challenges and solutions to pain assessment research in karen snow kaiser, phd, rn; deborah b....

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?