Precision cancer medicine: What has translated into clinical use in Belgium?

RATIONALE: In 2016, Belgium launched the Next Generation Sequencing (NGS) Roadbook, consisting in 10 Actions, across the health care system, to facilitate the uptake of NGS in routine clinical practice. We compiled feedback on deployment of the NGS Roadbook from governmental stakeholders and beneficiaries: health policy makers, insurance providers, pathologists, geneticists, and oncologists. MAIN FINDINGS: The Roadbook ensured the establishment of a Commission on Personalized Medicine and NGS testing guidelines. A national benchmarking trial ensued, and 10 networks of hospitals and laboratories adopted a reimbursement convention with the Belgian Health Insurance Agency. The Healthdata.be platform centralizes the collection of NGS metrics, and citizens were consulted on their views about NGS and genomics. CONCLUSION: The Roadbook facilitated the implementation of NGS in routine (hemato-)oncology care in Belgium. Some challenges remain linked to data sharing and access by a wider range of stakeholders. Next steps include continuous monitoring of health outcomes and the budgetary impact.

Toward an Objective Assessment of Implementation Processes for Innovations in Health Care: Psychometric Evaluation of the Normalization Measure Development (NoMAD) Questionnaire Among Mental Health Care Professionals.

BACKGROUND: Successfully implementing eMental health (eMH) interventions in routine mental health care constitutes a major challenge. Reliable instruments to assess implementation progress are essential. The Normalization MeAsure Development (NoMAD) study developed a brief self-report questionnaire that could be helpful in measuring implementation progress. Based on the Normalization Process Theory, this instrument focuses on 4 generative mechanisms involved in implementation processes: coherence, cognitive participation, collective action, and reflexive monitoring. OBJECTIVE: The aim of this study was to translate the NoMAD questionnaire to Dutch and to confirm the factor structure in Dutch mental health care settings. METHODS: Dutch mental health care professionals involved in eMH implementation were invited to complete the translated NoMAD questionnaire. Confirmatory factor analysis (CFA) was conducted to verify interpretability of scale scores for 3 models: (1) the theoretical 4-factor structure, (2) a unidimensional model, and (3) a hierarchical model. Potential improvements were explored, and correlated scale scores with 3 control questions were used to assess convergent validity. RESULTS: A total of 262 professionals from mental health care settings in the Netherlands completed the questionnaire (female: 81.7%; mean age: 45 [SD=11]). The internal consistency of the 20-item questionnaire was acceptable (.62≤alpha≤.85). The theorized 4-factor model fitted the data slightly better in the CFA than the hierarchical model (Comparative Fit Index=0.90, Tucker Lewis Index=0.88, Root Mean Square Error of Approximation=0.10, Standardized Root Mean Square Residual=0.12, χ22=22.5, P≤.05). However, the difference is small and possibly not outweighing the practical relevance of a total score and subscale scores combined in one hierarchical model. One item was identified as weak (λCA.2=0.10). A moderate-to-strong convergent validity with 3 control questions was found for the Collective Participation scale (.47≤r≤.54, P≤.05). CONCLUSIONS: NoMAD's theoretical factor structure was confirmed in Dutch mental health settings to acceptable standards but with room for improvement. The hierarchical model might prove useful in increasing the practical utility of the NoMAD questionnaire by combining a total score with information on the 4 generative mechanisms. Future research should assess the predictive value and responsiveness over time and elucidate the conceptual interpretability of NoMAD in eMH implementation practices.

Assessment of the Implementation of Pakistan's National Action Plan on Antimicrobial Resistance in the Agriculture and Food Sectors.

The agriculture and food (agrifood) sectors play key roles in the emergence, spread, and containment of antimicrobial resistance (AMR). Pakistan's first National Action Plan (NAP) on AMR was developed to guide One Health interventions to combat AMR through 2017-2022. To improve subsequent iterations, we assessed the implementation of Pakistan's NAP in the agrifood sectors (NAPag) in October 2022, using the Progressive Management Pathway on AMR tool developed by the Food and Agriculture Organization of the United Nations (FAO). The assessment tool addressed four crucial focus areas of the NAPag: governance, awareness, evidence, and practices. Each focus area contains multiple topics, which involve four sequential stages of activities to progressively achieve systematic management of AMR risk in the agrifood sectors. High-level representatives of the NAPag stakeholders provided information for the assessment through pre-event documentary review and workshop discussions. The assessment results showed that Pakistan's NAPag had an overall moderate coverage (59%) of the anticipated activities. Gaps were particularly notable in strengthening governance, good practices, and interventions in non-livestock sectors. Furthermore, only 12% of the evaluated activities were fully executed and documented, consistently remaining at the planning and piloting stages in the livestock sector across all the examined topics. Insufficient attention to non-livestock sectors, inadequate regulation and enforcement capacity, and resource constraints have hindered scalable and sustainable interventions under the current plan. This assessment provides valuable insights to strengthen the inclusiveness and contribution of the agrifood sectors in the next NAP iteration. In the short-to-medium term, strategic prioritization is necessary to optimize the use of limited resources and target the most critical gaps, such as improving awareness among key stakeholders and fortifying regulations for prudent antimicrobial use. In the long term, integration of AMR into the country's broader health, development, and agricultural transformation agendas will be needed to generate sustainable benefits.

Evaluating the design and implementation of Kazakhstan's workfare program.

Workfare programs (WPs) in low- and middle-income countries have become a primary instrument to fight poverty associated with temporary economic shocks or to create a pathway out of chronic poverty. In this paper, we examine the design and implementation of a WP in Kazakhstan. We do so by executing a cost effectiveness analysis (CEA) and performing a case study analysis which investigates how the implementation process unfolded and what factors shaped it most. We find that the high cost per unit of current benefit of Kazakhstan's WP is, in part, the result of benefit 'leakage' to the non-poor, high levels of informal labor, and means-testing applicants. Furthermore, overly bureaucrat requirements of official residency and household asset documents, poor staff training because of high staff turnover, staff not following standardized procedures because of low wages and corruption, and central government KPIs resulted in "creaming" of the best applicants and improper blending with other active labor market policies. Our findings provide important lessons, such as (1) formal restrictions on eligibility lead to expensive means-testing of applicants and (2) official residency and household asset documents lead to "creaming" of the best applicants.

"It depends on the people!" - A qualitative analysis of contextual factors, prior to the implementation of digital health innovations for chronic condition management, in a German integrated care network.

Objective: Integrated care and digital health technology interventions are promising approaches to coordinate services for people living with chronic conditions, across different care settings and providers. The EU-funded ADLIFE project intends to provide digitally integrated personalized care to improve and maintain patients' health with advanced chronic conditions. This study conducted a qualitative assessment of contextual factors prior to the implementation of the ADLIFE digital health platforms at the German pilot site. The results of the assessment are then used to derive recommendations for action for the subsequent implementation, and for evaluation of the other pilot sites. Methods: Qualitative interviews with healthcare professionals and IT experts were conducted at the German pilot site. The interviews followed a semi-structured interview guideline, based on the HOT-fit framework, focusing on organizational, technological, and human factors. All interviews were audio recorded, transcribed, and subsequently analysed following qualitative content analysis. Results: The results of the 18 interviews show the interviewees' high openness and motivation to use new innovative digital solutions, as well as an apparent willingness of cooperation between different healthcare professionals. Challenges include limited technical infrastructure and large variability of software to record health data, lacking standards and interfaces. Conclusions: Considering contextual factors on different levels is critical for the success of implementing innovations in healthcare and the transfer into other settings. In our study, the HOT-fit framework proved suitable for assessing contextual factors, when implementing IT innovations in healthcare. In a next step, the methodological approach will be transferred to the six other European pilot sites, participating in the project, for a cross-national assessment of contextual factors.

Assessment of the implementation context in preparation for a clinical study of machine-learning algorithms to automate the classification of digital cervical images for cervical cancer screening in resource-constrained settings.

Introduction: We assessed the implementation context and image quality in preparation for a clinical study evaluating the effectiveness of automated visual assessment devices within cervical cancer screening of women living without and with HIV. Methods: We developed a semi-structured questionnaire based on three Consolidated Framework for Implementation Research (CFIR) domains; intervention characteristics, inner setting, and process, in Cape Town, South Africa. Between December 1, 2020, and August 6, 2021, we evaluated two devices: MobileODT handheld colposcope; and a commercially-available cell phone (Samsung A21ST). Colposcopists visually inspected cervical images for technical adequacy. Descriptive analyses were tabulated for quantitative variables, and narrative responses were summarized in the text. Results: Two colposcopists described the devices as easy to operate, without data loss. The clinical workspace and gynecological workflow were modified to incorporate devices and manage images. Providers believed either device would likely perform better than cytology under most circumstances unless the squamocolumnar junction (SCJ) were not visible, in which case cytology was expected to be better. Image quality (N = 75) from the MobileODT device and cell phone was comparable in terms of achieving good focus (81% vs. 84%), obtaining visibility of the squamous columnar junction (88% vs. 97%), avoiding occlusion (79% vs. 87%), and detection of lesion and range of lesion includes the upper limit (63% vs. 53%) but differed in taking photographs free of glare (100% vs. 24%). Conclusion: Novel application of the CFIR early in the conduct of the clinical study, including assessment of image quality, highlight real-world factors about intervention characteristics, inner clinical setting, and workflow process that may affect both the clinical study findings and ultimate pace of translating to clinical practice. The application and augmentation of the CFIR in this study context highlighted adaptations needed for the framework to better measure factors relevant to implementing digital interventions.

Development and Implementation of Couple-Based Collaborative Management Model of Type 2 Diabetes Mellitus for Community-Dwelling Chinese Older Adults: A Pilot Randomized Trial.

Background: To mobilize family's positive involvement in improving and sustaining self-management activities of older adults with diabetes, we developed a couple-based collaborative management model (CCMM) for community-dwelling older Chinese. Methods: The model was developed stepwise through applying theoretical models, interviewing older couples and community healthcare workers, as well as incorporating expert reviews. A 3-month pilot study was conducted to test the model's feasibility and its treatment effects by linear regression on 18 pairs of older couples aged 60 years+, who were equally divided into a couple-based intervention arm and a patient-only control arm. Results: The developed CCMM covered four theory-driven intervention modules: dyadic assessment, dyadic education, dyadic behavior-change training, and dyadic monitoring. Each module was delivered by community healthcare workers and targeted at older couples as the management units. Based on interviews with older couples and healthcare workers, 4 weekly education and training group sessions and 2-month weekly behavior change booster calls were designed to address older adults' main management barriers. These modules and session contents were evaluated as essential and relevant by the expert panel. Furthermore, the CCMM showed good feasibility and acceptability in the pilot, with non-significant yet more positive changes in physiological outcomes of diabetic participants and couples' well-being and exercise levels of these in the intervention arm than their controlled counterparts. Conclusion: We systematically developed a couple-based collaborative management model of diabetes, which was well-received by healthcare practitioners and highly feasible among older Chinese couples living in the community. The model's treatment effects need to be verified in fully powered randomized controlled trials. Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=42964, identifier: ChiCTR1900027137.

Process Evaluation of a Community-Based Microbial Larviciding Intervention for Malaria Control in Rural Tanzania.

Microbial larviciding can be an effective component of integrated vector management malaria control schemes, although it is not commonly implemented. Moreover, quality control and evaluation of intervention activities are essential to evaluate the potential of community-based larviciding interventions. We conducted a process evaluation of a larval source management intervention in rural Tanzania where local staff were employed to apply microbial larvicide to mosquito breeding habitats with the aim of long-term reductions in malaria transmission. We developed a logic model to guide the process evaluation and then established quantitative indicators to measure intervention success. Quantitative analysis of intervention reach, exposure, and fidelity was performed to assess larvicide application, and interviews with larviciding staff were reviewed to provide context to quantitative results. Results indicate that the intervention was successful in terms of reach, as staff applied microbial larvicide at 80% of identified mosquito breeding habitats. However, the dosage of larvicide applied was sufficient to ensure larval elimination at only 26% of sites, which does not meet the standard set for intervention fidelity. We propose that insufficient training and protocol adaptation, environment and resource issues, and human error contributed to low larvicide application rates. This demonstrates how several small, context-specific details in sum can result in meaningful differences between intervention blueprint and execution. These findings may serve the design of other larval source management interventions by demonstrating the value of additional training, supervision, and measurement and evaluation of protocol adherence.

Delivering environmental benefit from the use of Environmental Quality Standards: why we need to focus on implementation.

The UK has adopted a broader approach to the introduction of Environmental Quality Standard (EQS) for the aquatic environment than many other jurisdictions around the world, with a greater focus on the implementation of scientifically derived standards. This follows the publication of a report by the Royal Commission on Environmental Pollution in 1998 which drew attention to the need to recognise that whilst an EQS is often just viewed as a numerical value, it also has other important characteristics that need to be recognised if it is to be a practical and effective regulatory tool. One of the aspects that has not always been recognised was that of implementation assessment, i.e. the steps needed to ensure that a standard actually delivers environmental benefit or improvements. In many jurisdictions, there is considerable technical and sometimes political emphasis on the numerical value of the EQS (e.g. the critical concentration in an environmental matrix like water), including the method of derivation, the scrutiny of the reliability and relevance of the ecotoxicity test data and extensive deliberations of unquantified uncertainties in relation to the choice of assessment factor. The regulatory value of an EQS only comes through a comparison against a measured environmental concentration, yet only relatively limited regulatory effort has historically been expended on this component of the classic environmental risk assessment paradigm. For example, there needs to be an acceptable (i.e. small) uncertainty in the EQS, an appropriate analytical method and detection limit in the correct matrix, a method to deliver a comparison with the EQS and a robust statistical method to draw unbiased conclusions about environmental risk. In addition, we argue that there is a case for checking the consequences of introducing a standard against field data, wherever possible. This validation of the EQS rarely happens currently. We explain what implementation assessment is and why it is needed. We give examples of how implementation assessment can be integrated with EQS derivation and also present examples of what happens when the focus is only upon the derivation of a numerical value. It is clear from this evidence that advances in derivation methods need to be coupled with practical solutions of implementation if we are to realise environmental benefit from an EQS in a cost-effective manner.

Avaliação da integração das ações de vigilância da Covid-19 na atenção primária à saúde: uma perspectiva das equipes de Saúde da Família do município de Angra dos Reis / Evaluation of the integration of Covid-19 surveillance actions in primary health care: a perspective of Family Health teams in the municipality of Angra dos Reis

A pandemia por Covid-19 impôs a reinvenção dos serviços de saúde ampliando os desafios dos municípios na vigilância e controle da doença e suas consequências na saúde da população. O objetivo foi avaliar se as ações de vigilância da Covid-19 estão integradas com a Atenção Primária à Saúde na perspectiva da Estratégia de Saúde da Família no município de Angra dos Reis. Foi realizada uma avaliação de implementação cuja estratégia metodológica foi a do estudo de caso, com seleção de caso único, abordagem qualitativa e característica formativa. A ênfase dada foi na conformidade dos processos e melhoria da intervenção considerando o contexto político e organizacional em âmbito local para a definição do grau de implementação. Os dados primários coletados foram das entrevistas semi-estruturadas realizadas em ambiência digital pelo distanciamento social; os dados secundários foram webinários com pesquisadores ou agentes governamentais que trataram sobre o tema, além da análise de documentos disponíveis em site da prefeitura do município estudado. Os critérios e indicadores definidos orientaram a análise de conteúdo do material coletado por tematização. As ações em sua maioria foram consideradas implementadas com destaque para o monitoramento de casos e contatos, a adaptação para retorno das atividades de rotina e a vacinação. Foi demonstrado planejamento administrativo e esforço pela integração das ações entre gestão e profissionais de saúde, porém os fatores que comprometeram permanecem impondo desafios e dificultando a ampliação da capacidade de resposta às emergências no nível territorial. Concluiu-se que as ações de vigilância da Covid-19 foram integradas a Atenção Primária a Saúde na perspectiva da Estratégia de Saúde da Família através do monitoramento dos casos. Fica evidente o esforço das eSF no enfrentamento da pandemia nos territórios em que pese as inúmeras dificuldades já existentes e as que foram ampliadas no período. A estratégia da gestão da criação das "tendas" como ponto de referência para o atendimento exclusivo dos pacientes com sintomas respiratórios se demonstrou imprescindível para atenção em tempos oportuno, apesar das demais dificuldades existentes. Recomenda-se com o estudo a qualificação dos Agentes Comunitários de Saúde e Agentes comunitários de Endemias para além da continuidade do cuidado, mas também como agente de apoio social às famílias em situação de vulnerabilidade e de vigilância comunitária, assim como a maior participação democrática dos profissionais de saúde na tomada de decisão.

A proteção social na reestruturação da assistência em saúde mental: o programa de bolsa-auxílio do Hospital Psiquiátrico de Jurujuba Niterói (RJ) / The social protection in the restructuring of the attendance in mental health: the program of bag-aid of Hospital de Jurujuba Niterói (RJ)

As ações reformistas implementadas no subsetor Saúde Mental ocasionaram transformações no hospital psiquiátrico e trouxeram a necessidade de uma nova agenda de proteção social para um grupo excluído historicamente ­ os loucos, que percebidos como capazes e passíveis de convívio social devem ser apoiados e (re)inseridos. No setor saúde a municipalização e a descentralização deram aos governos locais autonomia e recursos para realizar novas ações do seu interesse. A descentralização e a desinstitucionalização implementadas do município de Niterói/RJ ocasionaram propostas inovadoras como o Programa de Bolsa-Auxílio do Hospital de Jurujuba, um mecanismo de transferência direta de renda criado para dar suporte à política de saúde mental local. A Bolsa-Auxílio constitui-se numa estratégia de intervenção do Programa de Saúde Mental na busca da melhoria da assistência e da qualidade de vida dos usuários da rede de serviços de saúde de Niterói. O presente estudo descreve e avalia o processo de formulação e implementação do Programa e alguns efeitos produzidos em seus beneficiários: se e de que maneira o Programa interferiu no processo de desinstitucionalização e na criação e (re)composição dos vínculos sociais dos bolsistas. Na implementação os pontos críticos foram: pouca atuação sistematizada dos gerentes dificultando a visão global do programa; subaproveitamento dos recursos financeiros; ausência de instrumento formal de avaliação; critérios amplos, confusos e pouco difundidos e o desenho do Programa que propicia a permanência dos usuários. A Bolsa-Auxílio contribuiu para o processo de desinstitucionalização de seus beneficiários porque lhes conferiu autonomia, auto-estima, aumento de poder social e contratual, ampliação da rede social. e conhecimentos. A maior atuação do Programa foi na (re)criação dos vínculos simbólicos, na produção de uma percepção de validade social e individual por parte de bolsistas, técnicos e familiares.