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AIM: To understand participants' experiences with a culturally specific DEmentia Competence Education for Nursing home Taskforce programme within the contexts which was delivered. DESIGN: An exploratory descriptive qualitative approach. METHODS: Semi-structured individual interviews were conducted within one week with the participants upon their completion of the programme from July 2020 to January 2021. A purposive sample of participants with different demographic characteristics in five nursing homes was recruited to maximize the sample variation. Interviews were audiotaped and transcribed verbatim for qualitative content analysis. Participation was on voluntary and anonymous basis. RESULTS: Four major themes were identified, including perceived benefits of the programme (i.e., enhanced sensitivity to the needs of residents with dementia, increased communication with families of residents with dementia, facilitated guidance on care for residents with dementia), facilitators (i.e., comprehensive content, active learning, qualified trainer, intrinsic motivation and organizational support), barriers (i.e., busy working schedules, discrimination against care assistants' learning capability) and suggestions for improvement. CONCLUSION: The results suggested the acceptability of the programme. The participants positively appraised the programme in enhancing their dementia-care competence. The facilitators, barriers and suggestions identified provide insights on improving programme implementation. IMPACT: The qualitative findings from the process evaluation are pertinent to support the sustainability of dementia competence programme in nursing home setting. Future studies could address the modifiable barriers to enhance its effectiveness. REPORTING METHOD: This study was reported in adherence to the Consolidated criteria for reporting qualitatve studies (COREQ) checklist. PATIENT AND PUBLIC CONTRIBUTION: Nursing-home staff was involved in intervention development and delivery. IMPLICATIONS FOR PRACTICE/POLICY: The educational programme could be integrated into the routine practice in nursing homes to improve staff's dementia-care competence. More attention should be paid on the educational needs of the taskforce when implementing the educational programme in nursing homes. Organizational support is the precondition for the educational programme and cultivates a culture for practice change.
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Demência , Recursos Humanos de Enfermagem , Humanos , Casas de Saúde , Competência Clínica , Comunicação , Pesquisa QualitativaRESUMO
The care for people with dementia (PwD) in low- and middle-income countries (LMICs) is dominated by home care and supplemented sporadically by public care provided using public resources. In the context of community resources cannot meet the demand for high-quality services for PwD, dementia-friendly communities (DFCs) provide ideas for alleviating this situation by integrating resources from multiple stakeholders. However, there is still a considerable gap between the capacity of services and the demand of PwD. Based on the experience of elderly services and DFCs construction in Nanjing, China, this study developed a stakeholder collaboration model and clarified the collaborative relationship among stakeholders such as the government, communities, and medical institutions in meeting the needs of PwD. This work summarizes the partnerships and specific actions of stakeholders and highlights the importance of facilitating resource integration to provide comprehensive services.
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Demência , Humanos , Idoso , ChinaRESUMO
BACKGROUND: Survival following melanoma and chronic lymphocytic leukemia (CLL) have both been individually associated with previous history of non-melanoma skin cancers (specifically keratinocyte carcinomas [KC]). Furthermore, melanoma and CLL have been reported to occur within the same patients. The survival experience of patients with both cancers is understudied, and the role of history of KC is unknown. Additional research is needed to tease apart the independent associations between KC and CLL survival, KC and melanoma survival, and the co-occurrence of all three cancers. METHODS: A retrospective cohort study was conducted among patients who were diagnosed with melanoma and/or CLL at a comprehensive cancer center between 2008 and 2020. Multivariable Cox regression models were used to examine the association between history of KC and survival following melanoma and/or CLL with careful consideration of calendar year of diagnosis, treatment regimens and other risk factors. A nested case-control study comparing patients with both CLL and melanoma to those with only CLL or only melanoma was conducted to compare blood parameters across the three groups. RESULTS: A time-dependent association was observed between history of KC and favorable melanoma survival within 4 years following diagnosis and poorer survival post 7 years after melanoma diagnosis. History of KC was not significantly associated with survival following the diagnosis of CLL, after adjustment for clinical factors including historical/concurrent melanoma. Patients with co-occurring melanoma and CLL tended to be diagnosed with melanoma first and had elevated blood parameters including white blood cell and lymphocyte counts as compared with patients who were diagnosed with only melanoma. CONCLUSIONS: History of KC was an independent predictor of survival following melanoma but not of CLL. Additional studies are needed to determine if blood parameters obtained at the time of melanoma diagnosis could be used as a cost-effective way to identify those at high risk of asymptomatic CLL for the promotion of earlier CLL diagnosis.
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Carcinoma , Leucemia Linfocítica Crônica de Células B , Melanoma , Neoplasias Cutâneas , Humanos , Leucemia Linfocítica Crônica de Células B/complicações , Leucemia Linfocítica Crônica de Células B/epidemiologia , Leucemia Linfocítica Crônica de Células B/patologia , Neoplasias Cutâneas/epidemiologia , Estudos Retrospectivos , Estudos de Casos e Controles , Melanoma/complicações , Melanoma/epidemiologia , Carcinoma/patologia , Queratinócitos/patologiaRESUMO
The emergence of novel respiratory infections (e.g., COVID-19) and expeditious development of nanoparticle-based COVID-19 vaccines have recently reignited considerable interest in designing inhalable nanoparticle-based drug delivery systems as next-generation respiratory therapeutics. Among various available devices in aerosol delivery, dry powder inhalers (DPIs) are preferable for delivery of nanoparticles due to their simplicity of use, high portability, and superior long-term stability. Despite research efforts devoted to developing inhaled nanoparticle-based DPI formulations, no such formulations have been approved to date, implying a research gap between bench and bedside. This review aims to address this gap by highlighting important yet often overlooked issues during pre-clinical development. We start with an overview and update on formulation and particle engineering strategies for fabricating inhalable nanoparticle-based dry powder formulations. An important but neglected aspect in in vitro characterization methodologies for linking the powder performance with their bio-fate is then discussed. Finally, the major challenges and strategies in their clinical translation are highlighted. We anticipate that focused research onto the existing knowledge gaps presented in this review would accelerate clinical applications of inhalable nanoparticle-based dry powders from a far-fetched fantasy to a reality.
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COVID-19 , Nanopartículas , Humanos , Pós , Administração por Inalação , Sistemas de Liberação de Medicamentos/métodos , Pesquisa Translacional Biomédica , Vacinas contra COVID-19 , Aerossóis e Gotículas Respiratórios , Inaladores de Pó Seco , Tamanho da PartículaRESUMO
BACKGROUND: Cutaneous human papillomaviruses (cuHPV) and polyomaviruses (HPyV) have been implicated in skin cancers; however, interpretation of findings across studies is complicated by limited understanding of the natural history of these infections across normal tissue types. METHODS: In total, 675 eyebrow hair (EBH) and skin swab (SSW) samples were collected from 71 skin cancer screening patients every 6 months over 2 years and measured for presence of ß-HPV, γ-HPV, and HPyV. Incidence, persistence, and clearance of cuHPV/HPyV were estimated, and risk factors associated with infection were examined. RESULTS: Prevalence, incidence, and persistence of ß-HPV, γ-HPV, and HPyV were consistently higher in SSW than in EBH, with types 5, 24, 49, 76 and Merkel cell polyomavirus (MCPyV) having incidence rates greater than 20 per 1000 person-months. Prevalent γ-HPV EBH infections persisted more often in women (Pâ =â .024), incident ß-HPV EBH infections persisted less often among individuals with history of blistering sunburn (Pâ =â .019), and prevalent MCPyV SSW infections persisted more often in those with a history of skin cancer (Pâ =â .033). CONCLUSIONS: Incidence and persistence of cuHPV/HPyV were observed in SSW and EBH; however, none of the risk factors examined were commonly associated with cuHPV/HPyV infections across normal tissue types.
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Alphapapillomavirus , Infecções por Papillomavirus , Infecções por Polyomavirus , Polyomavirus , Neoplasias Cutâneas , DNA Viral/genética , Feminino , Humanos , Papillomaviridae/genética , Polyomavirus/genética , Infecções por Polyomavirus/epidemiologia , Neoplasias Cutâneas/epidemiologiaRESUMO
BACKGROUND: Treatment outcomes of advanced non-small cell lung cancer (NSCLC) have substantially improved with immune checkpoint inhibitors (ICI), although only approximately 19% of patients respond to immunotherapy alone, increasing to 58% with the addition of chemotherapy. The gut microbiome has been recognized as a modulator of ICI response via its priming effect on the host immune response. Antibiotics as well as chemotherapy reduce gut microbial diversity, hence altering composition and function of the gut microbiome. Since the gut microbiome may modify ICI efficacy, we conducted a retrospective study evaluating the effects of prior antibiotic or chemotherapy use on NSCLC patient response to ICI. METHODS: We retrospectively evaluated 256 NSCLC patients treated between 2011-2017 at Moffitt Cancer Center with ICI ± chemotherapy, examining the associations between prior antibiotic or chemotherapy use, overall response rate and survival. Relative risk regression using a log-link with combinatorial expectation maximization algorithm was performed to analyze differences in response between patients treated with antibiotics or chemotherapy versus patients who didn't receive antibiotics or chemotherapy. Cox proportional hazards models were constructed to evaluate associations between risk factors and overall survival. RESULTS: Only 46 (18% of 256) patients used antibiotics prior to and/or during ICI treatment, and 146 (57%) had prior chemotherapy. Antibiotic users were 8% more likely to have worse overall response rate (RR:1.08; CI:0.93-1.26; p = 0.321), as well as a 35% worse overall survival (HR:1.35; CI:0.91-2.02; p = 0.145), although results were not statistically significant. However, prior use of chemotherapy was significantly associated with poor ICI response (RR:1.24; CI:1.05-1.47; p = 0.013) and worse overall survival (HR:1.47; CI:1.07-2.03; p = 0.018). CONCLUSIONS: Patients receiving antibiotics prior to and/or during ICI therapy might experience worse treatment outcomes and survival than unexposed patients, although these associations were not statistically significant and hence warrant further prospective study. Prior chemotherapy significantly reduced ICI response and overall survival. Antibiotic or chemotherapy exposure may negatively impact ICI response, perhaps through disruption of the eubiotic gut microbiome.
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Antibacterianos/efeitos adversos , Antineoplásicos/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Imunoterapia/mortalidade , Neoplasias Pulmonares/tratamento farmacológico , Idoso , Carcinoma Pulmonar de Células não Pequenas/imunologia , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Feminino , Microbioma Gastrointestinal/efeitos dos fármacos , Microbioma Gastrointestinal/imunologia , Humanos , Inibidores de Checkpoint Imunológico/imunologia , Inibidores de Checkpoint Imunológico/uso terapêutico , Neoplasias Pulmonares/imunologia , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do TratamentoRESUMO
AIMS: To translate 25-item Dementia Knowledge Assessment Scale into Chinese and evaluate its psychometric properties amongst Chinese healthcare providers. BACKGROUND: The prevalence of dementia is increasing in China, but development of relevant training for healthcare providers is still in its infancy stage. A comprehensive, valid and reliable Chinese knowledge-of-dementia measure is needed to identify training needs and evaluate the effect of educational interventions. DESIGN: A cross-sectional survey. METHODS: The Dementia Knowledge Assessment Scale was translated into Chinese following the modified Brislin's translation model. Content and face validity were established by an expert panel in dementia care and healthcare providers. A convenience sample of 290 healthcare providers in care homes and hospitals was recruited. Construct validity was evaluated through confirmatory factor analysis, concurrent validity and known groups' comparisons method. Reliability was evaluated through internal consistency reliability and 2-week test-retest reliability. This study used the STROBE checklist for reporting. RESULTS: The content validity index was 0.98. The confirmatory factor analysis model revealed that the four-factor model was partly supported in the present study. The moderate correlation between Chinese version of Dementia Knowledge Assessment Scale and Alzheimer's Disease Knowledge Scale indicated acceptable concurrent validity. The mean score of the scale and subscale scores showed significant differences between health professionals and care assistants, except for the subscale of "Care Considerations." The reliability was demonstrated with Cronbach's alpha of .77 and intra-class correlation coefficients of each subscale between .74 and .92 among 56 respondents. CONCLUSIONS: The Chinese version of Dementia Knowledge Assessment Scale demonstrated acceptable concurrent validity but marginal factorial validity and satisfactory reliability amongst Chinese healthcare providers. Therefore, applying the four-factor structure of Chinese version scale should be considered. RELEVANCE TO CLINICAL PRACTICE: Chinese version of Dementia Knowledge Assessment Scale can be used to understand the training needs of healthcare providers in dementia.
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Doença de Alzheimer , Pessoal de Saúde , China , Estudos Transversais , Humanos , Psicometria , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Healthcare providers' dementia-care competence is crucial for quality dementia care. A reliable and valid instrument is needed to assess the gaps in their dementia-care competence, and thereby identifying their educational needs. Therefore, this study aims to translate the 17-item Sense of Competence in Dementia Care Staff (SCIDS) scale into Chinese (SCIDS-C) and to validate the SCIDS-C among Chinese healthcare providers. METHODS: The translation procedure followed the modified Brislin's translation model. A cross-sectional survey was conducted using the translated version. The validity, including content validity, confirmatory factor analysis, concurrent validity and known-groups validity, was tested. Reliability in terms of internal consistency and test-retest reliability with a 2-week interval was evaluated. RESULTS: A total of 290 healthcare providers in 12 nursing homes and a hospital completed the survey. The scale-level content validity index was .99. The confirmatory factor analysis model marginally supported the original 4-factor structure. Positive but weak correlations were noted between the total score of the SCIDS-C and that of the Dementia Knowledge Assessment Scale (r = .17, p = .005) and Approaches to Dementia Questionnaire (r = .22, p < .001), suggesting acceptable concurrent validity. Differences between health professionals and care assistants were significant in two subscales scores. The internal consistency of the scale was high, with Cronbach's α of .87. Test-retest reliability was demonstrated with intra-class correlation coefficient of 0.88. CONCLUSIONS: The SCIDS-C demonstrated acceptable reliability and validity although the known-groups validity between health professionals and care assistants was not fully established. It can be used to measure the level of sense of competence and as an outcome measure in educational intervention aiming at improving dementia care among Chinese healthcare providers.
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BACKGROUND: Care homes have been disproportionately affected during the COVID-19 pandemic. Practical challenges of enacting infection control measures in care home settings have been widely reported, but little is known about the ethical concerns of care home staff during the implementation of such measures. . OBJECTIVES: To understand the ethical challenges perceived by care home staff during the early months of the COVID-19 pandemic. RESEARCH DESIGN: An exploratory qualitative study. PARTICIPANTS AND RESEARCH CONTEXT: A purposive sample of 15 care home staff in different roles and ranks in Hong Kong was recruited to take part in semi-structured interviews between June and August 2020. ETHICAL CONSIDERATIONS: Ethical approval for this study was obtained. Participation was voluntary and anonymous. Participants had the right to withdraw from the study at any time without reprisal. FINDINGS: Three themes were identified: unclear legitimacy regarding infection control measures, limited autonomy in choices over infection control measures and inevitable harms to residents' well-being. While the participants expected that they would have legitimated power to implement infection control measures, they were resistant when their right to self-determination of testing and vaccination was infringed. They also felt trapped between ethical duties to protect care home residents from infection risk and the anticipated detrimental effects of infection control measures. CONCLUSIONS: The findings of this study reveal tensions among the ethical obligations of care home staff in response to a public health emergency. They highlight the importance of strengthening ethical sensitivity and ethical leadership in identifying and resolving the challenges of pandemic responses.
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COVID-19 , Casas de Saúde , Humanos , Pandemias , Pesquisa Qualitativa , Autonomia PessoalRESUMO
The complex interplay between ultraviolet radiation (UVR) and cutaneous viral infections in the context of cancer etiology is challenging to unravel, given the limited information on the independent association between UVR and cutaneous viral infections. Using multiple biomarkers of infection with 24 types of cutaneous human papillomavirus (HPV) and 4 types of polyomaviruses (HPyV), we investigated cross-sectional associations with recent UVR exposure, using skin pigmentation measured by spectrophotometer. Age- and sex-adjusted associations between UVR and viral seropositivity, viral DNA present in eyebrow hairs (EBH) and skin swabs (SSW) were estimated using logistic regression. Beta-HPV seropositivity was associated with viral DNA positivity in EBH (OR = 1.40, 95% CI = 1.05-1.88) and SSW (OR = 1.86, 95% CI = 1.25-2.74). Similar associations were observed for Merkel cell polyomavirus. Participants in the highest tertile of UVR exposure were more likely to be seropositive for beta-HPV (OR = 1.81, 95% CI = 1.16-2.38), and have beta-HPV DNA in EBH (OR = 1.57, 95% CI = 1.06-2.33) and SSW (OR = 2.22, 95% CI = 1.25-3.96), compared to participants with the lowest tertile of UVR exposure. UVR exposure was positively associated with three different markers of beta-HPV infection. Therefore, future studies of HPV associated KC development should address more directly the role of HPV and UVR exposure as potential co-carcinogens.
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Neoplasias Induzidas por Radiação/etiologia , Infecções por Papillomavirus/etiologia , Infecções por Polyomavirus/etiologia , Dermatopatias Virais/etiologia , Neoplasias Cutâneas/etiologia , Estudos de Coortes , DNA Viral , Sobrancelhas/virologia , Feminino , Humanos , Queratinócitos/patologia , Masculino , Pessoa de Meia-Idade , Neoplasias Induzidas por Radiação/patologia , Neoplasias Induzidas por Radiação/virologia , Papillomaviridae/genética , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/patologia , Infecções por Papillomavirus/virologia , Polyomavirus/genética , Polyomavirus/isolamento & purificação , Infecções por Polyomavirus/patologia , Infecções por Polyomavirus/virologia , Estudos Prospectivos , Dermatopatias Virais/patologia , Dermatopatias Virais/virologia , Neoplasias Cutâneas/patologia , Neoplasias Cutâneas/virologia , Pigmentação da Pele , Raios UltravioletaRESUMO
BACKGROUND: Gamification has been adopted in the health care field for broaching sensitive topics and increasing motivation for behavior changes. Games developed to stimulate discussion surrounding end-of-life issues, and thereby promoting advance care planning also emerged. AIM: The aim is to integrate the quantitative evidence and qualitative evidence to understand the effectiveness of and experience with games for advance care planning. DESIGN: A mixed-methods systematic review and meta-analysis (PROSPERO ID: CRD42020163312) was undertaken. Joanna Briggs Institute Critical Appraisal tools were used for quality appraisal. Data were synthesized and pooled for meta-analysis or meta-aggregation when appropriate. DATA SOURCES: We searched MEDLINE, CINAHL, EMBASE, PsycINFO, Cochrane Library, WanFang, China Knowledge Resource Integrated Database, and Chinese Biomedical Literature Database from the inception of the databases for qualitative, quantitative, and mixed-method studies. RESULTS: Eleven articles of ten studies were included, six of which were feasibility studies. The quality of the quantitative component of most included studies (7/8) was rated as low, and the qualitative component of most included studies (7/8) was rated as moderate. The meta-analysis showed that games for advance care planning are effective to increase self-efficacy, readiness, knowledge, and process of advance care planning behaviors. The meta-aggregation showed that games for advance care planning are highly acceptable and the participants perceived the game experience as fun and enjoyable. CONCLUSIONS: Advance care planning games seem to be a promising intervention for increasing the uptake of advance care planning behaviors. Well-designed randomized controlled trials evaluating the effectiveness of games for advance care planning are needed in the future.
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Planejamento Antecipado de Cuidados , China , HumanosRESUMO
Given the increasing prevalence of people with dementia in long-term care, various educational interventions have been developed to enhance the dementia care competence of healthcare providers. The study aim was to appraise the evidence of the effects of dementia care educational programs on improving the preparedness of nursing home staff. Articles on dementia care education interventions for nursing home staff were searched from eight databases. The primary outcomes were staff knowledge, attitude, competence, and sense of competence or self-efficacy related to dementia. The secondary outcomes were psychological outcomes, including burnout, caregiving stress, well-being, and job satisfaction. The quality of evidence was appraised using the Joanna Briggs Institute Critical Appraisal tool. Out of the 3269 articles identified, 19 randomized controlled trials comprising 3947 participants from eight countries were included. The methodological quality of included studies was fair. A significant improvement in staff knowledge regarding dementia was reported. The intervention effects on attitudes and competence were insignificant, and the effects on the sense of competence or self-efficacy related to dementia care were inconsistent. The effects on psychological outcomes seem limited because few significant changes were found. Multiple teaching methods, peer support, qualified trainers, and post-training support were effective components in designing the educational interventions. However, given the variations in content and dose and the methodological limitations of the included studies, the effects of educational programs were inconclusive. The findings highlight the necessity of high-quality studies on dementia-care educational interventions, especially in other cultures than Western countries, such as in Asia.
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Demência/enfermagem , Pessoal de Saúde/educação , Pessoal de Saúde/psicologia , Casas de Saúde , HumanosRESUMO
UV radiation (UVR) causing DNA damage is a well-documented risk factor for nonmelanoma skin cancer. Although poorly understood, UVR may also indirectly contribute to carcinogenesis by promoting immune evasion. To our knowledge, we report the first epidemiological study designed to investigate the association between quantitative measures of UVR, obtained using a spectrophotometer, and circulating T regulatory (Treg) cells. In addition to total Treg cells, the proportion of functionally distinct Treg cell subsets defined by CD45RA and CD27 phenotypic markers, graded expression of FOXP3 and CD25, and those expressing cutaneous lymphocyte-associated Ag and the chemokine receptor CCR4 were enumerated in 350 individuals undergoing routine skin cancer screening exams and determined not to have prevalent skin cancer. No associations were identified for UVR exposure or the overall proportion of circulating Treg cells; however, Treg cell subpopulations with an activation-associated phenotype, CD45RA-/CD27-, and those expressing cutaneous homing receptors were significantly positively associated with UVR. These subpopulations of Treg cells also differed by age, sex, and race. After stratification by natural skin tone, and adjusting for age and sex, we found that spectrophotometer-based measures of UVR exposure, but not self-reported measures of past sun exposure, were positively correlated with the highest levels of these Treg cell subpopulations, particularly among lighter-skinned individuals. Findings from this large epidemiologic study highlight the diversity of human Treg cell subpopulations associated with UVR, thus raising questions about the specific coordinated expression of CD45RA, CD27, CCR4, and cutaneous lymphocyte-associated Ag on Treg cells and the possibility that UVR contributes to nonmelanoma skin cancer carcinogenesis through Treg cell-mediated immune evasion.
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Exposição à Radiação/efeitos adversos , Neoplasias Cutâneas/imunologia , Subpopulações de Linfócitos T/imunologia , Linfócitos T Reguladores/imunologia , Raios Ultravioleta/efeitos adversos , Carcinogênese/efeitos da radiação , Estudos de Coortes , Detecção Precoce de Câncer , Feminino , Fatores de Transcrição Forkhead/metabolismo , Humanos , Tolerância Imunológica , Imunofenotipagem , Antígenos Comuns de Leucócito/metabolismo , Masculino , Pessoa de Meia-Idade , Receptores CCR4/metabolismo , Neoplasias Cutâneas/epidemiologia , Fenômenos Fisiológicos da Pele , Pigmentação da Pele , Subpopulações de Linfócitos T/efeitos da radiação , Linfócitos T Reguladores/efeitos da radiação , Evasão Tumoral , Membro 7 da Superfamília de Receptores de Fatores de Necrose Tumoral/metabolismo , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Findings from previous studies of cutaneous human papillomavirus (cuHPV) infection and keratinocyte carcinomas have varied due to several factors, including use of different sample types for cuHPV DNA detection. Elucidating the relationship between cuHPV infection in eyebrow hairs (EBHs) and skin swabs (SSWs) is critical for advancing the design of future studies. METHODS: DNA corresponding to 46 ß-HPV and 52 γ-HPV types was measured in EBHs and SSWs obtained from 370 individuals undergoing routine skin cancer screening examinations. RESULTS: Prevalence of ß-HPV/γ-HPV was 92%/84% and 73%/43% in SSWs and EBHs, respectively, with 71%/39% of patients testing positive for ß-HPV/γ-HPV in both sample types. Number of cuHPV types detected and degree of infection were correlated across SSWs and EBHs. When the EBH was positive for a given ß-HPV/γ-HPV type, the SSW was positive for that same type 81%/72% of the time. CONCLUSIONS: Testing SSWs captures more cuHPV infection than EBHs, with EBH infections usually representing a subset of SSW infections. The importance of optimizing sensitivity of cuHPV infection detection using SSWs vs specificity using EBHs (or a combination of the 2) will be ascertained in an ongoing cohort study investigating cuHPV associations with subsequent keratinocyte carcinomas.
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Sobrancelhas/virologia , Papillomaviridae/classificação , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/virologia , Pele/virologia , Idoso , Idoso de 80 Anos ou mais , Testes Diagnósticos de Rotina/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Sensibilidade e Especificidade , Manejo de Espécimes/métodosRESUMO
OBJECTIVES: Clinical trial data sharing is crucial for promoting transparency and collaborative efforts in medical research. Differential privacy (DP) is a formal statistical technique for anonymizing shared data that balances privacy of individual records and accuracy of replicated results through a "privacy budget" parameter, ε. DP is considered the state of the art in privacy-protected data publication and is underutilized in clinical trial data sharing. This study is focused on identifying ε values for the sharing of clinical trial data. MATERIALS AND METHODS: We analyzed 2 clinical trial datasets with privacy budget ε ranging from 0.01 to 10. Smaller values of ε entail adding greater amounts of random noise, with better privacy as a result. Comparison of rates, odds ratios, means, and mean differences between the original clinical trial datasets and the empirical distribution of the DP estimator was performed. RESULTS: The DP rate closely approximated the original rate of 6.5% when ε > 1. The DP odds ratio closely aligned with the original odds ratio of 0.689 when ε ≥ 3. The DP mean closely approximated the original mean of 164.64 when ε ≥ 1. As ε increased to 5, both the minimum and maximum DP means converged toward the original mean. DISCUSSION: There is no consensus on how to choose the privacy budget ε. The definition of DP does not specify the required level of privacy, and there is no established formula for determining ε. CONCLUSION: Our findings suggest that the application of DP holds promise in the context of sharing clinical trial data.
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Pesquisa Biomédica , Privacidade , Disseminação de Informação/métodos , ConsensoRESUMO
Data sharing is highly advocated in the scientific community, with numerous organizations, funding agencies, and journals promoting transparency and collaboration. However, limited research exists on actual data sharing practices. We conducted a comprehensive analysis of the intent to share individual participant data (IPD) in a total of 313,990 studies encompassing clinical trials and observational studies obtained from ClinicalTrials.gov, spanning the period from 2000 to 2023. Our study found that only 10.3% of principal investigators (PIs) expressed intent to share IPD. Clinical trials were more likely to share data than observational studies (odds ratio, OR = 1.98, 95% CI: 1.92-2.04). Large sample size studies were 1.69 times more likely to share data than small ones (95% CI: 1.65-1.73). Studies registered after 2018 were 1.6 times more likely to share data (95% CI: 1.57-1.64) than before 2019. NIH and other US Federal agency-funded studies had 1.49 times higher odds of sharing data (95% CI: 1.43-1.55) than other funders. USA-based studies were 1.53 times more likely to share data (95% CI: 1.49-1.57) than out of USA. Biological trials were 1.58 times more likely to share data than drug and other trials (95% CI: 1.51-1.66). Phase III trials had the highest odds, 2.47 times, of sharing data (95% CI: 2.38-2.56) than non-Phase III trials.
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Pesquisa Biomédica , Disseminação de Informação , Humanos , Ensaios Clínicos como Assunto , Estudos Observacionais como Assunto , Estados UnidosRESUMO
BACKGROUND: COVID-19 infection severity differs by race and ethnicity, but its long-term effect on cancer-related outcomes is unknown. Therefore, information on COVID-19 history is critical to ascertain among new cancer patients in order to advance research on its impact on cancer outcomes and potentially related health disparities. METHODS: A cross-sectional study was conducted among 16,025 new patients seeking care at Moffitt Cancer Center (MCC) between 2021 and 2022. Patient self-reported histories of COVID-19 infection and other pre-existing health conditions were obtained from electronic questionnaires administered to all new MCC patients. Associations between demographics and COVID-19 infection and hospitalization were examined. RESULTS: A total of 1,971 patients (12.3%) reported ever having COVID-19. Self-reported COVID-19 history was significantly more prevalent in Hispanic vs. non-Hispanic patients (OR = 1.24, 1.05-1.45) and less prevalent in Asian versus White patients (OR = 0.49, 95% 0.33-0.70). Among patients who ever had COVID-19, 10.6% reported a COVID-19-related hospitalization. Males had higher odds of a COVID-19 related hospitalization than females (OR = 1.50, 95% CI = 1.09-2.05), as did Black/African American patients (OR = 2.11, 95% CI = 1.18-3.60) and patients of races other than Black/African American and Asian (OR = 2.61, 95% CI = 1.43-4.54) compared to White patients. Hispanic patients also experienced higher odds of hospitalization (OR = 2.06, 95% CI-1.29- 3.23) compared with non-Hispanic patients of all races in a sensitivity analysis that combined race/ethnicity. Pre-existing lung and breathing problems were associated with higher odds of being hospitalized with COVID-19 (OR = 2.38, 95% CI = 1.61-3.48), but these and other health conditions did not explain the observed associations between race and COVID-19 hospitalization. CONCLUSIONS: Higher rates of COVID-19 hospitalization were observed among patients identifying as Black/African American or Hispanic independent of pre-existing health conditions. Future studies evaluating long-term effects of COVID-19 should carefully examine potential racial/ethnic disparities in cancer outcomes.
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BACKGROUND: National Cancer Institute cancer centers (NCICCs) provide specialized cancer care including precision oncology and clinical treatment trials. While these centers can offer novel therapeutic options, less is known about when patients access these centers or at what timepoint in their disease course they receive specialized care. This is especially important since precision diagnostics and receipt of the optimal therapy upfront can impact patient outcomes and previous research suggests that access to these centers may vary by demographic characteristics. Here, we examine the timing of patients' presentation at Moffitt Cancer Center (MCC) relative to their initial diagnosis across several demographic characteristics. METHODS: A retrospective cohort study was conducted among patients who presented to MCC with breast, colon, lung, melanoma, and prostate cancers between December 2008 and April 2020. Patient demographic and clinical characteristics were obtained from the Moffitt Cancer Registry. The association between patient characteristics and the timing of patient presentation to MCC relative to the patient's cancer diagnosis was examined using logistic regression. RESULTS: Black patients (median days = 510) had a longer time between diagnosis and presentation to MCC compared to Whites (median days = 368). Black patients were also more likely to have received their initial cancer care outside of MCC compared to White patients (odds ratio [OR] and 95% confidence interval [CI] = 1.45 [1.32-1.60]). Furthermore, Hispanics were more likely to present to MCC at an advanced stage compared to non-Hispanic patients (OR [95% CI] = 1.28 [1.05-1.55]). CONCLUSIONS: We observed racial and ethnic differences in timing of receipt of care at MCC. Future studies should aim to identify contributing factors for the development of novel mitigation strategies and assess whether timing differences in referral to an NCICC correlate with long-term patient outcomes.
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Institutos de Câncer , Disparidades em Assistência à Saúde , Medicina de Precisão , Humanos , Demografia , Disparidades em Assistência à Saúde/etnologia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Hispânico ou Latino/estatística & dados numéricos , Medicina de Precisão/estatística & dados numéricos , Neoplasias da Próstata/epidemiologia , Neoplasias da Próstata/terapia , Estudos Retrospectivos , Estados Unidos/epidemiologia , Institutos de Câncer/estatística & dados numéricos , Brancos/estatística & dados numéricos , Negro ou Afro-Americano/estatística & dados numéricos , Tempo para o Tratamento/estatística & dados numéricos , National Cancer Institute (U.S.)/estatística & dados numéricosRESUMO
PURPOSE: Electronic health record (EHR) data are widely used in precision medicine, quality improvement, disease surveillance, and population health management. However, a significant amount of EHR data are stored in unstructured formats including scanned documents external to the treatment facility presenting an informatics challenge for secondary use. Studies are needed to characterize the clinical information uniquely available in scanned outside documents (SODs) to understand to what extent the availability of such information affects the use of these real-world data for cancer research. MATERIALS AND METHODS: Two independent EHR data abstractions capturing 30 variables commonly used in oncology research were conducted for 125 patients treated for advanced non-small-cell lung cancer at a comprehensive cancer center, with and without consideration of SODs. Completeness and concordance were compared between the two abstractions, overall, and by patient groups and variable types. RESULTS: The overall completeness of the data with SODs was 77.6% as compared with 54.3% for the abstraction without SODs. The differences in completeness were driven by data related to biomarker tests, which were more likely to be uniquely available in SODs. Such data were prone to missingness among patients who were diagnosed externally. CONCLUSION: There were no major differences in completeness between the two abstractions by demographics, diagnosis, disease progression, performance status, or oral therapy use. However, biomarker data were more likely to be uniquely contained in the SODs. Our findings may help cancer centers prioritize the types of SOD data being abstracted for research or other secondary purposes.
Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Registros Eletrônicos de Saúde , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/epidemiologia , Oncologia , Progressão da DoençaRESUMO
BACKGROUND: Randomized clinical trials of novel treatments for solid tumors normally measure disease progression using the Response Evaluation Criteria in Solid Tumors. However, novel, scalable approaches to estimate disease progression using real-world data are needed to advance cancer outcomes research. The purpose of this narrative review is to summarize examples from the existing literature on approaches to estimate real-world disease progression and their relative strengths and limitations, using lung cancer as a case study. METHODS: A narrative literature review was conducted in PubMed to identify articles that used approaches to estimate real-world disease progression in lung cancer patients. Data abstracted included data source, approach used to estimate real-world progression, and comparison to a selected gold standard (if applicable). RESULTS: A total of 40 articles were identified from 2008 to 2022. Five approaches to estimate real-world disease progression were identified including manual abstraction of medical records, natural language processing of clinical notes and/or radiology reports, treatment-based algorithms, changes in tumor volume, and delta radiomics-based approaches. The accuracy of these progression approaches were assessed using different methods, including correlations between real-world endpoints and overall survival for manual abstraction (Spearman rank ρ = 0.61-0.84) and area under the curve for natural language processing approaches (area under the curve = 0.86-0.96). CONCLUSIONS: Real-world disease progression has been measured in several observational studies of lung cancer. However, comparing the accuracy of methods across studies is challenging, in part, because of the lack of a gold standard and the different methods used to evaluate accuracy. Concerted efforts are needed to define a gold standard and quality metrics for real-world data.