Abstract
Quality of life is severely affected in laryngeal cancer patients, who have undergone total laryngectomy, particularly with regard to cancer diagnosis and the consequences of total laryngectomy. The aim of the present study is to record and evaluate the problems related with the quality of life in laryngectomized patients. A further goal is to investigate, whether a correlation exists between demographics and clinical characteristics of the patients. Fifty male patients, who underwent total laryngectomy, participated in the study. Two questionnaires were used to test various quality of life parameters, the EORTC QLQ C30 version 3.0 and EORTC QLQ H&N35. Specific demographic and clinical data of the patients were also recorded. The overall quality of life index was similar in both studied patients and the reference group of cancer patients provided by the European Organization for Research and Treatment of Cancer (EORTC). However, the following discrepancies were noted: voice, senses, dyspnoea were more problematic in studied patients, whereas the functional status of cognitive, physical, social and emotional function were better. In most recorded symptoms, the intensity was mild. The demographic and clinical data appeared to have interesting correlations with specific functional aspects and symptoms. Although several quality of life aspects are found to be negatively affected in laryngectomized patients, overall quality of life appears to be satisfactory.
Keywords: Laryngeal cancer, Total laryngectomy, Quality of life, EORCT
Introduction
Total laryngectomy is a radical surgical method reserved for the treatment of advanced laryngeal carcinoma or as a salvage therapy. This type of surgery leads to significant anatomic and functional alterations, such as permanent tracheostoma, voice, senses, and feeding problems. Additionally, this surgery brings about aesthetic and psychological consequences and patient perception of physical health is significantly damaged. Important aspects of life, such as social relations, communication, sexuality, and emotional status are also negatively affected. Hence, the surgical intervention of total laryngectomy, as well as the diagnosis of cancer has a major impact on patient’s quality of life (QoL) [1–3].
The most common problems reported in literature are loss of ability of verbal communication [2, 4], dysphagia when consuming specific foods or [5, 6], anosmia or hyposmia [4], problems related to permanent tracheostoma such as chronic cough, dyspnoea, increased secretions, frequent airway infections [2, 4, 7], sexual problems [1], social isolation [1–4], and psychological as well as emotional problems[1–3].
Considering that QoL has become a significant part of evaluation criteria for cancer therapy, it is important to investigate the impact of radical surgical methods, like total laryngectomy, on patients’ life after surgery. Several studies have been conducted trying to evaluate the QoL, using various tools and questionnaires. Among them, 2 important questionnaires have been proposed by the European Organization for Research and Treatment of Cancer (EORTC) in recent years. These tools are the EORTC QLQ C30 and EORTC QLQ H&N35 questionnaires. The first one (QLQ C30) is a general questionnaire used to evaluate QoL in cancer patients, and the second one (H&N 35) is a specific questionnaire designed for Head and Neck cancer patients (EORTC manual). The combination of the 2 questionnaires has been used to investigate the QoL in Head and Neck cancer patients, and has been proved to be a very useful, reliable and accurate tool. The 2 questionnaires have been used for laryngeal cancer patients in some countries [7–9]. To the best of our knowledge, no study has been performed in the Greek population to evaluate the impact of total laryngectomy on patients’ QoL, using the EORTC QLQ C30 version 3.0 and EORTC QLQ H&N35 questionnaires.
The aim of the present study is to record the problems arising after total laryngectomy and their impact on laryngectomized patients’ QoL in the Greek population. A further goal is to evaluate the significance of aforementioned problems, and to compare resulting data with the ones characterising patients with Head and Neck cancer. Finally, we aimed at associating the recorded problems with the demographic and clinical data of the patients.
Materials and Methods
This is a retrospective cross sectional study. Studied population was laryngeal cancer patients having undergone total laryngectomy. They were recruited at the Otolaryngology Departmentt of “G. Papanikolaou” Hospital, Thessaloniki, Greece from February 2017 to May 2019. The induction criteria were as follows:
Surgery (total laryngectomy) was performed at least 6 months prior to recruitment.
Adjuvant treatment (radiotherapy or chemoradiotherapy) was received at least 6 months prior to recruitment.
Disease-free patients, with no recurrence or residual tumor.
Regular follow-up in the outpatient ENT oncology clinic.
Demographic and clinical data was available.
Study procedure was elaborately explained to every potential recruit and sufficient time was given for questions. Participation was voluntary and was preceded by written informed consent. The study was approved by the bioethics committee of the hospital.
Two questionnaires were used, the EORTC QLQ C30 version 3.0 and EORTC QLQ H&N35. The questionnaires were obtained electronically by the EORTC, after relevant correspondence and permission by the Organization. The Greek version of the 2 questionnaires was used. Each patient was given the 2 questionnaires, after detailed explanation of the procedure. The questionnaires were filled in by the patients themselves. Additional information or assistance was provided individually, if needed.
For each patient, we recorded additional specific clinical and demographical data. The data recorded was age, sex, address, marital status, occupation, educational level, time elapsed after total laryngectomy, type of voice rehabilitation after surgery and additional treatment after surgery.
Statistical analysis of the data included descriptive statistics and inferential statistics. Qualitative variables were described via frequencies. For the analysis of quantitative variables Shapiro–Wilk test was performed (expected sample size < 2000) to determine whether their values were distributed normally. If this was the case, mean value and 95% confidence interval were used for their description. In case of non-normal distribution, median and interquartile range were used instead. For the comparison between quantitative variables we used Spearman rho correlation, while for the comparison between quantitative and quality variables we used Mann–Whitney and Kruskal–Wallis tests, depending on the number of the subgroups of the variables. The significance level was 5%. All statistical analyses were conducted using Version 24 of SPSS software (IBM Corp., Armonk, NY, USA).
Results
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Descriptive information on the sample
Fifty patients suffering from laryngeal cancer and having undergone total laryngectomy participated in the present study. All patients were male. The mean age was 66.6 years (SD = 8.7, range: 37.3–81.5). Patients’ demographic characteristics as well as type of voice rehabilitation and additional treatment following total laryngectomy are presented in Table 1. Finally, the last data recorded was the time that had elapsed after surgery. The mean value was 48.4 months (SD = 66.4, range: 6–300 months, median = 14 months).
Results of the studied patients and comparison with other control groups.
Table 1.
Sample characteristics
| n% | |
|---|---|
| Sex | |
| Male | 50 (100) |
| Female | 0 (0) |
| Residence | |
| Rural, | 26 (52) |
| Semi-urban | 8 (16) |
| Urban | 16 (32) |
| Educational level | |
| Illiterate | 1 (2) |
| Primary education | 29 (58) |
| Secondary education | 16 (32) |
| Higher education | 4 (8) |
| Marital status | |
| Married | 40 (80) |
| Single | 2 (4) |
| Divorced | 4 (8) |
| Widowers | 4 (8) |
| Additional treatment | |
| Radiotherapy | 17 (34) |
| Chemoradiotherapy | 3 (6) |
| Voice Rehabilitation | |
| Esophageal speech | 29 (58) |
| Voice prosthesis | 16 (32) |
| Electro-larynx | 5 (10) |
n number
Descriptive statistics for the QLQ C30 questionnaire are presented in Table 2. The scores are presented in accordance with the 2 sectors of functionality and symptoms of the questionnaire. Regarding functionality, higher scores indicate improvement in QoL, while with regard to symptoms scores, higher scores stand for symptom-derived deterioration in QoL. Data comparison shows that Greek patients appear to have higher functionality and milder symptomatology, apart from dyspnoea and financial problems. The comparison between the mean values data is presented in Fig. 1. Τhe mean values of the male group, the EORTC data of head and neck male patients as well as all cancers patients (questionnaire QLQ C30 v3.0) are summarized in Table 3.
Table 2.
QLQ C30 v3.0 questionnaire scores of studied population
| Abbreviation | Mean | (SD) | Median | (IQR) | |
|---|---|---|---|---|---|
| Global health status/QoL Score | QoL | 59.8 | (31.1) | 66.7 | [33, 3–85, 4] |
| Functionality | |||||
| Physical function score | PF | 86.3 | (18.7) | 93.3 | [73, 3–100] |
| Role function score | RF | 81.0 | (23.1) | 91.7 | [66, 7–100] |
| Emotional function score | EF | 78.1 | (22.5) | 83.3 | [66, 7–100] |
| Cognitive function score | CF | 94.7 | (9.8) | 100.0 | [83,3–100] |
| Social function score | SF | 85.7 | (21.0) | 100.0 | [83,3–100] |
| Symptomatology | |||||
| Fatigue score | FA | 17.1 | (23.6) | 11.1 | [0–25] |
| Nausea/Vomiting score | NV | 3.3 | (13.9) | 0.0 | [0–0] |
| Pain score | PA | 7.0 | (18.2) | 0.0 | [0–0] |
| Dyspnoea score | DY | 24.7 | (29.2) | 33.3 | [0–33, 3] |
| Insomnia score | SL | 17.3 | (31.0) | 0.0 | [0–33, 3] |
| Appetite loss score | AP | 9.3 | (27.0) | 0.0 | [0–0] |
| Constipation score | CO | 13.3 | (23.3) | 0.0 | [0–33, 3] |
| Diarrhoea score | DI | 0.0 | (0.0) | 0.0 | [0–0] |
| Financial problems score | FI | 20.0 | (31.6) | 0.0 | [0–33, 3] |
Fig. 1.
Comparative diagram between the mean values of the sample (blue line) and all cancer patients’ data (reference population of EORTC) (red line), for the questionnaire QLQ C30 v3.0
Table 3.
Comparative data of the mean values between the sample, and the EORTC data of head and neck male patients, and all cancers patients (questionnaire QLQ C30 v3.0)
| Sample (men) | Head & Neck cancer (men) | All cancers | |
|---|---|---|---|
| Global health status/QoL | 59.8 | 64.2 | 61.3 |
| Functionality | |||
| Physical function | 86.3 | 81.7 | 76.7 |
| Role function | 81.0 | 79.0 | 70.5 |
| Emotional function | 78.1 | 73.4 | 71.4 |
| Cognitive function | 94.7 | 86.0 | 82.6 |
| SocialfFunction | 85.7 | 82.9 | 75.0 |
| Symptomatology | |||
| Fatigue | 17.1 | 26.5 | 34.6 |
| Nausea/Vomiting | 3.3 | 5.0 | 9.1 |
| Pain | 7.0 | 22.4 | 27.0 |
| Dyspnoea | 24.7 | 18.9 | 21.0 |
| Insomnia | 17.3 | 26.5 | 28.9 |
| Appetite loss | 9.3 | 17.1 | 21.1 |
| Constipation | 13.3 | 10.7 | 17.5 |
| Diarrhoea | 0 | 6.0 | 9.0 |
| Financial problems | 20.0 | 18.3 | 16.3 |
Based on recorded values, it seems that overall QoL in the three groups (control, reference population for male patients with head and neck cancer and cancer patients in general) does not differ significantly (mean score: 59.8 vs 64.2 and 61.3 respectively). However, functionality parameters for Greek patients are on average higher than those cited by the Organization, particularly regarding perception, physical fitness, social status and emotional state (Cognitive, Physical, Social and Emotional Functions) (Fig. 1). All symptom-scores were low (especially for nausea/vomiting, pain and diarrhea), except for dyspnoea. They were also comparatively lower than those of reference groups, which indicates that Greek patients manifest milder symptomatology (Figs. 1, 2).
Fig. 2.
Comparative diagram between the mean values of the male sample with head and neck cancer (Head and Neck males) and reference male cancer population of the questionnaire QLQ C30 v3.0
With regard to symptoms, only Pain, Dyspnoea, Insomnia (sleep disorders) and Fatigue show statistically significant negative correlation with the overall QoL index. This means that the higher the index, the milder these four symptoms are (Table 4). Further positive or negative statistically inter-correlations exist between the indices of functionality and symptomatology. For example, Physical Function correlates positively with Social (social status), Role (role in life), Emotional (emotional state) and Cognitive Function (perception). What is more, the Fatigue index (tiredness) correlates positively with Pain (pain), Dyspnoea (breathlessness), Insomnia (sleep disorders), Appetite loss indices (decreased appetite) (Table 4).
Table 4.
Results of correlation between the variables in the QLQ C30 questionnaire
| Global health status/QoL Score | Physical function score | Role function score | Emotional function score | Cognitive function score | Social function score | Fatigue score | Nausea/Vomiting score | Pain score | Dyspnoea score | Insomnia score | Appetite loss score | Constipation score | Diarrhoea score | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Physical function score | r | 0.540*** | |||||||||||||
| p | .000 | ||||||||||||||
| Role function score | r | .325* | .481*** | 1.000 | |||||||||||
| p | .021 | .000 | |||||||||||||
| Emotional function score | r | .400** | .372** | .405** | 1.000 | ||||||||||
| p | .004 | .008 | .004 | ||||||||||||
| Cognitive function score | r | .386** | .298* | .375** | .221 | 1.000 | |||||||||
| p | .006 | .036 | .007 | .123 | |||||||||||
| Social function score | r | .418** | .303* | .621*** | .545*** | .321* | 1.000 | ||||||||
| p | .002 | .032 | .000 | .000 | .023 | ||||||||||
| Fatigue score | r | − .458** | − .610*** | − .423** | − .489*** | − .392** | − .434** | 1.000 | |||||||
| p | .001 | .000 | .002 | .000 | .005 | .002 | |||||||||
| Nausea/Vomiting score | r | − .180 | − .246 | − .309* | − .238 | − .034 | − .165 | .198 | 1.000 | ||||||
| p | .210 | .085 | .029 | .096 | .814 | .252 | .168 | ||||||||
| Pain score | r | − .294* | − .437** | .023 | − .237 | − .170 | .007 | .394** | .284* | 1.000 | |||||
| p | .039 | .002 | .874 | .097 | .238 | .960 | .005 | .046 | |||||||
| Dyspnoea score | r | − .492*** | − .626*** | − .439** | − .334* | − .382** | − .369** | .534*** | .020 | .278 | 1.000 | ||||
| p | .000 | .000 | .001 | .018 | .006 | .008 | .000 | .892 | .051 | ||||||
| Insomnia score | r | − .317* | − .245 | − .016 | − .288* | − .287* | .093 | .307* | .287* | .132 | .065 | 1.000 | |||
| p | .025 | .086 | .911 | .043 | .043 | .520 | .030 | .043 | .362 | .656 | |||||
| Appetite loss score | r | − .185 | − .236 | .091 | − .382** | − .165 | .106 | .285* | .160 | .313* | .269 | .626*** | 1.000 | ||
| p | .198 | .099 | .532 | .006 | .254 | .462 | .045 | .267 | .027 | .059 | .000 | ||||
| Constipation score | r | − .026 | − .045 | − .110 | − .102 | − .310* | − .241 | .084 | − .003 | .140 | .178 | − .060 | .034 | 1.000 | |
| p | .858 | .757 | .449 | .480 | .028 | .091 | .564 | .983 | .332 | .216 | .678 | .816 | |||
| Diarrhoea score | r | ||||||||||||||
| p | |||||||||||||||
| Financial problems score | r | − 0.317* | − 0.369** | − 0.325* | − 0.560*** | − 0.410** | − 0.461** | 0.589*** | 0.295* | 0.275 | 0.396** | 0.161 | 0.260 | 0.226 | |
| p | 0.025 | 0.008 | 0.021 | 0.000 | 0.003 | 0.001 | 0.000 | 0.038 | 0.053 | 0.004 | 0.264 | 0.068 | 0.114 |
*p < 0.05, **p < 0.01, ***p < 0.001
Results regarding the QLQ H & N35 questionnaire are presented in Table 5. Higher scores amass to increased discomfort or dysfunction. Senses, speech and social problems are more intense in the Greek population, whereas lower average discomfort or dysfunction were noted in relation to all other tested parameters (Fig. 3).
Table 5.
Sample values for the QLQ H & N35 questionnaire
| Mean | (SD) | Median | (IQR) | |
|---|---|---|---|---|
| Pain score | 6.0 | (11.7) | 0.0 | [0–8, 3] |
| Swallowing score | 12.0 | (22.8) | 0.0 | [0–10, 4] |
| Senses problems score | 31.0 | (30.5) | 33.3 | [0–50] |
| Speech problems score | 40.6 | (27.0) | 44.4 | [22, 2–58, 3] |
| Trouble with social eating score | 12.2 | (21.3) | 0.0 | [0–16, 7] |
| Trouble with social contact score | 17.9 | (18.4) | 13.3 | [0–33, 3] |
| Less sexuality score | 22.0 | (32.4) | 0.0 | [0–37, 5] |
| Teeth score | 15.0 | (28.1) | 0.0 | [0–33, 3] |
| Opening mouth score | 15.0 | (28.1) | 0.0 | [0–33, 3] |
| Dry mouth score | 1.3 | (6.6) | 0.0 | [0–0] |
| Sticky saliva score | 13.3 | (26.9) | 0.0 | [0–8, 3] |
| Coughing score | 30.7 | (30.0) | 33.3 | [0–33, 3] |
| Felt ill score | 12.7 | (24.2) | 0.0 | [0–33, 3] |
| Pain killers score | 18.0 | (38.8) | 0.0 | [0–0] |
| Nutritional supplements score | 2.0 | (14.1) | 0.0 | [0–0] |
| Feeding tube score | 2.0 | (14.1) | 0.0 | [0–0] |
| Weigh tloss score | 8.0 | (27.4) | 0.0 | [0–0] |
| Weight gain score | 30.0 | (46.3) | 0.0 | [0–100] |
Fig. 3.
Comparative diagram of distribution of sample values and the mean values of the reference population with head and neck cancer for the QLQ H & N35 questionnaire
Six to 300 months passed from initial operation to recruitment (mean: 48.4), with newly operated on patients being followed-up more frequently than older ones. Twenty out of fifty patients were subjected to adjuvant treatment (radiotherapy or a combination of radio- and chemotherapy) post-surgery. The choice was based on both clinical and histological findings, like tumor stage, presence of affected cervical lymph nodes etc.
Discussion
The main goal of this study is to evaluate QoL of patients with laryngeal cancer, who have been subjected to total laryngectomy. A further aim is to compare QoL parameters with clinical and demographic patient features. Fifty patients with laryngeal cancer were tested through two validated questionnaires by the EORTC, namely QLQ C30 (regarding cancer in general) and H&N 35 (regarding head and neck cancer in particular). All patients were male with a mean age of 66.6 years, resided mostly in rural areas and were primarily farmers and laborers, which is in accordance with known data regarding the features of this group of patients [10, 11].
The main finding of the study was that overall QoL is comparable with that of all cancer patients, whereas studied patients manifested improved functionality in every-day life (Cognitive, Physical, Social και Emotional Functions), as well as milder symptomatology. However, the studied population reported financial problems more frequently than the reference groups. Noted discrepancies seem to be attributed to the nature and special features of head and neck cancer, as well as the sequelae of total laryngectomy. This type of surgery doesn’t seem to burden patients, despite its radical nature, save for an increased feeling of breathlessness second to permanent tracheostoma. Any documented differences can be further explained through the particular characteristics of Greek patients in terms of way of living, mentality, familial support, recent financial crisis etc., comparing to their European counterparts.
Similar results have been reached by various groups of researchers. According to Woodard et al. [12] and Zotti et al. [8] total laryngectomy doesn’t significantly affect QoL in the majority of patients, and partial laryngectomy doesn’t lead to improved QoL compared to its more drastic alternative [7]. What is more, chemoradiotherapy with preservation of the larynx doesn’t improve QoL comparing to total laryngectomy either [13].
There is evidence that total laryngectomy imposes a greater burden on QoL and emotional state [9], while, according to an Italian study, chemoradiotherapy with preservation of the larynx was linked with better QoL and functionality indices, comparing to total laryngectomy followed by adjuvant radiotherapy [14]. What is more, further research points to more intense psychological, social and emotional repercussions in patients undergoing total laryngectomy [1–3].
Worse functionality, as revealed by the H&N35 questionnaire in the fields of senses, speech and social contacts (resulting from permanent tracheostoma) has already been documented as one of the issues related with total laryngectomy [15, 16]. Further studies support this finding, with the primary difficulty encumbered upon patients being communication problems second to loss of speech [1, 2, 4, 9], hyposmia or anosmia [4, 9, 14], permanent tracheostoma-related issues [2, 4, 7, 14],and social isolation [1–4].In contrast with the present study, further researchers report intensification of various malfunctioning physiologic processes, such as dysphagia to certain foods or even liquids [5, 6, 9], sexual problems [1] and pain [14].
Regarding symptoms, only three out of eight were statistically significantly linked with the overall QoL index, namely pain, dyspnoea and sleep disorder. Statistically significant correlations between functionality and symptomatology have also been documented, namely physical function and social status, life role, emotional state and perception. Additionally, pain was associated with dyspnoea, sleep disorder (insomnia) and loss of appetite. All these correlations can be deemed expected, as functionality parameters are interconnected, and some symptoms can be affected by others. The search of Greek and international literature did not come back with any publications mentioning correlations between QLQ C30 parameters for patients with laryngeal cancer. However, according to the instructions for use issued by EORTC regarding this questionnaire, there is increased likelihood of finding correlations of this sort in cancer patients (EORTC, 2011).
Age correlated negatively with perception and positively with fatigue and cough, which abides by common sense. According to Jensen et al. [17], increased age is linked with milder symptoms and higher functionality in Danish patients, results that only partly agree with the findings of the present study. Woodard et al. [12] also mention that patients older than 65 years had better overall QoL and higher levels of functionality in USA patients. British patients, who have undergone total laryngectomy, haven’t shown age-related differences regarding the parameters included in the two questionnaires [3].
Place of residence also statistically significantly influences the overall QoL index, as well as perception. More specifically, residents of rural areas had better QoL and higher perception comparing to residents of urban and semi-urban areas. This could be explained through the existence of closer interpersonal relationships in rural areas (both familial and social), as well as through the stronger psychological and practical support offered by smaller social structures. Literature search did not come back with any research investigating correlation between place of residence and QoL. Patients with lower educational level had better emotional state and better (albeit marginally) physical function compared to those having achieved higher educational goals. No other study was found to have looked into the relationship of educational level and QoL.
Patients having received adjuvant treatment post-laryngectomy had more viscous saliva. The change in saliva consistency is a known sequel to radiotherapy [18]. Further studies have found viscous saliva and/or xerostomia as a result of adjuvant radiotherapy [13, 14, 17]. Nausea and vomiting may be found more frequently in patients with voice prosthesis, whereas patients with electro-larynx may present with sexual dysfunction more frequently comparing to patients having been treated with other voice rehabilitation methods. Nausea and vomiting could be explained through the fact that patients with voice prosthesis essentially have a tracheoesophageal fistula, to which the prosthesis is attached. Consequently, the rear aspect of the prosthesis likely irritates the oesophagus and is responsible for these symptoms. Electro-larynx, on the other hand, demands that the patient constantly hold the device with one hand, in order to speak, possibly negatively impacting sexual intercourse by not allowing the patient to verbally communicate with their partner during its course. Moukarbel et al. [19] used a questionnaire designed to test voice in particular and found that patients with a voice prosthesis had better QoL comparing to those with electro-larynx, while patients with oesophageal speech scored slightly worse than patient with a voice prosthesis.
Last but not least, no statistically significant relationship was found between time since surgery and the various questionnaire parameters. Similar results were reached by further studies [12, 14], while another study performed on patients with laryngectomy found that the further in the past the surgery the more negative was the impact on patients with voice prosthesis [19]. Sex was not tested for correlations as all recruited patients were male. According to literature, women having undergone total laryngectomy are impacted more severely comparing to their male counterparts, in terms of both functionality and symptoms [3, 17].
QoL studies in cancer patients being subjected to radical surgical procedures help comprehend the problems experienced by those patients, both as a result of their primary disease, as well as its treatment. Questionnaire-based studies have revealed and explained unknown problems arising post-surgery. Surgical procedures should be revised based not only on best tumor removal techniques, but also according to their impact on QoL. Patients should always be thoroughly informed on the benefits, disabilities and various issues following each therapeutic tactic and play a part in the decision-making. Appropriate infrastructure should be in place to support patients facing social, financial, psycho-emotional and self-preservation problems.
Conclusion
To the best of our knowledge, this is the first Greek study evaluating QoL in cancer patients, who have undergone total laryngectomy, using the standardized EORTC QLQ C30 version 3.0 and EORTC QLQ H&N35 questionnaires. Its primary finding is that, although several QoL aspects are found to be negatively affected in laryngectomized patients, overall QoL appears to be satisfactory. However, further, larger studies are needed to more thoroughly investigate QoL in patients with laryngeal cancer.
Acknowledgements
This study was not supported by any company or persons other than the authors.
Funding
Researchers did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Declaration
Conflict of interest
All authors declare that there are no conflicts of interest to be reported.
Footnotes
Publisher's Note
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