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RECALL DESIGN

RECALL DESIGN. Recall Period. MSAS: past week MDASI: past 24 hours, past week EORTC: past week PROMIS: past week http://www.nihpromis.org/PROMIS%20The%20First%20Four%20years/PROMIS_The_First_Four_Years.doc Most PROMIS item banks utilize a 7-day recall period

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RECALL DESIGN

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  1. RECALL DESIGN

  2. Recall Period • MSAS: past week • MDASI: past 24 hours, past week • EORTC: past week • PROMIS: past week • http://www.nihpromis.org/PROMIS%20The%20First%20Four%20years/PROMIS_The_First_Four_Years.doc • Most PROMIS item banks utilize a 7-day recall period • Time frame chosen because it is on the upper limits of ecological validity for specific events (especially for subjective symptoms), yet long enough to allow time for people to experience enough events • Also, many clinical trials look for response to therapy over a few weeks time, and a longer recall time would undermine the ability to detect benefits • “The past 7 days” is the reference period for all items in Anxiety, Anger, Depression, Fatigue, Pain Behavior, Pain Impact, Satisfaction with Discretionary Social Activities, and Satisfaction with Social Roles • Physical function items emphasize current capabilities and therefore do not employ a recall period (stems begin with phrases such as “Does your health now limit you” or “Are you able to”) • Some global health items use a 7-day recall period while others do not employ a recall period and emphasize current status “in general”

  3. From: Stull DE, Leidy NK, Parasuraman B, Chassany O. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr Med Res Opin. 2009 Apr;25(4):929-42.

  4. SF-36: 4-Week Recall vs 1-Week Recall • Keller SD, Bayliss MS, Ware JE Jr, Hsu MA, Damiano AM, Goss TF. Comparison of responses to SF-36 Health Survey questions with one-week and four-week recall periods. Health Serv Res. 1997 Aug;32(3):367-84. • 3 time points: baseline, 2 weeks, 6 weeks • N=142 patients • Patients randomized to complete either the 4-week or the 1-week version (at all time points) • Recall was tested by comparing means at each time point • Standard psychometric properties evaluated for each form

  5. 2-Year Recall of Symptoms Following a Motor Vehicle Accident • Harvey AG, Bryant RA. Memory for acute stress disorder symptoms: a two-year prospective study. J Nerv Ment Dis. 2000 Sep;188(9):602-7. • N=92 assessed within 1-month post trauma • N=56 assessed 2-years later • At 2 years: 25% made no errors in recalling symptom, 50% incorrectly recalled symptoms from one cluster, 18% from two clusters, 3.6% from three clusters, and 2% from four clusters • Conclusion: Recall generally good but not perfect.

  6. COPD Recall of Fatigue and Dyspnea • Meek PM, Lareau SC, Anderson D. Memory for symptoms in COPD patients: how accurate are their reports? Eur Respir J 2001;18:474-481. • N=30 males w/ severe COPD in pulmonary outpatient clinic • Record fatigue and dyspnea daily for 2 weeks • Report average, greatest, and least fatigue and dyspnea over past two weeks on Day 14 • Primary contributor to Day 14 scores was symptom intensity on Day 14 (Pulmonary Functional Status and Dyspnoea Questionnaire-modified version).

  7. Memory of Pain • Eich E, Reeves JL, Jaeger B, Graff-Radford SB. Memory for pain: relation between past and present pain intensity. Pain. 1985 Dec;23(4):375-80. • N=25 • Hourly ratings of pain intensity (0-10), hourly rating of pain intensity (VAS), max/usual/min pain since last visit (VAS) • Patients overestimated their max/usual/min level of prior pain present pain was high; underestimated prior pain when present pain was low.

  8. Pain and Fatigue • Broderick JE, Schwartz JE, Vikingstad G, Pribbernow M, Grossman S, Stone AA. The accuracy of pain and fatigue items across different reporting periods. Pain. 2008 Sep 30;139(1):146-57. • N = 83 from a community rheumatology practice • Momentary pain and fatigue items completed on average of 5.4 times per day for a month using an electronic diary (on handheld device with auto notifications) • SF-36 v2, Brief Pain Inventory, McGill Pain Questionnaire, Brief Fatigue Inventory collected 6 times (two with 1-day recall, two with 3-day recall, one with 7-day recall, and one with 28-day recall) • Patients were randomized to one of 10 assessment schedules (ie, order of the recall periods) • 1-day recall: one on a weekend, one on a weekday • 3-day recall: one on a Monday, one on a Thursday or Friday • 7-day recall: took place on a weekday • 28-day recall: end of study for all subjects • No overlap of the recall periods, no assessments in the first 3-6 days • Patient was given 6 sealed envelopes with the assessments in them • Assessments were completed on paper and mailed as well as entered in IVRS for time/date stamp • Recall ratings were consistently inflated relative to averaged momentary ratings • 1-day recall corresponded well to the averaged momentary assessments for the day • Several, but not all, items demonstrated substantial correlations across the different reporting periods • An additional 7 day-by-day recall task suggested that patients have increasing difficulty actually remembering symptom levels beyond the past several days

  9. “We speculate that patients with a chronic illness…have a good idea of their typical pain and fatigue levels. Given the difficulty of recalling many previous days, as in the case of the 28-day reporting period, patients may refer to these beliefs, which provide a reasonably good estimate of average symptom levels. However, when asked to construct a rating to represent the past 7 days, patients may attempt to retrieve some memories from the week, which are subject to the distortion of the cognitive heuristics mentioned earlier (e.g., peak effect), thereby decreasing accuracy.”

  10. Recall Period • PRO-CTCAE: past week • Head/neck/gastroesoph receiving daily chemo-rad • Initial proposal: • 6 time points – Days 1 & 2, Days 15 & 16, and Days 35 & 36 • Plan to look at two psychometric properties with these patients: • Test-retest reliability: use consecutive days (e.g., Days 1 & 2) • Do we need to have multiple pairs of days? • Recall (design not specified)

  11. Recall – Proposed Change • Embark on a separate recall study which uses an interactive voice response system version of the PRO-CTCAE • Not limited by clinic visits so could include a wider variety of patients • Design similar to the Broderick et al. study • Testing recall in the current study in just head/neck/gastroesoph patients is too limited (limited power and limited generalizability) • Focus in the current study on validation / sensitivity ! • Proposal: • Two time points: Baseline and 3-4 weeks Post-baseline • Breast ca receiving adj chemo (N=70) • Lymphoma/myeloma ca receiving chemo (N=70) • Met prostate or bladder ca receiving chemo (N=70) • Met lung ca receiving chemo (N=70) • Met colorectal ca receiving chemo (N=70) • Three time points: Day 1, Day 2, and 3-4 weeks Post-baseline • Head/neck/gastroesoph receiving daily chemo-rad (N=50) • Still plan to use Day 1 & 2 in assessing test-retest reliability

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