Evaluation of Individual Quality of Life (QOL) Among Patients with Tracheostomy Using WHO-QOL BREF Questionnaire

Abstract

Tracheostomy is one of the most frequently performed surgical procedures worldwide. The placement of tracheostomy in a patient is associated with significant morbidities as apart from the physical impact of the procedure, a profound and persistent effect on psychosocial, financial, environmental and other aspects of global health of the patient becomes inevitable. However, there is a surprising paucity of literature assessing the Quality of Life (QOL) in patients with tracheostomy tube placement. This study was undertaken with the objective to assess the effect of tracheostomy on Quality of Life (QOL) of patients in an urban tertiary health care setup in India. Patients who underwent tracheostomy tube placement irrespective of the indication were included in the study and followed up for a period of up to 3 months to determine the effect of tracheostomy tube placement on the Quality of Life. A questionnaire based on World Health Organisation (WHO) QOL BREF scheme was utilized to evaluate QOL in the immediate post operative period and again appraised after a period of 3 months. The results were statistically analyzed, tabulated and compared using paired t test to evaluate the ‘p’ value in every domain i.e., physical, social, psychological and environmental, of the WHO QOL-BREF evaluation tool. 63 patients were enrolled in the study after excluding the patients not fulfilling the selection criteria. The majority of patients were male over the age of 50 years (mean age 57 years). There was a noteworthy depreciation in QOL score in patients as WHO-QOL-BREF scores in all the 4 domains were significantly lower after 3 months. The most affected were the Environmental domain (p value 5E−15) whereas the domain of Psychological showed least depreciation of mean QOL score (p value 7.7E−5). Insertion of a tracheostomy tube has a significant impact on the quality of life of the patient and the amount of burden increases with worsening quality of life. A holistic and scientific approach to assess and manage tracheostomy induced morbidity on the patient is necessary. The patients’ views of the aspects of life should be used by health policy makers, clinicians, and caregivers as a reliable guide to the most important priorities for treatment and medical interventions. Large prospective multicenter studies may be undertaken for the developement of a standardized and internationally accepted tracheostomy specific quality of life evaluation tool.

Introduction

The term tracheostomy refers to the creation of a permanent stoma between the trachea and cervical skin [1]. The first known reference to tracheostomy is found in the sacred Hindu scripture Rig Veda which dates back to 2000 BC. However, it gained popularity in the 1800 s as a recognized way of treating Diphtheria patients. Today, tracheostomy is a frequently performed procedure all over the globe for a wide array of indication, ranging from emergency tracheostomy to an elective one in Intensive Care Unit (ICU) setting. The placement of tracheostomy tube, nevertheless imparts a range of physical and psychosocial perils on the overall wellbeing of the patients. The feeling of having a “hole in the neck”, communication disability, burden of tracheostomy tube maintenance, financial liability and treatment of underlying disorder and various other tribulations impair normalcy of life in these patients. Regular and intensive care of the tracheostomy tube adds to the impediment of underlying disorder and worsens health related QOL in these patients.

According to World Health Organization (WHO), quality of life (QoL) is defined as “individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns” [2]. Health is described as “the state of complete physical, mental, and social well-being, not merely the absence of disease or infirmity” [3]. The approach to provide holistic care to a debilitating condition like tracheostomy therefore needs to incorporate all these variables to guide rehabilitation of the patient and address their needs more effectively. The development of different health related QOL questionnaires; both general and specific, provide tools for psychometric assessment with regard to their validity and reliability.

There is an alarming paucity of literature regarding quality of life data in patients with tracheostomy tube when compared with other chronic ailments. The significant stress of a tracheostomy tube in the neck should neither be overlooked nor underestimated. We undertook this study with the objective to evaluate the effect on QOL of patients undergoing tracheostomy using a questionnaire based on World Health Organisation (WHO) QOL BREF scheme to assist development of a better management protocol for need based intervention in tracheostomy patients.

Materials and Methods

Study Setting

The study was conducted in the otolaryngology ward at a tertiary health care set up in India. The centre deals with tracheostomy cases of various etiologies and their management on a regular basis.

Study Design

This observational study adopted a convenience sampling design to recruit 68 patients who were eligible for participation in the study in our department. The patients had undergone tracheostomy at our centre and were in regular follow up for a period of at least up to 3 months. These patients were selected regardless of age, sex, family and social traits, residential address and other features. Informed consent was obtained from participants after explaining the nature and purpose of study. Exclusion criteria included (1) terminally ill patients (2) associated mental health issues (3) follow up of less than 3 months and (4) patients with age less than 18 years. There was evident reluctance of a number of patients and their family members to engage in procedure related discussion soon after tracheostomy. We accepted their request to be not included in the study.

Procedure

A total of 68 patients aged between 18 and 72 years were enrolled into the study after they underwent tracheostomy and submitted for regular follow up. The appropriate therapeutic regimen for the underlying disorder requiring tracheostomy, as decided by treating surgeon was continued throughout the study. The medical records and other information regarding the patient, diagnosis and disease status were abstracted from case records. The QOL of patients was assessed once the patients were stabilized in the post operative period using the WHO QOL BREF questionnaire which is an internationally acceptable QOL assessment tool [4]. The essential information was collected primarily through individual interviews and the instrument-based questions in private. Interviews were conducted by a trained healthcare provider who is working in the otolaryngology unit and regularly interacts with tracheostomised patients”. Probing questions were used to explore the basis of the patients’ responses.

A total of 5 respondents out of 68 who consented for the study either dropped out of the study or answered questions incompletely, hence they were not considered for further processing to eliminate subject bias. Questions No 1 and 2 were framed to gauge the overall picture of respondents. For remaining 63 responses, we reversed scores for negative questions numbered 3, 4 and 26, as rest of the questions were positive. SPSS Syntax was used for carrying out data checking, cleaning and computing total scores. Then, we grouped responses domain wise by bringing responses of questions belonging to the same domain together. Then with the help of tables mentioned by WHOQOL-BREF, we transformed the raw domain scores of each respondent into QOL-100 scores by multiplying it by 4 so that it became comparable with WHOQOL-100. HR QOL of both the patients and parents were reassessed after 3 months of therapy, using the same scales of WHO QOL BREF questionnaire. Several factors and indices were studied using standard procedures and statistical analyses were conducted using the standardized software. The mean domain score for every domain were calculated individually at both point of times and compared statistically utilizing the paired t test and significance of ‘p’ value scores Unless otherwise mentioned, results were considered statistically significant if the probability of their occurrence was 0.05 or less.

The WHO QOL-BREF Questionnaire

This is a 26-item self-administered generic questionnaire, a short version of WHO QOL-100 scale [4]. The instrument has two parts, comprising of 26 items, assessing health in four domains, namely, physical health, psychological health, social relationships, and environment. The score may be self-administered, if the respondent has the ability, or may be interviewer assisted. The instrument was tried cross-culturally in 15 countries, including India, and is a valid tool. WHOQOL-BREF has well to excellent psychometric properties of reliability and performs well in preliminary tests of validity. Various studies indicate that overall, the WHOQOL-BREF is a sound, cross-culturally valid assessment of QOL, as reflected by its four domains (Table 1).

Table 1.

WHO QOL-BREF questionnaire

Domain name	Question no	Questions
General	1	How would you rate your quality of life?
Physical health	2	How satisfied are you with your health?
	3	To what extent do you feel that physical pain prevents you from doing what you need to do?
	4	How much do you need any medical treatment to function in your daily life?
	10	Do you have enough energy for everyday life?
	15	How well are you able to get around?
	16	How satisfied are you with your sleep?
	17	How satisfied are you with your ability to perform your daily living activities?
	18	How satisfied are you with your capacity for work?
Psychological	5	How much do you enjoy life?
	6	To what extent do you feel your life to be meaningful?
	7	How well are you able to concentrate?
	11	Are you able to accept your bodily appearance?
	19	How satisfied are you with yourself?
	26	How often do you have negative feelings such as blue mood, despair, anxiety, depression?
Social relationships	20	How satisfied are you with your personal relationships?
	21	How satisfied are you with your sex life?
	22	How satisfied are you with the support you get from your friends?
Environmental	8	How safe do you feel in your daily life?
	9	How healthy is your physical environment?
	12	Have you enough money to meet your needs?
	13	How available to you is the information that you need in your day-to-day life?
	14	To what extent do you have the opportunity for leisure activities?
	23	How satisfied are you with the conditions of your living place?
	24	How satisfied are you with your access to health services?

Various other measures such as the Schedule for the Evaluation of Individual Quality of Life (SEIQoL), SEIQoL-direct weighting (SEIQoL-DW) and WHO QOL-100 scale were considered. However, the SEIQoL is a comprehensive and complicated measure of an intricate process and its use in routine clinical situations may prove impractical [5]. Administration of the SEIQoL-DW for delicate patients such as older people and less-educated clients is accompanied with several limitations [6]. Hence, considering that the patient group in our study primarily consisted of old patients with a generalized difficulty in speech and communication skills, we adopted the WHO QOL BREF scale as reliable, validated, practical and integrated instrument for Quality of Life measurement.

Results

Data was collected and the responses were arranged in different domains of WHO QOL BREF scale. Questions number 3, 4 and 26 were negatively framed questions and hence, their ratings were reversed to convert into positive scoring. Cases where more than 20 percent data was missing were deleted or where people dropped out of study were excluded. Eventually out of 68 respondents only 63 were considered for final analysis. The age group ranged from 18 years to 72 years with a mean age of 57.2 years. The study included 47 male and 16 female patients, thus showing a male preponderance with a male to female ratio of 2.93:1. The commonest indications for patients undergoing long term tracheostomy in our study was laryngeal malignancy (66.17%), which was followed by laryngotracheal stenosis (17.64%), bilateral abductor palsy (8.82%) and burns (7.35%) and other conditions.

The mean score of items within each domain was used to calculate the individual domain score. Statistical analysis with different parameters was performed at 7 days and 3 months after tracheostomy and results were tabulated as under. Paired T test was applied to the scores and p value was calculated to assess statistical significance.

The complete descriptive analysis of each domain along with detailed p value analysis is is represented in tabulated charts as following:

Domain 1: Physical Health

Mean of physical health domain score was calculated 7 days after the tracheostomy procedure which was around 11.44 with SD of 1.3. The mean for the same domain score was calculated 3 months after which were 9.66 with SD 1.8 (Table 2).

Table 2.

Descriptive statistics of physical health

Physical health—before		Physical health—after
Descriptive statistics		Descriptive statistics
Mean	11.44671202	Mean	9.66893424
SE	0.174424965	SE	0.230328114
Median	11.42857143	Median	9.714285714
Mode	12	Mode	9.142857143
SD	1.384455237	SD	1.828172731
Sample variance	1.916716302	Sample variance	3.342215534
Kurtosis	1.54777913	Kurtosis	− 0.501780086
Skewness	− 0.347480929	Skewness	0.397860431
Range	7.428571429	Range	7.428571429
Minimum	7.428571429	Minimum	6.285714286
Maximum	14.85714286	Maximum	13.71428571
Sum	721.1428571	Sum	609.1428571
Count	63	Count	63

Paired t test was performed and p value was calculated to be 1E−08 which was statistically significant (Table 3).

Table 3.

T test: paired two sample means for physical health

t test: paired two sample for means physical health
	Variable 1	Variable 2
Mean	11.44671	9.668934
Variance	1.916716	3.342216
Observations	63	63
Pearson correlation	0.089806
Hypothesized mean difference	0
df	62
t stat	6.437709
P(T ≤ t) one-tail	1E−08
t critical one-tail	1.669804
P(T ≤ t) two-tail	2E−08
t critical two-tail	1.998972

Domain 2: Psychological Health

Mean of psychological domain score after 7 days was calculated to be 9.83 with Standard deviation of 2.07. The Mean of psychological domain score calculated 3 months after the procedure was 8.56 with SD 2.01 (Table 4).

Table 4.

Descriptive statistics of psychological health

Psychological—before		Psychological—after
Descriptive statistics		Descriptive statistics
Mean	9.832804233	Mean	8.560846561
SE	0.261565273	SE	0.253420072
Median	10	Median	8.666666667
Mode	9.333333333	Mode	9.333333333
SD	2.07610999	SD	2.011459461
Sample variance	4.31023269	Sample variance	4.045969164
Kurtosis	6.912167573	Kurtosis	− 0.63014699
Skewness	− 1.4841251	Skewness	0.168005063
Range	14	Range	8.666666667
Minimum	0	Minimum	4.666666667
Maximum	14	Maximum	13.33333333
Sum	619.4666667	Sum	539.3333333
Count	63	Count	63

Paired t test was applied and a p value of 7.7E−05 was obtained (Table 5).

Table 5.

T test: paired two sample means for psychological health

t test: paired two sample for means
Psychological
	Variable 1	Variable 2
Mean	9.832804	8.617989
Variance	4.310233	5.198166
Observations	63	63
Pearson correlation	0.399214
Hypothesized mean difference	0
df	62
t stat	4.028444
P(T ≤ t) one-tail	7.79E−05
t critical one-tail	1.669804
P(T ≤ t) two-tail	0.000156
t critical two-tail	1.998972

Domain 3: Social Relationship

Mean of social relationships domain score was calculated to be 9.33 with SD of 2.67 on day 7 after the tracheostomy procedure was performed. The mean calculated 3 months after was 7.73 with SD 2.79 (Table 6).

Table 6.

Descriptive statistics of social relationships

Social relationships—before		Social relationship—after
Descriptive statistics		Descriptive statistics
Mean	9.365079365	Mean	7.735449735
SE	0.3313402	SE	0.352347174
Median	9.333333333	Median	8
Mode	8	Mode	8
SD	2.629931303	SD	2.796668993
Sample variance	6.916538658	Sample variance	7.821357456
Kurtosis	3.620758909	Kurtosis	1.176356289
Skewness	− 1.163187342	Skewness	− 0.106990757
Range	14.66666667	Range	14.66666667
Minimum	0	Minimum	0
Maximum	14.66666667	Maximum	14.66666667
Sum	590	Sum	487.3333333
Count	63	Count	63

Paired t test was performed and p value was calculated to be 1.2E−06 which was statistically significant (Table 7).

Table 7.

T test: paired two sample means for social relationships

T test: paired two sample for means
Social relationships
	Variable 1	Variable 2
Mean	9.365079365	7.73544974
Variance	6.916538658	7.82135746
Observations	63	63
Pearson correlation	0.580091222
Hypothesized mean difference	0
df	62
t stat	5.192766767
P(T ≤ t) one-tail	1.2193E−06
t critical one-tail	1.669804163
P(T ≤ t) two-tail	2.43861E−06
t critical two-tail	1.998971517

Domain 4: Environmental

Mean of environmental domain score was 11.76 with SD of 1.81, 7 days after tracheostomy. The mean of environmental domain score 3 months after the procedure was 8.26 with SD 1.75 (Table 8).

Table 8.

Descriptive statistics of environmental

Environmental—before		Environmental—after
Descriptive statistics		Descriptive statistics
Mean	11.7675737	Mean	8.261904762
SE	0.228315545	SE	0.220510377
Median	12	Median	8
Mode	12	Mode	8
SD	1.812198455	SD	1.750246856
Sample variance	3.284063241	Sample variance	3.063364055
Kurtosis	− 0.046753296	Kurtosis	− 0.03014372
Skewness	0.315695646	Skewness	0.272668873
Range	8.5	Range	7.5
Minimum	8	Minimum	4.5
Maximum	16.5	Maximum	12
Sum	741.3571429	Sum	520.5
Count	63	Count	63

Paired t test was applied and a P value of 5E−15 was obtained (Table 9).

Table 9.

T test: paired two sample means for environmental

t test: paired two sample for means
Environmental
	Variable 1	Variable 2
Mean	11.76757	8.261905
Variance	3.284063	3.063364
Observations	63	63
Pearson correlation	− 0.19498
Hypothesized mean difference	0
df	62
t stat	10.10376
p(T ≤ t) one-tail	5E−15
t critical one-tail	1.669804
p(T ≤ t) two-tail	1E−14
t critical two-tail	1.998972

Thus, there is a definite decline in mean scores across all four domains of the WHO QOL-BREF evaluation tool in patients with tracheostomy. The p value score is also significant in all four domains giving idea about the decrease in quality of life over time after tracheostomy. This decrease is most evident in the Environmental domain whereas the least affected is Psychological domain.

Discussion

The term tracheostomy refers to the creation of a permanent stoma between the trachea and cervical skin [1]. It is one of the oldest documented surgical procedures with numerous vivid descriptions in ancient literature. The principles of modern tracheostomy were established by Chevalier Jackson at the beginning of twentieth century and they remain in place even today [7]. It is one of the commonest surgical procedures undertaken by an otolaryngologist today for a wide range of indications. The indications for tracheostomy can be broadly divided into the following categories:

• Mechanical upper airway obstruction.

• Retention of bronchial secretions

• Prolonged ventilation like cases of respiratory failure

• Protection of tracheobronchial tree from aspiration

• Elective tracheostomy as part of another procedure

The indications and utility of tracheostomy have evolved over time along with the broadened range of technical advancements and equipments. As a result of developments in medical care and technology, individuals with long-term or lifelong respiratory health care needs, such as a tracheostomy, are becoming increasingly common [8]. It is not an uncommon sight to find a significant number of patients with tracheostomy tube in situ in otolaryngology, cancer, intensive care and even paediatrics wards. While some patient may undergo decannulation once the underlying disorder is satisfactorily cured, a vast majority may have to live with the tube for a dreadfully extended period of time, and in some cases for life. The latter group of patients has to depend on the tracheostomy tube for their therapeutic care as well as for survival. The effects of tracheostomy in these patients ventures beyond physical aspects to involve the mental, social and financial health of the patient and the support system. Thus, it becomes imperative for the health care provider to be well abreast of all these aspects to ensure a complete and holistic treatment to the patient. We commenced this study to analyze the effect of tracheostomy tube on the overall health of the patient as there is a disquieting dearth of literature on this subject in spite of the wide prevalence. The tool we utilized for the purpose of assessment is the “Quality of Life (QOL)” evaluation methods in tracheostomised patients.

Tracheostomy is often perceived as a “hole in the neck” which in itself is not a comfortable idea to live with; especially it has to be maintained lifelong. While elaborate patient counseling may not be feasible in an emergency situation, elective tracheostomy counseling often tends to overlook this basic discontentment towards tracheostomy tubes. Once the tracheostomy has been performed and patients are stabilized, the onus of proper maintenance and care involves a series of interventions that aim to stabilize and then optimize the physiological state of patients. Humidification, regular suctioning and proper wound care are critical and sophisticated steps of management which requires careful and comprehensive learning and commitment on part of patients as well as caregivers. Any departure from the prescribed methods, inappropriate assessment or flawed criteria regarding management often meets patient’s disapproval and increases morbidity. Presence of the tracheostomy tube also impacts considerably on a patient’s ability to swallow safely by affecting mechanical as well as physiological factors of swallowing. The basic life function of swallowing may even have to be weigh up against the negative and potentially life threatening impact of aspirating any oral intake. The ability to communicate efficiently and consistently with people is hindered as the patient is incapable to express his needs, opinions and feelings. It is obvious to gauge the impact this communication problem as the patient’s competence to communicate with the people around them is paramount to their care, psyche and general well-being. Even the process of changing the tracheostomy tube carries significant risk and if exchange of tube fails, can even turn fatal [9]. Tube misplacement is a rare and potentially fatal complication of new tracheostomies which will necessitate urgent management to re-establish the tracheostomy or an alternative airway. Even a short period of hypoxia may lead to brain damage or cardiac arrest [10]. Thus, the prospect of learning the expertise essential to be independent in tracheostomy management can be daunting and even overwhelming, both for the patient and caregiver. The social acceptance of a patient with tracheostomy tube becomes dependent on family, support group and the prevalent socioeconomic conditions; factors which may not be entirely in command of the patient. Financial burden of continuing treatment further adds to the list of miseries if not suitably taken care of. Hence it is evident that apart from physical woes, tracheostomy also adversely affects the mental and socio economical aspects of patient’s life.

The tool we employed to evaluate this impact was assessment of quality of life (QOL) of a patient with a long standing tracheostomy tube in place. QOL, defined earlier, in practical terms is a subjective, multidimensional concept that defines a standard level for emotional, physical, material and social well-being such as freedom from pain, worry and sickness. The assessment of various domains of QOL is an internationally accepted appraisal tool. There is an emerging trend to specifically evaluate the health related QOL (HRQOL) which is primarily an assessment of how the individual’s well-being may be affected over time by a disease, disability or disorder [11]. A measurement of HRQOL is in effect an assessment of QOL and its association with health. The current concept of HRQOL are often multidimensional and cover physical, social, emotional, cognitive, work- or role-related, and possibly spiritual aspects as well as a wide variety of disease related symptoms, therapy induced side effects, and even the financial impact of medical conditions [12]. There are disease and condition specific HRQOL assessment instruments that are widely available nowadays for a wide range of disorders. International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) in urinary incontinence [13], European Organisation for Research and Treatment of Cancer (EORTC) for trials in oncology [14], The Stroke Specific Quality Of Life scale SS-QOL for stroke [15], RAQoL for rheumatoid arthritis [16], OAQoL for osteoarthritis [17], ASQoL for ankylosing spondylitis [18], SScQoL for systemic sclerosis [19] and PsAQoL for people with psoriatic arthritis [20] are some examples of disease specific HRQOL assessment tools. The nonexistence of a tracheostomy related QOL evaluation tool is therefore, surprising. We utilized the WHOQOL-BREF instrument in our study which is regarded as more convenient for use in large research studies or clinical trials.

The quality of life improvement attempts in tracheostomy directly relates to providing the patient and caregiver with a sound knowledge base, technical proficiency, decision making and problem solving skills. It is prudent to inform and educate the patient; at times even before the tracheostomy is performed if possible [21]; regarding the indication, clinical and psychological impact, long term management details and troubleshooting skills. At the outset, the complexity and quantity of knowledge and skills required to be learnt by the patient and the caregiver can be overwhelming. The ability of the patient and the family support group to acknowledge and understand the management protocols go a long way in improving the overall quality of life. The caregivers’ attention to details and proper planning can optimize the patients odds of adapting their way of life resourcefully and efficiently, without the tracheostomy influencing or restricting them unnecessarily. The shift from the assuring confines of health care centre to the uncertainties of home environment can disrupt the “continuity of care” which has been defined as ‘a philosophy and standard of care that involves patient, family and health care providers working together to provide a co-ordinated, comprehensive continuum of care [22]. Provision of knowledge and skills promotes independence and also helps reduce anxieties once away from the safety of the hospital setting. An interdisciplinary team approach is suited for these patients and may include treating surgeons, tracheostomy nurses, physiotherapists, occupational therapists, speech and language therapist, psychologists and community health care workers.

The patient, however, remains the focal point of any management conundrum. The body image issue pertains to physical appearance as well as control of body functions. The feeling of loss of command over breathing, voice and swallowing disrupts the independence of the patient. The sight of a tube in the neck through which sputum is bring expectorated can be a source of apprehension as well as depression. The financial burden of ongoing treatment and maintenance of tracheostomy tubes especially if the patient has to sacrifice his job has to be considered and taken care of by the patient. Hence, the patients’ individual capacity to maintain and take care of the tracheostomy significantly impacts the long term quality of life. Self and independent care should be promoted wherever possible to facilitate faster and smooth return to the previous lifestyle as much as possible without depending on others. A consistent ability to handle routine care and confidence in problem solving skills optimizes the patients’ chances of adapting their lifestyle resourcefully and efficiently. Use of purpose made scarves or high necklines can disguise or hide the stoma. The patient should be encouraged to regularly clean the stoma to prevent stoma related morbidities. The equipment box for tracheostomy tube change should be with the patient at all times. The individual should be introduced to other long-term tracheostomy users, to share their individual experiences and to provide a support system. Eventually, however, it is the manual dexterity, mental ability, behavioral predisposition and patients’ individual motivation that determines the long term quality of life in these patients. The patients’ views of the aspects of life could be used by health policy makers, clinicians, and caregivers as a reliable guide to the most important priorities for treatment and medical interventions

Summary

Insertion of a tracheostomy tube has a significant impact on the quality of life of the patient. Sincere effort on the part of caregiver and support system should be made to preserve and enhance the quality of life to ensure that the patient “thrives, not only survives” with the tracheostomy tube. A holistic and scientific approach to assessment of tracheostomy induced morbidity on the patient is necessary. Large prospective multicenter studies with larger sample size may be undertaken for the development of a standardized and internationally accepted tracheostomy specific quality of life (TQOL) evaluation tool for consistent and uniform assessment.

Funding

None.

Compliance with Ethical Standards

Conflict of interest

The authors declare that they have no conflict of interest.