Challenges and Solutions to Pain
Assessment Research in
Karen Snow Kaiser, PhD, RN; Deborah B. McGuire, PhD, RN, FAAN; Karen Soeken, PhD; JoAnne Reifsnyder, PhD, ACHPN ; andTimothy Keay, MD, MA-TH
Non-communicative Palliative Care Patients in an Acute Care Setting
National Institute of Nursing Research: Pain Assessment in Non-communicative Palliative Care Patients (1R01NR009684-01A1) (D.B. McGuire, PI)
Research Team members: Sue GutkinMary Ellen Haisfield-WolfeFlorence IyamuStephanie LeimenstollLisa SullivanRichard Shrout
Acknowledgements
Purposes
Identify four challenges associated with conducting pain assessment research in non-communicative palliative care patients in an acute care setting.
Discuss one to two solutions for addressing each challenge.
Background
Assessing pain in non-communicative palliative care patients poses formidable challenges to clinicians and researchers
Limited information on pain assessment in adult patients without dementia
Limited number of tools that can be used within and across clinical palliative care settings
Previous research conducted psychometric testing in self-reporting patients who were mildly cognitively impaired
Limited generalizability of findingsMOPAT study undertaken to address this gap
Specific AimsTest the reliability and validity of the
Multidimensional Objective Pain Assessment Tool (MOPAT) for assessing acute pain in non-communicative palliative care patients in an inpatient tertiary acute care hospital and in the inpatient units of a community-based hospice
Appraise the clinical utility of the MOPAT when used by nurses to assess acute pain in non-communicative patients in these settings.
Setting
University of Maryland Medical Center (UMMC)University of Maryland Medical Center (UMMC)
Study Design
Methodological instrument-testing design Validity and reliability Clinical utility (usefulness)
Cross-sectional approach In eligible patients, pairs of nurse raters assessed
patients before and after a pain-relieving intervention
• Study Nurse (SN) pairs
• Volunteer Staff Nurse (VSN) and SN pairs
Methodological Challenges
Four selected challengesAppropriate patient eligibility criteria Informed consent from non-communicative individualsEnrollment of eligible patientsPain rater subjectivity
Research Team and Interdisciplinary Clinical Advisory Board developed solutions to deal with the challenges
1: Patient Eligibility Criteria
Why important?Generalizability to relevant patients
• Variability in patient conditions and pain
Broad yet unique categories of pain• Clinically applicable and included most/all acute pain
Issue: Overlapping types of acute pain
• Breakthrough, movement-related, episodic, procedural, and uncontrolled
Category Operational DefinitionEpisodic pain Pain that occurs briefly during functional activities
such as bathing, turning, getting in or out of bed, or during physical or occupational therapy.
Procedural pain Pain that occurs as a result of a procedure such as peripheral blood draws, suctioning, dressing change, debridement, or nasogastric tube placement.
Uncontrolled or escalating persistent pain
Pain characterized by increasing intensity that appears to be due to underlying disease, new trauma, other medical conditions, or inadequate analgesia
1: Patient Eligibility Criteria (cont.)
Foley, K. 2005. Acute and Chronic Cancer Pain Syndromes Chapter 8.2.2. p. 298-316 In Doyle, D. Hanks, G., Cherney, N.I., Calman, K. (Eds.) Oxford Textbook of Palliative Medicine 3rd ed. Oxford University Press. New York, NY.
Mercadante, S., Radbruch, L., Caraceni, A., Cherny, N., Kaasa, S., Nauck, F., Ripamonti, C., De Conno, F., and The Steering Committee of the European Association for Palliative Care (EAPC) Research Network 2002. Episodic (Breakthrough) Pain: Consensus Conference of an Expert Working Group of the European Association for Palliative Care. Cancer. 94:832-839
1: Patient Eligibility Criteria (cont.)
18 years or older Met World Health Organization definition for
receiving palliative care Have a diagnosis or condition known to cause
acute pain (as defined previously) Unable to communicate their pain by self-
report due to any non-communicative state
1: Patient Eligibility Criteria (cont.)
Episodic pain 90 (55%)
Procedural pain 69 (42%)
Uncontrolled pain 4 (3%)
N = 163
2: Informed Consent
Why important? Foundational principle of ethical research Vulnerable population
• Cognitively impaired, critically ill, terminally ill or dying
Issue: Non-communicative patients unable to provide
own consent Appropriate alternative required
2: Informed Consent (cont.)
Solutions: Informed consent provided by patient’s Legally
Authorized Representative (LAR)• As identified in the medical record
Required rewriting of informed consent document to make it clear to LARs that they were providing consent on behalf of their loved ones
3: Enrollment
Why important? Statistical power for reliability/validity analyses Time limitation due to grant funding period
Issue: Window of opportunity was narrow LARS were frequently not available Attempts to contact LARs often unsuccessful Losing two-thirds of eligible patients
3: Enrollment (cont.)
Solution: Consultation with IRB resulted in a request for
waiver of written consent and full privacy waiver:• Minimal risk even if consent were waived
• Rights and welfare of subjects not affected
• Data collection procedures essentially no different from standard clinical nursing practice in pain assessment
• Study nurses did not touch or move patients and did not administer pain interventions
• Written informed consent was not practicably feasible
3: Enrollment (cont.)
Before waiver:Enrolled 16 patients in 6 months
After waiver: Enrolled 44 subjects in 3.5 months Within time period of grant award, exceeded
target sample size of 130 patients required to perform sufficiently powered analyses
163 non-communicative adult palliative care patients across 21-22 participating units 66% Male (n=107), 34% Female (n=56) Mean age=52.6 years (SD=18.72)
Racial Category # (%) Asian 5 (3%) Black/Afro-American 48 (29%) White 108 (66%) Unknown/ Not Reported 2 (1%)
3: Enrollment (cont.)
4: Pain Rater Subjectivity
Why important:Subjective assessment required by the MOPAT, and item
descriptions could have different meanings to different people Need to reduce variation between raters
Issue: Potential for discrepancies in nurse ratings of subjective pain behaviors
• Restlessness
• Tense muscles
• Frowning
• Patient sounds
Behavioral Dimension of MOPAT
4: Pain Rater Subjectivity (cont.)
Behavioral Pain
Indicators
0 (None or
Normal)
1 (Mild) 2 (Moderate) 3 (Severe)
Restless Quiet Slightly restless (fidgety)
Moderately restless (tossing/turning)
Very restless (agitated, constant movement)
Tense Muscles
(Muscle Tension)
Relaxed Slight tenseness (Guarding)
Moderate tenseness (sensitivity or mild resistance to movement)
Extreme tenseness (stiffness or total body rigidity)
4: Pain Rater Subjectivity (cont.)
Solutions:Developed a training video of three simulated
patient scenarios before/after pain interventionsDeveloped consensus ratings for each scenario
using experts (palliative care and pain nurses; ICU, non-ICU, geriatric experience)
Performed periodic appraisal of MOPAT rating performance and retraining if needed (at least once during the study)
4: Pain Rater Subjectivity (cont.)
Inter-rater reliability was acceptable overall, although higher between SN pairs compared to VSN/SN pairs.
MOPAT ItemSN Pairs (n=90) SN and VSN Pairs (n=72)
Association1 Kappa Association1 Kappa
Restless .89 .56 .83 .40
Tense Muscles .90 .63 .82 .45
Frowning/Grimacing .91 .49 .79 .35
Patient Sounds .90 .65 .91 .54
Mean: Behavioral Dimension .90 .58 .84 .44
1 Gamma for ordinal level data on Behavioral Dimension. All values significant at p<.001. Strength of agreement for kappa: 0 = poor, .01 -.20 = slight, .41-.60 = moderate, .61-.80 = substantial, and .81-1 almost perfect.
Conclusions
Rigorous instrument-testing research is possible in non-communicative subjects despite numerous methodological challenges
Challenges need to be identified and addressed, preferably at the start of the study
A team approach using consultation with clinical, methodological and regulatory experts is essential for handling challenges
Questions?