A Disease Register for ME/CFS: Report of a Pilot Study.

BACKGROUND: The ME/CFS Disease Register is one of six subprojects within the National ME/CFS Observatory, a research programme funded by the Big Lottery Fund and sponsored by Action for ME. A pilot study in East Anglia, East Yorkshire, and London aimed to address the problem of identifying representative groups of subjects for research, in order to be able to draw conclusions applicable to the whole ME/CFS population.While not aiming for comprehensive population coverage, this pilot register sought to recruit participants with ME/CFS in an unbiased way from a large population base. Those recruited are constituting a cohort for long-term follow-up to shed light on prognosis, and a sampling frame for other studies. FINDINGS: Patients with unidentified chronic fatigue were identified in GP databases using a READ-code based algorithm, and conformity to certain case definitions for ME/CFS determined. 29 practices, covering a population aged 18 to 64 of 143,153, participated.510 patients with unexplained chronic fatigue were identified. 265 of these conformed to one or more case definitions. 216 were invited to join the register; 160 agreed. 96.9% of participants conformed to the CDC 1994 (Fukuda) definition; the Canadian definition defined more precisely a subset of these. The addition of an epidemiological case definition increased case ascertainment by approximately 4%. A small-scale study in a specialist referral service in East Anglia was also undertaken.There was little difference in pattern of conformity to case definitions, age or sex among disease register participants compared with subjects in a parallel epidemiological study who declined to participate.One-year follow-up of 50 subjects showed little change in pain or fatigue scores. There were some changes in conformity to case definitions. CONCLUSIONS: Objective evaluation indicated that the aim of recruiting participants with ME/CFS to a Disease Register had been fulfilled, and confirmed the feasibility of our approach to case identification, data processing, transmission, storage, and analysis. Future developments should include expansion of the ME/CFS Register and its linkage to a tissue sample bank and post mortem tissue archive, to facilitate support for further research studies

Hand Grip Strength as a Clinical Biomarker for ME/CFS and Disease Severity.

Background: The diagnosis of myalgic encephalomyelitis (ME/CFS) in research and clinical practice has largely relied on clinical history, which can be subjective in nature. Clinical signs are often subtle, overlap with other conditions, and are not formally included as part of diagnostic workup. The characterization of clinical signs and biomarkers is needed for better diagnosis and classification of patients and to monitor treatment response. Hand grip strength (HGS) has been used as an objective measure of muscle strength and fatigue, which is a primary symptom of ME/CFS. We assessed the potential usefulness of HGS as a diagnostic marker in ME/CFS. Methods: We compared HGS measurements from participants in the UK ME/CFS Biobank, with groups consisting of people with ME/CFS of differing severity (n = 272), healthy (n = 136), multiple sclerosis (n = 76) controls, and others with chronic fatigue not meeting the diagnosis of ME/CFS (n = 37). We correlated the maximum and minimum of, and differences between, 3 repeated HGS measurements with parameters of disease severity, including fatigue and pain analog scales, and physical and mental component summaries from the SF-36v2TM questionnaire across recruitment groups. Results: HGS indicators were associated with having ME/CFS, with magnitudes of association stronger in severely affected than in mild/moderately affected patients. Compared with healthy controls, being severely affected was associated with a reduction in minimum HGS of 15.3 kg (95%CI 19.3-11.3; p < 0.001), while being mild/moderately affected was associated with a 10.5 kg (95%CI 13.2-7.8; p < 0.001) reduction. The association persisted after adjusting for age, sex and body mass index. ME/CFS cases also showed lower values of maximum HGS and significant drops in values from the first to second and third trials, compared to other study groups. There were significant correlations between HGS indicators and clinical parameters of disease severity, including fatigue analog scale (Spearman's Rho = -0.40, p < 0.001), pain analog scale (Rho = -0.38, p < 0.001), and physical component summary (Rho = 0.42, p < 0.001). Discussion: HGS is markedly reduced in ME/CFS, particularly in patients with more severe disease, and may indicate muscle and fatigue related symptoms. HGS is a potential diagnostic tool in ME/CFS, and could also be used to enhance patient phenotyping and as an outcome measure following interventions

Setting research priorities to improve global newborn health and prevent stillbirths by 2025.

BACKGROUND: In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013-2025. METHODS: We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts. RESULTS: Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour. CONCLUSION: These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed

Setting research priorities to improve global newborn health and prevent stillbirths by 2025

Background In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013-2025. Methods We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts. Results Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour. Conclusion These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adults: a qualitative study of perspectives from professional practice

Background Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) can cause profound and prolonged illness and disability, and poses significant problems of uncertainty for healthcare professionals in its diagnosis and management. The aim of this qualitative study was to explore the nature of professional 'best practice' in working with people with CFS/ME. Methods The views and experiences of health care practitioners (HCPs) were sought, who had been judged by people with CFS/ME themselves to have been particularly helpful and effective. Qualitative semi-structured interviews following a topic guide were carried out with six health care practitioners. Interviews were audio-recorded, transcribed and subject to thematic analysis. Results Five main themes were developed: 1) Diagnosis; 2) Professional perspectives on living with CFS/ME; 3) Interventions for treatment and management; 4) Professional values and support for people with CFS/ME and their families; 5) Health professional roles and working practices. Key findings related to: the diagnostic process, especially the degree of uncertainty which may be shared by primary care physicians and patients alike; the continued denial in some quarters of the existence of CFS/ME as a condition; the variability, complexity, and serious impact of the condition on life and living; the onus on the person with CFS/ME to manage their condition, supported by HCPs; the wealth of often conflicting and confusing information on the condition and options for treatment; and the vital role of extended listening and trustful relationships with patients. Conclusions While professional frustrations were clearly expressed about the variability of services both in primary and specialist care and continuing equivocal attitudes to CFS/ME as a condition, there were also strong positive messages for people with CFS/ME where the right services are in place. Many of the findings from these practitioners seen by their patients as helping them more effectively, accord with the existing literature identifying the particular importance of listening skills, respect and trust for establishing a therapeutic relationship which recognises key features of the patient trajectory and promotes effective person-centred management of this complex condition. These findings indicate the need to build such skills and knowledge more systematically into professional training informed by the experience of specialist services and those living with the condition

The expressed needs of people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A systematic review

Background: We aimed to review systematically the needs for support in managing illness and maintaining social inclusion expressed by people with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) Methods: We carried out a systematic review of primary research and personal ('own') stories expressing the needs of people with CFS/ME. Structured searches were carried out on Medline, AMED, CINAHL, EMBASE, ASSIA, CENTRAL, and other health, social and legal databases from inception to November 2007. Study inclusion, data extraction and risk of bias were assessed independently in duplicate. Expressed needs were tabulated and a conceptual framework developed through an iterative process. Results: Thirty two quantitative and qualitative studies, including the views of over 2500 people with CFS/ME with mainly moderate or severe illness severity, met the inclusion criteria. The following major support needs emerged: 1) The need to make sense of symptoms and gain diagnosis, 2) for respect and empathy from service providers, 3) for positive attitudes and support from family and friends, 4) for information on CFS/ME, 5) to adjust views and priorities, 6) to develop strategies to manage impairments and activity limitations, and 7) to develop strategies to maintain/regain social participation. Conclusions: Although the studies were heterogeneous, there was consistent evidence that substantial support is needed to rebuild lives. Gaining support depends - most importantly - on the ability of providers of health and social care, colleagues, friends and relatives, and those providing educational and leisure services, to understand and respond to those needs

Homenaje del Instituto del Noroeste de la Academia Nacional al Presidente Honorario Dr. Julio I. Altamira Gigena

Este número reúne trabajos de maestros del Derecho y de jóvenes profesionales, siguiendo el criterio y temperamento que inspira la Academia, esto es, prioridad al rigor científico y académico en el conocimiento y divulgación de distintos temas del universo jurídico.Presentación / Juan Carlos Veiga – Prólogo / Rodrigo Padilla – La conformación de la voluntad social y la jurisprudencia registral (Perú): ¡veinte años después! / Luis Alberto Aliaga Huaripata -- Reforma a la legislación laboral / Raúl Enrique Altamira Gigena – La empresa en su doble rol en el derecho del consumidor / Esteban Javier Arias Cáu – La teoría kantiana del derecho privado / Manuel Gonzalo Casas – El aseguramiento de la responsabilidad patrimonial del Estado / Gabriel Chibán – Inteligencia Artificial y responsabilidad civil de robots autónomos / Sandra Laura Dell’Osa – El derecho a la información en tiempos del COVID- 19. Desafíos constitucionales y convencionales / Oscar Flores – Reflexiones sobre los restos del derecho tributario frente a la era de la inteligencia artificial / Adolfo A. Iriarte Yanicelli – Las injurias en el derecho civil contemporáneo. Tensión entre bienes jurídicos en juego y modo de resolución / Julián Emil Jalil –La denominada “jurisdicción voluntaria” / Roberto Loutayf Ranea – Exposición realizada en el Instituto de Derecho Internacional “Walter Schering” de la Universidad de Kiel, Alemania, 22 de julio de 2019, sobre la Cuenca Interjurisdiccional del río Salí-Dulce / Pablo Ramón Lucatelli – Los privilegios en el Código Civil y Comercial de la Nación / Miguel Eduardo Marcotullio – Convenciones procesales / María Victoria Mosmann – El derecho de acceso a la información de los consumidores, como tutela de los demás derechos / María Sofía Nacul – El Instituto de Mediación en la provincia de Salta. Diseño e implementación como una política pública de acceso a Justicia / Marisa Nogaledo – La responsabilidad de ejercitar el derecho a la participación ciudadana en el control estatal de los servicios públicos concesionados / Gastón Andrés Navarro – Responsabilidad de los profesionales del derecho (escribanos y abogados) y de la empresa o sociedad de abogados / Rodrigo Padilla – Manifestación e investigación de bienes del deudor ejecutado: deber de transparencia patrimonial / Álvaro Pérez Ragone – La gestión del agua en la provincia de Salta, en relación a la producción agropecuaria. Los consorcios de riego / Martín Plaza – ¿Es el art. 144 CCC una herramienta para responsabilizar a funcionarios públicos? / Efraín Hugo Richard – Abuso de posición dominante / José H. Sahián – Federalismo judicial / Claudia Beatriz Sbdar – Consideraciones sobre el código procesal penal federal y su implementación / Ernesto Solá, Marcos Ovejero – Responsabilidad estatal por la inactividad administrativa convencional / Pamela Tenreyro – Alcance del derecho a recurrir el fallo de condena penal: impacto en el escenario nacional / Pablo Roberto Toledo – Principios y valores como herramientas preponderantes para la readecuación del contrato ante la emergencia del coronavirus / Guadalupe Valdés Ortiz – La empresa: nuevas modalidades de financiamiento / Juan Carlos Veiga – El derecho de acceso a la información pública en la Argentina y su papel en los sistemas democráticos y repúblicas modernas / Macarena María Villagra Vélez – Medidas cautelares: vías para impugnarlas o morigerar su impacto / Fernando Virgili – Fideicomiso, encargo fiduciario y financiamiento ambiental / Inés de los Ángeles Yamúss –Veiga, Juan Carlos. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Padilla, Rodrigo. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Aliaga Huaripata, Luis Alberto. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Altamira Gigena, Raúl Enrique. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Arias Cáu, Esteban Javier. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Casas, Manuel Gonzalo. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Chibán, Gabriel. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Dell'Ossa, Sandra Laura. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Flores, Oscar. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Iriarte Yanicelli, Adolfo A. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Jalil, Julián Emil. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Loutayf Ranea, Roberto. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Lucatelli, Pablo Ramón. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Marcotullio, Miguel Eduardo. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Mosmann, María Victoria. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Nacul, María Sofía. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Nogaledo, Marisa. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Navarro, Gastón Andrés. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Pérez Ragone, Álvaro. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Plaza, Martín. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Richard, Efraín Hugo. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Sahián, José H.. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Sbdar, Claudia Beatriz. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Solá, Ernesto. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Ovejero, Marcos. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Tenreyro, Pamela. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Toledo, Pablo Roberto. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Valdés Ortiz, Guadalupe. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Villagra Vélez, Macarena María. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Virgili, Fernando. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina.Yamúss, Inés de los Ángeles. Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Argentina