Methods | RCT Accrual: 2002 to 2005 Setting: tertiary centre Follow‐up: 60 months |
|
Participants | 110 participants (59 men and 51 women) curatively operated on for colorectal cancer Country: Sweden Setting: hospital |
|
Interventions | Experimental arm: surgeon‐led follow‐up Control arm: nurse‐led follow‐up |
|
Outcomes |
|
|
Notes | A nurse and surgeon performed follow‐up in the same way: 6 monthly visits for 3 years, then annually up to 5 years. Symptom enquiry occurred at each visit (bloods and CEA as indicated) Abdomen US and CXR (replaced by CT in latter half of the study) at 1 and 3 years If "clean" colon was established preoperatively, colonoscopy at 5 years |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomization to nurse (ES) or surgeon (KS) was performed using closed envelopes in blocks of four." Comment: the paper reported no more details, so we judged this domain to be at unclear risk of bias. |
Allocation concealment (selection bias) | Unclear risk | The stoma therapist (IN) provided written and verbal information and conducted the randomisation. We judged this domain to be at unclear risk of bias. |
Blinding of participants and personnel | Low risk | The study did not mention blinding of participants and personnel; it was probably not done, but unlikely to have introduced bias. |
Blinding of outcome assessment | Low risk | The study did not mention blinding of outcome assessment, but it was unlikely to have been done. |
Incomplete outcome data (attrition and exclusions) | Unclear risk | Quote (page 1001): "All patients completed the questionnaires." Comment: the paper reports that there was no attrition. Quote (page 1001): "One hundred and thirteen (113) consecutive patients were asked to participate in the study. Of these, three patients refused to participate, 56 were allocated to surgeon follow‐up and 54 to nurse‐led follow‐up." Comment: it is not clear if these were postrandomisation or prerandomisation exclusions. |
Selective reporting (reporting bias) | Unclear risk |
Outcomes prespecified
Actually reported
As we did not have access to the study protocol, we judged this domain to be at unclear risk of bias. |
Other sources of bias | Unclear risk | We detected no other bias. |