... ⸠Center of Respiratory Weaning and Rehabilitation, Auxilium Vitae, Volterra, .... ventilator-dependent patients: Call for action in specialized inpatient facilities.
Validation of the Multi-INdependence Dimensions (MIND) questionnaire for prolonged mechanically ventilated patients Javier Murcia¹, Joao C Winck², Hélène Gilet³, Peter Kalin⁴, Fabian Plano⁵, Antoine Regnault³, Michael Dreher⁶, Michele Vitacca⁷, Nicolino Ambrosino⁸ ¹ Division Homecare, Linde Healthcare, Bogota, Colombia, ² Linde AG, Linde Healthcare, Pullach, Germany, ³ Mapi HEOR & Strategic Market Access, Mapi, Lyon, France, ⁴ Linde Gas Therapeutics GmbH, Linde Healthcare, Oberschleissheim, Germany, ⁵ REMEO centre el Pilar, Linde Group, Argentina, ⁶ Department of Cardiology, Pneumology, Angiology and Intensive Care Medicine, University Hospital Aachen, Germany, ⁷ Respiratory and Rehabilitation Division, Fondazione S. Maugeri, IRCCS, Lumezzane, Italy, ⁸ Center of Respiratory Weaning and Rehabilitation, Auxilium Vitae, Volterra, Italy
Results
Background and Objectives
Methods
Evaluating the health status of patients with Prolonged Mechanical Ventilation (PMV) is of major importance to better define prognosis and to prescribe and evaluate results of multidisciplinary rehabilitation. However, no severity-of-illness scoring system has been specifically designed for patients under prolonged mechanical ventilation (PMV). A novel multi-disciplinary tool for healthcare professionals (HCPs) was developed from a Delphi panel and existing measures to address this gap. The Multi-INdependence Dimensions (MIND) questionnaire is a multi-dimensional tool consisting of 11 distinct PMV key areas of health assessment (Table 1). The items comprising the MIND questionnaire are routinely assessed in PMV rehabilitation settings and for completion only an oximeter and a peak flow meter are needed.
• Design: A longitudinal observational study was conducted in five REMEO® centres from Germany (Berlin and Mahlow), Colombia (Bogota and Medellin) and Argentina (El Pilar) belonging to an international network of facilities dedicated to weaning and management of post-ICU patients. • Study Population: All admitted patients (Table 2) with a recorded diagnosis, expected length of stay of more than 48 hours and providing informed consent.
The aim of the study was to assess the reliability and validity of the Multi-INdependence Dimensions (MIND) questionnaire for measuring the health status of PMV patients.
Table 1: Description of the MIND questionnaire
Table 2: Description of population
Component
Country (%) – N=128
Cognition Feeding/swallowing Sleep
Skin integrity Oxygenation Cough strength Secretion management Mobility Upper limb and lower limb strength Ventilator dependence Co-morbidities
Items Number of items 2 1 5
1 1 1 1 2 2 1 1
Item description Orientation, speech Feeding/swallowing Sleep depth, sleep latency, awakenings, return to sleep, sleep quality Skin integrity Oxygenation Cough strength Secretion management Sit to stand, stand to sit Upper limb strength, lower limb strength Ventilator dependence Co-morbidities
MIND = Multi-Independence Dimensions
• Evaluations: The study consisted of four parts in which MIND score as well as other validated scoring systems were measured in different timeframes (Figure 1). • Validation process: Consisted of three stages (Figure 2).
Figure 1: Validation study design overview
Baseline (Part I) • MIND questionnaire • MRC (Quadriceps and biceps) • SOFA • GCS • DNS • EQ-5D • HADS • Demographic and clinical data • Biomarker data
Age (years) – N=128 Gender (%) – N=128 Previous days of mechanical ventilation (days) – N=111 Primary diagnosis (%) – N=128
Use of (%) – N=128
Germany Colombia Argentina Mean (SD) Min – Max Male Mean (SD) Min – Max
Linde AG Linde Healthcare, Seitnerstrasse 70, 82049 Pullach, Germany
Day 1 (Part II) • MIND questionnaire • CGIC
Month 1 (Part III) • MIND questionnaire • CGIC
Discharge (Part IV) • MIND questionnaire • KATZ ADL • Weaning success
SOFA = Sequential Organ Failure Assessment, GCS = Glasgow Coma Scale, DNS = Dependence Nursing Scale, HADS = Hospital Anxiety and Depression Scale, CGIC = Clinical Global Impression of Change, ADL = Activities of daily living EQ-5D = EuroQol five dimensions questionnaire
Figure 2: Overview of Validation and Analysis Strategy 32.0 49.2 18.8 65.0 (16.5) 18.0 – 89.0 50.0
78.1 (134.9) 11.0 – 1025.0 Post-Acute Lung Injury 6.3 COPD/Chronic Lung Disease 34.4 Neuromuscular Disorders 18.8 Post-Operative 8.6 Cardiovascular Disorders 9.4 Trauma (Spinal Cord and Head Injury) 5.5 Cerebrovascular Disorders 10.9 Other 6.3 Non-invasive ventilation 6.3 Invasive ventilation 90.6 Tracheostomy collar 3.1
Stage 1
Stage 2
Stage 3
Specification of components • Description of item responses. • Specification of multi-item components. • Calculation of component scores. Composite score creation • Simple score. • Weighted score. • Short-form score. Validation of components and composite scores • Test-retest reliability. • Clinical validity. • Ability to detect change.
Stage 1 Specification of components • Item responses: There were no missing data for any of the 18 MIND items at all three timepoints of collection. • Specification of multi-item components: Internal consistency reliability was supported for the multi-item components. In Mobility the items were very highly correlated suggesting item redundancy (inter-item correlation 0.98). The “Stand to sit” item was removed. In the 5-item Sleep component, the “Sleep latency” item was found to be weakly correlated to the other four items (-0.20 to 0.01), and to highly decrease Cronbach’s alpha (from 0.90 to 0.72). The “Sleep latency” item was removed. • Calculation of component scores: Component scores were calculated as the mean of items within each component.
Stage 3 Validation of components and composite scores
Figure 3: Mean MIND score (+/- SEM) by MRC scale (quadriceps and biceps), SOFA and GCS classification
• Test-retest reliability: All MIND scores showed good test-retest reliability: Intraclass Correlation Coefficient greater than 0.82 were observed for all composite scores, indicating good testretest reliability (see Table 3). • Construct validity: All MIND scores correlated meaningfully with MRC score, SOFA, DNS, GCS and EQ-5D, supporting their validity (see Figure 3). • Ability to detect change: Ability to detect improvement at 30 days confirmed for all scores. Patients classed as improved from baseline had a mean 6.1 point higher MIND full version score at day 30 compared to baseline, corresponding to a moderate-large effect size (0.7). Prediction of deterioration of clinical status at 30 days unconfirmed (see Table 4).
Stage 2 Creation of a composite score • Simple score: Scores for all components were summated to form a single MIND score. • Weighted score: Weighting of the components (univariable regression coefficients with patient-rated quality of life EQ-5D Visual Analogue ScaleVAS) showed no clear sign of superiority. • Short-form score: Components were included only if they were significantly associated with EQ-5D VAS (p＜0.05) in a multiple regression model. The short form score contained two components: Feeding/swallowing and Cough strength. Table 3: Results, Test-retest Reliability 11-component composite 2-component composite
MIND score Simple summation Weighted summation Simple summation Weighted summation
ICC 0.89 0.83 0.83 0.84
1 (worst) 40
2
3 (best)
p < 0.001
p < 0.001
p < 0.001
p < 0.001
MRC quadriceps scale (0–2/3/4–5)
MRC biceps scale (0–2/3/4–5)
SOFA (3–8/0–2)
GCS (1–8/9–12/ 13–15)
30 20 10 0
SEM = Standard error of the mean; MIND = Multi-INdependence Dimensions; MRC = Medical Research Council; SOFA = Sequential Organ Failure Assessment; GCS = Glasgow Coma Scale
Table 4: Summary results, MIND Composite scores MIND Composite score 11-components (full version)
Stage 2 Calculation Simple summation
Stage 3 Components Test-retest 11 Passed
Weighted summation
11
Passed
2-components (short-form)
Simple summation
2
Passed
Weighted summation
2
Passed
Clinical validity DNS, VAS, HADS, MRC, SOFA, GCS DNS, VAS, HADS, MRC, SOFA, GCS DNS, VAS, HADS, MRC, SOFA, GCS DNS, VAS, HADS, MRC, SOFA, GCS
Detect change Passed
Decision Validated score
Passed
Drop candidate score
Passed
Validated score (short-form)
Passed
Drop candidate score
DNS = Dependence Nursing Scale, VAS = EQ-5D VAS, HADS = Hospital Anxiety and Depression Scale (both scales), MRC = Quadriceps and biceps scales, SOFA = Sequential Organ Failure Assessment, GCS = Glasgow Coma Score, KATZ = KATZ Index of Independence in Activities of Daily Living, Weaning = Weaning success at 30 days,
ICC = Intraclass correlation coefficient. Recommended threshold: ICC > 0.7 (highlighted)
Conclusion
The Delphi panel identified areas that are not covered by other routinely used assessment tools. The final MIND scores showed good reliability and validity, in particular to detect differences between known health states using a variety of specific health status measures (MRC, SOFA and GCS). In addition, it proved to be able to detect improvement over time.
This multi-national validation study included a heterogeneous population of PMV patients typical of those admitted to weaning facilities. However, additional research is required to evaluate the feasibility of using this instrument in other groups of patients, e.g. PMV patients living at home, and to test its responsiveness to multi-disciplinary rehabilitation programs.
The MIND questionnaire provides a comprehensive assessment of the multiple dimensions characterising the health status of PMV patients, and may be adopted as the appropriate test to evaluate patients under PMV.
COPD = Chronic Obstructive Pulmonary Disease References MacIntyre, N.R., et al., Management of patients requiring prolonged mechanical ventilation: report of a NAMDRC consensus conference. Chest, 2005. 128(6): p. 3937-54.
Carson, S.S. and P.B. Bach, Predicting mortality in patients suffering from prolonged critical illness: an assessment of four severity-of-illness measures. Chest, 2001. 120(3): p. 928-33. Pandian, V., et al., Development and validation of a quality-of-life questionnaire for mechanically ventilated ICU patients. Crit Care Med, 2015. 43(1): p. 142-8. Rose, L., et al., Psychological wellbeing, health related quality of life and memories of intensive care and a specialised weaning centre reported by survivors of prolonged mechanical ventilation. Intensive Crit Care Nurs, 2014. 30(3): p. 145-51. Winck, J., R. Camacho, and N. Ambrosino, Multidisciplinary rehabilitation in ventilator-dependent patients: Call for action in specialized inpatient facilities. Rev Port Pneumol (2006), 2015 21 (6): p.334–340
Acknowledgements The authors thank the contribution of the Local Clinical Investigators who provided and cared for the study patients, and collected data: Alejandra Ceballos, Marcela Botero, Sandra Hernandez and Milena Rozo (REMEO® Colombia), Felipe Alvarez Preciado and Jose Luis Soto (REMEO® Argentina), and Christoph Unger (REMEO® Germany). Thomas Guttenberger (Linde IS/Global Healthcare Strategy & Processes, Germany) designed data collection tools and monitored collection and management of data for the trial. Paul Williams (Mapi) contributed to the statistical analyses, interpretation of results and assistance in medical writing. Martin Kubitschek (Global Head REMEO®) for his support and contribution to this study.
