Thirty-day complications after laparoscopic or open cholecystectomy: a population-based cohort study in Italy.

OBJECTIVE: The objective of the study is to evaluate short-term complications after laparoscopic (LC) or open cholecystectomy (OC) in patients with gallstones by using linked hospital discharge data. DESIGN: Population-based cohort study. SETTING: Data were obtained from the Regional Hospital Discharge Registry Lazio Region in Central Italy (around 5 million inhabitants) in 2007-2008. PARTICIPANTS: All patients admitted to hospitals of Lazio with symptomatic gallstones (International Classification of disease, 9th Revision, Clinical Modification (ICD-9-CM)=574) who underwent LC (ICD-9-CM 51.23) or OC (ICD-9-CM 51.22). OUTCOME MEASURES: (1)'30-day surgical-related complications' defined as any complication of the biliary tract (including postoperative infection, haemorrhage or haematoma or seroma complicating a procedure, persistent postoperative fistula, perforation of bile duct and disruption of wound). (2) '30-day systemic complications' defined as any complications of other organs (including sepsis, infections from other organs, major cardiovascular events and selected adverse events). RESULTS: 13 651 patients were included; 86.1% had LC, 13.9% OC. 2.0% experienced surgical-related complications (SRC), 2.1% systemic complications (SC). The OR of complications after LC versus OC was 0.60 (p<0.001) for SRC and 0.52 (p<0.001) for SC. In relation to SRC, the advantage of LC was consistent across age categories, severity of gallstones and previous upper abdominal surgery, whereas there was no advantage among people with emergency admission (OR=0.94, p=0.764). For SC, no significant advantage of LC was seen among very old people (OR=0.99, p=0.975) and among those with previous upper abdominal surgery (OR=0.86, p=0.905). CONCLUSIONS: This large observational study confirms that LC is more effective than OC with respect to 30-day complications. Population-based linkage of administrative datasets can enlarge evidence of treatment benefits in clinical practice.

[Final results from four clinical studies in the field of cardiovascular diseases integrated in the "Mattoni del SSN - Mattone Outcome" Project]. / Le sperimentazioni dell'area cardiovascolare del Progetto Mattoni del SSN - Mattone Outcome: risultati finali. Sperimentazione dell'integrazione di fonti informative cliniche e amministrative del Programma PROGRESSI.

Observational outcome studies represent a valid approach to evaluating comparative treatment effectiveness in real populations. The main objective of outcome research is to underline what works and what does not work in the field of health assistance. In 2004 the Italian Ministry of Health launched the Project "Mattone Misura dell'Outcome" aimed at assessing the introduction of procedures and methods for the systematic evaluation of outcomes in the national health system. A new experience, the PROGRESSI program (PROGRamma ESiti per SIVeAS e LEA), started in 2008 with the aim to further develop the methodologies for outcome evaluation. In this Supplement the final results from four clinical studies named "Sperimentazioni dell'area cardiovascolare del Progetto Mattoni" are presented. These studies started between 2005 and 2007 and their main objectives were to evaluate: --the contribution of information from current informative systems and clinical studies in risk-adjustment methodologies; --the advisability of introducing some clinical items in current informative systems to improve outcome estimates; --the goodness of follow-up procedures from current informative systems; and --the role of disease registries in the validation of comparative evaluation measures. The four studies were designed as voluntary prospective multicentre studies. Results concerning the characteristics of the enrolled populations as well as the risk-adjustment models built using information from current informative systems and/or clinical information are presented. As expected, each study produced specific remarks both in terms of clinical findings and contribution of different informative systems to the risk-adjustment models. In general, models built with information from both current informative systems and clinical information show the best performance. Findings from these analyses will provide the public health system with suitable indications to improve statistical methodologies for outcome estimates.

Effects of socioeconomic position on 30-day mortality and wait for surgery after hip fracture.

OBJECTIVE: In countries where the National Health Service provides universal health coverage, socioeconomic position should not influence the quality of health care. We examined whether socioeconomic position plays a role in short-term mortality and waiting time for surgery after hip fracture. DESIGN: Retrospective cohort study. SETTING: and participants From the Hospital Information System database, we selected all patients, aged at least 65 years and admitted to acute care hospitals in Rome for a hip fracture between 1 January 2006 and 30 November 2007. The socioeconomic position of each individual was obtained using a city-specific index of socioeconomic variables based on the individual's census tract of residence. MAIN OUTCOME MEASURES: Three different outcomes were defined: waiting times for surgery, mortality within 30 days and intervention within 48 h of hospital arrival for hip fracture. We used a logistic regression to estimate 30-day mortality and a Cox proportional hazard model to calculate hazard ratios of intervention within 48 h. Median waiting times were estimated by adjusted Kaplan-Meyer curves. Analyses were adjusted for age, gender and coexisting medical conditions. RESULTS: Low socioeconomic level was significantly associated with higher risk of mortality [adjusted relative risk (RR) = 1.51; P < 0.05] and lower risk of early intervention (adjusted RR = 0.32; P < 0.001). Socioeconomic level had also an effect on waiting times within 30 days. CONCLUSIONS: Individuals living in disadvantaged census tracts had poorer prognoses and were less likely than more affluent people to be treated according to clinical guidelines despite universal healthcare coverage.

[Introduction to risk adjustment methods in comparative evaluation of outcomes]. / Introduzione ai metodi di risk adjustment nella valutazione comparativa degli esiti.

The increasing demand for comparative evaluation of outcomes requires the development and diffusion of epidemiologic research, the ability to correctly conduct analyses and to interpret results. When healthcare outcomes are used for comparing quality of care across providers, failure to use methods of risk adjustment to account for any variation in patient populations can lead to misinterpretation of the findings. The purpose of this paper is to provide a detailed but easy-reading review of different risk adjustment methodologies to compare health care outcomes. The paper is divided in two parts. Introduction describes the difference between experimental and observational studies, the role of confounding in observational studies and the ways confounding is identified and controlled (propensity adjustment and risk adjustment), Specific part on risk adjustment describes: (1) the methods for constructing the severity measures; (2) the methods that use the severity measures to obtain "adjusted" outcome measures for valid comparison between groups (stratified analysis, indirect and direct standardization); (3) identification and management of effect modification; (4) the methods to gain the precision of the estimates; (5) the risk adjustment methods used with multiple comparisons and (6) introduction to other models (multi-level models) used for risk adjustment. For policy makers and planners, epidemiologists and clinicians it is important to understand which factors can improve or worsen the effectiveness of treatments and services and to compare the performances of hospitals and healthcare providers. Decisions should be based on the validity and precision of study results, by using the best scientific knowledge available. The statistical methods described in this review cannot measure reality as it truly is, but can produce images of it, defining limits and uncertainties in terms of validity and precision. Since any risk-adjustment model used for comparative evaluation of outcomes must be time- and population-specific, only the studies that use credible risk adjustment strategies are more likely to yield reliable findings.

[Evidence-based emergency pathways for patients with acute coronary syndrome]. / Esperienze di reti regionali percorso clinico assistenziale in emergenza--sindromi coronariche acute.

We present an evidence-based diagnostic and therapeutic pathway for the treatment of subjects with suspected acute elevated ST-segment myocardial infarction (STEMI). The pathway was developed to aid the reorganization of the emergency service (ES) of the Lazio Region of Italy. Pathway development followed several phases: a) setting up of a multidisciplinary panel comprising all professional figures involved in the management of STEMI subjects; b) drafting of a list of important research questions with a particular focus on areas of clinical and organization uncertainty; c) systematic searches for relevant international scientific evidence to answer research questions; d) assessment, synthesis and classification of identified evidence according to the quality of evidence; e) formulation of management recommendations by their strength according to the methods used by the national guidelines program; f) presentation of draft findings and recommendations; g) external peer review of the draft document; h) editing the final version of the document. Our document identifies possible action scenarios (community, emergency room, major accident and emergency departments) and the following critical points: 1) quick diagnosis and individual risk definition; 2) rapid transmission of the electrocardiogram and vital parameters to the ES control center or to the competent coronary care unit (CCU) depending on where the event took place; 3) a direct link between the ES control center and the competent CCU; 4) the structuring of the regional CCU into a Hub & Spoke model; 5) electronic communication of data between ambulance, ES control center and the competent CCU. Our document also defines Hub regional reference centers and local Spoke centers. The pathway details roles and responsibilities of all players in the emergency chain for STEMI sufferers and critical points for the delivery of the pathway: regional programs on early warning, functions of relevant ES personnel and of emergency room physicians, efficiency of the electronic network and identification and organization of the regional Hub & Spoke network.