Research

Original Investigation

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

Invited Commentary
IMPORTANCE Current evidence suggests that nonoperative management of uncomplicated Author Audio Interview at
appendicitis is safe, but overall effectiveness is determined by combining medical outcomes jamasurgery.com
with the patients and familys 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 Author Affiliations: Center for
[$2514-$7795] vs $5029 [$4596-$5482], respectively; P = .01). Surgical Outcomes Research, The
Research Institute at Nationwide
Childrens Hospital, Columbus, Ohio
CONCLUSIONS AND RELEVANCE When chosen by the family, nonoperative management is an (Minneci, Mahida, Lodwick,
effective treatment strategy for children with uncomplicated acute appendicitis, incurring Sulkowski, Nacion, Cooper, Ambeba,
less morbidity and lower costs than surgery. Moss, Deans); Department of
Surgery, Nationwide Childrens
Hospital, Columbus, Ohio (Minneci,
TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01718275 Mahida, Lodwick, Sulkowski, Moss,
Deans).
Corresponding Author: Peter C.
Minneci, MD, MHSc, Center for
Surgical Outcomes Research, The
Research Institute at Nationwide
Childrens Hospital, 700 Childrens
Dr, JW 4914, Columbus, OH 43205
JAMA Surg. doi:10.1001/jamasurg.2015.4534 (peter.minneci@nationwidechildrens
Published online December 16, 2015. .org).

(Reprinted) E1

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 Research Original Investigation
A
cute appendicitis accounts for 11.4% of pediatric emer-
gency department admissions, with more than 70 000
children hospitalized for it annually in the United
States.1,2 Although curative, appendectomy is an invasive pro-
cedure requiring general anesthesia with associated periopera-
tive risks and postoperative pain and disability. Children may
miss up to 2 weeks of activities and their caregivers may expe-
rience a similar disruption to their normal schedule.3-5 Reported
rates of perioperative complications in patients undergoing an
appendectomy for uncomplicated appendicitis range from 5%
to 10%, with serious complications (such as reoperation or re-
admission) occurring in 1% to 7% of patients.3,4,6-17 Several re-
cent European randomized clinical trials (RCTs) have demon-
strated that nonoperative management of appendicitis is
medically safe and effective in adults, with a success rate rang-
ing from 63% to 85%.18-23 In addition, a recent European RCT
in children demonstrated a 1-year success rate of nonoper-
ative management of 66% and no difference in the rates of
complicated appendicitis.24
Although promising, these results may not reflect the
familys assessment of the effectiveness of offering nonoper-
ative management because patient preferences may affect
outcomes.25-32 In making a treatment decision involving sur-
gery, patients and families may have strong and varying treat-
ment preferences based on the risks and outcomes that are
most important to them such as pain, quality of life, disabil-
ity, and the avoidance of general anesthesia. In addition, with
nonoperative management of appendicitis, success may de-
pend on the patients and familys willingness to accept an
ongoing risk for recurrent appendicitis.
The purpose of this study was to evaluate the overall ef-
fectiveness of nonoperative management for acute uncom-
plicated pediatric appendicitis, in the context of engaging the
family in the treatment decision. This study used a patient
choice design and assessed patient-centered outcomes and
health care costs in addition to medical outcomes. We hypoth-
esized that a successful nonoperative management strategy
for uncomplicated appendicitis may improve the quality of
care related to the treatment of pediatric appendicitis with
potentially less morbidity, less disability, and lower costs than
surgery.
Methods
Trial Design
This was a prospective patient choice cohort study compar-
ing nonoperative management vs urgent laparoscopic appen-
dectomy in pediatric patients with acute appendicitis. There
were 2 planned analyses of this trial. The first analysis to as-
sess feasibility and initial safety was performed after the ini-
tial 77 enrolled patients reached 30-day follow-up and has been
previously reported.5 The first analysis demonstrated that the
success rate of nonoperative management was within the ac-
ceptable range; therefore, the trial continued to full enroll-
ment to allow assessment of our primary outcome, the suc-
cess rate of nonoperative management at 1 year. This article
reports the results after completion of trial enrollment and all
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Patient Choice in Management of Pediatric Appendicitis
participants reaching 1-year follow-up. This study was ap-
proved by the Nationwide Childrens Hospital Institutional Re-
view Board. Written informed consent and assent (for chil-
dren aged 9 years) were obtained. No stipends were provided
for participation; $20 stipends were provided as an incentive
to complete each survey after 30 days.
Patients presenting to our hospital from October 1, 2012,
through March 6, 2013, who met the following inclusion cri-
teria were approached for enrollment: aged 7 to 17 years; 48
hours or less of abdominal pain; white blood cell count less than
18 000/L (to convert to 109 per liter, multiply by 0.001); ra-
diographic evidence of nonruptured acute appendicitis with
an appendiceal diameter of 1.1 cm or less without fecalith, ab-
scess, or phlegmon on either ultrasonography or computed to-
mography; and surgical consultation confirming a clinical di-
agnosis of suspected acute appendicitis. These inclusion
criteria were chosen to minimize the potential for harm as
symptoms for longer than 48 hours, a white blood cell count
higher than 18 000/L, and an appendicolith on imaging
have all been associated with higher rates of failure of nonop-
erative management. 21,23,33 All patients with a radiology
reading of suspected perforation were excluded. Exclusion
criteria included diffuse peritonitis on clinical examination, C-
reactive protein level higher than 40 mg/L if collected (to con-
vert to nanomoles per liter, multiply by 9.524), a positive
pregnancy test, or a history of chronic abdominal pain.
After counseling on the treatment options, eligible pa-
tients and their families chose between nonoperative man-
agement (nonoperative group) and laparoscopic appendec-
tomy (surgery group). As all patients were younger than 18
years, the parents or legal guardians made the final treatment
choice. To minimize bias, all potential participants were
evaluated by 1 of 4 surgeons trained in the study methods to
confirm eligibility and perform enrollment. Study data were
managed using the Research Electronic Data Capture (RED-
Cap) tool.34
Treatment Groups
Patients choosing nonoperative management were admitted
to the hospital for observation and to receive intravenous an-
tibiotics (piperacillin sodiumtazobactam sodium or cipro-
floxacin hydrochloride and metronidazole hydrochloride if al-
lergic) for a minimum of 24 hours. After having oral food and
fluids withheld for at least 12 hours, patients with clinical
improvement (decreased reported pain or decreased tender-
ness on examination) had their diet advanced. When tolerat-
ing a regular diet, patients were switched to oral amoxicillin
clavulanate potassium (or ciprofloxacin and metronidazole if
allergic) with the first dose given as an inpatient to ensure tol-
erance. Patients were subsequently discharged with oral an-
tibiotics to complete a 10-day total course. Showing signs of
clinical worsening (increased pain or systemic signs of sep-
sis) or failure to show clinical improvement within 24 hours
(decreased pain or tenderness, resolution of nausea/emesis,
or improvement in fever curve) was considered a failure and
resulted in prompt laparoscopic appendectomy. After dis-
charge, any patient who returned with abdominal pain and had
clinical workup or evaluation findings consistent with recur-
jamasurgery.com
 Patient Choice in Management of Pediatric Appendicitis
rent appendicitis underwent urgent laparoscopic appendec-
tomy. Follow-up was performed at 2 to 5 days, 10 to 14 days,
30 days, 6 months, and 1 year after discharge.
Surgical management consisted of admission to the hos-
pital with prompt initiation of intravenous antibiotics and
laparoscopic appendectomy within 12 hours. All appendecto-
mies were performed by pediatric surgeons with anesthesia ad-
ministered by pediatric anesthesiologists. Patients were in-
structed to resume activities as tolerated, with resumption of
heavy activity or sports (eg, weight lifting, football) 2 weeks
postoperatively. Follow-up was performed at 30 days and 1 year
after discharge.
Outcomes
The primary outcome was the 1-year success rate of nonoper-
ative management with success defined as not having under-
gone an appendectomy at 1 year. Secondary outcomes in-
cluded rates of complicated appendicitis at 1 year; disability
days for the child at 1 year, defined as days on which the child
did not participate in all of his or her normal activities includ-
ing gym, recess, sports, and after-school activities; disability
days for the parent at 1 year, defined as days until he or she re-
sumed his or her normal schedule; health-related quality-of-
life (HRQOL) measures at 1 year using Pediatric Quality of Life
Inventory instruments35-41; and appendicitis-related total
health care costs at 1 year. A patient was defined as having com-
plicated appendicitis if pathological analysis revealed rup-
tured, perforated, or gangrenous appendicitis.
Hospital charges were calculated as a sum of charges from
the initial encounter and all clinical encounters within 1 year
related to appendicitis or treatment for appendicitis. Charges
were converted to costs using ratios of cost-to-charge esti-
mates. Products and services provided prior to enrollment were
not included in the calculations. For encounters outside our
institution, billable items were itemized and valued using costs
from our institution. Costs for visits after the initial visit were
adjusted using the US Consumer Price Index medical sector in-
flation rate (2.2% annual) over the study period.42,43 Patient
direct and indirect charges were self-reported.
Statistical Analysis
Based on an expected 1-year success rate of nonoperative man-
agement of 80%, 37 patients treated nonoperatively were
needed to have a 95% confidence interval with a lower limit
of 65%, based on the exact binomial distribution.5,23,44 The 65%
lower limit was considered the lowest acceptable 1-year suc-
cess rate to offer nonoperative management to patients in clini-
cal practice.
Variables were described with medians and interquartile
ranges (IQRs) or frequencies and percentages and compared
using Mann-Whitney U tests, Fisher exact tests, or 2 tests. Con-
fidence intervals for estimated proportions were calculated
using the adjusted Wald method.45 Kaplan-Meier survival
analysis was used to examine time to appendectomy (in
months) for the nonoperative group. A sensitivity analysis to
evaluate potential health care costs in patients lost to fol-
low-up was performed. For the surgery group, we assumed no
additional costs beyond those incurred prior to loss to follow-
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Original Investigation Research
up. For nonoperative management, assumed costs were equal
to the maximum costs in similar patients depending on
whether nonoperative management failed or succeeded.
All tests were 2-sided with P < .05 used to determine sta-
tistical significance. All analyses were performed using SAS
version 9.3 statistical software (SAS Institute, Inc).
Results
Demographic and Clinical Characteristics
During the study period, 629 patients presented with acute ap-
pendicitis, of whom 136 (21.6%) met inclusion criteria (Figure 1).
Of 102 patients who were enrolled, 37 chose nonoperative
management (median age, 11 years; IQR, 10-14 years; 24 male
[64.9%]) and 65 chose surgery (median age, 12 years; IQR, 9-13
years; 45 male [69.2%]). Compared with individuals who chose
surgery, individuals who chose nonoperative management
were less likely to have been transferred from another insti-
tution (28 [43.1%] vs 5 [13.5%], respectively; P = .002) and more
likely to speak a primary language other than English at home
(2 [3.1%] vs 8 [21.6%], respectively; P = .004) (Table 1). There
were no other significant differences in baseline characteris-
tics between the groups. In patients choosing surgery, the
negative appendectomy rate was 6.2% (4 patients) based on
pathology.
Success Rates of Nonoperative Management
The success rate of nonoperative management was 94.6% (95%
CI, 81.8%-99.3%) at hospital discharge (35 of 37 children),
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). At a median follow-up of 21 months, the overall suc-
cess rate of nonoperative management was 75.7% (28 of 37
patients). A Kaplan-Meier analysis of the success rate of non-
operative management is shown in Figure 2.
Comparison of Outcomes Between Nonoperative
Management and Surgery
Compared with the surgery group, the nonoperative group had
a longer length of stay (median [IQR], 20 [15-30] vs 37 [29-41]
hours, respectively; P < .001). Rates of appendicitis-related
medical care within 30 days were similar between the groups
(Table 2). Two patients in the nonoperative group were read-
mitted within 30 days and underwent laparoscopic appendec-
tomy for recurrent appendicitis (Table 2).
The rates of complicated appendicitis at 1 year were simi-
lar between the nonoperative management and surgery groups
(2.7% [1 of 37 children] vs 12.3% [8 of 65 children], respec-
tively; P = .15) (Table 2). The postoperative complication rate
at 1 year in patients choosing surgery was 7.7% (5 of 65 pa-
tients), with 2 major complications (1 readmission, 1 reopera-
tion). There were no postoperative complications among the
nonoperative patients who eventually underwent appendec-
tomy. The HRQOL scores for the nonoperative and surgery
groups were similar at 1 year (median [IQR] child-reported
scores: 95.7 [89.1-98.9] vs 91.3 [87.0-98.9], respectively; P = .31;
median [IQR] parent-reported scores: 91.9 [87.0-98.9] vs 93.0
(Reprinted) JAMA Surgery Published online December 16, 2015 E3
 Research Original Investigation Patient Choice in Management of Pediatric Appendicitis

Figure 1. Study Flow Diagram

629 Diagnosed as having acute

appendicitis

493 Excluded for 1 of following criteria

274 Appendicolith
150 Preoperative concern for rupture
149 Diameter of appendix >1.1 cm
176 WBC count >18 000/L
142 Abdominal pain >48 h
84 Aged <7 or 18 y
12 Elevated CRP level

136 Uncomplicated appendicitis

34 Excluded
20 Declined to participate
1 Withdrew from study
13 Not invited to participate

102 Offered treatment choice

37 Chose nonoperative management 65 Chose surgery

37 Received allocated intervention 65 Received allocated intervention

Lost to follow-up for secondary Lost to follow-up for secondary

outcome analyses outcome analyses
0 At 30 d 7 At 30 d
2 At 1 y 15 At 1 y

Analyzed Analyzed (not part of primary

37 For primary outcome
37 For secondary outcomes at 30 d
35 For secondary outcomes at 1 y
outcome analysis)
58 For secondary outcomes at 30 d
50 For secondary outcomes at 1 y
CRP indicates C-reactive protein;
WBC, white blood cell (to convert
WBC count to 109 per liter, multiply
by 0.001).

Table 1. Baseline Demographic and Clinical Characteristics for All 102 Enrolled Patients By Treatment Decision
Nonoperative Management Surgery
Characteristic (n = 37) (n = 65) P Value
Age, median (IQR), y 11 (10-14) 12 (9-13) .87
Male, No. (%) 24 (64.9) 45 (69.2) .65
White, No. (%) 25 (67.6) 53 (81.5) .09
Hispanic, No. (%) 4 (10.8) 3 (4.6) .16
Transferred from another institution, No. (%) 5 (13.5) 28 (43.1) .002
Primary language other than English in home, 8 (21.6) 2 (3.1) .004
No. (%)
Insurance status, No. (%)
Private 25 (67.6) 41 (63.1)
Medicaid 11 (29.7) 21 (32.3) .93
None 1 (2.7) 3 (4.6)
Symptoms on initial presentation
Duration of abdominal pain, median (IQR), h 13 (8-23) 16 (10-24) .20
Fever, No. (%) 8 (21.6) 10 (15.4) .43
Vomiting, No. (%) 18 (48.6) 21 (32.3) .10
Abbreviations: CT, computed
Diarrhea, No. (%) 4 (10.8) 6 (9.2) .80 tomography; IQR, interquartile range;
Ultrasonography, No. (%) 33 (89.2) 51 (78.5) .28 WBC, white blood cell.
CT scan, No. (%) 11 (29.7) 18 (27.7) .83 SI conversion factor: To convert WBC
count to 109 per liter, multiply by
WBC count, median (IQR), /L 12 900 (9000-14 800) 12 900 (10 000-14 600) .78
0.001.

[87.0-97.8], respectively; P = .76). Nonoperative manage- vs 21 [15-25] days, respectively; P < .001) and with lower total
ment, compared with surgery, was associated with signifi- appendicitis-related health care costs at 1 year (median [IQR],
cantly fewer disability days at 1 year (median [IQR], 8 [5-18] $4219 [$2514-$7795] vs $5029 [$4596-$5482], respectively;

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 Patient Choice in Management of Pediatric Appendicitis Original Investigation Research

P = .01). In the cost sensitivity analysis, total appendicitis-
related health care costs at 1 year remained significantly lower
in the group treated nonoperatively than in the surgery group
(median [IQR], $4219 [$2691-$6536] vs $4992 [$4688-
$5636], respectively; P = .01).
Discussion
When chosen by the family, nonoperative management with
antibiotics alone is an effective treatment strategy for chil-
dren with uncomplicated appendicitis. It incurs less morbid-
ity and lower costs than surgery. By 1-year follow-up, 75.7% of
patients who chose nonoperative management did not un-
dergo an appendectomy. There was no difference in the rate
of complicated appendicitis between those who had under-
Figure 2. Kaplan-Meier Curve for the Success Rate of Nonoperative
Management of Acute Appendicitis
100
80
Survival, %
gone appendectomy secondary to failure of nonoperative man-
agement and those who chose surgery initially. Compared with
surgery, nonoperative management was associated with fewer
disability days, lower total health care costs, and no differ-
ence in HRQOL at 1 year.
Several RCTs investigating nonoperative management of
acute appendicitis in adult patients have been reported from
non-US countries.19-23,46 The 1-year success rates of nonoper-
ative management in these trials range from 63% to 85%. A
meta-analysis of these trials concluded that antibiotic use is a
safe initial treatment for appendicitis and that nonoperative
management of appendicitis is associated with a signifi-
cantly lower risk of complications with no difference in the risk
of developing complicated appendicitis.47 These studies con-
firm that nonoperative management is a viable alternative from
the surgeons perspective, but they did not assess its overall
effectiveness from the patients and familys perspective. Our
study demonstrates that an initial nonoperative manage-
ment strategy is associated with fewer disability days and lower
costs at 1 year than urgent appendectomy. These additional re-
sults can help to further inform the decision-making process
of patients and families choosing between surgery and anti-
biotics alone.
A recently published RCT of nonoperative management of
uncomplicated appendicitis in children by Svensson et al24 re-

60
ported a 1-year success rate of 66%. In addition to using a ran-
40 domized design, there are several notable differences be-
tween these studies. First, the study by Svensson and
20 colleagues did not limit eligibility based on duration of symp-
toms, white blood cell count, or an appendicolith on imaging,
0 which have all been associated with higher rates of failure of
0 1 2 3 4 5 6 7 8 9 10 11 12
nonoperative management.21,23,33 Second, nonoperative pa-
Time to Appendectomy, mo
No. at risk 37 33 32 32 31 31 30 29 29 28 28 28 28
tients in the study by Svensson and colleagues received a mini-
mum of 48 hours of intravenous antibiotics and had oral food

Table 2. Comparison of Outcomes Between Nonoperative Management and Surgery

Characteristic Nonoperative Management Surgery P Value

Appendicitis-related medical care within 30 d, No. (%) (n = 37) (n = 58)
Outpatient visit or urgent carea 4 (10.8) 12 (20.7) .21
Emergency department 3 (8.1) 2 (3.4) .37
Hospital admission 2 (5.4) 0 .15
Surgery or other invasive procedure 2 (5.4) 0 .15
1 y after enrollment (n = 35) (n = 50)
Disability days, median (IQR)b 8 (5-18) 21 (15-25) <.001
Complicated appendicitis, No. (%)c 1 (2.7) 8 (12.3) .15
Health care costs, median (IQR), $
Initial hospital stay 3641 (2474-4227) 4960 (4588-5373) <.001
All appendicitis-related care 4219 (2514-7795) 5029 (4596-5482) .01
HRQOL questionnaire score, median (IQR)
Childd 95.7 (89.1-98.9) 91.3 (87.0-98.9) .31
Parent proxye 91.9 (87.0-98.9) 93.0 (87.0-97.8) .76
Abbreviations: HRQOL, health-related quality of life; IQR, interquartile range. parent or guardian; and office, emergency department, and inpatient visits.
a c
Outpatient visit excludes scheduled follow-up visits with the primary surgical Sample sizes are 37 for the nonoperative group and 65 for the surgery group.
team from the initial inpatient stay. d
Sample sizes are 17 for the nonoperative group and 32 for the surgery group.
b
Sum of the following: length of stay (in days); number of days of normal e
Sample sizes are 18 for the nonoperative group and 34 for the surgery group.
activity missed for the child; number of days of normal activity missed for the

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 Research Original Investigation Patient Choice in Management of Pediatric Appendicitis

and fluids withheld for 24 hours compared with a minimum
of 24 hours of intravenous antibiotics and 12 hours of with-
holding oral food and fluids in our study. Our nonoperative
treatment protocol was developed to minimize length of stay
as patients undergoing a laparoscopic appendectomy for un-
complicated appendicitis in the United States usually spend 1
day in the hospital.
Engaging families in shared decision making in pediatric
clinical care has been shown to improve medical outcomes.48-57
We believe that the results of our study reflect the effective-
ness of offering nonoperative management to patients and their
families in clinical practice for 2 reasons. First, the patient
choice design allows the patients and familys preferences to
be aligned with their choice of therapy, thereby minimizing the
potential effects of treatment preferences on outcomes.25-32
For families who do not want to accept the risk of recurrent
appendicitis, nonoperative management may potentially harm
the child. For example, if a family is so afraid of a recurrence
that they visit the emergency department every time their child
has abdominal pain, then their child will likely undergo
increased imaging and will eventually undergo an appen-
dectomy. In this case, letting them choose an appendec-
tomy up front may be the better choice for that child. Sec-
ond, in contrast to an RCT in which preferences may deter
families from enrolling in the trial, the patient choice design
can lead to broader enrollment among eligible patients.25-32
In our trial, 82.9% of approached eligible patients enrolled
and no appendectomies were performed without a clinical
presentation suggesting that a patients appendicitis had
recurred. In contrast, in the study by Svensson et al,24 only
40% of approached eligible participants agreed to enroll and
25% of patients in the nonoperative management group
underwent appendectomy at surgeon and parental discre-
tion within 1 year without developing recurrent appendici-
tis. The high enrollment rate and alignment of treatment
choice with preferences in our study allow our results to be
generalizable to clinical practice.
Treatment of several inflammatory intra-abdominal dis-
eases has changed from primarily surgical management to ini-
tial medical management, with patients who fail medical man-
agement subsequently undergoing surgery. These include
intra-abdominal abscesses from Crohn disease, tubo-ovarian
abscesses, and acute diverticulitis.58-62 These changes in prac-
tice have evolved because most of these patients can be effec-
tively treated with medical management, with minimal
adverse effects occurring in patients who fail medical man-
agement and require surgery. Based on our study and those
reported in the literature, treatment of uncomplicated appen-
dicitis appears to be similar. Initial treatment with antibiotics
alone allows 3 in 4 patients to avoid surgery, with 1 in 4 pa-
tients requiring appendectomy for failure of antibiotic therapy.
An initial trial of nonoperative management does not in-
crease the rate of complicated appendicitis and is associated
with fewer surgical complications, fewer disability days, and
lower costs.
Compared with an RCT, the patient choice design may lead
to unbalanced patient characteristics that may partially ac-
count for treatment differences. In our trial, more patients
choosing surgery were transferred from other institutions, and
patients with parents or guardians who spoke a primary lan-
guage other than English were more likely to select nonoper-
ative management. These differences between the groups are
likely due to differences in preferences of the families. Pa-
tients who were transferred from other institutions came far-
ther distances and many expressed concerns about the dis-
tance and time necessary to come back if the appendicitis were
to recur. The higher proportion of parents who spoke a pri-
mary language other than English choosing nonoperative
management is likely due to cultural values to avoid surgery
if possible. Accounting for these real-life concerns is impor-
tant in establishing the true effectiveness of a treatment in
clinical practice. The patient choice design allows a therapy
to be aligned with preferences of the patient and his or her
family, thereby minimizing the potential negative effects of
preferences.
The patient choice design creates the possibility of selec-
tion bias on the part of the medical team. We attempted to
minimize the bias introduced by using well-defined inclu-
sion and exclusion criteria and a standardized scripted con-
senting process. Another limitation of the patient choice de-
sign is that the treatment choice may be affected by a specific
patient characteristic. There were no significant pretreat-
ment differences between the groups with the exception of
transfer status and primary language as discussed earlier. In
addition, our reported cost analysis excluded all costs in-
curred prior to enrollment (including outside hospital emer-
gency department charges) to minimize any effect of a higher
proportion of surgery patients having been transferred. Fi-
nally, differences in disability days may vary based on the rec-
ommendations for activity resumption used in clinical prac-
tice by different surgeons.
Conclusions
When an initial nonoperative management strategy was
chosen by patients and families, 3 in 4 children with uncom-
plicated appendicitis avoided surgery at 1 year. Compared with
urgent appendectomy, nonoperative management was asso-
ciated with fewer disability days and lower health care costs
at 1 year and no difference in rates of complicated appendici-
tis or reported HRQOL.

ARTICLE INFORMATION
Accepted for Publication: September 16, 2015.
Published Online: December 16, 2015.
doi:10.1001/jamasurg.2015.4534.
Author Contributions: Dr Minneci had full access
to all of the data in the study and takes
responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Minneci, Mahida,
Lodwick, Sulkowski, Cooper, Moss, Deans.
Acquisition, analysis, or interpretation of data:
Minneci, Lodwick, Sulkowski, Nacion, Cooper,
Ambeba, Deans.
Drafting of the manuscript: Minneci, Mahida,
Nacion, Cooper, Ambeba, Deans.
Critical revision of the manuscript for important

E6 JAMA Surgery Published online December 16, 2015 (Reprinted) jamasurgery.com

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 Patient Choice in Management of Pediatric Appendicitis
intellectual content: Minneci, Mahida, Lodwick,
Sulkowski, Cooper, Moss, Deans.
Statistical analysis: Minneci, Mahida, Cooper,
Ambeba, Deans.
Administrative, technical, or material support:
Minneci, Lodwick, Sulkowski, Nacion, Cooper,
Moss, Deans.
Study supervision: Minneci, Lodwick, Cooper, Moss,
Deans.
Conflict of Interest Disclosures: None reported.
Funding/Support: This work was supported by
grant 5T32HL098039-03 from the National
Institutes of Health (Dr Sulkowski), intramural
funding from the Research Institute at Nationwide
Childrens Hospital, and grant UL1TR001070 from
the National Center for Advancing Translational
Sciences.
Role of the Funder/Sponsor: The funders had no
role in the design and conduct of the study;
collection, management, analysis, and
interpretation of the data; preparation, review, or
approval of the manuscript; and decision to submit
the manuscript for publication.
Disclaimer: The content of this work is solely the
responsibility of the authors and does not
necessarily represent the official views of the
National Center for Advancing Translational
Sciences or the National Institutes of Health.
Previous Presentation: The interim analysis was
presented at Clinical Congress 2014 of the
American College of Surgeons; October 29, 2014;
San Francisco, California.
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