Data Analysis Plan Research Articles

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study.

Epidemiological studies involving large samples usually face financial and operational challenges. To describe the planning and execution of ADHERE Brazil, an epidemiological study on 1,105 kidney transplant patients, and report on how the study was structured, difficulties faced and solutions found. Cross-sectional multicenter study in 20 Brazilian kidney transplantation centers. Actions developed in each phase of implementation were described, with emphasis on innovations used within the logistics of this study, aimed at estimating the prevalence of nonadherence to treatment. Coordination of activities was divided into four areas: general, regulatory, data collection and statistics. Weekly meetings were held for action planning. The general coordination team was in charge of project elaboration, choice of participating centers, definition of publication policy and monitoring other coordination teams. The regulatory team provided support to centers for submitting the project to ethics committees. The data collection team prepared a manual on the electronic collection system, scheduled web meetings and was available to respond to queries. It also monitored the data quality and reported any inadequacies found. Communication with the centers was through monthly reports via e-mail and distribution of exclusive material. The statistical team acted in all phases of the study, especially in creating the data analysis plan and data bank, generation of randomization lists and data extraction. Through these logistics, we collected high-quality data and built a local research infrastructure for further studies. We present supporting alternatives for conducting similar studies. http://clinicaltrials.gov/ on October 10, 2013; NCT02066935.

0347 Sleep health education and a personalized smartphone application improve sleep and productivity and reduce healthcare utilization among employees: Results of a randomized clinical trial

Abstract Introduction Sleep deficiency and undiagnosed or untreated sleep disorders are pervasive among employed adults, yet are often ignored in the context of workplace health promotion. Smartphone applications (apps) are a promising, scalable approach to improving sleep among employees. We evaluated an online sleep education program followed by access to a mobile sleep training program, the dayzz app, that promotes healthy sleep, sleep disorders awareness and intervention. Methods In a sample of daytime employees affiliated with a large healthcare organization, we evaluated the intervention (sleep education at baseline plus access to the personalized app for up to 9 months) in a parallel group, randomized controlled trial. Participants were randomly assigned to either the experimental condition that received the intervention in months 1 through 9 or the control group that was assigned to receive the intervention in month 10. In a prespecified data analysis plan, the experimental and control groups were compared in months 1 through 9; no outcome data was collected thereafter. We collected data on employee sleep, workplace outcomes, and healthcare utilization, monthly throughout the study. Results The final cohort was comprised of 794 participants assigned to the experimental and 561 to the control condition. Those assigned to the experimental condition were more likely to maintain consistent sleep schedules (OR:1.40;95%CI:1.12-1.75) and less likely to experience fatigue and sleepiness (OR:1.30;95%CI:1.08-1.57). At the 9-month follow-up assessment, the experimental group reported significantly longer sleep duration than the control group on work (experimental: 7.20hrs; control: 6.99hrs, p=0.01) and free (experimental: 8.26hrs; control: 8.04hrs, p=0.03) nights. The odds of poor sleep quality at follow-up were lower in the experimental condition (OR:0.79,95%CI:0.63-0.98) as compared to control. Mean total dollars lost due to presenteeism was less among experimental compared to control participants (p=0.0001), corresponding to an average of $274 saved per person per month. Finally, participants in the experimental group were less likely to report mental health visits (p=0.01) and had a lower rate of overall healthcare utilization (p=0.03), compared to the control group. Conclusion Results from this randomized clinical trial demonstrate that a digital workplace sleep wellness program can be beneficial to both employees and employers, by improving employee sleep and fatigue, increasing work productivity, and reducing direct healthcare costs. Support (If Any) This study was funded by dayzz Live Well Ltd.

Quantifying ship noise bias in fish abundance estimates in the Great Lakes

Prey fish abundances in the Great Lakes are a driver for several agencies commitments to the Council of Lake Committees to support fisheries management. These management decisions have profound economic and social impacts within the Great Lakes region. Fisheries estimates done by echosounders or trawling may be biased due to the propagated noise from large fisheries vessels. In the first year of a four year collaborative study, crewed fisheries vessels and uncrewed Saildrone vessels were used to compare abundance estimates between “loud” and “quiet” vessels. In order to quantify the effects of ship noise on prey fish abundance estimates, a mobile ship noise measurement system was designed and deployed to measure radiated acoustic signatures of several ships in the Great Lakes. This talk will discuss the deployment of a mobile underwater acoustic test range, and show initial results of ship noise measurements from the first year of the program. In addition, an overview of the echosounder abundance results will be given along with plans for future data generation, analysis, and comparison between crewed and autonomous systems.

The effects of induced sadness, stress sensitivity, negative urgency, and gender in laboratory gambling

ABSTRACT Previous research indicates that the invigorating effect of stress sensitivity on gambling behavior might be moderated by individual differences. The current preregistered study tested whether gender and negative urgency (i.e. an emotion-related impulsivity trait) moderate the relationship between perceived stress and laboratory gambling following experimentally induced sadness. One hundred twenty college students were randomly assigned to a sadness versus a control condition before completing a laboratory gambling task. Although the distribution of the main study variables forced us to slightly deviate from the preregistered data analysis plan, we were able to show that heightened stress sensitivity affects gambling behavior and that this effect differs by gender (but not in terms of negative urgency) under conditions of sadness versus neutral mood. Men with high stress sensitivity gambled more money and more frequently selected the riskier betting option in the sadness condition, whereas women with heightened stress sensitivity display the same pattern in the neutral condition. Our study is relevant from a methodological standpoint and answers recent calls for endorsing open-science practices in gambling research. Findings also suggest that more research into female gambling is warranted and that emotion-regulation skills should be a central component of problem gambling prevention.

Association Between Consumption of Fermented Food and Food-Derived Prebiotics With Cognitive Performance, Depressive, and Anxiety Symptoms in Psychiatrically Healthy Medical Students Under Psychological Stress: A Prospective Cohort Study.

BackgroundGut microbiota-based therapeutic strategies, such as probiotic and prebiotic preparations, may benefit mental health. However, commonly consumed fermented and prebiotic-containing foods have not been well-tested. The aim of the present study was to determine whether consumption of fermented food and food-derived prebiotics is associated with cognitive performance, depressive, and anxiety symptoms in psychiatrically healthy medical students under psychological stress.MethodsThe study protocol with data analysis plan was prospectively registered. Food consumption was evaluated with a 7-day dietary record. Cognitive performance was modeled with academic examination performance in relation to subject knowledge. Pre-exam depressive and anxiety symptoms were assessed with the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7, respectively.ResultsIn total, 372 medical students (22.7 ± 1.1 years of age, 66% female) completed the study. No relationship was observed between cognitive performance under stress and either fermented food (adjusted β 0.02, 95% CI −0.07–0.11, p = 0.63) or food-derived prebiotics consumption (adjusted β −0.00, 95% CI −0.09–0.09, p = 0.99). High intake of fermented food was associated with more severe depressive (adjusted β 0.11, 95% CI 0.01–0.20, p = 0.032) and anxiety symptoms under stress (adjusted β 0.13, 95% CI 0.04–0.22, p = 0.0065); however, no such link was observed for food-derived prebiotics (adjusted β 0.03, 95% CI −0.07–0.13, p = 0.50 and −0.01, 95% CI −0.11–0.08, p = 0.83, for depression and anxiety, respectively).ConclusionsUnder psychological stress in medical students, consumption of fermented food and food-derived prebiotics appears to be not associated with cognitive performance. High intake of fermented food, but not food-derived prebiotics, may be associated with severity of depressive and anxiety symptoms. The safety of fermented food in this regard therefore requires further clarification.

Arterial and Venous Thromboembolism in Critically Ill, COVID-19 Positive Patients Admitted to Intensive Care Unit

Arterial and Venous Thromboembolism in Critically Ill, COVID-19 Positive Patients Admitted to Intensive Care Unit

Problematic gaming risk among European adolescents: a cross-national evaluation of individual and socio-economic factors.

Background and AimsPrevious research has identified numerous risk and protective factors of adolescent problematic gaming (PG) at the individual and social levels; however, the influence of socio‐economic indicators on PG is less known. This study aimed to measure the contribution of individual and socio‐economic factors involved in PG risk among adolescents from 30 European countries.DesignMulti‐level logistic regression analysis of survey data from the 2019 European School Survey Project on Alcohol and Other Drugs (ESPAD) cross‐sectional study using self‐administered anonymous questionnaires.SettingThirty European countries.ParticipantsA representative cohort of 15–16‐year‐old students (n = 88 998 students; males = 49.2%).MeasurementsThe primary outcome measure was adolescents’ (low and high) risk of PG. Individual key predictors included self‐report assessments of socio‐demographic characteristics, time spent gaming and family variables (parental regulation and monitoring, family support). Main country‐level predictors comprised Gini coefficient for economic inequalities and benefits for families and children (% gross domestic product), retrieved from international public data sets and national thematic reports. The data analysis plan involved multi‐level logistic regression.FindingsParticipants who reported stronger parental regulation [odds ratio (OR) = 0.81, 95% confidence interval (CI) = 0.79–0.83] and higher family support (OR = 0.93, 95% CI = 0.91–0.95) reported lower risk of PG. At the country‐level, economic inequalities (OR = 1.05, 95% CI = 1.03–1.07) were positively associated with the risk of PG, while benefits for families and children (OR = 0.78, 95% CI = 0.70–0.89) were negatively correlated with the risk of PG.ConclusionsSupportive family environments, lower country‐level economic inequalities and higher government expenditures on benefits for families and children appear to be associated with a lower risk of problematic gaming among European adolescents.

Registration and primary outcome reporting in behavioral health trials

BackgroundRegistration of research studies is designed to lock investigators into a data collection and analysis plan before a study starts and thereby limit their ability to engage in flexible data analysis and selective outcome reporting. Studies of registered clinical trials show that one- to two-thirds are registered after the study has started and that non-adherence to important design and analytic features, such as reporting data pertaining to all primary outcomes, remains high. Less is known about the effects of registration on research transparency and integrity outside of clinical trials. To address this gap in knowledge, the current study examined the effects of registration on the reporting of research findings in a sample of behavioral health trials published in BMC Public Health.MethodsRegistered trials published in the BMC Public Health section “Health Behavior, Health Promotion and Society” between 2011 and 2015 were included in the study. For each trial, we reviewed associated online submissions from 13 different registration sites. For those determined to have been prospectively registered, we used the trial registry, MEDLINE (Pubmed), PsychINFO, Web of Science and e-mails to investigators to identify subsequent publications from the study that reported results pertaining to primary outcomes. The two investigators then independently reviewed the outcome publication(s) and compared the primary outcomes reported in these to the registered primary outcomes.ResultsThe final analytic sample comprised 136 locatable, registered trials with an identifiable start date. Sixty-eight of the 136 were prospectively registered. Among these prospectively registered trials, only 16 published manuscripts reported outcomes and methods that were concordant with their registrations.ConclusionsRetrospective submission of protocols for publication and retrospective registration remain common in public health research, and adherence to prespecified outcomes is rare. In its current form, registration of behavioral and health promotion trials is likely to have minimal effect on preventing selective outcome reporting in publications, and the pervasiveness of vague and incomplete registry entries means that registries will have limited utility in terms of facilitating replication studies.

Examining the protective function of perceptions of post-traumatic growth against entrapment and suicidal ideation

BackgroundRecent evidence has found that reporting post-traumatic growth (PTG) from a past stressful life event is associated with lower reports of suicidal ideation. Perceptions of PTG measure the extent to which an individual reports positive changes in their identity, relationships, and worldviews after a stressful event. However, little is known about how perceptions of PTG interact with feelings of defeat and entrapment to influence suicidal ideation. The current study examined this question through the Integrated Motivational-Volitional (IMV) Model of Suicidal Behavior. Methods521 adult participants (315 females with age range of 18–82, M = 30.4 years, SD = 13.6) completed an online cross-sectional questionnaire with defeat, entrapment, suicidal ideation, PTG, depression and anxiety measures. Hypotheses and data analysis plans were pre-registered prior to data collection. ResultsPTG negatively correlated with defeat, entrapment and suicidal ideation. PTG predicted lower suicidal ideation when controlling for entrapment, depression and anxiety. PTG did not moderate the relationship between defeat on entrapment or the relationship between entrapment on suicidal ideation. LimitationsThe findings were based on cross-sectional data where participants recalled experiences of defeat, entrapment and suicidal ideation from the past year. The sample was a large community (non-clinical) sample, and most of the participants identified as white (85%). ConclusionAlthough PTG did not function as a moderator within the IMV model of suicidality, it predicted lower suicidal ideation while controlling for other known predictors of suicidal ideation.Future research could explore the function of PTG in appraisal-based models of suicidality.

FRailty and Arterial stiffness - the role of oXidative stress and Inflammation (FRAXI study).

Objective:There is an association between frailty and arterial stiffness. However, arterial stiffness does not uniformly correlate with the spectrum of frailty states. Both oxidative stress and inflammaging contribute to vascular ageing. There are no human studies exploring links between arterial stiffness, oxidative stress, inflammaging and frailty. Our objective is to investigate arterial stiffness and inflammaging as predictors of frailty states.Methods:An observational longitudinal cohort study will be used to examine the association between arterial stiffness, oxidative stress and inflammation in 50 older adults (⩾70 years) with clinical frailty scores (CFS) ⩽6 over 6 months. All study measurements will be taken at baseline. Frailty assessment will include hand-grip strength, timed-up and go test, mini-mental state examination, geriatric depression scale and sarcopenia using body composition measurements with Tanita®. Arterial stiffness measurements will include carotid-femoral pulse wave velocity (cfPWV) and carotid-radial pulse wave velocity (crPWV) using Complior (Alam Medical, France). CAVI device will measure Cardio-ankle vascular index and ankle brachial index (ABI). Oxidative stress blood markers nitrotyrosine (NT) and 8-hydroxy-2’-deoxyguanosin (8-oxo-dG) and inflammation markers high-sensitive C-reactive protein (hs-CRP) and interlukin-6(IL-6) will be measured at baseline and 6 month along with lipid profile and glycated haemoglobin.Results (data analysis plan):Descriptive statistics for continuous data using means and standard deviations for normality distributed variables or medians and inter-quartile ranges for skewed variables will be used. Participants will be categorised into CFS 1-3, and CFS 4-6. Categorical data will use frequencies and comparison between groups. Change in frailty between the groups over 6 months will be compared using paired t-test. Simple linear regression will be done between frailty measures, arterial stiffness, inflammation and oxidative stress biomarkers. Significance will be at P < .05.Conclusion:This study data will inform a larger, multi-centre study exploring further the interplay between frailty, biomarkers and arterial stiffness parameters.

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial.

BackgroundThe prevalence of smoking among cervical cancer survivors is strikingly high, yet no smoking cessation interventions to date have specifically targeted this population. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial designed to evaluate the efficacy of a theoretically and empirically based Motivation And Problem Solving (MAPS) approach for promoting and facilitating smoking cessation among cervical cancer survivors. MAPS is a comprehensive, dynamic, and holistic intervention that incorporates empirically supported cognitive behavioral and social cognitive theory–based treatment strategies within an overarching motivational framework. MAPS is designed to be appropriate for all smokers regardless of their motivation to change and views motivation as dynamically fluctuating from moment to moment throughout the behavior change process.ObjectiveThis 2-group randomized controlled trial compares the efficacy of standard treatment to MAPS in facilitating smoking cessation among women with a history of high-grade cervical dysplasia or cervical cancer.MethodsParticipants (N=202) are current smokers with a history of high-grade cervical dysplasia or cervical cancer recruited nationally and randomly assigned to one of two treatment conditions: (1) standard treatment (ST) or (2) MAPS. ST consists of repeated letters referring participants to their state’s tobacco cessation quitline, standard self-help materials, and free nicotine replacement therapy when ready to quit. MAPS has all ST components along with 6 proactive telephone counseling sessions delivered over 12 months. The primary outcome is abstinence from tobacco at 18 months. Secondary outcomes include abstinence over time across all assessment points, abstinence at other individual assessment time points, quit attempts, cigarettes per day, and use of state quitlines. Hypothesized treatment mechanisms and cost-effectiveness will also be evaluated.ResultsThis study was approved by the institutional review boards at the University of Texas MD Anderson Cancer Center, the University of Oklahoma Health Sciences Center, and Moffitt Cancer Center. Participant enrollment concluded at Moffitt Cancer Center in January 2020, and follow-up data collection was completed in July 2021. Data analysis is ongoing.ConclusionsThis study will yield crucial information regarding the efficacy and cost-effectiveness of a MAPS approach for smoking cessation tailored to the specific needs of women with a history of high-grade cervical dysplasia or cervical cancer. Findings indicating that MAPS has substantially greater efficacy than existing evidence-based tobacco cessation treatments would have tremendous public health significance.Trial RegistrationClinicalTrials.gov NCT02157610; https://clinicaltrials.gov/ct2/show/NCT02157610International Registered Report Identifier (IRRID)DERR1-10.2196/34502

“To Evaluate the Effectiveness of Self Instructional Module Regarding Perineal Care among Primipara Postnatal Mothers”

Background: Perineal trauma, particularly caused following vaginal delivery, is associated with short and long-term morbidity for women; therefore, intervention that increases the probability of an intact perineum is necessary. When a child is born, the mother and the postnatal period are both extremely vulnerable.&#x0D; Objectives: 1. To assess the pretest knowledge regarding perineal care in primipara postnatal mothers. 2. To assess the posttest knowledge regarding perineal care in primipara postnatal mothers. 3. To assess the effectiveness of Self Instructional Module on knowledge regarding perineal care in primipara postnatal mothers. 4. To associate the posttest knowledge score regarding perineal care in primipara postnatal mothers with demographic variables.&#x0D; Materials and Methods: A pre-experimental one-group pretest and posttest design was adopted to assess the effectiveness of a self-instruction module on knowledge regarding perineal care among primipara postnatal mothers. This study was carried out using inferential and descriptive data. The techniques for testing knowledge regarding perineal care among primipara postnatal mothers are discussed in this chapter. It comprises a research method description, the design and validation of the tools and questionaries, the data collection procedure and data analysis plan, the identification of targets, and the sample and sampling techniques.&#x0D; Results: Better care with regular maintenance of hygiene of perineal area among the primipara postnatal mothers in selected area in Wardha district allow them from preventing from perineal discomfort and infection and a better quality of life with other intervention and by providing knowledge.

Challenges for assessing replicability in preclinical cancer biology.

We conducted the Reproducibility Project: Cancer Biology to investigate the replicability of preclinical research in cancer biology. The initial aim of the project was to repeat 193 experiments from 53 high-impact papers, using an approach in which the experimental protocols and plans for data analysis had to be peer reviewed and accepted for publication before experimental work could begin. However, the various barriers and challenges we encountered while designing and conducting the experiments meant that we were only able to repeat 50 experiments from 23 papers. Here we report these barriers and challenges. First, many original papers failed to report key descriptive and inferential statistics: the data needed to compute effect sizes and conduct power analyses was publicly accessible for just 4 of 193 experiments. Moreover, despite contacting the authors of the original papers, we were unable to obtain these data for 68% of the experiments. Second, none of the 193 experiments were described in sufficient detail in the original paper to enable us to design protocols to repeat the experiments, so we had to seek clarifications from the original authors. While authors were extremely or very helpful for 41% of experiments, they were minimally helpful for 9% of experiments, and not at all helpful (or did not respond to us) for 32% of experiments. Third, once experimental work started, 67% of the peer-reviewed protocols required modifications to complete the research and just 41% of those modifications could be implemented. Cumulatively, these three factors limited the number of experiments that could be repeated. This experience draws attention to a basic and fundamental concern about replication - it is hard to assess whether reported findings are credible.

33. Evaluation of Rural-Urban Differences in Hospitalization and Mortality Rates for US COVID-19 Patients in the United States

BackgroundRural communities are among the most vulnerable and resource-scarce populations in the United States. Rural data is rarely centralized, precluding comparability across regions, and no significant studies have studied this population at scale. The purpose of this study is to present findings from the National COVID Cohort Collaborative (N3C) to provide insight into future research and highlight the urgent need to address health disparities in rural populations.N3C Patient Distribution This figure shows the geospatial distribution of the N3C COVID-19 positive population. N3C contains data from 55 data contributors from across the United States, 40 of whom include sufficient location information to map by ZIP Code centroid spatially. Of those sites, we selected 27 whose data met our minimum robustness qualifications for inclusion in our study. This bubble map is to scale with larger bubbles representing more patients. A. shows all N3C patients. B. shows only urban N3C distribution. C. shows the urban-adjacent rural patient distribution. D. shows the nonurban-adjacent rural patient distribution, representing the most isolated patients in N3C.MethodsThis retrospective cohort of 573,018 patients from 27 hospital systems presenting with COVID-19 between January 2020 and March 2021, of whom 117,897 were admitted (see Data Analysis Plan diagram for inclusion/exclusion criteria), analyzes outcomes and 30-day survival for the hospitalized population by the degree of rurality.Multivariate Cox regression analysis and mixed-effects models were used to estimate the association between rurality, hospitalization, and all-cause mortality, controlling for major risk factors associated with rural-urban health discrepancies and differences in health system outcomes. The difference in distribution by rurality is described as well as supplemented by population-level statistics to confirm representativeness.Data Analysis Plan This data analysis plan includes an overview of study inclusion and exclusion criteria, the matrix for data robustness to determine potential sites to include, and our covariate selection, model building, and residual testing strategy.ResultsThis study demonstrates a significant difference between hospital admissions and outcomes in urban versus urban-adjacent rural (UAR) and nonurban-adjacent rural (NAR) lines. Hospital admissions for UAR (OR 1.41, p< 0.001, 95% CI: 1.37 – 1.45) and NAR (OR 1.42, p< 0.001, 95% CI: 1.35 – 1.50) were significantly higher than their urban counterparts. Similar distributions were present for all-cause mortality for UAR (OR 1.39, p< 0.001, 95% CI: 1.30 – 1.49) and NAR (OR 1.38, p< 0.001, 95% CI: 1.22 – 1.55) compared to urban populations. These associations persisted despite adjustments for significant differences in BMI, Charlson Comorbidity index Score, gender, age, and the quarter of diagnosis for COVID-19.Baseline Characteristics Hospitalized COVID-19 Positive Population by Rurality Category, January 2020 – March 2021 Survival Curves in Hospitalized Patients Over 30 Days from Day of Admission This figure shows a survival plot of COVID-19 positive hospitalized patients in N3C by rural category (A), Charlson Comorbidity Index (B), Quarter of Diagnosis (C), and Age Group (D) from hospital admission through day 30. Events were censored at day 30 based on the incidence of death or transfer to hospice care. These four factors had the highest predictive power of the covariates evaluated in this study.Unadjusted and Adjusted Odds Ratios for Hospitalization and All-Cause Mortality by Rural Category, January 2020 – March 2021 This figure shows the adjusted and unadjusted odds ratios for being hospitalized or dying after hospitalization for the COVID-19 positive population in N3C. Risk is similar between adjusted and unadjusted models, suggesting a real impact of rurality on all-cause mortality. A shows the unadjusted odds ratios for admission to the hospital after a positive COVID-19 diagnosis for all N3C patients. B shows the unadjusted odds ratios for all-cause mortality at any point after hospitalization for COVID-19 positive patients. C shows the adjusted odds ratios for being admitted to the hospital after a positive COVID-19 diagnosis for all N3C patients. D shows the adjusted odds ratios for all-cause mortality for all-cause mortality at any point after hospitalization for COVID-19 positive patients. Adjusted models include adjustments for gender, race, ethnicity, BMI, age, Charlson Comorbidity Index (CCI) composite score, rurality, and quarter of diagnosis. The data provider is included as a random effect in all models.ConclusionIn N3C, we found that hospitalizations and all-cause mortality were greater among rural populations when compared to urban populations after adjustment for several factors, including age and co-morbidities. This study also identified key demographic and clinical disparities among rural patients that require further investigation.Disclosures Sally L. Hodder, M.D., Gilead (Advisor or Review Panel member)Merck (Grant/Research Support, Advisor or Review Panel member)Viiv Healthcare (Grant/Research Support, Advisor or Review Panel member)

An artificially intelligent (or algorithm-enhanced) electronic medical record in orofacial pain.

This review examines how a highly structured data collection system could be used to create data-driven diagnostic classification algorithms. Some preliminary data using this process is provided. The data collection system described is applicable to any clinical domain where the diagnoses being explored are based predominately on clinical history (subjective) and physical examination (objective) information. The system has been piloted and refined using patient encounters collected in a clinic specializing in Orofacial Pain treatment. In summary, whether you believe a branching hybrid check-box based data collection system with built-in algorithms is needed, depends on your individual agenda. If you have no plans for data analysis or publishing about the various phenotypes discovered and you do not need pop-up suggestions for best diagnosis and treatment options, it is easier to use a semi-structured narrative note for your patient encounters. If, however, you want data-driven diagnostic and disease risk algorithms and pop-up best-treatment options, then you need a highly structured data collection system that is compatible with machine learning analysis. Automating the journey from data collection to diagnoses has the potential to improve standards of care by providing faster and reliable predictions.

Reporting Quality in Math Meta-Analyses for Students with or at Risk of Disabilities

Researchers and practitioners alike often look to meta-analyses to identify effective practices to use with students with disabilities. The number of meta-analyses in special education has also expanded in recent years. The purpose of this systematic review is to evaluate the quality of reporting in meta-analyses focused on mathematics interventions for students with or at risk of disabilities. We applied 53 quality indicators (QIs) across eight categories based on recommendations from Talbott et al. to 22 mathematics intervention meta-analyses published between 2000 and 2020. Overall, the meta-analyses met 61% of QIs and results indicated that meta-analyses most frequently met QIs related to providing a clear purpose (95%) and data analysis plan (77%), whereas meta-analyses typically met fewer QIs related to describing participants (39%) and explaining the abstract screening process (48%). We discuss the variation in quality indicator scores within and across the quality categories and provide recommendations for future researchers.

Behavioural Model for Decision-Makers’ towards the Intention to Adopt Green Information Technology: A Preliminary Study

This preliminary survey investigates and validates the measurement model of factors influencing decision makers’ intentions to adopt Green information technology (Green-IT) in manufacturing sectors in Nigeria. The Norm Activation Model (NAM) and Theory of Planned Behaviour (TPB) were used to explore the factors that could influence decision-makers’ intention in adopting Green-IT. Using constructs from the NAM and TPB, this survey proposes a model for identified behavioural factors. A quantitative research approach with a data collection and analysis plan using a cross-sectional survey design was adopted. A sample of 30 decision-makers in the top three manufacturing industries in Nigeria was selected using a purposive sampling procedure for participation in the study. The data collected was analysed using Partial Least Square Structural Equation Modelling (PLS-SEM) to test the proposed model. The model was validated in two phases: (i) Initial Measurement Model and (ii) Modified Measurement Model. Findings revealed that Green-IT Attitude, Subjective Norm, Ascription of Responsibility, Awareness of Consequences, Personal Norm, Environmental Concern, and Perceive Behavioural Control were the key elements of the behavioural intention model to adopt Green-IT, with 31 indicators having factor loadings of &gt;0.5, adequate internal consistency reliability, CR &gt; 0.7, and Cronbach’s Alpha, &gt;0.7. The result revealed convergent validity, and acceptable discriminant validity was assessed using AVE &gt; 0.5 and Fornell-lacker’s criterion. The results from the full-scale study would contribute to developing a context-specific model to examine Green-IT adoption in developing nations.

The Unknown Prevalence of Postrandomization Bias in 15 Physical Therapy Journals: A Methods Review.

To determine the prevalence of prospective clinical trial registration and postrandomization bias in published musculoskeletal physical therapy randomized clinical trials (RCTs). A methods review. Articles indexed in MEDLINE and published between January 2016 and July 2020 were included. Two independent blinded reviewers identified the RCTs using Covidence. We included RCTs related to musculoskeletal interventions that were published in International Society of Physiotherapy Journal Editors member journals. Data were extracted independently for the variables of interest from the identified RCTs by 2 blinded reviewers. The data were presented descriptively or in frequency tables. One hundred thirty-eight RCTs were identified. One third of RCTs were consistent with their prospectively registered intent (49/138); consistency with prospectively registered intent could not be determined for two thirds (89/138) of the RCTs. Four RCTs (8%)reported inconsistent results with the primary aims and 7 (14%) with the outcomes from the prospective clinical trial registry, despite high methodological quality (Physiotherapy Evidence Database [PEDro] scale score). Differences between prospectively registered and non-prospectively registered RCTs for PEDro scale scores had a medium effect size (r = 0.30). Two of 15 journals followed their clinical trial registration policy 100% of the time; in 1 journal, the published RCTs were consistent with the clinical trial registration. Postrandomization bias in musculoskeletal physical therapy RCTs could not be ruled out, due to the lack of prospective clinical trial registration and detailed data analysis plans. J Orthop Sports Phys Ther 2021;51(11):542-550. Epub 21 Sep 2021. doi:10.2519/jospt.2021.10491.

Neuropsychiatric Genetics of Psychosis in the Mexican Population: A Genome-Wide Association Study Protocol for Schizophrenia, Schizoaffective, and Bipolar Disorder Patients and Controls

No large-scale genome-wide association studies (GWASs) of psychosis have been conducted in Mexico or Latin America to date. Schizophrenia and bipolar disorder in particular have been found to be highly heritable and genetically influenced. However, understanding of the biological basis of psychosis in Latin American populations is limited as previous genomic studies have almost exclusively relied on participants of Northern European ancestry. With the goal of expanding knowledge on the genomic basis of psychotic disorders within the Mexican population, the National Institute of Psychiatry Ramón de la Fuente Muñiz (INPRFM), the Harvard T.H. Chan School of Public Health, and the Broad Institute’s Stanley Center for Psychiatric Research launched the Neuropsychiatric Genetics Research of Psychosis in Mexican Populations (NeuroMex) project to collect and analyze case-control psychosis samples from 5 states across Mexico. This article describes the planned sample collection and GWAS protocol for the NeuroMex study. The 4-year study will span from April 2018 to 2022 and aims to recruit 9,208 participants: 4,604 cases and 4,604 controls. Study sites across Mexico were selected to ensure collected samples capture the genomic diversity within the Mexican population. Blood samples and phenotypic data will be collected during the participant interview process and will contribute to the development of a local biobank in Mexico. DNA extraction will be done locally and genetic analysis will take place at the Broad Institute in Cambridge, MA. We will collect extensive phenotypic information using several clinical scales. All study materials including phenotypic instruments utilized are openly available in Spanish and English. The described study represents a long-term collaboration of a number of institutions from across Mexico and the Boston area, including clinical psychiatrists, clinical researchers, computational biologists, and managers at the 3 collaborating institutions. The development of relevant data management, quality assurance, and analysis plans are the primary considerations in this protocol article. Extensive management and analysis processes were developed for both the phenotypic and genetic data collected. Capacity building, partnerships, and training between and among the collaborating institutions are intrinsic components to this study and its long-term success.

Prevalence and Factors Associated with Hypertension

Aims: hypertension (HTN) is rapidly emerging as a public health problem among elderly in developing countries. The objective of this study was to assess the prevalence of hypertension and its associated factors among the elderly in Pokhara Metropolitan, Nepal.Methods: a cross-sectional analytical study was carried out to assess hypertension among 323 community dwelling elderly in Pokhara Metropolitan from October 2019 to March 2020. Quota sampling was used to collect the samples. Elderly those who were attending hospitals or with any serious medical conditions were excluded from the study. Face to face interview was done for data collection and anthropometric measurements, and semi structured standard STEPS questionnaires were used as data collection tools. Data were entered in Epi DATA [Version 3.1] and analyzed using SPSS [Version 20] as per data analysis plan. Bivariate logistic regression analysis were conducted and statistical significance was declared at a p-value ≤ 0.05.Results: prevalence of hypertension was reported among 34.4 percent (Male: 39.3%, Female 29%) elderly in Pokhara Metropolitan. The higher proportion of hypertensive cases were in age group 60-69 years (36%). The prevalence of hypertension was significantly associated with ethnicity (OR= 1.74, CI: 1.07-2.83), current alcohol intake (OR= 2.56, CI: 1.30-5.05) and mental stress (OR= 2.25, CI: 1.19-4.28).Conclusion: more than one third of the elderly had hypertension. Ethnicity, current alcohol intake and mental stress are found to be factors associated with hypertension. Periodic screening for early detection of hypertension and implementing health promotion interventions to encourage behavior change among elderly may promote healthy ageing.