Psychosocial Morbidity and its Correlates in Cancer Patients of the Mediterranean Area: Findings from the Southern European Psycho-Oncology Study

BACKGROUND: A few and partial data are available on psychosocial morbidity among cancer patients in Mediterranean countries. As a part of a more general investigation (Southern European Psycho-Oncology Study-SEPOS), the rate of psychosocial morbidity and its correlation with clinical and cultural variables were examined in cancer patients in Italy, Portugal and Spain. METHODS: A convenience sample of cancer outpatients with good performance status and no cognitive impairment were approached. The Hospital Anxiety-Depression scale (HAD-S), the Mini-Mental Adjustment to Cancer scale (Mini-MAC), and the Cancer Worries Inventory (CWI) were used to measure psychological morbidity, coping strategies and concerns about illness. RESULTS: Of 277 patients, 34% had pathological scores ("borderline cases" plus "true cases") on HAD-S Anxiety and 24.9% on HAD-S Depression. Total psychiatric "caseness" was 28.5% and 16.6%, according to different HAD cut-offs (14 and 19, respectively). Significant relationships of HAD-S Anxiety, HAD-S Depression, HAD-S Total score, with Mini-MAC Hopeless and Anxious Preoccupation, and CWI score were found. No differences emerged between countries on psychosocial morbidity, while some differences emerged between the countries on coping mechanisms. Furthermore, Fatalism, Avoidance and marginally Hopeless were higher compared to studies carried out in English-speaking countries. LIMITATIONS: The relatively small sample size and the good performance status prevent us to generalize data on patients with different cancer sites and advanced phase of illness. CONCLUSIONS: One-third of the patients presented anxiety and depressive morbidity, with significant differences in characteristics of coping in Mediterranean countries in comparison with English-speaking countries.

Use of Distress and Depression Thermometers to Measure Psychosocial Morbidity Among Southern European Cancer Patients

GOALS OF WORK: Recent literature has indicated the need for rapid evaluation of psychosocial issues secondary to cancer. Because of the problems of routine use of psychometric instruments, short instruments such as visual analogue scales or one-item 0-10 scales have been developed as valid assessment alternatives. PATIENTS AND METHODS: A study was conducted to examine the role of two 0-10 scales in measuring emotional stress (distress thermometer, DT) and depressed mood (mood thermometer, MT), respectively, in a multicenter study carried out in southern European countries (Italy, Portugal, Spain, and Switzerland). A convenience sample of 312 cancer outpatients completed the DT and MT and the Hospital Anxiety Depression Scale (HADS). MAIN RESULTS: DT was more significantly associated HADS anxiety than HADS depression while MT was related both to HADS anxiety and depression. The correlation of MT with HADS was higher than DT. A cutoff point >4 on the DT maximized sensitivity (65%) and specificity (79%) for general psychosocial morbidity while a cutoff >5 identified more severe "caseness" (sensitivity=70%; specificity=73%). On the MT, sensitivity and specificity for general psychosocial morbidity were 85% and 72% by using the cutoff score >3. A score >4 on the MT was associated with a sensitivity of 78% and a specificity of 77% in detecting more severe caseness. CONCLUSIONS: Two simple instruments, the DT and the MT, were found to have acceptable levels of sensitivity and specificity in detecting psychosocial morbidity. Compared to the HADS, however, the mood MT performed better than the DT.

Risk of Surgery for Congenital Heart Disease in the Adult: a Multicentered European Study

BACKGROUND: Surgery for congenital heart disease (CHD) has changed considerably during the last three decades. The results of primary repair have steadily improved, to allow treating almost all patients within the pediatric age; nonetheless an increasing population of adult patients requires surgical treatment. The objective of this study is to present the early surgical results of patients who require surgery for CHD in the adult population within a multicentered European study population. METHODS: Data relative to the hospital course of 2,012 adult patients (age > or = 18 years) who required surgical treatment for CHD from January 1, 1997 through December 31, 2004 were reviewed. Nineteen cardiothoracic centers from 13 European countries contributed to the data collection. RESULTS: Mean age at surgery was 34.4 +/- 14.53 years. Most of the operations were corrective procedures (1,509 patients, 75%), followed by reoperations (464 patients, 23.1%) and palliative procedures (39 patients, 1.9%). Six hundred forty-nine patients (32.2%) required surgical closure of an isolated ostium secundum atrial septal defect. Overall hospital mortality was 2%. Preoperative cyanosis, arrhythmias, and NYHA class III-IV, proved significant risk factors for hospital mortality. Follow-up data were available in 1,342 of 1,972 patients (68%) who were discharged home. Late deaths occurred in 6 patients (0.5%). Overall survival probability was 97% at 60 months, which is higher for corrective procedures (98.2%) if compared with reoperations (94.1%) and palliations (86.1%). CONCLUSIONS: Surgical treatment of CHD in adult patients, in specialized cardiac units, proved quite safe, beneficial, and low-risk.

Do Spirituality and Faith Make a Difference? Report from the Southern European Psycho-Oncology Study Group

OBJECTIVE: In the last decade, some attention has been given to spirituality and faith and their role in cancer patients' coping. Few data are available about spirituality among cancer patients in Southern European countries, which have a big tradition of spirituality, namely, the Catholic religion. As part of a more general investigation (Southern European Psycho-Oncology Study--SEPOS), the aim of this study was to examine the effect of spirituality in molding psychosocial implications in Southern European cancer patients. METHOD: A convenience sample of 323 outpatients with a diagnosis of cancer between 6 to 18 months, a good performance status (Karnofsky Performance Status > 80), and no cognitive deficits or central nervous system (CNS) involvement by disease were approached in university and affiliated cancer centers in Italy, Spain, Portugal, and Switzerland (Italian speaking area). Each patient was evaluated for spirituality (Visual Analog Scale 0-10), psychological morbidity (Hospital Anxiety and Depression Scale--HADS), coping strategies (Mini-Mental Adjustment to Cancer--Mini-MAC) and concerns about illness (Cancer Worries Inventory--CWI). RESULTS. The majority of patients (79.3%) referred to being supported by their spirituality/faith throughout their illness. Significant differences were found between the spirituality and non-spirituality groups (p ≤ 0.01) in terms of education, coping styles, and psychological morbidity. Spirituality was significantly correlated with fighting spirit (r = -0.27), fatalism (r = 0.50), and avoidance (r = 0.23) coping styles and negatively correlated with education (r = -0.25), depression (r = -0.22) and HAD total (r = -0.17). SIGNIFICANCE OF RESULTS: Spirituality is frequent among Southern European cancer patients with lower education and seems to play some protective role towards psychological morbidity, specifically depression. Further studies should examine this trend in Southern European cancer patients.

The Arterial Switch Operation in Europe for Transposition of the Great Arteries: a Multi-Institutional Study from the European Congenital Heart Surgeons Association

OBJECTIVES: This study analyzes the results of the arterial switch operation for transposition of the great arteries in member institutions of the European Congenital Heart Surgeons Association. METHODS: The records of 613 patients who underwent primary arterial switch operations in each of 19 participating institutions in the period from January 1998 through December 2000 were reviewed retrospectively. RESULTS: A ventricular septal defect was present in 186 (30%) patients. Coronary anatomy was type A in 69% of the patients, and aortic arch pathology was present in 20% of patients with ventricular septal defect. Rashkind septostomy was performed in 75% of the patients, and 69% received prostaglandin. There were 37 hospital deaths (operative mortality, 6%), 13 (3%) for patients with an intact ventricular septum and 24 (13%) for those with a ventricular septal defect (P < .001). In 36% delayed sternal closure was performed, 8% required peritoneal dialysis, and 2% required mechanical circulatory support. Median ventilation time was 58 hours, and intensive care and hospital stay were 6 and 14 days, respectively. Although of various preoperative risk factors the presence of a ventricular septal defect, arch pathology, and coronary anomalies were univariate predictors of operative mortality, only the presence of a ventricular septal defect approached statistical significance (P = .06) on multivariable analysis. Of various operative parameters, aortic crossclamp time and delayed sternal closure were also univariate predictors; however, only the latter was an independent statistically significant predictor of death. CONCLUSIONS: Results of the procedure in European centers are compatible with those in the literature. The presence of a ventricular septal defect is the clinically most important preoperative risk factor for operative death, approaching statistical significance on multivariable analysis.

Results of Surgery for Ebstein Anomaly: a Multicenter Study from the European Congenital Heart Surgeons Association

OBJECTIVE: Since most centers' experience with Ebstein anomaly is limited, we sought to analyze the collective experience of participating institutions of the European Congenital Heart Surgeons Association with surgery for this rare malformation. METHODS: The records of all 150 patients (median age 6.4 years) who underwent surgery for Ebstein anomaly in the 13 participating Association centers between January 1992 and January 2005 were reviewed retrospectively. Patients with congenitally corrected transposition were excluded. RESULTS: Most patients (81%) had Ebstein disease type B or C and significant functional impairment (61% in New York Heart Association class III or IV) and 16% had prior operations. Surgical procedures (n = 179) included valve replacement (n = 60, 33.5%), valve repair (n = 49, 27.3%), 1(1/2) ventricle repair (n = 46, 25.6%), palliative shunt (n = 13, 7.26%), and other complex procedures (n = 11, 6.14%). There were 20 hospital deaths (operative mortality 13.3%) after valve replacement in 5 patients, valve repair in 3, 1(1/2) ventricle repair in 7, palliative procedures in 3, and miscellaneous procedures in 2. Younger age and palliative procedures were univariate risk factors for operative death, but only age was an independent predictor on multivariable analysis. CONCLUSIONS: Most patients coming to surgery presented in childhood and were significantly symptomatic. More than half underwent valve replacement or repair, but a considerable proportion had severe disease necessitating 1(1/2) ventricle repair or palliative procedures. Operative mortality did not differ significantly among repair, replacement, and 1(1/2) ventricle repair but was associated with palliative procedures for severe disease early in life, young age being the only independent predictor of operative death.

Hopelessness and Related Variables among Cancer Patients in the Southern European Psycho-Oncology Study (SEPOS).

BACKGROUND: Although hopelessness has been studied in cancer, no data are available in non-English-speaking countries. OBJECTIVE: The authors sought to amass data from Southern European countries (Italy, Portugal, Spain, and Switzerland) in order to fill this void. METHOD: A group of 312 cancer patients completed the Mini-MAC Hopelessness subscale, the Hospital Anxiety and Depression Scale (HADS), the Cancer Worry Inventory (CWI), and a six-item Visual Analog scale (VAS) to measure intensity of physical symptoms, general well-being, difficulty in coping with cancer, intensity of social support from close relationships, leisure activity, and support from religious beliefs. RESULTS: Regression analysis indicated that HADS-Depression, VAS Maladaptive Coping and Well-Being, and the CWI explained 42% of the variance. CONCLUSION: Hopelessness in cancer patients seems not exclusively to correspond to depression, but is related to various other psychosocial factors, such as maladaptive coping, as well.

A Communication Intervention for Training Southern European Oncologists to Recognize Psychosocial Morbidity in Cancer. I - Development of the Model and Preliminary Results on Physicians' Satisfaction

BACKGROUND: The detection of psychosocial distress is a significant communication problem in Southern Europe and other countries. Work in this area is hampered by a lack of data. Because not much is known about training aimed at improving the recognition of psychosocial disorders in cancer patients, we developed a basic course model for medical oncology professionals. METHODS: A specific educational and experiential model (12 hours divided into 2 modules) involving formal teaching (ie, journal articles, large-group presentations), practice in small groups (ie, small-group exercises and role playing), and discussion in large groups was developed with the aim of improving the ability of oncologists to detect emotional disturbances in cancer patients (ie, depression, anxiety, and adjustment disorders). RESULTS: A total of 30 oncologists from 3 Southern European countries (Italy, Portugal, and Spain) participated in the workshop. The training course was well accepted by most participants who expressed general satisfaction and a positive subjective perception of the utility of the course for clinical practice. Of the total participants, 28 physicians (93.3%) thought that had they been exposed to this material sooner, they would have incorporated the techniques received in the workshop into their practices; 2 participants stated they would likely have done so. Half of the doctors (n = 15) believed that their clinical communication techniques were improved by participating in the workshop, and the remaining half thought that their abilities to communicate with cancer patients had improved. CONCLUSIONS: This model is a feasible approach for oncologists and is easily applicable to various oncology settings. Further studies will demonstrate the effectiveness of this method for improving oncologists skills in recognizing emotional disorders in their patients with cancer.

Inferior Vena Cava Filter Placement During Pregnancy: an Adjuvant Option When Medical Therapy Fails

The authors present a case of a 27-year-old multiparous woman, with multiple thrombophilia, whose pregnancy was complicated with deep venous thrombosis requiring placement of a vena cava filter. At 15th week of gestation, following an acute deep venous thrombosis of the right inferior limb, anticoagulant therapy with low-molecular-weight heparin (LMWH) was instituted without improvement in her clinical status. Subsequently, at 18 weeks of pregnancy, LMWH was switched to warfarin. At 30th week of gestation, the maintenance of high thrombotic risk was the premise for placement of an inferior vena cava filter for prophylaxis of pulmonary embolism during childbirth and postpartum. There were no complications and a vaginal delivery was accomplished at 37 weeks of gestation. Venal placement of inferior vena cava filters is an attractive option as prophylaxis for pulmonary embolism during pregnancy.

Long-Term Evaluation of Recurrence after Photodynamic Therapy with Topical Methyl Aminolevulinate for Non-Melanoma Skin Cancer: a Hospital-Based Study

Introduction & Objectives: Several factors may influence the decision to pursue nonsurgical modalities for the treatment of non-melanoma skin cancer. Topical photodynamic therapy (PDT) is a non-invasive alternative treatment reported to have a high efficacy when using standardized protocols in Bowen’s disease (BD), superficial basal cell carcinoma (BCC) and in thin nodular BCC. However, long-term recurrence studies are lacking. The aim of this study was to evaluate the long-term efficacy of PDT with topical methylaminolevulinate (MAL) for the treatment of BD and BCC in a dermato-oncology department. Materials & Methods: All patients with the diagnosis of BD or BCC, treated with MAL-PDT from the years 2004 to 2008, were enrolled. Treatment protocol included two MAL-PDT sessions one week apart repeated at three months when incomplete response, using a red light dose of 37-40 J/cm2 and an exposure time of 8’20’’. Clinical records were retrospectively reviewed, and data regarding age, sex, tumour location, size, treatment outcomes and recurrence were registered. Descriptive analysis was performed using chi square tests, followed by survival analysis with the Kaplan-Meier and Cox regression models. Results: Sixty-eight patients (median age 71.0 years, P25;P75=30;92) with a total of 78 tumours (31 BD, 45 superficial BCC, 2 nodular BCC) and a median tumour size of 5 cm2 were treated. Overall, the median follow-up period was 43.5 months (P25;P75=0;100), and a total recurrence rate of 33.8% was observed (24.4 % for BCC vs. 45.2% for BD). Estimated recurrence rates for BCC and BD were 5.0% vs. 7.4% at 6 months, 23.4% vs. 27.9% at 12 months, and 30.0% vs. 72.4% at 60 months. Both age and diagnosis were independent prognostic factors for recurrence, with significantly higher estimated recurrence rates in patients with BD (p=0.0036) or younger than 58 years old (p=0.039). The risk of recurrence (hazard ratio) was 2.4 times higher in patients with BD compared to superficial BCC (95% CI:1.1-5.3; p=0.033), and 2.8 times higher in patients younger than 58 years old (95% CI:1.2-6.5; p=0.02). Conclusions: In the studied population, estimated recurrence rates are higher than those expected from available literature, possibly due to a longer follow-up period. To the authors’ knowledge there is only one other study with a similar follow-up period, regarding BCC solely. BD, as an in situ squamous cell carcinoma, has a higher tendency to recur than superficial BCC. Despite greater cosmesis, PDT might no be the best treatment option for young patients considering their higher risk of recurrence.

Vulvar Lichen Sclerosus: Efficacy of Photodynamic Therapy Under Conscious Sedation with Inhaled 50% Nitrous Oxide and Oxygen Mixture

Anogenital lichen sclerosus is a chronic, inflammatory, mucocutaneous disorder of significant morbidity. Common symptoms include pruritus, pain, dysuria, and dyspareunia, frequently of difficult control. Photodynamic therapy (PDT) may be an effective therapeutic option in selected cases refractory to first--‐line treatment options. However, procedure--‐related pain is a limiting factor in patient adherence to treatment. Conscious sedation and analgesia with a ready--‐to--‐use gas mixture of nitrous oxide and oxygen is useful in short--‐term procedures. It provides a rapid, effective, and short--‐lived effect, without the need for anesthesiology support. A 75--‐year--‐old woman presented with a highly symptomatic, histologically confirmed vulvar lichen sclerosus, with at least 15 years of evolution. Pain, pruritus, and dysuria were intense and disabling. Treatment with ultrapotent topical corticosteroids proved to be ineffective despite patient compliance. She was then referred for PDT. A total of 3 sessions were performed, held at a mean interval of 9 weeks, and under the analgesic and sedative effect of nitrous oxide/oxygen gas. Response to treatment was evaluated through a daily, self--‐reported pain rating scale. Dysuria remitted completely after the first PDT session. An 80% reduction in pruritus and pain was observed after the third session, and has been sustained for the past six months without further need for topical corticotherapy. Treatment sessions were well tolerated and pain-- free, with no side effects to report. PDT appears to be effective in the symptomatic treatment of vulvar lichen sclerosus. To the authors’ knowledge this is the first case reporting the use of inhaled nitrous oxide/oxygen gas mixture during PDT performed in the genital area. Its analgesic and sedative effects may increase patients’ adherence to this painful procedure. Furthermore, given its safety, it can be easily managed in outpatient clinics by trained dermatologists.

Locally Advanced and Metastatic Prostate Cancer Treated with Intermittent Androgen Monotherapy or Maximal Androgen Blockade: Results from a Randomised Phase 3 Study by the South European Uroncological Group

BACKGROUND: Few randomised studies have compared antiandrogen intermittent hormonal therapy (IHT) with continuous maximal androgen blockade (MAB) therapy for advanced prostate cancer (PCa). OBJECTIVE: To determine whether overall survival (OS) on IHT (cyproterone acetate; CPA) is noninferior to OS on continuous MAB. DESIGN, SETTING, AND PARTICIPANTS: This phase 3 randomised trial compared IHT and continuous MAB in patients with locally advanced or metastatic PCa. INTERVENTION: During induction, patients received CPA 200 mg/d for 2 wk and then monthly depot injections of a luteinising hormone-releasing hormone (LHRH; triptoreline 11.25 mg) analogue plus CPA 200 mg/d. Patients whose prostate-specific antigen (PSA) was <4 ng/ml after 3 mo of induction treatment were randomised to the IHT arm (stopped treatment and restarted on CPA 300 mg/d monotherapy if PSA rose to ≥20 ng/ml or they were symptomatic) or the continuous arm (CPA 200 mg/d plus monthly LHRH analogue). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome measurement was OS. Secondary outcomes included cause-specific survival, time to subjective or objective progression, and quality of life. Time off therapy in the intermittent arm was recorded. RESULTS AND LIMITATIONS: We recruited 1045 patients, of which 918 responded to induction therapy and were randomised (462 to IHT and 456 to continuous MAB). OS was similar between groups (p=0.25), and noninferiority of IHT was demonstrated (hazard ratio [HR]: 0.90; 95% confidence interval [CI], 0.76-1.07). There was a trend for an interaction between PSA and treatment (p=0.05), favouring IHT over continuous therapy in patients with PSA ≤1 ng/ml (HR: 0.79; 95% CI, 0.61-1.02). Men treated with IHT reported better sexual function. Among the 462 patients on IHT, 50% and 28% of patients were off therapy for ≥2.5 yr or >5 yr, respectively, after randomisation. The main limitation is that the length of time for the trial to mature means that other therapies are now available. A second limitation is that T3 patients may now profit from watchful waiting instead of androgen-deprivation therapy. CONCLUSIONS: Noninferiority of IHT in terms of survival and its association with better sexual activity than continuous therapy suggest that IHT should be considered for use in routine clinical practice.

Compliance with ESPGHAN Position on Complementary Feeding in a Multicultural European Community. Does Ethnicity Matter?

Introduction: In 2008, ESPGHAN published a position paper on complementary feeding providing recommendations to health care professionals. Cultural and socio-economic factors might affect the compliance to these orientations. Aim: To estimate the prevalence of inadequacies during complementary feeding (ESPGHAN, 2008) and its association with different ethnic backgrounds. Methods: Cross-sectional survey of a convenience sample of caretakers of children up to 24 months of age in a single community health centre in Greater Lisbon, through a volunteer, self-applied questionnaire. Results: From a sample of children with wide cultural diversity, 161 valid questionnaires were obtained (median child’s age 9 months, median mother’s age 32 years). The prevalence rate of at least one complementary feeding inadequacy was 46% (95%CI: 38.45-53.66). The commonest inadequacies were: avoiding lumpy solid foods after 10 months of age (66.7%), avoidance or delayed introduction of foods beyond 12 months (35.4%), introduction of gluten beyond 7 months (15.9%) or salt before 12 months (6.7%). For each increase of 1 month in the age of the child, the odds of inadequacies raised 36.7% (OR = 1.37; 95%CI: 1.20-1.56; p < 0.001). The odds for inadequacies in children of African or Brazilian offspring was three times higher that of Portuguese ancestry (OR = 3.31; 95%CI: 0.87-12.61; p = 0.079). The influence of grandparents was related to an increase in the odds of inadequacies (OR = 3.69; 95%CI: 0.96-14.18; p = 0.058).Conclusion: Inadequacies during complementary feeding are frequent and may be influenced by the cultural background.

Variation in Haemodynamic Monitoring for Major Surgery in European Nations: Secondary Analysis of the EuSOS Dataset

BACKGROUND: The use of cardiac output monitoring may improve patient outcomes after major surgery. However, little is known about the use of this technology across nations. METHODS: This is a secondary analysis of a previously published observational study. Patients aged 16 years and over undergoing major non-cardiac surgery in a 7-day period in April 2011 were included into this analysis. The objective is to describe prevalence and type of cardiac output monitoring used in major surgery in Europe. RESULTS: Included in the analysis were 12,170 patients from the surgical services of 426 hospitals in 28 European nations. One thousand four hundred and sixteen patients (11.6 %) were exposed to cardiac output monitoring, and 2343 patients (19.3 %) received a central venous catheter. Patients with higher American Society of Anesthesiologists (ASA) scores were more frequently exposed to cardiac output monitoring (ASA I and II, 643 patients [8.6 %]; ASA III-V, 768 patients [16.2 %]; p < 0.01) and central venous catheter (ASA I and II, 874 patients [11.8 %]; ASA III-V, 1463 patients [30.9 %]; p < 0.01). In elective surgery, 990 patients (10.8 %) were exposed to cardiac output monitoring, in urgent surgery 252 patients (11.7 %) and in emergency surgery 173 patients (19.8 %). A central venous catheter was used in 1514 patients (16.6 %) undergoing elective, in 480 patients (22.2 %) undergoing urgent and in 349 patients (39.9 %) undergoing emergency surgery. Nine hundred sixty patients (7.9 %) were monitored using arterial waveform analysis, 238 patients (2.0 %) using oesophageal Doppler ultrasound, 55 patients (0.5 %) using a pulmonary artery catheter and 44 patients (2.0 %) using other technologies. Across nations, cardiac output monitoring use varied from 0.0 % (0/249 patients) to 27.5 % (19/69 patients), whilst central venous catheter use varied from 5.6 % (7/125 patients) to 43.2 % (16/37 patients). CONCLUSIONS: One in ten patients undergoing major surgery is exposed to cardiac output monitoring whilst one in five receives a central venous catheter. The use of both technologies varies widely across Europe.