Community-acquired pneumonia - An EFIM guideline critical appraisal adaptation for internists.

BACKGROUND: In real-life settings, guidelines frequently cannot be followed since many patients are multimorbid and/or elderly or have other complicating conditions which carry an increased risk of drug-drug interactions. This document aimed to adapt recommendations from existing clinical practice guidelines (CPGs) to assist physicians' decision-making processes concerning specific and complex scenarios related to acute CAP. METHODS: The process for the adaptation procedure started with the identification of unsolved clinical questions (PICOs) in patients with CAP and continued with critically appraising the updated existing CPGs and choosing the recommendations, which are most applicable to these specific scenarios. RESULTS: Seventeen CPGs were appraised to address five PICOs. Twenty-seven recommendations were endorsed based on 7 high, 9 moderate, 10 low, and 1 very low-quality evidence. The most valid recommendations applicable to the clinical practice were the following ones: Respiratory virus testing is strongly recommended during periods of increased respiratory virus activity. Assessing the severity with a validated prediction rule to discriminate where to treat the patient is strongly recommended along with reassessing the patient periodically for improvement as expected. In adults with multiple comorbidities, polypharmacy, or advanced age, it is strongly recommended to check for possible drug interactions before starting treatment. Strong graded recommendations exist on antibiotic treatment and its duration. Recommendations on the use of biomarkers such as C-reactive protein or procalcitonin to improve severity assessment are reported. CONCLUSION: This document provides a simple and reliable updated guide for clinical decision-making in the management of complex patients with multimorbidity and CAP in the real-life setting.

Pulmonary embolism - An EFIM guideline critical appraisal and adaptation for practicing clinicians.

BACKGROUND: Several trials have been conducted in the last decades that challenged the management of patients with acute pulmonary embolism (PE) in terms of diagnosis and treatment. Updated international clinical practice guidelines (CPGs) endorsed the evidence from these trials. The aim of this document was to adapt recommendations from existing CPGs to assist physicians in decision making concerning specific and complex scenarios related to acute PE. METHODS: The flow for the adaptation procedure was first the identification of unsolved clinical issues in patients with acute PE (PICOs), then critically appraise the existing CPGs and choose the recommendations, which are the most applicable to these specific and complex scenarios. RESULTS: Five PICOs were identified and CPGs appraisal was performed. Concerning diagnosis of PE when computed tomographic pulmonary angiography is not available/contraindicated and d-dimer is less specific, perfusion lung scan is the preferred option in the majority of clinical scenarios. For the treatment of PE when relevant clinical conditions like pregnancy or severe renal failure are present heparin is to be used. Poor evidence and low-level recommendations exist on the best bleeding prediction rule in patients treated for PE. The duration of anticoagulation needs to be tailored concerning the presence of predisposing factors for index PE and the consequent risk for recurrence. Finally, recommendations on the opportunity to screen for cancer and thrombophilia patients without recognized thrombosis risk factors for PE are reported. Overall, 35 recommendations were endorsed and the rationale for the selection is reported in the main text. CONCLUSION: By the use of proper methodology for the adaptation process, this document offers a simple and updated guide for practicing clinicians dealing with complex patients.

Clinical practice guidelines adaptation for internists - An EFIM methodology.

The rising number of clinical guidelines poses a new challenge to the internists. The main problems are: 1) available documents suffer from heterogeneous methodological quality, and 2) most of clinical guidelines target an 'ideal' patient affected by a single condition, while in real practice internists must face with comorbid patients typically undergoing a polypharmacy. To help address this challenge, EFIM Clinical Practice Working Group started a project aimed to answer a series of relevant clinical questions, by selecting the best available guidance containing recommendations applicable to complex patients under polypharmacy. The project started with the creation of a research protocol containing details about all the steps needed to write the Clinical Practice Guideline Summary. In particular, this methodological document specifies the rules: 1) to select topics and clinical questions; 2) to build up a panel of experts, carefully managing eventual conflict of interests; 3) to critically appraise clinical guidelines (using a validated tool as AGREE II), selecting the most valid and applicable to the common clinical practice (using ADAPTE; 4) to address and solve potential disagreements among the selected documents.

Safety of Permanent Pacemaker Implantation: A Prospective Study.

Although pacemaker implantation is considered to be low risk, it is not exempt from complications and technical failures during the procedure, both in the short and long term, and the complications that such patients may present remain unknown. The aim has been to analyze the complication rates associated with permanent pacing and to identify if these differ between patients with or without previous antithrombotic therapy. We used a prospective, single center, observational study of 310 adult patients with indications of permanent pacing. They were hospitalized from 1 January to 31 December 2014 and followed up for 6 months after the pacemaker implant. The participants were distributed into two groups according to the antithrombotic therapy prior to the implant. The most frequent major complications were pneumothorax (3.87%) and lead dislodgement (8.39%), while superficial phlebitis (12.90%) and uncomplicated hematomas (22.58%) were presented as the most recurrent minor complications. Hematomas were the most frequent minor complication in the antithrombotic therapy cohort, and shoulder pain was reported as the most recurrent minor complication in the non-exposed group. Finding out about complications in pacemaker implants enables a complete view of the process, and hence the prioritization of actions aimed at improving safety and reducing associated risks.

Clinical Decision Support using a Terminology Server to improve Patient Safety.

Clinical Decision Support Systems (CDSS) are software applications that support clinicians in making healthcare decisions providing relevant information for individual patients about their specific conditions. The lack of integration between CDSS and Electronic Health Record (EHR) has been identified as a significant barrier to CDSS development and adoption. Andalusia Healthcare Public System (AHPS) provides an interoperable health information infrastructure based on a Service Oriented Architecture (SOA) that eases CDSS implementation. This paper details the deployment of a CDSS jointly with the deployment of a Terminology Server (TS) within the AHPS infrastructure. It also explains a case study about the application of decision support to thromboembolism patients and its potential impact on improving patient safety. We will apply the inSPECt tool proposal to evaluate the appropriateness of alerts in this scenario.

Transmyocardial laser revascularization versus medical therapy for refractory angina.

BACKGROUND: This is an update of a review previously published in 2009. Chronic angina and advanced forms of coronary disease are increasingly more frequent. In spite of the improvement in the efficacy of available revascularization treatments, a subgroup of patients continue suffering from refractory angina. Transmyocardial laser revascularization (TMLR) has been proposed to improve the clinical situation of these patients. OBJECTIVES: To assess the effects (both benefits and harms) of TMLR versus optimal medical treatment in people with refractory angina who are not candidates for percutaneous coronary angioplasty or coronary artery bypass graft, in alleviating angina severity, reducing mortality and improving ejection fraction. SEARCH METHODS: We searched the following resources up to June 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the metaRegister of Controlled Trials database, ClinicalTrials.gov, and the WHO International Clinical Trials Registry. We applied no languages restrictions. We also checked reference lists of relevant papers. SELECTION CRITERIA: We selected studies if they fulfilled the following criteria: randomized controlled trials (RCTs) of TMLR, by thoracotomy, in patients with Canadian Cardiovascular Society or New York Heart Association angina grade III-IV who were excluded from other revascularization procedures. DATA COLLECTION AND ANALYSIS: Three authors independently extracted data for each trial about the population and interventions compared and assessed the risk of bias of the studies, evaluating randomisation sequence generation, allocation concealment, blinding (of participants, personnel and outcome assessors), incomplete outcome data, selective outcome reporting, and other potential sources of bias. MAIN RESULTS: From a total of 502 references, we retrieved 47 papers for more detailed evaluation. We selected 20 papers, reporting data from seven studies, which included 1137 participants, of which 559 were randomized to TMLR. Participants and professionals were not blinded, which suggests high risk of performance bias. Overall, 43.8% of participants in the treatment group decreased two angina classes, as compared with 14.8% in the control group: odds ratio (OR) 4.63, 95% confidence interval (CI) 3.43 to 6.25), and heterogeneity was present. Mortality by intention-to-treat analysis was similar in both groups at 30 days (4.0% in the TMLR group and 3.5% in the control group), and one year (12.2% in the TMLR group and 11.9% in the control group). However, the 30-day mortality as-treated was 6.8% in the TMLR group and 0.8% in the control group (pooled OR was 3.76, 95% CI 1.63 to 8.66), mainly due to a higher mortality in participants crossing from standard treatment to TMLR. The assessment of subjective outcomes, such as improvement in angina, was affected by a high risk of bias and this may explain the differences found. Other adverse events such as myocardial infarction, arrhythmias or heart failure, were not considered in this review, as they were not predefined outcomes in trials design and they show a high inconsistency across studies. No new trials on transmyocardial laser revascularization have been published in the last ten years and it is very unlikely that new research will be undertaken in this field. AUTHORS' CONCLUSIONS: This review shows that risks associated with TMLR outweigh the potential clinical benefits. Subjective outcomes are subject to high risk of bias and no differences were found in survival, but a significant increase in postoperative mortality and other safety outcomes suggests that the procedure may pose unacceptable risks.

Guía de práctica clínica sobre terapia intravenosa con dispositivos no permanentes en adultos / Clinical practice guideline on intravenous therapy with temporary devices in adults

El objetivo principal de la guía es proporcionar a los profesionales sanitarios una herramienta que les permita tomar decisiones basadas en evidencia sobre aspectos de la atención al paciente adulto con indicación de terapia intravenosa con dispositivos no permanentes. Además, se señalan los objetivos secundarios siguientes: aumentar la calidad de las intervenciones, evitar complicaciones relacionadas con la terapia intravenosa y reducir la variabilidad existente entre los profesionales sanitarios.

The guideline includes recommendations for taking care of adult patients with intravenous therapy who are at primary care centres, hospitals and homes.

Role of biological and non biological factors in congestive heart failure mortality: PREDICE-SCORE: a clinical prediction rule.

BACKGROUND: Congestive heart failure (HF) is a chronic, frequent and disabling condition but with a modifiable course and a large potential for improving. The aim of this project was to develop a clinical prediction model of biological and non biological factors in patients with first diagnosis of HF that facilitates the risk-stratification and decision-making process at the point of care. METHODS AND RESULTS: Historical cohort analysis of 600 patients attended at three tertiary hospitals and diagnosed of a first episode of HF according Framingham criteria. There were followed 1 year. We analyzed sociodemographic, clinical and laboratory data with potential prognostic value. The modelling process concluded into a logistic regression multivariable analysis and a predictive rule: PREDICE SCORE. Age, dependency for daily basic activities, creatinine clearance, sodium levels at admission and systolic dysfunction diagnosis (HF with left ventricular ejection fraction 〈 40%) were the selected variables. The model showed a c-statistic of 0.763. PREDICE Score, has range of 22 points to stratifications of 1-year mortality. CONCLUSIONS: The follow-up of 600 patients hospitalized by a first episode of congestive HF, allowed us to obtain a predictive 1 year mortality model from the combination of demographic data, routine biochemistry and easy handling social and functional variables at the point of care. The variables included were non-invasive, undemanding to collect, and widely available. It allows for risk stratification and therapeutical targeting and may help in the clinical decisions process in a sustainable way.

Guías clínicas para la prevención de la enfermedad tromboembólica venosa en ancianos / Clinical guidelines for prophylaxis of venous thromboembolism in the elderly

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[Assessment of clinical practice guidelines evaluation. Scales and criteria]. / Valoración de escalas y criterios para la evaluación de Guías de Práctica Clínica.

Not only are there large number of guides, protocols and other support tools available for the clinical decision-making process in the Spanish National Health System, but there is also a major degree of variability among them, reflecting inconsistencies and low quality of those documents. This study is aimed at conducting all inventory of the Clinical Practice Guideline assessment scales and clinical analysis tools and to propose a scale or set of criteria for assessing the quality of the Clinical Practice Guidelines put out in Spain. A systematic search of critical evaluation scales was conducted. The inclusion criteria and the concordance analysis of the items by three evaluators were independently applied. The discordances were resolved by explicit consensus. Ten suggested critical assessment scales and sets of criteria from eleven institutions were identified, eight of which consist of scales and tools proposed for assessing the quality of the Clinical Practice Guidelines, the other two being proposals for assessing the implementation and inclusion of the Clinical Practice Guidelines in a register. In the comparative analysis, the criteria most often repeated on the scales analysed were related to the areas included in the AGREE Instrument. The areas considered in most of the critical assessment scales were the same as those of the AGREE Instrument. Although this tool does not take in criteria for guide implementation assessment purposes, it is considered suitable for use in the assessment prior to inclusion to the national CPG register.