Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. METHODS: In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). DISCUSSION: Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.

Predicting the onset of hazardous alcohol drinking in primary care: development and validation of a simple risk algorithm.

BACKGROUND: Little is known about the risk of progressing to hazardous alcohol use in abstinent or low-risk drinkers. AIM: To develop and validate a simple brief risk algorithm for the onset of hazardous alcohol drinking (HAD) over 12 months for use in primary care. DESIGN AND SETTING: Prospective cohort study in 32 health centres from six Spanish provinces, with evaluations at baseline, 6 months, and 12 months. METHOD: Forty-one risk factors were measured and multilevel logistic regression and inverse probability weighting were used to build the risk algorithm. The outcome was new occurrence of HAD during the study, as measured by the AUDIT. RESULTS: From the lists of 174 GPs, 3954 adult abstinent or low-risk drinkers were recruited. The 'predictAL-10' risk algorithm included just nine variables (10 questions): province, sex, age, cigarette consumption, perception of financial strain, having ever received treatment for an alcohol problem, childhood sexual abuse, AUDIT-C, and interaction AUDIT-C*Age. The c-index was 0.886 (95% CI = 0.854 to 0.918). The optimal cutoff had a sensitivity of 0.83 and specificity of 0.80. Excluding childhood sexual abuse from the model (the 'predictAL-9'), the c-index was 0.880 (95% CI = 0.847 to 0.913), sensitivity 0.79, and specificity 0.81. There was no statistically significant difference between the c-indexes of predictAL-10 and predictAL-9. CONCLUSION: The predictAL-10/9 is a simple and internally valid risk algorithm to predict the onset of hazardous alcohol drinking over 12 months in primary care attendees; it is a brief tool that is potentially useful for primary prevention of hazardous alcohol drinking.

The risk for major depression conferred by childhood maltreatment is multiplied by BDNF and SERT genetic vulnerability: a replication study.

BACKGROUND: There is limited evidence for a moderating role of both serotonin transporter (SERT) and brain-derived neurotrophic factor (BDNF) genes on the risk for major depression (MD) developing after childhood maltreatment. However, research on this topic remains inconclusive, and there is a lack of data from longitudinal studies with large and representative population samples. Our study aimed to clarify whether, in the presence of previous childhood maltreatment, individuals carrying low functional alleles for both SERT 5-HTTLPR and BDNF Val66Met polymorphisms had a higher risk for MD. METHODS: We explored 2- and 3-way gene (SERT and BDNF) × environment (childhood maltreatment) interactions in a large sample of Spanish adults who were followed up over a 3-year period and assessed in person for both DSM-IV MD and exposure to childhood maltreatment. RESULTS: Our study included 2679 participants. Those with both the 5-HTTLPR s allele and the BDNF Met allele showed the highest risk of MD if they had previously experienced emotional (z = 2.08, p = 0.037), sexual (z = 2.19, p = 0.029) or any kind of childhood abuse (z = 2.37, p = 0.018). These 3-way interactions remained significant regardless of whether the 5-HTTLPR triallelic or the 5-HTTLPR biallelic polymorphisms were included in the analyses. LIMITATIONS: Retrospective assessment of childhood maltreatment may have resulted in a moderate degree of recall bias. CONCLUSION: Our results confirm that the risk of depression conferred by childhood maltreatment is modified by variation at both SERT and BDNF genes.

Predicting the onset of anxiety syndromes at 12 months in primary care attendees. The predictA-Spain study.

BACKGROUND: There are no risk algorithms for the onset of anxiety syndromes at 12 months in primary care. We aimed to develop and validate internally a risk algorithm to predict the onset of anxiety syndromes at 12 months. METHODS: A prospective cohort study with evaluations at baseline, 6 and 12 months. We measured 39 known risk factors and used multilevel logistic regression and inverse probability weighting to build the risk algorithm. Our main outcome was generalized anxiety, panic and other non-specific anxiety syndromes as measured by the Primary Care Evaluation of Mental Disorders, Patient Health Questionnaire (PRIME-MD-PHQ). We recruited 3,564 adult primary care attendees without anxiety syndromes from 174 family physicians and 32 health centers in 6 Spanish provinces. RESULTS: The cumulative 12-month incidence of anxiety syndromes was 12.2%. The predictA-Spain risk algorithm included the following predictors of anxiety syndromes: province; sex (female); younger age; taking medicines for anxiety, depression or stress; worse physical and mental quality of life (SF-12); dissatisfaction with paid and unpaid work; perception of financial strain; and the interactions sex*age, sex*perception of financial strain, and age*dissatisfaction with paid work. The C-index was 0.80 (95% confidence interval=0.78-0.83) and the Hedges' g=1.17 (95% confidence interval=1.04-1.29). The Copas shrinkage factor was 0.98 and calibration plots showed an accurate goodness of fit. CONCLUSIONS: The predictA-Spain risk algorithm is valid to predict anxiety syndromes at 12 months. Although external validation is required, the predictA-Spain is available for use as a predictive tool in the prevention of anxiety syndromes in primary care.

Adherencia terapéutica en pacientes depresivos de atención primaria: un estudio longitudinal / Therapeutic adherence in primary care depressed patients: a longitudinal study

Introducción: La falta de adherencia se asocia a una reducción de la eficacia del tratamiento antidepresivo, incrementando la probabilidad de recurrencias y la persistencia de los síntomas clínicos. Los pacientes con mala adherencia a la medicación presentan más enfermedades médicas concomitantes y más sintomatología somática y generan mayor uso de los servicios de salud. Método: Estudio observacional y longitudinal del grado de adherencia terapéutica en pacientes con trastorno depresivo atendidos en 3 centros de Atención Primaria (AP). Se realizaron 8 evaluaciones a lo largo de 6 meses a un total de 29 sujetos mayores de 18 años, con diagnóstico DSM-IV-TR de Depresión Mayor. Se pretendía determinar el grado de adherencia al tratamiento, analizar los datos sociodemográficos y perfiles clínicos que intervienen en la adherencia y observar la evolución de la sintomatología depresiva. Resultados: Un 72.4% de los pacientes mostraron una buena adherencia terapéutica. Aparecieron diferencias estadísticamente significativas en el Drug Attitude Inventory (U=107.5; p=0.036), instrumento que evalúa el efecto percibido de la medicación, con una mejor percepción en los pacientes con buena adherencia. En estos pacientes se produjo una reducción progresiva en la puntuación de la Escala de Hamilton en cada una de las 6 visitas de seguimiento, alcanzando remisión de síntomas en la evaluación del 4º mes. En el análisis de supervivencia no se observaron diferencias significativas entre ambos grupos [Log Rank (χ2=1.610, p=0.205)]. Conclusiones: La adherencia encontrada en este estudio longitudinal en AP es elevada y se asocia a una mejoría en el curso de la enfermedad. Un mejor efecto percibido del tratamiento está significativamente relacionado con una mejoría en la sintomatología depresiva

Introduction: Lack of adherence has been associated to lower efficacy of anti-depressant treatment, increasing the risk of recurrence and persistence of clinical symptoms. Patients with poor medication adherence have more concomitant medical illnesses and somatic symptoms. Furthermore, this increases use of healthcare services. Method: Longitudinal and observational study on therapeutic adherence level in depressive outpatients treated in 3 Primary Care (PC) centers. Eight evaluations during 6 months were carried out in 29 patients over 18, with DSM-IV-TR major depression diagnosis. The purpose of the present study was to determine adherence level, to analyze socio-demographic factors and clinical profiles involved in adherence, and to observe the evolution of depressive symptoms. Results: Good therapeutic adherence was observed in72.4% of patients. Significant differences in the Drug Attitude Inventory (U=107.5; p=0.036) were found. This tool evaluates the perceived effect of the medication, with a better perception observed in adherent patients. In those patients a progressive reduction on the Hamilton Depression Scale was found over the course of six monthly follow-up visits, with clinical remission observed in month 4. The analysis of survival rate did not reveal any significant difference between the two groups [Log Rank (χ2=1.610, p=0.205)]. Conclusions: The therapeutic adherence observed in this longitudinal PC study is high, and it is associated with an improvement in the illness. A better perceived effect of the treatment showed a significant connection to an improvement in symptoms of depression

Therapeutic adherence in primary care depressed patients: a longitudinal study.

INTRODUCTION: Lack of adherence has been associated to lower efficacy of anti-depressant treatment, increasing the risk of recurrence and persistence of clinical symptoms. Patients with poor medication adherence have more concomitant medical illnesses and somatic symptoms. Furthermore, this increases use of healthcare services. METHOD: Longitudinal and observational study on therapeutic adherence level in depressive outpatients treated in 3 Primary Care (PC) centers. Eight evaluations during 6 months were carried out in 29 patients over 18, with DSM-IV-TR major depression diagnosis. The purpose of the present study was to determine adherence level, to analyze socio-demographic factors and clinical profiles involved in adherence, and to observe the evolution of depressive symptoms. RESULTS: Good therapeutic adherence was observed in 72.4% of patients. Significant differences in the Drug Attitude Inventory (U=107.5; p=0.036) were found. This tool evaluates the perceived effect of the medication, with a better perception observed in adherent patients. In those patients a progressive reduction on the Hamilton Depression Scale was found over the course of six monthly follow-up visits, with clinical remission observed in month 4. The analysis of survival rate did not reveal any significant difference between the two groups [Log Rank (χ2=1.610, p=0.205)]. CONCLUSIONS: The therapeutic adherence observed in this longitudinal PC study is high, and it is associated with an improvement in the illness. A better perceived effect of the treatment showed a significant connection to an improvement in symptoms of depression.

Psychometric properties of the List of Threatening Experiences--LTE and its association with psychosocial factors and mental disorders according to different scoring methods.

BACKGROUND: The List of Threatening Experiences (LTE) questionnaire is frequently used to assess stressful events; however, studies of its psychometric properties are scarce. We examined the LTE's reliability, factorial structure, construct validity and explored the association between LTE scores and psychosocial variables and mental disorders. METHOD: This study involved interviewing 5442 primary care attendees from Spain. Associations between four different methods of quantifying LTE scores, psychosocial factors, major depression (CIDI), anxiety disorders (PRIME-MD), alcohol misuse and dependence (AUDIT) were measured. RESULTS: The LTE showed high test-retest reliability (Kappa range=0.61-0.87) and low internal consistency (α=0.44). Tetrachoric factorial analysis yielded four factors (spousal and relational problems; employment and financial problems; personal problems; illness and bereavement in close persons). Logistic multilevel regression found a strong association between greater social support and a lower occurrence of stressful events (OR range=0.36-0.79). The association between religious-spiritual beliefs and the LTE, was weaker. The association between mental disorders and LTE scores was greater for depression (OR range=1.64-2.57) than anxiety (OR range=1.35-1.97), though the highest ORs were obtained with alcohol dependence (OR range=2.86-4.80). The ordinal score (ordinal regression) was more sensitive to detect the strength of association with mental disorders. LIMITATIONS: We are unable to distinguish the direction of the association between stressful events, psychosocial factors and mental disorders, due to our cross-sectional design of the study. CONCLUSIONS: The LTE is a valid and reliable measure of stress in mental health, and the strength of association with mental disorders depends on the method of quantifying LTE scores.

Psychosocial and sociodemographic predictors of attrition in a longitudinal study of major depression in primary care: the predictD-Spain study.

BACKGROUND: Few data exist on the psychosocial factors associated with attrition in longitudinal surveys. This study was undertaken to determine psychosocial and sociodemographic predictors of attrition from a longitudinal study of the onset and persistence of episodes of major depression in primary care. METHODS: A systematic random sample of general practice attendees was recruited in seven Spanish provinces between October 2005 and February 2006. Major depression was diagnosed using the Composite International Diagnostic Interview and a set of 39 individual and environmental risk factors for depression were assessed at baseline and after 6 and 12 months of follow-up. Data were analysed using multilevel logistic regression. RESULTS: 7777 primary care attendees aged 18-75 years were selected, of whom 1251 (16.1%) were excluded. Of the remaining 6526, 1084 (16.6%) refused to participate. Thus, 5442 patients (attending 231 family physicians in 41 health centres) were interviewed at baseline, of whom 3804 (70%) and 3567 (66%) remained at 6 and 12 months of follow-up, respectively. The province and sociodemographic factors were stronger predictors of attrition than psychosocial factors. Depression and anxiety had no effect but other psychosocial factors affected attrition. There were different profiles for the patients lost at 12 months when predictors measured at baseline versus 6 months were included. CONCLUSIONS: These findings suggest that several psychosocial factors might be considered factors of attrition in primary care cohorts and confirm that baseline characteristics are insufficient for analysing non-response in longitudinal studies, indicating that different retention strategies should be applied for patients interviewed at 6 and 12 months.

Predicting the onset and persistence of episodes of depression in primary health care. The predictD-Spain study: methodology.

BACKGROUND: The effects of putative risk factors on the onset and/or persistence of depression remain unclear. We aim to develop comprehensive models to predict the onset and persistence of episodes of depression in primary care. Here we explain the general methodology of the predictD-Spain study and evaluate the reliability of the questionnaires used. METHODS: This is a prospective cohort study. A systematic random sample of general practice attendees aged 18 to 75 has been recruited in seven Spanish provinces. Depression is being measured with the CIDI at baseline, and at 6, 12, 24 and 36 months. A set of individual, environmental, genetic, professional and organizational risk factors are to be assessed at each follow-up point. In a separate reliability study, a proportional random sample of 401 participants completed the test-retest (251 researcher-administered and 150 self-administered) between October 2005 and February 2006. We have also checked 118,398 items for data entry from a random sample of 480 patients stratified by province. RESULTS: All items and questionnaires had good test-retest reliability for both methods of administration, except for the use of recreational drugs over the previous six months. Cronbach's alphas were good and their factorial analyses coherent for the three scales evaluated (social support from family and friends, dissatisfaction with paid work, and dissatisfaction with unpaid work). There were 191 (0.16%) data entry errors. CONCLUSION: The items and questionnaires were reliable and data quality control was excellent. When we eventually obtain our risk index for the onset and persistence of depression, we will be able to determine the individual risk of each patient evaluated in primary health care.

Withdrawal from long-term benzodiazepine use: randomised trial in family practice.

BACKGROUND: The long-term use of benzodiazepines is highly prevalent in developed societies and is not devoid of risks. Withdrawing patients from these drugs is often difficult. Tapering off benzodiazepines has been shown to be a good strategy for discontinuing their long-term use. AIM: To establish the efficacy of an intervention programme for reducing the chronic use of benzodiazepines. DESIGN OF STUDY: Randomised, two-arm, parallel, non-blinded controlled trial. SETTING: Three urban healthcare centres covering a population of 50,000 inhabitants (Mallorca, Spain). METHOD: Adult patients (n = 139) taking benzodiazepines daily for more than a year and visited by their family physician were randomised into an intervention group (n = 73) that received standardised advice and a tapering off schedule with biweekly follow-up visits, or into a control group (n = 66), that was managed following routine clinical practice. Both were followed for a year. RESULTS: Patients achieved withdrawal or reduced their dose by at least 50% after 6 and 12 months. Abstinence and withdrawal symptoms were also measured. Both groups were homogeneous for personal, clinical and psychological characteristics and for benzodiazepine use. Only two patients from each group were lost to follow-up. After 12 months, 33 (45.2%) patients in the intervention group and six (9.1%) in the control group had discontinued benzodiazepine use; relative risk = 4.97 (95% confidence interval [CI] = 2.2 to 11.1), absolute risk reduction = 0.36 (95% CI = 0.22 to 0.50). For every three interventions, one patient achieved withdrawal. Sixteen (21.9%) subjects from the intervention group and 11 (16.7%) controls reduced their initial dose by more than 50%. CONCLUSION: Standardised advice given by the family physician, together with a tapering off schedule, is effective for withdrawing patients from long-term benzodiazepine use and is feasible in primary care.

Indicadores de calidad de la prescripción farmacológica basado en el consumo farmaceútico / Quality indicatives of hte pharmacological prescription based on pharmaceutical consumption

Objetivo: el objetivo de este trabajo es doble: por una parte sentar las bases metodológicas para el desarrollo de indicadores basados en datos de consumo farmacéutico. Por otra diseñar un conjunto de indicadores y proponer valores óptimos que puedan servir para la mejora de calidad de prescripción en atención primaria. Material y métodos: se creó un grupo de expertos que debía tomar sus decisiones por consenso. El procedimiento de trabajo se basó en la selección de los grupos farmacológicos más relevantes en atención primaria y en la propuesta inicial de un gran número de indicadores de consumo de principios activos expresados en Dosis Diarias Definidas. Tras analizar su significación y potencial utilidad y efectuar su seguimiento en diversas áreas del Insalud, se seleccionó un conjunto reducido para los que, en su mayoría, se han propuesto valores óptimos. Para la determinación de los valores óptimos se han considerado tanto los datos históricos de consumo, como datos epidemiológicos y diversos estudios internacionales. Únicamente en un grupo muy reducido de indicadores no se han establecido estos valores óptimos, por estimarse más oportuna la fijación de estándares locales, en función de las circunstancias epidemiológicas y sociosanitarias particulares. Resultados: se han propuesto indicadores de consumo para principios activos de utilidad terapéutica alta de los siguientes grupos: Antiulcerosos, antidiabéticos orales, hipolipemiantes, antiagregantes plaquetarios antihipertensivos, antiinflamatorios no esteroideos, analgésicos narcóticos, tratamiento de la hiperplasia benigna de próstata, tranquilizantes e hipnóticos, antidepresivos, antibióticos y antiasmáticos. Además, se proponen otra serie de indicadores seleccionados por completar la aproximación a la calidad desde perspectivas complementarias a la estricta relevancia farmacológica. Entre ellos se encuentran indicadores de eficiencia, de utilización de genéricos, de adhesión a la guía farmacológica, de novedad terapéutica sin aportación relevante y de alerta. Conclusiones: el análisis del consumo farmacéutico puede ser una herramienta muy útil para evaluar la calidad en la prescripción farmacológica, ya que permite detectar con facilidad consumos excesivos y/o ineficientes, puede identificar el uso de medicamentos ineficaces y permite comparaciones sencillas y fáciles de interpretar, a partir de una toma de datos sencilla y fiable. Sin embargo, tiene como limitaciones la dificultad de relacionar de relacionar el diagnóstico con la indicación y el hecho de que no siempre lo consumido es igual a lo prescrito. Se espera que este primer grupo de indicadores propuestos sean discutidos, mejorados y ampliados por todo el colectivo de profesionales interesados en el tema (AU)