Randomized Control Trial Research Research Articles

American Indian and Alaska Native recruitment strategies for health-related randomized controlled trials: A scoping review.

Significant health disparities exist among American Indian and Alaska Natives (AI/ANs), yet AI/ANs are substantially underrepresented within health-related research, including randomized controlled trials (RCTs). Although research has previously charted representation inequities, there is however a gap in the literature documenting best practice for recruitment techniques of AI/ANs into RCTs. Therefore, the aim of this review was to systematically gather and analyze the published literature to identify common strategies for AI/AN participant recruitment for RCTs in the US. A scoping review methodology was engaged with a systematic search operationalized within relevant databases to February 19, 2022, with an additional updated search being carried out up until January 1, 2023: PubMed, Embase, Web of Science, PsycINFO, CINAHL, and Google Scholar. A two-stage article review process was engaged with double reviewers using Covidence review software. Content analysis was then carried out within the included articles by two reviewers using NVivo software to identify common categories within the data on the topic area. Our review identified forty-one relevant articles with the main categories of recruitment strategies being: 1) recruitment methods for AI/ANs into RCTs (passive advertising recruitment approaches, individual-level recruitment approaches, relational methods of recruitment); 2) recruitment personnel used within RCTs; and, 3) relevant recruitment setting. The majority of the included studies used a culturally relevant intervention, as well as a community-involved approach to operationalizing the research. Increasing AI/AN representation in RCTs is essential for generating evidence-based interventions that effectively address health disparities and improve health outcomes. Researchers and funding agencies should prioritize the engagement, inclusion, and leadership of AI/AN communities throughout the RCT research process. This includes early community involvement in study design, implementation of culturally tailored recruitment strategies, and dissemination of research findings in formats accessible to AI/AN communities.

Relaksasi Otot Progresif dalam Manajemen Nyeri Pembedahan Ortopedi

This writing aims to determine the effect of progressive muscle relaxation as a non-pharmacological therapy that can be used as a complementary or additional therapy in pain management in patients after orthopedic surgery. The method used was a systematic search for articles through the PubMed, Science Direct, Proquest, and Francis Taylor databases and published from 2013 to 2023 using the keywords "progressive muscle relaxation" AND "Pain" OR "Postoperative Pain" AND "Orthopedics surgery." From the search results, 11,262 articles were obtained, and it was determined that five articles that met the inclusion criteria were RCT (Randomized Control Trial) research studies. The study's results showed that 521 patients who met the inclusion criteria reported significant pain differences between the intervention and control groups. The intervention group given progressive muscle relaxation showed better pain reduction than the control group. The heterogeneity of study participants included patients after lumbar surgery (lumbar disc herniation, microdiscectomy, laminectomy), after TKA (Total Knee arthroplasty), and after tibiofibular fracture surgery. Four research articles provided progressive muscle relaxation interventions without combining them with other interventions, while one research article combined progressive muscle relaxation with other interventions in the form of physiotherapy. In conclusion, the latest evidence from several studies shows the role of progressive muscle relaxation as an additional or complementary therapy in managing pain in patients after orthopedic surgery, whether given together or without in combination with other interventions, shows positive results in helping reduce pain. Keywords: Pain, Orthopedic Surgery, Progressive Muscle Relaxation

The efficacy of alveolar ridge split on implants: a systematic review and meta-analysis

ObjectivesTo evaluate the effects of the alveolar ridge split (ARS) technique on gained horizontal width of the alveolar ridge and implant survival rate.Materials and methodsElectronic searching was performed in six electronic databases (Pubmed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure, and SIGLE) from January 1, 2010, to November 1, 2023. Two authors performed study selection, data extraction, and study qualities (ROBINS-I and RoB 2.0) independently. Meta-analysis was performed by Comprehensive meta-analysis 3.0.Results24 included studies were observational, and 1 study was a randomized controlled trial (RCT). 14 studies investigated the gained width of the horizontal alveolar ridge, and 17 examined the implants’ survival rate. For assessment of risk of bias, nine studies were high risk of bias and 16 studies were moderate risk of bias. Meta-analysis demonstrated that the pooled gained alveolar ridge width was 3.348 mm (95%CI: 4.163 mm, 2.533 mm), and the implant survival rate was 98.1% (95%CI: 98.9%, 96.9%). Seven studies showed seven different complications including exposure, infection, bad split, dehiscence, fracture, paresthesia and soft tissue retraction.ConclusionRecent ARS technique seems to be an effective method of bone augmentation with enough gained width and a high implant survival rate. Further long-term and RCTs research remains needed to enhance the study quality.Clinical relevanceThe ARS technique could generate sufficient bone volume, and implants had a high-level survival rate. Therefore, ARS has been proposed to be a reliable horizontal bone augmentation technique that creates good conditions for the implantation of narrow alveolar crests.

Stimulation of vagus nerve for patients with disorders of consciousness: a systematic review.

The purpose of this study is to evaluate the efficacy and safety of stimulating the vagus nerve in patients with disorders of consciousness (DOCs). A comprehensive systematic review was conducted, encompassing the search of databases such as PubMed, CENTRAL, EMBASE and PEDro from their inception until July 2023. Additionally, manual searches and exploration of grey literature were performed. The literature review was conducted independently by two reviewers for search strategy, selection of studies, data extraction, and judgment of evidence quality according to the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM) Study Quality Scale. A total of 1,269 articles were retrieved, and 10 studies met the inclusion criteria. Among these, there were three case reports, five case series, and only two randomized controlled trials (RCTs). Preliminary studies have suggested that stimulation of vagus nerve can enhance the levels of DOCs in both vegetative state/unresponsive wakefulness state (VS/UWS) and minimally conscious state (MCS). However, due to a lack of high-quality RCTs research and evidence-based medical evidence, no definitive conclusion can be drawn regarding the intervention's effectiveness on consciousness level. Additionally, there were no significant adverse effects observed following stimulation of vagus nerve. A definitive conclusion cannot be drawn from this systematic review as there was a limited number of eligible studies and low-quality evidence. The findings of this systematic review can serve as a roadmap for future research on the use of stimulation of vagus nerve to facilitate recovery from DOCs.

Team approach to polypharmacy evaluation and reduction: feasibility randomized trial of a structured clinical pathway to reduce polypharmacy

BackgroundPolypharmacy is associated with poorer health outcomes in older adults. Other than the associated multimorbidity, factors contributing to this association could include medication adverse effects and interactions, difficulties in managing complicated medication regimes, and reduced medication adherence. It is unknown how reversible these negative associations may be if polypharmacy is reduced. The purpose of this study was to determine the feasibility of implementing an operationalized clinical pathway aimed to reduce polypharmacy in primary care and to pilot measurement tools suitable for assessing change in health outcomes in a larger randomized controlled trial (RCT).MethodsWe randomized consenting patients ≥ 70 years old on ≥ 5 long-term medications into intervention or control groups. We collected baseline demographic information and research outcome measures at baseline and 6 months. We assessed four categories of feasibility outcomes: process, resource, management, and scientific. The intervention group received TAPER (team approach to polypharmacy evaluation and reduction), a clinical pathway for reducing polypharmacy using “pause and monitor” drug holiday approach. TAPER integrates patients’ goals, priorities, and preferences with an evidence-based “machine screen” to identify potentially problematic medications and support a tapering and monitoring process, all supported by a web-based system, TaperMD. Patients met with a clinical pharmacist and then with their family physician to finalize a plan for optimization of medications using TaperMD. The control group received usual care and were offered TAPER after follow-up at 6 months.ResultsAll 9 criteria for feasibility were met across the 4 feasibility outcome domains. Of 85 patients screened for eligibility, 39 eligible patients were recruited and randomized; two were excluded post hoc for not meeting the age requirement. Withdrawals (2) and losses to follow-up (3) were small and evenly distributed between arms. Areas for intervention and research process improvement were identified. In general, outcome measures performed well and appeared suitable for assessing change in a larger RCT.ConclusionsResults from this feasibility study indicate that TAPER as a clinical pathway is feasible to implement in a primary care team setting and in an RCT research framework. Outcome trends suggest effectiveness. A large-scale RCT will be conducted to investigate the effectiveness of TAPER on reducing polypharmacy and improving health outcomes.Trial registrationclinicaltrials.gov NCT02562352, Registered September 29, 2015.

Bat4RCT: A suite of benchmark data and baseline methods for text classification of randomized controlled trials.

Randomized controlled trials (RCTs) play a major role in aiding biomedical research and practices. To inform this research, the demand for highly accurate retrieval of scientific articles on RCT research has grown in recent decades. However, correctly identifying all published RCTs in a given domain is a non-trivial task, which has motivated computer scientists to develop methods for identifying papers involving RCTs. Although existing studies have provided invaluable insights into how RCT tags can be predicted for biomedicine research articles, they used datasets from different sources in varying sizes and timeframes and their models and findings cannot be compared across studies. In addition, as datasets and code are rarely shared, researchers who conduct RCT classification have to write code from scratch, reinventing the wheel. In this paper, we present Bat4RCT, a suite of data and an integrated method to serve as a strong baseline for RCT classification, which includes the use of BERT-based models in comparison with conventional machine learning techniques. To validate our approach, all models are applied on 500,000 paper records in MEDLINE. The BERT-based models showed consistently higher recall scores than conventional machine learning and CNN models while producing slightly better or similar precision scores. The best performance was achieved by the BioBERT model when trained on both title and abstract texts, with the F1 score of 90.85%. This infrastructure of dataset and code will provide a competitive baseline for the evaluation and comparison of new methods and the convenience of future benchmarking. To our best knowledge, our study is the first work to apply BERT-based language modeling techniques to RCT classification tasks and to share dataset and code in order to promote reproducibility and improvement in text classification in biomedicine research.

Evaluation on the Efficacy and Safety of Panax Notoginseng Saponins in the Treatment of Stroke among Elderly People: A Systematic Review and Meta-Analysis of 206 Randomized Controlled Trials.

Evidence regarding the effect of Panax notoginseng saponins (PNS) on treating elderly stroke patients is scare and inconsistent. This study investigated the efficacy and safety of PNS by means of meta-analysis so as to provide an evidence-based reference for the treatment of elderly patients with stroke. We searched the PubMed, Embase, Cochrane Library, Web of Science, CNKI, VIP, Wanfang, and China Biomedical Database to identify the eligible randomized controlled trials (RCTs) concerning using PNS to treat elderly people with stroke from their inception to first, May 2022. Meta-analysis was used for pool analysis of the included studies, whose quality was assessed via Cochrane Collaboration's RCT risk of bias tool. Altogether 206 studies published between 1999 and 2022 with a low risk of bias were included, covering 21,759 participants. The results showed that the improved neurological status shown in the intervention group with PNS alone was statistically significant (SMD = -0.826, 95% CI: -0.946 to -0.707) in contrast to the control group. The total clinical efficacy (Relative risk (RR) = 1.197, 95% Confidence interval (CI): 1.165 to 1.229) and daily living activities (SMD = 1.675, 95% C: 1.218 to 2.133) of elderly stroke patients were significantly improved as well. In addition, the invention group using PNS combined with WM/TAU displayed significant improvement in neurological status (SMD = -1.142, 95% CI: -1.295 to -0.990) and the total clinical efficacy (RR = 1.191, 95% CI: 1.165 to 1.217) compared with the control group. Single PNS intervention or PNS combined with WM/TAU significantly improves the neurological status, the overall clinical efficacy and daily living activities of elderly stroke patients. However, more multicenter RCT research with high quality is required in the future to verify the results in this study. The trial registration number: Inplasy protocol 202330042. doi:10.37766/inplasy2023.3.0042.

Acceptance and Commitment Therapy and Weight-Related Difficulties in Overweight and Obese Adults: A Systematic Review.

Multiple studies have investigated the efficacy of acceptance and commitment therapy (ACT) in improving psychological flexibility among overweight and obese individuals. However, to date, no specific reviews have focused on ACT and weight-related difficulties in this population. This systematic review of the literature aims to identify and assemble all ACT interventions in randomized controlled trials (RCT) that address weight-related difficulties in the treatment of overweight and obese adults. The PRISMA 2020 framework was used for the systematic review, includes manual and computerized database searches. Five databases (Medline, PubMed, Scopus, PsycInfo, and Google) were utilized to gather all articles that: (a) published in English; (b) adopted the RCT design; (c) used ACT as an intervention; (d) included adult participants aged over 18 years with BMI of over 25kg/m2, and (e) included weight-related difficulties and weight as outcome measures. The review identified seven studies comprising 698 overweight or obese participants of both genders. Improvements were reported in weight-related difficulties and percentage of weight loss in the ACT group and the non-ACT group. The present review supports ACT as an effective intervention that can help adults with weight-related difficulties and excess body weight. Further studies should be conducted in various overweight or obese populations with a more systematic RCT research design to establish the effectiveness of ACT in this area.

Selection and application of explanatory and pragmatic randomized controlled trials in clinical research of acupuncture

In the view of the controversy that there is no efficacy difference between true and sham acupuncture in acupuncture randomized controlled trials (RCTs), it is analyzed that one of the reasons is that many clinical studies do not properly understand the design of RCT research and interpret the research results. Starting from the concept and coverage of explanatory RCT and pragmatic RCT, this study lists the application examples of two types of RCTs in the field of acupuncture from five aspects: research purpose and trial environment, subject selection, intervention measures, control measures and outcome evaluation, so as to provide some ideas for their application in clinical trials.

Research Participation in Substance Use Disorder Trials: Design and Methods of a Multi-Site Nested Qualitative Study

Background Given the health and social harms of problematic substance use, randomized controlled trials (RCTs) are critical in developing and testing pharmacotherapies for substance use disorders. However, substance use RCTs can be challenging to conduct, considering the social and structural barriers to participating in research among people with substance use disorders (PSUD), including stigma, poverty, and criminalization—factors that can shape trial recruitment, enrollment, protocol adherence and study retention. Despite these barriers, adequate representation and participation of PSUD in RCT research is essential to assessing and developing treatments, and thus a deeper understanding of RCT participation dynamics among PSUD is needed to support clinical trial research. Methods We conducted a nested qualitative study within a Canadian, multisite, phase IV, open-label, pragmatic RCT that tested two approved opioid agonist treatments, methadone and buprenorphine/naloxone, among patients with prescription opioid use disorder. A subset of individuals ( n = 60) participating in this RCT were interviewed across four different regions in Canada at the beginning and end of their trial involvement, as well as study clinicians ( n = 16) and staff ( n = 16) operating the trial. Conclusion As a nested study within a real-world addiction medicine trial, this research offers an innovative approach to investigating the experiences, strategies, and challenges associated with RCTs among PSUD. While we acknowledge challenges related to the operations of multisite research and engaging marginalized populations in experimental research, this study has the potential to generate critical insights around the RCT experiences of PSUDs and trial staff to inform the conduct of future RCTs.

Traditional Chinese medicine as an adjunctive therapy for mild and common COVID-19: A systematic review and network meta-analysis.

Background:Coronavirus disease 2019 (COVID-19) in many countries is still very serious. At present, there is no specific and effective drug for this disease. Traditional Chinese medicine (TCM) has played a great role in fighting against COVID-19. However, their effectiveness and safety are still obscure and deserve further investigation. The aim of the study was to evaluate the efficacy and safety of TCM assisted in conventional treatment in the treatment of mild and common COVID-19.Methods:PubMed, EMbase, MEDLINE, China National Knowledge Infrastructure Database, WANFANG DATA, and VIP Chinese Science and Technology Periodical Database were searched for randomized controlled trials (RCTs) and non-randomized controlled trials of TCM assisted in conventional treatment. The RCT research quality was evaluated by Cochrane 5.1.0 bias risk scale and the non-randomized controlled trial research quality was evaluated by Newcastle Ottawa scale, and the statistical analysis was conducted by Revman 5.3 and R software. The bias and sensitivity of the statistical results were analyzed by STATA 14.0. Registration number: CRD42020210619.Results:Fifteen studies were included with 7 RCT studies and 8 retrospective cohort studies, involving a total of 1623 patients. Compared with the control group, TCM can improve the main index clinical effective rate (odds ratio [OR] = 2.64, 95% Confidence interval (CI) [1.94,3.59], P < .00001). The results of Begg test (Pr > z = 0.266) and sensitivity analysis showed that the results were relatively stable. Toujie Quwen (OR = 4.9, 95%CI [1.9,14.0]), Shufeng Jiedu (OR = 2.9, 95%CI [1.5,5.7]), and Lianhua Qingwen (OR = 2.4, 95%CI [1.6,3.6]) were with the best. It can also improve the main clinical symptoms (fever, cough, fatigue, and the regression time of the 3 symptoms), severe conversion rate, and computed tomography improvement rate. Its safety was not significantly compared with conventional treatment. However, in terms of safety of a single TCM, Shufeng Jiedu (OR = –0.86, 95%CI [–1.89,0.09]) and Lianhua Qingwen (OR = –0.49, 95%CI[–0.94,–0.05]) were lower than those of conventional treatment.Conclusion:TCM as an adjuvant therapy combined with conventional treatment has good curative effect on mild and common type of COVID-19 patients. Its advantages lie in clinical efficacy and improvement of symptom group, and can prevent patients from transforming to severe disease. In terms of clinical efficacy and safety, Shufeng Jiedu and Lianhua Qingwen have obvious advantages, which are worthy of clinical promotion.

Psychological Interventions in Chronic Low Back Pain: A Systematic Review

Background and Aim: Chronic low Back Pain (CLBP) is one of the most common musculoskeletal disorders with possible psychological consequences for the patients. This study aimed to review all evidence on the effectiveness of psychological interventions in improving the mental status of people with CLBP and providing recommendations for future therapeutic interventions. Methods and Materials/Patients: This systematic review was conducted on the articles published from January 2010 to December 2020. The keywords included “psychology”, “intervention”, “low back pain”, “chronic disease”, “quality of life”, “empowerment”, “psychotherapy”, “psychological interventions”, “clinical trials”, and “randomized clinical trials” in the indexing databases of Magiran, PubMed, Scopus, and Google Scholar. Of the total 1740 articles found, 14 articles were selected for review. Results: The results showed that Cognitive-Behavioral Therapy (CBT) and its combination therapies with mindfulness techniques played an influential role in improving psychological status and quality of life, and reducing pain perception in CLBP patients. The lack of RCT (randomized controlled trial) research and follow-up to assess long-term outcomes are the main limitations of the studies conducted in Iran. Conclusion: It is recommended that psychological interventions be considered alongside medical therapies to improve CLBP patients’ adjustment to chronic condition and their quality of life. Researchers and therapists should consider treatment programs based on RCT plans and long-term follow-up.

The effectiveness and safety of traditional Chinese medicine for the treatment of children with COVID-19.

Introduction:With the widespread spread of novel coronavirus pneumonia, more and more countries have been affected. Some research reports have shown that traditional Chinese medicine has a significant effect on COVID-19 infection, and the treatment of traditional Chinese medicine is used in some special people, such as children. At present, there is a lack of high-quality systematic reviews on the safety and efficacy of using Chinese medicine to treat children with novel coronavirus pneumonia.Materials and methods:We will search Cochran library, MEDLINE, EMBASE, China National Knowledge Infrastructure Database (CNKI), China Biomedical Database (CBM), VIP Database (VIP), and Wanfang database for research. This study includes randomized controlled trials (RCTs) and non-RCTs, and uses the Cochrane systematic review to review the safety and efficacy of traditional Chinese medicine in preventing and treating children with novel coronavirus pneumonia. RCT research tools and quantitative research quality assessment tools for non-randomized studies will be used to assess the risk of bias in studies included in the systematic review. We will use Revman 5.3 software for meta-analysis, the main result is odds ratio, and then a subgroup analysis will be performed based on the age, intervention degree, and disease severity of the patients reviewed.Ethics and dissemination:This systematic review protocol is designed to provide evidence regarding the effectiveness and safety of traditional Chinese medicine for the treatment of children with COVID-19, such evidence may be useful and important for clinical treatment decisions. The results should be disseminated through publication in a peer-reviewed journal. Since the data and results used in the systematic review will be extracted exclusively from published studies, approval from an ethics committee will not be required.Registration information:PROSPERO CRD42020179150.

Evidence-based policy analysis? The strange case of the randomized controlled trials of community-led total sanitation

AbstractOur purpose in this paper is to review the findings of 14 randomized controlled trials (RCTs) of community-led total sanitation (CLTS) and recent rural sanitation interventions to assess their usefulness and implications for sanitation policy-making in low- and middle-income countries. The results of the RCT research programme to evaluate CLTS and related sanitation interventions suggest that the magnitude of the treatment effects was much smaller and uncertain than proponents once anticipated. For example, of the ten studies that reported results for reductions in childhood diarrhoea, only three found statistically significant decreases. Surprisingly, the RCT research teams and their funders do not seem to have thought about how their multi-million dollar research agenda would support decision-making on sanitation. Information on the parameters needed for cost-effectiveness analysis or benefit–cost analysis was not collected. However, making reasonable assumptions about the missing information on parameter values, we show that cost–benefit analysis may still ‘save’ CLTS because small treatment effects may still yield net positive economic benefits if the costs of implementing CLTS programmes are modest. We also discuss the need to move beyond the desire for sanitation policies that are proven to be effective globally, and the importance of focusing on analysis of the local sanitation situation. We describe the data needed to make this shift in policy focus from the global to the local level and stress the importance of interdisciplinary communication between the proponents of RCTs and ‘evidence-based policy’, and economists who will be responsible for the economic analysis of investments in CLTS and other sanitation interventions. We also argue that the results of these RCTs highlight the importance of coordinating investments in piped water and sanitation with investments in improved housing.

The challenges of scaling effective interventions: A path forward for research and policy

Abstract With minimal statistical or theoretical assumptions, randomized controlled trials (RCTs) provide a necessary input for poverty analysis: credibly estimated causal relationships. But complexities arise when moving from RCT research results to anti-poverty policy, with unintended consequences. RCT evidence by itself offers an incomplete prediction of the effects of policy, due to heterogenous effects, spillovers and general equilibrium changes, macroeconomic and welfare effects, political economy reactions, and implementation challenges, when programs are scaled. We suggest strategies for tightening the link between development research and anti-poverty policy, for example, by changing the practice of RCTs to be more ambitious about what is randomized, and to combine the analysis of experimental data with other rigorous methods that go beyond estimating treatment effects. We describe our efforts to encourage and coordinate this type of work via a new research initiative.

Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial.

BackgroundThere is a paucity of controlled clinical trial data based on research with Indigenous peoples. A lack of data specific to Indigenous peoples means that new therapeutic methods, such as those involving electronic health (eHealth), will be extrapolated to these groups based on research with other populations. Rigorous, ethical research can be undertaken in collaboration with Indigenous communities but requires careful attention to culturally safe research practices. Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research. To be effective, researchers must first gain an in-depth understanding of Indigenous determinants of health, including the harmful consequences of colonialism. Second, researchers need to learn how colonialism affects the research process. The challenge then for eHealth researchers is to braid Indigenous ethical values with the requirements of good research methodologies into a culturally safe research protocol.ObjectiveA recent systematic review showed that Indigenous peoples are underrepresented in randomized controlled trials (RCTs), primarily due to a lack of attention to providing space for Indigenous perspectives within the study frameworks of RCTs. Given the lack of guidelines for conducting RCTs with Indigenous communities, we conducted an analysis of our large evaluation data set collected in the Diagnosing Hypertension-Engaging Action and Management in Getting Lower Blood Pressure in Indigenous Peoples and Low- and Middle- Income Countries (DREAM-GLOBAL) trial over a period of five years. Our goal is to identify wise practices for culturally safe, collaborative eHealth and RCT research with Indigenous communities.MethodsWe thematically analyzed survey responses and qualitative interview/focus group data that we collected over five years in six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL. We established themes that reflect culturally safe approaches to research and then developed wise practices for culturally safe research in pragmatic eHealth research.ResultsBased on our analysis, successful eHealth research in collaboration with Indigenous communities requires a focus on cultural safety that includes: (1) building a respectful relationship; (2) maintaining a respectful relationship; (3) good communication and support for the local team during the RCT; (4) commitment to co-designing the innovation; (5) supporting task shifting with the local team; and (6) reflecting on our mistakes and lessons learned or areas for improvement that support learning and cultural safety.ConclusionsBased on evaluation data collected in the DREAM-GLOBAL RCT, we found that there are important cultural safety considerations in Indigenous eHealth research. Building on the perspectives of Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities.Trial RegistrationClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226

Chinese medicine JQ granule combined with half-dose omeprazole for nonerosive reflux disease: A multicenter, randomized, double-blind, placebo-controlled trial study protocol

IntroductionNonerosive reflux disease (NERD) is a kind of esophageal disease manifesting mainly as heartburn and regurgitation. The prevalence of NERD in patients with gastroesophageal reflux disease is up to 70%, and it significantly affects the quality of life of patients. In China, besides proton-pump inhibitors (PPIs), a herbal formula is widely used in nonerosive reflux disease, which can improve intestinal and extra-intestinal symptoms of patients. This study will evaluate in a large, independent, randomized controlled trial (RCT) the comparative effectiveness of a specific type of Chinese herbal granule with half-dose PPI and full-dose PPI in managing nonerosive reflux disease. Methods and analysisThis trial will be a multicenter, randomized, double-blind, placebo-controlled RCT. A total of 204 participants will be enrolled and randomized (1:1) to each group: herb granules plus 10 mg omeprazole plus 10 mg dummy omeprazole; and dummy herb granules plus 20 mg omeprazole. The efficacy measures will be the changes in scores in the Gastroesophageal Reflux Disease Questionnaire, the Short-Form 36, the Patient Report Outcome, the 17-item Hamilton Depression Scale, and the Signs and Symptoms Scale. DiscussionThis study will focus on the quality control of a Chinese medical formulation. The RCT research procedure will be conducted under the supervision of the Good Clinical Practice (GCP) center. This trial will reduce the routine dosage of omeprazole while adding Jianpi Qinghua JQ granule, with the aim to discuss the safety and effectiveness of the Chinese herbal granule on esophageal and extraesophageal symptoms while meeting the ethical requirements.

Web-Based Parent Training Intervention With Telephone Coaching for Disruptive Behavior in 4-Year-Old Children in Real-World Practice: Implementation Study.

BackgroundParent training is the most effective approach to the psychosocial treatment of disruptive behavioral problems in childhood. However, no studies exist on how well Web-based training programs work when they make the transition from the research setting to implementation in primary health care.ObjectiveThe study aimed to examine how the randomized controlled trial (RCT) and implementation study groups of the Strongest Families Smart Website (SFSW) intervention differed in child psychopathology, family demographics and treatment-related factors, such as therapeutic alliance and parents’ satisfaction rates. The intervention was conducted in the pediatric primary health care in Finland.MethodsThe study focused on 232 parents who had taken part in the SFSW intervention, which formed part of a 2-arm RCT study, and 882 families that would participate in the subsequent SFSW implementation study group. Both groups comprised parents whose children displayed high levels of parent-reported disruptive behavioral problems when they were screened in child health clinics at 4 years of age. Parents in both groups were provided with the SFSW intervention, which consisted of a Web-based training program with 11 weekly themes and associated telephone sessions.ResultsDemographic factors or duration of behavioral problems did not differ statistically or clinically between the RCT and implementation groups. Overall, 42.0% (362/862) of children in the implementation group and 35.4% (80/226) in the RCT intervention group had suffered from behavioral difficulties more than 1 year before the screening phase (χ12=3.2; P=.07). The mean duration of telephone coaching calls was very similar in the implementation and RCT intervention groups, that is, 38 and 37 min per call, respectively (t279.5=0.26; P=.79). The total time spent on the website of the program was 451 min in the implementation group and 431 min in the RCT intervention group (t318.8=1.38; P=.17). In the RCT intervention group, 52 of the 232 participants (22.4%) discontinued the program before the tenth week, whereas in the implementation group, 109 of the 882 participants (12.4%; odds ratio 2.05, 95% CI 1.4-3.0; P<.001) discontinued. Parents in both the implementation (77.1% to 98.5%, 498/742 to 731/742, respectively) and the RCT (64.8% to 98.2%, N=105/162- to 159/162, respectively) groups reported qualitatively similar and high level of posttreatment satisfaction rates in improved parenting skills, expectations, and stress relief. Parents in both groups reported a high level of satisfaction in skills and professionalism of the telephone coaches.ConclusionsThe implementation of population-based screening of Web-based parent training intervention with telephone coaching resulted in good feasibility, fidelity, accessibility, and similar satisfaction level post treatment when compared with intervention in RCT research setting. The discontinuation of treatment in the implementation group was exceptionally low.

Efficacy of levosimendan in patients with left ventricular dysfunction undergoing cardiac surgery: a Meta-analysis

Objective To explore the effect of levosimendan in patients with left ventricular dysfunction undergoing cardiac surgery. Methods Databases including PubMed, EMBASE and Cochrane database were systematically queried to identify randomized controlled trial (RCT) research regarding levosimendan treatment for patients with left ventricular dysfunction undergoing cardiac surgery published from inception to July 2017. Meta-analysis was performed using RevMan 5.3. Relevant outcomes included early mortality, acute kidney injury, need for renal replacement therapy, hypotension and arrhythmia. Results Nine literatures with a total of 1 464 participants were included, with 736 patients in levosimendan group and 728 patients in control group respectively. Compared with control drugs, levosimendan reduced early mortality [odds ratio (OR)=0.5, 95% confidence interval (CI): 0.31-0.81, P=0.004], the incidence of acute kidney injury (OR=0.5, 95%CI: 0.32-0.78, P=0.003) and renal replacement therapy (OR=0.54, 95%CI: 0.32-0.90, P=0.03) in patients undergoing cardiac surgery, but did not affect the incidence of hypotension and arrhythmias (OR=1.29, 95%CI: 0.83-1.99, P=0.26. OR=0.65, 95%CI: 0.32-1.35, P=0.25). Conclusions Perioperative administration of levosimendan in patients with left ventricular dysfunction undergoing cardiac surgery may improve patient′s prognosis and reduce complications. The scope of this study is small, so more high quality RCT research are needed to provide more conclusive evidence regarding the benefit of this drug. Key words: Levosimendan; Cardiac insufficiency; Cardiac surgery; Mortality; Acute kidney injury

Recent RCT Research on the Effects of Acupuncture on Dementia - Based on a PubMed Search of Literature Published from 2000 to 2018

Objective The purpose of this study is to investigate recent clinical studies on the effects of acupuncture on dementia. Method We searched RCTs (randomized controlled trials) using the database PubMed (2000-2018). Clinical RCT studies of acupuncture used to treat dementia in humans were included. Nine randomized controlled trials were included. Results Various acupoints such as Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24) were used to treat symptoms. The studies reported a decrease in evaluation criteria, such as the Mini Mental State Examination (MMSE) and activities of daily living (ADL), for measuring cognitive ability. The acupuncture process, the results for outcome measure, and the effectiveness of studies were analyzed. We then assessed “risk of bias.” Conclusions Through this review, we found that acupuncture is applicable for the treatment of dementia. This can be used for future study. Keywords: dementia, acupuncture, review