- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02132351
Hepatic Fibrosis Non-invasive Methods Questionnaire
Acceptability, Reliability and Applicability of Liver Biopsy and Noninvasive Methods for Assessment of Hepatic Fibrosis and Cirrhosis Among Hepatologists; a Web Based Survey
Studieoversigt
Detaljeret beskrivelse
Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.
Methods:
The study is a survey study among hepatologists. Four thousand hepatologists will be invited to participate in the questionnaire through e-mail invitations to answer 50 questions of the questionnaire. The questionnaire will be hosted on Survey monkey website and results will be analyzed to get the consensus opinion of participants for the use of invasive and non-invasive methods for assessment of hepatic fibrosis and cirrhosis and factors affecting their preferences.
Statistical analysis plan Analysis of data will be performed using Statistical Package for Scientific Studies 17 for Windows. Description of qualitative variables will be in the form of numbers (No.) and percent (%). Description of quantitative variables will be in the form of mean, standard deviation (SD). Questionnaire results will be compared against different baseline characteristics of the studied group. According to the type and distribution of data, suitable tests for inferential statistics will be used. Significance of the results will be presented in the form of P-value.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Cairo, Egypten, 11884
- Al-Azhar Uinversity
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- hepatologists
Exclusion Criteria:
- Non hepatologists
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Hepatologists
Doctors working as hepatologists
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hepatic fibrosis
Tidsramme: 3 years
|
Percentage of hepatologists accepting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
|
3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Trust in non-invasive methods
Tidsramme: 3 years
|
Percentage of hepatologists trusting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
|
3 years
|
use of non-invasive methods
Tidsramme: 3 years
|
Percentage of hepatologists who use invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
|
3 years
|
combining non-invasive methods
Tidsramme: 3 years
|
Percentage of hepatologists combining different non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mohamed Alboraie, M.Sc, Al-Azhar University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MB-1
- AlazharU-MB-1 (Anden identifikator: AlazharU-MB)
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