Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments: Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial

Hyunju Yang, Alexa Watach, Miranda Varrasse, Tonya S. King, Amy M. Sawyer

Research output: Contribution to journalArticle

Abstract

Study Objectives: Determine the Multivariable Apnea Prediction (MAP) index predictive utility for enrollment enrichment in a clinical trial wherein enrollment was prior to obstructive sleep apnea diagnosis. Methods: Secondary analysis of screening data (n = 264) from randomized, double-blind, pilot trial. Clinical sleep center patients with complete screening and polysomnography data were included. To determine diagnostic test accuracy of the MAP index using apnea-hypopnea index criterion ? 10 events/h (primary) and ? 5, ? 15, and ? 30 events/h (secondary), sensitivity, specificity, negative and positive predictive values, likelihood positive and negative ratios, and receiver operating characteristic curves were calculated. Predictive utility was examined by characteristic variables. Results: Middle-aged, overweight or obese, men and women were included. Employing a MAP index threshold ? 0.5, sensitivity for obstructive sleep apnea (apnea-hypopnea index ? 10 events/h) was 83.6%; specificity was 46.4%; area under the curve = 0.74. Sensitivity was higher in males than females (95.3%, 68.7%, respectively); specificity was lower in males than females (30.4%, 57.6%, respectively) with similar area under the curve (0.74 versus 0.72, respectively). MAP accuracy was higher in younger versus older adults (younger than 50 years, or 50 years or older; area under the curve 0.82 versus 0.63, respectively). Varied apnea-hypopnea index criteria produced stable accuracy estimates. Conclusions: Recruitment/enrollment is a high-cost endeavor. Screening procedures may confer resource savings but careful evaluation prior to study implementation assures effectiveness and efficiency.

Original languageEnglish (US)
Pages (from-to)173-181
Number of pages9
JournalJournal of Clinical Sleep Medicine
Volume14
Issue number2
DOIs
StatePublished - Feb 15 2018

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Apnea
Clinical Trials
Research
Area Under Curve
Obstructive Sleep Apnea
Polysomnography
Routine Diagnostic Tests
ROC Curve
Young Adult
Sleep
Costs and Cost Analysis
Sensitivity and Specificity

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Neurology
  • Clinical Neurology

Cite this

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title = "Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments: Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial",
abstract = "Study Objectives: Determine the Multivariable Apnea Prediction (MAP) index predictive utility for enrollment enrichment in a clinical trial wherein enrollment was prior to obstructive sleep apnea diagnosis. Methods: Secondary analysis of screening data (n = 264) from randomized, double-blind, pilot trial. Clinical sleep center patients with complete screening and polysomnography data were included. To determine diagnostic test accuracy of the MAP index using apnea-hypopnea index criterion ? 10 events/h (primary) and ? 5, ? 15, and ? 30 events/h (secondary), sensitivity, specificity, negative and positive predictive values, likelihood positive and negative ratios, and receiver operating characteristic curves were calculated. Predictive utility was examined by characteristic variables. Results: Middle-aged, overweight or obese, men and women were included. Employing a MAP index threshold ? 0.5, sensitivity for obstructive sleep apnea (apnea-hypopnea index ? 10 events/h) was 83.6{\%}; specificity was 46.4{\%}; area under the curve = 0.74. Sensitivity was higher in males than females (95.3{\%}, 68.7{\%}, respectively); specificity was lower in males than females (30.4{\%}, 57.6{\%}, respectively) with similar area under the curve (0.74 versus 0.72, respectively). MAP accuracy was higher in younger versus older adults (younger than 50 years, or 50 years or older; area under the curve 0.82 versus 0.63, respectively). Varied apnea-hypopnea index criteria produced stable accuracy estimates. Conclusions: Recruitment/enrollment is a high-cost endeavor. Screening procedures may confer resource savings but careful evaluation prior to study implementation assures effectiveness and efficiency.",
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Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments : Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial. / Yang, Hyunju; Watach, Alexa; Varrasse, Miranda; King, Tonya S.; Sawyer, Amy M.

In: Journal of Clinical Sleep Medicine, Vol. 14, No. 2, 15.02.2018, p. 173-181.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments

T2 - Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial

AU - Yang, Hyunju

AU - Watach, Alexa

AU - Varrasse, Miranda

AU - King, Tonya S.

AU - Sawyer, Amy M.

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