A systematic review of economic evaluations assessing interventions aimed at preventing or treating pressure ulcers.

BACKGROUND: Pressure ulcers have an adverse impact on patients and can also result in additional costs and workload for healthcare providers. Interventions to prevent pressure ulcers are focused on identifying at risk patients and using systems such as mattresses and turning to relieve pressure. Treatments for pressure ulcers are directed towards promoting wound healing and symptom relief. Both prevention and treatments have associated costs for healthcare providers. The aim of this study was to systematically review the economic evidence for prevention and treatment interventions for pressure ulcers. DESIGN: A systematic review of comparative clinical studies that evaluate interventions to either prevent or treat pressure ulcers. DATA SOURCES: Searches of the major electronic databases were conducted to identify citations that reported costs or economic analysis for interventions directed towards prevention or treatment of pressure ulcers. Only comparative clinical studies were included. Review articles, case-series, non-randomised studies, and studies in a foreign language that did not have an abstract in English were excluded from the review. REVIEW METHODS: Decisions regarding inclusion or exclusion were based on a consensus of the authors after review of the title or abstract. Potential citations were obtained for more detailed review and assessed against the inclusion criteria. The studies identified for inclusion were assessed against the 24 key criteria contained in the CHEERS checklist. Costs were standardised to US dollars and adjusted for inflation to 2012 rates. RESULTS: The searches identified 105 potential studies. After review of the citations a total of 23 studies were included: 12 examined prevention interventions and 11 treatments. Review against the CHEERS criteria showed that the majority of included trials had poor reporting and a lack of detail regarding how costs were calculated. Few studies reported more than aggregate costs of treatments with only a small number reporting unit cost outcomes. CONCLUSIONS: Existing evidence was poor in regard to the economic evaluation of interventions for the prevention and treatment of pressure ulcers. Much of the published literature had poor reporting quality when compared to guidelines which provide key criteria for studies to adequately examine costs within an economic analysis.

Endovascular repair of abdominal aortic aneurysm.

BACKGROUND: An abnormal dilatation of the abdominal aorta is referred to as an abdominal aortic aneurysm (AAA). Due to the risk of rupture, surgical repair is offered electively to individuals with aneurysms greater than 5.5 cm in size. Traditionally, conventional open surgical repair (OSR) was considered the first choice approach. However, over the past two decades endovascular aneurysm repair (EVAR) has gained popularity as a treatment option. This article intends to review the role of EVAR in the management of elective AAA. OBJECTIVES: To assess the effectiveness of EVAR versus conventional OSR in individuals with AAA considered fit for surgery, and EVAR versus best medical care in those considered unfit for surgery. This was determined by the effect on short, intermediate and long-term mortality, endograft related complications, re-intervention rates and major complications. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (January 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 12). The TSC also searched trial databases for details of ongoing or unpublished studies. SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) comparing EVAR with OSR in individuals with AAA considered fit for surgery. and comparing EVAR with best medical care in individuals considered unfit for surgery. We excluded studies with inadequate data or using an inadequate randomisation technique. DATA COLLECTION AND ANALYSIS: Three reviewers independently evaluated trials for appropriateness for inclusion and extracted data using pro forma designed by the Cochrane PVD Group. We assessed the quality of trials using The Cochrane Collaboration's 'Risk of bias' tool. We entered collected data in to Review Manager (version 5.2.3) for analysis. Where direct comparisons could be made, we determined odds ratios (OR). We tested studies for heterogeneity and, when present, we used a random-effects model; otherwise we used a fixed-effect model. We tabulated data that could not be collated. MAIN RESULTS: Four high-quality trials comparing EVAR with OSR (n = 2790) and one high-quality trial comparing EVAR with no intervention (n = 404) fulfilled the inclusion criteria. In individuals considered fit for surgery, a pooled analysis, including 1362 individuals randomised to EVAR and 1361 randomised to OSR, found short-term mortality (including 30-day or inhospital mortality, excluding deaths prior to intervention) with EVAR to be significantly lower than with OSR (1.4% versus 4.2%, OR 0.33, 95% confidence interval (CI) 0.20 to 0.55; P < 0.0001). Using intention-to-treat analysis (ITT) there was no significant difference in mortality at intermediate follow-up (up to four years from randomisation), with 221 (15.8%) and 237 (17%) deaths in the EVAR (n = 1393) and OSR (n = 1390) groups, respectively (OR 0.92, 95% CI 0.75 to 1.12; P = 0.40). There was also no significant difference in long-term mortality (beyond four years), with 464 (37.3%) deaths in the EVAR and 470 (37.8%) deaths in the OSR group (OR 0.98, 95% CI 0.83 to 1.15; P = 0.78). Similarly, there was no significant difference in aneurysm-related mortality between groups, either at the intermediate- or long-term follow up.Studies showed that both EVAR and OSR were associated with similar incidences of cardiac deaths (OR 1.14, 95% CI 0.86 to 1.52; P = 0.36) and fatal stroke rate (OR 0.81, 95% CI 0.42 to 1.55; P = 0.52). The long-term reintervention rate was significantly higher in the EVAR group than in the OSR group (OR 1.98, 95% CI 1.12 to 3.51; P = 0.02; I(2) = 85%). Results of the reintervention analysis should be interpreted with caution due to significant heterogeneity. Operative complications, health-related quality of life and sexual dysfunction were generally comparable between the EVAR and OSR groups. However, there was a slightly higher incidence of pulmonary complications in the OSR group compared with the EVAR group (OR 0.36, 95% CI 0.17 to 0.75; P = 0.006).In individuals considered unfit for conventional OSR, the one included trial found no difference between the EVAR and no-intervention groups with regard to all-cause mortality at final follow up, with 21.0 deaths per 100 person-years in the EVAR group and 22.1 deaths per 100 person years in the no-intervention group (adjusted hazard ratio (HR) with EVAR 0.99, 95% CI 0.78 to 1.27; P = 0.97). Aneurysm-related deaths were, however, significantly higher in the no-intervention group than in the EVAR group (adjusted HR 0.53, 95% CI 0.32 to 0.89; P = 0.02). There was no difference in myocardial events (HR 1.07, 95% CI 0.60 to 1.91) between the groups in this study. AUTHORS' CONCLUSIONS: In individuals considered fit for conventional surgery, EVAR was associated with lower short-term mortality than OSR. However, this benefit from EVAR did not persist at the intermediate- and long-term follow ups. Individuals undergoing EVAR had a higher reintervention rate than those undergoing OSR. Most of the reinterventions undertaken following EVAR, however, were catheter-based interventions associated with low mortality. Operative complications, health-related quality of life and sexual dysfunction were generally comparable between EVAR and OSR. However, there was a slightly higher incidence of pulmonary complications in the OSR group than in the EVAR group.In individuals considered unfit for open surgery, the results of a single trial found no overall short- or long-term benefits of EVAR over no intervention with regard to all-cause mortality, but individuals may differ and individual preferences should always be taken into account.

Surgery for varicose veins: use of tourniquet.

BACKGROUND: Varicose vein surgery is a common surgical procedure but there is no consensus regarding the best surgical technique. The use of tourniquets during varicose vein surgery has been advocated as a means of reducing the potential for blood loss during the operation. OBJECTIVES: To identify whether the use of a tourniquet should be recommended when undertaking surgery for the management of primary varicose veins. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2013) and the CENTRAL (2013, Issue 3). SELECTION CRITERIA: All studies described as randomised controlled trials that examined the use of tourniquets during surgery for patients with primary varicose veins were included. DATA COLLECTION AND ANALYSIS: Data from eligible studies were extracted and summarised independently by two authors. All studies were cross-checked independently by the authors. MAIN RESULTS: No additional studies were included or excluded in the updated review. Twenty papers detailing 18 trials were considered. Only three trials were randomised controlled trials and were included in the review. The remaining fifteen studies were excluded for various reasons. All three included trials had a small sample size and reported the trial design, outcome measures and analysis poorly. There were also variations in the outcome measures used between the trials. In addition, there was no consistency on the reporting of mean and medians for blood loss during the operation. It was therefore not possible to pool the data to perform meta-analysis. However, the reported blood loss when using a tourniquet was between 0 and 16 ml compared to between 107 to 133 ml when not using a tourniquet (P < 0.01). AUTHORS' CONCLUSIONS: Although there were significant quality issues with the available evidence, the use of a tourniquet would appear to reduce blood loss during surgery. There were no reported differences between the use or non-use of a tourniquet in terms of complications and morbidity. However, the available trials were not of sufficient size to detect rarer complications such as nerve damage.

A systematic review of health-related quality of life instruments used for people with venous ulcers: an assessment of their suitability and psychometric properties.

AIMS AND OBJECTIVES: To review the quality of life questionnaires used to measure the impact of venous ulceration and to evaluate their psychometric properties. BACKGROUND: Venous leg ulcers have a negative impact on quality of life. Health-related quality of life can be measured using structured questionnaires. Nurses are the primary care providers for patients with venous ulceration and are ideally placed to assess and develop these types of questionnaires. There may also be an opportunity to use such quality of life instruments to measure the impact of nursing interventions in other areas where nurses are the key care providers. DESIGN: Systematic review. METHOD: Studies were sought that used quality of life instruments to evaluate the impact of venous ulceration. Fourteen electronic bibliographical databases and 11 Internet-based health services research related resources were searched. In addition, grey literature was sought and the reference lists of relevant articles checked. Data were extracted regarding the type of instrument used, sample, number of items and domains and psychometric performance of the instrument. RESULTS: The initial search identified a total of 338 potential citations. After review, a total of 31 studies were included: 17 used generic and 14 used disease-specific instruments. Five different types of generic and seven disease-specific instruments were identified. There was significant heterogeneity between the studies in terms of study design, aetiology of ulceration and times of assessment. The disease-specific instruments showed limitations in relation to their applicability to venous ulcer patients because of flaws in design or validation. CONCLUSIONS: The literature on quality of life related to venous ulceration failed to sufficiently distinguish between those with different causes of leg ulceration. There appeared to be problems with the ability of current quality of life instruments to detect changes in quality of life related to ulcer healing. Relevance to clinical practice. There appears to be an opportunity for nurses to develop a health-related quality of life health-related quality of life instruments to evaluate their impact on patient outcomes. Such instruments could potentially allow nursing interventions to be assessed more effectively than the recently proposed nursing metrics.

Impact of intravenous drug use on quality of life for patients with venous ulcers.

AIM: This paper is a report of a study to examine, from the perspective of patients, the impact of venous leg ulcers on health-related quality of life in current and former intravenous drug users and the general population. BACKGROUND: Venous ulceration can be caused by intravenous drug use. There has been little examination on how this affects the quality of life of this group of patients and how they compare with other patients who have venous ulcers. METHOD: A qualitative approach was adopted, using framework analysis. Semi-structured interviews with 19 participants who had a venous leg ulcer were conducted between August 2005 and February 2006. Interview audiotapes were analysed to identify recurring themes relating to the impact of venous leg ulcers on overall quality of life. FINDINGS: A complex interaction between symptoms, social restriction and attribution of illness influenced the impact of venous leg ulcers. Smell and pain were the symptoms that had the most profound impacts. In addition to the physical and psychological consequences, participants' activities and social interactions were restricted. Intravenous drug users experienced more social isolation and difficulties in accessing treatment for their venous ulcers. CONCLUSION: While leg ulcer services remain focused on the needs of older people, services for young intravenous drug users are unlikely to improve. A more coherent and earlier intervention, when the ulcers are not as difficult to treat, would decrease time and costs to the health service. The challenge is to find new ways of providing effective and accessible care to this growing population.