Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer.

Selective internal radiotherapy (SIRT) is a liver-directed treatment involving the injection of yttrium-90 microspheres into the blood supply of liver tumours. There are very few studies assessing health-related quality of life (HRQOL) in patients treated with SIRT. Patients with liver metastases from colorectal cancer (CRC) were randomised in the FOXFIRE (FFr; ISRCTN83867919), SIRFLOX (SF; NCT00724503) and FOXFIRE-Global (FFrG; NCT01721954) trials of first-line oxaliplatin-fluorouracil (FOLFOX) chemotherapy combined with SIRT versus FOLFOX alone. HRQOL was assessed using the three-level EQ-5D, European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and EORTC Colorectal Liver Metastases cancer module (EORTC QLQ-LMC21) at baseline, ≤3 months, 6 months, 12 months and annually thereafter from randomisation, and at disease progression. Analyses were conducted on an intention-to-treat basis. In total, 554 patients were randomised to SIRT + FOLFOX and 549 patients to FOLFOX alone. HRQOL was statistically significant lower in SIRT + FOLFOX patients ≤3 months after SIRT administration in all three instruments, particularly global health, physical and role functioning and symptoms of fatigue, nausea/vomiting and appetite loss. By accepted thresholds, these differences were deemed not clinically important. Differences between SIRT + FOLFOX and FOLFOX alone over the 2-year follow up and at disease progression were also not clinically important. Although there is some decrease in HRQOL for up to 3 months following SIRT, the addition of SIRT to FOLFOX chemotherapy does not change HRQOL to a clinically important degree in metastatic CRC patients.

First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.

BACKGROUND: Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival. METHODS: FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA). Chemotherapy-naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation were randomly assigned (1:1) to either oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy. In FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy; 85 mg/m2 oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin 350 mg infusion over 2 h, and 400 mg/m2 bolus fluorouracil followed by a 2400 mg/m2 continuous fluorouracil infusion over 46 h). In SIRFLOX and FOXFIRE-Global, FOLFOX chemotherapy was modified FOLFOX6 (85 mg/m2 oxaliplatin infusion over 2 h, 200 mg leucovorin, and 400 mg/m2 bolus fluorouracil followed by a 2400 mg/m2 continuous fluorouracil infusion over 46 h). Randomisation was done by central minimisation with four factors: presence of extrahepatic metastases, tumour involvement of the liver, planned use of a biological agent, and investigational centre. Participants and investigators were not masked to treatment. The primary endpoint was overall survival, analysed in the intention-to-treat population, using a two-stage meta-analysis of pooled individual patient data. All three trials have completed 2 years of follow-up. FOXFIRE is registered with the ISRCTN registry, number ISRCTN83867919. SIRFLOX and FOXFIRE-Global are registered with ClinicalTrials.gov, numbers NCT00724503 (SIRFLOX) and NCT01721954 (FOXFIRE-Global). FINDINGS: Between Oct 11, 2006, and Dec 23, 2014, 549 patients were randomly assigned to FOLFOX alone and 554 patients were assigned FOLFOX plus SIRT. Median follow-up was 43·3 months (IQR 31·6-58·4). There were 411 (75%) deaths in 549 patients in the FOLFOX alone group and 433 (78%) deaths in 554 patients in the FOLFOX plus SIRT group. There was no difference in overall survival (hazard ratio [HR] 1·04, 95% CI 0·90-1·19; p=0·61). The median survival time in the FOLFOX plus SIRT group was 22·6 months (95% CI 21·0-24·5) compared with 23·3 months (21·8-24·7) in the FOLFOX alone group. In the safety population containing patients who received at least one dose of study treatment, as treated, the most common grade 3-4 adverse event was neutropenia (137 [24%] of 571 patients receiving FOLFOX alone vs 186 (37%) of 507 patients receiving FOLFOX plus SIRT). Serious adverse events of any grade occurred in 244 (43%) of 571 patients receiving FOLFOX alone and 274 (54%) of 507 patients receiving FOLFOX plus SIRT. 10 patients in the FOLFOX plus SIRT group and 11 patients in the FOLFOX alone group died due to an adverse event; eight treatment-related deaths occurred in the FOLFOX plus SIRT group and three treatment-related deaths occurred in the FOLFOX alone group. INTERPRETATION: Addition of SIRT to first-line FOLFOX chemotherapy for patients with liver-only and liver-dominant metastatic colorectal cancer did not improve overall survival compared with that for FOLFOX alone. Therefore, early use of SIRT in combination with chemotherapy in unselected patients with metastatic colorectal cancer cannot be recommended. To further define the role of SIRT in metastatic colorectal cancer, careful patient selection and studies investigating the role of SIRT as consolidation therapy after chemotherapy are needed. FUNDING: Bobby Moore Fund of Cancer Research UK, Sirtex Medical.

Does eating family meals and having the television on during dinner correlate with overweight? A sub-study of the PRO GREENS project, looking at children from nine European countries.

OBJECTIVE: Family meals have been negatively associated with overweight in children, while television (TV) viewing during meals has been associated with a poorer diet. The aim of the present study was to assess the association of eating family breakfast and dinner, and having a TV on during dinner, with overweight in nine European countries and whether these associations differed between Northern and Southern & Eastern Europe. DESIGN: Cross-sectional data. Schoolchildren reported family meals and TV viewing. BMI was based on parental reports on height and weight of their children. Cut-off points for overweight by the International Obesity Task Force were used. Logistic regressions were performed adjusted by age, gender and parental education. SETTING: Schools in Northern European (Sweden, the Netherlands, Iceland, Germany and Finland) and Southern & Eastern European (Portugal, Greece, Bulgaria and Slovenia) countries, participating in the PRO GREENS project. SUBJECTS: Children aged 10-12 years in (n 6316). RESULTS: In the sample, 21 % of the children were overweight, from 35 % in Greece to 10 % in the Netherlands. Only a few associations were found between family meals and TV viewing during dinner with overweight in the nine countries. Northern European children, compared with other regions, were significantly more likely to be overweight if they had fewer family breakfasts and more often viewed TV during dinner. CONCLUSIONS: The associations between family meals and TV viewing during dinner with overweight were few and showed significance only in Northern Europe. Differences in foods consumed during family meals and in health-related lifestyles between Northern and Southern & Eastern Europe may explain these discrepancies.

Irrational prescribing of over-the-counter (OTC) medicines in general practice: testing the feasibility of an educational intervention among physicians in five European countries.

BACKGROUND: Irrational prescribing of over-the-counter (OTC) medicines in general practice is common in Southern Europe. Recent findings from a research project funded by the European Commission (FP7), the "OTC SOCIOMED", conducted in seven European countries, indicate that physicians in countries in the Mediterranean Europe region prescribe medicines to a higher degree in comparison to physicians in other participating European countries. In light of these findings, a feasibility study has been designed to explore the acceptance of a pilot educational intervention targeting physicians in general practice in various settings in the Mediterranean Europe region. METHODS: This feasibility study utilized an educational intervention was designed using the Theory of Planned Behaviour (TPB). It took place in geographically-defined primary care areas in Cyprus, France, Greece, Malta, and Turkey. General Practitioners (GPs) were recruited in each country and randomly assigned into two study groups in each of the participating countries. The intervention included a one-day intensive training programme, a poster presentation, and regular visits of trained professionals to the workplaces of participants. Reminder messages and email messages were, also, sent to participants over a 4-week period. A pre- and post-test evaluation study design with quantitative and qualitative data was employed. The primary outcome of this feasibility pilot intervention was to reduce GPs' intention to provide medicines following the educational intervention, and its secondary outcomes included a reduction of prescribed medicines following the intervention, as well as an assessment of its practicality and acceptance by the participating GPs. RESULTS: Median intention scores in the intervention groups were reduced, following the educational intervention, in comparison to the control group. Descriptive analysis of related questions indicated a high overall acceptance and perceived practicality of the intervention programme by GPs, with median scores above 5 on a 7-point Likert scale. CONCLUSIONS: Evidence from this intervention will estimate the parameters required to design a larger study aimed at assessing the effectiveness of such educational interventions. In addition, it could also help inform health policy makers and decision makers regarding the management of behavioural changes in the prescribing patterns of physicians in Mediterranean Europe, particularly in Southern European countries.

Comparison of visual acuity charts in young adults and patients with diabetic retinopathy.

PURPOSE: To compare visual acuity (VA) assessed in healthy eyes and eyes with diabetic retinopathy (DR) using three different logMAR charts: the Sloan letter European-wide chart, the tumbling E chart, and the Landolt C chart. METHODS: Measurements on one eye of 40 volunteers (aged 29 ± 4 years) without visual impairment and 31 DR patients (aged 70 ± 9 years) with mild/moderate visual impairment were included. Visual acuity was assessed, with habitual refractive correction, using each of the three charts. Bland-Altman charts were constructed, and 95% limits of agreement were calculated to measure agreement. RESULTS: Mean VA in the group of young adults was -0.05 ± 0.10 (Sloan letter), -0.02 ± 0.13 (tumbling E), and 0.00 ± 0.12 (Landolt C) logMAR. Average VA estimates differed to a statistically significant extent between all charts. Mean VA in the DR group was 0.46 ± 0.25 (Sloan letter), 0.48 ± 0.26 (tumbling E), and 0.59 ± 0.28 (Landolt C). A statistically significant difference was observed for average Sloan letter versus Landolt C (p < 0.001) and tumbling E versus Landolt C (p < 0.001) acuities. Moreover, in healthy eyes, a moderate correlation (r = -0.38, p = 0.015) was found between the discrepancy in Sloan letter and Landolt C acuity and the mean VA estimate. The 95% limits of agreement were wide (more than approximately 0.2 logMAR for each comparison) and wider in the DR group chart comparisons than in healthy eyes. CONCLUSIONS: Landolt C charts resulted in worse VA estimates compared with letter and tumbling E charts in both young adults and visually impaired subjects with DR. These differences seem more pronounced in DR patients who exhibit worse VAs. The specific study population must be considered in comparing outcomes from different clinical practices.

Effect of blur and subsequent adaptation on visual acuity using letter and Landolt C charts: differences between emmetropes and myopes.

PURPOSE: To compare the effects of defocus induced blur and blur adaptation on visual acuity and to evaluate any differences between emmetropes and myopes using letter and Landolt C logMAR charts. METHODS: The sample consisted of 26 volunteers, with a mean age of 27 ± 3 years, comprising 13 emmetropes (spherical equivalent range: -0.63 to +0.50 D) and 13 myopes (spherical equivalent range: -0.75 to -5.00 D). Monocular visual acuity (VA) was measured in each eye using letter and Landolt C logMAR charts under the following conditions: (1) with the distance refractive correction, (2) immediately after exposure to +2.00 D defocus and (3) following 60 min of binocular adaptation to +2.00 D blur. Objective refraction at the beginning and at the end of the experimental procedure was evaluated. Averaged VA data between the two eyes were used for analysis. RESULTS: Deterioration in VA with +2.00 D defocus was greater in the emmetropes compared to myopes for both charts. The mean difference between the two refractive groups was more pronounced for the Landolt-C (0.17 logMAR) compared to the letter chart (0.10 logMAR). The reduction in VA with blur was related to the amount of the refractive error. Following 60 min of adaptation, a significant improvement in VA was observed in both groups that did not differ between the two charts. The improvement in VA following adaptation using the letter chart was linearly correlated with spherical equivalent refractive correction. CONCLUSIONS: Myopes show higher tolerance to retinal defocus compared to emmetropes, which could be attributed to previous blur experience. The effect of blur on VA is more pronounced using Landolt C optotypes than with letters. Prolonged exposure to blur results in equally improved performance for both refractive groups.

Prospective study of foveal thickness alterations after cataract surgery assessed by optical coherence tomography.

BACKGROUND/AIMS: To evaluate the alterations of mean foveal thickness (MFT) and visual acuity (VA) outcomes after uncomplicated cataract surgery in different groups of patients. METHODS: This study included eyes of consecutive patients who underwent cataract surgery between November 2007 and June 2009. The patients included in the study were divided into 4 groups, as follows: history-free patients, patients with diabetes mellitus without macular involvement at baseline, patients with glaucoma, and patients with epiretinal membrane (ERM). Preoperatively and at 1, 3 and 6 months postoperatively, patients were evaluated for MFT by optical coherence tomography at the central 1-mm macular zone and for logarithm of the minimum angle of resolution best spectacle-corrected VA (BSCVA). RESULTS: A total of 202 eyes were included in the study. MFT values demonstrated a statistically significant increase (p < 0.01) after cataract surgery in all groups at the first and third postoperative month. The history-free (p = 0.09) and glaucoma (p = 0.19) groups did not demonstrate a statistically significant difference in MFT values between the preoperative and 6-month measurements. MFT values 6 months after cataract surgery in the diabetes and ERM groups remained significantly higher (p < 0.01). Despite these findings, VA increased significantly (p < 0.01) in all groups at all postoperative follow-ups. CONCLUSIONS: MFT values increased significantly in all groups at the first and third months after cataract surgery. At 6 months, MFT values returned to preoperative levels in the history-free and glaucoma patients, while they remained significantly higher in the diabetic and ERM patients. Despite these macular alterations, BSCVA improved significantly after cataract surgery in all groups at all postoperative follow-ups.

Approaches to breast cancer screening among primary care physicians in rural areas of crete, Greece.

The aim of this study was to assess levels of knowledge regarding breast cancer screening among primary care physicians in rural areas of Crete. A cross-sectional survey of 106 general practitioners and internists and 83 trainee general practitioners (GPs) employed as of October 2004 and practicing at 14 primary health centers in Crete was performed. It was a self-administered survey with 27 items exploring knowledge, attitudes, and behaviors concerning delivery of general preventive and cancer screening services. The main outcome measures were responses to four items on approaches to breast cancer screening practices. Overall response rate was 55% (primary care physicians (PCPs) = 53%; trainee GPs = 60%). Respondents demonstrated a limited awareness of international recommendations for breast cancer screening and exhibited marked variation in their responses to survey items. Agreement with current international guidelines ranged from 31% to 58% for the individual survey items. This survey revealed limited knowledge among PCPs to well-publicized breast cancer screening guidelines and variations in approaches to breast cancer early detection.

A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials.

OBJECTIVES: To systematically assess the kind of placebos used in investigator-initiated randomized controlled trials (RCTs), from where they are obtained, and the hurdles that exist in obtaining them. STUDY DESIGN AND SETTING: PubMed was searched for recently published noncommercial, placebo-controlled randomized drug trials. Corresponding authors were invited to participate in an online survey. RESULTS: From 423 eligible articles, 109 (26%) corresponding authors (partially) participated. Twenty-one of 102 (21%) authors reported that the placebos used were not matching (correctly labeled in only one publication). The main sources in obtaining placebos were hospital pharmacies (32 of 107; 30%) and the manufacturer of the study drug (28 of 107; 26%). RCTs with a hypothesis in the interest of the manufacturer of the study drug were more likely to have obtained placebos from the drug manufacturer (18 of 49; 37% vs. 5 of 29; 17%). Median costs for placebos and packaging were US$ 58,286 (IQR US$ 2,428- US$ 160,770; n = 24), accounting for a median of 10.3% of the overall trial budget. CONCLUSION: Although using matching placebos is widely accepted as a basic practice in RCTs, there seems to be no standard source to acquire them. Obtaining placebos requires substantial resources, and using nonmatching placebos is common.

Atorvastatin for diabetic macular edema in patients with diabetes mellitus and elevated serum cholesterol.

BACKGROUND AND OBJECTIVE: To determine the efficacy of atorvastatin in reducing hard exudates and diabetic macular edema. PATIENTS AND METHODS: An uncontrolled clinical case series included 18 eyes with diabetic maculopathy and an elevated baseline lipid profile. All patients were treated with atorvastatin. Ophthalmologic evaluation, including fundus photography and fluorescein angiography, was performed at presentation and repeated at 3, 6, and 12 months. Hard exudates, hemorrhages, and fluorescein leakage at 12 months were evaluated and compared with baseline findings. RESULTS: Eighteen subjects with diabetic maculopathy received atorvastatin, and a significant decrease in total cholesterol and low-density lipoprotein cholesterol was seen (P < .05). Hard exudates and fluorescein leakage were decreased. No evidence of an association between change in hemorrhage status and treatment was found. CONCLUSION: Oral atorvastatin therapy in patients with diabetes mellitus and dyslipidemia seems to reduce the severity of hard exudates and fluorescein leakage in diabetic maculopathy and could be useful as an adjuvant therapy in the management of diabetic macular edema.

Dual Erb B Inhibition in Oesophago-gastric Cancer (DEBIOC): A phase I dose escalating safety study and randomised dose expansion of AZD8931 in combination with oxaliplatin and capecitabine chemotherapy in patients with oesophagogastric adenocarcinoma.

BACKGROUND: AZD8931 has equipotent activity against epidermal growth factor receptor, erbB2, and erbB3. Primary objectives were to determine the recommended phase II dose (RP2D) of AZD8931 + chemotherapy, and subsequently assess safety/preliminary clinical activity in patients with operable oesophagogastric cancer (OGC). METHODS: AZD8931 (20 mg, 40 mg or 60 mg bd) was given with Xelox (oxaliplatin + capecitabine) for eight 21-day cycles, continuously or with intermittent schedule (4 days on/3 off every week; 14 days on/7 off, per cycle) in a rolling-six design. Subsequently, patients with OGC were randomised 2:1 to AZD8931 + Xelox at RP2D or Xelox only for two cycles, followed by radical oesophagogastric surgery. Secondary outcomes were safety, complete resection (R0) rate, six-month progression-free survival (PFS) and overall survival. RESULTS: During escalation, four dose-limiting toxicities were observed among 24 patients: skin rash (1) and failure to deliver 100% of Xelox because of treatment-associated grade III-IV adverse events (AEs) (3: diarrhoea and vomiting; vomiting; fatigue). Serious adverse events (SAE) occurred in 15 of 24 (63%) patients. RP2D was 20-mg bd with the 4/3 schedule. In the expansion phase, 2 of 20 (10%) patients in the Xelox + AZD8931 group and 5/10 (50%) patients in the Xelox group had grade III-IV AEs. Six-month PFS was 85% (90% CI: 66%-94%) in Xelox + AZD8931 and 100% in Xelox alone. Seven deaths (35%) occurred with Xelox + AZD8931 and one (10%) with Xelox. R0 rate was 45% (9/20) with Xelox + AZD8931 and 90% (9/10) with Xelox-alone (P = 0.024). CONCLUSION: Xelox + AZD8931 (20 mg bd 4/3 days) has an acceptable safety profile administered as neoadjuvant therapy in operable patients with OGC. (Trial registration: EudraCT 2011-003169-13, ISRCTN-68093791).

Cognitive impairment in a primary healthcare population: a cross-sectional study on the island of Crete, Greece.

OBJECTIVES: Cognitive impairment is known to have a significant impact on the quality of life of individuals and their caregivers, yet it is often underdiagnosed. The objective of this study is to assess the extent of cognitive impairment among elders visiting primary healthcare (PHC) practice settings, to explore associated risk factors and discuss current care challenges for PHC providers. DESIGN: A cross-sectional study was conducted between March 2013 and May 2014. SETTING: Fourteen PHC units located in rural and urban areas of the Heraklion district in Crete, Greece. PARTICIPANTS: Consecutive visitors aged at least 60 years attending selected PHC practices. PRIMARY AND SECONDARY OUTCOME MEASURES: The Mini-Mental State Examination (MMSE) was used to indicate cognitive status. Associations of low MMSE scores (≤23/24, adjusted for education level) with 12 socio-demographic factors, comorbidities and lifestyle factors were assessed. RESULTS: A total of 3140 PHC patients met inclusion criteria (43.2% male; mean age 73.7±7.8 years). The average MMSE score was 26.0±3.8; 26.7±3.5 in male and 25.4±3.9 in female participants (p<0.0001). Low MMSE scores were detected in 20.2% of participants; 25.9% for females vs 12.8% for males; p<0.0001. Female gender (adjusted OR (AOR)=2.72; 95% CI 2.31 to 3.47), age (AOR=1.11; 95% CI 1.10 to 1.13), having received only primary or no formal education (AOR=2.87; 95% CI 2.26 to 3.65), alcohol intake (AOR=1.19; 95% CI 1.03 to 1.37), reporting one or more sleep complaints (AOR 1.63; 95% CI 1.14 to 2.32), dyslipidaemia (AOR=0.80; 95% CI 0.65 to 0.98) and history of depression (AOR=1.90; 95% CI 1.43 to 2.52) were associated with low MMSE scores. CONCLUSIONS: This study identified a relatively high prevalence of low MMSE scores among persons attending PHC practices in a southern European community setting and associations with several known risk factors.

Fatty acid composition of subcutaneous adipose tissue and gastric mucosa: is there a relation with gastric ulceration?

BACKGROUND: Both in vitro and epidemiological studies indicate that dietary polyunsaturated fatty acids may play a protective role against peptic ulcer in humans. Adipose tissue fatty acid composition is thought to reflect dietary fatty acid intake. The aim of the present study is to investigate adipose and gastric mucosa fatty acid levels in relation to gastric ulceration status. METHODS: Fifty two adult outpatients undergoing upper gastrointestinal tract endoscopy participated in the study. Adipose tissue samples were taken from the abdomen and buttock during the endoscopy procedure and samples from gastric tissue were taken from a subsample of 30 subjects. The presence of Helicobacter pylori was determined using the CLO test. Capillary gas chromatography was used for the extraction of 36 and 42 adipose tissue and gastric mucosa lipids respectively. RESULTS: The monounsaturated fatty acids (MUFAs) C18:1n-12c, C16:1n-5, C16:4n-1 and the polyunsaturated fatty acids (PUFAs) C16:3n-4, C20:3n-3, C20:4n-6, C21:5n-3 and C18:2n-9c,12t of the gastric mucosa were present in higher proportions in ulcer negative patients. These unsaturated fatty acids, however, each contributed less than 1% on average to total fatty acid content. In addition, higher average levels of eicosapentaenoic acid (EPA) C20:5n-3 and docosahexaenoic acid (DHA) C22:6n-3 were detected in abdominal and buttock samples in CLO negative controls, compared to CLO positive controls. Adipose tissue and gastric mucosa n-6 and trans fatty acid levels were positively linearly correlated (r = 0.37 and 0.41 for n-6 and trans fatty acids respectively). CONCLUSION: Certain minor MUFAs and PUFAs of the gastric mucosa appear to be present in higher proportions in ulcer negative patients. Overall, the findings provide only weak evidence of an association between the gastric mucosal fatty acids and the presence of gastric ulceration. The higher average levels of EPA and DHA in abdominal and buttock adipose tissue in CLO negative controls could be an indicator that dietary FAs inhibit Helicobacter pylori growth. Larger studies are necessary to provide evidence of a biologically relevant effect.

Myopia and visual acuity impairment: a comparative study of Greek and Bulgarian school children.

PURPOSE: To compare the proportions of school children with myopia and impaired visual acuity in Greece and Bulgaria. METHODS: A sample of 898 children, aged 10-15 years, was selected from two primary and two secondary schools in a Greek city (Heraklion), and one primary and secondary school in a Bulgarian city (Stara Zagora). Five hundred and eighty eight children were Greek (65.5%, mean age 12.5 +/- 0.08 years) and 310 Bulgarian (34.5%, age 12.4 +/- 0.07 years). VA was assessed with the habitual refractive correction. Refractive error was measured in the absence of cycloplegia using an auto-refractor. RESULTS: The percentage of children, tested with their habitual refractive correction, with decimal VA <0.5 in at least one eye was 11.7% (95% CI 9.1-14.3%) for Greek and 5.2% (95% CI 2.7-7.6%) for Bulgarian pupils. The percentage of myopic children also differed between the two countries with the proportion with myopic refractive error

"Cancer Control Practices": translation and cultural adaptation of an instrument in Crete, Greece.

BACKGROUND: Although early detection and systematic prevention of cancer improves outcomes and reduces mortality, General Practitioners' (GP) effectiveness remains an issue that merits further investigation. METHODS: To explore cancer control practices of Greek GPs, a version of the Cancer Control Practices questionnaire, originally developed in Western New York in 2001, was translated and culturally adapted. RESULTS: Its reliability was found satisfactory in most the items. CONCLUSIONS: The instrument can be useful in determining Greek GPs' knowledge and application of internationally established cancer-related guidelines, barriers they face in daily practice, and educational or training needs.

Lack of an association of depression with n-3 polyunsaturated fatty acids in adipose tissue and serum phospholipids in healthy adults.

Studies have shown that depression relates to biomarkers of both short-term and long-term polyunsaturated fatty acid intake. However, it is not known which of these two biomarkers is more closely related to depression. The aim of this study was to examine the relationship of depression with both adipose tissue and serum phospholipid polyunsaturated fatty acids and to assess the importance of each of these two biomarkers in relating to depression. This is a cross-sectional study of healthy adults from the island of Crete. Subjects were examined by the Preventive Medicine and Nutrition Clinic of the University of Crete. Subjects were 394 healthy adults (175 males, 219 females) aged 18-60. The sample consisted of farmers from a number of rural communities of Crete. Fatty acids were determined by gas chromatography in adipose tissue and serum phospholipids. Information about depression was obtained through the Beck Depression Inventory (BDI) and Zung Self-rating Depression Scale (ZSRDS). Adipose tissue alpha-linolenic acid (ALA) (C18:3n-3) was inversely correlated to BDI (r=-0.17, p<0.02). Multiple linear regression analysis taking into account the possible confounding effect of age, gender, body mass index (BMI), smoking and educational level did not confirm this association. The other polyunsaturated fatty acids in adipose tissue were not related to depression. Serum phospholipid polyunsaturated fatty acids did not correlate with depression. This study did not show that the polyunsaturated fatty acids in the adipose tissue are better predictors of depression than those in serum phospholipids.

Active inflammatory bowel disease: head-to-head comparison between 99mTc-hexamethylpropylene amine oxime white blood cells and 99mTc(V)-dimercaptosuccinic acid scintigraphy.

PURPOSE: Evaluation and comparison between pentavalent 99mTc dimercaptosuccinic acid (99mTc(V)-DMSA) and 99mTc-hexamethylpropylene amine oxime white blood cell (99mTc-HMPAO WBC) scintigraphy in the detection and assessment of disease activity in patients with active inflammatory bowel disease (IBD). MATERIALS AND METHODS: 99mTc(V)-DMSA scintigraphy was performed in 23 patients with active IBD and true positive 99mTc-HMPAO WBC scintigraphy. Images were considered positive when an area of increased uptake was observed. To assess severity of IBD, semi-quantitative analysis was included with reference to the uptake in the iliac crest. Comparison with endoscopic, radiological and clinical data was performed. RESULTS: The diagnostic accuracy of 99mTc-HMPAO WBC and 99mTc(V)-DMSA was 91% and 84%, respectively. A significant correlation between the findings of both radioisotopic methods and scintigraphy score was demonstrated. Endoscopic findings were significantly correlated with scintigraphic results. Kappa statistics showed a moderate to good agreement between the two scintigraphic methods. Two patients (8.8%) had negative findings with 99mTc(V)-DMSA scintigraphy (false negative results). CONCLUSION: 99mTc(V)-DMSA compared to 99mTc-HMPAO WBC could provide a simple, non-invasive alternative method for the assessment of disease activity, although it is slightly inferior to 99mTc-HMPAO WBC scintigraphy especially in the evaluation of disease localization in IBD patients.

Septal cartilage reshaping with the use of an Erbium doped glass fiber laser. Preliminary results.

STATEMENT OF PROBLEM: To evaluate the efficacy of Erbium doped glass fiber laser in patients undergoing nasal septal cartilage reshaping. METHOD OF STUDY: A prospective study was conducted in patients undergoing laser nasal septal cartilage reshaping. Microsurgical sponges soaked in a tetracaine solution plus adrenaline were applied in each side of the nose for ten minutes before the procedure. The cartilage of nasal septum was straightened and fixed in the median position using a modified nasal speculum. An optothermomechanical contactor with transparent indenter and thermocouple sensor was placed on septal regions of maximum mechanical stress. Patients were asked to evaluate the severity of pain during the procedure on a visual analog scale. A rhinomanometric evaluation was conducted preoperatively and postoperatively. All patients were asked to evaluate the improvement of their symptoms. All patients' data and potential complications were entered in a database and were statistically assessed. MAIN RESULTS: Our series consisted of 64 patients. Statistical analysis showed significant improvement of their symptoms and of rhinomanometric results. No complications or side effects occurred. The mean operative time was 35 minutes. PRINCIPAL CONCLUSION: Septal cartilage reshaping is an easy painless and bloodless method using en Erbium doped glass fiber Laser. Laser device LSC-701 (Arcuo Medical Inc.) is effective, safe and inexpensive medical equipment.

Perifoveal capillary network quantification in young diabetic patients with subclinical or no retinopathy.

OBJECTIVE: To assess the morphology of perifoveal capillary network with quantitative parameters in young patients with diabetes mellitus type I (DM I) using an algorithm. METHODS: Fifty-three images (33 eyes of 33 DM I patients and 20 eyes of 20 non-DM controls) were chosen retrospectively from the University Hospital of Heraklion digital fluorescein angiography database. An additional group consisting of patients with advanced DR abnormalities was included in our analysis to investigate whether our method detects alterations when they are present. The developed algorithm allows the user to manually trace the perifoveal capillary network by selecting with the cursor in a 5° × 5° subimage field of the original image, including the foveal avascular zone (FAZ), and provides measurements of the capillary density, the branch point density, and the FAZ surface in this subarea. RESULTS: The age in the patient group was 19 ± 5 years; age was 21 ± 8 years for the control group. Patients had a history of DM I for 11 ± 5 years. The mapping revealed a perifoveal capillary density of 2.494 ± 0.559 deg-1 in the DM I group versus 2.974 ± 0.442 deg-1 in the control group (p = 0.005). The branch point density was 3.041 ± 0.919 branch points/deg2 and 3.613 ± 1.338 branch points/deg2 in each group, respectively (p = 0.128). The FAZ area was 0.216 ± 0.061 deg2 in the diabetic group and 0.208 ± 0.060 deg2 in the control group (p = 0.672). CONCLUSIONS: The selected quantitative parameters tend to increase or decrease in diabetic patients, in agreement with previous studies. Among the parameters, capillary density may represent the most sensitive metric for the detection of very early diabetic changes. Further improvement of the method could contribute to the development of an automated processing tool for capillary network quantitative assessment.