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. 2020 Dec 11;2020(12):CD013814. doi: 10.1002/14651858.CD013814

2. Criteria for a judgement of 'yes' for the sources of risk of bias.

1 A random (unpredictable) assignment sequence. Examples of adequate methods are coin toss (for studies with 2 groups), rolling a dice (for studies with 2 or more groups), drawing of balls of different colours, drawing of ballots with the study group labels from a dark bag, computer‐generated random sequence, pre‐ordered sealed envelopes, sequentially ordered vials, telephone call to a central office, and pre‐ordered list of treatment assignments. Examples of inadequate methods are: alternation, birth date, social insurance/security number, date in which they are invited to participate in the study, and hospital registration number.
2 Assignment 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 decision about eligibility of the patient.
3 Index and control groups are indistinguishable for the participants, or if the success of blinding was tested among the participants and it was successful.
4 Index and control groups are indistinguishable for the care providers, or if the success of blinding was tested among the care providers and it was successful.
5 Adequacy of blinding should be assessed for each primary outcome separately. This item should be scored 'yes' if the success of blinding was tested among the outcome assessors and it was successful, or:
  • for participant‐reported outcomes in which the participant is the outcome assessor (e.g. pain, disability): the blinding procedure is adequate for outcome assessors if participant blinding is scored 'yes';

  • for outcome criteria assessed during scheduled visit and that supposes a contact between participants and outcome assessors (e.g. clinical examination): the blinding procedure is adequate if participants are blinded, and the treatment or adverse effects of the treatment cannot be noticed during clinical examination;

  • for outcome criteria that do not suppose a contact with participants (e.g. radiography, magnetic resonance imaging): the blinding procedure is adequate if the treatment or adverse effects of the treatment cannot be noticed when assessing the main outcome;

  • for outcome criteria that are clinical or therapeutic events that will be determined by the interaction between participants and care providers (e.g. co‐interventions, hospitalization length, treatment failure), in which the care provider is the outcome assessor: the blinding procedure is adequate for outcome assessors if item '4' (care providers) is scored 'yes';

  • for outcome criteria that are assessed from data of the medical forms: the blinding procedure is adequate if the treatment or adverse effects of the treatment cannot be noticed on the extracted data.

6 The number of participants who were included in the study but did not complete the observation period or were not included in the analysis must be described and reasons given. If the percentage of withdrawals and dropouts does not exceed 20% for short‐term follow‐up and 30% for long‐term follow‐up and does not lead to substantial bias, a 'yes' is scored (note: these percentages are arbitrary, not supported by literature).
7 All randomized participants are reported and analyzed in the group to which they were allocated by randomization for the most important moments of effect measurement (minus missing values), irrespective of non‐compliance and co‐interventions.
8 All the results from all prespecified outcomes have been adequately reported in the published report of the trial. This information is either obtained by comparing the protocol and the report, or in the absence of the protocol, assessing that the published report includes enough information to make this judgement.
9 Groups have to be similar at baseline regarding demographic factors, duration and severity of complaints, percentage of participants with neurological symptoms, and value of main outcome measure(s).
10 If there were no co‐interventions, or they were similar between the index and control groups.
11 The reviewer determines if 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 example, physiotherapy treatment is usually administered for several sessions; therefore, it is necessary to assess how many sessions each participant attended. For single‐session interventions (e.g. surgery), this item is irrelevant.
12 Timing of outcome assessment should be identical for all intervention groups and for all primary outcome measures.
13 Other types of biases. For example:
  • when the outcome measures were not valid. There should be evidence from a previous or present scientific study that the primary outcome can be considered valid in the context of the present;

  • industry‐sponsored trials. The conflict of interest (COI) statement should explicitly state that the researchers have had full possession of the trial process from planning to reporting without funders with potential COI having any possibility of interfering in the process. If, for example, the statistical analyses have been done by a funder with a potential COI, usually 'unsure' is scored.

COI: conflict of interestFurlan 2015