Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

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Randomized Controlled Trials in the Evaluation of Antenatal Care

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462300012885 ◽

1992 ◽

Vol 8 (S1) ◽

pp. 40-45 ◽

Cited By ~ 3

Author(s):

Murray W. Enkin

Keyword(s):

Clinical Trials ◽

Antenatal Care ◽

Randomized Controlled Trials ◽

Perinatal Outcome ◽

Randomized Clinical Trials ◽

Well Being ◽

Controlled Trials ◽

Adverse Perinatal Outcome ◽

Randomized Controlled

AbstractMany of the practices carried out during antenatal care improve the well-being of mother or baby and reduce the burden of adverse perinatal outcome. Other practices have either not been evaluated or have been shown to be ineffective. Evidence from randomized clinical trials provides the best evidence about the effectiveness of these practices.

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TRUST Study: Participation in Randomized Controlled Trials and Subsequent Adherence to Visiting Medical Institutions and Taking Medications in Patients with Cardiovascular Diseases. Part I. Motives for the Patients' Participation in Clinical Trials

Rational Pharmacotherapy in Cardiology ◽

10.20996/1819-6446-2019-15-4-546-552 ◽

2019 ◽

Vol 15 (4) ◽

pp. 546-552 ◽

Cited By ~ 1

Author(s):

S. Yu. Martsevich ◽

N. O. Vasyukova ◽

N. P. Kutishenko ◽

Yu. V. Lukina ◽

O. I. Zvonareva

Keyword(s):

Clinical Trials ◽

Medical Care ◽

Randomized Controlled Trials ◽

Randomized Clinical Trials ◽

Personal Contact ◽

Controlled Trials ◽

Full Time ◽

Scientific Center ◽

Randomized Controlled ◽

Medical Institutions

Aim. To describe the design of TRUST study (Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor) and present the first part of this study to determine the motives of patient participation in clinical trials.Material and methods. The main group of TRUST study included patients of the outpatient registrar PROFILE, which were taking part in one or more international randomized clinical trials, conducted from 2011 to 2018. The standard registration card of PROFILE register was used to assess the clinical and demographic data of patients.In 2019 full-time/telephone contact with patients was established, during which, based on the original questionnaire, the motives of the participation in trials, their attitude towards randomized controlled trials (RCT), and their adherence to monitoring in medical institutions were determined. This publication presents the results of the first part of the study.Results. 102 patients were enrolled in the study, telephone /personal contact was established for 88 patients, the life status of 9 of them by 2019 was defined as "dead", 77 were interviewed, 2 – refused to answer. Over 80% of patients completed participation in RCTs more than one year ago. 71.6% of patients participated in more than one RCT. In 60% of cases, patients claimed that this was the proposal of the doctor of the scientific center. For 79% of patients, RCTs had the opportunity to access highly skilled medical care. Only 18% of patients indicated that they received the necessary qualified medical care before entering the study. In cases where patients answered dichotomous questions (such as "yes"/"no"), the overwhelming majority of patients (74%) claimed that it was the authority of the doctor of the scientific center and the fear of losing the possibility of further observation became the main reason for participating in RCTs.Conclusion. In the first part of the TRUST study, it was revealed that in Russia the main reason of participation in RCT is the recommendation of a doctor from a specialized scientific center.

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Hydroxychloroquine plus standard care compared with the standard care alone in COVID-19: a meta-analysis of randomized controlled trials

10.1101/2020.06.05.20122705 ◽

2020 ◽

Author(s):

Bahman Amani ◽

Ahmad Khanijahani ◽

Behnam Amani

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trials ◽

Standard Care ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Significant Difference

AbstractBackground & ObjectiveThe efficacy and safety of Hydroxychloroquine (HCQ) in treating coronavirus disease COVID-19 pandemic is disputed. This study aimed to examine the efficacy and safety of HCQ plus the standard of care in COVID-19 patients.MethodsPubMed, The Cochrane Library, Embase, and web of sciences were searched up to June 1, 2020. The references list of the key studies was reviewed for additional relevant resources. Clinical studies registry databases were searched for identifying potential clinical trials. The quality of the included studies was evaluated using the Cochrane Collaboration’s tool. Meta-analysis was performed using RevMan software (version 5.3).ResultsThree randomized controlled trials with total number of 242 patients were identified eligible for meta-analysis. No significant differences were observed between HCQ and standard care in terms of viral clearance (Risk ratio [RR] = 1.03; 95% confidence interval [CI] = 0.91, 1.16; P = 0.68), disease progression (RR = 0.92; 95% CI = 0.10, 0.81; P = 0.94), Chest CT (RR = 1.40; 95% CI = 1.03, 1.91; P = 0.03). There is a significant difference between HCQ and standard care for adverse events (RR = 2.88; 95% CI = 1.50, 5.54; P = 0.002).ConclusionAlthough the current meta-analysis failed to confirm the efficacy and safety of HCQ in the treatment of COVID-19 patients, further rigorous randomized clinical trials are necessary to evaluate conclusively the efficacy and safety of HCQ against COVID-19.

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Gene × Environment Interaction in Obesity: The Contribution of Randomized Clinical Trials

Statistical Approaches to Gene X Environment Interactions for Complex Phenotypes ◽

10.7551/mitpress/9780262034685.003.0007 ◽

2016 ◽

Author(s):

Jeanne M. McCaffery ◽

Caroline Y. Doyle

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trials ◽

Randomized Clinical Trials ◽

Environmental Variable ◽

Controlled Trials ◽

Environment Interaction ◽

Behavioral Weight Loss ◽

Randomized Controlled ◽

Gene Environment ◽

Behavioral Weight Loss Intervention

Gene x environment (GxE) interaction is most commonly examined in epidemiologic studies.Yet randomized, controlled trials permit several methodological advantages to the detection of GxE.Primary among these is randomization of the “environmental exposure”, reducing measurement error for the environmental variable as well as confounding due to differences in the exposed relative to unexposed groups, including gene-environment correlation.To the extent that the trial was successful, the exposure exerts a demonstrated environmental main effect on the outcome of interest, providing a fertile ground to detect GxE.In addition, randomized, controlled trials provide the opportunity to look at novel phenotypes critical in the era a Precision Medicine, most notably genetic influences on response to a given treatment.In this chapter, we illustrate the use of randomized, controlled trials to detect GxE with evidence-based behavioral weight loss intervention clinical trials as a prototype.

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Are massage parameters well reported in clinical trials? A systematic review

Journal of Evidence-Based Healthcare ◽

10.17267/2675-021xevidence.v1i1.1948 ◽

2019 ◽

Vol 1 (1) ◽

pp. 55

Author(s):

Roberto Rodrigues Bandeira Tosta Maciel ◽

Kelly Lima ◽

Bruno Cesar Ferreira

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trials ◽

Randomized Clinical Trials ◽

Modern Society ◽

Good Clinical Practice ◽

Controlled Trials ◽

Therapeutic Massage ◽

Randomized Controlled ◽

Electronic Search ◽

Direction Of Movement

INTRODUCTION: Lumbar and cervical spine pains are one of the biggest health problems in modern society. Among the physical resources aimed at reducing the perception of pain in the spine, the therapeutic massage stands out. Following the principles of good clinical practice, it is expected that the techniques performed can be reproducible. Objectives: To investigate, through an initial exploration of the question, how appropriate is the description of the physiotherapy technique in randomized controlled trials of spinal massage. METHODS: An electronic search strategy was carried out on Medline through Pubmed. The search was restricted to the literature in English and Portuguese. We included Randomized Clinical Trials whose therapeutic massage was the main intervention performed in the spine. The parameters evaluated were: 1) pressure of manipulation, 2) direction of movements, 3) velocity of movements, 4) rhythm of movements, 5) frequency of movements and 6) duration of sessions. Twelve studies were included in this critical review of the evidence. Most of the studies did not report or report in a dubious manner, the pressure of manipulation, velocity of movements and rhythm of movements. Only 66% (n = 8) of the studies adequately reported the direction of movement. CONCLUSION: Physiotherapy techniques for spinal massage are not usually adequately described in randomized controlled trials. We suggest the improvement of reports of randomized clinical trials in the field of manual therapy.

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How complete is the reporting of somatic sensory training interventions in individuals following a stroke? Protocol for a systematic review.

10.1101/2021.09.16.21263676 ◽

2021 ◽

Author(s):

Daniel Feller ◽

Caterina Pedri ◽

Paolo Gozzer ◽

Tiziano Innocenti ◽

Francesca Trentin

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Controlled Trials ◽

Randomized Clinical Trials ◽

Descriptive Analysis ◽

Controlled Trials ◽

Training Interventions ◽

Randomized Controlled ◽

The Individual ◽

Sensory Training

Background: To implement intervention from research to clinical practice, treatments must be adequately described in randomized clinical trials. Specific reporting guidelines, such as the TIDieR checklist, have been developed to enhance the reporting of intervention in clinical trials. Objective: We aim to evaluate the adherence to the TIDieR checklist in randomized controlled trials evaluating somatic sensory training interventions in individuals following a stroke. Material and Methods: We will perform a systematic review of the literature, searching PubMed, CENTRAL, and PEDro for randomized controlled trials that evaluate the efficacy of any rehabilitative intervention on somatic sensation in patients with a history of stroke, independently form the comparator. Two authors independently will evaluate the completeness of the reporting of the intervention using the TIDieR checklist. A descriptive analysis of the total score and the individual items of the TIDieR will be produced. Ethics and dissemination: A manuscript with results will be submitted for publication in a peer-reviewed journal in the rehabilitation field.

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The effect of almond intake on lipid profile: a systematic review and meta-analysis of randomized controlled trials

Food & Function ◽

10.1039/d0fo02878a ◽

2021 ◽

Author(s):

Omid Asbaghi ◽

Vihan Moodi ◽

Amir Hadi ◽

Elham Eslampour ◽

Mina Shirinbakhshmasoleh ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Controlled Trials ◽

Lipid Profile ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.

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Trends in randomized controlled trials in ENT: a 30-year review

The Journal of Laryngology & Otology ◽

10.1017/s0022215100138101 ◽

1997 ◽

Vol 111 (7) ◽

pp. 611-613 ◽

Cited By ~ 9

Author(s):

K. W. Ah-See ◽

N. C. Molony ◽

A. G. D. Maran

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Randomized Controlled Trials ◽

Gold Standard ◽

Controlled Trials ◽

Evidence Based ◽

Controlled Clinical Trials ◽

Medline Search ◽

Randomized Controlled Clinical Trials ◽

Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

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MANAGEMENT OF ENDOCRINE DISEASE: Effects of telecare intervention on glycemic control in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials

Acta Endocrinologica ◽

10.1530/eje-14-0441 ◽

2015 ◽

Vol 172 (3) ◽

pp. R93-R101 ◽

Cited By ~ 42

Author(s):

Zhenru Huang ◽

Hong Tao ◽

Qingdong Meng ◽

Long Jing

Keyword(s):

Type 2 Diabetes ◽

Glycemic Control ◽

Randomized Controlled Trials ◽

Sample Size ◽

Plasma Glucose ◽

Small Sample ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled

ObjectiveTo review the published literature on the effects of telecare intervention in patients with type 2 diabetes and inadequate glycemic control.Design and methodsA review of randomized controlled trials on telecare intervention in patients with type 2 diabetes, and a search of electronic databases such as The Cochrane Library, PubMed, EBSCO, CINAHL, Science Direct, Journal of Telemedicine and Telecare, and China National Knowledge Infrastructure (CNKI), were conducted from December 8 to 16, 2013. Two evaluators independently selected and reviewed the eligible studies. Changes in HbA1c, fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), BMI, and body weight were analyzed.ResultsAn analysis of 18 studies with 3798 subjects revealed that telecare significantly improved the management of diabetes. Mean HbA1c values were reduced by −0.54 (95% CI, −0.75 to −0.34; P<0.05), mean FPG levels by −9.00 mg/dl (95% CI, −17.36 to −0.64; P=0.03), and mean PPG levels reduced by −52.86 mg/dl (95% CI, −77.13 to −28.58; P<0.05) when compared with the group receiving standard care. Meta-regression and subgroup analyses indicated that study location, sample size, and treatment-monitoring techniques were the sources of heterogeneity.ConclusionsPatients monitored by telecare showed significant improvement in glycemic control in type 2 diabetes when compared with those monitored by routine follow-up. Significant reduction in HbA1c levels was associated with Asian populations, small sample size, and telecare, and with those patients with baseline HbA1c greater than 8.0%.

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A Review of Marital Intimacy-Enhancing Interventions among Married Individuals

Global Journal of Health Science ◽

10.5539/gjhs.v8n8p74 ◽

2015 ◽

Vol 8 (8) ◽

pp. 74 ◽

Cited By ~ 4

Author(s):

Maryam Kardan-Souraki ◽

Zeinab Hamzehgardeshi ◽

Ismail Asadpour ◽

Reza Ali Mohammadpour ◽

Soghra Khani

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trials ◽

Cochrane Library ◽

Controlled Trials ◽

Main Concern ◽

Care Providers ◽

Marital Intimacy ◽

Randomized Controlled ◽

The Impact

BACKGROUND: Lack of intimacy is currently the main concern rather than main concern of the experts in psychology and counseling. It is considered as one of the most important causes for divorce and as such to improve marital intimacy a great number of interventions have been proposed in the literature. Intimacy training and counseling make the couples take effective and successful steps to increase marital intimacy. No study has reviewed the interventions promoting marital intimacy after marriage. Thus, this review study aimed to classify the articles investigating the impact of interventional programs on marital intimacy after marriage.SEARCH METHODS: In April 2015, we performed a general search in Google Scholar search engines, and then we did an advanced search the databases of Science Direct, ProQuest, SID, Magiran, Irandoc, Pubmed, Scopus, <a href="http://www.cochranelibrary.com/">Cochrane Library</a>, and Psych info; Cumulative Index to Nursing and Allied Health Literature (CINAHL). Also, lists of the references of the relevant articles were reviewed for additional citations. Using Medical Subject Headings (MESH) keywords: Intervention (Clinical Trials, Non-Randomized Controlled Trials, Randomized Controlled Trials, Education), intimacy, marital (Marriage) and selected related articles to the study objective were from 1995 to April 2015. Clinical trials that evaluated one or more behavioral interventions to improve marital intimacy were reviewed in the study.MAIN RESULTS: 39 trials met the inclusion criteria. Eleven interventions had follow-up, and 28 interventions lacked follow-up. The quality evidence for 22 interventions was low, for 15 interventions moderate, and for one intervention was considered high. Findings from studies were categorized in 11 categories as the intimacy promoting interventions in dimensions of emotional, psychological, physical, sexual, temporal, communicational, social and recreational, aesthetic, spiritual, intellectual intimacy, and total intimacy.AUTHORS’ CONCLUSIONS: Improving and promoting communication, problem solving, self-disclosure and empathic response skills and sexual education and counseling in the form of cognitive-behavioral techniques and based on religious and cultural context of each society, an effective step can be taken to enhance marital intimacy and strengthen family bonds and stability. Health care providers should consider which interventions are appropriate to the couple characteristics and their relationships.

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