Perception of the Benefits and Effectiveness of Inhalation Therapy in Patients With Obstructive Dyspnea

STUDY OBJECTIVE

This project aims to optimize the diagnostic and therapeutic pathway of patients with obstructive ventilatory disorders (COPD, asthma, and pulmonary emphysema), with the goal of improving disease awareness, treatment appropriateness, and adherence to prescribed therapies.

Primary Objective

The primary objective of the study is to investigate patients' perceptions of the usefulness and effectiveness of inhalation therapy, as well as any difficulties they may encounter in its use and management, through a specifically designed structured interview.

Secondary Objectives

1. To assess patients' perceptions of their disease and explore their beliefs about medications in general and those specifically prescribed for their respiratory condition.
2. To qualitatively evaluate and compare patients' perceptions of the usefulness and effectiveness of other treatment modalities, including oral therapies, intravenous/intramuscular treatments, oxygen therapy, and respiratory physiotherapy. Materials and Methods Study Population The study population will consist of patients with obstructive ventilatory disorders (COPD, asthma, or pulmonary emphysema) admitted to the Respiratory Rehabilitation Unit as inpatients, receiving short-term care (MAC), attending outpatient visits at the Istituti Clinici Scientifici Maugeri in Lumezzane (Brescia), or referred to the outpatient clinic of the Respiratory Medicine Unit at Spedali Civili of Brescia. Inclusion Criteria Confirmed spirometric diagnosis of COPD and/or pulmonary emphysema, or functional/clinical diagnosis of asthma according to ATS/ERS criteria. Diagnosis established at least 6 months before enrollment. Signed informed consent confirming the patient's voluntary participation in the study. Exclusion Criteria Known cognitive impairment or Mini-Mental State Examination score < 24. Refusal to participate. The project will be conducted through five main phases: (1) preliminary audit and development of the structured interview, (2) protocol finalization, (3) interview administration and questionnaire completion, (4) data analysis, and (5) preparation of a scientific manuscript for publication. Phase 1 - Audit The first phase will involve the establishment of a multidisciplinary audit team composed of two psychologists, one psychology fellow, two pulmonologists, two nurses, two physiotherapists, and two expert patients. Drawing on the scientific literature, professional expertise, and personal experience, the team will develop a structured interview specifically designed to explore patients' perceptions of inhalation therapy. The structured interview will include closed-ended questions, multiple-choice items, dichotomous yes/no questions, and 5-point Likert-scale ratings. The interview will address the following key domains: Patients' perceptions and opinions regarding inhalation therapy (e.g., method of administration, frequency and ease of use, perceived effectiveness, reasons for prescription, and perceived disease severity associated with its use). Disease awareness and knowledge.Perceptions of treatment in general and therapy preferences. Motivation and willingness to adhere to prescribed treatments. A preliminary, non-exhaustive list of potential items includes: Do you think your condition will significantly worsen over time? Have you ever received educational material about your respiratory disease? Do you consider your condition a serious chronic illness? Do you think your actions can help control your symptoms? Do you believe your actions can influence the course of your disease? What type of medication do you prefer to take? Have you ever considered changing your current treatment? Which type of treatment do you find easiest to take and maintain over time? Do you find inhalation therapy easy to use? Do you consider inhaled therapy somewhat unnecessary when symptoms are absent? Phase 2 - Protocol Finalization In addition to the structured interview, the protocol will include assessment tools investigating patients' perceptions of the usefulness and effectiveness of inhalation therapy. Once approved by the expert panel, the draft version of the structured interview will be administered to five patients to assess its clarity, comprehensibility, and feasibility. Feedback obtained from this pilot testing phase will be used to refine and finalize the interview. Based on available evidence from the scientific literature, the protocol will also incorporate selected sections of validated questionnaires currently used in clinical practice:
3. Medication Use Assessment Section 3 of the InQoL questionnaire will be considered.
4. Assessment of Medication Beliefs The Beliefs about Medicines Questionnaire (BMQ) will be administered. Phase 3 - Interview Administration and Assessment Scales Following protocol finalization, the study will be conducted among patients admitted to the Respiratory Rehabilitation Unit, those receiving care in the Medical-Surgical Ward, and outpatients attending either the Istituti Clinici Scientifici Maugeri in Lumezzane (Brescia) or the Respiratory Medicine outpatient clinic at Spedali Civili of Brescia. Patients who agree to participate will complete both the structured interview developed during Phase 1 and the assessment questionnaires identified in Phase 2. Administration will be performed by trained personnel, including a clinical psychologist or psychology fellow. Both the interview and questionnaires will be provided in paper format. The estimated completion time will not exceed 60 minutes. Sample Size Calculation Assuming that 50% of patients perceive inhalation therapy as not useful, only slightly useful, or not particularly effective, a sample of 43 patients will be required to estimate this prevalence with a precision of ±15% (95% confidence interval: 35%-65%) and a confidence level of 95%. Considering a potential dropout rate of approximately 15% due to refusal, clinical exacerbation, or transfer to another healthcare facility, a total of 50 patients will be recruited. Sample size calculations for proportions were performed using the OpenEpi software (https://www.openepi.com/SampleSize/SSPropor.htm). The final version of the structured interview will then be administered to 50 consecutive patients attending the Respiratory Rehabilitation Unit as inpatients, MAC patients, or outpatients at either the Istituti Clinici Scientifici Maugeri in Lumezzane (Brescia) or the Respiratory Medicine outpatient clinic at Spedali Civili of Brescia over an anticipated recruitment period of approximately 10 months. All participating adults, regardless of sex, must meet the predefined inclusion and exclusion criteria and provide written informed consent together with authorization for personal data processing. Measurements For each enrolled participant, the following data will be collected:
5. Baseline Data Collection Anthropometric and demographic data Age Sex Body Mass Index Clinical data Disease duration Use of oxygen therapy Current medications Presence of comorbidities Presence of a caregiver Functional data Forced Expiratory Volume in 1 second (FEV1) (% predicted) Forced Vital Capacity (FVC) (% predicted) FEV1/FVC ratio
6. Structured Interview A structured interview investigating perceptions of inhalation therapy will be administered and will include: Assessment scales exploring beliefs about respiratory medications, medications in general, and the perceived benefits and adverse effects associated with alternative therapeutic modalities (oral treatments, intravenous/intramuscular therapies, oxygen therapy, and respiratory physiotherapy), as described in Phase 2. Patient-rated disease severity using a 10-point Likert scale (0 = worst; 10 = best). Clinician-rated disease severity using the same 10-point Likert scale (0 = worst; 10 = best). Phase 4 - Data Analysis Descriptive analyses will be performed for each item included in the structured interview. Interview items will also be grouped into domains reflecting: Perceived usefulness of medical therapy in general. Perceived usefulness of inhalation therapy. Perceived effectiveness of inhalation therapy. For exploratory purposes, a composite score will be calculated for each domain and correlated with scores obtained from a different questionnaire (i.e.Beliefs about Medicines Questionnaire). Associations between interview scores and questionnaire scores will be evaluated using Spearman's rank correlation coefficient. Differences in perceptions of benefits and side effects across treatment modalities will be assessed using one-way Analysis of Variance or, when appropriate, the non-parametric Kruskal-Wallis test. Statistical analyses will be performed using R (Vienna, Austria). Statistical significance will be defined as a two-sided p-value < 0.05. Phase 5 - Scientific Manuscript Preparation The findings generated by the study will be used to prepare at least one scientific manuscript for publication in a peer-reviewed journal.