Abstract

Objective: The aim of this study was to develop a general method to estimate the minimal number of repeated examinations needed to detect patients with random responsiveness, given a limited rate of missed diagnosis.Methods: Basic statistical theory was applied to develop the method. As an application, 100 patients with disorders of consciousness (DOC) were assessed with the Coma Recovery Scale–Revised (CRS-R). DOC patients were supposed to be examined for 13 times over 20 days, while anyone who was diagnosed as a minimally conscious state (MCS) in a round would no longer be examined in the subsequent rounds. To test the validation of this method, a series of the stochastic simulation was completed by computer software under all the conditions of possible combinations of three kinds of distributions for p, five values of p, and four sizes of the sample and repeated for 100 times.Results: A series of formula was developed to estimate the probability of a positive response to a single examination given by a patient and the minimal number of successive examinations needed based on the numbers of patients detected in the first i (i =1, 2,.) rounds of repeated examinations. As applied to the DOC patients assessed with the CRS-R, with a rate of missed diagnosis < 0.0001, the estimate of the minimal number of examinations was six in traumatic brain injury patients and five in non-traumatic brain injury patients. The outcome of the simulation showed that this method performed well under various conditions possibly occurring in practice.Interpretation: The method developed in this paper holds in theory and works well in application and stochastic simulation. It could be applied to any other kind of examinations for random responsiveness, not limited to CRS-R for detecting MCS; this should be validated in further research.

Highlights

  • In clinical practice, bedside evaluation of patients has always been regarded as the “gold standard” (Giacino et al, 2009)

  • The aim of this study is to develop a general method to estimate the minimal number of repeated examinations needed to detect patients with random responsiveness, given a limited rate of missed diagnosis and to validate the method by computer stochastic simulation

  • There is a consensus that the fluctuations in responsiveness are inherent to minimally conscious state (MCS) patients (Giacino et al, 2002, 2009; Majerus et al, 2005), so people should repeat the examination to obtain a reliable diagnosis while using the Coma Recovery Scale-Revised (CRS-R)

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Summary

Introduction

Bedside evaluation of patients has always been regarded as the “gold standard” (Giacino et al, 2009). The fluctuation of behavioral responses of patients is very common, especially in the minimally conscious state (MCS) (Giacino et al, 2002). The fluctuations in the responsiveness of MCS patients are inherent (Majerus et al, 2005), and this is due to the patient’s motor or language impairments and vigilance fluctuations (Seel et al, 2010). Both unresponsive wakefulness syndrome/vegetative state (UWS/VS) (Laureys et al, 2010) and MCS are referred to as “disorders of consciousness” (DOC), but clinicians often make mistakes when differentiating between these patients. Recent guidelines have emphasized the importance of repeated assessments to increase the accuracy of clinical diagnosis (Giacino et al, 2018; Kondziella et al, 2020)

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