European Cancer Organisation Essential Requirements for Quality Cancer Care: Hematological malignancies

European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCCs) are primarily organizational recommendations, giving politicians, managers, oncology teams, patients, and patient advocacy groups a non-technical overview of the elements needed to provide high-quality care throughout the patient journey. They are not clinical guidelines, but define the actions necessary to deliver high-quality care to patients with specific cancer types, here applied to hematological malignancies in Europe. The recommendations set out an aspirational but realistic standard that should be within reach for most countries, given adequate resourcing. They include the need for (1) fast and easy access to accurate diagnostic tests; (2) clearly established pathways for referral to specialist centers; (3) services to be centralized; (4) continuous monitoring of patient well-being; (5) treatment strategies to be agreed by a core multidisciplinary team; and (6) patients and their families to be involved at all stages of decision-making. The foundation of ERQCCs is quality. This has become increasingly important in all aspects of healthcare as new and complex treatments come into use and pressure grows on resources. Improving quality means delivering cancer care that is timely, safe, effective, and efficient; that puts the patient at the center; and that gives all people in Europe equal access to high-quality services. Variations in cancer outcomes and disparities in management and funding across Europe make quality frameworks essential.1 The European Guide on Quality Improvement in Comprehensive Cancer Control (2017) underscored this fact, recommending comprehensive cancer centers and integrated care networks.2 However, while some progress has been made in concentrating expertise for specific tumor types such as breast and prostate cancers, dedicated multidisciplinary units are lacking for most cancers, including hematological malignancies. Recent initiatives such as Europe's Beating Cancer Plan have added a new momentum to quality initiatives, emphasizing multidisciplinary collaboration and timely access to quality treatment, aligning closely with ERQCC principles. Hematological malignancies (blood cancers) are the fifth most common cancer group in economically developed regions. They include leukemias, lymphomas, and myelomas, with over 100 clinically meaningful subtypes defined by the World Health Organization's Classification of Tumours of Haematopoietic and Lymphoid Tissues and the International Consensus Classification.3-6 The European Society for Medical Oncology (ESMO) and the European Hematology Association (EHA) have issued clinical practice guidelines for many of the subtypes and these are regularly updated. The European-Commission-funded HAEMACARE project has produced crude, age-specific, and age-standardized incidence rates for hematological malignancies in Europe, categorized according to morphological subtype.7 These were derived from data on 66,371 diagnosed lymphoid malignancies and 21,796 myeloid malignancies recorded between 2000 and 2002 by 44 European cancer registries. The age-standardized incidence rates were 24.5 (per 100,000) for lymphoid malignancies and 7.55 for myeloid malignancies. Among lymphoid malignancies, the most prevalent subtypes were plasma cell neoplasms (4.62), small B-cell lymphocytic lymphoma/chronic lymphatic leukemia (3.79), diffuse B-cell lymphoma (3.13), and Hodgkin lymphoma (2.41). Meanwhile, the most common myeloid malignancies included acute myeloid leukemia (2.96), other myeloproliferative neoplasms (1.76), and myelodysplastic syndromes (1.24). Lymphoid malignancies with unknown morphology were most prevalent in Northern Europe (7.53), whereas unknown morphology myeloid malignancies were the most common in Southern Europe (0.73). Overall, the incidence of hematological malignancies was the lowest in Eastern Europe, with lower rates observed in women. Southern Europe showed the highest incidence for most lymphoid malignancies, while the United Kingdom and Ireland showed the highest incidence for myeloid malignancies. Variations in diagnostic and registration criteria significantly contribute to disparities in incidence, alongside differences in the distribution of hematological malignancy risk factors. Classification is complicated, and two different classifications are currently in use.8 An integrative approach to disease definition based on clinical, pathologic, and genetic features was introduced by the Revised European-American (REAL) classification of lymphoid neoplasms.9 This approach has been expanded in successive editions of the WHO classification of tumors of the hematopoietic and lymphoid tissue and more recently by the International Consensus Classification (ICC).5, 6, 10, 11 Current recommendations for diagnostic reporting are based on the 5th Edition of the WHO classification.12 The recommendation of the Society for Hematopathology in the USA and of the European Association for Haematopathology is to use both classifications for routine diagnosis, especially in those cases where the classifications differ. Identification of hematological malignancies in primary care can be challenging due to their diverse and non-specific symptoms, such as fatigue and bone pain (myeloma) and swollen glands (lymphoma). This can result in diagnostic delays, leading to patient dissatisfaction, frequent GP consultations, and more emergency presentations before diagnosis compared with other cancers. Multiple myeloma patients typically endure three misdiagnoses and a three-month delay before receiving a correct diagnosis.13 This impacts treatment, survival, and quality of life.14 Prompt diagnosis relies on primary care physicians recognizing potential malignancies and conducting appropriate tests, followed by diagnosis confirmation by hematopathologists within specialized multidisciplinary teams (MDTs). These teams play a crucial role in educating non-hematological healthcare providers about hematological malignancies, to reduce late diagnosis. Maintaining quality of life is paramount for hematological malignancy patients. Many will survive for long periods with their disease. Therefore, maintaining self-esteem and a sense of control, along with accurate assessments of physical and mental functioning, are vital.15 Quality of life considerations may thus take precedence over other clinical endpoints in some cases. To maintain quality of life, it is essential to properly measure and manage treatment toxicity. As with other cancers, fatigue can have a significant impact and needs to be addressed according to current ESMO clinical practice guidelines.16 Increasing efforts are being made to assess, record, and report quality of life using patient-reported outcome assessments. Addressing issues of long-term adherence to treatments is becoming increasingly important, given the growing use of oral therapies over extended periods. Research has shown that adherence is poor in one fifth of chronic myeloid leukemia patients.17 Adherence can be promoted through specialized nursing support and pharmacist monitoring within multidisciplinary follow-up clinics at specialist centers. This may be especially useful with older patients, who may be taking multiple medications for comorbidities. Psychosocial challenges are prevalent among hematological malignancy patients and require comprehensive support services. Anxiety affects 45% of newly diagnosed lymphoma patients.18 Fear of recurrence, isolation, being a burden to others, and death are common.19 Distress disorder affects up to 27% of survivors and 44% of their partners, while clinical depressive symptoms afflict 12% to 33% of hematological malignancy patients.20, 21 Notably, depressive symptoms at diagnosis have been linked to lower survival rates.22 Treatment of hematological malignancies can be financially burdensome due to prolonged treatment periods and the use of novel, often expensive, agents. This leads to reimbursement difficulties and inequalities in care access. Disparities in access are particularly notable in Central and Eastern European nations.23 Age-related inequalities also exist. Older patients with conditions like acute myeloid leukemia can face significantly poorer outcomes compared to younger counterparts. This can only in part be attributed to higher comorbidity rates in older people. Essential requirements for the organization of quality care for people with hematological malignancies are summarized in Table 1. Fast access to accurate diagnosis and a second expert opinion if required. Timely treatment at all stages following diagnosis. Effective and continuing care and survivorship planning centered on a multidisciplinary approach. Care pathways that cover the entire patient journey. Care in specialized centers that treat sufficient patients on a daily basis to provide quality of care. High-quality supportive and palliative care spanning the entire patient journey. A patient-centered approach, with patients provided with information and involved in shared decision-making at every stage. Referral to patient/caregiver/advocacy organizations for information and practical and emotional support. Efficient and rapid access to diagnostics, high-quality testing, and rapid turnover of test results to clinicians and patients are all essential. Different tests and different samples are required for the diagnosis of different hematological malignancies. Blood and bone marrow morphological analysis is usually required for most hematological malignancies, which is further analyzed by flow cytometry and/or used for genetic tests, including cytogenetics and mutational analyses. Lymph node biopsy material is typically required for lymphomas, either by surgical excision or core biopsy by interventional radiologists. These tests are needed to make the correct diagnosis and the most appropriate choice of treatment and response monitoring. Different types of imaging can be added to provide additional information. Errors and delays at this stage can significantly impact patient outcomes, so there is a need for quality diagnostics overseen by specialist hematopathologists. The ideal is that clinicians will together be able to work from an “integrated report,” pulling together histology, flow cytometry, cytogenetics, and molecular testing into a single diagnosis. There are important recommendations on hematological malignancy diagnostics and monitoring from ESMO, EHA, the European Leukemia Net (ELN), and the European Myeloma Network (EMN).24-27 Useful recommendations have also been produced by health technology assessment programs in European countries. In the UK, for example, the National Institute for Health and Care Excellence recommends that specialist-integrated hematological malignancy diagnostic services should have a predefined diagnostic pathway that is followed for each specimen type or clinical problem.28 Establishing clear referral pathways to specialist centers is essential if treatment for suspected hematological malignancies is to be started promptly. There are well-established guidelines on the diagnosis and management of hematological malignancies from ESMO and EHA.24, 25 Services in different countries may have distinct qualities and different guidelines, but the need for rapid referral mechanisms is universal. There are two models of care for hematological malignancies: either services centralized into larger centers (sometimes at the of a and with or more to the This expert recommends a centralized approach of the of many hematological malignancy subtypes and the need for specialized expertise and including molecular is particularly important to treat acute in larger referral centers. hematological malignancies may be at centers but with from a which may be required to provide specialized services such as cell and cell support into routine care is support should be within treatment centers and the should in and be in cancer and The ESMO clinical practice on and in cancer patients an Research has shown that clinical with a is to patients and in a complex and Distress is it in need of of hematological malignancy patients should be closely for and if The of is a for in hematological malignancy The of hematological malignancies are with or the of long such as myeloma and the treatment is to life and quality of is often with poor is with for example, cell or cell patients hematological malignancy is treatments are to and quality of This of palliative care will be by and other of the patients with symptoms or life of a should be introduced to the specialist palliative care including physicians and specialist the will work with pain and for care should and comprehensive support. a diagnosis is timely referral to a hematological malignancy is essential. are crucial for the outcomes for patients and are a core of cancer Cancer management diverse health expertise and collaboration between an approach shared all along the treatment pathway that is for the from through to palliative Treatment strategies for hematological malignancy patients should be on the basis of in the core may according to the but a used is are not part of the core in hematological malignancies, but may be required for diagnosis by surgical excision and if the referral is to a for diagnostic core and their essential The core multidisciplinary should include from the following and are the primary healthcare for diagnostics and treatment for hematological malignancy patients. They typically with a foundation in and on to in and/or to expertise in the diagnosis, treatment, and management of and cancers. Many and further their expertise by on specific can significantly on the or healthcare in which may be more involved in clinical or may primarily on patient care. They work in collaboration with and to comprehensive treatment for patients. These play an and crucial role in complex therapies such as bone marrow and role is to the multidisciplinary approach required for hematological malignancy care in such as and in diagnostics, diagnosis, management and treatment and follow-up of patients with hematological malignancies. of to patients for specialized treatments such as cell in imaging in such as bone marrow and to and tests, including and molecular to and and manage their of for and interventional and to their potential to supportive including and treatment of pain and in patient and to cell and cell Hematopathology the accurate and timely hematological malignancy that are required for clinical decision-making. They play a role in the and in clinical decision-making based on a diagnosis for each patient at the of diagnostic and hematopathologists may from to a is specialized expertise in hematological malignancies. This is a and including in in flow cytometry, and analysis of and/or and analysis has become increasingly important for accurate diagnosis of myeloid and lymphoid The need for cytogenetics and molecular testing is becoming to provide diagnosis and is increasingly being used to in hematological malignancies, often using set up to cover the of in Table one of and of to comprehensive clinical including patient clinical clinical diagnosis, and information of or to an with a of needed for accurate diagnosis, analysis with the most used and molecular for analysis to flow cytometry testing is also to a correct diagnosis of a specific disease in current classifications and a diagnostic report with a and results of the tests in quality assessments to accurate to an for molecular testing on or as a can or as as in lymphoid malignancies that be by physical required for are by interventional especially using and To the of disease before treatment, imaging with or is the standard of care for lymphoma and In imaging is used to such as before and The choice of the imaging in lymphoma and myeloma on treatment response or is the standard of care in most lymphoma subtypes as as in multiple is the standard of care for assessment and is the standard has shown or in a of and may be used as an or are the standard of care for be in for all imaging by the European Association of is with other clinicians is To correct of imaging clinicians imaging about the type of hematological malignancy lymphoma or treatment type of and other information disease or other for be between clinicians and imaging Table in imaging to different hematological malignancies. to imaging guidelines, such as for lymphoma and for with response assessment including the for and criteria for with clinicians to and biopsy the of interventional for diagnosis and assessment of treatment a significant role in aspects of can as primary treatment for is crucial in symptoms or such as is also an essential in treatments for Hodgkin lymphoma and In cases of may as a to is often used as a palliative to patients with or also as a treatment for bone marrow this specialist and should only be in centers that treat sufficient of patients to and To outcomes with late should and take care in and long-term access to technology and such as and and able to to treatment centers if including a in treatment and/or a to define disease at response to treatment, and define appropriate and the care pathway from the including (1) in the treatment (2) the and at (3) the treatment (4) quality of treatment including and and (5) the need for and follow-up the in different hematological malignancies, as as and potential of in multidisciplinary treatment a and expertise in in to the treatment for each with a of and with specific expertise in hematological malignancies. of clinical and specific clinical guidelines such as those from the International Oncology up patients to on and late and be part of a survivorship for hematological malignancy patients specialized to the of and and such as Essential nursing requirements in specialized care and patients through The of patients at the of all and management The of educating patients on the nursing there is for clinical and to out expanded including physical assessments and and late to care for patients with the appropriate additional in the of In specialized be in the of including and other of the of treatment and the and symptoms of hematological with patients to about quality of life, response to treatment, and The role of the oncology pharmacist is to with the about treatments and management of to and The pharmacist the of oncology and with the to manage important role is to patients about their treatment, especially for of oral with and supportive between based on and and and monitoring of and and patient and of and with the European Quality for the Oncology and a continuing in oncology at the or European information for patients on their to support adherence and with on clinical cancer in hematological malignancy primarily treatment like and They also which should be for all patients expertise in and expertise in and expertise in support a crucial role in and in hematological malignancy patients. and access to oral or are all essential. To the risk of guidelines from ESMO and the European Society of and all patients with to and to the of support to be at risk of should if support as a of supportive care. access to oral if or of adequate of and particularly and according to by including and palliative care teams should be involved in the care of hematological malignancy patients with symptoms or life comprehensive management and support for specialist palliative care and make recommendations to other about and other patients who need palliative care through the assessment of and and symptoms and and care. support for integrated palliative care in with care with primary care palliative care from at diagnosis, most patients are not support referral to support or patient not have the to treatment and that more with about and their families should be involved in all and at all of the decision-making treatment and care. As part of shared healthcare should provide and information and for and is crucial to that hematological malignancy patients have access to diagnostic and test should support patient in information and with the and patients should be to take of that their quality of life and the of the such as patients with the and needed to and manage from and healthcare should that receiving treatment in may patient to They should in that while survival is important to all patients, there are significant in Research has shown that healthcare often more on survival, while many hematological patients more on quality of report that the most important information for treatment decision-making to treatment survival treatment will disease and treatment and quality of outcome quality of life and symptoms should be used in clinical are such as the Myeloma such as are to hematological advocacy organizations can support patients and their families by information in and in the can patients the treatment and clinical support can be provided face to in the or the The patient is and has a on with the European Hematology the European of and such as the International that patients reach out to patient and have access to the information that of hematological malignancies the of data from multiple including flow cytometry, and molecular These are the diagnostic data elements within a which is a for an “integrated report,” all diagnostic elements necessary to a hematological malignancies The of has established by report as The International on Cancer also and data for cancer However, data set for hematological malignancies has been to The most hematological malignancy recommendations are on the The are based on classification such as the and WHO The groups of hematological malignancy should be in a reporting where is the classification of the integrated diagnosis and the assessment and of the and and as in and genetic The ERQCC expert group recommends that centers hematological malignancy patients should quality and data management that with the essential requirements in this and quality initiatives should be by patient-reported outcomes, that the patient is to care. be in to clinical pathways that to guidelines, and should be established to and high-quality patient care and an patient with clear within Effective data management and reporting are crucial for monitoring and care. meaningful with patients, and support groups is to accurate reporting of outcomes and continuous of care and patient-reported outcomes should be and in These can be developed in the of quality management on the health of an should their using with and also with of can be according to European the quality of care of patients, patient of and their quality of life is important and currently patient-reported outcome data is a part of and there needs to be more on patient-reported outcome information to to decision-making. is the means by which a can that it is to a required of practice in with agreed of among and between countries. example, in the of hematopoietic cell and as there is the This expert group recommends in or programs such as those by the Organisation of European Cancer and European Cancer of Oncology and Care for oncology and palliative The European are together healthcare providers to complex or conditions that require specialized treatment and a of the in hematological malignancies, an important and between specialist centers and cancer care in the Hematology specialist centers should make the most of the that the to expertise and National at the the World of EHA, and the European of provide and the European Hematology which and across Europe. The European Association for Haematopathology continuing and Research the specialist where most to the and clinical care are closely so it is important that there are between the specialist clinics and care in Hematological malignancy centers need to be involved in or There is a need for quality of life data in given that many hematological into long-term chronic The information in this a comprehensive of the essential requirements for a high-quality for hematological cancers. The ERQCC expert group is that it is not to a for all countries, but recommendations to set out a realistic standard of quality that is within have fast and easy access to accurate diagnostic tests quality of diagnostics both treatment outcomes and the patient There should be clearly established referral pathways to specialist centers a hematological malignancy is timely access to Services should be according to a centralized which and the of required to treat monitoring of patient and treatment is with supportive care provided Treatment strategies should be and agreed by a core multidisciplinary which will the treatment pathway for the patient from of through and to palliative care if of the multidisciplinary be in of patient and support. and their families should be involved in decision-making at every that their and are in the treatment were part of a group planning of the and based on their and In and the group and the of the which was by and on successive of the The of The and of this were and for by the European Cancer is not to this as data were or analyzed the current