Rupak Ghosh ¹, Saikat Nag ¹, Rantu Paul ², Rana Dey ² , Ratna Dey ², Avijit Chowdhury ³ , Parthasarathi Bhattacharyya ¹.

¹Consultant, ²Research Assistant, Institute of Pulmocare & Research. ³Consultant, West Bengal Liver Foundation (WBLF) .

Abstract

Background: Pulmonary rehabilitation is a cost effective non pharmacological intervention with rewarding effects in allaying symptoms and promoting well being. Such programs are not feasible and virtually not exercised in rural areas of the developing world.

Methods: Multiple single point intensive education on COPD were imparted along with formatted training on major elements of rehabilitation as use of inhalation therapy, respiratory exercise and life style modification etc. on a cohort of rural COPD population in several rural camps at the Birbhum district of West Bengal, India. The changes in the major symptoms (shortness of breath, cough, and wheeze) and the perceptions of the overall health status were measured on visual analogue scale before and 6 weeks after intervention in a group of COPD patients.

Results: There has been a statistically significant improvement (p<0.001) in symptoms and also in the perception of overall health status.

Conclusion: Single point, intensive education and rehabilitation intervention appears significantly effective in rural COPD population in allaying symptoms and improving the perception of the health status over a period of six weeks.

KEY WORDS: COPD, pulmonary rehabilitation, VAS (The Pulmo -Face, 2014; 14:1, 10-14 )

Address of correspondence: Dr. Parthasarathi Bhattacharyya, Institute of Pulmocare and Research, CB- 16, Salt Lake, Kolkata- 700 064, India. Email: parthachest@yahoo.com.

ABBREVIATIONS:

6MWT - 6 minute walk test
SGRQ- Saint Georges Respiratory Questionnaire
TDI- Transition dyspnoea index
HRQoL- Health related quality of life
IHD- Ischemic heart disease
VAS- Visual Analogue Scale
PR- Pulmonary rehabilitation
BDI- Baseline dyspnoea index
COPD- Chronic Obstructive Pulmonary Disease
FVC- Forced vital capacity
FEV1- Forced expiratory volume in one second

INTRODUCTION:

The prevalence of COPD is increasing globally. ⁽¹⁾ The dimension is quite significant in India; ^{(2), (3), (4)} but information especially from rural background appears scanty. ⁽⁵⁾ In our experience, 12.18 % of total OPD turnover has been from COPD. ⁽⁶⁾ Most of the time, pharmacotherapy remains the sole management of the disease for several Logistic constraints. Therefore, COPD rehabilitation has not been practiced formally except for limited urban hospitals and published data is yet to be available regarding the Indian experience.

The situation in the rural areas is likely to be even worse for several reasons as lack of education and awareness, economic constraints, lack of access to modern health care, and different other geo-socio-cultural reasons. Scanty data is available regarding our rural COPD patients (5) and there is hardly any information regarding any effort of non pharmacological interventions in them.

Since it is not possible to adopt a formal COPD rehabilitation that requires a lot of organizational input and economic commitments, we decided to make a single point intervention of education and training based on a simple curriculum. This was prepared with our background experience of teaching COPD patients attending our OPDs and training camps incorporating the basic issues as proper inhalation technique, breathing exercise, walking, nutrition etc. On a follow up visit after 6 weeks of such intervention we assessed the situation based on visual analogue scale (VAS).

METHODS AND MATERIALS:

Inclusion criteria: Patients of either sex aged more than 40 years with or without history of active smoking but with history of progressive shortness of breath, cough and/or expectoration for over 2 years were screened for presence of COPD. Those who show feature of airflow limitations ( FEV1/FVC < 70 %, and FEV1 < 70 %) without reversibility (less than 10 % increment of peak expiratory flow rate after 20 minutes of 4 puffs of salbutamol with a spacer) were regarded as cases of COPD.

Exclusion criteria: Patients with recurrent purulent expectoration, clinically detected clubbing/ cyanosis or any skeletal deformity, known or suspected ischemic heart disease, congenital or valvular heart disease apparent in clinical examination, any other significant pulmonary or cardiac problem apparent from the chest x-ray (done on clinical suspicion), or having any known co-morbidity of significant dimension, were excluded from the study. Very sick patients, those unable to perform spirometry or unwilling to give consent were also excluded.

The whole work has been approved by the Institutional Ethics Committee before starting.

The effort essentially involved three components as (A) formatting a one day COPD education and training course effectively, (B) reaching and ensuring the co-operation and compliance of the rural COPD patients and, (C) actually performing the job

A) The past experience of doing several COPD education and training camps with publication of a booklet as a part of our institutional activities helped us a lot to formulate, print and publish a simple curriculum in Bengali (with pictures describing several exercises and inhalation devices and their uses) apt for the population to address and also to plan the actual course of action foreseeing the planned camps. The curriculum also provides a review of what to do and what not to do for the patients. It includes practical and essential elements on areas as a) about the disease with role of smoking in its pathogenesis, b) when to suspect and diagnose COPD, c) what happens in COPD to the lungs and what are the symptoms, d) what a patient of COPD should know, e) how to use inhalers, f) required life style modifications as smoking cessation, exercise, proper food, avoidance of smoke and irritants, and use of oxygen when required.

We experimented the booklet in our conventional COPD camps and became confident and apt in using it to a gathering of patients with or without audio visual assistance.

B) Reaching to the target population was possible through the infrastructure and man power help of an organization (West Bengal Liver Foundation) engaged in rural based epidemiological work and the involvement of our consultant working in Rural Bengal, Suri, Birbhum. Ten volunteers, chosen from the WBLF, were trained beforehand to suspecting COPD patients in villages based on appropriate response to a set of simple questions (not yet validated) and bring them (about ten patients each) to the camps at 8.30 A.M. and 9.00 A.M. in summer and winter time respectively.

C) Actually performing the job: a) fixing a venue: mostly the municipality building or school (in weekends) where a big room being fixed for common address, b) making provision for spirometry with three spirometers and Indian Chest Society certified trained technicians, c) joining our rural consultants with two doctors and two trainers from our head quartersto accomplish the physical examination and education.

The modus operandi has been discussed and decided in the evening before the program. A program line has been followed with different points as

1) Welcome and registrations : White desk

2) Filling up the basic data : Black desk -here we fill up some basic facts including symptoms and keep a record on VAS on shortness of breath, cough, wheeze, and overall health status being perceived by each patient.

3) Spirometry : Green desk

4) Clinical examination and prescription : Blue desk

The movement of the patients has been shown in Fig 1

Individual members were entrusted with their role and small mock exercise is performed for the camps.

5) Once the clinical examination is over, the participants were addressed on our formatted education program in a common gathering with some questions and answers.

In the same, use of inhalers and respiratory exercise (diaphragmatic breathing and breathing with positive expiratory pressure – 'pursed leap') are demonstrated. One or two patients are usually selected randomly to repeat the procedure so to ensure the attention of the audience to register the issues in their minds. Free questions regarding the disease, the treatment and the demonstrated exercises were allowed thereafter.

6) Following that the team gets divided into 3 groups to check inhalation technique in one to one fashion and re-educate on breathing exercise. We used only DPI (with lupihaler, Lupin Pharma) for the purpose.

7) Drug distribution: We arranged for 15 days course of DPI for all the patients who attended and needed the drug. The travel cost was also reimbursed at this point.

8) It was followed by tea and a food packet. They were told to revisit us after 6 weeks on a fixed date.

FOLLOW UP:

The patients were followed up after 6 weeks in another subsequent camp when we arrange a rehearsal of inhalation, exercise and education on a common gathering along with rectifying flaws, if any in the techniques. The impression of symptoms as shortness of breath, cough, wheeze and overall health status being perceived by each patient were all recorded on VAS.

RESULTS:

The pooled data from three such camps were collected for analysis. A total of 175 patients attended the camps before compilation of data. Out of them 40 patients were excluded for several reasons [6 had severe dyspnoea, 4 had active hemoptysis, 3 had suspected / proved active tuberculosis (carrying RNTCP record), 1 had features of moderate pleural effusion, 8 could not perform spirometry, 4 showed reversibility in spirometry, 2 had normal spirometry, and 12 had findings suggesting clinically significant some other diseases]. The patients with active problems were referred to the local/ district Govt. Hospitals. Thus, 135 patients were finally diagnosed COAD and all of them agreed to undergo the study and to mark their symptoms on VAS. However, 90 out of 135 did not come for follow up after 6 weeks. Hence, only 45 patients were incorporated for the final analysis.

The mean age of the patients included for analysis was 56.58 ± 9.65 years with the sex ratio (male: female) was 3.2: 1.3. The mean duration of shortness of breath, cough, and wheeze were 5.66±3.46, 4.62±3.70, and 4.73±3.79 years respectively. All male patients (32 of 45) were either active or ex smokers while the female subjects too were ex-smokers (n=11) or passive smokers (n=2). Very few patients were aware about their co-morbidities (hypertension in one, diabetes in one, is chemic heart disease in two). Six patients had the history of hospitalization due to shortness of breath or suspected pneumonia. The mean BMI was as low as 16.73 ± 3.17; speaking about the poor nutritional status of the selected participants. Spirometric data analysis showed the mean FVC, mean FEV1 and the mean FEV1/FVC ratio to be 1.34 ± 0.67 litres, 0.88 ± 0.47 litres and 67.53 ± 17.97 % respectively.

The change in the VAS scoring has been found significant (p< 0.001) for all the symptoms and the overall perceived well being (see table 1).

Table 1: Mean scoring on VAS of symptoms and perceived well being

Parameters	1st visit	Follow up visit (after 6 weeks)	p-value
Shortness of breath (n=45)	38.67 ± 13.20	60.22 ± 24.14	<0.001*
Cough (n=45)	39.44 ± 13.54	58.56 ± 24.65	<0.001*
Wheeze (n=43)	42.09 ± 14.53	58.26 ± 21.38	<0.001*
Overall health status (n=45)	37.56 ± 11.11	58.56 ± 22.07	<0.001*

 

* statistically significant

The table 1 shows the change in symptoms and the perceived sense of wellbeing before and after 6 weeks of intervention. There has been a significant improvement in visual analogue scale in all the parameters.

DISCUSSION:

COPD is a global and increasing public health problem. ^{(1, 7)} In India, the dimension is quite huge ^{(2, 3, 4)} with significant prevalence of COPD in rural areas. ⁽⁵⁾ COPD rehabilitation is a definite effective non pharmacological intervention. ^{(8, 9)} While the data from the developing world regarding the epidemiology of COPD is scanty, that regarding the COPD rehabilitation in rural areas of the developing world is hardly available. The reason being manifold; the rural areas of the developing world are frequently burdened with poverty, overpopulation, geo-socio-political adversities, lack of education and awareness with lack of access to proper health care. Therefore, many a times, the patients seek medical attention late in advanced stage and it appears not possible to implement the structured organized interventions of formal COPD rehabilitation programs in rural India.

Since the burden of COPD is so huge ^{(2, 3)} and the evidence in favor of rehabilitation is so strong ^{(9, 10, 11, 12)} that despite the adverse ground realities, there should be efforts for best possible rehabilitation of these patients. Significant clinical and statistical improvement in basal dyspnoea and quality of life has been seen with simple home-based exercise training programs using the shuttle walking test. ⁽¹³⁾ Even a simple outpatient-based pulmonary rehabilitation program can improve the exercise endurance, quality of life, and reduce dyspnoea scale and hospital utilization with reduction in the health care cost. ⁽¹⁴⁾ The worthwhile benefit of out-patient rehabilitation program can persist for a period of 2 years in terms of significant reduction in exacerbations, improvement in perception of dyspnoea, and HRQoL. ⁽¹⁵⁾ Home based rehabilitation program has also been found comparable to hospital based program. ⁽¹⁶⁾ Duration wiser, even a shortened 4-week supervised pulmonary rehabilitation program is as effective as a 7-week supervised programme at the comparable time points of 7 weeks and 6 months. ⁽¹⁷⁾

So it appears that any intervention for rehabilitation should, perhaps, be better than none. Hence, we decided to try a single point structured and organized intervention for COPD education and training for self managed care and rehabilitation in rural areas on a curriculum covering the major important issues related to the disease in simple question-answer forms. The area of operation and the manpower support were thoughtfully selected in collaboration with the West Bengal Liver Foundation. Finally, a structured modus operandi was prepared through repeated discussions and interactions amongst the working members keeping the logistics and expected practical problems in view. Perhaps, the key to success of such a program has been the appropriate training and mobilization of the manpower concerned according to the perceived scenario.

Visual analogue scale has been in use to assess several disease entities; the beauty being its simplicity to use. Conducted to see the relative power of outcome measurements of COPD rehabilitation program between the most frequently used and validated variables as exercise performance, dyspnoea, and health-related quality along with VAS in a population of patients with severe COPD qualifying for lung volume reduction surgery, a trial revealed that the VAS at peak exercise, BDI/TDI, and CRQ adequately reflect the beneficial effects of pulmonary rehabilitation and all of them correlate well with each other ⁽¹⁸⁾. Due to their simplicity and sensitivity, VAS at peak exercise, 6MWT, and CRQ may be the best practical tools to evaluate responsiveness to PR. (18) Although the sensitivity of the VAS to bronchodilation has been found to be better in asthmatics than in COPD subjects, ⁽¹⁹⁾ we choose to see the effects on VAS alone although concomitant assessment with other valid parameters like SGRQ, 6MWT, BDI/TDI, etc could have been better. Using VAS happened to be the most feasible option to assess the changes in symptoms (dyspnoea, cough, wheeze) and the subjective perception of the overall health status for such single point intervention in rural COPD population.

COPD rehabilitation in rural areas is not new and people, so far, have tried to replicate the formal evidence based COPD rehabilitation program in rural areas. (20) Effort intensive program at the primary care with implementation of evidence based guidelines have found to have a significant positive impact in several parameters as HRQoL, health status, changes in practice behaviour, improvement in smoking cessation and healthcare utilization. ⁽²⁰⁾ It has also been found to reduce effectively the health care cost in rural areas. ⁽²¹⁾

In our study, we had to adopt a deviation in confirming COPD by lung function. For obvious pragmatic reason we had to resort to post bronchodilator PEFR measurement and we kept a PEFR change of 10% to exclude the diagnosis of asthma. The criteria, certainly, appear stringent. Doing post bronchodilator FEV1 was not possible by us in one day camp set ups and form the initial flow volume loop and the FEV1 value (0.88 ± 0.47 liters) along with lack of reversibility in PEFR, we are fairly sure to have no asthma patient included in our list. However, we cannot rule out the inclusion one or two patients of chronic asthma with remodeling and loss of reversibility to bronchodilators.

The impressive change in all the parameters concerned as shortness of breath, cough, wheeze, and overall health status perceived by the patients (p< 0.001) signifies the impact of such one point simple, feasible but intensive intervention along with the pharmacotherapy in our rural COPD sufferers. Some additional interventions as supply of the full course of medication, monitoring by the rural volunteers, and applying rewards for smoking cessation and adherence to the exercise and proper inhalation etc. could have helped more. All the subjects attending the COPD education and training camps were economically constrained people. A systematic record with a much higher number of recruits with analysis of the impact of several factors as monthly income, family status, educational status etc. could have been definitely better to provide an insight regarding their compounding effects on the intervention. Moreover, we did not incorporate an organized smoking cessation program and we have not analyzed the effects of such intervention on smoking cessation. We have no idea about the existing treatment for their disease and the positive change may also be partly contributed by pharmacotherapy with the training and education; it is not possible to isolate the impact of the two from the results. A concomitant control group with pharmacotherapy alone could have been a useful adjunct.

In conclusion, it appears that a little organized and intensive effort of education and training alone with pharmacotherapy can bring forth significant positive changes in the suffering of our COPD boors through self-managed rehabilitation efforts. Further research should be done to identify separately the positive impact of education and training and finally formulate and validate an alternative but easy, effective, and feasible rehabilitation program for rural COPD patients. This will probably mean a great change in the saving health and improving quality of life in our rural population.

ACKNOWLEDGMENTS :

1) Acknowledgments section that describes the role of each author in the preparation of the manuscript.

2) West Bengal Liver Foundation for allowing the irvolunteers to work for us

3) Lupin laboratories for providing us with spirometers and helping manpower

ACCP : for offering the chest foundation award to us; although the fund was not meant for research, the actual job would not have been possible without the help of the award money.

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Dr. Parthasarathi Bhattacharyya
Consultant, Institute of Pulmocare and Research, Kolkata
Email: parthachest@yahoo.com