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Purpose: To date there are only a few studies published, dealing with delirium in critically ill patients. The problem with these studies is that prevalence rates of delirium could only be estimated because of the lack of validated delirium assessment tools for the paediatric intensive care unit (PICU). The paediatric Confusion Assessment Method for the Intensive Care Unit (pCAM-ICU) was specifically developed and validated for the detection of delirium in PICU patients. The purpose of this study was the translation of the English pCAM-ICU into German according to international validated guidelines.
Methods: The translation process was performed according to the principles of good practice for the translation and cultural adaptation process for patient reported outcomes measures: From three independently created German forward-translation versions one preliminary German version was developed, which was then retranslated to English by a certified, state-approved translator. The back-translated version was submitted to the original author for evaluation. The German translation was evaluated by clinicians and specialists anonymously (German grades) in regards to language and content of the translation.
Results: The results of the cognitive debriefing revealed good to very good results. After that the translation process was successfully completed and the final version of the German pCAM-ICU was adopted by the expert committee.
Conclusion: The German version of the pCAM-ICU is a result of a translation process in accordance with internationally acknowledged guidelines. Particularly, with respect to the excellent results of the cognitive debriefing, we could finalise the translation and cultural adaptation process for the German pCAM-ICU.
Zielsetzung: Aktuell sind nur sehr wenige wissenschaftliche Untersuchungen zu deliranten Syndromen bei intensivpflichtigen Kindern vorhanden. In diesen wenigen Untersuchungen war die Ermittlung tatsächlicher Prävalenzraten insbesondere dadurch erschwert, dass bisher kein, speziell für die pädiatrische Intensivstation (PITS) entwickeltes, valides Messinstrument für die Detektion eines Delirs vorhanden war. Mit der Confusion Assessment Method für die pädiatrische Intensivstation (pCAM-ICU) wurde nun erstmals ein Delir-Messinstrument speziell für die PITS in englischer Sprache entwickelt und validiert. Ziel dieser Studie war die richtlinienkonforme Übersetzung der ursprünglich für den angloamerikanischen Raum entwickelten pCAM-ICU aus dem Englischen ins Deutsche.
Methoden: Der Übersetzungsprozess erfolgte nach den international anerkannten Richtlinien der Translation and Cultural Adaptation of Patient Reported Outcomes Measures – Principles of Good Practice (PGP): aus drei unabhängig voneinander entstandenen Versionen der Vorwärtsübersetzung wurde eine vorläufige deutsche Fassung erarbeitet, die dann durch einen diplomierten, staatlich anerkannten Übersetzer ins Englische rückübersetzt wurde. Die rückübersetzte Version wurde dem Originalautor zur Bewertung vorgelegt. Die deutsche Vorwärtsübersetzung wurde von klinisch tätigem Fachpersonal mit Hilfe eines anonymen Evaluationsbogens in Form von Schulnoten („1 = sehr gut“ bis „6 = ungenügend“) hinsichtlich der Verständlichkeit von Sprache und Inhalt der Testitems bewertet.
Ergebnisse: Die englische Rückübersetzung der deutschen Vorwärtsübersetzung wurde durch den Originalautor genehmigt. Die Verständlichkeitsbeurteilung der einzelnen pCAM-ICU-Items in Bezug auf Sprache und Inhalt (“kognitives Debriefing”) war im Mittel „sehr gut“ bis „gut“. Damit konnte der Übersetzungsprozess erfolgreich abgeschlossen und die finale deutsche Version der pCAM-ICU verabschiedet werden.
Schlussfolgerung: Die deutsche Version der pCAM-ICU ist Resultat eines richtlinienkonformen Übersetzungsprozesses, der auch aufgrund der guten Resultate im Rahmen des kognitiven Debriefings mit dieser Arbeit erfolgreich finalisiert werden konnte.
To date, only a few studies have dealt with the occurrence of paediatric intensive care unit (PICU) delirium. The criteria of the revised fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) and the criteria of the International Statistical Classification of Diseases, 10th revision (ICD-10) are still the gold standard for diagnosing delirium , . Four recently published, prospective studies reported prevalences of delirium in critically ill children between 4.6–16.9%, diagnosed by an expert with gold standard criteria , , . Similar to delirium in critically ill adults, the prevalence rate of delirium in mechanical ventilated children of 23.5% is even higher compared to the prevalence in non-ventilated children .
Devlin and colleagues could demonstrate that the use of validated delirium assessment tools significantly increased the detection of delirium in the ICU . It was found that delirium detection by physicians showed the most significant improvement when using validated scores . Because of the known underdiagnosis of delirium when not using validated scores and due to the large number of prospective studies demonstrating that delirium significantly worsens outcome in the critically ill, guidelines recommend routine delirium monitoring in critically ill children . Last year, the pCAM-ICU, a delirium score specifically developed for use in the PICU, was published in English. The first validation study (n=68) revealed a sensitivity of 83% (CI 66–93%) and a specificity of 99% (CI 95–100%) when compared with DSM-IV-TR criteria as the gold standard .
The pCAM-ICU as well as the CAM-ICU for adult patients is based on the DSM-IV-TR criteria for delirium. The 4 test features of the pCAM-ICU summarise the DSM-IV-TR criteria and thereby transform them into a easy to use assessment tool for routine use in the ICU:
The systematic evaluation of sedation and delirium is a fundamental part of evidence based treatment for critically ill patients ,. Hence, the delirium assessment with the pCAM-ICU is part of the overall consciousness assessment. Consciousness is defined in two parts – arousal level plus content. The first step is to determine the level of consciousness with the Richmond Agitation Sedation Scale (RASS). Patients with a RASS of –4 to –5 should not be evaluated with the pCAM-ICU. However, at the lighter levels of consciousness (RASS >–4), the tester should continue with the delirium assessment, evaluating the content of consciousness performing the “Vigilance-A-Test” or “ASE-Picture-Test”. If the patient with a RASS of >–4 makes more than 3 errors, the feature "inattention" is positive (for any reason). The baseline mental status according to the pCAM-ICU is always the pre-hospital mental status of the patient. The ICU staff should get this information from the patients family and friends. A fluctuating course of mental status can often be determined with a fluctuation of the Glascow Coma Scale (GCS) or RASS within 24 hours.
The purpose of this study was the translation of the English pCAM-ICU into German according to international validated guidelines.
In 1999, after having reviewed 12 major sets of guidelines available for the translation and cultural adaptation, including the standards of the World Health Organisation, the Translation and Cultural Adaptation (TCA) group of the International Society for Pharmacoeconomics and Outcome Research (ISPOR) reached a consensus on how to translate and adapt assessment tools for the use in different countries. The results of this consensus are set out as “Translation and Cultural Adaptation of Patient Reported Outcomes Measures – Principles of Good Practice” . These guidelines of the TCA group are summarised in Table 1 (Tab. 1). The intention of a standardised translation and cultural adaptation process is in particular to achieve an unaltered transformation of the instrument that retains the intentions of the original author. Thus, test results in different countries are more comparable .
After receiving permission from the original author for the translation process physicians developed 3 independent forward translations of the pCAM-ICU (English → German). After reconciliation of the 3 forward translations one final forward translation was ready for back translation. The back translation (German → English) of the reconciled German translation into the source language was conducted by a registered state-approved translator who did not know the original version. The English back translation was than reviewed against the source language to ensure the conceptual equivalence of the translation. The back translation was also reviewed by the original author.
The newly translated measure underwent a cognitive debriefing. ICU nurses and physicians evaluated the final translation with the help of anonymously questionnaires. Each test feature had to be evaluated with respect to the comprehension of language and content (German grades: “1 = very good” to “6 = insufficient”). Furthermore there was a separate section within the questionnaire for any additional comments. After statistical analysis of the questionnaires the translation and cultural adaptation process was finalised.
The continuous variables from the cognitive debriefing are expressed as medians with interquartile range. Data were analysed, using Aabel, Version 3.0.6, 2012 Gigawiz Ltd. Co.
The English back translation of the German forward translation was approved by the original author of the pCAM-ICU.
The medians of the cognitive debriefing are shown in Table 2 (Tab. 2). The comprehension of language and content was ‘good’ to ‘very good’ for each of the translated test features (Figure 3 (Fig. 3)).
The expert team reviewed the results from the cognitive debriefing considering the comments of the nurses and physicians made within the questionnaires. Only minor errors which have been missed during the translation process had to be corrected. Due to the entirely good to very good results from the cognitive debriefing the translation and cultural adaptation process according to ISPOR guidelines could be successfully finalised. The German version of the pCAM-ICU was than adopted at the final meeting of the expert team (Figure 1 (Fig. 1) and Figure 2 (Fig. 2)).
This is the first published German translation of the pCAM-ICU. The translation and cultural adaptation process for Germany was performed according to international guidelines in cooperation with the original author of the pCAM-ICU.
Delirium in the PICU is still rarely diagnosed . The main cause for this is, that without a valid assessment tool, especially hypoactive delirium is often not detected.
Delirium in critically ill patients is characterised by a more acute onset compared to adult delirium. Moreover children with delirium have more severe perceptual disturbances, more intense hallucinations, more severe delusions, greater agitation, and more severe lability of mood but less severe cognitive deficits, less severe sleep-wake cycle disturbance, and less variability of symptoms over time . Delirium in adult ICU patients is associated with a significantly morbidity and mortality . Even though data on delirium in children are still limited, there is preliminary evidence for significantly worse outcome in children with delirium compared to children without delirium. A prospective study in ICU children could show that delirium was an independent risk factor for a longer ICU stay . The impact of delirium on mortality in children remains unclear. In a retrospective study on 84 paediatric patients Turkel and colleagues could show an increased mortality of 20% but without reaching a statistical significance due to the lack of a control group . A study done by Smeets and coworkers revealed an even lower mortality rate for children with delirium. These contradictory results need further investigations in future prospective studies. Nonetheless, because of the known negative outcome for adult patients with delirium and corresponding preliminary results in critically ill children, the German S3-guideline recommends routine delirium management in the PICU . This includes the identification of the underlying cause of delirium and an early symptom oriented therapy. On the one hand, children with hyperactive delirium are a safety hazard for themselves due to self removal of catheters and endotracheal tubes or by falling out of bed. On the other hand, the symptom complex of ICU delirium is a traumatic event for the patients and relatives. This may cause through metabolic stress a prolonged illness and can lead to a post traumatic stress disorder (PTSD) . In summary, paediatric delirium is a severe complication in critically ill children. A didactic staff member training on delirium and how to assess it with valid assessment tools significantly improves the ability and compliance of physicians and nurses to detect delirium and to detect it even earlier , . However, because of the different stages of cognitive development in children, assessment tools that have been validate in critically ill adults, cannot be necessarily be adopted for use in the PICU . To date, the pCAM-ICU is the only validated delirium score, exclusively developed for the detection of delirium in critically ill children aged 5 years or over. The pCAM-ICU was adapted from the CAM-ICU for adult patients. The 4 items of the pCAM-ICU refer to the DSM-IV-TR criteria for delirium which is currently the international accepted reference standard for paediatric delirium. The pCAM-ICU uses the four cardinal clinical features of delirium for diagnosis: fluctuation or an acute change in mental status, inattention, altered level of consciousness and disorganised thinking. The aim with the development of the pCAM-ICU was to allow an expeditious, valid and reliable assessment for clinical routine. The first validation study of the pCAM-ICU revealed good sensitivity (83%) und very good specificity (99%).
Beside the pCAM-ICU, 3 other assessment tools were examined for the detection of delirium in critically ill children: the Delirium Rating Scale (DRS) , the Delirium Rating Scale-Revised (DRS-R-98)  and the Pediatric Anesthesia Emergence Delirium (PAED) scale . A recently published study validated these 3 scores against the gold standard for delirium diagnosis (DSM-IV-TR). Including the results of 154 patients in data analysis, the PAED was the most rateable (94%) scale compared to DRS (67%) and DRS-R-98 (47%). The PAED scale revealed a sensitivity of 91% and a specificity of 98% . However, the assessments with the 3 different scores were performed by the same tester. Therefore, it is likely that the results of the second or third assessment were biased by the result of the first assessment. Furthermore, only 16% of the included patients were mechanically ventilated and only 15% received sedation. Particularly the evaluation for delirium in sedated and mechanically ventilated patients is often challenging. It might be that such specific instruments like the pCAM-ICU are advantageous when using in specific patient cohorts (e.g. sedated and mechanical ventilated ICU patients). The pCAM-ICU includes the examination of cognitive functions. In contrast, an assessment tool like the PAED scale focuses on the subjective evaluation of abnormal behaviour of the patient without including neurocognitive measures . The advantage of the PAED scale is that it can also be performed in patients under the age of 5. For patients under the age of 1, there is still no validated delirium score available.
This publication of the German pCAM-ICU provides the first delirium assessment tool for the use in German PICUs (patients aged 5 years and above). This is a result of a translation and cultural adaptation process in accordance with international recommended guidelines. This translation process creates the condition that will enable implementation of routine delirium monitoring in German PICUs. Further studies are needed for the validation of the pCAM-ICU in critically ill patients.
The authors declare that they have no competing interests.
Clemens de Grahl and Alawi Luetz contributed equally to this work. Clemens de Grahl died on 20.03.2012.