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. Author manuscript; available in PMC: 2017 Aug 2.
Published in final edited form as: PM R. 2015 Aug 24;8(4):356–366. doi: 10.1016/j.pmrj.2015.08.009

Table 1.

Criteria used for scoring in PEDro scale, Oxford scale, and AAN classification

The Oxford Centre for Evidence Based Medicine Levels PEDro Scale AAN Guidelines for Therapeutic Intervention
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    1a Systematic review with homogeneity of RCTs

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    1b Individual RCT (with narrow confidence interval)

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    1c All or none

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    2a Systematic review (with homogeneity of cohort studies)

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    2b Individual cohort study (including low quality RCT; eg, < 80% follow-up)

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    2c Outcomes (research, ecologic studies)

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    3a Systematic review (with homogeneity) of case-control studies

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    3b Individual case-control study

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    4 Case series (and poor-quality cohort and case control studies)

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    5 Expert opinion without explicit critical appraisal or based on physiology, bench research, or first principles

  1. Eligibility criteria were specified. No/yes

  2. Where subjects were randomly allocated to groups (in a crossover study, subjects were randomly allocated an order in which treatments were received). No/yes

  3. Where allocation was concealed. No/yes, where the groups were similar at baseline regarding the most important prognostic indicators. No/yes

  4. Where there was blinding of all subjects. No/yes

  5. Where there was blinding of all therapists who administered the therapy. No/yes

  6. Where there was blinding of all assessors who measured at least one key outcome. No/yes

  7. Where measures of at least 1 key outcome were obtained from more than 85% of the subjects initially allocated to groups. No/yes

  8. Where all subjects for whom outcome measures were available received the treatment or control condition as allocated, or,

  9. Where this was not the case, data for at least one key outcome were analyzed by intention to treat. No/yes

  10. Where the results of between-group statistical comparisons are reported for at least one key outcome. No/yes

  11. Where the study provides both point measures and measures of variability for at least one key outcome. No/yes

Class I - Randomized, RCT in a representative population
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    Masked or objective outcome assessment

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    Relevant baseline characteristics are presented and substantially equivalent between treatment groups, or there is appropriate statistical adjustment for differences

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    Also required:
    1. Concealed allocation
    2. Primary outcome(s) clearly defined
    3. Exclusion/inclusion criteria clearly defined
    4. Adequate accounting for dropouts (with at least 80% of enrolled subjects completing the study) and crossovers with numbers sufficiently low to have minimal potential for bias
    5. For noninferiority or equivalence trials claiming to prove efficacy for one or both drugs, the following are also required*:
      1. The authors explicitly state the clinically meaningful difference to be excluded by defining the threshold for equivalence or noninferiority
      2. The standard treatment used in the study is substantially similar to that used in previous studies establishing efficacy of the standard treatment (eg, for a drug, the mode of administration, dose, and dosage adjustments are similar to those previously shown to be effective)
      3. The inclusion and exclusion criteria for patient selection and the outcomes of patients on the standard treatment are comparable to those of previous studies establishing efficacy of the standard treatment
      4. The interpretation of the study results is based on a per-protocol analysis that accounts for dropouts or crossovers
Class II - Cohort study meeting criteria a–e (see Class I) or an RCT that lacks one or two criteria b–e (see Class I)
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    All relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences

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    Masked or objective outcome assessment

Class III - Controlled studies (including well-defined natural history controls or patients serving as their own controls)
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    A description of major confounding differences between treatment groups that could affect outcome

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    Outcome assessment masked, objective or performed by someone who is not a member of the treatment team

Class IV - Did not include patients with the disease
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    Did not include patients receiving different interventions

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    Undefined or unaccepted interventions or outcome measures

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    No measures of effectiveness or statistical precision presented or calculable

PEDro = Physiotherapy Evidence Database; AAN = American Academy of Neurology; RCT = randomized controlled trial.