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  • Publication . Conference object . 2004
    Restricted English
    Authors: 
    Mark S. Ackerman; Marlene Huysman; John M. Carroll; Barry Wellman; Giorgio DeMichelis; Volker Wulf;
    Country: Netherlands

    Communities are social entities whose actors share common needs, interests, or practices: they constitute the basic units of social experience. With regard to communities, social capital captures the structural, relational and cognitive aspects of the relationships among their members. Social capital is defined as a set of properties of a social entity (e.g. norms, level of trust, and intensive social networking) which enables joint activities and cooperation for mutual benefit. It can be understood as the glue which holds communities together. On this panel we will discuss whether and how information technology can strengthen communities by fostering social capital.

  • Restricted
    Authors: 
    Alexander V. Louie; Suresh Senan; Max Dahele; Ben J. Slotman; Wilko F.A.R. Verbakel;
    Country: Netherlands

    Purpose Use of stereotactic ablative radiation therapy (SABR) for subcentimeter lung tumors is controversial. We report our outcomes for tumors with diameter ≤1 cm and their visibility on cone beam computed tomography (CBCT) scans and retrospectively evaluate the planned dose using a deterministic dose calculation algorithm (Acuros XB [AXB]). Methods and Materials We identified subcentimeter tumors from our institutional SABR database. Tumor size was remeasured on an artifact-free phase of the planning 4-dimensional (4D)-CT. Clinical plan doses were generated using either a pencil beam convolution or an anisotropic analytic algorithm (AAA). All AAA plans were recalculated using AXB, and differences among D95 and mean dose for internal target volume (ITV) and planning target volume (PTV) on the average intensity CT dataset, as well as for gross tumor volume (GTV) on the end respiratory phases were reported. For all AAA patients, CBCT scans acquired during each treatment fraction were evaluated for target visibility. Progression-free and overall survival rates were calculated using the Kaplan-Meier method. Results Thirty-five patients with 37 subcentimeter tumors were eligible for analysis. For the 22 AAA plans recalculated using AXB, Mean D95 ± SD values were 2.2 ± 4.4% (ITV) and 2.5 ± 4.8% (PTV) lower using AXB; whereas mean doses were 2.9 ± 4.9% (ITV) and 3.7 ± 5.1% (PTV) lower. Calculated AXB doses were significantly lower in one patient (difference in mean ITV and PTV doses, as well as in mean ITV and PTV D95 ranged from 22%-24%). However, the end respiratory phase GTV received at least 95% of the prescription dose. Review of 92 CBCT scans from all AAA patients revealed that the tumor was visualized in 82 images, and its position could be inferred in other images. The 2-year local progression-free survival was 100%. Conclusions Patients with subcentimeter lung tumors are good candidates for SABR, given the dosimetry, ability to localize tumors with image guidance, and excellent local control.

  • Restricted
    Authors: 
    Caroline F. Finch; Roald Bahr; Jonathan A. Drezner; Jiri Dvorak; Lars Engebretsen; Timothy E. Hewett; Astrid Junge; Karim M. Khan; Domhnall MacAuley; Gordon O. Matheson; +2 more
    Country: Netherlands

    A decade ago, Blair1 pondered the future of physical activity research, much of which has since come to pass. More recently, a BJSM Blog2 invited readers to consider how their future research would look. Given the increased international focus on reducing injury/illness in athletes, it is timely to consider what research needs to be undertaken and acted on to achieve feasible reductions over the next 10 years. ‘Future Studies’3 or ‘Thought Leadership’ happens when a defined group of experts calls attention to what they think will be important for their field in the future. This is common in social science disciplines (eg, finance) and in scientific areas with major implications for policy development (eg, in climate control/environmental science). It has been less commonly applied in medicine, though it has underpinned discussion in areas like cancer research4 and academic medicine.5 Thought leadership involves big picture thinking and can lead to new ideas for major developments over time. There is evidence that such exercises can significantly shape research agenda and priority setting. This novel approach was applied to Sports and Exercise Medicine through asking a select group of international experts to contribute their priority research directions for the next 10 years. This is intended as a starting point only, to stimulate discussion with, and elicit responses from, the broader community interested in the prevention of injury and illness in athletes. International experts were invited to participate if they had delivered ≥1 keynote addresses at the International Olympic Committee (IOC) World Conferences of Prevention of Injury and Illness in Sport in 2011, 2014 or their precursor conferences organised by the Oslo Sports Trauma Research Centre in 2005 and 2008. Of 21 keynote speakers, 12 contributed their views to this paper. The experts covered a range of disciplines, including clinical sports …

  • Restricted
    Authors: 
    Alain Goulet; Nancy Nieuborg; Andrew G. Kirk; P. Koczyk; Paul Heremans; Maarten Kuijk; C. De Tandt; Willy Ranson; Roger Vounckx; Irina Veretennicoff; +1 more
    Country: Belgium

    We demonstrate a reconfigurable data transparent optical fanout operation and a switchable digital optical logical inverter between planes of optical thyristors using polarization-selective diffractive optical elements.

  • Publication . Article . Other literature type . 2019
    Restricted
    Authors: 
    Jessica Chan; Jeppe Friborg; Mikhail Chernov; Mikhail Cherkashin; Cai Grau; Michael Brundage; Ben J. Slotman;
    Publisher: Elsevier BV
    Country: Netherlands

    Summary Cancer is a substantial health burden for Inuit populations, an Indigenous peoples who primarily inhabit the circumpolar regions of Alaska, Canada, Greenland, and Russia. Access to radiotherapy is lacking or absent in many of these regions, despite it being an essential component of cancer treatment. This Review presents an overview of factors influencing radiotherapy delivery in each of the four circumpolar Inuit regions, which include population and geography, health-systems infrastructure, and cancer epidemiology. This Review also provides insight into the complex patient pathways needed to access radiotherapy, and on radiotherapy use. The unique challenges in delivering radiotherapy to circumpolar Inuit populations are discussed, which, notably, include geographical and cultural barriers. Recommendations include models of care that have successfully addressed these barriers, and highlight the need for increased collaboration between circumpolar referral centres in Alaska, Canada, Greenland, and Russia to ultimately allow for better delivery of cancer treatment.

  • Restricted
    Authors: 
    George Rodrigues; Cary Oberije; Suresh Senan; Kayoko Tsujino; T. Wiersma; Marta Moreno-Jiménez; Tae Hyun Kim; Lawrence B. Marks; Ramesh Rengan; Luigi De Petris; +6 more
    Country: Netherlands

    Purpose The clinical benefits and risks of dose escalation (DE) for stage III non–small-cell lung cancer (NSCLC) remain uncertain despite the results from Radiation Therapy Oncology Group (RTOG) protocol 0617. There is significant heterogeneity of practice, with many clinicians prescribing intermediate dose levels between the 0617 study arms of 60 and 74 Gy. This study investigated whether this strategy is associated with any survival benefits/risks by analyzing a large multi-institutional database. Methods and Materials An individual patient database of stage III NSCLC patients treated with radical intent concurrent chemoradiation therapy was created (13 institutions, n=1274 patients). Patients were divided into 2 groups based on tumor Biological Effective Dose at 10 Gy (BED 10): those receiving standard dose (SD; n=552), consisting of 72Gy ≤ BED 10 ≤ 76.8 Gy (eg 60-64 Gy/30-32 fractions [fr]), and those receiving intermediate dose (ID; n=497), consisting of 76.8Gy 64 Gy/32 fr and Results Matched groups were found to be balanced except for N stage (more N3 disease in SD), median treatment year (SD in 2003; ID in 2007), platinum and taxane chemotherapy (SD in 28%; ID in 39%), and median follow-up (SD were 89 months; ID were 40 months). Median dose fractionation was 60 Gy/30 fr in SD (BED 10 IQR: 72.0-75.5 Gy) and 66 Gy/33 fr (BED 10 IQR: 78.6-79.2 Gy) in ID. Survival curves for SD and ID matched cohorts were statistically similar ( P =.27); however, a nonstatistically significant trend toward better survival for ID was observed after 15 months (median survival SD: 19.3 months; ID: 21.0 months). There was an increase in grades III to V lung toxicity associated with ID (13.0% vs 4.9%, respectively). Conclusions No significant overall survival benefits were found with intermediate DE; however, more grade III or greater lung toxicity was observed. The separation of survival curves after 15 months of follow-up suggests that a small overall survival improvement associated with intermediate DE cannot be excluded.

  • Restricted English
    Authors: 
    Rik Tjallingii; Martin Claussen; Jan-Berend W Stuut; Jens Fohlmeister; Alexandra Jahn; Torsten Bickert; Frank Lamy; Ursula Röhl;
    Country: Netherlands

    The evolution of the northwest African hydrological balance throughout the Pleistocene epoch influenced the migration of prehistoric humans. The hydrological balance is also thought to be important to global teleconnection mechanisms during Dansgaard-Oeschger and Heinrich events. However, most high-resolution African climate records do not span the millennial-scale climate changes of the last glacial-interglacial cycle, or lack an accurate chronology. Here, we use grain-size analyses of siliciclastic marine sediments from off the coast of Mauritania to reconstruct changes in northwest African humidity over the past 120,000 years. We compare this reconstruction to simulations of palaeo-humidity from a coupled atmosphere-ocean-vegetation model. These records are in good agreement, and indicate the reoccurrence of precession-forced humid periods during the last interglacial period similar to the Holocene African Humid Period. We suggest that millennial-scale arid events are associated with a reduction of the North Atlantic meridional overturning circulation and that millennial-scale humid events are linked to a regional increase of winter rainfall over the coastal regions of northwest Africa.

  • Publication . Part of book or chapter of book . Other literature type . 2019
    Restricted English
    Authors: 
    Johnston, Bradley C.; Patrick, Donald L.; Devji, Tahira; Maxwell, Lara J.; Bingham, Clifton O.; Beaton, Dorcas E.; Boers, Maarten; Briel, Matthias; Busse, Jason W.; Carrasco-Labra, Alonso; +19 more
    Publisher: Wiley
    Country: Netherlands

    Authors of systematic reviews that include patient-reported outcomes (PROs) should have a good understanding of how patient-reported outcome measures (PROMs) are developed, including the constructs they are intended to measure, their reliability, validity and responsiveness. This chapter describes the category of outcomes known as PROs and their importance for healthcare decision making, and illustrates the key issues related to reliability, validity and responsiveness that systematic review authors should consider when including PROs. It also addresses the structure and content of PROs and provides guidance for combining information from different PROs. The chapter outlines a step-by-step approach to addressing each of these elements in the systematic review process. The focus is on the use of PROs in randomized trials, and what is crucial in this context when selecting PROs to include in a meta-analysis. The chapter describes PROMs in more detail and discusses some issues to consider when deciding which PROMs to address in a review.

  • Restricted
    Authors: 
    A S, Gallus; M, Nurmohamed; M, Nurmohammed; C, Kearon; M, Prins;
    Country: Netherlands

    Because of the serious lack of useable, relevant information, most recommendations for prevention of thrombosis in non-surgical patients are extrapolations from much larger clinical trials experienced in surgery. Directly relevant evidence comes predominantly from very small randomized trials, many of them open label and carried out more than 20 years before the introduction of more recent and important changes in clinical care that may have substantially reduced the baseline thrombosis risk. In these early studies, low-dose heparin and low-molecular-weight heparins prevented subclinical deep vein thrombosis in ischaemic stroke, myocardial infarction and among elderly medical inpatients. Although it is likely that these drugs also prevent subclinical deep vein thrombosis after spinal cord injury or other major trauma, and when patients require intensive medical care, the supporting evidence in these circumstances comes mainly from cohort studies and poorly controlled comparisons. In contrast, the heparins have not reduced mortality or demonstrably prevented pulmonary embolism after ischaemic stroke or among elderly medical inpatients in large and well-conducted clinical endpoint trials, from which no clinically important benefit could be demonstrated. From analyses it is suggested that such benefit is probably more difficult to demonstrate for medical than for surgical patients. In the absence of sufficient information that is specific to medical patients, various forms of prophylaxis known to be effective in surgery will continue to be applied in high-risk individuals. After venous thromboembolism, it now appears that the best duration of oral anticoagulant therapy to prevent a recurrence is determined to a greater extent by whether the thrombotic episode was idiopathic or triggered by a clinically recognizable cause, whether it was transient or continuing, and whether the deep vein thrombosis was extensive, limited to the calf veins or was a first or recurrent event.

  • Restricted
    Authors: 
    Walter P. Maksymowych; Robert Landewé; Paul P. Tak; C. Ritchlin; Mikkel Østergaard; Philip J. Mease; Hani El-Gabalawy; Patrick Garnero; Dafna D. Gladman; Oliver FitzGerald; +12 more
    Publisher: The Journal of Rheumatology
    Country: Netherlands

    Objectives.A draft set of criteria for the validation of soluble biomarkers reflecting damage endpoints was proposed at OMERACT 8. At OMERACT 9 we aimed to scrutinize the necessity for each of these criteria according to the objectives of the working group.Methods.The OMERACT 8 draft criteria and the principle objectives of the validation process were clarified at a meeting of the working group in London, December 2007. A new framework was proposed after the following steps were conducted: (A) A systematic review of the literature focusing on the draft criteria and a preselected group of biomarkers (MMP3, CTX-II, RANKL, OPG, CTX-I) followed by a Delphi consensus exercise addressing the importance of individual criteria and identification of omissions in the draft set. (B) Formal debate as well as group discussion centered on the key arguments for inclusion/exclusion of specific criteria. (C) Onsite interactive electronic voting on the importance of specific criteria. The framework was presented and discussed at OMERACT 9 in both breakout and plenary sessions followed by a vote on its acceptance.Results.The objectives of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis biomarkers in relation to their predictive validity for damage endpoints was clarified and supported by OMERACT 9 participants. The OMERACT 8 draft validation criteria were reformulated into an essential category focused on criteria addressing the OMERACT Filter elements of discrimination (incorporating truth) and feasibility, and a desirable but nonessential category of other criteria addressing truth. This revised draft set was endorsed by participants at OMERACT 9.Conclusion.A revised set of validation criteria has been drafted by consensus at OMERACT 9 that focuses on the performance characteristics of biomarker assays, the importance of addressing potential confounders, and the essential requirement for clinical validation studies.

Advanced search in
Research products
arrow_drop_down
Searching FieldsTerms
Any field
arrow_drop_down
includes
arrow_drop_down
Include:
The following results are related to Canada. Are you interested to view more results? Visit OpenAIRE - Explore.
726 Research products, page 1 of 73
  • Publication . Conference object . 2004
    Restricted English
    Authors: 
    Mark S. Ackerman; Marlene Huysman; John M. Carroll; Barry Wellman; Giorgio DeMichelis; Volker Wulf;
    Country: Netherlands

    Communities are social entities whose actors share common needs, interests, or practices: they constitute the basic units of social experience. With regard to communities, social capital captures the structural, relational and cognitive aspects of the relationships among their members. Social capital is defined as a set of properties of a social entity (e.g. norms, level of trust, and intensive social networking) which enables joint activities and cooperation for mutual benefit. It can be understood as the glue which holds communities together. On this panel we will discuss whether and how information technology can strengthen communities by fostering social capital.

  • Restricted
    Authors: 
    Alexander V. Louie; Suresh Senan; Max Dahele; Ben J. Slotman; Wilko F.A.R. Verbakel;
    Country: Netherlands

    Purpose Use of stereotactic ablative radiation therapy (SABR) for subcentimeter lung tumors is controversial. We report our outcomes for tumors with diameter ≤1 cm and their visibility on cone beam computed tomography (CBCT) scans and retrospectively evaluate the planned dose using a deterministic dose calculation algorithm (Acuros XB [AXB]). Methods and Materials We identified subcentimeter tumors from our institutional SABR database. Tumor size was remeasured on an artifact-free phase of the planning 4-dimensional (4D)-CT. Clinical plan doses were generated using either a pencil beam convolution or an anisotropic analytic algorithm (AAA). All AAA plans were recalculated using AXB, and differences among D95 and mean dose for internal target volume (ITV) and planning target volume (PTV) on the average intensity CT dataset, as well as for gross tumor volume (GTV) on the end respiratory phases were reported. For all AAA patients, CBCT scans acquired during each treatment fraction were evaluated for target visibility. Progression-free and overall survival rates were calculated using the Kaplan-Meier method. Results Thirty-five patients with 37 subcentimeter tumors were eligible for analysis. For the 22 AAA plans recalculated using AXB, Mean D95 ± SD values were 2.2 ± 4.4% (ITV) and 2.5 ± 4.8% (PTV) lower using AXB; whereas mean doses were 2.9 ± 4.9% (ITV) and 3.7 ± 5.1% (PTV) lower. Calculated AXB doses were significantly lower in one patient (difference in mean ITV and PTV doses, as well as in mean ITV and PTV D95 ranged from 22%-24%). However, the end respiratory phase GTV received at least 95% of the prescription dose. Review of 92 CBCT scans from all AAA patients revealed that the tumor was visualized in 82 images, and its position could be inferred in other images. The 2-year local progression-free survival was 100%. Conclusions Patients with subcentimeter lung tumors are good candidates for SABR, given the dosimetry, ability to localize tumors with image guidance, and excellent local control.

  • Restricted
    Authors: 
    Caroline F. Finch; Roald Bahr; Jonathan A. Drezner; Jiri Dvorak; Lars Engebretsen; Timothy E. Hewett; Astrid Junge; Karim M. Khan; Domhnall MacAuley; Gordon O. Matheson; +2 more
    Country: Netherlands

    A decade ago, Blair1 pondered the future of physical activity research, much of which has since come to pass. More recently, a BJSM Blog2 invited readers to consider how their future research would look. Given the increased international focus on reducing injury/illness in athletes, it is timely to consider what research needs to be undertaken and acted on to achieve feasible reductions over the next 10 years. ‘Future Studies’3 or ‘Thought Leadership’ happens when a defined group of experts calls attention to what they think will be important for their field in the future. This is common in social science disciplines (eg, finance) and in scientific areas with major implications for policy development (eg, in climate control/environmental science). It has been less commonly applied in medicine, though it has underpinned discussion in areas like cancer research4 and academic medicine.5 Thought leadership involves big picture thinking and can lead to new ideas for major developments over time. There is evidence that such exercises can significantly shape research agenda and priority setting. This novel approach was applied to Sports and Exercise Medicine through asking a select group of international experts to contribute their priority research directions for the next 10 years. This is intended as a starting point only, to stimulate discussion with, and elicit responses from, the broader community interested in the prevention of injury and illness in athletes. International experts were invited to participate if they had delivered ≥1 keynote addresses at the International Olympic Committee (IOC) World Conferences of Prevention of Injury and Illness in Sport in 2011, 2014 or their precursor conferences organised by the Oslo Sports Trauma Research Centre in 2005 and 2008. Of 21 keynote speakers, 12 contributed their views to this paper. The experts covered a range of disciplines, including clinical sports …

  • Restricted
    Authors: 
    Alain Goulet; Nancy Nieuborg; Andrew G. Kirk; P. Koczyk; Paul Heremans; Maarten Kuijk; C. De Tandt; Willy Ranson; Roger Vounckx; Irina Veretennicoff; +1 more
    Country: Belgium

    We demonstrate a reconfigurable data transparent optical fanout operation and a switchable digital optical logical inverter between planes of optical thyristors using polarization-selective diffractive optical elements.

  • Publication . Article . Other literature type . 2019
    Restricted
    Authors: 
    Jessica Chan; Jeppe Friborg; Mikhail Chernov; Mikhail Cherkashin; Cai Grau; Michael Brundage; Ben J. Slotman;
    Publisher: Elsevier BV
    Country: Netherlands

    Summary Cancer is a substantial health burden for Inuit populations, an Indigenous peoples who primarily inhabit the circumpolar regions of Alaska, Canada, Greenland, and Russia. Access to radiotherapy is lacking or absent in many of these regions, despite it being an essential component of cancer treatment. This Review presents an overview of factors influencing radiotherapy delivery in each of the four circumpolar Inuit regions, which include population and geography, health-systems infrastructure, and cancer epidemiology. This Review also provides insight into the complex patient pathways needed to access radiotherapy, and on radiotherapy use. The unique challenges in delivering radiotherapy to circumpolar Inuit populations are discussed, which, notably, include geographical and cultural barriers. Recommendations include models of care that have successfully addressed these barriers, and highlight the need for increased collaboration between circumpolar referral centres in Alaska, Canada, Greenland, and Russia to ultimately allow for better delivery of cancer treatment.

  • Restricted
    Authors: 
    George Rodrigues; Cary Oberije; Suresh Senan; Kayoko Tsujino; T. Wiersma; Marta Moreno-Jiménez; Tae Hyun Kim; Lawrence B. Marks; Ramesh Rengan; Luigi De Petris; +6 more
    Country: Netherlands

    Purpose The clinical benefits and risks of dose escalation (DE) for stage III non–small-cell lung cancer (NSCLC) remain uncertain despite the results from Radiation Therapy Oncology Group (RTOG) protocol 0617. There is significant heterogeneity of practice, with many clinicians prescribing intermediate dose levels between the 0617 study arms of 60 and 74 Gy. This study investigated whether this strategy is associated with any survival benefits/risks by analyzing a large multi-institutional database. Methods and Materials An individual patient database of stage III NSCLC patients treated with radical intent concurrent chemoradiation therapy was created (13 institutions, n=1274 patients). Patients were divided into 2 groups based on tumor Biological Effective Dose at 10 Gy (BED 10): those receiving standard dose (SD; n=552), consisting of 72Gy ≤ BED 10 ≤ 76.8 Gy (eg 60-64 Gy/30-32 fractions [fr]), and those receiving intermediate dose (ID; n=497), consisting of 76.8Gy 64 Gy/32 fr and Results Matched groups were found to be balanced except for N stage (more N3 disease in SD), median treatment year (SD in 2003; ID in 2007), platinum and taxane chemotherapy (SD in 28%; ID in 39%), and median follow-up (SD were 89 months; ID were 40 months). Median dose fractionation was 60 Gy/30 fr in SD (BED 10 IQR: 72.0-75.5 Gy) and 66 Gy/33 fr (BED 10 IQR: 78.6-79.2 Gy) in ID. Survival curves for SD and ID matched cohorts were statistically similar ( P =.27); however, a nonstatistically significant trend toward better survival for ID was observed after 15 months (median survival SD: 19.3 months; ID: 21.0 months). There was an increase in grades III to V lung toxicity associated with ID (13.0% vs 4.9%, respectively). Conclusions No significant overall survival benefits were found with intermediate DE; however, more grade III or greater lung toxicity was observed. The separation of survival curves after 15 months of follow-up suggests that a small overall survival improvement associated with intermediate DE cannot be excluded.

  • Restricted English
    Authors: 
    Rik Tjallingii; Martin Claussen; Jan-Berend W Stuut; Jens Fohlmeister; Alexandra Jahn; Torsten Bickert; Frank Lamy; Ursula Röhl;
    Country: Netherlands

    The evolution of the northwest African hydrological balance throughout the Pleistocene epoch influenced the migration of prehistoric humans. The hydrological balance is also thought to be important to global teleconnection mechanisms during Dansgaard-Oeschger and Heinrich events. However, most high-resolution African climate records do not span the millennial-scale climate changes of the last glacial-interglacial cycle, or lack an accurate chronology. Here, we use grain-size analyses of siliciclastic marine sediments from off the coast of Mauritania to reconstruct changes in northwest African humidity over the past 120,000 years. We compare this reconstruction to simulations of palaeo-humidity from a coupled atmosphere-ocean-vegetation model. These records are in good agreement, and indicate the reoccurrence of precession-forced humid periods during the last interglacial period similar to the Holocene African Humid Period. We suggest that millennial-scale arid events are associated with a reduction of the North Atlantic meridional overturning circulation and that millennial-scale humid events are linked to a regional increase of winter rainfall over the coastal regions of northwest Africa.

  • Publication . Part of book or chapter of book . Other literature type . 2019
    Restricted English
    Authors: 
    Johnston, Bradley C.; Patrick, Donald L.; Devji, Tahira; Maxwell, Lara J.; Bingham, Clifton O.; Beaton, Dorcas E.; Boers, Maarten; Briel, Matthias; Busse, Jason W.; Carrasco-Labra, Alonso; +19 more
    Publisher: Wiley
    Country: Netherlands

    Authors of systematic reviews that include patient-reported outcomes (PROs) should have a good understanding of how patient-reported outcome measures (PROMs) are developed, including the constructs they are intended to measure, their reliability, validity and responsiveness. This chapter describes the category of outcomes known as PROs and their importance for healthcare decision making, and illustrates the key issues related to reliability, validity and responsiveness that systematic review authors should consider when including PROs. It also addresses the structure and content of PROs and provides guidance for combining information from different PROs. The chapter outlines a step-by-step approach to addressing each of these elements in the systematic review process. The focus is on the use of PROs in randomized trials, and what is crucial in this context when selecting PROs to include in a meta-analysis. The chapter describes PROMs in more detail and discusses some issues to consider when deciding which PROMs to address in a review.

  • Restricted
    Authors: 
    A S, Gallus; M, Nurmohamed; M, Nurmohammed; C, Kearon; M, Prins;
    Country: Netherlands

    Because of the serious lack of useable, relevant information, most recommendations for prevention of thrombosis in non-surgical patients are extrapolations from much larger clinical trials experienced in surgery. Directly relevant evidence comes predominantly from very small randomized trials, many of them open label and carried out more than 20 years before the introduction of more recent and important changes in clinical care that may have substantially reduced the baseline thrombosis risk. In these early studies, low-dose heparin and low-molecular-weight heparins prevented subclinical deep vein thrombosis in ischaemic stroke, myocardial infarction and among elderly medical inpatients. Although it is likely that these drugs also prevent subclinical deep vein thrombosis after spinal cord injury or other major trauma, and when patients require intensive medical care, the supporting evidence in these circumstances comes mainly from cohort studies and poorly controlled comparisons. In contrast, the heparins have not reduced mortality or demonstrably prevented pulmonary embolism after ischaemic stroke or among elderly medical inpatients in large and well-conducted clinical endpoint trials, from which no clinically important benefit could be demonstrated. From analyses it is suggested that such benefit is probably more difficult to demonstrate for medical than for surgical patients. In the absence of sufficient information that is specific to medical patients, various forms of prophylaxis known to be effective in surgery will continue to be applied in high-risk individuals. After venous thromboembolism, it now appears that the best duration of oral anticoagulant therapy to prevent a recurrence is determined to a greater extent by whether the thrombotic episode was idiopathic or triggered by a clinically recognizable cause, whether it was transient or continuing, and whether the deep vein thrombosis was extensive, limited to the calf veins or was a first or recurrent event.

  • Restricted
    Authors: 
    Walter P. Maksymowych; Robert Landewé; Paul P. Tak; C. Ritchlin; Mikkel Østergaard; Philip J. Mease; Hani El-Gabalawy; Patrick Garnero; Dafna D. Gladman; Oliver FitzGerald; +12 more
    Publisher: The Journal of Rheumatology
    Country: Netherlands

    Objectives.A draft set of criteria for the validation of soluble biomarkers reflecting damage endpoints was proposed at OMERACT 8. At OMERACT 9 we aimed to scrutinize the necessity for each of these criteria according to the objectives of the working group.Methods.The OMERACT 8 draft criteria and the principle objectives of the validation process were clarified at a meeting of the working group in London, December 2007. A new framework was proposed after the following steps were conducted: (A) A systematic review of the literature focusing on the draft criteria and a preselected group of biomarkers (MMP3, CTX-II, RANKL, OPG, CTX-I) followed by a Delphi consensus exercise addressing the importance of individual criteria and identification of omissions in the draft set. (B) Formal debate as well as group discussion centered on the key arguments for inclusion/exclusion of specific criteria. (C) Onsite interactive electronic voting on the importance of specific criteria. The framework was presented and discussed at OMERACT 9 in both breakout and plenary sessions followed by a vote on its acceptance.Results.The objectives of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis biomarkers in relation to their predictive validity for damage endpoints was clarified and supported by OMERACT 9 participants. The OMERACT 8 draft validation criteria were reformulated into an essential category focused on criteria addressing the OMERACT Filter elements of discrimination (incorporating truth) and feasibility, and a desirable but nonessential category of other criteria addressing truth. This revised draft set was endorsed by participants at OMERACT 9.Conclusion.A revised set of validation criteria has been drafted by consensus at OMERACT 9 that focuses on the performance characteristics of biomarker assays, the importance of addressing potential confounders, and the essential requirement for clinical validation studies.