Minimum Clinically Important Differences of the Hospital for Special Surgery Dysphagia and Dysphonia Inventory and Other Dysphagia Measurements in Patients Undergoing ACDF
Authors: Okano Ichiro , Ortiz Miller Courtney , Salzmann Stephan N. , Hoshino Yushi , Shue Jennifer , Sama Andrew A. , Cammisa Frank P. , Girardi Federico P. , Hughes Alexander P. 
Published: April 2020

Abstract

Background
Postoperative dysphagia is a common complication after anterior cervical surgery, and it can be measured using patient-reported outcome measures (PROMs). The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) is a condition-specific PROM to evaluate dysphagia and dysphonia after anterior cervical discectomy and fusion (ACDF). The minimum clinically important difference (MCID) of the HSS-DDI has not, to our knowledge, been established. Other PROMs have been used to assess dysphagia (SWAL-QOL and MD Anderson Dysphagia Inventory [MDADI]) in ACDF. Currently, few studies have addressed the MCIDs of these PROMs.

Questions/purposes
To determine (1) the minimum detectable changes (MDC) of the HSS-DDI, SWAL-QOL, and MDADI using a distribution-based approach, and (2) the MCID of the HSS-DDI, SWAL-QOL, and MDADI, using an anchor-based approach.

Methods
We used a longitudinally maintained database that was originally established for the HSS-DDI development and validation study. In all, 323 patients who underwent elective ACDF were assessed for enrollment eligibility; 83% (268 of 323) met the inclusion criteria and completed the HSS-DDI Week 4 survey. We set six outcomes: distribution-based MDCs for the (1) HSS-DDI, (2) SWAL-QOL, (3) MDADI, in addition to anchor-based MCIDs for the (4) HSS-DDI, (5) SWAL-QOL, and (6) MDADI. The HSS-DDI consists of 31 questions and ranges 0 (worst) to 100 (normal). We used the focused SWAL-QOL, which consists of 14 selected items from the original SWAL-QOL and ranges from 0 (worst) to 100 (normal). The MDADI is a 20-item survey and ranges from 20 (worst) to 100 (normal). A distribution-based approach is used to calculate values defined as the smallest difference above the measurement error. An anchor-based approach is used to determine the MCIDs based on an external scale, called an anchor, which indicates the minimal symptom change that is considered clinically important. All 268 patients were used for the distribution-based (0.5 SD) HSS-DDI MDC analysis. The first 16% (44 of 268) of patients completed retesting of the HSS-DDI via a telephone interview and were used for another distribution-based (standard error of measurement: SEM) MDC analysis. The number of patients for the test-retest group was determined based on the previously reported minimum required sample size of reliability studies. The first 63% (169 of 268, SWAL-QOL and 168 of 268, MDADI) of patients completed two other surveys for the external validation of the HSS-DDI, and were used for the SWAL-QOL and MDADI 0.5 SD analyses. Among the patients, 86% (230 of 268) completed the Week 8 HSS-DDI survey that was used for the anchor-based HSS-DDI MCID analysis, and 56% (SWAL-QOL, 150 of 268 and MDADI, 151 of 268) of patients completed the Week 8 surveys that were used for the SWAL-QOL and MDADI MCID analyses. Subjective improvement grades from the previous assessment were used as the anchor. The MCIDs were calculated as the mean score changes among those who reported little better or greater in the improvement assessment and receiver operating characteristic (ROC) curve analyses. We adopted the higher value of these two as the MCID for each PROM.

Results
The distribution-based MDCs for the HSS-DDI total score, SWAL-QOL, and MDADI were 11 of 100, 9 of 100, and 8 of 80 points, respectively, using the 0.5 SD method. Using the SEM-based method, the MDC for the HSS-DDI total score was 9 of 100 points. Regarding the anchor-based MCIDs, the values calculated with the mean score change method were consistently higher than those of ROC analysis and were adopted as the MCIDs. The MCIDs were 10 for the total HSS-DDI total score, 8 for the SWAL-QOL, and 6 for the MDADI.

Conclusions
Improvements of less than 10 points for the HSS-DDI score, 9 points for the SWAL-QOL, and 6 points for the MDADI are unlikely to be perceived by patients to be clinically important. Future studies on dysphagia after anterior cervical surgery should report between-group differences in light of this, rather than focusing on p values and statistical significance.

Level of Evidence
Level III, therapeutic study.