Wattchow 2006.
Methods | RCT; Unit of allocation: Patient | |
Participants | Patients having had surgery for colon cancer with histologic grade Dukes stage A, B or C (cases of disseminated cancer were excluded) and having completed post‐surgical chemotherapy. Setting / country: Hospitals in South Australia, Victoria, Western Australia and Northern Territory / Australia Type of cancer: Colorectal Phase of care: Surveillance Sample size at randomisation: 203 |
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Interventions | Follow‐up by general practitioners (GPs): Follow‐up guidance, based on current clinical practice and guidance was provided, and inserted into the patients GP records. The recommended follow‐up regimen (over 5 years) comprised: review of the patient 3 monthly for the first 2 years postoperatively and then 6 monthly for the next 3 years; patient history; physical examination; diagnostic tests. In accordance with the study pragmatic design, there was no compulsion for clinicians in either setting to adhere to the guidance. Participating clinicians received regular study information from contact with the study researcher and a newsletter. Patients could be referred back to surgical clinics at any point. Control: Follow‐up by surgeons: Follow‐up guidance concerning timing of physical exams and diagnostic tests (based on current clinical practice and guidance) was provided and inserted in surgeon/hospital record. The recommended follow‐up regimen (over 5 years) comprised: review of the patient 3 monthly for the first 2 years postoperatively and then 6 monthly for the next 3 years; patient history; physical examination; diagnostic tests. In accordance with the study's pragmatic design, there was no compulsion for clinicians to adhere to the guidance. Participating clinicians received regular study information from contact with the study researcher and a newsletter. Patients could consult their GP at any point. |
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Outcomes | Patient: QoL, anxiety and depression (distress), satisfaction, number and time to detection of recurrences, death rate Process: Number and type of investigations |
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Notes | Length of follow‐up: 24 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Consenting patients were then randomly allocated to either GP‐led or surgeon‐led follow‐up using an Excel random number generator. Randomisation was conducted by the study researchers, who were not involved in the design of the study or the clinical care of the patients, and was concealed until the interventions were assigned. The study was single‐blinded. Researchers at all times were unaware of the patient allocation until after the randomisation process." |
Allocation concealment (selection bias) | Low risk | See quote first item. |
Blinding (performance bias and detection bias) All outcomes | High risk | Self‐report questionnaires were used, and patients could not be blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: Proportions of patients who completed follow‐up were similar in the control (76%) and intervention groups (78%). The reasons for attrition were equivalent for deaths, but other reasons for withdrawal are not mentioned. Because non‐parametric analyses were used, it is not possible to evaluate if missing values could have had an impact on intervention effect estimate. |
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 | Quote: "Comparisons adjusting for baseline values were undertaken using analysis of covariance on ranks." Comment: According to table 3, the two groups were similar at baseline for the two outcome measures; no significant difference was observed in unadjusted or adjusted data for baseline values. In addition, analysis were adjusted for baseline differences. |
Baseline characteristics similar? | Low risk | Quote: "Table 2 shows the characteristics of the trial participants at baseline. Of patients, 70% were recruited in SA. Groups had similar characteristics with the exception of education, where there was a trend towards higher levels of education in the surgeon follow‐up group. To examine external validity of our sample we compared age, sex and Dukes staging with SA Cancer Registry data (Cancer Council of SA, 2001) (included in Table 2) using Chi2‐tests. Study participants did not differ significantly compared with registry patients with respect to gender (P = 0.53) and Dukes staging (P = 0.12), but had a slightly narrower age distribution (P = 0.05)." Comment : Education likely unaffected study results. |
Protected against contamination? | High risk | Quote: "Patients allocated to 'GP‐led' follow‐up could be referred back to surgical clinics at any point in the study; similarly, patients in the 'surgeon‐led' follow‐up group could consult their GP at any time during the course of the study. Comment: Patients from the 2 groups were followed generally in different settings, but a possibility for contamination existed. |