Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration

Norquist, Josephine M.; Girman, Cynthia J.; Fehnel, Sheri; DeMuro-Mercon, Carla; Santanello, Nancy C.

doi:10.1007/s11136-011-0003-8

Cited by 92 publications

(87 citation statements)

References 20 publications

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“…27 The choice of a short recall period may lead to underestimation of symptom severity, when symptoms have a day-to-day fluctuation, or else may place undue burden on the patient, if patients are too ill to frequently complete the questionnaire. However, a long recall period may over- or underestimate the true health status of the patient.…”

Section: Discussionmentioning

confidence: 99%

Development and Validation of a Symptom-Based Activity Index for Adults With Eosinophilic Esophagitis

et al. 2014

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BACKGROUND & AIMS Standardized instruments are needed to assess the activity of eosinophilic esophagitis (EoE), to provide endpoints for clinical trials and observational studies. We aimed to develop and validate a patient-reported outcome (PRO) instrument and score, based on items that could account for variations in patients’ assessments of disease severity. We also evaluated relationships between patients’ assessment of disease severity and EoE-associated endoscopic, histologic, and laboratory findings. METHODS We collected information from 186 patients with EoE in Switzerland and the US (69.4% male; median age, 43 years) via surveys (n = 135), focus groups (n = 27), and semi-structured interviews (n = 24). Items were generated for the instruments to assess biologic activity based on physician input. Linear regression was used to quantify the extent to which variations in patient-reported disease characteristics could account for variations in patients’ assessment of EoE severity. The PRO instrument was prospectively used in 153 adult patients with EoE (72.5% male; median age, 38 years), and validated in an independent group of 120 patients with EoE (60.8% male; median age, 40.5 years). RESULTS Seven PRO factors that are used to assess characteristics of dysphagia, behavioral adaptations to living with dysphagia, and pain while swallowing accounted for 67% of the variation in patients’ assessment of disease severity. Based on statistical consideration and patient input, a 7-day recall period was selected. Highly active EoE, based on endoscopic and histologic findings, was associated with an increase in patient-assessed disease severity. In the validation study, the mean difference between patient assessment of EoE severity and PRO score was 0.13 (on a scale from 0 to 10). CONCLUSIONS We developed and validated an EoE scoring system based on 7 PRO items that assesses symptoms over a 7-day recall period. Clinicaltrials.gov number: NCT00939263.

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Section: Discussionmentioning

confidence: 99%

Development and Validation of a Symptom-Based Activity Index for Adults With Eosinophilic Esophagitis

et al. 2014

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“…More specifically, choice of recall period should be affected by the purpose and intended use of the OHIP scores, the patient population, the patients’ disease or condition, the treatment or device, and the study design [38]. Similarly, as noted by Norquist et al “(1) recall depends on what the patient-reported outcome measure captures, its intended use, and attributes of the disease and study; (2) within the same disease area, recall can vary depending on the concept or phenomenon of interest; (3) recall must consider patient burden and their ability to easily and accurately recall the information requested; and (4) recall must be consistent with the duration of the trial and the scheduled clinic visits” [39]. While the choice of the OHIP recall period, such as the one-month or 7-day recall period, may not be substantially different for the patient’s burden, the measured phenomenon (e.g., current perceived oral health versus an average disease impact over a certain time) may be more accurately assessed using a particular recall period.…”

Section: Discussionmentioning

confidence: 99%

A 7-day recall period for a clinical application of the oral health impact profile questionnaire

et al. 2015

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Objectives Aims were to investigate and compare the validity and reliability of Oral Health Impact Profile (OHIP) scores referencing 7-day and one-month recall periods in international prosthodontic patients. Material and Methods A sample of 267 patients (mean age = 54.0 years, SD = 17.2 years, 58% women) with stable oral health-related quality of life was recruited from prosthodontic treatment centers in Croatia, Germany, Hungary, Japan, Slovenia, and Sweden. These patients completed the OHIP on two occasions using a new 7-day recall period and the traditional one-month recall period. OHIP score validity and reliability were investigated with structural equation models (SEMs) that included OHIPpast 7 days and OHIPone-month latent factors and single indicator measures of global oral health status. The SEMs assessed measurement invariance and the relative validities of the two OHIP latent factors (representing the two recall periods). Results The SEMs provided cogent evidence for recall period measurement invariance for the two OHIP forms and equal validities (r = .48) with external measures of global oral health status. Conclusion When assessed in international prosthodontic patients, OHIP scores using the new 7-day recall period were as reliable and valid as the scores using the one-month recall period. Clinical relevance Conceptual advantages make a 7-day recall period a preferred frame of reference in clinical applications of the OHIP questionnaire.

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“…PRO is defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else [34]. It highlights the importance of assessing the effectiveness of health care from the patients’ perspective.…”

Section: Methodsmentioning

confidence: 99%

The Effectiveness of Acupuncture Combined with Tuina Therapy in Patients with Migraine

et al. 2019

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Background: This study aimed to explore the effectiveness of acupuncture combined with tuina therapy in patients with migraine. Methods: A prospective, randomized controlled assessor-blind clinical trial was performed between January 2017 and May 2018, and 135 patients were assigned into acupuncture combined with tuina (A), acupuncture (B), and control (flunarizine hydrochloride) (C) groups, each with 45 patients. Treatments were performed for 12 weeks and a 4-week follow-up. Frequency of attacks, severity of pain, duration of migraine, associated symptoms, patient-reported outcome (PRO) scores, and frequency of analgesic consumption were assessed. Results: The total effective rate was 95.6, 88.9, and 75.6% for group A, B, and C, respectively, with a significant reduction in attack frequency, severity of pain, duration of migraine, and associated symptoms at post-treatment and follow-up compared to pre-treatment. The PRO scores and frequency of analgesic consumption were significantly improved (group A, p < 0.01; groups B and C, p < 0.05). The differences in pre-/post-treatment and in pre-treatment/follow-up in groups A and B were significantly improved compared to group C (A vs. C, p < 0.01; B vs. C, A vs. B, p < 0.05). No significant adverse events occurred. Conclusion: Acupuncture combined with tuina could significantly increase the therapeutic effect of acupuncture in migraine treatment.

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Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration

Cited by 92 publications

References 20 publications

Development and Validation of a Symptom-Based Activity Index for Adults With Eosinophilic Esophagitis

Development and Validation of a Symptom-Based Activity Index for Adults With Eosinophilic Esophagitis

A 7-day recall period for a clinical application of the oral health impact profile questionnaire

The Effectiveness of Acupuncture Combined with Tuina Therapy in Patients with Migraine

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