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Efficacy and safety of Chinese herbal footbaths for the treatment of dysmenorrhea: Protocol for a systematic review and meta-analysis

2021-05-03T00:00

Background

Chinese herbal footbaths are an external therapy of traditional Chinese medicine that has been widely used to treat dysmenorrhea. This review aims to systematically evaluate its efficacy and safety for the treatment of dysmenorrhea.

Methods

Databases of PubMed, EMBASE, Cochrane Library, CIHAHL, Web of Science, Chinese National Knowledge Infrastructure(CNKI), Chinese Scientific Journals Database (VIP), Wanfang Database, China Biomedical Literature Database(CBM), and Chinese Biomedical Literature Service System (SinoMed) will be searched from the inception to September 30, 2020. The eligible randomized controlled trials (RCTs) will be identified and included. The primary outcomes include pain intensity measured by validated scales of visual analog scale, numeric rating scale, and response rate of symptom reduction. The secondary outcomes are scores on validated pain questionnaires, quality of life measured by SF-36 or other validated scales, and adverse events. Study selection, data extraction, and assessment of bias risk will be conducted by two reviewers independently. RevMan software (V.5.3.5) will be utilized to perform data synthesis. Subgroup and sensitivity analysis will be performed when necessary. The strength of the evidence will be evaluated with the Grading of Recommendations Assessment, Development and Evaluation System.

Results

A high-quality synthesis of current evidence of Chinese herbal footbaths for patients with dysmenorrhea will be provided in this study.

Conclusion

This systematic review will provide evidence of whether Chinese herbal footbaths are an effective and safe intervention for the treatment of dysmenorrhea.

Systematic review registration

PROSPERO CRD42020188256.

Current trends in the application of causal inference methods to pooled longitudinal observational infectious disease studies—A protocol for a methodological systematic review

2021-04-29T00:00

Introduction

Pooling (or combining) and analysing observational, longitudinal data at the individual level facilitates inference through increased sample sizes, allowing for joint estimation of study- and individual-level exposure variables, and better enabling the assessment of rare exposures and diseases. Empirical studies leveraging such methods when randomization is unethical or impractical have grown in the health sciences in recent years. The adoption of so-called “causal” methods to account for both/either measured and/or unmeasured confounders is an important addition to the methodological toolkit for understanding the distribution, progression, and consequences of infectious diseases (IDs) and interventions on IDs. In the face of the Covid-19 pandemic and in the absence of systematic randomization of exposures or interventions, the value of these methods is even more apparent. Yet to our knowledge, no studies have assessed how causal methods involving pooling individual-level, observational, longitudinal data are being applied in ID-related research. In this systematic review, we assess how these methods are used and reported in ID-related research over the last 10 years. Findings will facilitate evaluation of trends of causal methods for ID research and lead to concrete recommendations for how to apply these methods where gaps in methodological rigor are identified.

Methods and analysis

We will apply MeSH and text terms to identify relevant studies from EBSCO (Academic Search Complete, Business Source Premier, CINAHL, EconLit with Full Text, PsychINFO), EMBASE, PubMed, and Web of Science. Eligible studies are those that apply causal methods to account for confounding when assessing the effects of an intervention or exposure on an ID-related outcome using pooled, individual-level data from 2 or more longitudinal, observational studies. Titles, abstracts, and full-text articles, will be independently screened by two reviewers using Covidence software. Discrepancies will be resolved by a third reviewer. This systematic review protocol has been registered with PROSPERO (CRD42020204104).

Incidence of lung cancer and mortality among civil construction industry workers: A protocol for a systematic review and meta-analysis

2021-04-26T00:00

Background

The construction sector is one of the most stable growth industries in the world. However, many studies have suggested an association between occupational exposure in civil construction and lung cancer risk. Thus, this study aims to assess lung cancer risk in civil construction workers occupationally exposed to physical and chemical agents through a systematic review and meta-analysis.

Methods/design

Studies will be identified by searching PUBMED, Embase, SCOPUS, WEB OF SCIENCE and the reference list of included articles. Eligible study designs will be cohort, cross-sectional, and case-control studies that report occupational exposure to physical or chemical agents and lung cancer risk through mortality or incidence outcomes. A meta-analysis will be used to combine odds ratios (ORs) from case-control studies and relative risks (RR) from cohort studies. Two reviewers will independently screen articles, extract data, and assess scientific quality using standardized forms and ROBINS-E tool if available. Otherwise, the New-Castle Ottawa rating scale will be used. Any of those will also be used in combination with the GRADE approach for quality of evidence. Overall risk estimates and their corresponding 95% confidence intervals (CIs) will be obtained using the random-effects model meta-analysis. This systematic review and meta-analysis will be conducted following the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.

Discussion

This review will identify and synthesize studies investigating the association between occupational exposure in the construction industry and lung cancer. The findings will help governmental entities and researchers with evidence-based decision-making because they will integrate and validate the evidence on construction workers’ health effects due to occupational exposure.

Systematic review registration

PROSPERO CRD42020164209

Nucleic acid amplification techniques for rapid diagnosis of nontuberculous mycobacteria: A protocol of systematic review and meta-analysis

2021-04-22T00:00

Background

Nontuberculous mycobacteria (NTM) infection is similar to Mycobacterium tuberculosis (MTB) infection. Early clinical identification and differentiation of NTM and MTB infections continues to be a major challenge. Nucleic acid amplification tests (NAATs) have the ability to efficiently and rapidly detect pathogens and are widely used in mycobacterial infections. The objective of this study is to estimate the diagnostic accuracy of NAATs for NTM.

Methods

We will search candidate studies that assessing the accuracy of NAATs for diagnosis of NTM through PubMed, Embase and the Cochrane Library until May 2021. Studies with full text that meet the inclusion criteria will be included. Following a revised tool for Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2), two researchers will independently evaluate the study quality. The STATA software (version 15.0) will be used to carry out meta-analyses. When heterogeneity is observed, subgroup analyses and meta-regression analyses will be used to explore sources of heterogeneity. Sensitivity analyses will be used to check the robustness of analyses.

Conclusion

We hope that this study will provide meaningful evidence for the early and rapid diagnosis of NAATs for NTM, which will help to guide the treatment of NTM and improve the prognosis of patients.

eNose-TB: A trial study protocol of electronic nose for tuberculosis screening in Indonesia

2021-04-21T00:00

Background

Even though conceptually, Tuberculosis (TB) is almost always curable, it is currently the world’s leading infectious killer. Patients with pulmonary TB are the source of transmission. Approximately 23% of the world’s population is believed to be latently infected with TB bacteria, and 5–15% of them will progress at any point in time to develop the disease. There was a global diagnostic gap of 2.9 million between notifications of new cases and the estimated number of incident cases, and Indonesia carries the third-highest of this gap. Therefore, screening TB among the community is of great importance to prevent further transmission and infection. The electronic nose for screening TB (eNose-TB) project is initiated in Yogyakarta, Indonesia, to screen TB by breath test with an electronic-nose that is easy-to-use, point-of-care, does not expose patients to radiation, and can be produced at low cost.

Methods/Design

The objectives of the two-phase planned project are to: 1) investigate the potential of an eNose-TB as a screening tool in Indonesia, in comparison with screening with clinical symptoms and chest radiology, which are currently used as a standard, and 2) analyze the time and cost of a screening algorithm with eNose-TB to obtain additional case detection. A cross-sectional study will be conducted in the first phase to validate the eNose-TB. The validation phase will involve 395 presumptive TB patients in the Surakarta General Hospital, Central Java. In the second phase, a cross-sectional research will be conducted, involving 1,383 adults and children in the municipality of Yogyakarta and Kulon Progo district of Yogyakarta Province.

Discussion

The findings will provide data concerning the sensitivity and specificity of the eNose-TB as a screening tool for tuberculosis, and the time and cost analysis of a screening algorithm with the eNose.

Trial registration

NCT04567498; https://clinicaltrials.gov/.

The effect of Moringa oleifera capsule in increasing breastmilk volume in early postpartum patients: A double-blind, randomized controlled trial

2021-04-06T00:00

Moringa oleifera is an herbal galactagogue that has been used to increase the volume of breastmilk. Few studies have evaluated the effect of Moringa oleifera in breastfeeding. There are conflicting data whether it can increase the volume of breastmilk or not. Thus, the objective of this study is to evaluate the efficacy of Moringa oleifera leaves in increasing the volume of breastmilk in early postpartum mothers. A randomized, double-blind, placebo-controlled trial will be conducted. The outcomes of this study will provide the data of Moringa oleifera as an herbal medication to increase the volume of breastmilk. This information will be used to increase the rate of exclusive breastfeeding for the first 6 months as recommended by the World Health Organization.

Clinical trial registration

This clinical trial was registered at ClinicalTrials.gov (Clinical trials registration: NCT04487613).

HIV-associated nephropathy: Protocol and rationale for an exploratory genotype-phenotype study in a sub-Saharan African population

2021-04-06T00:00

Background

HIV-positive persons of African descent are disproportionately affected by chronic kidney disease (CKD). Deterioration to end-stage kidney disease (ESKD) also occurs in this population at a higher frequency. There remains a lot to learn about the genetic susceptibility to CKD in HIV positive patients, and the pathophysiology of progression to ESKD.

Objectives

We will conduct an exploratory genotype-phenotype study in HIV-positive persons with CKD in Aminu Kano Teaching Hospital, Nigeria, to determine blood-based differential gene expression biomarkers in different kidney risk groups according to the KDIGO 2012 criteria.

Methods

We will consecutively screen 150 HIV-positive adults (≥18 years of age) attending the HIV clinic of Aminu Kano Teaching Hospital, Kano, Nigeria, for CKD based on proteinuria and elevation of estimated glomerular filtration rate. Among these, two separate groups of 16 eligible participants each (n = 32) will be selected in the four (4) KDIGO 2012 kidney risk categories. The groups will be matched for age, sex, viral suppression level and antiretroviral (ARV) regimen. In the first group (n = 16), we will determine differential gene expression markers in peripheral blood mononuclear cells using mRNA-sequencing (RNA-Seq). We will validate the differential expression markers in the second group (n = 16) using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Using a systems-based approach, we will construct, visualize and analyze gene-gene interaction networks to determine the potential biological roles of identified differential expression markers based on published literature and publicly available databases.

Results

Our exploratory study will provide valuable information on the potential roles of differential expression biomarkers in the pathophysiology of HIV-associated kidney disease by identifying novel biomarkers in different risk categories of CKD in a sub-Saharan African population. The results of this study will provide the basis for population-based genome-wide association studies to guide future personalized medicine approaches.

Conclusion

Validated biomarkers can be potential targets for the development of stage-specific therapeutic interventions, an essential paradigm in precision medicine.

MicroRNA biomarkers of type 2 diabetes: A protocol for corroborating evidence by computational genomics and meta-analyses

2021-04-06T00:00

Background

Few microRNAs were found consistently dysregulated in type 2 diabetes (T2D) that would gain confidence from Big Pharma to develop diagnostic or therapeutic biomarkers. This study aimed to corroborate evidence from eligible microRNAs-T2D association studies according to stringent quality criteria covering both biological and statistical significance in T2D for biomarker development.

Methods and analyses

Controlled microRNA expression profiling studies on human with T2D will be retrieved from PubMed, ScienceDirect, and Embase for selecting the statistically significant microRNAs according to pre-specified search strategies and inclusion criteria. Multiple meta-analyses with restricted maximum-likelihood estimation and empirical Bayes estimation under the random-effects model will be conducted by metafor package in R. Subgroup and sensitivity analyses further examine the microRNA candidates for their disease specificity, tissue specificity, blood fraction specificity, and statistical robustness of evidence. Biologically relevant microRNAs will then be selected through genomic database corroboration. Their association with T2D is further measured by area under the curve (AUC) of receive operating characteristic (ROC). Meta-analysis of AUC of potential biomarkers will also be conducted. Enrichment analysis on potential microRNA biomarkers and their target genes will be performed by iPathwayGuide and clusterProfiler, respectively. The corresponding reporting guidelines will be used to assess the quality of included studies according to their profiling methods (microarray, RT-PCR, and RNA-Seq).

Ethics and dissemination

No ethics approval is required since this study does not include identifiable personal patient data.

Protocol registration number

CRD42017081659.

Establishing how social capital is studied in relation to cardiovascular disease and identifying gaps for future research—A scoping review protocol

2021-04-08T00:00

Introduction

Though the relationship between social capital and health has been widely studied, the evidence of this relationship in cardiovascular disease is limited, with varied and inconsistent measures. This scoping review seeks to address this gap by answering the following questions: (1) How has social capital been characterized and measured in the literature related to cardiovascular disease? and (2) What gaps exist in the evaluation of the relationship between social capital and cardiovascular disease?

Materials and methods

A scoping review will be used to answer the research questions. The scoping review will apply established methods described by Arksey and O’Malley, Levac and colleagues, and the Joanne Briggs Institute: (1) identifying the research question(s); (2) identifying relevant studies; (3) selecting the studies; (4) charting the data; and (5) collating, summarizing, and reporting the results.

Results

Our findings will be reported in accordance with the guidance provided in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement.

Discussion

The synthesis of this evidence base is intended to provide a framework for how social capital has been defined and measured in the cardiovascular literature, with additional guidance for future research and evaluation. The findings will be disseminated through peer-reviewed publication and presentations at relevant seminars.

Investigating colonization patterns of the infant gut microbiome during the introduction of solid food and weaning from breastmilk: A cohort study protocol

2021-04-02T00:00

The first exposures to microbes occur during infancy and it is suggested that this initial colonization influences the adult microbiota composition. Despite the important role that the gut microbiome may have in health outcomes later in life, the factors that influence its development during infancy and early childhood have not been characterized fully. Guidelines about the introduction of solid foods and cessation of breastfeeding, which is thought to have a significant role in the transition to a more adult-like microbiota, are not based on microbiome research. There is even less understanding of approaches used to transition to solid food in the preterm population. The purpose of this study is to identify the impact of early life dietary events on gut microbiome community structures and function among infants born at term and pre-term. We plan to prospectively monitor the gut microbiome of infants during two critical timepoints in microbial development: the introduction of solid foods and cessation from breastmilk. A total of 35 participants from three primary observational birth cohorts (two full-term cohorts and one pre-term cohort) will be enrolled in this sub-study. Participants will be asked to collect stool samples and fill out a study diary before, during and after the introduction of solids and again during weaning from breastmilk. We will use frequent fecal sampling analyzed using 16S rRNA gene profiling, metagenomics, metabolomics, and targeted bacterial culturing to identify and characterize the microbial communities, as well as provide insight into the phenotypic characteristics and functional capabilities of the microbes present during these transitional periods of infancy. This study will provide a comprehensive approach to detailing the effects of dietary transition from breastmilk to a more adult-like solid food diet on the microbiome and in doing so will contribute to evidence-based infant nutrition guidance.

Improving dog training methods: Efficacy and efficiency of reward and mixed training methods

2021-02-19T00:00

Dogs play an important role in our society as companions and work partners, and proper training of these dogs is pivotal. For companion dogs, training helps preventing or managing dog behavioral problems—the most frequently cited reason for relinquishing and euthanasia, and it promotes successful dog-human relationships and thus maximizes benefits humans derive from bonding with dogs. For working dogs, training is crucial for them to successfully accomplish their jobs. Dog training methods range widely from those using predominantly aversive stimuli (aversive methods), to those combining aversive and rewarding stimuli (mixed methods) and those focusing on the use of rewards (reward methods). The use of aversive stimuli in training is highly controversial and several veterinary and animal protection organizations have recommended a ban on pinch collars, e-collars and other techniques that induce fear or pain in dogs, on the grounds that such methods compromise dog welfare. At the same time, training methods based on the use of rewards are claimed to be more humane and equally or more effective than aversive or mixed methods. This important discussion, however, has not always been based in solid scientific evidence. Although there is growing scientific evidence that training with aversive stimuli has a negative impact on dog welfare, the scientific literature on the efficacy and efficiency of the different methodologies is scarce and inconsistent. Hence, the goal of the current study is to investigate the efficacy and efficiency of different dog training methods. To that end, we will apply different dog training methods in a population of working dogs and evaluate the outcome after a period of training. The use of working dogs will allow for a rigorous experimental design and control, with randomization of treatments. Military (n = 10) and police (n = 20) dogs will be pseudo-randomly allocated to two groups. One group will be trained to perform a set of tasks (food refusal, interrupted recall, dumbbell retrieval and placing items in a basket) using reward methods and the other group will be trained for the same tasks using mixed methods. Later, the dogs will perform a standardized test where they will be required to perform the trained behaviors. The reliability of the behaviors and the time taken to learn them will be assessed in order to evaluate the efficacy and efficiency, respectively, of the different training methods. This study will be performed in collaboration with the Portuguese Army and with the Portuguese Public Security Police (PSP) and integrated with their dog training programs.

Articulatory motor planning and timbral idiosyncrasies as underlying mechanisms of instrument-specific absolute pitch in expert musicians

2021-02-19T00:00

The study of musical expertise illustrates how intense training in a specialized domain may instigate development of implicit skills. While absolute pitch, or the ability to identify musical pitches without external reference, is rare even in professional musicians and is understood to have a genetic component, anecdotal evidence and pilot data suggest that some musicians without traditional absolute pitch are nonetheless better able to name notes played on their musical instrument of expertise than notes played on less familiar instruments. We have previously termed this particular gain in absolute pitch identification ability “instrument-specific absolute pitch” (ISAP) and have proposed that this skill is related to learned instrument type-specific timbral and intonational idiosyncrasies and articulatory motor planning activated by the timbre of the instrument. In this Registered Report Protocol, we describe two experiments designed to investigate ISAP in professional oboists. Experiment 1 tests for ISAP ability by comparing oboists’ pitch identification accuracies for notes played on the oboe and on the piano. A subset of the participants from Experiment 1 who demonstrate this ability will be recruited for Experiment 2; the purpose of Experiment 2 is to test hypotheses concerning a mechanistic explanation for ISAP. The outcome of these experiments may provide support for the theory that some individuals have ISAP and that the underlying mechanisms of this ability may rely on the perception of subtle timbral/intonational idiosyncrasies and on articulatory motor planning developed through intensive long-term training. In general, this work will contribute to the understanding of specialized expertise, specifically of implicit abilities and biases that are not addressed directly in training, but that may yet develop through practice of a related skill set.

Protocol: A systematic review and meta-analysis of the role of fetal and infantile environmental exposure in etiopathogenesis of infantile hypertrophic pyloric stenosis

2021-02-16T00:00

Infantile hypertrophic pyloric stenosis (IHPS) is one of the hallmark pediatric surgical diseases. However, its etiology remains incompletely understood. By systematically reviewing the literature, we aim to clarify the effect of the effect of occupational and environmental factors and role of nitric oxide (NO) metabolism in the etiopathogenesis of IHPS. The systematic review is drafted with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement (PRISMA) and the Meta-analysis of Observational Studies in Epidemiology (MOOSE). Systematic literature search will be performed for the period 2000 (Jan) to 2020 (Dec) in the databases: MEDLINE, EMBASE, PubMed. The systematic search will cover the literature in English and Turkish language and will be limited to studies on human subjects. Four investigators will independently search the databases (MEDLINE, EMBASE, PubMed) according to the defined search strategy. The full-text of the selected articles will be screened independently by four reviewers, against the inclusion criteria. Descriptive data will be extracted from each study regarding: study details, methods, participants, outcomes and calculations of association for potential further statistical analysis. If meta-analysis could not be undertaken, systematic approach to analyzing the findings of included multiple studies will be described. Heterogeneity will be assessed by quantifying the inconsistency across studies using I² statistic. Statistical analysis will be performed using Comprehensive Meta-Analysis Version 3.0 software. The p values lower than 0.05 will be considered statistically significant for all analyses.

Profiles of competence development in upper secondary education and their predictors

2021-01-29T00:00

This registered report protocol elaborates on the theory, methods, and material of a study to identify latent profiles of competence development in reading and mathematics among German students in upper secondary education. It is expected that generalized (reading and mathematical competence develop similarly) and specialized (one of the domains develops faster) competence profiles will be identified. Moreover, it is hypothesized that students’ domain-specific interest and educational history will predict membership of these latent profiles as these factors influence the students’ learning environments. For this study, we will use data from the German National Educational Panel Study, including students from ninth grade in secondary schools (expected N = 14,500). These students were tracked across six years and provided competence assessments on three occasions. The latent profiles based on the students’ reading and mathematical competences will be identified using latent growth mixture modeling. If different types of profiles can be identified, multinomial regression will be utilized to analyze whether the likelihood of belonging to a certain competence development profile is influenced by students’ domain-specific interest or educational history. As this protocol is submitted before any analyses were conducted, it will provide neither results nor conclusions.

Machine learning model for predicting severity prognosis in patients infected with COVID-19: Study protocol from COVID-AI Brasil

2021-02-01T00:00

The new coronavirus, which began to be called SARS-CoV-2, is a single-stranded RNA beta coronavirus, initially identified in Wuhan (Hubei province, China) and currently spreading across six continents causing a considerable harm to patients, with no specific tools until now to provide prognostic outcomes. Thus, the aim of this study is to evaluate possible findings on chest CT of patients with signs and symptoms of respiratory syndromes and positive epidemiological factors for COVID-19 infection and to correlate them with the course of the disease. In this sense, it is also expected to develop specific machine learning algorithm for this purpose, through pulmonary segmentation, which can predict possible prognostic factors, through more accurate results. Our alternative hypothesis is that the machine learning model based on clinical, radiological and epidemiological data will be able to predict the severity prognosis of patients infected with COVID-19. We will perform a multicenter retrospective longitudinal study to obtain a large number of cases in a short period of time, for better study validation. Our convenience sample (at least 20 cases for each outcome) will be collected in each center considering the inclusion and exclusion criteria. We will evaluate patients who enter the hospital with clinical signs and symptoms of acute respiratory syndrome, from March to May 2020. We will include individuals with signs and symptoms of acute respiratory syndrome, with positive epidemiological history for COVID-19, who have performed a chest computed tomography. We will assess chest CT of these patients and to correlate them with the course of the disease. Primary outcomes:1) Time to hospital discharge; 2) Length of stay in the ICU; 3) orotracheal intubation;4) Development of Acute Respiratory Discomfort Syndrome. Secondary outcomes:1) Sepsis; 2) Hypotension or cardiocirculatory dysfunction requiring the prescription of vasopressors or inotropes; 3) Coagulopathy; 4) Acute Myocardial Infarction; 5) Acute Renal Insufficiency; 6) Death. We will use the AUC and F1-score of these algorithms as the main metrics, and we hope to identify algorithms capable of generalizing their results for each specified primary and secondary outcome.

Comparing phonological and orthographic networks: A multiplex analysis

2021-02-01T00:00

The complexity of natural language can be explored by means of multiplex analyses at different scales, from single words to groups of words or sentence levels. Here, we plan to investigate a multiplex word-level network, which comprises an orthographic and a phonological network defined in terms of distance similarity. We systematically compare basic structural network properties to determine similarities and differences between them, as well as their combination in a multiplex configuration. As a natural extension of our work, we plan to evaluate the preservation of the structural network properties and information-based quantities from the following perspectives: (i) presence of similarities across 12 natural languages from 4 linguistic families (Romance, Germanic, Slavic and Uralic), (ii) increase of the size of the number of words (corpus) from 10⁴ to 50 × 10³, and (iii) robustness of the networks. Our preliminary findings reinforce the idea of common organizational properties among natural languages. Once concluded, will contribute to the characterization of similarities and differences in the orthographic and phonological perspectives of language networks at a word-level.

A One Health approach to assessing occupational exposure to antimicrobial resistance in Thailand: The FarmResist project

2021-01-28T00:00

This Southeast Asia-Europe research project will use a One Health approach to identify the major parameters responsible for the presence of animal-associated antimicrobial resistant bacteria in animal production facilities in Thailand and the risk of their transmission from animals to humans. We will focus on traditional, small, extensive pig and poultry farms where information on antibiotic use is scarce and animals live in close contact with humans. This cross-sectional study will be based on the epidemiological analysis of the antimicrobial resistance (AMR) present in fecal samples from animals and humans. Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) and Enterobacteriaceae resistant to colistin will be actively searched in the feces of farm animals (pigs and poultry), small wild rodents and farmers. Phenotypic (selective plating) and genotypic (multilocus seuquence typing and sequencing) methods will be used for the detection of AMR, the identification of antibiotic resistance genes (ARGs) and the characterization of strains carrying resistance genes. Questionnaires will be administered to investigate the effects of antibiotic use, farm characteristics and biosecurity measures on the occurrence of AMR in animals. Subsequently, the fecal carriage of AMR and ARGs in farmers will be compared to a control population with no occupational contacts with animals, thus enabling an estimation of the risk of transmission of AMR/ARGs from animals to farmers.

Identifying causative mechanisms linking early-life stress to psycho-cardio-metabolic multi-morbidity: The EarlyCause project

2021-01-21T00:00

Introduction

Depression, cardiovascular diseases and diabetes are among the major non-communicable diseases, leading to significant disability and mortality worldwide. These diseases may share environmental and genetic determinants associated with multimorbid patterns. Stressful early-life events are among the primary factors associated with the development of mental and physical diseases. However, possible causative mechanisms linking early life stress (ELS) with psycho-cardio-metabolic (PCM) multi-morbidity are not well understood. This prevents a full understanding of causal pathways towards the shared risk of these diseases and the development of coordinated preventive and therapeutic interventions.

Methods and analysis

This paper describes the study protocol for EarlyCause, a large-scale and inter-disciplinary research project funded by the European Union’s Horizon 2020 research and innovation programme. The project takes advantage of human longitudinal birth cohort data, animal studies and cellular models to test the hypothesis of shared mechanisms and molecular pathways by which ELS shapes an individual’s physical and mental health in adulthood. The study will research in detail how ELS converts into biological signals embedded simultaneously or sequentially in the brain, the cardiovascular and metabolic systems. The research will mainly focus on four biological processes including possible alterations of the epigenome, neuroendocrine system, inflammatome, and the gut microbiome. Life-course models will integrate the role of modifying factors as sex, socioeconomics, and lifestyle with the goal to better identify groups at risk as well as inform promising strategies to reverse the possible mechanisms and/or reduce the impact of ELS on multi-morbidity development in high-risk individuals. These strategies will help better manage the impact of multi-morbidity on human health and the associated risk.

Evaluating equality in prescribing Novel Oral Anticoagulants (NOACs) in England: The protocol of a Bayesian small area analysis

2021-02-04T00:00

Background

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting about 1.6% of the population in England. Novel oral anticoagulants (NOACs) are approved AF treatments that reduce stroke risk. In this study, we estimate the equality in individual NOAC prescriptions with high spatial resolution in Clinical Commissioning Groups (CCGs) across England from 2014 to 2019.

Methods

A Bayesian spatio-temporal model will be used to estimate and predict the individual NOAC prescription trend on ‘prescription data’ as an indicator of health services utilisation, using a small area analysis methodology. The main dataset in this study is the “Practice Level Prescribing in England,” which contains four individual NOACs prescribed by all registered GP practices in England. We will use the defined daily dose (DDD) equivalent methodology, as recommended by the World Health Organization (WHO), to compare across space and time. Four licensed NOACs datasets will be summed per 1,000 patients at the CCG-level over time. We will also adjust for CCG-level covariates, such as demographic data, Multiple Deprivation Index, and rural-urban classification. We aim to employ the extended BYM2 model (space-time model) using the RStan package.

Discussion

This study suggests a new statistical modelling approach to link prescription and socioeconomic data to model pharmacoepidemiologic data. Quantifying space and time differences will allow for the evaluation of inequalities in the prescription of NOACs. The methodology will help develop geographically targeted public health interventions, campaigns, audits, or guidelines to improve areas of low prescription. This approach can be used for other medications, especially those used for chronic diseases that must be monitored over time.

Realist evaluation to improve health systems responsiveness to neglected health needs of vulnerable groups in Ghana and Vietnam: Study protocol

2021-01-22T00:00

Background

Socio-economic growth in many low and middle-income countries has resulted in more available, though not equitably accessible, healthcare. Such growth has also increased demands from citizens for their health systems to be more responsive to their needs. This paper shares a protocol for the RESPONSE study which aims to understand, co-produce, implement and evaluate context-sensitive interventions to improve health systems responsiveness to health needs of vulnerable groups in Ghana and Vietnam.

Methods

We will use a realist mixed-methods theory-driven case study design, combining quantitative (household survey, secondary analysis of facility data) and qualitative (in-depth interviews, focus groups, observations and document and literature review) methods. Data will be analysed retroductively. The study will comprise three Phases. In Phase 1, we will understand actors’ expectations of responsive health systems, identify key priorities for interventions, and using evidence from a realist synthesis we will develop an initial theory and generate a baseline data. In Phase 2, we will co-produce jointly with key actors, the context-sensitive interventions to improve health systems responsiveness. The interventions will seek to improve internal (i.e. intra-system) and external (i.e. people-systems) interactions through participatory workshops. In Phase 3, we will implement and evaluate the interventions by testing and refining our initial theory through comparing the intended design to the interventions’ actual performance.

Discussion

The study’s key outcomes will be: (1) improved health systems responsiveness, contributing to improved health services and ultimately health outcomes in Ghana and Vietnam and (2) an empirically-grounded and theoretically-informed model of complex contexts-mechanisms-outcomes relations, together with transferable best practices for scalability and generalisability. Decision-makers across different levels will be engaged throughout. Capacity strengthening will be underpinned by in-depth understanding of capacity needs and assets of each partner team, and will aim to strengthen individual, organisational and system level capacities.

Text messaging as a tool to improve cancer screening programs (M-TICS Study): A randomized controlled trial protocol

2021-01-22T00:00

Background

Short message service (SMS) based interventions are widely used in healthcare and have shown promising results to improve cancer screening programs. However, more research is still needed to implement SMS in the screening process. We present a study protocol to assess the impact on health and economics of three targeted SMS-based interventions in population-based cancer screening programs.

Methods/Design

The M-TICs study is a randomized controlled trial with a formal process evaluation. Participants aged 50–69 years identified as eligible from the colorectal cancer (CRC) and breast cancer (BC) screening program of the Catalan Institute of Oncology (Catalonia, Spain) will be randomly assigned to receive standard invitation procedure (control group) or SMS-based intervention to promote participation. Two interventions will be conducted in the CRC screening program: 1) Screening invitation reminder: Those who do not participate in the CRC screening within 6 weeks of invite will receive a reminder (SMS or letter); 2) Reminder to complete and return fecal immunochemical test (FIT) kit: SMS reminder versus no intervention to individuals who have picked up a FIT kit at the pharmacy and they have not returned it after 14 days. The third intervention will be performed in the BC screening program. Women who had been screened previously will receive an SMS invitation or a letter invitation to participate in the screening.

As a primary objective we will assess the impact on participation for each intervention. The secondary objectives will be to analyze the cost-effectiveness of the interventions and to assess participants’ perceptions.

Expected results

The results from this randomized controlled trial will provide important empirical evidence for the use of mobile phone technology as a tool for improving population-based cancer screening programs. These results may influence the cancer screening invitation procedure in future routine practice.

Trial registration

Registry: NCT04343950 (04/09/2020); clinicaltrials.gov.

Using prosocial behavior to safeguard mental health and foster emotional well-being during the COVID-19 pandemic: A registered report protocol for a randomized trial

2021-01-27T00:00

The COVID-19 pandemic, the accompanying lockdown measures, and their possible long-term effects have made mental health a pressing public health concern. Acts that focus on benefiting others—known as prosocial behaviors—offer one promising intervention that is both flexible and low cost. However, neither the range of emotional states prosocial acts impact nor the size of those effects is currently clear, both of which directly influence its attractiveness as a treatment option. Using a large online sample from Canada and the United States, we will examine the effect of a three-week prosocial intervention on two indicators of emotional well-being (happiness and the belief that one’s life is valuable) and mental health (anxiety and depression). Respondents will be randomly assigned to perform prosocial, self-focused, or neutral behaviors each week. Two weeks after the intervention, a final survey will assess whether the intervention has a lasting effect on mental health and emotional well-being. Our results will illuminate whether prosocial interventions are a viable approach to addressing mental health needs during the current COVID-19 pandemic, as well for those who face emotional challenges during normal times.

The value of TI-RADS combined with superb microvascular imaging in distinguishing thyroid nodules: A protocol for systematic review and meta-analysis

2021-01-07T00:00

Background

As a novel ultrasonic technique, superb microvascular imaging (SMI) can quickly, simply and noninvasively observe the microvascular distribution in a tumor and evaluate the microvascular perfusion. Previous studies have shown that SMI can detect the blood flow signals of neovascularization in tumors and increase the sensitivity for detecting thyroid cancer. However, the results of these studies have been contradictory, and the sample sizes were too small. Therefore, the present meta-analysis will aim at evaluating the value of a thyroid imaging report and data system (TI-RADS) combined with SMI in distinguishing between benign and malignant thyroid nodules.

Methods

We will search PubMed, Web of Science, Cochrane Library, Google Scholar, and Chinese biomedical databases from their inceptions to the June 31, 2020. Two authors will independently carry out searching literature records; scanning titles, abstracts, and full texts; collecting data; and assessing risk of bias. Review Manager 5.2 and Stata14.0 software will be used for data analysis.

Results

This systematic review will evaluate the value of TI-RADS combined with SMI in distinguishing between benign and malignant thyroid nodules.

Systematic review registration

INPLASY202070113.

Semantic priming supports infants’ ability to learn names of unseen objects

2021-01-07T00:00

Human language permits us to call to mind objects, events, and ideas that we cannot witness directly. This capacity rests upon abstract verbal reference: the appreciation that words are linked to mental representations that can be established, retrieved and modified, even when the entities to which a word refers is perceptually unavailable. Although establishing verbal reference is a pivotal achievement, questions concerning its developmental origins remain. To address this gap, we investigate infants’ ability to establish a representation of an object, hidden from view, from language input alone. In two experiments, 15-month-olds (N = 72) and 12-month-olds (N = 72) watch as an actor names three familiar, visible objects; she then provides a novel name for a fourth, hidden fully from infants’ view. In the Semantic Priming condition, the visible familiar objects all belong to the same semantic neighborhood (e.g., apple, banana, orange). In the No Priming condition, the objects are drawn from different semantic neighborhoods (e.g., apple, shoe, car). At test infants view two objects. If infants can use the naming information alone to identify the likely referent, then infants in the Semantic Priming, but not in the No Priming condition, will successfully infer the referent of the fourth (hidden) object. Brief summary of results here. Implications for the development of abstract verbal reference will be discussed.

Effects of whole-body electromyostimulation on function, muscle mass, strength, social participation, and falls-efficacy in older people: A randomized trial protocol

2021-01-25T00:00

Background

Resistance training has a positive impact on functional capacity and muscle mass in the elderly. However, due to physical limitations or a simple aversion against regular exercise, a majority of the elderly do not reach the recommended exercise doses. This led us to evaluate the effect of whole-body electromyostimulation (WB-EMS), a novel, time-efficient, and smooth training technology on physical function, fat-free mass, strength, falls-efficacy, and social participation of the elderly.

Methods

The present study is a randomized, parallel group clinical trial approved by the Ethics Committee of our Institution. Sixty-six volunteers (age ≥ 60 years) will be recruited from the geriatric outpatient department in a tertiary hospital and primary care units and randomized into two groups: WB-EMS group or active control group (aCG). The WB-EMS or aCG protocol will consist of 16 sessions for 8 consecutive weeks, twice per week. The primary outcomes will be maximal isometric knee extension (IKE), functional lower extremity strength, fat-free mass, gait speed, and risk of falls measured before and after intervention. The secondary outcomes will be social participation and falls-efficacy assessed before and after the intervention and at three and six months of follow-up. Participant’s satisfaction with and awareness of electrical stimulation therapy will also be assessed immediately after the 8-week intervention.

Discussion

Patients receiving WB-EMS exercises are believed to have better outcomes than those receiving conventional, more time-consuming resistance exercises. Hence, innovative, time-efficient, joint-friendly, and highly individualized exercise technologies (such as WB-EMS) may be a good choice for the elderly with time constraints, physical limitations, or little enthusiasm, who are exercising less than the recommended amounts for impact on muscle mass, strength, and function.

Antimicrobial efficacy of silver nanoparticles against Candida albicans: A systematic review protocol

2021-01-25T00:00

Introduction

Denture-induced stomatitis is one form of candidiasis. It is characterised as inflammation and erythema of the oral mucosa underneath the denture-bearing areas and clinically classified into three types according to severity. Denture hygiene, appropriate mouth rinses and the use of antifungal therapy are commonly used to treat the condition, but new technologies are emerging that may assist in its treatment.

Aim

The aim of this systematic review is to determine if silver nanoparticles inhibit the growth of Candida Albicans when included in acrylic dentures and in different denture liners.

Methodology

A protocol was developed and published on PROSPERO (Registration No: CRD42019145542) and with the institutional ethics committee (Registration No: BM20/4/1).

The protocol includes all aspects of a systematic review namely: selection criteria, search strategy, selection methods using predetermined eligibility criteria, data collection, data extraction, critical appraisal of included studies, and the intended statistical analyses such as calculating risk ratios (RR) for dichotomous outcomes and presented at 95% confidence intervals, a meta-analysis, if possible or a narrative report as needed.

Expected results

With rigorous inclusion criteria set and databases identified for searching, appropriate clinical and laboratory studies may be obtained but the results and its interpretation and translation into clinical practice may be a challenge as these depend on the quality of the research.

Application and utility of a clinical framework for spinally referred neck-arm pain: A cross-sectional and longitudinal study protocol

2020-12-28T00:00

Background

The clinical presentation of neck-arm pain is heterogeneous with varying underlying pain types (nociceptive/neuropathic/mixed) and pain mechanisms (peripheral/central sensitization). A mechanism-based clinical framework for spinally referred pain has been proposed, which classifies into (1) somatic pain, (2) neural mechanosensitivity, (3) radicular pain, (4) radiculopathy and mixed pain presentations. This study aims to (i) investigate the application of the clinical framework in patients with neck-arm pain, (ii) determine their somatosensory, clinical and psychosocial profile and (iii) observe their clinical course over time.

Method

We describe a study protocol. Patients with unilateral neck-arm pain (n = 180) will undergo a clinical examination, after which they will be classified into subgroups according to the proposed clinical framework. Standardized quantitative sensory testing (QST) measurements will be taken in their main pain area and contralateral side. Participants will have to complete questionnaires to assess function (Neck Disability Index), psychosocial factors (Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Depression, anxiety and stress scale), neuropathic pain (Douleur Neuropathique 4 Questions, PainDETECT Questionnaire) and central sensitization features (Central Sensitization Inventory). Follow-ups at three, six and 12 months include the baseline questionnaires. The differences of QST data and questionnaire outcomes between and within groups will be analyzed using (M)AN(C)OVA and/or regression models. Repeated measurement analysis of variance or a linear mixed model will be used to calculate the differences between three, six, and 12 months outcomes. Multiple regression models will be used to analyze potential predictors for the clinical course.

Conclusion

The rationale for this study is to assess the usability and utility of the proposed clinical framework as well as to identify possible differing somatosensory and psychosocial phenotypes between the subgroups. This could increase our knowledge of the underlying pain mechanisms. The longitudinal analysis may help to assess possible predictors for pain persistency.

A human-based assisted reproduction protocol for the menstruating spiny mouse, Acomys cahirinus

2020-12-28T00:00

The Egyptian or Common spiny mouse (A. cahirinus) is the first rodent species to show human-like menstruation and spontaneous decidualisation. We consider from these, and its other, human-like characteristics that this species will be a more useful and appropriate small animal model for human reproductive studies. Based on this, there is a need to develop specific laboratory-based assisted reproduction protocols including superovulation, in-vitro fertilisation, embryo cryopreservation and transfer to expand and make this model more relevant. Because standard rodent superovulation has not been successful in the spiny mouse, we have selected to test a human protocol. Female spiny mice will receive a subcutaneous GnRH agonist implant and be allowed to recover. Menstrual cycle lengths will then be allowed to stabilize prior to ovarian stimulation. After recovery, females will be injected IP once a day for 4 days with a FSH analogue, to induce follicular growth, and on day 5 will be injected IP with a hCG analogue to trigger ovulation. Females will either be culled 36hrs after trigger to collect oocytes or immediately paired with a stud male and two cell embryos collected 48hrs later. Mature oocytes will be inseminated using fresh spiny mouse spermatozoa and all in-vitro grown and in-vivo collected two cell embryos will be cryopreserved using methods developed in a close spiny mouse relative, the Mongolian gerbil. For embryo transfer, vitrified embryos will be rapidly warmed and non-surgically transferred to surrogate mice. Surrogates will be monitored until pregnancy is apparent (roughly 30 days) and then left undisturbed until birth, 38–40 days after transfer. By successfully developing robust assisted reproduction protocols in A. cahirinus we will be able to use this rodent as a more effective model for human reproduction.

Group-affirmation and trust in international relations: Evidence from Ukraine

2020-12-31T00:00

How can states with a history of recent armed conflict trust one another? Distrust between Ukraine and Russia aggravates security fears and limits hopes for a meaningful resolution of the bloodiest armed conflict in Europe since 1994. Hostility levels have risen dramatically between the populations of Ukraine and Russia after the events of 2013–2015. Political psychology offers two competing approaches to increase trust between the publics of different countries: appealing to an overarching, common identity above the national level vs. affirming a sense of national identity. This project asks which of these approaches increases trust towards Russia among the Ukrainian public. The study employs a survey experiment (between-subjects design) to evaluate these competing claims. The survey is to be fielded by a reputable public opinion research firm, the Kiev International Institute of Sociology, based in Ukraine.

Study protocol for COvid-19 Vascular sERvice (COVER) study: The impact of the COVID-19 pandemic on the provision, practice and outcomes of vascular surgery

2020-12-30T00:00

Background

The novel Coronavirus Disease 2019 (COVID-19) pandemic is having a profound impact on global healthcare. Shortages in staff, operating theatre space and intensive care beds has led to a significant reduction in the provision of surgical care. Even vascular surgery, often insulated from resource scarcity due to its status as an urgent specialty, has limited capacity due to the pandemic. Furthermore, many vascular surgical patients are elderly with multiple comorbidities putting them at increased risk of COVID-19 and its complications. There is an urgent need to investigate the impact on patients presenting to vascular surgeons during the COVID-19 pandemic.

Methods and analysis

The COvid-19 Vascular sERvice (COVER) study has been designed to investigate the worldwide impact of the COVID-19 pandemic on vascular surgery, at both service provision and individual patient level. COVER is running as a collaborative study through the Vascular and Endovascular Research Network (VERN), an independent, international vascular research collaborative with the support of numerous national and international organisations). The study has 3 ‘Tiers’: Tier 1 is a survey of vascular surgeons to capture longitudinal changes to the provision of vascular services within their hospital; Tier 2 captures data on vascular and endovascular procedures performed during the pandemic; and Tier 3 will capture any deviations to patient management strategies from pre-pandemic best practice. Data submission and collection will be electronic using online survey tools (Tier 1: SurveyMonkey® for service provision data) and encrypted data capture forms (Tiers 2 and 3: REDCap® for patient level data). Tier 1 data will undergo real-time serial analysis to determine longitudinal changes in practice, with country-specific analyses also performed. The analysis of Tier 2 and Tier 3 data will occur on completion of the study as per the pre-specified statistical analysis plan.

Situation analysis for delivering integrated comprehensive sexual and reproductive health services for displaced population of Kasaï, Democratic Republic of Congo: Protocol for a mixed method study

2020-12-21T00:00

Introduction

Delivering integrated sexual and reproductive health services (SRHS) in emergencies is important in order to save lives of the most vulnerable as well as to combat poverty, reduce inequities and social injustice. More than 60% of preventable maternal deaths occur in conflict areas and especially among the internally displaced persons (IDP). Between 2016 and 2018, unprecedented violence erupted in the Kasaï’s region, in the Democratic Republic of Congo (DRC), called the Kamuina Nsapu Insurgency. During that period, an estimated three million of adolescent girls and women were forced to flee; and have faced growing threat to their health, safety, security, and well-being including significant sexual and reproductive health challenges. Between August 2016 and May 2017, the “Sous-Cluster sur les violences basées sur le genre (SC-VBG)” in DRC (2017) reported 1,429 Gender Based Violence (GBV) incidents in the 49 service delivery points in the provinces of Kasaï, Kasaï Central and Kasaï Oriental. Rape cases represented 79% of reported incidents whereas sexual assault and forced marriage accounted for respectively 11% and 4% of Gender Based Violence (GBV) among women and adolescent girls. This study aims to assess the availability of SRHS in the displaced camps in Kasaï; to evaluate the SRHS needs of young girls and women in the reproductive age (12–49). Studies of sexual and reproductive health (SRH) in the Democratic Republic of Congo (DRC) have often included adolescent girls under the age of 15 because of high prevalence of child marriage and early onset of childbearing, especially in the humanitarian context. According to the 2013 Demographic and Health Survey (DHS), about 16% of surveyed women got married by age 14 while the prevalence of early child marriage (marriage by 15) was estimated at 30%; to assess the use of SRHS services and identify barriers as well as challenges for SRH service delivery and use. Findings from this study will help provide evidence to inform towards more needs-based and responsive SRH service delivery. This is hoped for ultimately improve the quality and effectiveness of services, when considering service delivery and response in humanitarian settings.

Data and methods

We will conduct a mixed-methods study design, which will combine quantitative and qualitative approaches. Based on the estimation of the sample size, quantitative data will be drawn from the community-based survey (500 women of reproductive age per site) and health facility assessments will include assessments of 45 health facilities and 135 health providers’ interviews. Qualitative data will comprise materials from 30 Key Informant Interviews (KII) and 24 Focus Group Discussions (FGDs), which are believed to achieve the needed saturation levels. Data analysis will include thematic and content analysis for the KIIs and FGDs using ATLAS.ti software for the qualitative arm. For the quantitative arm, data analysis will combine frequency and bivariate chi-square analysis, coupled with multi-level regression models, using Stata 15 software. Statistic differences will be established at the significance level of 0.05. We submitted this protocol to the national ethical committee of the ministry of health in September 2019 and it was approved in January 2020. It needs further approval from the Scientific Oversee Committee (SOC) and the Provincial Ministry of Health. Prior to data collection, informed consents will be obtained from all respondents.

Systematic review of education and practical guidance on regression modeling for medical researchers who lack a strong statistical background: Study protocol

2020-12-21T00:00

In the last decades, statistical methodology has developed rapidly, in particular in the field of regression modeling. Multivariable regression models are applied in almost all medical research projects. Therefore, the potential impact of statistical misconceptions within this field can be enormous Indeed, the current theoretical statistical knowledge is not always adequately transferred to the current practice in medical statistics. Some medical journals have identified this problem and published isolated statistical articles and even whole series thereof. In this systematic review, we aim to assess the current level of education on regression modeling that is provided to medical researchers via series of statistical articles published in medical journals. The present manuscript is a protocol for a systematic review that aims to assess which aspects of regression modeling are covered by statistical series published in medical journals that intend to train and guide applied medical researchers with limited statistical knowledge. Statistical paper series cannot easily be summarized and identified by common keywords in an electronic search engine like Scopus. We therefore identified series by a systematic request to statistical experts who are part or related to the STRATOS Initiative (STRengthening Analytical Thinking for Observational Studies). Within each identified article, two raters will independently check the content of the articles with respect to a predefined list of key aspects related to regression modeling. The content analysis of the topic-relevant articles will be performed using a predefined report form to assess the content as objectively as possible. Any disputes will be resolved by a third reviewer. Summary analyses will identify potential methodological gaps and misconceptions that may have an important impact on the quality of analyses in medical research. This review will thus provide a basis for future guidance papers and tutorials in the field of regression modeling which will enable medical researchers 1) to interpret publications in a correct way, 2) to perform basic statistical analyses in a correct way and 3) to identify situations when the help of a statistical expert is required.

Ascertaining breast cancer patient experiences through a journey map: A qualitative study protocol

2020-12-21T00:00

Background

The current cancer care system must be improved if we are to have in-depth knowledge about breast cancer patients’ experiences throughout all the stages of their disease.

Aim

This study seeks to describe breast cancer patients’ experience over the course of the various stages of illness by means of a journey model.

Methods

This is a qualitative descriptive study. Individual, semi-structured interviews will be administered to women with breast cancer and breast cancer survivors. Patients will be recruited from nine large hospitals in Spain and intentional sampling will be used. Data will be collected by means of a semi-structured interview that was elaborated with the help of medical oncologists, nurses, and psycho-oncologists. Data will be processed adopting a thematic analysis approach.

Discussion

The outcomes of this study will afford new insights into breast cancer patients’ experiences, providing guidance to improve the care given to these individuals. This protocol aims to describe the journey of patients with breast cancer through the healthcare system to establish baseline data that will serve as the basis for the development and implementation of a patient-centered, evidence-based clinical pathway.

Effects of neuromuscular training compared to classic strength-resistance training in patients with acute coronary syndrome: A study protocol for a randomized controlled trial

2020-12-23T00:00

The aim of the present clinical trial is to evaluate the effectiveness of neuromuscular versus classical strength-resistance training as part of a cardiac rehabilitation programme in patients following acute coronary syndrome. The study is designed as a double-blinded, randomised, and controlled clinical trial. Thirty participants suffering from acute coronary syndrome who meet our inclusion criteria will be recruited by a private tertiary hospital. The intervention group will follow 20 sessions of a cardiac rehabilitation programme divided into two parts: aerobic training and neuromuscular strength-resistance training. The control group will complete the same aerobic training as well as a classical strength-resistance training workout programme. The primary outcome of the study will be the mean difference in change from baseline in the Incremental Shuttle Walking Test. The secondary outcomes will be the cardiorespiratory fitness of the patients (assessed by means of the Chester Step Test), lower-limb performance (assessed with the 30-Second Chair Stand Test and Single-Leg Squat Test), lower-limb strength (hip flexor handheld dynamometry), sexual dysfunction assessment (Sex Health Inventory for Men) and quality of life (EQ-5D-5L). This work will provide evidence for the effectiveness of a neuromuscular versus a classic strength-training programme in terms of cardiorespiratory fitness, lower-limb performance capacities and quality of life, in cardiac patients. The data obtained could lead to more effective and functional workouts which, in turn, may enhance the speed at which these patients can return to their everyday activities of life and improve the efficiency of their movement patterns and heart responses. Furthermore, patients may find neuromuscular workout routines more motivating and engaging, thus encouraging them to adopt healthier lifestyle patterns.