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BackgroundSince February 2022, the start of the full-scale war in Ukraine, millions of women and children have fled the country. Vaccination of refugee children is important to protect this vulnerable population from disease.AimWe investigate the determinants of vaccination intention in refugee mothers from Ukraine residing in Poland and test the effect of three message frames.MethodsParticipants were randomised into either a control group or one of three intervention groups encouraging vaccination using a specific frame: (i) trust in the Polish health system, (ii) ease of access to vaccination or (iii) risk aversion. Primary outcomes were intention to vaccinate a child in Poland and clicking on a vaccination scheduling link.ResultsThe study was completed by 1,910 Ukrainian refugee mothers. Compared with the control group, the risk aversion message significantly increased vaccination intention (adjusted odds ratio (AOR): 2.35, 95% confidence interval (CI): 1.25-4.42) and clicking on the vaccine scheduling link (AOR: 1.53, 95% CI: 1.12-2.09). Messages around trust and ease of access did not have an effect. Important determinants of vaccination intention were perceived importance of vaccination (AOR: 1.12 95% CI: 1.01-1.25) and trusting vaccination information official health institutes (AOR: 1.40 95% CI: 1.06-1.83) and social media (AOR: 2.09 95% CI: 1.33-3.27).DiscussionUsing a risk aversion frame highlighting the vulnerability to infection that refugees face resulted in increased vaccination intention and clicks on a vaccination scheduler. Health workers who interact with Ukrainian refugees could use this frame in their vaccination communication.
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Refugiados , Vacinação , Humanos , Refugiados/psicologia , Polônia , Ucrânia , Feminino , Vacinação/psicologia , Vacinação/estatística & dados numéricos , Adulto , Criança , Intenção , Conhecimentos, Atitudes e Prática em Saúde , Masculino , Mães/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Emergências , Confiança , Adulto JovemRESUMO
Routine childhood immunization is one of the most effective methods of preventing infectious diseases in children. In Argentina, there has been a decline in routine immunization coverage since 2015, with very little evidence to date on underlying drivers of this steady decline. We administered an online nationwide behavioral insights survey in Argentina between July 1-25, 2022, targeting parents with at least one child under the age of 12 years. Our survey included 1504 parents, 7% (n = 111) of whom did not or only partially vaccinated their children. We found that, compared to the youngest parents (aged 18-24), older parents were less likely to under-vaccinate their children (e.g., 30-34 year-old parents: adjusted Odds Ratio (aOR): 0.31, 95% Confidence Interval (CI) 0.16-0.57). Parents who undervaccinated their children were more likely to take vaccination advice from parent and wellness social media influencers (parent influencers: aOR 2.51, 95% CI 1.46-4.31), and were less likely to trust the social media accounts of official health organizations (aOR 0.82, 95% CI 0.70-0.96). Furthermore, these parents had heightened concerns about routine immunizations, including the number of vaccines given to children and potential for adverse side effects. When asked whether they knew enough to make a vaccine decision for their children, parents who undervaccinated their children were more likely to report that they did not know enough about vaccines or the vaccination schedule to make a decision. These results offer important insights into parental concerns surrounding routine childhood immunization and suggest potential drivers of - and solutions to - the decline in routine immunization seen in Argentina since 2015.
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Pais , Vacinação , Humanos , Argentina , Estudos Transversais , Masculino , Feminino , Adulto , Pais/psicologia , Adolescente , Criança , Adulto Jovem , Vacinação/estatística & dados numéricos , Vacinação/psicologia , Pré-Escolar , Lactente , Inquéritos e Questionários , Cobertura Vacinal/estatística & dados numéricos , Imunização/estatística & dados numéricos , Imunização/psicologia , Pessoa de Meia-Idade , Conhecimentos, Atitudes e Prática em Saúde , Hesitação Vacinal/estatística & dados numéricos , Hesitação Vacinal/psicologia , Vacinas/administração & dosagemRESUMO
Social media platforms have a wide and influential reach, and as such provide an opportunity to increase vaccine uptake. To date, there is no large-scale, robust evidence on the offline effects of online messaging campaigns. We aimed to test whether pre-tested, persuasive messaging campaigns from UNICEF, disseminated on Facebook, influenced COVID-19 vaccine uptake in Ukraine, India, and Pakistan. In Ukraine, we deployed a stepped-wedge randomized controlled trial (RCT). Half of the 24 oblasts (provinces) received five weeks of the intervention, the other half ten weeks of the intervention. In India, an RCT with an augmented synthetic control was conducted in five states (Bihar, Chhattisgarh, Jharkhand, Madhya Pradesh, Rajasthan), whereby 40 out of 174 districts were randomized to receive six weeks of intervention. In Pakistan we deployed a pre-post design, whereby 25 city districts received six weeks of the intervention. Weekly COVID-19 vaccination data was sourced through government databases. Using Poisson regression models, the association between the intervention and vaccine uptake was estimated. In Ukraine we conducted a survey among Facebook users at three time points during the RCT, to ascertain vaccination intentions and trust in vaccines. The campaigns reached more than 110 million Facebook users and garnered 2.9 million clicks. In Ukraine, we found that the intervention did not affect oblast-level vaccination coverage (Relative Risk (RR): 0.93, 95% Confidence Interval (CI) 0.86-1.01). Similarly, in India and Pakistan we found no effect of our intervention (India: RR 0.85, 95% CI 0.70-1.04; Pakistan: RR 0.64, 95% CI 0.01-29.9). The survey among Facebook users in Ukraine showed that trust in vaccines and information sources was an important predictor of vaccination status and intention to get vaccinated. Our campaigns on Facebook had a wide reach, which did not translate in shifting behaviours. Timing and external events may have limited the effectiveness of our interventions.
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BACKGROUND: Magnetic resonance guided focused ultrasound (MRgFUS) is United States Food and Drug Administration approved for the treatment of tremor-dominant Parkinson's disease (TdPD), but only limited studies have been described in practice. OBJECTIVES: To report the largest prospective experience of unilateral MRgFUS thalamotomy for the treatment of medically refractory TdPD. METHODS: Clinical outcomes of 48 patients with medically refractory TdPD who underwent MRgFUS thalamotomy were evaluated. Tremor outcomes were assessed using the Fahn-Tolosa-Marin scale and adverse effects were categorized using a structured questionnaire and clinical exam at 1 month (n = 44), 3 months (n = 34), 1 year (n = 22), 2 years (n = 5), and 3 years (n = 2). Patients underwent magnetic resonance imaging <24 hours post-procedure. RESULTS: Significant tremor control persisted at all follow-ups (P < 0.001). All side effects were mild. At 3 months, these included gait imbalance (38.24%), sensory deficits (26.47%), motor weakness (17.65%), dysgeusia (5.88%), and dysarthria (5.88%), with some persisting at 1 year. CONCLUSIONS: MRgFUS thalamotomy is an effective treatment for sustained tremor control in patients with TdPD. © 2023 International Parkinson and Movement Disorder Society.
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Tremor Essencial , Doença de Parkinson , Humanos , Tremor/etiologia , Tremor/cirurgia , Doença de Parkinson/complicações , Doença de Parkinson/cirurgia , Estudos Prospectivos , Tálamo/cirurgia , Resultado do Tratamento , Imageamento por Ressonância Magnética/métodosRESUMO
The effects of COVID-19-associated restrictions on youth sexual and reproductive health (SRH) care during the pandemic remain unclear, particularly in sub-Saharan Africa. This study uses interrupted time series analyses to assess changes in SRH care utilisation (including visits for HIV testing and treatment, family planning, and antenatal care) adolescent girls' and young women's (AGYW; aged 15-24 years old) in eSwatini following COVID-19 lockdown beginning in March 2020. SRH utilisation data from 32 clinics in the Manzini region that remained open throughout the 2020 COVID-19 period were extracted from eSwatini's electronic health record system. We tabulated and graphed monthly visits (both overall and by visit type) by AGYW during the two-year period between January 2019 and December 2020. Despite the March to September 2020 lockdown, we did not detect significant changes in monthly visit trends from 2019 to 2020. Our findings suggest little change to AGYW's SRH utilisation in eSwatini during the 2020 COVID-19 lockdown period.
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COVID-19 , Infecções por HIV , Serviços de Saúde Reprodutiva , Humanos , Feminino , Adolescente , Gravidez , Adulto Jovem , Adulto , Essuatíni/epidemiologia , COVID-19/epidemiologia , Controle de Doenças Transmissíveis , Comportamento Sexual , Saúde ReprodutivaRESUMO
Magnetic resonance-guided high-intensity focused ultrasound (MRgFUS) is a rapidly developing technique used for tremor relief in tremor-predominant Parkinson's disease (PD) and essential tremor that has demonstrated successful results. Here, we describe the neuropathological findings in a woman who died from a fall 10 days after successful MRgFUS for tremor-predominant PD. Histological analysis demonstrates the characteristic early postoperative MRI findings including 3 distinct zones on T2-weighted imaging: (1) a hypointense core, (2) a hyperintense region with hypointense rim, and (3) a slightly hyperintense, poorly marginated surrounding area. Histopathological analyses also demonstrate the suspected cellular processes composing each of these regions including central hemorrhagic necrosis with surrounding cytotoxic edema and a rim of mostly unaffected vasogenic edema with some reactive and reparative processes. Overall, this case demonstrates the correlation of postoperative imaging findings with the subacute neuropathological findings after MRgFUS for PD.
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Tremor Essencial , Doenças do Sistema Nervoso , Doença de Parkinson , Feminino , Humanos , Tremor , Resultado do Tratamento , Tálamo/cirurgia , Imageamento por Ressonância Magnética/métodos , Tremor Essencial/cirurgia , Doença de Parkinson/cirurgiaRESUMO
Efforts to engage adolescent girls and young women (AGYW) in HIV services have struggled, in part, due to limited awareness of services and stigma. Strategic marketing is a promising approach, but the impact on youth behavior change is unclear. We report findings from a mixed methods evaluation of the Girl Champ campaign, designed to generate demand for sexual and reproductive services among AGYW, and piloted in three clinics in the Manzini region of eSwatini. We analyzed and integrated data from longitudinal, clinic-level databases on health service utilization among AGYW before and after the pilot, qualitative interviews with stakeholders responsible for the implementation of the pilot, and participant feedback surveys from attendees of Girl Champ events. Girl Champ was well received by most stakeholders based on event attendance and participant feedback, and associated with longitudinal improvements in demand for HIV services. Findings can inform future HIV demand creation interventions for youth.
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Infecções por HIV , Serviços de Saúde Reprodutiva , Adolescente , Essuatíni , Feminino , Infecções por HIV/prevenção & controle , Humanos , Marketing , Saúde Reprodutiva , Comportamento SexualRESUMO
BACKGROUND: Public-private partnerships (PPPs) in global health are increasingly common to support sustainable development and strengthen health systems in low- and middle-income countries. Since the release of the Sustainable Development Goals (SDGs) in 2015 culminating in a discrete goal "to revitalize the global partnership for sustainable development," public health scholars have sought to understand what makes PPPs successful in different contexts. While trust has long been identified as a key component of successful strategic alliances in the private sector, less is known about how trust emerges between public- and private- sector partners, particularly in global health. Therefore, we investigated how trust between partners evolved in the context of Project Last Mile (PLM), a global health partnership that translates the business acumen of The Coca-Cola Company to strengthen public health systems across Africa. METHODS: This study draws upon secondary analysis of qualitative data generated as part of the longitudinal, mixed-methods evaluation of PLM across country settings. Seventy-seven interviews with a purposeful sample of key stakeholders were conducted in Mozambique, South Africa and eSwatini between August 2016 and July 2018. Trained qualitative interviewers followed a standard discussion guide, and audio-recorded interviews with participants' consent. In this secondary analysis, we analyzed qualitative data to understand how trust between partners was cultivated across settings. RESULTS: We drew upon stakeholder experiences to inform an inductive framework for how trust develops over time. Our analysis revealed five domains that were foundational to building trust: (1) reputational context, (2) team composition, (3) tangible outputs, (4) shared values, and (5) effective communication. CONCLUSION: The framework may be useful for private and public sector entities seeking to establish and sustain trust within their global health partnerships.
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Saúde Global , Confiança , Humanos , Setor Privado , Motivação , Parcerias Público-Privadas , África do SulAssuntos
Aborto Espontâneo , Médicos , Empatia , Feminino , Humanos , Avaliação de Resultados da Assistência ao Paciente , Gravidez , EnsinoRESUMO
BACKGROUND: South Africa is home to 7.7 million people living with HIV and supports the largest antiretroviral therapy (ART) program worldwide. Despite global investment in HIV service delivery and the parallel challenge of non-communicable diseases (NCDs), there are few examples of integrated programs addressing both HIV and NCDs through differentiated service delivery. In 2014, the National Department of Health (NDoH) of South Africa launched the Central Chronic Medicines Dispensing and Distribution (CCMDD) program to provide patients who have chronic diseases, including HIV, with alternative access to medications via community-based pick-up points. This study describes the expansion of CCMDD toward national scale. METHODS: Yale monitors CCMDD expansion as part of its mixed methods evaluation of Project Last Mile, a national technical support partner for CCMDD since 2016. From March 2016 through October 2019, cumulative weekly data on CCMDD uptake [patients enrolled, facilities registered, pick-up points contracted], type of medication provided [ART only; NCD only; and ART-NCD] and collection sites preferred by patients [external pick-up points; adherence/outreach clubs; or facility-based fast lanes], were extracted for descriptive, longitudinal analysis. RESULTS: As of October 2019, 3,436 health facilities were registered with CCMDD across 46 health districts (88 % of South Africa's districts), and 2,037 external pick-up points had been contracted by the NDoH. A total of 2,069,039 patients were actively serviced through CCMDD, a significant increase since 2018 (p < 0.001), including 76 % collecting ART [64 % ART only, 12 % ART plus NCD/comorbidities] and 479,120 [24 %] collecting medications for chronic diseases only. Further, 734,005 (35 %) of patients were collecting from contracted, external pick-up points, a 73 % increase in patient volume from 2018. DISCUSSION: This longitudinal description of CCMDD provides an example of growth of a national differentiated service delivery model that integrates management of HIV and noncommunicable diseases. This study demonstrates the success of the program in engaging patients irrespective of their chronic condition, which bodes well for the potential of the program to address the rising burden of both HIV and NCDs in South Africa. CONCLUSIONS: The CCMDD program expansion signals the potential for a differentiated service delivery strategy in resource-limited settings that can be agnostic of the patients chronic disease condition.
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Infecções por HIV , Doenças não Transmissíveis , Doença Crônica , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Instalações de Saúde , Humanos , Doenças não Transmissíveis/tratamento farmacológico , Doenças não Transmissíveis/epidemiologia , África do Sul/epidemiologiaRESUMO
In eSwatini and across sub-Saharan Africa, adolescent girls and young women (AGYW) are at significantly higher risk of HIV infection and poorer sexual and reproductive health (SRH) than their male counterparts. AGYW demonstrate low demand for SRH services, further contributing to poor outcomes. Strategic marketing approaches, including those used by multinational corporations, have potential to support demand creation for SRH services among AGYW, but there is limited empirical evidence on the direct application of private-sector strategic marketing approaches in this context. Therefore, we examined how Project Last Mile worked with eSwatini's Ministry of Heath to translate strategic marketing approaches from the Coca-Cola system to attract AGYW to SRH services. We present qualitative market research using the ZMET® methodology with 12 young Swazi women (ages 15-24), which informed development of a highly branded communication strategy consistent with other successful gain-framing approaches. Qualitative in-depth interviews with 19 stakeholders revealed receptivity to the market research findings, and highlighted local ownership over the strategic marketing process and brand. These results can inform similar efforts to translate strategic marketing to support demand generation in pursuit of public health goals to reduce HIV risk and improve SRH.
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Infecções por HIV , Adolescente , Adulto , Essuatíni/epidemiologia , Feminino , Infecções por HIV/prevenção & controle , Serviços de Saúde , Humanos , Masculino , Setor Privado , Comportamento Sexual , Adulto JovemRESUMO
The cases of Charlie Gard and Alfie Evans placed the withdrawal of treatment from terminally ill infants at the forefront of medical law and ethics. In the medico-legal context, Scottish court procedures materially differ from those in England. This article considers these differences in light of the possibility that a similar case might soon be called before the Scottish courts. The Court of Session would then be required to consider whether to utilise its parens patriae jurisdiction to consent to the withdrawal of treatment as if it were the parent of the infant. The operation of this jurisdiction is such that the outcome of any Scottish case cannot be said to be certain, as the Scottish courts are bound to pay more heed to parental autonomy than their English counterparts do.
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AIMS: To understand the impact of urban violence and crime on HIV care delivery. BACKGROUND: Urban violence and crime can put pressure on the healthcare system and on nursing staff. Whilst there is research about the impact this has at the individual level, there is less research that places this in the context of the overall social eco-system. DESIGN: A qualitative design using inductive thematic analysis. METHODS: Between July 2016 - February 2017, we conducted in-depth interviews with 10 nurses working in two neighbourhoods with high levels of violence in Cape Town, South Africa. RESULTS: The effects of crime and violence were evident at multiple levels resulting in participants feeling "safe and unsafe" in a context where people view crime as endemic. Resilience emerged as a key concept in the findings. Resilience was apparent at individual, community, and organizational levels and enabled continued delivery of HIV care. CONCLUSION: The findings demonstrate the potential role of resilience in the social eco-health system required to sustain delivery of HIV care in the midst of urban violence and gangsterism. IMPACT: This study examined the impact of and response to urban violence on HIV care delivery. The findings indicate that resilience manifests at all levels of the social eco-system. Understanding the mechanisms employed to cope with endemic violence helps to address these challenges in the study setting, but also has a much wider application to other areas with endemic urban violence and crime.
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Atenção à Saúde/estatística & dados numéricos , Infecções por HIV/psicologia , Infecções por HIV/terapia , Recursos Humanos de Enfermagem Hospitalar/psicologia , Atenção Primária à Saúde/estatística & dados numéricos , Resiliência Psicológica , Violência/psicologia , Adaptação Psicológica , Adulto , Idoso , Idoso de 80 Anos ou mais , Atitude do Pessoal de Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , África do Sul , População Urbana/estatística & dados numéricosRESUMO
BACKGROUND: Immunohistochemistry (IHC) is often used in personalisation of cancer treatments. Analysis of large data sets to uncover predictive biomarkers by specialists can be enormously time-consuming. Here we investigated crowdsourcing as a means of reliably analysing immunostained cancer samples to discover biomarkers predictive of cancer survival. METHODS: We crowdsourced the analysis of bladder cancer TMA core samples through the smartphone app 'Reverse the Odds'. Scores from members of the public were pooled and compared to a gold standard set scored by appropriate specialists. We also used crowdsourced scores to assess associations with disease-specific survival. RESULTS: Data were collected over 721 days, with 4,744,339 classifications performed. The average time per classification was approximately 15 s, with approximately 20,000 h total non-gaming time contributed. The correlation between crowdsourced and expert H-scores (staining intensity × proportion) varied from 0.65 to 0.92 across the markers tested, with six of 10 correlation coefficients at least 0.80. At least two markers (MRE11 and CK20) were significantly associated with survival in patients with bladder cancer, and a further three markers showed results warranting expert follow-up. CONCLUSIONS: Crowdsourcing through a smartphone app has the potential to accurately screen IHC data and greatly increase the speed of biomarker discovery.
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Biomarcadores Tumorais/genética , Telefone Celular , Crowdsourcing , Neoplasias da Bexiga Urinária/diagnóstico , Feminino , Humanos , Imuno-Histoquímica , Queratina-20/genética , Proteína Homóloga a MRE11/genética , Masculino , Pessoa de Meia-Idade , Neoplasias da Bexiga Urinária/genética , Neoplasias da Bexiga Urinária/patologiaRESUMO
The Fee for Value (FFV) Task Force, a subgroup of the American Academy of PAs' Research and Strategic Initiatives Commission, has examined tools and mechanisms aimed at better clarifying the volume and value of PA work and how that work contributes to improving access to high-quality care. Establishing the value of PAs has been a challenging task for many healthcare providers. Often, PA value has been defined by their clinical productivity, without any clear direction as to what constitutes value versus productivity. The objective of this article is to unmask the value of PAs through the role of electronic health records and highlight PAs' ability to produce services that are value-oriented and quantifiably productive.
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Registros Eletrônicos de Saúde , Assistentes Médicos/economia , Assistentes Médicos/normas , Qualidade da Assistência à Saúde , Mineração de Dados , Eficiência , HumanosRESUMO
BACKGROUND: Academic pathology suffers from an acute and growing lack of workforce resource. This especially impacts on translational elements of clinical trials, which can require detailed analysis of thousands of tissue samples. We tested whether crowdsourcing - enlisting help from the public - is a sufficiently accurate method to score such samples. METHODS: We developed a novel online interface to train and test lay participants on cancer detection and immunohistochemistry scoring in tissue microarrays. Lay participants initially performed cancer detection on lung cancer images stained for CD8, and we measured how extending a basic tutorial by annotated example images and feedback-based training affected cancer detection accuracy. We then applied this tutorial to additional cancer types and immunohistochemistry markers - bladder/ki67, lung/EGFR, and oesophageal/CD8 - to establish accuracy compared with experts. Using this optimised tutorial, we then tested lay participants' accuracy on immunohistochemistry scoring of lung/EGFR and bladder/p53 samples. RESULTS: We observed that for cancer detection, annotated example images and feedback-based training both improved accuracy compared with a basic tutorial only. Using this optimised tutorial, we demonstrate highly accurate (>0.90 area under curve) detection of cancer in samples stained with nuclear, cytoplasmic and membrane cell markers. We also observed high Spearman correlations between lay participants and experts for immunohistochemistry scoring (0.91 (0.78, 0.96) and 0.97 (0.91, 0.99) for lung/EGFR and bladder/p53 samples, respectively). CONCLUSIONS: These results establish crowdsourcing as a promising method to screen large data sets for biomarkers in cancer pathology research across a range of cancers and immunohistochemical stains.
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Biomarcadores Tumorais/metabolismo , Crowdsourcing/métodos , Neoplasias/metabolismo , Análise Serial de Tecidos , Pesquisa Translacional Biomédica/métodos , Interpretação Estatística de Dados , Humanos , Processamento de Imagem Assistida por Computador/métodos , Imuno-Histoquímica , Seleção de PacientesRESUMO
BACKGROUND: Citizen science, scientific research conducted by non-specialists, has the potential to facilitate biomedical research using available large-scale data, however validating the results is challenging. The Cell Slider is a citizen science project that intends to share images from tumors with the general public, enabling them to score tumor markers independently through an internet-based interface. METHODS: From October 2012 to June 2014, 98,293 Citizen Scientists accessed the Cell Slider web page and scored 180,172 sub-images derived from images of 12,326 tissue microarray cores labeled for estrogen receptor (ER). We evaluated the accuracy of Citizen Scientist's ER classification, and the association between ER status and prognosis by comparing their test performance against trained pathologists. FINDINGS: The area under ROC curve was 0.95 (95% CI 0.94 to 0.96) for cancer cell identification and 0.97 (95% CI 0.96 to 0.97) for ER status. ER positive tumors scored by Citizen Scientists were associated with survival in a similar way to that scored by trained pathologists. Survival probability at 15 years were 0.78 (95% CI 0.76 to 0.80) for ER-positive and 0.72 (95% CI 0.68 to 0.77) for ER-negative tumors based on Citizen Scientists classification. Based on pathologist classification, survival probability was 0.79 (95% CI 0.77 to 0.81) for ER-positive and 0.71 (95% CI 0.67 to 0.74) for ER-negative tumors. The hazard ratio for death was 0.26 (95% CI 0.18 to 0.37) at diagnosis and became greater than one after 6.5 years of follow-up for ER scored by Citizen Scientists, and 0.24 (95% CI 0.18 to 0.33) at diagnosis increasing thereafter to one after 6.7 (95% CI 4.1 to 10.9) years of follow-up for ER scored by pathologists. INTERPRETATION: Crowdsourcing of the general public to classify cancer pathology data for research is viable, engages the public and provides accurate ER data. Crowdsourced classification of research data may offer a valid solution to problems of throughput requiring human input.
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Neoplasias da Mama/patologia , Crowdsourcing , Patologia Molecular , Neoplasias da Mama/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos de Riscos Proporcionais , Curva ROC , Receptores de Estrogênio/metabolismoRESUMO
CONTEXT: Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. OBJECTIVE: To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. DESIGN: Cluster-randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard of care. SETTING: Publicly funded HIV clinical care sites. PATIENTS: One thousand eight hundred ninety-one PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). INTERVENTION: Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information-Motivation-Behavioral (IMB) Skills model during routine clinical care. MAIN OUTCOME MEASURES: Number of sexual events without a condom in the past 4 weeks with partners of any HIV status, and with partners perceived to be HIV negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. RESULTS: Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared with standard-of-care participants. Differences in sexually transmitted infection incidence between arms were not observed. CONCLUSIONS: Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. TRIAL REGISTRATION: Not applicable.