International Collaborative Approach Research Articles

Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis.

Localized cutaneous leishmaniasis (LCL) is a chronic ulcerating disease. A literature review identified inconsistencies in clinical trials. The aims of this study were to reach a consensus on the most important domains to measure when assessing LCL, agree on parameters to measure the domains, and develop a tool representing a Core Outcome Set (COS), for use in clinical assessment of LCL. A literature review was conducted to identify any existing COS for LCL embracing agreed Outcome Domains, i.e. what to measure and any Outcome Measurement Instruments (OMIs). As no COS was available, potential outcome domains for assessment of LCL were identified through an international collaborative approach using e-consultations and virtual discussions with expert stakeholders (n = 20) from geographically different LCL endemic countries. Subsequent judgmental validation process included a face-to-face multidisciplinary stakeholders' meeting adopting the Nominal Group Technique. A final consensual agreement on outcome domains and items required to measure these domains was established. "Clinical Cure" was defined as the ideal overall "General Concept". The five Core Outcome Domains included Signs capturing clinical morphology, diameter, and induration of an index lesion with the aid of a palpability score, Treatment Efficacy assessing percentage change in size of the lesion and re-epithelialization compared to baseline, Treatment Impact which included an investigator and patient visual analogue score, and Clinical Sequelae rating pigment change, atrophic and hypertrophic/keloid scars. It was agreed that two open-ended questions should be included to capture some aspects of Health-Related Quality of Life as a means of capturing a patient-focused approach. LeishCOM_LCL was generated to reflect a COS for LCL. This captured demographic details, agreed outcome domains and measures to assess these domains. Validation of LeishCOM_LCL will be reported in a separate paper. Development of a Patient Reported Outcome Measure will be considered in the future.

Proton Therapy in Non-Rhabdomyosarcoma Soft Tissue Sarcomas of Children and Adolescents.

This paper provides insights into the use of Proton Beam Therapy (PBT) in pediatric patients with non-rhabdomyosarcoma soft tissue sarcomas (NRSTS). NRSTS are a heterogeneous group of rare and aggressive mesenchymal extraskeletal tumors, presenting complex and challenging clinical management scenarios. The overall survival rate for patients with NRSTS is around 70%, but the outcome is strictly related to the presence of various variables, such as the histological subtype, grade of malignancy and tumor stage at diagnosis. Multimodal therapy is typically considered the preferred treatment for high-grade NRSTS. Radiotherapy plays a key role in the treatment of children and adolescents with NRSTS. However, the potential for radiation-induced side effects partially limits its use. Therefore, PBT represents a very suitable therapeutic option for these patients. The unique depth-dose characteristics of protons can be leveraged to minimize doses to healthy tissue significantly, potentially allowing for increased tumor doses and enhanced preservation of surrounding tissues. These benefits suggest that PBT may improve local control while reducing toxicity and improving quality of life. While clear evidence of therapeutic superiority of PBT over other modern photon techniques in NRSTS is still lacking-partly due to the limited data available-PBT can be an excellent treatment option for young patients with these tumors. A dedicated international comprehensive collaborative approach is essential to better define its role within the multidisciplinary management of NRSTS. Shared guidelines for PBT indications-based on the patient's age, estimated outcome, and tumor location-and centralization in high-level referral centers are needed to optimize the use of resources, since access to PBT remains a challenge due to the limited number of available proton therapy facilities.

An international collaborative approach to learning histology using a virtual microscope.

Histology is often taught in higher education settings using online virtual microscopes (VM). This study aimed to develop and evaluate the use of VM in teaching on a BSc degree at the University of Nottingham by surveying students and staff. A key development was the use of an e-workbook so that students were actively engaged in creating their own bespoke revision material. Subsequently, this approach was used in a second study evaluating the use of VM in teaching the histology and pathology of the gastrointestinal (GI) tract via group work with students from two BSc courses at the University of Nottingham; one based at Derby (RDHC) and the other in Malaysia (UNMC). Students worked together in groups to complete an e-workbook, develop a presentation, and decide how to collaborate and communicate. An evaluation of these activities revealed advantages in developing transferrable skills, and good engagement with both the histology topic and group work. Analysis of assessment of the module at UNMC showed that student performance improved in the histology-based module after the intervention (p< 0.01) and that this improvement was not evident in other modules taken by the cohort. Furthermore, when interrogating the questions from the examination paper that asked students to identify features from histological images, fewer questions were seen as 'difficult' (p< 0.001) and more were seen as 'average' (p< 0.01). This study demonstrates that the use of VM in histology combined with active learning in creating a revision resource enhances engagement and depth of learning. When further combined with collaborative active group work, students developed a range of histology knowledge and transferrable skills, with notable improvement in examination performance relative to other contemporaneous modules.

Endovascular thrombectomy beyond 24 hours from ischemic stroke onset: a propensity score matched cohort study

BackgroundThe safety and functional outcome of endovascular thrombectomy (EVT) in the very late (VL; >24 hours) time window from ischemic stroke onset remains undetermined.MethodsUsing data from a national stroke registry,...

The development and implementation of a computer adaptive progress test across European countries

Longitudinal progress testing promotes self-directed deep learning across a full spectrum of knowledge, enabling early detection of underperformance and opportunities for remediation. Computer adaptive testing (CAT), where the difficulty of a test dynamically adjusts according to a test taker's ability, has benefits in a progress testing context, but significant resource and experience is required to develop appropriate test materials. This study describes how a transnational consortium from eight medical schools in five countries across Europe was formed to develop a computer adaptive progress test applicable across international curricula. 1,212 students from more than 40 nationalities took part in the study, of whom more than 70% were not native English speakers, though nearly all reported competence in English. A content map for an international assessment blueprint was agreed and a substantial bank of 1,127 English language progress test items was successfully calibrated after pilot testing to form the computer adaptive progress test (CA-PT) item bank. Results from the CA-PT pilot showed reliable convergence to stable estimates of ability, low standard errors of measurement and high test reliability for all participants. This study shows that an international collaborative consortium approach enables effective development of progress testing resources appropriate for computer adaptive testing, with potential for application across international borders and in populations where English is not the native language. Pooling resources internationally facilitates the comparison and development of appropriate assessment blueprints and the efficient generation of high-quality assessment items. • Computer adaptive testing is applicable for progress testing locally and internationally. • Consortium approaches improve productivity in test blueprint and item development. • Collaboration can generate a large calibrated item bank efficiently with little redundancy. • Computer adaptive progress testing improves individual test reliability. • Adaptive algorithms sampling items from blueprints enhances personalised assessment for learning.

RETention of urine After INguinal hernia Elective Repair (RETAINER study I and II).

Purpose:Post-operative urinary retention (POUR) is a well-recognised complication of inguinal hernia repair (IHR). The magnitude of the problem is unclear, and contradictory evidence surrounds postulated risk factors. POUR risks patient distress, catheter-complications and a financial and logistical burden to services. Separately, in the field of IHR, there has been a lack of research into patients’ perceptions of surgical ‘success’. Our aim is to perform a two-phase, multi-centre prospective study to:Assess the rate, risk factors and impact related to POUR post IH repair.Develop and validate a patient reported outcome measure (PROM) for inguinal hernia repair.Methods:RETAINER I: We propose a 24-week prospective study with voluntary international participation in 4 week blocks. All patients undergoing elective IH repair (minimally-invasive/open) will be eligible. Standardised data collection will include patient and perioperative factors. Primary outcome will be development of POUR, defined as the need for insertion of a urinary catheter as determined by the treating clinician. Secondary outcomes will be identification of factors predisposing to POUR and the impact of POUR.RETAINER II: A patient reported outcome measure will be developed using representative patient focus groups for item generation, from which an initial questionnaire will be developed and piloted. Validity, reliability, sensitivity and reproducibility will be assessed using the QQ-10 and standard psychometric methodology.Conclusions:Using an international multicentre collaborative approach will produce the necessary volume of patients, whilst capturing inter-centre variability, to accurately reflect POUR rates and allow analysis of risk factors. This patient pool will provide an excellent opportunity to develop a PROM using appropriate qualitative methodology.Highlights: RETAINER I & II ProtocolsRETAINER (RETention of urine After INguinal hernia Elective Repair) I is a prospective, multicentre, international observational study.RETAINER I aims to explore the incidence of and risk factors for urinary retention following elective inguinal hernia repair.Urinary retention following inguinal hernia repair has a marked impact on patients and creates a significant financial and logistical burden for hospital services.RETAINER II is a prospective, qualitative study, recruiting patients to guide the creation of a patient-reported outcome measure (PROM) for elective inguinal hernia repair.

An International Collaborative Approach to Developing Training Guidelines for Veterinary Paraprofessionals.

Veterinary paraprofessionals (VPPs) are engaged worldwide in animal health management, disease surveillance and food safety control. In many countries, particularly developing countries, VPPs are critical to national veterinary services provision. Until recently, there were no globally recognized training requirements for VPPs. Recognition of VPPs' qualifications and roles, and requirements for registration, vary greatly between jurisdictions. To address these issues, the World Organisation for Animal Health (OIE) has developed competency and curricular guidelines for VPPs. A collaborative approach was essential to this mission. Extensive consultation with individuals and agencies representing various countries, animal health and veterinary sectors, and forms of expertise, was undertaken. Collaborative methods included the formation of a guidelines development ad hoc group whose diversity reflected project needs, the use of existing OIE Member Country data to understand roles of VPPs globally, conducting stakeholder surveys to collate VPP competency expectations and solicit feedback on draft guidelines, and in-country missions to validate draft curricular models. The initial deliverable from this work was publication of Competency Guidelines for VPPs. This document provides recommendations on the knowledge, skills, attitudes, and aptitudes that could be expected of VPPs following effective training. The companion document, OIE Curricular Guidelines for VPPs, provides recommendations on coursework structure and content to achieve these competencies. These guidelines will assist countries worldwide in more effectively training and qualifying VPPs so that they can contribute positively to the provision of veterinary services. Another potential impact is to catalyze the review of educational and regulatory standards regarding the respective work rights and activities of veterinarians and VPPs.

Position Paper on Global Extracorporeal Membrane Oxygenation Education and Educational Agenda for the Future: A Statement From the Extracorporeal Life Support Organization ECMOed Taskforce.

The purpose of this position paper is two-fold: first, to describe the state of extracorporeal membrane oxygenation education worldwide, noting current limitations and challenges; and second, to put forth an educational agenda regarding opportunities for an international collaborative approach toward standardization. Relevant medical literature was reviewed through literature search, and materials from national organizations were accessed through the Internet. Taskforce members generated a consensus statement using an iterative consensus process through teleconferences and electronic communication. In 2018, the Extracorporeal Life Support Organization convened the ECMOed Taskforce at two structured, face-to-face meetings of 40 healthcare practitioners and educators with expertise in caring for the extracorporeal membrane oxygenation patient and in extracorporeal membrane oxygenation education. None. None. The ECMOed Taskforce identified seven educational domains that would benefit from international collaborative efforts. Of primary importance, the Taskforce outlined actionable items regarding 1) the creation of a standardized extracorporeal membrane oxygenation curriculum; 2) defining criteria for an extracorporeal membrane oxygenation course as a vehicle for delivering the curriculum; 3) outlining a mechanism for evaluating the quality of educational offerings; 4) utilizing validated assessment tools in the development of extracorporeal membrane oxygenation practitioner certification; and 5) promoting high-quality educational research to guide ongoing educational and competency assessment development. Significant variability and limitations in global extracorporeal membrane oxygenation education exist. In this position paper, we outline a road map for standardizing international extracorporeal membrane oxygenation education and practitioner certification. Ongoing high-quality educational research is needed to evaluate the impact of these initiatives.

Systematic review of current randomised control trials in chronic subdural haematoma and proposal for an international collaborative approach.

Chronic subdural haematoma (CSDH) is a pathology that is frequently encountered by neurosurgeons. Nevertheless, there is a lack of guidelines based on solid evidence. There has been a recent and considerable increase in the interest on management and outcomes for CSDH. Therefore, we systematically reviewed all currently running randomised controlled trials (RCTs) in chronic subdural haematoma to understand the areas under investigation and plan future collaborative trials. Clinical trials databases (Cochrane Controlled Register of Trials, WHO ICTRP and clinical trials.gov) were searched for trials relevant to chronic subdural haematoma. It was then established which trials were currently running and fulfilled robust research methodology for a RCT. There are 26 currently running RCTs in CSDH, with the most common topics covering application of steroids (7), surgical techniques (5) and tranexamic acid (5). Further to this, there are trials running on other pharmacological agents (4), middle meningeal artery (MMA) embolisation (2) and peri-operative management (3). Pharmacological agents are a particular focus of CSDH management currently, and a wealth of studies on steroids will hopefully lead to more harmonised, evidence-based practice regarding this in the near future. Surgical techniques and new procedures such as MMA embolisation are also important focuses for improving patient outcomes. There is an on-going need for future RCTs and evidence-based guidelines in CSDH, particularly including low- and middle-income countries, and it is hoped that the establishment of the iCORIC (International COllaborative Research Initiative on Chronic Subdural Haematoma) will help address this.

Global Macadamia Science: Overview of the Special Section

Macadamia is a rapidly developing global crop; however, limited cultivation history and size of the industry means many challenges remain to support sustained productivity and profitability of this industry. This paper summarizes oral and poster presentations, and subsequent papers included in this volume, delivered at the 2017 International Macadamia Research Symposium, held in Hilo, HI, in September of that year. This was the first international meeting of macadamia researchers since 1992. The 28 oral and seven poster presentations covered propagation technology, tree physiology, soils and nutrition, pollination, pest and disease, orchard management, genetics and breeding, product development, and new production regions. Notable messages were that micrografting of macadamias is commercially viable; planting density and girdling could increase early yield per hectare; resource availability may limit cross-pollination yield; and yield production of individual branches is not independent. Integrated pest management was described to develop pest-resilient farming systems and manage felted coccid; an international collaborative approach was proposed for effective disease management and early detection; and the concept of integrated orchard management was used to translate research outputs into a common language for grower adoption. In the areas of breeding and genetic resources, research demonstrated that modern macadamia cultivars are two to four generations from wild but do not capture all wild diversity; progress was reported on the Macadamia Genome Project to produce the first macadamia reference genome; and advances in phenotypic selection and cultivar development were described.

Challenges of conducting qualitative research of non-suicidal self-injury in South Korea: An international nursing research collaboration

Understanding non-suicidal self-injury in foreign countries considering their cultural context requires collaboration among international researchers. Through an international collaborative approach, gaps in cultural views can be closed, thereby increasing the understanding of non-suicidal self-injury at a global level. The aim of this article was to illustrate the methodological and ethical challenges of an international collaboration that occurred during a qualitative study with South Korean young adults and the corresponding strategies that were implemented. It is hoped that the dissemination of these strategies and lessons learned can assist other researchers as they pursue international collaborative research.

Priorities for Nutrition Research in Pediatric Critical Care

Widespread variation exists in pediatric critical care nutrition practices, largely because of the scarcity of evidence to guide best practice recommendations. The objective of this paper was to develop a list of topics to be prioritized for nutrition research in pediatric critical care in the next 10 years. A modified 3-round Delphi process was undertaken by a newly established multidisciplinary group comprising 11 international researchers in the field of pediatric critical care nutrition. Items were ranked on a 5-point Likert scale. Forty-five research topics (with a mean priority score >3(0-5) were identified within the following 10 domains: the pathophysiology and impact of malnutrition in critical illness; nutrition assessment: nutrition risk assessment and biomarkers; accurate assessment of energy requirements in all phases of critical illness; the role of protein intake; the role of pharmaco-nutrition; effective and safe delivery of enteral nutrition; enteral feeding intolerance: assessment and management; the role of parenteral nutrition; the impact of nutrition status and nutrition therapies on long-term patient outcomes; and nutrition therapies for specific populations. Ten top research topics (that received a mean score >4(0-5) were identified as the highest priority for research. This paper has identified important consensus-derived priorities for clinical research in pediatric critical care nutrition. Future studies should determine topics that are a priority for patients and parents. Research funding should target these priority areas and promote an international collaborative approach to research in this field, with a focus on improving relevant patient outcomes.

Development and delivery of an evidence-based medicine programme for Traditional Chinese Medicine students using an international collaborative approach: An action research project

IntroductionEvidence based medicine (EBM) is increasingly embraced by complementary and alternative medicine. Academics from China, Australia and UK developed a Summer School EBM course for Traditional Chinese Medicine (TCM) students in China. MethodsAn action research approach was used to evaluate the effects of an international collaborative approach to improve learning and teaching. A systematic analysis of an EBM course conducted in 2015 with (66) students and (16) teacher/assistants was used to inform the 2016 course design. Before and after implementation of the 2016 course, (10) teacher/assistant and (20) student pre-/post-course survey responses were recorded to measure attitudes, knowledge and intention to apply EBM in TCM practice. Focus groups, teachers’ diaries, field notes and survey data were analysed using descriptive statistics for quantitative data and thematic analysis for qualitative data. ResultsChanges made in the 2016 course include changing topic focus, catering for different language abilities and varying the learning format. Students and teachers found the course engaging and relevant. Chinese teachers adopted interactive teaching methods and believed they improved student engagement and learning. Teachers reported teaching EBM to TCM students in English was challenging but benefited from the experience. Students embraced the concepts of EBM and performed beyond their and their teachers’ expectations. ConclusionsCross-cultural collaboration in teaching a culturally challenging topic in a foreign language using unfamiliar teaching methods is demanding However, utilisation of an action research model can result in positive student evaluation and change in teacher beliefs and practice through sharing reflections and ideas.

A systematic review of diagnostic criteria for psoriasis in adults and children: evidence from studies with a primary aim to develop or validate diagnostic criteria.

The diagnosis of psoriasis in adults and children is made clinically, for both patient management and the selection of participants in research. Diagnostic criteria provide a structure for clinical assessment, which in turn helps standardize patient recruitment into clinical trials and case definitions in observational studies. The aim of this systematic review was to identify and critically appraise the published studies to date that had a primary research aim to develop or validate diagnostic criteria for psoriasis. A search of Ovid MEDLINE and Ovid Embase was conducted in October 2016. The primary objective was to record the sensitivity and specificity of diagnostic criteria for psoriasis. Secondary objectives included diagnostic recommendations, applicability to children and study characteristics. Diagnostic accuracy studies were critically appraised for risk of bias using the QUADAS-2 tool. Twenty-three studies met the inclusion criteria. None detailed clinical examination-based diagnostic criteria. The included criteria varied from genetic and molecular diagnostic models to skin imaging, histopathology, and questionnaire-based, computer-aided and traditional Chinese medicine criteria. High sensitivity and specificity (> 90%) were reported in many studies. However, the study authors often did not specify how the criteria would be used clinically or in research. This review identified studies with varying risk of bias, and due to each study developing separate criteria meta-analysis was not possible. Clinical examination-based diagnostic criteria are currently lacking for psoriasis. Future research could follow an international collaborative approach and employ study designs allowing high-quality diagnostic accuracy testing. Existing and newly developed criteria require validation.

Pediatric Emergency and Critical Care in Low Middle Income Countries – an International Collaborative Approach to Capacity Building in Kenya

Pediatric Emergency and Critical Care in Low Middle Income Countries – an International Collaborative Approach to Capacity Building in Kenya

Academic libraries’ role in Research Data Management Services: a South African perspective

Research Data Management (RDM) services are being implemented by academic and research libraries globally in support of university research activities. In South Africa, some libraries are beginning to provide frameworks for these services with some degree of success as policies are being formulated, infrastructure set up, library staff trained, and awareness and advocacy campaigns held with academic staff and researchers. Challenges being faced include availability of resources and infrastructures and limited data management skills among library staff. This paper reports on how the Library at the Cape Peninsula University of Technology is developing and integrating RDM services into institutional research workflows. The paper includes issues that are driving e-research at the institution and how requirements of researchers in the field of biomedical research have been used in a pilot e-research project. The report also details how the university library is using these user requirements to develop tools such as data management plans, electronic laboratory journals and systems for integration with institutional research workflows. The paper further outlines how an international collaborative approach has assisted the Library to participate in the development of an open source platform for the management of the full research lifecycle in support of RDM. It concludes with how further skills development within the Library is being undertaken to support data services and some of the likely challenges for further development of the services.

NEW DIAGNOSTIC AND THERAPEUTIC STRATEGIES FOR VASCULAR COGNITIVE IMPAIRMENT (VCI): LEARNING FROM BIOMARKERS AND MULTI-PART APPROACHES IN STROKE

The term vascular cognitive impairment (VCI) is used to describe individuals with significant cognitive impairments produced by cerebrovascular disease (CVD). Risk factors for VCI are the same as traditional risk factors for CVD. Early identification of subjects at higher risk of VCI is important for the development of effective preventive strategies. Circulating biomarkers have emerged as potential tools for early diagnosis, as they could provide in vivo measures of the underlying pathophysiology. New interventions should be tested in large multicenter pre-clinical and clinical trials to speed-up the translation process. The Barcelona-AsIA (Asymptomatic Intracranial Atherosclerosis) study and ISSYS (Investigating Silent Strokes in hYpertensives) study are two excellent examples of large cohorts to explore biological predictors of VCI. Hypertension, intracranial atherosclerosis, and silent cerebrovascular lesions (SCL) detected by brain magnetic resonance imaging (MRI) are associated with an increased risk of cognitive decline. In that prospective observational study in 1000 hypertensive patients, aged 50-70 years, with no prior history of stroke or dementia, we studied the presence of mild cognitive impairment (MCI) and the relationship between SCL, an array of blood biomarkers, and cognition. MULTI-PART (Multicentre Preclinical Animal Research Team) is an international collaborative approach to overcoming the translational roadblock in neuroprotection and neuroregeneration research with the key objective to establish and implement a platform for international multicenter preclinical stroke trials using the repertoire of randomized clinical trial design and the complexities of a multicenter, multimodel paradigm. We will show examples of blood biomarkers that add predictive value to clinical and radiological models to anticipate the appearance of VCI. We are developing and implementing international, multicenter ‘phase III’-type preclinical trials of promising, novel ischemic stroke therapies to inform the possible transition from animal modeling to clinical trial. In addition, demonstrating neuroprotection and/or neurorepair in this prototypical acute CNS disorder would have vast implications for the development of treatments in many other chronic neurological and neuropsychiatric diseases such as VCI. Combining prediction of VCI through novel biomarkers and a new trial paradigm (MULTI-PART) could serve as a novel strategy to push translation of cellular/molecular mechanistic VCI studies.

Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines

With the advent of new vaccines targeted to highly endemic diseases in low- and middle-income countries (LMIC) and with the expansion of vaccine manufacturing globally, there is an urgent need to establish an infrastructure to evaluate the benefit-risk profiles of vaccines in LMIC. Fortunately the usual decade(s)-long time gap between introduction of new vaccines in high and low income countries is being significantly reduced or eliminated due to initiatives such as the Global Alliance for Vaccines and Immunizations (GAVI) and the Decade of Vaccines for the implementation of the Global Vaccine Action Plan. While hoping for more rapid disease control, this time shift may potentially add risk, unless appropriate capacity for reliable and timely evaluation of vaccine benefit-risk profiles in some LMIC's are developed with external assistance from regional or global level. An ideal vaccine safety and effectiveness monitoring system should be flexible and sustainable, able to quickly detect possible vaccine-associated events, distinguish them from programmatic errors, reliably and quickly evaluate the suspected event and its association with vaccination and, if associated, determine the benefit-risk of vaccines to inform appropriate action. Based upon the demonstrated feasibility of active surveillance in LMIC as shown by the Burkina Faso assessment of meningococcal A conjugate vaccine or that of rotavirus vaccine in Mexico and Brazil, and upon the proof of concept international GBS study, we suggest a sustainable, flexible, affordable and timely international collaborative vaccine safety monitoring approach for vaccines being newly introduced. While this paper discusses only the vaccine component, the same system could also be eventually used for monitoring drug effectiveness (including the use of substandard drugs) and drug safety.

One World, One Woman: AKyoseiApproach to Primary Ovarian Insufficiency

One World, One Woman: A<i>Kyosei</i>Approach to Primary Ovarian Insufficiency

Antiphospholipid Syndrome Clinical Research Task Force Report

The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing guidelines for researchers to help improve the quality of APS research; and b) prioritizing the ideas for a well-designed multicenter clinical trial and discussing the pragmatics of getting such a trial done. Following a systematic working algorithm, the Task Force identified five major issues that impede APS clinical research and the ability to develop evidence-based recommendations for the management of aPL-positive patients: (1) aPL detection has been based on partially or non-standardized tests, and clinical (and basic) APS research studies have included patients with heterogeneous aPL profiles with different clinical event risks; (2) clinical (and basic) APS research studies have included a heterogeneous group of patients with different aPL-related manifestations (some controversial); (3) thrombosis and/or pregnancy risk stratification and quantification are rarely incorporated in APS clinical research; (4) most APS clinical studies include patients with single positive aPL results and/or low-titer aPL ELISA results; furthermore, study designs are mostly retrospective and not population based, with limited number of prospective and/or controlled population studies; and (5) lack of the understanding the particular mechanisms of aPL-mediated clinical events limits the optimal clinical study design. The Task Force recommended that there is an urgent need for a truly international collaborative approach to design and conduct well-designed prospective large-scale multi-center clinical trials of patients with persistent and clinically significant aPL profiles. An international collaborative meeting to formulate a good research question using 'FINER' (Feasible; Interesting; Novel; Ethical; and Relevant) criteria took place in November 2010.