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The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world-foundations, government agencies, and industry-now mandate data sharing. Here we outline ICMJE's proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016.The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Further details may be found in the "Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals" at www.icmje.org.As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individualpatient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the article's findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements. † Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals.

OBJECTIVE:Choices of pharmacologic therapies for pulmonary arterial hypertension (PAH) are ideally guided by high-level evidence. Th e objective of this guideline is to provide clinicians advice regarding pharmacologic therapy for adult patients with PAH as informed by available evidence. METHODS:Th is guideline was based on systematic reviews of English language evidence published between 1990 and November 2013, identified using the MEDLINE and Cochrane Library databases. Th e strength of available evidence was graded using the Grades of Recommendations, Assessment, Development, and Evaluation methodology. Guideline recommendations, or consensus statements when available evidence was insufficient to support recommendations, were developed using a modifi ed Delphi technique to achieve consensus. RESULTS:Available evidence is limited in its ability to support high-level recommendations. Th erefore, we draft ed consensus statements to address many clinical questions regarding pharmacotherapy for patients with PAH. A total of 79 recommendations or consensus statements were adopted and graded.CONCLUSIONS: Clinical decisions regarding pharmacotherapy for PAH should be guided by high-level recommendations when suffi cient evidence is available. Absent higher level evidence, consensus statements based upon available information must be used. Further studies are needed to address the gaps in available knowledge regarding optimal pharmacotherapy for PAH. ABBREVIATIONS : 6MWD 5 6-min walk distance ; AHRQ 5 Agency for Healthcare Research and Quality ; ARIES 5 Ambrisentan in Pulmonary Arterial Hypertension, Randomized Double-Blind, PlaceboControlled, Multicenter, Efficacy Study ; BNP 5 brain natriuretic peptide ; CB 5 consensus-based ; CCB 5 calcium channel blocker ; CO 5 cardiac output ; COI 5 conflict of interest ; CTEPH 5 chronic thromboembolic pulmonary hypertension ; EPC 5 Evidence-Based Practice Center ; ETRA 5 endothelin receptor antagonist ; FC 5 functional class ; FDA 5 US Food and Drug Administration ; GOC 5 Guidelines Oversight Committee ; GRADE 5 Grades of Recommendations, Assessment , Development , and Evaluation ; HR 5 hazard ratio ; IOM 5 Institute of Medicine ; IPAH 5 idiopathic pulmonary arterial hypertension ; mPAP 5 mean pulmonary artery pressure ; PAH 5 pulmonary arterial hypertension ; PDE5 5 phosphodiesterase-5 ; PH 5 pulmonary hypertension ; PVR 5 pulmonary vascular resistance ; RCT 5 randomized controlled trial ; WHO 5 World Health Organization For treatment naive PAH patients with WHOFC I symptoms, we suggest continued monitoring for the development of symptoms that would signal disease progression and warrant the initiation of pharmacotherapy (Grade CB) . 5. We suggest that patients at risk for the development of PAH (eg, patients with systemic sclerosis or the presence of a known mutation placing the patient at risk for PAH) be monitored for the development of symptoms of PAH (Grade CB) . 6. We suggest also that contributing causes of PH (eg, sleep apnea and systemic hypertension) in patients wi...

Portopulmonary hypertension affects up to 6% of patients with advanced liver disease, but the predictors and biologic mechanism for the development of this complication are unknown. We sought to determine the clinical risk factors for portopulmonary hypertension in patients with advanced liver disease. We performed a multicenter case-control study nested within a prospective cohort of patients with portal hypertension recruited from tertiary care centers. Cases had a mean pulmonary artery pressure > 25 mm Hg, pulmonary vascular resistance > 240 dynes ⅐ second ⅐ cm ؊5 , and pulmonary capillary wedge pressure < 15 mm Hg. Controls had a right ventricular systolic pressure < 40 mm Hg (if estimable) and normal right-sided cardiac morphology by transthoracic echocardiography. The study sample included 34 cases and 141 controls. Female sex was associated with a higher risk of portopulmonary hypertension than male sex (adjusted odds ratio ‫؍‬ 2.90, 95% confidence interval 1.20-7.01, P ‫؍‬ 0.018). Autoimmune hepatitis was associated with an increased risk (adjusted odds ratio ‫؍‬ 4.02, 95% confidence interval 1.14-14.23, P ‫؍‬ 0.031), and hepatitis C infection was associated with a decreased risk (adjusted odds ratio ‫؍‬ 0.24, 95% confidence interval 0.09-0.65, P ‫؍‬ 0.005) of portopulmonary hypertension. The severity of liver disease was not related to the risk of portopulmonary hypertension. Conclusion: Female sex and autoimmune hepatitis were associated with an increased risk of portopulmonary hypertension, whereas hepatitis C infection was associated with a decreased risk in patients with advanced liver disease. Hormonal and immunologic factors may therefore be integral to the development of portopulmonary hypertension. (HEPATOLOGY 2008;48:196-203.) See Editorial on Page 13 P ulmonary arterial hypertension (PAH) is a progressive disease which is characterized by elevated pulmonary vascular resistance, right heart failure, exercise limitation, and an increased risk of death. Histopathologic examination reveals intimal proliferation, medial hypertrophy, and adventitial fibrosis in the small muscular pulmonary arteries. Plexiform lesions and in situ thrombosis are also commonly seen. Most commonly idiopathic, PAH may also be associated with portal hypertension, termed portopulmonary hypertension (PPHTN