Johansson 1999.
Methods | RCT; Unit of allocation: Patient; Stratified by: Diagnosis, stage of disease | |
Participants | Patients newly diagnosed with breast cancer or under examination for a suspected breast cancer or diagnosed with colorectal, gastric or prostate cancer. Setting / country: Primary healthcare services in Uppsala county / Sweden Type of cancer: Gastric, breast, prostate, colorectal Phase of care: Any phase Sample size at randomisation: 527 |
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Interventions | (1) Individual support (IS) by intensified primary healthcare services (IPC): Each patient was referred by project staff to ordinary home‐care nurse. Patients GP was informed of cancer diagnosis and of referral to home‐care nurse. The home‐care nurse contacted the patient and suggested follow‐up contacts during the period of primary treatment and rehabilitation or palliative care. GP and home‐care nurse received copies of medical record each time patient was discharged from hospital, or at each visit to specialist clinics. Education and supervision in cancer care was also provided for general practitioners and home‐care nurses (12 seminars). Home‐care nurses were offered supervision by an oncology team (dietitian, psychologist, physiotherapist, urotherapist, specialist nurse). The supervision aimed to support the nurse in dealing with patient problems. A further aim was to ensure that the nurse was informed about the patient's diagnosis, treatments, impairments, etc. The nurses were invited to participate in open supervision groups regularly. An oncology nurse led the groups and was assisted by members of the oncology team. In total, 55 supervision meetings were arranged during the project period. Nurses who did not participate in the supervision meetings were regularly contacted by telephone. All home‐care nurses also had the possibility to contact the oncology team as needed. The individual support intervention comprised psychological support and nutritional support for patients with GI cancer. (2) Group rehabilitation (R) a group intervention starting approximately 3 months after diagnosis; (3) Combination of (1) and (2) Control: Standard care (SC) |
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Outcomes | Process: Situation about continuing/discontinuing contact with the home‐care nurse 6 months after diagnosis, number of follow‐up contacts with home‐care nurse, psychologist and/or dietician, utilization of inpatient specialist care | |
Notes | Length of follow‐up: 6 or 3 (group Rehabilitation only) months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from ref #2: "Patients were randomised (computer‐generated allocation schedule) to one of four alternatives: (1) individual support (IS), starting at diagnosis; (2) group rehabilitation (GR), starting 3 months after diagnosis; (3) a combination of individual support and group rehabilitation (ISGR), and (4) standard care (SC)." |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: Only reported objective measures will be included in the reviewed so there are no outcome assessors. Patients' satisfaction was evaluated with a questionnaire that was not validated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote from reference #1: "100 patients (19%) failed to complete the measures (Figure 1). Comparisons between these patients and those who are included in the present analysis shows that the former group has a higher mean age (69 vs. 65 years.) and a larger portion of patients with advanced disease (40% vs. 18%). However, these patients are equally distributed between the comparison groups (controls, n = 52 vs. IPC, n = 48)." Comment: Similar proportions of missing data and reasons for attrition in control group (79%) and individual support intervention group (84%). Only subjects that completed the study were analysed (no imputation was used). |
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 | Comment: Outcomes could not be assessed at baseline (use of services). |
Baseline characteristics similar? | Low risk | Quote from ref #1: "Table 1 summarizes the demographic and medical characteristics of the patients included in the present analysis. There were no statistically significant differences (chi‐square test) between patient's randomised to IPC and patients randomised to controls regarding these variables." |
Protected against contamination? | Unclear risk | The intensified primary care program seems to have been done by a different group of healthcare professionals than the standard care program, so contamination seems unlikely, but no details were provided by the authors on this issue. |