Central Adjudication Committee and Clinical Site Investigator Agreement on Outcomes in the PARITY Trial: A Secondary Analysis of the PARITY Trial Data.
Journal
The Journal of bone and joint surgery. American volume
ISSN: 1535-1386
Titre abrégé: J Bone Joint Surg Am
Pays: United States
ID NLM: 0014030
Informations de publication
Date de publication:
19 07 2023
19 07 2023
Historique:
medline:
21
7
2023
pubmed:
19
7
2023
entrez:
19
7
2023
Statut:
ppublish
Résumé
The detection of a surgical site infection (SSI) in patients with metal implants requires a high degree of clinical acumen. The inherent subjectivity of SSI diagnosis poses a challenge in the design of surgical trials because this subjectivity raises concern for outcome assessment bias. Central Adjudication Committees (CACs) are often utilized to minimize the variability in outcome assessment. Little research has been done to determine the reliability of outcome assessment in trials utilizing a CAC. In the present study, we determined the agreement between the study CAC and the clinical site investigators for the primary and secondary outcome assessments. The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial was a multicenter, blinded, parallel 2-arm, randomized controlled trial that aimed to determine the effect of a 5-day versus 1-day postoperative prophylactic antibiotic regimen on the rate of SSI in patients undergoing surgical excision of tumors in the femur or tibia. The blinded PARITY CAC adjudicated all primary and secondary outcomes identified during the 1-year study follow-up. In the present secondary analysis, the Cohen kappa statistic was utilized to determine the level of agreement. The primary outcome of SSI diagnosis demonstrated a substantial level of agreement between the CAC and the site investigators (0.699; 95% confidence interval [CI], 0.595 to 0.803]). Categorization of the SSI (i.e., superficial, deep, or organ space) showed moderate agreement (0.470; 95% CI, 0.382 to 0.558). Secondary outcomes such as the types of reoperations and the indication for reoperation typically showed substantial to almost perfect agreement, whereas antibiotic-related complications showed fair agreement (0.241; 95% CI, 0.000 to 0.474). Although there was a substantial level of agreement between the PARITY CAC and site investigators on the diagnosis of an SSI, as well as typically at least substantial agreement on the causes and types of reoperations, there was less agreement regarding the type of SSI and the occurrence of an antibiotic-related complication. Therefore, the CAC appears to have provided value when adjudicating the depth of infection and when determining the causality of medical complications associated with antibiotics. Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Sections du résumé
BACKGROUND
The detection of a surgical site infection (SSI) in patients with metal implants requires a high degree of clinical acumen. The inherent subjectivity of SSI diagnosis poses a challenge in the design of surgical trials because this subjectivity raises concern for outcome assessment bias. Central Adjudication Committees (CACs) are often utilized to minimize the variability in outcome assessment. Little research has been done to determine the reliability of outcome assessment in trials utilizing a CAC. In the present study, we determined the agreement between the study CAC and the clinical site investigators for the primary and secondary outcome assessments.
METHODS
The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial was a multicenter, blinded, parallel 2-arm, randomized controlled trial that aimed to determine the effect of a 5-day versus 1-day postoperative prophylactic antibiotic regimen on the rate of SSI in patients undergoing surgical excision of tumors in the femur or tibia. The blinded PARITY CAC adjudicated all primary and secondary outcomes identified during the 1-year study follow-up. In the present secondary analysis, the Cohen kappa statistic was utilized to determine the level of agreement.
RESULTS
The primary outcome of SSI diagnosis demonstrated a substantial level of agreement between the CAC and the site investigators (0.699; 95% confidence interval [CI], 0.595 to 0.803]). Categorization of the SSI (i.e., superficial, deep, or organ space) showed moderate agreement (0.470; 95% CI, 0.382 to 0.558). Secondary outcomes such as the types of reoperations and the indication for reoperation typically showed substantial to almost perfect agreement, whereas antibiotic-related complications showed fair agreement (0.241; 95% CI, 0.000 to 0.474).
CONCLUSIONS
Although there was a substantial level of agreement between the PARITY CAC and site investigators on the diagnosis of an SSI, as well as typically at least substantial agreement on the causes and types of reoperations, there was less agreement regarding the type of SSI and the occurrence of an antibiotic-related complication. Therefore, the CAC appears to have provided value when adjudicating the depth of infection and when determining the causality of medical complications associated with antibiotics.
LEVEL OF EVIDENCE
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Identifiants
pubmed: 37466583
doi: 10.2106/JBJS.22.01363
pii: 00004623-202307191-00014
doi:
Substances chimiques
Anti-Bacterial Agents
0
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
73-78Informations de copyright
Copyright © 2023 by The Journal of Bone and Joint Surgery, Incorporated.
Déclaration de conflit d'intérêts
Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/H546).
Références
Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74.
Peel TN. Studying biofilm and clinical issues in orthopedics. Front Microbiol. 2019 Feb 26;10(FEB):359.
Scheuermann-Poley C, Wagner C, Hoffmann J, Moter A, Willy C. [The significance of biofilm for the treatment of infections in orthopedic surgery: 2017 Update]. Unfallchirurg. 2017 Jun;120(6):461-71.
Barrett L, Atkins B. The clinical presentation of prosthetic joint infection. J Antimicrob Chemother. 2014 Sep;69(Suppl 1):i25-7.
Inman RD, Gallegos KV, Brause BD, Redecha PB, Christian CL. Clinical and microbial features of prosthetic joint infection. Am J Med. 1984 Jul;77(1):47-53.
Atkins BL, Athanasou N, Deeks JJ, Crook DW, Simpson H, Peto TE, McLardy-Smith P, Berendt AR; The OSIRIS Collaborative Study Group. Prospective evaluation of criteria for microbiological diagnosis of prosthetic-joint infection at revision arthroplasty. J Clin Microbiol. 1998 Oct;36(10):2932-9.
Orthopaedic Research Society. 2018 International Consensus on Musculoskeletal Infection - ORS. Accessed 2022 Nov 27. https://www.ors.org/2018-icm/
Parvizi J, Jacovides C, Zmistowski B, Jung KA. Definition of periprosthetic joint infection: is there a consensus? Clin Orthop Relat Res. 2011 Nov;469(11):3022-30.
Centers for Disease Control and Prevention. Surgical Site Infection Event (SSI). 2023. Accessed 2023 Jan 14. https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Vannabouathong C, Saccone M, Sprague S, Schemitsch EH, Bhandari M. Adjudicating outcomes: fundamentals. J Bone Joint Surg Am. 2012 Jul 18;94(Suppl 1):70-4.
Nuttall J, Evaniew N, Thornley P, Griffin A, Deheshi B, O’Shea T, Wunder J, Ferguson P, Randall RL, Turcotte R, Schneider P, McKay P, Bhandari M, Ghert M. The inter-rater reliability of the diagnosis of surgical site infection in the context of a clinical trial. Bone Joint Res. 2016 Aug;5(8):347-52.
Ghert M, Deheshi B, Holt G, Randall RL, Ferguson P, Wunder J, Turcotte R, Werier J, Clarkson P, Damron T, Benevenia J, Anderson M, Gebhardt M, Isler M, Mottard S, Healey J, Evaniew N, Racano A, Sprague S, Swinton M, Bryant D, Thabane L, Guyatt G, Bhandari M, PARITY Investigators. Prophylactic antibiotic regimens in tumour surgery (PARITY): protocol for a multicentre randomised controlled study. BMJ Open. 2012 Nov 28;2(6):e002197.
Ghert M, Schneider P, Guyatt G, Thabane L, Vélez R, O’Shea T, Randall RL, Turcotte R, Wilson D, Wunder JS, Baptista AM, Cheng EY, Doung YC, Ferguson PC, Giglio V, Hayden J, Heels-Ansdell D, Khan SA, Sampath Kumar V, McKay P, Miller B, van de Sande M, Zumárraga JP, Bhandari M; Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) Investigators. Comparison of Prophylactic Intravenous Antibiotic Regimens After Endoprosthetic Reconstruction for Lower Extremity Bone Tumors: A Randomized Clinical Trial. JAMA Oncol. 2022 Mar 1;8(3):345-53.
Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37-46.
Lippe J, Spang JT, Leger RR, Arciero RA, Mazzocca AD, Shea KP. Inter-rater agreement of the Goutallier, Patte, and Warner classification scores using preoperative magnetic resonance imaging in patients with rotator cuff tears. Arthroscopy. 2012 Feb;28(2):154-9.
Ihejirika RC, Thakore RV, Sathiyakumar V, Ehrenfeld JM, Obremskey WT, Sethi MK. An assessment of the inter-rater reliability of the ASA physical status score in the orthopaedic trauma population. Injury. 2015 Apr;46(4):542-6.
Hammond KE, Dierckman BD, Burnworth L, Meehan PL, Oswald TS. Inter-observer and intra-observer reliability of the Risser sign in a metropolitan scoliosis screening program. J Pediatr Orthop. 2011 Dec;31(8):e80-4.
Tamma PD, Avdic E, Li DX, Dzintars K, Cosgrove SE. Association of Adverse Events With Antibiotic Use in Hospitalized Patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-15.
Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2.