| Methods |
Same trial as Thomas 2002a, but results are presented as two subanalyses because there was one group of patients randomised to placebo or no treatment (see above), and another group randomised to telephone contact, exercise and placebo versus telephone contact and exercise. |
| Participants |
See Thomas 2002a
|
| Interventions |
Placebo: dolomite (calcium and magnesium) twice weekly for two years
Untreated: no tablets
Experimental: see Thomas 2002a
(Co‐intervention: exercise and telephone contact) |
| Outcomes |
See Thomas 2002a
|
| Notes |
See Thomas 2002a
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'computer generated lists in permuted blocks of 10, stratified by sex and age' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (home based exercise/placebo) |
| Blinding?
Outcome assessor |
Unclear risk |
Patient reported outcome (interviewer was blinded) |
| Incomplete outcome data addressed?
All outcomes |
High risk |
|
| Free of selective reporting? |
High risk |
No protocol available. Results not presented for placebo and no‐treatment, but authors provided additional data. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 233 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
|
