validity of fatigue recall ratings mark p. jensen, ph.d. ascpro steering committee meeting, october...
TRANSCRIPT
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Validity of Fatigue Recall Ratings
Mark P. Jensen, Ph.D.ASCPRO Steering Committee Meeting, October 2007
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Issue of symptom recall is critical
FDA Guidance
“…instruments that require patients to rely on memory, especially if they must recall over a period of time, or to average their response over a period of time may threaten the accuracy of PRO date” (p. 11)
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Validity of pain recall
Tendency to over-estimate previous pain (on average; e.g., Jamison et al., 1989; Porzelius, 1995; Stone et al., 2004; Tasmuth et al., 1996; but not always -- see Babul and Darke, 1994; Kwilosz et al., 1984; finding may be related to possible tendency to consider periods of pain only; Kikuchi et al., 2006; Stone et al., 2004)
There is evidence for “end” effects (although the effect sizes of end effects are rather weak 12% & 13% in 7-day recall, Stone et al., 2000; Jensen et al., 1996; 2%-4% in 24-hr recall, Jensen et al., in press)
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Validity of pain recall
Assessor status impacts accuracy (Phone call from physician elicited accurate recall ratings; call from RA elicited over-estimates; Williams et al., 2007).
Variability of pain impacts accuracy (Higher variability during the week = larger over-estimate, Stone et al., 2005; and = weaker association, Kikuchi et al., 2006).
Without clear instructions, people use varying strategies to determine recalled average pain ( Broderick et al., 2006; Williams, et al., 2000).
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Validity of pain recall
Recall of worst pain tends to be more strongly associated with measures of functioning then recall of average pain (e.g., Shi et al., under review; Tittle et al., 2003; Yun et al., 2004; Zelman et al., 2005)
Recall of worst pain (past 7 days) is less accurate than recall of average pain, which is less accurate than least pain (Jensen et al., 1996)
But…
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Validity of pain recall
Recall of average pain over the last week shows strong associations to actual averages from diaries (e.g., ICC = .82, Bolton, 1999; r > .90, Jamison et al., 2006; r = .85, Jamison et al., 1989;
r = .78, Jensen et al., 1996; r = .72, Stone et al., 2000; rs = .75 & .79, Stone et al., 2004; r = .68 for h/a, Kikuchi et al., 2006).
Recall ratings are responsive to changes in pain with treatment (100s [1,000s?] of clinical trials; too many to list)
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What to do?
Option 1
- Assess current pain multiple times, - Compute worst, least, and average pain from multiple ratings. - Resulting measures are likely more valid (then recall) of actual worst least and average pain. - Problem solved…
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Except…
- Assessment burden and cost.
- Between 5% and 10% missing data.
- Increasing accuracy of recall ratings may or may not increase ability of measure to detect change.
- Judgments of validity are tied to use;
fly swatter vs. bazooka.
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Validity of pain recall
Pain recall ratings
- At times over-estimate past pain, - Are influenced by: most recent pain, variability, pain domain assessed, and status of assessor, and - Are adequately valid for assessing characteristic or average pain in clinical trials.
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Validity of fatigue recall ratings
- One study (Meek, Lareau, and Anderson, 2001)
- 30 patients with chronic obstructive pulmonary disease rated today’s “tiredness” (and also shortness of breath) daily on 0 – 10 scales for 14 days
- Asked to rate 2-wk average, greatest, and least tiredness and dyspnea on final visit
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Validity of fatigue recall ratings
- Recall ratings of average, greatest and least tiredness (and also dyspnea) were similar
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Validity of fatigue recall ratings
- In regression analyses, today’s tiredness was the strongest predictor of recall rating (consistent with an end effect)
- Association between actual and recalled average was not computed
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Validity of fatigue recall ratings
- Recall (mostly 7 days, sometimes past 2-3 days or past 24 hours) ratings are commonly used in fatigue research
- Recall fatigue ratings are responsive to expected changes in treatment
- Findings from the one study on fatigue recall and clinical trial results are consistent with pain recall research, suggesting that…
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Validity of fatigue recall ratings
- …fatigue recall ratings are (probably) adequately valid for assessing characteristic or average fatigue in clinical trials; but
- Research is needed to - compare worst, average and least recall, - determine if accuracy can be improved (e.g., using of electronic diaries); but - remember to examine validity with respect to the planned purpose