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] LSHTM Data Compass. London, United Kingdom: 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.

Description

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
FromTo
12 August 201124 July 2013
Date (Completed) 1 October 2015
Geographical area covered
North LatitudeEast LongitudeSouth LatitudeWest Longitude
9.0278338.8478.9189738.6963
Language(s) of written materials English
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
Funders
ProjectFunderGrant NumberFunder URI
Assessing Ciclosporin in the Treatment of Leprosy Reactions: Evidence from a Randomized Controlled Trial and Other StudiesHospital and Homes of St GilesITCRBY24UNSPECIFIED
Ciclosporin in the management of acute T1RUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Depositor Saba Lambert
Date Deposited 11 Nov 2015 14:05
Last Modified 11 Nov 2015 14:19
Publisher London School of Hygiene & Tropical Medicine

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Filename: CnTRA-dataset.zip

Description: Anonymised dataset of ciclosporin treatment analysis

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Documentation

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Filename: Ciclospori_Reaction_Studies_SOP.pdf

Description: Standard Operation Procedure/Protocol for study

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Study Instrument

Filename: PatientRecordForm.pdf

Description: Patient record form used for data capture

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