Objective Measurements of Physical Function to Predict Survival in Patients with Metastatic Cancer.

BACKGROUND/OBJECTIVES: Physician-reported performance status (PS) constitutes the established method for stratifying oncologic patients in therapeutic decision-making. Objective measurements of physical function may further refine prognostication. SUBJECTS/METHODS: In this prospective observational study, 103 patients with metastatic cancer who were referred for systemic therapy initiation were evaluated. PS was evaluated using the Eastern Cooperative Oncology Group Performance Status (ECOG-PS) and five objective physical function measurements (handgrip strength [HGS], chair stand test [CST], timed up and go [TUG] test, 4-m gait speed [GS] test, and short physical performance battery [SPPB] test). Overall survival and treatment complications were recorded from the medical records. RESULTS: Patients with low PS according to ECOG-PS (hazard ratio [HR]: 3.80, 95% confidence interval [CI]: 1.84, 7.80), HGS (HR: 2.37, 95% CI: 1.24, 4.55), SPPB (HR: 3.43, 95% CI: 1.55, 7.57), GS (HR: 3.03, 95% CI: 1.44, 6.38), and TUG (HR: 5.16, 95% CI: 2.19, 12.14) had shorter overall survival after adjustment for sex, age, symptomatology, comorbidity, percentage of weight loss, and tumor localization. CONCLUSIONS: Among the studied objective physical function measurements, HGS, SPPB, GS, and TUG were independent predictors of survival in a sample of patients with metastatic cancer, with TUG showing the highest effect size.

Sustained improvements in the cardiometabolic profile of patients with obstructive sleep apnea after a weight-loss Mediterranean diet/lifestyle intervention: 12-month follow-up (6 months post-intervention) of the "MIMOSA" randomized clinical trial.

BACKGROUND AND AIMS: Obstructive sleep apnea (OSA) and the metabolic syndrome (MS) frequently coexist and lead to increased cardiometabolic morbidity. We aimed to explore the long-term cardiometabolic benefits of a weight-loss Mediterranean diet/lifestyle intervention in OSA. METHODS AND RESULTS: As many as 180 adults with overweight/obesity and polysomnography-diagnosed moderate-to-severe OSA were randomized to a standard care (SCG, n = 62), a Mediterranean diet (MDG, n = 59) or a Mediterranean lifestyle group (MLG, n = 59). All groups were prescribed with continuous positive airway pressure (CPAP), while intervention arms (MDG/MLG) additionally participated in a 6-month weight-loss intervention based on the Mediterranean diet/lifestyle. Cardiometabolic parameters were evaluated at baseline and 12 months (6 months post-intervention). Data were analyzed using the intention-to-treat method, and 12-month between-group differences were explored while adjusting for age, sex, baseline status and CPAP use. Compared to the SCG, intervention arms exhibited lower insulin, triglycerides and high-sensitivity C-reactive protein, and higher high-density lipoprotein cholesterol; the MDG also exhibited lower diastolic blood pressure, while the MLG exhibited lower glucose and systolic blood pressure (all P < 0.050). The relative risk (95% confidence interval) of MS was 0.60 (0.36, 0.99) in the MDG versus the SCG, 0.33 (0.20, 0.55) in the MLG versus the SCG and 0.55 (0.32, 0.93) in the MLG versus the MDG. The risk of MS remained lower in the MLG versus the other study groups (both P < 0.050) after additional adjustment for body weight change. CONCLUSION: Cardiometabolic benefits of a 6-month healthy dietary/lifestyle intervention are sustainable 6 months post-intervention in OSA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02515357, August 4, 2015.

Poor performance of predictive equations to estimate resting energy expenditure in patients with Crohn's disease.

Studies exploring the accuracy of equations calculating Resting Energy Expenditure (REE) in patients with Crohn's disease are lacking. The aim of this study was to investigate the accuracy of REE predictive equations against indirect calorimetry in Crohn's disease patients. REE was measured using indirect calorimetry (mREE) after an overnight fasting. Fourteen predictive equations, with and without body composition analysis parameters, were compared with mREE using different body weight approaches. Body composition analysis was performed using dual X-ray absorptiometry. 186 Crohn's disease outpatients (102 males) with mean age 41.3±14.1 years and 37.6% with active disease were evaluated. Mean mREE in the total sample was 1734±443 kcal/day. All equations under-predicted REE and showed moderate correlations with mREE (Pearson's r or Spearman's rho 0.600-0.680 for current weight, all p-values<0.001). Accuracy was low for all equations at the individual level (28-42% and 25-40% for current and adjusted body weight, respectively, 19-33% for equations including body composition parameters). At the group level, accuracy showed wide limits of agreement and proportional biases. Accuracy remained low when sample was studied according to disease activity, sex, body mass index and medication use. All predictive equations underestimated REE and showed low accuracy. Indirect calorimetry remains the best method for estimating REE of patients with Crohn's disease.

Trial to Encourage Adoption and Maintenance of a MEditerranean Diet (TEAM-MED): a randomised pilot trial of a peer support intervention for dietary behaviour change in adults from a Northern European population at high CVD risk.

Adhering to a Mediterranean diet (MD) is associated with reduced CVD risk. This study aimed to explore methods of increasing MD adoption in a non-Mediterranean population at high risk of CVD, including assessing the feasibility of a developed peer support intervention. The Trial to Encourage Adoption and Maintenance of a MEditerranean Diet was a 12-month pilot parallel group RCT involving individuals aged ≥ 40 year, with low MD adherence, who were overweight, and had an estimated CVD risk ≥ 20 % over ten years. It explored three interventions, a peer support group, a dietician-led support group and a minimal support group to encourage dietary behaviour change and monitored variability in Mediterranean Diet Score (MDS) over time and between the intervention groups, alongside measurement of markers of nutritional status and cardiovascular risk. 118 individuals were assessed for eligibility, and 75 (64 %) were eligible. After 12 months, there was a retention rate of 69 % (peer support group 59 %; DSG 88 %; MSG 63 %). For all participants, increases in MDS were observed over 12 months (P < 0·001), both in original MDS data and when imputed data were used. Improvements in BMI, HbA1c levels, systolic and diastolic blood pressure in the population as a whole. This pilot study has demonstrated that a non-Mediterranean adult population at high CVD risk can make dietary behaviour change over a 12-month period towards an MD. The study also highlights the feasibility of a peer support intervention to encourage MD behaviour change amongst this population group and will inform a definitive trial.

Association of adherence to the Mediterranean diet and physical activity habits with the presence of insomnia in patients with obstructive sleep apnea.

PURPOSE: Insomnia and obstructive sleep apnea (OSA) are among the most prevalent sleep disorders and frequently co-occur, defining the sleep apnea-insomnia syndrome. However, data exploring associations between insomnia and lifestyle habits in patients with OSA are lacking. Therefore, the aim of the present study was to investigate potential associations between insomnia presence and individual lifestyle parameters in patients with mild/moderate-to-severe OSA evaluated by attended polysomnography. METHODS: These are secondary analyses, using data from a cross-sectional study among 269 Greek patients with OSA. Clinical, anthropometric, socioeconomic, and lifestyle data were collected for all participants. Insomnia presence was evaluated through the validated psychometric instrument "Athens Insomnia Scale" (AIS). Adherence to the Mediterranean diet was estimated with the MedDietScale index and physical activity habits were assessed through a validated questionnaire. Backward stepwise multiple logistic regression analysis was used to estimate the association between lifestyle habits (i.e., adherence to the Mediterranean diet and physical activity) and the likelihood of having insomnia, while adjusting for potential confounders. RESULTS: Of 269 patients newly diagnosed with OSA (aged 21-70 years; 73% men), 146 (54%) were categorized as having insomnia. In multivariable models, higher adherence to the Mediterranean diet and engagement in physical activity for ≥ 30 min/day were both associated with a lower likelihood of having insomnia (odds ratio (95% confidence intervals): 0.40 (0.18-0.91) and 0.49 (0.28-0.86), respectively). CONCLUSIONS: Results add to the limited data on the role of lifestyle in insomnia and should be further explored both in epidemiological and clinical studies.

Higher refined cereal grain intake is positively associated with apnoea-hypopnoea index in patients with obstructive sleep apnoea.

BACKGROUND: Given that obesity is a well-known risk factor for obstructive sleep apnoea (OSA) development, dietary habits may be involved in its pathogenesis. However, little is known about the associations between dietary habits and OSA severity. The present study aimed to investigate possible associations between cereal grain intake and apnoea/hypopnoea indices in OSA patients. METHODS: This was a cross-sectional study of 269 patients (21-70 years; 73.2% males) diagnosed with OSA via an attended in-hospital polysomnography. Information on demographics, medical history, anthropometric indices and lifestyle habits were collected at enrolment. Biochemical measurements were performed in all study participants using standard procedures. Cereal grain consumption was evaluated using a validated food frequency questionnaire. Severe OSA was defined as having an apnoea-hypopnoea index ≥30 events h-1 . RESULTS: In adjusted analyses, higher intake of refined cereal grains was positively associated with apnoea-hypopnoea index (ptrend = 0.022), after adjusting for age, sex, socio-economic parameters, smoking habits, waist circumference, physical activity level, adequacy of night-time sleep, diet's quality as assessed by a relevant score, insulin resistance and C-reactive protein levels). Multiple logistic regression analysis also showed that energy-adjusted refined grain intake was associated with increased likelihood of severe OSA (odds ratio = 1.56, 95% confidence interval = 1.06-2.30). Νo association between apnoea/hypopnoea indices and non-refined grain intake was observed in this study. CONCLUSIONS: The findings show that obstructive sleep apnoea (OSA) is associated with cereal grain intake and suggest that a higher intake of refined cereal grains may be a risk factor for OSA severity.

Myostatin in combination with creatine phosphokinase or albumin may differentiate patients with cirrhosis and sarcopenia.

In patients with liver cirrhosis (LC), sarcopenia is correlated with frequent complications and increased mortality. Myostatin, a myokine, is a potential biomarker of skeletal mass and/or sarcopenia. The aim of this study was to examine the association between myostatin and muscle mass and evaluate myostatin as a biomarker of sarcopenia in LC. Skeletal muscle index (SMI) and myosteatosis were evaluated by computed tomography scan. Muscle quantity and quality along with muscle strength and function were used to diagnose sarcopenia. Serum myostatin was measured by ELISA. One hundred and fifteen consecutive patients with LC [72.2% male, median age 59 yr (IQR 52-67), MELD 12 (8-16), 28.7% with compensated LC] were included. Low SMI was diagnosed in 49.6% and sarcopenia in 34.8% (21.7% severe). Myostatin levels were lower in low (P < 0.001) compared with patients with normal SMI and were strongly correlated with SMI in MELD score ≥ 15 (r = 0.571, P < 0.001). Myostatin was also lower in patients with sarcopenia compared with those without (P < 0.001) and even lower in severe sarcopenia (P < 0.001). In multivariate analysis, myostatin, age, and albumin remained significant predictors of low SMI after adjustment for sex, MELD, and creatine phosphokinase (CPK). Similarly, myostatin and age predicted sarcopenia after adjustment for sex, MELD, CPK, and albumin. The ratios log10myostatin-to-CPK or albumin-to-myostatin were found to have acceptable diagnostic accuracy in ruling out sarcopenia in total patients. However, the best diagnostic performance was shown in MELD ≥ 15 (AUROC 0.829 or 0.801, respectively). Myostatin is independently associated with both skeletal muscle mass and sarcopenia. Myostatin in combination with CPK or albumin are good surrogate markers in excluding sarcopenia.NEW & NOTEWORTHY Serum levels of myostatin were significantly lower in cirrhotic patients with impaired skeletal mass index (SMI) and sarcopenia than those without. Serum levels of myostatin have a positive correlation with SMI. Myostatin levels are independently associated with sarcopenia, diagnosed according to the latest criteria, in patients with cirrhosis. Myostatin in combination with creatine phosphokinase or albumin have good accuracy excluding sarcopenia in patients with cirrhosis.

A weight-loss Mediterranean diet/lifestyle intervention ameliorates inflammation and oxidative stress in patients with obstructive sleep apnea: results of the "MIMOSA" randomized clinical trial.

PURPOSE: Inflammation and oxidative stress are implicated in obstructive sleep apnea (OSA) pathophysiology. We aimed at exploring whether the combination of a weight-loss Mediterranean diet/lifestyle intervention with OSA standard care, i.e., continuous positive airway pressure (CPAP) prescription, can lead to greater improvements in inflammation and oxidative stress, compared to standard care alone. METHODS: This was a randomized controlled clinical trial in 187 adult, overweight patients with moderate-to-severe OSA. Participants were randomized to a standard care (SCG, n = 65), a Mediterranean diet (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All groups received OSA standard care. Intervention arms participated in a 6-month behavioral weight-loss intervention based on the Mediterranean diet, while the MLG also received counselling on physical activity and sleep habits. RESULTS: Seven patients were excluded and 53/180 were lost to follow-up. In intention to treat analysis (n = 180), the SCG did not exhibit changes in any of the markers assessed. Post-intervention age-, sex-, baseline- and CPAP use-adjusted plasma high sensitivity C-reactive protein levels (mg/L) were lower in the MDG and the MLG compared to the SCG (mean difference - 1.33, P = 0.039 and - 1.68, P = 0.007, respectively). The MLG also exhibited lower urinary 8-iso prostaglandin F2a levels (ng/mg creatinine) compared to the SCG and the MDG (mean difference - 1.10, P < 0.0001 and - 0.80, P = 0.001, respectively). Adiponectin and oxidized guanine levels were not altered in any of the study groups. Results were similar in per protocol analysis (n = 127). CONCLUSION: A weight-loss Mediterranean diet/lifestyle intervention on top of CPAP has anti-inflammatory and antioxidant benefits in OSA. REGISTRATION: The trial was prospectively registered at ClinicalTrials.gov (NCT02515357) on August 4, 2015.

Comparison of the Mediterranean diet and the Dietary Approach Stop Hypertension in reducing the risk of 10-year fatal and non-fatal CVD events in healthy adults: the ATTICA Study (2002-2012).

OBJECTIVE: To compare the Mediterranean and Dietary Approaches to Stop Hypertension (DASH) diets in deterring 10-year CVD. DESIGN: Prospective cohort (n 2020) with a 10-year follow-up period for the occurrence of combined (fatal or non-fatal) CVD incidence (International Classification of Diseases (ICD)-10). Baseline adherence to the Mediterranean and DASH diets was assessed via a semi-quantitative FFQ according to the MedDietScore and DASH scores, respectively. SETTING: Attica, Greece. PARTICIPANTS: Two thousand twenty individuals (mean age at baseline 45·2 (sd 14·0) years). RESULTS: One-third of individuals in the lowest quartile of Mediterranean diet consumption, as compared with 3·1 % of those in the highest quartile, developed 10-year CVD (P < 0·0001). In contrast, individuals in the lowest and highest DASH diet quartiles exhibited similar 10-year CVD rates (n (%) of 10-year CVD in DASH diet quartiles 1 v. 4: 79 (14·7 %) v. 75 (15·3 %); P = 0·842). Following adjustment for demographic, lifestyle and clinical confounding factors, those in the highest Mediterranean diet quartile had a 4-fold reduced 10-year CVD risk (adjusted hazard ratio (HR) 4·52, 95 % CI 1·76, 11·63). However, individuals with highest DASH diet quartile scores did not differ from their lowest quartile counterparts in developing such events (adjusted HR 1·05, 95 % CI 0·69, 1·60). CONCLUSIONS: High adherence to the Mediterranean diet, and not to the DASH diet, was associated with a lower risk of 10-year fatal and non-fatal CVD. Therefore, public health interventions aimed at enhancing adherence to the Mediterranean diet, rather than the DASH diet, may most effectively deter long-term CVD outcomes particularly in Mediterranean populations.

Evaluation of the effectiveness of eight screening tools in detecting risk of malnutrition in cirrhotic patients: the KIRRHOS study.

Malnutrition risk screening in cirrhotic patients is crucial, as poor nutritional status negatively affects disease prognosis and survival. Given that a variety of malnutrition screening tools is usually used in routine clinical practice, the effectiveness of eight screening tools in detecting malnutrition risk in cirrhotic patients was sought. A total of 170 patients (57·1 % male, 59·4 (sd 10·5) years, 50·6 % decompensated ones) with cirrhosis of various aetiologies were enrolled. Nutritional screening was performed using the Malnutrition Universal Screening Tool, Nutritional Risk Index, Malnutrition Screening Tool, Nutritional Risk Screening (NRS-2002), Birmingham Nutritional Risk Score, Short Nutritional Assessment Questionnaire, Royal Free Hospital Nutritional Prioritizing Tool (RFH-NPT) and Liver Disease Undernutrition Screening Tool (LDUST). Malnutrition diagnosis was defined using the Subjective Global Assessment (SGA). Data on 1-year survival were available for 145 patients. The prevalence of malnutrition risk varied according to the screening tools used, with a range of 13·5-54·1 %. RFH-NPT and LDUST were the most accurate in detecting malnutrition (AUC = 0·885 and 0·892, respectively) with a high sensitivity (97·4 and 94·9 %, respectively) and fair specificity (73·3 and 58 %, respectively). Malnutrition according to SGA was an independent prognostic factor of within 1-year mortality (relative risk was 2·17 (95 % CI 1·0, 4·7), P = 0·049) after adjustment for sex, age, disease aetiology and Model for End-stage Liver Disease score, whereas nutrition risk according to RFH-NPT, LDUST and NRS-2002 showed no association. RFH-NPT and LDUST were the only screening tools that proved to be accurate in detecting malnutrition in cirrhotic patients.

Adherence to a DASH-style diet and cardiovascular disease risk: The 10-year follow-up of the ATTICA study.

BACKGROUND: Recent findings suggest a protective role of the DASH dietary pattern on cardiovascular disease (CVD) incidence and mortality. AIM: In this direction, we aimed at investigating the relationship between adherence to a DASH-style diet and CVD risk in a Greek cohort. METHODS: This sub-sample from the ATTICA epidemiological study consisted of 669 adults with a complete dietary profile at baseline, adequate to calculate DASH-diet score, and complete 10-year follow-up (2002-2012). Demographic, clinical and lifestyle parameters were thoroughly assessed at baseline and CVD incidence was recorded upon medical records at follow-up. Adherence to the DASH-style diet was assessed by a DASH-style diet score developed for the study (range 9-45). RESULTS: Mean value (SD) of the DASH-diet score was 27.1 (5.1) (range 13-41). Adherence to a DASH-style diet was associated neither with the 10-year CVD risk nor with baseline clinical parameters. Multiple regression analysis revealed that, after appropriate adjustments, only age (46% increase per 5-life-years) and BMI (9.7% increase per unit of BMI) were associated with 10-year CVD events. CONCLUSIONS: In this small cohort of a Mediterranean population, a cardioprotective effect of a DASH-style diet was not detected.

Adherence to the Mediterranean diet and IVF success rate among non-obese women attempting fertility.

STUDY QUESTION: Is adherence to the Mediterranean diet (MedDiet) associated with better IVF performance in women attempting fertility? SUMMARY ANSWER: Greater adherence to the MedDiet, defined using the validated Mediterranean diet score (MedDietScore), was associated with a higher likelihood of achieving clinical pregnancy and live birth among non-obese women <35 years of age. WHAT IS KNOWN ALREADY: Diet impacts fertility and certain nutrients and food groups appear to have a greater effect on reproductive health, but there are relatively few published data on the role of dietary patterns, and the MedDiet in particular, on assisted reproductive performance. STUDY DESIGN, SIZE, DURATION: This prospective cohort study included 244 non-obese women (22-41 years of age; BMI < 30 kg/m2) who underwent a first IVF treatment in an Assisted Conception Unit in Athens, Greece, between November 2013 and September 2016. The study was designed to evaluate the influence of habitual dietary intake and lifestyle on fertility outcomes. PARTICIPANTS/MATERIALS, SETTING, METHODS: Diet was assessed before the IVF treatment via a validated food-frequency questionnaire. Adherence to the MedDiet was assessed through the MedDietScore (range: 0-55), with higher scores indicating greater adherence. Intermediate outcomes (oocyte yield, fertilization rate and embryo quality measures) and clinical endpoints (implantation, clinical pregnancy and live birth) were abstracted from electronic medical records. Associations between MedDietScore and IVF outcomes were analysed using generalized linear models adjusting for age, ovarian stimulation protocol, BMI, physical activity, anxiety levels, infertility diagnosis, caloric intake and supplements use. MAIN RESULTS AND THE ROLE OF CHANCE: No association of MedDietScore with any of the intermediate outcomes or with implantation was found. However, compared with women in the highest tertile of the MedDietScore (≥36, n = 86), women in the lowest tertile (≤30, n = 79) had significantly lower rates of clinical pregnancy (29.1 vs 50.0%, P = 0.01) and live birth (26.6 vs 48.8%, P = 0.01). The multivariable-adjusted relative risk (95% CI) for clinical pregnancy comparing women in the lowest with women in the highest tertile of the MedDietScore was 0.35 (0.16-0.78; P-trend=0.01), and for live birth it was 0.32 (0.14-0.71; P-trend = 0.01). These associations were significantly modified by women's age (P-interaction <0.01 for both outcomes). MedDietScore was positively related to clinical pregnancy and live birth among women <35 years old (P ≤ 0.01) but not among women ≥35 years. Among women <35 years, a beneficial 5-point increase in the MedDietScore was associated with ~2.7 times higher likelihood of achieving clinical pregnancy and live birth. LIMITATIONS, REASONS FOR CAUTION: Our finding cannot be generalized to the whole reproductive population nor to obese women nor to women attending infertility clinics around the world. In addition, due to the observational study design, causal inference is limited. WIDER IMPLICATIONS OF THE FINDINGS: The results suggest that diet modifications and greater compliance to the Mediterranean diet may help increase the chances of a successful pregnancy and delivering a live baby for women undergoing IVF treatment. STUDY FUNDING/COMPETING INTEREST(S): This work was partially supported by a grand from Harokopio University (KE321). All authors declare no conflicts of interest. TRIAL REGISTRATION NUMBER: NCT03050944.

Improvements in clinical characteristics of patients with non-alcoholic fatty liver disease, after an intervention based on the Mediterranean lifestyle: a randomised controlled clinical trial.

Lifestyle interventions remain the cornerstone therapy for non-alcoholic fatty liver disease (NAFLD). This randomised controlled single-blind clinical trial investigated the effect of Mediterranean diet (MD) or Mediterranean lifestyle, along with weight loss, in NAFLD patients. In all, sixty-three overweight/obese patients (50 (sd 11) years, BMI=31·8 (sd 4·5) kg/m2, 68 % men) with ultrasonography-proven NAFLD (and elevated alanine aminotransferase (ALT) and/or γ-glutamyl transpeptidase (GGT) levels) were randomised to the following groups: (A) control group (CG), (B) Mediterranean diet group (MDG) or (C) Mediterranean lifestyle group (MLG). Participants of MDG and MLG attended seven 60-min group sessions for 6 months, aiming at weight loss and increasing adherence to MD. In the MLG, additional guidance for increasing physical activity and improving sleep habits were given. Patients in CG received only written information for a healthy lifestyle. At the end of 6 months, 88·8 % of participants completed the study. On the basis of intention-to-treat analysis, both MDG and MLG showed greater weight reduction and higher adherence to MD compared with the CG (all P<0·05) at the end of intervention. In addition, MLG increased vigorous exercise compared with the other two study groups (P<0·001) and mid-day rest/naps compared with CG (P=0·04). MLG showed significant improvements in ALT levels (i.e. ALT<40 U/l (P=0·03) and 50 % reduction of ALT levels (P=0·009)) and liver stiffness (P=0·004) compared with CG after adjusting for % weight loss and baseline values. MDG improved only liver stiffness compared with CG (P<0·001) after adjusting for the aforementioned variables. Small changes towards the Mediterranean lifestyle, along with weight loss, can be a treatment option for patients with NAFLD.

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

BACKROUND: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. METHODS: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. RESULTS: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. CONCLUSIONS: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Association between adherence to the Mediterranean diet and semen quality parameters in male partners of couples attempting fertility.

STUDY QUESTION: Is adherence to the Mediterranean diet (MedDiet) associated with better semen quality in men of subfertile couples attempting fertility? SUMMARY ANSWER: Greater adherence to the MedDiet, as assessed through the validated Mediterranean diet score (MedDietScore), was significantly associated with higher sperm concentration, total sperm count and sperm motility. WHAT IS KNOWN ALREADY: A-posteriori dietary pattern approaches have revealed that dietary patterns characterized by high intakes of fruits, vegetables, whole grains, fish and low intake of meat are associated with better semen quality. Yet, whether adherence to the MedDiet is associated with better semen profile remains largely unexplored. STUDY DESIGN, SIZE, AND DURATION: This was a cross-sectional study of 225 men from couples attending a fertility clinic in Athens, Greece, recruited between November 2013 and May 2016. The study was designed to evaluate the influence of habitual dietary intake and lifestyle on fertility outcomes. PARTICIPANTS/MATERIALS, SETTING, METHODS: Men aged 26-55 years, 51.1% overweight or obese, 20.9% smokers, with complete dietary data were analyzed. Diet was assessed via a food-frequency questionnaire and adherence to the MedDiet was assessed through the MedDietScore (range: 0-55; higher scores indicating greater adherence to MedDiet). Semen quality was evaluated according to World Health Organization 2010 guidelines. Multiple logistic regression analysis was used to evaluate associations between tertiles of the MedDietScore and the likelihood of having abnormal semen parameters, after adjusting for potential confounders. MAIN RESULTS AND THE ROLE OF CHANCE: Compared to men in the highest tertile of the MedDietScore (≥37, N = 66), a higher percentage of men in the lowest tertile of the score (≤30, N = 76) exhibited below the WHO reference values for sperm concentration (47.4% vs 16.7%, P < 0.001), total sperm count (55.3% vs 22.7%, P < 0.001), total motility (65.8% vs 31.8%, P < 0.001), progressive motility (84.2 vs 62.1%, P = 0.011) and sperm morphology (50.0 vs 28.8%, P = 0.023). In the multivariable adjusted models, men in the lowest tertile of the MedDietScore had ~2.6 times higher likelihood of having abnormal sperm concentration, total sperm count and motility, compared to men in the highest tertile of the score. LIMITATIONS, REASONS FOR CAUTION: The main limitation of the study stems from its cross-sectional nature, limiting our ability to determine causality. WIDER IMPLICATIONS OF THE FINDINGS: The results suggest that greater compliance to the MedDiet may help improve semen quality. Whether this translates into differences in male fertility remains to be elucidated. Our findings are consistent with previous studies showing that dietary patterns with some of the characteristics of the MedDiet, i.e. rich in fruit, vegetables, legumes and whole grains, are associated with better measures of semen quality. STUDY FUNDING/COMPETING INTERESTS: No funding was obtained. The authors have no competing interests to declare. TRIAL REGISTRATION NUMBER: n/a.

EORTC QLQ-COMU26: a questionnaire for the assessment of communication between patients and professionals. Phase III of the module development in ten countries.

PURPOSE: Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals. METHODS: Questionnaire development followed the EORTC QLG Module Development Guidelines. A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed. RESULTS: One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients' comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients' answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items. CONCLUSIONS: The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients.

Detailed Dietary Assessment in Patients with Inoperable Tumors: Potential Deficits for Nutrition Care Plans.

Advanced cancer often results in reduced dietary intake; however, data on actual intake at the time of diagnosis are limited. In the present study, a detailed dietary intake assessment was performed in patients with metastatic lung and upper gastrointestinal cancer, before initiation of systemic therapy. Basic demographics and performance status (PS) were recorded. Nutritional status was evaluated through anthropometry, Mini Nutritional Assessment (MNA), and 3 nonconsecutive 24-hour dietary recalls. Of the 84 patients enrolled, 61.4% were protein, energy, or protein-energy undernourished, regardless of body mass index (BMI) or MNA category. No differences in energy, macronutrients, and micronutrients intakes across BMI categories were recorded. Very low consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), irrespective of energy intake, tumor site, BMI category, or PS was found. Suboptimal micronutrients intakes were recorded even in well-nourished and overweight/obese patients. Patients with adequate PS and better MNA score reported significantly higher intake of certain macro- and micronutrients (all P < 0.05). Most patients exhibited reduced dietary intake in terms of energy, macronutrient, and micronutrient. Very low EPA and DHA intake was recorded for the whole sample, whereas micronutrient suboptimal intakes were also prevalent in well-nourished or overweight patients. All the above should be taken into account during patients' nutritional care.

Whole Grain Consumption and Breast Cancer: A Case-Control Study in Women.

OBJECTIVE: Whole grain consumption has long been associated with human health. However, its relationship with breast cancer remains not well understood and appreciated. The aim of this work was to evaluate the association between whole grain consumption and breast cancer in women. METHODS: A case-control study was designed. Two hundred and fifty consecutive, newly diagnosed breast cancer female patients (56 ± 12 years) and 250 one-to-one age-matched controls were enrolled. A standardized, validated questionnaire assessing various sociodemographic, clinical, lifestyle, and dietary characteristics was applied through face-to-face interviews. Moreover, data on regular consumption of whole grains (i.e., never/rarely, 1-6 times/week, >7 times/week) were recorded. Overall dietary habits were assessed through the level of adherence to the Mediterranean diet using the MedDietScore (theoretical range 0-55). RESULTS: Whole grain consumption of more than 7 times/week was associated with a 0.49-fold (odds ratio = 0.49; 95% confidence interval, 0.29, 0.82) lower likelihood of having breast cancer, after adjustments were made. CONCLUSIONS: This study suggested that whole grain consumption more than 7 times/week was consistently associated with reduced risk of breast cancer.

Dietary patterns and breast cancer: a case-control study in women.

PURPOSE: Since dietary habits have been associated with breast cancer, the tested research hypothesis was the associations between food patterns, as derived through multivariate methods, and breast cancer. METHODS: In a case-control study, Two-hundred and fifty consecutive, newly diagnosed breast cancer female patients (56 ± 12 years) and 250 one-to-one age-matched, healthy controls were studied. A standardized, validated questionnaire assessing various socio-demographic, clinical, lifestyle, and dietary characteristics was applied through face-to-face interviews. Factor analysis, with principal components method, was applied to extract dietary patterns from 86 foods or food groups consumption reported by the controls. RESULTS: Three components were derived explaining 43% of the total variation in consumption. Component 1 was characterized by the consumption of potatoes, red meat and its products, poultry and white meat, dairy products, use of margarine/butter in cooking or at the table, consumption of sausages, fried food as well as grilled meat or fish; component 2 was characterized by the consumption of whole grains, fruits, and vegetables; and component 3 was characterized by olive oil and fish consumption. After adjusting for various confounders, components 2 and 3 were favorably associated with the absence of having breast cancer [odds ratio (OR) 0.60, 95% CI 0.47-0.75 and OR 0.81, 95% CI 0.66-0.99, respectively], while component 1 was not significantly associated with the disease. CONCLUSIONS: Adherence to healthy dietary patterns (including whole grains, fruits, and vegetables, olive oil, and fish) seems to be favorable in not having breast cancer, among middle-aged women.