| Experimental Study Design |
Controlled study |
RCT |
Pre-Post |
Controlled study |
Pilot RCT |
2 Pilot RCTs |
RCT |
RCT |
Pre-Post |
RCT |
| Score/27 (%) (Downs & Black, 1998) |
11 (40.7) |
16 (59.3%) |
10 (37%) |
19 (70.4%) |
17 (62.9%) |
17 (62.9%) |
24 (88.9%) |
22 (81.5%) |
16 (59.3%) |
23 (85.2%) |
| Reporting |
Hypothesis/aim/objective |
Yes |
No |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| Clear description of- |
Main outcomes to be measured |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
|
Patient characteristics |
No explicit exclusion criteria |
No explicit exclusion criteria |
No explicit exclusion criteria |
No explicit exclusion criteria |
No explicit exclusion criteria |
No explicit exclusion criteria |
Yes |
Yes |
Yes |
Yes |
|
Intervention |
Yes |
No |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
|
Distribution of principal confounders |
No |
No |
No |
Yes |
Yes |
No |
Yes |
Yes |
Yes |
Yes |
|
Main findings |
No data for subject rank |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
|
Estimates of random variability in data for main outcomes |
Not reported |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
|
All adverse events |
No |
No |
No |
No |
No |
No |
No |
No |
Yes |
No |
|
Characteristics of patients lost to followup |
Not reported |
Yes |
Not reported |
Not reported |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
|
Actual probability values reported |
Yes |
Yes |
No |
No |
Yes |
Yes |
Yes |
Yes |
Not reported |
Yes |
| External Validity |
Subjects approached representative of entire population |
Unable to determine |
Yes |
Unable to determine |
Yes |
Unable to determine |
Yes |
Yes |
Unable to determine |
Unable to determine |
Yes |
|
Participants representative of entire population |
Unable to determine |
Unable to determine |
Unable to determine |
Unable to determine |
Unable to determine |
Unable to determine |
Yes |
Unable to determine |
Unable to determine |
Yes |
|
Staff and facilities representative of treatment usually received |
Yes |
Yes |
Yes |
Yes |
No |
Yes |
Yes |
Yes |
Yes |
Yes |
| Internal validity |
Subjects blinded to intervention |
No |
No |
No |
No |
No |
No |
No |
No |
No |
Yes |
| (bias) |
Measurers of main outcomes blinded |
No |
Yes |
No |
No |
No |
No |
Yes |
Yes |
No |
Yes |
|
Unplanned analyses reported |
No unplanned analyses |
Yes |
No unplanned analyses |
Yes |
No unplanned analyses |
Yes |
No unplanned analyses |
No unplanned analyses |
No unplanned analyses |
No unplanned analyses |
|
Adjustment of different lengths of follow-up |
Same time period for follow up |
Same time period for follow up |
Same time period for follow up |
Same time period for follow up |
Same time period for follow up |
Same time period for follow up |
Yes |
Same time period for follow up |
Same time period for follow up |
Same time period for follow up |
|
Appropriate statistical tests to assess main outcomes |
Yes |
Yes |
Unable to determine |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
|
Reliable compliance with intervention |
Unable to determine |
Yes |
Yes |
Yes |
Unable to determine |
Yes |
Yes |
Yes |
Yes |
Unable to determine |
|
Accurate outcome measures (valid and reliable) |
Yes |
Yes |
Yes |
Yes |
Yes |
Main outcome valid and reliable. Additional measures not outlined in method. |
Yes |
Yes |
Yes |
Yes |
| Internal validity (confounds) |
Recruitment of intervention and control from same population |
Yes |
Yes |
No control group |
Yes |
Yes |
Yes |
Yes |
Yes |
No control group |
Yes |
|
Recruitment over same period of time for control and intervention |
Yes |
Yes |
No control group |
Yes |
Yes |
Yes |
Yes |
Yes |
No control group |
No- quasi random by month |
|
Randomisation to groups |
Unable to determine |
No- alternate allocation |
No |
Yes |
No- quasi random by intervention |
Study 1- unable to determine; Study 2- randomised by session |
Yes- block randomised stratified for site, derived from computer program |
Yes- randomised to intervention or control by throw of dice |
Not randomised |
No- quasi random: 1 month intervention then 1 month control |
|
Concealment of randomisation |
Unable to determine |
No |
Not randomised |
No |
No |
No |
Concealed from staff, not patients |
Concealed from staff, not patients |
Not randomised |
Yes |
|
Adjustment for confounding |
No |
No |
No |
Yes |
No statistically significant differences between groups regarding number of times in hospital or age. |
Yes |
Yes |
Yes |
No |
No significant differences between groups |
|
Loss of patients to follow up taken into account |
No |
Yes |
No |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
