Table 1 Quality assessment (Based on Moncrieff et al., 2001)

(1) Objectives and specification

main outcomes a priori

0 = objectives unclear

1 = objectives clear but main outcomes not specified a priori

2 = objectives clear with a priori specification of main method

for assessment of outcome

(2) Adequate sample size (n per group)

0 = inadequate (< 50/group)

1 = moderate (50-100/group)

2 = large (> 100/group or justified by power calculations)

(3) Appropriate duration of trial including follow up

0 = too short (< 3 months)

1 = reasonable length (3-6 months)

2 = long enough for assessment of long term outcomes (6-12 months)

(4) Power calculation

0 = not reported

1 = mentioned without details

2 = details of calculations provided

(5) Method of allocation

0 = unrandomized and likely to be biased

1 = partially or quasi randomized with some bias possible

2 = randomized allocation

(6) Concealment of allocation

0 = not done or not reported

2 = concealment of allocation code detailed

(7) Clear description of treatments (including doses of drugs used) and adjunctive treatments

0 = main treatments not clearly described

1 = inadequate details of main or adjunctive treatments

2 = full details of main and adjunctive treatments

(8) Blinding of subjects

0 = not done

1 = done but no test of blind

2 = done and integrity of blind tested

(9) Source of subjects described and representative sample recruitment

0 = source of subjects not described

1 = source of subjects given but no information on sampling or use

of unrepresentative sample (for example, volunteers)

2 = source of subjects described plus representative sample taken

(for example, all consecutive admissions or referrals, or random

sample taken)

(10) Use of diagnostic criteria (or clear specification of inclusion criteria)

0 = none

1 = diagnostic criteria or clear inclusion criteria

2 = diagnostic criteria plus specification of severity

(11) Record of exclusion criteria and number of exclusions and refusals reported

0 = criteria and number not reported

1 = criteria or number of exclusions and refusals not reported

2 = criteria and number of exclusions and refusals reported

(12) Description of sample demographics

0 = little/no information (only age/sex)

1 = basic details (for example, marital status/ethnicity)

2 = full description (for example, socioeconomic status,

clinical history)

(13) Blinding of assessor

0 = not done

1 = done but no test of blind

2 = done and integrity of blind tested

(14) Record of number and reasons for withdrawal by group

0 = no info on withdrawals by group

1 = withdrawals by group reported without reason

2 = withdrawals and reason by group

(15) Outcome measures described clearly (and therefore replicable) or use of validated (or referenced) instruments

0 = main outcomes not described clearly

1 = some of main outcomes not clearly described 2 = main outcomes clearly described or valid and reliable

instruments used

(16) Information on comparability and adjustment

for differences in analysis

0 = no information on comparability

1 = some information on comparability with appropriate

adjustment

2 = sufficient information on comparability with appropriate adjustment

(17) Inclusion of all subjects in analyses (Intention to treat analysis)

0 = no

2 = yes

(18) Presentation of results with inclusion of data forre-analysis of main outcomes (for example, SDs)

0 = little information presented

1 = adequate information

2 = comprehensive

(19) Appropriate statistical analysis (including correction for multiple tests where applicable)

0 = inadequate

1 = adequate

2 = comprehensive and appropriate

(20) Conclusions justified

0 = no

1 = partially

2 = yes

(21) Declaration of interests (for example, 0 = no

source of funding)

0 = no

2 = yes