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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]