Challenges and Solutions to Pain Assessment Research in

1. 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 ; and Timothy Keay, MD, MA-TH Non-communicative Palliative Care Patients in an Acute Care Setting

2. Acknowledgements • National Institute of Nursing Research: Pain Assessment in Non-communicative Palliative Care Patients (1R01NR009684-01A1) (D.B. McGuire, PI) • Research Team members: • Sue Gutkin • Mary Ellen Haisfield-Wolfe • Florence Iyamu • Stephanie Leimenstoll • Lisa Sullivan • Richard Shrout

3. 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.

4. 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 findings MOPAT study undertaken to address this gap

5. Specific Aims • Test 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.

6. Setting University of Maryland Medical Center (UMMC)

7. 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

8. Methodological Challenges • Four selected challenges • Appropriate patient eligibility criteria • Informed consent from non-communicative individuals • Enrollment of eligible patients • Pain rater subjectivity • Research Team and Interdisciplinary Clinical Advisory Board developed solutions to deal with the challenges

9. 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

10. 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

11. 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

12. 1: Patient Eligibility Criteria (cont.) N = 163

13. 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

14. 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

15. 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

16. 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

17. 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

18. 3: Enrollment (cont.) • 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)

19. 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 BehavioralDimension of MOPAT

20. 4: Pain Rater Subjectivity (cont.)

21. 4: Pain Rater Subjectivity (cont.) • Solutions: • Developed a training video of three simulated patient scenarios before/after pain interventions • Developed 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)

22. 4: Pain Rater Subjectivity (cont.) Inter-rater reliability was acceptable overall, although higher between SN pairs compared to VSN/SN pairs. 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.

23. 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

24. Questions?