Ethical justification of single-blind and double-blind placebo-controlled response tests in neuropathic pain and N-of-1 treatment paradigm in clinical settings

Figures & data

Figure 1 Initial and extended double-blind response test.

Abbreviation: NRS, numerical rating scale.

Table 1 Key questions for N-of-1 RCT

1. Is an N-of-1 RCT indicated for this patient?

a. Is the effectiveness of the treatment really in doubt?

b. Will the treatment, if effective, be long-term?

c. Is the patient eager to collaborate in designing and carrying out an N-of-1 RCT?

2. Is an N-of-1 RCT feasible in this patient?

a. Does the treatment have a rapid onset?

b. Does the treatment stop acting soon after it is discontinued?

c. Is an optimal duration of treatment feasible?

d. Can clinically relevant targets be measured?

e. Can sensible criteria for stopping the trial be established?

f. Is an unblinded run-in period necessary?

3. Is the trial feasible in my practice setting?

a. Is there a pharmacist who can help me?

b. Are strategies for interpreting the data in place?

c. Is the trial ethical?

Abbreviation: RCT, randomized clinical trial.