Box 2002.

Methods	Parallel group randomised controlled trial, stratification by surgical procedure (complete local excision or modified radical mastectomy).
Participants	Patients treated surgically for breast cancer (all stages except advanced disease), complete local excision or modified radical mastectomy, including ALND. Mean age (SD) 56 (10.6)
Interventions	Intervention Group (n = 32) Physiotherapy Management Care Plan (PMCP). PMCP includes preoperative individual risk assessment, identification of possible risk factors, education on the lymphatic system, education about early signs of lymphoedema and introduction of risk‐minimisation strategies for identified precipitating factors in the preoperative phase. Postoperatively, outpatient reviews are scheduled (monitoring of shoulder ROM, progression of exercise, provision of LO awareness, individualised intervention if required). Control Group (n = 33) No physiotherapy.
Outcomes	Primary outcomes: Lymphoedema defined by three criteria (each was evaluated separately): 1. Increase of 5 cm or more from preoperative sum of circumferences of the arm, operated arm vs non‐operated side; 2. Increase of 200 mL or more from preoperative total arm volume difference between the operated and non‐operated side. 3. Multifrequency Bioelectrical Impedance Measurement: A MFBIA ratio of the arm operated side and non‐operated side lower than 95% confidence interval from preoperative data; or a 10% change from baseline in the ratio of operated arm to unoperated arm. Secondary outcomes: Range of motion (goniometer) for shoulder flexion, abduction, extension and rotations; Non‐validated functional tasks questionnaire.
Follow up	1, 3, 6, 12 months
Country, setting	Australia, University Hospital
Year of conduct	1996 to 1999
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random number table.
Allocation concealment (selection bias)	High risk	Chronological recruitment with allocation from random number table, without attempts at blinding.
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Medical and nursing staff were blinded for group allocation, participants were not. Contamination seems unlikely due to the nature of the intervention.
Blinding of outcome assessment (detection bias) Measured outcomes	High risk	Outcome measurements were taken by a blinded PT for “as many women as possible”; it is unclear in how many cases this was actually the case.
Incomplete outcome data (attrition bias) Objective outcomes	Low risk	There is a 9% loss to follow‐up, for reasons unrelated to the outcome.
Selective reporting (reporting bias)	Low risk	All outcomes mentioned in the methods sections are reported.
Other bias	Unclear risk	Women in the treatment group on average had more lymph nodes removed (16 vs 13 nodes), more often had level 2 (81% vs 64%) or 3 (16% vs 9%) axillary dissection, and more often had radiotherapy (66% vs 49%). No sensitivity analysis or adjusted analysis were performed due to the low number of events. Analyses on shoulder function measurements were adjusted for age, number of removed lymph nodes, level of ALND, history of shoulder problems, radiotherapy, chemotherapy and wound infection.