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Table 2 Analysis of trial outcomes assessed at two or more time-points

From: Medical student INtervention to promote effective nicotine dependence and tobacco HEalthcare (MIND-THE-GAP): single-centre feasibility randomised trial results

 

3 months (n)

6 months

Per protocol analysis: 3-month

ITT analysis: 3-month

Per protocol analysis: 6-month

ITT analysis 6-month

Repeated measures (random effects analyses)

 

Intervention

Usual Care

Intervention

Usual Care

 

Primary outcome:

 

β = .57 (−.03 to

MTSS; mean (SD), number(n)

5.43 (1.36) (n = 21)

4.57 (1.73) (n = 23)

5.65 (1.46) (n = 17)

4.27 (2.21) (n = 22)

F = 0.66, df = 4, p = 0.619

F = 0.59, df = 4, p = 0.671

F = 1.42, df = 3, p = 0.239

F = 1.53, df = 3, p = 0.207

1.18), p = 0.064

Secondary outcomes:

Reported use of cessation medications

PP = 60% (n = 20) ITT = 18.2%

PP = 42.9% (n = 21) ITT = 14.7%

PP = 73.3% (n = 15) ITT = 9.09%

PP = 44% (n = 25) ITT = 17.7%

OR = 2.0 (0.58 to 6.94), p = 0.275

OR = 1.29 (.35 to 4.7), p = .701

OR = 3.5 (0.87 to 14.1), p = .077

OR = 0.47 (.10 to 2.04) p = .312

OR = 22.4 (0.31 to 1626.5), p = 0.155

7-day point prevalent abstinence rates

PP = 22.7% (n = 22) ITT = 27.3%

PP = 4.4% (n = 23) ITT = 5.9%

PP = 58.8% (n = 17) ITT = 30.3%

PP = 20.8% (n = 24) ITT = 14.7%

OR = 6.47 (.69 to 60.7), p = .102

OR = 6.0 (1.18 to 30.3), p = 0.030*

OR = 5.43 (1.37 to 21.6), p = .016*

OR = 2.52 (0.76 to 8.41), p = 0.132

OR = 7.2 (1.10 to 47.3), p = .040*

Other outcomes:

Quit attempts (any = 1, none = 0)

PP = 50% (n = 22) ITT = 42.4%

PP = 39.1% (n = 23) ITT = 29.4%

PP = 70.6% (n = 17) ITT = 36.4%

PP = 41.7% (n = 24) ITT = 29.4%

OR = 1.56 (.48 to 5.08), p = .464

OR = 1.77 (.64 to 4.86), p = .269

OR = 3.36 (.90 to 12.6), p = .072

OR = 1.37 (.49 to 3.81), p = .545

OR = 2.1 (.89 to 5.0), p = .089

Receipt of professional quit advice

PP = 40% (n = 20) ITT = 24.4%

PP = 27.3% (n = 22) ITT = 17.7%

PP = 46.7% (n = 15) ITT = 21.2%

PP = 42.1% (n = 19) ITT = 23.5%

OR = 1.78 (.48 to 6.5), p = .384

OR = 1.49 (.46 to 4.9), p = 0.508

OR = 1.2 (.31 to 4.7), p = .790

OR = 0.875 (0.28 to 2.77), p = .820

OR = 1.56 (.52 to 4.7), p = .429

  1. *p < .05; Inter = intervention group; ITT = intention to treat analysis (denominator is 33 and 34 respectively for intervention and usual care – see Fig. 1); PP = per protocol analysis (denominator changes due to missing data for each outcome)