documentation is too much, especially in situations at high risk for malpractice claims because of the patient’s diagnosis or the physician’s specialty [85]. Careful, complete documentation provides proof that the physician did the right thing and demonstrates that the physi- cian gave logical thought and consideration to the case [85; 97]. Despite the importance of complete medical records, surveys of office practices have shown that documentation is frequently incomplete or poor, with the most often lacking elements being [140]: • Updated problem list • Discussion of medications • Allergies • Informed consent process • Physician signature (to indicate review) Physicians should ensure that all essential information is docu- mented in every patient’s record ( Table 6 ) [9; 85; 141; 142].
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