title: Monitoring diagnostic accuracy and complications. A report from the Children's Oncology Group Hodgkin lymphoma study.
abstract: OBJECTIVE
  Cancer studies mandate quality assurance programs for clinical trials. Surgeons consistently play 2 roles early in the management of Hodgkin lymphoma in children and adolescents: obtaining a specimen for pathologic diagnosis and placing a central venous catheter to assist with therapy delivery. A surgical quality assurance program was embedded as part of the of the Hodgkin lymphoma study (AHODOOO31) to assess diagnostic accuracy and complications.
  
  
  METHODS
  Surgical checklists and operative and pathology reports were reviewed concurrently. Diagnostic technique, success rate, location of biopsy, combined procedures under one anesthetic, and complications are reported.
  
  
  RESULTS
  One hundred eighty-five cases were reviewed, with 169 having complete data. Diagnostic techniques included open biopsy (n = 148), computed tomography-guided core biopsy (n = 5), thoracoscopic/laparoscopic biopsy (n = 10) and fine-needle aspirations (n = 4). No staging laparotomies were performed. Biopsy sites included cervical (133), mediastinal (18), axillary (7), and others (11). Diagnostic accuracy was 145 of 148 (98.5%) for the open biopsy; 4 of 5, core biopsy (80%); 6 of 10 (60%), thoracoscopic/laparoscopic biopsy; and 1 of 4, fine-needle aspiration (25%). Eighteen had mediastinal disease only, 9 of whom had a thoracoscopic biopsy with a 55% diagnostic accuracy. Inadequate sample was the only reason for a lack of diagnosis. A second open operation was required in these cases for diagnosis. At biopsy, frozen section confirmed a malignancy in 68. In 38 of these 68 children, a central line was placed during the same anesthetic. The most common complication was inadequate sampling. Three wound infections were reported.
  
  
  CONCLUSIONS
  With an appropriate surgical approach to obtain an adequate tissue specimen, diagnostic accuracy is high and surgical complications are low in children with Hodgkin lymphoma. Diagnostic technique should ensure adequate tissue sampling especially when not using an open procedure. When possible, central line insertion should be performed under the same anesthetic. Fine-needle aspiration was not used enough to assess its role in the diagnosis of children with Hodgkin lymphoma.
authors.affiliation: Department of Pediatric Surgery and University of Michigan Medical Center, Ann Arbor, MI 48104, USA. pehrlich@med.umich.edu
authors.forename: Peter F
authors.initials: PF
authors.lastname: Ehrlich
authors.forename: Debra L
authors.initials: DL
authors.lastname: Friedman
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Schwartz
mesh_terms: D000293:Adolescent; D001706:Biopsy / Q000009:adverse effects / Q000379:methods*; D044963:Biopsy, Fine-Needle; D002648:Child; D006689:Hodgkin Disease / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000175:diagnosis*; D011785:Quality Assurance, Health Care; D013906:Thoracoscopy