Braces for idiopathic scoliosis in adolescents

Stefano Negrini; Silvia Minozzi; Josette Bettany‐Saltikov; Nachiappan Chockalingam; Theodoros B. Grivas; Tomasz Kotwicki; Toru Maruyama; Michele Romano; Fabio Zaina

doi:10.1002/14651858.CD006850.pub3

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Figure 1

Study flow diagram.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Brace versus observation (RCT), Outcome 1 Quality of life (PedsQL scores).

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Analysis 1.2

Comparison 1 Brace versus observation (RCT), Outcome 2 Risk of success at 2 years.

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Analysis 1.3

Comparison 1 Brace versus observation (RCT), Outcome 3 Risk of success at 3 years.

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Analysis 1.4

Comparison 1 Brace versus observation (RCT), Outcome 4 Risk of success at 5 years.

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Analysis 2.1

Comparison 2 Brace versus observation (cohort studies), Outcome 1 Quality of life (PedsQL score).

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Analysis 2.2

Comparison 2 Brace versus observation (cohort studies), Outcome 2 Risk of success at 2 years.

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Analysis 2.3

Comparison 2 Brace versus observation (cohort studies), Outcome 3 Risk of success at 3 years.

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Analysis 2.4

Comparison 2 Brace versus observation (cohort studies), Outcome 4 Risk of success at 4 years.

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Analysis 2.5

Comparison 2 Brace versus observation (cohort studies), Outcome 5 Any adverse event.

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Analysis 2.6

Comparison 2 Brace versus observation (cohort studies), Outcome 6 Adverse event back pain.

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Analysis 3.2

Comparison 3 Brace and exercise versus observation in high degree curves (cohort study), Outcome 2 Risk of success per protocol at 2‐9 years.

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Analysis 3.3

Comparison 3 Brace and exercise versus observation in high degree curves (cohort study), Outcome 3 Risk of success intention to treat at 2‐9 years.

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Analysis 4.2

Comparison 4 Rigid versus elastic brace (RCT), Outcome 2 Risk of success at 4 years.

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Summary of findings for the main comparison. Brace compared with observation (randomized controlled trial) for idiopathic scoliosis in adolescents

Brace compared with observation (randomized controlled trial) for idiopathic scoliosis in adolescents
Patient or population: adolescents with idiopathic scoliosis Settings: Intervention: brace Comparison: observation
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Observation (RCT)	Brace
Quality of life PedsQL scores¹ Follow‐up: 2 years	The mean quality of life in the control groups was 83.0 ± 13.2 (0‐100)²	The mean quality of life in the intervention groups was 2.1 lower (7.69 lower to 3.49 higher)	‐	111 (1 study)	⊕⊝⊝⊝ very low^3,4	Higher scores indicating a better quality of life
Risk of success Curves remaining below 50° Follow‐up: 2 years	Study population		RR 1.79 (1.29 to 2.5)	116 (1 study)	⊕⊕⊝⊝ low⁵	‐
	415 per 1000	744 per 1000 (536 to 1000)
	Moderate
	415 per 1000	743 per 1000 (535 to 1000)
Pulmonary disorders, disability, back pain, psychological issues, and cosmetic issues Subjective	Study population		Not estimable	0 (0)	See comment	None of the included studies assessed these outcomes
	See comment	See comment
	Moderate
	‐	‐
Any adverse event Number of participants reporting at least 1 adverse event	See comment	See comment	Not estimable	0 (0)	See comment	None of the included studies assessed this outcome
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PedsQL: Pediatric Quality of Life Inventory; RCT: randomized controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ PedsQL, a generic quality‐of‐life instrument used in studies of acute and chronic illness (Varni 2001; Varni 2003).² Scores range from 0 to 100, with higher scores indicating a better quality of life. ³ Unclear risk of selection bias for allocation concealment. ⁴ Only one study with 111 participants. ⁵ Only one study with 116 participants.

Summary of findings for the main comparison. Brace compared with observation (randomized controlled trial) for idiopathic scoliosis in adolescents

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Summary of findings 2. Bracing compared with observation (cohort studies) for idiopathic scoliosis in adolescents

Brace compared with observation (cohort studies) for idiopathic scoliosis in adolescents
Patient or population: adolescents with idiopathic scoliosis Settings: Intervention: brace Comparison: observation (cohort studies)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Observation (cohort studies)	Brace
Quality of life PedsQL score¹ Follow‐up: 2 years	The mean quality of life in the control groups was 83.3 ± 13.3 (0‐100)²	The mean quality of life in the intervention groups was 0.1 higher (3.9 lower to 4.1 higher)	‐	236 (1 study)	⊕⊝⊝⊝ very low³	Higher scores indicating a better quality of life
Risk of success curves remaining below 50° Follow‐up: 2 years	479 per 1000	719 per 1000 (570 to 906)	RR 1.5 (1.19 to 1.89)	242 (1 study)	⊕⊝⊝⊝ very low⁴	Highly clinically relevant
Any adverse event number of participants with at least 1 adverse event Follow‐up: 2 years	427 per 1000	542 per 1000 (410 to 713)	RR 1.27 (0.96 to 1.67)	242 (1 study)	⊕⊝⊝⊝ very low⁴	‐
Pulmonary disorders, disability, back pain, psychological issues, and cosmetic issues subjective or objective	See comment	See comment	Not estimable	0 (0)	See comment	None of the included studies assessed these outcomes
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PedsQL: Pediatric Quality of Life Inventory; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ PedsQL, a generic quality‐of‐life instrument used in studies of acute and chronic illness (Varni 2001; Varni 2003). ² Scores range from 0 to 100, with higher scores indicating a better quality of life. ³ Only one observational study with 236 participants.⁴ Only one observational study with 242 participants.

Summary of findings 2. Bracing compared with observation (cohort studies) for idiopathic scoliosis in adolescents

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Summary of findings 3. Brace and exercise compared with observation in high degree curves (cohort study) for idiopathic scoliosis in adolescents

Brace and exercise compared with observation in high degree curves (cohort study) for idiopathic scoliosis in adolescents
Patient or population: adolescents with idiopathic scoliosis Settings: Intervention: brace and exercise Comparison: observation in high degree curves (cohort study)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Observation in high degree curves (Cohort study)	Brace and exercise
Quality of life	See comment	See comment	Not estimable	0 (0)	See comment	None of the included studies assessed this outcome
Risk of success no progression over 50°, no fusion, no waiting list for fusion	Study population		RR 1.79 (1.04 to 3.07)	57 (1 study)	⊕⊝⊝⊝ very low^1,2	‐
	444 per 1000	796 per 1000 (462 to 1000)
	Moderate
	444 per 1000	795 per 1000 (462 to 1000)
Any adverse event number of participants with at least 1 adverse event	See comment	See comment	Not estimable	0 (0)	See comment	None of the included studies assessed this outcome
Pulmonary disorders, disability, back pain, psychological issues, and cosmetic issues subjective or objective	Study population		Not estimable	0 (0)	See comment	None of the included studies assessed these outcomes
	See comment	See comment
	Moderate
	‐	‐
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Lost at follow‐up (19.3%), unbalanced between groups: 7.7% in the experimental group, 44.4% in the control group. ² Only one study with 57 participants.

Summary of findings 3. Brace and exercise compared with observation in high degree curves (cohort study) for idiopathic scoliosis in adolescents

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Summary of findings 4. Rigid versus elastic brace (randomized controlled trial) for idiopathic scoliosis in adolescents

Rigid versus elastic brace (randomized controlled trial) for idiopathic scoliosis in adolescents
Patient or population: adolescents with idiopathic scoliosis Settings: Intervention 1: rigid brace Intervention 2: elastic brace
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Rigid versus elastic brace (RCT)
Quality of life	See comment	See comment	Not estimable	0 (0)	See comment	None of the included studies assessed this outcome
Risk of success curves remaining below 50° Follow‐up: 4 years	682 per 1000	955 per 1000 (702 to 1000)	RR 1.4 (1.03 to 1.89)	43 (1 study)	⊕⊕⊝⊝ low¹	‐
Any adverse event number of participants with at least 1 adverse event	See comment	See comment	Not estimable	0 (0)	See comment	None of the included studies assessed this outcome
Pulmonary disorders, disability, back pain, psychological issues, and cosmetic issues subjective or objective	See comment	See comment	Not estimable	0 (0)	See comment	None of the included studies assessed these outcomes
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ only one study with 43 participants.

Summary of findings 4. Rigid versus elastic brace (randomized controlled trial) for idiopathic scoliosis in adolescents

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Comparison 1. Brace versus observation (RCT)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Quality of life (PedsQL scores) Show forest plot	1	111	Mean Difference (IV, Fixed, 95% CI)	‐2.10 [‐7.69, 3.49]

2 Risk of success at 2 years Show forest plot	1	116	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [1.29, 2.50]

3 Risk of success at 3 years Show forest plot	1	47	Risk Ratio (M‐H, Fixed, 95% CI)	1.88 [1.11, 3.20]

4 Risk of success at 5 years Show forest plot	1	47	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.83, 1.98]

5 Any adverse event	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Brace versus observation (RCT)

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Comparison 2. Brace versus observation (cohort studies)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Quality of life (PedsQL score) Show forest plot	1	236	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐3.90, 4.10]

2 Risk of success at 2 years Show forest plot	1	242	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [1.19, 1.89]

3 Risk of success at 3 years Show forest plot	1	240	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [1.42, 2.16]

4 Risk of success at 4 years Show forest plot	1	240	Risk Ratio (M‐H, Fixed, 95% CI)	2.22 [1.70, 2.90]

5 Any adverse event Show forest plot	1	242	Risk Ratio (M‐H, Fixed, 95% CI)	1.27 [0.96, 1.67]

6 Adverse event back pain Show forest plot	1	242	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.47, 1.10]

Comparison 2. Brace versus observation (cohort studies)

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Comparison 3. Brace and exercise versus observation in high degree curves (cohort study)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Quality of life	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Risk of success per protocol at 2‐9 years Show forest plot	1	43	Risk Ratio (M‐H, Fixed, 95% CI)	15.21 [1.00, 230.23]

3 Risk of success intention to treat at 2‐9 years Show forest plot	1	57	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [1.04, 3.07]

4 Any adverse event	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Brace and exercise versus observation in high degree curves (cohort study)

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Comparison 4. Rigid versus elastic brace (RCT)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Quality of life	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Risk of success at 4 years Show forest plot	1	43	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.03, 1.89]

3 Any adverse event	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Rigid versus elastic brace (RCT)

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