Table 1 Details of two series of N-of-1 trials conducted by our research group
From: Conducting research in individual patients: lessons learnt from two series of N-of-1 trials
Series A [3] | Series B [4] | |
|---|---|---|
Setting | General practice | General practice |
Subjects | Patients who had been taking NSAIDs regularly in the treatment of pain and disability related to osteoarthritis of the hip or knee. | Long-term users of temazepam (10 or 20 mg) for sleep disturbances. |
Objective | 1) Is paracetamol as effective as NSAIDs? 2) Is medication-use influenced by presenting the personal results to each individual patient? | 1) Is placebo as effective as temazepam (10 or 20 mg), or, in some patients, is 10 mg temazepam as effective as 20 mg temazepam? 2) Is medication-use influenced by presenting the personal results to each individual patient? |
Primary outcome measures | 1) individual main complaints 2) intensity of pain | 1) individual main complaint 2) time to fall asleep |
Treatment pairs | 2 weeks of paracetamol and 2 weeks of NSAIDs | 1 week of placebo and 1 week of 10 mg temazepam, or 1 week of placebo and 1 week of 20 mg temazepam, or 1 week of 10 mg temazepam and 1 week of 20 mg temazapam |
Total trial period | 20 weeks (5 pairs of treatment periods) | 10 weeks (5 pairs of treatment periods) |
Sequence of treatments | Randomisation within each treatment pair | Randomisation within each treatment pair |
Blinding | The patient, the investigator and the GP were blinded for the sequence of treatments. | The patient, the investigator and the GP were blinded for the sequence of treatments. |