GAPS phase II: development and pilot results of the global assessment in pediatric surgery, an evidence-based pediatric surgical capacity assessment tool for low-resource settings.

PURPOSE: Pediatric surgical care in low- and middle-income countries is often hindered by systemic gaps in healthcare resources, infrastructure, training, and organization. This study aims to develop and validate the Global Assessment of Pediatric Surgery (GAPS) to appraise pediatric surgical capacity and discriminate between levels of care across diverse healthcare settings. METHODS: The GAPS Version 1 was constructed through a synthesis of existing assessment tools and expert panel consultation. The resultant GAPS Version 2 underwent international pilot testing. Construct validation categorized institutions into providing basic or advanced surgical care. GAPS was further refined to Version 3 to include only questions with a > 75% response rate and those that significantly discriminated between basic or advanced surgical settings. RESULTS: GAPS Version 1 included 139 items, which, after expert panel feedback, was expanded to 168 items in Version 2. Pilot testing, in 65 institutions, yielded a high response rate. Of the 168 questions in GAPS Version 2, 64 significantly discriminated between basic and advanced surgical care. The refined GAPS Version 3 tool comprises 64 questions on: human resources (9), material resources (39), outcomes (3), accessibility (3), and education (10). CONCLUSION: The GAPS Version 3 tool presents a validated instrument for evaluating pediatric surgical capabilities in low-resource settings.

A minimally invasive hybrid procedure to correct pectus arcuatum.

BACKGROUND: Pectus arcuatum, also known as horns of steer anomaly or Currarino-Silverman Syndrome, is a distinct chest wall anomaly characterized by severe manubriosternal angulation, a shortened sternum, and mild pectus excavatum. The anomaly is typically repaired using open techniques, employing orthopedic fixation devices. Here, we report the results of a minimally invasive hybrid procedure to repair pectus arcuatum. METHODS: The procedure combines a standard Nuss procedure to correct the depressed sternum with a short upper chest (in boys) or inter-mammary (in girls) incision for bilateral subperichondrial resection of the upper costal cartilages, osteotomy, and correction of the manubrial angulation. The medical records of all patients who underwent the procedure over the last 10 years were reviewed. RESULTS: Five patients, 3 boys and 2 girls, aged 14 to 17 years, underwent the procedure. Three patients had their pectus bars removed 3-4 years after repair. Follow-up after correction ranged from 6 months to 7 years. Good correction resulted in all patients achieving recovery without complications and recurrence. To date, all patients have been satisfied with their results. CONCLUSIONS: The minimally invasive hybrid procedure adequately corrects pectus arcuatum with minimal scarring and high satisfaction.

The Canadian Pediatric Surgery Workforce: A 10-year Prospective Assessment.

BACKGROUND: The Canadian Association of Paediatric Surgeons launched a 10-year prospective assessment of the Canadian pediatric surgery workforce and training environment, beginning in 2013. The results of the first 5 years (2013-2017) were previously published. Here, we present the results of the last 5 years (2018-2022), and the cumulative results of the past decade. METHODS: With IRB approval, a web-based survey was sent to all pediatric surgery division chiefs in Canada each year (2013-2022). The survey gathered workforce data on pediatric surgery practices, as well as data regarding fellowship graduates from Canadian training programs. RESULTS: Complete responses were received from all 18 divisions (100% response rate). Over the decade studied, the number of pediatric surgeons and full-time equivalent positions increased from 73 to 81, and 65 to 82, respectively. Thirty positions were vacated (15 retirement, 6 new Canadian practice, 8 leaving Canada, 1 other), and 38 were filled (20 new Canadian fellowship graduates, 8 Canadian surgeons moving from other sites in Canada, 10 surgeons coming from outside Canada). Seventy-five fellows completed training eligible for North American certification, including 34 Canadians, 31 Americans, and 10 non-North American foreign nationals (9 of whom left North America after training). The proportion of Canadian graduates who desired, but could not find, a Canadian position improved from 44% in the first 5 years to 20% in the second 5 years. CONCLUSIONS: The Canadian pediatric surgery workforce has experienced a modest increase over a decade. A mismatch still exists between Canadian pediatric surgery graduates and attending staff positions, but the situation has improved during the last 5 years. TYPE OF STUDY: Survey.

The Impact of Educational Materials on Parental Anxiety and Productivity: A Clinical Trial in Pediatric Appendicitis.

OBJECTIVES: There is limited literature on how acute appendicitis, the most common acute children's surgical illness, affects the family. We conducted a prospective study to assess the impact of educational materials on parents' anxiety and productivity during the child's illness. METHODS: A quasi-experimental clinical trial was conducted among parents of children undergoing laparoscopic appendectomy. In Phase I, parents received the standard explanations at diagnosis and throughout the postoperative period. In Phase II, parents also received a comprehensive educational brochure on pediatric appendicitis at diagnosis. The primary outcome, parental preoperative anxiety, was assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The secondary outcome, parental productivity, was evaluated through a post-recovery online questionnaire based on the Productivity and Disease Questionnaire (PRODISQ). Baseline characteristics and outcomes were compared between the two cohorts using t-tests, Mann-Whitney, chi-square, or Fischer's exact test as appropriate. RESULTS: Phases I and II included 67 and 66 families, respectively. Patient demographics and disease severity were similar between both groups. Of the 53 parents (80.3%) in Phase II who answered the postoperative questionnaire, most recommended the booklet (96.2%), as it decreased their stress (78.0%) and enhanced their understanding of appendicitis (94.1%). However, the two groups showed similar preoperative anxiety levels and postoperative productivity loss. CONCLUSIONS: Educational materials increased satisfaction with surgical care but did not mitigate the high parental preoperative anxiety levels and postoperative productivity loss. Additional research is required to elucidate interventions that may improve these important patient and family-centered outcomes. TYPE OF STUDY: Non-Randomized Clinical Trial. LEVEL OF EVIDENCE: II.

Using Artificial Intelligence to Label Free-Text Operative and Ultrasound Reports for Grading Pediatric Appendicitis.

PURPOSE: Data science approaches personalizing pediatric appendicitis management are hampered by small datasets and unstructured electronic medical records (EMR). Artificial intelligence (AI) chatbots based on large language models can structure free-text EMR data. We compare data extraction quality between ChatGPT-4 and human data collectors. METHODS: To train AI models to grade pediatric appendicitis preoperatively, several data collectors extracted detailed preoperative and operative data from 2100 children operated for acute appendicitis. Collectors were trained for the task based on satisfactory Kappa scores. ChatGPT-4 was prompted to structure free text from 103 random anonymized ultrasound and operative records in the dataset using the set variables and coding options, and to estimate appendicitis severity grade from the operative report. A pediatric surgeon then adjudicated all data, identifying errors in each method. RESULTS: Within the 44 ultrasound (42.7%) and 32 operative reports (31.1%) discordant in at least one field, 98% of the errors were found in the manual data extraction. The appendicitis grade was erroneously assigned manually in 29 patients (28.2%), and by ChatGPT-4 in 3 (2.9%). Across datasets, the use of the AI chatbot was able to avoid misclassification in 59.2% of the records including both reports and extracted data approximately 40 times faster. CONCLUSION: AI chatbot significantly outperformed manual data extraction in accuracy for ultrasound and operative reports, and correctly assigned the appendicitis grade. While wider validation is required and data safety concerns must be addressed, these AI tools show significant promise in improving the accuracy and efficiency of research data collection. LEVELS OF EVIDENCE: Level III.

James Warden and the Global Alliance Partnership: A Pediatric Surgery Giant and His Enduring PAPS Landmark.

The discipline of pediatric surgery has honored many of the early giants through programs that bear their names. One of those programs is the M. James Warden Global Alliance Partnership, a landmark program celebrated at each annual meeting of the Pacific Association of Pediatric Surgeons since 1989. This article describes James Warden and his legacy as a surgeon and humanitarian and provides an update on the past, present, and future of the Global Alliance Partnership that bears his name. LEVEL OF EVIDENCE: 5.

Open and laparoscopic inguinal hernia repair in children: A regional experience.

PURPOSE: The optimal approach for pediatric inguinal hernia repair continues to be debated. We conducted a regional retrospective study to assess rates of recurrence and metachronous hernias after open repair (OPEN) and laparoscopic repair (LAP) METHODS: A retrospective cohort study was conducted at two children's hospitals that serve a region of approximately 4 million people. All patients < 14 years old undergoing OPEN or LAP by pediatric surgeons during a 5-year period (2011 - 2015) were analyzed after a minimum follow up of 4 years. Cox proportional regression was used to compare the effect of surgical approach on hernia recurrence and metachronous contralateral hernias. RESULTS: A total of 1,952 patients, 587 female (30%) and 1365 male (70%), had 2305 hernias repaired. Median post operative follow up time was 6.6 years (range 4-9 years). OPEN and LAP were performed for 1827 (79%) and 478 (21%) hernias, respectively. There were no significant differences in rate of prematurity, age at repair, or frequency of emergent repair. LAP was associated with a lower incidence of metachronous contralateral hernias compared to OPEN (1.4% vs 3.8%, p = 0.047), and a higher incidence of recurrence (9% vs 0.9%, p < 0.001). After adjusting for confounders, LAP had a higher rate of recurrence than OPEN (hazard ratio 10.4, 95% CI 6-18.1).The recurrence rate did not decrease over the study period (p = 0.731). CONCLUSION: Laparoscopic inguinal hernia repair in children resulted in a modest decrease in the incidence of metachronous hernias, at the cost of a significant increase in recurrence. TYPE OF STUDY: Retrospective Comparative Study. LEVEL OF EVIDENCE: Level III.

"Your child needs surgery": A survey-based evaluation of simulated expert consent conversations by key stakeholders.

BACKGROUND: Consent conversations in pediatric surgery are essential components of pre-operative care which, when inadequate, can lead to significant adverse consequences for the child, parents, surgeon, and others in the healthcare system. The aim of this study is to explore expert consenting practice from the key stakeholders' perspective. METHODS: Four senior attending pediatric surgeons obtained consent from a standardized mother of a child requiring surgery in two scenarios: a low-risk elective surgery (inguinal hernia repair - Video 1), and a high-risk emergency surgery (intestinal atresia - Video 2). All sessions were recorded. Families of children who had undergone minor or major surgery, families without medical or surgical background, and healthcare professionals were invited to view and evaluate the videos using a semi-structured questionnaire. RESULTS: Out of 251 distributed surveys, 56 complete responses were received. Thirty two participants (57.1%) evaluated video 1 and 24 (42.9%) evaluated. Overall, 22 (69%) respondents to video 1 and 20 (84%) respondents to video 2 were "very satisfied" with the recorded consent conversation. Qualitative responses shared common themes of valuing surgeon empathy, good surgeon communication, patient engagement, and adequate time and information. Suggestions for improvement included additional resources and visual aids, improved patient engagement, and discussion of post-operative expectations. CONCLUSION: Our data identifies strengths and gaps in the current consent process from the perspective of patient families and providers. Identified areas for improvement in the informed consent process based on multi-stakeholder input will guide the planned development of a consenting educational video resource. LEVEL OF EVIDENCE: IV.

Patient experience or patient satisfaction? A systematic review of child- and family-reported experience measures in pediatric surgery.

PURPOSE: Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are increasingly recognized as important health care quality indicators. PREMs measure patients' perception of the care they have received, differing from satisfaction ratings, which measure their expectations. The use of PREMs in pediatric surgery is limited, prompting this systematic review to assess their characteristics and identify areas for improvement. METHODS: A search was conducted in eight databases from inception until January 12, 2022, to identify PREMs used with pediatric surgical patients, with no language restrictions. We focused on studies of patient experience but also included studies that assessed satisfaction and sampled experience domains. The quality of the included studies was appraised using the Mixed Methods Appraisal Tool. RESULTS: Following title and abstract screening of 2633 studies, 51 were included for full-text review, of which 22 were subsequently excluded because they measured only patient satisfaction rather than experience, and 14 were excluded for a range of other reasons. Out of the 15 included studies, questionnaires used in 12 studies were proxy-reported by parents and in 3 by both parents and children; none focused only on the child. Most instruments were developed in-house for each specific study, without patients' involvement in the process, and were not validated. CONCLUSIONS: Although PROMs are increasingly used in pediatric surgery, PREMs are not yet in use, being typically substituted by satisfaction surveys. Significant efforts are needed to develop and implement PREMs in pediatric surgical care, in order to effectively capture children's and families' voices. LEVEL OF EVIDENCE: IV.

Treatment and Outcomes of Congenital Ovarian Cysts A Study by the Canadian Consortium for Research in Pediatric Surgery (CanCORPS).

OBJECTIVE: We conducted a multicenter study to assess treatments and outcomes in a national cohort of infants with congenital ovarian cysts. SUMMARY BACKGROUND DATA: Wide variability exists in the treatment of congenital ovarian cysts. The effects of various treatment strategies on outcomes, specifically ovarian preservation, are not known. METHODS: Female infants diagnosed with congenital intra-abdominal cysts between 2013 and 2017 at 10 Canadian pediatric surgical centers were retrospectively evaluated. Sonographic characteristics, median time to cyst resolution, incidence of ovarian preservation, and predictors of surgery were evaluated. Subgroup analyses were performed in patients with complex cysts and cysts ≥40 mm in diameter. RESULTS: The study population included 189 neonates. Median gestational age at diagnosis and median maximal prenatal cyst diameter were 33 weeks and 40 mm, respectively. Cysts resolved spontaneously in 117 patients (62%), 14 (7%) prenatally, and the remainder at a median age of 124 days. Intervention occurred in 61 patients (32%), including prenatal aspiration (2, 3%), ovary sparing resection (14, 23%), or oophorectomy (45, 74%). Surgery occurred at a median age of 7.4weeks. Independent predictors of surgery included postnatal cyst diameter ≥40 mm [odds ratio (OR) 6.19, 95% confidence interval (CI) 1.66-35.9] and sonographic complex cyst character (OR 63.6, 95% CI 10.9-1232). There was no significant difference in the odds of ovarian preservation (OR 3.06, 95% CI 0.86 -13.2) between patients who underwent early surgery (n = 22) and those initially observed for at least 3 months (n = 131). CONCLUSIONS: Most congenital ovarian cysts are asymptomatic and spontaneously resolve. Early surgical intervention does not increase ovarian preservation.

The Canadian Consortium for Research in Pediatric Surgery: Roadmap for Creation and Implementation of a National Subspecialty Research Consortium.

Clinical practice should be driven by high-quality research that produces evidence to inform best practices. Generation of such evidence is often challenging, particularly for smaller specialties, such as pediatric surgery, that treat many patients with rare diseases. Multi-institutional collaboration is seen as a major strategy to address these challenges. We have recently created the Canadian Consortium for Research in Pediatric Surgery, a national consortium that includes all major pediatric surgical services across Canada. The mission of the Consortium is to improve pediatric surgical care through high-quality collaborative research. In this article, we describe the rationale and methodology for creation of the Canadian Consortium for Research in Pediatric Surgery, demonstrate its achievements to date, and share a number of foundational concepts that are integral to its success. Our aim is to provide a model for creation of such consortia, ultimately leading to improvements in the quality of clinical research and patient care.

Gastroschisis prognostic score successfully identifies Brazilian newborns with high-risk gastroschisis.

BACKGROUND: The Gastroschisis Prognostic Score (GPS) stratifies patients as high or low risk based on the visual assessment of intestinal matting, atresia, perforation, or necrosis. Despite being a simple score, its applicability to low and middle-income countries (LMICs) remains unknown. We tested the hypothesis that GPS can predict outcomes in LMICs, by assessing the prognostic value of the GPS in a middle-income country. METHODS: This prospective study followed all newborns with gastroschisis in a Brazilian neonatal unit based in a public hospital from 2015-2019. Infants were stratified into low and high-risk cohorts based on the GPS. In addition to basic demographics, data collected included duration of parenteral nutrition (TPN), mechanical ventilation (MV), length of stay (LOS), suspicion of infection that led to the use of antibiotics, and mortality. Univariate and multivariate analyses were conducted to identify which outcomes the GPS independently predicted. RESULTS: Sixty-one newborns with gastroschisis were treated during the study period. The mean birth weight, gestational age, and 5' Apgar score were 2258 g, 36 weeks, and 9. Twenty-four infants (39.3%) were identified as low-risk (GPS < 2) and 37 (60.7%) as high-risk (GPS > 2). The high-risk group presented with prolonged TPN use (p<0.001), MV (p<0.001), and LOS (p:0.002). GPS did not predict antibiotic therapy or mortality. CONCLUSION: In the first study in a middle-income country, the GPS predicted several important clinical outcomes. The GPS is a reliable tool for parental counseling and resource allocation in diverse settings. LEVEL OF EVIDENCE: II.c (cohort prospective).

Patient-reported outcome measures in pediatric surgery - A systematic review.

PURPOSE: With improved long-term survival rates, measuring the quality of surgical care has gradually shifted from clinical morbidity and mortality to patient-reported outcome measures (PROMs). Since the use of PROMs in pediatric surgery is still limited, we undertook a study to identify current PROMs, assess their characteristics, and identify gaps and areas for improvement. METHODS: A search was conducted in eight databases from their inception until May 2021 to identify PROMs that have been used in pediatric surgical patients. PRISMA standards were followed, and screening was completed by two independent reviewers. The quality of the included studies was appraised using the AXIS and the Mixed Methods Appraisal Tool. RESULTS: Of 8282 studies screened, 101 articles met the inclusion criteria. Most of the studies (99%) were cross-sectional. We identified 85 different PROMs among the studies, 53 being disease-specific and the rest generic. The PedsQL™ was the most frequently used tool (42 studies). Almost half of the instruments (41 studies) were not validated, and 28% were developed ad hoc for each specific study. Significantly, all PROMs encountered were standardized (consisting of pre-determined domains), with no individualized tools currently in use. The overall quality of the included studies was good. CONCLUSIONS: PROMs are increasingly used in pediatric surgery. Disease-specific PROMs predominate the field, yet validated and especially individualized PROMs are notably absent. Future efforts are needed to develop robust tools that reflect individual patient and family needs, preferences, and values, with the aim of furthering family-centered pediatric surgical care.

Postoperative pain following minimally invasive repair of pectus excavatum: A descriptive study.

BACKGROUND: Minimally Invasive Repair of Pectus Excavatum (MIRPE) is associated with significant postoperative pain. The objective of our study was to characterize the severity and duration of this pain, and to investigate possible associations with pectus severity. METHODS: We conducted a retrospective cohort study of pediatric patients who underwent MIRPE from January 2014 to April 2018. Pectus excavatum (PE) severity was determined with 3 indices measured from computed tomography: Depression Index (DI), Correction Index (CI), and Haller index (HI). Mean pain scores for every 6-hour period and the presence of pain and intake of analgesics during follow-up were extracted from the medical record. RESULTS: The cohort included 57 patients with a mean age of 15.9 ± 1.3 years. All 3 severity indices were positively correlated, with a correlation coefficient of 0.8 between the DI and CI. The requirement for 2 bars was significantly associated with higher indices (95% CI:0.18-0.63, p = 0.01). Pain was managed with thoracic epidural analgesia for all but one patient. Growth linear modeling identified five different pain trajectory subgroups of patients up to post-operative day 5. None of the tested predictors (age, gender, body image, physical activity level, DI, CI, HI, difference deformity-epidural level) were significantly associated with class membership. Persistent pain at one-year follow-up was present in 18% of patients, all with severe deformity (DI≥0.8). CONCLUSION: Pain trajectory and intensity after MIRPE can be classified into discrete patterns but are not influenced by PE severity. Severe deformity seems to predict persistent pain at one year.

Use of a risk communication survey to prioritize family-valued outcomes and communication preferences for children undergoing outpatient surgical procedures.

BACKGROUND: Effective shared decision-making in pediatric surgery requires clarity regarding which surgical outcomes are most important to patients and their families, and how they prefer to receive the information. Despite how essential this is for effective risk communication, little is known about the communication needs and preferences of patients and their families in elective pediatric surgery. METHODS: We administered a mailed and online cross-sectional survey in English and French to 548 families before or after surgery for hernia/hydrocele repair or tonsillectomy/adenoidectomy between July 2019 and February 2021. The survey consisted of 22 questions eliciting most valued patient-reported outcomes (PROs) across 4 domains: health-related quality of life (5), functional status (5), symptoms and symptom burden (5), health behaviours and patient experience (7), as well as overall impressions (3), surgical risks (5), communication preferences (4), and demographic questions (16). RESULTS: The survey was completed by 368 patient families (60 preoperative, 308 postoperative, response rate 67.2%). Most respondents (72%) indicated a significant desire to be informed on all listed PROs alongside surgical complications, and highly valued all functional and quality of life outcomes (92.9% & 89.8%, respectively). Preoperatively, patient families preferred to receive information in the form of pamphlets and websites, whereas postoperatively they preferred direct communication. CONCLUSION: Families value functional and quality of life PROs as much as clinical outcomes, and increasingly seek more contemporary (electronic) means of risk communication than we currently offer. This data will inform the development of mobile tools for personalized communication in pediatric surgery.

The utility of echocardiography and pulmonary function testing in the preoperative evaluation of pectus excavatum.

PURPOSE: Echocardiography (ECHO) and pulmonary function testing (PFT) are routinely performed during the preoperative evaluation of pectus excavatum (PE). We hypothesized that these investigations may be performed selectively based on patient symptoms and pectus severity. METHODS: A retrospective review of all PE patients who underwent a Nuss procedure during a 15-year period (2004-2018) was conducted. Symptoms, clinical characteristics, ECHO, and PFT results were extracted from the medical chart. PE severity on computed tomography was measured using the Haller Index (HI) and Correction Index (CI), and reported as mean ± SEM. Logistic and linear regression assessed the ability of symptoms and indices to predict abnormal cardiopulmonary test results. RESULTS: Of 119 patients, 116 patients had symptom documentation, and 74 (64%) had one or more symptoms. HI and CI were 3.8 ± 1.0 and 31.6 ± 10.3, respectively. Of those with ECHO available (111), 14 (13%) were abnormal, and 12 of 14 required cardiology follow-up. Of those with PFT available (90), the results were abnormal in 15 (17%), including 9 (11%) obstructive, 4 (5%) restrictive, and 2 (2%) mixed. The presence of symptoms did not predict abnormal ECHO or PFT, but each standard deviation increase in the CI was associated with abnormal PFT and ECHO by a factor of 2.2 and 2.0 respectively. HI severity was only associated with ECHO. CONCLUSION: The rates of abnormal ECHO and PFT testing in PE patients are low, and do not correlate with symptoms. Routine ECHO is still recommended to detect anomalies requiring follow-up. Elevated CI severity may be used to guide selective PFT testing. LEVELS OF EVIDENCE: Retrospective Study, Level III.

Differentiating congenital ovarian cysts from other abdominal cystic lesions in female infants: A study by the Canadian Consortium for Research in Pediatric Surgery (CanCORPS).

PURPOSE: The origin of congenital abdominal cysts in the female fetus often dictates management. While most arise from the ovary and are often managed non-operatively, some are non-ovarian and are frequently removed. We analyzed a national sample of female infants with congenital abdominal cysts to elucidate prenatal and postnatal factors associated with the diagnosis of a non-ovarian cyst. METHODS: A retrospective cohort study of female infants who were prenatally diagnosed with abdominal cysts between 2013 and 2017 at 10 Canadian pediatric surgical centres was performed. Clinical characteristics, pre- and postnatal sonographic findings, and cyst trajectories were compared between patients with proven ovarian etiology and those with cysts arising from other organs. RESULTS: Of 185 infants with prenatally diagnosed abdominal cysts, 22 (12%) were non-ovarian, five of which had clear non-ovarian organ of origin on prenatal ultrasound. Comparison of the other 17 cysts with 163 congenital ovarian cysts showed the following factors to be associated with a non-ovarian origin: earlier gestational age at diagnosis (23.5 vs 33.5 weeks, p <0.001), smaller diameter on first prenatal ultrasound (15.8 vs. 39.7 mm, p <0.001), change in sonographic character from simple to complex (87% vs 22%, p <0.001), and postnatal sonographic characteristics of complex cyst (87% vs. 48%, p = 0.004). CONCLUSION: Clear organ of origin, diagnosis earlier in gestation, smaller initial prenatal cyst diameter, and sonographic cyst character change differentiate congenital non-ovarian cysts from their ovarian counterparts. These characteristics may be used to guide diagnosis and management.

International Core Outcome Set for Acute Simple Appendicitis in Children: Results of a Systematic Review, Delphi Study, and Focus Croups With Young People.

OBJECTIVE: To develop an international core outcome set (COS), a minimal collection of outcomes that should be measured and reported in all future clinical trials evaluating treatments of acute simple appendicitis in children. SUMMARY OF BACKGROUND DATA: A previous systematic review identified 115 outcomes in 60 trials and systematic reviews evaluating treatments for children with appendicitis, suggesting the need for a COS. METHODS: The development process consisted of 4 phases: (1) an updated systematic review identifying all previously reported outcomes, (2) a 2-stage international Delphi study in which parents with their children and surgeons rated these outcomes for inclusion in the COS, (3) focus groups with young people to identify missing outcomes, and (4) international expert meetings to ratify the final COS. RESULTS: The systematic review identified 129 outcomes which were mapped to 43 unique outcome terms for the Delphi survey. The first-round included 137 parents (8 countries) and 245 surgeons (10 countries), the second-round response rates were 61% and 85% respectively, with 10 outcomes emerging with consensus. After 2 young peoples' focus groups, 2 additional outcomes were added to the final COS (12): mortality, bowel obstruction, intraabdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events related to treatment, major and minor complications. CONCLUSION: An evidence-informed COS based on international consensus, including patients and parents has been developed. This COS is recommended for all future studies evaluating treatment ofsimple appendicitis in children, to reduce heterogeneity between studies and facilitate data synthesis and evidence-based decision-making.