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Perioperative Patient-Reported Outcomes Predict Serious Postoperative Complications: a Secondary Analysis of the COST Trial

Abstract

Background

Decreased survival after colon cancer surgery has been reported in patients with deficient preoperative quality of life. We hypothesized that deficits in preoperative quality of life are associated with postoperative complications.

Patient and Methods

A secondary analysis of the Clinical Outcomes Surgical Therapy trial NCCTG 93-46-53 (INT 0146, Alliance) was performed. Quality of life deficit was defined as overall quality of life score <50 on a 100-point scale and used for univariate and multivariate analysis.

Results

Of 431 patients enrolled in the quality of life portion of the trial, 81 patients (19 %) experienced complications including two deaths (0.5 %). Fifty-five patients (13 %) had a preoperative quality of life score <50. Patients with a preoperative deficit were more likely to have a serious early complication (16 vs 6 %, p = 0.023). Using stepwise logistic model, the variables significantly associated with having any early complications (yes/no) were age, ASA III and change in “activity” from baseline to day 14. Patients with an early complication experienced a 3.5-day longer hospital stay (p = 0.0001). Gender, race, tumor stage, and laparoscopic or open approach were not associated with an increased frequency of complications. After adjusting for demographics, tumor stage, ASA, and operative approach, significant predictors for readmission were preoperative pain (odds ratio (OR) 1.61, confidence interval (CI) 1.11–2.34, p = 0.0125), and changes from baseline to day 2 in fatigue (OR 1.34, CI 1.03–1.74, p = 0.032).

Conclusions

This study suggests that quality of life can provide an early indicator for patients at risk of complications. Further studies should evaluate how perioperative quality of life assessment may assist to improve outcomes.

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Funding

Research reported in this manuscript was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number K23DK93553 and to the Alliance for Clinical Trials in Oncology (Monica M. Bertagnolli, M.D., Chair, CA31946), to the Alliance Statistics and Data Center (Daniel J. Sargent, Ph.D., CA33601) and the American College of Surgeons Oncology Group (ACOSOG) CA149950-03. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the American College of Surgeons Oncology Group (ACOSOG). Original funding of the Clinical Outcomes of Surgical Therapy trial 93-46-53 was provided by the National Cancer Institute in association with the North Central Cancer Treatment Group.

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Correspondence to Juliane Bingener.

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Discussant

Dr. Vassiliki Li Tsikitis (Portland, OR): I would like to congratulate you and your team on an interesting, well-written, study demonstrating that a clinically meaningful preoperative deficit of QOL is associated with early post-op complications. The authors also show that changes in QOL from baseline to POD#2 and #14 are associated with overall increased post-op morbidity. What makes the study significant, compared to other QOL studies, is that there is large patient cohort examined to provide the power to identify +5 points difference in the QOL scale with a 95 % confidence interval.

Comments:

1. I am intrigued on how the patient’s subjective appreciation of lack in appearance, decreased concentration, and difficulty in breathing on POD#2 was not correlated with the resident/surgeon perception of early morbidity. Were there any correlations with objective findings, such as fluctuation in the pulse ox or change in the vital signs?

2. Could you comment on whether or not the perceived low QOL is a surrogate of comorbidities/health issues that have gone un/or under-diagnosed? I understand that you use ASA in your analysis, but this is still a rudimentary measure of health.

3. Poor outlook and overall mental health issues are clearly under-appreciated factors that negatively affect longevity and specifically cancer survival. How do you propose working up patients before a cancer operation, which is a time sensitive issue (i.e., should PCP do global QOL assessment before surgery)?

Closing Discussant

Dr. Bingener: Thank you very much for your comments and questions. As this was a legacy trial started in 1994, we unfortunately do not have granular data on vital signs or pulse oximetry. We also do not have the clinical impression of the treating team at the time for this early postoperative period available for our analysis.

To your second question, comorbidities and health issues certainly influence QOL. However, we know that patients who are terminally ill and in hospice care often have near normal QOL as their current needs are being met. So, QOL and comorbidities while certainly confounding each other are probably not just surrogates of each other.

Your third question poses the most interesting challenge, how do we intervene now. An early preoperative QOL assessment paired with possible interventions (e.g., providing information on financial or social assistance) may indeed be of benefit. Surgical teams are likely not the most efficient providers of this type of intervention, and close collaboration with all other stakeholders in the patients care may be necessary.

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Bingener, J., Sloan, J.A., Novotny, P.J. et al. Perioperative Patient-Reported Outcomes Predict Serious Postoperative Complications: a Secondary Analysis of the COST Trial. J Gastrointest Surg 19, 65–71 (2015). https://doi.org/10.1007/s11605-014-2613-2

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Keywords

  • Quality of life
  • Outcomes
  • Surgery
  • Complication
  • Colon cancer