EVIDENCE BASED MEDICINE WORKSHEET FOR STUDIES ON THERAPY- EXPLANATION

APPRAISING AND APPLYING THE EVIDENCE

Randomisation
i).Randomised trial? ii).Randomisation methods: a. Well-documented? b. Adequate?

iii). Evidence that assigned groups (e.g. intervention and control) similar in characteristics at the start of study? iv). Evidence that assigned groups (e.g. intervention and control) treated equally throughout the study?

Accountability
i).Could we trace the progress of ALL participants throughout the study? ii). Was there mention of the use of intention-to-treat analysis? ii). Was the drop-out rate acceptable (< 20%)?

Measurement
i). Was the main outcome measurement objective? Ii). Was there blinding of intervention to: a).Patients? b).Clinicians? c). Assessors? OVERALL VALIDITY OF THIS STUDY: GOOD ACCEPTABLE WITH SOME CONCERNS POOR and I would stop here and not appraise further

FURTHER APPRAISAL

Results
i). What is the main result that I am interested in (i.e. that answers my question)? ii). Was there a big enough difference between the intervention and control groups in terms of this result?

Application
i). My patient is similar to the study participants (i.e. not within the exclusion criteria) ii). The treatment is available and feasible in my setting iii). The treatment is likely to be acceptable for my patient and his/her family

My conclusions
Suggested answers: 1. This article provides some evidence on the effectiveness of . (treatment/medication name) for patients with .. (disease/condition), as applicable to my setting. However, I will look for further studies or a systematic review to confirm its findings. 2. This article has some major flaws, and therefore does not contribute to clinical evidence on the effectiveness of . (treatment/medication name) for patients with .. (disease/condition). I will look for further studies or a systematic review to answer my clinical questions. The major flaws of this study include:(pick this answer if the overall validity of the article was POOR, as further appraisal was left blank) 3. This article provides some evidence on the lack of benefit of . (treatment/medication name) for patients with .. (disease/condition), as applicable to my setting. However, I will look for further studies or a systematic review to confirm its findings.

SAMPLE CALCULATIONS ON STUDY ON THERAPY Occurrence of diabetic neuropathy at 5 years among insulin-dependent diabetics in the DCCT trial Usual insulin Intensive insulin regimen regimen control event experimental rate (CER) event rate (EER) 9.6% 2.8% Relative risk reduction (RRR) Absolute risk reduction (ARR) Number needed to treat (NNT)

CER EER CER 9.6% - 2.8% 9.6% = 71% 95% CI *

CER-EER

1/ARR

9.6% - 2.8% = 6.8% 4.4% to 9.2%

1/6.8% = 15 patients 11 to 23