The paediatric Confusion Assessment Method for the Intensive Care Unit (pCAM-ICU): translation and cognitive debriefing for the German-speaking area.
ABSTRACT: 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.
Project description:<b>Objectives: </b>The primary objective of this study was to develop the Japanese version of the Patient Centred Assessment Method (PCAM) and its user guide. The secondary objective was to examine the validity and reliability in the primary care setting.<br><br><b>Design: </b>Cross-sectional study.<br><br><b>Setting: </b>Three family physician teaching clinics located in urban residential areas in Tokyo, Japan.<br><br><b>Participants: </b>Patients who were aged 20 years or older, and who had an appointment with physicians at the three participating clinics.<br><br><b>Main outcome measures: </b>Patient complexity measured by PCAM and complexity/burden level measured by a Visual Analogue Scale (VAS).<br><br><b>Results: </b>Although confirmatory factor analysis using a model described in a previous study revealed that the indices did not meet the criteria for good fit, exploratory factor analysis revealed a new three-factor structure of 'Personal well-being,' 'Social interaction' and 'Needs for care/service.' Cronbach's alpha of PCAM was 0.86. Spearman's rank correlation coefficients between PCAM scores and VAS scores were 0.51 for complexity (p<0.001) and 0.41 for burden (p<0.001). There were 42 patients (14.3% of total patients) with PCAM scores greater than its mean of 16.5 but with complexity VAS scores less than its mean of 20.8.<br><br><b>Conclusions: </b>The Japanese version of PCAM and its user guide were developed through Japanese translation and cultural adaptation by cognitive debriefing. PCAM is a valid and reliable tool to assess patient complexity in the primary care settings in Japan. Additionally, although the correlation between total PCAM scores and complexity/burden as assessed by VAS was moderate, PCAM can more precisely identify patient complexity than skilled physician's intuition.
Project description:Delirium is associated with various negative clinical outcomes, such as decline in cognitive ability, increased length of hospital stay, and higher mortality. For these reasons, early diagnosis of delirium is critical. Unfortunately, there are no reliable diagnostic criteria or tool of delirium for infants and preschool-aged children in Japan.The aim of the present study was to translate a new delirium assessment tool, the Preschool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU), for accurately diagnosing clinically ill infants and preschool-aged children, from English to Japanese.The translation was undertaken with the internationally established back-translation method. The translation was repeated blindly and independently by eight medical researchers and clinicians from multiple disciplines. Any discrepancy evident from the translated works was discussed and resolved.We report the successful development of the Japanese version of psCAM-ICU. However, before its full application, this diagnostic tool requires further testing and study, most notably for its validation and reliability.A Japanese version of the psCAM-ICU was developed.
Project description:Debriefing is essential for effective learning during simulation-based medical education. To assess the quality of debriefings, reliable and validated tools are necessary. One widely used validated tool is the Objective Structured Assessment of Debriefing (OSAD), which was originally developed in English. The aim of this study was to translate the OSAD into German, and to evaluate the reliability and validity of this German version (G-OSAD) according the 'Standards of Educational and Psychological Measurement'. In Phase 1, the validity evidence based on content was established by a multistage cross-cultural adaptation translation of the original English OSAD. Additionally, we collected expert input on the adequacy of the content of the G-OSAD to measure debriefing quality. In Phase 2, three trained raters assessed 57 video recorded debriefings to gather validity evidence based on internal structure. Interrater reliability, test-retest reliability, internal consistency, and composite reliability were examined. Finally, we assessed the internal structure by applying confirmatory factorial analysis. The expert input supported the adequacy of the content of the G-OSAD to measure debriefing quality. Interrater reliability (intraclass correlation coefficient) was excellent for the average ratings (three raters: ICC = 0.848; two raters: ICC = 0.790), and good for the single rater (ICC = 0.650). Test-retest reliability was excellent (ICC = 0.976), internal consistency was acceptable (Cronbach's ? = 0.865), and composite reliability was excellent (? = 0.93). Factor analyses supported the unidimensionality of the G-OSAD, which indicates that these G-OSAD ratings measure debriefing quality as intended. The G-OSAD shows good psychometric qualities to assess debriefing quality, which are comparable to the original OSAD. Thus, this G-OSAD is a tool that has the potential to optimise the quality of debriefings in German-speaking countries.
Project description:OBJECTIVE: Medical students encounter specific stressors during their studies. As a result, they develop anxiety, depression and burnout symptoms more frequently than their similarly aged, but employed counterparts. In 1984, Vitaliano et al. published a 13-item instrument for the measurement of stress specific to medical school: the "Perceived Medical School Stress Instrument" (PMSS). Since then, it has been widely applied and validated in English-speaking countries. No German version of the PMSS exists to date. Thus, our aim was to translate the instrument into the German language in order to be able to measure medical school stress in German-speaking countries. METHOD: The items of the PMSS were translated into German by three separate researchers. The resulting translations were compared and combined with each other to establish a first German version of each item in the PMSS. These items were then translated back into English by two native English speakers to validate the correct primary translation. Based on a revised German version, a cognitive debriefing with 19 German medical students and a theoretical testing on 169 German medical students, the final German translations for each of the 13 items were determined. RESULTS: The PMSS was easily translated into German and there was a high congruency between the primary translations into German and the secondary translations back into English. Incongruities between the translations were solved quickly. The assessment of the German equivalent of the PMSS showed good results regarding its reliability (Cronbach's Alpha 0.81). CONCLUSION: A German version of the PMSS is now available for measuring the medical school related stress in German-speaking countries.
Project description:To determine the costs associated with delirium in critically ill children.Prospective observational study.An urban, academic, tertiary-care PICU in New York city.Four-hundred and sixty-four consecutive PICU admissions between September 2, 2014, and December 12, 2014.None.All children were assessed for delirium daily throughout their PICU stay. Hospital costs were analyzed using cost-to-charge ratios, in 2014 dollars. Median total PICU costs were higher in patients with delirium than in patients who were never delirious ($18,832 vs $4,803; p < 0.0001). Costs increased incrementally with number of days spent delirious (median cost of $9,173 for 1 d with delirium, $19,682 for 2-3 d with delirium, and $75,833 for > 3 d with delirium; p < 0.0001); this remained highly significant even after adjusting for PICU length of stay (p < 0.0001). After controlling for age, gender, severity of illness, and PICU length of stay, delirium was associated with an 85% increase in PICU costs (p < 0.0001).Pediatric delirium is associated with a major increase in PICU costs. Further research directed at prevention and treatment of pediatric delirium is essential to improve outcomes in this population and could lead to substantial healthcare savings.
Project description:Delirium is a form of acute cerebral dysfunction and is associated with increased length of hospital stay, mortality, and health-care costs for adult patients in intensive care. However, in Japan, there are currently no reliable criteria or tools for diagnosing delirium in critically ill pediatric patients. The purpose of this study was to translate the Cornell Assessment of Pediatric Delirium (CAPD)-a screening tool for pediatric delirium-from English to Japanese for use in the diagnosis of delirium for pediatric patients in pediatric intensive care units.The back-translation method was used to ensure equivalence in the Japanese version of the CAPD and its accompanying developmental anchor points. The translation process was repeated by a multidisciplinary committee of medical researchers and clinicians.The final back-translated version of the CAPD was submitted to the original author, who gave her approval.The Japanese CAPD was developed and its effectiveness tested using a standardized procedure. Further study is required to test the validity and reliability of the Japanese version of the CAPD.
Project description:BACKGROUND:One third of patients admitted to an intensive care unit (ICU) will develop delirium. However, delirium is under-recognized by bedside clinicians without the use of delirium screening tools, such as the Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU was updated in 2014 to improve its use by clinicians throughout the world. It has never been validated compared to the new reference standard, the Diagnostic and Statistical Manual of Mental Disorders 5th version (DSM-5). METHODS:We made a prospective psychometric study in a 16-bed medical-surgical ICU of a French academic hospital, to measure the diagnostic performance of the 2014 updated CAM-ICU compared to the DSM-5 as the reference standard. We included consecutive adult patients with a Richmond Agitation Sedation Scale (RASS) ? -3, without preexisting cognitive disorders, psychosis or cerebral injury. Delirium was independently assessed by neuropsychological experts using an operationalized approach to DSM-5, by investigators using the CAM-ICU and the ICDSC, by bedside clinicians and by ICU patients. The sensitivity, specificity, positive and negative predictive values were calculated considering neuropsychologist DSM-5 assessments as the reference standard (primary endpoint). CAM-ICU inter-observer agreement, as well as that between delirium diagnosis methods and the reference standard, was summarized using ? coefficients, which were subsequently compared using the Z-test. RESULTS:Delirium was diagnosed by experts in 38% of the 108 patients included for analysis. The CAM-ICU had a sensitivity of 83%, a specificity of 100%, a positive predictive value of 100% and a negative predictive value of 91%. Compared to the reference standard, the CAM-ICU had a significantly (p < 0.05) higher agreement (? = 0.86 ± 0.05) than the physicians,' residents' and nurses' diagnoses (? = 0.65 ± 0.09; 0.63 ± 0.09; 0.61 ± 0.09, respectively), as well as the patient's own impression of feeling delirious (? = 0.02 ± 0.11). Differences between the ICDSC (? = 0.69 ± 0.07) and CAM-ICU were not significant (p = 0.054). The CAM-ICU demonstrated a high reliability for inter-observer agreement (? = 0.87 ± 0.06). CONCLUSIONS:The 2014 updated version of the CAM-ICU is valid according to DSM-5 criteria and reliable regarding inter-observer agreement in a research setting. Delirium remains under-recognized by bedside clinicians.
Project description:INTRODUCTION:Delirium is frequently observed in the intensive care unit (ICU) population, in particular. Until today, there is no evidence for any reliable pharmacological intervention to treat delirium. The Basel BOMP-AID (Better Outcome with Melatonin compared to Placebo Administered to normalize sleep-wake cycle and treat hypoactive ICU Delirium) randomised trial targets improvement of hypoactive delirium therapy in critically ill patients and will be conducted as a counterpart to the Basel ProDex Study (Study Protocol, BMJ Open, July 2017) on hyperactive and mixed delirium. The aim of the BOMP-AID trial is to assess the superiority of melatonin to placebo for the treatment of hypoactive delirium in the ICU. The study hypothesis is based on the assumption that melatonin administered at night restores a normal circadian rhythm, and that restoration of a normal circadian rhythm will cure delirium. METHODS AND ANALYSIS:The Basel BOMP-AID study is an investigator-initiated, single-centre, randomised controlled clinical trial for the treatment of hypoactive delirium with the once daily oral administration of melatonin 4?mg versus placebo in 190 critically ill patients. The primary outcome measure is delirium duration in 8-hour shifts. Secondary outcome measures include delirium-free days and death at 28 days after study inclusion, number of ventilator days, length of ICU and hospital stay, and sleep quality. Patients will be followed after 3 and 12 months for activities of daily living and mortality assessment. Sample size was calculated to demonstrate superiority of melatonin compared with placebo regarding the duration of delirium. Results will be presented using an intention-to-treat approach. ETHICS AND DISSEMINATION:This study has been approved by the Ethics Committee of Northwestern and Central Switzerland and will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use; Good Clinical Practice (GCP) or ISO EN 14155 (as far as applicable), as well as all national legal and regulatory requirements. Study results will be presented in international conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03438526. PROTOCOL VERSION:Clinical Study Protocol Version 3, 10.03.2019.
Project description:Background:Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients. Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives. Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.The use of non-pharmacologic interventions has been recommended by sedation guidelines. However, non-pharmacological measures in PICU, including music and noise reduction, have been inadequately studied. Methods:The Music Use for Sedation in Critically ill Children (MUSiCC trial) pilot study is an investigator-initiated, three-arm, randomized controlled trial (RCT) on the use of music for sedation in PICU. The main goal of the study is to demonstrate feasibility of a music trial in PICU and to obtain the necessary information to plan a larger trial. The study compares music versus noise cancelation versus control in sedated and mechanically ventilated children admitted to PICU. In the music group, children receive the music (modified classical music) three times a day for 30?min at a time. Music is delivered with noise cancelation headphones. The noise cancelation group receives the same intervention but with a no music (sham playlist). The control group receives usual care with no specific intervention. Children remain in the study until extubation or a maximum of 7?days. The primary outcomes of the study are feasibility and sedation/analgesia requirements. Secondary outcomes include change in vital signs before and during the intervention, ICU delirium, and adverse effects related to the intervention. The estimated sample size is 20 subjects per group for a total of 60 children. Discussion:Despite being recommended by current guidelines, evidence to support the use of music in PICU is lacking. Music has the potential to reduce sedation requirements and their negative side effects. This pilot RCT will demonstrate feasibility and provide the necessary information to plan a larger trial focusing on the effectiveness of the intervention. Trial registration:The study was registered at ClinicalTrials.gov (NCT03497559) on April 13, 2018.
Project description:BACKGROUND/OBJECTIVES:Delirium is a neurobehavioural disturbance that frequently develops particularly in the intensive care unit (ICU) population. It was first described more than half a century ago, where it was already discovered as a state that might come along with serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. However, in most cases, there is still lack of proof for causal relationship. Its presence frequently remains unrecognised due to suggested predominance of the hypoactive form. Furthermore, in the general ICU population, it has been shown that the duration of delirium is associated with worse long-term cognitive function. Due to the multifactorial origin of delirium, we have several but no incontestable treatment options. Nonetheless, delirium bears a high burden for patient, family members and the medical care team.The Basel ProDex Study targets improvement of hyperactive and mixed delirium therapy in critically ill patients. We will focus on reducing the duration and severity of delirium by implementing dexmedetomidine into the treatment plan. Dexmedetomidine compared with other sedatives shows fewer side effects representing a better risk profile for delirium treatment in general. This could further contribute to higher patient safety.The aim of the BaProDex Trial is to assess the superiority of dexmedetomidine to propofol for treatment of hyperactive and mixed delirium in the ICU. We hypothesise that dexmedetomidine, compared with propofol administered at night, shortens both the duration and severity of delirium. METHODS/DESIGN:The Basel ProDex Study is an investigator-initiated, one-institutional, two-centre randomised controlled clinical trial for the treatment of delirium with dexmedetomidine versus propofol in 316 critically ill patients suffering from hyperactive and mixed delirium. The primary outcome measure is delirium duration in hours. Secondary outcomes include delirium-free days at day 28, death at day 28, delirium severity, amount of ventilator days, amount of rescue sedation with haloperidol, length of ICU and hospital stay, and pharmaceutical economic analysis of the treatments. Sample size was estimated to be able to show the superiority of dexmedetomidine compared with propofol regarding the duration of delirium in hours. The trial will be externally monitored according to good clinical practice (GCP) requirements. There are no interim analyses planned for this trial. ETHICS AND DISSEMINATION:This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the International Conference on Harmonization- Good Clinical Practice (ICH-GCP) or Europäische Norm International Organization for Standardization (ISO EN 14155; as far as applicable) as well as all national legal and regulatory requirements. Only the study team will have access to trial specific data. Anonymisation will be achieved by a unique patient identification code. Trial data will be archived for a minimum of 10 years after study termination. We plan to publish the data in a major peer-reviewed clinical journal. TRIALS REGISTRATION:ClinicalTrials.gov Identifier: NCT02807467 PROTOCOL VERSION: Clinical Study Protocol Version 2, 16.08.2016.