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Background: Risky alcohol consumption (RAC) can lead to alcohol-related liver disease (ALD). Liver cirrhosis caused by ALD continues to increase as alcohol consumption continues unabated. In turn, the elderly are more sensitive to alcohol. Population ageing calls for preventive activities to improve their health. Brief interventions have proven to be cost-effective in addressing risk behaviours. Aim: We aimed to analyse the prevalence of RAC in people > 64 years and to assess the effect of a brief intervention in the subgroup of risky consumers. Methods: population-based study in two phases: (1) Phase I: Cross-sectional, descriptive multicentre study of prevalence of RAC in people > 64 years. (2) Phase II: Cluster randomized, controlled, single-blind, community-based clinical trial with two comparison groups of subjects with RAC, to assess the effectiveness of a brief intervention compared to standard practice in reducing alcohol consumption in primary care. Results: Out of the 932 subjects, 455 (49%) (268 men (64%) and 187 women (36%)) had an alcohol consumption that was considered to be risky. Overall, the brief intervention was effective in reducing alcohol consumption showing 1.8 OR (p = 0.030). That effect was caused by women whose group showed 3.3 OR (p = 0.009). There was no effect on men (p = 0.468). Conclusions: RAC in the elderly is very high, far more in men than in women. A brief intervention was successful in reducing alcohol consumption but not below risk levels. Further research is needed to determine which types of interventions are most effective in this population subgroup. [ABSTRACT FROM AUTHOR]

Introduction: In the management of hypertension and diabetes mellitus, a systematic response like modifications in lifestyles is needed along with the medication. The study was conducted to determine the impact of comprehensive lifestyle modifications on hypertension and diabetes and to compare it with that of physical activity alone as a health education intervention. Materials and Method: A risk factor-based community intervention trial was conducted for one year in 3 villages in coastal Karnataka. The sample of 305 was calculated depending on the expected change in blood pressure and an equal sample size was drawn from each of the villages using a systematic random sampling method. Baseline data on blood pressure level, random blood sugar, and HbA1c levels were recorded. After 1 year of intervention, all the parameters were further recorded along with the adherence to medication for these non-communicable diseases. Results: The mean difference between the groups suggested that participants with physical activity intervention reported a statistically significant reduction in systolic blood pressure. In the comprehensive lifestyle modification group, there was a significant reduction in both diastolic blood pressure and glycated hemoglobin levels (21 mmHg and 2.1%; p < 0.001). Conclusion: The study indicates that in the management of hypertension and diabetes mellitus, the impact of comprehensive lifestyle modifications was more significant compared to physical activity alone. [ABSTRACT FROM AUTHOR]

The article focuses on the evolution and impact of the concept "Clinical Research as a Care Option" (CRAACO), which was co-developed by the author and Jennifer Byrne to highlight the value of clinical trials in advancing patient care. Topics include the historical context of CRAACO, the positive results from a survey comparing patient satisfaction with clinical research-related care, and the ongoing efforts to enhance public awareness and accessibility of clinical trials.

This article discusses the experience of participants in community-based clinical trials conducted in rural Maharashtra, India. The study analyzed feedback forms from over 4,000 participants who took part in vaccine clinical trials. The findings revealed that the primary sources of information about the studies were prestudy home visits and village-level community meetings. The participants reported that health-care benefits, health awareness and counseling, and supportive study staff were the main reasons for their participation. Overall, the majority of participants had a satisfactory experience and would recommend it to others. The article emphasizes the importance of participant feedback in community-based studies and highlights the need for effective community engagement strategies. [Extracted from the article]

Background: Little is known about the emotional experience and benefits of undertaking direct acting antiviral (DAA) treatment for hepatitis C. A better understanding of individual treatment outcomes can inform acceptable treatment delivery and promotion. We aimed to explore participant-perceived emotional benefits and transformations throughout DAA treatment among people who inject drugs, who were initiating treatment. Methods: Participants were recruited from either a community based clinical trial or community health clinics. Semi structured interviews were conducted with each participant before, during and following treatment. Interviews focussed on treatment perceptions, physical and mental wellbeing and modifiable health behaviours. Interviews were recorded, transcribed verbatim and thematically analysed. Participant and cohort matrices were produced to assess at which time point themes were present and whether themes changed or remained stable over time. Results: This paper presents analysis from 19 participants interviewed between 2017–2019. Most participants were male, with no or mild fibrosis. At baseline, all but one participant had injected drugs in the past month. Three themes relating to the emotional wellbeing and behaviour change described a common treatment experience; 'hopes for better wellbeing', 'lifting the weight' and 'closing the chapter'. Participants were hopeful treatment would improve their emotional wellbeing. Hopes were actualised during treatment as participants began to feel uncertainty and stress easing. Completing treatment improved some participants perceptions of self. Some participants consciously changed their injecting behaviours during treatment. Conclusion: Undertaking and completing treatment was an emotionally and behaviourally transformative period. Participant perceived benefits should be used to inform how treatment benefit is conceptualised and how treatment is promoted in primary care settings. [ABSTRACT FROM AUTHOR]

Background: For the design and analysis of clinical trials with time-to-event outcomes, the Cox proportional hazards model and the logrank test have been the cornerstone methods for many decades. Increasingly, the key assumption of proportionality-or time-fixed effects-that underpins these methods has been called into question. The availability of novel therapies with new mechanisms of action and clinical trials of longer duration mean that non-proportional hazards are now more frequently encountered.Methods: We compared several regression-based methods to model time-dependent treatment effects. For illustration purposes, we used selected endpoints from a large, community-based clinical trial of low dose daily aspirin in older persons. Relative and absolute estimands were defined, and analyses were conducted in all participants. Additional exploratory analyses were undertaken by selected subgroups of interest using interaction terms in the regression models.Discussion: In the trial with median 4.7 years follow-up, we found evidence for non-proportionality and a time-dependent treatment effect of aspirin on cancer mortality not previously reported in trial findings. We also found some evidence of time-dependence to an aspirin by age interaction for major adverse cardiovascular events. For other endpoints, time-fixed treatment effect estimates were confirmed as appropriate.Conclusions: The consideration of treatment effects using both absolute and relative estimands enhanced clinical insights into potential dynamic treatment effects. We recommend these analytical approaches as an adjunct to primary analyses to fully explore findings from clinical trials. [ABSTRACT FROM AUTHOR]

Objectives: This cluster‐randomized controlled community trial aimed to assess the efficacy and costs of fluoride varnish (FV) application for caries prevention in a high‐risk population in South Africa. Methods: 513 children aged 4–8 years from two schools in a township in South Africa were randomly allocated by class to the FV or Control (CO) groups. In addition to supervised toothbrushing with fluoridated toothpaste in both groups, FV was applied in 3‐month intervals by trained local non‐professional assistants. Intraoral examinations were conducted at baseline, 12, 21 and 24 months. Primary outcome was the increment of teeth with cavitated lesions (i.e. newly developed or progressed, formerly non‐cavitated lesions), requiring restoration or extraction over the study period. Additionally, treatment and re‐treatment costs were analyzed. Results: 513 children (d1‐4mft 5.9 ± 4.3 (mean ± SD)) were randomly allocated to FV (n = 287) or CO (n = 226). 10.2% FV and CO teeth received or required a restoration; 3.9% FV and 4.1% CO teeth were extracted, without significant differences between groups. While FV generated high initial costs, follow‐up costs were comparable in both groups, resulting in FV being significantly more expensive than CO (1667 ± 1055 ZAR vs. 950 ± 943 ZAR, p <.001). Conclusions: Regular FV application, in addition to daily supervised toothbrushing, had no significant caries‐preventive effect and was not cost‐effective in a primary school setting within a peri‐urban, high‐risk community in South Africa. Alternative interventions on community or public health level should be considered to reduce the caries burden in high‐risk communities. [ABSTRACT FROM AUTHOR]

Introduction: Stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) is comparable in efficacy to standard TF-CBT for child posttraumatic stress symptoms (PTSS), but less is known about the effectiveness of SC-TF-CBT on child and parent secondary outcomes. The aim of this community-based randomized clinical trial was to compare child- and caregiver-secondary outcomes among SC-TF-CBT versus TF-CBT participants.Methods: Children (ages 4 to 12) with PTSS and their caregivers were randomly assigned to either SC-TF-CBT (n = 91) or TF-CBT (n = 92). Secondary child (internalizing and externalizing behavior problems, anger outburst and sleep disturbances) and parent outcomes (PTSS, depression symptoms, and parenting stress) were measured at baseline, post-treatment and 6- and 12-month follow-up.Results: There were comparable changes at all-time points in child and caregiver secondary outcomes. Non-inferiority tests indicated that for completers and intent-to-treat samples, SC-TF-CBT was non-inferior to TF-CBT for all outcomes except parenting stress at 6-months. The analysis with completers did not support non-inferiority at post-treatment for internalizing and externalizing problems and at 6- and 12-month follow-up assessments for externalizing problems, but the intent-to-treat analysis did support non-inferiority.Limitations: Limitations included modest rates of attrition, excluding in vivo component for standard TF-CBT, parent-only assessments, and no control condition.Conclusions: SC-TF-CBT is an effective alternative treatment method although parents with high stress may need more support and children with externalizing problems may need more standard TF-CBT sessions. [ABSTRACT FROM AUTHOR]

Community-based clinical trials of the inhaled corticosteroid budesonide in early COVID-19 have shown improved patient outcomes. We aimed to understand the inflammatory mechanism of budesonide in the treatment of early COVID-19. The STOIC trial was a randomised, open label, parallel group, phase 2 clinical intervention trial where patients were randomly assigned (1:1) to receive usual care (as needed antipyretics were only available treatment) or inhaled budesonide at a dose of 800 μg twice a day plus usual care. For this experimental analysis, we investigated the nasal mucosal inflammatory response in patients recruited to the STOIC trial and in a cohort of SARS-CoV-2-negative healthy controls, recruited from a long-term observational data collection study at the University of Oxford. In patients with SARS-CoV-2 who entered the STOIC study, nasal epithelial lining fluid was sampled at day of randomisation (day 0) and at day 14 following randomisation, blood samples were also collected at day 28 after randomisation. Nasal epithelial lining fluid and blood samples were collected from the SARS-CoV-2 negative control cohort. Inflammatory mediators in the nasal epithelial lining fluid and blood were assessed for a range of viral response proteins, and innate and adaptive response markers using Meso Scale Discovery enzyme linked immunoassay panels. These samples were used to investigate the evolution of inflammation in the early COVID-19 disease course and assess the effect of budesonide on inflammation. 146 participants were recruited in the STOIC trial (n=73 in the usual care group; n=73 in the budesonide group). 140 nasal mucosal samples were available at day 0 (randomisation) and 122 samples at day 14. At day 28, whole blood was collected from 123 participants (62 in the budesonide group and 61 in the usual care group). 20 blood or nasal samples were collected from healthy controls. In early COVID-19 disease, there was an enhanced inflammatory airway response with the induction of an anti-viral and T-helper 1 and 2 (Th1/2) inflammatory response compared with healthy individuals. Individuals with COVID-19 who clinically deteriorated (ie, who met the primary outcome) showed an early blunted respiratory interferon response and pronounced and persistent Th2 inflammation, mediated by CC chemokine ligand (CCL)-24, compared with those with COVID-19 who did not clinically deteriorate. Over time, the natural course of COVID-19 showed persistently high respiratory interferon concentrations and elevated concentrations of the eosinophil chemokine, CCL-11, despite clinical symptom improvement. There was persistent systemic inflammation after 28 days following COVID-19, including elevated concentrations of interleukin (IL)-6, tumour necrosis factor-α, and CCL-11. Budesonide treatment modulated inflammation in the nose and blood and was shown to decrease IL-33 and increase CCL17. The STOIC trial was registered with ClinicalTrials.gov , NCT04416399. An initial blunted interferon response and heightened T-helper 2 inflammatory response in the respiratory tract following SARS-CoV-2 infection could be a biomarker for predicting the development of severe COVID-19 disease. The clinical benefit of inhaled budesonide in early COVID-19 is likely to be as a consequence of its inflammatory modulatory effect, suggesting efficacy by reducing epithelial damage and an improved T-cell response. Oxford National Institute of Health Research Biomedical Research Centre and AstraZeneca. [ABSTRACT FROM AUTHOR]

Background: Impact and efficiency of oral cancer and oral potentially malignant disorders screening are most realized in "at‐risk" individuals. However, tools that can provide essential knowledge on individuals' risks are not applied in risk‐based screening. This study aims to optimize a simplified risk scoring system for risk stratification in organized oral cancer and oral potentially malignant disorders screening. Methods: Participants were invited to attend a community‐based oral cancer and oral potentially malignant disorders screening program in Hong Kong. Visual oral examination was performed for all attendees and information on sociodemographic characteristics as well as habitual, lifestyle, familial, and comorbidity risk factors were obtained. Individuals' status of those found to have suspicious lesions following biopsy and histopathology were classified as positive/negative and this outcome was used in a multiple logistic regression analysis with variables collected during screening. Odds ratio weightings were then used to develop a simplified risk scoring system which was validated in an external cohort. Results: Of 979 participants, 4.5% had positive status following confirmatory diagnosis. A 12‐variable simplified risk scoring system with weightings was generated with an AUC, sensitivity, and specificity of 0.82, 0.71, and 0.78 for delineating high‐risk cases. Further optimization on the validation cohort of 491 participants yielded a sensitivity and specificity of 0.75 and 0.87 respectively. Conclusions: The simplified risk scoring system was able to stratify oral cancer and oral potentially malignant disorders risk with satisfactory sensitivity and specificity and can be applied in risk‐based disease screening. [ABSTRACT FROM AUTHOR]

A better understanding of suicidal ideation (SI), including patterns of SI, may help elucidate links between depression, SI, and suicidal behavior. This study sought to identify trajectories of SI in a large, community-based clinical trial of participants with major depressive disorder (MDD) and to investigate the relationships between these trajectories and predictors of interest, including anxiety and anhedonia. A longitudinal latent class analysis was conducted in 3923 participants enrolled in Level 1 of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study of citalopram for the treatment of MDD. An unconditional latent class analysis was conducted using SI at study weeks 0, 2, 4, 6, and 9 as the indicators. A multinomial regression was then conducted with SI trajectory as the outcome and anhedonia, severity of depressive symptoms, atypical depression, anxiety, history of suicide attempt, history of substance abuse, history of trauma, and other covariates as the predictors. Four SI trajectories were identified: 1) variable SI; 2) little-to-no SI; 3) persistent SI; and 4) improving SI. Compared to the little-to-no SI trajectory, those with more severe anhedonia were more likely to experience persistent SI, while those with more severe anxiety were more likely to experience improving SI. Factors that distinguish SI trajectories, such as anxiety and anhedonia, may be critical targets for intervention or profiles for prognosis. [ABSTRACT FROM AUTHOR]

Children in rural settings are under‐represented in clinical trials, potentially contributing to rural health disparities. We performed a scoping review describing available literature on barriers and facilitators impacting participation in pediatric clinical trials in rural and community‐based (nonclinical) settings. Articles identified via PubMed, CINAHL, Embase, and Web of Science were independently double‐screened at title/abstract and full‐text levels to identify articles meeting eligibility criteria. Included articles reported on recruitment or retention activities for US‐based pediatric clinical studies conducted in rural or community‐based settings and were published in English through January 2021. Twenty‐seven articles describing 31 studies met inclusion criteria. Most articles reported on at least one study conducted in an urban or suburban or unspecified community setting (n = 23 articles; 85%); fewer (n = 10; 37%) reported on studies that spanned urban and rural settings or were set in rural areas. More studies discussed recruitment facilitators (n = 25 studies; 81%) and barriers (n = 19; 61%) versus retention facilitators (n = 15; 48%) and barriers (n = 8; 26%). Descriptions of recruitment and retention barriers and facilitators were primarily experiential or subjective. Recruitment and retention facilitators were similar across settings and included contacts/reminders, community engagement, and relationship‐building, consideration of participant logistics, and incentives. Inadequate staff and resources were commonly cited recruitment and retention barriers. Few studies have rigorously examined optimal ways to recruit and retain rural participants in pediatric clinical trials. To expand the evidence base, future studies examining recruitment and retention strategies should systematically assess and report rurality and objectively compare relative impact of different strategies. [ABSTRACT FROM AUTHOR]

Background: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 Physical Functioning subscale is a widely used patient‐reported outcome measure that quantifies cancer patients' physical functioning. Strong floor/ceiling effects can affect a scale's sensitivity to change. The aim of this study was to characterize floor/ceiling effects of the physical functioning domain in patients with advanced/metastatic breast cancer enrolled in commercial clinical trials and a community‐based trial. Methods: The clinical trial cohort comprised patients from 5 registrational trials submitted to the Food and Drug Administration for review (2010‐2017). The community cohort comprised a subgroup of patients from the Alliance Patient Reported Outcomes to Enhance Cancer Treatment (PRO‐TECT) trial. The distribution of patient responses to Physical Functioning items and the summed score were assessed at the baseline and 3‐month follow‐up for both cohorts. Descriptive statistics were used to determine floor/ceiling effects at the item and scale levels. Results: The clinical trial cohort and the community cohort consisted of 2407 and 178 patients, respectively. Twenty‐four percent or more of the respondents reported "not at all" for having trouble/needing help with each Physical Functioning item across both cohorts and measurement time points. Fourteen to twenty percent of the patients scored perfectly (100 of 100) on the Physical Functioning subscale summary measure (where higher scores indicated better physical functioning) across both cohorts and time points. Conclusions: Minor floor effects and notable ceiling effects were found at the item and scale levels of the Physical Functioning subscale, regardless of cohort, and this creates some uncertainty about its ability to detect changes in physical functioning among high‐functioning patients. Investigators may consider adding additional high‐functioning items from the EORTC's item library to more accurately describe the impact of anticancer treatment on patients' physical functioning. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 Physical Functioning subscale is an important tool for measuring cancer patients' physical function in global clinical trials because of its validation across multiple linguistic and cultural contexts. The addition of high‐functioning items from the EORTC item library to the Physical Functioning subscale may allow investigators to more accurately describe the impact of anticancer treatment on patients who are high functioning at the baseline. [ABSTRACT FROM AUTHOR]

Background: Exception from informed consent (EFIC) enables the enrollment of research subjects with emergent conditions to clinical trials without prior consent. EFIC study approval requires community consultation and public disclosure. We hypothesized that the integration of social media with targeted emails and in‐person outreach is an effective community consultation strategy. Methods: We utilized social media with targeted emails and in‐person outreach for the community consultation of the ACCESS cardiac arrest trial. Study advertisements were disseminated using Facebook and Instagram, and targeted emails were sent to emergency medicine, prehospital, and cardiology providers. We also interviewed at‐risk individuals with cardiac conditions, their caretakers, and patient advocacy groups. Participants were asked to complete a survey about their opinions about the study. Results: We collected 559 surveys over an 8‐week period, and 70.5% of the surveys were obtained using social media. The median (IQR) age of survey respondents was 44 (33‐57) years; 89.9% were White and 60.1% were women. A total of 91.3% believed ACCESS was an important study. Compared to the in‐person group, more from social media (81.8% vs. 63.3%, p < 0.05) and targeted email (77.4% vs. 63.3%, p < 0.05) groups said they would include their loved ones in the study. More from the in‐person group believed that their opinion would be considered seriously compared to the social media (75.9% vs. 62.6%, p < 0.05) and targeted email (75.9% vs. 54.5%, p < 0.05) groups. The incorporation of social media and targeted emails for community consultation reduced the cost per survey by fourfold compared to an in‐person–only strategy. Conclusions: The integration of social media with targeted emails and in‐person outreach was a feasible and cost‐saving approach for EFIC community consultation. Future work is necessary to determine the perception and best utilization of social media for community consultation. [ABSTRACT FROM AUTHOR]

Background: Community Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania.Methodology: We adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We conducted In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1.Results: The findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members.Conclusion: The study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants. [ABSTRACT FROM AUTHOR]

Context: During the COVID-19 pandemic, community-based research studies experienced prolonged shutdowns unless able to pivot to remote study procedures.Objectives: To describe the revision of two National Institutes of Health funded community-based palliative-focused clinical trials serving underserved populations to accommodate remote subject enrollment and examine its impact.Methods: Transitioning to remote processes required multiple protocol and procedural changes including: altering informed consent processes; reducing the number of surveys administered; adding internet access as an inclusion criterion. To understand technological challenges, a screening tool was developed for one study to identify potentially eligible subjects' technology abilities and accessibility.Results: Subjects' limited access to the internet and internet-enabled devices and discomfort with technology led to changes in recruitment patterns. Lack of familiarity with technology increased the amount of time it took research team members and subjects to connect remotely. Patients with significant cognitive and/or sensory deficits were at higher risk of experiencing fatigue during remote study visits leading to streamlining of data collection. A researcher-developed technology screening tool found that potential subjects were not comfortable with videoconferencing through Zoom expressing a preference for phone visits. Reduced travel time made scheduling remote study visits more efficient.Conclusion: Future community- and home-based palliative care trials must consider the best way to utilize remote recruitment, enrollment, and data collection processes to increase efficiency and reduce costs. Researchers should consider technology accessibility and train staff to ensure the greatest possible opportunity to recruit underserved populations who have traditionally been underrepresented in research studies. [ABSTRACT FROM AUTHOR]

Importance: Older adults with insomnia have a high risk of incident and recurrent depression. Depression prevention is urgently needed, and such efforts have been neglected for older adults.Objective: To examine whether treatment of insomnia disorder with cognitive behavioral therapy for insomnia (CBT-I) compared with an active comparator condition, sleep education therapy (SET), prevents major depressive disorder in older adults.Design, Setting, and Participants: This assessor-blinded, parallel-group, single-site randomized clinical trial assessed a community-based sample of 431 people and enrolled 291 adults 60 years or older with insomnia disorder who had no major depression or major health events in past year. Study recruitment was performed from July 1, 2012, to April 30, 2015. The trial protocol was modified to extend follow-up from 24 to 36 months, with follow-up completion in July 2018. Data analysis was performed from March 1, 2019, to March 30, 2020.Interventions: Participants were randomized to 2 months of CBT-I (n = 156) or SET (n = 135).Main Outcomes and Measures: The primary outcome was time to incident major depressive disorder as diagnosed by interview and Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria. Secondary outcome was sustained remission of insomnia disorder before depression event or duration of follow-up.Results: Among 291 randomized participants (mean [SD] age, 70.1 [6.7] years; 168 [57.7%] female; 7 [2.4%] Asian, 32 [11.0%] Black, 3 [1.0%] Pacific Islander, 241 [82.8%] White, 6 [2.1%] multiracial, and 2 [0.7%] unknown), 156 were randomized to CBT-I and 135 to SET. A total of 140 participants (89.7%) completed CBT-I and 130 (96.3%) participants completed SET (χ2 = 4.9, P = .03), with 114 (73.1%) completing 24 months of follow-up in the CBT-I group and 117 (86.7%) in the SET group (χ2 = 8.4, P = .004). After protocol modification, 92 (59.0%) of the CBT-I participants and 86 (63.7%) of the SET participants agreed to extended follow-up (χ2 = 0.7, P = .41), with 81 (51.9%) of the CBT-I participants and 77 (57.0%) of the SET group completing 36 months of follow-up (χ2 = 0.8; P = .39). Incident or recurrent major depression occurred in 19 participants (12.2%) in the CBT-I group and in 35 participants (25.9%) in the SET group, with an overall benefit (hazard ratio, 0.51; 95%, CI 0.29-0.88; P = .02) consistent across subgroups. Remission of insomnia disorder continuously sustained before depression event or during follow-up was more likely in CBT-I participants (41 [26.3%]) compared with the SET participants (26 [19.3%], P = .03). Those in the CBT-I group with sustained remission of insomnia disorder had an 82.6% decreased likelihood of depression (hazard ratio, 0.17; 95%, CI 0.04-0.73; P = .02) compared with those in the SET group without sustained remission of insomnia disorder.Conclusions and Relevance: The findings of this randomized clinical trial indicate that treatment of insomnia with CBT-I has an overall benefit in the prevention of incident and recurrent major depression in older adults with insomnia disorder. Community-level screening for insomnia concerns in older adults and wide delivery of CBT-I-based treatment for insomnia could substantially advance public health efforts to treat insomnia and prevent depression in this vulnerable older adult population.Trial Registration: ClinicalTrials.gov Identifier: NCT01641263. [ABSTRACT FROM AUTHOR]

The article discusses the role of a clinical trials nurses which serve as a study coordinator, a role that includes liaising between the principal investigator and site-specific assessment office and collaborating with clinical and nonclinical managers, clinicians, governing body, and trial participants. It discuses some of the shared responsibilities across both roles involve removing barriers to participation and ensuring that patients follow the study protocols.

Objectives: Objective outcome measures of systemic sclerosis (SSc)-related Raynaud's phenomenon (RP) are badly needed. Our objectives were to validate the thermographic response to a standard hand cold challenge as an outcome measure by assessing sensitivity to change, and to explore mobile phone thermography as a feasible, ambulatory tool.Method: Twelve patients with an SSc-spectrum disorder admitted for intravenous iloprost infusions underwent a standard cold challenge before and after one infusion. Thermographic measurements included area under the rewarming curve (AUC) and maximum rewarming temperature (MAX). Before and during another infusion, each patient underwent monitoring of finger skin temperature by two methods: continuous thermocouple recording (standard method) and mobile phone thermography.Results: All cold challenge summary measures, including AUC and MAX, increased after iloprost (most not significantly). However, when the response curves were modelled after averaging across fingers (linear mixed models, three versions), significant change was detected. For example, with Model 1 (no interaction between period and time), temperature was on average 1.67ºC [95% confidence interval (CI) 1.49-1.85, p < 0.001] higher post-iloprost. Mobile phone and thermocouple temperature measurements showed a strong estimated latent correlation (0.88, 95% CI 0.81-0.92). The estimated increases/hour were 0.25ºC (95% CI 0.05-0.45) for the thermocouple and 0.36ºC (95% CI 0.13-0.60) for mobile phone thermography.Conclusion: Our pilot study suggests that the thermographic response to a cold challenge is sensitive to change and mobile phone thermography could bring feasibility to thermographic parameters as outcome measures in later-phase, large-scale, community-based clinical trials of RP. [ABSTRACT FROM AUTHOR]

Introduction: Chronic undernutrition and a homebound state are corelated and are both important components of frailty. However, whether social network intervention combined with protein supplementation is an effective strategy to prevent functional decline among frail older adults is unclear. Methods: 150 frail older adults participated in a 3-month, 3-armed, community-based clinical trial and were randomly assigned to one of 3 groups: high-protein supplementation (additional 27 g of protein/day), the Social Nutrition Program (additional 27 g of protein/day and social network intervention), or a control group. Those assigned to the Social Nutrition Program group received individual counseling from 1 dietitian and 1 social worker during 6 home visits and were encouraged to participate in 4 sessions of community-based cooking activities, the social kitchen program. Primary outcomes were changes in Physical Functioning (PF) and the Timed Up and Go (TUG) test and were assessed at 0 months (baseline), 1.5 months (interim), and 3, 6, and 9 months (postintervention). Results: Compared with the control group, participants in the Social Nutrition Program showed an average improvement of 2.2–3.0 s in the TUG test and this improvement persisted for 3 months after the end of the program (post hoc p ≤ 0.030). The Social Nutrition Program also increased PF by 1.3 points while the control group showed a 1.4 point reduction at the end of the program (post hoc p = 0.045). Improvement in PF and TUG results was primarily observed for the socially frail subgroup of older adults in the Social Nutrition Program group rather than the physically frail subgroup. Frequency of leaving home functioned as a mediator (p = 0.042) and explained 31.2% of the total effect of the Social Nutrition Program on PF change. Conclusion: Our results indicate that social network intervention combined with protein supplementation can improve both the magnitude and duration of functional status among frail older community-dwelling adults. [ABSTRACT FROM AUTHOR]

Background: In the light of the existence of social inequalities in health, a CBPR (Community Based Participatory Research) programme for health promotion started in Malmö, Sweden, in 2017. The programme was based on a penta-helix structure and involved a strategic steering group with representatives from academia, voluntary organisations, the business sector, the public sector, and citizens from the community where the programme took place. The aim of this study was to explore how the penta-helix collaboration worked from the perspectives of all partners, including the citizens.Methods: Individual interviews, that were based on a guide for self-reflection and evaluation of CBPR partnerships, were conducted with the representatives (N = 13) on three occasions, during the period 2017-2019. A qualitative content analysis was used to analyse the interviews.Results: Six themes emerged from the analysis, including Challenges for the partners in the penta-helix collaboration; Challenges for the professionals at the local level; Citizen-driven processes are important for the penta-helix collaboration; Health promoters are essential to build trust between different sectors of society; Shift of power; and System changes take time. The analysis shows that the penta-helix collaboration worked well at the local level in a governance-related model for penta-helix cooperation. In the overall cooperation it was the citizen-driven processes that made the programme work. However, the findings also indicated an inflexibility in organisations with hierarchical structures that created barriers for citizen involvement in the penta-helix collaboration.Conclusion: The main issue uncovered in this study is the problem of vertically organised institutions where discovery and innovation processes flow down from the top, thereby eliminating the essential input of the people and community that they are supposed to serve. The success of the programme was based on an interprofessional cooperation at a local level, where local professions worked together with voluntary organisations, social workers, CBPR researchers from the university, citizens and local health promoters. [ABSTRACT FROM AUTHOR]

Background: The Korean National Cancer Screening Program has been providing annual fecal immunochemical test for colorectal cancer (CRC) to adults aged 50 years and older since 2004. The Korean Colonoscopy Screening Pilot Study was developed to evaluate the effectiveness of colonoscopy screening for CRC incidence and mortality, screening-related complications, and acceptability of colonoscopy as a primary modality for the national CRC screening program.Methods: This study and its protocols have been approved by the Korean Public Institutional Review Board and the National Cancer Center Institutional Review Board. We obtain written informed consent from all participants. The target population is males and females aged 50-74 years living within the pilot sites. A total of 26,640 participants will be recruited for colonoscopy screening. Subjects who have been diagnosed with CRC, who are currently undergoing treatment for CRC, or who have undergone colonoscopy screening within the past 5 years are not allowed to participate. All participants need to complete baseline questionnaires. This pilot study is currently conducted by 104 endoscopists from 57 national cancer screening institutions (42 primary, 10 secondary, and 5 tertiary institutions) located in Goyang-si, Gimpo-si, and Paju-si. The number of endoscopists, medical institutions, and districts participating in the pilot study will be expanded, if necessary. Participating endoscopists at each medical institution perform colonoscopy and report the colonoscopy results to a centralized electronic case report system. We conduct a telephone survey after 7 days and 4 weeks post-colonoscopy to assess for procedure-related complications and satisfaction of the participants. In case of abnormal findings from colonoscopy screening, we track the results from follow-up diagnostic tests. Data from this pilot study will be linked to the diagnostic workup results, the Korean Cancer Registry, and death certificate data for analysis of the performance, long-term effects, and cost-effectiveness of colonoscopy.Discussion: The results will provide critical information to determine whether the introduction of colonoscopy as the primary modality of the Korean National Cancer Screening Program would be acceptable and feasible. Trial registration Korean Clinical Research Information Service registry, KCT0004142. Registered on 15 July 2019, http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16227. [ABSTRACT FROM AUTHOR]

Background The Figure-of-8-Walk test (F8WT) is a performance measure of the motor skill of walking. Unlike walking speed over a straight path, it captures curved path walking, which is essential to real-world activity, but meaningful cut-points have yet to be developed for the F8WT. Methods A secondary analysis of 421 community-dwelling older adults (mean age 80.7 ± 7.8), who participated in a community-based exercise clinical trial, was performed. Area under receiver operating characteristic curves (AUROCC) were calculated using baseline data, with F8WT performance discriminating different self-reported global mobility and balance dichotomies. Cut-points for the F8WT were chosen to optimize sensitivity and specificity. For validation, F8WT cut-points were applied to postintervention F8WT data. Participants were called monthly for 12 months after intervention completion to record self-reported incident falls, emergency department visits, and hospitalizations; risks of the outcomes were compared between those who performed well and poorly on the F8WT. Results F8WT performance times of ≤9.09 seconds and ≤9.27 seconds can discriminate those with excellent (sensitivity = 0.647; specificity = 0.654) and excellent/very good global mobility (sensitivity = 0.649; specificity = 0.648), respectively. A total number of steps ≤17 on the F8WT can discriminate those with excellent/very good/good global balance (sensitivity = 0.646; specificity = 0.608). Compared to those who performed poorly, those who performed well had a lower incidence of negative outcomes: F8WT time ≤9.09 seconds = 46%–59% lower; F8WT time ≤9.27 seconds = 46%–56% lower; F8WT steps ≤17 = 44%–50% lower. Conclusions Clinicians may consider these preliminary cut-points to aid in their clinical decision making, but further study is needed for definitive recommendations. [ABSTRACT FROM AUTHOR]

Objective: The practice of breastfeeding is considered a blessing since its effects on health are well recognized and applies to both mothers and infants. The objective of this study was to evaluate the effectiveness of peer support and training on breastfeeding initiation, duration and exclusivity. Materials and methods: This community-based clinical trial, (IRCT No: 201504049568N12), was conducted during 2015 in the Municipality of Tehran 19 District. First, a total of 150 mothers with their infants from 4 to 20 months of age were asked to complete a questionnaire, which included the demographic characteristics, educational level, and the type of lactation, the initial age of infant for breastfeeding, and the duration of exclusive breastfeeding. Afterwards, 25 volunteer women were selected for lactation counseling. After 6 months, another sample of 116 nursing mothers in the region who had received peer counseling was selected and questioned through the previously mentioned questionnaire. Finally, the results, which were collected from the behavior of the target population before and after the intervention, were compared. Results: The results of the present study indicated that the nursing mothers who received peer counseling proved to have longer durations of breastfeeding (P-value = 0.039), and higher frequency of first hour initiation of breastfeeding (P-value = 0.003) however, the volunteer counselors were mainly housewives who had lower levels of education (P-value = 0.009) and were younger (P-value = 0.009) than those of untrained control group. Conclusion: The study demonstrated the significant effect of peer counseling on breastfeeding initiation and continuation. It is suggested that lactation training could be initiated during the prenatal period along with the conventional methods of training. [ABSTRACT FROM AUTHOR]

Objectives: The primary objective is to evaluate the efficacy of camostat to prevent respiratory deterioration in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. Secondary objectives include assessment of the ability of camostat to reduce the requirement for Coronavirus disease 2019 (COVID-19) related hospital admission and to reduce the requirement for supplementary oxygen and ventilation as treatment for SARS-CoV-2 infection, to evaluate overall mortality related to COVID-19 and to evaluate the efficacy of camostat by effect on clinical improvement. Research objectives include to assess change in COVID-19 symptom severity, to evaluate the ability of camostat to reduce viral load throughout duration of illness as well as translational research on host and viral genomics, serum antibody production, COVID-19 diagnostics, and validation of laboratory testing methods and biomarkers.Trial Design: SPIKE-1 is a randomised, multicentre, prospective, open label, community-based clinical trial. Eligible patients will be randomised 1:1 to the camostat treatment arm and control arm (best supportive care). The trial is designed to include a pilot phase recruiting up to 50 patients in each arm. An initial review at the end of the pilot phase will allow assessment of available data and inform the requirement for any protocol adaptations to include refinement of eligibility criteria to enrich the patient population and sample size calculations. Up to 289 additional patients will be randomised in the continuation phase of the trial. A formal interim analysis will be performed once 50% of the maximum sample size has been recruited PARTICIPANTS: The trial will recruit adults (≥ 18 years) who score moderate to very high risk according to COVID-age risk calculation, with typical symptoms of COVID-19 infection as per Public Health England guidance or equivalent organisations in the UK, Health Protection Scotland, Public Health Wales, Public Health Agency (Northern Ireland) and with evidence of current COVID-19 infection from a validated assay. The trial is being conducted in the UK and patients are recruited through primary care and hospital settings.Intervention and Comparator: Eligible patients with be randomised to receive either camostat tablets, 200 mg four times daily (qds) for 14 days (treatment arm) or best supportive care (control arm).Main Outcomes: Primary outcome measure: the rate of hospital admissions requiring supplemental oxygen. Secondary outcome measures include: the rate of COVID-19 related hospital admission in patients with SARS-CoV-2 infection; the number of supplementary oxygen-free days and ventilator-free days measured at 28 days from randomisation; the rate of mortality related to COVID-19 one year from randomisation; the time to worst point on the nine-point category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019)) or deterioration of two points or more, within 28 days from randomisation. Research outcomes include the assessment of change in COVID-19 symptom severity on days 1-14 as measured by (1) time to apyrexia (maintained for 48 hrs) by daily self-assessment of temperature, time to improvement (by two points) in peripheral oxygenation saturation defined by daily self-assessment of fingertip peripheral oxygenation saturation levels, (3) assessment of COVID-19 symptoms using the Flu-iiQ questionnaire (determined by app recording and/or daily video call (or phone) consultation and (4) assessment of functional score (where possible) at screening, day 7 and 14. The ability of camostat to reduce viral load throughout duration of illness will be assessed by (1) change in respiratory (oropharyngeal/nasopharyngeal swab RT-PCR) log10 viral load from baseline to Days 7 and 14, (2) change in respiratory (saliva RT-PCR) log10 viral load from baseline to Days 1-14 and (3) change in upper respiratory viral shedding at Day 1 -14 measured as time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs by qPCR. Additional translational research outcomes include assessment of host and viral genomics, serum antibody production and COVID-19 diagnostics at baseline and on Days 7 and 14.Randomisation: Eligible patients will be randomised using an interactive web response system (IWRS) in a 1:1 ratio to one of two arms: (1) treatment arm or (2) control arm.Blinding (masking): The trial is open-label.Numbers To Be Randomised (sample Size): The trial is designed to include a pilot and a continuation phase. Up to 100 patients (randomised 1:1 treatment and control arm) will be recruited in the pilot phase and a maximum of 289 patients (randomised 1:1 treatment and control) will be recruited as part of the continuation phase. The total number of patients recruited will not exceed 389.Trial Status: Protocol version number v3 25 September 2020. Trial opened to recruitment on 04 August 2020. The authors anticipate recruitment to be completed by October 2021.Trial Registration: EudraCT 2020-002110-41; 18 June 2020 ClinicalTrials.gov NCT04455815 ; 02 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). Unpublished PK data provided under confidentiality agreement to the trial Sponsor has been removed from the background section of the protocol to allow for publication of the trial protocol. In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. [ABSTRACT FROM AUTHOR]

Community‐based pharmacy residency programs, which emerged over 35 years ago, have grown to 218 programs to be the second largest first‐year postgraduate pharmacy residency education and training program in the United States. This paper is intended to provide a history and current status of community‐based pharmacy residency education and training. Multiple major milestones and activities, including funding, advisory panels, training for meeting the Accreditation Standard and other resources have contributed to the evolution of community‐based pharmacy residency programs. Over the years, the community‐based residency program education and training guidelines and standards have changed to focus on the individual. This focus has resulted in the emergence of new practice sites for training such as health‐system community pharmacies and federally‐qualified healthcare centers. The longitudinal learning experiences of the Standard enable residency graduates to function as community‐based pharmacist practitioners (CPPs). CPPs provide leadership and patient care services to meet the needs of patients in the communities that they serve. The next generation of CPPs will lead the advancement and transformation of community‐based pharmacy practice and provide increased access to care and improved patient outcomes. [ABSTRACT FROM AUTHOR]

Objective: The relationship of specific dementia-related behaviors to caregiver depression and moderating factors is unclear. We examined the role of rejection of care, aggression, and agitation to caregiver depression and if social support and mastery independently moderated associations.Methods: The method used was a cross-sectional, secondary analysis using baseline data from two community-based clinical trials. We examined frequency of occurrence of presenting behaviors and their combinations in persons with dementia. Multiple logistic regression analyses examined associations between nonoverlapping behavioral clusters (agitation alone, agitation + rejection, agitation + aggression, and agitation + rejection + aggression) and caregiver depression. Multiple logistic regression with interaction terms was also used to investigate whether social support or caregiver mastery moderated the relationship between behavioral symptom clusters and caregiver depression.Results: Three of four symptom clusters (all three behaviors [adjusted odds ratio (AOR) = 2.22; 95% CI, 1.02-4.83], agitation + rejection of care [AOR = 2.55; 95% CI, 1.06-6.13], and agitation + aggression [AOR = 2.63; 95% CI, 1.17-5.89]) had a positive association with caregiver depression, whereas agitation alone was not significantly associated with caregiver depression. Neither social support nor mastery significantly moderated the relationship between these three behavioral clusters and caregiver depression.Conclusion: Caregiver depression was associated with different combinations of behaviors but not with agitation alone. These results have implications for intervention development and identifying caregivers at risk for depression. Level of social support and mastery does not appear to moderate impact on caregiver depression. [ABSTRACT FROM AUTHOR]

Context: Few studies have evaluated the impact of an interprofessional advance care planning (ACP) intervention in primary care. A structured ACP training as part of the implementation of the Serious Illness Care Program (SICP) was adapted to include an interprofessional team-based approach to ACP. Objective: To evaluate the impact of being trained in an Interprofessional team-based approach to ACP compared to being trained in an individual clinician-based ACP approach on primary healthcare professionals' (HCP's) intention to engage patients in serious illness conversations Study design and analysis: We conducted a comparative effectiveness study using post-interventions measures from a cluster-randomized clinical trial Setting: community-based primary care practices (PCPs) in the United States and in Canada recruited from 7 practice-based research networks (PBRNs) that are part of the Meta-Larc consortium. The unit of randomization was the PCPs stratified by PBRN. Population: HCP's recruited through primary care practices. Intervention: Practices were assigned to either an interprofessional team-based training (intervention) or individual clinician-based (comparator). Both trainings were adapted from the SICP developed by Ariadne Labs and lasted 3 hours (1.5h online tutorial and 1.5h in-person role-play session). Outcome Measures: the intention of primary HCP's to have serious illness conversations after being trained in an interprofessional team-based approach or an individual clinician-based approach of the SICP, measured using the CPD-REACTION questionnaire. Results: 38 of 45 (84.4%) practices participated and 373 of 535 (69.7%) HCP's fully answered the CPDREACTION in the study (64.1% under 44 years old; 78.0% women; 85.0% at least 4-years university studies 71.6.2% were primary care clinicians; 53.9% in urban settings). After training, mean intention scores for the interprofessional team-based (n=223) and individual clinician-based (n=150) were 6.0 ± 1.1 and 6.5 ± 0.7, respectively. Mean difference was -0.45 (CI -0.79; -0.11; p=0.01). Adjusted for education level and profession, mean difference was -0.05(CI -0.38;0.29); p=0.77). Conclusions: Participants in the interprofessional team-based training did not perform better than the individual clinician-based approach in impacting healthcare professionals' intentions to have serious illness conversations. Profession and education may have a role in the results found. [ABSTRACT FROM AUTHOR]

Effect of diet and exercise on knee pain in patients with osteoarthritis and overweight or obesity: The WE-CAN communicaity-based randomized clinical trial. Because previous studies show that weight losses of 5% to 10% lead to health improvement, it is disappointing that in this trial, the primary outcome of osteoarthritis pain was statistically but not clinically significant: decrease in pain of 2.4 in the in intervention group vs 1.8 in the control group ( I P i <.02 at 18-month). The pragmatic trial was based on an earlier clinical trial by Ma et al[4] that compared a coach-led DPP, a self-directed DPP video program, and a usual care control group involving high-risk patients in a primary care clinic. [Extracted from the article]

Background. Although emerging research has suggested that “positive psychological well-being” is associated with better health outcomes, studies of long-term health and mortality in the elderly are limited. This study assessed the relationship of mental attitude and mortality in older adults followed up for 35 years. Methods. In the 1980s, the Leisure World Cohort Study recruited residents of a California retirement community to a prospective cohort study of health promotion and disease prevention. Participants completed a postal survey including seven positively worded items from the Zung self-rating depression scale. Age-adjusted and multivariable-adjusted (for lifestyle behaviors and disease conditions) hazard ratios (HRs) for death were calculated using Cox regression for 8682 women and 4992 men (median age at entry, 74 years). During follow-up (1981–2016), 13,405 participants died (median age at death, 88 years). Results. In both women and men, HRs for death were significantly related to mental attitude with increasing risk with decreasing positive responses for total attitude and the seven individual items. The multivariable-adjusted HR (95% CI) for death for individuals in the lowest vs. highest quarter of total attitude was 1.24 (1.16, 1.32) for women and 1.30 (1.19, 1.41) for men. Some attenuation in the observed associations occurred after adjustment for potential confounders and after elimination of the first five years of follow-up. Conclusions. Our study suggests that persons with negative attitude have an increased risk of death even after many years of follow-up. Research into strategies to improve mental outlook may help improve the quantity as well as the quality of life. [ABSTRACT FROM AUTHOR]

Objective: The authors sought to determine whether a multicomponent, community-based program for preventing maternal depression also promotes engagement with mental health services for individuals with persistent symptoms.Methods: Mothers of children enrolled in Head Start were randomly assigned between February 2011 and May 2016 to Problem-Solving Education (PSE) (N=111) or usual services (N=119) and assessed every two months for 12 months.Results: Among 230 participants, 66% were Hispanic; 223 participants were included in the analysis. For all PSE participants, engagement with specialty mental health services increased from approximately 10% to 21% between two and 12 months. The PSE group was more likely than the control group to be engaged in specialty services at 12 months (adjusted odds ratio [AOR]=2.36, 95% confidence interval [CI]=1.07-5.20), and the rate of engagement with specialty services over time (treatment × time interaction) favored PSE (p=.016). Among PSE participants with persistent depressive symptoms over the follow-up period, engagement with specialty services increased from 12% (two months) to approximately 46% (12 months), whereas among control group participants, engagement fluctuated between 24% and 33%, without a clear trajectory pattern. At 12 months, PSE participants with persistent symptoms were more likely to engage with specialty care compared with their counterparts in the control group (AOR=6.95, CI=1.50-32.19). The treatment × time interaction was significant for the persistently symptomatic subgroup (p=.029) but not for the episodically symptomatic or the asymptomatic subgroups.Conclusions: Embedding mental health programs in Head Start is a promising strategy to engage parents with depressive symptoms in care, especially those with persistent symptoms. [ABSTRACT FROM AUTHOR]

Highlights • 93% participants at high risk of cardiovascular disease (CVD) (QRISK2 score ≥10%). • 1 in 3 of all screening attendees at high risk of CVD but not taking a statin. • Those screened had double the CVD risk than controls (21.1% vs. 10.3%, p < 0.001). • And 10-times more likely to be high risk than controls (OR 10.2; 95% CI 7.3–14.0). • Lung cancer (PLCO M2012) and CVD risk (QRISK) scores correlated (r = 0.26, p < 0.001). Abstract Background Cardiovascular disease (CVD) is a major cause of morbidity and mortality in populations eligible for lung cancer screening. The aim of this study was to determine whether a brief CV risk assessment, delivered as part of a targeted community-based lung cancer screening programme, was effective in identifying individuals at high risk who might benefit from primary prevention. Methods The Manchester Lung Screening Pilot consisted of annual low dose CT (LDCT) over 2 screening rounds, targeted at individuals in deprived areas at high risk of lung cancer (age 55–74 and 6-year risk ≥1.51%, using PLCO M2012 risk model). All participants of the second screening round were eligible to take part in the study. Ten-year CV risk was estimated using QRISK2 in participants without CVD and compared to age (±5 years) and sex matched Health Survey for England (HSE) controls; high risk was defined as QRISK2 score ≥10%. Coronary artery calcification (CAC) was assessed on LDCT scans and compared to QRISK2 score. Results Seventy-seven percent (n = 920/1,194) of screening attendees were included in the analysis; mean age 65.6 ± 5.4 and 50.4% female. QRISK2 and lung cancer risk (PLCO M2012) scores were correlated (r = 0.26, p < 0.001). Median QRISK2 score was 21.1% (IQR 14.9–29.6) in those without established CVD (77.6%, n = 714/920), double that of HSE controls (10.3%, IQR 6.6–16.2; n = 714) (p < 0.001). QRISK2 score was significantly higher in those with CAC (p < 0.001). Screening attendees were 10-fold more likely to be classified high risk (OR 10.2 [95% CI 7.3–14.0]). One third (33.7%, n = 310/920) of all study participants were high risk but not receiving statin therapy for primary CVD prevention. Discussion Opportunistic CVD risk assessment within a targeted lung cancer screening programme is feasible and is likely to identify a very large number of individuals suitable for primary prevention. [ABSTRACT FROM AUTHOR]

Background: This study investigated how differences in the method of the first‐line androgen deprivation therapy (ADT) affected the time to castration‐resistant prostate cancer. Methods: The Japan Study Group of Prostate Cancer compiled a nationwide community‐based database on prostate cancer patients who underwent ADT. That database included 13 774 patients who were started on ADT by surgical or medical castration alone (monotherapy group, 5395 cases) or ADT in combination with a nonsteroidal anti‐androgen (combined androgen blockade (CAB) group, 8379 cases). We used logistic regression analysis with background factors as independent factors to calculate propensity scores in regard to selection of CAB. Next, for 8826 cases of propensity score‐matched patients, we compared the survival rates in the two groups. Results: The CAB group showed a significantly better progression‐free survival (PFS) rate (65.6% vs 59.6% at 5 years; median time to progression, 11.6 vs 7.1 years; hazard ratio in the CAB group: 0.78, with a 95% confidence interval of 0.72 to 0.84; P < 0.001). In subgroup analysis based on the background factors, the PFS rate was generally better in the CAB group in all risk subgroups except for those having significant risk factors. Conclusion: Propensity score matching analysis revealed the prolongation of PFS by CAB in prostate cancer patients without significant risk factors. It would possible to decide the type of the first‐line ADT according to the prostate cancer risk. Propensity score matching analysis using community‐based multi‐institutional database across Japan revealed that combined androgen blockade achieved better oncological outcome in androgen deprivation therapy for prostate cancer. [ABSTRACT FROM AUTHOR]

Background: Data Monitoring Committees (DMCs) are essential to the good conduct of many trials. Typically they comprise a small expert group which monitors safety, efficacy, progress and early outcome data as trials recruit. DMCs can recommend protocol revisions and early stopping of a trial. As DMC meetings usually consider unblinded interim data confidentially, their deliberations are seldom exposed to research scrutiny. Although there have been some case studies from trials from mixed specialties which offer insights into some of the common issues faced by DMCs, we have, however, little empirical information about the challenges faced within specific clinical settings. Methods: In-depth interviews with participants in the BRACELET Study on death and bereavement in neonatal intensive care trials produced qualitative accounts of experiences and views of a subgroup of 18 DMC members. These interviews explored views of DMC members in relation to the clinical context of neonatal intensive care and the conduct of neonatal intensive care trials. Results: Interviewees felt that an understanding of both the neonatal intensive care setting and population was crucial in a DMC. They considered the neonatal intensive care research population especially vulnerable, and that outcomes that included both death and severe disability raised particular challenges rarely faced in other settings. In exploring these key outcomes they were mindful of the need to meet high scientific standards and the needs of babies in the trials and their families. DMC members discussed particular difficulties around the composite outcome of death and severe disability, especially when mortality data were available long before data on longer term disability. While statistical stopping guidance is helpful, DMC members described decisions about stopping, revising or continuing a trial being informed by a wider set of considerations and discussions than a pre-set p value. These included potentially competing needs of current trial participants and future patients, and reflections on the nature of benefit and harm. Given their cognisance of the potential impact and consequences of the decisions made by DMCs in this setting of life, death, and disability, interviewees commonly used the imagery of bravery, and described DMCs either holding or losing their nerve. Conclusions: DMCs for trials in other fields may also face difficult ethical trade-offs in monitoring composite outcomes. The experience from this sample of DMC members suggest that for neonatal intensive care trials there are some very specific challenges seldom faced elsewhere. The vulnerability of the population, and the different timescales for essential data becoming available to inform decisions, presented particular challenges. We suggest that it is important to consider the challenges raised in other settings to better understand the complex work of these committees and to prepare future generations of DMC members. [ABSTRACT FROM AUTHOR]

Low socio-economic status, high exposure to health risk and poor access to basic treatment are the main determinants of high child mortality in sub-Saharan African rural regions. 50 to 80% of child deaths are caused by a triptych of infectious diseases. Early 2000's Inter Aide made the postulate that it was possible to act on under-five mortality through a strategy combining raising under five mothers awareness on major diseases, spreading of prevention means and local access to basic care. An operational model was thus defined, contributing in a few years to a frank, rapid and lasting reduction of under five mortality in all areas where the methodology could be applied. The importance of community-based care in relation to an institutional health system unable to provide early management of diarrhoea and malaria cases is fundamental. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Snoring has been associated with a number of abnormal conditions, but little work has been done on its association with components of metabolic syndrome based on the epidemiology in Chinese adults. Objective: This study aimed to investigate the association between snoring and components of metabolic syndrome in southeastern Chinese adults. Methods: A two‐stage, cross‐sectional community‐based study was performed in Fuzhou, Southeast China, from 2005 to 2009. Stage 1: 5500 subjects were administered a questionnaire. Data on self‐reported snoring status, daytime somnolence, demographic data, disease histories, and potential confounders were collected and anthropometric measurements were performed. Stage 2: 1000 subjects who were already investigated underwent a blood test and measurement of blood pressure. Results: Data from 4286 subjects were available; 606 subjects were habitual snorers. The prevalence of overweight or obesity, hyperglycemia, hypertension, and dyslipidemia in occasional and habitual snorers was higher than that in the study population (16.66%, 7.89%, 10.52%, and 5.81%, respectively). A significantly increasing trend based on snoring frequency existed in the prevalence of metabolic disorders. The prevalence of components of metabolic syndrome continued to be significantly associated with snoring frequency after controlling confounding factors. Odds ratios of suffering from the aforementioned conditions for occasional and habitual snorers were 1.5–2.5 (P < 0.05) and 2.4–4.8 (P < 0.001) times higher, respectively, compared with nonsnorers. Conclusions: The prevalence of snoring and components of metabolic syndrome is high in southeastern Chinese adults. Both habitual and occasional snoring are closely associated with metabolic disorders independent of confounding factors. [ABSTRACT FROM AUTHOR]

Background: Despite effective assessment methods and medications targeting osteoporosis and related fractures, screening for fracture risk is not currently advocated in the UK. We tested whether a community-based screening intervention could reduce fractures in older women.Methods: We did a two-arm randomised controlled trial in women aged 70-85 years to compare a screening programme using the Fracture Risk Assessment Tool (FRAX) with usual management. Women were recruited from 100 general practitioner (GP) practices in seven regions of the UK: Birmingham, Bristol, Manchester, Norwich, Sheffield, Southampton, and York. We excluded women who were currently on prescription anti-osteoporotic drugs and any individuals deemed to be unsuitable to enter a research study (eg, known dementia, terminally ill, or recently bereaved). The primary outcome was the proportion of individuals who had one or more osteoporosis-related fractures over a 5-year period. In the screening group, treatment was recommended in women identified to be at high risk of hip fracture, according to the FRAX 10-year hip fracture probability. Prespecified secondary outcomes were the proportions of participants who had at least one hip fracture, any clinical fracture, or mortality; and the effect of screening on anxiety and health-related quality of life. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN 55814835.Findings: 12 483 eligible women were identified and participated in the trial, and 6233 women randomly assigned to the screening group between April 15, 2008, and July 2, 2009. Treatment was recommended in 898 (14%) of 6233 women. Use of osteoporosis medication was higher at the end of year 1 in the screening group compared with controls (15% vs 4%), with uptake particularly high (78% at 6 months) in the screening high-risk subgroup. Screening did not reduce the primary outcome of incidence of all osteoporosis-related fractures (hazard ratio [HR] 0·94, 95% CI 0·85-1·03, p=0·178), nor the overall incidence of all clinical fractures (0·94, 0·86-1·03, p=0·183), but screening reduced the incidence of hip fractures (0·72, 0·59-0·89, p=0·002). There was no evidence of differences in mortality, anxiety levels, or quality of life.Interpretation: Systematic, community-based screening programme of fracture risk in older women in the UK is feasible, and could be effective in reducing hip fractures.Funding: Arthritis Research UK and Medical Research Council. [ABSTRACT FROM AUTHOR]

Background: Patient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public. However, current guidance on involving clinical trial participants in PPI activities is not consistent.Methods: We reviewed the concept of participant involvement, based on our experience. Two workshops were held at the MRCCTU at UCL with the aim of defining participant involvement, considering its rationale; benefits and challenges; and identifying appropriate models for participant involvement in clinical trials. We considered how participant involvement might complement the involvement of other public contributors. Both workshops were attended by two patient representatives and seven staff members with experience of PPI in trials. Two of the staff members had also been involved in studies that had actively involved participants. They shared details of that work to inform discussions.Results: We defined trial participants as individuals taking part in the study in question, including those who had already completed their trial treatment and/or follow-up. Because of their direct experience, involving participants may offer advantages over other public contributors; for example, in studies of new interventions or procedures, and where it is hard to identify or reach patient or community groups that include or speak for the study population. Participant involvement is possible at all stages of a trial; however, because there are no participants to involve during the design stage of a trial, prior to enrolment, participant involvement should complement and not replace involvement of PPI stakeholders. A range of models, including those with managerial, oversight or responsive roles are appropriate for involving participants; however, involvement in data safety and monitoring committees may not be appropriate where there is a potential risk of unblinding. Involvement of participants can improve the trial experience for other participants; optimising study procedures, improving communications; however, there are some specific, notably, managing participant confidentiality and practicalities relating to payments.Conclusions: Participant involvement in clinical trials is feasible and complements other forms of PPI in clinical trials. Involving active participants offers significant advantages, particularly in circumstances where trials are assessing new, or otherwise unavailable, therapies or processes. We recommend that current guidance on PPI should be updated to routinely consider including participants as valid stakeholders in PPI and potentially useful approach to PPI. [ABSTRACT FROM AUTHOR]

Objective To describe the methodology of a 2-arm randomized controlled trial that compared the effects of a narrative and didactic version of the Witness CARES (Community Awareness, Reach, & Empowerment for Screening) intervention on colorectal cancer screening behavior among African Americans, as well as the cognitive and affective determinants of screening. Methods Witness CARES targeted cognitive and affective predictors of screening using a culturally competent, community-based, narrative or didactic communication approach. New and existing community partners were recruited in two New York sites. Group randomization allocated programs to the narrative or didactic arm. Five phases of data collection were conducted: baseline, post-intervention, three-month, six-month, and qualitative interviews. The primary outcome was screening behavior; secondary outcomes included cognitive and affective determinants of screening. Results A total of 183 programs were conducted for 2655 attendees. Of these attendees, 19.4% ( N = 516) across 158 programs (50% narrative; 50% didactic) were study-eligible and consented to participate. Half (45.6%) of the programs were delivered to new community partners and 34.8% were delivered at faith-based organizations. Mean age of the total sample was 64.7 years and 75.4% were female. Conclusion The planned number of programs was delivered, but the proportion of study-eligible attendees was lower than predicted. This community-based participatory research approach was largely successful in involving the community served in the development and implementation of the intervention and study. [ABSTRACT FROM AUTHOR]

DESIGN: Universal voluntary HIV counselling and testing followed by prompt initiation of antiretroviral therapy (ART) for all those diagnosed HIV-infected (universal test and treat, UTT) is now a global health standard. However, its population-level impact, feasibility and cost remain unknown. Five community-based trials have been implemented in sub-Saharan Africa to measure the effects of various UTT strategies at population level: BCPP/YaTsie in Botswana, MaxART in Swaziland, HPTN 071 (PopART) in South Africa and Zambia, SEARCH in Uganda and Kenya and ANRS 12249 TasP in South Africa. This report describes and contrasts the contexts, research methodologies, intervention packages, themes explored, evolution of study designs and interventions related to each of these five UTT trials. METHODS: We conducted a comparative assessment of the five trials using data extracted from study protocols and collected during baseline studies, with additional input from study investigators. We organized differences and commonalities across the trials in five categories: trial contexts, research designs, intervention packages, trial themes and adaptations. RESULTS: All performed in the context of generalized HIV epidemics, the trials highly differ in their social, demographic, economic, political and health systems settings. They share the common aim of assessing the impact of UTT on the HIV epidemic but differ in methodological aspects such as study design and eligibility criteria for trial populations. In addition to universal ART initiation, the trials deliver a wide range of biomedical, behavioural and structural interventions as part of their UTT strategies. The five studies explore common issues, including the uptake rates of the trial services and individual health outcomes. All trials have adapted since their initiation to the evolving political, economic and public health contexts, including adopting the successive national recommendations for ART initiation. CONCLUSIONS: We found substantial commonalities but also differences between the five UTT trials in their design, conduct and multidisciplinary outputs. As empirical literature on how UTT may improve efficiency and quality of HIV care at population level is still scarce, this article provides a foundation for more collaborative research on UTT and supports evidence-based decision making for HIV care in country and internationally. [ABSTRACT FROM AUTHOR]

Decolonizing methodologies are gaining increasing prominence in diverse research contexts in which Indigenous peoples are researchers, research partners, participants, and knowledge users. As political and intellectual allies committed to actively resisting and redressing the colonizing potential of research and advancing social change, non-Indigenous scholars are also enacting decolonizing methodologies. By drawing on the author's experiences as a non-Indigenous researcher partnering with an Indigenous early childhood program in Canada, this article illustrates the interconnected ways in which relationality provides the necessary epistemological scaffolding to actualize the underlying motives, concerns, and principles that characterize decolonizing methodologies. Relationality draws attention to the multiple intersecting influences that shape research and knowledge itself, emphasizes reciprocity, and is compatible with many Indigenous worldviews. This article contributes toward the ongoing international dialogue about decolonizing methodologies and is directed primarily to non-Indigenous researchers and graduate students who are questioning how to "do" community-based decolonizing research involving Indigenous peoples. [ABSTRACT FROM AUTHOR]