Epoprostenol-associated ascites in pulmonary arterial hypertension.

The development of ascites in pulmonary arterial hypertension (PAH) in the absence of pre-existing hepatic dysfunction is usually associated with decompensated right heart failure or cardiac cirrhosis. Ascites in PAH has rarely been associated with intravenous epoprostenol, a synthetic form of the prostaglandin PGI2.

Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.

Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy.Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine.Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines.Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; "sequential").Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.

Community-acquired Pneumonia Guideline Recommendations-Impact of a Consensus-based Process versus Systematic Reviews.

BACKGROUND: The American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) Community-acquired Pneumonia (CAP) guidelines were developed using systematic reviews to inform every recommendation, as suggested by the Institute of Medicine Standards for Trustworthy Guidelines. Recent studies suggest that an expert consensus-based approach, called the Convergence of Opinion on Recommendations and Evidence (CORE) process, can produce recommendations that are concordant with recommendations informed by systematic reviews. PURPOSE: The goal of the study was to evaluate the efficacy of the CORE process had it been used to develop the ATS/IDSA CAP guidelines. METHODS: Experts in CAP who were not on the guideline panel and had no knowledge of the guideline's systematic reviews or recommendations were recruited to participate in the CORE process, addressing the same questions asked by the guideline panel. Recommendations derived from the CORE process were compared to the guideline recommendations. Concordance of the course of action, strength of recommendation, and quality of evidence were determined. RESULTS: Using a threshold of 70% of experts selecting the same course of action to make a recommendation, the CORE process yielded a recommendation for 20 of 31 (65%) questions. Among the 20 CORE-derived recommendations, 19 (95%) were concordant with the guideline recommendations (kappa agreement 0.88, 95% CI .64-1.00). There was less agreement among the strength of recommendations (58%) and quality of evidence (42%). CONCLUSIONS: If the CORE process had been used, 11 systematic reviews would have been necessary rather than 31, with minimal impact on the recommended courses of action.

Prevalence and Mortality of Pulmonary Hypertension in ESRD: A Systematic Review and Meta-analysis.

INTRODUCTION: Pulmonary hypertension (PH) in the setting of end-stage renal disease (ESRD) has important prognostic and therapeutic consequences. We estimated the prevalence of PH among patients with ESRD and compared mortality between ESRD patients with and without PH. METHODS: Two independent reviewers searched three databases using a search strategy built around the medical subject headings of "hypertension, pulmonary" and "kidney failure, chronic." Keywords and synonyms were also used. Study selection criteria included (1) Enrollment of patients with ESRD undergoing hemodialysis or peritoneal dialysis, (2) Assessment for the presence of PH using transthoracic echocardiography, and (3) Determination of PH prevalence or associated mortality. The primary outcomes were prevalence of PH or associated mortality. The Grading, Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to rate the quality of evidence. RESULTS: The initial search identified 1046 publications, from which 41 studies were selected. The median prevalence of PH identified by echocardiographic criteria among patients with ESRD was 38% (range 8% to 70%), and was significantly increased in patients undergoing hemodialysis (HD) (median 40%, range 16-70%) as compared with peritoneal dialysis (PD) (median 19%, range 8-37%). Meta-analysis demonstrated that overall mortality was higher among ESRD patients with echocardiographic evidence of PH than ESRD patients without echocardiographic evidence of PH (RR 2.02; 95% CI 1.70-2.40). CONCLUSIONS: Echocardiographic evidence of PH is common among ESRD patients undergoing dialysis and associated with increased mortality. Identification of those patients with evidence of pulmonary hypertension on transthoracic echocardiography may warrant further evaluation and treatment.

Idiopathic Pulmonary Fibrosis Guideline Recommendations. Need for Adherence to Institute of Medicine Methodology?

Rationale: The 2018 idiopathic pulmonary fibrosis (IPF) guidelines were developed using an approach that adhered to the Institute of Medicine (IOM) standards, in which each recommendation was informed by a systematic review. The convergence of opinion on recommendations and evidence (CORE) process is a modified Delphi process that does not require a systematic review but yields similar recommendations. Objectives: To determine the importance of systematic reviews to the recommendations made by the IPF guidelines. Methods: IPF experts who were not on the IPF guideline panel and had no knowledge of the guideline's evidence synthesis or recommendations were recruited to answer the same questions as the guidelines but using a modified CORE process. Recommendations derived from the modified CORE process and IOM-adherent process were then compared. Concordance of the course of action, strength of recommendation, and quality of evidence was measured. Results: Ten questions were addressed. The modified CORE process and IOM-adherent process yielded concordant recommendations for 9 of 10 (90%) questions (ĸ-agreement, 0.84; 95% confidence interval, 0.55-1.00). The strength of the recommendations was the same for seven of eight (88%) graded recommendations (ĸ-agreement, 0.75; 95% confidence interval, 0.31-1.00), but ratings of the quality of evidence were discordant. The modified CORE process was less expensive and required less time and effort than the IOM-adherent process. Conclusions: The modified CORE process developed recommendations that were concordant with those developed by an experienced guideline panel using the robust standards of the IOM; however, it was less expensive and less burdensome.

A Comparative Analysis of Pulmonary and Critical Care Medicine Guideline Development Methodologies.

RATIONALE: The Institute of Medicine (IOM) standards for guideline development have had unintended negative consequences. A more efficient approach is desirable. OBJECTIVES: To determine whether a modified Delphi process early during guideline development discriminates recommendations that should be informed by a systematic review from those that can be based upon expert consensus. METHODS: The same questions addressed by IOM-compliant pulmonary or critical care guidelines were addressed by expert panels using a modified Delphi process, termed the Convergence of Opinion on Recommendations and Evidence (CORE) process. The resulting recommendations were compared. Concordance of the course of action, strength of recommendation, and quality of evidence, as well as the duration of recommendation development, were measured. MEASUREMENTS AND MAIN RESULTS: When 50% agreement was required to make a recommendation, all questions yielded recommendations, and the recommended courses of action were 89.6% concordant. When 70% agreement was required, 17.9% of questions did not yield recommendations, but for those that did, the recommended courses of action were 98.2% concordant. The time to completion was shorter for the CORE process (median, 19.3 vs. 1,309.0 d; P = 0.0002). CONCLUSIONS: We propose the CORE process as an early step in guideline creation. Questions for which 70% agreement on a recommendation cannot be achieved should go through an IOM-compliant process; however, questions for which 70% agreement on a recommendation can be achieved can be accepted, avoiding a lengthy systematic review.

Surveillance versus clinical adjudication: differences persist with new ventilator-associated event definition.

BACKGROUND: The National Healthcare Safety Network (NHSN) has recently supported efforts to shift surveillance away from ventilator-associated pneumonia to ventilator-associated events (VAEs) to decrease subjectivity in surveillance and minimize concerns over clinical correlation. The goals of this study were to compare the results of an automated surveillance strategy using the new VAE definition with a prospectively performed clinical application of the definition. METHODS: All patients ventilated for ≥2 days in a medical and surgical intensive care unit were evaluated by 2 methods: retrospective surveillance using an automated algorithm combined with manual chart review after the NHSN's VAE methodology and prospective surveillance by pulmonary physicians in collaboration with the clinical team administering care to the patient at the bedside. RESULTS: Overall, a similar number of events were called by each method (69 vs 67). Of the 1,209 patients, 56 were determined to have VAEs by both methods (κ = .81, P = .04). There were 24 patients considered to be a VAE by only 1 of the methods. Most discrepancies were the result of clinical disagreement with the NHSN's VAE methodology. CONCLUSIONS: There was good agreement between the study teams. Awareness of the limitations of the surveillance definition for VAE can help infection prevention personnel in discussions with critical care partners about optimal use of these data.

A prospective evaluation of ventilator-associated conditions and infection-related ventilator-associated conditions.

BACKGROUND: The Centers for Disease Control and Prevention has shifted policy away from using ventilator-associated pneumonia (VAP) and toward using ventilator-associated conditions (VACs) as a marker of ICU quality. To date, limited prospective data regarding the incidence of VAC among medical and surgical ICU patients, the ability of VAC criteria to capture patients with VAP, and the potential clinical preventability of VACs are available. METHODS: This study was a prospective 12-month cohort study (January 2013 to December 2013). RESULTS: We prospectively surveyed 1,209 patients ventilated for ≥ 2 calendar days. Sixty-seven VACs were identified (5.5%), of which 34 (50.7%) were classified as an infection-related VAC (IVAC) with corresponding rates of 7.0 and 3.6 per 1,000 ventilator days, respectively. The mortality rate of patients having a VAC was significantly greater than that of patients without a VAC (65.7% vs 14.4%, P < .001). The most common causes of VACs included IVACs (50.7%), ARDS (16.4%), pulmonary edema (14.9%), and atelectasis (9.0%). Among IVACs, 44.1% were probable VAP and 17.6% were possible VAP. Twenty-five VACs (37.3%) were adjudicated to represent potentially preventable events. Eighty-six episodes of VAP occurred in 84 patients (10.0 of 1,000 ventilator days) during the study period. The sensitivity of the VAC criteria for the detection of VAP was 25.9% (95% CI, 16.7%-34.5%). CONCLUSIONS: Although relatively uncommon, VACs are associated with greater mortality and morbidity when they occur. Most VACs represent nonpreventable events, and the VAC criteria capture a minority of VAP episodes.