Trial methodology

BACKGROUND: 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...

BACKGROUND AND OBJECTIVE: With more research completed using Motor imagery (MI) in people with Parkinson's disease, this study gathered and synthesized evidence on the use of MI for Parkinson's disease in improving rehabilitation outcomes. METHODS: Medical Literature Analysis and Retrieval System Online, Embase, Web of Science, The Cochrane Library, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Scopus were searched from inception to May 2023...

Objective: This systematic review aims to assess the impact of music therapy and musical interventions on neuropsychiatric outcomes among patients with moderate and severe mental disorders, in comparison with conventional treatment in isolation. Methods: The review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive search was conducted on November 16, 2021, using the following databases and search interfaces: Cumulative Index to Nursing and Allied Health Literature, Embase, SCOPUS, Web of Science; PubMed, PsycINFO, Literatura Latino-Americana e do Caribe em Ciências da Saúde, and Scientific Electronic Library Online...

Background: Palliative care, a cornerstone of comprehensive healthcare, prioritizes quality of life for individuals with life-threatening illnesses. Aromatherapy, with its holistic approach and patient-reported benefits, emerges as a promising complementary therapy for managing symptoms and enhancing well-being in palliative care. Objective: The objective of this systematic review is to assess the efficacy of aromatherapy interventions in symptom management, with a focus on pain, anxiety, nausea, and sleep disturbances among palliative care patients...

BACKGROUND: Peri-implant diseases (peri-implant mucositis and peri-implantitis) are pathologies of an infectious-inflammatory nature of the mucosa around dental implants. Probiotics are microorganisms that regulate host immunomodulation and have shown positive results in the treatment of peri-implant diseases. The objective of the systematic review and meta-analysis was to evaluate the efficacy of probiotics in the treatment of peri-implant oral diseases. METHODS: According to the PRISMA guidelines, the research question was established: Are probiotics able to favorably modify clinical and immunological biomarkers determinants of peri-implant pathologies? and an electronic search of the databases MEDLINE/PubMed, Embase, Cochrane Central, Web of Science, (until December 2023) was performed...

BACKGROUND: This work was commissioned by the WHO and FAO to inform their update of the vitamin D requirements for children below 4 years old. OBJECTIVE: The objective of this work was to undertake multi-level and multivariable dose-response modelling of serum 25OHD to total vitamin D intake in children below 4 years of age and to derive updated vitamin D requirements for young children. METHODS: Systematically identified randomized controlled trials among healthy children from 2 weeks up to 3...

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Careful consideration of how we approach design is crucial to all areas of biotechnology. However, choosing or developing an effective design methodology is not always easy as biology, unlike most areas of engineering, is able to adapt and evolve. Here, we put forward that design and evolution follow a similar cyclic process and therefore all design methods, including traditional design, directed evolution, and even random trial and error, exist within an evolutionary design spectrum. This contrasts with conventional views that often place these methods at odds and provides a valuable framework for unifying engineering approaches for challenging biological design problems...

OBJECTIVE
This study aimed to examine differences in heart rate variability (HRV) across accelerometer-derived position, self-reported sleep, and different summary measures (sleep, 24h-HRV) in free-living settings using open-source methodology. 
APPROACH
HRV is a biomarker of autonomic activity. As it is strongly affected by factors such as physical behaviour, stress, and sleep, ambulatory HRV analysis is challenging. Beat-to-beat heart rate (HR) and accelerometry data were collected using single-lead electrocardiography and trunk- and thigh-worn accelerometers among 160 adults participating in the SCREENS trial...

BACKGROUND: Endoxifen, a protein kinase C inhibitor and selective estrogen receptor modulator, primarily used in breast cancer treatment, has recently emerged as a potential therapeutic option for managing manic episodes associated with bipolar disorder (BD). This review aims to assess the existing evidence base for endoxifen in BD treatment and evaluate the strengths and limitations of current research findings. METHODS: A systematic search was conducted on Medline, Embase, and Web of Science databases...

Recent years have seen a resurgence in randomized, placebo controlled trials (RCTs) utilizing non-classical psychedelics (e.g. 3,4-methyl enedioxy methamphetamine [MDMA]), and classical psychedelics (e.g. psilocybin, lysergic acid diethylamide [LSD], and N,N-dimethyltryptamine [DMT/ayahuasca]) in conjunction with assisted therapy (AT) for psychiatric disorders. A notable methodological challenge in psychedelic AT, however, is the complexity of blinding procedures. The lack of efficacious blinding can introduce considerable response bias, reduce internal validity, and compromise participant retention...

BACKGROUND: Automated insulin delivery (AID) systems, permit improved treatment of type 1 diabetes (T1D). Unfortunately, malfunctioning in the insulin pump or in the infusion set can prevent insulin from being administered, reducing the AID efficacy and posing the patient at risk. Different data-driven methods available in the literature can be used to deal with the problem of automatically detecting complete insulin suspension in real-time. This article investigates both supervised and unsupervised strategies and proposes a fair comparison under either population or personalized settings...

BACKGROUND: Acute appendicitis is one of the most common emergency general surgical conditions worldwide. Uncomplicated/simple appendicitis can be treated with appendectomy or antibiotics. Some studies have suggested possible benefits with antibiotics with reduced complications, length of hospital stay, and the number of days off work. However, surgery may improve success of treatment as antibiotic treatment is associated with recurrence and future need for surgery. OBJECTIVES: To assess the effects of antibiotic treatment for uncomplicated/simple acute appendicitis compared with appendectomy for resolution of symptoms and complications...

BACKGROUND: Despite the known harms, alcohol consumption is common in pregnancy. Rates vary between countries, and are estimated to be 10% globally, with up to 25% in Europe. OBJECTIVES: To assess the efficacy of psychosocial interventions and medications to reduce or stop alcohol consumption during pregnancy. SEARCH METHODS: We searched the Cochrane Drugs and Alcohol Group Specialised Register (via CRSLive), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science, and PsycINFO, from inception to 8 January 2024...

BACKGROUND: Autologous platelet-rich plasma (PRP) consists of plasma and a concentrate of platelets extracted from fresh whole blood of the person being treated. Research has suggested that intrauterine or intraovarian infusion/injection of PRP before embryo transfer may improve endometrial receptivity and response to ovarian stimulation in women undergoing assisted reproduction. We compared these interventions to standard treatment, placebo, or other interventions (mechanical or pharmacological)...

The Chinese Society of Critical Care Medicine (CSCCM) has developed clinical practice guidelines for nutrition assessment and monitoring for patients in adult intensive care units (ICUs) in China. This guideline focuses on nutrition evaluation and metabolic monitoring to achieve optimal and personalized nutrition therapy for critically ill patients. This guideline was developed by experts in critical care medicine and evidence-based medicine methodology and was developed after a thorough review of the system and a summary of relevant trials or studies published from 2000 to July 2023...

Background The outbreak of the COVID-19 pandemic led to the rise of various social issues apart from medical ones. Several myths regarding COVID-19 vaccination were found worldwide, and some of the common ones identified were abortions, birth defects, bad pregnancy outcomes such as abortions, ectopic pregnancy, risk of infertility, and irregular menstrual cycles. Although no scientific theories or data backed those myths, pregnancy was still omitted from trials for a long time as any drug/vaccine given during pregnancy may affect the fetus...

OBJECTIVES: This research program involves two phases to identify enablers and barriers to diabetes care for Aboriginal people on Ngarrindjeri country; and co-design a strength-based metabolic syndrome and Type 2 Diabetes (T2D) remission program with the Ngarrindjeri community. STUDY DESIGN: A study protocol on qualitative research. METHODS: The study will recruit Aboriginal people living on Ngarrindjeri country above 18 years of age with a diagnosis of metabolic syndrome or T2D...

BACKGROUND: Among youth, symptoms of depression, anxiety, and alcohol use are associated with considerable illness and disability. Youth face many personal and health system barriers in accessing mental health care. Mobile applications (apps) offer youth potentially accessible, scalable, and anonymous therapy and other support. Recent systematic reviews on apps to reduce mental health symptoms among youth have reported uncertain effectiveness, but analyses based on the type of app-delivered therapy are limited...

OBJECTIVES: 1.1Biases inherent in electronic health records (EHRs), and therefore in medical artificial intelligence (AI) models may significantly exacerbate health inequities and challenge the adoption of ethical and responsible AI in healthcare. Biases arise from multiple sources, some of which are not as documented in the literature. Biases are encoded in how the data has been collected and labeled, by implicit and unconscious biases of clinicians, or by the tools used for data processing...