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

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

International Social Survey Programme: Role of Government I-V ADD ON - ISSP 1985-1990-1996-2006-2016

The International Social Survey Programme (ISSP) is a continuous programme of cross-national collaboration running annual surveys on topics important for the social sciences. The programme started in 1984 with four founding members - Australia, Germany, Great Britain, and the United States – and has now grown to almost 50 member countries from all over the world. As the surveys are designed for replication, they can be used for both, cross-national and cross-time comparisons. Each ISSP module focuses on a specific topic, which is repeated in regular time intervals. Please, consult the documentation for details on how the national ISSP surveys are fielded. The present study focuses on questions about political attitudes and the role of government.The release of the cumulated ISSP ´Role of Government´ modules for the years 1985, 1990, 1996, 2006 and 2016 consists of two separate datasets: ZA4747 Role of Government I-V and ZA4748 Role of Government I-V Add On. ZA4747 contains all the cumulated variables, while the supplementary data file ZA4748 contains all those variables that could not be cumulated for various reasons. A comprehensive overview on the contents, the structure and basic coding rules of both data files are provided in the Variable Reports. Role of government I-V Add On: Country-specific variables (for countries included in the cumulated dataset): education (highest degree earned), party affiliation, party voted for in last general election, size of community, country-specific occupational codes (respondent and spouse), personal income, household income, country of origin or ethnic group, religious affili-ation or denomination; Slovakia 2006: political interest; New Zealand 2016: political interest. Module-specific variables: respondent´s religious affiliation or denomination 2006, employment status 2016 (respondent and spouse), living in steady partnership 2016, spouse: working hours 2016; spouse: supervise other employees 2016; parents´ country if birth 2016; Italy: type of housing 1985; type of community (urban/ rural) 1985, 1990, 1996. Additionally coded: Unique cumulation respondent ID Number; Country/ Sample Prefix ISO 3166 Code – alphanumeric; region (country-specific).Das International Social Survey Programme (ISSP) ist ein länderübergreifendes, fortlaufendes Umfrageprogramm, das jährlich Erhebungen zu Themen durchführt, die für die Sozialwissenschaften wichtig sind. Das Programm begann 1984 mit vier Gründungsmitgliedern - Australien, Deutschland, Großbritannien und den Vereinigten Staaten - und ist inzwischen auf fast 50 Mitgliedsländer aus aller Welt angewachsen. Da die Umfragen auf Replikationen ausgelegt sind, können die Daten sowohl für länder- als auch für zeitübergreifende Vergleiche genutzt werden. Jedes ISSP-Modul konzentriert sich auf ein bestimmtes Thema, das in regelmäßigen Zeitabständen wiederholt wird. Details zur Durchführung der nationalen ISSP-Umfragen entnehmen Sie bitte der Dokumentation. Die vorliegende Studie konzentriert sich auf Fragen zu politischen Einstellungen und der Rolle der Regierung.Die Veröffentlichung der kumulierten ISSP-Module "Role of Government" für die Jahre 1985, 1990, 1996, 2006 und 2016 besteht aus zwei separaten Datensätzen: ZA4747 Role of Government I-V und ZA4748 Role of Government I-V Add On. ZA4747 enthält alle kumulierten Variablen, während der Zusatzdatensatz ZA4748 all jene Variablen enthält, die aus verschiedenen Gründen nicht kumuliert werden konnten. Ein umfassender Überblick über den Inhalt, die Struktur und die grundlegenden Kodierungsregeln beider Datenfiles wird in den Variablenreports gegeben. Rolle des Staates I-V Add On: Länderspezifische Variablen (für die im kumulierten Datensatz enthaltenen Länder): Bildung (höchster erworbener Abschluss), Parteizugehörigkeit, bei den letzten allgemeinen Wahlen gewählte Partei, Größe der Gemeinde, länderspezifische Berufscodes (Befragter und Ehepartner), persönliches Einkommen, Haushaltseinkommen, Herkunftsland oder ethnische Gruppe, Religionszugehörigkeit oder Konfession; Slowakei 2006: politisches Interesse; Neuseeland 2016: politisches Interesse. Modulspezifische Variablen: Religionszugehörigkeit oder Konfession des Befragten 2006, Beschäftigungsstatus 2016 (Befragter und Ehegatte), Leben in fester Partnerschaft 2016, Ehegatte: Arbeitszeit 2016; Ehegatte: Aufsicht über andere Mitarbeiter 2016; Geburtsland der Eltern 2016; Italien: Art der Wohnung 1985; Art der Gemeinde (Stadt/Land) 1985, 1990, 1996. Zusätzlich kodiert: Eindeutige Kumulierungs-ID-Nummer des Befragten; Land/Stichprobenpräfix ISO 3166 Code - alphanumerisch; Region (länderspezifisch)