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\begin{document}

\title{The use of tracheostoma humidification by people with total laryngectomy
in the UK: a cross-sectional survey.}



\author[1]{Jane Dunton}%
\author[2]{Joanne Patterson}%
\author[3]{Carol Glaister}%
\author[4]{Kate Baker}%
\author[5]{Sarah Woodman}%
\author[6]{Elizabeth Rowe}%
\author[7]{Roganie Govender}%
\affil[1]{Guy's and St Thomas' Hospitals NHS Trust}%
\affil[2]{University of Liverpool}%
\affil[3]{Birmingham City University}%
\affil[4]{Royal Marsden NHS Foundation Trust}%
\affil[5]{South Tees Hospitals NHS Foundation Trust}%
\affil[6]{Chesterfield Royal Hospital NHS Foundation Trust}%
\affil[7]{UCL}%


\vspace{-1em}



  
  \date{May 25, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
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\selectlanguage{english}
\begin{abstract}
Objectives: To investigate the use of tracheostoma humidification by
people with total laryngectomy (PTL) in the UK and explore influencing
factors. Design: National cross-sectional survey and case note review.
Setting: 26 UK National Health Service (NHS) centres providing care to
PTL. Participants: PTL reviewed by speech and language therapy (SLT)
between March and September 2020. Methods: Secondary analysis of data
collected during a national multi-centre audit of PTL completed in
response to the Covid-19 pandemic. Data were collected on type of
humidification used by PTL and demographic information. Type of
humidification was dichotomised as `HME' (closed-system heat moisture
exchanger) or `non-HME' (alternative stoma cover or no stoma cover).
Univariable analysis was performed to determine the association with
several potential explanatory variables including gender, age, living
circumstances, distance from treatment centre, communication method and
time elapsed since laryngectomy. A backwards selection procedure was
used to determine the final model for multiple regression analysis.
Results: Data were obtained from 1216 PTL from 26 centres across the UK;
information on type of tracheostoma humidification used was available
for 1097 PTL. Most PTL (69\%) used an HME. Following multiple regression
analysis, time elapsed since laryngectomy (p=\textless{}0.001), living
circumstances (p=0.002) and communication method (p=\textless{}0.001)
were statistically significant factors in HME use. Conclusion: In the
UK, most PTL follow recommendations to use a closed-system HME, though
there is marked variability across centres. HME use is influenced by
time elapsed since laryngectomy, living circumstances and communication
method.%
\end{abstract}%



\sloppy


\textbf{The use of tracheostoma humidification by people with total
laryngectomy in the UK: a cross-sectional survey. }

\emph{Abstract}

\textbf{Objectives:} To investigate the use of tracheostoma
humidification by people with total laryngectomy (PTL) in the UK and
explore influencing factors.

\textbf{Design:} National cross-sectional survey and case note review.

\textbf{Setting:} 26 UK National Health Service (NHS) centres providing
care to PTL.

\textbf{Participants:} PTL reviewed by speech and language therapy (SLT)
between March and September 2020.

\textbf{Methods:}   Secondary analysis of data collected during a
national multi-centre audit of PTL completed in response to the Covid-19
pandemic. Data were collected on type of humidification used by PTL and
demographic information. Type of humidification was dichotomised as
`HME' (closed-system heat moisture exchanger) or `non-HME' (alternative
stoma cover or no stoma cover). Univariable analysis was performed to
determine the association with several potential explanatory variables
including gender, age, living circumstances, distance from treatment
centre, communication method and time elapsed since laryngectomy. A
backwards selection procedure was used to determine the final model for
multiple regression analysis.

\textbf{Results:} Data were obtained from 1216 PTL from 26 centres
across the UK; information on type of tracheostoma humidification used
was available for 1097 PTL. Most PTL (69\%) used an HME. Following
multiple regression analysis, time elapsed since laryngectomy
(p=\textless{}0.001), living circumstances (p=0.002) and communication
method (p=\textless{}0.001) were statistically significant factors in
HME use.

\textbf{Conclusion: }  In the UK, most PTL follow recommendations to use
a closed-system HME, though there is marked variability across centres.
HME use is influenced by time elapsed since laryngectomy, living
circumstances and communication method.

\textbf{Key words~}

total laryngectomy, humidification, neck-breathers, tracheostoma, stoma
covers, HMEs

\textbf{Key points}

\begin{itemize}
\tightlist
\item
  PTL are advised to wear a closed-system heat moisture exchange system
  (HME) to optimise pulmonary health.
\item
  Across the UK, 69\% of PTL use a closed-system HME. This figure can be
  used as a benchmark for UK services.
\item
  There is significant variability in HME use across treatment centres
  which may indicate inequity of service across regions.
\item
  Factors influencing HME use include time elapsed since surgery, living
  circumstances and communication method.
\item
  Findings may indicate a need for targeted education regarding
  pulmonary health for specific groups of PTL and their carers.
\end{itemize}

\emph{}

\emph{INTRODUCTION}

People with total laryngectomy (PTL) have a permanent separation of the
trachea and oesophagus and rely on a surgically created neck
tracheostoma to breathe. This altered anatomy results in a loss of
filtering and humidification capacity of the upper airways and
consequent reduced respiratory resistance. The detrimental impact of
this on pulmonary health is well-established, with increased bronchial
secretions and reduced mucociliary clearance resulting in increased risk
of chest infections, reduced respiratory capacity and negative effects
on quality of life\textsuperscript{1,2}. Additionally, the permanent
tracheostoma leaves PTL at risk of airway invasion by airborne particles
or foreign bodies. PTL are advised to use a tracheostoma cover to
protect the airway and to optimise pulmonary health.

A number of different tracheostoma covers are available: simple covers
with no humidification properties (e.g. scarves); foam-based covers or
bibs that offer some humidification\textsuperscript{3}; closed-system
heat moisture exchange (HME) devices comprising a filter cassette
secured with an adhesive baseplate or laryngectomy tube (Figure 1).
Closed-system HMEs have been available on prescription in the UK since
the mid-1990s and are now considered the gold standard for
humidification for PTL. UK guidelines recommend the use of HME as soon
as possible post-surgery\textsuperscript{4} and initiation of HME use at
day one post-surgery has been reported\textsuperscript{5}.

While closed system HMEs are more expensive than alternative stoma
covers\textsuperscript{3}, the benefits are well recognised including
reduced coughing, shortness of breath, mucous production, plug formation
and chest infections\textsuperscript{5,6,7}. There is a correlation
between duration of HME use and pulmonary benefit\textsuperscript{8}.~
HME use has been found to significantly enhance quality of life for
PTL\textsuperscript{9}, and can offer PTL with surgical voice
restoration (SVR) improved digital occlusion for voicing and better
speech intelligibility\textsuperscript{8,9}.

Despite evidence of efficacy, variable compliance rates with HME use
have been reported, from 35\% to 83\%\textsuperscript{10,5}. Reported
reasons for resistance to HME use include excessive mucus production,
blockage of the filter and poor baseplate seal\textsuperscript{6}.  In
some healthcare systems the financial burden of HME use may be a
barrier\textsuperscript{3}. Additional factors that could influence use
of HME include patient age, time elapsed since surgery, neck contour,
and the recommendations from different health services, clinicians and
patient communities.

With the onset of the Covid-19 pandemic in March 2020, PTL were thought
to be a high-risk group for contracting and transmitting Covid-19
infection through respiratory droplet formation and aerosolisation due
to their altered airways\textsuperscript{11,13}.  This paper reports on
the use of tracheostoma~ covers as reported by patients and/or their
clinicians during a UK-wide audit of PTL during the first UK national
lockdown period. The audit was initiated in response to queries
regarding the specific risks associated with Covid-19 for PTL. Data on
shielding, hospital admission and mortality have been reported
previously\textsuperscript{13}. The objectives of the current paper are
to report on the following:

The usage of tracheostoma covers by PTL in the UK, specifically use of a
commercially available closed-system HME (termed ``HME'' for this
analysis) versus all alternatives (termed ``non-HME'' for this
analysis).

The factors that may influence HME use by PTL in the UK.

\par\null

Based on literature and clinical experience, we postulate the following
factors may influence HME use in the UK: age, gender, time elapsed since
surgery, distance from the treating centre, employment status, living
circumstances and primary communication method.

\emph{}

\emph{METHODS}

This paper has been prepared with reference to the STROBE checklist for
cross-sectional studies.

\textbf{2.1. Ethical considerations  }

The Health Research Authority decision tool
(\emph{http://www.hra-decisiontools.org.uk/research/}) identified the
project as service evaluation, which was approved by the Applied Health
in Cancer Governance Group at the lead NHS site. Individual sites sought
local approval to share data. A data flowchart is attached as
supplementary information.

\textbf{2.2 Study design and setting }

A national multi-centre audit of PTL was completed in response to the
Covid-19 pandemic over a six-month period (March to September 2020). The
background and development of the project has been described in detail
previously\textsuperscript{13}. This is a secondary analysis of data
collected during the audit.

\textbf{2.3 Participants }

All PTL under the care of participating centres were eligible for
inclusion. Data were collected during the six-month period on PTL who
were reviewed by SLT either in person or via telehealth during the first
national lockdown.

\textbf{2.4 Data collection }

Data were obtained via case note review and survey questions. A data
capture worksheet (devised in Excel, password protected and encrypted)
was used to collect data. Personal identifying information was minimised
as advised by the information governance team. Verbal patient consent
was obtained whenever possible.

Data were collected on the potential explanatory variables described
above. The type of tracheostoma cover used was recorded at two time
points: before the onset of the Covid-19 pandemic (time point 1) and
during the six-month period of data collection (time point 2). This
paper reports on data collected from time point 1 to describe HME use
among PTL in the UK before the onset of Covid-19. Data on incidence of
Covid-19 infection, hospital admission and shielding advice were also
collected and have been reported
previously\textsuperscript{13}. Detailed analysis of factors influencing
primary communication method will be reported independently of this
paper.

\textbf{2.5 Data analysis }

Analyses were carried out using SPSS for Windows. A univariable analysis
was initially performed to evaluate the association between each
potential explanatory variable and HME use, using Pearson's chi-square
test for categorical variables and the two-sample t-test or Mann-Whitney
U test for continuous variables. Logistic regression analysis was
conducted to examine the association of selected variables with HME. A
backwards selection procedure was used to determine the final model
(criteria for entry p\textless{}0.05 and for removal
p\textgreater{}0.1). The overall fit of the model was ascertained using
the Hosmer and Lemeshow goodness of fit test.

\emph{RESULTS}

\textbf{3.1 Participants}

Twenty-six centres across England and Wales submitted data for analysis.
Data were collected on a total of 1216 PTL. Details of the participating
centres and patient demographics are described in previous
work\textsuperscript{13}.

\textbf{3.2 HME vs non-HME use}

Data on type of tracheostoma cover were available for 1097 PTL. The
majority (n= 835, 69\%) used a closed-system HME. A range of alternative
tracheostoma covers was used by 17\% (n=219). Only four percent (n=43)
were recorded as not using a tracheostoma cover (Table 1). For
subsequent analysis PTL were grouped into HME users (n= 835, 69\%) or
non-HME users (n=262, 21\%). One hundred and nineteen (10\%) PTL were
excluded from further analysis due to missing data. Patient demographics
are illustrated in Table 2.

There was marked variation in the number of cases submitted for analysis
and the percentage of PTL using HME across centres (Figure 2). In two
centres (centres 1 and 19) 95\% of PTL used a closed-system HME.~
However, in four centres (3, 5, 13 and 26) less than 50\% did so.~ The
amount of missing data also varied across centres. Centre 1 submitted
the largest number of cases (n=110) and also reported the highest HME
use, while centre 26 submitted only 3 cases with only 1 patient (33\%)
using an HME. Centre 13 had the lowest HME use at 28\% (n=12), but also
had a large amount of missing data (n=16, 37\%).

\textbf{3.3 Factors associated with HME use}

In univariable analysis, age (p=0.02), gender (p=0.01), time elapsed
since surgery (p\textless{}0.0001), living circumstances (p=0.01) and
communication method (p\textless{}0.0001) demonstrated significant
differences between HME users and non-HME users. Distance from the
treating centre (p=0.92) and employment status (p=0.19) were not
significant factors.

Following multiple regression analysis, time elapsed since surgery
(p\textless{}0.001), living circumstances (p=0.003) and communication
method (p\textless{}0.001) remained statistically significant (Table 3).
Time elapsed since surgery was longer for non-HME users than for HME
users (median 108 months vs 59 months). Only 42\% of PTL living in a
care facility used an HME, compared with 77\% of those living with
someone or alone. SVR users were more likely to use an HME than non-SVR
users (80\% vs 65\%).

\emph{DISCUSSION}

This is a novel study exploring HME usage among PTL in the UK. It
reports secondary analysis of data obtained in the UK national audit of
PTL carried out during the first national Covid-19 lockdown. To our
knowledge this is the largest audit of current practice in the
management of PTL and provides an important opportunity for
benchmarking. Our findings show that the majority of PTL (69\%) included
in the audit used a closed-system HME. While this is a lower proportion
than has been quoted in previous studies\textsuperscript{5}, HME usage
varied across centres from 28\% to 95\%. The centre with the largest
number of cases also reported the highest HME use, while many of those
centres with lower HME use also reported higher levels of missing data.
This may reflect SLT capacity and resources at those centres, and such
variability may indicate inequity of service across regions.

Although age was significant at univariable analysis, this was not
retained following multivariable analysis indicating that older PTL are
not disadvantaged in access to pulmonary rehabilitation. Similarly,
although males demonstrated higher use of HME than females (78\% vs
69\%) this was not significant in multivariable analysis. Employment
status and distance from the treating centre were not significant,
suggesting that these factors do not impact on access to rehabilitation
and advice or influence decision-making around humidification.

Factors found to be significantly associated with HME use in
multivariable logistic regression were time elapsed since surgery,
living circumstances and primary communication method.

\textbf{4.1 Time elapsed since surgery}

Average time post-surgery was 96 months, range 0-578 months. PTL who
were longer post-surgery were less likely to use an HME. Adherence to
HME use is improved with early introduction\textsuperscript{14},
therefore PTL who had surgery since closed-system HMEs have been widely
available on prescription are perhaps more likely to have commenced
early use and be ongoing HME users than those who had surgery before
this time. Average time elapsed since surgery for PTL with non-HME in
our study was nine years, and as HMEs have been available on
prescription since the mid-1990s it is clear that other factors are also
involved.

\textbf{4.2 Living circumstances}

Although previous studies have looked at factors that might predict
discharge destination following laryngectomy\textsuperscript{15}, as far
as we are aware no study has looked at the impact of living
circumstances on HME use.~ We found that PTL living in a care facility
were significantly less likely to use an HME which may relate to wider
issues around the complexity of adherence to healthcare recommendations
in care facilities\textsuperscript{16} and has important implications
for the pulmonary health of this vulnerable group. Given HME use
involves specialist intervention and ongoing use of specialist
consumables, it may be that lower usage in care facilities indicates a
need for training and therapeutic input in this setting. Further
investigation is warranted.

\textbf{4.3 Communication method}

It is recognised that a closed-system HME supports improved digital
occlusion for voicing and better speech intelligibility for SVR
users\textsuperscript{8,9}, therefore it may be expected that PTL with
SVR are more likely to use an HME. This is consistent with our findings.
This highlights the importance of pulmonary rehabilitation for non-SVR
users, who may receive less direct SLT intervention over time than those
PTL receiving regular input for voice prosthesis management.

\textbf{4.4 Limitations of the study}

This study reports on a range of factors that may influence HME use,
however there are additional factors that may account for the
variability identified. In order to optimise participation in the
audit~a limited data set was selected, inevitably leading to a series of
unknowns. For example, we did not collect data on duration of HME use.
Full adherence is considered to be [?]20 hours per
day\textsuperscript{17}and various factors could influence this. We did
not collect data on barriers to HME use, whether HMEs are suitable for
all PTL or on which MDT member takes responsibility for pulmonary
rehabilitation at each centre. These factors could be explored in future
work.

There was an amount of missing data in our study. It is not clear
whether this was due to pressure on the services providing data, reduced
contact with PTL due to the Covid-19 pandemic or other factors.

\textbf{4.5 Future directions}

Several professional organisations produced guidelines during the
Covid-19 pandemic that may have influenced advice given to patients
regarding humidification, including advice regarding the use of
specialist viral filter HMEs\textsuperscript{11,12,18}. A survey of PTL
in the USA\textsuperscript{19} found that more patients reported
self-initiated changes to their HME use due to the pandemic than their
clinicians had advised. We note however that the ability of
closed-system HMEs to protect users against SARS-CoV-2 has not been
demonstrated.~ The current study presents data on HME use in the UK
pre-Covid-19 (time point 1).~~ Future work could investigate behaviour
change as a result of the pandemic.~ The impact of social factors that
may outweigh clinician advice, such as the impact of marketing, social
media and peer influence\textsuperscript{19}, could also be explored.

For the purpose of current analysis, PTL were divided into those using a
commercially available closed-system (``HME'') and all others
(``non-HME''). However, some researchers have found bibs to be superior
to closed-system HMEs in terms of humidity and
temperature\textsuperscript{3}. Future work could explore factors
associated with the use of non-HMEs.

Our study identified marked variability in HME use across the UK, with
some centres reporting much higher HME use than others. The underlying
reasons for variation in practice could be examined to support equity of
access to pulmonary rehabilitation across centres.

Current findings suggest there may be education and training needs
around pulmonary rehabilitation for PTL who are less likely to use an
HME, such as those who are longer post-surgery, those living in care
facilities, and non-SVR users. This paper supports the need to target
education and training to ensure equity of access to pulmonary
rehabilitation for all PTL.

\emph{CONCLUSIONS}

Across the UK, most PTL follow advice to use a closed-system HME to
maximise pulmonary health after surgical alteration to their upper
airway. Use of HMEs varies across participating treatment centres but
was found to be primarily impacted by certain factors: time elapsed
since surgery (PTL with a shorter time since surgery were more likely to
use an HME), living circumstances (PTL living in a care facility were
less likely to use an HME than those living alone or with someone) and
primary communication method (SVR users were more likely to use an HME
than PTL without SVR). The national average of 69\% of PTL using an HME
serves as a benchmark for UK services. Education and training should be
targeted to ensure equity of access to pulmonary rehabilitation for all
PTL.

\textbf{List of Tables and Figures:}

\textbf{Table 1: Type of tracheostoma cover used by PTL.~}

\textbf{Table 2: Patient demographics, HME vs non-HME.~}

\textbf{Table 3. Variables associated with HME use from Multivariable
Logistic Regression.}

\textbf{Figure 1: Types of tracheostoma cover.}

\textbf{Figure 2: HME vs non-HME use by centre.~}

\emph{}

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\end{enumerate}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-1/Figure-1}

\end{center}
\end{figure}

\textbf{Hosted file}

\verb`Table 1.docx`  available at \url{https://authorea.com/users/565765/articles/612652-the-use-of-tracheostoma-humidification-by-people-with-total-laryngectomy-in-the-uk-a-cross-sectional-survey}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-2/Figure-2}

\end{center}
\end{figure}

\textbf{Hosted file}

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\textbf{Hosted file}

\verb`Table 3 v2.docx`  available at \url{https://authorea.com/users/565765/articles/612652-the-use-of-tracheostoma-humidification-by-people-with-total-laryngectomy-in-the-uk-a-cross-sectional-survey}

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