Measuring Surgical Outcomes: Are Surgical Objectives Important Enough to Document?

During the past decade, there has been an explosion of interest in measuring the effectiveness of medical care. [1] Clinical research in surgical subspecialties focused on physiological outcomes such as ambulation, muscle strength or deficits.[2-4] In recent years, however, there has been increasing attention given to the rigorous measurement of functional status, satisfaction with treatment and healthcare costs associated with interventions.[5-7] There is an emerging understanding for the need to improve the quality and comprehensiveness of the assessment of the outcomes of these interventions.[5] There is also a growing recognition that patient perspectives are essential, both in making medical decisions and in judging the results of treatment.[6-9] Furthermore, with escalating healthcare costs, there has been a growing interest in measuring the cost-utility in surgery to determine the quality and appropriateness of various interventions. [1-4,6]

Surgical outcomes research refers to a genre of clinical investigation that emphasizes the measurement of surgical objectives and patient health outcomes, including the patient's symptoms, functional status, quality of life, satisfaction with treatment results and healthcare costs. It seeks to inform healthcare decisions by providing evidence on the effectiveness, benefits and harms of different surgical options. Such outcomes ought to be more closely scrutinized in patients undergoing surgery. The happenings of the operating room can no longer parallel that of a secret society: we ought to compare patient quality of life indices (pre- and post-operatively) to surgeons' perspectives, successes, failures and/or compromises that occur in the operating room. Were the predetermined operative objective(s) achieved? Are qualitative and quantitative scales available to determine if aspects of the operations, successes and/or failures, affect outcome?

We do know, for example, that simple steps in the operating room such as a checklist can greatly affect surgical outcomes.[10] Nevertheless, the response to this effort from surgeons has been dawdling and even oppositional at times. A privately owned company, mTuitive, a leading provider of synoptic reporting and structured data solutions for healthcare organizations, conducted a preliminary survey to determine whether a "surgical objectives" section should be included in its OpNote product, a digital, point-of-care, operative note that allows for rapid completion of the standardized operative note by having information entered into discreet data fields with many surgeon-specific customizations. Interestingly, despite the potential benefits of adding a "surgical objectives" section, the majority of responses indicated surgeons were not interested in documenting surgical outcomes in the operative note.

Specifically, mTuitive distributed approximately one thousand emails to surgeons with twenty-two returns for incorrect email addresses (970 total emails sent). Of these, there was a 9.8 percent (95 count) response rate. Responses included dichotomous yes/no answers as whether or not to include a surgical objectives section in the OpNote program, as well as free-text commentary. Of the ninety-five responses, forty voted for inclusion (42.1 percent), while fifty-five (57.9 percent) opted for exclusion.



Comments on the survey in favor of the objectives measures included:

"The reason for a surgery should always be crystal clear with a definitive primary objective and possibly alternative goals. Furthermore, there certainly is a need for the EMR to be abstractable across different institutional platforms to allow for better patient care including following outcomes."

"It would seem to me that any surgery has an outcome objective. In addition to that outcome objective, the estimated probability of success in achieving the outcome, the estimated probability of complications, and the documentation of patient notification of the above should be part of each surgical record. Informed consent is part of each physician's responsibility. I think a clear delineation of the issues and the respective preoperative probabilities would decrease rather than increase the risk of lawsuit."

Comments in favor of excluding the objectives measures included:

""In most instances the Outcome Objective is obvious and not subtle or deserving of enumeration."

" I would not include. The legal argument may soon be overcome, however, by reimbursement requirements being developed by CMS around outcomes."

A paradigm shift is underway in medicine, but despite the increasing prominence of evidence-based practice in surgery, a standardized rubric for collecting, analyzing and presenting this data has yet to be established. This provides a remarkable opportunity for surgical centers in the United States to lead the charge towards improved surgical outcomes.

Companies such as mTuitive have already spearheaded efforts to ensure that operative data is collected in discreet fields to help facilitate future extraction and analysis. Furthermore, many (roughly 42 percent, according to the survey) practitioners agree that including a surgical objective data field is the appropriate next step in quality control, outcomes analysis and patient satisfaction. For many, this is already commonplace in their practice, such as in the informed consent or the pre-operative or peri-operative process, and has simply not been effectively used as an objectives metric.

Despite the optimism, more physicians in this survey were opposed to including a surgical objectives field in the operative note. From analyzing the responses, it is clear that the apprehension stems primarily from fear of litigation. This issue should not be undervalued as it affects the delivery of healthcare more than the public is willing to admit. However, with further review of malpractice claims and policy, and relatively good evidence to support that well-documented and transparent reporting would not make a physician more vulnerable to lawsuits, it is the hope of this author that the fear of litigation will be somewhat mitigated. My approach may be deemed naïve by my more veteran and well-weathered colleagues; however, I feel strongly that when given a tool to prospectively collect data in our surgical patients, we are behooved to take advantage of it. Our operative objectives and our outcomes should make us better — better equipped to deal with our patients' medical conditions and, frankly, their expectations. Evidence-based medicine ought to include surgery as well.

Footnotes:

[1 ]Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996:1-413.

[2] Compendium of Outcome Instruments for Assessment and Research of Neurosurgical Disorders. Gatchel RJ, Editor. North American Neurosurgery Society. 2001.

[3] Gerszten PC. Outcomes Research: A Review. Neurosurgery 43:1146-1156, 1998.

[4] Haines S. Evidence-Based Neurosurgery. Neurosurgery 52:36-47, 2003.

[5] Ament JD, Black P. Levels of Evidence in Medical Publications. The Asian Journal of
Neurosurgery 2008;3:1-4.

[6] King JT, Tsevat J, Moossy JJ, Roberts MS. Preference-Based Quality of Life Measurement in
Patients with Cervical Spondylotic Myelopathy. Neurosurgery 29:1271-1280, 2004.

[7] King JT, McGinnis KA, Roberts MS. Quality of Life Assessment with the Medical Outcomes Study Short Form-36 Among Patients with Cervical Spondylotic Myelopathy. Neurosurgery 52:113-121, 2003.

[8] McDowell I, Newell C. Measuring Health: A Guide to Rating Scales and Questionnaires. Second Edition. New York, Oxford Press, 1996.

[9] Feeny, David, William Furlong, Michael Boyle, and George W. Torrance, "Multi-Attribute Health Status Classification Systems: Health Utilities Index." PharmacoEconomics, Vol 7, No 6, June 1995, pp 490-502.

[10] Ziewacz JE, Arriaga AF, Bader AM, Berry WR, Edmondson L, Wong JM, Lipsitz SR, Hepner DL, Peyre S, Nelson S, Boorman DJ, Smink DS, Ashley SW, Gawande AA. Crisis checklists for the operating room: development and pilot testing. J Am Coll Surg. 2011 Aug;213(2):212-217.e10.

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5 News Items, Studies on Training for the Operating Room
Who Should Lead Improvement Initiatives in the OR? 9 Responses






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