Abstract Behavioral intervention technologies (BITs) are web-based and mobile interventions intended to support patients and consumers in changing behaviors related to health, mental health, and ...well-being. BITs are provided to patients and consumers in clinical care settings and commercial marketplaces, frequently with little or no evaluation. Current evaluation methods, including RCTs and implementation studies, can require years to validate an intervention. This timeline is fundamentally incompatible with the BIT environment, where technology advancement and changes in consumer expectations occur quickly, necessitating rapidly evolving interventions. However, BITs can routinely and iteratively collect data in a planned and strategic manner and generate evidence through systematic prospective analyses, thereby creating a system that can “learn.” A methodologic framework, Continuous Evaluation of Evolving Behavioral Intervention Technologies (CEEBIT), is proposed that can support the evaluation of multiple BITs or evolving versions, eliminating those that demonstrate poorer outcomes, while allowing new BITs to be entered at any time. CEEBIT could be used to ensure the effectiveness of BITs provided through deployment platforms in clinical care organizations or BIT marketplaces. The features of CEEBIT are described, including criteria for the determination of inferiority, determination of BIT inclusion, methods of assigning consumers to BITs, definition of outcomes, and evaluation of the usefulness of the system. CEEBIT offers the potential to collapse initial evaluation and postmarketing surveillance, providing ongoing assurance of safety and efficacy to patients and consumers, payers, and policymakers.
Although widely reported among Latino populations, contradictory evidence exists regarding the generalizability of the immigrant paradox, i.e., that foreign nativity protects against psychiatric ...disorders. The authors examined whether this paradox applies to all Latino groups by comparing estimates of lifetime psychiatric disorders among immigrant Latino subjects, U.S-born Latino subjects, and non-Latino white subjects.
The authors combined and examined data from the National Latino and Asian American Study and the National Comorbidity Survey Replication, two of the largest nationally representative samples of psychiatric information.
In the aggregate, risk of most psychiatric disorders was lower for Latino subjects than for non-Latino white subjects. Consistent with the immigrant paradox, U.S.-born Latino subjects reported higher rates for most psychiatric disorders than Latino immigrants. However, rates varied when data were stratified by nativity and disorder and adjusted for demographic and socioeconomic differences across groups. The immigrant paradox consistently held for Mexican subjects across mood, anxiety, and substance disorders, while it was only evident among Cuban and other Latino subjects for substance disorders. No differences were found in lifetime prevalence rates between migrant and U.S.-born Puerto Rican subjects.
Caution should be exercised in generalizing the immigrant paradox to all Latino groups and for all psychiatric disorders. Aggregating Latino subjects into a single group masks significant variability in lifetime risk of psychiatric disorders, with some subgroups, such as Puerto Rican subjects, suffering from psychiatric disorders at rates comparable to non-Latino white subjects. Our findings thus suggest that immigrants benefit from a protective context in their country of origin, possibly inoculating them against risk for substance disorders, particularly if they emigrated to the United States as adults.
Evidence-based medicine is the application of scientific evidence to clinical practice. This article discusses the difficulties of applying global evidence ("average effects" measured as population ...means) to local problems (individual patients or groups who might depart from the population average). It argues that the benefit or harm of most treatments in clinical trials can be misleading and fail to reveal the potentially complex mixture of substantial benefits for some, little benefit for many, and harm for a few. Heterogeneity of treatment effects reflects patient diversity in risk of disease, responsiveness to treatment, vulnerability to adverse effects, and utility for different outcomes. Recognizing these factors, researchers can design studies that better characterize who will benefit from medical treatments, and clinicians and policymakers can make better use of the results.
This exploratory trial was conducted to test the effects of an alpha7 nicotinic receptor partial agonist, TC-5619, on cognitive dysfunction and negative symptoms in subjects with schizophrenia. In ...the United States and India, 185 outpatients (18-60 years; male 69%; 46% tobacco users) with schizophrenia treated with quetiapine or risperidone monotherapy were randomized to 12 weeks of placebo (n=91) or TC-5619 (n=94; orally once daily 1 mg day 1 to week 4, 5 mg week 4 to 8, and 25 mg week 8 to 12). The primary efficacy outcome measure was the Groton Maze Learning Task (GMLT; executive function) of the CogState Schizophrenia Battery (CSB). Secondary outcome measures included: CSB composite score; Scale for Assessment of Negative Symptoms (SANS); Clinical Global Impression-Global Improvement (CGI-I); CGI-severity (CGI-S); and Subject Global Impression-Cognition. GMLT statistically favored TC-5619 (P=0.036) in this exploratory trial. SANS also statistically favored TC-5619 (P=0.030). No other secondary outcome measure demonstrated a drug effect in the total population; there was a statistically significant drug effect on working memory in tobacco users. The results were typically stronger in favor of TC-5619 in tobacco users and occasionally better in the United States than in India. TC-5619 was generally well tolerated with no clinically noteworthy safety findings. These results support the potential benefits of TC-5619 and alpha7 nicotinic receptor partial agonists for cognitive dysfunction and negative symptoms in schizophrenia.
Objective: Given the growing number of military service members with families and the multiple combat deployments characterizing current war time duties, the impact of deployments on military ...children requires clarification. Behavioral and emotional adjustment problems were examined in children (aged 6 through 12) of an active duty Army or Marine Corps parent currently deployed (CD) or recently returned (RR) from Afghanistan or Iraq. Method: Children (N = 272) and their at-home civilian (AHC) (N = 163) and/or recently returned active duty (AD) parent (N = 65) were interviewed. Child adjustment outcomes were examined in relation to parental psychological distress and months of combat deployment (of the AD) using mixed effects linear models. Results: Parental distress (AHC and AD) and cumulative length of parental combat-related deployments during the child's lifetime independently predicted increased child depression and externalizing symptoms. Although behavioral adjustment and depression levels were comparable to community norms, anxiety was significantly elevated in children in both deployment groups. In contrast, AHC parental distress was greater in those with a CD (vs. RR) spouse. Conclusions: Findings indicate that parental combat deployment has a cumulative effect on children that remains even after the deployed parent returns home, and that is predicted by psychological distress of both the AD and AHC parent. Such data may be informative for screening, prevention, and intervention strategies. (Contains 3 figures and 5 tables.)
Alternatives to the Randomized Controlled Trial West, Stephen G; Duan, Naihua; Pequegnat, Willo ...
American journal of public health (1971),
08/2008, Letnik:
98, Številka:
8
Journal Article
Recenzirano
Odprti dostop
Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible ...option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented.
The authors sought to determine whether a significant association exists between the use of stimulants and the rare event of sudden unexplained death in children and adolescents.
A matched ...case-control design was performed. Mortality data from 1985-1996 state vital statistics were used to identify 564 cases of sudden death occurring at ages 7 through 19 years across the United States along with a matched group of 564 young people who died as passengers in motor vehicle traffic accidents. The primary exposure measure was the presence of amphetamine, dextroamphetamine, methamphetamine, or methylphenidate according to informant reports or as noted in medical examiner records, toxicology results, or death certificates.
In 10 (1.8%) of the sudden unexplained deaths it was determined that the youths were taking stimulants, specifically methylphenidate; in contrast, use of stimulants was found in only two subjects in the motor vehicle accident comparison group (0.4%), with only one involving methylphenidate use. A significant association of stimulant use with sudden unexplained death emerged from the primary analysis, which was based on exact conditional logistic regression (odds ratio=7.4, 95% CI=1.4 to 74.9). A comprehensive series of sensitivity analyses yielded qualitatively similar findings.
This case-control study provides support for an association between the use of stimulants and sudden unexplained death among children and adolescents. Although sudden unexplained death is a rare event, this finding should be considered in the context of other data about the risk and benefit of stimulants in medical treatment.
The COVID-19 pandemic spurred publication of a rapid proliferation of studies on potential therapeutic agents. While important for the advancement of clinical care, pressure to collect, analyze, and ...report data in an expedited manner could potentially increase the rate of important errors, some of which would be captured in published errata. We hypothesized that COVID-19 therapeutic studies published in the early years of the pandemic would be associated with a high rate of published errata and that, within these errata, there would be a high prevalence of serious errors.
We performed a review of published errata associated with empirical studies of COVID-19 treatments. Errata were identified via a MEDLINE and Embase search spanning January 2020 through September 2022. Errors located within each published erratum were characterized by location within publication, error type, and error seriousness.
Of 47 studies on COVID-19 treatments with published errata, 18 met inclusion criteria. Median time from publication of the original article to publication of the associated erratum was 76 days (range, 12-511 days). A majority of errata addressed issues with author attribution or conflict of interest disclosures (39.5%) or numerical results (25.6%). Only one erratum contained a serious error: a typographical error which could have misled readers into believing that the treatment in question had serious adverse effects when in fact it did not.
Despite accelerated publication times, we found among studies of COVID-19 treatments the majority of errata (17/18) reported minor errors that did not lead to misinterpretation of the study results. Retractions, an indicator of scientific misdirection even more concerning than errata, were beyond the scope of this review.
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