Surgical site infections in Italian Hospitals: a prospective multicenter study

Background  

Surgical site infections (SSI) remain a major clinical problem in terms of morbidity, mortality, and hospital costs. Nearly 60% of SSI diagnosis occur in the postdischarge period. However, literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence. A national prospective multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI, and the associated risk factors.     

The A1chieve study: a 60 000-person,global, prospective,observational study of basal,meal-time,and biphasic insulin analogs in daily clinical practice

While evidenced-based guidelines promote glycated hemoglobin (HbA1_c) targets <7.0% in order to reduce the long-term risk of diabetic complications, many individuals with type 2 diabetes do not achieve these targets. Fear of hypoglycemia provides a major barrier to improving blood glucose control as a result of delayed insulin initiation and failure to appropriately titrate insulin following initiation. Modern insulin analogs were designed to achieve improved blood glucose control with similar hypoglycemic risk compared with non-analog insulins (or similar blood glucose control with reduced hypoglycemic risk). While this has been demonstrated in randomized controlled trials, there is a need to confirm these findings in an everyday clinical setting. The A₁chieve study will evaluate adverse events and effectiveness of premix (biphasic insulin aspart 30 [NovoMix 30]), basal (insulin detemir [Levemir]), and meal-time (insulin aspart [NovoRapid]) insulin analogs in people with type 2 diabetes in near-routine clinical practice. A₁chieve is an international, prospective, multi-center, open-label, non-interventional, 24-week study of people with type 2 diabetes using an insulin analog. The study will recruit 60 000 people from 30 countries across four continents (Asia, Africa, South America, and Europe). The primary aim of the study is to assess the adverse event profile of the study insulins in routine clinical practice, including rates of hypoglycemia. In addition, effectiveness (HbA_1c, fasting plasma glucose, and postprandial plasma glucose) and patient quality of life outcomes will be measured. Comprehensive epidemiological data will be collected at baseline, including recent plasma glucose results and hypoglycemic episodes, prevalence of diabetes-related complications, and measures of current standards of care. Thus, A₁chieve should provide important information about how insulin analogs perform in daily clinical practice.     

Eosinophilia in rheumatologic diseases: a prospective study of 1000 cases

The role of eosinophilia in connective tissue diseases and the relationship between symptoms of rheumatic disease and eosinophilia have not been clearly established. The purpose of the present study was to explore the prevalence of eosinophilia in rheumatologic disease and determine its relationship to the symptoms. One thousand patients who applied to our rheumatology outpatient clinic between 2001 and 2002 were prospectively studied. The upper limit of normal blood eosinophil numbers was determined as 500 cells/µl of blood. A detailed history was obtained from all patients and careful physical examination was done. A negative correlation was observed between eosinophilia and dryness of the mouth, vitiligo, and fatigue (P<0.05). Nonsteroidal anti-inflammatory drug usage correlated positively with eosinophilia, which was also statistically meaningful (P<0.05). Twenty-six of our patients with fibromyalgia (n=293), three of our subjects with rheumatoid arthritis who were using methotrexate (n=182), 15 of whom who were not on methotrexate therapy, and one of the 26 with vasculitis had eosinophilia, which was not statistically significant (P>0.05). None of the patients with scleroderma (n=12) had eosinophilia. Eleven of the patients with gout had eosinophilia, and only one of them was using allopurinol. We conclude that eosinophilia can be seen in various rheumatologic conditions but, as corticosteroids are one of the most common medications used in collagen tissue diseases, the eosinophil numbers found may be lower than expected and eosinophilia may be more frequent than reported.     

Noninvasive ventilation initiation in clinical practice: A six-year prospective, observational study

BACKGROUND:

Despite evidence supporting the role of noninvasive ventilation (NIV) in diverse populations, few publications describe how NIV is used in clinical practice.

OBJECTIVE:

To describe NIV initiation in a teaching hospital that has a guideline, and to characterize temporal changes in NIV initiation over time.

METHODS:

A prospective, observational study of continuous positive airway pressure ventilation (CPAP) or bilevel NIV initiation from January 2000 to December 2005 was conducted. Registered respiratory therapists completed a one-page data collection form at NIV initiation.

RESULTS:

Over a six-year period, NIV was initiated in 623 unique patients (531 bilevel NIV, 92 CPAP). Compared with bilevel NIV, CPAP was initiated more often using a nasal interface, with a machine owned by the patient, and for chronic conditions, especially obstructive sleep apnea. Whereas CPAP was frequently initiated and continued on the wards, bilevel NIV was most frequently initiated and continued in the emergency department, intensive care unit and the coronary care unit. Patients initiated on bilevel NIV were more likely to be female (OR 1.8, 95% CI 1.08 to 2.85; P=0.02) and to have an acute indication compared with CPAP initiations (OR 7.5, 95% CI 1.61 to 34.41; P=0.01). Bilevel NIV was initiated more often in the emergency department than in the intensive care unit (OR 5.8, 95% CI 0.89 to 38.17; P=0.07). Bilevel NIV initiation increased from 2000 to 2005.

CONCLUSIONS:

The present study illustrates how NIV is used in clinical practice and confirms that NIV initiation has increased over time.     

Empirical use of antibiotics and adjustment of empirical antibiotic therapies in a university hospital: a prospective observational study

Background  

Several strategies to optimise the use of antibiotics have been developed. Most of these interventions can be classified as educational or restrictive. Restrictive measures are considered to be more effective, but the enforcement of these measures may be difficult and lead to conflicts with prescribers. Any intervention should be aimed at targets with the highest impact on antibiotic prescribing. The aim of the present study was to assess the adequacy of empirical and adjusted antibiotic therapies in a Swiss university hospital where no antibiotic use restrictions are enforced, and to identify risk factors for inadequate treatment and targets for intervention.     

Switch of protease inhibitor-containing HAART in routine clinical practice: a four-year prospective observational study

An evaluation was made of the frequency of outcomes, the features, and one-year outcomes of the substitution, carried out because of failure or toxicity, of protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART). Nine hundred and seventy-two HIV-infected patients were prospectively followed up since 1996, with the condition that they had a minimum 80% adherence to prescribed regimens. Four hundred and fifty-two changes occurred in 397 of the 876 evaluable patients (45.3%). Virological and/or immunological failure was of concern in 245 cases (54.2%). Interest in saquinavir had the greatest incidence and earliest occurrence (although the subsequent switch had a significantly better outcome than that of patients failing with other PIs); nelfinavir benefited from a shorter time to change and a worse long-term outcome (probably attributable to its predominant use in indinavir- and ritonavir-experienced patients); while indinavir showed the lowest overall frequency of substitution. Intolerance occurred in the remaining 207 cases (45.8%); with saquinavir being better tolerated than other PIs. A favourable outcome was obtained more frequently when poor tolerability was of concern, compared with therapeutic failure (P<0.008), while no significant differences were found according to prior antiretroviral experience and the subsequently selected HAART regimen. The overall one-year outcome per single substituted compound proved significantly better for patients who stopped using saquinavir and ritonavir, by contrast with those who stopped using indinavir and nelfinavir (P<0.0008). A significantly shorter mean time to substitution was recognized for nelfinavir and saquinavir than with ritonavir and indinavir (P<0.0001). When analysing the subset of patients experiencing HAART failure, a highly significant reverse relationship was demonstrated between mean time to failure, and rate of subsequent response to a modified antiretroviral regimen (P<0.0001). When considering the different patterns of efficacy, durability, resistance induction, expected adherence, and safety of each antiretroviral drug, initial and subsequent therapeutic choices should be carefully balanced against expected benefits and risks.     

Adherence to evidence-based therapies after discharge for acute coronary syndromes: an ongoing prospective, observational study

PURPOSE: To determine the rates of patient adherence to key evidence-based therapies at 6 months after hospital discharge for an acute coronary syndrome. METHODS: In this nonrandomized, prospective, multinational, multicenter study, adherence to aspirin, beta-blockers, statins, or angiotensin-converting enzyme (ACE) inhibitors 6 months after discharge for myocardial infarction or unstable angina was assessed in 21,408 patients aged 18 years or older. Patients were enrolled at 104 tertiary and community hospitals representing a broad range of care facilities and practice settings (e.g., teaching vs. nonteaching). RESULTS: Of 13,830 patients, discontinuation of therapy was observed at 6-month follow-up in 8% of those taking aspirin on discharge, 12% of those taking beta-blockers, 20% of those taking ACE inhibitors, and 13% of those taking statins. In a multivariate analysis, adherence to beta-blocker therapy was higher in patients with a myocardial infarction (odds ratio [OR] = 1.25; 95% confidence interval [CI]: 1.06 to 1.47), hypertension (OR = 1.33; 95% CI: 1.15 to 1.54), ST-segment elevation myocardial infarction (OR = 1.33; 95% CI: 1.11 to 1.61), or non-ST-segment elevation myocardial infarction (OR = 1.25; 95% CI: 1.08 to 1.45). Aspirin adherence was higher among patients cared for by cardiologists (OR = 1.45; 95% CI: 1.19 to 1.75; P <0.001) than among those cared for by nonspecialists. Male sex and prior heart failure were associated with improved adherence to ACE inhibitor therapy. Hypertension was associated with poorer adherence to statin therapy (OR = 0.85; 95% CI: 0.74 to 0.99; P = 0.04). CONCLUSION: Among patients prescribed key evidence-based medications at discharge, 8% to 20% were no longer taking their medication after 6 months. The reasons for noncompliance are complex, and may be elucidated by future studies of medical and social determinants.     

Outcome and quality of life of elderly critically ill patients: an Italian prospective observational study

The demand of critical care admissions to intensive care unit (ICU) is projected to rise in the next decade. The aim of this study was to evaluate short and long-term mortality and quality of life (QoL) of elderly patients (80 years and older) admitted to two ICUs for medical conditions, abdominal surgery (planned and unplanned) and orthopedic surgery for hip fractures, over a 6-year period. Three months and one year after ICU discharge, patients or family members were contacted by telephone to obtain follow-up information using the EuroQoL questionnaire. The data were compared with an age-matched of the Italian population. Two hundred eighty-eight patients were included in the study. ICU mortality of medical (14.8%) and unplanned surgical patients (26.4%) was higher than that of planned surgical (5.0%) and orthopedic patients (2.5%), as was hospital mortality (27.7% vs. 50.0% vs. 5.0% vs. 14.3%). Three months and 12 months mortality rates after ICU discharge were 40.7% and 61.1% in medical patients, 70.5% and 76.4% in unplanned surgical patients, 20.0% and 30.0% in planned surgical patients, 36.2% and 46.2% in orthopedic patients. QoL measures revealed that, one year after ICU discharge, medical and orthopedic patients had significantly more severe problems vis-à-vis mobility, self-care and activity than abdominal surgical patients and control population. Type of admission was the independent risk factor associated with ICU and long-term mortality, whereas age 90 year and older was associated with long-term mortality. Orthopedic surgery for hip fractures seems to influence QoL similar to medical diseases.     

Endoscopic papillectomy: Data of a prospective observational study

AIM:To investigate the clinical value of endoscopic papillectomy indicated by feasibility and safety of the procedure in various diseases of the papilla in a representative number of patients in a setting of daily clinical and endoscopic practice and care by means of a systematic prospective observational study. METHODS:Through a defined time period, all consecutive patients with tumor-like lesions of the papilla, who were considered for papillectomy, were enrolled in this systematic bicenter prospective observational study, and subdivided into 4 groups according to endoscopic and endoscopic ultrasonography (EUS) findings as well as histopathological diagnosis:adenoma; carcinoma/ neuroendocrine tumor (NET)/lymphoma; papilla into which catheter can not be introduced; adenomyomatosis, respectively. Treatment results and outcome were characterized by R0 resection, complication, recurrence rates and tumor-free survival.RESULTS:Over a 7-year period, 58 patients underwent endoscopic papillectomy. Main symptoms prompting to diagnostic measures were unclear abdominal pain in 50% and cholestasis with and without pain in 44%. Overall, 54/58 patients [inclusion rate, 93.1%; sex ratio, males/females = 25/29 (1:1.16); mean age, 65 (range, 22-88) years] were enrolled in the study. Prior to papillectomy, EUS was performed in 79.6% (n = 43/54). Group 1 (adenoma, n = 24/54; 44.4%):91.6% (n = 22/24) with R0 resection; tumor-free survival after a mean of 18.5 mo, 86.4% (n = 19/22); recurrence, 13.6% (n = 3/22); minor complications, 12.5% (n = 3/24). Group 2 (carcinoma/NET/lymphoma, n = 18/54; 33.3%):75.0% (n = 10/18) with R0 resection; tumor-free survival after a mean of 18.5 (range, 1-84) mo, 88.9% (n = 8/9); recurrence, 11.1% (n = 1/9). Group 3 (adenomyomatosis, n = 4/54; 7.4%). Group 4 (primarily no introducible catheter into the papilla, n = 8; 14.8%). The overall complication rate was 18.5% (n = 10/54; 1 subject with 2 complications):Bleeding, n = 3; pancreatitis, n = 7; perforation, n = 1 (intervention-related mortality, 0%)     

Short- and medium-term clinical efficacy of three endoscopic therapies for achalasia: a single-blinded prospective study.

OBJECTIVE: to compare the efficacy of three endoscopic therapies for achalasia and to identify predictors of response. DESIGN: prospective, single-blinded study at short and medium term. MATERIAL AND METHODS: 22 patients (9M/13 F; mean age: 47.45 +/- 21.01 years) with confirmed clinical and manometric achalasia were randomised in three groups: intrasphincteric injections of botulinum toxin (group 1: 10 patients ), injections of 1% polidocanol (group 2:6 patients), and a combined therapy with both of them (group 3: 6 patients). Clinical response was evaluated by a score (0-5) of tested symptoms (dysphagia, regurgitation and chest pain) at 1 and 24 weeks post-treatment. RESULTS: at 24 weeks post-treatment group 2 had the best complete response (CR) rate (33.33%), whereas CR in both the botulinum toxin and combined therapy groups was 10 and 0%, respectively. Groups 1 and 2 got an overall improvement in clinical score at 1 (p= 0.02) and 24 weeks (p= 0.04). Five patients (50%) in group 1, two patients (33.33%) in group 2, and three patients (50%) in group 3 needed other therapies (dilation or surgery) because of treatment failure. Separately, neither age nor sex, time from diagnosis or type of therapy could distinguish responders from non-responders in these three groups. However, absence of response within the first week, and an initial clinical score above 7 were predictive factors of poor response at six months. CONCLUSIONS: short- and medium-term clinical response to these endoscopic therapies was limited. The absence of response at seven days and a severe initial clinical score were predictive factors of poor medium-term response.     

Leflunomide in Pakistani patients with rheumatoid arthritis: prospective study in daily rheumatology practice

Introduction: Leflunomide is a disease‐modifying anti‐rheumatic drug (DMARD) for rheumatoid arthritis (RA). It has been widely studied in the West but there is no available local Pakistani data. Objective: To evaluate the efficacy and safety profile of leflunomide in Pakistani patients with RA, either alone or in combination with methotrexate. Materials and methods: A prospective, non‐comparator, open‐label study in a setting of ‘care as usual’ was performed. In this study, 63 consecutive RA patients on leflunomide were enrolled. Leflunomide dose was started with full loading in 5 (8%), half loading in 39 (62%) and without loading in 19 (30%) patients. Methotrexate was also used in 20 (32%) patients. Primary end‐point was 20% improvement in American College of Rheumatology response criteria (ACR‐20). Safety was assessed by adverse events and abnormalities in laboratory parameters. Results: Out of 63 patients, 54 (85.7%) were female. Mean age was 46 ± 12.6 years. Mean disease duration was 5.1 ± 4.5 years. Fifty‐two (86.6%) patients achieved ACR‐20 response at 6 months; 32 (53%) achieved ACR‐50 response at 6 months; 20% experienced at least one adverse event, which resolved by reducing leflunomide dose. Only seven (11%) had raised liver enzymes from baseline. Conclusion: This prospective study conducted in the setting of a daily rheumatology practice shows that leflunomide is an effective and safe DMARD in treatment of RA in Pakistani patients.