Partridge 2017.
Study characteristics | ||
Methods | Design: RCT Date of study: Nov 2012 to Feb 2014 Power calculation: yes, Assuming 80% power and a two‐sided significance level of 5%, a total sample size of 198 patients was required (99 per group). Attrition rates were expected to be negligible from previous observational work that showed no dropouts10; the target sample size was inflated (by 5%) to 208. Inclusion criteria: patients aged at least 65 years scheduled for elective endovascular/open aortic aneurysm repair or lower‐limb arterial bypass surgery. Exclusion criteria: admitted directly to the ward from the surgical clinic or emergency department for emergency or very urgent surgery, which precluded the opportunity for outpatient preoperative assessment and optimisation. |
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Participants | Sample size: 209 Country: UK Setting: teaching hospital with a tertiary referral practice for vascular arterial surgery Age: mean age 75.5 (SD = 6.6) in intervention, Mean age 75.5 (SD = 6.3) Sex: males, 80 (76.9%) in intervention, males, 79 (75.2%) in control Co‐morbidity: there were some differences between the randomised groups in relation to CVD (C: 21 of 100 (21⋅0) versus I: 10 (9⋅6), falls C: 10(9.5) versus I: 26 of 100 (26.0) Dementia: 2 (1.9%) in intervention, 5 (4.8) in control Frailty: not reported |
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Interventions | Intervention: comprehensive geriatric assessment and optimisation in an outpatient clinic setting. Patients were assessed and optimised according to peer‐reviewed protocols based on current evidence, national and hospital guidelines, and expert opinion. Control: the control group received standard preoperative care. Within the participating centre, this consisted of a nurse led preoperative assessment clinic where a protocolised appraisal of anaesthetic and medical issues was conducted. |
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Outcomes | Outcomes reported: ‐Incident delirium using CAM ‐Inpatient mortality (not explicit included as outcome but data reported in study flow chart) ‐Length of hospital admission ‐Withdrawal ‐Readmission to hospital within 30 days of discharge (unplanned 30‐day readmission) ‐Falls Outcomes from study not reported: None Frequency of outcomes assessment: recorded routinely by hospital staff |
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Notes | Funding source: Research Into Ageing–Age UK–British Geriatrics Society grant (reference 366) and the Guy’s and St Thomas’ Charity (EFT120610). Declarations of interest:No conflicts of interest Delirium is not excluded at enrolment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Internet‐based randomisation using a 1:1 allocation and stratified according to sex and site of surgical procedure |
Allocation concealment (selection bias) | Low risk | Performed independently by the King’s Clinical Trials Unit |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded due to nature of the intervention. Those providing their postoperative care were unaware of the patient’s involvement in study, however they had access to individualised care plans generated as part of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes were recorded by an unblinded research nurse using data collected by the routine clinical teams. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Primary outcome data missing for significant proportion of those randomised. Figures in CONSORT diagram do not account for all individuals from allocation to analysis. |
Selective reporting (reporting bias) | Low risk | Outcomes reported as per ISRCTN protocol, retrospectively registered. |
Other bias | Low risk | No evidence of other bias |