Kinley 2001.
| Methods | Multicentre RCT based in three centres including three university hospitals and one district general hospital in the UK. Designed as an equivalence/non‐inferiority trial Trial ran from April 1998 to March 1999 |
|
| Participants | 1907 participants attending for assessment before general anaesthesia for general, vascular, urological or breast surgery. Excluded if unable to understand trial. No age restriction. 1874 participants completed evaluation Mean age: nurse 56.9 years; non‐specialist doctor 56.8 years % female: nurse 48.0%; non‐specialist doctor 49.2% |
|
| Interventions | Trial took place at 354 routine preoperative assessment clinics, and participants were randomly assigned to either nurse or non‐specialist doctor. After this assessment, one of two specialist registrars in anaesthesia examined each participant and compared his or her results with those of the nurse or house officer. Under‐assessments then evaluated by consultant, who could revise the assessment 954 participants randomly assigned to nurse assessment, of which 948 completed the trial. Nurse training included anatomy, physical examination and test ordering modules of Master's course. Supervised by mentor, who approved a learning logbook at the end of training. One‐month pilot run to establish basic level of experience in clinical setting. Three nurses took part in the trial 953 participant randomly assigned to non‐specialist doctor (first year after qualification) assessment, of which 926 completed the trial. Preregistration house officers, who received no additional training in preoperative assessment, except that given in medical school education. Numerous different non‐specialist doctors took part. |
|
| Outcomes | Under‐assessment of history taking, physical examination or tests ordered possibly affecting management Over‐assessment of test ordered Qualitative assessment of participant satisfaction based on postoperative interviews with 42 participants and a focus group with six participants. Participants not sampled randomly Costs modelled on the basis of estimate of time of assessment, training tests ordered and costs of extra tests/delays Costs and participant satisfaction are the only relevant outcomes for this systematic review |
|
| Notes | Statement indicates no conflicts of interest. Study funding from Health Technology Assessment programme | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block randomized (four participants in each block) separately at each of three centres |
| Allocation concealment (selection bias) | Low risk | Opaque sealed consecutively numbered envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Staff and participants were aware of allocations. No standard forms? |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Specialist registrar and consultant aware of allocation when reviewing preoperative assessment notes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up greater in non‐specialist doctor group (27/953) but < 3% loss |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
| Other bias | Low risk | |