Background
The treatment of chronic obstructive pulmonary disease (COPD) combines pharmacological and non-pharmacological strategies aimed at improving quality of life and reducing exacerbations.1,2 Among non-pharmacological interventions, self-management education has become an essential pillar, as it promotes disease understanding, active patient participation, and informed decision-making regarding their care.1–5
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines define self-management as “a structured, personalized, and multicomponent intervention aimed at motivating, engaging, and supporting patients to adopt healthy behaviours and develop skills to better manage their disease.”1 This approach highlights the value of education as a transformative tool for behaviour change, enabling patients to acquire effective strategies to manage symptoms, prevent exacerbations, and improve their quality of life.
Thus, self-management education constitutes an essential component of the non-pharmacological management of COPD, as it encourages patients to understand their condition, actively participate in their treatment, and assume a shared responsibility in decision-making.2–5 In this process, respiratory therapists (RTs) play a fundamental role as educational mediators, facilitating understanding and the learning of self-care strategies.6 However, in Colombia, respiratory therapy training programs present limitations in their pedagogical approach, including variability in curricular content related to patient education, a predominance of traditional lecture-based instruction, and limited incorporation of active learning and competency-based educational strategies. These factors may contribute to heterogeneity in the knowledge, attitudes, and practices (KAP) of RTs regarding educational interventions for patients with COPD, underscoring the need for a standardized instrument to assess these domains.
To address this topic and provide a valid methodological tool, an instrument was developed to assess the KAP of RTs regarding self-management education for COPD, based on the conceptual guidelines proposed by GOLD 2025. Although KAP-based instruments are practical for studying educational and healthcare processes, they are prone to biases related to item design, question interpretation, and contextual application. Therefore, their development requires careful consideration of the target population, item formulation, response option construction, scoring methods, and rigorous validation procedures.7,8 This highlights the need to validate their content before using it in research or clinical practice.9
In this context, the present study aimed to validate the content of the instrument designed to assess the KAP of RTs regarding self-management education for COPD. This validation aims to ensure that the instrument’s items are relevant, clear, coherent, and understandable with respect to the component and construct being measured, thereby guaranteeing the instrument’s methodological consistency and robustness before its application in research.
Methods
Study design
This was an observational, descriptive, cross-sectional study focused on the development and content validation of a questionnaire designed to assess the KAP of respiratory therapists regarding self-management education for patients with COPD, based on the GOLD 2025 framework.
Items generation
During the development of the main protocol, formal working meetings were held with an interdisciplinary team composed of a respiratory therapist, a public health physician, an education specialist, and several experts in research and education. The discussions were video recorded to facilitate subsequent analysis, and based on these discussions and the GOLD 2025 guidelines, the questionnaire items were defined and structured into three main domains: (a) knowledge, (b) attitudes, and (c) practices. After several rounds of review by the research team and the progressive refinement of the items, the final version of the instrument was consolidated with 25 questions (see Table 1). In addition, complementary questions were included to collect demographic, educational, occupational, and other relevant contextual information (see Supplementary File 1). The questionnaire, along with the other components of the instrument, was originally developed in Spanish, as the study was conducted in a Spanish-speaking context.
Content validation
The content validation of the instrument was carried out by experts selected for their extensive experience in Respiratory Therapy, management of patients with COPD, and background in education or teaching. The identification of participants was conducted in collaboration with the Colegio Colombiano de Terapeutas Respiratorios (Colombian College of Respiratory Therapy), which recommended qualified professionals. Participants who agreed to take part in the validation process but did not submit their responses within the established timeframe were excluded.
Regarding the number of experts involved in the content validation process, it is important to note that methodological literature does not define large sample sizes as a requirement for expert-based content validity studies.7,10–13 Authors such as Lynn and Polit and Beck recommend panels of 5 to 10 experts as adequate to ensure robust judgment while maintaining feasibility and depth of evaluation, particularly when the panel has extensive clinical and educational experience.11–13 In this study, ten of the twelve invited respiratory therapists with a high level of expertise in COPD management and education participated, which meets and exceeds the minimum recommended threshold. Furthermore, with ten experts, an I-CVI value ≥ 0.78 is considered evidence of excellent content validity, strengthening the methodological rigour of the validation process.7,10,11
Each item was evaluated in three aspects: Relevance, Clarity and Coherence, and Vocabulary. The assessment was conducted using an online instrument, assigning a score from 0 to 5 (0–1 = inadequate, 2–3 = moderately adequate, 4–5 = excellent) (Supplementary File 2).
The method proposed by Lynn was applied, considering both the item-level content validity index (I-CVI) and the scale-level content validity index (S-CVI/Average).12,13 For the I-CVI, an item was considered essential if it obtained an average score ≥ 4.0. The S-CVI/Average was calculated for each component (Relevance, Clarity and Coherence, and Vocabulary), and by subsequently integrating all items and components, a global S-CVI/Average was obtained.
Additionally, Aiken’s V coefficient was calculated for each item, weighting the scores assigned by the experts to complement the results and assess the degree of agreement among them.14,15 The I-CVI was obtained by dividing the number of experts who rated an item as essential by the total number of experts, while the S-CVI/Average was calculated by averaging the I-CVI values of all items within each component, thus providing an overall view of content validity.
It was considered that an I-CVI ≥ 0.78 for each item constitutes evidence of excellent content validity. I-CVI values between 0.70 and 0.77 were interpreted as acceptable or moderate, whereas values below 0.70 indicated insufficient or low validity, in accordance with the criteria proposed by various authors.12,13
An S-CVI/Ave ≥ 0.90 for the overall scale was considered indicative of excellent content validity, while values between 0.80 and 0.89 reflected good validity. In this case, values below 0.70 were also interpreted as evidence of insufficient or poor validity.12,13
The evaluation was complemented by an analysis of Aiken’s V coefficient, with values between 0.90 and 1.00 considered indicative of excellent validity, and values between 0.70 and 0.89 representing adequate or good validity. Values below 0.70 were deemed insufficient or inadequate, indicating low agreement among evaluators.14,15
The I-CVI and Aiken’s V coefficient were selected as the primary quantitative measures of content validity because they are widely recommended and extensively used methods for evaluating the relevance, clarity, and representativeness of instrument items based on expert judgment, particularly in healthcare research and instrument development.10–13 The I-CVI provides a straightforward, interpretable estimate of the proportion of experts who consider an item relevant, making it especially appropriate for studies focused on expert-based content evaluation rather than on inter-rater reliability.10–12 Aiken’s V was additionally included as a complementary measure because it accounts for the ordinal nature of rating scales and provides a robust estimate of the degree of agreement among experts regarding item adequacy.14
Alternative approaches such as the Delphi technique, Content Validity Ratio (CVR), and the modified kappa statistic were not used in this study. The Delphi technique is primarily designed to achieve consensus through multiple iterative rounds, whereas this study aimed to conduct a structured quantitative evaluation of content validity in a single expert-review phase. The CVR was not selected because it relies on dichotomous ratings (essential vs. non-essential), which provide less sensitivity than ordinal scales for evaluating multiple content dimensions such as relevance, clarity, and coherence. Similarly, the modified kappa statistic is mainly intended to adjust for chance agreement, whereas the primary objective of this study was to evaluate expert-perceived content adequacy rather than chance-corrected agreement. Therefore, the combined use of the I-CVI and Aiken’s V coefficient was considered the most appropriate and methodologically robust approach to ensure a comprehensive and reliable quantitative assessment of content validity.
Statistics
Data were initially entered and cleaned in Microsoft Excel before being exported to the statistical software Jamovi version 2.5.3 for further analysis. For the evaluators’ characteristics, categorical variables were described using frequencies and percentages, while numerical variables were tested for normality and reported as means and standard deviations as appropriate. The values provided by the experts were recorded as quantitative variables for calculating the I-CVI, categorizing items as essential or non-essential according to the established criterion (score ≥ 4.0). In parallel, these data were also used to compute Aiken’s V coefficient to complement the content validity analysis.
Ethical considerations
This report is part of the research project entitled “Knowledge, attitudes, and practices of respiratory therapists from Medellín and the Eastern Antioquia region regarding education for self-management of chronic obstructive pulmonary disease”, which was approved by the Ethics Committee of the Institute of Medical Research at the University of Antioquia, as recorded in minutes No. 095 dated October 9, 2025.
Results
Characteristics of experts
Of the 12 invited experts, 10 completed and submitted the data collection form within the established time frame (response rate: 83.3%). All participants were professionals in Respiratory Therapy (n = 10; 100%), with an average professional experience of 20.2 ± 7.6 years. The mean experience specifically in managing patients with COPD was 15.3 ± 7.2 years, and all participants reported experience in teaching or education (n = 10; 100%).
Regarding academic qualifications, all experts held at least one postgraduate degree (100%). Notably, five experts (n = 5; 50%) had formal postgraduate training in education, pedagogy, or teaching, including specialization and master’s degrees in education-related fields. Additionally, several experts held postgraduate degrees in public health (n = 2; 20%), project management (n = 3; 30%), and healthcare administration (n = 2; 20%), further supporting the academic and methodological strength of the expert panel. Detailed descriptive results are presented in Table 2.
The normality analysis using the Shapiro–Wilk test indicated a normal distribution for the quantitative variables of professional experience (W = 0.952; p = 0.696) and COPD experience (W = 0.932; p = 0.469).
Item-level content validity
A total of 96% (72 out of 75) of the evaluated items belonging to the three components of the KAP instrument achieved I-CVI values of 1.00 or 0.90. When analyzing the three assessment dimensions—Relevance, Clarity and Coherence, and Vocabulary—it was observed that the lowest I-CVI values were concentrated in the Clarity and Coherence dimension of the Knowledge component (Table 3). In this dimension, items Q1, Q3, and Q8 obtained an I-CVI of 0.70, corresponding to the lowest recorded value.
Aiken’s V values ranged from 0.84 to 1.00 across all items of the instrument. In the Knowledge component, within the Clarity and Coherence dimension where the lowest I-CVI values were recorded, items Q1, Q3, and Q8 showed Aiken’s V values between 0.84 and 0.86, while the remaining items were above 0.90. In the Attitudes and Practices components, I-CVI and Aiken’s V values were consistent across the three dimensions, mostly ranging from 0.90 to 1.00.
Scale-level content validity
The S-CVI/Ave demonstrated excellent content validity in two of the evaluated criteria and good validity in one (Table 4). Specifically, Relevance showed an S-CVI/Ave of 0.96, Clarity and Coherence 0.88, and Vocabulary 0.98. The overall average for the instrument reached an S-CVI/Ave of 0.94.
Discussion
This report showed that the overall S-CVI/Ave value (0.94) exceeds the recommended minimum threshold of 0.90 for acceptable content validity, indicating that the items were evaluated as appropriate and representative of the content on knowledge, attitudes, and practices regarding self-management education for COPD across the dimensions of Relevance, Clarity and Coherence, and Vocabulary.12,13 Complementarily, Aiken’s V coefficients ranged from 0.84 to 1.00, supporting the relevance and adequacy of the items according to the weighting provided by the expert judges.14,15
Previous studies have documented the content validation of KAP-type instruments in various fields, where values above 0.70 or 0.78 are interpreted as evidence of excellent quality and semantic consistency of the items. For example, in the study by Kusi-Amponsah et al., which compared the content validity of two instruments used to measure knowledge and attitudes regarding pediatric pain, a cutoff of I-CVI ≥ 0.70 was applied.16 In contrast, other studies have used a cutoff of 0.78 as a reference.17–19 In the present report, the obtained values exceed both reference thresholds, demonstrating a robust content validity of the evaluated items.
Our findings contribute to the growing international use of structured KAP instruments to evaluate healthcare professionals’ competencies across diverse clinical and educational contexts.7,8 Several studies have reported the development or use of KAP-based questionnaires to assess professionals’ knowledge, perceptions, and practices in areas such as pediatric pain management, radiation safety, geriatric care, and chronic disease education, demonstrating their usefulness as standardized tools to identify educational needs and guide professional training strategies.20–24 Although these instruments have demonstrated acceptable psychometric properties, the content validation process is not always described comprehensively, particularly with respect to the use of quantitative agreement indices and standardized expert-based validation procedures. Given that rigorous content validation is essential to ensure the conceptual relevance, clarity, and representativeness of instrument items, the present study contributes to the international body of evidence by providing a rigorously content-validated tool specifically designed to assess respiratory therapists’ KAP regarding COPD self-management education, addressing an important methodological and clinical gap in the availability of validated instruments for this purpose.
Among the three evaluated criteria, the Clarity and Coherence dimension showed the lowest S-CVI/Ave value (0.88), primarily in the Knowledge component. Although this value remains acceptable, it suggests opportunities to improve the wording of certain items, specifically Q1, Q3, and Q8, which obtained the minimum I-CVI value (0.70).11–13 These variations are consistent with the observations of Polit and Beck, who note that differences often occur in items involving higher cognitive load or technical terminology.13 In this study, the Knowledge section was designed with multiple-choice questions with a single correct answer, a format that generally presents greater difficulty for participants and may explain part of the observed variability, aligning with Polit and Beck’s observations.13 Although expert feedback indicated that potential improvements related mainly to the Clarity and Coherence of the items, no modifications were made.
Specifically, the research team’s decision not to modify items Q1, Q3, and Q8, despite lower ratings in the Clarity and Coherence dimension, was influenced by assessments from a minority of experts (3 out of 10), who assigned a score of 3.00 in this dimension. In their qualitative comments, these evaluators preferred to assess these concepts using open-ended questions. However, given the quantitative nature of the study and the instrument’s standardized multiple-choice format, no changes were introduced, as the items were considered relevant and representative of the evaluated component, as supported by both the S-CVI/Ave and Aiken’s V values.
The high indices achieved in the Relevance (0.96) and Vocabulary (0.98) criteria confirm that the content of the instrument closely aligns with the theoretical components of the KAP model and the conceptual framework of the GOLD 2025 strategy for COPD self-management. This supports the theoretical consistency of the instrument, as the items reflect the multidimensional approach proposed by GOLD, which integrates knowledge acquisition, attitude formation, and practice modification as interrelated components of the educational process.1–4
The inclusion of experts with extensive professional and teaching experience in respiratory therapy strengthened the validity of the process. The judges’ profiles (with an average of over 15 years of professional experience and active involvement in education) enabled them to provide informed, contextualized judgments on the relevance and wording of the items. This approach aligns with methodological literature, which recognizes expert evaluation as the reference standard for assessing conceptual and linguistic adequacy in the validation of educational and clinical instruments.25–27
From a practical perspective, the results support the use of this instrument as a reliable Spanish-language tool for assessing the KAP of respiratory therapists regarding patient self-management education in COPD. Instruments of this nature can guide the design of targeted training strategies and contribute to the development of pedagogical models that strengthen the non-pharmacological management of COPD.2–5 Furthermore, they provide a methodological foundation for future psychometric evaluations, such as construct validity and reliability, which are necessary steps for the full consolidation of the instrument.28–30
Nevertheless, this report has important limitations. One major limitation is that construct validity (Cronbach’s alpha) and Kendall’s W coefficient were not assessed, as the primary objective of this study was to evaluate content validity through expert judgment and the instrument was not administered to a sample of respondents, making these analyses methodologically inappropriate at this stage. Consequently, evidence regarding internal consistency and inter-rater reliability could not be established.29,31,32 Additionally, although the selected experts were highly qualified, the sample was restricted to professionals from a single country, and the instrument was developed exclusively in Spanish without formal cross-cultural or linguistic adaptation, which may limit the generalizability and applicability of the findings in other linguistic contexts. Although indices such as the I-CVI and S-CVI/Ave are numerical and inherently language-independent, the absence of formal transcultural and linguistic validation may affect the interpretation and use of the instrument across languages and cultural settings. Therefore, it is recommended that future research incorporate construct validity analyses, calculate Kendall’s W, expand participation to international judges, adapt the instrument to different languages, and conduct cognitive interviews with practicing professionals to optimize item comprehension and clarity. Following the completion of content validation and consideration of the research team’s available resources, the next phase will involve evaluating the instrument’s construct validity and internal consistency, followed by its application within the broader research project framework. This process will allow the identification of educational gaps among respiratory therapists and support the development and evaluation of targeted educational interventions in COPD self-management. These steps will help ensure that the instrument is not only methodologically robust but also reliable and applicable across clinical, academic, and research settings.
Conclusion
The instrument designed to assess the knowledge, attitudes, and practices (KAP) of respiratory therapists regarding COPD self-management education demonstrated excellent content validity in the Relevance and Vocabulary components, and good validity in the Clarity and Coherence component, supported by I-CVI, S-CVI/Ave, and Aiken’s V values. These results confirm that the items are relevant, clear, coherent, and use appropriate vocabulary. Nevertheless, further studies are needed to evaluate the instrument’s construct validity and reliability.
Acknowledgement
We express our sincere gratitude to all the evaluators, who, despite their numerous professional demands, generously agreed to participate in this expert panel, contributing their knowledge and experience without any compensation. Their commitment and dedication were essential to the development of this work.
Funding
This study received no funding.
Contributors
All authors contributed to the conception or design of the work, the acquisition, analysis, or interpretation of the data. All authors were involved in drafting and commenting on the paper and have approved the final version.
Competing interests
The authors declare no conflict of interest.
Ethical approval
This project was approved by the Ethics Committee of the Institute of Medical Research at the University of Antioquia, No. 095, October 9, 2025.
AI statement
No generative AI or AI-assisted technology was used to generate this manuscript or its content.
