Phase I: the development and content analysis of the pediatric sedation agitation scale.
The authors' PICU is embedded in one section of an adult ICU. It consists of 10 beds and receives pediatric patients with either medical or surgical conditions that require care in the ICU setting. Nurses who work in the PICU must demonstrate competency in the care of patients across the age spectrum from birth through adolescence. There is no objective pediatric sedation scale currently in use in the authors' unit. Pediatric sedation and agitation are assessed according to the subjective judgment of individual practitioners. The Sedation-Agitation Scale (SAS) (Riker, Picard, & Fraser, 1999) is used for the assessment of adult patients in the authors' ICU. The SAS has been identified as one of the more reliable scales (Binnekade, Vroom, de Vos, & de Haan, 2006; McGaffigan, 2002) and is used in numerous ICUs.
Staff in the PICU identified the benefits of using a consistent assessment scale for all patients. However, because children are in a constant state of physical, emotional, and cognitive development, they require their own instrument for health care assessment that is appropriate for their developmental stage when they enter the hospital (McDonald et al., 2008). Dr. Riker granted permission for the development of a pediatric sedation agitation scale adapted from the SAS for children less than 18 years of age (personal communication, March 16, 2006).
Review of the Literature
A review of CINAHL and Medline was completed using the search terms sedation protocols, sedation instruments and pediatric patients, or PICU. The goal was to find scientific, peer-reviewed articles that focused on the assessment of pediatric sedation. A secondary focus was to find information on tool or instrument development and assessment. The searches resulted in a number of articles that were used to increase the overall knowledge of the development team regarding pediatric sedation, tool development, and validation strategies.
Critically ill children in need of mechanical ventilation frequently experience pain and anxiety. Pain is associated with procedures, including surgery, or the use of medical devices, such as chest tubes (Ratnapalan & Schneeweiss, 2007). Anxiety and distress are often related to the environmental characteristics of the PICU, such as high noise levels, intrusive stimuli, and unfamiliar routines (Aitken, Marshall, Elliot, & McKinley, 2008; Brinker, 2004). Anxiety is a response based on worry or apprehension, which may be linked to a perceived or real threat. Agitation is identified as a more intense level of nervous anxiety (McGaffigan, 2002).
Pain and anxiety cause catecholamine release that results in increased heart rate and muscle tone, responses that are detrimental to already compromised critically ill patients. Sedatives and analgesics alleviate such symptoms and improve patient comfort, cause amnesia, and increase patient safety. Patient safety includes prevention of self-harm, improved compliance with procedures, increased ventilator/patient synchrony, and the promotion of hemodynamic stability (Chulay, 2004; Grap, Pickler, & Munro, 2006). These authors could find no published studies providing data related to the incidence of under- or over-sedation; the magnitude of the problem is based on anecdotal reports and staff experience caring for this vulnerable population.
PICU nurses struggle with a number of clinical questions regarding sedation management, including timing and dosage of sedatives; sedation goals; nurse's feeling of competency; and consistent communication among members of the health care team (Aitken et al., 2008). The use of an objective instrument by multiple disciplines can guide practice and improve communication by providing a common language. In today's PICU, there is infrequent use of objective instruments and minimal understanding of how PICU nurses manage sedation in their patients (Aitken et al., 2008). Many nurses react to any patient motor activity by administering sedation rather than attempt non-pharmacological strategies. Novice nurses may lack the experience to integrate data from multiple sources, such as hemodynamic stability, oxygenation status, and patient comfort, into their assessment of sedation level (Benner, 1984). Patients' sedation needs also fluctuate according to multiple factors, including stimulation and physiological condition; therefore, medication administration must be tailored to address the child's current state.
Sedation management in the critical care environment has evolved; patients were previously managed in a deeply sedated state (Fraser & Riker, 2007). Deep sedation increased the risk of complications of immobility, including ventilator-associated pneumonia (VAP), and increased use of neurological diagnostic testing if a patient was slow to wake following use of sedatives (Fraser & Riker, 2007; Turton, 2008). These factors caused an increased length of stay and increased health care costs, and made inefficient use of available ICU resources (Fraser & Riker, 2007; McGaffigan, 2002; Quenot et al., 2007; Turton, 2008). Current evidence encourages clinicians to manage patients in a sleepy-calm yet easily rousable state (Avramov & White, 1995; Williams et al., 2008). However, research reveals that too often, patients continue to be managed in an "over-sedated" state (Fraser & Riker, 2007).
McGaffigan (2002) identified that clinicians believed they were providing appropriate sedation to their adult critically ill patients only 50% of the time. Physicians more frequently believed their patients were oversedated, while nurses believed their patients were under-sedated. Anecdotally, the same situation can be seen in the care of critically ill pediatric patients. The disparity in assessment findings frequently leads to conflict between providers. The use of an objective assessment tool with a clearly identified sedation goal, aligned with appropriate sedation protocol orders (Bennett, 2003), may improve communication and reduce conflict. Each practitioner caring for the patient has the same goals, including patient safety and optimal patient outcome through family-centered care.
Reasons for deep sedation, defined as lack of arousal (Malviya, Voepel-Lewis, & Tait, 2006), may be related to the level of clinician experience, common unit practices, and nurse-to-patient ratio. Family members may request deeper sedation levels because they believe the child appears uncomfortable or awake based on increased movement (Fraser & Riker, 2007). Current regulatory requirements to use less physical restraints may also mean staff use more "chemical restraints," which can also lead to over-sedation. The child's condition and goals of care, which change daily, should drive decisions on target sedation levels. The child requiring sedation for intracranial hypertension or poor oxygenation may need a deeper level of sedation, while mild (anxiolysis) or moderate (appropriate response to stimuli) levels of sedation may be more appropriate for general comfort and safety (Brinker, 2004).
Pediatric medication dosing is most frequently based on weight-based calculations, which are titrated based on the child's physiological condition and length of time requiring sedation (Brinker, 2004). Prolonged sedation often necessitates escalating doses of medication and increases the likelihood that a second medication will be required, such as a benzodiazepine with an opioid. Long-term use of opioids and benzodiazepines to achieve deep sedation puts the patient at risk for physical dependence and withdrawal, causing concern among families and clinicians (Ista, van Dijk, Gamel, Tibboel, & de Hoog, 2008). Medications can be difficult to wean effectively. Symptoms of both withdrawal and agitation include increased muscle tone, anxiety, and facial grimacing (Ista et al., 2008). Careful assessment using an objective tool and consideration of the patient's "sedation medication" history can help prevent withdrawal in this population (Ista et al., 2008).
The original Comfort Scale was developed in the 1990s and was found to have good interrater reliability (r = 0.84, n = 50, p < 0.01) and internal consistency (0.9) (Ambuel, Hamlett, Marx, & Blumer, 1992). The Comfort Scale was designed to assess distress in pediatric patients admitted to the PICU. The original scale included 8 behavioral rating scales: alertness, calmness/agitation, respiratory response, physical movement, mean arterial blood pressure, heart rate, muscle tone, and facial tension. The patient is scored in each behavioral rating scale based on five descriptors valued between 1 and 5 that provide a total score ranging from 8 to 40, which is the Comfort score. The scale has been changed; the new Comfort B Scale includes the addition of crying for non-ventilated patients and removal of the physiological parameters (heart rate and blood pressure), which may be altered for reasons other than agitation (Ista, van Dijk, Tibboel, & de Hoog, 2005; Van Dijk, Peters, Van Deventer, & Tibboel, 2005).
Grap and colleagues (2006) studied 20 intubated children in a PICU between the ages of 1 month and 14 years comparing movement and the scores obtained on the Comfort B Scale, and their relationship to depth of sedation. Their findings indicate there is a positive correlation between increased movements, including body or facial activity, and a lower Comfort B score (a more active behavior state).
The State Behavioral Scale (SBS) was developed and evaluated in an 18-bed medical-surgical PICU (Curley, Harris, Fraser, Johnson, & Arnold, 2006). The study sample consisted of 91 patients ranging in age from 6 weeks to 6 years who required intubation and mechanical ventilation. The investigators compared a numeric rating scale (NRS) with the SBS using paired evaluators; 198 evaluations were completed, and patient participants were evaluated once or twice during the time they met the study criteria. There was moderate to good interrater reliability (weighted kappa scores ranged from 0.44 to 0.76) and construct validity when compared to the NRS in cluster groups (one-way analysis of variance [ANOVA] F = 75.8, df = 4, p < 0.001) (Curley et al., 2006).
Malviya and colleagues (2006) compared the University of Michigan Sedation Scale (UMSS), the Bispectral Index (BIS), and the Modified Maintenance of Wakefulness Test (MMWT). BIS, or Bispectral index of the electroencephalography (EEG), is a system developed to measure the effects of anesthetics and sedatives (McGaffigan, 2002). BIS is an objective tool that measures the patient's hypnotic level, which correlates with changing levels of consciousness. Malviya et al. (2006) studied 39 participants from birth to 18 years of age who received sedation or a general anesthetic. The children were observed as they woke following completion of their procedure. The investigators found a moderate to high correlation between UMSS and BIS (rho = -0.73) and between the UMSS and MMWT (rho = -0.59, p < 0.01), and a significant but low correlation between BIS and MMWT (r = 0.36, p < 0.01). Their findings indicate that observational tools are the most reliable and feasible method to accurately identify the sedation depth in infants.
BIS has been compared to the UMSS (Shields, Styadi-Park, McCown, & Creamer, 2005) for procedural sedation in 38 patients. Shields et al. (2005) found that agreement between BIS and UMSS was poor, with BIS under-estimating the depth of sedation. However, a separate study comparing BIS and UMSS found there was a definite correlation between the two instruments in children less than 12 years of age, although this was dependent on the medication used for sedation (McDermott et al., 2003). BIS was also compared to the Comfort B Scale and was found to have moderate correlation (Courtman, Wardurgh, & Petros, 2003).
Although these tools have been validated, they do not meet the needs of our pediatric population. The pediatric population seen in the authors' PICU is from birth to 18 years, and the completed studies used narrower age ranges (for example, SBS range of 6 weeks to 6 years) (Curley et al., 2006). The UMSS is a strictly procedural sedation assessment tool, and while the authors' PICU uses procedural sedation, the primary need is for an objective assessment tool for patients requiring longer-term sedation during mechanical ventilation. The Comfort and Comfort B scales were studied in children from birth to adolescence (Ambuel et al., 1992; Grap et al., 2006), but both scales were perceived to be cumbersome in clinical practice in a busy PICU.
The purpose of this study was to assess the face and content validity of the Pediatric Sedation-Agitation Scale (P-SAS) (see Figure 1). Face validity assesses whether the items in the scale look reasonable, important, and acceptable. Content validity assesses whether the items are relevant, representative, and clear (Bannigan & Watson, 2009). A review of current literature and an expert panel were used to evaluate the overall content validity of the P-SAS. The purpose for developing the P-SAS was to provide a sedation and agitation assessment tool for use with pediatric patients admitted to our unit.
The development of the P-SAS occurred in sequential steps. The initial step involved the identification of age groups based on developmental stage and accompanying behavioral characteristics. The four groups were defined as infant (0 to 1 year), toddler (1 to 3 years), preschooler and early school-age (4 to 7 years), and school-age through adolescence (8 to 18 years). The groups are based on a child's cognitive ability. A child from 2 to 7 years of age is preoperational and uses magical thinking and animism; however, by 8 years of age, a child should have a more accurate understanding of cause and effect (Colyar, 2003). The use of cognitive development stages allowed for developmentally appropriate descriptions of behavior to be ascribed to each of the 7 levels along the sedation/agitation continuum. The domains in the P-SAS include level of consciousness and motor activity or behavior that if continued, would lead to self-harm (Chulay, 2004).
Based on the SAS, the P-SAS levels of sedation/agitation range from 1 (unarousable) to 7 (dangerous agitation). "Sedation depth" is the level of response to a stimulus whether applied intermittently (such as endotracheal suctioning) or a constant "noxious" stimulus (such as endotracheal intubation and ventilator support) (Binnekade et al., 2006). The child's response to the stimulus as well as the stimulus applied helps to identify the depth of sedation. Descriptors for the P-SAS levels were initially based on the SAS and adjusted based on children's developmental stages identified by the team of PICU clinicians involved in the project.
An investigator-developed questionnaire was administered to a sample of 30 physicians and nurses identified as experts in pediatric acute care and sedation. The goal of the questionnaire was to assess their understanding of the characteristics of a sedated and agitated child and the level to which the scale matched their understanding. The four age-group subsets of the P-SAS were printed on separate pages; experts were asked to rate the behavioral characteristics of each level of sedation/agitation for representativeness, importance, and clarity. A 4-point Likert-type scale was used (1 = not representative, clear, or important; 4 = very representative, clear, and important). Space was provided for narrative comments.
The instrument development team identified a multidisciplinary group to serve as the expert panel based on the potential panel member's experience caring for pediatric patients requiring sedation. The use of expert review during the development of scales has been used in both the State Behavioral Scale (Curley et al., 2006) and the Comfort B Scale (Marx et al., 1994). The group included attending physicians from the Emergency Department and Department of Anesthesia, as well as PICU intensivists. Pediatric residents who had completed their PICU rotation were chosen based on their experience and comfort level working with intubated critically ill children.
At least two members of the development team had to acknowledge the PICU nurses who were included as experts (Benner, Tanner, & Chesla, 1992). The education levels and experience of the PICU nurses were as follows: 60% had their bachelor's degree, 2 of the 8 had their CCRN certification, and the group had a mean of 21.6 (SD = 3.38) years of PICU experience. The advanced practice nurses (APNs) were identified based on their pediatric focus as well as knowledge of the individual by the development team members and through recommendation from other members of the expert panel.
Individuals were contacted by e-mail to explain the study and solicit their participation in analyzing the scale. Participation was voluntary, and agreement to participate implied consent. The scale and questionnaire were then distributed with a cover letter through either internal mail or the postal service. The two physicians and APN who received their questionnaire through the mail also received a stamped addressed return envelope. Expert panel members who had not responded were sent two subsequent reminders approximately one month apart, beginning one month after the initial posting. One nurse practitioner responded that she did not feel qualified as a pediatric expert, and thus, was removed from the list.
Data were collected and analyzed three months after the original mailing. The final response rate was 58% (see Table 1), which is higher than the benchmark of 50% recently identified by Baruch and Holtom (2008) for individual responses to a survey. Statistical analysis was completed using the Statistical Package for the Social Sciences (SPPS, Inc.). Responses from the expert sample showed a high level of agreement in each of the three subcategories (representativeness, importance, and clarity), with overall mean scores ranging from 3.72 to 3.90 out of a possible 4.0 (see Table 2). When reviewing the mean scores based on individual practitioner roles, the resident physicians had the poorest response at 43% and the lowest rated score consistently for each category of the scale.
The expert panel rated the 8 to 18-year-old age group scale representativeness, importance, and clarity as higher than the other age groups. The 0 to 1-year-old age group scale had the lowest mean score for clarity -3.72 (SD = 0.53). The lowest scoring section was in the 0 to 1-year-old age group for P-SAS scale--level 6 (very agitated) (M = 3.33, SD = 0.91), which was consistent with written feedback in the narrative section of the questionnaire.
When responses were stratified by panel role (see Table 3), the nurses as a group scored the scale for the 0 to 1-year-old age group as least representative, with a mean of 3.68 (SD = 0.37). The attending physicians and residents scored the 1 to 3-year-old age scale the lowest -3.77 (SD = 0.37) and 3.5 (SD = 0.71), respectively. Residents scored the importance in each scale category as 3.48 (SD = 0.91), and rated the clarity in the 1 to 3-year-old age scale as 3.5 (SD = 0.71), each out of a possible 4.0.
When the PICU nurses and APNs were separated (see Table 4), the PICU nurses mean ratings for each division of the scale were higher than that of the APNs. The differences were not statistically significant, and the results showed a high level of agreement (Kappa: K = 0.771, p = 0.000, and Chronbach's alpha = 0.790). The overall mean scores for the scale ranged from 3.5 to 4.0 (out of 4.0) in most descriptors in both groups. On average, mean scores for the PICU nurses for level 6 (very agitated) in both the 0 to 1 and 1 to 3-year-old age groups was 3.0 (SD = 1.41) in the representative and clarity sections. They also scored level 6 (very agitated) in the 0 to 1-year-old age group representative descriptors as 3.25 (SD = 1.50).
Scores were consistently supportive of the original scale, with the associated narrative comments suggesting minor revisions and changes in the scoring system. The child from birth to 3 years of age is the most difficult group to identify behavioral patterns that accurately reflect levels of agitation. This was reflected in the lower scores under the representative and clarity scales for this population, and the written feedback from the expert panel. After completing the statistical analysis of the P-SAS, changes were made by the development team based on scores and narrative comments. A senior pediatric resident and an expert PICU nurse who were both part of the original panel then reviewed and agreed with the changes. They both believed the changes had improved the representativeness and clarity of the scale.
The P-SAS has been developed based on the SAS, which has been identified as one of the more reliable scales in use in adult ICUs (Binnekade et al., 2006; McGaffigan, 2002). As in the SBS and the Comfort B Scale, the P-SAS uses primarily behavioral measures to identify the child's depth of sedation (Curley et al., 2006; Van Dijk et al., 2005). The assessment of behavioral measures has been validated by Grap et al. (2006), who found that reduced level of sedation correlated with increased movement in pediatric patients. The P-SAS is an observational instrument, which Malviya et al. (2006) found to be the most reliable method to accurately identify the sedation depth in infants.
A limitation in the study is the poor response to the questionnaire from the expert panel; this may be related to their busy schedule and lack of understanding of the importance of their response. Individuals who responded did not always complete each category of the questionnaire, which had a negative impact on the strength of data collected. The incomplete questionnaires were tabulated in the statistical results; their feedback was deemed valuable by the development team. The responses received included insightful comments that stimulated further discussion of the descriptors and clarification from the individual as appropriate.
Another limitation of this study is that content validity is the first step in the assessment of a tool's validity and reliability. Recognizing this limitation, further psychometric testing of this scale is required before it is accepted as appropriate for use in a clinical environment.
Critically ill children in need of mechanical ventilation often experience pain and anxiety. Medications are administered to these children to reduce anxiety, increase amnesia, and maintain patient safety. The use of a valid tool to assess sedation and agitation is vital for this vulnerable population. It improves interdisciplinary communication by reducing conflict related to differences in sedation assessment. The objective assessment and improved interdisciplinary communication improves patient outcomes and increases family and patient satisfaction by reducing the risk of over- or under-sedation.
In units that provide care to both children and adults, the use of a single objective tool simplifies patient care and can improve compliance; using the P-SAS for children and the SAS with adult patients will achieve this goal. The identification of a valid and reliable sedation assessment instrument allows for development of sedation protocols. Protocols have been shown to improve patient outcomes and provider practices, and reduce length of stay and PICU costs, ultimately improving patient and family satisfaction (Brinker, 2004).
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Catherine M. Lyden, MSN, RN, CCRN, is a PICU Staff Nurse, Maine Medical Center, Portland, ME.
Debra Kramlich, MSN, RN, CCRN, is Database Coordinator, Cardiac Surgery, Maine Medical Center, Portland ME.
Rachel Groves, MSN, RN, CCRN, is employee with Maine Medical Center College of Nursing and Health Professions, Lewiston ME.
Sandra P. Bagwell, MD, FCCP, FCCM, is an Attending Physician, Maine Medical Center PICU, Portland ME.
Table 1. Expert Panel Characteristics and Response Rate Role Number Response Percentage PICU RN 7 4 57 Attendings 7 6 85 Residents 8 3 37 APN 5 4 80 Other RN 3 1 33 Total 30 18 58 Table 2. Scale Means of Representativeness, Importance and Clarity by Age Group Age Group Representative Importance Clarity 0 to 1 year old 3.75 3.87 3.72 1 to 3 years old 3.75 3.88 3.75 4 to 7 years old 3.81 3.90 3.85 8 to 18 years old 3.83 3.90 3.85 Table 3. Overall Mean Scale Rating of Age Range and Category by Expert Panel Role Nurse Attending Physician Representative n M SD n M SD 0 to 1 year old 8 3.68 0.37 5 3.86 0.17 1 to 3 years old 8 3.77 0.26 5 3.77 0.30 4 to 7 years old 9 3.83 0.26 5 3.97 0.06 8 to 18 years old 8 3.89 0.17 5 4.00 0.00 Importance n M SD n M SD 0 to 1 year old 9 3.95 0.07 5 3.94 0.13 1 to 3 years old 8 3.95 0.07 5 3.97 0.00 4 to 7 years old 9 3.98 0.05 5 4.00 0.00 8 to 18 years old 9 3.98 0.05 5 4.00 0.00 Clarity n M SD n M SD 0 to 1 year old 8 3.77 0.35 5 3.80 0.24 1 to 3 years old 8 3.77 0.35 4 3.79 0.43 4 to 7 years old 9 3.84 0.24 5 3.94 0.08 8 to 18 years old 9 3.84 0.24 5 4.00 0.00 Resident Representative n M SD 0 to 1 year old 3 3.62 0.54 1 to 3 years old 2 3.50 0.71 4 to 7 years old 3 3.57 0.49 8 to 18 years old 3 3.57 0.52 Importance n M SD 0 to 1 year old 3 3.48 0.91 1 to 3 years old 3 3.48 0.91 4 to 7 years old 3 3.48 0.91 8 to 18 years old 3 3.48 0.91 Clarity n M SD 0 to 1 year old 3 3.57 0.52 1 to 3 years old 2 3.50 0.71 4 to 7 years old 3 3.67 0.58 8 to 18 years old 3 3.57 0.52 Table 4. APN versus PICO RN Overall Ratings Role Mean SD 0 to 1 year old SCU RN 3.75 0.338 APN/NP 3.71 0.481 1 to 3 years old SCU RN 3.81 0.223 APN/NP 3.75 0.317 4 to 7 years old SCU RN 3.93 0.143 APN/NP 3.86 0.202 8 to 18 years old SCU RN 3.93 0.143 APN/NP 3.82 0.270
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|Author:||Lyden, Catherine M.; Kramlich, Debra; Groves, Rachel; Bagwell, Sandra P.|
|Date:||Sep 1, 2012|
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