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1.
Circ J ; 2024 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-39261026

RESUMO

BACKGROUND: This study aimed to clarify recent clinical features and treatment outcomes in Japanese patients with newly diagnosed Takayasu arteritis (TAK) during the first 2 years of treatment. METHODS AND RESULTS: A nationwide multicenter retrospective cohort study for TAK was implemented to collect data between 2007 and 2014. The primary outcome of the study was clinical remission at Week 24. Of the 184 participants registered, 129 patients with newly diagnosed TAK were analyzed: 84% were female and the mean age at onset was 35 years. Clinical symptoms at diagnosis were mostly associated with large-vessel lesions. Frequent sites of vascular involvement included the carotid artery, subclavian artery, aortic arch, and descending aorta. The mean initial dose of prednisolone administered was 0.68 mg/kg/day, and 59% and 17% of patients received immunosuppressive drugs and biologics, respectively, by Week 104. Clinical remission at Week 24 and sustained clinical remission with daily prednisolone at ≤10 mg at Week 52 were achieved in 107 (82.9%) and 51 (39.5%) patients, respectively. The presence of signs and symptoms linked to large-vessel lesions was associated with failure to achieve sustained clinical remission at Week 52. CONCLUSIONS: We elucidated the clinical characteristics, treatment outcomes, and factors associated with failure to achieve sustained clinical remission in patients with newly diagnosed TAK in Japan during the first 2 years of treatment.

2.
Scand J Public Health ; : 14034948241277057, 2024 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-39340353

RESUMO

STUDY AIM: The objective of this scoping review was to explore and summarise emerging themes in existing studies on personal experiences of migrant parents of children with special health and welfare needs and their interaction with health and welfare services in the Nordic countries. METHODS: A comprehensive and systematic search for relevant articles in electronic databases was conducted in PubMed, PsycINFO and Web of Science between 2 April 2023 and 31 May 2023. The scoping review followed identified guidelines in conducting scoping reviews. Out of the initial 1836 study results, 62 studies were read and assessed as full text and a total of 13 studies met the inclusion criteria. RESULTS: Using thematic analysis, three key thematic categories were identified: (a) Initial responses to having a child with health and welfare challenges; (b) encountering the Nordic health and welfare services; (c) implications on social inclusion. The challenges to participation faced by migrants threatened their wellbeing, impacted their relationships and influenced their coping strategies and opportunities for social inclusion. CONCLUSIONS: The Nordic countries have accessible, affordable and well-equipped infrastructure for health and welfare services compared with the home countries of most migrants. Future research is necessary to explore alternative strategies and spaces to promote participation and involvement of migrant parents of children with special health and welfare needs to inform public health and welfare services development and research.

3.
Scand J Public Health ; : 14034948241232040, 2024 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-38506846

RESUMO

Aims: This systematic review aims to identify and describe how children of parents with mental illness, substance dependence, or severe physical illness/injury, experience and practise their everyday life. Methods: The review followed the four stepwise recommendations of Harden and colleagues when including quantitative and qualitative studies on peoples' experiences and views. In all, 23 studies with data from Norway (2010-2022) have been included. Brown and Clark's thematic analysis was applied. Results: Three themes were constructed from the reviewed articles: (a) Children practice their relational agency by actively doing practical tasks, occasionally jobs to maintain family economy, and organising fun activities with the ill parent. (b) Emotional ambivalence when their own needs were set aside in favour of the parents. They loved their parents but also felt guilt, anger, disappointment, shame, fear of inheriting the illness and longed for a 'normal' everyday life. (c) Supportive contextual factors were, for example, at least one significant adult recognising them, participating in leisure activities, socialising with friends, and talking with other peers who shared similar experiences as next of kin. Obstructive factors were lack of information and recognition as well as silence and lack of dialogue within the family and/or health professional. Conclusions: There is a strong need for more knowledge and competence on the situation and needs of these children when it comes to professionals, parents and the public. Public health initiatives are needed to honour their agency and recognise their contributions in present time to prevent psychosocial problems later in life.

4.
BMC Health Serv Res ; 24(1): 219, 2024 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-38368329

RESUMO

BACKGROUND: As coproduction in public services increases, understanding the role of leadership in this context is essential to the tasks of establishing relational partnerships and addressing power differentials among groups. The aims of this review are to explore models of coproduction leadership and the processes involved in leading coproduction as well as, based on that exploration, to develop a guiding framework for coproduction practices. METHODS: A systematic review that synthesizes the evidence reported by 73 papers related to coproduction of health and welfare. RESULTS: Despite the fact that models of coleadership and collective leadership exhibit a better fit with the relational character of coproduction, the majority of the articles included in this review employed a leader-centric underlying theory. The practice of coproduction leadership is a complex activity pertaining to interactions among people, encompassing nine essential practices: initiating, power-sharing, training, supporting, establishing trust, communicating, networking, orchestration, and implementation. CONCLUSIONS: This paper proposes a novel framework for coproduction leadership practices based on a systematic review of the literature and a set of reflective questions. This framework aims to help coproduction leaders and participants understand the complexity, diversity, and flexibility of coproduction leadership and to challenge and enhance their capacity to collaborate effectively.


Assuntos
Liderança , Humanos
5.
BMC Health Serv Res ; 24(1): 222, 2024 Feb 20.
Artigo em Inglês | MEDLINE | ID: mdl-38373916

RESUMO

BACKGROUND: Given Japan's rapidly aging population, the Ministry of Health, Labour and Welfare's policy of reducing hospital beds and replacing medical care with nursing care requires the establishment of a coordinated system of medical and care services tailored to regional characteristics. To gain useful knowledge for the development of such a system, this study aimed to identify differences in the structure of the relationship between medical and care resources due to differences in regional characteristics. METHODS: Initially, regional characteristics were used to group all 334 secondary medical areas (SMA) in Japan by principal component analysis. Subsequently, the related structure of the distribution of medical and care resources for each group were compared. For these comparisons, first, the related structure of the distribution of medical and care resources nationwide was modeled using structural equation modeling. Secondly, multigroup analysis was conducted to investigate differences among the models across groups. RESULTS: The nationwide SMAs were grouped largely based on urbanicity and middle-density regionality. The groups with high urbanicity and high middle-density regionality consisted of SMAs with a high and medium population density. By contrast, the low middle-density regionality group consisted of SMAs containing large cities with a high population density and depopulated areas with a low population density. The model of the related structure of the distribution of medical and care resources differed among these groups. In the non-urbanicity and middle-density regionality groups, nursing care abundance tended to increase acute care abundance. In addition, in all groups, nursing care abundance tended to increase long-term hospitalization care abundance and clinic care abundance (with beds). CONCLUSIONS: The key finding of this study was that the government's objective of reducing hospital beds may not be achieved solely by expanding nursing homes. This is because many of the models did not show a tendency that higher nursing care abundance reduces the values of the factors which increase more hospital beds. This finding was particularly relevant in middle-density regionality groups. This finding suggests that the location of nursing homes should be monitored because of concerns about the oversupply of nursing homes and sprawl in those areas.


Assuntos
Envelhecimento , Casas de Saúde , Humanos , Idoso , Japão , Assistência de Longa Duração , Hospitalização
6.
J Fish Dis ; 47(9): e13985, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38923541

RESUMO

Fish meal (FM) replacement is essential for the sustainable expansion of aquaculture. This study focussed on the feasibility of replacing FM with a single-cell protein (SCP) derived from methanotrophic bacteria (Methylococcus capsulatus, Bath) in barramundi fry (Lates calcarifer). Three isonitrogenous and isoenergetic diets were formulated with 0%, 6.4% and 12.9% inclusion of the SCP, replacing FM by 0%, 25% and 50%. Barramundi fry (initial body weight 2.5 ± 0.1 g) were fed experimental diets for 21 days to assess growth performance, gut microbiome composition and gut histopathology. Our findings revealed that both levels of SCP inclusion induced detrimental effects in barramundi fry, including impaired growth and reduced survival compared with the control group (66.7% and 71.7% survival in diets replacing FM with SCP by 25% and 50%, respectively; p < .05). Both dietary treatments presented mild necrotizing enteritis with subepithelial oedema and accumulation of PAS positive, diastase resistant droplets within hepatocytes (ceroid hepatopathy) and pancreatic atrophy. Microbiome analysis revealed a marked shift in the gut microbial community with the expansion of potential opportunistic bacteria in the genus Aeromonas. Reduced overall performance in the highest inclusion level (50% SCP) was primarily associated with reduced feed intake, likely related to palatability issues, albeit pathological changes observed in gut and liver may also play a role. Our study highlights the importance of meticulous optimization of SCP inclusion levels in aquafeed formulations, and the need for species and life-stage specific assessments to ensure the health and welfare of fish in sustainable aquaculture practices.


Assuntos
Ração Animal , Dieta , Doenças dos Peixes , Microbioma Gastrointestinal , Perciformes , Animais , Ração Animal/análise , Doenças dos Peixes/microbiologia , Doenças dos Peixes/patologia , Doenças dos Peixes/prevenção & controle , Microbioma Gastrointestinal/efeitos dos fármacos , Dieta/veterinária , Aquicultura/métodos , Proteínas Alimentares
7.
BMC Med Inform Decis Mak ; 24(1): 64, 2024 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-38443898

RESUMO

BACKGROUND: Because poor health in youth risk affecting their entry in adulthood, improved methods for their early identification are needed. Health and welfare technology is widely accepted by youth populations, presenting a potential method for identifying their health problems. However, healthcare technology must be evidence-based. Specifically, feasibility studies contribute valuable information prior to more complex effects-based research. The current study assessed the process, resource, management, and scientific feasibility of the Youth Health Report System prototype, developed within a youth health clinic context in advance of an intervention study. METHODS: This mixed-methods feasibility study was conducted in a clinical setting. The process, resource, management, and scientific feasibility of the Youth Health Report System were investigated, as recommended in the literature. Participants were youth aged 16-23 years old, attending a youth health clinic, and healthcare professionals from three clinics. The youth participants used their smart phones to respond to Youth Health Report System health questions and healthcare professionals used their computer to access the results and for registration system entries. Qualitative data were collected from interviews with healthcare professionals, which were described with thematic analysis. Youth participants' quantitative Youth Health Report System data were analyzed for descriptive statistics. RESULTS: Feasibility analysis of qualitative data from interviews with 11 healthcare professionals resulted in three themes: We expected it could be hard; Information and routines helped but time was an issue; and The electronic case report form was valuable in the health assessment. Qualitative data were collected from the Youth Health Report System. A total of 54 youth participants completed the evaluation questionnaire, and healthcare professionals retrieved information from, and made post-appointment system entries. Quantitative results revealed few missing items and acceptable data variability. An assessment template of merged qualitative and quantitative data guided a consensus discussion among the researchers, resulting in acceptable feasibility. CONCLUSIONS: The process-, resource-, management-, and scientific feasibility aspects were acceptable, with some modifications, strengthening the potential for a successful Youth Health Report System intervention study.


Assuntos
Instituições de Assistência Ambulatorial , Projetos de Pesquisa , Humanos , Adolescente , Adulto Jovem , Adulto , Estudos de Viabilidade , Consenso , Confiabilidade dos Dados
8.
Sensors (Basel) ; 24(7)2024 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-38610396

RESUMO

The increasing popularity of pigs has prompted farmers to increase pig production to meet the growing demand. However, while the number of pigs is increasing, that of farm workers has been declining, making it challenging to perform various farm tasks, the most important among them being managing the pigs' health and welfare. This study proposes a pattern mining-based pig behavior analysis system to provide visualized information and behavioral patterns, assisting farmers in effectively monitoring and assessing pigs' health and welfare. The system consists of four modules: (1) data acquisition module for collecting pigs video; (2) detection and tracking module for localizing and uniquely identifying pigs, using tracking information to crop pig images; (3) pig behavior recognition module for recognizing pig behaviors from sequences of cropped images; and (4) pig behavior analysis module for providing visualized information and behavioral patterns to effectively help farmers understand and manage pigs. In the second module, we utilize ByteTrack, which comprises YOLOx as the detector and the BYTE algorithm as the tracker, while MnasNet and LSTM serve as appearance features and temporal information extractors in the third module. The experimental results show that the system achieved a multi-object tracking accuracy of 0.971 for tracking and an F1 score of 0.931 for behavior recognition, while also highlighting the effectiveness of visualization and pattern mining in helping farmers comprehend and manage pigs' health and welfare.


Assuntos
Algoritmos , Reconhecimento Psicológico , Suínos , Animais , Fazendas , Análise de Sistemas
9.
BMC Public Health ; 23(1): 1444, 2023 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-37507675

RESUMO

BACKGROUND: In this study we investigated the health-related rehabilitation trajectories of young Norwegian adults between 2004-2019. The study period is interesting because it overlaps with an extensive welfare system reform that occurred in Norway between 2006-2011. In parallel with the reform there was a substantial increase in health-related welfare dependency among young people due to mental health conditions. To better understand this group, we addressed three questions: 1) what were the most typical health-related rehabilitation trajectories for young Norwegians aged 23-27 between 2004-2019, 2) did the trajectories and composition of health-related benefit recipients change overtime and 3) in parallel with the welfare reform, do we see improved labour market outcomes in our study population? METHODS: Using high-quality Norwegian registry data, we established four cohorts of Norwegian health-related rehabilitation benefit recipients aged 23-27 in either 2004 (cohort 1), 2008 (cohort 2), 2011 (cohort 3) or 2014 (cohort 4). The follow-up period for each cohort was six years. We used sequence and cluster analyses to identify typical health-related rehabilitation trajectories. In addition, descriptive statistics and multinomial logistic regression were used to scrutinise the relationship between trajectory types, sociodemographic characteristics and cohort membership. RESULTS: The majority follow trajectories consisting of welfare dependency, unemployment and unstable, low-income work. Both the trajectories and composition of the study population changed across cohorts. Over the observation period there was a 1) three-fold increase in the proportion following a trajectory ending in permanent disability benefits, 2) nine-fold increase in the proportion following trajectories characterised by long periods of health-related rehabilitation, 3) five-fold decrease in the share following unemployment occupational handicap trajectories 4) 6.9% increase in the proportion of early school leavers and 5) 8.9% decrease in the share with disabled parents. CONCLUSION: Our study population is a vulnerable group with suboptimal mental health, functioning and employment outcomes. In conjunction with the welfare reform, we witnessed a significant drop in use of work-related benefits, accompanied by a substantial increase in uptake of health-related rehabilitation- and disability benefits. Thus, it appears that rather than improving employment outcomes, welfare policy changes have created a new problem by steering a greater proportion into disability benefits.


Assuntos
Pessoas com Deficiência , Transtornos Mentais , Adulto , Humanos , Adolescente , Noruega , Emprego , Transtornos Mentais/epidemiologia , Desemprego
10.
BMC Health Serv Res ; 23(1): 1024, 2023 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-37740220

RESUMO

BACKGROUND: Health and welfare technologies (HWT) are increasingly procured and implemented by public providers in Swedish municipalities, but it remains unclear if and how evidence for these technologies' effectiveness is used in both processes. The aim of this study was to investigate the use of evidence in Swedish municipal public sector procurement and implementation of HWT. METHODS: A telephone survey of 197 municipalities was conducted with questions regarding the use of evidence in both processes, as well as eventual support needs regarding its use. Standard definitions of HWT and evidence were provided prior to the survey. Response frequencies and percentage proportions were calculated per question. Lambda (Λ) values with corresponding significance values were calculated for associations between responses to selected questions and the size and type of municipality, with values of 0.01 to 0.19 designated as weak associations, 0.20 to 0.39 as moderate, and 0.40 and above as strong. RESULTS: Sixty-four municipalities completed the entire survey. Consistent use of evidence for effectiveness of HWT occurred in less than half of respondents' municipal public procurement processes. Two-thirds of municipalities did not have an established model or process for implementation of HWT that used evidence in any manner. More than three quarters of municipalities lacked a systematic plan for follow-up and evaluation of effectiveness of implemented HWT, and of those that did less than half followed their plan consistently. Most municipalities expressed the need for support in using evidence in HWT-related processes but did not consider evidence and systematic evaluation to be prioritized. CONCLUSIONS: Weaknesses and gaps in using evidence in procurement and implementation processes may create a legacy of sub-optimal implementation of HWT in Swedish municipal health- and social care services, and lost opportunities for real-world evidence generation. There was a clear indication of the need for unified national guidance for using and generating evidence in key HWT-related municipal processes and implementation. Such guidance needs to be developed and effectively communicated.


Assuntos
Tecnologia Biomédica , Serviço Social , Humanos , Cidades , Suécia , Setor Público
11.
Adv Exp Med Biol ; 1430: 211-219, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37526850

RESUMO

Due to rapid development of biotechnology in recent years, the field of regenerative medicine has attracted considerable attention. Regenerative medicine-related regulations have been established in several countries to ensure the quality, safety, and efficacy of innovative treatments. Considering the diversity of regenerative medicine, the regulatory framework in Taiwan has been adjusted in response to global trend and local demand. Before 2010, cell and gene therapies were regarded as "new medical practice" under the "Medical Care Act." Along with the establishment of Taiwan Food and Drug Administration (TFDA) in 2010, regenerative medicine was regulated as "medicinal products" under the "Pharmaceutical Affairs Act." Then, the Ministry of Health and Welfare (MOHW) established a new dual-track regulatory pathway for regenerative medicine in 2016. The dual-track pathway divided regenerative medicine into medical practices and medicinal products, aiming to improve the accessibility of new treatments to patients and maintain the flexibility for clinical operations. In order to refine the regulation, the MOHW proposed two draft Acts for regenerative medicine in 2022. The two draft Acts are currently under legislative process. It is expected that the research and development of regenerative medicine can be further accelerated, thus providing early access to innovative therapies for patients in the future.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos , Medicina Regenerativa , Humanos , Taiwan , Terapia Genética , Biotecnologia
12.
Sensors (Basel) ; 23(6)2023 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-36991606

RESUMO

The popularity of dogs has been increasing owing to factors such as the physical and mental health benefits associated with raising them. While owners care about their dogs' health and welfare, it is difficult for them to assess these, and frequent veterinary checkups represent a growing financial burden. In this study, we propose a behavior-based video summarization and visualization system for monitoring a dog's behavioral patterns to help assess its health and welfare. The system proceeds in four modules: (1) a video data collection and preprocessing module; (2) an object detection-based module for retrieving image sequences where the dog is alone and cropping them to reduce background noise; (3) a dog behavior recognition module using two-stream EfficientNetV2 to extract appearance and motion features from the cropped images and their respective optical flow, followed by a long short-term memory (LSTM) model to recognize the dog's behaviors; and (4) a summarization and visualization module to provide effective visual summaries of the dog's location and behavior information to help assess and understand its health and welfare. The experimental results show that the system achieved an average F1 score of 0.955 for behavior recognition, with an execution time allowing real-time processing, while the summarization and visualization results demonstrate how the system can help owners assess and understand their dog's health and welfare.


Assuntos
Coleta de Dados , Cães , Animais
13.
J Rural Stud ; 97: 95-104, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36560979

RESUMO

Lameness is a significant health and welfare issue in farmed animals. This paper uses a governmentality approach, which focuses on how a problem is made governable, to examine an emerging 'ecology of devices' introduced to intervene in, and attempt to reduce, on-farm incidence of lameness. These devices are associated with advisers who work with farmers on-farm; they enact lameness as a governable entity, are tools to assess the existence of lameness against established norms, and prescribe actions to be taken in response to evidence of lameness. In doing this they subjectify farmers and advisers into seeing and responding to lameness in particular ways. Using concepts of governmentality alongside other perspectives on the power relations and the simplifications and complexities involved in interventions in animal health and farm practice, the paper draws on in-depth research with advisers including vets and other paraprofessionals who work with farmers, and their cows and sheep. It explores how this set of devices introduces particular techniques and practices in lameness management, and produces farmer and adviser subjectivities. It then explores some of the problematics of this mode of governing lameness, including analysis of the limitations and unintended consequences of attempts to simplify lameness management. The paper concludes by arguing that its approach is valuable in analysing ongoing intensification of interventions in farming practices and in understanding the limits of such interventions and the unanticipated divergences from expected conduct.

14.
Int J Health Geogr ; 21(1): 4, 2022 06 06.
Artigo em Inglês | MEDLINE | ID: mdl-35668432

RESUMO

BACKGROUND: Local policymakers require information about public health, housing and well-being at small geographical areas. A municipality can for example use this information to organize targeted activities with the aim of improving the well-being of their residents. Surveys are often used to gather data, but many neighborhoods can have only few or even zero respondents. In that case, estimating the status of the local population directly from survey responses is prone to be unreliable. METHODS: Small Area Estimation (SAE) is a technique to provide estimates at small geographical levels with only few or even zero respondents. In classical individual-level SAE, a complex statistical regression model is fitted to the survey responses by using auxiliary administrative data for the population as predictors, the missing responses are then predicted and aggregated to the desired geographical level. In this paper we compare gradient boosted trees (XGBoost), a well-known machine learning technique, to a structured additive regression model (STAR) designed for the specific problem of estimating public health and well-being in the whole population of the Netherlands. RESULTS: We compare the accuracy and performance of these models using out-of-sample predictions with five-fold Cross Validation (5CV). We do this for three data sets of different sample sizes and outcome types. Compared to the STAR model, gradient boosted trees are able to improve both the accuracy of the predictions and the total time taken to get these predictions. Even though the models appear quite similar in overall accuracy, the small area predictions at neighborhood level sometimes differ significantly. It may therefore make sense to pursue slightly more accurate models for better predictions into small areas. However, one of the biggest benefits is that XGBoost does not require prior knowledge or model specification. Data preparation and modelling is much easier, since the method automatically handles missing data, non-linear responses, interactions and accounts for spatial correlation structures. CONCLUSIONS: In this paper we provide new nationwide estimates of health, housing and well-being indicators at neighborhood level in the Netherlands, see 'Online materials'. We demonstrate that machine learning provides a good alternative to complex statistical regression modelling for small area estimation in terms of accuracy, robustness, speed and data preparation. These results can be used to make appropriate policy decisions at a local level and make recommendations about which estimation methods are beneficial in terms of accuracy, time and budget constraints.


Assuntos
Habitação , Aprendizado de Máquina , Humanos , Modelos Estatísticos , Países Baixos/epidemiologia , Características de Residência
15.
J Clin Pharm Ther ; 47(9): 1395-1401, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35488803

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Regulatory authorities in several regions have introduced a number of expedited programs (EPs) to promote the development of innovative drugs for patients in their own countries. The EPs in the United States (US), alone or in combination, have been successful in shortening the clinical development time in the US. We examined whether US-EPs, as well as other related factors, have an impact on the clinical development time in Japan to obtain new insights for more efficient drug development. METHODS: In total, 168 drugs approved as new molecular entities (NMEs) in Japan and approved in the US between 2012 and 2019 were surveyed. We compared the clinical development time in Japan for those drugs with or without US-EPs. We also examined the impact of overlapping designations of US-EPs on clinical development time in Japan. Multiple regression analysis was performed to identify associated factors related to clinical development time in Japan, including US-EPs. RESULTS AND DISCUSSION: The clinical development time in Japan was significantly shorter at 37.4 [Interquartile range, IQR, 28.7-48.9] months for Accelerated Approval (AA), 42.2 [30.0-53.6] months for Breakthrough Therapy (BT), 42.3 [29.3-56.4] months for Fast Track (FT), 44.5 [30.7-60.0] months for US Priority Review, and 45.2 [31.3-61.8] months for US Orphan Designation. Multiple regression analysis revealed that AA (p = 0.008), FT (p = 0.013), Japan Priority Review, and the difference in development initiation dates between the US and Japan were significant factors related to a decrease in the clinical development time in Japan, whereas Japan Orphan Designation and the development of anticancer drugs were significant factors linked to an increase in the clinical development time. WHAT IS NEW AND CONCLUSION: US-EPs were associated with a decrease in the clinical development time in Japan for the drugs that were approved as NMEs in Japan and approved in the US. This association was not restricted to particular therapeutic areas or development strategies. Stakeholders involved in drug development, including the drug developers and regulatory authorities in Japan, should realize these effects for efficient drug development.


Assuntos
Antineoplásicos , Aprovação de Drogas , Antineoplásicos/uso terapêutico , Desenvolvimento de Medicamentos , Humanos , Japão , Estados Unidos , United States Food and Drug Administration
16.
BMC Health Serv Res ; 22(1): 357, 2022 Mar 17.
Artigo em Inglês | MEDLINE | ID: mdl-35300663

RESUMO

BACKGROUND: Health and welfare technologies (HWT) are becoming increasingly employed in the Nordic countries, and in Sweden in particular. The amount of HWT public procurement is likely increasing at a similar rate, but requirements for evidence for effectiveness placed on bidders during this process may be lacking. METHOD: This study investigated the use of evidence as a requirement in public sector tendering process of HWT, and how it affected bidder attributes and procurement outcomes. A novel type of systematic review and content analysis of requests for tenders for HWT announced prior to June 2021 was therefore conducted in Swedish public procurement databases. RESULT: Ninety requests for tenders for 11 types of HWT met the inclusion criteria for review, accounting for potential contracts worth 246 to 296 million EUR. Criteria requiring evidence for effectiveness were used in 16 requests for tenders, accounting for 183 million EUR in potential contracts. Eight of the requests referred to an established independent standard to confirm such evidence, such as CE standard of conformity, MDR and/or MDD. This prevalence appears to cut across all types of procuring organisations and all types of HWT. The use of any evidence criteria, or lack thereof, does not appear to affect the outcomes of the tendering process. CONCLUSION: Criteria requiring evidence for effectiveness are used in less than a fifth of all public procurements of health- and welfare technologies in Sweden, and less than 10% refer to some form of independent standard as confirmation of such evidence. The procurement process therefore risks creating a legacy of sub-optimal technologies in health- and social care services. More prevalent and specific requirements for evidence and its continual generation in the procurement process are highly recommended. Recommendations for decision makers, procurement managers, and developers are provided.


Assuntos
Contratos , Setor Público , Humanos , Suécia
17.
J Med Internet Res ; 24(3): e29307, 2022 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-35319479

RESUMO

BACKGROUND: The need to assess the effectiveness and value of interventions involving digital health and health and welfare technologies is becoming increasingly important due to the rapidly growing development of these technologies and their areas of application. Systematic reviews of scientific literature are a mainstay of such assessment, but publications outside the realm of traditional scientific bibliographic databases-known as gray literature-are often not included. This is a disadvantage, particularly apparent in the health and welfare technology (HWT) domain. OBJECTIVE: The aim of this article is to investigate the significance of gray literature in digital health and HWT when reviewing literature. As an example, the impact of including gray literature to the result of two systematic reviews in HWT is examined. METHODS: In this paper, we identify, discuss, and suggest methods for including gray literature sources when evaluating effectiveness and appropriateness for different review types related to HWT. The analysis also includes established sources, search strategies, documentation, and reporting of searches, as well as bias and credibility assessment. The differences in comparison to scientific bibliographic databases are elucidated. We describe the results, challenges, and benefits of including gray literature in 2 examples of systematic reviews of HWT. RESULTS: In the 2 systematic reviews described in this paper, most included studies came from context-specific gray literature sources. Gray literature contributed to the overall result of the reviews and corresponded well with the reviews' aims. The assessed risk of bias of the included studies derived from gray literature was similar to the included studies from other types of sources. However, because of less standardized publication formats, assessing and extracting data from gray literature studies were more time-consuming and compiling statistical results was not possible. The search process for gray literature required more time and the reproducibility of gray literature searches were less certain due to more unstable publication platforms. CONCLUSIONS: Gray literature is particularly relevant for digital health and HWT but searches need to be conducted systematically and reported transparently. This way gray literature can broaden the range of studies, highlight context specificity, and decrease the publication bias of reviews of effectiveness of HWT. Thus, researchers conducting systematic reviews related to HWT should consider including gray literature based on a systematic approach.


Assuntos
Literatura Cinzenta , Humanos , Reprodutibilidade dos Testes
18.
J Community Psychol ; 50(1): 541-552, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34096626

RESUMO

This study examined the accessibility of community resources (e.g., welfare programs and afterschool programs) for underserved youth and families with mental health needs. Mental health professionals (n = 52) from a large community mental health and welfare agency serving predominantly low-income, Latinx families completed a semistructured interview that asked about the accessibility of community resources. Participant responses were coded using an inductive thematic analysis. Results showed that 71% of participants endorsed availability barriers (e.g., limited local programs), 37% endorsed logistical barriers (e.g., waitlists), 27% endorsed attitudinal barriers (e.g., stigmatized beliefs about help-seeking), and 23% endorsed knowledge barriers (e.g., lacking awareness about local programs). Professionals' perceived availability barriers were mostly consistent with the actual availability of community resources. Findings highlight the compounding challenges that underserved communities face and point to opportunities for promoting enhanced well-being and functioning for youth and families with mental health needs.


Assuntos
Recursos Comunitários , Serviços de Saúde Mental , Adolescente , Humanos , Saúde Mental , Pobreza , Pesquisa Qualitativa
19.
BMC Health Serv Res ; 21(1): 622, 2021 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-34187472

RESUMO

BACKGROUND: Nocturnal digital surveillance technologies are being widely implemented as interventions for remotely monitoring elderly populations, and often replace person-based surveillance. Such interventions are often placed in care institutions or in the home, and monitored by qualified personnel or relatives, enabling more rapid and/or frequent assessment of the individual's need for assistance than through on-location visits. This systematic review summarized the effects of these surveillance technologies on health, welfare and social care provision outcomes in populations ≥ 50 years, compared to standard care. METHOD: Primary studies published 2005-2020 that assessed these technologies were identified in 11 databases of peer-reviewed literature and numerous grey literature sources. Initial screening, full-text screening, and citation searching steps yielded the studies included in the review. The Risk of Bias and ROBINS-I tools were used for quality assessment of the included studies. RESULT: Five studies out of 744 identified records met inclusion criteria. Health-related outcomes (e.g. accidents, 2 studies) and social care outcomes (e.g. staff burden, 4 studies) did not differ between interventions and standard care. Quality of life and affect showed improvement (1 study each), as did economic outcomes (1 study). The quality of studies was low however, with all studies possessing a high to critical risk of bias. CONCLUSIONS: We found little evidence for the benefit of nocturnal digital surveillance interventions as compared to standard care in several key outcomes. Higher quality intervention studies should be prioritized in future research to provide more reliable evidence.


Assuntos
Qualidade de Vida , Apoio Social , Idoso , Humanos
20.
BMC Health Serv Res ; 21(1): 480, 2021 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-34016102

RESUMO

BACKGROUND: Chronic care involves multiple activities that can be performed by individuals and healthcare staff as well as by other actors and artifacts, such as eHealth services. Thus, chronic care management can be viewed as a system where the individual interacts with people and eHealth services performing activities to maintain or improve health and functioning, called co-care. Yet, the system perspective is not reflected in concepts such as person-centered care and shared decision making. This limits the understanding of individuals' global experience of chronic care management and subsequently the ability to optimize chronic care. The aim of this study was threefold: (1) to propose a theory-based operationalization of co-care for chronic care management, (2) to develop a scale to measure co-care as a distributed system of activities, and (3) to evaluate the scale's psychometric properties. With the theory of distributed cognition as a theoretical underpinning, co-care was operationalized along three dimensions: experience of activities, needs support, and goal orientation. METHODS: Informed by the literature on patient experiences and work psychology, a scale denoted Distribution of Co-Care Activities (DoCCA) was developed with the three conceptualized dimensions, the activities dimension consisting of three sub-factors: demands, unnecessary tasks, and role clarity. It was tested with 113 primary care patients with chronic conditions in Sweden at two time points. RESULTS: A confirmatory factor analysis showed support for a second-order model with the three conceptualized dimensions, with activities further divided into the three sub-factors. Cronbach's alpha values indicated a good to excellent reliability of the subscales, and correlations across time points with panel data indicated satisfactory test-retest reliability. Convergent, concurrent and predictive validity of the scale were, overall, satisfactory. CONCLUSIONS: The psychometric evaluation supports a model consisting of activities (demands, unnecessary tasks, and role clarity), needs support and goal orientation that can be reliably measured with the DoCCA scale. The scale provides a way to assess chronic care management as a system, considering the perspective of the individuals with the chronic condition and how they perceive the work that must be done, across situations, either by themselves or through healthcare, eHealth, or other means.


Assuntos
Psicometria , Análise Fatorial , Humanos , Reprodutibilidade dos Testes , Inquéritos e Questionários , Suécia
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