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Turner 2012[27]
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Randomised using a random computer sequence generation (√)
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No information (?)
|
Attempted blinding as ALL patients received mailed brochures about heart disease.
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Clinical outcomes (changes in 4 year CHD risk, systolic and diastolic blood pressure) assessors were blinded (√)
|
85% completed blood pressure assessment and 69% completed CHD risk assessment. No difference between groups. More withdrawals in intervention group (20/136 v 13/144). Multiple imputation for all missing values (√)
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No protocol, description of clinical assessments correspond to outcomes (X)
|
|
No self report outcomes (√)
|
|
Walker 2011[28]
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Randomised using a random computer sequence generation (√)
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No information (?)
|
Attempted blinding as ALL patients received mailed brochures about heart disease. Self report outcomes used (X)
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No blinding (X)
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87% completed outcomes assessments at 12 months. No difference between groups. More withdrawals in control group (3/264 v 2/262). Multiple imputation for all missing values (√)
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No protocol, description of clinical assessments correspond to outcomes (X)
|
|
Outcomes self-report by telephone. Physiological measures completed using the ‘dry-dot methodology’ involving patient mailing sample to the lab (?)
|
|
Heisler 2010[33]
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Randomised using a random sequence generation (√)
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Centrally (√)
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Blinded patients, research staff and care managers at baseline. Intervention was described as a comparison of 2 diabetes self-management support models to participants. Not clear after baseline (X)
|
Only data assessors were blinded (X)
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89% completed HbA1c assessments and 95% completed survey assessments, no differences between groups, justification is provided (√)
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No protocol, description of measures orresponds to outcomes (X)
|
|
Dale 2009[9]
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No details about sequence generation – states randomised only (?)
|
Opaque sealed envelopes (X)
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Attempted blinding as ALL patients received one telephone call (X)
|
Outcomes self report by post (?)
|
91% follow up at 6 months (93.3%, 86.4% and 91.8% overall) no reasons given (?)
|
Protocol reported diabetes self care activities measure which was not reported in the main trial (X)
|
|
Physiological measures assessed blinded to group (√)
|
|
Samuel-Hodge 2009[32]
|
Cluster randomised. Computer generated random number (√)
|
Sequentially numbered sealed envelopes (X)
|
No blinding, self report outcome (X)
|
HbA1c measures masked to study group (√)
|
87% follow up at 8 months, 85% at 12 months, no difference between groups, more withdrawals in intervention group (6/102 v 1/72) (√)
|
No protocol, insufficient information (?)
|
|
Physical activity not clear (?)
|
|
FFQ and other psychosocial outcomes by telephone, masked to study group but not clear if it could have been broken (?)
|
|
Parry 2009[34]
|
Internet based randomisation service (√)
|
Central (√)
|
No blinding, self report outcome (X)
|
Researchers blinded to group allocation, self reported outcomes, but not clear if could have been broken (?)
|
Follow up 94% at 8 weeks, no difference between groups, reasons given (√)
|
No protocol, insufficient information (?)
|
|
Batik 2008[30]
|
Non random assignment of late new participants to control group (X)
|
No information (?)
|
No blinding, self report outcome (X)
|
Outcomes self-report (?)
|
No data reported on follow up (?)
|
No protocol, insufficient information (?)
|
|
Physiological measures (?)
|
|
Carroll 2007[31]
|
No details about sequence generation, states randomised only (?)
|
No information (?)
|
No blinding, self report outcome (X)
|
Outcomes self-report via telephone (?)
|
18.6% attrition, no reasons given (?)
|
No protocol, insufficient information (?)
|
|
Young 2005[35]
|
Post-recruitment block randomisation, stratified by baseline HbA1c using SAS software (√)
|
Randomise intervention to control in a ratio of 2:1 (√)
|
No information (?)
|
No information (?)
|
8.2% lost at follow-up, justification is provided, intention to treat analyses (√)
|
No information (?)
|
|
Keyserling 2002[29]
|
Randomised using random numbers generated using a personal computer (√)
|
Consequently numbered sealed envelopes containing study group assignments (X)
|
No blinding, self report outcome (X)
|
Clinicians were informed of participants group assignment, no more information is provided (X)
|
88% and 84% of participants completed the 6th and 12th month follow-up, no differences between groups, justification is provided (√)
|
Protocol includes self-care, but no outcomes are reported (X)
|
