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We investigated the effectiveness of a sustained and spiraled content literacy intervention that emphasizes building domain and topic knowledge schemas and vocabulary for elementary-grade students. The model of reading engagement intervention underscores thematic lessons that provide an intellectual structure for helping students connect new learning to a general schema in Grade 1 (animal survival), Grade 2 (scientific investigation of past events like dinosaur mass extinctions), and Grade 3 (scientific investigation of living systems). A total of 30 elementary schools (N = 2,870 students) were randomized to a treatment or control condition. In the treatment condition (i.e., full spiral curriculum), students participated in content literacy lessons from Grades 1 to 3 during the school year and wide reading of thematically related informational texts in the summer following Grades 1 and 2. In the control condition (i.e., partial spiral curriculum), students participated in lessons in only Grade 3. The Grade 3 lessons for both conditions were implemented online during the COVID-19 pandemic school year. Results reveal that treatment students outperformed control students on science vocabulary knowledge across all three grades. Furthermore, intent-to-treat analyses revealed positive transfer effects on Grade 3 science reading (ES =.14), domain-general reading comprehension (ES =.11), and mathematics achievement (ES =.12). Treatment impacts were sustained at 14-month follow-up on Grade 4 reading comprehension (ES =.12) and mathematics achievement (ES =.16). Findings indicate that a content literacy intervention that spirals topics and vocabulary across grades can improve students' long-term academic achievement outcomes. Public Significance Statement: This experimental study illustrates how sustaining and spiraling science schemas (background knowledge) and vocabulary from Grades 1 to 3 can improve students' ability to comprehend passages in science, English language arts, and mathematics. Furthermore, findings suggest that systematically building background and vocabulary knowledge can sustain positive gains in elementary-grade students' reading comprehension ability through the end of Grade 4, 14 months after the conclusion of the intervention activities. [ABSTRACT FROM AUTHOR]

Objective: Conventional randomized controlled trials (RCTs) have long served as the foundation of research in clinical psychology; however, most treatments for eating disorders show only modest effects on reduction of symptoms and maintenance of long‐term remission. New options for psychotherapy treatment development research, beyond continuing to pursue additive or subpopulation approaches, are needed. Methods: One option is to apply dose–response designs, which are commonplace in studies of pharmacology, toxicology, and medical research, and characterized by the evaluation of the amount of exposure (dose) to an intervention, and the resulting changes in body function or health (response). Results: Eating disorder interventions are particularly well‐suited for dose–response treatment designs. The deadly nature of eating disorders makes it imperative that patients are not turned away for not being "ready" to engage with treatment. By identifying optimal doses, research will likely yield a more parsimonious course of treatment, which will lend itself to reduced costs, greater uptake, and reduced drop‐out. Discussion: Limited use of within‐subject designs in trials for patients with eating disorders has produced fast‐track efficacy studies and omitted key elements in the treatment development pathway. To decrease reliance on RCT's, dose–response methods should be applied as an alternative study design. Public Significance: Eating disorders are associated with medical and psychiatric comorbidities, poor quality of life, and high mortality. Access to evidence‐based services for patients with eating disorders is limited, and identifying additional effective treatment options can be difficult because of challenges inherent to randomized‐controlled trials. This manuscript describes an alternative trial methodology to maximize the information that can be gathered prior to utilizing a standard large‐scale efficacy design. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Midwifery & Health Sciences is the property of Ataturk University Coordinatorship of Scientific Journals and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: To assess the use of evidence-based research (EBR) approach in randomized controlled trials (RCTs) of acupuncture-related therapies for primary dysmenorrhea (PD). Methods: PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Database, and China Science and Technology Journal Database were searched from January 2013 to December 2022 for RCTs of acupuncture on PD. The full text and references of each RCT were read to assess whether systematic reviews (SRs) or other types of studies with similar research questions and end-users' perspectives were cited to justify and design the trial. In addition, the discussion section were analyzed to evaluate whether trials placed the new result in the existing SRs to draw a conclusion. Multivariable logistic regression was used to find variables that associated with 3 aspects of EBR approach: (1) citing clinical studies for justification, (2) citing relevant studies that obtain the perspectives of end users, and (3) citing clinical studies for results discussion. Results: Of 473 RCTs included, 45.67% (216) of the trials cited relevant similar studies, 21.56% (102) referenced to the studies that collected end-users' perspectives, and 10.99% (52) placed result in the context of the previous research. Few RCTs appropriately applied EBR approach. Among all the included studies, 3.17% (15) of the trials used SRs to inform study questions but none of them used updated SRs with acceptable quality; 1.05% (5) of the trials cited SRs of end-user's perspectives in the justification and design of the study, and only 1 trial added results in existing SR to draw a conclusion. Year of publication, language, funding, registration, ethical approval and number of sites were significantly associated with 1 of the 3 aspects of EBR approach. Conclusions: Few RCTs in acupuncture-related therapies for PD used the EBR approach to minimize research redundancy. Researchers, research institutes, funding agencies, ethics committees, journals and peer reviewers in acupuncture should make efforts to use and promote the EBR approach to ensure the value of new trials. [ABSTRACT FROM AUTHOR]

Purpose: Poverty continues to be a pervasive social problem within the United States despite a plethora of services and government assistance programs. Currently, universal and guaranteed basic income programs are being actively promoted. Method: This review incorporated universal or guaranteed basic income primary reports open to any country and in English from four academic databases including grey literature between January 1, 2013, and April 8, 2023, using randomized controlled trials or quasi-experimental study designs with no specified outcome. Results: Out of an initial 147 articles, four of the primary studies utilized a randomized controlled trial and one used a quasi-experimental design. One study occurred in the United States. Discussion: Despite the increasing implementation of such programs throughout the United States and their associated high cost, evidence is lacking based on their long-term impact and effectiveness. Further study is recommended including stronger evaluations of current and future programs. [ABSTRACT FROM AUTHOR]

This Phase IV placebo-controlled clinical trial was designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia. This monocenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial (registration number: DRKS00003261) was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment. In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis (p-values between 0.505–0.773, Student's t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of KPC vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Student's t-test). Adverse event (AE) rates were similar between treatment groups, in both groups six AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment. Trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) are considered to produce the highest level of evidence in the original studies that informs the practice of evidence-based medicine (EBM). By manipulating an independent variable to study its impact on the outcome, RCTs establish causal relationships and provide valuable insights into clinical treatment. To improve patient outcomes and optimize the use of clinical resources, the practice of EBM plays a crucial role in designing and conducting RCTs to evaluate the effectiveness of clinical interventions. This review aims to explore the essential steps involved in conducting a rigorous and reliable RCT, ensuring the generation of highquality evidence. [ABSTRACT FROM AUTHOR]

Background: The training methods utilized in football play a crucial role in improving player performance. Complex training, which combines strength and conditioning exercises with sport-specific movements, has shown promise in enhancing athletic performance. However, previous studies investigating the effectiveness of complex training for football players have been limited by small sample sizes, warranting further investigation. Purpose: The purpose of this study was to rigorously examine the effectiveness of complex training for intermediate football players. Materials and Methods: A randomized controlled trial design was implemented, enlisting a total of 120 intermediate-level football players who were randomly assigned to either a complex training group (n=60) and a conventional group (n=60). The complex training group engaged in a 6 week complex training program, while the conventional group adhered to a conventional training. Pre and post-test were conducted to evaluate performance measures. Results: The findings demonstrated statistically significant improvements in the complex training group compared to the conventional group across all performance measures. The complex training group exhibited substantial enhancements in agility (pre: M=8.21, SD=1.05; post: M=9.43, SD=1.08; p<0.001), speed (pre: M=5.76, SD=0.68; post: M=6.12, SD=0.59; p<0.05), power (pre: M=225.68, SD=34.27; post: M=258.94, SD=30.91; p<0.01), and kicking accuracy (pre: M=73.41%, SD=5.86; post: M=81.52%, SD=6.21; p<0.001), indicating superior performance in the experimental group. Conclusion: This study provides robust evidence supporting the effectiveness of complex training in enhancing various aspects of performance among intermediate football players, enabling them to improve agility, speed, power, and kicking accuracy. [ABSTRACT FROM AUTHOR]

Telehealth is increasingly important in nursing, encouraging mothers of preterm infants with ventilators to have confidence in their infant care. This study investigated the impact of a telehealth program on maternal self-efficacy in caring for preterm infants with ventilators in the early postpartum period. We employed a randomized controlled trial using the block allocation method, enrolled 42 mothers of preterm infants receiving ventilators and randomly assigned 21 in the experiment group and 21 in the control group. The experimental group received asynchronous and synchronous telehealth programs for six days to enhance their self-efficacy. Data were obtained using the demographic data questionnaire and the maternal self-efficacy questionnaire. Data were analyzed using the Chi-square test, Fisher's Exact test, Mann--Whitney U test, independent t-test, and paired t-test. After completing the program, the experimental group had a significantly higher mean score of maternal perceived self-efficacy than the control group, and this was significantly higher than before the trial. A telehealth program is effective for mothers with preterm infants with ventilators. Nurses should allow the mothers to practice care activities with infants at least once before discharge and when they arrive home and provide health information via telehealth. These can enhance maternal self-efficacy in caring for premature infants with ventilators in the first week of life. However, further testing of the program in other settings is needed before widespread implementation. [ABSTRACT FROM AUTHOR]

Copyright of Retos: Nuevas Perspectivas de Educación Física, Deporte y Recreación is the property of Federacion Espanola de Asociaciones de Docentes de Educacion Fisica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: The results of trials can inform health care decisions. However, this is dependent on both clear and transparent reporting. The aim of this study was to assess the reporting quality of split-mouth trials in implant dentistry in relation to the CONSORT extension checklist for reporting within-person randomized clinical trials (RCTs). Materials and Methods: Split-mouth trials published between January 1, 1997, and September 30, 2020, were identified from four databases. Study characteristics at the level of each trial were extracted. Each trial was assessed against a 37-item checklist and assigned one of four categories. Descriptive statistics and the frequencies of the ratings per checklist item were calculated. A percentage score was calculated per study. Linear regression assessed associations between the aggregate score and the study characteristics. Results: Two hundred forty-four trials were analyzed. More than 50% of the RCTs were published between 2016 and 2020, were published in specialty journals (81.2%), and were interventional-type RCTs (98.4%). Generally, the reporting of checklist items was suboptimal in many areas. The reporting score was predicated by the number of authors (> 7 vs baseline [1 to 4] authors: β: 6.00; 1.48, 10.52; P = .01), authors' continent (Europe vs Americas: β: 5.30; 0.85, 9.74; P = .02), and the number of participants (per-unit increase: β: .07; 0.01, 0.12; P = .02). Conclusion: The reporting of split-mouth trials in implant dentistry seems to be suboptimal. The endorsement and adherence to the CONSORT extension for the within-person trials checklist by journal editors and investigators could improve reporting quality and transparency. [ABSTRACT FROM AUTHOR]

Randomization is a distinguishing feature of clinical trials for unbiased assessment of treatment efficacy. With a growing demand for more flexible and efficient randomization schemes and motivated by the idea of adaptive design, in this article we propose the network and covariate adjusted response‐adaptive (NCARA) design that can concurrently manage three challenges: (1) maximizing benefits of a trial by assigning more patients to the superior treatment group randomly; (2) balancing social network ties across treatment arms to eliminate potential network interference; and (3) ensuring balance of important covariates, such as age, gender, and other potential confounders. We conduct simulation with different network structures and a variety of parameter settings. It is observed that the NCARA design outperforms four alternative randomization designs in solving the above‐mentioned problems and has comparable power and type I error for detecting true difference between treatment groups. In addition, we conduct real data analysis to implement the new design in two clinical trials. Compared to equal randomization (the original design utilized in the trials), the NCARA design slightly increases power, largely increases the percentage of patients assigned to the better‐performing group, and significantly improves network and covariate balances. It is also noted that the advantages of the NCARA design are augmented when the sample size is small and the level of network interference is high. In summary, the proposed NCARA design assists researchers in conducting clinical trials with high‐quality and high‐efficiency. [ABSTRACT FROM AUTHOR]

The current paper reports long-term impacts of the Chicago School Readiness Project (CSRP) on measures of achievement, cognitive functioning, and behavioral regulation taken toward the end of students' high school careers. The CSRP was a self-regulation-focused early childhood intervention implemented in Head Start centers serving high-poverty neighborhoods in Chicago. The intervention was evaluated through a cluster randomized control trial, providing us with rare longitudinal evidence from an experimental study. However, the study was limited by issues with low power and baseline differences between experimental groups. Here, we report on follow-up data taken approximately 11–14 years after program completion, including measures of participants' (N = 430) academic achievement, executive functioning, emotional regulation, and behavioral problems, and we provide a range of analytic estimates to address the study's methodological concerns. Across our estimates, we found little evidence that the program had lasting impacts on indicators of late-adolescent functioning. Main effects were estimated with some imprecision, but nearly all models produced null effects across the broad array of outcomes considered. We also observed few indications that effects were moderated by posttreatment high school quality or later assignment to a light-touch mindset intervention. Implications for developmental theory and early childhood policy are discussed. Public Significance Statement: This study evaluated the long-term effects of an early childhood intervention focused on self-regulation. Despite initial promise, the authors found virtually no evidence to suggest that the preschool intervention had long-lasting positive effects on key outcomes such as achievement, college enrollment, or behavioral dysregulation. This work carries important implications for our continued development of early childhood programs targeting children from low-income families. [ABSTRACT FROM AUTHOR]

Well-designed randomized controlled clinical trials assessing treatments in the field of physical medicine and rehabilitation are essential for evidence-based patient care. However, there are challenges unique to clinical trials in physical medicine and rehabilitation due to complex health interventions in this field. We highlight routinely encountered empirical challenges and provide evidence-based recommendations on statistical and methodological approaches for the design and conduct of randomized controlled trials. Some of the issues addressed include challenges with blinding treatment groups in a rehabilitation setting, heterogeneity in treatment therapy, heterogeneity of treatment effects, uniformity in patient-reported outcome measures, and effect on power with varying scales of information. Furthermore, we discuss challenges with estimation of sample size and power, adaption to poor compliance with treatment and missing outcomes, and preferred statistical approaches for longitudinal data analysis. [ABSTRACT FROM AUTHOR]

Interventions to reduce childhood stunting burden require clinical trials with a primary outcome of linear growth. When growth is measured longitudinally, there are several options for including baseline measurements in the analysis. This study compares the performance of several methods. Randomized controlled trials evaluating a hypothetical intervention to improve length‐for‐age z‐score (LAZ) from birth through 24 months of age were simulated. The intervention effect was evaluated using linear regression and five methods for handling baseline measurements: comparing final measurements only (FINAL), comparing final measurement adjusted for baseline (ADJUST), comparing the change in the measurement over time (DELTA), adjusting for baseline when comparing the changes over time (DELTA+ADJUST) and adjusting for baseline in two‐step residuals approach (RESIDUALS). We calculated bias, precision and power of each method for scenarios with and without a baseline imbalance in LAZ. Using a 0.15 effect size at 18 months, FINAL and DELTA required 1200 and 1500 enroled participants, respectively, to reach 80% power, whereas ADJUST, DELTA+ADJUST and RESIDUALS only required 900 participants. The adjusted models also produced unbiased estimates when there was a baseline imbalance, whereas the FINAL and DELTA methods produced biased estimates, as large as 0.07 lower and higher, respectively, than the true effect. Adjusted methods required smaller sample size and produced more precise results than both DELTA and FINAL methods in all test scenarios. If randomization fails, and there is an imbalance in LAZ at baseline, DELTA and FINAL methods can produce biased estimates, but adjusted models remain unbiased. These results warn against using the FINAL or DELTA methods. Key messages: Several options exist for including baseline measurements in the analysis of a randomized control trial measuring linear growth over time.Adjusted methods required a smaller sample size and produced more precise results than both DELTA and FINAL methods in all tested scenarios.If randomization fails, and there is in imbalance in length‐for‐age z‐score at baseline, DELTA and FINAL methods can produce biased estimates, but adjusted models remain unbiased.Researchers should avoid using the FINAL or DELTA methods. [ABSTRACT FROM AUTHOR]

Medical research study designs are many and varied. At first glance, they may be difficult to distinguish. Knowledge of their specific strengths and limitations is helpful for investigators planning new projects and for readers of the medical literature. The aims of the review are threefold: (i) to present an overview of medical research types, (ii) to attract attention to multiple characteristics of medical study designs, and (iii) to provide a concise educational resource for young researchers in the health sciences. Analysing the characteristics of medical study designs leads to achieving the goals. [ABSTRACT FROM AUTHOR]

Many businesses conduct experiments to scientifically test, measure, and optimize decisions in areas like sales, marketing, and operations efficiency. While randomized controlled trials (RCTs) or A/B tests are the dominant method for conducting business experiments especially for business-to-consumer marketing, adaptive designs have yet to make extensive inroads outside of the pharmaceutical and medical industries. In this study, we aim to raise awareness of the applicability and advantages of multi-arm multi-stage adaptive designs outside of clinical settings and we use simulations to demonstrate the value of these designs to modern business experiments, with a focus on business-to-business experiments such as testing alternative sales techniques. Our simulation results show that, compared to RCT, multi-arm multi-stage adaptive designs (MAMS) can reduce the sample size requirements and expected time to experiment completion whilst maintaining a similar level of statistical power. We also demonstrate that these benefits can translate into actual cost savings in conjunction with shorter time to market, resulting in higher overall efficiency over the traditional RCTs. MAMS serves as a strong alternative methodology in experiments where not all customers can be contacted at once such as business-to-business campaigns and general live channel programs which typically take weeks to months to complete. [ABSTRACT FROM AUTHOR]

Background: Despite its prevalent and impactful nature, dry mouth remains an underexposed and undertreated symptom in patients with a life-limiting condition or frailty. The main contributing factors are a lack of awareness and knowledge amongst both healthcare professionals and patients, and a scarcity of effective, evidence-based interventions. In the DRy mOuth Project (DROP), we address these factors by investigating both a non-pharmacological and a pharmacological intervention: a nurse-led patient education program and locally applied pilocarpine. Methods: This intervention-based research project consists of two parallel studies. The non-pharmacological study is a cluster non-randomized controlled trial in 228 palliative nursing home and hospital patients, investigating the effect of structured use of guidelines and of patient education on dry mouth symptoms. This intervention, a nurse-led patient education program (the Mouth Education Program, MEP), will be compared to care as usual, the control. The pharmacological study is a double-blind placebo-controlled randomized trial that examines the effect of locally applied pilocarpine drops in 120 patients with dry mouth symptoms. Both studies use the same mixed-methods study design, in which the primary outcome is the clinical response to the intervention at 4 weeks, as measured by a dry mouth severity score (numeric rating scale from 0 to 10). Other outcomes, as measured by questionnaires over a 12-week follow-up period, include durability of the effect, impact on quality of life and, adherence and acceptability of the intervention. In addition, the feasibility and cost-effectiveness are evaluated by means of questionnaires and focus groups with healthcare professionals, and interviews with patients. Discussion: This study investigates the effectiveness and feasibility of two interventions for dry mouth symptoms in patients with life-limiting conditions or frailty. Due to the large-scale and mixed-method nature of the study, this study will also improve our understanding of dry mouth and its relating factors and of the patients' and healthcare professionals' experiences with symptoms, care and guidelines of dry mouth, including any perceived barriers and facilitators. Trial registration: NCT05964959 & NCT05506137. [ABSTRACT FROM AUTHOR]

It is generally agreed that one origin of machine bias is resulting from characteristics within the dataset on which the algorithms are trained, i.e., the data does not warrant a generalized inference. We, however, hypothesize that a different 'mechanism' may also be responsible for machine bias, namely that biases may originate from (i) the programmers' cultural background, including education or line of work, or (ii) the contextual programming environment, including software requirements or developer tools. Combining an experimental and comparative design, we study the effects of cultural and contextual metaphors, and test whether each of these are 'transferred' from the programmer to the program, thus constituting a machine bias. Our results show that (i) cultural metaphors influence the programmer's choices and (ii) contextual metaphors induced through priming can be used to moderate or exacerbate the effects of the cultural metaphors. Our studies are purposely performed with users of varying educational backgrounds and programming skills stretching from novice to proficient. [ABSTRACT FROM AUTHOR]

Background: Tirofiban is a glycoprotein IIb/IIIa receptor inhibitor that has been shown to be effective in the treatment of acute coronary syndromes. However, it remains unknown whether it improves outcomes in patients with acute ischemic stroke. Objective: This trial investigates the efficacy and safety of tirofiban compared with aspirin for acute ischemic stroke within 24 h after symptom onset. Methods and design: The Efficacy and Safety of Tirofiban Compared with Aspirin in the Treatment of Acute Ischemic Stroke (RESCUE BT 2) Trial is an investigator-initiated, prospective, randomized, double-blind, double-dummy, multicenter clinical trial. Up to 1158 eligible patients will be consecutively randomized to receive antiplatelet therapy with tirofiban or aspirin in 1:1 ratio across approximately 100 stroke centers in China. Outcomes: The primary endpoint is the proportion of patients with excellent functional outcomes defined as a modified Rankin scale score of 0 to 1 at 90 days after randomization. Lead safety endpoints include mortality at 90 days and symptomatic intracerebral hemorrhage within 48 h after treatment. Trial registry number: ChiCTR2000029502 (www.chictr.org.cn). [ABSTRACT FROM AUTHOR]

Background: Delirium is common in critically ill patients. Haloperidol has long been used for the treatment of delirium. Dexmedetomidine has recently been used to treat delirium among intubated critically ill patients. However, the efficacy of dexmedetomidine for delirium in non-intubated critically ill patients remains unknown. We hypothesize that dexmedetomidine is superior to haloperidol for sedation of patients with hyperactive delirium, and would reduce the prevalence of delirium among non-intubated patients after administration. We will conduct a randomized controlled trial to compare dexmedetomidine and haloperidol for the treatment of nocturnal hyperactive delirium in non-intubated patients in high dependency units (HDUs). Methods: This is an open-label, parallel-group, randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for nocturnal hyperactive delirium in non-intubated patients at two HDUs of a tertiary hospital. We will recruit consecutive non-intubated patients who are admitted to the HDU from the emergency room, and allocate them in a 1:1 ratio to the dexmedetomidine or haloperidol group in advance. The allocated investigational drug will be administered only when participants develop hyperactive delirium (Richmond Agitation-Sedation Scale [RASS] score ≥1 and a positive score on the Confusion Assessment Method for the ICU between 19:00 and 6:00 the next day) during the night at an HDU. Dexmedetomidine is administered continuously, while haloperidol is administered intermittently. The primary outcome is the proportion of participants who achieve the targeted sedation level (RASS score of between -3 and 0) 2h after the administration of the investigational drug. Secondary outcomes include the sedation level and prevalence of delirium on the day following the administration of the investigational drugs, and safety. We plan to enroll 100 participants who develop nocturnal hyperactive delirium and receive one of the two investigational drugs. Discussion: This is the first randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for sedation of non-intubated critically ill patients with hyperactive delirium in HDUs. The results of this study may confirm whether dexmedetomidine could be another option to sedate patients with hyperactive delirium. Trial registration: Japan Registry of Clinical Trials, jRCT1051220015, registered on 21 April 2022. [ABSTRACT FROM AUTHOR]

Background: Standard treatment for drug-susceptible tuberculosis (DS-TB) includes a multidrug regimen requiring at least 6 months of treatment, and this lengthy treatment easily leads to poor adherence. There is an urgent need to simplify and shorten treatment regimens to reduce interruption and adverse event rates, improve compliance, and reduce costs. Methods: ORIENT is a multicenter, randomized controlled, open-label, phase II/III, non-inferiority trial involving DS-TB patients to evaluate the safety and efficacy of short-term regimens compared with the standardized six-month treatment regimen. In stage 1, corresponding to a phase II trial, a total of 400 patients are randomly divided into four arms, stratified by site and the presence of lung cavitation. Investigational arms include 3 short-term regimens with rifapentine 10 mg/kg, 15 mg/kg, and 20 mg/kg, while the control arm uses the standardized six-month treatment regimen. A combination of rifapentine, isoniazid, pyrazinamide, and moxifloxacin is administered for 17 or 26 weeks in rifapentine arms, while a 26-week regimen containing rifampicin, isoniazid, pyrazinamide, and ethambutol is applied in the control arm. After the safety and preliminary effectiveness analysis of patients in stage 1, the control arm and the investigational arm meeting the conditions will enter into stage 2, which is equivalent to a phase III trial and will be expanded to recruit DS-TB patients. If all investigational arms do not meet the safety conditions, stage 2 will be canceled. In stage 1, the primary safety endpoint is permanent regimen discontinuation at 8 weeks after the first dose. The primary efficacy endpoint is the proportion of favorable outcomes at 78 weeks after the first dose for both two stages. Discussion: This trial will contribute to the optimal dose of rifapentine in the Chinese population and suggest the feasibility of the short-course treatment regimen containing high-dose rifapentine and moxifloxacin for DS-TB. Trial registration: The trial has been registered on ClinicalTrials.gov on 28 May 2022 with the identifier NCT05401071. [ABSTRACT FROM AUTHOR]

Background: Dementia is characterized by neurocognitive decline which interferes with daily function and independence. Cognitive stimulation therapy (CST) is an evidence-based cognitive psychosocial intervention for people with dementia. Materials and Methods: A prospective interventional study of single-blind RCT design conducted in the Department of Neurology at ABVIMS and Dr RML Hospital amongst patients with DSM-V major neurocognitive disorder aged more than 50 years. Participants were randomized to CST and control groups using a block-randomized design. The control group participants received treatment as usual while the CST group delivered 45-min virtual group CST sessions for a total of 14 sessions over seven weeks. All participants in both groups were assessed at baseline and eight weeks using the Montreal Cognitive Assessment Scale (MoCA), Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog), neuropsychiatric inventory, instrumental activities of daily living, and Zarit Burden Interview for Caregiver Burden (ZBI) by a rater blind to group randomization. Results: Total MoCA scores improved significantly in the CST group, compared to the control group which showed a statistically significant decrease. The mean total ADAS-Cog score in the CST group improved significantly compared to controls. The Lawton Instrumental Activities of Daily Living Scale showed a statistically significant change in the control group compared to the intervention group. From the comparison of the mean total neuropsychiatric inventory scale, it was observed that there was a statistically significant decrease in the severity of Behavioural and Psychological Symptoms of Dementia (BPSD) symptoms in the CST group. The mean total ZBI score decreased significantly in the CST group favoring less caregiver burden. Conclusion: This study proved that CST has a significant impact on cognitive outcomes in dementia and it also proved its effectiveness in controlling the BPSD outcomes and caregiver burden in dementia. [ABSTRACT FROM AUTHOR]

Health literacy is fundamental to people's ability to manage their health and make appropriate health decisions. Health literacy enhancement can maximize self-management and health outcomes, especially among uncontrolled type 2 diabetes persons with chronic symptoms that can cause microvascular and macrovascular complications. This randomized controlled trial examined the effects of the Enhance Health Literacy through Transformative Learning Program on self-management and HbA1C levels among adults with uncontrolled type 2 diabetes. The sample included 64 adults with uncontrolled type 2 diabetes visiting two health- promoting hospitals in a province in central Thailand. They were randomly allocated to either the experimental group (n = 32) receiving the 4-week transformative learning program in addition to usual care or the control group (n = 32) receiving only usual care. A demographic data questionnaire, the Self-Management Behaviors Scale, and the HbA1C record form were instruments for obtaining data. Data were analyzed using descriptive statistics, two-way repeated measures ANOVA, and independent t-tests. Results showed that after receiving the program, the experimental group had significantly higher self-management scores than the control group and was more elevated. In addition, the experimental group had significantly lower HbA1C levels than the control group after the intervention at 12 weeks than before receiving the program. In conclusion, the Enhance Health Literacy through Transformative Learning Program can increase self-management behaviors and lower HbA1C levels. However, nurses need to further test the effectiveness of the literacy program before implementing widely in practice. [ABSTRACT FROM AUTHOR]

In a randomized controlled trial (RCT), it is possible to improve precision and power and reduce sample size by appropriately adjusting for baseline covariates. There are multiple statistical methods to adjust for prognostic baseline covariates, such as an ANCOVA method. In this paper, we propose a clustering‐based stratification method for adjusting for the prognostic baseline covariates. Clusters (strata) are formed only based on prognostic baseline covariates, not outcome data nor treatment assignment. Therefore, the clustering procedure can be completed prior to the availability of outcome data. The treatment effect is estimated in each cluster, and the overall treatment effect is derived by combining all cluster‐specific treatment effect estimates. The proposed implementation of the procedure is described. Simulations studies and an example are presented. [ABSTRACT FROM AUTHOR]

Community colleges are essential for United States higher education, but their students have low retention and graduation rates. Community college students assigned to mathematics remediation are particularly unlikely to graduate. Corequisite remediation (college-level coursework with additional support) has shown short-term increased student success. The current study examined the 7-year results of a randomized controlled trial of corequisite remediation with college-level statistics. Students assigned to the corequisite group were 50 percent more likely to complete associate's degrees within 3 years, and 100 percent more likely to complete bachelor's degrees within 5 years. Corequisite students also earned, on average, $3,000–$4,500 more in years 5 to 7. Mediation analysis further suggests that the wage treatment effect was due to shortened time to degree. [ABSTRACT FROM AUTHOR]

Objective: To introduce a novel analytical approach for randomized controlled trials that are underpowered because of low participant enrollment or engagement.Data Sources: Reanalysis of data for 805 patients randomized as part of a pilot complex care intervention in 2015-2016 in a large delivery system. In the pilot randomized trial, only 64.6% of patients assigned to the intervention group participated.Study Design: A case study and simulation. The "Distillation Method" capitalizes on the frequently observed correlation between the probability of subjects' participation or engagement in the intervention and the magnitude of benefit they experience. The novel method involves three stages: first, it uses baseline covariates to generate predicted probabilities of participation. Next, these are used to produce nested subsamples of the randomized intervention and control groups that are more concentrated with subjects who were likely to participate/engage. Finally, for the outcomes of interest, standard statistical methods are used to re-evaluate intervention effectiveness in these concentrated subsets.Data Extraction Methods: We assembled secondary data on patients who were randomized to the pilot intervention for one year prior to randomization and two follow-up years. Data included program enrollment status, membership data, demographics, utilization, costs, and clinical data.Principal Findings: Using baseline covariates only, Generalized Boosted Regression Models predicting program enrollment performed well (AUC 0.884). We then distilled the full randomized sample to increasing levels of concentration and reanalyzed program outcomes. We found statistically significant differences in outpatient utilization and emergency department utilization (both follow-up years), and in total costs (follow-up year two only) at select levels of population concentration.Conclusions: By offering an internally valid analytic framework, the Distillation Method can increase the power to detect effects by redefining the estimand to subpopulations with higher enrollment probabilities and stronger average treatment effects while maintaining the original randomization. [ABSTRACT FROM AUTHOR]

Copyright of Hoitotiede is the property of Hoitotieteiden Tutkimusseura HTTS r.y. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Auriculotherapy may activate the parasympathetic nerve system and reduce anxiety levels. Short-term auriculotherapy's effects and safety on university students' anxiety levels was assessed prior to exams. Methods: A randomized, controlled pilot trial was conducted. The day before the exam, university students were randomly allocated to the auriculotherapy group (AA, n = 13) or the waiting-list group (WG, n = 13). Baseline measures were taken 4 weeks before the exam at Time point (TP 0); at 7.30 a.m. on the day before the exam (TP I); at 11 a.m. before auriculotherapy (TP II); 30 min after AA (TP III); and at 7.30 a.m. before the exam (TP IV). The outcomes were the State-Trait-Anxiety Inventory (STAI); quality of night-sleep, Visual Analogue scale (VAS) for anxiety, and salivary cortisol. Adverse events were also recorded. Results: A total of 26 students participated in this study and became more anxious as assessed by STAI in TPII (p = 0.002) and TPIV (p = 0.000) than TP0. AA reduced the STAI in TPIII (p = 0.045) and PIV (p = 0.001) and the VAS (p = 0.012) in TPIV. Cortisol was reduced in TPIII (p = 0.004), and the AA slept better (p = 0.014) at TPIV. Discomfort at the auricular site was reported in only one AA participant. Conclusions: Auriculotherapy appeared safe and effective in reducing anxiety levels before university exams. [ABSTRACT FROM AUTHOR]

The Dutch Committee for the Evaluation of Oncological Agents (cieBOM) assesses the clinical benefit of systemic anti-cancer treatments (SACTs). For SACTs tested in non-randomized trials (NRTs), cieBOM primarily utilizes response-related thresholds as assessment criteria. As sufficiency of NRT-based evidence for benefit assessments is questionable, this study investigated whether and how NRTs can be used to assess the clinical benefit of new SACTs initially appraised by cieBOM based on randomized controlled trials (RCTs). Using the RCTs underpinning cieBOM recommendations issued between 2015 and 2017, we searched for matching NRTs and applied the NRT-related assessment criteria by cieBOM to them. We then compared the assessment outcomes to the respective RCT-based cieBOM recommendations. Further, we investigated how the assessments would change when applying different response-related thresholds and adding a progression-free survival (PFS) threshold. For 13 of the 37 eligible recommendations, a matching NRT was found. Two treatments were assessed positively and six negatively; five treatments were non-assessable. Two positive recommendations matched a positive NRT-based assessment; one matching negative assessment was found, and one treatment could not be assessed based on either trial results. Adding a > 6 months PFS threshold decreased the number of non-assessable NRTs (five to two). Limited publications and inconsistent data reporting hampered the viability of NRTs for clinical benefit assessments of SACTs beyond the scope of rare indications. Further, response-related assessment criteria alone might not fully grasp the clinical benefit of novel SACTs. NRT-based assessments should be considered with caution due to uncertainty of the trial results. • CieBOM assesses the clinical value of NRT-tested SACTs on response-based criteria. • Scarce publications and lack of data impede NRT-based clinical value evaluations. • Comparing assessment outcomes shows differences between RCTs and NRTs as basis. • Adding a PFS threshold as a criterion reduces the number of non-assessable SACTs. • Generalization of value assessment criteria to non-rare indications is unfeasible. [ABSTRACT FROM AUTHOR]

Objective: Long-term acupoint stimulation (LAS), also called embedding acupuncture, is a modified acupuncture technique. The preliminary results have demonstrated its efficacy in body-weight control. However, the low quality of available trials limited its application. This study aimed to evaluate the efficacy and safety of LAS in body-weight control by using a randomized, parallel, sham-controlled clinical trial design. Methods: This was a randomized, single-blind, sham-controlled clinical trial including 84 adult participants (18-60 years) with a body mass index (BMI) of = 24 kg/m² conducted in three general hospitals in Shanghai, China. Participants were equally assigned to receive LAS or sham LAS (SLAS) once per 10 days, eight times in total. After completion, an additional intervention with a 3-month follow-up period was set to examine the continued effect of LAS. The primary outcome was the change in body weight from baseline to treatment endpoint within the intention-to-treat (ITT) analysis. Secondary outcomes contained changes in waist-to-hip ratio (WHR), lipid metabolism, and visceral and subcutaneous adipose tissues. Results: From 14 May 2018 to 03 November 2019, 84 participants out of 201 screened individuals met the eligibility criteria, were randomized, and were analyzed (42 participants in each group). From baseline to treatment endpoint, the body-weight reduction in the LAS group was significantly larger than in the sham control (net difference: 1.57 kg, 95% CI: 0.29-2.86, p = 0.012). The superior weight reduction effect persisted in the follow-up period (net difference: 3.20 kg, 95% CI: 1.17-5.21, p = 0.001). LAS therapy also showed improvement in triglyceride and subcutaneous adipose tissue (SAT) compared with sham control. One participant in the LAS group reported a slightly uncomfortable and tingling sensation after the additional intervention. No other adverse events (AEs) were documented. Conclusion: LAS, a modified acupuncture technique, is safe and effective in body-weight control. It could be used as an alternative choice to classical acupuncture for obesity management. [ABSTRACT FROM AUTHOR]

The REPORT guide is a 'How to' guide to help you report your clinical research in an effective and transparent way. It is intended to supplement established first choice reporting tools, such as Consolidated Standards of Reporting Trials (CONSORT), by adding tacit knowledge (ie, learnt, informal or implicit knowledge) about reporting topics that we have struggled with as authors or see others struggle with as journal reviewers or editors. We focus on the randomised controlled trial, but the guide also applies to other study designs. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing and more. Preprint (open access): https://doi.org/10.31219/osf.io/qsxdz. [ABSTRACT FROM AUTHOR]

Several data indicate that the success of pharmacological treatment in major depressive disorder (MDD) is still unsatisfactory. The reasons for the low response and remission rates are multiple and depend on environmental and biological factors intrinsic to the disease and drug treatments. Pharmacogenetic (PG) tests have the potential to increase efficacy predicting outcome and to reduce antidepressant discontinuation due to side effects. Several studies investigated the utility of PG tests for antidepressants in MDD with interesting but contrasting results. To date most of them are observational studies with no comparator group, and few are randomized controlled trials (RCTs). The aim of this review is to provide an evaluation of the state of art on clinical methodologic features of RCTs with PG tests for antidepressant drugs in MDD, offering suggestions and favoring new insights that could be useful in the implementation of future trials. Several limitations concerning study design, generalization of results, duration of trials, patients group studied, and cost-effectiveness ratio were found, and a number of barriers have been noted in the adoption of PG tests into clinical practice. Despite some preliminary positive results, there is the need for larger and longer‐term RCT studies, with the goal to capture the real impact of PG tests, also with stratified analysis concerning MDD features in terms of severity and antidepressant treatment failures in different ethnicity cohorts. [ABSTRACT FROM AUTHOR]

Background: Chronic pain that follows amputation of a limb is reported as "one of the most severe pains in the human experience," due to the magnitude of tissue injury and the multiple potential of pain generators at the local peripheral, spinal, and cortical levels. The Altius® System was developed to deliver high-frequency nerve block (HFNB) therapy via a cuff electrode applied to the peripheral nerve(s) and an implantable pulse generator. We report a novel clinical trial design for the first study of an active-implantable medical device in subjects with lower-limb post-amputation pain utilizing a multicenter, double-blinded, randomized, active-sham controlled clinical study protocol called QUEST, which is an ongoing investigational device exemption study to support United States Food and Drug Administration approval. Methods: The study enrollment of 180 subjects was completed in September 2021. Subjects were randomized 1:1 to the treatment group or the active-sham control group for the 3-month primary effectiveness and safety endpoints. After month 3, the active-sham control program group crossed over to the treatment program group and all subjects continued to the 12-month study endpoint. Study effectiveness success is determined by a superiority test between responder rates in the treatment and control groups at 3 months. A responder is defined as someone who experiences a 50% or greater reduction in pain scores – after a 30-minute treatment session – for more than 50% of all pain episodes in which the treatment was used. Discussion: The QUEST study design employs an active-sham control group to objectively assess the effectiveness of HFNB therapy. Additionally, the electronic diary repeated measures data collection in QUEST is expected to reduce the intra-subject variation typically observed in pain treatment studies. Finally, the longitudinal measurement of health-related quality of life and use of pain medication may, for example, show effectiveness in reducing opioid use over time. [ABSTRACT FROM AUTHOR]

Copyright of Revista Latinoamericana de Metodología de las Ciencias Sociales is the property of Universidad Nacional de La Plata and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Clinical trials are performed to determine the safety, efficacy, or effectiveness of a medical or surgical intervention. A clinical trial is, by definition, prospective in nature with a uniform treatment of a defined patient cohort. The outcomes assessment should also be uniform. Often a control group is included. At present, the number of neurosurgical clinical trials is increasing, and the study designs have become more sophisticated. Historically, the standard of neurosurgical care has evolved from the findings from many case series and retrospective comparative studies. However, in the present report, we have focused exclusively on prospective clinical trials. An urgent need exists to understand how clinical trials have been performed in the past and how they can be improved to advance our neurosurgical practice. In the present review, we have discussed the barriers, successes, and failures regarding prospective clinical trials in neurosurgery with an outlook to the future. [ABSTRACT FROM AUTHOR]

Conflicts between humans and mammalian predators are globally widespread and increasing, creating a long‐lasting challenge for conservation and local livelihoods. Protection interventions, which are essential to conflict mitigation, should be based on solid evidence of effectiveness produced by robust study designs. Yet, it is unclear what study designs have been used in predator‐targeted interventions and how they can be improved to provide best practices for replications. I examined how applications of five study designs (before‐after, before‐after‐control‐impact, control‐impact, crossover [i.e., the same randomly assigned study units acting as treatments and controls during alternating trials], and randomized controlled trial) have changed over time and how these changes are related to authors, predator species, countries, and intervention types (aversion, husbandry, mixed interventions, invasive management, lethal control, and noninvasive management). I applied multinomial regression modeling to 434 cases (28 predator species and 45 countries) from 244 studies published from 1955 to 2020. Study design was related only to intervention type. Less reliable before‐after and control‐impact studies were the most common (47.7% and 38.2% of cases, respectively), and their use increased over years as did all interventions. The contribution of the most robust before‐after‐control‐impact (7.4%), randomized controlled trial (5.3%), and crossover designs (1.4%) remained minor over time. Crossover is suitable for aversion, most husbandry techniques, and a few other interventions, but crossover interventions also have the most limitations in terms of applicability. Randomized controlled trial is generally applicable, but impractical or inappropriate for some interventions, and before‐after‐control‐impact appears to be the most widely applicable study design for predator‐targeted interventions. [ABSTRACT FROM AUTHOR]

Purpose: To determine the clinical efficacy and safety of growth factors in the treatment of tympanic membrane (TM) perforations from randomized controlled trials (RCTs). Methods: Databases, including PubMed, EMBASE, Cochrane library, Ebsco, Ovid, Scopus, and Web of Science, were searched for articles in any language about studies on the treatment of TM perforations with growth factors. Inclusion criteria were: (1) randomized controlled trials (RCTs); (2) only patients with TM perforations included; and (3) any kinds of growth factors or related products were used as an intervention. Exclusion criteria were: (1) study was not reported as a full paper, only as an abstract; (2) review studies and case reports; and (3) an inability to extract valid data. Outcomes of interest included perforation closure rate, closure time, hearing improvement, and complications. Results: Nineteen RCTs with a total of 1335 participants were included. Growth factors effectively increased the rate of perforation closure [risk ratio (RR): 1.21 95% confidence interval (1.12, 1.30), p < 0.01] and shortened closure time [mean difference (MD): − 16.71 (− 22.74, − 10.15), p < 0.01]. There was no significant difference in hearing improvement [MD: 0.10 (− 0.50, 0.70), p = 0.74] or complications [RR: 1.49 (0.96, 2.32), p = 0.07] between the growth factor intervention group and the control group. Conclusion: Growth factors are effective and safe in the treatment of TM perforations. However, better designed clinical trials should be carried out in the future to obtain more robust findings about the effectiveness of growth factors in the treatment of TM perforations. [ABSTRACT FROM AUTHOR]

This article introduces and describes the articles that are part of the thematic special series on investigating research questions to improve services for students with learning disabilities using single-case research design. The issue includes an article for peer reviewers that serves as a guide for decision-making and evaluation of single-case research design manuscripts. The other articles are intended for researchers who are interested in designing academic and behavioral interventions for students with LD using single-case research designs. The articles provide readers with descriptions of methods, approaches, and techniques that lead to high-quality research design. [ABSTRACT FROM AUTHOR]

Background: Although transition programs have been evaluated for adolescents with chronic conditions, these have rarely involved process evaluations. Indeed, outcomes of complex interventions are dependent on how the intervention is implemented in practice and evaluations of implementation process are therefore pivotal. The aim of this study was to evaluate the extent to which a transition program for adolescents with congenital heart disease was delivered as intended. Research questions were 1) to what level of fidelity was the program delivered? and 2) what potential moderating factors affected the delivery of the program and overall fidelity?Methods: A mixed methods design was used, where a process evaluation was embedded in the STEPSTONES randomized controlled trial in Sweden. The implementation fidelity framework by Carrol (2007) and Hasson (2010) was used to design, collect and analyze data. Quantitative data consisted of intervention records on adherence and were analyzed with descriptive statistics. Qualitative data on moderators affecting fidelity were collected through interviews, log-books and focus group interviews with healthcare professionals implementing the intervention and participatory observations of the implementation process. Data were analyzed with deductive content analysis. Triangulation was used to integrate quantitative and qualitative data within the fidelity framework.Results: Six out of eight components of the transition program were delivered to an extent that adhered to the program theory or achieved a high level of fidelity. However, components involving peer support had a low attendance by the participating sample (32.2%), and the joint transfer meeting was challenging to implement, despite achieving high adherence. Moderators affecting the implementation process were the adolescent's and healthcare professional's engagement in the intervention, contextual factors and a lack of standard operating procedures for all components in the program.Conclusion: Barriers and facilitators for a future implementation of transition programs have been illuminated in this study. The use of an implementation fidelity framework in the process evaluation proved successful in providing a comprehensive evaluation of factors affecting the implementation process. However, implementation fidelity must be considered in relation to adaptations to the local and personal prerequisites in order to create interventions that can achieve fit. [ABSTRACT FROM AUTHOR]

Background Dietary exposure assessments are a critical issue in evaluating human nutrition studies; however, nutrition-specific criteria are not consistently included in existing bias assessment tools. Objectives Our objective was to develop a set of risk of bias (RoB) tools that integrated nutrition-specific criteria into validated generic assessment tools to address RoB issues, including those specific to dietary exposure assessment. Methods The Nutrition QUality Evaluation Strengthening Tools (NUQUEST) development and validation process included 8 steps. The first steps identified 1) a development strategy; 2) generic assessment tools with demonstrated validity; and 3) nutrition-specific appraisal issues. This was followed by 4) generation of nutrition-specific items and 5) development of guidance to aid users of NUQUEST. The final steps used established ratings of selected studies and feedback from independent raters to 6) assess reliability and validity; 7) assess formatting and usability; and 8) finalize NUQUEST. Results NUQUEST is based on the Scottish Intercollegiate Guidelines Network checklists for randomized controlled trials, cohort studies, and case-control studies. Using a purposive sample of 45 studies representing the 3 study designs, interrater reliability was high (Cohen's κ: 0.73; 95% CI: 0.52, 0.93) across all tools and at least moderate for individual tools (range: 0.57–1.00). The use of a worksheet improved usability and consistency of overall interrater agreement across all study designs (40% without worksheet, 80%–100% with worksheet). When compared to published ratings, NUQUEST ratings for evaluated studies demonstrated high concurrent validity (93% perfect or near-perfect agreement). Where there was disagreement, the nutrition-specific component was a contributing factor in discerning exposure methodological issues. Conclusions NUQUEST integrates nutrition-specific criteria with generic criteria from assessment tools with demonstrated reliability and validity. NUQUEST represents a consistent and transparent approach for evaluating RoB issues related to dietary exposure assessment commonly encountered in human nutrition studies. [ABSTRACT FROM AUTHOR]

The second wave of devastating consequences of the COVID-19 pandemic has been linked to dramatic declines in well-being. While much of the well-being literature is based on descriptive and correlational studies, this paper evaluates a growing body of causal evidence from high-quality randomized controlled trials (RCTs) that test the efficacy of positive psychology interventions (PPIs). This systematic review analyzed the findings from 25 meta-analyses, 42 review papers, and the high-quality RCTs of PPIs designed to generate well-being that were included within those studies. Findings reveal PPIs have the potential to generate well-being even during a global pandemic, with larger effect sizes in non-Western countries. Four exemplar PPIs—that have been tested with a high-quality RCT, have positive effects on well-being, and could be implemented during a global pandemic—are presented and discussed. Future efforts to generate well-being can build on this causal evidence and emulate the most efficacious PPIs to be as effective as possible at generating well-being. However, the four exemplars were only tested in WEIRD (Western, Educated, Industrial, Rich, and Democratic) countries but seem promising for implementation and evaluation in non-WEIRD contexts. This review highlights the overall need for more rigorous research on PPIs with more diverse populations and in non-WEIRD contexts to ensure equitable access to effective interventions that generate well-being for all. [ABSTRACT FROM AUTHOR]

Interventional studies are specifically designed to evaluate direct impact of therapeutic or preventive measures on outcomes by assigning participants into treatment/intervention or control group. Main types of interventional study designs are: single-arm interventional studies, non-randomized controlled trials, cross-over trials, randomized controlled trials, and cluster randomized trials. Each of these study designs has its own set of advantages and disadvantages, which need to be assessed and reviewed in the design phase of the study to choose the most appropriate design. Purpose of this article is to provide concept and processes of various interventional study designs along with their utility and limitations. [ABSTRACT FROM AUTHOR]

Background: Recent trials have revealed that sodium-glucose co-transporter 2 inhibitors (SGLT2-i) are effective against hyperglycemia and also reduce micro- and macro-vascular complications in patients with type 2 diabetes mellitus (T2DM). Most of the beneficial cardiovascular effects have been investigated in patients with heart failure and coronary artery disease (CAD). Yet, few human studies have been conducted to investigate the molecular mechanisms underlying these clinically beneficial effects in patients with CAD. Accordingly, the EMPA-CARD trial was designed to focus on the molecular effects of empagliflozin in patients with T2DM and CAD.Methods: In this multicenter, triple-blind randomized controlled trial, patients with documented known T2DM and CAD will be recruited. They will be randomized on a 1:1 ratio and assigned into two groups of empagliflozin 10 mg/daily and placebo. The primary endpoint is the effect of empagliflozin on changes of plasma interleukin 6 (IL-6) after 26 weeks of treatment. The secondary endpoints will consist of changes in other inflammatory biomarkers (Interleukin 1-beta and high-sensitive C-reactive protein), markers of oxidative stress, platelet function, and glycemic status.Discussion: The EMPA-CARD trial mainly tests the hypothesis that SGLT2 inhibition by empagliflozin may improve inflammatory status measured as reduction in inflammatory biomarkers in patients with T2DM and CAD. The results will provide information about the underlying mechanisms of SGLT2 inhibition that mediate the beneficial effects of this medication on clinical outcomes.Trial Registration: Iranian Registry of Clinical Trials. www.IRCT.ir , Identifier: IRCT20190412043247N2. Registration Date: 6/13/2020. Registration timing: prospective. [ABSTRACT FROM AUTHOR]

Background: Sample size calculation is a key point in the design of a randomized controlled trial. With time-to-event outcomes, it's often based on the logrank test. We provide a sample size calculation method for a composite endpoint (CE) based on the geometric average hazard ratio (gAHR) in case the proportional hazards assumption can be assumed to hold for the components, but not for the CE.Methods: The required number of events, sample size and power formulae are based on the non-centrality parameter of the logrank test under the alternative hypothesis which is a function of the gAHR. We use the web platform, CompARE, for the sample size computations. A simulation study evaluates the empirical power of the logrank test for the CE based on the sample size in terms of the gAHR. We consider different values of the component hazard ratios, the probabilities of observing the events in the control group and the degrees of association between the components. We illustrate the sample size computations using two published randomized controlled trials. Their primary CEs are, respectively, progression-free survival (time to progression of disease or death) and the composite of bacteriologically confirmed treatment failure or Staphylococcus aureus related death by 12 weeks.Results: For a target power of 0.80, the simulation study provided mean (± SE) empirical powers equal to 0.799 (±0.004) and 0.798 (±0.004) in the exponential and non-exponential settings, respectively. The power was attained in more than 95% of the simulated scenarios and was always above 0.78, regardless of compliance with the proportional-hazard assumption.Conclusions: The geometric average hazard ratio as an effect measure for a composite endpoint has a meaningful interpretation in the case of non-proportional hazards. Furthermore it is the natural effect measure when using the logrank test to compare the hazard rates of two groups and should be used instead of the standard hazard ratio. [ABSTRACT FROM AUTHOR]

A pregnant woman was enrolled in a double‐blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention—whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision‐making. We review information about the benefits and harms of unblinding. [ABSTRACT FROM AUTHOR]

The National Institutes of Health estimated that $3–$4 billion is spent supporting clinical trials annually, yet an average of 17 years is required for research evidence to be implemented into practice. Study designs that balance external and internal validity, based on the goals of the study and relative to the state of the science, may accelerate knowledge translation. The purpose of this case study was to evaluate two randomized control trials on the effectiveness-efficacy continuum using the PRagmatic Explanatory Continuum Indicator Summary and the Research Effectiveness Adoption Implementation Maintenance model. Findings provided insight into strategies that may lead to more balanced approaches to research design. Incorporating tools such as PRECIS-2 and RE-AIM when designing and implementing research interventions may accelerate knowledge translation to close the gap between scientific knowledge and clinical practice. [ABSTRACT FROM AUTHOR]

We investigated the association between discontinuation due to withdrawal of consent (DWC) in schizophrenia trials and the use of long-acting injectable antipsychotics (LAI-APs). In two categorical meta-analyses of randomized controlled trials, we compared DWC: individual and pooled LAI-APs vs. (1) placebo and (2) oral antipsychotics (OAPs). We also performed conducted a single-group meta-analysis to calculate the average DWC and a meta-regression analysis to examine the association between the results of the meta-analyses and factors related to study design, treatment, and patients. We identified 52 studies (total adult patients = 18,675, LAI-APs = 12,613, placebo = 2,083, and OAPs = 3,979; median study duration = 32 weeks). DWC was higher for LAI-aripiprazole than for the placebo [risk ratio (95% confidence interval) = 1.70 (1.23–2.39)]. Neither pooled nor individual LAI-APs differed from the placebo for fluphenazine, olanzapine, paliperidone, and risperidone or from the OAPs for aripiprazole, fluphenazine, haloperidol, olanzapine, paliperidone, risperidone, and zuclopenthixol. The average DWC of each LAI-AP was as follows: LAI-aripiprazole = 10.98%, LAI-fluphenazine = 7.65%, LAI-flupenthixol = 3.33%, LAI-haloperidol = 6.71%, LAI-olanzapine = 10.50%, LAI-paliperidone = 10.38%, LAI-perphenazine = 7.06%, LAI-risperidone = 10.39%, LAI-zuclopenthixol = 4.45%, pooled LAI-APs = 9.88%, and placebo = 11.17%. Meta-regression analysis demonstrated that publication year (β = 0.02), percentage of males (β = 0.02), and mean age (β = 0.05) were associated with an average DWC for pooled LAI-APs. Study duration (β = −0.03), percentage of males (β = 0.08), and patient status (β = −0.85) were associated with an average DWC for LAI-aripiprazole. Presence of a placebo arm (β = 1.60) was associated with an average DWC for LAI-fluphenazine. LAI-AP use was unlikely to be associated with DWC. Although the LAI-aripiprazole had a higher DWC than did the placebo, its average DWC was similar to other those of LAI-APs. • 52 randomized trials for schizophrenia were included (18,675 patients). • The outcome was discontinuation rate due to withdrawal of consent (DWC). • No difference between LAI-APs and placebo was observed. • No difference between LAI-APs and OAPs was observed. • The average DWC in pooled LAI-AP was 9.88%. [ABSTRACT FROM AUTHOR]

To support evidence-based nursing practice, the authors provide guidelines for appraising research based on quality, quantity, and consistency. This is the first of a three-part series. [ABSTRACT FROM AUTHOR]

Background: The value of systematic reviews (SRs) is determined by methodology and reporting quality of primary studies and how the SR is conducted and reported. Aim: This study discusses key aspects of clinical trials (CTs) that might affect the value of SRs. Design: Narrative review. Results: We highlighted the following CT factors that could affect SR value: Defining the purpose of CTs is important because it could directly impact whether an SR question is appropriately answered and formulated; choose the most appropriate intervention to answer a proposed SR question is critical because we can exclude or include different studies, directly influencing selection bias; when conducting SRs, the study's search must be restricted to equal or highly similar comparison groups, allowing suitable comparisons of the outcomes' estimates; in SRs, it may be interesting to explore the effect of the most common definition of the disease used in clinical practice, being useful in evidence‐based dentistry and easily translated to daily practitioners; and deficiencies in CT reporting can lead to unusable reports, biased results, and conclusions. Conclusion: All aspects discussed were found to be important for improving the use of evidence from CTs. [ABSTRACT FROM AUTHOR]