Impact of hypertension diagnosis on morbidity and mortality: a retrospective cohort study in primary care.

BACKGROUND: Hypertension is responsible for a huge burden of disease. The aim of this study was to evaluate the impact of newly diagnosed hypertension on the occurrence of kidney or cardiovascular events (K/CVEs) and on mortality among community dwellers. METHODS: Retrospective cohort study, conducted from January, 2007, to December, 2018. All patients (age > 18) newly diagnosed with hypertension and no previous K/CVEs in 2007 and 2008, in the primary care centers of Madrid (Spain) (n = 71,770), were enrolled. The control group (n = 72,946) included patients without hypertension, matched by center, sex and age. The occurrence of kidney or CV events, including mortality from these causes and total mortality were evaluated using Cox regression and multistate models. Data were collected from three sources: personal data from administrative records, clinical data from medical records, and mortality data from regional and national databases. RESULTS: The median follow-up was 138.61 months (IQR: 124.68-143.97 months). There were 32,896 K/CVEs (including 3,669 deaths from these causes) and 12,999 deaths from other causes. Adjusted for sex, smoking, diabetes and socioeconomic status, K/CVEs HR was 4.36 (95% CI: 3.80-5.00) for diagnoses before 45 years of age, 2.45(95% CI: 2.28- 2.63) for diagnosis between 45 to 54 years, and HR decreased to 1.86 (95% CI: 1.64-210) for diagnoses over age 85. Total mortality risk was only higher for hypertension diagnosed before 55 years of age (HR: 2.47, 95% CI: 1.90-3.19 for ages 18 to 44; and HR: 1.14, 95% CI: 1.02-1.28 for ages 45 to 54). CONCLUSION: The diagnosis of hypertension in the community environment, in patients without evidence of previous kidney or CV disease, is associated with a large increase in the risk of K/CVEs, but especially in individuals diagnosed before the age of 55. This diagnosis is only associated with an increase in kidney or cardiovascular mortality or overall mortality when it occurs before age 55.

Comparison of Cardiovascular Risk and Events among Spanish Patients with and without Ocular Pseudoexfoliation.

The purpose of this study was to calculate and compare individual cardiovascular risk (CVR) and the development of cardiovascular events and mortality in patients with and without ocular pseudoexfoliation (PEX). A cohort study was carried out to compare two groups of patients who underwent cataract surgery: patients with (n = 99) and without PEX (n = 239). The CVR factors were recorded for all the subjects, and CVR was calculated for each individual using ERICE risk assessment charts. After a six-year follow-up, the cardiovascular events and mortality rates were compared between the two groups. The mean CVR was 36.41% in the PEX group and 33.72% in the non-PEX group (p = 0.13). High blood pressure was detected in significantly more PEX patients (71.4%) than non-PEX patients (58.6%, p = 0.035), yet no differences were found in the other CVR factors. The prevalence of cardiovascular events in the PEX and non-PEX patients was 17.1% and 12.5%, respectively (p = 0.26), with 5% of patients in the PEX group and 5% in the non-PEX group suffering an acute coronary event (p = 0.9). Moreover, 12% of the PEX patients and 7.5% of the non-PEX patients experienced a stroke (p = 0.17), and the six-year mortality rate was 29.3% in the PEX group and 25.9% in the non-PEX group (p = 0.52). PEX was associated with high blood pressure in our cohort of patients, although cardiovascular risk was not shown to be higher in this group. In addition, patients with PEX did not experience more cardiovascular events or have a higher mortality rate than patients without PEX during the period studied.

Stratification for Identification of Prognostic Categories In the Acute RESpiratory Distress Syndrome (SPIRES) Score.

OBJECTIVES: To develop a scoring model for stratifying patients with acute respiratory distress syndrome into risk categories (Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score) for early prediction of death in the ICU, independent of the underlying disease and cause of death. DESIGN: A development and validation study using clinical data from four prospective, multicenter, observational cohorts. SETTING: A network of multidisciplinary ICUs. PATIENTS: One-thousand three-hundred one patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The study followed Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis guidelines for prediction models. We performed logistic regression analysis, bootstrapping, and internal-external validation of prediction models with variables collected within 24 hours of acute respiratory distress syndrome diagnosis in 1,000 patients for model development. Primary outcome was ICU death. The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score was based on patient's age, number of extrapulmonary organ failures, values of end-inspiratory plateau pressure, and ratio of Pao2 to Fio2 assessed at 24 hours of acute respiratory distress syndrome diagnosis. The pooled area under the receiver operating characteristic curve across internal-external validations was 0.860 (95% CI, 0.831-0.890). External validation in a new cohort of 301 acute respiratory distress syndrome patients confirmed the accuracy and robustness of the scoring model (area under the receiver operating characteristic curve = 0.870; 95% CI, 0.829-0.911). The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score stratified patients in three distinct prognostic classes and achieved better prediction of ICU death than ratio of Pao2 to Fio2 at acute respiratory distress syndrome onset or at 24 hours, Acute Physiology and Chronic Health Evaluation II score, or Sequential Organ Failure Assessment scale. CONCLUSIONS: The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score represents a novel strategy for early stratification of acute respiratory distress syndrome patients into prognostic categories and for selecting patients for therapeutic trials.

Efficacy of a self-management education programme on patients with type 2 diabetes in primary care: A randomised controlled trial.

AIM: The purpose of this study was to assess the efficacy of the Spanish Diabetes Self-Management Program (SDSMP) versus usual care in adults with type 2 diabetes mellitus (T2DM) residing in a Spanish region. METHODS: A two-year follow-up randomised controlled trial. The intervention consisted of 6 weekly structured peer-to-peer workshops. The primary outcome was change in HbA1c levels. Secondary outcomes included other clinical measures, quality of life, self-efficacy, life-style changes, medication and use of healthcare services. Mixed effect models were fitted. RESULTS: n=297 patients were recruited in each study arm. Baseline HbA1c levels were comparable in both groups with an overall mean 7.1 (SD=1.2). The intervention did not significantly modify HbA1c, or other cardiovascular variables. Significant improvements were seen in self-efficacy, and in particularly its disease control component. Certain differences were also observed in the use of healthcare resources and medication consumption. High workshop participation and satisfaction rates were achieved. CONCLUSION: HbA1c reductions are difficult to obtain in adequately controlled patients. On the other hand, raising awareness on one's disease can increase disease control self-efficacy. This finding, accompanied by reduced medication consumption and healthcare use rates, highlights that usual care would be benefited by incorporating certain SDSMP aspects. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01642394.

[Concepts. Minimally disruptive medicine]. / Conceptos. Medicina mínimamente disruptiva.

This paper presents some concepts about overdiagnosis and its consequences: overtreatment and the medicalization of the society. It recalls the origin of the term, that comes from the screening and diagnosis of cancer, and it reviews the strategies to overdiagnose. Furthermore, it analyses the conversion of illnesses diagnostic thresholds as well as the transformation of normal and vital processes and risk factors in illnesses. It shows some strategies to confront overdiagnosis at the time of medical consultation, including the management of uncertainty and the shared decision making through the right interpretation of the diagnosis results and treatment estimators. Finally, it shows the minimally disruptive medicine as the best strategy to face the disease burden induced by the overtreatment in patients suffering from multimorbidity.

Conceptos. Medicina mínimamente disruptiva / Concepts. Minimally disruptive medicine

En este artículo se presentan algunos conceptos acerca del sobrediagnóstico y sus consecuencias: sobretratamiento y medicalización de la sociedad. Se recuerda el origen del término a partir del cribado y diagnóstico del cáncer y se revisan las estrategias para "sobrediagnosticar", como la modificación de los umbrales diagnósticos de las enfermedades y la conversión de procesos vitales normales, así como los factores de riesgo, en enfermedad. Se exponen algunas estrategias para afrontar el sobrediagnóstico "desde la consulta", como son el manejo de la incertidumbre y la toma compartida de decisiones a través de la correcta interpretación de los estimadores de resultado de diagnóstico y de tratamiento. Finalmente, se presenta la medicina mínimamente disruptiva como la mejor estrategia para afrontar la carga de enfermedad a la que conduce el sobretratamiento en los pacientes con multimorbilidad

This paper presents some concepts about overdiagnosis and its consequences: overtreatment and the medicalization of the society. It recalls the origin of the term, that comes from the screening and diagnosis of cancer, and it reviews the strategies to overdiagnose. Furthermore, it analyses the conversion of illnesses diagnostic thresholds as well as the transformation of normal and vital processes and risk factors in illnesses. It shows some strategies to confront overdiagnosis at the time of medical consultation, including the management of uncertainty and the shared decision making through the right interpretation of the diagnosis results and treatment estimators. Finally, it shows the minimally disruptive medicine as the best strategy to face the disease burden induced by the overtreatment in patients suffering from multimorbidity

Is Overall Mortality the Right Composite Endpoint in Clinical Trials of Acute Respiratory Distress Syndrome?

OBJECTIVES: Overall mortality in patients with acute respiratory distress syndrome is a composite endpoint because it includes death from multiple causes. In most acute respiratory distress syndrome trials, it is unknown whether reported deaths are due to acute respiratory distress syndrome or the underlying disease, unrelated to the specific intervention tested. We investigated the causes of death after contracting acute respiratory distress syndrome in a large cohort. DESIGN: A secondary analysis from three prospective, multicenter, observational studies. SETTING: A network of multidisciplinary ICUs. PATIENTS: We studied 778 patients with moderate-to-severe acute respiratory distress syndrome treated with lung-protective ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We examined death in the ICU from individual causes. Overall ICU mortality was 38.8% (95% CI, 35.4-42.3). Causes of acute respiratory distress syndrome modified the risk of death. Twenty-three percent of deaths occurred from refractory hypoxemia due to nonresolving acute respiratory distress syndrome. Most patients died from causes unrelated to acute respiratory distress syndrome: 48.7% of nonsurvivors died from multisystem organ failure, and cancer or brain injury was involved in 37.1% of deaths. When quantifying the true burden of acute respiratory distress syndrome outcome, we identified 506 patients (65.0%) with one or more exclusion criteria for enrollment into current interventional trials. Overall ICU mortality of the "trial cohort" (21.3%) was markedly lower than the parent cohort (relative risk, 0.55; 95% CI, 0.43-0.70; p < 0.000001). CONCLUSIONS: Most deaths in acute respiratory distress syndrome patients are not directly related to lung damage but to extrapulmonary multisystem organ failure. It would be challenging to prove that specific lung-directed therapies have an effect on overall survival.

Methodological systematic review identifies major limitations in prioritization processes for updating.

OBJECTIVES: The aim of the study was to identify and describe strategies to prioritize the updating of systematic reviews (SRs), health technology assessments (HTAs), or clinical guidelines (CGs). STUDY DESIGN AND SETTING: We conducted an SR of studies describing one or more methods to prioritize SRs, HTAs, or CGs for updating. We searched MEDLINE (PubMed, from 1966 to August 2016) and The Cochrane Methodology Register (The Cochrane Library, Issue 8 2016). We hand searched abstract books, reviewed reference lists, and contacted experts. Two reviewers independently screened the references and extracted data. RESULTS: We included 14 studies. Six studies were classified as descriptive (6 of 14, 42.9%) and eight as implementation studies (8 of 14, 57.1%). Six studies reported an updating strategy (6 of 14, 42.9%), six a prioritization process (6 of 14, 42.9%), and two a prioritization criterion (2 of 14, 14.2%). Eight studies focused on SRs (8 of 14, 57.1%), six studies focused on CGs (6 of 14, 42.9%), and none were about HTAs. We identified 76 prioritization criteria that can be applied when prioritizing documents for updating. The most frequently cited criteria were as follows: available evidence (19 of 76, 25.0%), clinical relevance (10 of 76; 13.2%), and users' interest (10 of 76; 13.2%). CONCLUSION: There is wide variability and suboptimal reporting of the methods used to develop and implement processes to prioritize updating of SRs, HTAs, and CGs.

Prescription Strategies in Acute Uncomplicated Respiratory Infections: A Randomized Clinical Trial.

IMPORTANCE: Delayed antibiotic prescription helps to reduce antibiotic use with reasonable symptom control. There are different strategies of delayed prescription, but it is not yet clear which one is the most effective. OBJECTIVE: To determine the efficacy and safety of 2 delayed strategies in acute, uncomplicated respiratory infections. DESIGN, SETTING, AND PARTICIPANTS: We recruited 405 adults with acute, uncomplicated respiratory infections from 23 primary care centers in Spain to participate in a pragmatic, open-label, randomized clinical trial. INTERVENTIONS: Patients were randomized to 1 of 4 potential prescription strategies: (1) a delayed patient-led prescription strategy; (2) a delayed prescription collection strategy requiring patients to collect their prescription from the primary care center; (3) an immediate prescription strategy; or (4) a no antibiotic strategy. Delayed prescription strategies consist of prescribing an antibiotic to take only if the symptoms worsen or if there is no improvement several days after the medical visit. MAIN OUTCOMES AND MEASURES: The primary outcomes were the duration of symptoms and severity of symptoms. Each symptom was scored using a 6-point Likert scale (scores of 3 or 4 were considered moderate; 5 or 6, severe). Secondary outcomes included antibiotic use, patient satisfaction, and patients' beliefs in the effectiveness of antibiotics. RESULTS: A total of 405 patients were recruited, 398 of whom were included in the analysis; 136 patients (34.2%) were men; mean (SD) age, 45 (17) years. The mean severity of symptoms ranged from 1.8 to 3.5 points on the Likert scale, and mean (SD) duration of symptoms described on first visit was 6 (6) days. The mean (SD) general health status on first visit was 54 (20) based on a scale with 0 indicating worst health status; 100, best status. Overall, 314 patients (80.1%) were nonsmokers, and 372 patients (93.5%) did not have a respiratory comorbidity. The presence of symptoms on first visit was similar among the 4 groups. The mean (SD) duration of severe symptoms was 3.6 (3.3) days for the immediate prescription group and 4.7 (3.6) days for the no prescription group. The median (interquartile range [IQR]) of severe symptoms was 3 (1-4) days for the prescription collection group and 3 (2-6) days for the patient-led prescription group. The median (IQR) of the maximum severity for any symptom was 5 (3-5) for the immediate prescription group and the prescription collection group; 5 (4-5) for the patient-led prescription group; and 5 (4-6) for the no prescription group. Patients randomized to the no prescription strategy or to either of the delayed strategies used fewer antibiotics and less frequently believed in antibiotic effectiveness. Satisfaction was similar across groups. CONCLUSIONS AND RELEVANCE: Delayed strategies were associated with slightly greater but clinically similar symptom burden and duration and also with substantially reduced antibiotic use when compared with an immediate strategy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01363531.

A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country.

Purpose. The purpose of this study was to assess the feasibility of the Spanish Diabetes Self-Management Program (SDSMP) in the primary care setting of the Basque Health Service and offer initial estimations of the randomized controlled trial (RCT) effects. Methods. Ten health centers (HCs) participated in a single-arm pilot study with a 6-month follow-up period between February 2011 and June 2012. Recruitment was performed via invitation letters, health professionals, and the local media. Each intervention group consisted of 8-15 people. The ability of each HC in forming up to 2 groups, participants' compliance with the course, and coordination and data collection issues were evaluated. Glycated haemoglobin (HbA1c) was the main outcome variable. Secondary outcomes were cardiovascular risk factors, drugs consumption, medical visits, quality of life, self-efficacy, physical exercise, and diet. Results. Two HCs did not organize a course. A total of 173 patients initiated the program, 2 dropped out without baseline data, and 90% completed it. No pre-post HbA1c differences existed. Certain improvements were observed in blood pressure control, self-efficacy, physical activity, and some dietary habits. Conclusion. The SDSMP is feasible in our setting. Our experience can be of interest when planning and conducting this program in similar health settings. The trial is registered with ClinicalTrials.gov identifier NCT01642394.

Conflictos de intereses y necesidad de transparencia: a propósito del consenso sobre prescripción de los nuevos anticoagulantes orales / Conflicts of interest and need for transparency: in light of consensus on prescribing of new oral anticoagulants

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Assessment of PaO2/FiO2 for stratification of patients with moderate and severe acute respiratory distress syndrome.

OBJECTIVES: A recent update of the definition of acute respiratory distress syndrome (ARDS) proposed an empirical classification based on ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) at ARDS onset. Since the proposal did not mandate PaO2/FiO2 calculation under standardised ventilator settings (SVS), we hypothesised that a stratification based on baseline PaO2/FiOv would not provide accurate assessment of lung injury severity. DESIGN: A prospective, multicentre, observational study. SETTING: A network of teaching hospitals. PARTICIPANTS: 478 patients with eligible criteria for moderate (100300). PRIMARY AND SECONDARY OUTCOMES: Group severity and hospital mortality. RESULTS: At ARDS onset, 173 patients had a PaO2/FiO2≤100 but only 38.7% met criteria for severe ARDS at 24 h under SVS. When assessed under SVS, 61.3% of patients with severe ARDS were reclassified as moderate, mild and non-ARDS, while lung severity and hospital mortality changed markedly with every PaO2/FiO2 category (p<0.000001). Our model of risk stratification outperformed the stratification using baseline PaO2/FiO2 and non-standardised PaO2/FiO2 at 24 h, when analysed by the predictive receiver operating characteristic (ROC) curve: area under the ROC curve for stratification at baseline was 0.583 (95% CI 0.525 to 0.636), 0.605 (95% CI 0.552 to 0.658) at 24 h without SVS and 0.693 (95% CI 0.645 to 0.742) at 24 h under SVS (p<0.000001). CONCLUSIONS: Our findings support the need for patient assessment under SVS at 24 h after ARDS onset to assess disease severity, and have implications for the diagnosis and management of ARDS patients. TRIAL REGISTRATION NUMBERS: NCT00435110 and NCT00736892.

En relación con "Recursos bibliográficos para atención primaria en las bibliotecas virtuales de salud de las comunidades autónomas" / Statement by SemFYC on the access to scientific information by general practioners

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Impact of a self-care education programme on patients with type 2 diabetes in primary care in the Basque Country.

BACKGROUND: Type 2 diabetes mellitus (DM2) is a disease with high prevalence and significant impact in terms of mortality and morbidity. The increased prevalence of the disease requires the implementation of new strategies to promote patient self-management. The Spanish Diabetes Self-Management Program (SDSMP) has proven to be effective in other settings. The objective of this study is to assess its effectiveness in terms of care for DM2 patients in primary care settings within the Basque Health Service - Osakidetza (Spain). METHOD/DESIGN: This is a randomised clinical trial in which patients diagnosed with DM2, 18-79 years of age, from four health regions within the Basque Health Service will be randomised into two groups: an intervention group, who will follow the SDSMP, and a control group, who will receive usual care in accordance with the clinical guidelines for DM2 and existing regulations in our region. The intervention consists of 2,5 hour-group sessions once a week for six weeks. The sessions cover target setting and problem solving techniques, promotion of physical exercise, basic knowledge of nutrition, proper use of medication, effective communication with relatives and health professionals, and basic knowledge about DM2 and its complications. This content is complemented by educational material: books, leaflets and CDs. The primary outcome measure will be the change in glycated haemoglobin (HbA1c), and secondary outcome measures will include changes in levels of physical activity and intake of fruit and vegetables, cardiovascular risk, quality of life, self-efficacy, number of consultations and drug prescriptions. The results will be analysed 6, 12 and 24 months after the intervention. DISCUSSION: If the intervention were to be effective, the programme should be spread to the entire diabetic population in the Basque Country and it could also be applied for other diseases. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01642394.

Rationale, design and organization of the delayed antibiotic prescription (DAP) trial: a randomized controlled trial of the efficacy and safety of delayed antibiotic prescribing strategies in the non-complicated acute respiratory tract infections in general practice.

BACKGROUND: Respiratory tract infections are an important burden in primary care and it's known that they are usually self-limited and that antibiotics only alter its course slightly. This together with the alarming increase of bacterial resistance due to increased use of antimicrobials calls for a need to consider strategies to reduce their use. One of these strategies is the delayed prescription of antibiotics. METHODS: Multicentric, parallel, randomised controlled trial comparing four antibiotic prescribing strategies in acute non-complicated respiratory tract infections. We will include acute pharyngitis, rhinosinusitis, acute bronchitis and acute exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (mild to moderate). The therapeutic strategies compared are: immediate antibiotic treatment, no antibiotic treatment, and two delayed antibiotic prescribing (DAP) strategies with structured advice to use a course of antibiotics in case of worsening of symptoms or not improving (prescription given to patient or prescription left at the reception of the primary care centre 3 days after the first medical visit). DISCUSSION: Delayed antibiotic prescription has been widely used in Anglo-Saxon countries, however, in Southern Europe there has been little research about this topic. The DAP trial wil evaluate two different delayed strategies in Spain for the main respiratory infections in primary care. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number http://NCT01363531.