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Table 2 Assessment of methodological quality of eligible studies using Downs & Black checklist (Downs and Black 1998)a

From: Outcome measures for assessing change over time in studies of symptomatic children with hypermobility: a systematic review

Items Criteria Bale (2019) Hsieh (2018) Revivo (2018) Pacey (2013) Kemp (2010) Scheper (2017)
REPORTING
1 Study hypothesis/aim/objective clearly described 1 1 1 1 1 0
2 Main outcomes in Introduction or Methods section 1 1 1 1 1 1
3 Patient characteristics clearly described 1 1 1 1 1 1
4 Relevant interventions including controls clearly described 1 1 1 1 1 NA
5 Distributions of principal confounders clearly described 0 0 1 0 0 2
6 Main findings (including outcomes) clearly described 1 1 1 1 1 1
7 Estimates of random variability in data for the main outcomes provided 1 1 1 1 1 1
8 All important adverse events related to intervention(s) reported 0 0 0 1 0 NA
9 Patient characteristics lost to follow-up described 1 1 1 1 0 0
10 Actual probability values for main outcomes reported 1 1 1 1 1 1
EXTERNAL VALIDITY
11 Subjects asked to participate were representative of target populations 1 1 1 1 1 1
12 Subjects prepared to participate were representative of target populations 1 1 1 1 1 1
13 Treatment facilities and delivery were representative of target populations 1 1 1 1 1 1
INTERNAL VALIDITY – bias
14 Study participants blinded to intervention administered 0 0 0 1 0 NA
15 Investigators blinded to assessment of main intervention outcomes 1 1 0 1 1 NA
16 Any data dredging was made clear at onset of study 0 0 1 1 1 0
17 Analyses adjust for different lengths of follow-up of participants 1 0 1 1 0 1
18 Statistical tests to assess the main outcomes were appropriate 1 1 1 1 1 1
19 Reliability of compliance with intervention(s) 1 1 1 1 0 NA
20 Main outcome measures used accurate in terms of validity and reliability. 1 1 1 1 1 1
INTERNAL VALIDITY - confounding (selection bias)
21 All participants were recruited from the same target population 1 1 1 1 1 1
22 All participants were recruited over the same period of time 1 1 0 1 1 1
23 Participants were randomised to intervention group(s) 1 1 0 1 1 NA
24 Randomised intervention assignment was concealed from both participants and investigators 0 0 0 1 0 NA
25 Adequate adjustment for confounding 0 0 0 0 0 1
26 Lost to follow-up considered 1 0 1 1 0 0
27 Statistical power- clinical meaningful effect or power calculation reported b 1~ 1 1 1 1 1
  1. ~Power calculation reported but not clinically meaningful
  2. a The scoring given for each criteria was 1 point for ‘Yes’ or 0 point for ‘No’ except question 5 which is scored as 2 for ‘Yes’, 1 for partially or 0 for ‘No’ related to the distribution of principle confounders [35]. For observational study NA=Not applicable.
  3. b Only one point was awarded to an interventional study powered to detect a meaningful clinical effect [37, 38]