Content, Semantic, and Psychometric Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Content Validity Index (CVI) of the Questionnaire Items
研究概览
简要总结
This methodological study aims to develop and validate a questionnaire named for the Assessment of Patient Knowledge in Pulmonary Arterial Hypertension. The study will be conducted in four phases: (1) questionnaire development based on guidelines and literature; (2) content validation by expert judges; (3) semantic validation with patients; and (4) psychometric testing in a sample of up to 200 patients with confirmed pulmonary arterial hypertension (PAH).
In addition to validation, the study will collect clinical and functional data from medical records, including risk stratification using the COMPERA 2.0 method The final instrument is expected to support patient education strategies and contribute to improved clinical management of PAH.
详细描述
This is a methodological study with a quantitative approach, developed in four main phases, aimed at constructing and validating a questionnaire to assess the knowledge of patients with pulmonary arterial hypertension (PAH). The study will be conducted at a reference outpatient center in Brazil and will follow established methodological guidelines for the development and validation of health-related instruments.
Phase 1 - Questionnaire Development:
The initial version of the questionnaire, will be created based on the 2022 ESC/ERS Guidelines for PAH, a review of the scientific literature on patient knowledge in chronic diseases, and validated instruments in other conditions (e.g., chronic kidney disease, inflammatory bowel disease, rheumatoid arthritis). Items will cover the following domains: basic concepts, signs and symptoms, diagnosis and exams, available treatments and their mechanisms, adherence and self-care, and side effect management. Items will be multiple-choice with the option "I don't know".
Phase 2 - Content Validation:
At least five expert judges with experience in PAH, health education, and instrument development will evaluate each item for clarity, relevance, representativeness, and appropriateness using a 4-point Likert scale. The Content Validity Index (CVI) will be calculated for each item (I-CVI) and for the total instrument (S-CVI). Items with I-CVI ≥ 0.78 will be retained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
No masking was applied. This is an open-label, non-randomized methodological study to validate a questionnaire. All participants and investigators were aware of the intervention (questionnaire application).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Confirmed diagnosis of Group 1 Pulmonary Arterial Hypertension (PAH)
- •Ability to read and understand the questionnaire language
- •Provided informed consent to participate in the study
- •For expert judges (content validation phase): professionals with recognized expertise in pulmonary hypertension, with academic or clinical experience in the field
排除标准
- •Cognitive, visual, or auditory impairments that hinder questionnaire comprehension
- •Refusal to participate or withdrawal of informed consent
- •Inability to complete the questionnaire due to clinical instability
研究组 & 干预措施
Single Group
Participants in this arm will take part in one of three phases of the questionnaire validation study:
- content validation by expert judges,
- semantic validation by patients with pulmonary arterial hypertension (PAH),
- psychometric validation in a larger sample of up to 200 patients with confirmed PAH.
In the psychometric phase, participants will complete the final version of the SAVOIR questionnaire. Additional clinical and functional data will be collected from medical records, including:
risk stratification using the COMPERA 2.0 method,
These data will be used to explore associations between patient knowledge and clinical/functional outcomes.
干预措施: Application of Patient Knowledge Questionnaire on Pulmonary Hypertension (Other)
结局指标
主要结局
Content Validity Index (CVI) of the Questionnaire Items
时间窗: 4 weeks after expert panel review
Proportion of agreement among expert judges regarding the relevance and clarity of each item. Items with CVI ≥ 0.80 will be considered valid.
Semantic Clarity Rating by Patients
时间窗: 2 weeks after patient interview
Assessment of the clarity and comprehension of each item by patients using a structured form. Items with ≥ 85% of patients rating them as clear or very clear will be considered semantically valid.
Internal Consistency of the Questionnaire (Cronbach's Alpha)
时间窗: 4 weeks after questionnaire completion
Psychometric evaluation of the final version of the SAVOIR questionnaire using Cronbach's alpha. A coefficient ≥ 0.70 will be considered acceptable. The analysis will be conducted in a sample of up to 200 patients.
次要结局
- Test-Retest Reliability (Intraclass Correlation Coefficient - ICC)(2 weeks after first questionnaire administration)
- Completion Rate and Acceptability of the Questionnaire(At the time of first questionnaire administration (Day 1))
- 6. Association Between questionnaire Score and Risk Stratification (COMPERA 2.0)(Within 4 weeks of questionnaire completion)
- Association Between questionnaire Score and Number of PAH-related Hospitalizations(Within 4 weeks of questionnaire completion)
- Association Between the questionnaire Score (being developed) and Quality of Life Measures (EMPHASIS-10)(Within 4 weeks of questionnaire completion)
- Association Between Patient Knowledge and Treatment Adherence using Martin-Bayarre-Grau (MBG Score)(Within 4 weeks of questionnaire completion)
研究者
Caio Júlio César dos Santos Fernandes
Principal Investigator
University of Sao Paulo General Hospital