Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial

Punja, Salima; Nikles, Jane; Senior, Hugh; Mitchell, Geoffrey; Schmid, Christopher H.; Heussler, Helen; Witmans, Manisha; Vohra, Sunita

doi:10.1186/s13063-016-1499-6

Cited by 9 publications

(13 citation statements)

References 43 publications

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“…The posterior estimates of the individual treatment effects represent weighted averages of the individual’s measurements and the average effect. Ultimately, these individual posterior estimates may be used to inform individuals of their response to treatment in light of how others have responded.”55…”

Section: Section 3c: Methods—data Collection Management and Analysismentioning

confidence: 99%

“…“Any significant amendments to the protocol will be submitted to Health Canada, Therapeutic Goods Australia, and to the University of Alberta and University of Queensland ethics committees for approval. Trial registries will also be notified of any major amendments.”55…”

Section: Section 3d: Methods (Monitoring)mentioning

confidence: 99%

“…Master lists will be held at each participating site. Data will be analyzed according to ID number only.”55…”

Section: Section 4: Ethics and Disseminationmentioning

confidence: 99%

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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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Section: Section 3c: Methods—data Collection Management and Analysismentioning

confidence: 99%

Section: Section 3d: Methods (Monitoring)mentioning

confidence: 99%

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

Porcino¹,

Shamseer

Chan

et al. 2020

BMJ

Self Cite

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“…Coxeter et al reported the effectiveness of valerian versus placebo in 24 patients with chronic insomnia [15]. Punja et al have described a protocol to assess the effectiveness of melatonin in children (ages [6][7][8][9][10][11][12][13][14][15][16][17] taking medications for ADHD [16]. Nikles et al have described a protocol to assess the effectiveness of melatonin in patients with PD [17].…”

Section: Chronic Insomnia: a Testbed For Implementation Of N-of-1 Trialsmentioning

confidence: 99%

Exploring the potential for collaborative use of an app-based platform for n-of-1 trials among healthcare professionals that treat patients with insomnia

Bobe

Freitas

Glicksberg

2020

Preprint

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Background: N-of-1 trials are single patient, multiple crossover, comparative effectiveness experiments. Despite their rating as level 1 evidence, they are not routinely used in clinical medicine to evaluate the effectiveness of treatments. Objective: We explored the potential for implementing a mobile app-based n-of-1 trial platform for collaborative use by clinicians and patients to support data-driven decisions around the treatment of insomnia. Methods: A survey assessing awareness and utilization of n-of-1 trials was administered to healthcare professionals that frequently treat patients with insomnia at the Icahn School of Medicine at Mount Sinai in New York City. 1M electronic health records were analyzed to evaluate evidence for a comorbid relationship between insomnia and dementia or Alzheimers disease among a patient population that may benefit from n-of-1 trials for the selection of optimal sleep treatments. Results: A total of 45 healthcare professionals completed the survey and were included in the analysis. We found that 64% of healthcare professionals surveyed had not heard of n-of-1 trials. After a brief description of these methods, 75% of healthcare professionals reported that they are likely or highly likely to use an app-based n-of-1 trial at least once in the next year if the service were free and easy to offer to their patients. Conclusions: An app-based n-of-1 trials platform might be a valuable tool for clinicians and patients to identify the best treatments for insomnia. Educational interventions that raise awareness and provide training are also likely necessary. The electronic health record (EHR) may help identify eligible patients.

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“…We are also aware of an ongoing N-of-1 randomized controlled trial to assess the effects of melatonin on sleep in youth with ADHD treated with psychostimulants [11]. Finally, although there have been additional studies, the impact of surgery for ADHD-like symptoms in children with ADHD, we could not retrieve any RCT specifically focusing on this.…”

mentioning

confidence: 99%