Cost-effectiveness Analysis of Three Corticosteroids in ILDs
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      This was a 3 months prospective, open label, and parallel study to test the efficacy of 3
      different corticosteroids in the management of interstitial lung diseases. Followed by a
      pharmacoeconomic analysis to find which regimen (betamethasone, dexamethasone or
      prednisolone) is the most cost-effective.
    

Detailed description: 
      Three different corticosteroid regimens were evaluated for the management of interstitial
      lung diseases (ILDs) with specific focus on hypersensitivity pneumonitis (HP) where the
      patients were divided into 3 treatment groups:

        -  Group I: patients receiving weekly pulse doses of betamethasone IM injection (equivalent
           dose to that of prednisolone daily dose in a week).

        -  Group II: patients receiving weekly pulse doses of dexamethasone IV injection
           (equivalent dose to that of prednisolone daily dose in a week).

        -  Group III: patients receiving oral prednisolone daily (dose range 15-20 mg/day).

           10 mg oral prednisolone oral ≡ 1.5 mg dexamethasone intravenous ≡ 1.2 mg betamethasone
           intramuscular.

      After the administration of the above-mentioned medications, the patients were followed-up
      over 3 months to evaluate their disease progression. Informed consent was obtained from all
      subjects or their surrogate after explanation and understanding of the nature, purpose, and
      potential risks of the study. The study protocol was approved by the Ethics Committee,
      Faculty of Pharmacy, Cairo University (protocol serial number: CL (2183)) .

      A special patient information sheet was designed to collect all information required for data
      analysis. The sheet was designed to be divided into several sections:

        1. Demographic Data The first section of the patients' information sheet was designed to
           accommodate the basic general and demographic data (name, address, age, telephone
           number, social status, weight, and height of the patient). These details were documented
           from the patient's medical notes.

        2. Medical Data Medical records were used to obtain other data including date and time of
           examination, the diagnosis, medications on recruitment (if any), smoking habits,
           patient's medical history, in addition to the patient's medication history.

        3. Parameters Used to Measure Effectiveness as KL-6, PFTs, ESR, CRP

        4. Parameters to Evaluate Treatment Safety Liver Function Tests, Random Blood Glucose
           (RBG), Blood Pressure

      Cost Effectiveness Analysis The study is designed from patient perspective where the direct
      medical costs as well as the indirect costs (e.g., loss of patients' income) are studied. The
      costs are collected directly from the patient prospectively throughout the study period. All
      costs were actual covering the treatment expenses as: the cost of the medications, the cost
      of administration, the cost of the hospital stay due to ILD during the study period, the cost
      of the physician's visit and the cost afforded by the patient in order to administer the
      recommended medication, any extra costs due to exacerbations or adverse effects due to the
      use of corticosteroids and costs of transportation and days-off.
    

Intervention name(s): Betamethasone, Dexamethasone, Prednisolone
Intervention type(s): Drug
Intervention description(s): Corticosteroids
Intervention MeSH terms: Dexamethasone; Prednisolone; Betamethasone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment