Clinical Trial Designs

Nair, Brijesh

doi:10.4103/idoj.idoj_475_18

Cited by 84 publications

(38 citation statements)

References 20 publications

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“…Furthermore, the effects of prolonged use of a “sham” type of ILF-Neurofeedback should be verified to avoid possible iatrogenic effects on participants. For these reasons, an active concurrent control design (as in Balt et al, 2020 ) should be considered whenever possible, as proposed by the Declaration of Helsinki (World Medical Association, 2018 ; Nair, 2019 ).…”

Section: Resultsmentioning

confidence: 99%

Infra-Low Frequency Neurofeedback: A Systematic Mixed Studies Review

Bazzana

Finzi

Fini

et al. 2022

Front. Hum. Neurosci.

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IntroductionNeurofeedback training is increasingly applied as a therapeutic tool in a variety of disorders, with growing scientific and clinical interest in the last two decades. Different Neurofeedback approaches have been developed over time, so it is now important to be able to distinguish between them and investigate the effectiveness and efficiency characteristics of each specific protocol. In this study we intend to examine the effects of Neurofeedback based on slow brain activity, the so-called Infra-Low Frequency (ILF) training a recently developed methodology that seems promising for the regulation of the central nervous system.AimsWith this review we intend to summarize the currently existing literature on ILF-Neurofeedback, examine its quality and formulate indications about the clinical effectiveness of ILF-Neurofeedback.MethodsLiterature search was first conducted according to PRISMA principles, described, and then assessed using the MMAT appraisal tool. 18 well-documented studies of ILF-Neurofeedback training in human subjects were picked up and analyzed. Reports include group interventions as well as single case studies.ResultsResearch data indicates good potential for ILF-Neurofeedback to influence brain activity and neurovegetative parameters. From the clinical profile, a salient common observation is a high level of individualization as a specific characteristic of ILF-Training: this feature seems to correlate with effectiveness of ILF-Neurofeedback, but also poses a challenge for researchers in terms of producing controlled and comparable findings; according to this point, some recommendation for future research on ILF-Neurofeedback are proposed. In conclusion, ILF-neurofeedback shows great potential for application for all those conditions in which the regulation of brain activity and neurophysiological processes are crucial. Further research will make it possible to complete the available data and to have a broader overview of its possible applications.

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Section: Resultsmentioning

confidence: 99%

Infra-Low Frequency Neurofeedback: A Systematic Mixed Studies Review

Bazzana

Finzi

Fini

et al. 2022

Front. Hum. Neurosci.

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“…An outcome of interest is then compared between these groups and estimates the impact of the intervention. The clinical trials may be classified into different types ( 12 , 13 ), namely, parallel, crossover and factorial designs (see Table 2 ), depending on the objective of the study and the population studied.…”

Section: Selecting the Appropriate Study Designmentioning

confidence: 99%

Common Bias and Challenges in Physical and Rehabilitation Medicine Research: How to Tackle Them

Thibaut

Beaudart

Martens

et al. 2022

Front. Rehabilit. Sci.

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The importance of evidence-based medicine is crucial, especially in physical and rehabilitation medicine (PRM), where there is a need to conduct rigorous experimental protocols, as in any medical field. Currently, in clinical practice, therapeutic approaches are often based on empirical data rather than evidence-based medicine. However, the field of PRM faces several challenges that may complicate scientific research. In addition, there is often a lack of appropriate research training in educational programs. In this context, we aim to review the methodological challenges in PRM and provide clear examples for each of them as well as potential solutions when possible. This article will cover the following themes: (1) Choosing the right study design and conducting randomized and benchmarking controlled trials; (2). Selecting the appropriate controlled, placebo or sham condition and the issue of blinding in non-pharmacological trials; (3) The impact of populations' heterogeneity and multi-comorbidities; (4). The challenge of recruitment and adherence; (5). The importance of homogeneity and proper quantification of rehabilitative strategies; and (6). Ethical issues. We are convinced that teaching the basics of scientific research in PRM could help physicians and therapists to choose a treatment based on (novel) scientific evidence. It may also promote scientific research in PRM to develop novel and personalized rehabilitation strategies using rigorous methodologies and randomized or benchmarking controlled trials in order to improve patients' management.

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“…Following the randomization procedure, each participant will remain in his or her assigned treatment arm for the duration of the study. This design is the simplest and allows two or more therapies to be compared simultaneously [30]. An example of this type of design in nutrition was carried out by Hussey and Klein in 1990; through a parallel design RCT, they compared the effect of vitamin A administration against placebo, concluding that vitamin A reduces mortality caused by measles in minors [31].…”

Section: Parallel Designmentioning

confidence: 99%

“…The first is that the disease or condition being studied must be chronic and stable, and the characteristics must not change between the two study periods. The second criterion that must be met is that the intervention's effects must not be irreversible, and changes should preferably be visible in a short period of time [30]. In the case of the DASH diet, both criteria are met; hypertension is a chronic and stable disease, and the intervention does not result in permanent changes, that is, a patient with hypertension can lower his blood pressure while adhering to a specific nutritional plan, but his blood pressure may rise again after quitting or adopting harmful habits.…”

Section: Crossover Designmentioning

confidence: 99%

Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions

et al. 2022

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Nutrition is an essential component when promoting human health. Without a doubt, improving the quality of one’s diet can improve one’s quality of life as a whole and help postpone the onset or control of many chronic diseases. The volume of publications in this field has increased in recent years, in line with increased awareness of the importance of nutrition in health; however, the quality of the evidence on which most nutritional guidelines are based remains low, due to errors in conducting nutritional interventions or because the information is primarily derived from observational studies. To enhance the evidence supporting clinical guidelines in nutrition, the quality of randomized clinical trials (RCT) based on nutritional interventions must be improved; nevertheless, due to their heterogeneous nature and a lack of specific guidelines for designing, performing, documenting, and reporting on this type of intervention, conducting a nutritional intervention is a real challenge. Following a review of the literature on the methodological and ethical standards, as well as four extensions of the CONSORT (Consolidated Standards of Reporting Trials) guidelines that should be considered when implementing a nutritional intervention, seven essential aspects were identified. The current narrative review includes definitions, examples, diagrams, and algorithms regarding aspects of the appropriate study design, the intervention of the control group, the randomization and blinding processes, the study population selection, as well as a description of the type of intervention and the personnel involved in carrying out the study in order to make the implementation of a nutritional intervention easier.

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Clinical Trial Designs

Cited by 84 publications

References 20 publications

Infra-Low Frequency Neurofeedback: A Systematic Mixed Studies Review

Infra-Low Frequency Neurofeedback: A Systematic Mixed Studies Review

Common Bias and Challenges in Physical and Rehabilitation Medicine Research: How to Tackle Them

Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions

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