Improving synergy among regulation, health technology assessment (HTA) and clinical guideline development is relevant as these independent processes are building on shared evidence-based grounds. The two objectives were first to assess how convergence of evidentiary needs among stakeholders may be achieved, and second, to determine to what extent convergence can be achieved.
Qualitative study using eight online dual-moderator focus groups.
Discussions had a European focus and were contextualised in four case studies on head and neck cancer, diabetes mellitus, multiple sclerosis and myelodysplastic syndromes.
Forty-two experienced (over 10 years) European regulators, HTA representatives and clinicians participated in the discussion.
Participants received information on the case study and research topic in advance. An introductory background presentation and interview guide for the moderators were used to steer the discussion.
Convergence may be achieved through improved communication institutionalised in multistakeholder early dialogues, shared definitions and shared methods. Required data sets should be inclusive rather than aligned. Deliberation and decision-making should remain independent. Alignment could be sought for pragmatic clinical trial designs and patient registries. Smaller and lower-income countries should be included in these efforts.
Actors in the field expressed that improving synergy among stakeholders always involves trade-offs. A balance needs to be found between the convergence of processes and the institutional remits or geographical independence. A similar tension exists between the involvement of more actors, for example, patients or additional countries, and the level of collaboration that may be achieved. Communication is key to establishing this balance.

BACKGROUND: Nigeria has unimpressive maternal and child health indicators. Compliance with the WHO guidelines on the minimum number of antenatal care (ANC) contacts could improve these indicators. We assessed the compliance with WHO recommended standards on ANC contacts in Nigeria and identify the associated factors.
METHODS: Nationally representative cross-sectional data during pregnancy of 21,785 most recent births within five years preceding the 2018 Nigeria Demographic Health Survey was used. The number of ANC contacts was categorised into \"None\", \"1-3\", \"4-7\" and \"8 or more\" contacts based on subsequent WHO guidelines. Descriptive statistics, bivariable and multivariable multinomial logistic regression was used at p = 0.05.
RESULTS: About 25 % of the women had no ANC contact, 58 % had at least 4 contacts while only 20 % had 8 or more ANC contacts. The highest rate of 8 or more ANC contacts was in Osun (80.2 %), Lagos (76.8 %), and Imo (72.0 %) while the lowest rates were in Kebbi (0.2 %), Zamfara (1.1 %) and Yobe (1.3 %). Respondents with higher education were twelve times (adjusted relative risk (aRR): 12.46, 95 % CI: 7.33-21.2), having secondary education was thrice (aRR: 2.91, 95 % CI: 2.35-3.60), and having primary education was twice (aRR: 2.17, 95 % CI: 1.77-2.66) more likely to make at least 8 contacts than those with no education. Respondents from households in the richest and middle wealth categories were 129 and 67 % more likely to make 8 or more ANC contacts compared to those from households in the lowest wealth category respectively. The likelihood of making 8 ANC contacts was 89 and 47 % higher among respondents from communities in the least and middle disadvantaged groups, respectively,  compared to the most disadvantaged group. Other significant variables were spouse education, health care decision making, media access, ethnicity, religion, and other community factors.
CONCLUSIONS: Compliance with WHO guidelines on the minimum number of ANC contacts in Nigeria is poor. Thus, Nigeria has a long walk to attaining sustainable development goal\'s targets on child and maternal health. We recommend that the maternal and child health programmers should review existing policies and develop new policies to adopt, implement and tackle the challenges of adherence to the WHO recommended minimum of 8 ANC contacts. Women\'s education, socioeconomic status and adequate mobilization of families should be prioritized. There is a need for urgent intervention to narrow the identified inequalities and substantial disparities in the characteristics of pregnant women across the regions and states.

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: Blood pressure (BP) exhibits seasonal variation with lower levels at higher environmental temperatures and higher at lower temperatures. This is a global phenomenon affecting both sexes, all age groups, normotensive individuals, and hypertensive patients. In treated hypertensive patients it may result in excessive BP decline in summer, or rise in winter, possibly deserving treatment modification. This Consensus Statement by the European Society of Hypertension Working Group on BP Monitoring and Cardiovascular Variability provides a review of the evidence on the seasonal BP variation regarding its epidemiology, pathophysiology, relevance, magnitude, and the findings using different measurement methods. Consensus recommendations are provided for health professionals on how to evaluate the seasonal BP changes in treated hypertensive patients and when treatment modification might be justified. (i) In treated hypertensive patients symptoms appearing with temperature rise and suggesting overtreatment must be investigated for possible excessive BP drop due to seasonal variation. On the other hand, a BP rise during cold weather, might be due to seasonal variation. (ii) The seasonal BP changes should be confirmed by repeated office measurements; preferably with home or ambulatory BP monitoring. Other reasons for BP change must be excluded. (iii) Similar issues might appear in people traveling from cold to hot places, or the reverse. (iv) BP levels below the recommended treatment goal should be considered for possible down-titration, particularly if there are symptoms suggesting overtreatment. SBP less than 110 mmHg requires consideration for treatment down-titration, even in asymptomatic patients. Further research is needed on the optimal management of the seasonal BP changes.

BACKGROUND: von Willebrand disease (VWD) is an inherited bleeding disorder caused by a quantitative or qualitative dysfunction of von Willebrand factor. Clinicians, patients and other stakeholders have many questions about the diagnosis and management of the disease.
OBJECTIVE: To identify topics of highest importance to stakeholders that could be addressed by guidelines to be developed by the American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), the National Hemophilia Foundation (NHF) and the World Federation of Hemophilia (WFH).
METHODS: A survey to determine and prioritize topics to be addressed in the collaborative development of guidelines for VWD was distributed to international stakeholders including patients, caregivers and healthcare providers (HCPs). Representatives of the four organizations coordinated the distribution strategy. The survey focused on both diagnosis and management of VWD, soliciting 7-point Likert-scale responses and open-ended comments, in English, French and Spanish. We conducted descriptive analysis with comparison of results by stakeholder type, gender and countries\' income classification for the rating questions and qualitative conventional content data analysis for the open-ended responses.
RESULTS: A total of 601 participants responded to the survey (49% patients/caregivers and 51% healthcare providers). The highest priority topics identified were diagnostic criteria/classification, bleeding assessment tools and treatment options for women and surgical patients. In contrast, screening for anaemia and differentiating plasma-derived therapy versus recombinant therapies received lower ratings.
CONCLUSIONS: This survey highlighted areas of importance to a diverse representation of stakeholders in the diagnosis and management of VWD, providing a framework for future guideline development and implementation.

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BACKGROUND: In the United States, tick-borne illnesses account for a significant number of patients that have been seen and treated by health care facilities. This in turn, has resulted in a significant morbidity and mortality and economic costs to the country.
METHODS: The distribution of these illnesses is geographically variable and is related to the climate as well. Many of these illnesses can be diagnosed and treated successfully, if recognized and started on appropriate antimicrobial therapy early in the disease process. Patient with illnesses such as Lyme disease, Wet Nile illness can result in chronic debilitating diseases if not recognized early and treated.
CONCLUSIONS: This paper covers illnesses such as Lyme disease, West Nile illness, Rocky Mountain Spotted fever, Ehrlichia, Tularemia, typhus, mosquito borne illnesses such as enteroviruses, arboviruses as well as arthropod and rodent borne virus infections as well. It covers the epidemiology, clinical features and diagnostic tools needed to make the diagnosis and treat these patients as well.

There is no consensus regarding strategies to optimally treat children with a brachial plexus birth injury (BPBI). Comparison of outcome data presented by different centers is impossible due to the use of (1) many different outcome measures to evaluate results; (2) different follow-up periods after interventions; and (3) different patient ages at the time of assessment. The goal of iPluto (international PLexus oUtcome sTudy grOup) was to define a standardized dataset which should be minimally collected to evaluate upper limb function in children with BPBI. This dataset must enable comparison of the treatment results of different centers if prospectively used. Three rounds of internet surveys were used to reach consensus on the dataset. A Delphi-derived technique was applied using a nine point Likert scale. Consensus was defined as having attained a rating of 7/8/9 by > = 75% of the participants. A total of 59 participants from five continents participated in the Second and Third Rounds of the survey. Consensus was reached regarding four elements: (1) evaluation should take place at the age of 1/3/5/7 years; range of motion in degrees should be measured for (2) passive joint movement; (3) active range of motion; and (4) the Mallet score should be determined. Consensus on how to asses and report outcome for BPBI was only reached on motor items from the \"Body Function and Structure\" domain. Consensus regarding additional ICF domains to obtain a more elaborate set of outcome items, should be addressed in future research. © 2018 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of the Orthopaedic Research Society. J Orthop Res 36:2533-2541, 2018.

A descriptive and documental study was performed from August to October 2016 to analyze compliance by state plans for food and nutritional security (PlanSAN) with the guidelines set by the Brazilian National Policy for Food and Nutritional Security (PNSAN). The state plans were accessed via the websites of the Inter-Ministerial Chamber for Food and Nutritional Security (CAISAN) or the state governments, plus complementary data collection at the state level. All the states of Brazil joined the National System for Food and Nutritional Security (SISAN), while fewer than half (13 states, 48%) had drafted their plans. Of these, 5 (38%) of the PlanSAN had schedules that coincided with the same state\'s pluriannual plan, 5 (38%) of the PlanSAN specified the budget requirements for meeting the proposed targets, 7 (54%) specified mechanisms for monitoring the plan, and only 2 (15%) defined methodologies for monitoring food and nutritional security. The recent existence of (and adherence to) the CAISAN appear to be related to the lack of state plans in half the states. Although most of the states that did have plans met some of the guidelines laid out by the PNSAN, these mechanisms become weak and impractical when they lack earmarked budget funds to meet their targets. Since the PNSAN is structurally inter-sectorial, the development of plans requires collective work by various government departments. Importantly, the items analyzed here are all guidelines, which implies the need for mechanisms to monitor their actual implementation.
Com o intuito de analisar a adequação dos Planos Estaduais de Segurança Alimentar e Nutricional (PlanSAN) às normas estabelecidas pela Política Nacional de Segurança Alimentar e Nutricional (PNSAN), foi realizada pesquisa descritiva e documental, com coleta de dados entre agosto a outubro de 2016. O acesso aos planos foi realizado na página de Internet da Câmara Interministerial de Segurança Alimentar e Nutricional (CAISAN) ou dos governos estaduais, com coleta de informações complementares no âmbito dos estados. Todos os estados brasileiros aderiram ao Sistema de Segurança Alimentar e Nutricional (SISAN), entretanto menos da metade (13 estados, 48%) elaborou seus planos, destacando-se alguns aspectos: 5 (38%) dos PlanSAN tinham vigência correspondente ao plano plurianual do estado; 5 (38%) dos PlanSAN descreviam os requisitos orçamentários para execução das metas propostas; e 7 (54%) descreviam mecanismos de monitoramento do plano e apenas 2 (15%) definiam metodologia para monitoramento de segurança alimentar e nutricional. O menor tempo de existência da CAISAN e de adesão parecem estar relacionados com a inexistência de PlanSAN. Ainda que a maioria dos estados com planos atendam algumas normativas estabelecidas pela PNSAN, esses instrumentos tornam-se frágeis e pouco exequíveis quando não possuem vinculação orçamentária para suas metas. Pelo fato de a PNSAN ser estruturalmente intersetorial, a construção dos planos depende de um trabalho coletivo das diversas secretarias de governo. Reforça-se que os itens analisados foram todos normativos, o que implica necessidade do estabelecimento de mecanismos que garantam a sua adequada execução.
Con el propósito de analizar la adecuación de los planes estatales de seguridad alimentaria y nutricional (PlanSAN), a las normas establecidas por la Política Nacional de Seguridad Alimentaria y Nutricional (PNSAN), se realizó una investigación descriptiva y documental, con una recogida de datos entre agosto a octubre de 2016. El acceso a los planes se realizó en el sitio web de la Cámara Interministerial de Seguridad Alimentaria y Nutricional (CAISAN) de los gobiernos estatales, con una recogida de información complementaria en el ámbito de los estados. Todos los estados brasileños se adhirieron al Sistema de Seguridad Alimentaria y Nutricional (SISAN), mientras que menos de la mitad (13 estados, un 48%) elaboró sus planes, destacándose algunos aspectos: 5 (38%) de los PlanSAN tenían una vigencia correspondiente al plan plurianual del estado; 5 (38%) de los PlanSAN describían los requisitos presupuestarios para la ejecución de las metas propuestas; y 7 (54%) describían mecanismos de monitoreo del plan y solamente 2 (15%) definían la metodología para el monitoreo de la seguridad alimentaria y nutricional. El menor tiempo de existencia de la CAISAN y de adhesión parecen estar relacionados con la inexistencia de PlanSAN. A pesar de que la mayoría de los estados con planes atiendan algunas normativas establecidas por la PNSAN, esos instrumentos se convierten en frágiles y poco viables, cuando no poseen una vinculación presupuestaria para sus metas. Debido al hecho de que el PNSAN sea estructuralmente intersectorial, la construcción de los planes depende de un trabajo colectivo de las diversas secretarías de gobierno. Se refuerza que los ítems analizados fueron todos normativos, lo que implica necesidad del estabelecimiento de mecanismos que garanticen su adecuada ejecución.