Interaction of functional and participation issues on quality of life after total laryngectomy

Abstract

Objective
Total laryngectomy (TL) leads to lifelong physical changes which can lead to functional and participation issues. To assess the relationship between self‐reported quality of life and functional and participation issues, a large international online questionnaire was used.

Method
A questionnaire was sent out to 8119 recipients of whom 1705 (21%) responded. The questionnaire consisted of 26 questions regarding demographic information, product use of the respondents, experienced overall health and independence, and functional and participation issues. Respondents were grouped based on sex, age, time since TL, educational level, and country of residence. Questions were grouped in one measure of reported quality of life (r‐QoL) and seven issue themes (“esthetic issues,” “experienced limitations in daily activities,” “avoiding social activities,” “communication issues,” “experienced vulnerability due to environmental factors,” “pulmonary issues,” and “sleep issues”) to assess the underlying relations.

Results
This study showed that more functional and participation issues and a lower r‐QoL are reported in the group of younger respondents (<60 years), women, and respondents who have had the TL procedure less than 2 years ago. The issue themes “experienced limitations in daily activities” and “avoiding social activities” are related to r‐QoL. Most participants report “pulmonary issues,” and these issues have a strong correlation with most other themes.

Conclusion
The ability to participate in meaningful and social activities is a major factor in r‐QoL. Due to the frequency and strong correlations of pulmonary issues with other issue themes, pulmonary issues might be an underlying cause of many other issues.

Level of evidence
3b

Full text

ORIGINAL RESEARCH
Interaction of functional and participation issues on quality
of life after total laryngectomy
Maartje Leemans MSc
1
| Klaske E. van Sluis MSc
1,2
| Rob J. J. H. van Son PhD
1,2
|
Michiel W. M. van den Brekel MD, PhD
1,2
1
Department of Head and Neck Oncology and
Surgery, Netherlands Cancer Institute-Antoni
van Leeuwenhoek, Amsterdam, The
Netherlands
2
Amsterdam Center for Language and
Communication, University of Amsterdam,
Amsterdam, The Netherlands
Correspondence
Michiel W. M. van den Brekel, MD, PhD,
Department of Head and Neck Oncology and
Surgery, Netherlands Cancer Institute-Antoni
van Leeuwenhoek, Plesmanlaan 121, 1066 CX,
Amsterdam, The Netherlands.
Email: m.vd.brekel@nki.nl
Funding information
Atos Medical (Malmo, Sweden), Grant/Award
Number: 0
Abstract
Objective: Total laryngectomy (TL) leads to lifelong physical changes which can lead to
functional and participation issues. To assess the relationship between self-reported
quality of life and functional and participation issues, a large international online ques-
tionnaire was used.
Method: A questionnaire was sent out to 8119 recipients of whom 1705 (21%)
responded. The questionnaire consisted of 26 questions regarding demographic
information, product use of the respondents, experienced overall health and indepen-
dence, and functional and participation issues. Respondents were grouped based on
sex, age, time since TL, educational level, and country of residence. Questions were
grouped in one measure of reported quality of life (r-QoL) and seven issue themes
(“esthetic issues,”“experienced limitations in daily activities,”“avoiding social
activities,”“communication issues,”“experienced vulnerability due to environmental
factors,”“pulmonary issues,”and “sleep issues”) to assess the underlying relations.
Results: This study showed that more functional and participation issues and a lower
r-QoL are reported in the group of younger respondents (<60 years), women, and
respondents who have had the TL procedure less than 2 years ago. The issue themes
“experienced limitations in daily activities”and “avoiding social activities”are related
to r-QoL. Most participants report “pulmonary issues,”and these issues have a strong
correlation with most other themes.
Conclusion: The ability to participate in meaningful and social activities is a major fac-
tor in r-QoL. Due to the frequency and strong correlations of pulmonary issues with
other issue themes, pulmonary issues might be an underlying cause of many other
issues.
Level of evidence: 3b
KEYWORDS
participation, quality of life, rehabilitation, self-reported issues, total laryngectomy
Klaske E. van Sluis and Maartje Leemans share first authorship.
Received: 14 October 2019 Revised: 6 January 2020 Accepted: 24 March 2020
DOI: 10.1002/lio2.381
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any
medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2020 The Authors. Laryngoscope Investigative Otolaryngology published by Wiley Periodicals, Inc. on behalf of The Triological Society.
Laryngoscope Investigative Otolaryngology. 2020;5:453–460. wileyonlinelibrary.com/journal/lio2 453

1|INTRODUCTION
A total laryngectomy (TL) leads to lifelong changes in physical, psycho-
logical, and social functioning, severely impacting the patients' normal
daily functioning and quality of life (QoL). First of all, due to the
removal of the larynx, one of the immediate consequences is that the
patient loses his ability of laryngeal speech. The fact that patients now
breathe through a tracheostoma instead of their nose or mouth can
lead to pulmonary problems, such as coughing, dyspnea, excessive
mucus production, forced expectoration, and stoma cleaning.
1-6
A
total laryngectomy can also lead to other functional problems such as
difficulties in swallowing, olfaction, sleeping difficulties, fatigue, and
pain in throat and neck.
4,6,7
The functional consequences of the TL procedure also impact the
patient's self-image, which can lead to psychological problems such as
anxiety and depression,
4,5,8,9
and reduced sexuality.
7,10-12
Last, due to
the visible scarring and difficulties with communication it can lead to
worsened social interactions and participation.
4,5,7,13
To help total laryngectomized patients rehabilitate their lost func-
tions, in particular their pulmonary condition and speech, multiple
medical devices have been developed in the last few decades. The
most important medical devices include the voice prosthesis, and the
heat and moisture exchanger (HME) with various fixation methods. It
has been proven that HMEs reduce pulmonary issues, such as
coughing and mucus production, and improve other related functional
issues such as voice and sleeping.
14-18
To restore speech and voice,
tracheoesophageal speech generated with the help of a voice prosthe-
sis has become the “gold standard”in the many parts of the world.
19
To ensure an optimal rehabilitation and QoL for each patient, an
understanding of possible consequences of the TL procedure and the
correlation of self-reported participation and functional issues can
provide a unique insight. Atos Medical AB (Malmö, Sweden), with help
of ReD Associates (Copenhagen, Denmark), a strategy consultancy
company, recently send out a questionnaire to Atos Medical clients
from different countries to investigate the hidden needs and com-
plaints of total laryngectomized patients. We were able to use the
obtained responses for our analysis. Thus, with the aforementioned
physical and social consequences of the TL procedure in mind, we
developed the following research question:
What relation exists between demographic character-
istics and reported-quality of life (r-QoL) ratings of
total laryngectomized individuals and their self-
reported participation and functional issues?
2|MATERIALS AND METHODS
2.1 |Questionnaire
An online questionnaire was developed by Atos Medical AB (Malmö,
Sweden) and ReD Associates (Copenhagen, Denmark) with input from
the Netherlands Cancer Institute. The scope of the questionnaire was
to assess the impact of TL on daily life and examine the use of medical
devices, experienced functional and participation issues, and possible
hidden needs regarding medical devices for the rehabilitation after
TL. A pilot version of the questionnaire was send via email by Atos
Medical AB to a cohort of 250 TL clients in the United States of
America, with a response rate of 12%. Based on the pilot, adjustments
were made. The final version of the online questionnaire consisted of
26 main questions regarding demographic information (not obligatory)
and product use of the respondents, experienced overall health and
independence, and experienced functional and participation issues.
The final questionnaire was sent out via email by Atos Medical AB to
8119 clients in nine countries; the United Kingdom, United States,
Germany, France, Sweden, the Netherlands, Brazil, Italy, and Spain. All
approached Atos Medical clients were treated with TL and older than
18 years. One reminder-email was sent out and the questionnaire was
available online for 3 weeks. The data were collected by ReD
Associates, and made available to the Netherlands Cancer Institute.
2.2 |Statistical analysis
The responses of the questionnaire were analyzed anonymously by
the Netherlands Cancer Institute using the statistical package
R(version 3.5.1.). Respondents from the pilot study (n= 29) were
excluded from the analysis, resulting in a cohort of n= 1705. As pri-
mary outcome measure the relation between the reported quality of
life (r-QoL) ratings and the reported participation and functional issues
was tested. As secondary outcome measure the relations between
demographics and participation and functional issues were tested.
A linear model was selected with the “step”function (setting direction
“both”) in R using the Bayesian information criterion.
20
The relative
importance of the themes was determined with the “calc.relimp”
function (setting type “first”).
21
2.3 |Grouping of respondents
For the analysis of the primary and secondary outcomes, the respon-
dents were grouped. The grouping was based on:
•Sex: male vs female
•Age: <60 years of age vs 60+ years of age. In the questionnaire,
the respondents were asked to indicate their age through a choice
between five decade age brackets. The age brackets were simpli-
fied in our analyses to just two age groups, roughly representing
the “pre-retirement”age group and “post-retirement”age group.
•Time since TL: <2 years since TL vs 2+ years since TL. This group-
ing was based on clinical experts consensus that the most initial
rehabilitation issues of the TL procedure are resolved within
2 years.
•Educational level: respondents without tertiary education (defined
as an educational degree after High School) vs respondents with
tertiary education.
454 LEEMANS ET AL.

•Country of residence: country specific analyses were only per-
formed for countries with a response rate of >5%. The countries
Sweden, Brazil, and Spain were therefore excluded in this specific
analysis.
2.4 |Grouping of questions
Because this questionnaire was not based on validated QoL scales or
validated questionnaires, we performed a clustering of semantically
related questions into general issue themes. Because some questions
could belong to multiple themes, the semantic clustering of questions
was based on the experience of the clinical experts (K. E. v S. and
M. W. M. vd B.), discussed in multiple consensus meetings.
The self-reported ratings of overall health and independence
(both rating scales from 0 to 10) were combined to one sum measure:
the reported r-QoL rating (scale from 0 to 20). In this article, the term
r-QoL is used to refer to this combined measure of the following two
specific scale questions:
“How would you rate your overall health from 0 to 10?
0 means worst imaginable health state, 10 means best
imaginable health state”
“On a scale from 0 to 10, how independent do you feel
in completing the activities you want? 0 means the
least imaginable independence in completing the activ-
ities you want, 10 means the most imaginable indepen-
dence in completing the activities you want”
The internal correlation between these two scale questions is
R
2
= .366 (percentage of variance explained).
Clustering of related self-reported participation and functional
issues questions was performed into the following general issue
themes (see Supporting Information Appendix A for an overview of
the grouped questionnaire per theme):
•Esthetic issues (5 yes-no questions)
•Experienced limitations in daily activities (9 yes-no questions)
•Avoiding social activities (2 yes-no questions)
•Communication issues (4 yes-no questions)
•Experienced vulnerability due to environmental factors (7 yes-no
questions)
•Pulmonary issues (14 yes-no questions)
•Sleep issues (3 yes-no questions)
2.5 |Average number of reported experienced
issues per theme
The average number of reported issues per patient per theme (as a
percentage of the maximum number of questions of that theme), and
the influence of the grouping of respondents on the number of
reported experienced issues is presented. This approach was chosen
to make the themes mutually comparable on the basis of seriousness,
since the average weight per issue is not linear and the number and
content of issue questions per theme were different.
TABLE 1 Demographic characteristics of respondents
Characteristic No. (%)
Countries United Kingdom 159 (9)
United States 786 (46)
Germany 98 (6)
France 342 (20)
The Netherlands 184 (11)
Italy 79 (5)
Sweden 43 (3)
Brazil 10 (<1)
Spain 4 (<1)
Sex
a
Male 1361 (80)
Female 263 (15)
Age (y)
a
<60 296 (17)
60+ 1328 (78)
Time since TL (y) <2 336 (20)
2-5 568 (33)
5-10 392 (23)
>10 294 (17)
No answer 115 (7)
Employment status
a
Retired 1124 (66)
Full-time 183 (11)
Part-time 108 (6)
Occasionally 0 (0)
Unpaid work 62 (4)
Seeking work 33 (2)
Not seeking work 114 (7)
Education No High School 113 (7)
High School 508 (30)
Occupational 411 (24)
University 617 (36)
No answer 56 (3)
Level of tertiary
education (defined as
an educational degree
after High School)
Total 1028 (62)
United Kingdom 105 (67)
United States 519 (68)
Germany 50 (54)
France 215 (67)
The Netherlands 76 (43)
Italy 32 (43)
Note: Total number of respondents n= 1705. Respondents of which we
obtained the complete demographic information n= 1624 (including sex,
age, and employment status).
Abbreviation: TL, total laryngectomy.
a
A small number of respondents (n= 81) did not consent to provide this
(personal) demographical information.
LEEMANS ET AL.455

3|RESULTS
3.1 |Respondents
The demographic characteristics of the respondents are shown in
Table 1. In total, 1705 clients completed the questionnaire (response
rate of 21%), of which the majority were from United States, France,
The Netherlands, United Kingdom, Germany, and Italy. A minority of
the respondents were from Sweden, Brazil, and Spain. Of 1624
respondents, we obtained the complete demographic information,
including the more personal information, such as sex, age, and
employment status (n= 81 respondents did not give consent to pro-
vide this information). Type of voice rehabilitation was not in the
scope of this questionnaire. Most respondents are male (male-to-
female ratio 5:1) with a median age in the 60-69 bracket, and have
had their TL procedure in the last 5 years (median 5 years ago). The
distribution of age between countries is very comparable. The educa-
tion level of the respondents, however, varies between countries,
with 68% of respondents having tertiary education in the United
States, vs only 43% of respondents in the Netherlands and Italy.
3.2 |r-QoL rating
Figure 1 shows the distribution of the two separate rating scales (scale
0-10) of which this combined r-QoL rating consists; a score of 7 (out of
10) or higher was given by more than 50% of the respondents for their
overall health and independence. Age and time since TL procedure have
a significant influence (a negative relation p= .004, and a positive relation
p< .001, respectively) on the overall health rating and time since laryn-
gectomy has a significant influence on the independence rating (negative
relation p≤.001).
Since the overall health and independence ratings have a high
internal correlation and were combined to one sum measure, from
now on they will be represented as one outcome measure r-QoL.
The average combined r-QoL rating is 14.4 (scale 0-20). It appears
that respondents under 60 years of age and who have had their TL
procedure less than 2 years ago at the time of the questionnaire rate
their r-QoL much lower. Sex, educational level, and country of
residence did not have a significant influence (p>.05)onther-QoL
rating.
3.3 |Average number of reported experienced
issues per theme
Figure 2 shows the average percentage of reported issues per patient
per theme (as a percentage of the number of questions in that theme),
and the influence of the grouping of respondents on the number of
reported issues. The figures do not represent the percentage of
respondents that experiences these issues, but the percentage of spe-
cific issues within the theme that an average respondent will have
experienced or encountered. Because the results are averaged over a
large group of respondents, it gives a sensitive comparison method.
See Supporting Information Appendix A for an overview of the
grouped questionnaire questions per theme and their response rate.
Educational level and country of residence did not have a significant
influence (p> .05) on the experienced issues per theme and were
therefore excluded from the presentation of the results. Sex, age, and
time since TL procedure do all have an influence on the number of
experienced issues of almost all themes. In general, younger respon-
dents (<60 years), especially women, who have had the TL procedure
less than 2 years ago, are uniquely disadvantaged in terms of reported
participation and functional issues.
3.4 |Correlations between r-QoL rating and
themes
The correlations between different themes, representing overarching
issues, and the r-QoL can be found in Table 2 and Figure 3. To illus-
trate, as seen in Table 2 ~29% of the variance (R
2
) in the r-QoL ratings
FIGURE 1 Distribution of the self-reported rating of overall health and independence (the score of 0 is the worst imaginable situation, the
score of 10 is the best imaginable situation). Due to rounding off, the sum does not add to 100%
456 LEEMANS ET AL.

can be explained by the reported issues in the themes “experienced
limitations in daily activities”(71% of the 29%) and “avoiding social
activities”(29% of the 29%).
However, the theme “pulmonary issues”seems to play an
important role and has a significant correlation to most other
themes: ~41% of the variance (R
2
) can be explained by the reported
issues in the themes “experienced limitations in daily activities”
(22% of the 41%), “avoiding social activities”(10% of the 41%),
“communication issues”(16% of the 41%), “experienced vulnerability
due to environmental factors”(20% of the 41%), and “sleep issues”
(32% of the 41%).
The significance of the pulmonary issues can be illustrated by the
fact that of the specific included questions within this “pulmonary
issues”theme, for example 89% of the respondents report they have
to clean out mucus from their stoma or HME several times a day (see
Supporting Information Appendix A, 7.5.), and 47% of the respon-
dents experience frequent coughing during the day (see Supporting
Information Appendix A, 7.1.).
FIGURE 2 The influence of the
grouping of respondents on the average
percentage of reported issues per
respondent per theme. The specific
grouping of respondents does not add up
to the total number of respondents:
missing data in the “time since TL”
(n= 115 respondents gave “no answer”),
“sex”and “age”(n= 81 respondents did
not give consent to provide this personal
information). r-QoL, reported quality of
life; TL, total laryngectomy
LEEMANS ET AL.457

4|DISCUSSION
This study presents a large sample oftotal laryngectomizedrespondents
from multiple countries, examining both a large range of participation
and functional issues and r-QoL. The study data is unique and relevant,
nevertheless the study lacks validated measures as well as respondents'
information regarding, for example, marital status and type of voice
rehabilitation. To reduce this limitation of the use on a non-validated
questionnaire, the method of semantic clusteringof questions was used,
comparable to validated QoL questionnaires (e.g. EORTC-C30).
22-24
Clustering of both questions in r-QoL seems feasible since it is known
that independence isan attribute of the concept QoL.
23,24
The demographic characteristics of the respondents (the distribu-
tion of age, sex, educational level, and time since laryngectomy) were
comparable to other studies and correspond to the characterization of
“the average total laryngectomized person”as a middle-aged man
(around 65 years old, male-to-female ratio of ~6:1).
13,25-29
Outcomes of the rating scales regarding overall health and inde-
pendence both had an average rating of 7.2 (on a scale 0-10). These
two ratings are both notably high, since a TL procedure is usually
associated with a lower QoL rating and depressive symptoms.
13,30
However, retrospective study set-ups like this questionnaire tend to
have a larger inclusion of nonproblematic patients than prospective
studies, and thus, more positive results (e.g. a more positive r-QoL rat-
ing).
30
However, the distribution of the independence rating is discon-
certing: for example, 25% of respondents rate their independence a
score of 5 or lower, which can be interpreted as being unable to par-
ticipate in many daily activities.
Our study shows that respondents who were <2 years since TL,
and respondents <60 years old in general report a lower r-QoL rating.
For almost all the issue themes, sex, age, and time since laryngectomy
have a significant influence on (the number of) experienced participa-
tion and functional issues. Therefore, younger respondents (<60 years),
especially women, and those who have had the TL procedure less than
2 years ago, seem to be uniquely disadvantaged in terms of r-QoL rat-
ings and reported participation and functional issues.
The influence of age, sex, and time since TL procedure have also
been underlined by other studies. Age as an influencing factor on r-
QoL is supported by multiple studies reporting that indeed younger
total laryngectomized patients experience a higher psychological dis-
tress, impacting their coping, since younger patients may have a bet-
ter preoperative baseline functional status and activity level.
4,31,32
FIGURE 3 Correlations between themes and r-QoL. The single
arrows indicate a one-way correlation (e.g. “esthetics issues”only has an
influence on the variance of the “experienced vulnerability due to
environmental factors,”but not vice versa), the double arrows indicate an
asymmetrical interdependent correlation. r-QoL, reported quality of life
TABLE 2 Correlations between themes and r-QoL
Theme
Influence on
variance (%) Relative importance, sum 100%
% of theme
variance (R
2
)
explained
by other themes r-QoL
Esthetic
issues
Experienced
limitations
daily
activities
Avoiding
social
activities
Communication
issues
Experienced
vulnerability
due to
environ.
factors
Pulmonary
issues
Sleep
issues
r-QoL 29 X71 29
Esthetic issues 4 X40 60
Exp. limitations in
activities
39 41 X20 25 14
Avoiding social activities 25 7 46 X26 21
Communication issues 20 10 37 X53
Exp. vulnerability environ. 18 6 X60 34
Pulmonary issues 41 22 10 16 20 X32
Sleep issues 25 15 85 X
Note: Due to the type of analysis, the correlations are not symmetrical.
Abbreviation: r-QoL, reported quality of life.
458 LEEMANS ET AL.

Time since laryngectomy as an influencing factor on reported issues
has been supported by multiple papers: on average the reported prob-
lems decrease over time.
5,33
The fact that after the first 2 years after
the TL procedure the r-QoL improves, shows that rehabilitation and
coping can be effective, but take several years. Earlier studies have
shown that gender differences are present in reported issues after
TL. Women are inclined to experience more post-operative com-
plaints, and issues with social interaction due to stigmatization.
4,31,34
The “pulmonary issues”seem to have a strong correlation to most
other themes. Therefore these pulmonary issues might be partially
responsible for other reported issues.
5
Although reported less fre-
quently, the issues from the two themes “avoiding social activities”
and “experienced limitations in daily activities”are the main
influencers of the variance in r-QoL. Thus, the ability to fulfill mean-
ingful activities seems to have a greater impact on r-QoL than the
purely physical consequences of TL in general. The inclusion of the
independence rating in the r-QoL rating could have introduced a bias
in the correlation analysis. The concept QoL includes development
and improvement of life (adapting to changed health condition and
finding new meaning), independence, achievement of goals and aspi-
rations, and autonomy.
22-24
The study design has its limitations. The response rate was 21%;
the questionnaire was sent via email and was shortly available online.
Non-response bias might be present and can cause a bias in how well
the data represents the actual total laryngectomized population. Addi-
tionally, the respondents of this questionnaire were all clients of Atos
Medical AB. The selection bias concerns patients most likely using
voice prostheses and/or HMEs, education level and internet use over-
all and across countries, financial status, and insurance or
reimbursement systems between countries.
3
It is likely that Atos
Medical clients with a higher age or lower educational level were less
well reached with this online questionnaire in certain countries. This
could explain the differences in education level between countries as
well as the relatively high education level in this questionnaire.
5|CONCLUSION
Younger respondents (<60 years), especially women, and those who
have had the TL procedure less than 2 years ago, seem to be uniquely
disadvantaged in terms of r-QoL ratings and reported participation and
functional issues. The experienced limitations in daily activities and
avoiding social activities are associated with decrements in the respon-
dents' r-QoL rating. The r-QoL rating is mainly influenced by the ability
to do meaningful activities, and less by purely physical consequences of
TL. Most issue themes are interdependently correlated. The theme “pul-
monary issues”seems to have a strong correlation with most other
themes and is key in most other reported issues. Therefore, pulmonary
issues might be an underlying cause of many other issues, including
experienced limitations in daily activities and avoiding social activities.
To improve clinical practice, it is recommended to adequately prepare
and monitor patients regarding their participation in social activities,
meaningful activities, and pulmonary issues to enhance their QoL.
ACKNOWLEDGMENTS
Atos Medical AB (Malmö, Sweden) and ReD Associates (Copenhagen,
Denmark) are acknowledged for their work for making the database
available to the Netherlands Cancer Institute—Antoni van Leeuwen-
hoek. The Netherlands Cancer Institute receives a research grant from
Atos Medical AB (Malmö, Sweden), which contributes to the existing
infrastructure for quality of life research of the Department of Head
and Neck Oncology and Surgery.
CONFLICT OF INTEREST
The authors declare no conflicts of interest.
ORCID
Maartje Leemans https://orcid.org/0000-0003-2976-5368
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SUPPORTING INFORMATION
Additional supporting information may be found online in the
Supporting Information section at the end of this article.
How to cite this article: Leemans M, van Sluis KE, van
Son RJJH, van den Brekel MWM. Interaction of functional and
participation issues on quality of life after total laryngectomy.
Laryngoscope Investigative Otolaryngology. 2020;5:453–460.
https://doi.org/10.1002/lio2.381
460 LEEMANS ET AL.