A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction in Ethiopia

Lambert, S. 2015. A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction in Ethiopia. [Online]. London School of Hygiene & Tropical Medicine, London, United Kingdom. Available from: https://doi.org/10.17037/DATA.18.

Lambert, S. A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction in Ethiopia [Internet]. London School of Hygiene & Tropical Medicine; 2015. Available from: https://doi.org/10.17037/DATA.18.

Lambert, S (2015). A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction in Ethiopia. [Data Collection]. London School of Hygiene & Tropical Medicine, London, United Kingdom. https://doi.org/10.17037/DATA.18.

Methods

Description of data capture

Data from each assessment was recorded on standardised Patient Record Forms (PRF) and kept in a set of case notes separate from other hospital record. Data was verified and entered into Case Record Forms (CRF) by the study physicians. Double data entry into a Microsoft Access 2007 database was performed by Saba Lambera and a data manager at ALERT/AHRI. The double entry was then verified using Epi-Info 3.5.4, with an initial rate of detected errors being under 10%. Errors in the data were verified and corrected in Ethiopia. Errors were traced back to the CRFs and correct. Epi-info was re-run and procedures repeated until two identical and correct databases were obtained. The MS Access data tables were subsequently transferred to SPSS v20 for analysis.

Data capture method

Measurements and tests

Data Collection Period

From	To
12 August 2011	24 July 2013

Date (Date submitted to LSHTM repository)

1 October 2015

Geographical area covered (offline during plugin upgrade)

North Latitude	East Longitude	South Latitude	West Longitude
9.02783	38.847	8.91897	38.6963

Language(s) of written materials

English

People & Groups

Data Creators	Lambert, S
Associated roles	Nicholls, P (Data Manager), Yamuah, L (Data Manager), Lockwood, D (Project Leader), Tsegaye, D (Data Collector) and Nigusse, S (Data Collector)
LSHTM Faculty/Department	Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Participating Institutions	London School of Hygiene & Tropical Medicine, London, United Kingdom

Projects

Funders

Project	Funder	Grant Number	Funder URI
Assessing Ciclosporin in the Treatment of Leprosy Reactions: Evidence from a Randomized Controlled Trial and Other Studies	Hospital and Homes of St Giles	ITCRBY24	UNSPECIFIED