Alonso-Coello P.,Biomedical Research Institute Sant Pau |
Alonso-Coello P.,CIBER ISCIII |
Martinez Garcia L.,Biomedical Research Institute Sant Pau |
Carrasco Gimeno J.M.,Aragon Health science Institute |
And 2 more authors.
Implementation Science | Year: 2011
Background: Clinical practice guidelines (CPGs) have become increasingly popular, and the methodology to develop guidelines has evolved enormously. However, little attention has been given to the updating process, in contrast to the appraisal of the available literature. We conducted an international survey to identify current practices in CPG updating and explored the need to standardize and improve the methods.Methods: We developed a questionnaire (28 items) based on a review of the existing literature about guideline updating and expert comments. We carried out the survey between March and July 2009, and it was sent by email to 106 institutions: 69 members of the Guidelines International Network who declared that they developed CPGs; 30 institutions included in the U.S. National Guideline Clearinghouse database that published more than 20 CPGs; and 7 institutions selected by an expert committee.Results: Forty-four institutions answered the questionnaire (42% response rate). In the final analysis, 39 completed questionnaires were included. Thirty-six institutions (92%) reported that they update their guidelines. Thirty-one institutions (86%) have a formal procedure for updating their guidelines, and 19 (53%) have a formal procedure for deciding when a guideline becomes out of date. Institutions describe the process as moderately rigorous (36%) or acknowledge that it could certainly be more rigorous (36%). Twenty-two institutions (61%) alert guideline users on their website when a guideline is older than three to five years or when there is a risk of being outdated. Twenty-five institutions (64%) support the concept of "living guidelines," which are continuously monitored and updated. Eighteen institutions (46%) have plans to design a protocol to improve their guideline-updating process, and 21 (54%) are willing to share resources with other organizations.Conclusions: Our study is the first to describe the process of updating CPGs among prominent guideline institutions across the world, providing a comprehensive picture of guideline updating. There is an urgent need to develop rigorous international standards for this process and to minimize duplication of effort internationally. © 2011 Alonso-Coello et al; licensee BioMed Central Ltd.
Stanworth S.J.,University of Oxford |
Walsh T.S.,Royal Infirmary |
Prescott R.J.,University of Edinburgh |
Lee R.J.,University of Edinburgh |
And 2 more authors.
Critical Care | Year: 2011
Introduction: Fresh frozen plasma (FFP) is widely used, but few studies have described patterns of plasma use in critical care. We carried out a multicentre study of coagulopathy in intensive care units (ICUs) and here describe overall FFP utilisation in adult critical care, the indications for transfusions, factors indicating the doses used and the effects of FFP use on coagulation.Methods: We conducted a prospective, multicentre, observational study of all patients sequentially admitted to 29 adult UK general ICUs over 8 weeks. Daily data throughout ICU admission were collected concerning coagulation, relevant clinical outcomes (including bleeding), coagulopathy (defined as international normalised ratio (INR) >1.5, or equivalent prothrombin time (PT)), FFP and cryoprecipitate use and indications for transfusion.Results: Of 1,923 admissions, 12.7% received FFP in the ICU during 404 FFP treatment episodes (1,212 FFP units). Overall, 0.63 FFP units/ICU admission were transfused (0.11 units/ICU day). Reasons for FFP transfusion were bleeding (48%), preprocedural prophylaxis (15%) and prophylaxis without planned procedure (36%). Overall, the median FFP dose was 10.8 ml kg-1, but doses varied widely (first to third quartile, 7.2 to 14.4 ml kg-1). Thirty-one percent of FFP treatments were to patients without PT prolongation, and 41% were to patients without recorded bleeding and only mildly deranged INR (<2.5). Higher volumes of FFP were administered when the indication was bleeding (median doses: bleeding 11.1 ml kg-1, preprocedural prophylaxis 9.8 ml kg-1, prophylaxis without procedure 8.9 ml kg-1; P = 0.009 across groups) and when the pretransfusion INR was higher (ranging from median dose 8.9 ml kg-1at INR ≤1.5 to 15.7 ml kg-1at INR >3; P < 0.001 across ranges). Regression analyses suggested bleeding was the strongest predictor of higher FFP dose. Pretransfusion INR was more frequently normal when the transfusion indication was bleeding. Overall, posttransfusion corrections of INR were consistently small unless the pretransfusion INR was >2.5, but administration during bleeding was associated with greater INR corrections.Conclusions: There is wide variation in FFP use by ICU clinicians, and a high proportion of current FFP transfusions are of unproven clinical benefit. Better evidence from clinical trials could significantly alter patterns of use and modify current treatment costs. © 2011 Stanworth et al.; licensee biomed central ltd.
Chalmers J.D.,University of Dundee |
McHugh B.J.,Queens Medical Research Institute |
Doherty C.,University of Edinburgh |
Smith M.P.,Royal Infirmary |
And 3 more authors.
The Lancet Respiratory Medicine | Year: 2013
Background: Mannose-binding lectin (MBL) is a key component of innate immunity. MBL deficiency is common (10-30% of the general population depending on the definition used) and has been associated with disease progression in cystic fibrosis. We aimed to assess the effect of MBL deficiency on disease severity in non-cystic fibrosis bronchiectasis. Methods: We recruited patients with non-cystic fibrosis bronchiectasis and age-matched and sex-matched controls at a specialist bronchiectasis clinic in Edinburgh, UK. We assessed MBL function with genotyping (low-expressing genotype [deficiency] defined as homozygosity for exon 1 mutations [YO/YO] or compound heterozygosity [XA/YO]; YA/YO and XA/XA genotypes were defined as intermediate-expressing with all other genotypes defined as high-expressing) and serum measurements (deficiency defined with two parameters: <500 ng/mL or <200 ng/mL). We assessed rates of exacerbation, chronic bacterial colonisation, and lung function during 4 years of follow-up. Findings: We included 470 patients with bronchiectasis and 414 controls. MBL genotype frequencies and MBL serum concentrations did not differ between patients and controls. 55 (12%) patients with bronchiectasis had low-expressing genotypes. These patients had a mean of 2·7 exacerbations per year (SD 1·8), compared with 1·9 per year (1·2) for 135 patients with intermediate-expressing genotypes and 1·9 per year (1·3) for 280 patients with high-expressing genotypes (p<0·0001). Chronic colonisation with bacteria was most frequent in patients with low-expressing genotypes (47 [85%] patients vs 82 [61%] patients with intermediate-expressing genotypes and 183 [65%] patients with high-expressing genotypes; p=0·0041); especially P aeruginosa colonisation (19 [35%] patients vs 13 [10%] patients and 36 [13%] patients; p<0·0001). Patients with low-expressing genotypes were more likely to be admitted to hospital for severe exacerbations during follow-up (27 [49%] patients vs 42 [31%] patients and 87 [31%] patients; p=0·032). Patients with low-expressing genotypes also had increased scores for radiological severity and worse quality of life compared with the other two groups. MBL serum deficiency (<200 ng/mL) was associated with increased exacerbations, hospital admissions, and radiological severity. When <500 ng/mL was used as the definition of deficiency, the associations with exacerbation frequency and radiological severity were no longer significant. Interpretation: MBL might be an important modifier of disease severity in non-CF bronchiectasis. Funding: UK Medical Research Council, UK Chief Scientists Office. © 2013 Elsevier Ltd.
Chalmers J.D.,University of Dundee |
Matsushita M.,Tokai University |
Kilpatrick D.C.,Scottish National Blood Transfusion Service |
Hill A.T.,Royal Infirmary
Inflammation | Year: 2015
Mycobacterium tuberculosis (TB) may utilise the lectin complement pathway to facilitate entry into its niche within macrophages. Previous studies examining mannose-binding lectin (MBL) in patients with TB have been limited by failure to correlate genotype/phenotype relationships. This study investigated serum levels and genotypes of MBL, Ficolin-2, Ficolin-3 and MASP-2 in 168 patients with pulmonary tuberculosis and 168 age/sex-matched controls. Low serum levels of MBL and Ficolin-2 were defined using cut-offs previously identified in the literature. Median MBL serum levels were higher in TB patients than controls—1400 ng/ml (IQR 435–2520) vs 1030 ng/ml (350–2050), p = 0.02—but this was not mirrored by a difference in MBL haplotype frequencies (MBL deficient haplotypes were observed in 11.9 % of TB patients and 11.3 % of controls). Severe Ficolin-2 deficiency (<1200 ng/ml) was more frequent in TB than controls (7.1 vs 3.0 %, odds ratio 2.51 95 % CI 0.86–7.28, p = 0.1) but the difference was not statistically significant. No relationship between Ficolin-2, Ficolin-3 or MASP-2 genotypes or serum levels and TB were observed. No strong relationship between the lectin complement pathway and pulmonary tuberculosis was observed. Previous data linking high MBL serum levels with TB were likely due to an acute phase response rather than a true effect on disease susceptibility. © 2015, Springer Science+Business Media New York.
News Article | December 21, 2016
HONG KONG, Dec. 21, 2016 /PRNewswire/ -- Hong Kong Science and Technology Parks Corporation ("HKSTP") and Guangzhou Institutes of Biomedicine and Health ("GIBH") cohosted the second Hong Kong and Guangzhou International Conference on Stem Cell & Regenerative Medicine on December 16. During this high-profile event which was attended by HKSAR Chief Executive The Hon CY Leung and a number of major government officials, the Chinese Academy of Science ("CAS"), a research and development authority in Mainland China, announced the setting up of the Guangzhou Hong Kong Stem Cell and Regenerative Medicine Research Centre at Hong Kong Science Park ("HKSP"), under the auspices of its subsidiary GIBH. Remarking on this significant initiative, The Hon. Fanny Law, GBS, JP, Chairperson of HKSTP, said: "We see opportunities for Hong Kong to evolve into a cell therapy centre, capitalising on Hong Kong's world-class medical system, and credible clinical trial centres with data accepted by FDA, EMA as well as CFDA, which is unique to Hong Kong." "Our ambition is to grow an industry in advanced therapy medicinal products, leveraging on the complementary strengths of Hong Kong, Guangzhou and Shenzhen, to form a leading 'Cell Therapy Valley' where the latest technologies are being developed, tested and implemented for the benefit of ethnic Chinese patients who suffer from existing incurable diseases," Mrs Law said. Prof Bai Chunli, President of CAS, said that the proposed research centre "will create the environment for stakeholders to make connections, share information and tap into each other's academic resources for the benefits of the world", and the centre has the potential to mature into a platform that will "strengthen existing partnerships, maximise innovation capacities and reinforce strategic co-operations of the science and technology communities between China and Hong Kong". GIBH is yet another world-renowned biomedicine research authority to set up its base in HKSP, after Karolinska Institutet, which opened the Hong Kong node of its dedicated regenerative medicine facility, the Ming Wai Lau Centre for Reparative Medicine, at HKSP in October 2016. HKSP is also home to 14 other stem cell and cell therapy companies from around the world. At the conference, expert speakers shared their latest research discoveries and insights in stem cell therapy for liver fibrosis, cell therapy for diabetes, and epigenetic fingerprinting and tissue engineering that facilitate pre-clinical drug discovery for Alzheimer's disease, reaffirming stem cell therapy holds great promise in curing debilitating diseases such as Parkinson's, Alzheimer's, spinal cord injury, diabetes and stroke and presenting great potentials for researchers in the field. As HKSTP is stepping up its effort to develop HKSP and Hong Kong as the ideal R&D base and hub for stem cell research and regenerative medicine, Mrs Law pointed out at the conference that a set of clear regulatory guidelines that facilitates clinical translation of advanced cell therapies while safeguarding the interests of patients is fundamental for realising this vision. World stem cell experts from the US, the UK, Mainland China, Europe and Australia attending the Stem Cell Conference joined Hong Kong colleagues in a pre-event round-table discussion to recommend the way forward for the regulatory environment in Hong Kong, referencing the regulatory structures in other countries. Group convenor Prof Marc Turner, who is the Medical Director of Scottish National Blood Transfusion Service, reported at the conference that the group suggested a single stream of legislation covering supply of starting materials, manufacture, administration and follow up. "Since Hong Kong has a relatively clear space, our advice would be to join up tissue and cell legislation with cellular therapy and advanced therapy legislation all in one piece, to be consistent. That would be the most coherent way to do it, therefore in the longer term it will be the most efficient," he said. HKSTP Chief Executive Officer Mr Albert Wong said: "HKSTP has established a strong rapport with the global biomedical community. This is apparent in the sterling speaker lineup of our Stem Cell Conference. Stem cell R&D is a key pillar for supporting healthy ageing, which is one of the key priorities of HKSTP. We will redouble efforts in building the cell therapy ecosystem in Science Park and help the community excel and develop, so that we can ride on the global momentum of stem cell R&D to move forward in the advanced therapy value chain, as Hong Kong endeavours to develop an appropriate regulatory environment for this field." Comprising Science Park, InnoCentre and Industrial Estates, Hong Kong Science & Technology Parks Corporation (HKSTP) is a statutory body dedicated to building a vibrant innovation and technology ecosystem to connect stakeholders, nurture technology talents, facilitate collaboration, and catalyse innovations to deliver social and economic benefits to Hong Kong and the region. Established in May 2001, HKSTP has been driving the development of Hong Kong into a regional hub for innovation and growth in several focused clusters including Electronics, Information & Communications Technology, Green Technology, Biomedical Technology, Materials and Precision Engineering. We enable science and technology companies to nurture ideas, innovate and grow, supported by our R&D facilities, infrastructure, and market-led laboratories and technical centres with professional support services. We also offer value added services and comprehensive incubation programmes for technology start-ups to accelerate their growth. Technology businesses benefit from our specialised services and infrastructure at Science Park for applied research and product development; enterprises can find creative design support at InnoCentre; while skill-intensive businesses are served by our three industrial estates at Tai Po, Tseung Kwan O and Yuen Long. More information about HKSTP is available at www.hkstp.org.
Tinegate H.,NHS Blood and Transplant |
Birchall J.,NHSBT Filton |
Gray A.,Better Blood Transfusion |
Haggas R.,Leeds Teaching Hospitals |
And 6 more authors.
British Journal of Haematology | Year: 2012
Although acute non-haemolytic febrile or allergic reactions (ATRs) are a common complication of transfusion and often result in little or no morbidity, prompt recognition and management are essential. The serious hazards of transfusion haemovigilance organisation (SHOT) receives 30-40 reports of anaphylactic reactions each year. Other serious complications of transfusion, such as acute haemolysis, bacterial contamination, transfusion-related acute lung injury (TRALI) or transfusion-associated circulatory overload (TACO) may present with similar clinical features to ATR. This guideline describes the approach to a patient developing adverse symptoms and signs related to transfusion, including initial recognition, establishing a likely cause, treatment, investigations, planning future transfusion and reporting within the hospital and to haemovigilance organisations. Key recommendations are that adrenaline should be used as first line treatment of anaphylaxis, and that transfusions should only be carried out where patients can be directly observed and where staff are trained in manging complications of transfusion, particularly anaphylaxis. Management of ATRs is not dependent on classification but should be guided by symptoms and signs. Patients who have experienced an anaphylactic reaction should be discussed with an allergist or immunologist, in keeping with UK resuscitation council guidelines. © 2012 Blackwell Publishing Ltd.
Cleland A.,Scottish National Blood Transfusion Service |
Smith L.,Scottish National Blood Transfusion Service |
Crossan C.,Glasgow Caledonian University |
Blatchford O.,Health Protection Scotland |
And 4 more authors.
Vox Sanguinis | Year: 2013
Background and Objectives: Published prevalence figures for hepatitis E virus (HEV) reveal significant regional differences. Several studies have reported virus transmission via blood transfusion. The aim of this study was to establish HEV seroprevalence and investigate a potential HEV RNA presence in Scottish blood donors. Materials and Methods: IgG and IgM were determined in individual serum samples. HEV RNA was investigated in plasma mini-pools corresponding to 43 560 individual donations using nested PCR. Samples amenable to reamplification with primers from a different region were considered confirmed positives, sequenced and analysed. Results: A total of 73 of 1559 tested individual sera (4·7%) were IgG positive, none tested positive for IgM. Plasma mini-pool testing revealed an HEV RNA frequency of 1 in 14 520 donations. Three confirmed positives belonged, as expected to genotype 3. Conclusions: HEV IgG and RNA figures in Scottish blood donors are lower than those published for the rest of the UK, but sufficiently high to prompt further studies on potential transmission rates and effects of HEV infection, especially for immunosuppressed individuals. © 2013 International Society of Blood Transfusion.
Galea G.,Scottish National Blood Transfusion Service
Transfusion Medicine and Hemotherapy | Year: 2011
Background: The Scottish National Blood Transfusion Service (SNBTS) is the main provider of tissues in Scotland. Tissue collection programmes were established in the mid-1990s, and the range of tissues collected has increased progressively over the years. Methods: Whilst the majority of tissues are obtained from cadaveric donations, bone is collected only from living donors who are usually patients undergoing primary hip replacement surgery (surgical donors). The bone is collected in an operating theatre, and, once stored, no further processing takes place prior to issue. Bone that fails for any reason (quality, microbiology or virological nonnegative result) is discarded. Results: The deferral rate amongst live surgical bone donors in Scotland is around 65%, and it has been slowly and progressively rising from around 55% over the past few years. This needed investigated, particularly because comparisons with blood donors show that the deferral rate amongst bone donors is more than double that of first-time blood donors (29.7%). Our processes and systems are standardised, and our cohort of bone bank nurses have all been similarly trained and competency assessed. Moreover our data collection was done in a uniform fashion. It was therefore possible to conduct a 6-year audit on bone donor deferrals. It was found that a history of transfusion (16%), history of malignancy (18%) and bone quality (26%) were the main reasons for bone donor deferrals, accounting for 60% of all deferrals. Conclusions: When these are taken into account, the residual deferral rates become very similar numerically to blood donors. It is important to note however that there are significant differences between the blood and bone donor cohorts. This study also highlighted some of deferral reasons. Particularly malignancy is a cause of significant numbers of deferrals, and the evidence of transmissibility of malignancy through bone donation is not strong. More robust risk assessments should be undertaken prior to implementing deferral conditions. © 2011 S. Karger AG, Basel.
Galea G.,Scottish National Blood Transfusion Service
Essentials of Tissue Banking | Year: 2010
Presents much-needed, up-to-date information on essential scientific aspects of tissue banking Incorporates new regulations and risk-assessment requirements into tissue banking methodologies Meets a significant need in a time of rapid change in tissue bankin Tissue banking is undergoing a paradigm shift. There are now a plethora of guidance and regulatory documents, in response to recent regulation. There is however, relatively little information on the scientific and technical principles on routine tissue banking practices. The information that exists is relatively old and in somewhat obscure journals. This book attempts to provide a coherent and up to date approach. Each author, who is a recognized expert in their field, was asked to illustrate the processes involved in modern tissue banking practices. Where these are based on evidence and science, they were asked to explain this in a clear and concise manner. Where evidence it is not available, the authors were asked to provide the reasons why they believe practices have developed the way they have. This could range from the precautionary principle, custom and practice, common sense approach etc. This book has been split into 5 sections: Management of donors and the banking of common tissues and cells, principles of storage and processing of tissues, ensuring safety of the products by testing the donor, the tissue and the environment, ensuring quality of the products by establishing a quality system and an IT infrastructure and the Regulatory and ethical environment in which we operate. Although it is possible to bank all types of cells, including stem cells, these are not covered in this book. The organisation and target audiences for stem cells are quite different from those of tissues. Cord blood banking, on the other hand is very similar and they have therefore been included. The intention of this book is to cover the basis of current practices, rather than future developments, such as embryonic cell developments, tissue engineering and gene therapy. These are more akin to cellular therapies. Although they share many banking similarities to tissues, their inclusion in this book would have made it too cumbersome. © 2010 Springer Science+Business Media B.V. All rights reserved.
Petrik J.,Scottish National Blood Transfusion Service
Biologicals | Year: 2010
Blood donation screening represents rather a unique set of blood grouping-related and pathogen detection assays. We are confronted with continuously growing numbers of testing targets. Ideally, the spectrum of clinically significant blood group antigens and alloantibodies would be wider than allowed by current routine tests. At the same time, we are witnessing an increase in emerging and re-emerging human pathogens due to urbanisation, increased international travel and trade, climate change and other factors. The spectrum of blood-borne infectious agents requiring donation screening is expected to grow correspondingly. Dengue and chikungunya viruses, variant CJD and hepatitis E virus represent just some of the candidate infectious agents for future donation screening. Multiplexing techniques, such as microarrays are well suited to address the growing number of targets, pending the increase in sensitivity of some of the microarrays assays. There are several possible scenarios for future testing algorithms, combining new multiplexing techniques with the existing blood testing assays. New generation testing platforms capable of microbiology screening, blood grouping and potential additional types of targets, are also being developed. © 2009 The International Association for Biologicals.