Zuleika Saz-Parkinson

Meta-analysis of percutaneous radiofrequency ablation versus ethanol injection in hepatocellular carcinoma

BackgroundPercutaneous radiofrequency ablation (RFA) has gained popularity in the treatment of hepatocellular carcinoma (HCC). However, its role versus other conventional minimally invasive therapies is still a matter of debate. The purpose of this work is to analyse the efficacy and safety of RFA versus that of ethanol injection (PEI), the percutaneous standard approach to treat nonsurgical HCC.MethodsSystematic review and meta-analysis of randomised or quasi-randomised controlled trials published up to August 2008 in PubMed, ISI Web of Science and The Cochrane Library. Overall survival, local recurrence rate and adverse effects were considered as primary outcomes. Studies were critically appraised and estimates of effect were calculated according to the random-effects model. Inconsistency across studies was evaluated using the I2 statistic. Sensitivity analyses were conducted to explore statistical heterogeneity.ResultsSix studies were eligible. The studies reported data on 396 patients treated by RFA and 391 treated by PEI. In general, subjects were in Child-Pugh class A (74%) and had unresectable HCC (mean size 2.5 cm). Mean follow-up was 25 ± 11 months. The survival rate showed a significant benefit for RFA over PEI at one, two, three and four years. The advantage in survival increased with time with Relative Risk values of: 1.28 (95%CI:1.12–1.45) and 1.24 (95%CI:1.05–1.48) for RFA versus PEI at 3- and 4-years respectively. Likewise, RFA achieved significantly lower rates of local recurrence (RR: 0.37, 95%CI: 0.23–0.59). The overall rate of adverse events was higher with RFA (RR:2.55, 95%CI: 1.8–3.6) yet no significant differences were found concerning major complications (RR:1.85, 95%CI: 0.68–5.01). There was not enough evidence supporting a better cost-effectiveness ratio for RFA compared to PEI.ConclusionAvailable evidence from adequate quality controlled studies support the superiority of RFA versus PEI, in terms of better survival and local control of the disease, for the treatment of patients with relatively preserved liver function and early-stage non-surgical HCC. However, the higher rate of adverse events displayed is something that will have to be tested with appropriate weighting of the possible benefits in each individual case. Overall cost-effectiveness of RFA needs further evaluation.

Is Europe putting theory into practice? A qualitative study of the level of self-management support in chronic care management approaches

BackgroundSelf-management support is a key component of effective chronic care management, yet in practice appears to be the least implemented and most challenging. This study explores whether and how self-management support is integrated into chronic care approaches in 13 European countries. In addition, it investigates the level of and barriers to implementation of support strategies in health care practice.MethodsWe conducted a review among the 13 participating countries, based on a common data template informed by the Chronic Care Model. Key informants presented a sample of representative chronic care approaches and related self-management support strategies. The cross-country review was complemented by a Dutch case study of health professionals’ views on the implementation of self-management support in practice.ResultsSelf-management support for chronically ill patients remains relatively underdeveloped in Europe. Similarities between countries exist mostly in involved providers (nurses) and settings (primary care). Differences prevail in mode and format of support, and materials used. Support activities focus primarily on patients’ medical and behavioral management, and less on emotional management. According to Dutch providers, self-management support is not (yet) an integral part of daily practice; implementation is hampered by barriers related to, among others, funding, IT and medical culture.ConclusionsAlthough collaborative care for chronic conditions is becoming more important in European health systems, adequate self-management support for patients with chronic disease is far from accomplished in most countries. There is a need for better understanding of how we can encourage both patients and health care providers to engage in productive interactions in daily chronic care practice, which can improve health and social outcomes.

Balloon kyphoplasty in malignant spinal fractures: a systematic review and meta-analysis.

BackgroundSpinal fractures are a common source of morbidity in cancer patients. Balloon Kyphoplasty (BKP) is a minimally invasive procedure designed to stabilize fractures and correct vertebral deformities. We performed a meta-analysis to determine the efficacy and safety of BKP for spinal fractures in cancer patients.MethodsWe searched several electronic databases up to September 2008 and the reference lists of relevant publications for studies reporting on BKP in patients with spinal fractures secondary to osteolytic metastasis and multiple myeloma. Outcomes sought included pain relief, functional capacity, quality of life, vertebral height, kyphotic angle and adverse events. Studies were assessed for methodological bias, and estimates of effect were calculated using a random-effects model. Potential reasons for heterogeneity were explored.ResultsThe literature search revealed seven relevant studies published from 2003 to 2008, none of which were randomized trials. Analysis of those studies indicated that BKP resulted in less pain and better functional outcomes, and that these effects were maintained up to 2 years post-procedure. While BKP also improved early vertebral height loss and spinal deformity, these effects were not long-term. No serious procedure-related complications were described. Clinically asymptomatic cement leakage occurred in 6% of all treated levels, and new vertebral fractures in 10% of patients. While there is a lack of studies comparing BKP to other interventions, some data suggested that BKP provided similar pain relief as vertebroplasty and a lower cement leakage rate.ConclusionIt appears that there is level III evidence showing BKP is a well-tolerated, relatively safe and effective technique that provides early pain relief and improved functional outcomes in patients with painful neoplastic spinal fractures. BKP also provided long-term benefits in terms of pain and disability. However, the methodological quality of the original studies prevents definitive conclusions being drawn. Further investigation into the use of BKP for spinal fractures in cancer patients is warranted.

Epidemiology and recent trends of severe sepsis in Spain: a nationwide population-based analysis (2006-2011)

BackgroundAlthough severe sepsis constitutes an important burden for healthcare systems, there is limited nationwide data on its epidemiology in European countries. Our objective was to examine the most recent epidemiological characteristics and trends of severe sepsis in Spain, from a population perspective.MethodsAnalysis of the 2006-2011 National Hospital Discharge Registry. Cases were identified by combining specific ICD-9CM codes. We estimated demographics, clinical characteristics and outcomes and calculated age- and sex- adjusted estimations of incidence and mortality rates. Trends were assessed in terms of annual percent change (APC) in rates using joinpoint regression analysis.ResultsOver the 6-year period we identified 240939 cases of severe sepsis nationwide representing 1.1% of all hospitalisations and 54% of hospitalisations with sepsis. Incidence was 87 cases per 100,000 population. Overall 58% of cases were men, 66% were over the age of 65 and about 67% had associated comorbidities. Bacteremia was coded in 16% of records. Almost 54% of cases had one organ dysfunction, 26% two and around 20% three or more dysfunctions. In-hospital case-fatality was 43% and associated with age, gender, comorbidities and organ dysfunctions, among others. We found significant demographic and clinical changes over time with an increase in the mean age of cases, comorbidities, number of organ dysfunctions and in the number of cases with gram-negative pathogens. Furthermore, even with gender disparities, standardised incidence and mortality rates increased with an overall APC of 8.6% (95% CI 5.1, 12.1) and 6% (95% CI 1.9, 10.3), respectively. Conversely, we detect a significant decrease in case-fatality rates with an overall APC of -3.24% (95% CI: -4.2, -2.2).ConclusionsThis nationwide population-based study shows that hospitalizations with severe sepsis are frequent and associated with substantial in-hospital mortality in Spain. Furthermore it indicates that the incidence and mortality rates of severe sepsis have notably increased in recent years, showing also a significant increase in the age and severity of the affected population. Despite this, there has been a significant decreasing trend in case-fatality rates over time. This information has significant implications for health-care system planning and may prove useful to estimate future care requirements.

Reported barriers to evaluation in chronic care: Experiences in six European countries.

INTRODUCTION The growing movement of innovative approaches to chronic disease management in Europe has not been matched by a corresponding effort to evaluate them. This paper discusses challenges to evaluation of chronic disease management as reported by experts in six European countries. METHODS We conducted 42 semi-structured interviews with key informants from Austria, Denmark, France, Germany, The Netherlands and Spain involved in decision-making and implementation of chronic disease management approaches. Interviews were complemented by a survey on approaches to chronic disease management in each country. Finally two project teams (France and the Netherlands) conducted in-depth case studies on various aspects of chronic care evaluation. RESULTS We identified three common challenges to evaluation of chronic disease management approaches: (1) a lack of evaluation culture and related shortage of capacity; (2) reluctance of payers or providers to engage in evaluation and (3) practical challenges around data and the heterogeity of IT infrastructure. The ability to evaluate chronic disease management interventions is influenced by contextual and cultural factors. CONCLUSIONS This study contributes to our understanding of some of the most common underlying barriers to chronic care evaluation by highlighting the views and experiences of stakeholders and experts in six European countries. Overcoming the cultural, political and structural barriers to evaluation should be driven by payers and providers, for example by building in incentives such as feedback on performance, aligning financial incentives with programme objectives, collectively participating in designing an appropriate framework for evaluation, and making data use and accessibility consistent with data protection policies.

Approach to the epidemiology of venomous bites in Spain.

This review presents a geographic distribution of the three autochthonous venomous snake species, which are the only viperids present in Spain, among the Iberian fauna: Vipera aspid; Vipera seoianei and Vipera latasti. This is followed by a detailed descriptive analysis of hospital care provided to patients admitted into hospital due to venomous bites, in the period from 1997 to 2009, using the data from the Spanish hospital discharge registry database. This analysis reveals that in Spain, during this period, 1649 cases were recorded, which means that hospital care was required for more than one hundred cases per year, of which nearly 1% of the cases resulted in death. Cases were recorded in all the Autonomous communities, but more than half (54, 14%) were concentrated in the following four regions: Cataluña, Castilla and León, Galicia and Andalucía. It is notable that this concentration of cases is not associated only with the population demographics of the community, but is also the result of the concurrence of very diverse factors of exposure including: habitat of venomous fauna, volume of rural population, farming activities, and practice of outdoor leisure activities. We also carried out a gross economic calculation for the use of hospital resources by each snakebite case requiring hospital care in Spain, which provided us with an approximate figure of 2000€ per case.

Epidemiology of snakebite in Europe: comparison of data from the literature and case reporting.

A better assessment of the incidence and mortality due to envenomation should improve the antivenom supply and consequently management of snakebites. Currently, in most countries, notification of snakebite is insufficient and irregular. An alternative is to consider data from the literature to estimate the incidence and mortality. The gaps and bias resulting from this method can be corrected using a meta-analytic model adjusted with a randomized coefficient, which provides an average incidence and mortality taking into account the relative weight and representativeness of each sample. The aim of the present study is to compare the results of the application of the meta-analytic model with the national notifications of snakebites in different European countries. To achieve this goal, a questionnaire was sent to health services of all European countries asking for the incidence, mortality and some parameters defining the population at risk of snakebites in Europe. Notifications were compared with the results of a recently published meta-analysis of literature data. Results showed an acceptable agreement, although significant differences in the incidence of snakebites occurred in some countries. The discussion emphasizes the limitations regarding notifications and underlines the potential biases that restrict the reliability of data from the literature. Finally, pending reliable notification of snakebites in all European countries, analyzing data from the literature is likely to be an acceptable and simple solution.

Evaluating chronic disease management in real-world settings in six European countries: Lessons from the collaborative DISMEVAL project

Objective To describe the interventions, research methods and main findings of the international DISMEVAL project, in which the “real-world” impact of exemplary European disease management approaches was investigated in six countries using advanced analytic techniques. Design Across countries, the project captured a wide range of disease management strategies and settings; approaches to evaluation varied per country, but included, among others, difference-in-differences analysis and regression discontinuity analysis. Setting Austria, Denmark, France, Germany, The Netherlands, and Spain. Participants Health care providers and/or statutory insurance funds providing routine data from their disease management interventions, mostly retrospectively. Intervention(s) This study did not carry out an intervention but evaluated the impact of existing disease management interventions implemented in European care settings. Main outcome measure(s) Outcome measures were largely dependent on available routine data, but could concern health care structures, processes, and outcomes. Results Data covering 10 to 36 months were gathered concerning more than 154,000 patients with three conditions. The analyses demonstrated considerable positive effects of disease management on process quality (Austria, Germany), but no more than moderate improvements in intermediate health outcomes (Austria, France, Netherlands, Spain) or disease progression (Denmark) in intervention patients, where possible compared with a matched control group. Conclusions Assessing the “real-world” impact of chronic disease management remains a challenge. In settings where randomization is not possible and/or desirable, routine health care performance data can provide a valuable resource for practice-based evaluations using advanced analytic techniques.

Outcomes of new quality standards of follitropin alfa on ovarian stimulation: meta-analysis of previous studies.

BackgroundHuman follicle-stimulating hormone (hFSH; follitropin alfa) can be employed therapeutically to induce ovarian follicular development in assisted reproduction treatments. Current recombinant hFSH (r-hFSH) preparations available for clinical use are labeled either in terms of the bioactivity expressed in international units (IU) or in mass (μg). Several clinical trials have tried to assess the clinical implications of the physicochemical improvements in the dosing of follitropin alfa filled by mass (FbM). The aim of this study was to perform a meta-analysis of previous studies in order to assess the efficacy and safety of ovarian stimulation using follitropin alfa FbM compared with follitropin alfa filled by international units (FbIU).MethodsA literature search was carried out in scientific databases to find published articles and abstracts comparing both hormone preparations. A fixed effects model meta-analysis was performed. The variables studied include the average dose (IU), days of treatment, estradiol peak, follicles >14 mm, number of extracted oocytes, number of embryos obtained, number of cases of ovarian hyperstimulation syndrome (OHSS), and clinical pregnancies.ResultsA total of six studies met the stated criteria and were included in the meta-analysis. In these studies, the average r-hFSH dose per patient was 230.29 IU less with administration of follitropin alfa FbM compared with FbIU, and the number of days of treatment was reduced by 0.48. In addition, a significantly greater number of oocytes (0.84) were extracted, more embryos (0.88) were obtained, and a higher peak level of estradiol (613.08 pmol/L) was achieved in the patients undergoing ovarian stimulation with follitropin alfa FbM. However, no statistically significant differences were observed in the number of follicles >14 mm, clinical pregnancies, or OHSS cases.ConclusionFollitropin alfa FbM, a technologically modified formulation of r-hFSH, is as safe as follitropin alfa FbIU but requires a smaller dose over a shorter period to produce more oocytes and final embryos.

Projeto e validação de um questionário de saúde oral para avaliação pré‐anestésica no pré‐operatório☆

BACKGROUND AND OBJECTIVES Dental injuries incurred during endotracheal intubation are more frequent in patients with previous oral pathology. The study objectives were to develop an oral health questionnaire for preanaesthesia evaluation, easy to apply for personnel without special dental training; and establish a cut-off value for detecting persons with poor oral health. METHODS Validation study of a self-administered questionnaire, designed according to a literature review and an expert groups recommendations. The questionnaire was applied to a sample of patients evaluated in a preanaesthesia consultation. Rasch analysis of the questionnaire psychometric properties included viability, acceptability, content validity and reliability of the scale. RESULTS The sample included 115 individuals, 50.4% of men, with a median age of 58 years (range: 38-71). The final analysis of 11 items presented a Person Separation Index of 0.861 and good adjustment of data to the Rasch model. The scale was unidimensional and its items were not biased by sex, age or nationality. The oral health linear measure presented good construct validity. The cut-off value was set at 52 points. CONCLUSIONS The questionnaire showed sufficient psychometric properties to be considered a reliable tool, valid for measuring the state of oral health in preoperative anaesthetic evaluations.