An activity-based journal club to help staff & students improve confidence at reading scientific papers Cornwall Health Library: Katy Oak Catriona Organ

Workshop: Background Activity More ideas

Knegt, N.C. et al Behavioral pain indicators in people with intellectual disabilities: a systematic review. Journal of Pain 14 (9) p885-896

West, R. Placebo-controlled trial of Cytisine for smoking cessation West, R. Placebo-controlled trial of Cytisine for smoking cessation. NEJM 2011 365 (13) p. 1193-1200

Journal Club objectives: Increase understanding & confidence reading articles Improve writing assignments Better analysis of academic articles

Journal Club format: Activity Checklist Paper Breaking complex principles in to more basic elements and then using these to build their knowledge

Strongly Agree Agree

"A journey of a thousand miles begins with a single step“ Lao Tzu Reading RCT papers Going to look at an activity for understanding RCT methodology. Activity starts Assessment questions: Rate yourself, stand in line and divide in to groups.

Does caffeine increase the heart rate of people attending the HLG Conference in Keele? Design and run an RCT as best you can. If you can’t practically do something that you think should be included then write this in to your presentation.

Sample Randomisation placebo caffeine Control group Experimental group Measure heart rate Measure heart rate placebo caffeine Remember that an RCT is really trying to find out if whatever is being tested in the experimental arm has made a difference to the outcome being measured. We need to try to eliminate anything else that may effect the results.

Other micro-teaches

From here: Slides for explanation if needed

Power Calculation Before trial Sample size Ability to detect smallest clinically relevant difference 0.8 or 80% probability of finding a difference if it exists Statistical power is how likely a study is to detect a difference if it truly exists. Should be 80-90% So, 10-20% chance of not showing a difference. Power is used to set the sample size needed before the study begins.

West, R. Placebo-controlled trial of Cytisine for smoking cessation West, R. Placebo-controlled trial of Cytisine for smoking cessation. NEJM 2011 365 (13) p. 1193-1200

Randomisation 01, 10, 02, 34, 75, 36, 09, 24, 98 O, E, E, E, O, E, O, E, E Block, stratified Odd = placebo Even = experimental

CONSORT statement aims to improve reporting of RCTs ITT – preserves randomisation - include all randomised participants in the analysis, all retained in the group to which they were allocated. Missing data to achieve ITT : imputation = worst-case, similar subject’s data, last obs – but you need to know Less than 20% What to look for in a paper: ITT analysis or Pragmatic approach – most likely to give more conservative results On-Treatment Analysis or Per-protocol = ignore data from dropouts – can give ‘true effect’ view but can introduce bias. Flow diagram

Randomisation 01, 10, 02, 34, 75, 36, 09, 24, 98 O, E, E, E, O, E, O, E, E Block, stratified Odd = placebo Even = experimental

P - values The probability that the result would have occurred by chance. The lower the p – value, the less likely that the result is due to chance. P < 0.05 statistically significant. P < 0.01 = 1 / 100 P < 0.001 = 1/ 1000

Confidence Intervals We are 95% confident that the true population result lies within the given range

Confidence Intervals Difference between MEANS If the range crosses zero then the result is not significant Difference between RISK & ODDs If the range crosses 1 then the result is not significant

How good is the methodology? How far can the results be …...generalised to a wider population?