THE LONG TERM PSYCHOLOGICAL EFFECTS OF DAILY SEDATIVE INTERRUPTION IN CRITICALLY ILL PATIENTS

Transcription

1 THE LONG TERM PSYCHOLOGICAL EFFECTS OF DAILY SEDATIVE INTERRUPTION IN CRITICALLY ILL PATIENTS John P. Kress, MD, Brian Gehlbach, MD, Maureen Lacy, PhD, Neil Pliskin, PhD, Anne S. Pohlman, RN, MSN, and Jesse B. Hall, MD ONLINE DATA SUPPLEMENT 24

2 Methods Online Supplement Patients queried about recollection of ICU experiences Patients were recruited by mail followed by a telephone call. During the initial phone call, all subjects were asked if they were aware of a previous ICU admission requiring mechanical ventilation ( a breathing machine ). They were also asked at which hospital this experience occurred. Those who passed this preliminary cognitive screen by answering correctly were invited to participate. All patients were further screened during the face to face interview by determining that they were able to read the various test questionnaires a screen that all patients who were interviewed were able to pass. All patients were initially asked if they recalled being in the ICU. Those with ICU recall were subsequently questioned for spontaneous recall ( What exactly do you recall? ) as well as cued recall (multiple choice questions). Patients were asked whether they remembered being awakened in the ICU. The experience of awakening was based on an answer to the question: Do you remember being awakened from sleep in the ICU? Those who recalled being awakened in the ICU were asked if they were instructed to do anything when being awakened. This was done in the form of a multiple choice question [ Did the doctor ask you to do anything? : A.) Stick out tongue, B.) Sing, C.) Squeeze hand, D.) Raise feet, E.) Close eyes, F.) Stand up), with some of the choices being those routinely assessed as a part of the wake up assessment during daily sedative interruption at our institution (e.g. stick out tongue, squeeze hand) while others were not (e.g. sing, raise feet, close eyes, stand up) (E1). Psychological evaluation Impact of Events Scale 25

3 This scale uses a 15 item self-report questionnaire that measures stress symptoms present in the last week. Each question is scaled from zero ( not at all ) to four ( often ), with higher scores correlating with worse psychological response to a traumatic or stressful event. This scale assesses: 1.) Avoidance behaviors (8 questions) and intrusive thoughts (7 questions). The items from the subscales are combined to create a total Impact of Events Score, with between group comparisons made by Students t test. Scores for the total Impact of Events Score are categorized as follows: -8 Subclinical range; 9-25 Mild range; Moderate range; > 44 Severe range. It is recommended that patients with scores in the Moderate or Severe range receive psychiatric intervention. Internal consistency coefficients range from.79 to.9 for the subscales. The intrusion and avoidance subscales are correlated, but assess distinct concepts. The Impact of Events Score has been shown to be sensitive to change over time and discriminates traumatized from nontraumatized samples (E6) Medical Outcomes Study 36 Item Short-Form Health Survey (SF-36) The SF-36 queries patients regarding eight health concepts, which include: (1) physical functioning (1 questions), (2) role limitations due to physical health problems (4 items), (3) bodily pain (2 items), (4) general health self-assessment (5 questions), (5) vitality (4 questions assessing energy/fatigue), (6) social functioning (2 questions), (7) role limitations due to emotional problems (3 questions), and (8) mental health (5 questions assessing psychological distress and psychological well-being). Scale scores are computed by summing the items from each domain. This raw score is subtracted from the lowest possible raw score and then divided by the possible raw score range. This number is then multiplied by 1, to create a Transformed 26

4 SF-36 score based on a -1 scale: [(Lowest score possible in a domain) - Score obtained / 25*] X 1. *(Range of possible scores one can obtain in a domain is 5 to 3 points = 25). This transformation converts the lowest possible scores to zero and highest possible scores to 1. SF-36 items and scales are scored so that higher scores correlate with better health state. Means and standard deviations of transformed SF-36 scores for the general US population are as follows: Physical Functioning (84.2 ± 23.3), Role Functioning (81 ± 34), Bodily Pain (75.2 ± 23.7), General Health (72 ± 2.3), Vitality (6.9 ± 21.), Social Functioning (83.3 ± 22.7), Role-Emotional (81.3 ± 33), and Mental Health (74.7 ± 18). The reliability and validity of this health outcome measure has been well documented. (E2). The SF-36 has also been shown to correlate with other measures of quality of life (E3). The State-Trait Anxiety Inventory The State-Trait Anxiety Inventory has been used extensively in research and clinical practice. The State-Trait Anxiety Inventory Manual provides significant data supporting the reliability and validity of this measure (E4). The first 2 questions in this test assess acute or state anxiety and require the respondent to report how they are feeling right now. For each item, the respondent records the intensity of their feelings: 1) not at all, 2) somewhat 3) moderately so or 4) very much so. After the state anxiety questions, a series of 2 questions assessing chronic or trait characteristics are asked. This portion of the analysis requires the respondent to report how he or she generally feels. In answering the trait questions, respondents must rate the frequency of their feelings of anxiety using the following scale: 1) almost never 2) sometimes 3) often or 4) almost always. Each of the 4 questions is given a weighted 27

5 score of 1 to 4 based on the scaled answers noted above. Scores for both the State Anxiety and Trait Anxiety scales can range from a minimum of 2 (low anxiety) to a maximum of 8 (high anxiety). These raw scores were then converted to percentile rankings (mean of ) compared to a sample of healthy adults. As such, a percentile score of is considered normal. Responses to the State-Trait Anxiety Index were compared to a national sample to determine percentile rankings. Clinically, patients who endorse symptoms one standard deviation above the mean are considered to be experiencing a significance level of anxiety. Scores above 84% are one standard deviation above the normal mean score of % and considered indicative of a clinical intensity (State) or frequency (Trait) of anxiety. The Beck Depression Inventory-2 The Beck Depression Inventory-2 consists of 21 questions, each rated on a scale from zero to three (maximal score is 63). Scores on this test are broken down as follows: 1 to 1 normal, 11 to 16 mild mood disturbance, 17 to 2 borderline clinical depression, 21 to 3 moderate depression, 31 to 4 severe depression, over 4 extreme depression. A score of 17 has been recommended as the cutoff score for depression. The Beck Depression Inventory-2 is highly correlated with other measures assessing depression including: The Beck Hopelessness Scale (r =.68), The Hamilton Psychiatric Rating Scale for Depression (r =.71) and the Scale for Suicide Ideation (r =.37) (E5). This measure has also shown to have solid diagnostic discriminative ability (p <.1), between mood disorders and anxiety and adjustment conditions. Psychosocial Adjustment to Illness Scale (PAIS) 28

6 The Psychosocial Adjustment to Illness Scale (PAIS) is a brief multi-domain interview designed to assess a patient s psychosocial adjustment to a current medical illness, or the sequelae of a prior illness. All norms are represented in terms of normalized area T-scores, giving each T- score a true percentile-based equivalent. In this normative method, a T-score of represents the th percentile of the normative distribution. A T-score of 6 is one standard deviation above the mean, placing the respondent at the 84 th percentile of the adjustment norm. Scores greater than 6 should be considered marginally clinically significant, and scores greater than or equal to 63 should be considered to be clearly signaling significant problems of psychological adjustment. This frequently used measure of adjustment in medically ill adults has shown good reliability (Coefficient alpha of.87), internal consistency across scales (. to.86) and high correlations with other adjustment measures (E7, E8). This test evaluates several domains of psychosocial adjustment, which include: 1.) Health Care Orientation (attitudes about health care, quality of health information, patient expectations), 2.) Vocational Environment (perceived quality of vocational performance, vocational satisfaction, lost time, vocational interest, quality of adjustment in the work sphere), 3.) Domestic Environment (family living, financial impact of illness, family communication, quality of relationships), 4.) Sexual Relationships (sexual interest, frequency, performance, satisfaction), 5.) Extended Family Relationships (impact of illness on communication, quality of relationships, interest in interacting with family), 6.) Social Environment (current social and leisure time activities), and 7.) Psychological Distress (dysphoric thoughts and feelings). The sum total of all seven domains is reported as the PAIS total score. Higher scores on this test correlate with poorer psychosocial adjustment to illness. 29

7 Online References E1. Kress JP, O'Connor MF, Pohlman AS, Olson D, Lavoie A, Toledano A, Hall JB. Sedation of critically ill patients during mechanical ventilation. A comparison of propofol and midazolam. Am J Respir Crit Care Med 1996;153: E2. Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992;35: E3. Ware JJ, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care 1992;3: E4. Spielberger CD. State-Trait Anxiety Inventory: Sampler Set Manual, Test, Scoring Key Redwood, California: Mind Spring. E5. Beck AT, Steer RA, and Brown G. BDI-II Manual San Antonio, Texas: The Psychological Corporation. E6. Briere J. Psychological assessment of adult posttraumatic states Washington, D.C.: American Psychological Association. E7. Rodrigue JR, Kanasky WF, Jackson SI, Perri MG. The Psychosocial Adjustment to Illness Scale: Factor structure for adult organ transplant candidates Psychological Assessment 2;12: E8. Derogatis Psychological Test site. 3

8 Figure Legends Figure 1e. Individual Patient Distribution of Overall Impact of Events Scores Figure 2e. Individual Patient Distribution of Impact of Events Avoidance Subscale Scores Figure 3e. Individual Patient Distribution of Impact of Events Intrusive Thoughts Subscale Scores Figure 4e. Individual Patient Distribution of SF-36 Physical Functioning Scores Figure 5e. Individual Patient Distribution of SF-36 Role Physical Scores Figure 6e. Individual Patient Distribution of SF-36 Bodily Pain Scores Figure 7e. Individual Patient Distribution of SF-36 General Health Scores Figure 8e. Individual Patient Distribution of SF-36 Vitality Scores Figure 9e. Individual Patient Distribution of SF-36 Role Emotional Scores Figure 1e. Individual Patient Distribution of SF-36 Social Functioning Scores Figure 11e. Individual Patient Distribution of SF-36 Mental Health Scores 31

9 Figure 12e. Individual Patient Distribution of State-Trait Anxiety Inventory State Anxiety Scores Figure 13e. Individual Patient Distribution of State-Trait Anxiety Inventory Trait Anxiety Scores Figure 14e. Individual Patient Distribution of Beck Depression Inventory Scores Figure 15e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Total Scores Figure 16e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Health Care Orientation Scores Figure 17e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Vocational Environment Scores Figure 18e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Domestic Environment Scores Figure 19e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Sexual Relationship Scores Figure 2e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Extended Family Scores 32

10 Figure 21e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Social Environment Scores Figure 22e. Individual Patient Distribution of Psychosocial Adjustment to Illness Scale Psychological Distress Scores 33

11 Results Online Supplement Table 1e. Baseline Characteristics of All Interviewed vs. All Lost-to-Follow-Up All All Lost to Difference in means P Interviewed Follow Up (95% CI) value N Age 47.3 ± ± (-19.5 to -4.3).3 Sex 2F/12M 34F/39M.2 APACHE II score 18.1 ± ± (-4.6 to.6).13 Hospital length of stay (days) 18. ± ± (-5.9 to 3.8).66 ICU length of stay (days) 1.5 ± ± (-4.8 to 2.7).49 Duration of mechanical 8.3 ± ± (-3.6 to 2.7).84 ventilation (days) 34

12 Table 2e. Baseline Characteristics of Patients Interviewed vs. Lost-to-Follow- Up Lost Difference in means P Interviewed to Follow Up (95% CI) value N Age 47.2 ± ± (-25.5 to -5.1).7 Sex 11F/8M 19F/2M.71 APACHE II score 18.4 ± ± (-5.1 to 2.4).48 Hospital length of stay (days) 19.3 ± ± (-8.7 to 5.).59 ICU length of stay (days) 12.8 ± ± (-5.9 to 4.9).78 Duration of mechanical 9.6 ± ± (-5.2 to 4.1).93 ventilation (days) 35

13 Table 3e. Baseline Characteristics of Patients Interviewed vs. Lost-to- Follow-Up Difference in P value Interviewed Lost to means (95% CI) Follow Up N Age 49.5 ± ± (-21.6 to 3.4).15 Sex 9F/4M 15F/19M.19 APACHE II score 16.2 ± ± (-6.8 to.3).7 Hospital length of stay (days) 17.6 ± ± (-7.7 to 5.8).78 ICU length of stay (days) 6.9 ± ± (-7.8 to 2.3).22 Duration of mechanical 5.6 ± ± (-5.1 to 2.8).36 ventilation (days) 36

14 Table 4e. Baseline Characteristics of All Enrolled in Original Sedative Interruption Study vs. All Contemporaneous (not in Original Sedative Interruption Study) Patients All Enrolled All Difference in P in Original Contemporaneous means (95% CI) value Study N 75 3 Age 57.4 ± ± (-3.5 to 13.3).21 Sex 4F/35M 14F/16M.69 APACHE II score 19. ± ± (-4.5 to 1.).21 Hospital length of stay 18.5 ± ± (-6.9 to 3.4).22 (days) ICU length of stay (days) 1.9 ± ± (-4.7 to 2.3).2 Duration of mechanical 8.1 ± ± (-5.3 to 1.4).12 ventilation (days) 37

15 Table 5e. Sedative, Opiate and Neuromuscular Blocking Agent Data Difference in means (95% CI) P value N MSO 4 (mg/kg/hr).5 ±.5.6 ± (-.4 to.4).88 MSO 4 (total mg) ± ± ( to 3.6).64 Midazolam (mg/kg/hr).11 ±.8.7 ±.7.4 (-.6 to.13).38 Midazolam (total mg) ± ± ( to 116.2).62 Propofol (mcg/kg/minute) 44.3 ± ± (-2.1 to 31.7).64 Propofol (total mg) 33, , ,1.6 (-8,292.9 to.8 ± 24,.3 ± 13, ,314.1) Neuromuscular blockade (all received cisatracurium) (N) 38

16 Figure 1e Overall Impact of Events Scores 6 Score Figure 2e Avoidance Subscale Impact of Events Scores Score

17 Figure 3e Intrusive Thoughts Subscale Impact of Events Scores Score

18 Figure 4e SF-36 Physical Functioning Transformed Score Figure 5e 1 SF-36 Role Physical Transformed Score 41

19 Figure 6e SF-36 Bodily Pain 1 Transformed Score 75 Figure 7e SF-36 General Health Transformed Score 25 42

20 Figure 8e SF-36 Vitality 1 Transformed Score

21 Figure 9e SF-36 Role Emotional 1 Transformed Score 44

22 Figure 1e SF-36 Social Functioning 1 Transformed Score 1 Figure 11e SF-36 Mental Health Transformed Score

23 Figure 12e State Anxiety 1 Percentile Score 1 Figure 13e Trait Anxiety Percentile Score 46

24 Figure 14e Beck Depression Inventory Distribution Number of Patients Normal Mild Mood Disturbance Borderline Clinical Depression Moderate Depression Severe Depression Extreme Depression 47

25 Figure 15e PAIS-Total T-Score Figure 16e 8 PAIS-Health Care Orientation 7 T-Score

26 Figure 17e PAIS-Vocational Environment 7 6 T-Score Figure 18e 7 6 PAIS-Domestic Environment T-Score

27 Figure 19e PAIS-Sexual Relationships 7 6 T-Score Figure 2e PAIS-Extended Family T-Score 6 4

28 Figure 21e PAIS-Social Environment T-Score Figure 22e PAIS-Psychological Distress 6 T-Score