Table 5.

Risk of bias (RoB) assessment with CONSORT items

CONSORT item		Controlled psychotherapy studies				Controlled pharmacological studies					Open psychotherapy studies		Open pharmacological studies
		Müller, Mueller, et al. (2008)	Müller et al. (2013)	Benson et al. (2014)	Mitchell et al. (2006)	Nicoli de Mattos et al. (2020)	Black et al. (2000)	Koran et al. (2003)	Ninan et al. (2000)	Koran et al. (2007)	Granero et al. (2017)	Filomensky & Tavares (2009)	Grant et al. (2012)	Koran (2002)
Title and abstract	1a	2	0	2	0	2	0	0	0	0
	1b	2	1	1	1	1	1	1	1	0	1		1	1
Background and objectives	2a	2	2	2	2	2	1	2	1	1	2	1	1	2
	2b	1	2	2	0	2	1	2	1	1	1	1	2	2
Trial design	3a	2	2	1	1	2	1	2	1	1	1	1	1	1
	3b
Participants	4a	2	2	2	2	2	2	2	2	1	1	1	2	2
	4b	2	0	2	0	2	0	0	1	1	2	0	0	0
Interventions	5	2	2	2	2	2	2	2	2	2	2	1	1	1
Outcomes	6a	2	2	2	1	2	2	2	1	1	2	2	2	2
	6b
Sample size	7a	0	0	0	0	2	0	0	0	0	0	0	0	0
	7b
Sequence generation	8a	0	1	0	0	2	0	0	0	0
	8b	0	2	0	0	2	0	0	0	0
Allocation concealment mechanism	9	0	0	0	0	2	0	0	0	0
Implementation	10	0	0	0	0	0	1	0	0	0
Blinding	11a	1	0	0	0	1	0	0	0	1
	11b					0	0	0	0	0
Statistical methods	12a	2	2	1	2	2	2	2	2	2
	12b	2	2	1	0	1	0	0	0	0	2	2	1	1
Participant flow	13a	2	1	1	1	2	1	1	1	1			1	1
	13b	2	2	2	1	2	2	2	2	2	1	0	1	1
Recruitment	14a	2	1	1	1	2	0	1	0	1	0	0	2	1
	14b
Baseline data	15	2	1	1	1	2	2	1	0	0	1	0	2	1
Numbers analyzed	16	2	2	2	2	2	2	2	2	2	2	0	1	1
Outcomes and estimation	17a	2	2	1	2	2	1	1	1	1	1	0	1	1
	17b	0	0	0	0	0	0	0	0	0	0	0	0	0
Ancillary analyses	18	2	2	2	0	1	0	0	0	0	1	0	1	0
Harms	19	0	0	0	0	2	2	1	2	1	0	0	2	1
Limitations	20	2	2	2	1	2	1	1	2	1	1	0	2	2
Generalizability	21	2	2	2	1	2	1	1	1	1	2	0	0	0
Interpretation	22	2	2	2	1	2	2	1	2	1	2	1	1	2
Registration	23	2	0	0	0	2	0	0	0	0	0	0	2	0
Protocol	24	2	0	0	0	2	0	0	0	0	0	0	0	0
Funding	25	1	1	0	1	2	1	1	1	1	1	1	1	1
RoB Sum		47	38	34	23	56	28	28	26	23	26	11	28	24

Note. References are sorted from lowest to highest risk of bias with higher sum scores indicating lower risk of bias. A detailed description of the CONSORT items can be retrieved from Moher et al. (2012). If no evaluation of the item was possible (e.g., open studies, no randomization), no rating was given.

1a = Identify as an “N-of-1 trial” in the title. For series: Identify as “a series of N-of-1 trials” in the title, 1b = Structured summary of trial design, 2a = Scientific background and explanation of rationale, 2b = Specific objectives or hypotheses, 3a = Describe trial design, planned number of periods, and duration of each period (including run-in and wash out, if applicable) and in addition for series: Whether and how the design was individualized to each participant, and explain the series design, 3b = Important changes to methods after trial start, 4a = Diagnosis or disorder, diagnostic criteria, comorbid conditions, and concurrent therapies. For series: Eligibility criteria for participants, 4b = Settings and locations where the data were collected, 4c = Whether the trial(s) represents a research study and if so, whether institutional ethics approval was obtained, 5 = The interventions for each period with sufficient details to allow replication, including how and when they were actually administered, 6a = Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed, 6b = Any changes to trial outcomes after the trial commenced, with reasons, 7a = How sample size was determined, 7b = When applicable, explanation of any interim analyses and stopping guidelines, 8a = Whether the order of treatment periods was randomized, with rationale, and method used to generate allocation sequence, 8b = When applicable, type of randomization; details of any restrictions, 9 = Mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until interventions were assigned, 10 = Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions, 11a = If done, who was blinded after assignment to interventions and how, 11b = If relevant, description of the similarity of interventions, 12a = Methods used to summarize data and compare interventions for primary and secondary outcomes, 12b = For series: If done, methods of quantitative synthesis of individual trial data, including subgroup analyses, adjusted analyses, and how heterogeneity between participants was assessed, 13a = For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome, 13b = For each group, losses and exclusions after randomization, together with reasons, 14a = Dates defining the periods of recruitment and follow-up, 14b = Whether any periods were stopped early and/or whether trial was stopped early, with reason(s), 15 = A table showing baseline demographic and clinical characteristics for each group, 16 = For each intervention, number of periods analyzed. In addition, for series: if quantitative synthesis was performed, number of trials for which data were synthesized, 17a = For each primary and secondary outcome, results for each group, and the estimated effect size and its precision, 17b = For binary outcomes, presentation of both absolute and relative effect sizes is recommended, 18 = Results of any other analyses performed, including assessment of carryover effects, period effects, intra-subject correlation. In addition for series: If done, results of subgroup or sensitivity analyses, 19 = All harms or unintended effects for each intervention, 20 = Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses, 21 = Generalizability of the trial findings, 22 = Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence, 23 = Registration number and name of trial registry, 24 = Where the full trial protocol can be accessed, if available, 25 = Sources of funding and other support, role of funders.