Test-retest Reliability of the BREAST-Q IS in the Australian Breast Device Registry

Author(s):  
Michelle Merenda ◽  
Swarna Vishwanath ◽  
Sze Ng ◽  
Emily Parker ◽  
Arul Ernest ◽  
...  

Abstract Background Patient Reported Outcome Measures (PROM) are increasingly used in healthcare to assess outcomes. The BREAST-Q Implant Surveillance (BREAST-Q IS) is a 5-question Patient Reported Outcome Measure (PROM) used by the Australian Breast Device Registry (ABDR) to monitor the performance of breast devices. Validation of this tool is needed to assess its utility in this setting. Objectives The objective of our study was to assess the test-retest reliability of the BREAST-Q IS among breast implant recipients within a registry setting. Methods A test-retest reliability study was undertaken. Patients who had breast augmentation or breast reconstruction and registered with the ABDR were eligible to participate. Two hundred and fifty surveys were distributed. The BREAST-Q IS was administered to the same group of participants on two separate occasions with a 2-week test interval. Participants were divided into two groups, breast augmentation and breast reconstruction. A weighted kappa coefficient was calculated to assess the degree of test-retest reliability of the BREAST-Q IS. Results Two hundred and seven participants completed both tests. Response rate was 82% (n=113) for the breast augmentation group and 94% (n=94) for the breast reconstruction group. All 5 questions on the BREAST-Q IS obtained weighted kappa scores above 0.74 among both groups. Conclusions The BREAST-Q IS has good-to-excellent test-retest reliability for use among breast implant recipients in a registry setting. Further validation of the BREAST-Q IS will be required to establish the BREAST-Q IS as a valid and reliable PROM tool for breast implant recipients following breast device surgery.

2019 ◽  
Vol 39 (8) ◽  
pp. NP314-NP321 ◽  
Author(s):  
Sze Ng ◽  
Andrea Pusic ◽  
Emily Parker ◽  
Swarna Vishwanath, ◽  
Rodney D Cooter ◽  
...  

Abstract Background The Breast-Q Implant Surveillance module (BREAST-Q IS) is a patient-reported outcome measure (PROM) that asks 5 questions on satisfaction (shape, feel, and rippling) and symptoms (pain and tightness) derived from the BREAST-Q. Objectives We aimed to pilot BREAST-Q IS on patients within the Australian Breast Device Registry (ABDR), an opt-out clinical quality device registry, and explored Short Message Service (SMS) communication as a follow-up method. Methods Patients with a breast device surgery in the previous 10 to 15 months, age ≥18 years, with a mobile phone number, were invited to complete the 5-question PROM via SMS initially, followed by 3 phone call attempts if no response, an e-mail, and then a letter by post as a final engagement strategy. Results The study included 197 participants [breast augmentation (BA) = 118; breast reconstruction (BR) = 79]. Mean ± SD age was 40 ± 12 years (BA) and 44 ± 11 years (BR). Mean ± SD time since surgery was 414 ± 36 days (BA) and 413 ± 51 days (BR). The total response rate, including opt-outs, was 76%. Responses indicated that >90% of BA and >79% of BR were very or somewhat satisfied with shape, feel, and wrinkling; >70% of BA and >46% of BR reported no pain or tightness. Completion of survey via SMS was 51% (BA) and 55% (BR). Further responses were received by phone (25%, 26%), post (21%, 16%), and e-mail (3%, 3%). Conclusions This pilot demonstrated high levels of satisfaction and low levels of pain and tightness in patients with breast augmentation and breast reconstruction 1 year postoperatively. It also showed the effectiveness of our engagement strategy, which achieved a 76% response rate. Over 50% of respondents used SMS to reply to a 5-question PROM assessing long-term surgical outcomes. This engagement strategy will be used as BREAST-Q IS is rolled out nationally.


2020 ◽  
Vol 33 (4) ◽  
pp. 480-489 ◽  
Author(s):  
Lazar Tosic ◽  
Elior Goldberger ◽  
Nicolai Maldaner ◽  
Marketa Sosnova ◽  
Anna M. Zeitlberger ◽  
...  

OBJECTIVEThe 6-minute walking test (6WT) is used to determine restrictions in a subject’s 6-minute walking distance (6WD) due to lumbar degenerative disc disease. To facilitate simple and convenient patient self-measurement, a free and reliable smartphone app using Global Positioning System coordinates was previously designed. The authors aimed to determine normative values for app-based 6WD measurements.METHODSThe maximum 6WD was determined three times using app-based measurement in a sample of 330 volunteers without previous spine surgery or current spine-related disability, recruited at 8 centers in 5 countries (mean subject age 44.2 years, range 16–91 years; 48.5% male; mean BMI 24.6 kg/m2, range 16.3–40.2 kg/m2; 67.9% working; 14.2% smokers). Subjects provided basic demographic information, including comorbidities and patient-reported outcome measures (PROMs): visual analog scale (VAS) for both low-back and lower-extremity pain, Core Outcome Measures Index (COMI), Zurich Claudication Questionnaire (ZCQ), and subjective walking distance and duration. The authors determined the test-retest reliability across three measurements (intraclass correlation coefficient [ICC], standard error of measurement [SEM], and mean 6WD [95% CI]) stratified for age and sex, and content validity (linear regression coefficients) between 6WD and PROMs.RESULTSThe ICC for repeated app-based 6WD measurements was 0.89 (95% CI 0.87–0.91, p < 0.001) and the SEM was 34 meters. The overall mean 6WD was 585.9 meters (95% CI 574.7–597.0 meters), with significant differences across age categories (p < 0.001). The 6WD was on average about 32 meters less in females (570.5 vs 602.2 meters, p = 0.005). There were linear correlations between average 6WD and VAS back pain, VAS leg pain, COMI Back and COMI subscores of pain intensity and disability, ZCQ symptom severity, ZCQ physical function, and ZCQ pain and neuroischemic symptoms subscores, as well as with subjective walking distance and duration, indicating that subjects with higher pain, higher disability, and lower subjective walking capacity had significantly lower 6WD (all p < 0.001).CONCLUSIONSThis study provides normative data for app-based 6WD measurements in a multicenter sample from 8 institutions and 5 countries. These values can now be used as reference to compare 6WT results and quantify objective functional impairment in patients with degenerative diseases of the spine using z-scores. The authors found a good to excellent test-retest reliability of the 6WT app, a low area of uncertainty, and high content validity of the average 6WD with commonly used PROMs.


2020 ◽  
Vol 28 (1) ◽  
pp. 386-404 ◽  
Author(s):  
C. F. Davies ◽  
R. Macefield ◽  
K. Avery ◽  
J. M. Blazeby ◽  
S. Potter

Abstract Background Breast reconstruction (BR) is performed to improve outcomes for patients undergoing mastectomy. A recently developed core outcome set for BR includes six patient-reported outcomes that should be measured and reported in all future studies. It is vital that any instrument used to measure these outcomes as part of a core measurement set be robustly developed and validated so data are reliable and accurate. The aim of this systematic review is to evaluate the development and measurement properties of existing BR patient-reported outcome measures (PROMs) to inform instrument selection for future studies. Methods A PRISMA-compliant systematic review of development and validation studies of BR PROMs was conducted to assess their measurement properties. PROMs with adequate content validity were assessed using three steps: (1) the methodological quality of each identified study was assessed using the COSMIN Risk of Bias checklist; (2) criteria were applied for assessing good measurement properties; and (3) evidence was summarized and the quality of evidence assessed using a modified GRADE approach. Results Fourteen articles reported the development and measurement properties of six PROMs. Of these, only three (BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23) were considered to have adequate content validity and proceeded to full evaluation. This showed that all three PROMs had been robustly developed and validated and demonstrated adequate quality. Conclusions BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23 have been well-developed and demonstrate adequate measurement properties. Work with key stakeholders is now needed to generate consensus regarding which PROM should be recommended for inclusion in a core measurement set.


2019 ◽  
Vol 14 (8) ◽  
pp. 1-13
Author(s):  
Aynsley Cowie ◽  
Mario Hair ◽  
Emma Kerr ◽  
Janet McKay ◽  
Lesley Allan ◽  
...  

Background/Aims This article details how a patient-reported outcome measure (PROM), termed PROM-CR1, was tested for acceptability, validity and test-retest reliability at the end of an outpatient cardiac rehabilitation programme. Methods PROM-CR1 was completed by 138 service users (mean age 66.95 years, range 42–94 years; 115 males, 23 females; with a range of cardiac diagnoses), who used the tool at home twice: once at the end of the outpatient cardiac rehabilitation programme and 1 week later. Results PROM-CR1 demonstrated good acceptability, construct and concurrent validity, and test-retest reliability. The construct validity analysis highlighted that one item required removal from the PROM-CR1. Conclusions A finalised 30-item version of the tool will now be widely disseminated and further evaluated within cardiac rehabilitation clinical practice.


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