Tag: statistics

BMJ Open. 2024 Mar 20;14(3):e081455. doi: 10.1136/bmjopen-2023-081455.

ABSTRACT

INTRODUCTION: SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

METHODS AND ANALYSIS: The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

ETHICS AND DISSEMINATION: The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05533918 and NCT05533359.

PMID:38508633 | DOI:10.1136/bmjopen-2023-081455

BMJ Open. 2024 Mar 19;14(3):e075547. doi: 10.1136/bmjopen-2023-075547.

ABSTRACT

OBJECTIVES: To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

DESIGN: Qualitative interviews analysed using thematic analysis.

SETTING AND PARTICIPANTS: Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

RESULTS: Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

CONCLUSIONS: Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

PMID:38508621 | DOI:10.1136/bmjopen-2023-075547

BMJ Open. 2024 Mar 19;14(3):e079071. doi: 10.1136/bmjopen-2023-079071.

ABSTRACT

BACKGROUND: Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning-specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

METHODS AND ANALYSIS: We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

ETHICS AND DISSEMINATION: As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

REGISTRATION: https://doi.org/10.17605/OSF.IO/ZHDKR.

PMID:38508618 | DOI:10.1136/bmjopen-2023-079071

J Am Pharm Assoc (2003). 2024 Mar 18:102070. doi: 10.1016/j.japh.2024.102070. Online ahead of print.

ABSTRACT

BACKGROUND: North Carolina (NC) House Bill 96, effective February 2022, enabled trained immunizing pharmacists across the state to prescribe hormonal contraceptives (HCs). However, the extent and barriers to deployment are unknown. The purpose of this study was to describe the uptake and challenges from outpatient pharmacists who trained to provide HCs in an outpatient practice to assist others in the implementation of this service.

OBJECTIVES: The primary objective was to estimate the proportion of trained NC pharmacists who provided HCs in an outpatient setting. The secondary objective was to identify barriers during the implementation of this service.

METHODS: This cross-sectional, anonymous, web-based survey was emailed on December 13, 2022 to NC-licensed pharmacists enrolled in the required training. A reminder email was sent on January 10, 2023, with all responses considered up to January 31, 2023. Pharmacists licensed in NC who performed at least 50% of their clinical practice in an outpatient setting were included. The primary endpoint was having prescribed HC (Y/N). All endpoints were analyzed using descriptive statistics.

RESULTS: Of 1,633 pharmacists eligible, 96 completed responses were included in the analysis (5.9%). Training was incomplete in 11/96 (11.5%), and 66/96 (68.8%) completed the training without implementing the service. Of the remaining 19/96 (19.8%) that developed a HC service, 15/96 (15.6%) had prescribed HCs. Among the 15 prescribing pharmacists, all reported positive patient feedback, while 7/15 reported improved job satisfaction. Among all 96 respondents, barriers reported included time constraints (49%) and a lack of appropriate reimbursement (43.8%).

CONCLUSION: Few HC-trained NC outpatient pharmacists are prescribing HCs. Addressing prescribing barriers would potentially expand the scope of this service and further innovate the outpatient pharmacy setting.

PMID:38508518 | DOI:10.1016/j.japh.2024.102070

Can J Diabetes. 2024 Mar 18:S1499-2671(24)00059-5. doi: 10.1016/j.jcjd.2024.03.003. Online ahead of print.

ABSTRACT

BACKGROUND: No data are available regarding glycemic control of patients with type 1 diabetes mellitus (T1D) during Passover.

OBJECTIVE: To assess the effect of Passover on diabetes management and glycemic control in adults with T1D with nutritional changes during Passover (observant) compared with patients who did not change their dietary habits during Passover (non-observant).

METHODS: Observational pre-post study of adult patients with T1D, followed in a diabetes clinic in Israel. Data were downloaded from insulin pumps and CGM for 37 days: 2 weeks before Passover, 9 days of Passover, and 2 weeks thereafter. Differences in percentage of time spent above target (>10.0 mmol/l and >13.9 mmol/l), at target (3.9-10.0 mmol/l) and below target (<3.9mmol/l and <3.0 mmol/l) were compared using paired t-tests or paired signed rank tests.

RESULTS: The study cohort included 43 patients (23 observant, 20 non-observant). The average BG was significantly higher during Passover compared with the period before Passover – in non-observant patients 8.2±1.5 mmol/l and 7.9±1.3 mmol/l (p=0.043), respectively, and in observant patients 8.7±1.6 mmol/l and 8.4±1.6 mmol/l (p=0.048), respectively. Time above range (TAR) 10-13.9 mmol/l was increased in observant patients during Passover, as compared to the period before Passover – 24.9±16.2% and 20.6±12.4% (p=0.04), respectively. The dose of bolus insulin had increased significantly in observant patients – 27.4±13.9 units during Passover, as compared with 24.2±11.2 units before Passover (p=0.02).

CONCLUSIONS: Passover alters glycemic control and insulin needs in Jewish patients with T1D. It is advisable to make specific adjustments to maintain the recommended glycemic control.

PMID:38508514 | DOI:10.1016/j.jcjd.2024.03.003

J Clin Epidemiol. 2024 Mar 18:111327. doi: 10.1016/j.jclinepi.2024.111327. Online ahead of print.

ABSTRACT

OBJECTIVE: To apply a hierarchical model (HM) that addresses measurement error in regression of the treatment effect on the control group event rate (CR). We compare HM to weighted linear regression (WLR) which is subject to measurement error and mathematical coupling.

STUDY DESIGN AND SETTING: We reviewed published hierarchical models that address measurement error and implemented a Bayesian version in open-source code to facilitate adoption by meta-analysts. We compared WLR and HM across a very large convenience sample of meta-analyses published in the Cochrane Database of Systematic Reviews.

RESULTS: We applied both approaches (WLR and a HM that addresses measurement error) to 3,193 meta-analyses that included 33,071 studies (average 10.28 studies per meta-analysis). A statistically significant slope suggesting an association between the treatment effect and CR was demonstrated with both approaches in 568 (17.19%) meta-analyses, with neither approach in 2,036 (63.77%) meta-analyses, only with WLS in 229 (7.17%) and only with HM in 360 (11.28%) meta-analyses. The majority of slopes were negative (WLR 85%, HM 83%). In the majority of cases, HM had wider confidence intervals (72.53%) and slopes farther from the null (64.77%).

CONCLUSION: Approximately 28% of meta-analyses demonstrate a significant association between the treatment effect and CR when HM is used to address measurement error. User-friendly open-source code is provided to meta-analysts interested in exploring this association.

PMID:38508503 | DOI:10.1016/j.jclinepi.2024.111327

J Neurosci Methods. 2024 Mar 18:110112. doi: 10.1016/j.jneumeth.2024.110112. Online ahead of print.

ABSTRACT

BACKGROUND: Visualizing edges is critical for neuroimaging. For example, edge maps enable quality assurance for the automatic alignment of an image from one modality (or individual) to another.

NEW METHOD: We suggest that using the second derivative (difference of Gaussian, or DoG) provides robust edge detection. This method is tuned by size (which is typically known in neuroimaging) rather than intensity (which is relative).

RESULTS: We demonstrate that this method performs well across a broad range of imaging modalities. The edge contours produced consistently form closed surfaces, whereas alternative methods may generate disconnected lines, introducing potential ambiguity in contiguity.

COMPARISON WITH EXISTING METHODS: Current methods for computing edges are based on either the first derivative of the image (FSL), or a variation of the Canny Edge detection method (AFNI). These methods suffer from two primary limitations. First, the crucial tuning parameter for each of these methods relates to the image intensity. Unfortunately, image intensity is relative for most neuroimaging modalities making the performance of these methods unreliable. Second, these existing approaches do not necessarily generate a closed edge/surface, which can reduce the ability to determine the correspondence between a represented edge and another image.

CONCLUSION: The second derivative is well suited for neuroimaging edge detection. We include this method as part of both the AFNI and FSL software packages, standalone code and online.

PMID:38508496 | DOI:10.1016/j.jneumeth.2024.110112

Top Companion Anim Med. 2024 Mar 18:100862. doi: 10.1016/j.tcam.2024.100862. Online ahead of print.

ABSTRACT

Two studies were developed to compare Borrelia burgdorferi antibody detection between the VetScan Flex4 and SNAP 4Dx Plus tests. The objective of the first study was to evaluate the diagnostic sensitivity (Se) and specificity (Sp) of VetScan Flex4 and SNAP 4Dx Plus B. burgdorferi results using field sourced samples compared to a Western Blot reference method. The sensitivity and specificity of VetScan Flex4 were 81.9% (95% CI: 71.9%-89.5%) and 89.3% (95% CI: 85.2%-92.9%) respectively, and SNAP 4Dx Plus’s sensitivity and specificity were 80.7% (95% CI: 70.6%-88.6%) and 92.8% (95% CI: 89.1%-95.5%) respectively. When comparing VetScan Flex4 and Snap 4Dx Plus, the Simple Kappa Coefficient estimate was 0.76 (95% CI: 0.69-0.84) indicating substantial agreement between the two methods. McNemar’s Test revealed concordance between the two methods was not statistically significant (P = 0.05). The objective of the second study was to evaluate whether VetScan Flex4 differentiates between B. burgdorferi antibodies derived from infection versus vaccination with commonly used canine Lyme vaccines. The sensitivity and specificity of the VetScan Flex4 in differentiating canine Lyme vaccination from infection with Borrelia burgdorferi were 100% (Se 95% CI: 78.2%-100%; Sp 95% CI: 91.2%-100%). In conclusion, the VetScan Flex4 is a reliably sensitive and specific point-of-care test that is similar to Snap 4Dx Plus, can differentiate between infection and Lyme vaccination, and can be utilized by veterinarians for Lyme disease diagnosis and surveillance of B. burgdorferi exposure.

PMID:38508488 | DOI:10.1016/j.tcam.2024.100862

J Affect Disord. 2024 Mar 18:S0165-0327(24)00512-3. doi: 10.1016/j.jad.2024.03.089. Online ahead of print.

ABSTRACT

Exposure and response prevention (ERP) is an evidence-based treatment for obsessive-compulsive disorder (OCD). Theories for how it works vary in their emphasis on active mechanisms of change. The current study aimed to clarify mechanisms of change in ERP for OCD using network analysis, comparing ERP networks at the start and end of intensive treatment (partial hospital and residential). In our sample of 182 patients, the most central node in both networks was engagement with exposure, which was consistently related to greater understanding of ERP rationale, higher willingness, and less ritualization, accounting for all other variables in the network. There were no significant differences in networks between the start and end of treatment. These results suggest that nonspecific parameters like facilitating engagement in exposures without ritualizing and providing a clear rationale to clients may be key to effective treatment. As such, it may be useful for clinicians to spend adequate time underscoring the need to eliminate rituals to fully engage in exposure tasks and explaining the rationale for ERP prior to doing exposures, regardless of theoretical orientation. Nonetheless, findings represent group-level statistics and more fine-grained idiographic analyses may reveal individual-level differences with respect to central mechanisms of change. Other limitations include demographic homogeneity of our sample.

PMID:38508457 | DOI:10.1016/j.jad.2024.03.089

J Affect Disord. 2024 Mar 18:S0165-0327(24)00513-5. doi: 10.1016/j.jad.2024.03.090. Online ahead of print.

ABSTRACT

BACKGROUND: The association between physical multimorbidity and depression differs by populations. However, no direct inter- or intrapopulation comparison of the association has been conducted. Thus, this study aims to estimate the association in China and the United States and reveal inter- and intrapopulation differences in the association.

METHODS: Middle-aged and older adults from the China Health and Retirement Longitudinal Study and the Health and Retirement Study were included. Physical multimorbidity was defined as the simultaneous presence of two or more chronic physical conditions and depressive symptoms was measured by the Center for Epidemiologic Studies Depression Scale. Generalized estimating equation model and stratification multilevel method were the main statistical models.

RESULTS: The presence of physical multimorbidity was associated with a higher risk of depression in both China (RR = 1.360 [95 % CI: 1.325-1.395]) and the US (RR = 1.613 [95 % CI: 1.529-1.701]). For individuals at a low risk of multimorbidity, multimorbidity was associated with 47.4 % (95 % CI: 1.377-1.579) and 71.1 % (95 % CI: 1.412-2.074) increases in the likelihood of depression in China and the US. The effect size was smaller for individuals at a moderate or high risk. However, the cross-national differences were greater for those with a high risk of multimorbidity.

LIMITATIONS: The self-report measures, attribution bias.

CONCLUSIONS: Compared to Chinese adults, the presence of physical multimorbidity led to an additional increase in depressive symptoms for American counterparts. The association was stronger for individuals at a low risk of multimorbidity, but cross-national differences were observed mostly among individuals at a high risk.

PMID:38508455 | DOI:10.1016/j.jad.2024.03.090