Selection of patients with high risk endometrial cancer for surgical staging according to the evaluation of pre- and intraoperative risk factors.

BACKGROUND: The aim of this paper was to assess the accuracy of frozen sections histological examination and preoperative CA-125 to select patients with high risk endometrial cancer. METHODS: We reviewed women with type I endometrial cancer treated from January 2011 through January 2013 at the same university hospital. Preoperative CA-125 and intraoperative frozen sections were analyzed to select patients at high risk for metastases, according to Mayo Clinic algorithm. All patients underwent hysterectomy with bilateral adnexectomy. High risk patients underwent complete surgical staging. Respectively, we compared the accuracy of CA-125, frozen sections, and an algorithm combining Ca-125 plus frozen sections, with permanent sections histology as positive control. χ2 test, Landis and Koch kappa statistics (k), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were determined for each variable. RESULTS: One hundred seventy-two women were included. CA-125 levels, using 8.3 U/ml as cut-off value, showed 63.4% sensitivity, 51.6% specificity, 84.7% PPV, 25.0% NPV, 61.1% accuracy, and a low kappa statistics (k=0.106, P<0.125). Frozen sections demonstrated 97.3% sensitivity, 100% specificity, 100% PPV, 90.0% NPV, 97.8% accuracy and an optimal kappa statistics (k=0.934, P<0.001). The algorithm combining CA-125 with frozen sections showed 99.1% sensitivity, 48.1% specificity, 88.8% PPV, 92.9% NPV, 89.2% accuracy, and a satisfactory kappa statistics (k=0.578, P<0.001). CONCLUSIONS: We proved the utility of Mayo algorithm even in a different institution. Combining CA-125 plus frozen sections doesn't look like advantageous compared to frozen sections alone.

Intraoperative frozen section risk assessment accurately tailors the surgical staging in patients affected by early-stage endometrial cancer: the application of 2 different risk algorithms.

OBJECTIVE: The aim of this study was to investigate the frozen section (FS) accuracy in tailoring the surgical staging of patients affected by endometrial cancer, using 2 different risk classifications. METHODS/MATERIALS: A retrospective analysis of 331 women affected by type I endometrial cancer and submitted to FS assessment at the time of surgery. Pathologic features were examined on the frozen and permanent sections according to both the GOG33 and the Mayo Clinic algorithms. We compared the 2 models through the determination of Landis and Koch kappa statistics, concordance rate, sensitivity, specificity, positive predictive value, and negative predictive value for each risk algorithm, to assess whether there are differences in FS accuracy depending on the model used. RESULTS: The observed agreement between the frozen and permanent sections was respectively good (k = 0.790) for the GOG33 and optimal (k = 0.810) for the Mayo classification. Applying the GOG33 algorithm, 20 patients (6.7%) were moved to an upper risk status, and 20 (6.7%) were moved to a lower risk status on the permanent section; the concordance rate was 86.5%. With the Mayo Clinic algorithm, discordant cases between frozen and permanent sections were 19 (7.6%), and the risk of lymphatic spread was underestimated only in 1 case (0.4%); the concordance rate was 92.4%. The sensitivity, specificity, positive predictive value, and negative predictive value for the GOG33 were 92%, 94%, 92%, and 93%, whereas with the Mayo algorithm, these were 98%, 91%, 77%, and 99%, respectively. CONCLUSIONS: According to higher correlation rate and observed agreement (92.4% vs 86.5% and k = 0.810 vs 0.790, respectively), the Mayo Clinic algorithm minimizes the number of patients undertreated at the time of surgery than the GOG33 classification and can be adopted as an FS algorithm to tailor the surgical treatment of early-stage endometrial cancer even in different centers.

Exhaled nitric oxide is associated with cyclic changes in sexual hormones.

BACKGROUND: We hypothesized that changes in the levels of sexual hormones during the menstrual cycle influence the concentration of nitric oxide in the exhaled air (FeNO) and alveolar exhaled nitric oxide (CANO). METHODS: Twelve healthy, non allergic women in their reproductive age (age range 25-37 years) were recruited. Subjects were studied, on alternate days, over the course of their menstrual cycle. At each visit, measurements of FeNO and CANO were performed. Progesterone and 17-ß-estradiol concentrations were measured in salivary samples. RESULTS: Eight subjects completed the study. The levels of FeNO and CANO were 13 ± 4.7 pbb and 3.5 ± 1.9 pbb, respectively (mean ± SD). The mean salivary concentration of progesterone was 65.1 ± 16.2 pg/ml (mean ± SD), with a range of 32.4-107.7 pg/ml, and the concentration of 17 ß-estradiol was 6.0 ± 1.6 pg/ml, with a range of 3.1-12.9 pg/ml. The Generalized Estimating Equations procedure demonstrated that levels of progesterone influenced both FeNO and CANO (Wald χ2 = 11.60, p = 0.001; and Wald χ2 = 87.55, p = 0.001, respectively). On the contrary, the salivary levels of 17 ß-estradiol were not significantly associated with FeNO (Wald χ2 = 0.087, p = 0.768) or CANO (Wald χ2 = 0.58, p = 0.448). CONCLUSION: In healthy women, the menstrual cycle-associated hormonal fluctuations selectively influence the levels of bronchial and alveolar NO. The current findings may have important clinical implications for the interpretation of eNO levels, by identifying a patient-related factor that influences the eNO measurements.

Patient knowledge, perceptions, expectations and satisfaction on allergen-specific immunotherapy: a survey.

BACKGROUND: Assessing patient's perspective provides useful information enabling a customized approach which has been advocated by current guidelines. In this multicentre cross-sectional study we evaluated personal viewpoints on allergen-specific immunotherapy (SIT) in patients treated with subcutaneous (SCIT) or sublingual (SLIT) immunotherapy. METHODS: A survey of 28 questions assessing patient's knowledge, perceptions, expectations and satisfaction was developed by an expert panel and was applied by physicians from allergology centres in patients with respiratory allergy treated with SIT. Treating physicians independently reported their satisfaction level regarding SIT for each patient. RESULTS: Fully completed surveys from 434 patients (55.3% male; 66.7% poly-sensitized, 74% SLIT) were analysed. Mean duration of SIT was 2.5 years with different allergens. Most patients acquired their SIT knowledge from their physician (95%) and consequently, their physicians' opinion in their choice to start with SIT was important. Most patients perceived SIT to be safe and easy to integrate into their daily routine. The main motivations for SIT were its supposed potential to alter the course of the disease (45.7%), less need of (28.2%), or dissatisfaction with current pharmacotherapy (19.3%). Both patients' and physicians' satisfaction was high (VAS-scores 74/100 and 78/100, respectively) and showed a significant correlation (SCIT: r=0.612; SLIT: r=0.608). No major difference was found in patients' answers based on the level of education. CONCLUSION: In this real life study evaluating different aspects of patient's perspective on SIT, the majority of patients had an adequate level of knowledge, perceptions, expectations and satisfaction about SIT, which corresponded well with the physician's perceptions and satisfaction. Our data warrant the use of patient's perspectives on chronic SIT treatment.

Coping with asthma: is the physician able to identify patient's behaviour?

INTRODUCTION: The strategies patients use to manage their asthma (coping) have been found to be associated with clinical and patient-reported outcomes. OBJECTIVES: The aim of this large cross-sectional survey is to assess the use of coping methods employed by patients with asthma and to explore the ability of general practitioners (GPs) to correctly identify these strategies. METHODS: A modified Coping Orientations to Problem Experienced Questionnaire was completed by patients with asthma and their physicians. RESULTS: The survey was completed by 3089 GPs (69% male; mean age 55 ± 6) and by 6264 patients (52% male; mean age 45 + 14). Active strategies were reported as the predominant method of coping by 51-59% of patients, whilst passive/avoidant techniques accounted for 12-28%. GPs believed the active coping methods were employed primarily by 35-45% of patients and the passive/avoidant methods by 8-26%. Physicians were able to identify the specific strategy used by a patient in 34%-64% of cases. The ability to identify the use of active strategies rather than the passive/avoidant was significantly higher (T test 8,250, p < 0.0001). Coefficient of concordance between GPs' and patients' answers was fair. CONCLUSIONS: These results revealed the extent of maladaptive coping strategies used by patients and the tendency for physicians to underestimate these. These observations may well represent two obstacles in improving asthma clinical outcomes.

Frozen section pathology at time of hysterectomy accurately predicts endometrial cancer in patients with preoperative diagnosis of atypical endometrial hyperplasia.

OBJECTIVES: A significant number of women diagnosed with atypical endometrial hyperplasia (AEH) on endometrial biopsy will be diagnosed with endometrial cancer (EC) on the hysterectomy specimen at permanent section. Surgical treatment for AEH and EC differ substantially. We have assessed the concordance in EC between frozen and permanent sections on patients undergoing hysterectomy for AEH. MATERIALS AND METHODS: A retrospective review of 66 frozen sections on patients undergoing hysterectomy for AEH was performed. Frozen and permanent section diagnoses were categorized as negative or positive for malignancy. Permanent section carcinomas were classified as low or high risk based on their histopathology, myometrial invasion and differentiation. Correlation between frozen and permanent section and sensitivity, specificity, PPV, NPV and accuracy of frozen section in predicting EC in permanent section were calculated. Likelihood of diagnosing EC on frozen section was compared based on risk stratification at permanent section. RESULTS: Frozen and permanent sections revealed malignancy in 43.9% and 56% of the patients respectively. 94.1% of high risk carcinomas were identified as EC at frozen section as compared to 55% of low risk EC. Concordance was good (κ=0.75). Sensitivity, specificity, NPV, PPV and accuracy in predicting EC at frozen section were 73%, 93.1%, 73% and 93.1% respectively. Carcinomas were detected at frozen section significantly more often if they were at high risk. CONCLUSIONS: The substantial agreement between frozen and permanent sections allows minimizing under- and overtreatment of women undergoing hysterectomy for AEH. High risk EC are efficiently identified in frozen section.

Patients with asthma and comorbid allergic rhinitis: is optimal quality of life achievable in real life?

OBJECTIVES: Asthma trials suggest that patients reaching total disease control have an optimal Health Related Quality of Life (HRQoL). Moreover, rhinitis is present in almost 80% of asthmatics and impacts asthma control and patient HRQoL. We explored whether optimal HRQoL was reachable in a real-life setting, and evaluated the disease and patient related patterns associated to optimal HRQoL achievement. METHODS AND FINDINGS: Asthma and rhinitis HRQoL, illness perception, mood profiles, rhinitis symptoms and asthma control were assessed by means of validated tools in patients classified according to GINA and ARIA guidelines. Optimal HRQoL, identified by a Rhinasthma Global Summary (GS) score ≤20 (score ranging from 0 to 100, where 100 represents the worst possible HRQoL), was reached by 78/209 (37.32%). With the exception of age, no associations were found between clinical and demographic characteristics and optimal HRQoL achievement. Patients reaching an optimal HRQoL differed in disease perception and mood compared to those not reaching an optimal HRQoL. Asthma control was significantly associated with optimal HRQoL (χ(2) = 49.599; p<0.001) and well-controlled and totally controlled patients significantly differed in achieving optimal HRQoL (χ(2) = 7.617; p<0.006). CONCLUSION: Approximately one third of the patients in our survey were found to have an optimal HRQoL. While unsatisfactory disease control was the primary reason why the remainder failed to attain optimal HRQoL, it is clear that illness perception and mood also played parts. Therefore, therapeutic plans should be directed not only toward achieving the best possible clinical control of asthma and comorbid rhinitis, but also to incorporating individualized elements according to patient-related characteristics.

Influence of the anatomic characteristics of the pulmonary vein ostium, the learning curve, and the use of a steerable sheath on success of pulmonary vein isolation with a novel multielectrode ablation catheter.

AIMS: Anatomic variability of the pulmonary vein (PV) ostium may adversely affect isolation rates with the circular fixed-size pulmonary vein ablation catheter (PVAC). We wanted to assess the influence on PV isolation rates of anatomic characteristics of the ostium, increasing experience of four different operators, and additional use of a steerable sheath. METHODS AND RESULTS: In the first 190 patients (pts) undergoing PVAC ablation, minimum/maximum diameter, area and shape of the PV ostia, and the length of a common ostium were analysed from computed tomography 3D reconstructions of the left atrium and related to isolation rates. In addition, a comparison was drawn between pts at the beginning and after completion (isolation of all PVs in ≥ 85% of pts) of the learning curve, and the effect of a steerable sheath was assessed. Pulmonary vein isolation was achieved with the PVAC alone in 85% of pts and in 94% of veins after a median procedure and ablation time of 154 [interquartile ranges (IQR): 120, 200] and 51 (IQR: 38, 70) min. An increase in isolation rates was observed after the first 60 pts (73 vs. 90% of pts; P< 0.01; 88 vs. 96% of PVs; P< 0.001), coincident with routine use of a steerable sheath. Anatomic characteristics (larger minimum diameter and area) identified unsuccessful isolation only of the left inferior PV at the beginning of the learning curve. CONCLUSIONS: Pulmonary vein isolation rates using this catheter are high. Anatomic variability of PV ostia modestly affects PV isolation rates. Standard use of a steerable sheath plays a major role in increasing isolation rates and overcoming 'difficult' anatomies.

Chronic obstructive pulmonary disease patient well-being and its relationship with clinical and patient-reported outcomes: a real-life observational study.

BACKGROUND: Quality of life is an umbrella concept that refers to all aspects of a person's life, including health status and well-being. While health status measure focuses on the impact of the disease on physical functioning, well-being represents the self-representation of the emotional states related to the disease itself. OBJECTIVES: The objective of this study was to evaluate the psychological well-being and its determining factors in a real-life chronic obstructive pulmonary disease (COPD) population and to evaluate if patients with a different well-being differ in illness perception, health status and alexithymia. METHODS: Psychological well-being (Psychological General Well-Being Index), health status (SF-36), illness perception (Illness Perception Questionnaire), alexithymia (Toronto Alexithymia Scale), as well as clinical parameters were assessed in COPD out-patients. RESULTS: One hundred and sixty-four patients, with a mean forced expiratory volume in 1 s of 58.5%, were recruited. Forty percent of them had a moderately/severely impaired well-being, not correlated with forced expiratory volume in 1 s and the Charlson index value but significantly with the Medical Research Council score (p = 0.0001) that appeared to be the dominant factor. Patients with impaired well-being showed a different illness perception in terms of correct identification of symptoms, disease consequences, emotional representation and confidence in treatment compared with those having a positive well-being. The latter presented a lower alexithymia prevalence and a better health status. CONCLUSIONS: In order to minimize the disease-negative effects on patients' lives, assessment of well-being and its determining factors, as well as planning specific behavioural, educational and therapeutic interventions seem to be relevant and useful.

Asthma management failure: a flaw in physicians' behavior or in patients' knowledge?

OBJECTIVES: Patient-physician communication and patients' knowledge about asthma are relevant factors that influence health outcomes. The aim of this study was to explore general practitioners' (GPs) behaviors, asthma patients' knowledge requirements, and the relationship between physicians' communicative issues, and failures in patients' knowledge. METHODS: GPs participating in a continuing medical education program on asthma completed an ad hoc survey on communicative style and recruited at least three adult asthma patients to indicate, among 10 options, three aspects of asthma about which they felt less informed. RESULTS: The survey was completed by 2332 GPs (mean age 54.39 ± 5.93 years) and 7884 patients (mean age 49.59 ± 18.03 years). Several ineffective strategies emerged in the physicians' behaviors: 28.5% of GPs did not encourage patients to express doubts, expectations, or concerns; 39.4% tried to frighten patients concerning disease-related risks; only 25.7% used a written action plan. In addition, 18.6% of GPs were not averse to informing the patient about potential side effects; 16.3% did not try to simplify asthma treatment; approximately 30% considered ease of use when selecting drugs; 18% were not disposed to carry out a partnership with the patient; 36.9% were unlikely to involve the patient in asthma management; and 73% tried to retain control over their patients. Finally, 90.3% of GPs declared they want to be consulted before any treatment change. The three topics on which patients felt less informed were the meaning of asthma control (14% of patients); integration of asthma into daily life (13.3%); and periodic checkups (12.7%). There were significant associations between patients' choices and physicians' answers. CONCLUSION: These results demonstrate that in general medicine the recommendations of international guidelines on education, communication, and development of a doctor-patient partnership are still ignored and that patients' educational priorities may differ from those identified by medical specialists and by patients belonging to patients' associations.

Disability in COPD and its relationship to clinical and patient-reported outcomes.

OBJECTIVE: To assess the presence of disability in chronic obstructive pulmonary disease (COPD) patients and its relationships with disease severity, comorbidities, and patient-reported outcomes. RESEARCH DESIGN AND METHOD: COPD outpatients completed validated questionnaires designed to investigate illness perception, well-being, quality of life, and stress, while physicians collected data concerning disability, dyspnea, and comorbidities (Charlson Index). RESULTS: Of 164 patients, 37.3% exhibited a degree of disability and 67.7 % of them reported the loss of at least one relevant function in daily life (mean 2.34 ± 2.41). Although disability was associated with disease severity (χ(2) = 8.292; p < 0.016), disability was present to some degree in all disease stages and in 44.9% of patients with moderate COPD. Barthel Index scores were related to MRC scores (r = 0.529; p < 0.001), GOLD stage (r = 0.223; p < 0.006), and Charlson Index (r = 0.163; p < 0.032). Disabled patients had a lower mean FEV(1) value (50.96 ± 20.99 vs. 65.00 ± 23.63; p < 0.001) than self-sufficient patients (p < 0.001). The stepwise regression analysis showed that the MRC score was the most relevant factor in inducing COPD patient disability (F = 56.5; p = 0.001). Compared to self-sufficient patients, disabled patients reported lower levels of well-being and health status, increased levels of distress, and a different illness perception. CONCLUSIONS: Disability can be identified in each disease stage, with dyspnea serving as the most relevant inducing factor. Since disability substantially impacts patient perception of and experience with COPD, its presence must be taken into account during disease management. The cross-sectional nature of the study and the characteristics of the sample size represent a limitation in the possibility to generalize the results.

Pitfalls in respiratory allergy management: alexithymia and its impact on patient-reported outcomes.

OBJECTIVES: Alexithymia is a personality trait characterized by a limited ability to identify and express emotions and it represents a possible risk factor for disease development and management. The objective of the study is to evaluate alexithymia in patients with persistent asthma and comorbid rhinitis and its relation with patient-reported outcomes (PROs). METHODS: Alexithymia, quality of life, illness perception, and stress were assessed, as well as rhinitis symptoms and asthma control in out-patients classified according to GINA and ARIA guidelines. RESULTS: Out of 115 patients, 19% turned out to be alexithymic (TAS-20 ≥ 61). Concerning alexithymia level, no difference was detected between males and females (χ(2) = 0.317) and among GINA levels (χ(2) = 0.22). Alexithymics had significantly lower Asthma Control Test scores when compared with non-alexithymics (15.86 vs. 19; p = .02). Alexithymics had a worse quality of life (p< .001) and, concerning illness perception, they ascribed to respiratory allergy symptoms that are not strictly disease related and referred to asthma and rhinitis more serious negative consequences (p < .001) and emotional representations (p < .035). Moreover, they had lower illness coherence (p < .001) and lived their disease as a cyclical rather than a chronic disorder (p < .035). As regards stress, alexithymics reported less energy (p < .001), higher levels of tension (p < .001), depression (p < .001), confusion (p > .001), and inertia (p < .001). CONCLUSION: Alexithymia is present in a relevant percentage of subjects and, as it can modulate illness perception, quality of life, and stress, it should be considered in disease management.

Frozen section underestimates the need for surgical staging in endometrial cancer patients.

OBJECTIVE: To compare the risk status for lymph nodal metastasis at frozen section in endometrial cancer by applying a model based on tumor grade and myometrial involvement. STUDY DESIGN: A retrospective analysis was performed on 174 early-stage endometrial cancer patients on whom an intraoperative frozen section was requested. Patients were retrospectively divided into low, intermediate, and high risk for lymph nodal involvement based on tumor grade and myometrial invasion based on Gynecologic Oncology Group 33 data. Concordance of risk status at frozen and permanent sections was performed. RESULTS: Risk status at frozen and permanent sections were highly correlated (P < 0.01). Agreement between frozen and permanent sections was substantial (kappa = 0.625). In 16% of the cases, frozen section underestimated the risk when compared with permanent section. CONCLUSION: Relying on intraoperative frozen section of the uterus to assess risk status for lymph nodal involvement in early-stage endometrial cancer patients leads to suboptimal management in a substantial number of cases.

Strategies to minimize discomfort during diagnostic hysterosalpingography with disposable balloon catheters: a randomized placebo-controlled study with oral nonsteroidal premedication.

OBJECTIVE: To assess whether oral administration of 100 mg of nimesulide reduces pain during or after a hysterosalpingography (HSG) performed with disposable balloon catheters. DESIGN: Prospective, randomized, placebo-controlled study. SETTING: Reproductive Centre, Department of Obstetrics and Gynaecology, University of Genoa. PATIENT(S): Four hundred and forty patients undergoing HSG with a balloon catheter without applying a tenaculum. INTERVENTION(S): Patients were randomized to receive either 100 mg of oral nimesulide or a placebo solution 30 minutes before the HSG was performed. MAIN OUTCOME MEASURE(S): Patients recorded the degree of pain experienced during the examination, 2 hours afterward, and during the following week on a questionnaire using a 10-mm visual analogue scale (VAS). RESULT(S): Of the 331 (75.2 %) patients who returned the questionnaire, 151 had received nimesulide and 180 placebo. There was no difference in pain score between the two groups at any study point. Pain during HSG was correlated with nulliparity and tubal occlusion. Balloon inflation (cervix versus cavity) was not related to pain. CONCLUSION(S): Nimesulide does not reduce pain during or after HSG when the procedure is accomplished with a balloon catheter.