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Table 2 Risk of bias assessment summary

From: Physical and mechanical therapies for lower limb symptoms in children with Hypermobility Spectrum Disorder and Hypermobile Ehlers-Danlos Syndrome: a systematic review

Risk of Bias
Domain Pacey et al. (2013) Evidence Kemp et al. (2010) Evidence
Sequence Generation Low risk ‘The simple randomisation list was generated in a 1:1 ratio using a computer-generated sequence by a person independent of the research group.’ Low risk ‘The randomization list was generated in a 1: 1 ratio using a computer-generated sequence with random variable block size of four and six.’
Allocation Concealment Low risk ‘Treatment allocation was concealed in a sealed, opaque, sequentially numbered envelope which was opened by the treating physiotherapist just prior to the participant’s first physiotherapy session.’ Low risk ‘Treatment allocation was concealed by placing an allocation card between two blank cards in a sealed, opaque, sequentially numbered envelope.’
Blinding of Participants, Personnel and Outcome Assessors High risk Participants: Not blinded
Personnel: Not blinded
Outcome assessors: for participant-rated outcomes, not blinded. For other measures, outcome assessor was blinded.
‘Following the 8 week intervention, participants underwent
a third assessment by an assessor blinded to treatment
allocation.’
High risk Participants: Not blinded
Personnel: Not blinded
Outcome assessors: for participant-rated outcomes, not blinded. For other measures, outcome assessor was blinded.
‘All physiotherapy assessments (at baseline, mid-point assessment and final follow-up) …. were conducted by one senior physiotherapist assessor (I.R.); patients and treating physiotherapist (S.K.) were asked not to divulge the allocated treatment to the assessing physiotherapist.’
Incomplete outcome data Unclear One participant was lost to follow up from the ‘training in hypermobile range’ group. The participant was unable to be contacted so the reason for loss to follow up is not known. Low risk Missing outcome data were balanced in numbers across intervention groups, with similar reasons for missing data across groups. Reasons included: repeated non-attendance, successful rehabilitation, changes in family circumstances and requirement for further investigation.
Selective outcome reporting Unclear Insufficient information to permit judgment. Unclear Insufficient information to permit judgment.
Other sources of bias Low risk None identified. Low risk None identified.