Investigation of Two Preliminary Analysis-Altering Elements: Ordinate Scaling and DPPXYR.

The purpose of this pre-registered study (Peltier & McKenna) was to conceptually replicate if the truncation of the ordinate and DPPXYR increased analysts' estimation of a functional relation and magnitude of treatment effect. Visual analysts (n = 27) evaluated eight data sets reporting null (n = 2), small (n = 2), moderate (n = 2), and large (n = 2) effects. Each data set was graphed six times with manipulations of the ordinate and DPPXYR, resulting in 48 ABAB graphs. We estimated two separate three-level mixed effect models with variations nested in datasets and nested in participants to evaluate the impact of graph characteristics for (1) confidence in determining a functional relation and (2) the estimated magnitude of the treatment effect. We included ordinate scaling and DPPXYR at level 1 and graph effect size at level 2, including all interactions. Overall, graph manipulation consistently did not impact confidence in a functional relation. Results suggest mixed findings for graph manipulation on the estimated magnitude of the treatment effect. Findings will be couched in current literature and recommendations for graph construction and future research will be discussed.

The latest developments with internet-based psychological treatments for depression.

INTRODUCTION: Internet-based psychological treatments for depression have been around for more than 20 years. There has been a continuous line of research with new research questions being asked and studies conducted. AREAS COVERED: In this paper, the author reviews studies with a focus on papers published from 2020 and onwards based on a Medline and Scopus search. Internet-based cognitive behavior therapy (ICBT) programs have been developed and tested for adolescents, older adults, immigrant groups and to handle a societal crisis (e.g. COVID-19). ICBT works in regular clinical settings and long-term effects can be obtained. Studies on different treatment orientations and approaches such as acceptance commitment therapy, unified protocol, and tailored treatments have been conducted. Effects on quality-of-life measures, knowledge acquisition and ecological momentary assessment as a research tool have been reported. Factorial design trials and individual patient data meta-analysis are increasingly used in association with internet intervention research. Finally, prediction studies and recent advances in artificial intelligence are mentioned. EXPERT OPINION: Internet-delivered treatments are effective, in particular if therapist guidance is provided. More target groups have been covered but there are many remaining challenges including how new tools like artificial intelligence will be used when treating depression.

Single-case intervention research design standards: Additional proposed upgrades and future directions.

Single-case intervention research design standards have evolved considerably over the past decade. These standards serve the dual role of assisting in single-case design (SCD) intervention research methodology and as guidelines for literature syntheses within a particular research domain. In a recent article (Kratochwill et al., 2021), we argued for a need to clarify key features of these standards. In this article we offer additional recommendations for SCD research and synthesis standards that have been either underdeveloped or missing in the conduct of research and in literature syntheses. Our recommendations are organized into three categories: expanding design standards, expanding evidence standards, and expanding the applications and consistency of SCDs. The recommendations we advance are for consideration for future standards, research design training, and they are especially important to guide the reporting of SCD intervention investigations as they enter the literature-synthesis phase of evidence-based practice initiatives.

Are Currently Selected Laboratory Animals Useful in the Research of How Female Hormones Influence Orthodontic Biomechanics?

Animal testing was and remains the only method of introducing a certain treatment and medical procedure on humans. On the other hand, animals have their rights resulting from applicable legal acts, including Directive 2010/63/EU and, indirectly, the World Medical Association International Code of Medical Ethics (Helsinki Declaration, 1975, amended 2000). Thus, the question arises whether the credibility of the results of hormonal and orthodontic tests obtained so far and their usefulness for the human population is scientifically justified and worth sacrificing laboratory animals for. Especially that, according to statistical data, about 50% of laboratory animals are euthanized at the conclusion of the experiments. The aim of this article was to determine whether animal experiments are scientifically or morally justified in bringing significant evidence in studies that may validate the influence of changes in the concentration of female hormones secreted by the ovaries in various phases of the menstrual cycle in young patients on the duration of an increased tooth movement rate in orthodontic treatment. Papers reporting the results of the original research into female hormones, either natural or exogeneous ones, likely to alternate the orthodontic tooth movement rate were critically evaluated in terms of animal selection. Thorough analysis supported by veterinary knowledge proved that none of the publications enabled an extrapolation of the results to humans. The evaluation of the relation between the rate of tooth movement upon loading with orthodontic forces and hormones either secreted during the menstrual cycle of women or released from the contraceptives already present in the market, does not require sacrificing laboratory animals.

Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent.

Recently, we have been noticing an increase in the emergence and re-emergence of microbial infectious diseases. In the previous 100 years, there were several incidences of pandemics caused by different microbial species like the influenza virus, human immunodeficiency virus (HIV), dengue virus, severe acute respiratory syndrome Coronavirus (SARS-CoV), middle east respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-2 that were responsible for severe morbidity and mortality among humans. Moreover, non-communicable diseases, including malignancies, diabetes, heart, liver, kidney, and lung diseases, have been on the rise. The medical fraternity, people, and governments all need to improve their preparedness to effectively tackle health emergencies. Clinical research, therefore, assumes increased significance in the current world and may potentially be applied to manage human health-related problems. In the current review, we describe the critical aspects of clinical research that include research designs, types of study hypotheses, errors, types of sampling, ethical concerns, and informed consent.

Cannabis use as a predictor and outcome of positive and negative affect in college students: An ecological momentary assessment study.

BACKGROUND: Reinforcement models identify negative affect (NA) and positive affect (PA) to be important momentary determinants and outcomes of cannabis use. Sensitization and allostatic models further suggest that these mood-cannabis associations are stronger among individuals with more cannabis-related problems. Despite this theoretical background and the fact that cannabis is commonly used for its mood-enhancing effects among college students, surprisingly, little is known about the momentary associations between mood and cannabis use in this population. AIMS: To examine the associations between (a) momentary within-person variations in NA (worried, stressed, nervous) and PA (happy, enthusiastic, proud, excited) and intention to use cannabis within the next hour, (b) the within-person variations in time elapsed since last cannabis use, amount used and momentary NA and PA, and (c) to test whether cannabis-related problems moderate the stated associations. METHOD: Eighty, more-than-weekly, cannabis using students at the University of Amsterdam reported on cannabis use, NA and PA three times daily for 14 consecutive days. Mixed-effects models were performed to analyze the dataset. RESULTS: Within-persons, relatively high PA and low NA were associated with a higher likelihood of intending to use cannabis. Within-persons, more recent and greater amounts of cannabis use were associated with relatively high PA. More recent cannabis use was associated with relatively low NA. Cannabis-related problems did not moderate the associations. CONCLUSIONS: While recent cannabis use related to higher PA and lower NA, high PA but low NA preceded use, supporting positive reinforcement rather than negative reinforcement in this college sample of regular cannabis users.

Sports Medicine Research Practices for Categorizing Transgender and/or Intersex Participants.

CONTEXT: Approximately 1 to 1.4 million individuals (0.58% of the population) in the United States identify as transgender, yet no literature could be found regarding how researchers should adapt clinical research studies when intersex or transgender individuals volunteer as participants. Therefore, the objective was to determine if there is a consensus among recently published researchers in 3 athletic training and sports medicine journals regarding procedures used to categorize participants and data of transgender or intersex individuals in a research study. METHODS: The authors developed a 14-item survey using Qualtrics XM to assess how researchers categorize individuals and their data when intersex or transgender individuals volunteer to participate in clinical research studies that are not intended to focus on intersex or transgender individuals. The survey was sent to 378 individuals in athletic training and related fields who recently published research manuscripts from 2018 to 2020 in one or more of 3 leading journals in the field including the Journal of Athletic Training, the Journal of Sport Rehabilitation, and the Athletic Training and Sports Health Care Journal. RESULTS: A total of 82 respondents completed the survey, yielding a response rate of 21.69%. When categorizing research participants who were not using hormones or surgery to transition, several respondents were unsure how to categorize transgender individuals (n = 14, 17.1%) or intersex individuals (n = 35, 42.7%). If the research participant was using hormones and/or surgery to transition, many respondents were unsure how to categorize the sex of the individual (n = 27, 32.9%). Only 5 (6.1%) respondents indicated that their organization has policies that guide their inclusion of transgender and/or intersex individuals in research studies. CONCLUSIONS: There does not appear to be consensus among researchers who recently published in athletic training and sports medicine journals regarding how to categorize transgender and intersex individuals who volunteer to participate in research studies.

Single-case design standards: An update and proposed upgrades.

In this paper, we provide a critique focused on the What Works Clearinghouse (WWC) Standards for Single-Case Research Design (Standards 4.1). Specifically, we (a) recommend the use of visual-analysis to verify a single-case intervention study's design standards and to examine the study's operational issues, (b) identify limitations of the design-comparable effect-size measure and discuss related statistical matters, (c) review the applicability and practicality of Standards 4.1 to single-case designs (SCDs), and (d) recommend inclusion of content pertaining to diversity, equity, and inclusion in future standards. Within the historical context of the WWC Pilot Standards for Single-Case Design (1.0), we suggest that Standards 4.1 may best serve as standards for meta-analyses of SCDs but will need to make clear distinctions among the various types of SCD studies that are included in any research synthesis. In this regard, we argue for transparency in SCD studies that meet design standards and those that do not meet design standards in any meta-analysis emanating from the WWC. The intent of these recommendations is to advance the science of SCD research both in research synthesis and in promoting evidence-based practices.

Joining Forces: How to Coordinate Large, Multicenter Randomized Trials.

This article details the pros, cons, challenges/pitfalls, and elements required for the successful conduct of multicenter randomized trials, with specific focus on trials related to pleural diseases. Several networks dedicated to the multicenter study of important pleural conditions have developed, yielding practice-changing studies in pleural disease. This review describes the importance of multicenter trials, major elements required for the conduct of such trials, and lessons learned from the ongoing development of the Interventional Pulmonary Outcomes Group, a consortium of interventional pulmonologists dedicated to advancing diagnostic and management strategies in pleural, pulmonary parenchymal, and airway disease by generating high-quality multicenter evidence.

From Research to Practice: Toward the Examination of Combined Interventions for Autism Spectrum Disorders.

The use of biological (i.e., medications) in conjunction with applied behavior analysis is relatively common among people with ASD, yet research examining its benefit is scarce. This paper provides a brief overview of the existing literature on the combined interventions, including promising developments, and examines the existing barriers that hinder research in this area, including the heavy reliance on RCTs. Recommendations for possible solutions, including the creation of health homes, are provided in order to move toward a more integrated approach.

Study Designs in Clinical Research.

Background: The quality of scientific literature is judged by study design, validity, and applicability to unique patient populations. Methods: We searched the available literature to explore the hierarchy of evidence, explain research fundamentals such as sample size calculation, and discuss common study designs employed in surgical research and the interpretation of trial designs. Results: Each unique study design has restraints created by some degree of systematic errors and bias. This article provides definitions for the scientific boundaries of case control, retrospective, before-and-after, prospective observational, randomized controlled designs, and meta-analyses. Conclusion: Critical thinking and appraisal of the literature is a skill that requires lifelong training and practice. Clinical research education and design need to garner more attention in the medical community.

No causal associations between childhood family income and subsequent psychiatric disorders, substance misuse and violent crime arrests: a nationwide Finnish study of >650 000 individuals and their siblings.

BACKGROUND: Childhood family income has been shown to be associated with later psychiatric disorders, substance misuse and violent crime, but the consistency, strength and causal nature of these associations remain unclear. METHODS: We conducted a nationwide cohort and co-sibling study of 650 680 individuals (426 886 siblings) born in Finland between 1986 and 1996 to re-examine these associations by accounting for unmeasured confounders shared between siblings. The participants were followed up from their 15th birthday until they either migrated, died, met criteria for the outcome of interest or reached the end of the study period (31 December 2017 or 31 December 2018 for substance misuse). The associations were adjusted for sex, birth year and birth order, and expressed as adjusted hazard ratios (aHRs). The outcomes included a diagnosis of a severe mental illness (schizophrenia-spectrum disorders or bipolar disorder), depression and anxiety. Substance misuse (e.g. medication prescription, hospitalization or death due to a substance use disorder or arrest for drug-related crime) and violent crime arrests were also examined. Stratified Cox regression models accounted for unmeasured confounders shared between differentially exposed siblings. RESULTS: For each $15 000 increase in family income at age 15 years, the risks of the outcomes were reduced by between 9% in severe mental illness (aHR = 0.91; 95% confidence interval: 0.90-0.92) and 23% in violent crime arrests (aHR = 0.77; 0.76-0.78). These associations were fully attenuated in the sibling-comparison models (aHR range: 0.99-1.00). Sensitivity analyses confirmed the latter findings. CONCLUSIONS: Associations between childhood family income and subsequent risks for psychiatric disorders, substance misuse and violent crime arrest were not consistent with a causal interpretation.

Self-care research: How to grow the evidence base? (reprint).

BACKGROUND AND OBJECTIVE: The number of studies in the area of self-care is growing and international researchers are increasingly developing self-care interventions to improve outcomes of individual patients and communities. However, growth of the evidence is still slow due to challenges with designing and testing self-care interventions. In this article we address major methodological challenges with regard to the definition of self-care, use of theory, and research design, intended to provide guidance to researchers in this field. METHOD: During the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019 we identified important issues in existing self-care research. Discussion and literature review lead to eight recommendation for future self-care research. RESULTS: In preparation, begin with a theoretically sound definition of self-care. In planning the intervention, build on and extend previous studies. Use theory to develop self-care interventions and consider translational models to guide development, evaluation and implementation of complex self-care interventions. Employ a study design that fits the current phase and objectives of the research and measure self-care and related factors carefully. In reporting, describe the sample and setting sufficiently so that others can draw conclusions about generalizability and applicability to their practice and patient population. In interpretation, describe how the intervention is assumed to work (causal assumptions) and its key components. CONCLUSION: Our review of existing self-care research clearly illustrates that the recommendations we provide are needed if we are to substantially grow the evidence base supporting self-care. Embracing a core set of principles will allow us to build on each other's work. Tweetable abstract: A core set of methodological principles is needed to substantially grow the evidence base supporting self-care.

Time to address the spatiotemporal uncertainties in COVID-19 research: Concerns and challenges.

In this correspondence, we emphasize methodological caveats of ecological studies assessing associations between COVID-19 and its physical and social environmental determinants. First, we stress that inference is error-prone due to the modifiable areal unit problem and the modifiable temporal unit problem. The possibility of confounding from using aggregated data is substantial due to the neglect of person-level factors. Second, studying the viral transmission of COVID-19 solely on people's residential neighborhoods is problematic because people are also exposed to nonhome locations and environments en-route along their daily mobility path. We caution against an uncritical application of aggregated data and reiterate the importance of stronger research designs (e.g., case-control studies) on an individual level. To address environmental contextual uncertainties due to people's day-to-day mobility, we call for people-centered studies with mobile phone data.

Mode and Intensity of Physical Activity During the Postacute Phase of Sport-Related Concussion: A Systematic Review.

INTRODUCTION: Sports-related concussions (SRCs) have received attention due to their prevalence in youth. An SRC results from a strong force causing neurological impairment. Recent research has recommended rehabilitation within the first week post-SRC after 24 to 48 hours of rest. The postacute phase is defined as 48 hours to 7 days post-SRC. It is imperative to evaluate the most effective mode and intensity of physical activity to reduce symptoms and improve outcomes. METHODS: CINAHL, PubMed, SPORTDiscus, and Web of Science databases were used to search the terms "brain concussion" AND "exercise" and variations of these terms. The evidence level for each study was evaluated using the 2011 Oxford Center for Evidence-Based Medicine Guide. The methodological rigor of each study was evaluated using a scale adapted from Medlicott and Harris. RESULTS: Two thousand sixty-eight records were identified. Six studies were included in this systematic review. Three studies were classified as moderately strong. The remaining 3 studies were considered weak. Five of the studies used either a cycle ergometer or a treadmill. The sixth study used walking, cycling, and swimming, as well as sports drills. All of these modes of exercise were determined to be safe. All studies utilized low- and moderate-intensity interventions, which were found to be nondetrimental and showed improved recovery time and symptom resolution. Five of the studies also incorporated components of high-intensity exercise that was also found to be nondetrimental, and they showed a positive influence on recovery time and symptom resolution. However, all activity in each of the reviewed studies started at a low level and progressed up to a higher level only as each individual client's symptoms permitted. DISCUSSION: Overall, this review found that various modes of activity at light-, moderate-, and high-intensity levels are efficacious and can be safely used during the postacute phase of SRC. CONCLUSION: Though the volume of literature at this time is limited, therapists should consider prescribing closely monitored individualized exercise programs utilizing progressive intensities when treating patients during the postacute phase of SRC.

A Systematic Review of External Validity in Pediatric Integrated Primary Care Trials.

OBJECTIVE: We used the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to conduct a systematic review of external validity reporting in integrated primary care (IPC) interventions for mental health concerns. METHODS: We searched Medline, CINAHL, PsycINFO, the Cochrane Center Register of Controlled Trials, and relevant literature to identify publications from 1998 to 2018 reporting on open, randomized, or quasi-randomized trials of IPC interventions that targeted child (ages 0-18 years) psychological symptoms. For each publication, we extracted the information reported in each RE-AIM domain and calculated the proportion of the total studies reviewed. RESULTS: Thirty-nine publications describing 25 studies were included in the review. Publications rarely reported some indicators of external validity, including the representativeness of participants (12%), rate of adoption clinics or providers (16%), cost of implementation (8%), or evidence of maintenance (16%). Few studies reported on key pragmatic factors such as cost or organizational change processes related to implementation and maintenance. Strengths of some studies included comparisons of multiple active treatments, use of tailorable interventions, and implementation in "real world" settings. CONCLUSIONS: Although IPC interventions appear efficacious under research conditions, there are significant knowledge gaps regarding the degree to which they reach and engage target recipients, what factors impact adoption and implementation of IPC interventions by clinicians, how fidelity can be maintained over time, and cost-effectiveness. Pediatric IPC researchers should embrace dissemination and implementation science methods to balance internal and external validity concerns moving forward.

Ensaio clínico randomizado: padrão ouro de desenhos experimentais - importância, vantagens, desvantagens e preconceitos / Randomized clinical trial: gold standard of experimental designs - importance, advantages, disadvantages and prejudice

Ensaios clínicos randomizados (ECR) são o padrão ouro para desenho experimental de estudo ou ensaio clínico. Apenas por meio de uma investigação do tipo ECR é possível avaliar e demonstrar a relação de causa-e-efeito entre um conjunto de variáveis independentes e dependentes. O ECR adicionou vantagens em relação aos outros modelos experimentais, principalmente devido à presença de um grupo controle. Existem várias críticas à validade interna das pesquisas em saúde, incluindo preconceitos e desvantagens que são apontadas para seu descrédito. OBJETIVO: O objetivo do presente estudo é informar características, vantagens, desvantagens e desvios deste método científico. MATERIAL E MÉTODOS: Análise crítica de método científico com base em revisão narrativa da literatura. Foi consultada a base de dados Medline por meio dos portais PubMed e Scopus, sem data de início e até julho de 2020, para extração das informações relativas aos ECR. Apenas artigos de língua inglesa foram incluídos, usando as palavras-chave "estudo randomizado controlado", "ensaio clínico randomizado", "projeto experimental" e "estudo experimental", intercaladas pelos operadores booleanos "AND ," "OR" e "NOT". Anais de conferências e resumos não foram considerados para a análise dos dados. RESULTADOS: Dos ECR selecionados, foram extraídas características, vantagens, desvantagens, importância e vantagens dos controles em pesquisa, o princípio de equilíbrio, ensaios clínicos randomizados na população pediátrica, ECR na população geriátrica, ameaças à validade interna e medidas para minimização de viéses e preconceitos em ECR. CONCLUSÃO: Tópicos relevantes dos ECR foram explicados nesta revisão que devem guiar pesquisadores clínicos.

Randomized controlled trial (RCT) is the gold standard of experimental design or clinical trial design. Only by RCT in research, the cause-and-effect relationship between a set of independent and dependent variables could be demonstrated. RCT has added advantages over other experimental designs due to the presence of the control group. The importance of control in health research trials and its advantages to be elaborated. Though various threats to internal validity in health research trials could be minimized by RCT, various biases in RCT and disadvantages add to its discredit. OBJECTIVE: The aim of the present narrative review is to brief the characteristics, advantages, disadvantages, and various biases in RCT. METHODS: This review does not follow the PRISMA statement, as it was a narrative review. Two databases, namely, Medline through PubMed and Scopus, were searched from inception to July 2020 for the information pertaining to RCTs and included in this narrative review. Only English language articles were searched with the keywords, "Randomized controlled trial," "Randomized clinical trial," "experimental design," and "experimental study." These keywords are linked together by the Boolean words, "AND," "OR" and "NOT." Conference proceedings and only abstracts were not considered for the review. RESULTS: RCTs were explained under characteristics, advantages, disadvantages, importance, and advantages of controls in research, the principle of equipoise, RCTs in the pediatric population, RCTs in the geriatric population, threats to internal validity and steps to minimize them and various biases in RCTs. CONCLUSION: The narrative presentation of RCTs under various important topics have been explained in this review.

Reliability of a Novel Semiautomated Ultrasound Segmentation Technique for Assessing Average Regional Femoral Articular Cartilage Thickness.

CONTEXT: Ultrasound imaging is a clinically feasible tool to assess femoral articular cartilage and may have utility in tracking early knee osteoarthritis development. Traditional assessment techniques focus on measurements at a single location, which can be challenging to adopt for novice raters. OBJECTIVE: To introduce a novel semiautomated ultrasound segmentation technique and determine the intrarater and interrater reliability of average regional femoral articular cartilage thickness and echo intensity of a novice and expert rater. DESIGN: Descriptive observational study. SETTING: Orthopedic clinic. PATIENTS OR OTHER PARTICIPANTS: Fifteen participants (mean [SD]; age 23.5 [4.6] y, height = 172.6 [9.3] cm, mass = 79.8 [15.7] kg) with a unilateral history of anterior cruciate ligament reconstruction participated. INTERVENTION: None. MAIN OUTCOME MEASURES: One rater captured anterior femoral cartilage images of the participants' contralateral knees using a transverse suprapatellar ultrasound assessment. The total femoral cartilage cross-sectional area of each image was segmented by a novice and expert rater. A novel custom program automatically separated the cartilage segmentations into medial, lateral, and intercondylar regions to determine the cross-sectional area and cartilage length. The average cartilage thickness in each region was calculated by dividing the cross-sectional area by the cartilage length. Echo intensity was calculated as the average gray-scale pixel value of each region. Two-way random effect intraclass correlations coefficient (ICC) for absolute agreement were used to determine the interrater reliability between a novice and expert rater, as well as the intrarater reliability of the novice rater. RESULTS: The novice rater demonstrated excellent intrarater (ICC [2,k] range = .993-.997) and interrater (ICC [2,k] range = .944-.991) reliability with the expert rater of all femoral articular cartilage average thickness and echo intensity regions. CONCLUSIONS: The novel semiautomated average cartilage thickness and echo-intensity assessment is efficient, systematic, and reliable between an expert and novice rater with minimal training.

Data integration using the building technique in mixed-methods instrument development: Methodological discussion.

AIMS: To discuss and illustrate how meaningful integration can be achieved in instrument development design. DESIGN: Discussion paper. DATA SOURCES: A mixed-methods study about challenges of nurse educators in Pakistan. The building technique was implemented when the findings of the qualitative phase were integrated to develop an instrument to determine educators' challenges while teaching nursing students in academic and clinical settings. IMPLICATIONS FOR NURSING: Nurses are required to use cultural- and population-specific instruments for data collection. The six-step building approach can enable nurses to develop such instruments using rigorous and robust mixed-methods design. CONCLUSION: Building and merging techniques are used in instrument development design during and after the completion of the study, respectively. However, building technique is essential for using the qualitative findings to develop the instrument. The proposed building approach starts with a robust qualitative data analysis and is strengthened with the selection of key themes and subthemes, linking them to the participants' quotes and then the conversion of the quotes into meaningful and pertinent items. Using the proposed building integration technique can enable researchers to meaningfully and efficiently use qualitative findings for developing instruments using mixed-methods designs. IMPACT: Mixed methods are valuable for the development of data collection instruments that are tailored to the study context and relevant for the study participants. There is limited guidance about how meaningful integration can be achieved when developing research instruments using mixed methods. We proposed a practical building technique that allows researchers to meaningfully use qualitative findings from one phase to develop an instrument for the subsequent phase. The proposed approach is useful for researchers aiming to develop data collection instruments using mixed methods.