Provider and center effect in multicenter randomized controlled trials of surgical specialties

An analysis on patient-level data

David J. Biau, Jens A. Halm, Hamid Ahmadieh, William Capello, Johannes Jeekel, Isabelle Boutron, Raphaël Porcher

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

OBJECTIVE: To estimate the importance of center and provider effect and its implication on the estimation of treatment effect in surgical randomized controlled trials. SUMMARY BACKGROUND DATA: Provider and center effect may play an important role in the estimated treatment effect of multicenter surgical randomized controlled trials (RCTs). However, such effects are rarely accounted for in surgical RCTs. METHODS: Analysis of patient-level data from 3 large surgical randomized controlled trials. One trial in ophthalmology comparing retinal detachment rate after retinal reattachment in 225 patients operated on by 32 providers across 10 centers; one trial in orthopaedics comparing Harris Hip Score after total hip replacement in 496 patients operated on by 22 providers across 18 centers; one trial in general surgery comparing recurrence rate of hernia repair in 200 patients operated on by 88 providers across 11 centers. A provider effect and a center effect were searched for by comparing nonadjusted and adjusted models. An analysis of volume (ie, number of procedures performed during the course of the trial) effect and, when relevant, a treatment-by-volume interaction was also sought. RESULTS: A significant provider effect was found in ophthalmology (P < 0.0001); center effect was not significant. In orthopaedics, significant provider (P = 0.0037) and volume effect (P = 0.019) were found; a correlation was found between provider effect and volume (r = 0.5, P = 0.018); moreover, a treatment-by-volume interaction was found (P = 0.033); treatment effect became significant when adjusting for volume and provider. In general surgery, center effect was more prominent than provider effect, although none were found significant. CONCLUSIONS: Provider and center effects play a significant role in the estimation of treatment effect of large randomized controlled surgical trials. Not accounting for such effects may lead to biased estimates and misleading conclusions. These effects should be accounted for in the design and analysis of such trials.

Original languageEnglish
Pages (from-to)892-898
Number of pages7
JournalAnnals of Surgery
Volume247
Issue number5
DOIs
StatePublished - May 2008

Fingerprint

Surgical Specialties
Randomized Controlled Trials
Ophthalmology
Orthopedics
Therapeutics
Hip Replacement Arthroplasties
Herniorrhaphy
Retinal Detachment
Hip
Recurrence

ASJC Scopus subject areas

  • Surgery

Cite this

Provider and center effect in multicenter randomized controlled trials of surgical specialties : An analysis on patient-level data. / Biau, David J.; Halm, Jens A.; Ahmadieh, Hamid; Capello, William; Jeekel, Johannes; Boutron, Isabelle; Porcher, Raphaël.

In: Annals of Surgery, Vol. 247, No. 5, 05.2008, p. 892-898.

Research output: Contribution to journalArticle

Biau, David J. ; Halm, Jens A. ; Ahmadieh, Hamid ; Capello, William ; Jeekel, Johannes ; Boutron, Isabelle ; Porcher, Raphaël. / Provider and center effect in multicenter randomized controlled trials of surgical specialties : An analysis on patient-level data. In: Annals of Surgery. 2008 ; Vol. 247, No. 5. pp. 892-898.
@article{5a002cfc066243298708a8a85a5c22e3,
title = "Provider and center effect in multicenter randomized controlled trials of surgical specialties: An analysis on patient-level data",
abstract = "OBJECTIVE: To estimate the importance of center and provider effect and its implication on the estimation of treatment effect in surgical randomized controlled trials. SUMMARY BACKGROUND DATA: Provider and center effect may play an important role in the estimated treatment effect of multicenter surgical randomized controlled trials (RCTs). However, such effects are rarely accounted for in surgical RCTs. METHODS: Analysis of patient-level data from 3 large surgical randomized controlled trials. One trial in ophthalmology comparing retinal detachment rate after retinal reattachment in 225 patients operated on by 32 providers across 10 centers; one trial in orthopaedics comparing Harris Hip Score after total hip replacement in 496 patients operated on by 22 providers across 18 centers; one trial in general surgery comparing recurrence rate of hernia repair in 200 patients operated on by 88 providers across 11 centers. A provider effect and a center effect were searched for by comparing nonadjusted and adjusted models. An analysis of volume (ie, number of procedures performed during the course of the trial) effect and, when relevant, a treatment-by-volume interaction was also sought. RESULTS: A significant provider effect was found in ophthalmology (P < 0.0001); center effect was not significant. In orthopaedics, significant provider (P = 0.0037) and volume effect (P = 0.019) were found; a correlation was found between provider effect and volume (r = 0.5, P = 0.018); moreover, a treatment-by-volume interaction was found (P = 0.033); treatment effect became significant when adjusting for volume and provider. In general surgery, center effect was more prominent than provider effect, although none were found significant. CONCLUSIONS: Provider and center effects play a significant role in the estimation of treatment effect of large randomized controlled surgical trials. Not accounting for such effects may lead to biased estimates and misleading conclusions. These effects should be accounted for in the design and analysis of such trials.",
author = "Biau, {David J.} and Halm, {Jens A.} and Hamid Ahmadieh and William Capello and Johannes Jeekel and Isabelle Boutron and Rapha{\"e}l Porcher",
year = "2008",
month = "5",
doi = "10.1097/SLA.0b013e31816ffa99",
language = "English",
volume = "247",
pages = "892--898",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - Provider and center effect in multicenter randomized controlled trials of surgical specialties

T2 - An analysis on patient-level data

AU - Biau, David J.

AU - Halm, Jens A.

AU - Ahmadieh, Hamid

AU - Capello, William

AU - Jeekel, Johannes

AU - Boutron, Isabelle

AU - Porcher, Raphaël

PY - 2008/5

Y1 - 2008/5

N2 - OBJECTIVE: To estimate the importance of center and provider effect and its implication on the estimation of treatment effect in surgical randomized controlled trials. SUMMARY BACKGROUND DATA: Provider and center effect may play an important role in the estimated treatment effect of multicenter surgical randomized controlled trials (RCTs). However, such effects are rarely accounted for in surgical RCTs. METHODS: Analysis of patient-level data from 3 large surgical randomized controlled trials. One trial in ophthalmology comparing retinal detachment rate after retinal reattachment in 225 patients operated on by 32 providers across 10 centers; one trial in orthopaedics comparing Harris Hip Score after total hip replacement in 496 patients operated on by 22 providers across 18 centers; one trial in general surgery comparing recurrence rate of hernia repair in 200 patients operated on by 88 providers across 11 centers. A provider effect and a center effect were searched for by comparing nonadjusted and adjusted models. An analysis of volume (ie, number of procedures performed during the course of the trial) effect and, when relevant, a treatment-by-volume interaction was also sought. RESULTS: A significant provider effect was found in ophthalmology (P < 0.0001); center effect was not significant. In orthopaedics, significant provider (P = 0.0037) and volume effect (P = 0.019) were found; a correlation was found between provider effect and volume (r = 0.5, P = 0.018); moreover, a treatment-by-volume interaction was found (P = 0.033); treatment effect became significant when adjusting for volume and provider. In general surgery, center effect was more prominent than provider effect, although none were found significant. CONCLUSIONS: Provider and center effects play a significant role in the estimation of treatment effect of large randomized controlled surgical trials. Not accounting for such effects may lead to biased estimates and misleading conclusions. These effects should be accounted for in the design and analysis of such trials.

AB - OBJECTIVE: To estimate the importance of center and provider effect and its implication on the estimation of treatment effect in surgical randomized controlled trials. SUMMARY BACKGROUND DATA: Provider and center effect may play an important role in the estimated treatment effect of multicenter surgical randomized controlled trials (RCTs). However, such effects are rarely accounted for in surgical RCTs. METHODS: Analysis of patient-level data from 3 large surgical randomized controlled trials. One trial in ophthalmology comparing retinal detachment rate after retinal reattachment in 225 patients operated on by 32 providers across 10 centers; one trial in orthopaedics comparing Harris Hip Score after total hip replacement in 496 patients operated on by 22 providers across 18 centers; one trial in general surgery comparing recurrence rate of hernia repair in 200 patients operated on by 88 providers across 11 centers. A provider effect and a center effect were searched for by comparing nonadjusted and adjusted models. An analysis of volume (ie, number of procedures performed during the course of the trial) effect and, when relevant, a treatment-by-volume interaction was also sought. RESULTS: A significant provider effect was found in ophthalmology (P < 0.0001); center effect was not significant. In orthopaedics, significant provider (P = 0.0037) and volume effect (P = 0.019) were found; a correlation was found between provider effect and volume (r = 0.5, P = 0.018); moreover, a treatment-by-volume interaction was found (P = 0.033); treatment effect became significant when adjusting for volume and provider. In general surgery, center effect was more prominent than provider effect, although none were found significant. CONCLUSIONS: Provider and center effects play a significant role in the estimation of treatment effect of large randomized controlled surgical trials. Not accounting for such effects may lead to biased estimates and misleading conclusions. These effects should be accounted for in the design and analysis of such trials.

UR - http://www.scopus.com/inward/record.url?scp=42549154261&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=42549154261&partnerID=8YFLogxK

U2 - 10.1097/SLA.0b013e31816ffa99

DO - 10.1097/SLA.0b013e31816ffa99

M3 - Article

VL - 247

SP - 892

EP - 898

JO - Annals of Surgery

JF - Annals of Surgery

SN - 0003-4932

IS - 5

ER -