Bonnema 1998.
Methods | RCT; Unit of allocation: Patient | |
Participants | Women with operable breast cancer (stage I or II) eligible for modified radical mastectomy or lumpectomy with axillary dissection. Setting / country: General hospital and cancer clinic at a university hospital in Rotterdam / Netherlands Type of cancer: Breast Phase of care: Discharge, Surveillance Sample size at randomisation: 139 |
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Interventions | An early discharge protocol was developed to guarantee continuity of care. Discharge was performed on the morning of day 4 after surgery. The protocol included structured patient education provided by the breast cancer nurse and also available in written form, referral to a community health nurse, provision of an emergency telephone number, the scheduling of follow‐up visits, and an information letter being sent to the general practitioner. Drain removal was performed at home or in the outpatient clinic. Control: Long stay after surgery: usually 9‐12 days. Drain was removed before discharge. |
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Outcomes | Patient: Complications, uncertainty, state and trait anxiety, object anxiety, loneliness, depression, sleep disturbance, feeling of loss of control, self‐esteem, cancer locus of control, symptoms, communication about the disease Process: Length of hospital stay |
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Notes | Length of follow‐up: 4 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A randomisation list was prepared by the statistician (PIMS) using a program for the generation of random numbers and assignment into two groups with a prespecified size of blocks. The size of the blocks (8 patients) was not known by the investigators, and no stratification was applied. The randomisation list was accessible only to the data managers of the central trial office at the Daniel den Hoed Cancer Center. The patient was informed of her diagnosis, treatment plan, and the design of the study by her surgeon. The patient's home situation was subsequently assessed by a breast cancer nurse. Surgeons telephoned the trial office to discover each eligible patient's randomisation before admission." |
Allocation concealment (selection bias) | Low risk | See quote first item. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quotes: "Clinical study end points were recorded in the diaries and patients' files by the doctors and nurses." "Three questionnaires were used to assess psychosocial variables and record demographic characteristics. The first was distributed at admission and completed the same day; the second questionnaire was distributed 1 month after surgery, and the third 3 months later, during outpatient visits." Comment: Complications were recorded by nurses and doctors who could not have been blinded to patient experimental group. Psychosocial variable seem to have been collected via self‐report questionnaires. Because the patient could not have been blinded then the assessors could not be blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: There are some missing data in the Table 1 presenting complications, with only results from 120 of the initial 125 patients presented. No details are given on numbers allocated in each groups or in number or reasons for loss of follow‐up. |
Selective reporting (reporting bias) | Low risk | All outcomes in the methods section are reported in the results section. |
Other bias | Low risk | No evidence of other bias. |
Baseline outcomes similar? | High risk | Quote: "Before surgery short stay patients scored higher than long stay patients on scales measuring depression (score 10.3 v 8.9, P = 0.03; minimum score 6, maximum score 24)."
"A shorter stay in hospital seemed to influence the extent to which the disease could be discussed within the patient's family. Before surgery there were no differences between the two groups, but at 1 and 4 months after surgery short stay patients were more likely to discuss their disease with their family ..." Comment: Score "NO" for Depression Score "UNCLEAR" for all other psychosocial variables. Score "Yes" for Communication about the disease and Complication and use of hospital services could not possibly be assessed at baseline. |
Baseline characteristics similar? | Low risk | Quote: "The two groups were comparable in tumour stage, type of treatment, age, marital status, family income, and educational level (data available on the internet at www.bmj.com)." |
Protected against contamination? | Low risk | Quote from ref #1: "Women randomised to short stay treatment were discharged on the morning of the fourth day after surgery, with the axillary drain in situ. Women randomised to long stay treatment were discharged after their drain had been removed." Comment: Because of the nature of the intervention, it is impossible that a patient from the controlled group received the intervention. |