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ORIGINAL ARTICLE

Interpretation of the Swedish Self Evaluation of Communication Experiences after


Laryngeal cancer: Cutoff levels and minimum clinically important differences

Lisa Tuomi, PhD,1* Mia Johansson, PhD, MD,2 Paulin Andrell, PhD, MD,3 Caterina Finizia, MD1

1
Department of Otorhinolaryngology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden,
2
Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden, 3Depart-
ment of Molecular and Clinical Medicine/Multidisciplinary Pain Center, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospi-
tal, Gothenburg, Sweden.

Accepted 6 December 2014


Published online 26 May 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/hed.23955

ABSTRACT: Background. The purpose of this study was to establish Attitudinal 5 5), presenting acceptable sensitivity and specificity. Initial
minimum clinically important difference (MCID) scores for the Swedish MCID estimates were obtained for all domains; improvement of 213
Self-Evaluation of Communication Experiences after Laryngeal Cancer points (p < .0001) or a deterioration of 18 points (p 5 .035) for the
(S-SECEL) in order to facilitate clinical interpretation and identify cutoff Total domain.
values for voice rehabilitation. Conclusion. MCID and cutoff scores for the S-SECEL have been identified
Method. One hundred nineteen patients with laryngeal cancer completed and may be used in clinical practice to help identify patients with laryn-
the S-SECEL instrument and an anchor question regarding acceptability geal cancer in need of voice rehabilitation. V
C 2015 Wiley Periodicals, Inc.

of speech in a social context pretreatment and 12-month postoncologic Head Neck 38: 689–695, 2016
treatment. Receiver operating characteristic (ROC) curves analysis was
used for calculation of cutoff values. KEY WORDS: Swedish Self-Evaluation of Communication Experien-
ces after Laryngeal Cancer (S-SECEL), quality of life, laryngeal neo-
Results. Voice rehabilitation cutoff values were identified for all
plasms, voice, patient outcome assessment
domains (Total 5 20; General 5 4; Environmental 5 16, and

INTRODUCTION compared to pretreatment.8 Conversely, abnormal findings


regarding breathiness and pitch have been reported 10 to
Laryngeal cancer treatment can affect the voice and com-
15 years posttreatment.9 PRO adds the aspect of patient
munication. Approximately 40% to 80% of the patients
functioning in everyday life, whereas Agarwal et al10
experience some persisting voice problems in terms of
reported that 3 to 6 months postradiotherapy all patients
self-rated function up to 10 years after initial laryngeal
experience some improvement of voice quality. Bibby
cancer treatment.1,2 In order to properly assess voice
et al4 also demonstrated that for patients with laryngeal
function, the European Laryngological Society recom-
cancer at 12 months postcurative radiotherapy, the voice
mends a multidimensional approach including, but not
quality had improved significantly when measuring self-
limited to, perceptual, acoustical, and patient-reported
perceived voice function. These findings indicate that
outcome (PRO) measures.3 When using acoustic meas-
some spontaneous improvement of voice quality occurs,
ures, voice improvement after radiotherapy is reported but
although many patients still experience considerable voice
does, however, not reach normal levels.4–6 Regarding per-
problems after laryngeal cancer treatment.1,2
ceptually rated voice quality, there are contradicting
PRO instruments have been developed to measure out-
results in which patients with laryngeal cancer are per-
comes from the patient’s own perspective. There are sev-
ceived as having more strained voices 1-year postonco-
eral instruments, both general and disease-specific, such
logic treatment compared to pretreatment,7 whereas 24
as the European Organisation for Research and Treatment
months postradiotherapy the qualities of a strained and
of Cancer Core Quality of Life Questionnaire and the
breathy voice have been reported to improve significantly
Head and Neck module.11,12 These instruments, however,
only include a few items about voice and communication,
which is why an instrument addressing the specific com-
*Corresponding author: L. Tuomi, Department of Otorhinolaryngology, Head munication challenges faced by the laryngeal cancer pop-
and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
E-mail: lisa.tuomi@gu.se
ulation is needed.13 There are several instruments used to
measure voice function after treatment for laryngeal can-
Contract grant sponsor: Mary von Sydows Foundation; Assar Gabrielsson Foun-
dation, Cancer Foundation; The Health & Medical Care Committee of the
cer8,14,15 including the Voice Handicap Index16 and the
Regional Executive Board; Region V€astra G€otaland; The Sahlgrenska University Voice Related Quality of life.17 Nevertheless, these
Hospital, Gothenburg University instruments do not assess the specific voice and

HEAD & NECK—DOI 10.1002/HED MAY 2016 689


TUOMI ET AL.

communication problems experienced by patients with because a change of communicative function was
laryngeal cancer. In order to assess communication dys- expected between these timepoints.4
function after laryngeal cancer, specific voice and com-
munication instruments have been developed. The Self- Vocally healthy control group
Evaluation of Communication Experiences after Laryn- Vocally healthy volunteers (n 5 35) were recruited
gectomy (SECEL)18 has been translated and validated from people accompanying patients to the Otorhinolar-
into several languages.19,20 It has also been adapted and yngology Clinic, Sahlgrenska University Hospital. Their
validated in Swedish (ie, the Swedish Self-Evaluation of larynx status was assessed as normal, and they all per-
Communication Experiences after Laryngeal cancer [S- ceived their voices as being normal. The vocally healthy
SECEL]).21 control group filled out the S-SECEL as well as the
Several PRO instruments provide guidelines regarding anchor question about acceptability of speech on one
clinical interpretation of the scores. However, for the S- occasion.
SECEL, guidelines for clinical interpretation of scales are
lacking. In clinical studies, small differences in a score Patient-reported outcome instruments
can be found to be statistically significant in a large
enough sample. Yet, a statistically significant score differ- Swedish Self-Evaluation of Communication Experiences after
ence does not necessarily reflect a clinically relevant Laryngeal cancer. The SECEL is a voice and communica-
change for the patient.22,23 The minimum clinically tion instrument developed to assess the challenges of
important difference (MCID) score is a threshold value communication for laryngectomees.18 It has been trans-
that defines a change that the patient experiences as lated to Swedish and adapted to assess communication for
worthwhile or meaningful.22 Guidelines of MCID have all patients with laryngeal cancer, regardless of what
been reported for the European Organisation for Research treatment they receive.21 The Swedish version (S-SECEL)
and Treatment of Cancer Core Quality of Life Question- has shown high construct and convergent validity and has
naire,24 which was developed using the patient’s own per- demonstrated sensitivity to change over time.13,25
ception of significant changes of health. An issue The instrument consists of 35 items addressing commu-
regarding MCIDs for deterioration is presented in a study nication experiences and dysfunction after laryngeal can-
by Osoba et al24 in which they found that fewer patients cer. Thirty-four of the items are divided into 3 domains.
reported “worse” health-related quality of life (HRQOL) The General (5 items) domain addresses attitudes about
ratings than patients who reported “better” HRQOL rat- being calm or relaxed in general and acknowledgment of
ings. This resulted in greater variability of results in the the sickness and treatment. The second domain, the Envi-
group of patients who reported “worse” and unclear non- ronmental (14 items), focuses on how the patients experi-
significant results. ence their voice in different settings. The third domain,
In the original version of the SECEL,18 guidelines the Attitudinal (15 items), describes attitudes regarding
regarding interpretation of results with a cutoff value speech, feelings about self-perception, and perceptions of
were presented, where patients who scored above this others. Each item is rated on a 4-point categorical Likert
value would be in need of rehabilitation. However, nei- scale ranging from 0 (never) to 3 (always) and addresses
ther cutoff values nor MCID have been previously pre- the previous 30 days. Scoring of a domain and total score
sented for the S-SECEL version. The purpose of this is performed through addition. Summary scores therefore
study was to identify the S-SECEL’s MCID in order to range from 0 to 15 for the General domain, 0 to 42 for
facilitate clinical interpretation and identify cutoff values the Environmental domain, 0 to 45 for the Attitudinal
for voice rehabilitation. domain, and 0 to 102 for the Total domain. A higher
score indicates a greater communicative dysfunction. The
last item “Do you talk the same amount now as before
MATERIALS AND METHODS your laryngeal cancer?” has 3 response alternatives (Yes/
Patients and settings More/Less) and is not included in the scoring system.
All patients with newly diagnosed as well as recurrent Anchor question regarding acceptability of speech
laryngeal cancer in the Western region of Sweden are dis-
cussed at a weekly head and neck cancer conference at The patients were asked to rate their communication
the Otolaryngology Department at the Sahlgrenska Uni- with the following question: “Is your speech acceptable
versity Hospital. At the conference, treatment options are in a social context?” on a Likert scale ranging from 0 to
discussed and decided upon. All patients diagnosed with 3 (3 indicates always good acceptability, 2 5 often,
laryngeal cancer who received treatment with curative 1 5 sometimes, and 0 5 never). This item has been used
intent were asked to participate. Patient inclusion criteria in previous studies and was found to detect differences
were: sufficient cognitive ability and general health, as over time as well as differences between patient groups
well as adequate knowledge of the Swedish language to who had been treated with different modalities.26,27 For
be able to independently complete the questionnaires. this study, answers 0 to 1 were considered indicative of
Patients participating in other concurrent studies were the need of rehabilitation and 2 to 3 were indicative of
excluded. The patients completed the study instruments acceptable communication.
before the start of treatment, 1 month, 2 months, 3
months, 6 months, and 12 months after the start of treat- Statistical methods
ment. Comparisons in this study were made between the Correlation analysis between dependent and independ-
pretreatment and 12 months posttreatment occasions, ent variables was performed with Spearman correlation

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INTERPRETATION OF THE SWEDISH SELF EVALUATION OF COMMUNICATION EXPERIENCES AFTER LARYNGEAL CANCER

TABLE 1. Patient characteristics. than 50% of the items in the domain were filled in. Total
score was calculated with the imputed score. If a patient
Patient Included No. of Dropouts No. of did not fill in the instruments at the 12-month occasion,
characteristics patients 5 119 (%) patients 5 7 (%)
then the last observation carried forward was applied. The
Mean age, y 66.0 74.4 data was analyzed using the SAS system, version 9
Sex (Copyright 2002–2010 SAS Institute).
Female 17 (14) 1 (14)
Male 102 (86) 6 (86) Ethical aspects
Localization
Glottic 90 (75.5) 2 (29) The study was approved by the Regional Ethical
Supraglottic 20 (17) 4 (57) Review Board in Gothenburg, Sweden, and was con-
Subglottic 6 (5) 0 ducted in accordance with the Declaration of Helsinki.
Transglottic 3 (2.5) 1 (14) All participants gave their informed consent before inclu-
Stage sion in the study.
0 4 (3.5) 1 (14.5)
I 68 (57) 2 (28.5) RESULTS
II 30 (25) 2 (28.5)
III 10 (8.5) 0 Patients and controls
IV 7 (6) 2 (28.5)
Treatment In total, 126 patients with laryngeal cancer chose to
Total laryngectomy 8 (7)* 0 enroll in the study and 155 patients did not enter the
Radiotherapy 115 (97) 7 (100) study for the following reasons: declined participation
Chemotherapy 7 (6) 0 (n 5 41), poor general health or impaired cognitive abil-
Smokers 39 (33) 5 (71) ities (n 5 77), insufficient knowledge of Swedish
(n 5 14), participation in other studies (n 5 20), and
* Two laryngectomies only, 2 in combination with chemotherapy, 4 in combination with unknown reason (n 5 3). One hundred nineteen patients
radiotherapy. treated for laryngeal cancer were included in the analysis
because 7 patients (6 men and 1 woman) chose to discon-
tinue their participation after inclusion. Two patients with
analysis. For the cutoff calculation, receiver operating recurrent disease were included in this study. Patient
characteristic (ROC) curves were calculated using logistic characteristics and oncologic treatment regimens for
regression with the acceptability score as dependent and laryngeal cancer are presented in Table 1. Five of the lar-
the S-SECEL domains as predictors. The cutoff value yngectomized patients were using voice prosthesis and 2
was chosen to be the score where the total amount of sen- were using an electrolarynx. The vocally healthy control
sitivity and specificity was the greatest. The S-SECEL group consisted of 35 participants, 6 women and 29 men,
scores, 12 months posttreatment, were used for these cal- with a mean age of 66 years. Thirteen of the vocally
culations. Correct classification was calculated in the healthy controls were smokers.
vocally healthy control group where the S-SECEL scores Last observation carried forward was performed for
were set to predict the acceptability of speech as 2 to 3 24% (n 5 29) of the patients included in the analysis. The
(often-always good acceptability). If the S-SECEL score item response rate was 99.5% (ie, only 0.5% of items
was below the cutoff and acceptability of speech was 2 or were imputed by mean imputation method).
3, it was considered to be a correct classification.
Evaluation of the MCID scores used both anchor-based Correlations
and distribution-based approaches. For calculation of the
The Spearman rho between the S-SECEL Total score,
anchor-based MCID, the change from pretreatment to 12
General, Environmental, and Attitudinal score compared
months posttreatment was used. Patients who improved or
to the anchor question regarding acceptability of speech
deteriorated in 0, 1, 2, or 3 steps, respectively, on the
at 12 months posttreatment was 20.729, 20.574,
acceptability scale were divided into 7 groups. A change
20.683, and 20.676, respectively. All correlations were
on the acceptability scale was compared to the change in
statistically significant (p < .0001). The change of S-
the S-SECEL scores. Patients who remained unchanged
SECEL Total score, General, Environmental, and Attitu-
or improved or deteriorated 1 step on the anchor question
dinal domains were correlated with the change in anchor
regarding acceptability of speech from pretreatment to 12
score as follows: 20.571, 20.416, 20.533, and 20.526,
months posttreatment are presented. Patients who showed
also statistically significant (p < .0001).
greater improvement or deterioration on the anchor item
were excluded from this analysis, because the calculation
of MCID focuses on minimal change. Testing between Cutoff values
the 2 occasions within each group was carried out using The cutoff value for the S-SECEL Total score was set
the Wilcoxon signed rank test. Distribution-based meth- to 20 points. For this cutoff value, sensitivity was 0.86,
ods were used as a complement to the anchor-based specificity was 0.79, and the estimated area under the
approach; 0.5 and 0.3 of the SDs at the 12-month follow- ROC curve was 0.892. Cutoff values for all the domains
up were calculated. of the S-SECEL are presented in Table 2 and illustrated
All significance tests were 2-sided and conducted at the in the ROC curves in Figure 1A to 1D. According to this
5% significance level. In case of missing items, simple classification, 71 patients (60%) were above the cutoff for
mean imputation within the domain was used if more the Total score (ie, in need of rehabilitation at the start of

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TUOMI ET AL.

TABLE 2. Cutoff values of the Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer when compared to the anchor question
regarding acceptability of speech.

Laryngeal cancer Control group

Domain Sensitivity Specificity Cutoff value AUC Correct classification Incorrect classification

Total 0.86 0.79 20.0 0.892 33 (94.3%) 2 (5.7%)


General 0.89 0.60 4.0 0.825 15 (42.9%) 20 (57.1%)
Environmental 0.75 0.93 16.0 0.887 34 (97.1%) 1 (2.9%)
Attitudinal 0.75 0.76 5.0 0.842 34 (97.1%) 1 (2.9%)

Abbreviation: AUC, area under the curve.


The cutoff values for all domains of the Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer (S-SECEL) showed high values for the AUC as well as high sensitivity and
specificity measures.

the study) and 43 patients (36%) were in need of vocal Total score, correct classification was found in 94% of
rehabilitation 1 year after the start of oncologic treatment. the healthy controls.
The vocally healthy control group was used to test the
construct validity of the cutoff values and results from Minimum clinically important difference
these calculations are also presented in Table 2. Correct MCID for the 4 domains of the S-SECEL instrument
classification implies that the patient scored below or are presented in Table 3. The MCID indicating improve-
equal to the cutoff (ie, 20 points for the Total score and ment in the S-SECEL total score was 213 points
at the same time scored 2 or 3 on the acceptability ques- (p < .0001) and deterioration was 8 points (p 5 .035).
tion), or the inverse; the patient scored above 20 points Deterioration in the General and Environmental domains
and scored 0 to 1 on the acceptability question. For the did not reach statistical significance. The patients who

FIGURE 1. (A) Total score.


Receiver operating characteris-
tic (ROC) curves – domains of
the Swedish Self-Evaluation of
Communication Experiences
after Laryngeal Cancer (S-
SECEL) as predictor, anchor
question about acceptability as
dependent. The circle indicates
the cutoff point. (B) General
score. ROC curves – domains of
the S-SECEL as predictor,
anchor question about accept-
ability as dependent. The circle
indicates the cutoff point. (C)
Environmental score. ROC
curves – domains of the S-
SECEL as predictor, anchor
question about acceptability as
dependent. The circle indicates
the cutoff point. (D) Attitudinal
score. ROC curves – domains of
the S-SECEL as predictor,
anchor question about accept-
ability as dependent. The circle
indicates the cutoff point.

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TABLE 3. Minimum clinically important differences.

Deterioration No change Improvement Distribution-based

No. of p value within No. of p value within No. of p value within No. of
patients 5 13 group* patients 5 43 group* patients 5 39 group* patients 5 119

Domain Mean (SD) Mean (SD) Mean (SD) 0.5/0.3 SD

Total 8.7 (12.3) .035 20.8 (12.6) .331 213.0 (12.3) < .0001 8.1/4.8
General 1.1 (4.2) .329 21.3 (2.7) .002 22.0 (2.2) < .0001 1.4/0.8
Environmental 2.5 (7.2) .174 20.3 (0.7) .706 27.0 (7.2) < .0001 4.1/2.5
Attitudinal 5.1 (4.3) .002 0.8 (6.5) .958 24.0 (5.8) < .0001 3.6/2.2

Change in scores for the Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer (S-SECEL) domains related to 1-step change for the anchor question regarding acceptability.
Distribution-based methods using 0.5 and 0.3 of the SD of values at 12-month follow-up.
* Significance analysis made with the Wilcoxon signed rank test for changes within the patients who remained unchanged/deteriorated/improved 1 step for the question on acceptability of speech.
Six patients deteriorated more than 1 step for Acceptability, 18 patients improved more than 1 step on the Acceptability question and are therefore not presented in the table.

rated their acceptability of speech as unchanged were results above 60 points are considered to represent the
found to improve significantly regarding the General need for in-depth communication rehabilitation. The large
domain (mean improvement 21.3; p 5 .002). Six patients discrepancy between this cutoff score and the one sug-
deteriorated more than 1 step for acceptability and 18 gested (20 points) in the present study might be explained
patients improved more than 1 step on the acceptability partly by the fact that Blood18 included laryngectomees
question and are therefore not presented in Table 3. All solely, whereas in the current work all patients receiving
differences calculated are between 5% and 13% of their oncologic treatment for laryngeal cancer were included.
domain score range. Furthermore, the methods used to calculate the cutoffs
MCID using 0.5 as well as 0.3 SD (ie, the distribution- scores differ between the 2 studies, where Blood18 based
based approach) are shown in Table 3. the cutoff score obtained with the Psychosocial Adjust-
ment to Illness Scale-Self Report.
Van Gogh et al2 found that 40% of patients after treat-
DISCUSSION ment for early glottic cancer experience persisting voice
The present study assessed patients with laryngeal can- problems. The present study supports this number,
cer pretreatment and postoncologic treatment according to because according to the classification of need for voice
the S-SECEL. The purpose of the study was to determine rehabilitation, 36% of our patients are above the cutoff
cutoff values for identifying voice rehabilitation need and value for the total score on the S-SECEL 1 year after the
present guidelines on how to interpret the results of the start of treatment. This could indicate that the cutoff
S-SECEL in the clinical setting through preliminary esti- value identified in this study is relevant to use in a laryn-
mation of the MCID scores. The correlations between the geal cancer population. The van Gogh study reported
S-SECEL domains and the acceptability scores were mod- results for patients up to 10 years postoncologic treat-
erate to strong, indicating high convergent validity (ie, ment, which indicated that the problems persist over a
comparisons between the 2 measures were possible). long time. Moreover, in a study by Morgan et al,9 the
The results of the cutoff values for all domains of the voices of patients with laryngeal cancer were still rated as
S-SECEL showed reasonably high values for the area abnormal 10 to 15 years after treatment. These findings
under curve as well as high sensitivity and specificity further support the need for voice rehabilitation.
measures (0.75–0.93). Sensitivity refers to the proportion To find the MCID, one of the most common methods
of correctly classified positives and specificity describes is to use an anchor-based approach where an external cri-
the proportion of correctly classified negative individuals. terion other than the instrument itself is used (ie, an
However, the General domain of the S-SECEL showed anchor).28 A global assessment scale is commonly used,
somewhat weaker results where the proportion of cor- where patients rate themselves as “better,” “unchanged,”
rectly classified individuals in the healthy control group or “worse,” and the MCID can be calculated as the mean
was low (43%). The General domain also showed inferior change of the patients who answered “better” and the
results, where patients who rated their acceptability of mean change who answered “worse,” respectively.22
speech as unchanged simultaneously showed a statisti- Other methods to find the MCID are distribution-based,
cally significant change in S-SECEL General score. The for example, using the SEM, the SD or effect sizes. The
General domain has previously been discussed as subopti- distribution-based approaches can be recommended as
mal20,21 and should perhaps, in a future version of the complements to anchor-based methods to the calculation
instrument, be adapted or excluded. However, in the pres- of MCID values.23
ent study, the S-SECEL’s Environmental, Attitudinal, and The anchor-based MCID presented in this study
Total domain showed promising results, suggesting that included the patients who improved or deteriorated 1 step
the cutoff values from these domains may be clinically on the anchor question regarding acceptability of speech.
useful. For the patients who reported an increased function on
For the original version of the SECEL, Blood18 has the question “Is your speech acceptable in a social con-
proposed a cutoff score for the Total domain, where text?” 1 year posttreatment, the results were statistically

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TUOMI ET AL.

significantly different than at pretreatment for all the S-SECEL. There are also recommended levels of
S-SECEL domains. However, for the patients who rated MCID for improvement or deterioration based on anchor
their communication as being worse according to the and distribution-based approaches. Possible application of
acceptability question, not all domains showed statisti- these guidelines includes use in the clinical setting and in
cally significant results from pretreatment to 12-month research to identify patients in need of rehabilitation as
follow-up (Table 3). This could be due to the fact that well as documentation of the treatment.
there were only 13 patients in this group. Osoba et al24
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