Table 3.

Evaluation of trial quality

Quality Index items	Imamura et al. (1998)	Tillu and Gupta (1998)	Perez Millan and Foster (2001)
Reporting
1. Study hypothesis/aim/objective	1	1	1
2. Main outcomes	1	1	1
3. Characteristics of the participants	0	0	0
4. Interventions of interest	0	1	0
5. Distributions of principal confounders in each group	0	0	0
6. Main findings	0	1	1
7. Estimates of random variability for main outcomes	1	0	1
8. All the important adverse events that may be a consequence of intervention	0	0	0
9. Characteristics of patients lost to follow-up	0	1	1
10. Actual probability values for main outcomes	0	1	0
External validity
11. Were subjects who were asked to participate representative of the entire population from which they were recruited?	1	1	0
12. Were subjects who were prepared to participate representative of the entire population from which they were recruited?	0	0	0
13. Were the staff, places, and facilities representative of the treatment the majority of subjects received?	1	0	1
Internal validity (bias)
14. Was an attempt made to blind subjects to the intervention they received?	0	0	0
15. Was an attempt made to blind those measuring main outcomes of the intervention?	0	0	0
16. If any of the results of the study were based on"data dredging", was this made clear?	0	1	1
17. Do analyses adjust for different lengths of follow-up?	0	1	1
18. Were appropriate statistical tests used to assess the main outcomes?	1	1	1
19. Was compliance with the intervention reliable?	1	1	1
20. Were main outcome measures reliable and valid?	0	0	0
Internal validity (selection bias)
21. Were patients in different intervention groups recruited from the same population?	0	0	0
22. Were subjects in different intervention groups recruited over the same period of time?	0	0	0
23. Were subjects randomized to intervention groups?	0	0	0
24. Was the randomized intervention assignment concealed from both patients and staff until recruitment was complete and irrevocable?	0	0	0
* 25. Was there adequate adjustment for confounding in the analyses from which main findings were drawn?	x	x	x
26. Were losses of subjects to follow-up taken into account?	0	1	1
Power
* 27. Did the study have sufficient power to detect a clinically important effect where the probability for a difference due to chance was less than 5%?	x	x	x
Total score (/27)	7	12	11

Instructions for use

For Q 1-9 one point is allocated for Yes and zero points for No.

For Q 5 two points are allocated for Yes, one point for Partially and zero points for No.

For Q 10 two points are allocated for Yes, one point for Partially and zero points for No.

For Q 11-27 one point is allocated for Yes, zero points for No and zero points for Unable to Determine.

* Item removed.