Automated Analyzers Are Suited for Diagnosing Celiac Disease Without a Biopsy

Rozenberg, Orit; Rinawi, Firas; Haritan, Yifat; Yerushalmi, Baruch; Kori, Michal; Morgenstern, Sara; Peleg, Sarit; Osyntsov, Lidia; Colodner, Raul; Shamir, Raanan

doi:10.1097/mpg.0000000000002711

“…In one such study, the no-biopsy algorithm showed a positive predictive value of 0.988 and a negative predictive value of 0.958 [41]. This and similar recent observations [60,61] led to rea rmation and further extension of no-biopsy approach to include asymptomatic children as well [12].…”

Section: European Movement Towards No-biopsysupporting

confidence: 70%

Value of Biopsy in a Cohort of Children with High-Titer Celiac Serologies: Observation of Dynamic Policy Differences between Europe and North America

Badizadegan¹,

Vanlandingham

²

,

Hampton

³

et al. 2020

Preprint

0

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Background: Healthcare systems implement change at different rates because of differences in incentives, organizational processes, key influencers, and management styles. A comparable set of forces may play out at the national and international levels as demonstrated in significant differences in the diagnostic management of pediatric Celiac Disease (CD) between European and North American practioners. Methods: We use retrospective clinical cohorts of 27,868 serum tissue transglutaminase (tTG) immunoglobulin A levels and 7,907 upper gastrointestinal endoscopy pathology reports to create a dataset of 793 pathology reports with matching tTG results between July 1 of 2014 and July 1 of 2018. We use this dataset to characterize histopathological findings in the duodenum, stomach and esophagus of patients as a function of serum tTG levels. In addition, we use the dataset to estimate the local and national cost of endoscopies performed in patients with serum tTG levels greater than 10 times the upper limit of normal. Results: Using evidence from a US tertiary care center, we show that in the cohort of pediatric patients with high pre-test probability of CD as determined by serum tTG levels, biopsy provides no additional diagnostic value for CD, and that it counter-intuitively introduces diagnostic uncertainty in a number of patients. We estimate that using the European diagnostic algorithms could avoid between 4,891 and 7,738 pediatric endoscopies per year in the US for evaluation of CD. Conclusions: This study considers the North American and European management guidelines for the diagnosis of pediatric CD and highlights the slow adoption in North America of evidence-based algorithms developed and applied in Europe for triage of endoscopy and biopsy. We suggest that the forces that maintain the status quo in North America go beyond medical evidence and include a variety of social and economic factors. This work contributes to the growing body of evidence that suggests that the dynamics that largely favor maintaining status quo management policies extend to clinical medicine and influence a variety of clinical decisions at the level of individual patients and the population.

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“…In one such study, the nobiopsy algorithm showed a positive predictive value of 0.988 and a negative predictive value of 0.958 [41]. This and similar recent observations [60,61] led to rea rmation and further extension of no-biopsy approach to include asymptomatic children as well [12].…”

Section: European Movement Towards No-biopsysupporting

confidence: 69%

Value of Biopsy in a Cohort of Children with High-Titer Celiac Serologies: Observation of Dynamic Policy Differences between Europe and North America

Badizadegan¹,

Vanlandingham

²

,

Hampton

³

et al. 2020

Preprint

0

View full text Add to dashboard Cite

Background: Healthcare systems implement change at different rates because of differences in incentives, organizational processes, key influencers, and management styles. A comparable set of forces may play out at the national and international levels as demonstrated in significant differences in the diagnostic management of pediatric Celiac Disease (CD) between European and North American practioners. Methods: We use retrospective clinical cohorts of 27,868 serum tissue transglutaminase (tTG) immunoglobulin A levels and 7,907 upper gastrointestinal endoscopy pathology reports to create a dataset of 793 pathology reports with matching tTG results between July 1 of 2014 and July 1 of 2018. We use this dataset to characterize histopathological findings in the duodenum, stomach and esophagus of patients as a function of serum tTG levels. In addition, we use the dataset to estimate the local and national cost of endoscopies performed in patients with serum tTG levels greater than 10 times the upper limit of normal. Results: Using evidence from a US tertiary care center, we show that in the cohort of pediatric patients with high pre-test probability of CD as determined by serum tTG levels, biopsy provides no additional diagnostic value for CD, and that it counter-intuitively introduces diagnostic uncertainty in a number of patients. We estimate that using the European diagnostic algorithms could avoid between 4,891 and 7,738 pediatric endoscopies per year in the US for evaluation of CD. Conclusions: This study considers the North American and European management guidelines for the diagnosis of pediatric CD and highlights the slow adoption in North America of evidence-based algorithms developed and applied in Europe for triage of endoscopy and biopsy. We suggest that the forces that maintain the status quo in North America go beyond medical evidence and include a variety of social and economic factors. This work contributes to the growing body of evidence that suggests that the dynamics that largely favor maintaining status quo management policies extend to clinical medicine and influence a variety of clinical decisions at the level of individual patients and the population.

show abstract

“…In one such study, the no-biopsy algorithm showed a positive predictive value of 0.988 and a negative predictive value of 0.958 [41]. This and similar recent observations [60,61] led to reaffirmation and further extension of no-biopsy approach to include asymptomatic children as well [12].…”

Section: European Movement Towards No-biopsysupporting

confidence: 65%

Value of biopsy in a cohort of children with high-titer celiac serologies: observation of dynamic policy differences between Europe and North America

Badizadegan¹,

Vanlandingham

²

,

Hampton

³

et al. 2020

BMC Health Serv Res

7

0

View full text Add to dashboard Cite

Background Healthcare systems implement change at different rates because of differences in incentives, organizational processes, key influencers, and management styles. A comparable set of forces may play out at the national and international levels as demonstrated in significant differences in the diagnostic management of pediatric Celiac Disease (CD) between European and North American practitioners. Methods We use retrospective clinical cohorts of 27,868 serum tissue transglutaminase (tTG) immunoglobulin A levels and 7907 upper gastrointestinal endoscopy pathology reports to create a dataset of 793 pathology reports with matching tTG results between July 1 of 2014 and July 1 of 2018. We use this dataset to characterize histopathological findings in the duodenum, stomach and esophagus of patients as a function of serum tTG levels. In addition, we use the dataset to estimate the local and national cost of endoscopies performed in patients with serum tTG levels greater than 10 times the upper limit of normal. Results Using evidence from a US tertiary care center, we show that in the cohort of pediatric patients with high pre-test probability of CD as determined by serum tTG levels, biopsy provides no additional diagnostic value for CD, and that it counter-intuitively introduces diagnostic uncertainty in a number of patients. We estimate that using the European diagnostic algorithms could avoid between 4891 and 7738 pediatric endoscopies per year in the US for evaluation of CD. Conclusions This study considers the North American and European management guidelines for the diagnosis of pediatric CD and highlights the slow adoption in North America of evidence-based algorithms developed and applied in Europe for triage of endoscopy and biopsy. We suggest that system dynamics influences that help maintain the status quo in North America include a variety of social and economic factors in addition to medical evidence. This work contributes to the growing body of evidence that the dynamics that largely favor maintaining status quo management policies in a variety of systems extend to clinical medicine and potentially influence clinical decisions at the level of individual patients and the population.

show abstract

Automated Analyzers Are Suited for Diagnosing Celiac Disease Without a Biopsy

Cited by 7 publications

References 30 publications

Value of Biopsy in a Cohort of Children with High-Titer Celiac Serologies: Observation of Dynamic Policy Differences between Europe and North America

Value of Biopsy in a Cohort of Children with High-Titer Celiac Serologies: Observation of Dynamic Policy Differences between Europe and North America

Value of Biopsy in a Cohort of Children with High-Titer Celiac Serologies: Observation of Dynamic Policy Differences between Europe and North America

Value of biopsy in a cohort of children with high-titer celiac serologies: observation of dynamic policy differences between Europe and North America

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