Impact of an SMS intervention to support type 2 diabetes self-management: DiabeText clinical trial.

BACKGROUND: Complications arising from uncontrolled Type 2 Diabetes Mellitus (T2DM) pose a significant burden on individuals' well-being and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition. AIM: To assess the impact of DiabeText, a new theory-based, patient-centered, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management. DESIGN AND SETTING: Pragmatic, Phase III, 12-month, two-arm randomized clinical trial with T2DM primary care patients in Spain. METHOD: 742 participants with suboptimal glycemic control (HbA1c>7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. The DiabeText group received, in addition to usual care, 165 messages focused on healthy lifestyle and medication adherence. PRIMARY OUTCOME: glycated hemoglobin (HbA1c). SECONDARY OUTCOMES: medication possession ratio, quality of life (EQ-5D-5L), diabetes self-efficacy (DSES); and self-reported adherence to medication, Mediterranean diet (MEDAS-14), and physical activity (IPAQ). RESULTS: Over the 12-month period, we observed no significant differences in HbA1c between the intervention and the control groups (Beta=-0.025 (-0.198 to 0.147; p=0.772)). In comparison with the control group, the DiabeText group showed significant (p<0.05) improvements in self-reported medication adherence (OR=1.4; 95%CI: 1.0 to 1.9), DSES (Cohen's d=0.35), and EQ5D-5L (Cohen's d=0.18) scores; but not in the rest of secondary outcomes. CONCLUSION: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.

SENECA study: staging endometrial cancer based on molecular classification.

OBJECTIVE: Management of endometrial cancer is advancing, with accurate staging crucial for guiding treatment decisions. Understanding sentinel lymph node (SLN) involvement rates across molecular subgroups is essential. To evaluate SLN involvement in early-stage (International Federation of Gynecology and Obstetrics 2009 I-II) endometrial cancer, considering molecular subtypes and new European Society of Gynaecological Oncology (ESGO) risk classification. METHODS: The SENECA study retrospectively reviewed data from 2139 women with stage I-II endometrial cancer across 66 centers in 16 countries. Patients underwent surgery with SLN assessment following ESGO guidelines between January 2021 and December 2022. Molecular analysis was performed on pre-operative biopsies or hysterectomy specimens. RESULTS: Among the 2139 patients, the molecular subgroups were as follows: 272 (12.7%) p53 abnormal (p53abn, 1191 (55.7%) non-specific molecular profile (NSMP), 581 (27.2%) mismatch repair deficient (MMRd), 95 (4.4%) POLE mutated (POLE-mut). Tracer diffusion was detected in, at least one side, in 97.2% of the cases; with a bilateral diffusion observed in 82.7% of the cases. By ultrastaging (90.7% of the cases) or one-step nucleic acid amplification (198 (9.3%) of the cases), 205 patients were identified with affected sentinel lymph nodes, representing 9.6% of the sample. Of these, 139 (67.8%) had low-volume metastases (including micrometastases, 42.9%; and isolated tumor cells, 24.9%) while 66 (32.2%) had macrometastases. Significant differences in SLN involvement were observed between molecular subtypes, with p53abn and MMRd groups having the highest rates (12.50% and 12.40%, respectively) compared with NSMP (7.80%) and POLE-mut (6.30%), (p=0.004); (p53abn, OR=1.69 (95% CI 1.11 to 2.56), p=0.014; MMRd, OR=1.67 (95% CI 1.21 to 2.31), p=0.002). Differences were also noted among ESGO risk groups (2.84% for low-risk patients, 6.62% for intermediate-risk patients, 21.63% for high-intermediate risk patients, and 22.51% for high-risk patients; p<0.001). CONCLUSIONS: Our study reveals significant differences in SLN involvement among patients with early-stage endometrial cancer based on molecular subtypes. This underscores the importance of considering molecular characteristics for accurate staging and optimal management decisions.

DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial.

AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.

Non-adherence to non-insulin glucose-lowering drugs: Prevalence, predictors and impact on glycemic control and insulin initiation. A longitudinal cohort study in a large primary care database in Spain.

BACKGROUND: A better understanding of patient non-adherence to type 2 diabetes medication is needed to design effective interventions to address this issue. OBJECTIVES: (1) To estimate the prevalence of non-adherence to diabetes medication; (2) to examine its impact on glycemic control and insulin initiation; (3) to develop and validate a prediction model of non-adherence. METHODS: We conducted a longitudinal cohort study based on data from electronic health records. We included adult patients registered within the Health Service of the Balearic Islands (Spain) starting a new prescription of a non-insulin glucose-lowering drug between January 2016 and December 2018. We calculated non-adherence at 12 months follow-up, defined as medication possession ratio (MPR) ≤ 80%. We fitted multivariable regression models to examine the association between non-adherence and glycemic control and insulin initiation and identified predictors of non-adherence. RESULTS: Of 18,119 patients identified, after 12 months follow-up, 5,740 (31.68%) were non-adherent. Compared with non-adherent, adherent patients presented lower HbA1c levels (mean difference = -0.32%; 95%CI = -0.38%; -0.27%) and were less likely to initiate insulin (aOR = 0.77; 95%CI = 0.63; 0.94). A predictive model explained 22.3% of the variation and presented a satisfactory performance (AUC = 0.721; Brier score = 0.177). The most important predictors of non-adherence were: non-Spanish nationality, currently working, low adherence to previous drugs, taking biguanides, smoker and absence of hypertension. CONCLUSION: Around one-third of the patients do not adhere to their non-insulin glucose-lowering drugs. More research is needed to optimise the performance of the predicting model before considering its implementation in routine clinical practice.

Sentinel Lymph Node Biopsy in Endometrial Cancer: Dual Injection, Dual Tracer-A Multidisciplinary Exhaustive Approach to Nodal Staging.

INTRODUCTION: Sentinel lymph node (SLN) has recently been introduced as a standard staging technique in endometrial cancer (EC). There are some issues regarding team experience and para-aortic detection. OBJECTIVE: to report the accuracy of SLN detection in EC with a dual tracer (ICG and Tc99) and dual injection site (cervix and fundus) during the learning curve. METHODS: A prospective, observational single-center trial including 48 patients diagnosed with early-stage EC. Dual intracervical tracer (Tc99 and ICG) was injected at different times. High-risk patients had a second fundus injection with both tracers. RESULTS: the detection rates were as follows: 100% (48/48) overall for SLNs; 98% (47/48) overall for pelvic SLNs; 89.5% (43/48) for bilateral SLNs; and 2% (1/48) for isolated para-aortic SLNs. In high-risk patients, the para-aortic overall DR was 66.7% (22/33); 60.7% (17/28) with ICG and 51.5% (17/33) with Tc99 (p = 0.048)). Overall rate of lymph node involvement was 14.6% (7/48). Macroscopic pelvic metastasis was found in four patients (8.3%) and microscopic in one case (2%). No metastasis was found in any para-aortic SLNs. Half of the patients with positive pelvic SLNs had positive para-aortic nodes. In high-risk patients, when para-aortic SLNs mapped failed, 36.4% (4/11) had positive nodes in para-aortic lymphadenectomy. The sensitivity and negative predictive value (NPV) of SLN pelvic detection was 100%. CONCLUSIONS: Multidisciplinary exhaustive approach gives a suitable accuracy of SLN during learning curve. Dual injection (cervical and fundal) with dual tracer (ICG and Tc99) offers good overall detection rates and increases para-aortic SLN detection.

[Evolution of the outpatient antibiotic prescription between 2012 and 2018. Characteristics of the ABPresclín platform created for the analysis of antibiotic prescription in the health service of the Balearic Islands.] / Evolución de la prescripción antibiótica ambulatoria entre 2012 y 2018. Características de la plataforma ABPresclín creada para el análisis de prescripción antibiótica en el Servicio de Salud de las Islas Baleares.

OBJECTIVE: One of the fist lines of action of the National Plan against Antibiotic Resistance (PRAN) is to monitor the use of antibiotics as a fundamental basis for the fight against resistance. In order to know the antibiotic prescription habits, we pretended to describe the outpatient prescription of systemic antibiotics in the Balearic Islands through exploitation of ABPresclín database. METHODS: It was an ecological descriptive study of the electronic outpatient prescriptions of systemic antibiotics of the Health Service of the Balearic Islands from 2012 to 2018. Combining the prescription with population information data by year and geographical area, prescription rates were obtained per 1,000 person, distributed by professional, health centres, geographical areas: distribution per patient characteristics, type of antibiotics and associated diagnoses. RESULTS: 3,517,101 prescriptions are analyzed with an average prescription period (TPp) per 1,000 person-years of 472.1. A quarter of the population received at least one prescription of antibiotics. TPp was higher in over 80 years (899.0) and in women (553.4). 68.9% of the prescription was made in primary care (AP) and 17.9% in out-of-hours settings. TPp in AP was 333.1, varying from 192.3 to 527.0, according to basic health areas. The TPp of the most commonly used antibiotics was: amoxicillin/clavulanic (143), amoxicillin (95.9), azithromycin (54.5), fosfomycin (41.5) and ciprofloxacin (29.7). The main associated diagnoses were: lower respiratory infections (16.5%), urinary infections (15%), non-infectious (15%), tonsillitis (14.3%) and upper respiratory infections (13%). CONCLUSIONS: Balearic Islands have a relatively low antibiotic prescription rate with a marked variability between prescribers. Amoxicillin/clavulanic was the most prescribed antibiotic, with an increase in azithromycin. Respiratory infections were the main reason for prescription. ABPresclín is useful to promote better use of antibiotics.

OBJETIVO: Una de las líneas de actuación del Plan Nacional frente a la Resistencia a los Antibióticos (PRAN) es la vigilancia del uso de los antibióticos como pilar fundamental en la lucha frente a la resistencia. Con la finalidad de conocer los hábitos de prescripción de antibióticos, este trabajo pretendió describir la prescripción ambulatoria de antibióticos sistémicos en Baleares mediante la explotación de la base de datos ABPresclín. METODOS: Se elaboró un diseño descriptivo ecológico de la prescripción ambulatoria de antibióticos sistémicos en el Servicio de Salud de las Islas Baleares, entre 2012 y 2018. Se realizó un análisis descriptivo de la prescripción antibiótica que, si se refería a un denominador poblacional por año o periodo, permitía obtener tasas de prescripciones por cada 1.000 personas, distribuidas por profesional, por cupo o por áreas geográficas (zonas básicas de salud y áreas), o bien según las características del paciente, el tipo de antibióticos y los diagnósticos asociados. RESULTADOS: Se analizaron 3.517.101 prescripciones, con una tasa de prescripción del período (TPp) por cada 1.000 personas-año de 472,1. Una cuarta parte de la población recibió al menos una prescripción de antibióticos. La TPp fue mayor en >80 años (899) y en mujeres (553,4). El 68,9% de la prescripción se realizó en consulta de atención primaria (AP) y el 17,9% en urgencias extrahospitalarias. La TPp en AP fue de 333,1, variando entre 192,3 y 527, según las zonas básicas de salud. La TPp de los antibióticos más utilizados fue: amoxicilina/clavulánico, 143; amoxicilina, 95,9; azitromicina, 54,5; fosfomicina, 41,5; y ciprofloxacino, 29,7. Se asociaron principalmente los diagnósticos de infecciones respiratorias de vías bajas (16,5%), infecciones urinarias (15%), no infecciosos (15%), amigdalitis (14,3%) e infecciones respiratorias de vías altas (13%). CONCLUSIONES: Baleares presenta una tasa de prescripción de antibióticos relativamente baja, con una marcada variabilidad. Amoxicilina/clavulánico es el antibiótico más prescrito, con incremento de la azitromicina. Las infecciones respiratorias son el principal motivo de prescripción. ABPresclín resulta útil para promover un mejor uso de antibióticos.

Incorporating Budget Impact Analysis in the Implementation of Complex Interventions: A Case of an Integrated Intervention for Multimorbid Patients within the CareWell Study.

OBJECTIVES: To develop a framework for the management of complex health care interventions within the Deming continuous improvement cycle and to test the framework in the case of an integrated intervention for multimorbid patients in the Basque Country within the CareWell project. METHODS: Statistical analysis alone, although necessary, may not always represent the practical significance of the intervention. Thus, to ascertain the true economic impact of the intervention, the statistical results can be integrated into the budget impact analysis. The intervention of the case study consisted of a comprehensive approach that integrated new provider roles and new technological infrastructure for multimorbid patients, with the aim of reducing patient decompensations by 10% over 5 years. The study period was 2012 to 2020. RESULTS: Given the aging of the general population, the conventional scenario predicts an increase of 21% in the health care budget for care of multimorbid patients during the study period. With a successful intervention, this figure should drop to 18%. The statistical analysis, however, showed no significant differences in costs either in primary care or in hospital care between 2012 and 2014. The real costs in 2014 were by far closer to those in the conventional scenario than to the reductions expected in the objective scenario. The present implementation should be reappraised, because the present expenditure did not move closer to the objective budget. CONCLUSIONS: This work demonstrates the capacity of budget impact analysis to enhance the implementation of complex interventions. Its integration in the context of the continuous improvement cycle is transferable to other contexts in which implementation depth and time are important.

[Dietary habits and physical activity in a secondary school in the Balearic islands]. / Habitos de alimentación y actividad física en un instituto de Educación Secundaria secundaria de Baleares.

OBJECTIVE: To evaluate the changes in dietary habits and physical activity, as well as the prevalence of obesity and overweight that have occurred in a cohort of 1st and 4th year secondary school pupils after non-structured health education activities. METHOD: A descriptive, longitudinal study, in which anthropometric variables, dietary habits, leisure and physical activity were collected in the 1st year secondary school pupils (n=61), and they were measured again when they were in the 4th year. The differences between the two school years were analysed using the Mc Nemar-Bowker Test. During the period of the study educational sessions were given on healthy eating and physical activity. RESULTS: The prevalence of overweight decreased significantly (from 14.8% to 3.7%) and the level of physical activity has increased. No statistical differences were detected in the quality of breakfast or in the quality of the Mediterranean diet. CONCLUSIONS: Some of the aspects studied have improved without being able to attribute this improvement to the educational sessions given. To determine and analyse the healthy living habits of adolescents would enable us to plan realistic interventions, adapted to the particular environment. They should be structured and continuous over time and approach areas of knowledge, skills and emotions, and directed, not only at the young people, but also their families, the internal environment of the educational centre. There should be coordination of community resources in order to make a coordinated approach.

[Estimating the coverage of systematic vaccinations among the Balearic Island infant population]. / Estimación de la cobertura de las vacunaciones sistemáticas en la población infantil de las Islas Baleares.

BACKGROUND: In order for vaccination programs to be carried out properly, it is essential for the vaccination coverage to be known. On the Balearic Islands, the reported coverage was much less than for the rest of Spain. The objective of this study is that of estimating the coverage of the vaccinations included on the recommended schedule up to 18 months of age (4 doses of oral polio, tetanus and diphtheria; 3 doses of whooping cough; 1 dose of measles, rubella and mumps). METHODS: A descriptive, cross-sectional study of the population base. The ideal-time frequency distribution estimators and the corresponding confidence intervals were calculated at 95% (CI95%) for a sample of the resident two-year-old (born in 1995) Balearic Island population selected by means of a single-stage conglomerate random sampling based on census sections. The National Public Health System and National Health Institute vaccination records were reviewed, the data from the vaccination document having been requested from the families and the clinical record from the private pediatricians by telephone. RESULTS: The sample included 606 children, it having been possible to obtain full information on 532 children. Full information was obtained on 377 cases (62%) from the public health sector records. The least degree of coverage was found for the diphtheria vaccine, 518 children having been fully vaccinated, 96.8% (CI95% = 94.8-98.1), the highest degree of coverage having been found for the whooping cough vaccine, 537 children, 98.9% (CI95% = 97.5-99.5). CONCLUSIONS: Good vaccination coverage was found to exist on the Balearic Islands, being similar to what has been being estimated for Spain as a whole. The objective included within the Polio Eradication Plan is accomplished, very little information being gathered from the public sector.