Perspectives

Hippocrates and informed consent

The purpose of this study was to propose questions that may be helpful to educate patients considering treatment approaches to manage low back pain (LBP) and to determine if the information currently presented in informed consent (IC) documents at chiropractic colleges is sufficient to help a patient considering chiropractic management of LBP make a fully informed decision.

Questions to inform decision making for a patient contemplating any intervention for LBP were developed by the authors based on their clinical and research experience. Answers to the questions were suggested based on findings from recent clinical practice guidelines and systematic reviews. Institutions that are members of the Association of Chiropractic Colleges (ACC) were surveyed and asked to provide a copy of the IC documents currently used in their outpatient educational clinics. The IC documents were analyzed to determine if they stated (or implied) information that may be helpful in addressing each of the proposed questions.

The list of 20 questions included 4 questions on each of the following 5 topics: condition, proposed treatment, potential benefits, potential harms, and possible alternatives. A total of 21 ACC institutions were contacted, of which 20 responded. The number of questions that could potentially be answered with information provided in the IC documents ranged from 2 to 13, with a mean of 6.5, including a mean of 3.6 stated answers and 2.9 implied answers.

Some information to help patients consider chiropractic management of LBP is currently included in the IC documents used in clinics of ACC institutions. However, many of the questions that could help achieve shared decision making are not included. Modifying IC documents may help patients understand the nature, benefits, harms, costs, and alternatives to LBP care.

Informed consent is an ethical imperative of surgical practice. This requires effective communication of procedural risks to patients and is learned during residency. No systematic review has yet examined current risk disclosure. This systematic review aims to use existing published information to assess preoperative provision of risk information by surgeons.

Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses as a guide, a standardized search in Ovid MEDLINE, Embase, CINHAL, and PubMed was performed. Three reviewers performed the study screening, with 2-reviewer consensus required at each stage. Studies containing objective information concerning preoperative risk provision in adult surgical patients were selected for inclusion. Studies exclusively addressing interventions for pediatric patients or trauma were excluded, as were studies addressing risks of anesthesia.

The initial search returned 12,988 papers after deduplication, 33 of which met inclusion criteria. These studies primarily evaluated consent through surveys of providers, record reviews and consent recordings. The most ubiquitous finding of all study types was high levels of intra-surgeon variation in what risk information is provided to patients preoperatively. Studies recording consents found the lowest rates of risk disclosure. Studies using multiple forms of investigation corroborated this, finding disparity between verbally provided information vs chart documentation.

The wide variance in what information is provided to patients preoperatively inhibits the realization of the ethical and practical components of informed consent. The findings of this review indicate that significant opportunities exist for practice improvement. Future development of surgical communication tools and techniques should emphasize standardizing what risks are shared with patients.