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Anesth Analg 2008; 106:72-78
© 2008 International Anesthesia Research Society
doi: 10.1213/01.ane.0000287680.21212.d0
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PEDIATRIC ANESTHESIOLOGY

A Comparison of the Clinical Utility of Pain Assessment Tools for Children with Cognitive Impairment

Terri Voepel-Lewis, MSN, RN*, Shobha Malviya, MD*, Alan R. Tait, PhD*, Sandra Merkel, MS, RN*, Roxie Foster, PhD, RN{dagger}, Elliot J. Krane, MD{ddagger}, and Section Editor Peter J. Davis

From the *University of Michigan Health Systems, Department of Anesthesiology, Ann Arbor, Michigan; {dagger}University of Colorado Health Sciences Center, School of Nursing, Denver, Colorado; {ddagger}Stanford University Medical Center, Department of Anesthesiology, Stanford, California.

Address correspondence and reprint requests to Terri Voepel-Lewis, MSN, RN, C.S. Mott Children’s Hospital, University of Michigan Health Systems, F3900 Box 0211, 1500 E. Medical Center Dr., Ann Arbor, MI 48109-0211. Address e-mail to terriv{at}umich.edu.

Abstract

BACKGROUND: Difficulty assessing pain has been cited as one of the primary reasons for infrequent and inadequate assessment and analgesia for children with cognitive impairment (CI). Several behavioral observational pain tools have been shown to have good psychometric properties for pain assessment in this population; however, routine clinical use may depend largely on their pragmatic qualities. We designed this study to evaluate pragmatic attributes or clinical utility properties of three recently developed pain assessment tools for children with CI.

METHODS: A sample of clinicians from three medical centers were asked to review 15 videotaped observations of children with CI, recorded during their first three postoperative days during participation in a previous study. Participants scored pain using the revised-Face, Legs, Activity, Cry, Consolability (r-FLACC) tool (individualized for the child during the previous study) for five observations, the noncommunicative Non-Communicating Children’s Pain Checklist-Postoperative Version (NCCPC-PV) for five, and the Nursing Assessment of Pain Intensity (NAPI) for five observations. After their review of all segments, participants completed the Clinical Utility Attributes Questionnaire (CUAQ) ranking three attributes of clinical utility; complexity, compatibility, and relative advantage.

RESULTS: Five physicians and 15 nurses comprised the sample. There was excellent agreement between the coded pain scores (i.e., mild, moderate, severe pain) assigned using all tools and r-FLACC scores assigned by original observers (88%–98% exact agreement; {kappa} 0.71–0.96). The internal consistency or reliability of the CUAQ was supported by high {alpha} values for each of the subscales ({alpha} = 0.84–0.93). Subscale and total CUAQ scores were higher for the r-FLACC and NAPI compared with the NCCPC-PV. The r-FLACC had similar scores for complexity, but slightly higher scores for compatibility, relative advantage, and total utility compared with the NAPI.

CONCLUSIONS: We found that clinicians rated the complexity, compatibility, relative advantage, and overall clinical utility higher for the r-FLACC and NAPI compared with the NCCPC-PV, suggesting that these tools may be more readily adopted into clinical practice.

The simplest and most reliable measure of postoperative pain assessment is self-report by the patient, but most individuals with cognitive impairment (CI) are unable to report or quantify pain severity.1–3 Difficulty assessing pain has been cited as one of the primary reasons for infrequent and inadequate assessment and analgesia in this population.4 Recently, observation of behaviors has been used to identify and quantify pain in patients with CI,5–10 which has lead to the development and testing of pain tools specifically designed for this population.11–17 Several of these tools have been found to have good inter-rater reliability, and construct and criterion validity in assessing pain in children with CI.11–14 Although these psychometric properties are necessary to ensure accurate pain assessment, the ability to implement these tools into routine clinical practice may depend largely on their pragmatic qualities.18 Indeed, it has been suggested that busy clinicians tend to be pragmatists, concerned mainly with the practicality of innovations when considering their translation into practice.19

The Diffusion of Innovations model,20 which is commonly used to evaluate translational strategies of technology and innovation in the public health sector,21,22 identifies several characteristics that affect or explain implementation of an innovation or idea into routine practice. These attributes include the innovation’s relative advantage compared with others (degree to which it is perceived as being better than the idea it supersedes), its compatibility (degree to which it is perceived as consistent with existing values), complexity (the degree to which it is perceived as difficult to understand and use), "trialability" (ability to quickly test the innovation), "observability" (actual use in practice), and cost.18,20,23 Hester et al.18 applied this framework in their review of studies addressing clinical implementation of pain assessment, and concluded that simplicity of the tool or technique was essential for rapid adoption in the clinical setting. These authors suggest that poor pragmatic attributes diminish the clinical usefulness of an assessment technique, slowing its adoption despite excellent psychometric properties.

To our knowledge, no study has systematically evaluated the clinical utility or feasibility of pain assessment tools. The purpose of this multicenter study, therefore, was to devise and test a preliminary measure of clinical utility using the Diffusion of Innovations model, and to compare the relevant attributes of three recently developed tools (i.e., the revised-Face, Legs, Activity, Cry, Consolability [r-FLACC],12 the Nursing Assessment of Pain Intensity [NAPI],13 and the Non-Communicating Children’s Pain Checklist-Postoperative Version [NCCPC-PV]11) that have been used to assess pain in children with CI (Table 1).


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  		Table 1. Description of the Tools Evaluated

 

METHODS

This study was approved by the IRB at the University of Michigan, and written consent was obtained from clinician participants. Six to seven clinicians (physicians and nurses) were recruited by three co-investigators from each of three major medical centers across the United States. Participants were sent a packet including a written overview of the study, consent form, and instructions, along with a DVD, including 15 videotaped observations of children with mild, moderate, or profound CI, recorded during their first three postoperative days during participation in a previous study.12 These recordings depicted children experiencing no pain, mild, moderate, or severe pain as scored by their bedside nurses. Pain was scored during the original trial by bedside nurses using the r-FLACC tool,12 and by video observers using the r-FLACC or NAPI. The r-FLACC tool contains an open-ended item under each category for recording additional pain behaviors that may be unique to that child. During the original trial, the r-FLACC was completed by parents to effectively individualize the tool to each child.

Participants in the present study were given specific instructions to view each taped observation in its entirety, pausing immediately afterward to score observed pain behaviors using the numbered assessment tool assigned for that patient observation. Observers were permitted to rewind the segment for review as necessary. Participants scored pain using the child’s individualized r-FLACC (included in the packet) for five observations, the NCCPC-PV for five, and the NAPI for five, and each grouping was prefaced with brief instructions on scoring with the respective pain assessment tool. The order in which these tools were used was randomly assigned for each observer to minimize potential bias. For each taped observation, participants were asked to record the time when they started viewing the segment and the time they completed their scoring.

After their review of the entire set of taped segments, observers were asked to complete a brief questionnaire evaluating the clinical utility or "feasibility" of each assessment tool in the hospital setting. The Clinical Utility Attributes Questionnaire (CUAQ; Table 2) was devised after review of the literature pertaining to diffusion of innovations in health care, with a specific focus on evaluating characteristics of the innovation (in this case, the pain tool). The survey contained items adapted from open-ended questions used previously by Hester et al.18 and Schade et al.,13 and addressed three primary attributes of interest, complexity, compatibility, and relative advantage of the instrument. Each attribute was defined by 3–4 items that were scored using a 5-point Likert-type scale, where 1 = strongly disagree to 5 = strongly agree. A panel of four clinicians (not involved with this study) reviewed the final CUAQ to score its content validity using the Scale-level Content Validity Index that scores each item on a 4-point ordinal scale (1 = not relevant; 2 = somewhat relevant; 3 = quite relevant; 4 = highly relevant).24 The average proportion of items on the CUAQ rated as 3 or 4 across the panel was 0.98 (range = 0.9–1.0), representing excellent content validity.24 Participants were instructed to answer each set of questions independently for the r-FLACC, the NCCPC-PV, and the NAPI. Finally, the following data were collected: demographics, profession, education, years in practice, type of health care setting, experience with pain assessment in children with CI, and pain tools routinely used in the care of children with and without CI. Participants were asked to return informed consent documents in separate envelopes from the data sheets, so that complete anonymity of respondents was maintained.


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  		Table 2. Clinical Utility Attributes Questionnaire

 

Statistical Analysis
Participant-assigned pain scores were compared with the originally assigned r-FLACC and NAPI scores to evaluate the reliability of the participants’ use of each instrument, given the brief set of instructions offered. Intraclass correlation coefficients were used to analyze the reliability of these measures. Additionally, since each tool uses a different set of metrics (i.e., r-FLACC 0-10; NAPI 0-11; NCCPC-PV 0-81), scores were coded as mild pain or moderate to severe pain, in accordance with initially described psychometric testing of each pain tool.11–13 As such, r-FLACC and NAPI scores of ≤3 and NCCPC-PV scores of 0–10 indicated mild pain, and r-FLACC and NAPI scores >3 and NCCPC-PV scores >10 indicated moderate to severe pain. Measures of exact agreement and {kappa} statistics were used to compare assigned pain scores in this study to r-FLACC and NAPI scores assigned previously. {kappa} >0.7 were accepted as good agreement between measures.

The internal consistency or reliability of the CUAQ was evaluated for the entire tool and its subscales using Cronbach’s (coefficient) {alpha}, and values of ≥0.75 were considered to represent satisfactory reliability. Total and subscale composite scores of the CUAQ were derived by summing the item scores. The attribute scores were compared among pain tools using Mann–Whitney U-test. Finally, the total observation and scoring times for each tool were compared using unpaired t-tests. P < 0.05 were considered significant.

Sample Size
Based on preliminary discussions with colleagues from other institutions who were familiar with observational pain tools, it was estimated that 80% of respondents would rate the clinical utility of the FLACC tool as high whereas 40% would do so for the NCCPC-PV or the NAPI. Therefore, 17 respondents were needed ({alpha} = 0.05; β = 0.20) to demonstrate a difference of at least this size in clinical utility.

RESULTS

The sample included 20 clinicians (5 physicians and 15 nurses) representing a variety of specialties at three sites. A description of the sample is presented in Table 3. Participants reported using the following self-report tools routinely in their practice: 0–10 Numbers Scale (100%), FACES (75%), Oucher (50%), Visual Analog Scale (20%), and Word scale (5%). They used the following observational tools routinely: FLACC (95%) and Premature Infant Pain Scale (25%), and Neonatal-Pain Agitation Sedation Scale (5%).


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  		Table 3. Description of the Sample

 

Intraclass correlation coefficients indicated good reliability among scores on all tools and originally assigned pain scores with the exception of the NCCPC-PV compared with NAPI (Table 4). Additionally, there was good to excellent agreement between the coded pain scores assigned using all tools and those assigned by original observers, further supporting the reliability of scoring. The internal consistency or reliability of the CUAQ was supported by high {alpha} values for each of the subscales: complexity {alpha} = 0.91, compatibility {alpha} = 0.93, and relative advantage {alpha} = 0.84. The interitem correlations ranged from 0.42 to 0.85 with an overall {alpha} = 0.96.


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  		Table 4. Reliability Between Pain Scores

 

The scores for the attribute subscales and the total CUAQ scores were higher for the r-FLACC and NAPI compared with the NCCPC-PV (Table 5). The r-FLACC had similar scores for complexity, but slightly higher scores for compatibility, relative advantage, and total utility compared with the NAPI. The time taken to score the r-FLACC and NAPI was significantly shorter than that to score the NCCPC-PV (2.9 ± 1.7 and 2.8 ± 1.5 vs 5.1 ± 2.2 min, respectively; P < 0.001).


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  		Table 5. Clinical Utility Attribute Questionnaire (CUAQ) Scores of the Pain Tools (presented as mean ± sd; median [Interquartile Range])

 

DISCUSSION

Systematic and frequent pain assessment has been shown to improve pain management for adults and children25 and is considered essential for optimal care.26 Such evidence, bolstered by the widespread implementation of pain standards established by the Joint Commission on Accreditation of Healthcare Organizations27 has lead to routine pain assessment for most surgical patients in acute care settings. However, difficulties assessing and documenting pain in populations such as the cognitively impaired may leave these patients vulnerable to suboptimal management.28 Despite the recent introduction of several valid and reliable tools for pain assessment in children with CI, their adoption into clinical practice may be hampered, in part, by the nature of the tools themselves.18 The clinical usefulness of a pain tool is dependent not only on its validity and reliability, but also its pragmatic qualities that include its complexity, compatibility, and advantage relative to other tools or techniques. This study evaluated these attributes and the overall clinical utility of three recent innovations for pain assessment in cognitively impaired children, demonstrating that the r-FLACC and NAPI have significantly better qualities for adoption into practice compared with the NCCPC-PV.

Evidence suggests that establishing and disseminating clinical guidelines alone have little impact on changing practice.21,29–31 Several studies have evaluated the translation or adoption of innovations and guidelines into practice, yet most have focused on the process,32–38 but few have evaluated the fundamental qualities of the innovations themselves, and their impact on translation. The concept of clinical utility of assessment measures has been introduced by clinicians from a variety of disciplines including psychology and neurology. The most basic and necessary component of a measure’s clinical utility is the relevance or meaningfulness of the information it provides (i.e., validity).39 Clinicians have suggested, however, that ease and efficiency of use are necessary criteria for incorporation of a tool into practice, citing several components necessary for clinical utility.40 Such characteristics include: availability and ease of use, administration time, learnability, format, scoring and information derived, and meaningful and relevant information obtained. Other attributes of clinical utility include the tool’s relative advantage compared with others, its compatibility or similarity to other tools already in place, and its relative complexity.18,23

Each of the pain tools evaluated in this study has been shown to have some or all of the psychometric properties relevant for valid and reliable use in measuring pain in children with CI. However, these tools have different structure, content, and scoring that, by definition, impact their clinical utility. The NCCPC-PV, for instance, requires the observer to score each of 27 items from 0 to 3 to provide an overall total from 0 to 81, which makes the scoring quite complex. Additionally, the interpretation of its scores is inconsistent with other clinical pain measures, thereby reducing the compatibility of this tool in practice. Indeed, this tool was ranked by clinicians as significantly lower for simplicity and compatibility compared with the r-FLACC and NAPI that, in contrast, yield total scores similar to other commonly used tools. Although the r-FLACC and NAPI have fewer items and greater simplicity, they were found to possess excellent reliability in scoring mild, moderate, and severe pain in children with CI.

Despite widespread knowledge of pain guidelines and standards, recent data suggest that postoperative pain continues to be under-managed.37,41 Several studies suggest that implementation of pain teams, guidelines, and standardized, consistent pain assessment techniques are successful methods to improve pain outcomes for postoperative patients.42–44 Although consistency in pain assessment measures may be desirable, differing populations require the use of different assessment tools.45,46 The compatibility of a pain tool with others not only facilitates clinical utility but promotes consistency as well. The r-FLACC is compatible with the original FLACC,47,48 that, based on its excellent psychometric properties, has been recommended as the first choice for behavioral assessment of postoperative pain in children.46 Defrin et al.45 found that pain behaviors differ in children with varying degrees of CI, suggesting the need for different tools within this population. The r-FLACC, however, allows for individualization of behaviors to account for differing baseline and potentially idiosyncratic behaviors in children with varying degrees of CI.12 Only one other tool that provides for individualized pain assessment has been reported in the literature, but its psychometric properties have not been studied.49 The r-FLACC that promotes individualization and has very good psychometric properties and clinical utility may, therefore, be the most desirable tool for postoperative pain assessment in this population.

Findings from this study may be limited in that participants were familiar with multiple pain assessment tools, yet unfamiliar with the NAPI and the NCCPC-PV. Such familiarity could have biased results. The use of instructional packets, random order for each tool’s use, and pretaped DVDs in this study may have helped to reduce such bias. However, further study of pain assessment tools in samples of novice health care providers (i.e., nursing or medical students) may provide more meaningful data. Additionally, despite the overall high clinical utility scores of the r-FLACC and NAPI, this study did not address their trialability or observability (routinization) in practice, nor scoring during direct patient observations, which may provide better measures for the ease of adoption. Since the r-FLACC requires preoperative assessment of parent-identified behaviors and communication of the individualized tool to subsequent providers, the tool’s adoption may be slower compared with others. However, initial efforts toward individualizing the tool may be offset by long-term benefits in terms of improved pain management, since children with CI are subject to continuing and repeated pain experiences.

We found that clinicians rated the complexity, compatibility, relative advantage, and overall clinical utility higher for the r-FLACC and NAPI compared with the NCCPC-PV, suggesting that these tools may be more readily adopted into clinical practice. Additionally, these tools had good measures of reliability and validity. Further study will be needed to determine whether adoption into practice is easy with these tools, and whether adoption has a positive impact on pain assessment and management in children with CI.

Footnotes

Accepted for publication August 23, 2007.

Supported entirely by the NICHD; Grant 5 RO3 HD043920-02.

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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins and Stanford University Libraries' HighWire Press®. Copyright 2008 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press