The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement

Figures & data

Figure 1. Common designs in the literature using a single participant. Reproduced from the expanded manual for the Risk of Bias in N-of-1 Trials (RoBiNT) Scale (Tate et al., 2015) with permission of the authors; an earlier version of the figure, taken from the original RoBiNT Scale manual (Tate et al., 2013a) was also published in 2013 (Tate et al., 2013b).

Figure 2. Flow diagram of the Delphi surveys.

Figure 3. Screen-shot of a discussion item at the consensus meeting.

Table 1. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Checklist.

Item number	Topic	Item description
TITLE and ABSTRACT
1	Title	Identify the research as a single-case experimental design in the title
2	Abstract	Summarize the research question, population, design, methods including intervention/s (independent variable/s) and target behavior/s and any other outcome/s (dependent variable/s), results, and conclusions
INTRODUCTION
3	Scientific background	Describe the scientific background to identify issue/s under analysis, current scientific knowledge, and gaps in that knowledge base
4	Aims	State the purpose/aims of the study, research question/s, and, if applicable, hypotheses
METHOD
	DESIGN
5	Design	Identify the design (e.g., withdrawal/reversal, multiple-baseline, alternating-treatments, changing-criterion, some combination thereof, or adaptive design) and describe the phases and phase sequence (whether determined a priori or data-driven) and, if applicable, criteria for phase change
6	Procedural changes	Describe any procedural changes that occurred during the course of the investigation after the start of the study
7	Replication	Describe any planned replication
8	Randomization	State whether randomization was used, and if so, describe the randomization method and the elements of the study that were randomized
9	Blinding	State whether blinding/masking was used, and if so, describe who was blinded/masked
	PARTICIPANT/S or UNIT/S
10	Selection criteria	State the inclusion and exclusion criteria, if applicable, and the method of recruitment
11	Participant characteristics	For each participant, describe the demographic characteristics and clinical (or other) features relevant to the research question, such that anonymity is ensured
	CONTEXT
12	Setting	Describe characteristics of the setting and location where the study was conducted
	APPROVALS
13	Ethics	State whether ethics approval was obtained and indicate if and how informed consent and/or assent were obtained
	MEASURES and MATERIALS
14	Measures	Operationally define all target behaviors and outcome measures, describe reliability and validity, state how they were selected, and how and when they were measured
15	Equipment	Clearly describe any equipment and/or materials (e.g., technological aids, biofeedback, computer programs, intervention manuals or other material resources) used to measure target behavior/s and other outcome/s or deliver the interventions
	INTERVENTIONS
16	Intervention	Describe the intervention and control condition in each phase, including how and when they were actually administered, with as much detail as possible to facilitate attempts at replication
17	Procedural fidelity	Describe how procedural fidelity was evaluated in each phase
	ANALYSIS
18	Analyses	Describe and justify all methods used to analyze data
	RESULTS
19	Sequence completed	For each participant, report the sequence actually completed, including the number of trials for each session for each case. For participant/s who did not complete, state when they stopped and the reasons
20	Outcomes and estimation	For each participant, report results, including raw data, for each target behavior and other outcome/s
21	Adverse events	State whether or not any adverse events occurred for any participant and the phase in which they occurred
	DISCUSSION
22	Interpretation	Summarize findings and interpret the results in the context of current evidence
23	Limitations	Discuss limitations, addressing sources of potential bias and imprecision
24	Applicability	Discuss applicability and implications of the study findings
	DOCUMENTATION
25	Protocol	If available, state where a study protocol can be accessed
26	Funding	Identify source/s of funding and other support; describe the role of funders

Tate, R. L., Rosenkoetter, U., Wakim, D., Sigmundsdottir, L., Doubleday, J., Togher, L.,… Perdices, M. (2015). The Risk of Bias in N-of-1 Trials (RoBiNT) Scale: An expanded manual for the critical appraisal of single-case reports. Sydney, Australia: Author.

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Tate, R. L., Perdices, M., Rosenkoetter, U., Wakim, D., Godbee, K., Togher, L., & McDonald, S. (2013a). Manual for the critical appraisal of single-case reports using the Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Unpublished manuscript, University of Sydney, Australia.

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Tate, R. L., Perdices, M., Rosenkoetter, U., Wakim, D., Godbee, K., Togher, L., & McDonald, S. (2013b). Revision of a method quality rating scale for single-case experimental designs and N-of-1 trials: The 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Neuropsychological Rehabilitation, 23, 619–638. http://dx.doi.org/10.1080/09602011.2013.824383

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