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Investigation performed at the Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY
Background: Dysphagia and dysphonia are common complications after anterior cervical spine surgery; however, re-
ported prevalences vary greatly due to a lack of reliable clinical standards for measuring postoperative swallowing and
speech dysfunction. The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) was developed as a
patient-derived, patient-reported instrument to measure dysphagia and dysphonia more accurately after anterior cervical
spine surgery than existing indices.
Methods: This multiphase survey-development study implemented a mixed-methods approach. Phase 1 involved quali-
tative assessment of postoperative patient-reported swallowing or speaking deficiencies to assemble a draft survey.
Phase 2 established test-retest reliability and finalized the 31-item HSS-DDI. Phase 3 compared the HSS-DDI with the
Swallowing-Quality of Life (SWAL-QOL) questionnaire and the M.D. Anderson Dysphagia Inventory (MDADI) for validity and
responsiveness.
Results: Phase 1, performed to formulate the draft survey, included 25 patients who were asked about speech and
swallowing dysfunction after anterior cervical spine surgery involving at least 3 vertebral levels. Phase 2 included 49
patients who completed the draft survey twice. The mean scores (and standard deviation) for each administration of the
HSS-DDI were 67 ± 24 and 75 ± 22, the Cronbach alpha coefficients were both 0.97, and the intraclass correlation
coefficient was 0.80. The 31-item HSS-DDI was finalized with all but 2 items having weighted kappa values of ‡0.40.
Phase 3 included 127 patients and established external validity, with most correlation coefficients between the HSS-DDI
and the SWAL-QOL and MDADI ranging from 0.5 to 0.7. Internal validity was established by identifying worsening HSS-DDI
scores with increases in the number of vertebral levels involved (p = 0.02) and in the Surgical Invasiveness Index (p =
0.006). HSS-DDI responsiveness ascertained by effect size (0.73) was better than that of the SWAL-QOL and MDADI. The
average administration time for the HSS-DDI was 2 minutes and 25 seconds.
Conclusions: The HSS-DDI is efficient, valid, and more responsive to change after anterior cervical spine surgery than
existing surveys.
Clinical Relevance: The HSS-DDI fills a gap in postoperative assessment by providing a reliable, more clinically sen-
sitive, patient and condition-specific evaluation of dysphagia and dysphonia prospectively and longitudinally.
A
nterior cervical spine surgery has been increasingly used lences of dysphagia and dysphonia after anterior cervical spine
to treat various cervical pathological conditions1,2. It is surgery are highly variable, ranging from <1% to 71% and
safe and effective, but dysphagia and dysphonia are <1% to 60%, respectively5-14. Possible reasons for these wide
commonly reported complications3-6. The published preva- ranges include different definitions of dysphagia and dysphonia
Disclosure: Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of
Health under Award Number UL1TR000457. On the Disclosure of Potential Conflicts of Interest forms, which are provided with the online version of the
article, one or more of the authors checked “yes” to indicate that the author had a relevant financial relationship in the biomedical arena outside the
submitted work (http://links.lww.com/JBJS/E672).
and variations in measurement methods, surgical techniques, swallowing and speech since the surgery and whether these
and reporting consistency6,11. Surgeon underreporting of these experiences affected their daily routines, interactions with others,
complications has also been described15. Dysphagia and dys- and mood. They also were asked whether they made accom-
phonia can be major determinants of patient outcomes and are modations for eating and speaking. Patients were encouraged
associated with increased morbidity, length of hospital stay, and to freely volunteer comments, and their responses were re-
hospital-related costs16. corded verbatim.
Patient-derived outcome instruments have been in- Their responses were assessed with standard qualitative
creasingly utilized across medical and surgical specialties. There techniques using grounded theory, a process by which responses
is consensus that the most valid, reliable, and sensitive way are reviewed to identify unique concepts and then grouped into
to measure clinical outcomes across a broad spectrum of larger categories through an iterative process. Three investi-
metrics is with patient-derived and validated instruments6,17. To gators independently conducted the analysis and, through
date, there is no universally accepted outcome measurement of consensus, arrived at the final set of categories. Patients were
dysphagia and dysphonia following anterior cervical spine enrolled until data saturation, when no new concepts were
surgery, making comparisons among studies difficult. Current volunteered.
instruments are either oversimplified, nonvalidated, not patient-
derived, or non-specific to patients treated with anterior cervical Phase 2: Assembling Draft Survey, Assessing Test-Retest
spine surgery6,17,18. A unique feature of this patient population is Reliability, Selecting Final Items, and Scoring
the anticipated improvement of postoperative dysphagia and A draft survey was assembled using categories from phase 1 as
dysphonia with time. A scale that is responsive to these lon- survey items. Dysphagia and dysphonia items were grouped
gitudinal changes is needed to counsel and manage patients separately. Items and ranked response options were phrased
clinically. For instance, patients treated with anterior cervical using patients’ terminology.
spine surgery have different psychosocial concerns and natural The draft survey was tested on additional patients who
histories compared with those with chronic neurodegenerative were enrolled in a manner similar to that used in phase 1. To
disease (the population for which the Swallowing-Quality of establish test-retest reliability, patients completed the ques-
Life [SWAL-QOL] questionnaire was developed) and those tionnaire twice, 3 to 5 days apart. The questionnaire was first
with oropharyngeal cancer (the patient population assessed administered in an in-person interview at enrollment and then
with the M.D. Anderson Dysphagia Inventory [MDADI])19,20. again during a telephone follow-up. Only patients without
Dysphagia and dysphonia are also subjective conditions for newly prescribed interventions for dysphagia or dysphonia
which patient-reported instruments seem to be more clinically were enrolled in phase 2. Furthermore, the total enrollment for
relevant and effective in assessing degrees of dysfunction phase 2 was meant to reflect rigorous criteria for repeatability
compared with clinician-administered surveys17. testing by including 35 to 50 patients25.
The purpose of this study was to create a valid, reli- The weighted kappa statistic was used to measure agree-
able, patient-derived, patient-reported survey instrument ment, above that due to chance, between the first and second
(the Hospital for Special Surgery Dysphagia and Dysphonia administrations for each item. Weighted kappa values range
Inventory [HSS-DDI]) to measure dysphagia and dysphonia from 21 (perfect disagreement) to 0 (agreement no better
after anterior cervical spine surgery. Additionally, we com- than chance) to 11 (perfect agreement)26. An item was re-
pared the performance of this novel instrument with that of tained for the final survey if the kappa value was ‡0.40. This is
preexisting, widely used surveys. The study design is similar lower than the customary threshold because the courses of
to previously validated methodologies used for patient-derived postoperative dysphagia and dysphonia are expected to change
instruments21-24. with time. Thus, perfect agreement reflecting an unchanged
status is not a realistic target. A system was developed to gen-
Materials and Methods erate an overall score (described below), and the intraclass
Variables Phase 1 (25 Patients)* Phase 2 (49 Patients) Phase 3 (127 Patients†)
*NA = not available. †Forty-eight patients also participated in phase 2. ‡The possible range for the SSI (Surgical Invasiveness Index) is 0 to 48,
with a higher score indicating more complex surgery.
The SWAL-QOL is a 44-item survey that assesses de- mental health, social function, fear of choking, eating duration,
creased quality of life (QOL) in 10 psychosocial areas due to eating desire, difficulty communicating, sleep disturbance, and
neurologic or mechanical oropharyngeal dysphagia. These fatigue. The MDADI is a 20-item survey that assesses the
areas, divided into scales, address food selection, burden, impact of head and neck cancer treatment on QOL. The
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TABLE II Sample Responses to Open-Ended Questions About Effects of Surgery on Swallowing and Speech
Throat pain “It was sore. If I ate something toasty it made my throat scratchy. It was horrible, a nightmare!”
“I have pain; it feels like a very sore throat. Like someone is stepping on my neck.”
Dependence on liquids “Lots of water helps. The water is soothing. I drink 10-12 bottles of water a day.”
“I have to have a glass of water with everything; otherwise I would spit it right back up.”
Modified eating habits “I get coughing spells when the portion is too large, the food isn't soft, or it is too hot or cold.”
“I chew more and chew longer.”
“I eat slower and smaller portions. I drink my soup through a straw.”
Fewer food options “Bread and meat don’t work at all. Applesauce and yogurt I can eat without complications.”
Difficulty taking pills “I would choke especially with calcium pills that are big. My husband would crush them up and put them in
applesauce or sweet potatoes so I can eat them.”
“Pills are getting stuck and it takes minutes to get them down.”
Regurgitation “I have massive difficulties swallowing. I will cough up food or pills that I thought went down hours after swallowing
them.”
“Well I try not eating in other people’s company. I cough, I regurgitate. Sometimes I have to spit into a napkin…
that’s gross.”
Limits social interactions “It was frustrating on a social level; you don't want to go out and it has an impact on what you want to eat.”
“I can't go out anymore. I have to eat with dozens of napkins around me so I can spit up food.”
Emotional effects “The nutrition person tried feeding me an apple. I felt like I couldn't breathe anymore. I get really anxious and scared
when I choke on food. I feel like I can't breathe.”
Quality of speech “I was hoarse because I felt like I had strep throat; you know how people sound, like that kind of hoarse.”
“I can't speak loud anymore at all. I can't yell.”
Interactions with others “I have to repeat words sometimes because my wife doesn't understand me. No particular words, just in general.”
“People have definitely noticed. It sounds real different.”
“I have short telephone calls with friends and family.”
Change in speaking “I would not speak for as long as I usually would. Talking felt like an effort.”
“I don't speak so loud and don't speak long sentences.”
“I hold my throat…when I talk.”
MDADI is divided into 4 scales: global impact of dysphagia and that of the SWAL-QOL and that of the MDADI using Spearman
impact of dysphagia on emotions, psychosocial function, and correlation coefficients with 95% CIs. Second, responsiveness
eating. For both surveys, each scale is scored separately with a was ascertained by comparing the effect sizes of the 3 scales. The
possible range of 0 to 100; higher scores reflect better status. effect size reflects the change in score as a function of the
Additionally, each scale is considered independently; an overall variability of the score and is calculated as the mean change in
score is not calculated. score divided by the standard deviation (SD) of that change.
At the second postoperative visit, patients were also asked Comparison of effect sizes among different scales reveals
to rate their swallowing and speech compared with the first which scale is more sensitive or responsive to change in a
postoperative visit. The response options were much worse, sample. By convention, an effect size of 0.2 is small, 0.5 is
worse, the same, better, and much better. moderate, and ‡0.8 is large. Finally, responsiveness was as-
Scores for all 3 surveys at each postoperative visit were certained by comparing the change in score with the global
calculated, and the percentages of patients scoring the mini- transition ratings of change in swallowing and speaking,
mum and maximum values were ascertained. HSS-DDI ex- which were captured at the second postoperative visit.
ternal validity was established by comparison with each of the Responses and score changes from the first to the second
SWAL-QOL and MDADI scales using Spearman correlation postoperative visits were compared using repeated-measures
coefficients with 95% confidence intervals (CIs). HSS-DDI analysis of variance (ANOVA).
internal validity was verified by demonstrating that more ex- Clinical and surgical data, including preoperative
tensive surgery (described below) was associated with worse diagnosis and number of vertebral levels involved, were ob-
survey scores. tained for patients at all phases by chart review. The mag-
Responsiveness was established in several ways. First, the nitude of surgery was assigned based on the spine-specific
within-patient change in score (postoperative visit-2 score minus Surgical Invasiveness Index (SII), a compendium of surgical
postoperative visit-1 score) for the HSS-DDI was compared with features accounting for the number of vertebrae involved,
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TABLE III Proportions of Patients Who Had Each Dysphagia and Dysphonia Item and Weighted Kappa Values
decompression, fusion, instrumentation, and approach27. Points saturation was achieved. The major categories that were
are assigned for each feature for each vertebral level, and a total identified were throat pain, dependence on liquids, modified
score is calculated as the sum of points from all levels. For the eating habits, fewer food options, difficulty taking pills,
cervical spine, the possible score range is 0 to 48, with a higher regurgitation, limitations in social interactions, emotional
score indicating greater invasiveness. In our study, scores were effects, quality of speech, interactions with others, and change in
grouped according to quartiles. speaking (Table II). Categories were then transformed into 20
dysphagia-related and 11 dysphonia-related items.
Results
Phase 1: Identifying Items for Draft Survey Phase 2: Assembling Draft Survey, Assessing Test-Retest
Fig. 1
Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI). 2017 Hospital for Special Surgery. All rights reserved.
prefaced with the statement “During the past 2 weeks how items (throat tightness when swallowing [kappa = 0.32] and
often did you experience the following?” Response options anxiety about breathing and swallowing [kappa = 0.39])
ranged from “none of the time” (4 points) to “all the time” were frequently endorsed (82% and 57%, respectively)
(0 points). and therefore were not eliminated. Thus, all items were re-
Another group of 49 patients (Table I), with involve- tained to form the 31-item HSS-DDI (Fig. 1). An overall
ment of up to 4 vertebral levels, were enrolled at a mean of score is calculated as the sum of all responses (raw score)
29 days (range, 14 to 38 days) after surgery. These patients divided by the maximum possible score (4 · 31 = 124)
completed the survey at enrollment and again during a multiplied by 100, and can range from 0 to 100. Higher
telephone interview at a mean of 5 days (range, 3 to 11 days) scores indicate better function, or less dysphagia and/or
later. The dysphagia items were endorsed more often (39% dysphonia (Fig. 2).
to 90%) than the dysphonia items (29% to 59%) (Table III). The mean scores (and SDs) for the first and second
All but 2 items had weighted kappa values of ‡0.40. These 2 administrations of the HSS-DDI to the patients in phase 2 were
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Fig. 2
Scoring of Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI). 2017 Hospital for Special Surgery. All rights
reserved.
TABLE IV Questionnaire Scores at First and Second Postoperative Visits and Effect Sizes
*The possible range is 0 to 100, with a higher score indicating better status. †Score from second postoperative visit minus score from first
postoperative visit. ‡Change in score divided by SD of change.
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67 ± 24 and 75 ± 22, the Cronbach alpha coefficients were both number of vertebral levels involved increased (80 for 1 level, 72
0.97, and the ICC was 0.80. for 2 levels, 61 for 3 levels, and 68 for ‡4 levels; p = 0.02).
Similarly, the HSS-DDI scores worsened as the SII increased
Phase 3: Validation and Responsiveness (80 for an SII of 5 to 8, 74 for 9 or 10, 61 for 11 or 12, and 67 for
One hundred and twenty-seven patients (Table I), with 13 to 15; p = 0.006).
involvement of up to 5 vertebral levels, were enrolled in phase When responsiveness was ascertained by calculating the
3 during the first postoperative visit, at a mean of 29 days difference in HSS-DDI scores between the first and second
(range, 9 to 44 days) after surgery. Patients completed the postoperative visits (Table IV) and comparing that value with
HSS-DDI, SWAL-QOL, and MDADI during this visit and the differences in the SWAL-QOL and MDADI scores (Table V),
again at the second postoperative visit at a mean of 31 days the Spearman correlation coefficients demonstrated a consis-
(range, 8 to 89 days) later. The mean score on the HSS-DDI at tent association for most comparisons. Also, the effect size of
the first visit was 71, with few patients having minimum or the HSS-DDI (0.73) was markedly larger than those of the
maximum values (Table IV). The mean scores for the dif- SWAL-QOL and MDADI (range, 0.14 to 0.59), indicating that
ferent scales of the SWAL-QOL ranged from 49 to 87, and the HSS-DDI captured more change as patients improved
more than a third collectively had the maximum score. This clinically. Finally, in the analysis of responsiveness according to
scenario was more pronounced for the MDADI, with almost the patients’ rating of the overall change in swallowing and
half of the patients having the maximum score. The scores on speech between postoperative visits, 5% rated swallowing to be
all surveys were higher at the second postoperative visit, worse or much worse, 38% rated it as the same, and 57% rated
indicating clinical improvement. it as better or much better and the corresponding changes in
The external validity of the HSS-DDI and each scale of the HSS-DDI scores were 22, 7, and 15 (p = 0.002). Similarly,
the SWAL-QOL and the MDADI was established with the 2% rated their speech as worse or much worse, 63% rated it as
Spearman correlation coefficient to account for the distribu- the same, and 35% rated it as better or much better and the
tions of the latter scales (Table V). Most coefficients were in the corresponding changes in the HSS-DDI scores were 23, 9,
0.5 to 0.7 range with narrow 95% CIs, and the HSS-DDI was and 16 (p = 0.007). The average administration times for the
consistently correlated with the SWAL-QOL and MDADI. HSS-DDI, SWAL-QOL, and MDADI were 2 minutes and
Internal validity was established by comparison with the extent 25 seconds, 5 minutes and 13 seconds, and 2 minutes and 13
of surgery. The HSS-DDI scores worsened (decreased) as the seconds, respectively.
SWAL-QOL
Food selection 0.59† 0.46-0.69 0.71† 0.61-0.79 0.39† 0.23-0.53
Burden 0.68† 0.57-0.76 0.79† 0.71-0.85 0.50† 0.36-0.62
Mental health 0.71† 0.61-0.78 0.80† 0.72-0.85 0.42† 0.27-0.56
Social functioning 0.63† 0.51-0.72 0.63† 0.51-0.72 0.38† 0.22-0.52
Fear of choking 0.69† 0.58-0.77 0.77† 0.68-0.83 0.44† 0.29-0.57
Eating duration 0.72† 0.63-0.80 0.80† 0.72-0.85 0.55† 0.42-0.66
Eating desire 0.58† 0.45-0.68 0.66† 0.55-0.75 0.31‡ 0.15-0.46
Communication 0.63† 0.51-0.72 0.63† 0.51-0.72 0.51† 0.37-0.63
Sleep 0.42† 0.26-0.55 0.44† 0.28-0.57 0.29‡ 0.12-0.44
Fatigue 0.49† 0.35-0.61 0.51† 0.37-0.63 0.23§ 0.05-0.39
MDADI
Global 0.68† 0.58-0.77 0.63† 0.51-0.72 0.41† 0.25-0.54
Emotional 0.69† 0.58-0.77 0.69† 0.58-0.77 0.30‡ 0.13-0.45
Functional 0.70† 0.60-0.78 0.57† 0.44-0.68 0.32‡ 0.15-0.47
Physical 0.84† 0.78-0.88 0.85† 0.79-0.89 0.55† 0.41-0.66
*Score from second postoperative visit minus score from first postoperative visit. †P £ 0.0001. ‡P < 0.001, > 0.0001. §P = 0.01.
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Roland Duculan, MD1 1Departmentof Orthopaedic Surgery, Hospital for Special Surgery,
Jennifer Shue, MS1 New York, NY
Frank P. Cammisa, MD1
Andrew A. Sama, MD1 2Department of Otolaryngology – Head and Neck Surgery, Weill Cornell
Federico P. Girardi, MD1 Medicine, New York, NY
Ashutosh Kacker, MD2
Carol A. Mancuso, MD1 ORCID iD for A.P. Hughes: 0000-0001-7293-9672
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