Table 2.

Items from the risk-of-bias tool and criteria for operationalisation

Question	Criteria for “Yes”
Was the method of randomisation adequate?	A random (unpredictable) assignment sequence. Examples of adequate methods are coin toss, rolling a dice, drawing of ballots with the study group labels from a dark bag, computer-generated random sequence, pre-ordered sealed envelopes and sequentially-ordered vials. Examples of inadequate methods are: alternation, birth date, social insurance/security number and hospital registration number
Was the treatment allocation concealed?	Assignments are generated by an independent person not responsible for determining the eligibility of the patients. This person has no information about the persons included in the trial and has no influence on the assignment sequence or on the eligibility decision of the patient
Were the groups similar at baseline regarding the most important prognostic indicators?	The groups have to be similar at baseline regarding demographic factors, duration and severity of complaints, percentage of patients with neurological symptoms, and value of main outcome measure(s)
Was the patient blinded to the intervention?	The index and control groups are indistinguishable for the patients
Was the care provider blinded to the intervention?	The index and control groups are indistinguishable for the care providers
Was the outcome assessor blinded to the intervention?	• For patient-reported outcomes with adequately blinded patients
	• For outcome criteria that supposes a contact between participants and outcome assessors: the blinding procedure is adequate if patients are blinded, and the treatment or adverse effects of the treatment cannot be noticed during examination
	• For outcome criteria that do not suppose a contact with participants: the blinding procedure is adequate if the treatment or adverse effects of the treatment cannot be noticed during the assessment
	• For outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers, in which the care provider is the outcome assessor: the report needs to be free of selective outcome reporting
Were co-interventions avoided or similar?	There were no co-interventions or they were similar between the index and control groups
Was the compliance acceptable in all groups?	The compliance with the interventions is acceptable, based on the reported intensity, duration, number and frequency of sessions for both the index intervention and control intervention(s). For single-session interventions (for ex: surgery), this item is irrelevant
Was the drop-out rate described and acceptable?	The number of participants who were included in the study but did not complete the observation period or were not included in the analysis are described and reasons are given and are <20% for short-term and <30% for long-term follow-up
Was the timing of the outcome assessment similar in all groups?	Timing of outcome assessment was identical for all intervention groups and for all important outcome assessments
Were all randomised participants analysed in the group to which they were allocated?	All randomised patients are reported/analysed in the group they were allocated to by randomisation for the most important moments of effect measurement (minus missing values) irrespective of non-compliance and co-interventions