|Year : 2022 | Volume
| Issue : 1 | Page : 9-16
Trends of chronic obstructive pulmonary disease diagnosis and treatment in rural setting in India: A large, two-center, prospective, observational study of 6000 cases in tertiary care setting in India
Shital Patil1, Gajanan Gondhali2, Manojkumar Bhadake2, Anil Jadhav1
1 Department of Pulmonary Medicine, MIMSR Medical College, Latur, Maharashtra, India
2 Department of Internal Medicine, MIMSR Medical College, Latur, Maharashtra, India
|Date of Submission||11-Apr-2022|
|Date of Decision||20-May-2022|
|Date of Acceptance||03-Jun-2022|
|Date of Web Publication||12-Aug-2022|
Department of Pulmonary Medicine, MIMSR Medical College, Latur, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Chronic obstructive pulmonary disease (COPD) is the leading cause of morbidity and mortality due to chronic respiratory illness in India. More than half of COPD patients were not getting adequate rationale inhalation treatment in primary to tertiary care setting. Materials and Methods: A prospective, observational, interview (questionnaire)-based complete workup COPD study conducted during June 2016 to June 2019 in the Department of Pulmonary Medicine, Venkatesh Chest Hospital, and MIMSR Medical College, Latur, screened 12,000 cases with chronic respiratory symptoms with cough, sputum production, and shortness of breath, and all cases were undergone spirometry and 6000 COPD cases were enrolled. In this study, we assessed disease knowledge and the methods of treatment offered to all patients before enrollment by applying questionnaire. Statistical analysis was done using single proportion test (Chi-square test). Observation and Analysis: We have observed that 3% of study cases were aware of their illness “COPD disease,” 54% are not knowing the disease or not counseled for COPD disease ever before, and 43% are not convinced as they are having COPD (categorized as “difficult patient”) (P < 0.0001). Inhalation treatment was offered in only 58% of COPD cases, levosalbutamol monotherapy in 31% of cases, levosalbutamol plus beclometasone in 18% of cases, and formoterol plus budesonide or salmeterol plus fluticasone only in 9% of COPD cases (P < 0.0001), latter being categorized as “difficult treatment” being costlier than former ones. We also observed irrational and exuberant use of oral medicines in 42% of COPD cases, theophylline in 16%, salbutamol in 7%, and oral steroids in 19%, and these medicines were preferred by treating doctors over inhalation treatment in spite of knowledge of inhalation treatment and categorized as “difficult doctor” (P < 0.0001). Conclusion: COPD is less efficiently evaluated and halfheartedly treated in rural setting, and more emphasis should be given to spirometry training for proper diagnosis and awareness regarding advantages of inhalation treatment over oral medicines.
Keywords: Chronic obstructive pulmonary disease, difficult doctor, inhalation treatment, salmeterol fluticasone, spirometry
|How to cite this article:|
Patil S, Gondhali G, Bhadake M, Jadhav A. Trends of chronic obstructive pulmonary disease diagnosis and treatment in rural setting in India: A large, two-center, prospective, observational study of 6000 cases in tertiary care setting in India. J Assoc Pulmonologist Tamilnadu 2022;5:9-16
|How to cite this URL:|
Patil S, Gondhali G, Bhadake M, Jadhav A. Trends of chronic obstructive pulmonary disease diagnosis and treatment in rural setting in India: A large, two-center, prospective, observational study of 6000 cases in tertiary care setting in India. J Assoc Pulmonologist Tamilnadu [serial online] 2022 [cited 2022 Oct 3];5:9-16. Available from: http://www.japt.com/text.asp?2022/5/1/9/353747
| Introduction|| |
Chronic obstructive pulmonary disease (COPD) is the second leading cause of death in India, which affects almost 53 million people. Various chronic respiratory diseases are common in India, including COPD, asthma, bronchiectasis, interstitial lung diseases, and posttuberculosis obstructive airway diseases. According to the Global Initiative for Obstructive Lung Disease (GOLD) 2021 guidelines, COPD is defined as a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities, usually caused by significant exposure to noxious particles or gases. COPD includes chronic bronchitis, emphysema, and small airway disease. Chronic bronchitis is clinical definition, emphysema is radiological definition, and small airway disease is spirometry definition. Chronic bronchitis is defined clinically as the presence of a chronic productive cough for 3 months on most of the days for 2 consecutive years, with other causes of cough being excluded. Emphysema is as an abnormal, permanent enlargement of the air spaces distal to the terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Although exact data of COPD disease prevalence and its impact are not available due to diverse population and cultural trends here in India with 1.35 billion plus population, few published studies have documented prevalence of asthma and COPD in particular geographical setting in India.,,, The National Health Policy of India 2017 recommends that premature mortality from noncommunicable diseases, including chronic respiratory diseases, should be reduced by 25% by 2025. COPD awareness has positive impact on disease diagnosis and rational treatment due to heterogeneous trends of practices in country as varieties of pathies (Allopathy, Homeopathy, Ayurveda, Unani, and others) are involved in treatment of these conditions, and nearly two-third of cases are still undiagnosed, while only one-fifth are getting rational inhalation treatment. Spirometry is recommended by GOLD and has vital role in diagnosis of COPD and other obstructive airway diseases like asthma, additionally it will also help in assessing severity of illness, predicting prognosis and guiding rational inhalation treatment. Spirometry facility is not available in majority of centers in country with its limited use due to lack of awareness, although it is the most cost-effective test to diagnose COPD.,, GOLD guidelines recommend inhalation treatment with combinations of long-acting beta-2 agonists (LABAs), long-acting antimuscarinic agents (LAMAs), and inhaled corticosteroids (ICSs) as frontline therapy for COPD. Various inhalers are available in India ranging from short-acting drugs salbutamol to long-acting salmeterol/formoterol with ICSs and tiotropium, former being cheaper and available in majority of government hospitals, while latter being the costlier and not available in government hospitals. In this study, we have studied awareness of COPD as disease knowledge, diagnosis trends, spirometry use, and rational inhalation treatment in rural zones of India.
| Materials and Methods|| |
A prospective, observational, interview (questionnaire)-based complete workup COPD study conducted during January 2016 to December 2019 in the Chest Diseases Department, in Venkatesh Chest Hospital, and MIMSR Medical College, Latur, after institutional review board and ethical committee approval, screened 12,000 cases with chronic respiratory symptoms with cough, sputum production, and shortness of breath lasted for more than 3 months, and all cases undergone spirometry. Finally, we enrolled 6000 COPD cases diagnosed by spirometry; written informed consent was taken from all enrolled cases in both the centers.
All cases above 35 years of age with cough, with or without sputum production and shortness of breath lasted for more than 3 months, and other causes of same in tropical setting ruled out.
Cases with chronic respiratory symptoms and having alternative diagnosis present or past history of tuberculosis, bronchiectasis, interstitial lung diseases, and lung abnormality on chest radiograph documenting alternative diagnosis.
Respiratory questionnaire for the study of COPD (RQCOPD) developed by expert group of teaching faculties of two institutes used during interview and assessment before spirometry: response to each of following question noted as yes, no, and don't know
This questionnaire is simple to understand and prepared in local language to use in all outdoor settings where patients are routinely visiting their illness and all aspects of COPD illness, symptomatology, risk factors, spirometry analysis, and treatment methodology available and used are analyzed.
- Are you having cough, sputum production, and shortness of breath lasted for 3 months or more?
- Are you having knowledge regarding your symptoms or illness causing it?
- Are you aware of terminology of COPD, asthma, or obstructive respiratory diseases?
- Are you knowing risk factors of your illness?
- Are you current or past smoker?
- Have you undergone any investigation for illness in the past?
- Have you undergone spirometry test in the past?
- Which treatment received for your illness, oral or inhalation?
- Why oral treatment is preferred and inhalation treatment is not preferred?
- Are you using oral medicines in spite of knowing pitfalls of treatment?
- Are you unaware of benefits of inhalation treatment?
- Why short-acting inhalers are preferred over long-acting inhalers, preferred by doctors or yourself?
- Is the cost factor driving your treatment options irrespective of knowing regarding benefits of long-acting inhalation over short-acting inhalation or oral medicines?
- Have you ever denied for inhalation treatment for your illness in spite of prescription from your treating doctor?
- Is your treating doctor prescribing oral medicines in spite of knowing your illness over inhalation treatment?
- Interview of treating family physician or primary healthcare facility provider has taken regarding knowledge of COPD disease, spirometry test, and knowledge about oral and inhalation treatment in COPD.
Case definitions considered in this study formulated by expert group of teaching faculties in two tertiary care institutes are:
- ”Difficult patient:” considered as when patients are not convinced or not ready to accept COPD disease and rational inhalation treatment in spite of spirometry abnormalities suggestive of disease with symptoms and knowing benefits of inhalation treatment over other options
- ”Difficult doctor:” considered as when primary treatment providers are not convinced or not ready to start inhalation treatment in COPD disease in spite of knowing benefits of it over other treatment options
- ”Difficult treatment:” considered as when patients' economic status is unable to take rational inhalation treatment in COPD in spite of prescription from healthcare expert and patient himself/herself knowing advantages or make aware of it over other treatment options.
All cases were subjected to general and systemic physical examination with vital parameter recordings, routine blood investigations as complete blood counts, blood sugar level, kidney functions and liver functions. Selected cases were also subjected to sputum examination and chest radiograph to rule out infective etiology and electrocardiogram to rule out systemic abnormality in view of chronic respiratory symptoms. All study cases were undergone spirometry analysis for the confirmation of COPD diagnosis. Spirometry test showing postbronchodilator forced expiratory volume in 1st second (FEV1)/forced vital capacity (FVC) ratio <0.7 were considered as cut off for chronic obstructive airway disease (COPD) without FEV1 reversibility or negative bronchodilator reversibility i.e., not showing improvement in FEV1 by at least 12% and 200 ml over prebronchodilator value after fulfilling acceptability and reproducibility criteria as per GOLD guidelines and ATS/ERS task force recommendations. Cases with meeting criteria for obstructive airway disease and having negative bronchodilator reversibly were enrolled as confirmed COPD study cases of COPD.
The statistical analysis was performed using Chi-square test in R-3.4 software. Significant values of χ2 were seen from probability table for different degrees of freedom required. P value was considered statistically significant if it was below 0.05 and highly significant in case if it was <0.001.
[R is available as a Free Software under the terms of the Free Software Foundation's GNU General Public License in source code form. R software is manufactured in Vienna, Austria is freeware and available in university repositories worldwide.]
| Observations and Analysis|| |
In the study of 6000 COPD cases, 68.33% (4100/6000) are males and 31.66% (1900/6000) cases females, aged between 35 and 91 years with mean age of 54.5 ± 17.5 years; 60.03% (3602/6000) of cases are above 55 years of age while 39.96% (2398/6000) cases are below 55 years of age group. Main symptoms in the study group are shortness of breath in 84.93% (5096/6000) of cases, cough especially dry in 69.15% (4149/6000) cases, sputum production in 61.15% (3669/6000) cases, fatigability in 31.15% (1869/6000) cases, and chest discomfort in 12.83% (770/6000) cases. Risk factor analysis documented smoking in 13.4% (804/6000) cases, smoking plus biomass fuel in 6.8% (408/6000) cases, biomass fuel exposure in 47.8% (2868/6000) cases and agricultural dust or work in dusty environment in 32% (1920/6000) cases.
In present study, staging of class of COPD as per GOLD guidelines documented 10.15% (609/6000) Group A cases, 34.85% (2091/6000) Group B cases, 29.33% (1760/6000) Group C cases, and 25.66% (1540/6000) Group D cases. Spirometry analysis were documented as FEV1/FVC <0.7 in all cases with FEV1> 80% in 14.85% (891/6000) cases, FEV1 50%– 80% in 30.15% (1809/6000) cases, FEV1 30%–50% in 35.15% (2109/6000) cases, and FEV1 <30% in 21.85% (1191/6000) cases. In present study, 41.15% cases (2469/6000) were having 0–1 exacerbation required hospitalization and 58.85% (3531/6000) cases with >2 exacerbations or >1 required hospitalization [Table 1].
We have observed that 3% of study cases were aware about their illness COPD disease, 54% cases are not having knowledge about disease, and 43% cases are not accepting the COPD diagnosis (P < 0.0001) [Table 2].
|Table 2: Analysis of awareness of chronic obstructive pulmonary disease by respiratory questionnaire (n=6000)|
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Inhalation treatment use is documented in 58% of COPD cases, levosalbutamol monotherapy in 31% cases, levosalbutamol plus beclometasone in 18% cases, and either formoterol plus budesonide or salmeterol plus fluticasone in 9% cases (P < 0.0001) [Table 3].
|Table 3: Inhalation treatment method use in chronic obstructive pulmonary disease cases (n=3480/6000)|
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Oral medicines use is documented in 42% COPD cases, theophylline in 16% cases, salbutamol in 7% cases, and oral steroids in 19% cases (P < 0.0001) [Table 4].
|Table 4: Oral treatment method use in chronic obstructive pulmonary disease cases (n=2520/6000)|
Click here to view
In present study, oral and inhalation treatments use were documented in 42% and 58% cases, respectively. In present study, 43% cases were difficult to accept COPD diagnosis and are labelled as “difficult patients,” 91% cases were not offered rational or standardised inhalation treatment and are labelled as “difficult treatment,” and 42% cases were received oral medicines treatment over rational inhalation treatment by treating physicians and are labelled as “'difficult doctor” [Table 5].
|Table 5: Difficult doctor, difficult treatment, and difficult patient in study cases (n=6000)|
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| Discussion|| |
Prevalence of awareness of chronic obstructive pulmonary disease in rural setting attending tertiary care hospital
We have observed that 3% of study cases are aware of their illness COPD disease, 54% are not having knowledge about disease, and 43% are not accepting the COPD diagnosis (P < 0.0001). As our study is conducted in peripheral part of India with predominant rural background, with a literacy rate approximately 60% with gender correction, COPD awareness is documented in 3% of cases only, and whatever knowledge about COPD they have is acquired form digital media. Ghorpade et al. conducted a study in urban slums and rural setting in India and documented awareness about COPD only in 1% population. Other studies have reported awareness rates of 49% in Turkey, 21% in Japan, 17% in Spain, 8% in France, 17% in Canada, 4% in Brazil, 10% in Germany, and 1% in Korea. If we compare our data with Ghorpade et al. in India and of western countries, Indian rural population is least aware about COPD.
Lack of knowledge, less awareness, and minimal use of spirometry by family physicians are the reasons for less awareness about COPD in community. We have documented that 54% of cases were unaware of their underlying chronic lung disease as the reason for chronic symptoms and they are totally new to spirometry test and COPD disease and they may be underreported due to lack of spirometry. Zielinski et al. observed 42% increase in COPD diagnosis with spirometry in symptomatic cases. Buffels et al. analyzed the usefulness of spirometry performed by general practitioners in early diagnosis of COPD.
We have documented that majority of COPD cases are missed due to underuse or nonavailability of spirometry and 91% of cases are halfheartedly treated in peripheral setting. Proper trainings regarding methodology of spirometry are must as many of the cases will be missed due to faulty techniques of spirometry. Eaton et al., Schermer et al., and Enright et al. documented similar observation and recommended proper training of spirometry and standard methodology to meet acceptability and reproducibility criteria. Mannino et al. in their largest population-based survey in the United States National Health and Nutrition Examination Survey documented that less than half cases with COPD receive actual physician diagnosis similar to our findings. Studies,,, have documented increased global prevalence of COPD due to increased tobacco consumption, which is equally associated with underdiagnosis and undertreatment.
Types of inhalation treatments prescribed to chronic obstructive pulmonary disease in rural setting attending tertiary care hospital
Inhalation treatment use is documented in 58% of COPD cases only, 31% of cases received levosalbutamol monotherapy, 18% of cases received levosalbutamol plus beclometasone, and only 9% of cases are getting rational inhalation treatment as per recommendations by the GOLD guidelines, i.e., either formoterol plus budesonide or salmeterol plus fluticasone with or without tiotropium (P < 0.0001). As per our study, high cost of these long-acting inhalation treatments along with lesser preference by family physicians is the reason for least preference to these medicines. Inhalation method is the preferred route of administration for COPD due to more targeted therapy with significant improvement in symptom control and lesser systemic side effects due to smaller volume of drug used as compared to oral or intravenous route of administration. Similarly, various studies have documented that COPD management remains suboptimal due to lack of knowledge or unaware regarding current guidelines by treating physicians and poor adherence to medicines prescribed due to less awareness in patients regarding rational inhalation treatment., Foster et al. documented similar observations to our study, and primary care physicians prefer different choices of drugs during the treatment of COPD, especially keep note on preference of LABA (salmeterol or formoterol) in 35% of cases of COPD which is very much higher to our study of 9% only. Numerous authors in their studies,,, have documented that the cost constraint is a major driving factor during rational inhalation treatment and the reason for underuse of LABA combination with ICSs. In addition, various authors,, have observed additional use of tiotropium in COPD cases and it will decrease overall cost of treatment by decreasing hospitalizations without too much increase in overall cost of treatment. Indian guidelines also recommended inhalation treatment as the rational therapy in the management of COPD.
Oral treatment prescribed to chronic obstructive pulmonary disease in rural setting attending tertiary care hospital
Oral medicines use was documented in 42% of COPD cases, theophylline in 16% cases, salbutamol in 7% cases, oral steroids in 19% cases (P < 0.0001) [Table 3], and oral and inhalation treatments in 42% and 58% cases, respectively (P < 0.0001). Lack of awareness regarding lesser benefit of these medicines in patient and doctor both; cost-effectiveness of these medicines over inhalation treatment is the reason for more preference by both. Various authors,,, in their studies have documented similar preferences and trends of use of oral medicines in COPD cases over inhalation treatment as it is cheaper one, easily available, and simple to use over inhalation treatment, and temporary symptom control with oral medicines although long term benefits are not known or not expected by patients. GOLD guidelines and Indian guidelines recommended against the use of oral medicines in COPD unless the patient is unaffordable and/or inhaled medicines are not available.
Beliefs, experiences, and behaviors observed during study as difficult treatment, difficult patient, and difficult doctor
We have observed that 43% of study cases diagnosed to have COPD after spirometry are not accepting the diagnosis and convinced for rational inhalation therapy recommended as per GOLD guidelines, and we called these cases as “Difficult patients.” We further asked reasons for opting out inhalation treatment and preference to oral medicines by these cases are their misbelief as once it is started it has to continue to take for entire life without any gap, also once inhalation treatment started it will decrease lung strength, and inhalation treatment are having adverse events over other organs of body including renal dysfunction; may be some of the COPD patients experienced increased creatinine due to worsened obstructive uropathy with tiotropium use with underlying benign prostatic hyperplasia. Few patients believed that inhalation is the last resort to control respiratory symptoms and it should be reserved till advancement of disease and oral medicines should be tried first during treatment, while some believe that inhaled medicines will weaken respiratory tract and should be avoided as far as possible. Few patients have experienced altered speech or dysphonia after inhalation use due to improper drug washout deposited in upper airways and they opted out due to feeling fear of loss of voice.
We have documented that in 58% of cases with inhalation treatment, the preference by patient and doctor both to levosalbutamol monotherapy in 31% of cases, levosalbutamol plus beclometasone in 18% of cases, and formoterol plus budesonide or salmeterol plus fluticasone only in 9% of COPD cases, i.e., 91% of cases do not receive rational inhalation treatment and labeled as “difficult treatment,” being costlier and not pocket-friendly than former ones. Most common misbelief is that patients consider higher strength treatment (longer acting bronchodilators LABA-LAMA with ICSs), being costlier than short-acting bronchodilators, and these medicines should be reserved during later course of illness or when disease course advances, and some patients also believe that these medicines may cause more systemic side effects. Patient experiences some reliefs with short-acting drugs which are cheaper although not as much as long-acting drugs which are costlier, and they consider symptomatic relief as basic disease control parameter although long-term outcomes and benefits are not explained. As per our study, cost is the basic factor for more preference to oral medicines over inhalation treatment in the management of COPD.
We have documented that 42% of COPD cases are treated with oral medicines in our study, and these medicines are preferred by treating doctors over inhalation treatment in spite of knowledge of inhalation treatment and categorized as “difficult doctor.” As per our study, the most common reasons for oral medicines preference are lack of knowledge regarding benefits of rational inhalation treatment over oral medicines, similar misbeliefs in correlation with patients, some general physicians believe that they have experienced lost to follow-up cases whenever they offered inhalation treatment and those patients received oral medicines showing adequate adherence irrespective of partial symptom control, i.e., patients demanding oral medicines over inhaled medicines, and due to lack of knowledge, physicians are experiencing difficulty in explaining benefits of rational treatment over oral medicines.
Other important observations from the present study
- Risk factor analysis documented smoking in 13.4% (804/6000) cases, smoking plus biomass fuel in 6.8% (408/6000) cases, biomass fuel exposure in 47.8% (2868/6000) cases and agricultural dust or work in dusty environment in 32% (1920/6000) cases. Due to heterogeneous cultural trends in rural setting, smoking is relatively less common as compared to western world, and agricultural dust/pollution or biomass fuel pollution is the predominant risk factor. This is the reason for more preference by medical experts to the combination of LABA-ICS over LAMA-LABA in rural setting
- In present study, staging of class of COPD as per GOLD guidelines documented 10.15% (609/6000) Group A cases, 34.85% (2091/6000) Group B cases, 29.33% (1760/6000) Group C cases, and 25.66% (1540/6000) Group D cases. In present study, we have documented more preference to short acting drugs over long-acting drugs of inhalation in spite of 55% cases were in group C and D i.e., cases with more symptoms, and 45% cases were in group A and B i.e., cases with mild symptoms due to their misbelief as symptom control as basic disease control parameter.
- Spirometry analysis were documented as FEV1/FVC <0.7 in all cases with FEV1> 80% in 14.85% (891/6000) cases, FEV1 50%– 80% in 30.15% (1809/6000) cases, FEV1 30%–50% in 35.15% (2109/6000) cases, and FEV1 <30% in 21.85% (1191/6000) cases. Spirometry has crucial role in picking up earlier disease, and 14.85% of cases were unaware of COPD before spirometry and 65% of cases had moderate-to-severe airflow obstruction, and majority of these cases are having a history of hospitalization due to exacerbations in the recent past still not on rational inhalation treatment
- In present study, 41.15% cases (2469/6000) were having 0–1 exacerbation required hospitalization and 58.85% (3531/6000) cases with >2 exacerbations or >1 required hospitalization [Table 1]. Although more than half of the cases are having either one exacerbation, still these cases are not honored with rational combinations of LABA-ICS and/or LAMA.
Issue needs further analysis and will have impact on diagnosis and treatment in chronic obstructive pulmonary disease (recommendations)
- More disease awareness regarding the use of spirometry in peripheral or rural setting by digital or social media with more emphasis for spirometry and rational inhalation treatment
- Spirometry trainings campaigns on regular intervals by medical schools, medical experts, and pulmonologists to train and involve general physicians/family physicians or primary healthcare providers
- Rational treatment awareness by government organizations and medical experts using social or digital media with “slogans” as:
Inhalers are right choice for COPD
Inhalers will control disease progression
Inhalers will decrease risk of hospitalization and overall cost of care in comparison to cost of rational inhalation medicines
Inhalers are safe to use for longer duration and for entire life without any side effects
Inhalers can be used in all age groups
Inhalers dose is less to oral medicines and ultimately lesser side effects
Inhalers should be taken after consultation with lung experts
Inhalers will prevent ”lung attack” or exacerbations
| Conclusion|| |
“Doctor–patient–drug trio” discordance clubbed as “difficult doctor, difficult patient, and difficult treatment” is a very common issue observed during diagnosis and management of COPD in peripheral setting in India. We recommend using spirometry test as a routine in all chronic respiratory symptom's patients for exact diagnosis of COPD, and more emphasis should be given for trainings of family physicians to spirometry. Oral medicines are commonly preferred treatments in COPD over universally accepted inhalation treatment due to misbeliefs, experiences, and behaviors of patients and doctors. We recommend more awareness and sensitization regarding benefits of rational inhalation treatment in COPD, especially advantages of these methods of treatment in symptom control, improvement in quality of life and long-term disease-related outcomes, and special emphasis on their role in decreasing hospitalization risk during exacerbation and overall cost of treatment.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]