This study assesses the impact of financial incentives on hygienic latrine ownership by poor/near-poor households in Vietnam. Rural communes were randomly assigned to a control group and three treatment arm groups: (T1) a rebate for households that installed a hygienic latrine; (T2) a financial reward for commune governments if the proportion of hygienic latrines in their commune increased by 30 percentage points; (T3) both a household rebate and a commune reward. We find a strong and positive effect from the household rebate (treatment arms 1 and 3) but an insignificant effect from the commune reward (treatment arm 2) on household ownership of a septic tank latrine. Our analysis provides suggestive evidence that microcredit is a channel through which a rebate encourages the installation of septic tank latrines. We also find that treatment arm 3 increases people\'s knowledge regarding sanitation and the availability of water and soap for handwashing within households.

Acceptance and commitment therapy (ACT) for obsessive-compulsive disorder (OCD) has been found efficacious in randomized clinical trials (RCTs), but the two widely known RCTs were conducted within the United States with predominantly White samples. Research that evaluates treatments like ACT for OCD outside the typical Western cultures is needed. The current scoping review summarizes the key characteristics and findings from 18 RCTs that evaluated ACT for OCD in Iran. These RCTs are largely unknown in the broader scientific literature despite representing the vast majority of ACT for OCD trials, in part because the majority are published in Persian. The preponderance of RCTs treated participants in groups, and most protocols did not include exposure exercises. Of 18 trials, 5 were single sex. Use of selective serotonin reuptake inhibitors (SSRIs) was common with all participants on stable doses at pretreatment in many of the trials. Methodological quality was low to medium. ACT was inconsistent against nontraditional comparison conditions, slightly favorable to empirically validated treatments, and favorable compared with the waitlist and SSRIs. The process of change data indicated that ACT increased the psychological flexibility more than cognitive behavior therapy or SSRIs. These results highlight that findings on ACT for OCD from Western populations replicate and generalize to individuals in Iran. These findings also offer insights gained from studying ACT in Iran and significantly expand the literature based on ACT for OCD that can be integrated into scholarship by all researchers.

OBJECTIVE: Randomized controlled trials (RCTs) are the gold standard for evaluating the comparative efficacy and safety of new cancer therapies. However, enrolling patients in control arms of clinical trials can be challenging for rare cancers, particularly in the context of precision oncology and targeted therapies. External Control Arms (ECAs) are a potential solution to address these challenges in clinical research design. We conducted a scoping review to explore the use of ECAs in oncology.
METHODS: We systematically searched four databases, namely MEDLINE, EMBASE, Web of Science, and Scopus. We screened titles, abstracts, and full texts for eligible articles focusing on patients undergoing therapy for cancer, employing ECAs, and reporting clinical outcomes.
RESULTS: Of the 629 articles screened, 23 were included in this review. The earliest included studies were published in 1996, while most studies were published in the past 5 years. 44% (10/23) of ECAs were employed in blood-related cancer studies. Geographically, 30% (7/23) of studies were conducted in the United States, 22% (5/23) in Japan, and 9% (2/23) in South Korea. The primary data sources used to construct the ECAs involved pooled data from previous trials (35%, 8/23), administrative health databases (17%, 4/23) and electronic medical records (17%, 4/23). While 52% (12/23) of the studies employed methods to align treatment and ECAs characteristics, 48% (11/23) lacked explicit strategies.
CONCLUSIONS: ECAs offer a valuable approach in oncology research, particularly when alternative designs are not feasible. However, careful methodological planning and detailed reporting are essential for meaningful and reliable results.

Mindfulness is a promising health promotion strategy for African Americans, and it is imperative that culturally responsive mindfulness approaches be accessible to this population. One way to address this need is to develop and test if culturally responsive mobile health (mhealth) applications are efficacious in reducing stress-related outcomes in this population. With this goal in mind, we employed a repeated-measures randomized control trial (RCT) across a 12-week intervention period to evaluate if participants in the intervention group outperformed a wait-list control group in reductions in stress, depressive symptoms, anxiety, emotional regulation difficulties as well as in increases in self-compassion, resilience, and mindfulness attitudes and behaviors. Our sample included 170 Black/African American participants who were randomly assigned to either the intervention condition (n = 84) or the wait-list control group (n = 86). Participants in the intervention condition reported more self-compassion, used more mindfulness, and had greater self-efficacy using mindfulness; yet, no other differences were evident. Participants expressed high levels of satisfaction with the app and gave it a positive rating for its relevance to their lives. These findings support the efficacy of a culturally responsive mindfulness mHealth app to enhance self-compassion and increase the use of health-promoting behaviors, like mindfulness, among African Americans. Implications for future research are discussed.

BACKGROUND: While the advantages of using the internet and social media for research recruitment are well documented, the evolving online environment also enhances motivations for misrepresentation to receive incentives or to \"troll\" research studies. Such fraudulent assaults can compromise data integrity, with substantial losses in project time; money; and especially for vulnerable populations, research trust. With the rapid advent of new technology and ever-evolving social media platforms, it has become easier for misrepresentation to occur within online data collection. This perpetuation can occur by bots or individuals with malintent, but careful planning can help aid in filtering out fraudulent data.
OBJECTIVE: Using an example with urban American Indian and Alaska Native young women, this paper aims to describe PRIOR (Protocol for Increasing Data Integrity in Online Research), which is a 2-step integration protocol for combating fraudulent participation in online survey research.
METHODS: From February 2019 to August 2020, we recruited participants for formative research preparatory to an online randomized control trial of a preconceptual health program. First, we described our initial protocol for preventing fraudulent participation, which proved to be unsuccessful. Then, we described modifications we made in May 2020 to improve the protocol performance and the creation of PRIOR. Changes included transferring data collection platforms, collecting embedded geospatial variables, enabling timing features within the screening survey, creating URL links for each method or platform of data collection, and manually confirming potentially eligible participants\' identifying information.
RESULTS: Before the implementation of PRIOR, the project experienced substantial fraudulent attempts at study enrollment, with less than 1% (n=6) of 1300 screened participants being identified as truly eligible. With the modified protocol, of the 461 individuals who completed a screening survey, 381 did not meet the eligibility criteria assessed on the survey. Of the 80 that did, 25 (31%) were identified as ineligible via PRIOR. A total of 55 (69%) were identified as eligible and verified in the protocol and were enrolled in the formative study.
CONCLUSIONS: Fraudulent surveys compromise study integrity, validity of the data, and trust among participant populations. They also deplete scarce research resources including respondent compensation and personnel time. Our approach of PRIOR to prevent online misrepresentation in data was successful. This paper reviews key elements regarding fraudulent data participation in online research and demonstrates why enhanced protocols to prevent fraudulent data collection are crucial for building trust with vulnerable populations.
BACKGROUND: ClinicalTrials.gov NCT04376346; https://www.clinicaltrials.gov/study/NCT04376346.
UNASSIGNED: DERR1-10.2196/52281.

Background: The COVID-19 pandemic has had a profound global impact, although the majority of recently infected cases have presented with mild to moderate symptoms. Previous clinical studies have demonstrated that Shufeng Jiedu (SFJD) capsule, a Chinese herbal patent medicine, effectively alleviates symptoms associated with the common cold, H1N1 influenza, and COVID-19. This study aimed to assess the efficacy and safety of SFJD capsules in managing symptoms of mild to moderate COVID-19 infection. Methods: A randomized, double-blind, placebo-controlled trial was conducted from May to December 2022 at two hospitals in China. Mild and moderate COVID-19-infected patients presenting respiratory symptoms within 3 days from onset were randomly assigned to either the SFJD or placebo groups in a 1:1 ratio. Individuals received SFJD capsules or a placebo three times daily for five consecutive days. Participants were followed up for more than 14 days after their RT-PCR nucleoid acid test for SARS-CoV-2 turned negative. The primary outcome measure was time to alleviate COVID-19 symptoms from baseline until the end of follow-up. Results: A total of 478 participants were screened; ultimately, 407 completed the trial after randomization (SFJD, n = 203; placebo, n = 204). No statistically significant difference in baseline parameters was observed between the two groups. The median time to alleviate all symptoms was 7 days in the SFJD group compared to 8 days in the placebo group (p = 0.037). Notably, the SFJD group significantly attenuated fever/chills (p = 0.04) and headache (p = 0.016) compared to the placebo group. Furthermore, the median time taken to reach normal body temperature within 24 h was reduced by 7 hours in the SFJD group compared to the placebo group (p = 0.033). No deaths or instances of serious or critical conditions occurred during this trial period; moreover, no serious adverse events were reported. Conclusion: The trial was conducted in a unique controlled hospital setting, and the 5-day treatment with SFJD capsules resulted in a 1-day reduction in overall symptoms, particularly headache and fever/chills, among COVID-19-infected participants with mild or moderate symptoms. Compared to placebo, SFJD capsules were found to be safe with fewer side effects. SFJD capsules could potentially serve as an effective treatment for alleviating mild to moderate symptoms of COVID-19. Clinical Trial Registration: https://www.isrctn.com/, identifier ISRCTN14236594.

In the context of rural Bangladesh, we assess whether agriculture training alone, nutrition Behavior Communication Change (BCC) alone, combined agriculture training and nutrition BCC, or agriculture training and nutrition BCC combined with gender sensitization improve: (a) production diversity, either on household fields or through crop, livestock or aquaculture activities carried out near the family homestead and (b) diet diversity and the quality of household diets. All treatment arms were implemented by government employees. Implementation quality was high. No treatment increased production diversification of crops grown on fields. Treatment arms with agricultural training did increase the number of different crops grown in homestead gardens and the likelihood of any egg, dairy, or fish production but the magnitudes of these effect sizes were small. All agricultural treatment arms had, in percentage terms, large effects on measures of levels of homestead production. However, because baseline levels of production were low, the magnitude of these changes in absolute terms was modest. Nearly all treatment arms improved measures of food consumption and diet with the largest effects found when nutrition and agriculture training were combined. Relative to treatments combining agriculture and nutrition training, we find no significant impact of adding the gender sensitization on our measures of production diversity or diet quality. Interventions that combine agricultural training and nutrition BCC can improve both production diversity and diet quality, but they are not a panacea. They can, however, contribute towards better diets of rural households.

BACKGROUND: Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this study aimed to summarize the epidemiological characteristics of the relevant trials and assess their reporting quality by the Adaptive designs CONSORT Extension (ACE) checklist.
METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to January 2020. We included drug RCTs that explicitly claimed to be adaptive trials or used any type of adaptative design. We extracted the epidemiological characteristics of included studies to summarize their adaptive design application. We assessed the reporting quality of the trials by Adaptive designs CONSORT Extension (ACE) checklist. Univariable and multivariable linear regression models were used to the association of four prespecified factors with the quality of reporting.
RESULTS: Our survey included 108 adaptive trials. We found that adaptive design has been increasingly applied over the years, and was commonly used in phase II trials (n = 45, 41.7%). The primary reasons for using adaptive design were to speed the trial and facilitate decision-making (n = 24, 22.2%), maximize the benefit of participants (n = 21, 19.4%), and reduce the total sample size (n = 15, 13.9%). Group sequential design (n = 63, 58.3%) was the most frequently applied method, followed by adaptive randomization design (n = 26, 24.1%), and adaptive dose-finding design (n = 24, 22.2%). The proportion of adherence to the ACE checklist of 26 topics ranged from 7.4 to 99.1%, with eight topics being adequately reported (i.e., level of adherence ≥ 80%), and eight others being poorly reported (i.e., level of adherence ≤ 30%). In addition, among the seven items specific for adaptive trials, three were poorly reported: accessibility to statistical analysis plan (n = 8, 7.4%), measures for confidentiality (n = 14, 13.0%), and assessments of similarity between interim stages (n = 25, 23.1%). The mean score of the ACE checklist was 13.9 (standard deviation [SD], 3.5) out of 26. According to our multivariable regression analysis, later published trials (estimated β = 0.14, p < 0.01) and the multicenter trials (estimated β = 2.22, p < 0.01) were associated with better reporting.
CONCLUSIONS: Adaptive design has shown an increasing use over the years, and was primarily applied to early phase drug trials. However, the reporting quality of adaptive trials is suboptimal, and substantial efforts are needed to improve the reporting.

BACKGROUND: Clinician collaboration can help high-risk individuals to manage their suicidal crises. However, limited research has directly examined how higher patient-clinician collaboration during assessment and intervention can effectively reduce suicidal ideation. This novel randomized clinical trial compared a high vs. low level of patient-clinician collaboration by pairing commonly used assessment (Structured Interview vs. Narrative Assessment) and intervention approaches (Safety Planning Intervention vs. Crisis Response Planning). We hypothesized that the interventions involving higher (than lower) patient-clinician collaboration during assessment (Narrative Assessment) or intervention (Crisis Response Planning) would lead to larger reductions in suicidal ideation.
METHODS: Eighty-two participants with a history of suicide ideation and/or attempts were randomly assigned to one of the four interventions varying in patient-clinician collaboration. After attrition, sixty-six participants completed the study. Suicidal ideation via ecological momentary assessment was measured 14 days before and 14 days after treatment.
RESULTS: Although the severity of suicidal ideation decreased in all groups, the two groups that included highly collaborative assessment had larger pre-post reductions in suicidal ideation (Narrative Assessment+Safety Plan; dwithin = 0.26, and Narrative Assessment+Crisis Response Plan; dwithin = 0.19) than the groups that included a checklist-based assessment (Structured Interview).
CONCLUSIONS: Longer follow-up periods with a larger sample would have provided an understanding of the durability of intervention effects.
CONCLUSIONS: Results suggest that the inclusion of higher patient-clinician collaboration techniques during suicide risk assessment can effectively reduce suicidal thoughts. Thus, clinician-led collaborative risk assessment approaches can enhance the effects of safety planning-type interventions among patients with elevated risk for suicide versus checklist-based assessment approaches.

BACKGROUND: In response to a growing need for accessible, efficient, and effective palliative care services, we designed, implemented, and evaluated a novel palliative care at home (PC@H) model for people with serious illness that is centered around a community health worker, a registered nurse, and a social worker, with an advanced practice nurse and a physician for support. Our objectives were to measure the impact of receipt of PC@H on patient symptoms, quality of life, and healthcare utilization and costs.
METHODS: We enrolled 136 patients with serious illness in this parallel, randomized controlled trial. Our primary outcome was change in symptom burden at 6 weeks. Secondary outcomes included change in symptom burden at 3 months, change in quality of life at 6 weeks and 3 months, estimated using a group t-test. In an exploratory aim, we examined the impact of PC@H on healthcare utilization and cost using a generalized linear model.
RESULTS: PC@H resulted in a greater improvement in patient symptoms at 6 weeks (1.30 score improvement, n = 37) and 3 months (3.14 score improvement, n = 21) compared with controls. There were no differences in healthcare utilization and costs between the two groups. Unfortunately, due to the COVID-19 pandemic and a loss of funding, the trial was not able to be completed as originally intended.
CONCLUSIONS: A palliative care at home model that leverages community health workers, registered nurses, and social workers as the primary deliverers of care may result in improved patient symptoms and quality of life compared with standard care. We did not demonstrate significant differences in healthcare utilization and cost associated with receipt of PC@H, likely due to inability to reach the intended sample size and insufficient statistical power, due to elements beyond the investigators\' control such as the COVID-19 public health emergency and changes in grant funding.