McClure 2010.
Methods | Design: single centre, RCT. Follow‐up: 2.5 week, 5 week and 3 months from baseline. | |
Participants | Major inclusion criteria: stage 1‐2 unilateral breast cancer related lymphoedema with ≥10% increased affected arm size compared with the unaffected arm, breast cancer surgery >3 months previously N = 21 (E: 10, C: 11) Mean age: E: 57.0 ± 2.9 years, C: 59.7 ± 2.1 years Stage of breast cancer: not reported |
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Interventions | E: physical (exercise) + education Exercise: group format, no information about intervention provider, 1 session per week of 60 minutes for 5 weeks, sessions included participation in the video of “From Lymphoedema Onto Wellness (exercise and relaxation programme)”, and the topics related to lymphoedema, coping and relaxation techniques, together with group discussion and hands‐on practice; self‐monitored home programme, daily practice of “From Lymphoedema Onto Wellness” and relaxation techniques for 3 months. Educational: written educational materials, topics included lymphedema, coping and relaxation techniques. C: usual care (to continue with the lymphoedema instructions from their medical team) |
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Outcomes | Quality of life: SF‐36 Others: BDI, Internally generated questionnaire for measuring adherence |
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Notes | BDI: Beck Depression Inventory, C: comparison, E: experimental, RCT: randomised controlled trial, SF‐36: Short Form (36) Health Survey. Dropouts or missing data where reported: Of the 32 participants entered into the study, 6 participants from experimental group and 5 subjects from control were excluded from analysis due to metastatic breast cancer, incomplete data collection or had lymphoedema < 10%. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation performed but method not described |
Allocation concealment (selection bias) | High risk | Although each participant opened a randomised, sealed, sequentially numbered envelope informing him or her of group status, the next allocation may be guessed by the screener as randomisation was done in groups of 8 with 4 in intervention and 4 in control |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were aware of group allocation. Study did not provide enough information to allow judgment as to whether personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants were aware of group allocation. Therapist was not aware of participant group status |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Of the 32 participants who entered the study, 11 were not included in analysis. Reasons for exclusion in intervention group are: metastatic breast cancer (1), did not continue past 2.5 weeks (3), L‐Dex scores and percentage swelling < 10 (2). Reasons for exclusion in control group are: triple bypass after baseline testing (1), L‐Dex scores and percentage swelling < 10 (4). No significant difference in participant characteristics for participants in primary analysis compared with those not included in primary analysis |
Selective reporting (reporting bias) | Unclear risk | Study protocol was not available. Study did not provide enough information to allow conclusion if all expected outcome measures were reported |
Other bias | High risk | Participation rate not described. Sampling bias likely present as non‐probability sampling used |