Efficiency and safety of varying the frequency of whole blood donation (INTERVAL): a randomised trial of 45 000 donors

Background: Limits on the frequency of whole blood donation exist primarily to safeguard donor health. However, there is substantial variation across blood services in the maximum frequency of donations allowed. We compared standard practice in the UK with shorter inter-donation intervals used in other countries. Methods: In this parallel group, pragmatic, randomised trial, we recruited whole blood donors aged 18 years or older from 25 centres across England, UK. By use of a computer-based algorithm, men were randomly assigned (1:1:1) to 12-week (standard) versus 10-week versus 8-week inter-donation intervals, and women were randomly assigned (1:1:1) to 16-week (standard) versus 14-week versus 12-week intervals. Participants were not masked to their allocated intervention group. The primary outcome was the number of donations over 2 years. Secondary outcomes related to safety were quality of life, symptoms potentially related to donation, physical activity, cognitive function, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin. This trial is registered with ISRCTN, number ISRCTN24760606, and is ongoing but no longer recruiting participants. Findings: 45 263 whole blood donors (22 466 men, 22 797 women) were recruited between June 11, 2012, and June 15, 2014. Data were analysed for 45 042 (99·5%) participants. Men were randomly assigned to the 12-week (n=7452) versus 10-week (n=7449) versus 8-week (n=7456) groups; and women to the 16-week (n=7550) versus 14-week (n=7567) versus 12-week (n=7568) groups. In men, compared with the 12-week group, the mean amount of blood collected per donor over 2 years increased by 1·69 units (95% CI 1·59–1·80; approximately 795 mL) in the 8-week group and by 0·79 units (0·69–0·88; approximately 370 mL) in the 10-week group (p<0·0001 for both). In women, compared with the 16-week group, it increased by 0·84 units (95% CI 0·76–0·91; approximately 395 mL) in the 12-week group and by 0·46 units (0·39–0·53; approximately 215 mL) in the 14-week group (p<0·0001 for both). No significant differences were observed in quality of life, physical activity, or cognitive function across randomised groups. However, more frequent donation resulted in more donation-related symptoms (eg, tiredness, breathlessness, feeling faint, dizziness, and restless legs, especially among men [for all listed symptoms]), lower mean haemoglobin and ferritin concentrations, and more deferrals for low haemoglobin (p<0·0001 for each) than those observed in the standard frequency groups. Interpretation: Over 2 years, more frequent donation than is standard practice in the UK collected substantially more blood without having a major effect on donors' quality of life, physical activity, or cognitive function, but resulted in more donation-related symptoms, deferrals, and iron deficiency. Funding: NHS Blood and Transplant, National Institute for Health Research, UK Medical Research Council, and British Heart Foundation

Understanding ‘error’ in the forensic sciences: A primer

This paper distils seven key lessons about ‘error’ from a collaborative webinar series between practitioners at Victoria Police Forensic Services Department and academics. It aims to provide the common understanding of error necessary to foster interdisciplinary dialogue, collaboration and research. The lessons underscore the inevitability, complexity and subjectivity of error, as well as opportunities for learning and growth. Ultimately, we argue that error can be a potent tool for continuous improvement and accountability, enhancing the reliability of forensic sciences and public trust. It is hoped the shared understanding provided by this paper will support future initiatives and funding for collaborative developments in this vital domain.This article is published as Martire, K.A., Chin, J.M., David, C., Edmond, G., Growns, B., Gorski, S., Kemp, R.I., Lee, Z., MarVerdon, C.M., Jansen, G., Lang, T., Neal, T.M.S., Searston, R., Slocum, J., Summersby, S., Tangen, J.M., Thompson, M.B., Towler, A., Watson, W., Werrett, M.V., Younan, M., & Ballantyne, K.N. (2024). Understanding “error” in the forensic sciences: A primer. Forensic Science International: Synergy, 8(100470). https://doi.org/10.1016/j.fsisyn.2024.100470. This article is under a Creative Commons License https://creativecommons.org/licenses/by-nc-nd/4.0/.The OCFS-EBFI Webinar Series was supported by funding from the Office of the Chief Forensic Scientist, Victoria Police Forensic Services Department. R.K. partially supported by ARC Discovery project (DP220100585). K.A.M. supported by ARC Discovery project (DP220102412). T.M.S.N. was supported by a PLuS Alliance Fellowship from Arizona State University and the University of New South Wales, as well as a Fulbright Scholarship from the Australian-American Fulbright Commission. This manuscript is not an official Department of State publication, and the views and information presented here are the authors' and do not represent the Fulbright Commission or the host country's government or institutions. R.A.S supported by ARC Industry Fellowship (IE230100380). A.T supported by ARC DECRA (DE210100357). J.M.T, R.A.S., G.E. & M.B.T supported by ARC Linkage Project (LP170100086)

Longer-term efficiency and safety of increasing the frequency of whole blood donation (INTERVAL): extension study of a randomised trial of 20 757 blood donors

Background: The INTERVAL trial showed that, over a 2-year period, inter-donation intervals for whole blood donation can be safely reduced to meet blood shortages. We extended the INTERVAL trial for a further 2 years to evaluate the longer-term risks and benefits of varying inter-donation intervals, and to compare routine versus more intensive reminders to help donors keep appointments. Methods: The INTERVAL trial was a parallel group, pragmatic, randomised trial that recruited blood donors aged 18 years or older from 25 static donor centres of NHS Blood and Transplant across England, UK. Here we report on the prespecified analyses after 4 years of follow-up. Participants were whole blood donors who agreed to continue trial participation on their originally allocated inter-donation intervals (men: 12, 10, and 8 weeks; women: 16, 14, and 12 weeks). They were further block-randomised (1:1) to routine versus more intensive reminders using computer-generated random sequences. The prespecified primary outcome was units of blood collected per year analysed in the intention-to-treat population. Secondary outcomes related to safety were quality of life, self-reported symptoms potentially related to donation, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin and other factors. This trial is registered with ISRCTN, number ISRCTN24760606, and has completed. Findings: Between Oct 19, 2014, and May 3, 2016, 20 757 of the 38 035 invited blood donors (10 843 [58%] men, 9914 [51%] women) participated in the extension study. 10 378 (50%) were randomly assigned to routine reminders and 10 379 (50%) were randomly assigned to more intensive reminders. Median follow-up was 1·1 years (IQR 0·7–1·3). Compared with routine reminders, more intensive reminders increased blood collection by a mean of 0·11 units per year (95% CI 0·04–0·17; p=0·0003) in men and 0·06 units per year (0·01–0·11; p=0·0094) in women. During the extension study, each week shorter inter-donation interval increased blood collection by a mean of 0·23 units per year (0·21–0·25) in men and 0·14 units per year (0·12–0·15) in women (both p<0·0001). More frequent donation resulted in more deferrals for low haemoglobin (odds ratio per week shorter inter-donation interval 1·19 [95% CI 1·15–1·22] in men and 1·10 [1·06–1·14] in women), and lower mean haemoglobin (difference per week shorter inter-donation interval −0·84 g/L [95% CI −0·99 to −0·70] in men and −0·45 g/L [–0·59 to −0·31] in women) and ferritin concentrations (percentage difference per week shorter inter-donation interval −6·5% [95% CI −7·6 to −5·5] in men and −5·3% [–6·5 to −4·2] in women; all p<0·0001). No differences were observed in quality of life, serious adverse events, or self-reported symptoms (p>0.0001 for tests of linear trend by inter-donation intervals) other than a higher reported frequency of doctor-diagnosed low iron concentrations and prescription of iron supplements in men (p<0·0001). Interpretation: During a period of up to 4 years, shorter inter-donation intervals and more intensive reminders resulted in more blood being collected without a detectable effect on donors' mental and physical wellbeing. However, donors had decreased haemoglobin concentrations and more self-reported symptoms compared with the initial 2 years of the trial. Our findings suggest that blood collection services could safely use shorter donation intervals and more intensive reminders to meet shortages, for donors who maintain adequate haemoglobin concentrations and iron stores. Funding: NHS Blood and Transplant, UK National Institute for Health Research, UK Medical Research Council, and British Heart Foundation

Some economic consequences of the GDPR

The EU General Data Protection Regulation (GDPR) is a wide ranging personal data protection regime of greater magnitude than any similar regulation previously in the EU, or elsewhere. In this paper, we outline how the GDPR impacts the value of data held by data collectors before proposing some potential unintended consequences. Given the distortions of the GDPR on data value, we propose that new complex financial products-essentially new data insurance markets-will emerge, potentially leading to further systematic risks. Finally we examine how market-driven solutions to the data property rights problems the GDPR seeks to solve-particularly using blockchain technology as economic infrastructure for data rights-might be less distortionary

Model forensic science

This article provides an explanation of the duties and responsibilities owed by forensic practitioners (and other expert witnesses) when preparing for and presenting evidence in criminal proceedings. It is written in the shadow of reports by the National Academy of Sciences (US), the National Institute of Standards and Technology (US), the Scottish Fingerprint Inquiry and a recent publication entitled ‘How to cross-examine forensic scientists: A guide for Lawyers’. The article examines potential responses to questions focused on the need for scientific research, validation, uncertainties, limitations and error, contextual bias and the way expert opinions are expressed in reports and oral testimony. Responses and the discussion is developed around thematics such as disclosure, transparency, epistemic modesty and impartiality derived from modern admissibility and procedure rules, codes of conduct, ethical and professional responsibilities and employment contracts. The article explains why forensic practitioners must respond to the rules and expectations of adversarial legal institutions. Simultaneously, in line with accusatorial principles, it suggests that forensic practitioners employed by the state ought to conduct themselves as model forensic scientists

Model forensic science

This article provides an explanation of the duties and responsibilities owed by forensic practitioners (and other expert witnesses) when preparing for and presenting evidence in criminal proceedings. It is written in the shadow of reports by the National Academy of Sciences (US), the National Institute of Standards and Technology (US), the Scottish Fingerprint Inquiry and a recent publication entitled ‘How to cross-examine forensic scientists: A guide for Lawyers’. The article examines potential responses to questions focused on the need for scientific research, validation, uncertainties, limitations and error, contextual bias and the way expert opinions are expressed in reports and oral testimony. Responses and the discussion is developed around thematics such as disclosure, transparency, epistemic modesty and impartiality derived from modern admissibility and procedure rules, codes of conduct, ethical and professional responsibilities and employment contracts. The article explains why forensic practitioners must respond to the rules and expectations of adversarial legal institutions. Simultaneously, in line with accusatorial principles, it suggests that forensic practitioners employed by the state ought to conduct themselves as model forensic scientists

Model forensic science

This article provides an explanation of the duties and responsibilities owed by forensic practitioners (and other expert witnesses) when preparing for and presenting evidence in criminal proceedings. It is written in the shadow of reports by the National Academy of Sciences (US), the National Institute of Standards and Technology (US), the Scottish Fingerprint Inquiry and a recent publication entitled ‘How to cross-examine forensic scientists: A guide for Lawyers’. The article examines potential responses to questions focused on the need for scientific research, validation, uncertainties, limitations and error, contextual bias and the way expert opinions are expressed in reports and oral testimony. Responses and the discussion is developed around thematics such as disclosure, transparency, epistemic modesty and impartiality derived from modern admissibility and procedure rules, codes of conduct, ethical and professional responsibilities and employment contracts. The article explains why forensic practitioners must respond to the rules and expectations of adversarial legal institutions. Simultaneously, in line with accusatorial principles, it suggests that forensic practitioners employed by the state ought to conduct themselves as model forensic scientists