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Shared Decision Making in Uncomplicated Appendicitis: It Is Time to Include Nonoperative Management

Shared Decision Making in Uncomplicated Appendicitis: It Is Time to Include Nonoperative Management JAMA Surgery Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis Peter C. Minneci, MD, MHSc; Justin B. Mahida, MD, MBA; Daniel L. Lodwick, MD, MS; Jason P. Sulkowski, MD; Kristine M. Nacion, MPH; Jennifer N. Cooper, PhD, MS; Erica J. Ambeba, PhD, MPH; R. Lawrence Moss, MD; Katherine J. Deans, MD, MHSc Importance Current evidence suggests that nonoperative management of uncomplicated appendicitis is safe, but overall effectiveness is determined by combining medical outcomes with the patient’s and family’s perspective, goals, and expectations. Objective To determine the effectiveness of patient choice in nonoperative vs surgical management of uncomplicated acute appendicitis in children. Design, Setting, and Participants Prospective patient choice cohort study in patients aged 7 to 17 years with acute uncomplicated appendicitis presenting at a single pediatric tertiary acute care hospital from October 1, 2012, through March 6, 2013. Participating patients and families gave informed consent and chose between nonoperative management and urgent appendectomy. Interventions Urgent appendectomy or nonoperative management entailing at least 24 hours of inpatient observation while receiving intravenous antibiotics and, on demonstrating improvement of symptoms, completion of 10 days of treatment with oral antibiotics. Main Outcomes and Measures The primary outcome was the 1-year success rate of nonoperative management. Successful nonoperative management was defined as not undergoing an appendectomy. Secondary outcomes included comparisons of the rates of complicated appendicitis, disability days, and health care costs between nonoperative management and surgery. Results A total of 102 patients were enrolled; 65 patients/families chose appendectomy (median age, 12 years; interquartile range [IQR], 9-13 years; 45 male [69.2%]) and 37 patients/families chose nonoperative management (median age, 11 years; IQR, 10-14 years; 24 male [64.9%]). Baseline characteristics were similar between the groups. The success rate of nonoperative management was 89.2% (95% CI, 74.6%-97.0%) at 30 days (33 of 37 children) and 75.7% (95% CI, 58.9%-88.2%) at 1 year (28 of 37 children). The incidence of complicated appendicitis was 2.7% in the nonoperative group (1 of 37 children) and 12.3% in the surgery group (8 of 65 children) (P = .15). After 1 year, children managed nonoperatively compared with the surgery group had fewer disability days (median [IQR], 8 [5-18] vs 21 [15-25] days, respectively; P < .001) and lower appendicitis-related health care costs (median [IQR], $4219 [$2514-$7795] vs $5029 [$4596-$5482], respectively; P = .01). Conclusions and Relevance When chosen by the family, nonoperative management is an effective treatment strategy for children with uncomplicated acute appendicitis, incurring less morbidity and lower costs than surgery. JAMA Surg. Published online December 16, 2015. doi:10.1001/jamasurg.2015.4534 In December 2015, JAMA Surgery published the results of a prospective cohort study by Minneci and colleagues1 assessing the effectiveness of shared decision making for nonoperative management of 102 patients (median age, 12 years; range, 7-17 years) with uncomplicated acute appendicitis. At 1 year, nonoperative management (chosen by 37 patients/families) was successful, as defined by no intervention at 1 year in 28 children (75%), and was associated with fewer disability days and lower appendicitis-related health care costs compared with children who underwent an operation (chosen by 65 patients/families). These findings corroborate a shorter-term nonrandomized clinical trial of the feasibility of nonoperative management for 30 children with uncomplicated appendicitis that had similar results.2 This study demonstrated nonoperative management was associated with fewer disability days, quicker return to school, and higher quality-of-life scores for both children and their parents at 30 days after surgery.2 The feasibility of treating some adult patients with appendicitis with antibiotics was demonstrated in the APPAC (Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis) trial.3 APPAC was a randomized clinical trial involving 540 patients with uncomplicated appendicitis who either underwent appendectomy or were treated with antibiotics alone. Of the 257 patients randomized to the antibiotic group, 187 (72.7%) did not require subsequent appendectomy at 1 year. Of those who did require subsequent appendectomy, no adverse clinical outcomes were associated with the delay.3 Two other recent studies support the long-term durability of nonoperative management for uncomplicated appendicitis in adults. Results of the NOTA (Nonoperative Treatment for Acute Appendicitis) study with 159 adult patients given antibiotics for right lower quadrant pain suspicious for appendicitis demonstrated pain recurrence in 22 patients (14%) at 2 years.4 A retrospective study including 3236 patients who underwent nonoperative management of uncomplicated appendicitis demonstrated treatment failure and recurrence rates of 5.9% and 4.4%, respectively. Median follow-up was a minimum of 7 years. Risk of perforation after nonoperative management was 3%, and no deaths were associated with treatment failure or recurrence.5 These results merit reconsideration about how uncomplicated appendicitis might be treated in select patients. Appendicitis treatment has progressed from mandated emergency operations to acceptance of delayed intervention and now to the proposal of whether any operative intervention is warranted for some patients. High-quality long-term data are needed before a definitive recommendation can be made; however, the growing body of literature supports the safety and efficacy of nonoperative management. The notion of nonoperative treatment of appendicitis has not been well received by the majority of the surgical community.6 However, the evidence demonstrating successful nonoperative treatment of appendicitis could result in classifying appendectomy for uncomplicated appendicitis as a “discretionary procedure.” If designated a discretionary procedure, this option must be discussed with patients as part of the Affordable Care Act (ACA) mandate for patient-provider shared decision making. Section 3506 of the ACA requires that programs be established to develop, test, and disseminate “patient decision aids.” These tools are designed to facilitate collaborative shared decision making between health care providers and patient beneficiaries.7 The law requires promotion and engagement of all stakeholders in informed decision making, mandates provision of up-to-date clinical evidence for all treatment options, and promotes decision making that accounts for individual beliefs, preferences, and circumstances. In accordance with the ACA, patients must be informed of the most recent clinical evidence and allowed to be key stakeholders in treatment decisions—regardless of the personal beliefs of the surgeon. While section 3506 is currently unfunded secondary to government fiscal constraints, it is only a matter of time before procedural decision making will be tied to quality assessment and reimbursement. Oshima Lee and Emanuel8 have proposed mandated application of decision aids for the 20 most frequently performed procedures. To give this proposal “teeth,” they also suggested that clinicians who did not document a shared decision-making process face a 10% reduction in Medicare payments, which would increase to 20% over 10 years.8 Because clinicians will soon be obligated by law to provide information about all potential forms of treatment about appendicitis, surgeons would be well served to take a leadership role in proactively developing decision aids to inform patients about the benefits and risks for both nonoperative antibiotic treatment and surgical treatment of appendicitis. Decision aids would include information on the known and accepted risks and benefits of operative intervention vs antibiotic therapy alone. Information on nonoperative management should include that approximately 75% of patients with uncomplicated appendicitis who opt for nonoperative management are symptom free at 1 year without increased risk of adverse outcome should symptoms recur. This should be tempered with information on the paucity of long-term data. At present, JAMA does offer a Patient Page detailing what patients should know about appendicitis.9 With this requirement for shared decision making coming down the pipeline, it is imperative that physicians and surgeons remain at the forefront of health care reform. What better way to start than with appendectomy? Back to top Article Information Corresponding Author: Dana A. Telem, MD, Division of Bariatric, Foregut, and Advanced Gastrointestinal Surgery, Department of Surgery, Stony Brook University Medical Center, 100 Nichols Rd, HSC T18-040, Stony Brook, NY 11794 (dana.telem@stonybrookmedicine.edu). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Telem reported having received research funding from Cook Medical and SurgiQuest, having a consulting agreement with Medtronic, and serving on an advisory board for Ethicon and course faculty for Gore. References 1. Minneci PC, Mahida JB, Lodwick DL, et al. Effectiveness of patient choice in nonoperative vs surgical management of pediatric uncomplicated acute appendicitis [published online December 16, 2015]. JAMA Surg. doi:10.1001/jamasurg.2015.4534.PubMedGoogle Scholar 2. Minneci PC, Sulkowski JP, Nacion KM, et al. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014;219(2):272-279.PubMedGoogle ScholarCrossref 3. Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: the APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348.PubMedGoogle ScholarCrossref 4. Di Saverio S, Sibilio A, Giorgini E, et al. The NOTA Study (Non Operative Treatment for Acute Appendicitis): prospective study on the efficacy and safety of antibiotics (amoxicillin and clavulanic acid) for treating patients with right lower quadrant abdominal pain and long-term follow-up of conservatively treated suspected appendicitis. Ann Surg. 2014;260(1):109-117.PubMedGoogle ScholarCrossref 5. McCutcheon BA, Chang DC, Marcus LP, et al. Long-term outcomes of patients with nonsurgically managed uncomplicated appendicitis. J Am Coll Surg. 2014;218(5):905-913.PubMedGoogle ScholarCrossref 6. Nonoperative treatment of appendicitis may have unknown long-term risks and costs [press release]. American College of Surgeons. https://www.facs.org/media/press-releases/jacs/appendicitis1215. Accessed January 27, 2016. 7. Read the law: the Affordable Care Act, section by section. US Dept of Health and Human Services. http://www.hhs.gov/healthcare/about-the-law/read-the-law/index.html. Accessed January 27, 2016. 8. Oshima Lee E, Emanuel EJ. Shared decision making to improve care and reduce costs. N Engl J Med. 2013;368(1):6-8.PubMedGoogle ScholarCrossref 9. Livingston EH. Appendicitis [JAMA Patient Page]. JAMA. 2015;313(23):2394. PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Shared Decision Making in Uncomplicated Appendicitis: It Is Time to Include Nonoperative Management

JAMA , Volume 315 (8) – Feb 23, 2016

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American Medical Association
Copyright
Copyright © 2016 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2016.0168
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Abstract

JAMA Surgery Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis Peter C. Minneci, MD, MHSc; Justin B. Mahida, MD, MBA; Daniel L. Lodwick, MD, MS; Jason P. Sulkowski, MD; Kristine M. Nacion, MPH; Jennifer N. Cooper, PhD, MS; Erica J. Ambeba, PhD, MPH; R. Lawrence Moss, MD; Katherine J. Deans, MD, MHSc Importance Current evidence suggests that nonoperative management of uncomplicated appendicitis is safe, but overall effectiveness is determined by combining medical outcomes with the patient’s and family’s perspective, goals, and expectations. Objective To determine the effectiveness of patient choice in nonoperative vs surgical management of uncomplicated acute appendicitis in children. Design, Setting, and Participants Prospective patient choice cohort study in patients aged 7 to 17 years with acute uncomplicated appendicitis presenting at a single pediatric tertiary acute care hospital from October 1, 2012, through March 6, 2013. Participating patients and families gave informed consent and chose between nonoperative management and urgent appendectomy. Interventions Urgent appendectomy or nonoperative management entailing at least 24 hours of inpatient observation while receiving intravenous antibiotics and, on demonstrating improvement of symptoms, completion of 10 days of treatment with oral antibiotics. Main Outcomes and Measures The primary outcome was the 1-year success rate of nonoperative management. Successful nonoperative management was defined as not undergoing an appendectomy. Secondary outcomes included comparisons of the rates of complicated appendicitis, disability days, and health care costs between nonoperative management and surgery. Results A total of 102 patients were enrolled; 65 patients/families chose appendectomy (median age, 12 years; interquartile range [IQR], 9-13 years; 45 male [69.2%]) and 37 patients/families chose nonoperative management (median age, 11 years; IQR, 10-14 years; 24 male [64.9%]). Baseline characteristics were similar between the groups. The success rate of nonoperative management was 89.2% (95% CI, 74.6%-97.0%) at 30 days (33 of 37 children) and 75.7% (95% CI, 58.9%-88.2%) at 1 year (28 of 37 children). The incidence of complicated appendicitis was 2.7% in the nonoperative group (1 of 37 children) and 12.3% in the surgery group (8 of 65 children) (P = .15). After 1 year, children managed nonoperatively compared with the surgery group had fewer disability days (median [IQR], 8 [5-18] vs 21 [15-25] days, respectively; P < .001) and lower appendicitis-related health care costs (median [IQR], $4219 [$2514-$7795] vs $5029 [$4596-$5482], respectively; P = .01). Conclusions and Relevance When chosen by the family, nonoperative management is an effective treatment strategy for children with uncomplicated acute appendicitis, incurring less morbidity and lower costs than surgery. JAMA Surg. Published online December 16, 2015. doi:10.1001/jamasurg.2015.4534 In December 2015, JAMA Surgery published the results of a prospective cohort study by Minneci and colleagues1 assessing the effectiveness of shared decision making for nonoperative management of 102 patients (median age, 12 years; range, 7-17 years) with uncomplicated acute appendicitis. At 1 year, nonoperative management (chosen by 37 patients/families) was successful, as defined by no intervention at 1 year in 28 children (75%), and was associated with fewer disability days and lower appendicitis-related health care costs compared with children who underwent an operation (chosen by 65 patients/families). These findings corroborate a shorter-term nonrandomized clinical trial of the feasibility of nonoperative management for 30 children with uncomplicated appendicitis that had similar results.2 This study demonstrated nonoperative management was associated with fewer disability days, quicker return to school, and higher quality-of-life scores for both children and their parents at 30 days after surgery.2 The feasibility of treating some adult patients with appendicitis with antibiotics was demonstrated in the APPAC (Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis) trial.3 APPAC was a randomized clinical trial involving 540 patients with uncomplicated appendicitis who either underwent appendectomy or were treated with antibiotics alone. Of the 257 patients randomized to the antibiotic group, 187 (72.7%) did not require subsequent appendectomy at 1 year. Of those who did require subsequent appendectomy, no adverse clinical outcomes were associated with the delay.3 Two other recent studies support the long-term durability of nonoperative management for uncomplicated appendicitis in adults. Results of the NOTA (Nonoperative Treatment for Acute Appendicitis) study with 159 adult patients given antibiotics for right lower quadrant pain suspicious for appendicitis demonstrated pain recurrence in 22 patients (14%) at 2 years.4 A retrospective study including 3236 patients who underwent nonoperative management of uncomplicated appendicitis demonstrated treatment failure and recurrence rates of 5.9% and 4.4%, respectively. Median follow-up was a minimum of 7 years. Risk of perforation after nonoperative management was 3%, and no deaths were associated with treatment failure or recurrence.5 These results merit reconsideration about how uncomplicated appendicitis might be treated in select patients. Appendicitis treatment has progressed from mandated emergency operations to acceptance of delayed intervention and now to the proposal of whether any operative intervention is warranted for some patients. High-quality long-term data are needed before a definitive recommendation can be made; however, the growing body of literature supports the safety and efficacy of nonoperative management. The notion of nonoperative treatment of appendicitis has not been well received by the majority of the surgical community.6 However, the evidence demonstrating successful nonoperative treatment of appendicitis could result in classifying appendectomy for uncomplicated appendicitis as a “discretionary procedure.” If designated a discretionary procedure, this option must be discussed with patients as part of the Affordable Care Act (ACA) mandate for patient-provider shared decision making. Section 3506 of the ACA requires that programs be established to develop, test, and disseminate “patient decision aids.” These tools are designed to facilitate collaborative shared decision making between health care providers and patient beneficiaries.7 The law requires promotion and engagement of all stakeholders in informed decision making, mandates provision of up-to-date clinical evidence for all treatment options, and promotes decision making that accounts for individual beliefs, preferences, and circumstances. In accordance with the ACA, patients must be informed of the most recent clinical evidence and allowed to be key stakeholders in treatment decisions—regardless of the personal beliefs of the surgeon. While section 3506 is currently unfunded secondary to government fiscal constraints, it is only a matter of time before procedural decision making will be tied to quality assessment and reimbursement. Oshima Lee and Emanuel8 have proposed mandated application of decision aids for the 20 most frequently performed procedures. To give this proposal “teeth,” they also suggested that clinicians who did not document a shared decision-making process face a 10% reduction in Medicare payments, which would increase to 20% over 10 years.8 Because clinicians will soon be obligated by law to provide information about all potential forms of treatment about appendicitis, surgeons would be well served to take a leadership role in proactively developing decision aids to inform patients about the benefits and risks for both nonoperative antibiotic treatment and surgical treatment of appendicitis. Decision aids would include information on the known and accepted risks and benefits of operative intervention vs antibiotic therapy alone. Information on nonoperative management should include that approximately 75% of patients with uncomplicated appendicitis who opt for nonoperative management are symptom free at 1 year without increased risk of adverse outcome should symptoms recur. This should be tempered with information on the paucity of long-term data. At present, JAMA does offer a Patient Page detailing what patients should know about appendicitis.9 With this requirement for shared decision making coming down the pipeline, it is imperative that physicians and surgeons remain at the forefront of health care reform. What better way to start than with appendectomy? Back to top Article Information Corresponding Author: Dana A. Telem, MD, Division of Bariatric, Foregut, and Advanced Gastrointestinal Surgery, Department of Surgery, Stony Brook University Medical Center, 100 Nichols Rd, HSC T18-040, Stony Brook, NY 11794 (dana.telem@stonybrookmedicine.edu). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Telem reported having received research funding from Cook Medical and SurgiQuest, having a consulting agreement with Medtronic, and serving on an advisory board for Ethicon and course faculty for Gore. References 1. Minneci PC, Mahida JB, Lodwick DL, et al. Effectiveness of patient choice in nonoperative vs surgical management of pediatric uncomplicated acute appendicitis [published online December 16, 2015]. JAMA Surg. doi:10.1001/jamasurg.2015.4534.PubMedGoogle Scholar 2. Minneci PC, Sulkowski JP, Nacion KM, et al. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014;219(2):272-279.PubMedGoogle ScholarCrossref 3. Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: the APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348.PubMedGoogle ScholarCrossref 4. Di Saverio S, Sibilio A, Giorgini E, et al. The NOTA Study (Non Operative Treatment for Acute Appendicitis): prospective study on the efficacy and safety of antibiotics (amoxicillin and clavulanic acid) for treating patients with right lower quadrant abdominal pain and long-term follow-up of conservatively treated suspected appendicitis. Ann Surg. 2014;260(1):109-117.PubMedGoogle ScholarCrossref 5. McCutcheon BA, Chang DC, Marcus LP, et al. Long-term outcomes of patients with nonsurgically managed uncomplicated appendicitis. J Am Coll Surg. 2014;218(5):905-913.PubMedGoogle ScholarCrossref 6. Nonoperative treatment of appendicitis may have unknown long-term risks and costs [press release]. American College of Surgeons. https://www.facs.org/media/press-releases/jacs/appendicitis1215. Accessed January 27, 2016. 7. Read the law: the Affordable Care Act, section by section. US Dept of Health and Human Services. http://www.hhs.gov/healthcare/about-the-law/read-the-law/index.html. Accessed January 27, 2016. 8. Oshima Lee E, Emanuel EJ. Shared decision making to improve care and reduce costs. N Engl J Med. 2013;368(1):6-8.PubMedGoogle ScholarCrossref 9. Livingston EH. Appendicitis [JAMA Patient Page]. JAMA. 2015;313(23):2394. PubMedGoogle ScholarCrossref

Journal

JAMAAmerican Medical Association

Published: Feb 23, 2016

Keywords: appendicitis,surgical procedures, operative,child

References