Attributes influencing parental decision-making to receive the Tdap vaccine to reduce the risk of pertussis transmission to their newborn - outcome of a cross-sectional conjoint experiment in Spain and Italy.

Pertussis vaccination of parents and household contacts ('cocooning') to protect newborn infants is an established strategy in many countries, although uptake may be low. Many aspects may influence such decision-making. We conducted a cross-sectional survey (NCT01890447) of households and other close contacts of newborns aged ≤6 months (or of expectant mothers in their last trimester) in Spain and Italy, using an adaptive discrete-choice experiment questionnaire. Aims were to assess the relative importance of attributes influencing vaccine adoption, and to estimate variation in vaccine adoption rates and the impact of cost on vaccination rates. Six hundred and fifteen participants (Spain, n = 313; Italy, n = 302) completed the survey. Of 144 available questionnaire scenarios, the most frequently selected (14% of respondents in both countries) were infant protection by household vaccination at vaccination center, recommendation by family physician and health authorities, with information available on leaflets and websites. The attribute with highest median relative importance was 'reduction in source of infection' in Spain (23.1%) and 'vaccination location' in Italy (18.8%). Differences between other attributes were low in both countries, with media attributes showing low importance. Over 80% of respondents indicated a definite or probable response to vaccine adoption (at no-cost) with estimated probability of adoption of 89-98%; applying vaccine costs (25€ per person) would reduce the probability of uptake by 7-20% in definite/probable respondents. Awareness of these determinants is helpful in informing Health Authorities and healthcare practitioners implementing a cocooning strategy for those populations where maternal immunization is not a preferred option.

High OPCAB surgical volume improves midterm event-free survival.

BACKGROUND: The aim of this study was to evaluate the midterm results of the initial phase of off-pump coronary artery bypass (OPCAB) surgery adoption in a single surgical unit, assessing the impact of procedural volume. METHODS: Study participants were 312 patients who underwent OPCAB during the period between August 2000 and January 2005 at S. Croce Hospital. Of these patients, 126 patients with an indication selected for comorbidities or 1-vessel disease underwent OPCAB performed by 4 low-volume surgeons, and 186 unselected patients underwent OPCAB performed by a single high-volume surgeon. RESULTS: OPCAB performed by low-volume surgeons was associated with less complete revascularization and less arterial conduit use. Early result analysis showed a low rate of in-hospital or 30-day adverse events. The 5-year survival was 0.88 (0.02 SE). OPCAB performance by a high-volume surgeon and complete revascularization were shown have a protective effect for midterm major adverse cardiac events (respectively, hazard ratio = 0.28, 95% confidence interval 0.11-0.74 and hazard ratio = 0.33, 95% confidence interval 0.15-0.73). CONCLUSION: Our study on the initial phase of OPCAB adoption suggests a benefit on midterm outcome from surgery performed by a high-volume surgeon.

Impact of incomplete revascularization following OPCAB surgery.

BACKGROUND AND AIM OF THE STUDY: The aim of this study was to evaluate the early and mid-term off-pump coronary artery bypass surgery (OPCAB) results in a single surgical unit, assessing the impact of completeness of revascularization. METHODS: Three hundred and twelve patients underwent OPCAB between August 2000 and January 2005. In-hospital data were collected prospectively for all patients undergoing OPCAB. Complete revascularization (CR) was derived by comparing significantly stenotic vessels at cardiac catheterization with surgically grafted coronary vessels. Grafting of all the significantly stenotic coronary vessels was considered CR. In-hospital outcomes were compared between patients with CR and incomplete revascularization (IR). A multivariate analysis based on the Cox proportional hazards regression model was performed. RESULTS: Patients receiving IR (105 patients, 43.7%) presented a worse preoperative risk profile then those having CR (mean Euroscore 6.8 +/- 2.9 vs. 4.3 +/- 2.8, p < 0.0001). IR was not associated with a higher incidence of early adverse events. Five-year freedom from death and major adverse cardiac events (MACE) were 0.88 (0.02 SE) and 0.86 (0.03 SE), respectively. Complete revascularization was protective for mid-term unstable angina recurrence [heart rate (HR) = 0.24, 95% confidence interval (CI) 0.10 to 0.58], acute myocardial infarction (HR = 0.25, 95% CI 0.09 to 0.73), all-cause repeat revascularization (HR = 0.35, 95% CI 0.13 to 0.90), and MACE (HR = 0.2, 95% CI 0.1 to 0.5). CONCLUSION: Our study suggests that, although incomplete revascularization may not result in increased short-term morbidity and mortality, it increases the incidence of mid-term MACE.

Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial.

To evaluate in a prospective multicenter trial the feasibility and clinical efficacy of the combination of alemtuzumab (Campath-1H) with the cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) regimen (CHOP-C) as the primary treatment for patients with peripheral T-cell lymphoma (PTCL), between January 2003 and December 2005, 24 consecutive patients with PTCL entered the study and received 8 CHOP courses. Alemtuzumab was added at 30 mg subcutaneously at day -1 initially to the first 4 courses (4 patients), and then to all 8 courses (20 patients). Complete remission (CR) was achieved in 17 (71%) patients, 1 had partial remission, and 6 had stable/progressive disease. At a median follow-up of 16 months (range, 5-42 months), 14 patients were alive, 9 had died from progressive disease, and 1 had died from pneumonia at day +198 while in CR. So far, 13 are disease-free, with an overall median duration of response of 11 months. The most frequent side effects were grade 4 neutropenia and cytomegalovirus (CMV) reactivation. Major infections were Jacob-Creutzfeldt (J-C) virus reactivation, pulmonary invasive aspergillosis, Staphylococcus sepsis, and pneumonia. This study shows that CHOP-C: (1) is a feasible chemoimmunotherapy regimen; (2) is effective in PTCL with a high rate of CR achievement; and (3) is associated with mostly manageable infectious complications. This clinical trial was registered with the Osservatorio Nazionale sulla Sperimentazione cinica as ID no. 141202.

The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease.

BACKGROUND AND OBJECTIVES: We explored the predictive value on therapy outcome of an early evaluation of treatment response by 18F-fluorodeoxyglucose position emission tomography (18F-FDG-PET) scan performed after two courses of conventional standard-dose chemotherapy in advanced-stage Hodgkin's disease. DESIGN AND METHODS: One hundred and eight patients with newly-diagnosed Hodgkin's disease in stage IIA with adverse prognostic factors, or in stage IIB through IVB, were re-staged with FDG-PET after two cycles of ABVD (PET-2). The end-point of the study was the predictive value of PET-2 on 2-year progression-free survival and 2-year failure-free survival. No treatment variation based only on PET-2 results was allowed. RESULTS: Eighty-eight patients attained complete remission (CR) while 20 showed disease progression during therapy or within 6 months after having reached CR; one patient relapsed. PET-2 was positive in 20 patients: 17 progressed during therapy, one relapsed and two remained in CR. By contrast, 85/88 (97%) patients with a negative PET-2 remained in CR; three progressed or relapsed early after the end of the chemotherapy. Thus, the positive predictive value of a PET-2 was 90% and the negative predictive value was 97%. The sensitivity, specificity and overall accuracy of PET-2 were 86%, 98% and 95%, respectively. The 2-year probability of failure-free survival for PET-2 negative and for PET-2 positive patients was 96% and 6%, respectively (log rank test = 116.7, p < 0.01). INTERPRETATION AND CONCLUSIONS: 18F-FDG-PET scan performed after two courses of conventional standard-dose chemotherapy in advanced-stage Hodgkin's disease was able to predict treatment outcome in 103/108 (95%) of the patients.

Clinical equivalence of two cytokeratin markers in mon-small cell lung cancer: a study of tissue polypeptide antigen and cytokeratin 19 fragments.

STUDY OBJECTIVES: We have longstanding experience with tissue polypeptide antigen (TPA), a tumor marker of the cytokeratin (CK) family. In the mid-1990s, a new CK marker, CK 19 fragments (CYFRA 21-1), became popular and widely accepted. This is the first study specifically designed to compare the two markers. DESIGN: Analysis of a single institution database over a 3-year period (ie, 1998 to 2000). SETTING: Community-based hospital and second referral level institution for a province of 500,000 people. PATIENTS: The study included 180 new consecutive patients (143 men) with pathologically documented non-small cell lung cancer (NSCLC), who were observed during and after treatment, and eventually were assessed for status. INTERVENTIONS: Anthropometric, clinical, and laboratory data, including TPA and CYFRA 21-1 serum levels, were recorded prospectively. Standard nonparametric tests, Kaplan-Meyer survival analyses, Cox proportional hazards models, receiver-operating characteristic (ROC) curves, and estimates were used for statistical analysis. MEASUREMENTS AND RESULTS: A total of 1,299 twin TPA and CYFRA 21-1 serum assays (180 performed at diagnosis and 1,119 performed during or after treatment) were obtained. Intermarker correlation tests revealed incredibly high Spearman rho indexes, ranging from 0.935 at diagnosis to 0.813 to 0.921 at the different follow-up times. The substantial equivalence of the two tests explained all the other results, as follows: their similar profile of correlation with the other variables (objective treatment response: TPA rho, 0.456; CYFRA 21-1 rho, 0.463; follow-up performance status: rho range, 0.424 to 0.435); their superimposable capability to predict important clinical situations (eg, recognizing a metastatic disease at diagnosis with areas under the ROC curve of 0.742 and 0.706, respectively); their nearly identical prognostic significance (the D statistic of the goodness-of-fit of a multivariate survival model: TPA, 851.0; CYFRA 21-1, 851.6). CONCLUSIONS: In most of their traditional clinical applications the two serum tests are equivalent because of their virtual identity. We strongly recommend using a CK test in the evaluation of each NSCLC patient. The choice between TPA and CYFRA 21-1 can be based on nonclinical factors, such as the laboratory experience or preference, and the cost of the two kits.

Plasma levels of D-dimer in lung carcinoma: clinical and prognostic significance.

BACKGROUND: The activation of the clotting-fibrinolytic system in cancer patients is common and represents an unfavorable clinical sign. D-dimer (DD) is a sensitive marker of fibrinolysis. METHODS: The current study comprised 826 new lung carcinoma patients seen consecutively in a single institution over a 10-year period (1992-2001). For each patient, 31 variables, including DD and survival duration, were available for analysis. RESULTS: Only weak relationships between DD and the other variables were found. The DD variable correlated best with the level of lactate dehydrogenase, performance status, tissue polypeptide antigen, stage of disease, and the number of metastases (rho = 0.33, -0.25, 0.18, 0.18, and 0.15, respectively). The D-dimer distinguished patients with different prognoses. The median survival periods were 154 days (95% confidence interval [CI], 122-189 days) and 308 days (95% CI, 227-409 days; log rank statistic, 26.56; P < 0.01), respectively, for abnormally elevated and normal values. The difference was greater in patients with adenocarcinoma and in patients presenting with a less advanced disease, especially in patients with pathologic Stage Ia disease. The best multivariate survival model selected 10 significant covariates, including DD. CONCLUSIONS: The authors recommend measuring the plasma level of DD in all new lung carcinoma patients. This measurement may help to formulate individual prognoses and can be used to indicate adjuvant treatment for surgical patients.