Potential clinical significance of perioperative levels of mRNA in plasma from patients with cancer of the larynx or hypopharynx.

BACKGROUND: The use of plasma as a "liquid biopsy" has gained increasing attention. The purpose of the present study was to evaluate the diagnostic and prognostic utility of the perioperative detection and quantitation of mRNAs encoding human telomerase reverse transcriptase (hTERT) and glyceraldehyde 3-phosphate dehydrogenase (GAPDH) in plasma from patients with cancer of the larynx or hypopharynx. METHODS: We recruited 47 patients with laryngeal cancer and 2 patients with hypopharyngeal cancer, plus 27 healthy subjects. A blood sample was taken from each patient before and after surgical resection of the tumor. We quantified hTERT mRNA and GAPDH mRNA in plasma by real-time polymerase chain reaction (PCR). RESULTS: Detection of hTERT mRNA before surgery had diagnostic value (sensitivity, 22%; specificity, 100%). Detection was more frequent in patients with supraglottic tumors than glottic tumors (p = .02) and was related to subsequent recurrence (p = .02). Preoperative levels of hTERT mRNA in plasma were higher in patients with subsequent recurrence (p = .046) and/or metastases (p = .047). The disease-free survival (DFS) and overall survival (OS) of patients with plasma samples positive for hTERT mRNA was poorer than that of patients with negative samples. Mean levels of plasma GAPDH mRNA in untreated patients were higher than in healthy subjects (p < .001). CONCLUSION: Detection and quantitation of hTERT and GAPDH mRNA in patients' plasma might be clinically significant in cases of laryngeal and hypopharyngeal cancer. © 2017 Wiley Periodicals, Inc. Head Neck 39: 647-655, 2017.

[Results of a telemedicine program for primary care patients with type 2 diabetes]. / Resultados de un programa de telemedicina para pacientes con diabetes tipo 2 en atención primaria.

OBJECTIVE: To evaluate the impact of a telemedicine program on self-perceived health in patients with type 2 diabetes in primary care, as well as patient acceptance of and satisfaction with this program. METHOD: We conducted an 18-month follow-up through telemedicine in 52 diabetic patients. The study design was non-experimental (before and after). In addition to weekly electronic transmission of fasting glucose levels, we regularly provided advice to patients about healthy habits. RESULTS: No statistically significant differences were observed when mean blood glucose values were compared during follow-up. However, at the end of participation, the mean score in self-perceived health was significantly higher than at the initial assessment (70.5±12.8 vs. 62.8±15.0, p=0.02). After 18 months of participation in the telemedicine program, 57.7% of patients were satisfied and 38.5% were very satisfied. CONCLUSIONS: Although glycemic control did not improve during the follow-up, electronic transmission of information was found to be feasible and satisfactory for patients. The patients reported a higher level of self-perceived health.

Effectiveness of a telemedicine programme for patients with metabolic syndrome.

BACKGROUND: There is a high prevalence of metabolic syndrome in Western societies, and it is therefore an example of chronic disease whose follow-up could be enhanced by telemedicine. OBJECTIVE: The objective of this study was to assess the effectiveness of a telemedicine programme for the follow-up and control of patients with metabolic syndrome in a primary-care setting. METHODS: Semi-experimental study in which 82 patients with metabolic syndrome were included in a telemedicine programme and compared to 82 patients routinely followed up at health-care facilities. The programme consisted of the teletransmission of analytical parameters via the PITES technological platform for chronic and dependent patients. Other study variables were lifestyle, treatment compliance, perceived health status and satisfaction with the programme. RESULTS: Follow-up showed that 68 patients (82.9%) continued in the programme after 6 months and 45 (54.9%) after one year, with a mean stay of 39.7 weeks. Comparison of the parameters obtained for the telemedicine and control-group patients indicated that the former registered significantly lower mean values for systolic blood pressure (125.5 ± 10.6 SD vs. 136.7 ± 12.0 SD), diastolic blood pressure (81.0 ± 6.3 SD vs. 84.0 ± 6.8 SD), total cholesterol (177.4 ± 34.5 SD vs. 202.4 ± 31.7 SD) and cLDL (106.0 ± 28.1 SD vs. 121.3 ± 30.6 SD). By the end of follow-up, the health status scores of the patients monitored by telemedicine had risen significantly (69.2 vs. 64.2; p=0.04), and 86.6% stated that they were satisfied. CONCLUSIONS: Telemedicine allows for better control of some of the defining parameters of metabolic syndrome than is achieved by routine clinical practice. Teletransmission is viable and satisfactory, and constitutes a novel contribution to the clinical management of these patients.

[Social-health characteristics of subjects who make a living will]. / Características sociosanitarias de quienes formalizan el documento de voluntades anticipadas.

INTRODUCTION: The Living Will (LW) is well publicised, and still largely unknown to the general public and health professionals. OBJECTIVE: To describe the characteristics of the subjects that formalize a LW related to socio-demographic situation, health status, degree of dependence, healthcare characteristics and psychosocial aspects. METHOD: Descriptive observational study conducted in the Health Area of Albacete including 123 people who formalized the LW in a Will Register in 2011. Study variables included: self-perceived health, functional status, morbidity, socio-demographic characteristics, use of health services, attitudes towards the LW, and psychosocial aspects. RESULTS: Those that made an LW, were mainly women (64.2%), had a mean age of 53.3 years (SD: 14.5), higher levels of education (61% with at least secondary education), and a lifestyle other than living with a partner, and with children (67.5%). The majority were self-sufficient for their daily living activities (98.4% to 94.3% for basic and instrumental), and suffered from chronic disease (73.2%). Despite lasting relationships with their physicians (9.4 years; SD: 7.9), there was very little talk about the end of life (18.3%). More than a half had a family member who had previously signed a document (54.5%). More than two-thirds (68.5%) considered this document useful in the death of a relative, and also a 56.7% had also served as a caregiver of a terminal patient. CONCLUSIONS: Middle-aged people, predominantly women, formalized an LW most often. They are usually chronic, but self-sufficient for their daily living activities, and are convinced that they can influence their health situation.

Follow up of patients who start treatment with antidepressants: treatment satisfaction, treatment compliance, efficacy and safety.

BACKGROUND: Measuring satisfaction with treatment has proved useful to ascertain the treatment features that are most important to the patients, and to explain increased treatment compliance. However, there are few studies that relate satisfaction to other clinical or self-perceived health status indicators. Recent studies have shown the close relationship between satisfaction with treatment, treatment compliance, and effectiveness. This study attempts to design and validate a scale to evaluate satisfaction with antidepressant drug therapy, assess treatment compliance (self-reported, validated questionnaire, drug accountability and electronic monitorization system), assess efficacy in reducing depressive symptoms and safety in patients who initiate antidepressant drug therapy, as well as to establish predictors of satisfaction, compliance and effectiveness with these drugs. METHODS/DESIGN: This is an observational longitudinal study with a cohort of adults initiating treatment with antidepressant drugs. A multi-centre study will be performed in which 20 Primary Care practices from Castilla-La Mancha are expected to participate. An initial interview and follow-up visits at 15 days, 1, 3, 6, 9 and 12 months will be conducted with all study participants. 706 subjects will be studied (95% confidence interval, precision ± 3%, expected rate of non-compliance 50%, expected non-responders and lost to follow up rate 15%). The following measurements will be performed: development and validation of a scale of satisfaction with antidepressant therapy, participant and antidepressant characteristics, treatment compliance evaluation (Haynes-Sackett Test, Morisky-Green Test, drug accountability and Medication Event Monitoring System), depression symptom reduction (Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale), observation of adverse effects, and beliefs about treatment (The Beliefs about Medicines Questionnaire). DISCUSSION: Antidepressant drugs are an extraordinarily important therapeutic group in the pharmacy composition; economic repercussions and social impact associated to their use is clear. Despite their well-established efficacy in clinical trials, treatment non-compliance is a major obstacle to their effectiveness in clinical practice. The proposed study brings about useful conclusions to improve the results of these drugs. Additionally, devising a scale specifically designed to evaluate satisfaction with antidepressant treatment could be of interest in healthcare outcomes research.

Validation of the Insomnia in the Elderly Scale for the detection of insomnia in older adults.

AIM: The main objective of this study was the validation of a brief support instrument for the diagnosis of insomnia in older adults. METHODS: An observational study was carried out for the evaluation of the Insomnia in the Elderly Scale using the psychiatric interview as the gold standard. Data was collected in a primary care setting in the city of Albacete, Spain. Participants were 926 non-institutionalized older adults aged ≥ 65 years. RESULTS: Sleep characteristics, and the health and sociodemographic status of the participants were assessed. The Insomnia in the Elderly Scale is divided into two subscales for the evaluation of the Diagnostic and Statistical Manual of Mental Disorders, Fouth Edition criteria A and B for insomnia. The area under the receiver operating characteristic curve for subscale A was 0.868. The cut-off point to detect the presence of diagnostic criterion A for insomnia was a score of ≥ 3 (sensitivity: 86.4%; specificity: 69.5%). The area under the receiver operating characteristic curve for subscale B was 0.832. The cut-off point to detect the presence of diagnostic criterion B was a score of ≥ 2 (sensitivity: 86.3%; specificity: 66.4%). CONCLUSIONS: The Insomnia in the Elderly Scale has appropriate psychometric properties. This scale compensates for the lack of validated instruments for use in the population aged 65 years or older. The fact that it is divided into two subscales to separately evaluate the insomnia criteria enables us to detect the presence of each of them. Finally, it has been validated in participants aged 65 years and older, which is the target population for this scale.

The reliability and validity of the daily activities dependence on vision (DADV) scale to evaluate vision related functional limitations.

The purpose was to determine the reliability and validity of the DADV scale to evaluate vision-related functional limitations in persons over 65 years. Cross sectional study was performed to determine the reliability and validity of a questionnaire (9 items). A total of 1387 subjects were selected by random sampling. An analysis of the intra/inter-observer reliability was performed and the convergent validity with the Visual Function Index, 14 items (VF-14) was determined. The number of patients who had some difficulty in performing any of the activities was 223 (19.2%; 95%CI=16.9-21.5). The intraclass correlation coefficient (ICC) of the intra/inter-observer reliability analysis was 0.883 and 0.900, respectively. Factorial analysis demonstrated that one single factor explained 63.2% of the total variance (visual function). The scale showed a high degree of convergent validity (ICC=0.857) with the VF-14. Visual acuity showed a moderate correlation with the DADV score (r=0.366). The Rasch analysis showed a satisfactory model fit for the items. Although the DADV scale is a short questionnaire it showed high correlation with the VF-14 and moderate correlation with visual acuity. The results indicate that the scale has acceptable reliability and is valid to efficiently evaluate visual function.

Effect of plant sterols on the lipid profile of patients with hypercholesterolaemia. Randomised, experimental study.

BACKGROUND: Studies have been conducted on supplementing the daily diet with plant sterol ester-enriched milk derivatives in order to reduce LDL-cholesterol levels and, consequently, cardiovascular risk. However, clinical practice guidelines on hypercholesterolaemia state that there is not sufficient evidence to recommend their use in subjects with hypercholesterolaemia. The main objective of this study is to determine the efficacy of the intake of 2 g of plant sterol esters a day in lowering LDL-cholesterol levels in patients diagnosed with hypercholesterolaemia. The specific objectives are: 1) to quantify the efficacy of the daily intake of plant sterol esters in lowering LDL-cholesterol, total cholesterol and cardiovascular risk in patients with hypercholesterolaemia; 2) to evaluate the occurrence of adverse effects of the daily intake of plant sterol esters; 3) to identify the factors that determine a greater reduction in lipid levels in subjects receiving plant sterol ester supplements. METHODS/DESIGN: Randomised, double-blind, placebo controlled experimental trial carried out at family doctors' surgeries at three health centres in the Health Area of Albacete (Spain). The study subjects will be adults diagnosed with "limit" or "defined" hypercholesterolaemia and who have LDL cholesterol levels of 130 mg/dl or over. A dairy product in the form of liquid yoghurt containing 2 g of plant sterol ester per container will be administered daily after the main meal, for a period of 24 months. The control group will receive a daily unit of yogurt not supplemented with plant sterol esters that has a similar appearance to the enriched yoghurt. The primary variable is the change in lipid profile at 1, 3, 6, 12, 18 and 24 months. The secondary variables are: change in cardiovascular risk, adherence to the dairy product, adverse effects, adherence to dietary recommendations, frequency of food consumption, basic physical examination data, health problems, lipid-lowering medication, physical activity, smoking habits and socio-demographic variables. DISCUSSION: If plant sterol ester supplements were effective a sounder recommendation for the consumption of plant sterols in subjects with hypercholesterolaemia could be made.

Validation of the Spanish version of the Short-Form Late-Life Function and Disability Instrument.

OBJECTIVES: To validate the Short-Form Late-Life Function and Disability Instrument (SF-LLFDI), a valid measure of functional limitations and disability in older adults, in Spanish-speaking populations and to analyze its psychometric properties. DESIGN: Validation study. SETTING: Complejo Hospitalario Universitario de Albacete, Spain. PARTICIPANTS: Sample population of 876 participants aged 70 and older from Albacete, Spain. MEASUREMENTS: Forward and back translation of the SF-LLFDI; concurrent validity was determined according to the Barthel Index and the Lawton Scale for disability and according to grip strength, gait speed, the Timed Up and Go Test, and the Short Physical Performance Battery (SPPB) for function. Construct validity, internal consistency, and floor and ceiling effect were determined. The area under the receiver operating characteristic curve (AUC) was calculated to identify function and disability. Intraclass correlation coefficients (ICCs) were used to analyze reliability in a subsample of 50 participants. RESULTS: The SF-LLFDI was significantly correlated with the Barthel Index (correlation coefficient (r)=0.827), the Lawton Scale (r=0.693), gait speed (r=0.661), and the SPPB (r=0.650). Internal consistency (Cronbach α=0.974), interobserver reliability (ICC=0.989; 95% confidence interval (CI)=0.984-0.993), and intraobserver reliability (ICC=0.982, 95% CI=0.967-0.990) were all excellent. The SF-LLFDI demonstrated excellent discriminant validity, as evidenced by an AUC for a Barthel Index less than 65 points of 0.991 (95% CI=0.986-0.996), with a better cutoff of less than 65 points (sensitivity, 94%; specificity, 94%), and for a Lawton Scale score of less than 4 of 0.976 (95% CI% 0.967-0.985), with a better cutoff of less than 72 (sensitivity, 91%; specificity, 91%). No participant had a maximum score; 36 (4.1%) obtained the minimum. CONCLUSION: The Spanish SF-LLDFI is a valid instrument for detecting disability and functional limitation.

Approach to major depression in old people.

BACKGROUND: The difficulty in identifying and distinguishing Major Depressive Disorder (MDD) in primary care is well known. The main objective of this study is to determine the frequency of MDD in persons aged 65 years and older using the Detection of Depression in the Elderly Scale (DDES). A second objective is to determine the convergent validity of the DDES with the Geriatric Depression Scale (GDS). METHODS: A cross-sectional, observational study was carried out of 1,387 subjects aged 65 years and older. The variables considered were: affective state (GDS and DDES), physical and cognitive functional state, health problems and sociodemographic characteristics. RESULTS: Using the DDES we identified MDD in 50 subjects (4.3%). There was a moderate correlation (r = 0.570; p < 0.001) between the DDES and the GDS scores (p < 0.001). According to logistic regression analysis, the variables associated with a probable MDD (DDES +) were: dependence in activities of daily living (OR: 3.3), female gender (OR: 2.3), marital status single/widowed/divorced (OR: 2.0), and the presence of four of more health problems (OR: 2.1). CONCLUSIONS: Using the DDES scale we found a 4.3% prevalence of MDD in a representative sample of older adults. Compared to the GDS, the most commonly used scale, the DDES may be considered a more sensitive screening tool for the identification of MDD in primary care.