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Evaluation of mode equivalence of the MSKCC Bowel Function Instrument, LASA Quality of Life, and Subjective Significance Questionnaire items administered by Web, interactive voice response system (IVRS), and paper.

ABSTRACT: To assess the equivalence of patient-reported outcome (PRO) survey responses across Web, interactive voice response system (IVRS), and paper modes of administration.Postoperative colorectal cancer patients with home Web/e-mail and phone were randomly assigned to one of the eight study groups: Groups 1-6 completed the survey via Web, IVRS, and paper, in one of the six possible orders; Groups 7-8 completed the survey twice, either by Web or by IVRS. The 20-item survey, including the MSKCC Bowel Function Instrument (BFI), the LASA Quality of Life (QOL) scale, and the Subjective Significance Questionnaire (SSQ) adapted to bowel function, was completed from home on consecutive days. Mode equivalence was assessed by comparison of mean scores across modes and intraclass correlation coefficients (ICCs) and was compared to the test-retest reliability of Web and IVRS.Of 170 patients, 157 completed at least one survey and were included in analysis. Patients had mean age 56 (SD = 11), 53% were male, 81% white, 53% colon, and 47% rectal cancer; 78% completed all assigned surveys. Mean scores for BFI total score, BFI subscale scores, LASA QOL, and adapted SSQ varied by mode by less than one-third of a score point. ICCs across mode were: BFI total score (Web-paper = 0.96, Web-IVRS = 0.97, paper-IVRS = 0.97); BFI subscales (range = 0.88-0.98); LASA QOL (Web-paper = 0.98, Web-IVRS = 0.78, paper-IVRS = 0.80); and SSQ (Web-paper = 0.92, Web-IVRS = 0.86, paper-IVRS = 0.79).Mode equivalence was demonstrated for the BFI total score, BFI subscales, LASA QOL, and adapted SSQ, supporting the use of multiple modes of PRO data capture in clinical trials.

SUBMITTER: Bennett AV

PROVIDER: S-EPMC4841708 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Evaluation of mode equivalence of the MSKCC Bowel Function Instrument, LASA Quality of Life, and Subjective Significance Questionnaire items administered by Web, interactive voice response system (IVRS), and paper.

Bennett Antonia V AV Keenoy Kathleen K Shouery Marwan M Basch Ethan E Temple Larissa K LK

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 20151121 5

<h4>Purpose</h4>To assess the equivalence of patient-reported outcome (PRO) survey responses across Web, interactive voice response system (IVRS), and paper modes of administration.<h4>Methods</h4>Postoperative colorectal cancer patients with home Web/e-mail and phone were randomly assigned to one of the eight study groups: Groups 1-6 completed the survey via Web, IVRS, and paper, in one of the six possible orders; Groups 7-8 completed the survey twice, either by Web or by IVRS. The 20-item surv ...[more]

PMID: 26590838

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Project description:PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system.Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0-4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed.103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55-0.90); tablet vs paper: 0.81 (0.62-0.96); IVRS vs paper: 0.78 (0.60-0.91); 89 % of ICCs were ?0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS?=?-0.04 [-0.16-0.22]; tablet vs paper = -0.02 [-0.11-0.14]; IVRS vs paper = 0.02 [-0.07-0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/-0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported "no problems" responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper.Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration.NCT Clinicaltrials.gov identifier: NCT02158637.

Project description:Background:Food frequency questionnaires (FFQs) are used to estimate the usual food and nutrient intakes over a period of time. Such estimates can suffer from measurement errors, either due to bias induced by respondent's answers or to errors induced by the structure of the questionnaire (e.g., using a limited number of food items and an aggregated food database with average portion sizes). The "structural validation" presented in this study aims to isolate and quantify the impact of the inherent structure of a FFQ on the estimation of food and nutrient intakes, independently of respondent's perception of the questionnaire. Methods:A semi-quantitative FFQ (n?=?94 items, including 50 items with questions on portion sizes) and an associated aggregated food composition database (named the item-composition database) were developed, based on the self-reported weekly dietary records of 1918 adults (18-79 years-old) in the French Individual and National Dietary Survey 2 (INCA2), and the French CIQUAL 2013 food-composition database of all the foods (n?=?1342 foods) declared as consumed in the population. Reference intakes of foods ("REF_FOOD") and nutrients ("REF_NUT") were calculated for each adult using the food-composition database and the amounts of foods self-reported in his/her dietary record. Then, answers to the FFQ were simulated for each adult based on his/her self-reported dietary record. "FFQ_FOOD" and "FFQ_NUT" intakes were estimated using the simulated answers and the item-composition database. Measurement errors (in %), spearman correlations and cross-classification were used to compare "REF_FOOD" with "FFQ_FOOD" and "REF_NUT" with "FFQ_NUT". Results:Compared to "REF_NUT," "FFQ_NUT" total quantity and total energy intake were underestimated on average by 198?g/day and 666 kJ/day, respectively. "FFQ_FOOD" intakes were well estimated for starches, underestimated for most of the subgroups, and overestimated for some subgroups, in particular vegetables. Underestimation were mainly due to the use of portion sizes, leading to an underestimation of most of nutrients, except free sugars which were overestimated. Conclusion:The "structural validation" by simulating answers to a FFQ based on a reference dietary survey is innovative and pragmatic and allows quantifying the error induced by the simplification of the method of collection.

Project description:BACKGROUND: Monitoring oral anticoagulants is logistically challenging for both patients and medical staff. We evaluated the effect of adding an interactive voice response system to computerized decision support for oral anticoagulant management. METHODS: We developed an interactive voice response system to communicate to patients the results of international normalized ratio testing and their dosage schedules for anticoagulation therapy. The system also reminded patients of upcoming and missed appointments for blood tests. We recruited patients whose anticoagulation control was stable after at least 3 months of warfarin therapy. We prospectively examined clinical data and outcomes for these patients for an intervention period of at least 3 months. We also collected retrospective data for each patient for the 3 months before study enrolment. RESULTS: We recruited 226 patients between Nov. 23, 2006, and Aug. 1, 2007. The mean duration of the intervention period (prospective data collection) was 4.2 months. Anticoagulation control was similar for the periods during and preceding the intervention (mean time within the therapeutic range 80.3%, 95% confidence interval [CI] 77.5% to 83.1% v. 79.9%, 95% CI 77.3% to 82.6%). The interactive voice response system delivered 1211 (77.8%) of 1557 scheduled dosage messages, with no further input required from clinic staff. The most common reason for clinic staff having to deliver the remaining messages (accounting for 143 [9.2%] of all messages) was an international normalized ratio that was excessively high or low, (i.e., 0.5 or more outside the therapeutic range). When given the option, 76.6% of patients (164/214) chose to continue with the interactive voice response system for management of their anticoagulation after the study was completed. The system reduced staff workload for monitoring anticoagulation therapy by 48 min/wk, a 33% reduction from the baseline of 2.4 hours. INTERPRETATION: Interactive voice response systems have a potential role in improving the monitoring of patients taking oral anticoagulants. Further work is required to determine the generalizability and cost-effectiveness of these results.

Dataset Information

Evaluation of mode equivalence of the MSKCC Bowel Function Instrument, LASA Quality of Life, and Subjective Significance Questionnaire items administered by Web, interactive voice response system (IVRS), and paper.

Publications

Evaluation of mode equivalence of the MSKCC Bowel Function Instrument, LASA Quality of Life, and Subjective Significance Questionnaire items administered by Web, interactive voice response system (IVRS), and paper.

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