A personalized intervention to prevent depression in primary care based on risk predictive algorithms and decision support systems: protocol of the e-predictD study

The predictD is an intervention implemented by general practitioners (GPs) to prevent depression, which reduced the incidence of depression-anxiety and was cost-effective. The e-predictD study aims to design, develop, and evaluate an evolved predictD intervention to prevent the onset of major depression in primary care based on Information and Communication Technologies, predictive risk algorithms, decision support systems (DSSs), and personalized prevention plans (PPPs). A multicenter cluster randomized trial with GPs randomly assigned to the e-predictD intervention + care-as-usual (CAU) group or the active-control + CAU group and 1-year follow-up is being conducted. The required sample size is 720 non-depressed patients (aged 18–55 years), with moderate-to-high depression risk, under the care of 72 GPs in six Spanish cities. The GPs assigned to the e-predictD-intervention group receive brief training, and those assigned to the control group do not. Recruited patients of the GPs allocated to the e-predictD group download the e-predictD app, which incorporates validated risk algorithms to predict depression, monitoring systems, and DSSs. Integrating all inputs, the DSS automatically proposes to the patients a PPP for depression based on eight intervention modules: physical exercise, social relationships, improving sleep, problem-solving, communication skills, decision-making, assertiveness, and working with thoughts. This PPP is discussed in a 15-min semi-structured GP-patient interview. Patients then choose one or more of the intervention modules proposed by the DSS to be self-implemented over the next 3 months. This process will be reformulated at 3, 6, and 9 months but without the GP–patient interview. Recruited patients of the GPs allocated to the control-group+CAU download another version of the e-predictD app, but the only intervention that they receive via the app is weekly brief psychoeducational messages (active-control group). The primary outcome is the cumulative incidence of major depression measured by the Composite International Diagnostic Interview at 6 and 12 months. Other outcomes include depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7), depression risk (predictD risk algorithm), mental and physical quality of life (SF-12), and acceptability and satisfaction (‘e-Health Impact' questionnaire) with the intervention. Patients are evaluated at baseline and 3, 6, 9, and 12 months. An economic evaluation will also be performed (cost-effectiveness and cost-utility analysis) from two perspectives, societal and health systems.Spanish Ministry of Health, the Institute of Health Carlos IIIThe European Regional Development Fund Una manera de hacer Europa (grant references: PI15/00401PI15/01035, and PI15/01021), the Andalusian Council of Health (grant reference: AP-0095-2016);Prevention and Health Promotion Research Network redIAPP (RD16/0007/0010RD16/0007/0005, RD16/0007/0003, and RD16/0007/0001), Ministry of Health of Andalusia (PS-0330- 2016)The Chronicity, Primary Care, and Prevention and Health Promotion Research Network RICAPPS (RD21/0016/0012RD21/0016/0005, RD21/0016/0010, and RD21/0016/0001)The Ministry of Science and Innovation, the Institute of Health Carlos III (SCIII)The European Funds of the Recovery, Transformation and Resilience Plan, and by the EU funds Next-Generatio

A personalized intervention to prevent depression in primary care based on risk predictive algorithms and decision support systems: protocol of the e-predictD study

The predictD is an intervention implemented by general practitioners (GPs) to prevent depression, which reduced the incidence of depression-anxiety and was cost-effective. The e-predictD study aims to design, develop, and evaluate an evolved predictD intervention to prevent the onset of major depression in primary care based on Information and Communication Technologies, predictive risk algorithms, decision support systems (DSSs), and personalized prevention plans (PPPs). A multicenter cluster randomized trial with GPs randomly assigned to the e-predictD intervention + care-as-usual (CAU) group or the active-control + CAU group and 1-year follow-up is being conducted. The required sample size is 720 non-depressed patients (aged 18–55 years), with moderate-to-high depression risk, under the care of 72 GPs in six Spanish cities. The GPs assigned to the e-predictD-intervention group receive brief training, and those assigned to the control group do not. Recruited patients of the GPs allocated to the e-predictD group download the e-predictD app, which incorporates validated risk algorithms to predict depression, monitoring systems, and DSSs. Integrating all inputs, the DSS automatically proposes to the patients a PPP for depression based on eight intervention modules: physical exercise, social relationships, improving sleep, problem-solving, communication skills, decision-making, assertiveness, and working with thoughts. This PPP is discussed in a 15-min semi-structured GP-patient interview. Patients then choose one or more of the intervention modules proposed by the DSS to be self-implemented over the next 3 months. This process will be reformulated at 3, 6, and 9 months but without the GP–patient interview. Recruited patients of the GPs allocated to the control-group+CAU download another version of the e-predictD app, but the only intervention that they receive via the app is weekly brief psychoeducational messages (active-control group). The primary outcome is the cumulative incidence of major depression measured by the Composite International Diagnostic Interview at 6 and 12 months. Other outcomes include depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7), depression risk (predictD risk algorithm), mental and physical quality of life (SF-12), and acceptability and satisfaction (‘e-Health Impact' questionnaire) with the intervention. Patients are evaluated at baseline and 3, 6, 9, and 12 months. An economic evaluation will also be performed (cost-effectiveness and cost-utility analysis) from two perspectives, societal and health systems.Trial registrationClinicalTrials.gov, identifier: NCT03990792

Prediction of depression in European general practice attendees: the PREDICT study

Background Prevention of depression must address multiple risk factors. Estimating overall risk across a range of putative risk factors is fundamental to prevention of depression. However, we lack reliable and valid methods of risk estimation. This protocol paper introduces PREDICT, an international research study to address this risk estimation. Methods/design This is a prospective study in which consecutive general practice attendees in six European countries are recruited and followed up after six and 12 months. Prevalence of depression is assessed at baseline and each follow-up point. Consecutive attendees between April 2003 and September 2004 who were aged 18 to 75 were asked to take part. The possibility of a depressive episode was assessed using the Depression Section of the Composite International Diagnostic Interview. A selection of presumed risk factors was based on our previous work and a systematic review of the literature. It was necessary to evaluate the test-retest reliability of a number of risk factor questions that were developed specifically, or adapted, for the PREDICT study. In a separate reliability study conducted between January and November 2003, consecutive general practice attendees in the six participating European countries completed the risk factor items on two occasions, two weeks apart. The overall response rate at entry to the study was 69%. We exceeded our expected recruitment rate, achieving a total of 10,048 people in all. Reliability coefficients were generally good to excellent. Discussion Response rate to follow-up in all countries was uniformly high, which suggests that prediction will be based on almost a full cohort. The results of our reliability analysis are encouraging and suggest that data collected during the course of PREDICT will have a satisfactory level of stability. The development of a multi-factor risk score for depression will lay the foundation for future research on risk reduction in primary care. Our data will also provide the necessary evidence base on which to develop and evaluate interventions to reduce the prevalence of depression

A personalized intervention to prevent depression in primary care based on risk predictive algorithms and decision support systems: protocol of the e-predictD study

The predictD is an intervention implemented by general practitioners (GPs) to prevent depression, which reduced the incidence of depression-anxiety and was cost-effective. The e-predictD study aims to design, develop, and evaluate an evolved predictD intervention to prevent the onset of major depression in primary care based on Information and Communication Technologies, predictive risk algorithms, decision support systems (DSSs), and personalized prevention plans (PPPs). A multicenter cluster randomized trial with GPs randomly assigned to the e-predictD intervention + care-as-usual (CAU) group or the active-control + CAU group and 1-year follow-up is being conducted. The required sample size is 720 non-depressed patients (aged 18–55 years), with moderate-to-high depression risk, under the care of 72 GPs in six Spanish cities. The GPs assigned to the e-predictD-intervention group receive brief training, and those assigned to the control group do not. Recruited patients of the GPs allocated to the e-predictD group download the e-predictD app, which incorporates validated risk algorithms to predict depression, monitoring systems, and DSSs. Integrating all inputs, the DSS automatically proposes to the patients a PPP for depression based on eight intervention modules: physical exercise, social relationships, improving sleep, problem-solving, communication skills, decision-making, assertiveness, and working with thoughts. This PPP is discussed in a 15-min semi-structured GP-patient interview. Patients then choose one or more of the intervention modules proposed by the DSS to be self-implemented over the next 3 months. This process will be reformulated at 3, 6, and 9 months but without the GP–patient interview. Recruited patients of the GPs allocated to the control-group+CAU download another version of the e-predictD app, but the only intervention that they receive via the app is weekly brief psychoeducational messages (active-control group). The primary outcome is the cumulative incidence of major depression measured by the Composite International Diagnostic Interview at 6 and 12 months. Other outcomes include depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7), depression risk (predictD risk algorithm), mental and physical quality of life (SF-12), and acceptability and satisfaction (‘e-Health Impact' questionnaire) with the intervention. Patients are evaluated at baseline and 3, 6, 9, and 12 months. An economic evaluation will also be performed (cost-effectiveness and cost-utility analysis) from two perspectives, societal and health systems.Trial registrationClinicalTrials.gov, identifier: NCT03990792

Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and health professionals: EIRA study (phase II)

Objective: To evaluate the implementation and development of a complex intervention on health promotion and changes in health-promoting behaviours in primary healthcare according to healthcare attendees and health professionals. Design: Descriptive qualitative evaluation research conducted with 94 informants. Data collection techniques consisted of 14 semistructured individual interviews, 9 discussion groups, 1 triangular group and 6 documents. Three analysts carried out a thematic content analysis with the support of Atlas.ti software. This evaluation was modelled on Proctor and colleagues’ concept of outcomes for implementation research. Setting: 7 primary care centres from seven Spanish regions: Andalusia, Aragon, Balearic Islands, Basque Country, Castilla-La Mancha, Castilla-Leon and Catalonia. Participants: The study population were healthcare attendees (theoretical sampling) and health professionals (opportunistic sampling) who had participated in the exploratory trial of the EIRA intervention (2015). Results: Healthcare attendees and professionals had a positive perception of the study. Healthcare attendees even reported that they would recommend participation to family and friends. Health professionals became aware of the significance of the motivational interview, especially for health promotion, and emphasised social prescribing of physical activity. They also put forward recommendations to improve recruitment, screening and retention of participants. Healthcare attendees modified behaviours and health professionals modified working practices. To achieve sustainability, health professionals believe that it is crucial to adapt agendas and involve all the staff. Conclusions: The discourses of all stakeholders on the intervention must be taken into consideration for the successful, setting-specific implementation of adequate, acceptable, equitable and sustainable strategies aimed at health promotion and well-being

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.This study was supported by the Spanish Ministry of Health (grant FIS references: PI041980, PI041771, PI042450 and PI06/1442) and the Andalusian Council of Health (grant references: 05/403 and 06/278); as well as the Spanish Network of Primary Care Research ‘redIAPP’ (RD06/0018), the ‘Aragón group’ (RD06/0018/0020), the ‘Baleares group’ (RD07/0018/0033), and the ‘SAMSERAP group’ (RD06/0018/0039)

Effects of HCV Eradication on Bone mineral density in HIV/HCV Coinfected Patients

Little is known about the effects of eradication of HCV on bone mineral density (BMD) and biomarkers of bone remodeling in HIV/HCV coinfected patients. We prospectively assessed standardized BMD (sBMD) at the lumbar spine and femoral neck, World Health Organization (WHO) BMD categories at both sites, and plasma concentrations of soluble receptor activator of nuclear factor-kappaβ ligand (sRANKL), and osteoprotegerin (OPG) at baseline (the date of initiation of anti-HCV therapy) and at 96 weeks. A total of 238 patients were included, median age 49.5 years, 76.5% males, 48.3% with cirrhosis, 98.3% on antiretroviral therapy, median CD4+ cell count 527 cells/mm 3, 86.6% with HIV-1 RNA < 50 copies/mL. The prevalence of osteoporosis at baseline at the lumbar spine (LS) and femoral neck (FN) was 17.6% and 7.2%, respectively. Anti-HCV therapy comprised pegylated interferon and ribavirin (PegIFN-RBV) plus one direct-acting antiviral in 53.4%, PegIFN-RBV in 34.5%, and sofosbuvir/RBV in 12.2%. A total of 145 (60.9%) patients achieved sustained viral response (SVR). No significant effect of SVR was observed on sBMD for the interaction between time and SVR either in the LS (P=0.801) or the FN (P=0.911). Likewise, no significant effect of SVR was observed in plasma levels of sRANKL (P=0.205), OPG (P=0.249), and sRANKL/OPG ratio (P=0.123) for the interaction between time and SVR. No significant correlation was found between fibrosis by transient elastography, and LS and FN sBMD, at baseline, and week 96. SVR was not associated with significant changes in BMD nor biomarkers of bone remodeling in HIV/HCV-coinfected persons.This study was supported by Instituto de Salud Carlos III (ISCII), grant numbers PI11/01556, PI14/01094, PI14/01581, and PI14CIII/00011, and by Ministerio de Sanidad, Servicios Sociales e Igualdad, grant number EC11-241. The study was also funded by the RD16/0025/0017, RD16/0025/0018 and RD16CIII/0002/0002 projects as part of the Plan Nacional R + D + I and cofunded by ISCIII-Subdirección General de Evaluación and the Fondo Europeo de Desarrollo Regional (FEDER).S

A multiproxy study distinguishes environmental change from diagenetic alteration in the recent sedimentary record of the inner Cadiz Bay (SW Spain)

In this study, we reconstruct the recent environmental evolution of the inner Cadiz Bay using sedimentary records reaching back as far as AD 1700. We report lithological descriptions of the sediments and extensive mineralogical and geochemical analyses. An extraction technique that identifies different Fe phases provides an assessment of diagenetic alteration, which allows an estimation of the original organic matter inputs to the inner Cadiz Bay. Downcore variations in Corg/N ratios, δ13Corg and δ15N are related to changes in organic matter sources and the trophic state of the water column. The downcore records of selected trace metals (e.g. Pb, Zn and Cu) are interpreted to reflect changes in heavy metal pollution in the bay, while records of other elements (e.g. Mn and P) are likely overprinted by diagenetic alteration. Major environmental shifts took place during the 20th century, when the population around Cadiz Bay increased exponentially. Increases in sediment accumulation rates, organic matter inputs and heavy metal contents, in parallel with increases in δ13Corg and δ15N over this period, are interpreted as direct effects of the increasing anthropogenic influence in the area. The results of this study suggest that multiproxy approaches and detailed consideration of diagenetic overprinting are required to reconstruct past environmental conditions from coastal sediments

A multiple health behaviour change intervention to prevent depression: A randomized controlled trial

Objective: To examine the effectiveness of a 12-month MHBC intervention in the prevention of onset depression in primary health care (PHC). Methods: Twenty-two PHC centres took part in the clusterrandomized controlled trial. Patients were randomized to receive either usual care or an MHBC intervention. The endpoints were onset of major depression and reduction of depressive symptoms in participants without baseline depression at a 12-month follow-up. Results: 2531 patients agreed and were eligible to participate. At baseline, around 43% were smokers, 82% were non-adherent to the Mediterranean diet and 55% did not perform enough physical activity. The intervention group exhibited a greater positive change in two or more behaviours (OR 1.75 [95%CI: 1.17 to 2.62]; p = 0.006); any behaviour (OR 1.58 [95%CI: 1.13 to 2.20]; p = 0.007); and adherence to the Mediterranean diet (OR 1.94 [95%CI: 1.29 to 2.94]; p = 0.002), while this increase was not statistically significant for smoking and physical activity. The intervention was not effective in preventing major depression (OR 1.17; [95% CI 0.53 to 2.59)]; p = 0.690) or reducing depressive symptoms (Mean difference: 0.30; [95% CI -0.77 to 1.36]; p = 0.726) during follow-up. Conclusions: As compared to usual care, the MHBC intervention provided a non-significant reduction in the incidence of major depression