Validation of a novel patient-reported outcome measure for parathyroid and thyroid disease (PROMPT)

Burneikis, Talia; Colvin, Jennifer S.; Jin, Judy; Berber, Eren; Krishnamurthy, Vikram D.; Shin, Joyce; Siperstein, Allan

doi:10.1016/j.surg.2018.04.091

Cited by 6 publications

(3 citation statements)

References 18 publications

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“…From these, 35 studies did not meet the inclusion criteria. Eleven studies were excluded because of different outcomes [7,15,19,[32][33][34][35][36][37][38][39], nine studies were excluded because of a different population [11,18,20,[40][41][42][43][44][45], three studies evaluated different time points [13,14,46], and one evaluated a different intervention [47]. The remaining eleven studies were either missing the full text, were duplicates, or were written in another language.…”

Section: Resultsmentioning

confidence: 99%

Quality of Life in Patients with Benign Non‐Toxic Goiter After Surgical Intervention: A Systematic Review and Meta‐Analysis

et al. 2022

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Background Prior studies evaluating health-related quality of life (HR-QoL) outcomes in patients undergoing surgery for benign non-toxic goiter have used different instruments and time points, leading to conflicting results. We sought to systematically review the differences in HR-QoL among patients with BNTG at baseline and 6 months after surgery, using exclusively the ThyPRO questionnaire. Methods A systematic search was performed using PubMed, Embase, Web of Science, Cochrane Central, CINAHL, and PsycINFO for papers reporting the assessment of HR-QoL utilizing ThyPRO. Data were meta-analyzed using a random-effects model, and pooled estimates were calculated using weighted mean differences (WMD) between baseline and 6 months after surgery. We assessed the quality and risk of bias of the studies using the Robins-I tool and previously published minimally important change (MIC) values to assess clinical significance. Results Six papers met the predefined inclusion criteria, describing a total of 496 patients. Meta-analysis demonstrated improved QoL in all thirteen domains of ThyPRO six months post-surgical intervention compared to baseline. Specifically, the largest improvement in QoL was seen in the domains of overall QoL, WMD -25.84 (95% CI -29.70, -21.98, p \ 0.001, I 2 = 23%), goiter symptoms, 23.96 (95% CI -30.29, -17.64, p \ 0.001, I 2 = 91%), and tiredness, -16.20 (95% , p \ 0.001, I 2 = 3%). The differences in scores 9 of 13 domains were clinically significant based on MIC. Conclusions Disease-specific HR-QoL improved in all ThyPRO domains after surgery in patients with BNTG. Future studies of QoL in thyroid surgery patients will benefit from a standard questionnaire and improved reporting of covariates including complications to ensure comparability across studies.

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Section: Resultsmentioning

confidence: 99%

Quality of Life in Patients with Benign Non‐Toxic Goiter After Surgical Intervention: A Systematic Review and Meta‐Analysis

et al. 2022

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“…Although thyroid disease-specific PRO tools exist, none currently assess patient expectations. [5][6][7][8] The most important initial step for developing a PRO tool is establishing content validity in accordance with the rigorous methodological recommendations included in the 2009 US Food and Drug Administration's ''Guidance for Industry-Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims.'' 9 Herein we describe the content validation and preliminary psychometric validation of ThyroidEx, a first-of-its-kind PRO instrument that we developed for the rigorous measurement of preoperative expectations in patients undergoing thyroid cancer surgery.…”

mentioning

confidence: 99%

“…However, the integration of quality measured by PROs and patient satisfaction into payment models requires an understanding of the influence of expectations, which is limited by a lack of tools to measure expectations in patients with thyroid cancer. Although thyroid disease–specific PRO tools exist, none currently assess patient expectations 5–8 . The most important initial step for developing a PRO tool is establishing content validity in accordance with the rigorous methodological recommendations included in the 2009 US Food and Drug Administration’s “Guidance for Industry—Patient‐Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims.” 9…”

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confidence: 99%

ThyroidEx: Development and Preliminary Validation of a Thyroid Surgery Expectations Measure

Patel

Atkinson

Tuttle

et al. 2020

Otolaryngol.--head neck surg.

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Objective To address the lack of validated patient-reported outcome (PRO) instruments that define and quantify patient expectations in thyroid cancer surgery, we developed and initially validated ThyroidEx, a novel disease-specific PRO instrument. Study Design Survey study. Setting Single-institution tertiary care cancer center. Methods An expert panel drafted an initial set of thyroid cancer–specific concepts, which was used in semistructured concept elicitation interviews with patients with thyroid cancer 4 weeks before and 8 weeks after surgery. Candidate items were generated per patient responses and refined via cognitive interviewing and additional review by the expert panel. The draft ThyroidEx was then preoperatively administered to a separate cohort undergoing thyroid cancer surgery to establish a final item set and initial psychometric evidence. Results Prospective concept elicitation interviews generated 358 patient-elicited concepts (n = 15 patients). These were then placed into 70 unique subcategories from which 41 items were generated for cognitive interviews with 20 patients preoperatively and 28 postoperatively. After expert panel review, ThyroidEx included 18 items across 2 scales (Expectations and Concerns), with an additional item about beliefs. In the preoperative cohort in phase 2 (n = 67), internal consistency Cronbach’s α values ranged from 0.81 to 0.89. Descriptive analysis showed significant differences between patients’ concerns and expectations and clinicians’ perceptions. Conclusion Defining expectations represents an important modifier in the measurement of PROs. Preliminary validation of ThyroidEx revealed incongruent expectations between expert opinion and patients. Future development and implementation of ThyroidEx may affect preoperative consultation and the consent process.

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Surgical Procedures. Parathyroidectomy: Indications, Operative Techniques, Management of Complications, Intraoperative PTH Monitoring, Role of Parathyroid Autofluorescence and ICG

Burneikis

Siperstein

2021

Endocrine Surgery Comprehensive Board Exam Guide

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Validation of a novel patient-reported outcome measure for parathyroid and thyroid disease (PROMPT)

Cited by 6 publications

References 18 publications

Quality of Life in Patients with Benign Non‐Toxic Goiter After Surgical Intervention: A Systematic Review and Meta‐Analysis

Quality of Life in Patients with Benign Non‐Toxic Goiter After Surgical Intervention: A Systematic Review and Meta‐Analysis

ThyroidEx: Development and Preliminary Validation of a Thyroid Surgery Expectations Measure

Surgical Procedures. Parathyroidectomy: Indications, Operative Techniques, Management of Complications, Intraoperative PTH Monitoring, Role of Parathyroid Autofluorescence and ICG

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