Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)
- Conditions
- Cystitis Acute
- Registration Number
- NCT06267040
- Lead Sponsor
- Al-Kindy College of Medicine
- Brief Summary
The goal of this prospective observational study is to provide an Arabic translation of the Acute Cystitis Symptom Score (ACSS) and to test the linguistic validity and clinical reliability of the translated Arabic version of ACCS (Arabic-ACCS) in Arabic-speaking women older than 18 years of age diagnosed with uncomplicated cystitis.
The main questions it aims to answer are:
* Do the questions of the Arabic-ACSS have sufficient clarity?
* Can the Arabic-ACCS serve its purpose in identifying the presence of uncomplicated cystitis in Arabic-speaking women? The participant will be asked to fill out the Arabic-ACCS questionnaire at the time of diagnosis. The participants will be asked to fill out the second part of the Arabic-ACCS questionnaire 5-10 days later after receiving the appropriate treatment according to the local health policy as prescribed by the treating physician.
Researchers will compare the results from the patients who filled out the first part of the questionnaire with the results of a comparable group of women who were presented with complaints unrelated to the lower urinary tract.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- women.
- presented to the urology or gynecology and obstetrics outpatient clinics.
- having the diagnosis of uncomplicated cystitis.
- pregnancy.
- urethral catheterization.
- anatomical abnormality of the urinary tract.
- Neurologic abnormality that affects bladder function.
- urinary tract stones.
- recent antibiotic usage (within 1 month).
- immunosuppression.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical reliability 7 months The linguistically validated, translated Arabic version of the Acute Cystitis Symptom Score questionnaire should be able to recognize patients with acceptable specificity and sensitivity.
The sum of the "typical symptoms," "deferential symptoms," and "quality of life" domain scores can range from 0 to 18, 0 to 12, and 0 to 9, respectively. The lower score signifies less severity; the top score is the most severe grade for each domain.
The "additional" domain consists of five "yes" or "no" questions designed to discover if there are any criteria that may exclude the diagnosis of uncomplicated cystitis or produce similar symptoms.
The sum of the "typical symptoms" domain alone will be tested for its diagnostic reliability.
In addition, the sum of both "typical symptoms" and "quality of life" domains is also to be tested for its diagnostic reliability.Linguistic validity 14 days Each question in the translated Arabic version of the Acute Cystitis Symptom Score questionnaire should be clear, and the answer to the question should provide the desired piece of information.
The acute cystitis symptom score questionnaire consists of four domains at the first visit. These domains ask about typical symptoms (6 questions), differential symptoms (4 questions), quality of life (3 questions), and additional information (5 questions). In addition to the aforementioned items, there is a dynamic domain (one question) that is only asked on the second visit.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Alkindy Teaching Hospital
🇮🇶Baghdad, Iraq
Al-Elwiya Maternity Teaching Hospital
🇮🇶Baghdad, Iraq