Random-start ovarian stimulation in an oocyte donation programme: a large, single-centre, experience.

RESEARCH QUESTION: Do live birth rates differ between recipients matched with donors using conventional ovarian stimulation compared with those using random-start protocols? DESIGN: Retrospective analysis of 891 ovarian stimulations in egg donors (January-December 2018) and clinical outcomes in matched recipients (n = 935). Donors commenced ovarian stimulation on day 1-3 of the menstrual cycle (n = 223) or in the mid/late-follicular (n = 388) or luteal phase (n = 280) under a conventional antagonist protocol. Live birth rate of matched recipients was the main outcome. RESULTS: Duration of stimulation and total gonadotrophin dose were comparable between conventional versus random-start groups. The number of collected eggs were similar (17.6 ± 8.8 versus 17.2 ± 8.5, P = 0.6, respectively). Sub-group analysis showed that stimulation length (10.2 ± 1.8 versus 9.8 ± 1.7 versus 10.4 ± 1.7, P < 0.001) and gonadotrophin consumption (2041.5 ± 645.3 versus 2003.2 ± 647.3 versus 2158.2 ± 685.7 IU, P = 0.01) differed significantly between the conventional, mid/late follicular and luteal phase groups, respectively. In matched recipients receiving fresh oocytes and undergoing fresh embryo transfer, the biochemical pregnancy (63.8% and 63.3%; P = 0.9), clinical pregnancy (54.6% and 56.1%; P = 0.8) and live birth rates (47.7% and 46.6%; P = 0.7) per embryo-transfer were similar between conventional versus random groups. Similar results were obtained in recipients receiving vitrified eggs. Euploidy rate was also comparable. CONCLUSIONS: No notable variations were found in clinical outcomes using oocytes obtained from random-start protocols and those proceeding from conventional ovarian stimulation in oocyte donation treatments. Luteal-phase stimulation seems to require longer stimulation and higher FSH consumption. Random-start stimulation strategy does not impair the potential of the oocyte yield or clinical outcomes in oocyte donation cycles.

A Spanish pillbox app for elderly patients taking multiple medications: randomized controlled trial.

BACKGROUND: Nonadherence and medication errors are common among patients with complex drug regimens. Apps for smartphones and tablets are effective for improving adherence, but they have not been tested in elderly patients with complex chronic conditions and who typically have less experience with this type of technology. OBJECTIVE: The objective of this study was to design, implement, and evaluate a medication self-management app (called ALICE) for elderly patients taking multiple medications with the intention of improving adherence and safe medication use. METHODS: A single-blind randomized controlled trial was conducted with a control and an experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7 professionals. ALICE was designed for Android and iOS to allow for the personalization of prescriptions and medical advice, showing images of each of the medications (the packaging and the medication itself) together with alerts and multiple reminders for each alert. The randomly assigned patients in the control group received oral and written information on the safe use of their medications and the patients in the experimental group used ALICE for 3 months. Pre and post measures included rate of missed doses and medication errors reported by patients, scores from the 4-item Morisky Medication Adherence Scale (MMAS-4), level of independence, self-perceived health status, and biochemical test results. In the experimental group, data were collected on their previous experience with information and communication technologies, their rating of ALICE, and their perception of the level of independence they had achieved. The intergroup intervention effects were calculated by univariate linear models and ANOVA, with the pre to post intervention differences as the dependent variables. RESULTS: Data were obtained from 99 patients (48 and 51 in the control and experimental groups, respectively). Patients in the experimental group obtained better MMAS-4 scores (P<.001) and reported fewer missed doses of medication (P=.02). ALICE only helped to significantly reduce medication errors in patients with an initially higher rate of errors (P<.001). Patients with no experience with information and communication technologies reported better adherence (P<.001), fewer missed doses (P<.001), and fewer medication errors (P=.02). The mean satisfaction score for ALICE was 8.5 out of 10. In all, 45 of 51 patients (88%) felt that ALICE improved their independence in managing their medications. CONCLUSIONS: The ALICE app improves adherence, helps reduce rates of forgetting and of medication errors, and increases perceived independence in managing medication. Elderly patients with no previous experience with information and communication technologies are capable of effectively using an app designed to help them take their medicine more safely. TRIAL REGISTRATION: Clinicaltrials.gov NCT02071498; http://clinicaltrials.gov/ct2/show/NCT02071498.

[Validation inspection of prescription drugs in Spain: current situation from a health professional perspective after its introduction in electronic form]. / El visado de inspección de medicamentos en España: situación actual desde la perspectiva de los profesionales sanitarios a partir de la introducción de su modalidad electrónica.

AIMS: To assess the current situation of the inspection validation of prescriptions (IVP) in Spain since the introduction of the electronic procedure (EP) from the healthcare professionals' perspective. DESIGN: Observational, cross sectional study, in two phases; combining qualitative and quantitative techniques. SETTING: Primary Care (PC), Secondary Care (SC) and the health care management sector. PARTICIPANTS: Primary care physicians (PCPs), endocrinologists, medical inspectors, pharmacists and health Authorities of Autonomous Communities (AACC). METHOD: Semi-structured surveys and Computer Assisted Telephone Interviewing. RESULTS: The IVP presents three modalities in Spain: manual, electronics and electronics linked to electronic prescription. The participants of the same level of management perceive in a similar way the purpose of the IVP, and there exist differences between the different levels of interviewed managers. Differences exist in the situation of EP between AACC. It is more implemented in primary care (PC) than in specialized (63% vs 37%), with similar degree in urban and rural areas. Six of 17 AACC presented a public access to the corresponding legislation. CONCLUSION: The IVP is perceived as a tool for the economic control in expenditure on drugs and as additional administrative load in PC. The rhythm of implementation of EP differs between AACC as well as the access to the regulation.

High sensitivity troponins: A potential biomarkers of cardiovascular risk for primary prevention.

There have been several approaches to building charts for CV risk, all of which have both strengths and limitations. Identifying early organ damage provides relevant information and should be included in risk charts, although the direct relationship with risk is imprecise, variability between operators at the time to assess, and low availability in some healthcare systems, limits its use. Biomarkers, like troponin (cTns) isoforms cTnI and cTnT, a cardiac specific myocyte injury marker, have the great advantage of being relatively reproducible, more readily accessible, and applicable to different populations. New and improved troponin assays have good analytical performance, can measure very low levels of circulating troponin, and have low intra individual variation, below 10 %. Several studies have analyzed the blood levels in healthy subjects and their predictive value for cardiovascular events in observational, prospective and post-hoc studies. All of them offered relevant information and shown that high sensitivity hs-cTnI has a place as an additional clinical marker to add to current charts, and it also reflects sex- and age-dependent differences. Although few more questions need to be answered before recommend cTnI for assessing CV risk in primary prevention, seems to be a potential strong marker to complement CV risk charts.

Feasibility study of portable microwave microstrip open-loop resonator for non-invasive blood glucose level sensing: proof of concept.

Self-management of blood glucose level is part and parcel of diabetes treatment, which involves invasive, painful, and uncomfortable methods. A proper non-invasive blood glucose monitor (NIBGM) is therefore desirable to deal better with it. Microwave resonators can potentially be used for such a purpose. Following the positive results from an in vitro previous work, a portable device based upon a microwave resonator was developed and assessed in a multicenter proof of concept. Its electrical response was analyzed when an individual's tongue was placed onto it. The study was performed with 352 individuals during their oral glucose tolerance tests, having four measurements per individual. The findings revealed that the accuracy must be improved before the diabetes community can make real use of the device. However, the relationship between the measuring parameter and the individual's blood glucose level is coherent with that from previous works, although with higher data dispersion. This is reflected in correlation coefficients between glycemia and the measuring magnitude consistently negative, although small, for the different datasets analyzed. Further research is proposed, focused on system improvements, individual calibration, and multitechnology approach. The study of the influence of other blood components different to glucose is also advised. Graphical abstract.

Quality-of-life and treatment satisfaction in actual clinical practice of patients with Type 1 diabetes mellitus (T1DM) and hypoglycemia treated with insulin degludec.

OBJECTIVE: The frequency of hypoglycemia in patients with T1DM is high and results in a poorer quality-of-life and low treatment satisfaction. The aim of this study is to demonstrate the effect of changing the basal insulin (glargine or detemir) to insulin degludec. METHODS: An observational analytical study was conducted on a cohort of 110 patients with T1DM. The patients were administered three questionnaires to assess treatment satisfaction (DTSQ-s), fear of hypoglycemia (HFS-II) and quality-of-life (EQ-5D), before the change and at 6 months. A statistical analysis was performed for repeated measures. RESULTS: The 110 patients with T1DM had a mean diabetes duration of 19.1 (11.6) years, 53.6% were men, the mean age was 43.4 (15.4) years, and the mean BMI was 25.2 (4.2) kg/m2. After 6 months, there was a significant reduction in baseline fasting plasma glucose (from 159.1 [68.6] to 132.9 [56.6] mg/dL; p < .001) and HbA1c levels (from 7.82% [1.2] to 7.6% [1.2]; p = .002). A reduction in the number of severe hypoglycemic episodes (0.17 [0.5] vs 0.05 [0.2]; p = .03) was observed. At 6 months, an improvement in the DTSQ-s (from 24.3 [5.5] to 27.3 [5.4]; p < .001) was observed. There was a decrease in the mean number of perceived hypoglycemia (from 2.9 [1.4] to 2.3 [1.4]; p = .003) and hyperglycemia (from 3.5 [1.3] to 2.7 [1.4]; p < .001). There was also a decrease in the mean HFS-II score (from 24.1 [14.0] to 20.0 [13.0]; p < .001). There were no significant differences in the EQ-5D index (from 0.91 [0.14] to 0.89 [0.16]; p = .13). However, there was significant improvement in the EQ-5D as measured by VAS (from 70.5 [16.5] to 73.6 [14.4]; p = .04). CONCLUSIONS: The change to insulin degludec in patients with T1DM improved their metabolic control, increased their satisfaction with the insulin therapy, and offered them improved quality-of-life.

[The hospital faced with a prolonged Legionella outbreak]. / El hospital ante un brote prolongado de legionelosis.

OBJECTIVE: To describe the health resources used in patients hospitalized with Legionella pneumonia during an outbreak of Legionnaire's disease in Alcoy (Spain), and to compare them with those used in other forms of pneumonia. METHODS AND RESULTS: Using a clinical protocol, 177 Legionella pneumonia patients were compared with 180 patients hospitalized for other types of pneumonia. Data on therapy and the resources used were collected. The most common antibiotic treatment in both groups was clarithromycin, but intensive care and mechanical ventilation requirements were greater in Legionella pneumonia. Home-based hospital care was successfully used in 15.6% of patients with Legionella pneumonia and in 11.3% of those with other types of pneumonia. Home oxygen therapy after discharge was less frequent in the Legionella pneumonia group (7.8%) than in the group with non-Legionella pneumonia (16.7%). CONCLUSIONS: Notable results were the greater requirement for mechanical ventilation in Legionella pneumonia and the good results obtained by home-based hospital care within current health care management.

Degree of control and delayed intensification of antihyperglycaemic treatment in type 2 diabetes mellitus patients in primary care in Spain.

OBJECTIVES: Primary aim: to determine the degree of control of HbA(1c) at the time of treatment intensification (TI) in T2DM patients. Secondary aims: fasting plasma glucose levels; estimation of the elapsed time between HbA(1c) exceeding 7% and TI; antidiabetic combinations used, % patients with good cardiometabolic control (LDL-c<100mg/dL; SBP<130 and DPB<80mmHg and HbA(1c)<7%). RESEARCH DESIGN AND METHODS: one-cohort, multicenter, retrospective, observational study conducted in Spain. Patients diagnosed with T2DM that had switched from monotherapy to combination antidiabetic therapy were evaluated at baseline and after one year of follow-up. RESULTS: a total of 1202 T2DM patients were analyzed. At the time of TI: mean HbA(1c) 8.1%; median time of uncontrolled disease: 2.0 years. After one-year of TI: significant reduction in mean HbA(1c) (8.1% vs.7.0%, p<0.001) and a mean fasting plasma glucose levels reduction (181.1mg/dL vs.144.1mg/dL, p<0.001) was also observed. The percentage of patients under glycemic control (HbA(1c)<7%) increased from 12.2% to 51.6% (p<0.001). Most common antidiabetic combinations: metformin+sulfonylurea (44.1%) and metformin+thiazolidindione (15.9%). CONCLUSIONS: in the population of T2DM patients analyzed, TI was carried out when HbA(1c) values were above those recommended in clinical guidelines (≤ 7%), with a delay of two years to address the second step of therapy, despite the consensus recommendation of the ADA/EASD of 3 months. TI was shown to be effective since addition of a second antidiabetic drug led to an average reduction of HbA(1c) of approximately 1%. Metformin was the drug most commonly used as monotherapy being the most frequent combination metformin+sulfonylurea.

Randomized clinical trial to assess the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in general practice: the PREseAP study.

INTRODUCTION AND OBJECTIVES: To assess the efficacy of a comprehensive program of secondary prevention of cardiovascular disease in general practice. METHODS: A cluster randomized clinical trial was carried out in a regular general practice setting. Male and female patients aged under 86 years with a diagnosis of ischemic heart disease, stroke or peripheral artery disease were recruited between January 2004 and May 2005. Study participants were seen at 42 health centers throughout the whole of Spain. The primary endpoint was the combination of all-cause mortality and hospital cardiovascular readmission at 3-year follow-up. RESULTS: In total, 1224 patients were recruited: 624 in the intervention group and 600 in the control group. The primary endpoint was observed in 29.9% (95% confidence interval [CI], 25.5-34.8%) in the intervention group and 25.6% (22.3-29.2%) in the control group (P=.15). At the end of follow-up, 8.5% (6.3-11.3%) in the intervention group and 11% (7.4-16%) in the control group were smokers (P=.07). The mean waist circumference of patients in the intervention and control groups was 100.44 cm (95% CI, 98.97-101.91 cm) and 102.58 cm (95% CI, 100.96-104.21 cm), respectively (P=.07). Overall, 20.9% (15.6-27.7%) of patients in the intervention group and 29.6% (23.9-36.1%) in the control group suffered from anxiety (P=.05), and 29.6% (22.4-37.9%) in the intervention group and 41.4% (35.8-47.3%) in the control group had depression (P=.02). CONCLUSIONS: A comprehensive program of secondary prevention of cardiovascular disease in general practice was not effective in reducing cardiovascular morbidity and mortality. However, some factors associated with a healthy lifestyle were improved and anxiety and depression were reduced.

Interest of home blood pressure measurements (HBPM) to establish degree of hypertensive control.

AIMS: To establish the validity and clinical value of home blood pressure measurements (HBPM) in the treatment follow-up of patients with essential hypertension to rule out or to confirm poor control of blood pressure obtained in the doctor's office with a mercury sphygmomanometer. MATERIAL AND METHODS: Observational, cross-sectional study was carried out to validate HBPM in treated hypertensive patients poorly controlled by office-based casual blood pressure measurements. Measurements were made on 2 consecutive days with six readings taken per day. To do this, 2 x 2 tables were drawn up to validate the HBPM using ABPM as the reference method. Sensitivity (S), specificity (Sp), positive probability quotient (+PQ) and negative probability quotient (-PQ) were calculated. The study population (n = 149) was selected by consecutive sampling of the hypertensive patients seen in the Vallada Health Centre. Only 124 patients could be evaluated. RESULTS: Values obtained with HBPM were: S 97.3% (95% CI 90.4-99.7%), Sp 62.7% (48.1-75.9%), +PQ 2.61 (1.82-3.73) and -PQ 0.04 (0.01-0.71). CONCLUSIONS: Home monitoring of blood pressure is a useful alternative to ABPM to rule out office-based poor control of hypertensive patients, but not to confirm it.

[Analysis of antibiotic use in the Community of Valencia (2000-2002)]. / Análisis del consumo de antibióticos en la Comunidad Valenciana durante los años 2000-2002.

OBJECTIVE: To quantify antibiotic prescriptions in the Autonomous Community of Valencia in the years 2000-2002 and analyze the differences in antibiotic use among 20 Valencian Community health areas. METHODS: Retrospective observational population study (3,983,464 inhabitants) of prescriptions recorded in Valencian Community pharmacies during the period 2000-2002. We calculated defined daily doses per 1000 inhabitants and day (DHD), for the population without pharmaceutical fees (e.g. pensioners), the population with pharmaceutical fees (e.g. actively working) and the total population. The antibiotics analyzed belonged the J01 group (ATC/DDD classification). RESULTS: Antibiotic consumption was 26.47 DHD in 2000, 23.56 DHD in 2001 and 23.48 DHD in 2002. The most frequently prescribed drug groups included: broad-spectrum penicillins (J01C) 11.8 DHD, macrolides (J01F) 5.6 DHD, and other beta-lactams (J01D) 3.95 DHD. There was considerable variation between the population without pharmaceutical fees and the population with pharmaceutical fees: JO1C (DHD 18.49 vs. 9.73), JO1F (11.06 vs. 3.84) and quinolones (J01M) (9.16 vs. 1.22) (p < 0.05). There was also substantial variation between areas, both overall and by groups (p < 0.05): J01C 6.36 DHD to 12.14 DHD; (J01F), 3.78 DHD to 6.08 DHD; (J01D), 2.28 DHD to 4.65 DHD, and (J01M) 2.39 DHD to 3.6 DHD. CONCLUSIONS: There was a slight trend to decreasing antibiotic use in the Community of Valencia over the period of 2000-2002. The population without pharmaceutical fees showed much higher antibiotic use than those with pharmaceutical fees, and there was considerable variation in prescriptions between the different public health care areas.