Wells 2004.
Methods | RCT; Unit of allocation: Patient; Stratified by: Breast operation | |
Participants | Patients with breast cancer requiring axillary clearance surgery (level 1, 2, and 3). Setting / country: Teaching hospital / UK Type of cancer: Breast Phase of care: Discharge, treatment, pre‐treatment, surveillance Sample size at randomisation: 108 patients and 86 carers |
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Interventions | Nurse‐led early discharge after surgery: discharge was done within 36 h of surgery, with wound drains still in situ. The essential components of the nurse‐led model of care were: (a) preoperative assessment, information and education about wound drain care and recognizing complications; (b) preoperative liaison with primary care (in particular community nurses) to negotiate postoperative involvement; (c) faxed discharge summary to primary healthcare team; (d) patients held records and care protocols to be shared with primary care staff; (e) joint home visit by designated breast care nurse and community nurse (if available) the day after discharge from hospital; (f) daily telephone assessment by breast care nurse until day after drain removal, including systematic assessment of symptoms, wound drainage and condition of wound; (g) negotiated home visits by breast care nurse or community nurse depending on needs; (h) removal of wound drain when 24 h drainage < 50 ml or at 5 days post‐operation; (i) 24 h access to breast care nurse via mobile phone, during supported early discharge period; (j) hospital review by breast care nurse for seroma aspiration, discussion of any problems or concerns. Control: Conventional hospital stay following surgery until wound drains were removed (approximately 6 days). |
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Outcomes | Patient: QoL, arm morbidity, satisfaction, wound healing, nursing dependency Informal carer: Carer burden Process: Use of home care and community services, hospital stay duration, surgical cancellations |
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Notes | Length of follow‐up: 12 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A central telephone service provided by the Scottish Cancer Therapy Network Trials Office randomised consenting patients using a block randomisation technique." Quote from author email: "The research nurse telephoned the SCTN randomisation hotline and provided details of whether the participant was scheduled for a mastectomy or wide local excision (our stratification factors). SCTN then used a computerised block randomisation technique and allocated the participant to one of 2 groups. This allocation was then provided to the research nurse. Neither the research nurse nor the patient could be blinded to the allocation, because it was obvious whether the patient was discharged the day after surgery or not. However, the randomisation process itself was not influenced in any way by the research nurse or the research team." |
Allocation concealment (selection bias) | Low risk | See quote first item. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "Owing to the nature of the intervention, it was not possible to blind participants, researchers or staff involved". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportion of completed questionnaires and patient attrition are similar between groups presented in Figure 1. |
Selective reporting (reporting bias) | Low risk | All outcomes described in Methods are reported in Results. |
Other bias | Low risk | No evidence of any other bias. |
Baseline outcomes similar? | Low risk | Baseline outcomes are presented in Table 1 and are not different between treatment groups. |
Baseline characteristics similar? | Low risk | Quote: "Baseline characteristics of patients (n = 108) and carers (n = 86) were similar for both groups (Table 1)." |
Protected against contamination? | High risk | Comment: Patients were the unit randomised. From what is presented in the paper, the breast care nurse seem to be available to both groups of patients, so a risk of contamination from this provider is cannot be ruled out. |