![]() This was done internally as part of an audit/evaluation, so as to improve our quality of care. Hence we did not seek/obtain ethical approval for a study but rather project approval from the Ministry of Health.ĥ) Our analysis looked retrospectively at outcomes for a large cohort of patients treated. The diagnostic protocol that we evaluated was the national protocol.Ĥ) The program was not set up as a study or research project, but as a treatment program. It is done for each patient without fail and as part of routine care, and is in no way an add-on for purposes of research.ģ) The paper does not report on the use of experimental or new protocols. Testing blood and CSF (as well as recording all other variables included in our analysis) is essential for confirming diagnosis and classifying patients. ![]() All data analysed were collected as part of routine diagnosis and treatment.Ģ) Patients were diagnosed and treated according to national guidelines and agreements. They did not seek informed consent or ethical committee approval for their study, and provided the followingġ) The paper does not report on primary research. The authors did a retrospective cohort study of patients treated under both policies, to see how this change affected outcomes. A paper reported the clinical outcomes of patients suffering from a neglected disease before and after a change in the national treatment policy which raised the threshold of one laboratory parameter before a more toxic, but more effective drug could be used.
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