Table 2.

International/national guidelines for physicians when informing haemophilia patients of pathogen transmission risk; highlighting the variability of how this important information is handled

Geographical region/country	Guidelines	Source
World	World Federation of Hemophilia (WFH) guidelines for the management of haemophilia: On the choice of products for haemophilia and related disorders: ‘The WFH strongly recommends the use of viral-inactivated plasma-derived or recombinant concentrates in preference to cryoprecipitate [Author’s note: cryoprecipitate harbours a high risk of viral contamination] or fresh frozen plasma for the treatment of haemophilia and other inherited bleeding disorders.....[Author’s note: harbours a high risk of hypervoluminemia] When selecting plasma-derived concentrates, consideration needs to be given to both the plasma quality and the manufacturing process. Two issues deserve special consideration:  Purity of product  Viral inactivation/elimination’	Section 4.1, Guidelines for the management of hemophilia [134]
	On pathogen safety: ‘The new challenge remains emerging and re-emerging infections, many of which are not amenable to current risk reduction measures. These include the non-lipid enveloped viruses and prions, for which diagnosis and elimination methods are still a challenge.’	Section 6.3, Guidelines for the management of hemophilia [134]
Germany	Clinical guideline for the use of blood and blood-derived products: ‘The responsible physician must obtain the patient’s informed consent before starting a transfusion.’ Contents of patient information are not further specified.	Cross-sectional guidelines for therapy with blood components and plasma derivatives [135]
	Guideline on the preparation and use of blood and blood-derived products: (Translation) ‘Blood components and plasma derivatives are prescription items and shall be subject to medical prescription. The indication must be considered thoroughly and with careful consideration of the individual patient. […] Informed consent should be obtained at the earliest possible time in order to allow the patient sufficient time before consent.’	Section 4.3, Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten (Hämotherapie) [43]
	(Translation) ‘If informed consent cannot be obtained, e.g. in emergency situations, patients shall be informed retrospectively about the administration of blood products and their risks, in particular infection and immunization risks.’	Section 4.3.10, Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten (Hämotherapie) [43]
Italy	Recommendations for the transfusion of plasma and platelets ‘In all cases, it is recommended that the patient and/or his/her parents/tutors receive detailed and clear information concerning the available therapeutic approaches and replacement products, in order to achieve shared decisions and the written informed consent for treatment and the choice of the product.’	Italian Society of Transfusion Medicine and Immunohaematology (SIMTI) Working Party [136]
	Patient consent: The patient consent form includes a detailed description of the different levels of pathogenic risk arising from different products for treating bleeding disorders, and requires the patients to confirm that they have understood and agreed to these risks.	Informed consent form for haemophilia treaters of Italy (Consenso Informato e informativa) [137]
Spain	Transfusion recipients are required to provide informed consent and information on pathogen risk is given within the informed consent form. However, no specific recommendations are provided pertaining to how physicians should advise patients on pathogen risk.	Estándares en Transfusión Sanguínea – Fundacion CAT (4th edition) [138] Informed consent form for transfusion (Son Espases University Hospital, Spain) [139]
UK	Patient information and consent for transfusion ‘Where possible, patients (and for children, those with parental responsibility) should have the risks, benefits and alternatives to transfusion explained to them in a timely and understandable manner. Standardized patient information, such as national patient information leaflets, should be used wherever possible’	Table 4.1, Handbook of transfusion medicine (5th Ed) [24]
	The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) recommends that ‘valid consent’ for blood transfusion should be obtained and documented in the clinical record. The following recommendations apply: ‘Use of standardized sources of information for all patients in the UK – appropriate information leaflets are available from the UK Transfusion Services and should be used in all hospitals.’	Section 4.4, Handbook of transfusion medicine (5th Ed) [24]
	‘Use of a standardized information resource for clinicians, indicating the key areas to be discussed when obtaining consent – an example is available from http://www.transfusionguidelines.org.uk/index.asp?Publication=BBT&Section=22&pageid=7691.’ ‘Patients needing long-term transfusion support should have a modified form of consent (e.g. annual review and re-consent) and this should be specified in local policies.’	http://www.transfusionguidelines.org.uk/index.asp?Publication=BBT&Section=22&pageid=7691
US	Guidance on informed consent for blood transfusion: ‘…..at a minimum, elements of the consent shall include the following: (1) a description of the risks, benefits, and treatment alternatives (including non-treatment), (2) the opportunity to ask questions, and (3) the right to accept or refuse transfusion.’	Friedman et al. [140]
	Guidance on blood donation: ‘Elements of the donation procedure shall be explained to the prospective donor in understandable terms. The explanation shall include information about risks of the procedure, tests performed to reduce the risks of transmission of infectious diseases to the allogeneic recipient and requirements to report donor information, including test results, to state or local health departments. The donor shall have an opportunity to ask questions and have them answered and to give or refuse consent for donation. In the case of a minor or a legally incompetent adult, consent shall be addressed in accordance with applicable law.’	AABB standards for blood banks and transfusion services, 26th edition [141]
	Information regarding attitudes, practices and training on informed consent for transfusions and procedures: ‘60% of respondents (medical students and physicians in the US) felt that their informed consent training was adequate. Multiple areas of difficulty in obtaining proper informed consent were identified that should be addressed with focused training or written guidelines.’	Vossoughi SR et al. [142]