Barth 1991.
Methods | RCT | |
Participants | 70 patients with type 2 diabetes mellitus ‐ randomised (intervention 38 vs control 32) Baseline risk for foot ulceration: PVD, intervention 19 vs control 6. Number of foot problems: 'no significant difference between groups' Baseline outcome measures: 'No significant difference between groups' Study setting: secondary outpatient care, outpatient clinic in Australia Inclusion criteria: people with type 2 diabetes mellitus > 3 months and current treatment > 1 month, sub optimal glucose control, BMI ≥ 25, energy fat intake at least 35%, no education in previous 6 months, competence in English language | |
Interventions | Intervention group:
Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear
4 weekly group patient education sessions of 1.5 to 2.5 hours (total 9 hours), 3 by podiatrist, 1 by psychologist on the base of cognitive motivation theory. Content: recommendations and foot care education and demonstration and practicing foot care procedures Control group: Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear Adherence: not described |
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Outcomes | Primary outcomes: not reported Secondary outcomes: foot care knowledge, behaviour assessment score, foot problems requiring treatment | |
Duration and completion of follow‐up | 6 months; 62 people completed follow‐up (intervention 33 vs control 29) | |
Types of assessment | Outcomes measured by multiple choice questions on knowledge and compliance. Number of questions and range of outcomes not reported | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) Blinding of outcome assessors | Low risk | Foot care knowledge and foot care routine compliance were assessed with a questionnaire using multiple choice answers. Foot problems were scored by an independent podiatrist, who was not aware of the patients' experimental conditions |
Incomplete outcome data (attrition bias) All outcomes | High risk | 62 of 70 people completed 6 months' follow‐up (intervention 33 vs control 29). Reasons for missing outcome data are described and are unlikely to be related to the outcome No ITT analyses were undertaken |
Selective reporting (reporting bias) | Low risk | No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section |
Other bias | High risk | Baseline risk for foot ulceration: PVD, intervention 19 vs control 6 (P < 0.05)
Number of foot problems: 'No significant difference between groups' Co‐interventions were not described Adherence to the intervention was not described |