The Department of Veterans Affairs (VA) has been an early leader in patient safety, mandating incident reporting (VHA Handbook 1050.1) and disclosure of clinical, institutional and large-scale adverse events to patients who have been harmed, including cases where the harm may not be obvious or severe, or where the harm may only be evident in the future (VHA Handbook 1004.08). Other U.S. and international organizations have taken similar stances to disclosure of unanticipated events to patients, including the National Quality Forum's Safe Practices for Better Healthcare and the Institute of Healthcare Improvement's Respectful Management of Serious Clinical Adverse Events.
Despite national standards and guidelines, physicians do not always report disclosing medical errors or unanticipated events to their patients. Many have argued that disclosure is as important for patients as it is for providers, stating that disclosure would enable providers to have an outlet for the emotional toll they experience as part of the adverse event itself. One fear of disclosure reported by physicians is that the disclosure process increases their risk of negative consequences. Very few studies have examined actual disclosures to patients and the impact of these disclosures on physicians. Moreover, no measure of disclosure currently exists. Research investigating the content and the process of actual disclosures is needed to better understand which elements of national standards and guidelines are incorporated into disclosures, why some elements are potentially not included while others are, and the impact of disclosures on providers.
1) To qualitatively examine how surgeons disclose adverse events to patients; 2) to create a quantitative measure of "appropriate disclosure" from interview findings mapped to the criteria from the VA's handbook on disclosing adverse events and 3) to quantitatively and qualitatively measure reported disclosures and their impact on surgeons. Two hypotheses were tested: 1) surgeons who report more facilitating attitudes towards disclosure of adverse events report more communicating more elements of appropriate disclosure; and 2) surgeons who communicated an adverse event using more elements of appropriate disclosure report less distress after disclosure.
This study took place at three VA medical centers in the U.S. Northeast and Pacific West from January 2011 through December 2013, following a one year pilot period at one site in 2010. Eleven major surgeries are performed at these facilities. The study was approved by each facility's Institutional Review Board, and a Certificate of Confidentiality from the National Institutes of Health was obtained, to protect the identity of surgeons participating in the study.
Participants: Attending, fellow and resident surgeons at the level of PGY 4 and above from these eleven surgical specialties provided informed consent in advance of participating in the study.
Process for identifying unanticipated surgical events: Eligible events involved a conversation with a patient or family member, where a patient experienced 1) an unplanned return to the operating room or 2) an unplanned procedural intervention following surgery, any time within 30 days of the original surgery.
Pilot study: In 2010, we interviewed 9 surgeons and eight patients and family members at one VA facility to understand the communication process during disclosure. From these interviews, a 7-item, yes/no "appropriate disclosure scale" was created, by mapping surgeon and patient disclosure perspectives to the criteria for disclosures described in the VHA Handbook.
Full study: From January 2011-December 2013, we recruited surgeons from three VA facilities. Surgeons provided written informed consent and completed a baseline "attitude towards disclosure" questionnaire, adapted from Kaldjian et al, 2007, to assess facilitating and impeding attitudes towards disclosure. These attitude questions were collected in response to two vignettes, one where a medical error was apparent, additional surgery was needed and the patient did not fare well (high harm; sponge scenario); the other where an intra-operative event took place but was corrected and the patient recovered well (low harm; blood loss).
Surgeons self-identified that they had disclosed an adverse event to a patient, and were then sent a link to complete the 22-item web-based survey, involving the "appropriate disclosure scale", and items on how much the disclosure impacted surgeons personally, their job satisfaction, confidence in their ability as a physician, their professional reputation, their anxiety about future outcomes or events, and their ability to sleep. Each consented surgeon was able to complete up to three surveys for three different adverse events during the study period. Additionally, surgeons were able to participate in a separate, semi-structured interview following the web-based survey, to explore these elements of disclosure in more depth.
67 (89%) of surgeons at the 3 VA facilities consented in advance to the study and completed baseline attitude surveys. 62 web-based surveys on disclosure were completed by 33 (50%) of these surgeons. 68% of the participating surgeons were male, and surgeons represented all 11 surgical specialties offered at each site. Of those participating in the web-based survey, 23 (37%) participate in an additional, semi-structured interview following the survey.
To test hypothesis 1, we used hierarchical linear modeling to regress surgeons' reports of facilitating and impeding attitudes towards disclosure on the appropriate disclosure scale, and found that when surgeons reported more facilitating attitudes in the low harm scenario (blood loss), they were more likely to report using more elements of appropriate disclosure in their communication with patients and family members ( =0.23, p<0.01), which upheld hypothesis 1. Similarly, we found that surgeons who reported more impeding attitudes towards disclosure reported more anxiety about future events following disclosure (OR=1.54, 95% CI 1.36, 2.06).To test hypothesis 2, we regressed surgeons' reports of appropriate disclosure on surgeons' reports of how the disclosure impacted them, and found that surgeons who reported using more elements of appropriate disclosure in their communication with patients and family members reported that the disclosure impacted them more personally than surgeons who did not use as many elements of appropriate disclosure ( =-0.37, p=0.02). This did not uphold hypothesis 2. Qualitative results from the interviews following the web-based surveys corroborated these findings.
These results highlight 1) the potential ability to predict which surgeons and other physicians will disclose adverse events appropriately to their patients, and 2) that the personal impact of disclosure for those who disclose appropriately is significant. Establishing peer support programs for surgeons may help to sustain full disclosure, because only other surgeons will understand this impact of disclosure. These peers may encourage disclosure by assessing others' attitudes towards disclosure to identify surgeons who may benefit from peer disclosure support.
- Elwy AR, Itani KM, Bokhour BG, Mueller NM, Glickman ME, Zhao S, Rosen AK, Lynge D, Perkal M, Brotschi EA, Sanchez VM, Gallagher TH. Surgeons' Disclosures of Clinical Adverse Events. JAMA surgery. 2016 Nov 1; 151(11):1015-1021.
- Elwy AR, Horton NJ, Saitz R. Physicians' attitudes toward unhealthy alcohol use and self-efficacy for screening and counseling as predictors of their counseling and primary care patients' drinking outcomes. Substance abuse treatment, prevention, and policy. 2013 May 30; 8(1):17.
- Bokhour BG, Mueller NM, Elwy AR. Communicating Adverse Patient Events in Surgery: The CAPES Study. Poster session presented at: American Academy on Communication in Healthcare International Annual Conference; 2010 Oct 4; Phoenix, AZ.
- Elwy AR, Mueller NM, Eisen SV, Gallagher TH, Rosen AK, Bokhour BG. Communicating adverse patient events in surgery: the CAPES study. Paper presented at: Communication, Medicine and Ethics (COMET) Interdisciplinary Annual Conference; 2010 Jun 28; Boston, MA.