0% READ
FULL TEXT
INTRODUCTION
Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous lung condition which is characterized by persistent respiratory symptoms and airflow limitation, due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases (Venkatesan, 2025). At a global level, the prevalence of COPD in 2020 across both males and females was estimated to be 10.6%, which translates to 480 million cases. Epidemiology models have estimated that the number of COPD cases are to increase by 112 million to a total of 592 million by 2050 (9.5% of the total population aged ≥25 years), a relative increase of 23.3% from 2020 to 2050 (Boers et al., 2023). Evidence from India suggested that COPD prevalence increases with age and exponentially after 30 years of age (Verma et al., 2021).
Studies have shown that patient education about their condition and patient self-management are key elements to successful treatment of COPD as they can reduce hospitalizations and improve overall quality of life (Omachi et al., 2010; Thakrar et al., 2014). A Swedish study concluded that patients with COPD required more knowledge about their condition in order to take an active role in their care, which led to better adherence to treatment plans and improved health outcomes (Sandelowsky et al., 2019). Poor knowledge about COPD has also been shown to be a significant risk factor for anxiety and depression in COPD patients (Zhang et al., 2014). A number of instruments are available to assess disease-specific health status which are reliable, valid and widely used in clinical practice, but they fail to focus on aspects that are unique to our study population such as exposure to biomass fuels and tea dust. Instruments such as COPD-Q and BCKQ lack components that address emotional aspects and adherence to inhaler therapy (Maples et al., 2010; White et al., 2006). The reliability and validation results of COPD Assessment Test are derived from the USA alone due to the availability of the data at the moment (Jones et al., 2009). To the best of our knowledge, no previous studies have evaluated the level of awareness of COPD in the Nilgiris population which has a high number of COPD cases.
The objective of our study was to develop, translate and validate a questionnaire to evaluate the disease awareness in patients with COPD in our setting. The developed questionnaire was to be translated to Tamil and back-translated as it is intended to be self-administered, making it more comprehensible to the Nilgiris population. Our ultimate goal was to understand if people in Nilgiris district of India were aware of their illness, risk factors and its management.
MATERIALS AND METHODS
Sample
The study employed convenience sampling and recruited 72 participants diagnosed with COPD from GMCH, Ooty. This study was approved by Institutional Ethics Committee (IEC) of Government Medical College and Hospital, Nilgiris (Ref. No.: 12/IEC/ICMR; Approval No.: IRBGMC0072). Patients of either sex aged > 18 yrs diagnosed with COPD with/without other comorbidities were included and those with history of psychiatric illness were excluded from the study. Pre-testing and cognitive interview were conducted in 12 participants and 60 participants were included to conduct the pilot study after consent was obtained. Various academic experts and physicians were approached for validation.
Procedure
The development of the questionnaire occurred in four steps:
Step 1: Item generation
After extensive review, the following two areas of knowledge were generated: 1. Understanding COPD with 14 items and 2. Management of COPD with 6 items. Validated tools assessing knowledge regarding a broader context of COPD were also reviewed (Hyland et al., 2006; White et al., 2006). Three questions (Q4, Q10 & Q12) were included with the correct answer being ‘No’, which allowed us to assess the accuracy of patient responses, as a validity check. Participants received a score of 1 for each correct answer, and 0 for each incorrect answer. A self -administered data collection form was designed with basic demographics and socioeconomic status (Modified Kuppusamy scale (Mandal & Hossain, 2024)).
Step 2: Construction and Validity of Questionnaire
The instrument is developed with 20 items in total. The instrument was subjected to content experts (4 senior academic experts with >20 years of experience in pulmonary research; 3 General Physicians; 1 Consultant Pulmonologist and 1 Senior Nurse) to rate the instrument. The experts were asked to rate the relevancy of each item to the respective domain in the questionnaire using a Likert Scale (1- Not relevant; 2- Somewhat relevant; 3- Quite relevant; 4- Highly relevant) and were asked to review each domain and independently to score the relevancy level of each item.
Step 3: Translation of the Questionnaire
The questionnaire was subjected to translation by implementing a multi-step methodology developed by Valmi D Sousa – forward translation and backward translation (Sousa & Rojjanasrirat, 2011). Expert panel revie (Perinetti, 2018) with two subject experts & healthcare experts followed by pre-testing.
Step 4: Field testing of the questionnaire
A total of 60 participants were recruited and administered with COPD-AQ during their first visit. This data was used for assessing the validity and internal consistency (α). Following the first visit, COPD-AQ was again administered to the same set of participants after a time period of three weeks (second visit). 13 participants out of 60 failed to complete their second visit. So, data from 47 participants were taken up for evaluation of test reliability.
Statistical Analysis
Demographic information of the patients was collected and entered in Excel. Data analysis was conducted using SPSS, Version 27. To evaluate the internal consistency of the questionnaire, Cronbach’s alpha was calculated, with a threshold of α ≥0.70 considered acceptable (Vishwas et al., 2017). For test-retest repeatability, Cohen’s Kappa (κ), Pearson’s correlation coefficient (r) and Intra-Class Correlation (ICC) were employed. A κ ≥ 0.60 was considered acceptable for reliability, while a r >0.70 was taken as an acceptable level of test-retest reliability (Mishra & Nitika, 2016; Sedgwick, 2012). ICC value >0.75 was regarded to be acceptable.
RESULTS
Phase I: Content Validity Analysis:
The Content Validity Index (CVI) was determined both at the Item-level (I-CVI) and the Scale-level (S-CVI) (Department of Medical Education, School of Medical Sciences, Universiti Sains Malaysia, MALAYSIA & Yusoff, 2019). The I-CVI was calculated based on the ratio of experts (out of 9 total) who rated each item a 3 or 4 to the total number of experts (Polit et al., 2007). The CVI cutoff is 0.83 (Lynn, 1986). CVI analysis on understanding and management of COPD domains are described in Tables 1 and 2, and demographic characteristics of the study participants are listed in Table 3. Responses for the individual items in COPD-AQ attained mean score values ranging between 0.05-0.88 with the Standard Deviation (SD) 0.22-0.54 and the median values from 0 to 1. The detailed descriptive statistics of COPD-AQ scores are listed in Table 4.
| R1 | R2 | R3 | R4 | R5 | R6 | R7 | R8 | R9 | Experts in agreement | Items CVI | U/A | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Under Standing of COPD | |||||||||||||
| Item1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 4 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 8 | 0.88 | 1 | |
| Item 5 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 8 | 0.88 | 1 | |
| Item 6 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 7 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 8 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 9 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 10 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 8 | 0.88 | 1 | |
| Item 11 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 12 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 13 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | |
| Item 14 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 8 | 0.88 | 1 | |
| S- CVI/Ave | 0.96 | 1 | |||||||||||
| Proportion | 1 | 0.92 | 1 | 1 | 0.92 | 0.92 | 1 | 0.92 | 1 | S- CVI/U/A | 1 |
| R1 | R2 | R3 | R4 | R5 | R6 | R7 | R8 | R9 | Experts in agreement | Items CVI | U/A | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Management of COPD | ||||||||||||
| Item 15 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 |
| Item 16 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 |
| Item 17 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 8 | 0.88 | 1 |
| Item 18 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 8 | 0.88 | 1 |
| Item 19 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 8 | 0.88 | 1 |
| Item 20 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 |
| S-CVI/ Ave | 0.94 | |||||||||||
| Proportion | 0.83 | 0.83 | 1 | 1 | 1 | 1 | 1 | 0.83 | 1 | S-CVI/ U/A | 1 |
| Parameter | Classification | N | % |
|---|---|---|---|
| Age | < 50 years | 6 | 10 |
| 50-59 years | 15 | 25 | |
| 60-69 years | 31 | 51.7 | |
| ≥ 70 years | 8 | 13.3 | |
| Gender | Male | 42 | 70 |
| Female | 18 | 30 | |
| Living condition | Own Home | 21 | 35 |
| Rental Home | 39 | 65 | |
| Marital status | Married | 47 | 78.3 |
| Widowed | 13 | 21.7 | |
| BMI | <18.5 | 14 | 23.3 |
| 18.5-24.9 | 16 | 26.7 | |
| 25.0-29.9 | 23 | 38.3 | |
| 30.0-34.9 | 7 | 11.7 | |
| Sleep disturbance | Yes | 57 | 95 |
| No | 3 | 5 | |
| Family history of respiratory disease | Yes | 23 | 38.3 |
| No | 37 | 61.7 | |
| Smoking history | Never smoked | 21 | 35 |
| Ex smoker | 14 | 23.3 | |
| Current smoker | 25 | 41.7 | |
| Smoking product* | Beedi | 28 | 46.7 |
| Cigarette | 11 | 18.3 | |
| Pack years* | 10-20 pack years | 1 | 1.7 |
| 21-30 pack pears | 11 | 18.3 | |
| 31-40 pack years | 23 | 38.3 | |
| 41-50 pack years | 4 | 6.7 | |
| Smokeless tobacco product | Yes | 36 | 60 |
| No | 24 | 40 | |
| Education | Primary school | 33 | 55 |
| Middle school | 19 | 31.7 | |
| High school | 8 | 13.3 | |
| Occupation | Elementary occupation | 31 | 51.7 |
| Plant and machine operators | 14 | 23.3 | |
| Craft and related trade workers | 7 | 11.7 | |
| Skilled workers and shop and market sales workers | 8 | 13.3 | |
| Monthly Income | ≤10702 | 46 | 76.7 |
| 10,703-31977 | 14 | 23.3 | |
| Socio-economic | Upper Lower | 47 | 78.3 |
| Lower Middle | 13 | 21.7 | |
| Alcoholic history | Non alcoholic | 22 | 36.7 |
| Past alcoholic | 7 | 11.6 | |
| Current alcoholic | 31 | 51.7 | |
| Exacerbation history (in last 6 months) | 0 to 1 | 24 | 40 |
| >1 or >2 | 36 | 60 |
| Item | Mean | Median | Std deviation | Item-total correlation |
|---|---|---|---|---|
| Q1 | 0.68 | 1 | 0.469 | 0.273** |
| Q2 | 0.6 | 1 | 0.494 | 0.672** |
| Q3 | 0.58 | 1 | 0.497 | 0.799** |
| Q4 | 0.6 | 1 | 0.494 | 0.795** |
| Q5 | 0.52 | 1 | 0.504 | 0.355** |
| Q6 | 0.62 | 1 | 0.49 | 0.741** |
| Q7 | 0.58 | 1 | 0.497 | 0.799** |
| Q8 | 0.52 | 1 | 0.504 | 0.355** |
| Q9 | 0.58 | 1 | 0.497 | 0.799** |
| Q10 | 0.5 | 0.5 | 0.504 | 0.19** |
| Q11 | 0.58 | 1 | 0.497 | 0.799** |
| Q12 | 0.73 | 1 | 0.446 | 0.489** |
| Q13 | 0.57 | 1 | 0.5 | 0.457** |
| Q14 | 0.52 | 1 | 0.504 | 0.238** |
| Q15 | 0.33 | 0 | 0.475 | 0.342** |
| Q16 | 0.43 | 0 | 0.5 | 0.299** |
| Q17 | 0.25 | 0 | 0.437 | 0.042** |
| Q18 | 0.05 | 0 | 0.22 | 0.271** |
| Q19 | 0.88 | 1 | 0.324 | 0.069** |
| Q20 | 0.23 | 0 | 0.427 | 0.116** |
Phase II: Validity & Internal Consistency
The Validity was analysed using Cronbach alpha (α=0.860) and Internal Consistency using Pearson’s correlation coefficient (r=0.932) & Cohen's Kappa (κ=0.714). The individual items and domains are provided in detail from Tables 5 and 6.
| Item | Cronbach alpha if alpha deleted | Pearson’s coefficient of Correlation | Kappa |
|---|---|---|---|
| Q1 | 0.861 | 0.894 | 0.887 |
| Q2 | 0.845 | 0.827 | 0.812 |
| Q3 | 0.839 | 0.785 | 0.762 |
| Q4 | 0.839 | 0.821 | 0.806 |
| Q5 | 0.858 | 0.841 | 0.829 |
| Q6 | 0.842 | 0.778 | 0.754 |
| Q7 | 0.839 | 0.912 | 0.908 |
| Q8 | 0.858 | 0.805 | 0.786 |
| Q9 | 0.839 | 0.82 | 0.816 |
| Q10 | 0.865 | 0.807 | 0.789 |
| Q11 | 0.839 | 0.785 | 0.762 |
| Q12 | 0.853 | 0.787 | 0.765 |
| Q13 | 0.854 | 0.826 | 0.826 |
| Q14 | 0.863 | 0.843 | 0.83 |
| Q15 | 0.858 | 0.914 | 0.91 |
| Q16 | 0.86 | 0.771 | 0.746 |
| Q17 | 0.868 | 0.899 | 0.894 |
| Q18 | 0.86 | 0.7 | 0.657 |
| Q19 | 0.865 | 0.902 | 0.897 |
| Q20 | 0.865 | 0.849 | 0.837 |
| Domain | Cronbach alpha | Pearson’s coefficient of Correlation | Kappa |
|---|---|---|---|
| Understanding COPD | 0.892 | 0.968 | 0.745 |
| Managing COPD | 0.77 | 0.959 | 0.863 |
Intra-Class Correlation (ICC)
Test-Retest reliability was estimated using ICC, based on two-way mixed effect model for absolute agreement. The ICC obtained for total score was 0.894 (95% CI 0.494-0.962) p<0.001, suggesting good reliability.
DISCUSSION
Due to a greater cultural diversity, existing validated tools DACQ and BCKQ might not be suitable for use in our population, as a result of limited resources and linguistic barrier (Banville et al., 2000). Hence the need for this study is to develop, translate and validate a culturally appropriate COPD awareness questionnaire considering the targeted population. The Questionnaire’s conceptual framework identified the following two domains: (i) 14 items assessing the “Understanding of COPD” (ii) 6 items related to ‘Management of COPD’ and the final instrument included 20 questions. The inclusion of the first domain is essential as it captures awareness about the disease, its risk factors, symptoms and general misconceptions while the second domain deals with the practical aspects such as vaccination, self- management practices and smoking cessation.
CVI is classified into two types: Item-level CVI (I-CVI) and Scale-level CVI (S-CVI). All 20 items attained an I-CVI score ≥ 0.83 and S-CVI/Ave values ≥0.90, indicating excellent content validity. Following this, the questionnaire was translated using a continuous multi-step process proposed by Valmi D. Sousa, along with WHO guidelines for translation and cultural adaptation (Hyland et al., 2006; Younan et al., 2019). It was then pilot tested among the Tamil speaking population to ensure its reliability. Cronbach’s alpha for COPD-AQ was found to be 0.860, suggesting good reliability (Tavakol & Dennick, 2011). Test-retest reliability was assessed using Pearson’s correlation coefficient and Cohen’s kappa (Vishwas et al., 2017). The results demonstrated a high positive correlation (r=0.932) with an overall kappa value (κ=0.714) proving that the developed tool performs consistently with a good agreement between individual items.
The strengths of this study include expert panel involvement for content validation and adherence to standard translation and validation methodologies. Care was taken to avoid absolute qualifiers such as “always” and “never,” which may encourage guessing. Compared to the BCKQ with 65 items, this 20-item questionnaire remains comprehensive while being concise, improving response rates, accessibility and ease of responding to questions (White et al., 2006).
One limitation in the development of COPD-AQ is that, only “Yes/No” options were provided and “Don’t know” option was not included, which could lead to response bias and a reduced discrimination between lack of knowledge and wrong belief. Further, multi-centre studies would be essential to support wider application of the questionnaire, verifying its usefulness in different centres.
The more the patients are aware of their disease, the more they actively participate in the treatment leading to improved therapeutic outcomes. Hence, the developed 20 item COPD- AQ is a versatile and locally adoptable instrument for use in cross-sectional studies, public health campaigns and outreach programs to assess the level of COPD awareness and tailor interventions accordingly.
CONCLUSION
The questionnaire was clear, easy to administer, and relevant to the target population. It covered culturally sensitive risk factors like exposure to biomass fuels and tea dust, which are usually missing in available tools. COPD-AQ is a valid, reliable, and locally applicable instrument appropriate for cross-sectional surveys and public health projects to enhance disease awareness and management in COPD patients among Tamil-speaking populations.