Roman Jaeschke

Publications of Roman Jaeschke

• GRADE guidelines 11-making an overall rating of confidence in effect estimates for a single outcome and for all outcomes.

  Authors: Gordon Guyatt, Andrew D Oxman, Shahnaz Sultan, Jan Brozek, Paul Glasziou, Pablo Alonso-Coello, David Atkins, Regina Kunz, Victor Montori, Roman Jaeschke, David Rind, Philipp Dahm, Elie A Akl, Joerg Meerpohl, Gunn Vist, Elise Berliner, Susan Norris, Yngve Falck-Ytter, Holger J Schünemann

  Journal of clinical epidemiology. 04/2012;

  GRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidence-high, moderate, low, or very low) for each important or critical outcome. GRADEGRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidence-high, moderate, low, or very low) for each important or critical outcome. GRADE suggests, for each outcome, the initial separate consideration of five domains of reasons for rating down the confidence in effect estimates, thereby allowing systematic review authors and guideline developers to arrive at an outcome-specific rating of confidence. Although this rating system represents discrete steps on an ordinal scale, it is helpful to view confidence in estimates as a continuum, and the final rating of confidence may differ from that suggested by separate consideration of each domain. An overall rating of confidence in estimates of effect is only relevant in settings when recommendations are being made. In general, it is based on the critical outcome that provides the lowest confidence.

• Consensus statement of the ESICM task force on colloid volume therapy in critically ill patients.

  Authors: Konrad Reinhart, Anders Perner, Charles L Sprung, Roman Jaeschke, Frederique Schortgen, A B Johan Groeneveld, Richard Beale, Christiane S Hartog

  Intensive care medicine. 03/2012; 38(3):368-83.

  PURPOSE: Colloids are administered to more patients than crystalloids, although recent evidence suggests that colloids may possibly be harmful in some patients. The European Society of Intensive CarePURPOSE: Colloids are administered to more patients than crystalloids, although recent evidence suggests that colloids may possibly be harmful in some patients. The European Society of Intensive Care Medicine therefore assembled a task force to compile consensus recommendations based on the current best evidence for the safety and efficacy of the currently most frequently used colloids--hydroxyethyl starches (HES), gelatins and human albumin. METHODS: Meta-analyses, systematic reviews and clinical studies of colloid use were evaluated for the treatment of volume depletion in mixed intensive care unit (ICU), cardiac surgery, head injury, sepsis and organ donor patients. Clinical endpoints included mortality, kidney function and bleeding. The relevance of concentration and dosage was also assessed. Publications from 1960 until May 2011 were included. The quality of available evidence and strength of recommendations were based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RECOMMENDATIONS AND CONCLUSIONS: We recommend not to use HES with molecular weight ≥ 200 kDa and/or degree of substitution >0.4 in patients with severe sepsis or risk of acute kidney injury and suggest not to use 6% HES 130/0.4 or gelatin in these populations. We recommend not to use colloids in patients with head injury and not to administer gelatins and HES in organ donors. We suggest not to use hyperoncotic solutions for fluid resuscitation. We conclude and recommend that any new colloid should be introduced into clinical practice only after its patient-important safety parameters are established.

• Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.

  Authors: Shannon M Bates, Roman Jaeschke, Scott M Stevens, Steven Goodacre, Philip S Wells, Matthew D Stevenson, Clive Kearon, Holger J Schunemann, Mark Crowther, Stephen G Pauker, Regina Makdissi, Gordon H Guyatt

  Chest. 02/2012; 141(2 Suppl):e351S-418S.

  Objective testing for DVT is crucial because clinical assessment alone is unreliable and the consequences of misdiagnosis are serious. This guideline focuses on the identification of optimalObjective testing for DVT is crucial because clinical assessment alone is unreliable and the consequences of misdiagnosis are serious. This guideline focuses on the identification of optimal strategies for the diagnosis of DVT in ambulatory adults. The methods of this guideline follow those described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. We suggest that clinical assessment of pretest probability of DVT, rather than performing the same tests in all patients, should guide the diagnostic process for a first lower extremity DVT (Grade 2B). In patients with a low pretest probability of first lower extremity DVT, we recommend initial testing with D-dimer or ultrasound (US) of the proximal veins over no diagnostic testing (Grade 1B), venography (Grade 1B), or whole-leg US (Grade 2B). In patients with moderate pretest probability, we recommend initial testing with a highly sensitive D-dimer, proximal compression US, or whole-leg US rather than no testing (Grade 1B) or venography (Grade 1B). In patients with a high pretest probability, we recommend proximal compression or whole-leg US over no testing (Grade 1B) or venography (Grade 1B). Favored strategies for diagnosis of first DVT combine use of pretest probability assessment, D-dimer, and US. There is lower-quality evidence available to guide diagnosis of recurrent DVT, upper extremity DVT, and DVT during pregnancy.

• Specialty outpatient care of diabetic patients in Poland--are we far from treatment targets? Rationale, design, and preliminary results of the OPTIMO study.

  Authors: Miłosz Jankowski, Małgorzata M Bała, Ewa Płaczkiewicz-Jankowska, Roman Topór-Mądry, Filip Mejza, Roman Jaeschke, Jacek Sieradzki, Piotr Gajewski

  Polskie Archiwum Medycyny Wewnętrznej. 11/2011; 121(11):375-8.

  While clinical practice guidelines reflect the best known evidence-based approach to patient care, it is individual clinicians and patients who make decisions and treatment choices, and individualWhile clinical practice guidelines reflect the best known evidence-based approach to patient care, it is individual clinicians and patients who make decisions and treatment choices, and individual patients who actually achieve (or not) the treatment goals. The aim of the study was to describe the population of diabetic patients attending specialty outpatient clinics, to characterize the management of patients with different types of diabetes, and to assess the accordance of management with the recommendations developed by Diabetes Poland. The OPTIMO observational study was conducted from 2006 to 2009 and included patients with diabetes diagnosed according to the 1999 World Health Organization criteria who were observed for 1 to 3 years, with control visits at least every 6 months. Participating physicians used pocket PCs equipped with specially developed software to collect patients' data and to provide educational reminders to clinicians. The final analysis involved 9600 patients for whom valid baseline questionnaires were available. Type 2 diabetes was observed in 92% and type 1 diabetes in 6% of the patients. Mean age was 60.5 years. Women constituted 54% of the population. Coronary heart disease was observed in 32% and arterial hypertension in 76% of the patients. At baseline, 23% of the patients had hemoglobin A1c level below 6.5% and 44% below 7.0. Total cholesterol and triglycerides treatment goals were met at baseline by slightly more than half of the patients, while low-density lipoprotein cholesterol treatment goal was met only by 33% of the patients. Baseline blood pressure below 130/80 mmHg was reported for 11% of the patients. At the beginning of the OPTIMO study, we have observed considerable deviations from treatment targets recommended by current clinical practice guidelines for diabetic patients, which leaves significant room for improvement in the care of diabetic patients.

• GRADE guidelines 6. Rating the quality of evidence--imprecision.

  Authors: Gordon H Guyatt, Andrew D Oxman, Regina Kunz, Jan Brozek, Pablo Alonso-Coello, David Rind, P J Devereaux, Victor M Montori, Bo Freyschuss, Gunn Vist, Roman Jaeschke, John W Williams, Mohammad Hassan Murad, David Sinclair, Yngve Falck-Ytter, Joerg Meerpohl, Craig Whittington, Kristian Thorlund, Jeff Andrews, Holger J Schünemann

  Journal of clinical epidemiology. 08/2011; 64(12):1283-93.

  GRADE suggests that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision. For practice guidelines, rating down the quality ofGRADE suggests that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision. For practice guidelines, rating down the quality of evidence (i.e., confidence in estimates of effect) is required if clinical action would differ if the upper versus the lower boundary of the CI represented the truth. An exception to this rule occurs when an effect is large, and consideration of CIs alone suggests a robust effect, but the total sample size is not large and the number of events is small. Under these circumstances, one should consider rating down for imprecision. To inform this decision, one can calculate the number of patients required for an adequately powered individual trial (termed the "optimal information size" [OIS]). For continuous variables, we suggest a similar process, initially considering the upper and lower limits of the CI, and subsequently calculating an OIS. Systematic reviews require a somewhat different approach. If the 95% CI excludes a relative risk (RR) of 1.0, and the total number of events or patients exceeds the OIS criterion, precision is adequate. If the 95% CI includes appreciable benefit or harm (we suggest an RR of under 0.75 or over 1.25 as a rough guide) rating down for imprecision may be appropriate even if OIS criteria are met.

• GRADE guidelines: 7. Rating the quality of evidence--inconsistency.

  Authors: Gordon H Guyatt, Andrew D Oxman, Regina Kunz, James Woodcock, Jan Brozek, Mark Helfand, Pablo Alonso-Coello, Paul Glasziou, Roman Jaeschke, Elie A Akl, Susan Norris, Gunn Vist, Philipp Dahm, Vijay K Shukla, Julian Higgins, Yngve Falck-Ytter, Holger J Schünemann

  Journal of clinical epidemiology. 07/2011; 64(12):1294-302.

  This article deals with inconsistency of relative (rather than absolute) treatment effects in binary/dichotomous outcomes. A body of evidence is not rated up in quality if studies yield consistentThis article deals with inconsistency of relative (rather than absolute) treatment effects in binary/dichotomous outcomes. A body of evidence is not rated up in quality if studies yield consistent results, but may be rated down in quality if inconsistent. Criteria for evaluating consistency include similarity of point estimates, extent of overlap of confidence intervals, and statistical criteria including tests of heterogeneity and I(2). To explore heterogeneity, systematic review authors should generate and test a small number of a priori hypotheses related to patients, interventions, outcomes, and methodology. When inconsistency is large and unexplained, rating down quality for inconsistency is appropriate, particularly if some studies suggest substantial benefit, and others no effect or harm (rather than only large vs. small effects). Apparent subgroup effects may be spurious. Credibility is increased if subgroup effects are based on a small number of a priori hypotheses with a specified direction; subgroup comparisons come from within rather than between studies; tests of interaction generate low P-values; and have a biological rationale.

• GRADE guidelines: 9. Rating up the quality of evidence.

  Authors: Gordon H Guyatt, Andrew D Oxman, Shahnaz Sultan, Paul Glasziou, Elie A Akl, Pablo Alonso-Coello, David Atkins, Regina Kunz, Jan Brozek, Victor Montori, Roman Jaeschke, David Rind, Philipp Dahm, Joerg Meerpohl, Gunn Vist, Elise Berliner, Susan Norris, Yngve Falck-Ytter, M Hassan Murad, Holger J Schünemann

  Journal of clinical epidemiology. 07/2011; 64(12):1311-6.

  The most common reason for rating up the quality of evidence is a large effect. GRADE suggests considering rating up quality of evidence one level when methodologically rigorous observational studiesThe most common reason for rating up the quality of evidence is a large effect. GRADE suggests considering rating up quality of evidence one level when methodologically rigorous observational studies show at least a two-fold reduction or increase in risk, and rating up two levels for at least a five-fold reduction or increase in risk. Systematic review authors and guideline developers may also consider rating up quality of evidence when a dose-response gradient is present, and when all plausible confounders or biases would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. Other considerations include the rapidity of the response, the underlying trajectory of the condition, and indirect evidence.

• GRADE guidelines: 8. Rating the quality of evidence--indirectness.

  Authors: Gordon H Guyatt, Andrew D Oxman, Regina Kunz, James Woodcock, Jan Brozek, Mark Helfand, Pablo Alonso-Coello, Yngve Falck-Ytter, Roman Jaeschke, Gunn Vist, Elie A Akl, Piet N Post, Susan Norris, Joerg Meerpohl, Vijay K Shukla, Mona Nasser, Holger J Schünemann

  Journal of clinical epidemiology. 07/2011; 64(12):1303-10.

  Direct evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes important toDirect evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes important to patients. Evidence can be indirect in one of four ways. First, patients may differ from those of interest (the term applicability is often used for this form of indirectness). Secondly, the intervention tested may differ from the intervention of interest. Decisions regarding indirectness of patients and interventions depend on an understanding of whether biological or social factors are sufficiently different that one might expect substantial differences in the magnitude of effect. Thirdly, outcomes may differ from those of primary interest-for instance, surrogate outcomes that are not themselves important, but measured in the presumption that changes in the surrogate reflect changes in an outcome important to patients. A fourth type of indirectness, conceptually different from the first three, occurs when clinicians must choose between interventions that have not been tested in head-to-head comparisons. Making comparisons between treatments under these circumstances requires specific statistical methods and will be rated down in quality one or two levels depending on the extent of differences between the patient populations, co-interventions, measurements of the outcome, and the methods of the trials of the candidate interventions.

• GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables.

  Authors: Gordon Guyatt, Andrew D Oxman, Elie A Akl, Regina Kunz, Gunn Vist, Jan Brozek, Susan Norris, Yngve Falck-Ytter, Paul Glasziou, Hans DeBeer, Roman Jaeschke, David Rind, Joerg Meerpohl, Philipp Dahm, Holger J Schünemann

  Journal of clinical epidemiology. 04/2011; 64(4):383-94.

  This article is the first of a series providing guidance for use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system of rating quality of evidence and gradingThis article is the first of a series providing guidance for use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system of rating quality of evidence and grading strength of recommendations in systematic reviews, health technology assessments (HTAs), and clinical practice guidelines addressing alternative management options. The GRADE process begins with asking an explicit question, including specification of all important outcomes. After the evidence is collected and summarized, GRADE provides explicit criteria for rating the quality of evidence that include study design, risk of bias, imprecision, inconsistency, indirectness, and magnitude of effect. Recommendations are characterized as strong or weak (alternative terms conditional or discretionary) according to the quality of the supporting evidence and the balance between desirable and undesirable consequences of the alternative management options. GRADE suggests summarizing evidence in succinct, transparent, and informative summary of findings tables that show the quality of evidence and the magnitude of relative and absolute effects for each important outcome and/or as evidence profiles that provide, in addition, detailed information about the reason for the quality of evidence rating. Subsequent articles in this series will address GRADE's approach to formulating questions, assessing quality of evidence, and developing recommendations.

• Cardiovascular risk factors control in Polish patients with type 2 diabetes within the first two years of diagnosis: results of the ARETAEUS1 study.

  Authors: Małgorzata M Bała, Wiktoria Leśniak, Ewa Płaczkiewicz-Jankowska, Roman Topór-Mądry, Roman Jaeschke, Jacek Sieradzki, Władysław Grzeszczak, Waldemar Banasiak

  Kardiologia polska. 01/2011; 69(12):1249-57.

  The practice guidelines of cardiological and diabetological societies emphasise that cardiovascular (CV) risk control in diabetic patients is especially important and should be stricter than inThe practice guidelines of cardiological and diabetological societies emphasise that cardiovascular (CV) risk control in diabetic patients is especially important and should be stricter than in subjects without diabetes. There are little data on the frequency of meeting treatment goals in patients with newly diagnosed diabetes mellitus type 2 (DM2). To characterise Polish patients with DM2 diagnosed within the previous two years and to assess if the treatment targets from the current (2008) guidelines of Diabetes Poland regarding control of CV risk factors are met. ARETAEUS1 was a cross-sectional questionnaire-based study conducted in various regions of Poland in 2009 (January-April). It involved 1,714 patients of all ages and both genders, who had DM2 treated for less than 24 months. They were recruited by randomly selected physicians. Total cholesterol treatment goal (< 4.5 mmol/L) was met in 22% of all patients, triglycerides treatment goal (< 1.7 mmol/L) in 44%, LDL cholesterol treatment goal (< 2.6 mmol/L) in 20% and HDL cholesterol treatment goal (> 1.0 mmol/L in men and > 1.3 mmol/L in women) in 55%. Only 13% of the overall population met the goal of blood pressure (BP) below 130/80 mm Hg. When a less restrictive BP control threshold (< 140/90 mm Hg) was applied, 48% of patients had their BP below the threshold. In the analysis of subgroups (patients with and without previous CV events; receiving 1-5 or not receiving antihypertensive drugs; receiving and not receiving statins and fibrates) we observed from 0% to 3.3% of patients meeting three (HbA1c, BP and cholesterol) treatment goals. The percentages of patients meeting two out of three treatment goals were between 8% and 33% in different subgroups. The percentages of patients meeting only one out of three treatment goals ranged from 27.8% to 46.7% or at least one - from 39% to 69%. Most patients with newly diagnosed diabetes are not meeting their treatment goals regarding control of CV risk factors, which indicates relatively low adherence to national guideline recommendations for diabetes control and primary CV prevention in DM2. Difficulties in achieving CV treatment targets in the diabetic population indicate the need for a great deal of effort on the part of clinicians and patients. Practice guidelines developers should consider what treatment targets are achievable at a reasonable expense of effort.

• The vexing problem of guidelines and conflict of interest: a potential solution.

  Authors: Gordon Guyatt, Elie A Akl, Jack Hirsh, Clive Kearon, Mark Crowther, David Gutterman, Sandra Zelman Lewis, Ian Nathanson, Roman Jaeschke, Holger Schünemann

  Annals of internal medicine. 06/2010; 152(11):738-41.

  Issues of financial and intellectual conflict of interest in clinical practice guidelines have raised increasing concern. Professional organizations have responded by more rigorous regulation ofIssues of financial and intellectual conflict of interest in clinical practice guidelines have raised increasing concern. Professional organizations have responded by more rigorous regulation of conflict of interest. Nevertheless, tension remains between the competing goals of optimizing guideline quality by using the experience and insight of experts and ensuring that financial and intellectual conflicts of interest do not influence recommendations. The executive committee of the American College of Chest Physicians' Antithrombotic Guidelines has developed a strategy comprising 3 innovative aspects to address this tension: First, place equal emphasis on intellectual and financial conflicts and provide explicit criteria for both; second, a methodologist without important conflicts of interest should have primary responsibility for each chapter; and third, experts with important financial or intellectual conflicts of interest can collect and interpret evidence, but only panel members without important conflicts can be involved in developing the recommendation for a specific question. These strategies may help to achieve the benefits of expert input without conflicts of interest influencing recommendations.

• An official American Thoracic Society Policy statement: managing conflict of interest in professional societies.

  Authors: Holger J Schünemann, Molly Osborne, Joel Moss, Constantine Manthous, Gregory Wagner, Leonard Sicilian, Jill Ohar, Shane McDermott, Lance Lucas, Roman Jaeschke

  American journal of respiratory and critical care medicine. 10/2009; 180(6):564-80.

  BACKGROUND: Competing interests occur frequently in health care. This results in the potential for conflict of interest (COI). COI can lead to biased generation or assessment of evidence andBACKGROUND: Competing interests occur frequently in health care. This results in the potential for conflict of interest (COI). COI can lead to biased generation or assessment of evidence and misinform healthcare decision makers. Declaration of COI is insufficient to neutralize potentially harmful effects. Medical professional societies are obliged to develop robust mechanisms to "manage" COI, particularly in the development of official guidance documents that affect health care. PURPOSE: This document describes the background, methods, and content of the new "American Thoracic Society (ATS) Policy on Management of COI in Official ATS Documents, Projects, and Conferences." METHODS: We used existing reviews on COI policies that were prepared for the World Health Organization and for an ATS guideline methodology workshop as the evidence base for this work. We reviewed existing policies of selected organizations and other relevant literature. Members of the ATS Documents Development and Implementation Committee and the ATS Ethics and COI Committee collaborated to draft a COI policy. We used face-to-face meetings, electronic correspondence, and teleconferences to finalize the draft. The policy then underwent review and ultimate approval by the ATS Board of Directors. RESULTS: The ATS developed a new policy and procedures for declaration and management of COI. These procedures include: (1) self declaration of COI, (2) review of potential participants' COI, (3) disclosure of COI to project participants, (4) refusal or excusal from certain decisions or recommendations when appropriate, (5) disclosure of COI to users of documents or attendees of conferences, (6) handling disputes in COI resolution. This policy includes a tool that may be useful for supporting decision makers in management of COIs as they assess the value and relevance of conflicts. CONCLUSIONS: The ATS Policy on Management of COI in Official ATS Documents, Projects, and Conferences, in effect since March 2008, promises greater organizational transparency. Application and ongoing evaluation of the policy will give the ATS the opportunity to determine its usefulness in specific settings.

• Characteristics of patients with type 2 diabetes of short duration in Poland: rationale, design and preliminary results of the ARETAEUS1 study.

  Authors: Małgorzata Bała, Ewa Płaczkiewicz-Jankowska, Roman Topór-Mądry, Wiktoria Leśniak, Ewa Wiercińska, Paulina Szczepaniak, Roman Jaeschke, Jacek Sieradzki, Władysław Grzeszczak, Waldemar Banasiak

  Polskie archiwum medycyny wewnetrznej. 09/2009; 119(9):533-540.

  Introduction There is a paucity of Polish data describing the characteristics of and assessing treatment goals in patients with relatively newly diagnosed type 2 diabetes. Objectives The aim of theIntroduction There is a paucity of Polish data describing the characteristics of and assessing treatment goals in patients with relatively newly diagnosed type 2 diabetes. Objectives The aim of the study was to describe the baseline characteristics of patients with newly diagnosed type 2 diabetes, who participated in the ARETAEUS1 study, and to assess to what degree diabetic control criteria recommended by the Polish Diabetes Association clinical practice guidelines are met. Patients and methods This cross-sectional questionnaire-based study was conducted from January to April 2009. It involved patients of any age and gender, diagnosed with type 2 diabetes after January 1, 2007, and recruited by randomly selected physicians, both diabetologists and non-diabetologists. Resultlts We analyzed 1714 valid questionnaires from 333 physicians: 1150 from non-diabetologists and 564 from diabetologists. Mean age of patients was 60 years, mean body mass index - 30.6 kg/m2, proportion of females - 50%. The levels of median glycated hemoglobin (HbA1c), total cholesterol and triglycerides, mean low-density lipoprotein (LDL) cholesterol, as well as blood pressure were above the thresholds recommended in the guidelines (i.e., <6.5% for HbA1c, <4.5 mmol/l for total cholesterol, <2.6 mmol/l [or <1.8 mmol/l in patients with coronary heart disease (CHD)] for LDL cholesterol, <1.7 mmol/l for triglycerides, and <130/80 mmHg for blood pressure). Cardiovascular disease risk factors were common: hypertension was reported in over 75% of patients, lipid disorders in nearly 75%, CHD in 27% (previous acute coronary syndrome or stable CHD), previous stroke in 4%, and previous transient ischemic attack in 5.5%. Diabetic foot was reported in 1.7% of patients, nephropathy in 7%, retinopathy in 9% (in the group of diabetologists) and in 21% of patients (in the group of non-diabetologists). Conclusions We observed a relatively high prevalence of cardiovascular disease risk factors and late diabetes complications in patients with diabetes diagnosed within the previous 2 years.

• 2009 evidence-based clinical practice guidelines for diagnosing a first episode of lower extremities deep vein thrombosis in ambulatory outpatients.

  Authors: Roman Jaeschke, Piotr Gajewski, Shannon M Bates, James Douketis, Bogdan Solnica, Mark Crowther, Wiktoria Leśniak, Jan L Brozek, Holger J Schünemann, Krystyna Zawilska, Witold Tomkowski, Anetta Undas, Jan Sznajd, Rafał Nizankowski, Małgorzata Bała, Gordon Guyatt

  Polskie archiwum medycyny wewnȩtrznej. 09/2009; 119(9):541-9.

  Introduction The GRADE working group has recently suggested a rigorous framework for clinical practice guidelines (CPG) addressing diagnostic tests and test strategies based on the impact ofIntroduction The GRADE working group has recently suggested a rigorous framework for clinical practice guidelines (CPG) addressing diagnostic tests and test strategies based on the impact of alternative approaches on patient-important outcomes. The framework mandates explicit evidence summaries, ratings of the quality of evidence, and specifying recommendations as strong or weak. Objectives To test the feasibility and performance of the GRADE approach, we applied this framework to well-researched issues in the diagnoses of deep venous thrombosis (DVT). Methods A 16-member panel with interest in thromboembolism and CPG development identified pertinent clinical questions. Our search for relevant studies included existing CPG and systematic reviews. We summarized the data in form of evidence tables and developed recommendations including, when needed, a formal consensus process. Results and conclusions We provide three groups of recommendations for clinicians practicing in settings with access to different types of D-dimer tests - highly sensitive, moderately sensitive, and no availability of D-dimer. We consider the use of clinical prediction rules in guiding the diagnostic process, the potential for negative D-dimer or venous ultrasound (US) to rule out disease, and the role of follow-up testing (US following positive D-dimer result, D-dimer following negative US, and serial US) depending on the probability of DVT at the start of diagnostic process. We recommend the following: that clinicians without access to a highly or moderately sensitive D-dimer test rely on US to guide DVT diagnosis; that those with access use the highly sensitive D-dimer to determine, in patients with low or moderate probability of DVT (by the Wells rule) whether US is needed; that in patients with low pre-test probability (pre-TP) and a negative D-dimer (either highly or moderately sensitive) they follow patients without further testing; that in patients with high pre-test probability they perform a compression ultrasound without D-dimer testing.

• GRADE: assessing the quality of evidence for diagnostic recommendations.

  Authors: Holger J Schünemann, Andrew D Oxman, Jan Brozek, Paul Glasziou, Patrick Bossuyt, Stephanie Chang, Paola Muti, Roman Jaeschke, Gordon H Guyatt

  ACP journal club. 01/2009; 149(6):2.

• [Polish guidelines for the prevention and treatment of venous thromboembolism: 2009 update].

  Authors: Krystyna Zawilska, Roman Jaeschke, Witold Tomkowski, Ewa Mayzner-Zawadzka, Rafał Nizankowski, Anita Olejek, Tomasz Pasierski, Adam Torbicki, Anetta Undas, Arkadiusz Jawień, Piotr Gajewski, Jan Sznajd, Jan Brozek

  Polskie Archiwum Medycyny Wewnętrznej. 01/2009; 119 Suppl 1:1-69.

  The overall objective of the Polish guidelines for the prevention and treatment of venous thromboembolism is to increase patient benefit and safety by appropriate prevention and treatment of deepThe overall objective of the Polish guidelines for the prevention and treatment of venous thromboembolism is to increase patient benefit and safety by appropriate prevention and treatment of deep vein thrombosis and pulmonary embolism as well as proper management of the complications associated with antithrombotic and thrombolytic therapy. These guidelines apply to adult trauma, cancer, surgical, and medical patients as well as those at increased risk of venous thromboembolism. Specific recommendations have been formulated for pregnant women, patients requiring surgery while receiving long-term oral anticoagulant treatment, and patients undergoing regional anesthesia and/or analgesia. We systematically identified all current clinical practice guidelines concerning the prevention and/or treatment of venous thromboembolism and assessed their methodological quality using the AGREE instrument. We chose to update existing Polish guidelines by adapting the most recent high quality guidelines that we identified to Polish cultural and organizational setting rather than develop all recommendations de novo. We based our recommendations primarily on the 8th edition of the American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines on Antithrombotic and Thrombolytic Therapy and on the European Society of Cardiology (ESC) Guidelines on the Diagnosis and Management of Acute Pulmonary Embolism. To make recommendations regarding specific management issues that had not been addressed in ACCP guidelines, or whenever panel members felt they needed additional information to reach the decision we also consulted guidelines developed by other professional societies and organizations as well as additional sources of evidence. For each recommendation we explicitly assessed its relevance and applicability in the context of health care system in Poland. We adapted recommendations when necessary, explicitly stating the rationale for modification and judgements about the values and preferences we assumed. We developed original recommendations on the use of new oral anticoagulants that have recently become available, following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

• Outpatients specialist care of chronic obstructive pulmonary disease patients in Poland - results of the KOMPAS study.

  Authors: Filip Mejza, Ewa Nizankowska-Mogilnicka, Ryszard Kurzawa, Paweł Górski, Bernard Wirkijowski, Roman Jaeschke

  Pneumonologia i alergologia polska : organ Polskiego Towarzystwa Ftyzjopneumonologicznego, Polskiego Towarzystwa Alergologicznego, i Instytutu Gruźlicy i Chorób Płuc. 01/2009; 77(6):507-16.

  Introduction: COPD is one of the most important lung diseases. It is responsible for significant proportion of outpatients pulmonary clinics visits. Data on outpatients care of COPD patients inIntroduction: COPD is one of the most important lung diseases. It is responsible for significant proportion of outpatients pulmonary clinics visits. Data on outpatients care of COPD patients in Poland are limited. This article presents design of the KOMPAS study and basic results relating to COPD patients. Material and methods: The aim of this prospective study was to describe population of patients with COPD treated by specialists, and to characterize methods of care used in various COPD stages. Participating physicians used pocket PCs equipped with specially developed software to collect COPD patients' data. Results: Data on 2958 COPD patients were analyzed. 2/3 of patients were males. Mean patients age was 63 years and mean FEV(1) - 57% of predicted value. 86% of all subjects underwent spirometry during the first visit or the previous 6 months. Cough and exertional dyspnoea were the most frequently reported COPD symptoms (about 80% of patients). At the first visit 32% of subjects were current smokers and 51% were ex-smokers. 17% of all study patients have never smoked. Before inclusion 2/3 of patients were treated with bronchodilatator, and about 1/3 with inhaled steroid. After entering the study, over 90% received bronchodilatator and more than 2/3 received inhaled steroid. Differences in treatment between stages of COPD based on its severity were relatively small. Conclusions: Results of the KOMPAS study provide basic information about COPD outpatients care in Poland. These data, especially concerning physicians' compliance with current COPD guidelines, may be useful in planning undergraduate/postgraduate training for physicians and for those who are responsible for health resource allocation.

• The safety of formoterol among patients with asthma using inhaled corticosteroids. Systematic review and meta-analysis.

  Authors: Roman Jaeschke, Paul M O'Byrne, Parameswaran Nair, Filip Mejza, Wiktoria Leśniak, Jan Brozek, Lehana Thabane, Ji Cheng, Małgorzata Bała, Holger J Schünemann, Malcolm R Sears, Gordon Guyatt

  Polskie archiwum medycyny wewnȩtrznej. 12/2008; 118(11):627-35.

  INTRODUCTION: It has been postulated that inhaled long acting beta-agonists (LABAs) when used as monotherapy in asthma may increase the incidence of asthma related deaths, intubations andINTRODUCTION: It has been postulated that inhaled long acting beta-agonists (LABAs) when used as monotherapy in asthma may increase the incidence of asthma related deaths, intubations and hospitalizations, but concomitant use of inhaled corticosteroids (ICS) may modify this effect. OBJECTIVES: To assess the safety of formoterol in patients with asthma using ICS. PATIENTS AND METHODS: We conducted a systematic review and meta-analysis of parallel group, blinded, randomized controlled trials with at least 12 weeks of treatment examining the impact of twice a day formoterol on asthma-related and total morbidity and mortality in patients concurrently using ICS. Our main analysis considering impact of LABAs (salmeterol and formoterol) has already been published. In this report we present detailed information from studies investigating use of twice daily formoterol among patients receiving ICS. RESULTS: The search yielded 16 relevant studies included in this analysis. Among over 10,000 participants (5,996 taking formoterol with over 4,000 patient-years observation in formoterol groups) there were 2 asthma-related deaths (both in formoterol groups) and no asthma-related non-fatal intubations. The risk of asthma-related hospitalizations (odds ratio [OR] 0.59, 95% CI 0.37-0.93) and asthma-related serious adverse events (mostly hospitalizations) [OR 0.58, 95% CI 0.37-0.91] were significantly lower in patients on formoterol and ICS compared to patients on ICS alone. The OR for total mortality was 1.22, 95% CI 0.38-3.90, reflecting 7 deaths in formoterol groups and 3 deaths in control groups respectively. CONCLUSIONS: In patients with asthma using inhaled corticosteroids formoterol decreased the risk of asthma-related hospitalizations. There were too few asthma-related deaths and intubations to establish formoterol's relative impact on these outcomes.

• Effects of megestrol acetate in patients with cancer anorexia-cachexia syndrome--a systematic review and meta-analysis.

  Authors: Wiktoria Leśniak, Małgorzata Bała, Roman Jaeschke, Maciej Krzakowski

  Polskie archiwum medycyny wewnȩtrznej. 12/2008; 118(11):636-44.

  INTRODUCTION: Anorexia-cachexia syndrome (ACS) often occurs in patients with advanced cancer. OBJECTIVES: To review the effect of megestrol acetate (MA) in patients with ACS. PATIENTS AND METHODS: ToINTRODUCTION: Anorexia-cachexia syndrome (ACS) often occurs in patients with advanced cancer. OBJECTIVES: To review the effect of megestrol acetate (MA) in patients with ACS. PATIENTS AND METHODS: To identify eligible studies, systematic review by Lopez et al. (2004) was used, electronic databases (MEDLINE, EMBASE and CENTRAL) were searched and reference lists of included studies were reviewed. The studies were included in the review if they were randomized, enrolled patients with non-hormone-sensitive cancer and ACS and assessed the effects of MA compared with placebo, other drugs or different doses of MA. RESULTS: The study population is characterized by high mortality and progressive weight loss irrespective of the treatment. Compared to placebo, the effect of MA on survival is similar, but MA increases appetite (number needed to treat [NNT]: 3) and leads to weight gain (NNT: 8) in more patients. The data on other aspects of the quality of life are limited. The comparison of MA and glucocorticosteroids showed no statistical difference in their effect on appetite and weight. CONCLUSIONS: Compared to placebo, MA reduces the symptoms of ACS, with no effect on survival. The beneficial effect of MA on the overall quality of life has not been confirmed. In identified studies the effect of MA and glucocorticosteroids on anorexia and cachexia is similar. The estimation of the treatment utility in ACS depends on the weight attributed to discomfort caused by symptoms, adverse effects of the drugs and the treatment cost. Because of the low quality of the included studies a new randomized controlled trial is needed for valid assessment of the effects of MA.

• The Safety of Long Acting Beta Agonists Among Patients with Asthma Using Inhaled Corticosteroids.

  Authors: Roman Jaeschke, Paul M O'Byrne, Filip Mejza, Parameswaran Nair, Wiktoria Lesniak, Jan Brozek, Lehana Thabane, Ji Cheng, Holger J Schunemann, Malcom R Sears, Gordon Guyatt

  American journal of respiratory and critical care medicine. 09/2008;

  BACKGROUND: Inhaled long acting beta agonists (LABAs) when used as monotherapy in asthma may increase asthma-related hospitalizations, life threatening events requiring intubation/mechanicalBACKGROUND: Inhaled long acting beta agonists (LABAs) when used as monotherapy in asthma may increase asthma-related hospitalizations, life threatening events requiring intubation/mechanical ventilation and asthma-related deaths, but concomitant use of inhaled corticosteroids (ICS) may modify this effect. METHODS: We conducted a systematic review and meta-analysis of parallel group, blinded, randomized controlled trials with at least 12 weeks of treatment addressing the impact of LABA on asthma-related and total morbidity and mortality in patients concomitantly using ICS. We searched MEDLINE, EMBASE, ACPJC, and Cochrane (Central) databases and contacted authors and sponsors. We used random effects model to pool results from different studies as odds ratio [OR] (95% confidence interval) (OR < 1.0 favors LABA). Findings: The search yielded 62 relevant studies included in this analysis. Among over 29,000 participants (15,710 taking LABA with over 8,000 patient-years observation in LABA groups) there were 3 asthma-related deaths and 2 asthma-related non-fatal intubations (all in LABA groups, no more than one event per study). Differences in asthma-related hospitalizations (OR 0.74, 95% CI 0.53 - 1.03) and asthma-related serious adverse events (mostly hospitalizations, OR 0.75, 95% CI 0.54 - 1.03) failed to reach statistical significance. The OR for total mortality was 1.26, 95% CI 0.58 - 2.74 reflecting 14 deaths in LABA groups and 8 deaths in control groups respectively. Interpretation: In patients with asthma using inhaled corticosteroids LABA did not increase the risk of asthma-related hospitalizations. There were very few asthma-related deaths and intubations, and events were too infrequent to establish LABA's relative effect on these outcomes.