Key characteristics of studies in vascular surgery (n=4)
| First author name | Year | Country | Primary or secondary aim | Sample (N=number of patients in analysis/eligible patients, Nt(i)=sample size per time point, Nc=patients with complications, N1=cases vs N2=controls) | Patient inclusion criteria | Study design | Type of surgery | Surgical complications/method of recording | Psychosocial outcome and time points | Significant association of complications with well-being (Yes/No/Confounding) | Types of complications and time-points of significant effects | Quality assessment score (out of 8) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lohse | 2009 | Germany | Secondary | N=110/124 Nc=? | Consecutive patients who received a replacement of the dilated ascending aorta | Observational, cross-sectional | Ascending aorta replacement | Retrospective list: postoperative bleeding, myocardial infarction, stroke, pneumonia, respiratory insufficiency, acute renal dysfunction, sepsis, lung fistula/method not specified | QoL/36.4±15.5 months postoperative (11–58 months)/SF-36 | NO | NA | 4 |
| Nguyena | 2007 | USA and Canada | Primary | Nt1=1296/1404 Nt2=862 Nt3=732 Nc=543 | Patients who underwent lower extremity vein bypass for CLI in community and university hospitals across the US and Canada | Observational, cohort, prospective | Lower extremity vein bypass for limb salvage in CLI patients | Wound complications (WC): patients having infection, necrosis, hematoma-haemorrhage, or seroma-lymphocele at the surgical incision or harvest site within 30 days of the bypass surgery/Adverse events clinical trial documentation with reference to source documentation (hospital notes etc.) | QoL/baseline, 3 and 12 months postoperative/VascuQol | Confounding* | Wound complications/3 months postsurgery | 8 |
| Nguyenb | 2006 | USA and Canada | Secondary | N1=1296/1404 (92.3%) N2=862 (61.4%) N3=732 (52.1%) Nc=? | Patients who underwent IB for CLI in community and university hospitals across the USA and Canada | Observational, cohort, prospective | Infrainguinal vein grafting for limb salvage in patients with CLI | GREs: development of a >70% graft stenosis or having undergone a percutaneous or surgical revision or a major amputation/clinical tests (angiography, ultrasonography, etc), source documentation (hospital notes, discharge notes, operative and procedural notes, etc) | QoL/preoperative, 3 and 12 months postoperative/VascuQol | Yes* | GREs/12 months postsurgery | 8 |
| Subramonia | 2005 | UK | Primary | Nt1=70/70 Nt2=59 Nt3=62 Nc(sensory abnormalities)=25 Nc(bruising at t1)=58 Nc(bruising at t2)=16 | Patients with varicose veins, either symptomatic or with skin changes, resulting from incompetence of the lesser saphenous vein system (LSV) as confirmed by handheld Doppler examination or duplex ultrasonography or both and requiring surgical intervention (both day cases and inpatients) | Observational, cohort, prospective | Conventional LSV stripping |
| QoL/preoperative, discharge and 6 weeks postoperative/Aberdeen Varicose Vein Questionnaire 2 | No* | NA | 7 |
*Study controlled for patients’ preoperative well-being.
CLI, critical limb ischaemia; GRE, graft-related event; NA, not available; QoL, quality of life; VascuQol, a validated instrument assessing pain, symptoms, activities, social life and emotional state in patients with vascular disease.