N-of-1 Trials in Healthcare

McDonald, Suzanne; Nikles, Jane

doi:10.3390/healthcare9030330

Cited by 13 publications

(17 citation statements)

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“…However, in the absence of a study group, a single-case experimental design (SCED) was suggested as an alternative methodology that is equally reliable as a randomization study [ 3 ]. The single case study designs are called N-of-1 type clinical trials [ 4 , 5 ]. The N-of-1 study design is being increasingly applied in healthcare-related research.…”

Section: Introductionmentioning

confidence: 99%

Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent

singh¹,

Vadakedath²,

Kandi³

2023

Cureus

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Recently, we have been noticing an increase in the emergence and re-emergence of microbial infectious diseases. In the previous 100 years, there were several incidences of pandemics caused by different microbial species like the influenza virus, human immunodeficiency virus (HIV), dengue virus, severe acute respiratory syndrome Coronavirus (SARS-CoV), middle east respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-2 that were responsible for severe morbidity and mortality among humans. Moreover, noncommunicable diseases, including malignancies, diabetes, heart, liver, kidney, and lung diseases, have been on the rise. The medical fraternity, people, and governments all need to improve their preparedness to effectively tackle health emergencies. Clinical research, therefore, assumes increased significance in the current world and may potentially be applied to manage human health-related problems. In the current review, we describe the critical aspects of clinical research that include research designs, types of study hypotheses, errors, types of sampling, ethical concerns, and informed consent.

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Section: Introductionmentioning

confidence: 99%

Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent

singh¹,

Vadakedath²,

Kandi³

2023

Cureus

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“…Barriers identified by doctors are lack of time and awareness, and insufficiently valuing reduced therapeutic uncertainty against inconvenience [ 12 ]. The ICN co-chairs SM and JN and other ICN members have conducted a systematic review of stakeholder perspectives about SCDs [ 67 ] and are conducting a qualitative study to identify the issues impeding wider uptake of SCDs in healthcare from the perspective of various stakeholder groups including health professionals, patients, clinical trial coordinators, research methodologists, biostatisticians, Institutional Ethics Review Board members, journal editors, regulators and health research funders [ 68 ]. The findings from these projects will inform the design and implementation of strategies to address the barriers identified.…”

Section: Introductionmentioning

confidence: 99%

Establishment of an International Collaborative Network for N-of-1 Trials and Single-Case Designs

Nikles

Onghena

Vlaeyen

et al. 2021

Contemporary Clinical Trials Communications

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In this article we briefly examine the unique features of Single-Case Designs (SCDs) (studies in a single participant), their history and current trends, and real-world clinical applications. The International Collaborative Network for N-of-1 Trials and Single-Case Designs (ICN) is a formal collaborative network for individuals with an interest in SCDs. The ICN was established in 2017 to support the SCD scientific community and provide opportunities for collaboration, a global communication channel, resource sharing and knowledge exchange. In May 2021, there were more than 420 members in 31 countries. A member survey was undertaken in 2019 to identify priorities for the ICN for the following few years. This article outlines the key priorities identified and the ICN's progress to date in these key areas including network activities (developing a communications strategy to increase awareness, collecting/sharing a comprehensive set of resources, guidelines and tips, and incorporating the consumer perspective) and scientific activities (writing position papers and guest editing special journal issues, exploring key stakeholder perspectives about SCDs, and working to streamline ethical approval processes for SCDs). The ICN provides a practical means to engage with this methodology through membership. We encourage clinicians, researchers, industry, and healthcare consumers to learn more about and conduct SCDs, and to join us in our mission of using SCDs to improve health outcomes for individuals and populations.

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“…To conduct adequate evaluation studies in forensic sports therapy the specific circumstances of forensic settings (heterogeneity, low sample size, and low compliance rate) should be addressed. N-of-1 studies are able to face these challenges [12,16,17,18] and are of particular interest in the healthcare sector [17]. They provide more detailed information about individual effects in health and well-being outcomes than RCTs [16][17][18], cohort studies or case-control studies [12].…”

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confidence: 99%

“…N-of-1 studies are able to face these challenges [12,16,17,18] and are of particular interest in the healthcare sector [17]. They provide more detailed information about individual effects in health and well-being outcomes than RCTs [16][17][18], cohort studies or case-control studies [12]. This brief report addresses the specific circumstances of forensic settings and presents possibilities and limitations of N-of-1 studies to evaluate effects of forensic sports therapy.…”

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confidence: 99%

How far are N-of-1 studies suitable evaluation designs in forensic psychiatric sports therapy?

Reimer

Kanning

2023

Sports Psychiatry

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Introduction: Some evidence showed positive effects of sports therapy in forensic settings. Most of these evaluation studies analyzed between-subject relations and used RCTs (randomized controlled trials) to investigate intervention effects. RCTs normally randomize participants to an intervention and a control group with the intention to compare averaged group-findings. However, such averaged results, which are based on group effects may not apply to every single forensic patient as they do not adequately address that these patients are unique due to their complex psychopathology. Thus, RCTs do not adequately address the following circumstances especially relevant in forensic settings: heterogeneity and low sample size of therapy groups and low compliance rate of forensic patients. To address these challenges, it could be worthwhile to focus on within-subject relations by using N-of-1 studies. Methods: This viewpoint summarizes the possibilities and limitations of N-of-1 study designs regarding the challenges heterogeneity, low sample size and a low compliance rate when evaluating forensic sports therapy. Results: N-of-1 studies offer a useful addition in the evaluation of sports therapy in forensic psychiatry. They are able to evaluate individual effects and they increase the power of the study by increasing the number of measurements. Nevertheless, they are associated with limitations, for example increased effort due to frequent measurements and long study duration or the difficulty to generalize the results. Conclusion: Future studies should implement N-of-1 study designs in forensic psychiatric sports therapy to gain evidence and should find solutions to deal with the limitations (e.g., digital technology).

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N-of-1 Trials in Healthcare

Abstract: Interest in N-of-1 trials and single-case designs is increasing worldwide, particularly due to the movement towards personalised medicine and patient-centred healthcare [...]

Cited by 13 publications

References 13 publications

Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent

Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent

Establishment of an International Collaborative Network for N-of-1 Trials and Single-Case Designs

How far are N-of-1 studies suitable evaluation designs in forensic psychiatric sports therapy?

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