Crossover design and its application in late‐phase diabetes studies

Wang, Tao; Malone, James; Fu, Haoda; Heilmann, Cory R.; Qu, Yongming; Huster, William J.

doi:10.1111/1753-0407.12412

Cited by 9 publications

(4 citation statements)

References 30 publications

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“…One of the reasons was that we assumed current study might decrease higher-order carryover effects because the second phase is no intervention for six weeks. Previous study suggested that a washout period was often unnecessary for diabetes studies if the second period is long enough to diminish carryover effect [39]. Another reason was that we would like to reduce dropouts and missing data that usually make a larger bias on crossover trials than on parallel group trials [40, 41].…”

Section: Discussionmentioning

confidence: 99%

Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients with Peripheral Neuropathy: An Open-Level, Crossover Pilot Study

Hung

Chen

Chang

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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Purpose. This study evaluated the effects of interactive video game-based (IVGB) exercise on balance in diabetic patients with peripheral neuropathy. Materials and Methods. Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent IVGB training in the subsequent 6 weeks. For all participants, the Modified Falls Efficacy Scale (MFES), Time Up and Go (TUG) test, Berg Balance Scale (BBS), and Unipedal Stance Test (UST) were employed at weeks 0, 6, and 12 of the experiment. Results. BBS, right-leg UST, and TUG test scores significantly improved after IVGB intervention, whereas MFES and left-leg UST tended to improve after IVGB intervention. Conclusions. This study revealed that 6-week balance-based exercise training using the IVGB system exerted positive effects on functional balance in patients with diabetic peripheral neuropathy (DPN).

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Section: Discussionmentioning

confidence: 99%

Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients with Peripheral Neuropathy: An Open-Level, Crossover Pilot Study

Hung

Chen

Chang

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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“…If used at the start of a trial, a run-in period can help to document a stable baseline state, determine tolerability, assess potential study regime adherence, or wash out any pretrial interventions if needed 444546. A run-in period might also occur at the beginning of any period of an intervention in a trial, if the intervention requires ramping up to the trial’s therapeutic dose.…”

Section: Section 3a: Methods—participants Interventions and Outcomesmentioning

confidence: 99%

SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist

Porcino¹,

Shamseer

Chan

et al. 2020

BMJ

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Randomised clinical trials are the preferred method for establishing average intervention effects for groups. Using key methodological elements of these trials, n-of-1 trials provide rigorous evidence of intervention effects for individuals. N-of-1 trials are particularly useful for situations where randomised clinical trials are not always feasible or appropriate, such as for individuals with rare diseases, comorbid conditions, or using concurrent treatments. N-of-1 trials enhance precision when intervention effects are heterogeneous between individuals. Here, we describe an extension to the SPIRIT (standard protocol items: recommendations for interventional trials) guideline, SPENT (SPIRIT extension for n-of-1 trials), to improve the completeness and transparency of n-of-1 trial protocols. SPENT is also aligned with the CONSORT (consolidated standards of reporting trials) extension for n-of-1 trials (CENT). The guideline development group followed the development strategy for reporting guidelines endorsed by the EQUATOR Network. SPENT began with a systematic review for n-of-1 protocol recommendations. After analysis to identify possible SPENT items, a three round Delphi process was implemented, with international participation involving researchers, patient advocates, and other stakeholders. This was followed by in-person meetings and email discussion of the SPENT group to achieve consensus. SPENT has 14 extension items specific to n-of-1 trials, a checklist for n-of-1 trial protocol abstracts, and additional guidance for eight SPIRIT items where trialists could encounter issues specific to n-of-1 trials. This paper describes the rationale and development process, and provides examples and explanations for each SPENT checklist item.

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“…The included participants were randomly and equally divided into three groups, A, B, and C, with 10 participants in each group, by using the random number method. The crossover study design was adopted for each group to use the three triage systems by randomized sequence to avoid potential bias on the results (Table 1) (11,12).…”

Section: Grouping Methodsmentioning

confidence: 99%

Assessment of three triage systems by medical undergraduate students using simulated disaster patients: a comparative study

Zhang,

Liu,

Chen

et al. 2023

Front. Disaster Emerg. Med.

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BackgroundTriage is an initial important step in emergency medical rescues for mass casualty incidents, and different triage systems are used in practice. However, quantitative analysis-based evidence comparing these triage systems in mass casualty incidents is limited.ObjectiveTo compare the performance of three triage systems, simple triage and rapid treatment (START), abbreviated scoring method for combat casualty (ASMcc), and sort assess lifesaving interventions treatment/transport (SALT) system, for simulated disaster patients, as assessed by medical undergraduate students.MethodsMedical undergraduates were recruited and randomly divided into three groups to evaluate the performance of the three triage systems by using simulated disaster patient cards. The triage time, accuracy, and overtriage and undertriage rates were analyzed among groups. Furthermore, a questionnaire survey was used to investigate the responses of the participants regarding learning, practice, and satisfaction among the three triage systems.ResultsA total of 30 participants were included in the study. The participants were male medical undergraduate students with a mean age of 20.73 ± 0.45 years. ASMcc had the highest accuracy of 75% with the lowest over-triage rate of 20%, SALT had the lowest undertriage rate of 19%, and START had the shortest triage time of 12.68 ± 4.96 min (all P < 0.05). Furthermore, the results of the questionnaire survey showed that START was easy to learn and recall with high efficiency and, among the three systems, had the highest satisfaction ratings from the participants.ConclusionThe results of the study showed that the three triage systems had their own characteristics and advantages, and they are all suitable for use in mass casualty incidents. Further studies involving more triage systems with data based on real conditions are recommended.

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Crossover design and its application in late‐phase diabetes studies

Cited by 9 publications

References 30 publications

Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients with Peripheral Neuropathy: An Open-Level, Crossover Pilot Study

Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients with Peripheral Neuropathy: An Open-Level, Crossover Pilot Study

SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist

Assessment of three triage systems by medical undergraduate students using simulated disaster patients: a comparative study

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