Surgical Overtreatment and Shared Decision-making—The Limits of Choice

Justin T. Clapp; Margaret L. Schwarze; Lee A. Fleisher

doi:10.1001/jamasurg.2021.4425

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October 13, 2021

Surgical Overtreatment and Shared Decision-making—The Limits of Choice

Justin T. Clapp, PhD, MPH^1,2; Margaret L. Schwarze, MD, MPP³; Lee A. Fleisher, MD^1,2

Author Affiliations Article Information

¹Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia
²Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia
³Department of Surgery, University of Wisconsin–Madison, Madison

JAMA Surg. 2022;157(1):5-6. doi:10.1001/jamasurg.2021.4425

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Overtreatment is medical intervention that is extremely unlikely to help a patient, is misaligned with a patient’s wishes, or both. Its harms to individual patients and families include iatrogenesis, financial burden, anxiety, and time wasted at hospitals and clinics. Overtreatment adds substantially to US health care costs.¹ Surgeons have been concerned with reducing overtreatment for decades. Early strategies were payer and physician focused: bundled payment systems, precertification, second opinion programs, and practice guidelines.² Recently, focus has shifted to conversations between surgeons and patients, presuming that overtreatment is not a reflection of poor clinical reasoning but is rooted in ineffective communication, misaligned expectations, and overbearing paternalism. Consequently, shared decision-making is now commonly proposed for mitigating overtreatment.³ In theory, improving communication by presenting treatment options, eliciting patients’ values, and incorporating these values into collaborative deliberation would reduce unnecessary surgery.

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November 1, 2021

BEING CLEAR ABOUT THE LIMITS OF CHOICE AND THE REQUIREMENTS OF SHARED DECISION-MAKING

Abeezar Sarela, MBBS, MS, MSc, PhD, FRCS | The Leeds Teaching Hospitals NHS Trust, UK

In discussing surgical overtreatment, Clapp et al highlight the contemporary emphases on self-determination and patient-choice.(1) As these authors allude, ‘choice’ has expanded from the notion of providing patients with an opportunity to decline the proposed treatment to the opportunity to choose amongst all available treatments. Yet, the basic premise that patient-choice can, and should, determine treatment remains problematic; and the socio-cultural issues that are discussed by Clapp et al are only a part of the problem.
The root of the problem residues in conceptual confusion about choice and the closely related concepts of respect for autonomy, self-determination, shared decision-making (SDM) and informed consent. This conceptual confusion has two aspects. First, there is lack of a clear distinction between the identification of options that are available, in the first place; and, then, selection or choice amongst these available options. Clarity can be gained from arguments in behavioural economics that choice must have a starting point; and this starting point, itself, cannot be self-determined.(2) For example, if the starting point is treatments A, B and C, then the patient’s choice extends to, but is also limited by, this range. The patient cannot now ‘choose’ to include D, E and F into the range of available options. However, the difficulty is to agree on the starting point: how, or by whom, should it be decided? UK law indicates that the responsibility to identify available treatments rests with physicians;(3) but other jurisdictions may differ and further work is required in this area.
The second aspect of the confusion about choice, as practiced through SDM, emerges as the ‘awkward ambivalence of trying to empower patients by presenting them with choices while simultaneously steering them toward decisions that clinicians or policy makers think appropriate’.(1) It need not be so. SDM allows physicians to make recommendations. In fact, it could be argued that the physician is obliged to make a recommendation as part of SDM.(4) Having identified A, B and C as available treatments, the physician should not only inform the patient about the pros and cons of each option but also indicate and explain the physician’s preferred option. Behavioural economics shows that people often cannot make decisions that correctly serve their own goals, particularly when choices are complex and involve high stakes.(2) Now, a professional ‘nudge’, in the form of a recommendation, can be a valuable tool to guide choice.(5) Physicians should not shy from making recommendations; otherwise, patients may be abandoned to misplaced choices.
References:
1. Clapp JT, Schwarze ML, Fleisher LA. Surgical Overtreatment and Shared Decision-making—The Limits of Choice [published online October 13 2021]. JAMA Surgery. doi:10.1001/jamasurg.2021.4425
2. Sunstein CR, Thaler RH. Libertarian Paternalism Is Not an Oxymoron. Univ Chic Law Rev. 2003;70(4):1159-202.
3. Sarela AI. Does the General Medical Council’s 2020 guidance on consent advance on its 2008 guidance? [published online August 23 2021]. J Med Ethics. doi:10.1136/medethics-2021-107347.
4. Sandman L, Munthe C. Shared Decision Making, Paternalism and Patient Choice. Health Care Anal. 2010;18(1):60-84.
5. Gorin M, Joffe S, Dickert N, Halpern S. Justifying Clinical Nudges. Hastings Cent Rep. 2017;47(2):32-8.

CONFLICT OF INTEREST: None Reported

November 3, 2021

Evidence: the missing word

Tom Treasure, MD | University College London UK

We applaud Dr Clapp and colleagues for addressing the problem of surgical overtreatment.(1) We largely agree with their thoughtful analysis, but there is an important omission — the word ‘evidence’ — also often missing in real-world surgical decision-making. Of 363 controlled studies (mainly RCTs) testing ‘standard of care’ treatments, 146 reversed practice and 138 reaffirmed it.(2) All 284 studies help to inform decision- making.

We have recently concluded a study of the clinical effectiveness of surgical removal of lung metastases from colorectal cancer (CRC). It has been assumed that any five-year survival rate above zero is attributable to the operation. We tested this in a prospective study of 512 patients with data collected to RCT standards. Of them 28 proved to have lung nodules of non-CRC aetiology and were excluded. Cancer teams chose to operate on 263 and to not operate on 128. Those they selected for operation were dominated by solitary metastases (69 vs 35%), had lower carcinoembryonic antigen levels, less frequent liver involvement (28% vs 36%), better lung function (predicted FEV1 96% vs 87%), better performance score and were on average five years younger. All predict longer survival in the treated patients. The survival difference was 40% very much as repeatedly reported in observational follow-up studies.(3) But in a nested RCT of 93 patients, where all these prognostic factors were excellently balanced, there was no survival difference.(4) All the survival difference could be accounted for by selection for surgery, rather than being attributable to the surgery itself.

Meta-analysis of 16 RCTs testing the effectiveness of monitoring to detect recurrence after primary surgery for CRC consistently failed to show survival benefit.(5) This casts doubt on the clinical utility of lung metastasectomy for CRC but it continued to be promoted as a ‘standard of care’. Direct RCT evidence suggests that patients may derive no survival benefit, and net harm to their quality of life. This evidence should surely be shared with patients before treating them.

Without RCTs, decisions are made on the basis of clinical impressions, patient preference, and financial considerations on both sides. Objective evidence of clinical effectiveness, would better inform the conversation. Surgical decision-making must include an objective presentation of the evidence of clinical effectiveness of the procedure - its benefits and harms. This may be hard for a surgeon with inevitable biases and competing interests and should always involve an impartial third party.

Fergus Macbeth DM Oncologist
Tom Treasure MD Thoracic Surgeon

References

1. Clapp JT, Schwarze ML, Fleisher LA. Surgical Overtreatment and Shared Decision-making-The Limits of Choice. JAMA Surg. 2021.
2. Prasad V, Vandross A, Toomey C, Cheung M, Rho J, Quinn S, et al. A decade of reversal: an analysis of 146 contradicted medical practices. Mayo Clin Proc. 2013;88(8):790-8.
3. Treasure T, Farewell V, Macbeth F, Batchelor T, Milosevic M, King J, et al. The Pulmonary Metastasectomy in Colorectal Cancer cohort study: Analysis of case selection, risk factors and survival in a prospective observational study of 512 patients. Colorectal Dis. 2021;23(7):1793-803.
4. Milosevic M, Edwards J, Tsang D, Dunning J, Shackcloth M, Batchelor T, et al. Pulmonary Metastasectomy in Colorectal Cancer: updated analysis of 93 randomized patients - control survival is much better than previously assumed. Colorectal Dis. 2020;22(10):1314-24.
5. Mokhles S, Macbeth F, Farewell V, Fiorentino F, Williams NR,

CONFLICT OF INTEREST: None Reported

Surgical Overtreatment and Shared Decision-making—The Limits of Choice

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