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National Guideline Alliance (UK). Cerebral palsy in under 25s: assessment and management. London: National Institute for Health and Care Excellence (NICE); 2017 Jan. (NICE Guideline, No. 62.)
H.1. Risk factors
Not applicable for this review
H.2. Causes of cerebral palsy
Not applicable for this review
H.3. Clinical and developmental manifestations of cerebral palsy
Table 1Accuracy of clinical and developmental manifestations to predict cerebral palsy in infants under 8 months
| Quality assessment | Summary of findings | Quality | Importance | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number | Diagnostic accuracy | True positive | ||||||||||||
| No of studies | Design | Risk of bias | Indirectness | Other | High risk | Low/no risk | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | AUC (95% CI) | Proportion / % | ||
| Abnormality of movement | ||||||||||||||
| Quality of fidgety movement defined according to Prechtl, assessed by General Movement Assessment at 10–18 weeks post-term. Reference test: Neurological outcome at 2 years, assessed by MDT (including MRI/CT scans). | ||||||||||||||
| 1 (Adde, 2007) | prosp cohort | serious1 | no serious indirectness | none | n = 25 (n = 17 preterm, n = 8 term)2 | N = 49 | 100% (68.9–100) | 98.3 (95–100) | 90.9 (58.7–98.5) | 100 (93.98–100) | NR | 10/25 high risk diagnosed3, 0/49 low risk. | MODERATE | CRITICAL |
| Infant motor profile (IMP) at 4 months. Reference test: Hempel assessment at 18 months corrected age | ||||||||||||||
| 1 (Heinman 2011) | prosp cohort | very serious4, 5 | no serious indirectness | none | n = 59 preterm | n = 30 term | NR | NR | NR | NR | 0.89 (0.80–0.98) | 8/59 preterm, 0/30 term6 | LOW | CRITICAL |
| Infant motor profile (IMP) at 6 months. Reference test: Hempel assessment at 18 months corrected age | ||||||||||||||
| 1 (Heinman 2011) | prosp cohort | very serious4, 5 | no serious indirectness | none | n = 59 preterm | n = 30 term | NR | NR | NR | NR | 0.91 (0.75–1.00) | 8/59 preterm6 | LOW | CRITICAL |
| Quality of writhing movements (GMA) at 1 month. Reference test: Neurodevelopmental outcome (Touwen’s criteria and Bayley scale) at 2 years | ||||||||||||||
| 1 (Brogna 2013) | prosp cohort | very serious7,8 | no serious indirectness | none | N=574 | NA | 100% | 86% | NR | NR | NR | 22/574 | LOW | CRITICAL |
| Quality of fidgety movements (GMA) at 3 months. Reference test: Neurodevelopmental outcome (Touwen’s criteria and Bayley scale) at 2 years | ||||||||||||||
| 1 (Brogna 2013) | prosp cohort | very serious7,8 | no serious indirectness | none | N=574 | NA | 100% | 97% | NR | NR | NR | 22/574 | LOW | CRITICAL |
| Quality of fidgety movements (GMA) at 12 weeks corrected age. Reference test: Neurological examination at 12 months (in line with Amiel-Tison and Gosselin, Peabody Developmental Motor Scale and Alberta Infant Motor Scale | ||||||||||||||
| 1 (Burger 2011) | prosp cohort | very serious7,9 | no serious indirectness | none | N=110 | NA | 89% (95% CI 51.75–99.72) | 100% (95% CI 96.41–100) | 100% (95% CI 63.06–100) | 99% (95% CI 94.66–99.98) | NR | 9/110 | LOW | CRITICAL |
| Quality of fidgety movements (GMA) at 3 months. Reference test: Neurological examination (Illingworth) at 2 years. | ||||||||||||||
| 1 (Semeciglenecki 2003) | prosp cohort | serious7 | no serious indirectness | none | N=120 | N=112 | 94% | 92% | 81% | 98% | NR | High risk 32/120 | MODERATE | CRITICAL |
| Quality of fidgety movements (GMA) at different time points. Reference test: Neurological outcome (Griffiths scale) at 2–3 years | ||||||||||||||
| 1 (Ferrari 2002) | prosp cohort | serious7 | no serious indirectness | none | N=93 enrolled N=83 N=79 N=70 N=84 | NA <37wks 38–42wks 43–46wks 47–60wks | 100 100 100 100 | 38 41 53 82 | 63 63 55 86 | 100 100 100 100 | 97.4 | 44/93 | MODERATE | CRITICAL |
| Cramped synchronised character of general movements at different time points. Reference test: Neurological outcome (Griffiths scale) at 2–3 years | ||||||||||||||
| 1 (Ferrari 2002) | prosp cohort | serious7 | no serious indirectness | none | N=93 enrolled N=83 N=79 N=70 N=84 | NA <37wks 38–42wks 43–46wks 47–60wks | 46 65 79 77 | 92 97 100 100 | 87 96 100 100 | 62 73 84 80 | NR | 44/93 | MODERATE | CRITICAL |
| Neurological examination at different time points. Reference test: Neurological outcome (Griffiths scale) at 2–3 years | ||||||||||||||
| 1 (Ferrari 2002) | prosp cohort | serious7 | no serious indirectness | none | N=93 enrolled N=83 N=79 N=70 N=84 | NA <37wks 38–42wks 43–46wks 47–60wks | 58 45 54 48 | 68 63 66 65 | 89 52 67 84 | 95 70 77 93 | NR | 44/93 | MODERATE | CRITICAL |
| Neurological examination (Amiel-Tison and Grenier) at 3 months. Reference test: Neurological outcomes (Illingworth) at 2 years | ||||||||||||||
| 1 (Semeciglenecki 2003) | prosp cohort | serious7 | no serious indirectness | none | N=120 | N=112 | 97% | 43% | 44% | 97% | NR | High risk 32/120 Low risk 35/112 | MODERATE | CRITICAL |
| Abnormal muscle tone at 11–16 weeks assessed by obligatory asymmetric tonic neck (ATN). Reference test: Towen’s neurological examination at 7–11 years | ||||||||||||||
| Normal FM’s, smooth and variable motor repertoire at 11–16 weeks | ||||||||||||||
| 1 (Bruggink 2008/2009) | prosp cohort | serious7 | no serious indirectness | none | N=21 | NA | NA | 95.24% (95% CI 76.18%–99.88%) | 0% (95% CI 0–97.5%) | 100% (95% CI 83.16–100%) | NR | 0/21 | MODERATE | CRITICAL |
| Normal FM’s, abnormal motor repertoire at 11–16 weeks | ||||||||||||||
| 1 (Bruggink 2008/2009) | prosp cohort | serious7 | no serious indirectness | none | N=28 | NA | 100% (95% CI 2.5–100%) | 74.07% (95% CI 53.72%–88.89%) | 12.50% (95% CI 0.32–52.65%) | 100% (95% CI 83.16–100%) | 1/28 | MODERATE | CRITICAL | |
| Abnormal FM’s, abnormal motor repertoire at 11–16 weeks | ||||||||||||||
| 1 (Bruggink 2008/2009) | prosp cohort | serious7 | no serious indirectness | none | N=11 | NA | NA | 90.91% (95% CI 58.72%–99.77%) | 0% (95% CI 0–97.50%) | 100% (95% CI 69.15–100%) | 0/11 | MODERATE | CRITICAL | |
| Absent FM’s, abnormal motor repertoire at 11–16 weeks | ||||||||||||||
| 1 (Bruggink 2008/2009) | prosp cohort | serious7 | no serious indirectness | none | N=73 | NA | 50% (95% CI 21.09–78.91%) | 100% (95% CI 2.5%–100%) | 100% (95% CI 54.07–100%) | 14.29% (95% CI 0.36–57.87%) | 6/13 | MODERATE | CRITICAL | |
| Delayed sitting | ||||||||||||||
| Sitting without support (population norms, white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=61 (35%) | NA | 93% | 71% | 52% | NR | NR | NR | VERY | LOW CRITICAL |
| Sitting without support (population norms, non-white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=121 (65%) | NA | 88% | 76% | 38% | NR | NR | NR | VERY LOW | CRITICAL |
| Sitting without support (race norms, white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=61 (35%) | NA | 93% | 75% | 56% | NR | NR | NR | VERY LOW | CRITICAL |
| Sitting without support (race norms, non-white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=121 (65%) | NA | 94% | 65% | 31% | NR | NR | NR | VERY LOW | CRITICAL |
| Sitting without support (delay cut offs, population norms) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=170 | N=381 Delay: 12.5% 25% 37.5% 50% | 100% 90% 84% 77% | 60% 74% 85% 94% | 36% 44% 55% 73% | NR NR NR NR | NR NR NR NR | NR NR NR NR | VERY LOW | CRITICAL |
| Come to a sitting position (population norms, white very preterm infants | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=61 (35%) | NA | 87% | 67% | 48% | NR | NR | NR | VERY LOW | CRITICAL |
| Come to a sitting position (population norms, non-white very preterm infants | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=121 (65%) | NA | 88% | 82% | 45% | NR | NR | NR | VERY LOW | CRITICAL |
| Come to a sitting position (race norms, white very preterm infants | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=61 (35%) | NA | 87% | 67% | 48% | NR | NR | NR | VERY LOW | CRITICAL |
| Come to a sitting position (race norms, non-white very preterm infants | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness10 | none | N=121 (65%) | NA | 94% | 68% | 33% | NR | NR | NR | VERY LOW | CRITICAL |
| Come to a sitting position (delay cut offs, population norms) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious7 | serious indirectness9 | none | N=167 | N=381 Delay: 12.5% 25% 37.5% 50% | 97% 87% 87% 87% | 55% 77% 83% 87% | 33% 47% 54% 61% | NR NR NR NR | NR NR NR NR | NR NR NR NR | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 1 due to reference test (neurological assessment at 2 years) undertaken with knowledge of index test results, this may lead to bias in interpretation of reference test.
- 2
high risk classified as pre-term or if one or more perinatal risk factor present including: perinatal stroke, perinatal asphyxia, intra/peri-ventricular haemorrhage, severe hypoglycaemia and e.coli sepsis, very low birth weight and/or gestational age, bronchopulmonary dysplasia
- 3
diagnoses were: 4 with quadriplegia, 4 with right hemiplegia, 1 with left hemiplegia and 1 with unspecified cp.
- 4
evidence was downgraded by 1 due to selection bias for term infants: recruited through colleagues and families.
- 5
evidence was downgraded by 1 due to unclear if physicians who carried out reference test also carried out index test.
- 6
diagnoses were: 3 unilateral spastic cerebral palsy, 5 bilateral spastic cerebral palsy
- 7
evidence was downgraded by 1 due to attrition bias; 95% ci not reported and/or missing data. These have been calculated where possible.
- 8
evidence was downgraded by 1 due to unclear if assessor of the reference test was blinded.
- 9
evidence was downgraded by 1 due to ‘suspect’ infants were removed from analysis which was not described in the methods. Sensitivity analysis was carried out including them in the normal and abnormal groups.
- 10
evidence was downgraded by 1 due to controls are from a wider population.
Table 5Accuracy of clinical and developmental manifestations to predict Cerebral Palsy in infants over 8 months
| Quality assessment | Summary of findings | Quality | Importance | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number | Diagnostic accuracy | True positive | ||||||||||||
| No of studies | Design | Risk of bias | Indirectness | Other | High risk | Low/no risk | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | AUC (95% CI) | Proportion / % | ||
| Infant motor profile (IMP) at 10 months. Reference test: Hempel assessment at 18 months corrected age | ||||||||||||||
| 1 (Heinman 2011) | prosp cohort | very serious1, 2 | no serious indirectness | none | n = 59 preterm | n = 30 term | NR | NR | NR | NR | 0.99 (0.96–1.00) | 8/59 pretermterm3 | LOW | CRITICAL |
| Infant motor profile (IMP) at 12 months. Reference test: Hempel assessment at 18 months corrected age | ||||||||||||||
| 1 (Heinman 2011) | prosp cohort | very serious1, 2 | no serious indirectness | none | n = 59 preterm | n = 30 term | NR | NR | NR | NR | 0.99 (0.96–1.00) | 8/59 preterm3 | LOW | CRITICAL |
| Walking | ||||||||||||||
| Walking at 18–24 months (population norms, white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious4 | serious indirectness5 | none | N=61 (35%) | NA | 100% | 75% | 58% | NR | NR | NR | VERY LOW | CRITICAL |
| Walking at 18–24 months (population norms, non white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious4 | serious indirectness5 | none | N=121 (65%) | NA | 94% | 80% | 44% | NR | NR | NR | VERY LOW | CRITICAL |
| Walking at 18–24 months (race norms, non white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious4 | serious indirectness5 | none | N=61 (35%) | NA | 100% | 75% | 58% | NR | NR | NR | VERY LOW | CRITICAL |
| Walking at 18–24 months (race norms, non white very preterm infants) | ||||||||||||||
| 1 (Allen 1992/1994) | case control | serious4 | serious indirectness5 | none | N=121 (65%) | NA | 94% | 73% | 37% | NR | NR | NR | VERY LOW | CRITICAL |
| Walking by 18 months (not adjusted for gestational age) | ||||||||||||||
| 1 (Johnson 1990) | prosp cohort | serious4 | no serious indirectness | none | N=4275 | NA | 86% | 92% | 16% | NR | NR | 77/4275 | MODERATE | CRITICAL |
- 1
evidence was downgraded by 2 due to Selection bias for term infants: recruited through colleagues and families.
- 2
evidence was downgraded by 2 due to Reference standard–unclear if interpreted without knowledge of index test results
- 3
diagnoses were: 3 unilateral spastic CP, 5 bilateral spastic CP
- 4
evidence was downgraded by 1 due to evidence was downgraded by 1 due to Attrition bias; 95% CI not reported and/or missing data. These have been calculated where possible.
- 5
controls are from a wider population
Table 6Accuracy of manifestations in predicting Cerebral Palsy in infants and children in the primary care setting or mixed (low risk and high risk) population
| Quality assessment | Summary of findings | Quality | Importance | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number | Diagnostic accuracy | True positive | |||||||||||
| No of studies | Design | Risk of bias | Indirectness | Other | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | AUC (95% CI) | Proportion / % | |||
| Definitely abnormal general movements1, assessed by video recording of spontaneous motility in the supine position for at least 5 minutes at corrected age of 3 months| follow up until 3 years 9 months | |||||||||||||
| 1 (Bouwstra 2010) | prosp. cohort | no serious risk of bias | no serious indirectness | none | n = 455 | 67% (13–98) | 97% (94–98) | 12% (2–38) | 100% (99–100) | NR | 3/4552 | HIGH | CRITICAL |
| Neonatal neurological examination adapted from Prechtl 1977 with added predictors3 at term or by latest 5 days after birth. Reference test: Bayley Scale of Infant Development (BSID) (Bayley 1969) | |||||||||||||
| 1 (Wolf, 1997) | prosp cohort | no serious risk of bias | serious4 | none | N = 142 | 73.9 (51.6–89.7) | 98.1 (93.3–99.7) | 89.5 (66.8–98.4) | 94.5 (88.4–97.9) | NR | 23/1425 | MODERATE | CRITICAL |
- 1
definitely abnormal general movements characterised by a serious reduction in movement variation and complexity
- 2
2 with bilateral spastic CP, 1 with unilateral left-sided spastic CP.
- 3
Contains predictors including variation of movement, fixation, fluctuating tone, nasogastric tube feeding, irritability and consolability.
- 4
Study conducted in a less resource rich country (Zimbabwe).
- 5
16 with quadriplegia, 2 with diplegia, 1 with hemiplegia and 4 with choreoathetosis
Table 7Association between manifestation and cerebral palsy diagnosis
| Quality assessment | Summary of findings | Quality | Importance | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Indirectness | Other | Number | Proportion of those with CP | Proportion of true positive with manifestation | |||
| High risk | Low/no risk | |||||||||
| Tone abnormalities, assessed by Amiel-Tison (1986) method at 3, 6, 9 and 12 months | ||||||||||
| 1 (Chaudhari, 2010) | prosp cohort | serious2 | serious1 | none | n = 1903 | n = 494 | 10/190 high risk | 100%, all had tone abnormalities5 | VERY LOW | CRITICAL |
| General Movement assessment classification of ‘definitely abnormal’ with Likert score = 2 at fidgety GM age (8–17 weeks post term) | ||||||||||
| 1 (Groen 2005) | prosp cohort | no serious risk of bias | no serious indirectness | none | n = 24 | n = 28 | 8/24 high risk | 3/8 | MODERATE | CRITICAL |
| General Movement assessment classification of ‘definitely abnormal’ with Likert score = 3 at fidgety GM age (8–17 weeks post term) | ||||||||||
| 1 (Groen 2005) | prosp cohort | no serious risk of bias | no serious indirectness | none | n = 24 | n = 28 | 8/24 high risk | 4/8 | MODERATE | CRITICAL |
| General Movement assessment classification of ‘mildly abnormal’ with Likert score = 5 at fidgety GM age (8–17 weeks post term) | ||||||||||
| 1 (Groen 2005) | prosp cohort | no serious risk of bias | no serious indirectness | none | n = 24 | n = 28 | 8/24 high risk | 1/8 | MODERATE | CRITICAL |
| Cramped synchronised general movements at writhing GM age (38–47 weeks post term) | ||||||||||
| 1 (Groen 2005) | prosp cohort | no serious risk of bias | no serious indirectness | none | n = 24 | n = 28 | 8/24 high risk | 7/8 (significant association p = 0.001)6 | MODERATE | CRITICAL |
| Jerky and stiff movement at writhing GM age (38–47 weeks post term) | ||||||||||
| 1 (Groen 2005) | prosp cohort | no serious risk of bias | no serious indirectness | none | n = 24 | n = 28 | 8/24 high risk | 4/8 | MODERATE | CRITICAL |
| Predominantly jerky movement at fidgety GM age (8–17 weeks post term) | ||||||||||
| 1 (Groen 2005) | prosp cohort | no serious risk of bias | no serious indirectness | none | n = 24 | n = 28 | 8/24 high risk | 4/8 | MODERATE | CRITICAL |
- 1
study conducted in a less resource rich country (India).
- 2
evidence was downgraded by 1 due to controls are not age matched.
- 3
high risk: included low birthweight, low gestational age, seizures, apnea, hypoxic ischemic encephalopathy, haemorrhage, hyper bilirubimia, respiratory distress.
- 4
normal: full term with normal antenatal, natal and postnatal course enrolled during same period.
- 5
4 had hypertonia, 6 had hypotonia
- 6
fisher’s test
Table 8Accuracy of tools to identify clinical and developmental manifestations in predicting Cerebral Palsy in high risk/preterm infants and children
| Quality assessment | Summary of findings | Quality | Importance | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number | Diagnostic accuracy | True positive | |||||||||||
| No of studies | Design | Risk of bias | Indirectness | Other | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | AUC (95% CI) | Proportion / % | |||
| Early Motor Pattern Profile (EMPP) at 6 months. Reference: Motor outcome at 36 months* | |||||||||||||
| 1 (Morgan 1996) | prosp. cohort | serious1 | no serious indirectness | none | n = 1171 | 87.13 (81.71–91.42) | 97.83 (96.71–98.65) | 89.34 (84.17–93.28) | 97.33 (96.11–98.25) | NR | 176/1171 | MODERATE | CRITICAL |
| Early Motor Pattern Profile (EMPP) at 12 months. Reference: Motor outcome at 36 months* | |||||||||||||
| 1 (Morgan 1996) | prosp. cohort | serious1 | no serious indirectness | none | n = 942 | 91.53 (86.41–95.18) | 97.91 (96.63–98.80) | 91.01 (85.81–94.77) | 98.04 (96.78–98.90) | NR | 162/942 | MODERATE | CRITICAL |
| Bayley Scales of Infant and Toddler Development (Bayley-III) at 2 years, Cut off of -1SD. Reference: Movement Assessment Battery for Children- second edition (MABC-2) at 4 years | |||||||||||||
| 1 (Spittle 2013) | prosp cohort | no serious risk of bias | no serious indirectness | none | N=120 eligible N =96 with 4 year follow up | 83 (36–100) | 94 (87–98) | 46 (17–77) | 99 (94–100) | NR | 6/96 | HIGH | CRITICAL |
| Bayley Scales of Infant and Toddler Development (Bayley-III) at 2 years, Cut off of -2SD. Reference: Movement Assessment Battery for Children- second edition (MABC-2) at 4 years | |||||||||||||
| 1 (Spittle 2013) | prosp cohort | no serious risk of bias | no serious indirectness | none | N=120 eligible N =96 with 4 year follow up | 67 (22–96) | 100 (96–100) | 100 (40–100) | 98 (93–100) | NR | 6/96 | HIGH | CRITICAL |
- 1
attrition bias; 95% CI not reported. These have been calculated where possible.
- *
Motor outcome assessed by a variety of tests and classed as normal, abnormal or suspected/minimal impairment.
H.4. Red flags for other neurological disorders
Not applicable for this review
H.5. MRI and identification of causes of cerebral palsy
Not applicable for this review
H.6. MRI and prognosis of cerebral pasly
Not applicable for this review
H.7. Prognosis for walking, talking and life expectancy
Not applicable for this review
H.8. Information and support
Not applicable for this review
H.9. Assessment of eating, drinking and swallowing difficulties
Table 2GRADE profile for index test (clinical assessment) versus videoflourscopy
| Quality assessment | Summary of findings | Quality | Importance | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Indirectness | Inconsistency | Imprecision | Number | Sensitivity (95% CI) | Specificity (95% CI) | Positive likelihood ratio (95% CI) | Negative likelihood ratio (95% CI) | ||
| Clinical assessment compared to videofluoroscopy for aspiration of fluids | ||||||||||||
| 1 (DeMatteo 2005) | prosp cohort | no serious risk of bias | serious1 | n/a | serious2 | 59 | 92% (95% CI: 73–99) | 46% (95% CI: 29–63) | 1.69 (95% CI: 1.22–2.34)3 | 0.18 (95% CI: 0.05–0.72)3 | LOW | CRITICAL |
| Clinical assessment compared to videofluoroscopy for aspiration of solids | ||||||||||||
| 1 (DeMatteo 2005) | prosp cohort | no serious risk of bias | serious1 | n/a | very serious4 | 32 | 33% (95% CI: 4.33–77.7) | 65% (44.3–82.8) | 0.96 (95% CI: 0.28–3.36)3 | 1.02 (0.54–1.92)3 | VERY LOW | CRITICAL |
| Clinical assessment compared to videofluoroscopy for penetration of fluids | ||||||||||||
| 1 (DeMatteo 2005) | prosp cohort | no serious risk of bias | serious1 | n/a | serious2 | 68 | 80% (95% CI: 63.5–90.7) | 42% (95% CI: 23.5–61) | 1.36 (95% CI: 0.96–1.91)3 | 0.50 (95% CI: 0.23–1.05)3 | LOW | CRITICAL |
| Clinical assessment compared to videofluoroscopy for penetration of solids | ||||||||||||
| 1 (DeMatteo 2005) | prosp cohort | no serious risk of bias | serious1 | n/a | very serious4 | 32 | 70% (95% CI: 35.8–93.3) | 55% (95% CI: 32.2–75.6) | 1.54 (95% CI: 0.84–2.84)3 | 0.55 (95% CI: 0.20–1.53)3 | VERY LOW | CRITICAL |
- 1
evidence was downgraded by one due to a mixed population of CP and other conditions. Proportion of children with CP was not reported and evidence was not stratified by condition.
- 2
evidence was downgraded by one due to wide confidence interval for sensitivity (width 20%–30%)
- 3
calculated by the NGA from data available in the study.
- 4
evidence was downgraded by two due to very wide confidence interval for sensitivity (width > 30%)
Table 3GRADE profile for index test (clinical assessment) versus fiberoptic endoscopic evaluation of swallowing (FEES)
| Quality assessment | Summary of findings | Quality | Importance | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Indirectness | Inconsistency | Imprecision | Number | Sensitivity (95% CI) | Specificity (95% CI) | Positive likelihood ratio (95% CI) | Negative likelihood ratio (95% CI) | ||
| Clinical assessment compared to FEES for aspiration of saliva | ||||||||||||
| 1 (Beer 2014) | reteros pcohort | no serious risk of bias | no serious indirectness | n/a | very serious1 | 5 | 67% (95% CI: 9.4 - 99.2) | 50% (95% CI: 1.7 - 98.7) | 1.33 (95% CI: 1.3 - 98.7)2 | 0.67 (95% CI: 0.1 - 5.5) | LOW | CRITICAL |
| Clinical assessment compared to FEES for aspiration of puree | ||||||||||||
| 1 (Beer 2014) | reteros pcohort | no serious risk of bias | no serious indirectness | n/a | very serious1 | 2 | 100% (95% CI: 15.8 - 100) | NC3 | NC3 | NC3 | LOW | CRITICAL |
| Clinical assessment compared to FEES for aspiration of liquids | ||||||||||||
| 1 (Beer 2014) | reteros pcohort | no serious risk of bias | no serious indirectness | n/a | very serious1 | 2 | 100% (95% CI: 15.8 - 100) | NC3 | NC3 | NC3 | LOW | CRITICAL |
- 1
evidence was downgraded by two due to very wide confidence interval for sensitivity (width > 30%)
- 2
calculated by the NGA from data available in the study
- 3
not calculable due to no false negatives.
H.10. Management of eating, drinking and swallowing difficulties
Table 4GRADE profile for oral sensorimotor therapy versus routine therapy
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Oral sensorimotor treatment versus routine treatment (randomised trials) | Control | Relative (95% CI) | Absolute | ||
| Anthropometric measure-mean weight kg percentiles for age (final) (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 2 (Gisel 1995 and Gisel 1996) | randomised trials1 | very serious2 | very serious3 | no serious indirectness | serious4 | none | 21 | 22 | - | MD 8.45 lower (11.91 to 5 lower) | VERY LOW | CRITICAL |
| Anthropometric measure- mean weight (kg) (final) (Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1996) | randomised trials | very serious2 | no serious inconsistency | no serious indirectness | serious4 | none | 11 | 12 | - | MD 2.47 lower (6.79 lower to 1.85 higher) | VERY LOW | CRITICAL |
| Anthropometric measure-mean weight (pounds, SD) (final at 9 weeks) (Better indicated by lower values) | ||||||||||||
| 1 (Ottenbacher 1981) | randomised trials | very serious | no serious inconsistency | serious5 | serious4 | none | 10 | 10 | - | MD 9.56 lower (18.65 to 0.47 lower) | VERY LOW | CRITICAL |
| Duration of mealtime (lunch or snack) - Lunch (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 2 (Gisel 1995 and Gisel 1996) | randomised trials1 | very serious2 | serious6 | no serious indirectness | serious4 | none | 21 | 22 | - | MD 4.2 higher (0.24 lower to 8.16 higher) | VERY LOW | CRITICAL |
| Duration of mealtime (lunch or snack) - Snack (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1995) | randomised trials1 | very serious2 | no serious inconsistency | no serious indirectness | serious4 | none | 10 | 10 | - | MD 2.5 lower (6.35 lower to 1.35 higher) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, final) - Puree (Apple sauce) (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1995) | randomised trials1 | very serious2 | no serious inconsistency | no serious indirectness | very serious7 | none | 10 | 10 | - | MD 0.4 lower (2.2 lower to 1.4 higher) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, final) - Viscous (Raisin) (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1995) | randomised trials1 | very serious2 | no serious inconsistency | no serious indirectness | very serious7 | none | 10 | 10 | - | MD 1.3 lower (5.79 lower to 3.19 higher) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, final) - Viscous (gelatine) (Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1995) | randomised trials1 | very serious2 | no serious inconsistency | no serious indirectness | serious4 | none | 10 | 10 | - | MD 3.2 higher (1.73 lower to 8.13 higher) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, final) - Solid (Biscuit) (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1study (GIsel 1995) | randomised trials1 | very serious2 | no serious inconsistency | no serious indirectness | serious4 | none | 10 | 10 | - | MD 2.2 higher (1.53 lower to 5.93 higher) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, final) - Solid (Cereal ring) (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1995) | randomised trials1 | very serious2 | no serious inconsistency | no serious indirectness | very serious7 | none | 10 | 10 | - | MD 9.9 lower (13.27 to 6.53 lower) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, change) - Puree (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1996) | randomised trials1 | very serious2 | no serious inconsistency | no serious indirectness | very serious7 | none | 11 | 12 | - | MD 9.79 higher (7.15 to 12.44 higher) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, change) - Viscous (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1996) | randomised trials | very serious2 | no serious inconsistency | no serious indirectness | very serious7 | none | 11 | 12 | - | MD 0.35 lower (4.58 lower to 3.88 higher) | VERY LOW | CRITICAL |
| Eating time of different food textures (mean seconds, SD, change) - Solid (follow-up 10 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 1996) | randomised trials | very serious2 | no serious inconsistency | no serious indirectness | very serious7 | none | 11 | 12 | - | MD 1.1 higher (4.95 lower to 7.14 higher) | VERY LOW | CRITICAL |
- 1
open label randomised trial
- 2
the evidence was downgraded by 2 due to selection bias and performance bias
- 3
the evidence was downgraded by 2 due to very serious heterogeneity (Chi-squared p <0.1, I-squared inconsistency statistic of 75%) and no plausible explanation was found with subgroup analysis
- 4
evidence was downgraded by one due to 95% confidence interval crossing one default MID (−0.5 to +0.5 SD)
- 5
majority of evidence has only 1 indirect aspect of PICO (population)
- 6
evidence was downgraded by 1 due to serious heterogeneity (chi-squared p<0.1, I-squared inconsistency statistic of 50%-74.99%) and no plausible explanation was found with sensitivity analysis.
- 7
the evidence was downgraded by 2 due to 95% confidence interval crossing 2 default MIDs −0.5 and +0.5 SDs
- 8
the evidence was downgraded by 1 due to performance bias
Table 5GRADE profile for ISMAR versus no ISMAR treatment
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | ISMAR treatment versus no ISMAR treatment (cohort) | Control | Relative (95% CI) | Absolute | ||
| Anthropometric measure-weight at 6 months (change) (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 9 | 8 | - | MD 0.87 higher (0.2 to 1.54 higher) | VERY LOW | CRITICAL |
| Anthropometric measure-weight at 12 months (change) (Better indicated by lower values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 10 | 7 | - | MD 1.44 lower (1.89 to 0.99 lower) | VERY LOW | CRITICAL |
| Anthropometric measure-height at 6 months (change) (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 9 | 8 | - | MD 0.15 lower (2.06 lower to 1.76 higher) | VERY LOW | CRITICAL |
| Anthropometric measure-height at 12 months (change) (follow-up 12 months; Better indicated by lower values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 10 | 7 | - | MD 2.68 higher (1.21 to 4.15 higher) | VERY LOW | CRITICAL |
| Competency in feeding (percentage) at 12 to 18 months (final) - Spoon feeding (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | no serious risk of bias | no serious inconsistency | no serious indirectness | serious2 | none | 9 | 8 | - | MD 5.8 lower (16.64 lower to 5.04 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 12 to 18 months (final) - Cup drinking (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 9 | 8 | - | MD 1.9 lower (10.09 lower to 6.29 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 12 to 18 months (final) - Swallowing (Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 9 | 8 | - | MD 16 lower (32.08 lower to 0.08 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 12 to 18 months (final) - Clearing (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 9 | 8 | - | MD 15.5 lower (31.03 lower to 0.03 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (final) - Spoon feeding (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 10 | 7 | - | MD 2.5 lower (14.97 lower to 9.97 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (final) - Cup drinking (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 10 | 7 | - | MD 2.5 lower (14.97 lower to 9.97 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (final) - Swallowing (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 10 | 7 | - | MD 19 lower (32.66 to 5.34 lower) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (final) - Clearing (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 10 | 7 | - | MD 13.9 lower (24.27 to 3.53 lower) | VERY LOW | |
| Competency in feeding (percentage) at 12 to 18 months (change) - Spoon feeding (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious2 | no serious inconsistency | no serious indirectness | very serious3 | none | 9 | 8 | - | MD 2.7 higher (2.85 lower to 8.25 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 12 to 18 months (change) - Cup drinking (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 9 | 8 | - | MD 3.3 higher (6.26 lower to 12.86 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 12 to 18 months (change) - Swallowing (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious4 | no serious inconsistency | no serious indirectness | very serious3 | none | 9 | 9 | - | MD 3.5 lower (15.62 lower to 8.62 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 12 to 18 months (change) - Clearing (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 9 | 8 | - | MD 4 lower (15.89 lower to 7.89 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (change) - Spoon feeding (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 10 | 7 | - | MD 0.8 higher (6.96 lower to 8.56 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (change) - Cup drinking (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 10 | 7 | - | MD 9.6 lower (14.23 to 4.97 lower) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (change) - Swallowing (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 10 | 7 | - | MD 2.2 lower (11.43 lower to 7.03 higher) | VERY LOW | IMPORTANT |
| Competency in feeding (percentage) at 18 to 24 months (change) - Clearing (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Gisel 2001) | observational studies | serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 10 | 7 | - | MD 3.6 higher (7.96 lower to 15.16 higher) | VERY LOW | IMPORTANT |
- 1
the evidence was downgraded by 1 due to performance bias
- 2
the evidence was downgraded by 1 due to 95% confidence interval crossing 1 default MID (−0.5 to +0.5 SDs)
- 3
the evidence was downgraded by 2 due to 95% confidence intervals crossing 2 default MIDs (−0.5 to +0.5 SDs)
Table 6Multi-component intervention versus routine physiotherapy
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Multi-component intervention | Routine physiotherapy | Relative (95% CI) | Absolute | ||
| Physical function - Spoon feeding (follow-up 6 months; measured with: mFFA; Better indicated by lower values) | ||||||||||||
| 1 (Sigan 2013) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 41 | 40 | - | MD 8.85 higher (1.55 to 16.15 higher) | LOW | IMPORTANT |
| Physical function - Swallowing (follow-up 6 months; measured with: mFFA; Better indicated by lower values) | ||||||||||||
| 1 (Sigan 2013) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 41 | 40 | - | MD 8.4 higher (1.54 to 15.26 higher) | LOW | IMPORTANT |
| Physical function - Drinking (follow-up 6 months; measured with: mFFA; Better indicated by lower values) | ||||||||||||
| 1 (Sigan 2013) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 41 | 40 | - | MD 4.13 higher (1.12 to 7.14 higher) | LOW | IMPORTANT |
- 1
the evidence was downgraded by 1 due to performance bias
- 2
evidence was downgraded by one due to 95% confidence interval crossing one default MID (-0.5 to +0.5 SD)
Table 7GRADE profile for oral sensorimotor stimulations
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Oral sensorimotor therapy | Control | Relative (95% CI) | Absolute | ||
| Mouth closure (follow-up 2 months; measured with: Oral motor assessment scale (change score); range of scores: 0–10; Better indicated by higher values) | ||||||||||||
| 1 (Baghbadorani 2014) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 12 | - | - | mean 1.33 (SD 1.15) | VERY LOW | IMPORTANT |
| Lip closure onto utensil (follow-up 2 months; measured with: Oral motor assessment scale (change score); range of scores: 0–10; Better indicated by higher values) | ||||||||||||
| 1 (Baghbadorani 2014) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 12 | - | - | mean 0.66 (SD 0.77) | VERY LOW | IMPORTANT |
| Lip closure during deglutition (follow-up 2 months; measured with: Oral motor assessment scale (change score); range of scores: 0–10; Better indicated by higher values) | ||||||||||||
| 1 (Baghbadorani 2014) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 12 | - | - | mean 0.5 (SD 0.67) | VERY LOW | CRITICAL |
| Control of food during deglutition (follow-up 2 months; measured with: Oral motor assessment scale (change score); range of scores: 0–10; Better indicated by higher values) | ||||||||||||
| 1 (Baghbadorani 2014) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 12 | - | - | mean 1 (SD 0.73) | VERY LOW | CRITICAL |
| Straw suction (follow-up 2 months; measured with: Oral motor assessment scale (change score); range of scores: 0–10; Better indicated by higher values) | ||||||||||||
| 1 (Baghbadorani 2014) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 12 | - | - | mean 0.41 (SD 0.51) | VERY LOW | CRITICAL |
| Control of liquid during deglutition (follow-up 2 months; measured with: Oral motor assessment scale (change score); range of scores: 0–10; Better indicated by higher values) | ||||||||||||
| 1 (Baghbadorani 2014) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 12 | - | - | mean 0.75 (SD 0.45) | VERY LOW | CRITICAL |
| Mastication (follow-up 2 months; measured with: Oral motor assessment scale (change score); range of scores: 0–10; Better indicated by higher values) | ||||||||||||
| 1 (Baghbadorani 2014) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 12 | - | - | mean 1 (SD 0.85) | VERY LOW | CRITICAL |
- 1
the evidence was downgraded by 1 due to performance and detection bias
- 2
not calculable
Table 8GRADE profile for the multi-component intervention (including Beckman oral exercise training, behavioural intervention and parenting training)
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Multi-component intervention | Control | Relative (95% CI) | Absolute | ||
| Height (follow-up 1 years; measured with: Percentile; Better indicated by higher values) | ||||||||||||
| 1 (Clawson 2007) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 8 | - | - | mean (SD) 16.13 higher (17.08) | VERY LOW | CRITICAL |
| Weight (follow-up 1 years; measured with: Percentile; Better indicated by higher values) | ||||||||||||
| 1 (Clawson 2007) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 8 | - | - | mean (SD) 10.28 higher (15.41) | VERY LOW | CRITICAL |
| Length of food time/time taken to feed (follow-up 5.8 weeks; measured with: Minutes; Better indicated by lower values) | ||||||||||||
| 1 (Clawson 2007) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 8 | - | - | mean (SD) 17.83 higher (2.06) | VERY LOW | CRITICAL |
- 1
the evidence was downgraded by 1 due to performance bias
- 2
not calculable
Table 9GRADE Profile for the six session training programme
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Six training sessions | Control | Relative (95% CI) | Absolute | ||
| Weight for age (follow-up 4–6 months; measured with: waz score; range of scores: -3–0; Better indicated by higher values) | ||||||||||||
| 1 (Adams 2011) | observational studies | very serious1 | no serious inconsistency | serious2 | no serious imprecision3 | none | 22 | - | - | mean 4.07 (SD 4.25) | VERY LOW | CRITICAL |
| Chest related illness at least once every 3 months (follow-up 4–6 months; assessed with: Frequency) | ||||||||||||
| 1 (Adams 2011) | observational studies | very serious1 | no serious inconsistency | serious2 | no serious imprecision3 | none | 6/22 P 0.005 | - | - | - | VERY LOW | CRITICAL |
| - | ||||||||||||
- 1
the evidence was downgraded by 2 due to performance, attrition and detection bias
- 2
the evidence was downgraded by 1 due to study setting in Bangladesh
- 3
not calculable
- 4
the absolute risk could not be calculated as there was no comparator group in the study
H.11. Optimising nutritional status
Table 10Immediate high energy feeding versus control
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | High energy feeding | Control | Relative (95% CI) | Absolute | ||
| Weight (measured with: kg; Better indicated by lower values) | ||||||||||||
| 1 (Patrick 1986) | randomised trials | very serious1 | N/A | no serious indirectness | serious2 | none | 5 | 5 | - | mean 6.1 higher (95% CI not calculable)3 | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 2 due to no information on randomisation process, blinding or allocation concealment given. Attrition bias due to missing data.
- 2
Imprecision not calculable: standard deviation for intervention group not reported.
- 3
Unable to calculate 95% CI as standard deviation for intervention group not available.
Table 11Tube fed versus orally fed
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Tube fed | Orally fed | Relative (95% CI) | Absolute | ||
| Weight (follow-up 12 months; measured with: z-score; Better indicated by lower values) | ||||||||||||
| 1 (Sullivan 2006) | observational studies | serious1 | N/A | no serious indirectness | very serious2 | none | 22 | 17 | - | MD 0.002 higher (0.64 lower to 0.65 higher) | VERY LOW | CRITICAL |
| Weight (measured with: z-score; Better indicated by lower values) | ||||||||||||
| 1 (Fung 2002) | observational studies | no serious risk of bias | N/A | no serious indirectness | serious4 | none | 49 | 70 | - | MD 0.62 higher (0.24 lower to 1.48 higher) | VERY LOW | CRITICAL |
| Weight (measured with: kg; Better indicated by lower values) | ||||||||||||
| 1 (Kong and Heung 2005) | observational studies | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | none | 48 | 62 | - | MD 0.51 higher (1.79 lower to 2.8 higher) | LOW | CRITICAL |
| Health related quality of life (CHQ) (measured with: CHQ: Global Health Score; Better indicated by lower values) | ||||||||||||
| 1 (Kong and Heung 2005) | observational studies | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | none | 48 | 62 | - | MD 0.51 higher (1.79 lower to 2.8 higher) | LOW | CRITICAL |
| Health related quality of life (CHQ) (measured with: CHQ: Global Health Score; Better indicated by lower values) | ||||||||||||
| 1 (Fung 2002) | observational studies | no serious risk of bias | N/A | no serious indirectness | no serious imprecision | none | 49 | 70 | - | MD 1.38 lower (1.79 to 0.97 lower) | LOW | IMPORTANT |
| Health related quality of life (CHQ) (measured with: CHQ: Physical Summary Score; Better indicated by lower values) | ||||||||||||
| 1 (Fung 2002) | observational studies | no serious risk of bias | N/A | no serious indirectness | no serious imprecision | none | 49 | 70 | - | MD 14.5 lower (19.35 to 9.65 lower) | LOW | IMPORTANT |
| Health related quality of life (CHQ) - Impact on Parent-Time: z-score (Better indicated by lower values) | ||||||||||||
| 1 (Fung 2002) | observational studies | no serious risk of bias | N/A | no serious indirectness | serious4 | none | 49 | 70 | - | MD 0.47 lower (1.11 lower to 0.17 higher) | VERY LOW | IMPORTANT |
- 1
evidence wasdowngraded by 1 due to attrition bias: Drop out rate at follow-up not given.
- 2
evidence was downgraded by 2 due to very serious imprecision as 95%CI crossed two default MID
- 3
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
- 4
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
H.12. Improving speech, language and communication: Speech intelligibility
Not applicable for this review
H.13. Improving speech, language and communication: Communication systems
Table 12GRADE profile for Blissymbols intervention
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Blissymbol | Control | Relative (95% CI) | Absolute | ||
| Number of symbols/signs understood (follow-up 10.5 months; Better indicated by higher values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | - | - | mean (SD) 54.0 higher (47.3) | VERY LOW | CRITICAL |
| Number of symbol/sign understood (follow-up 1.5 years; Better indicated by higher values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | very serious1,3 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | - | - | mean (SD) 113.7 higher (70.5) | VERY LOW | CRITICAL |
| Number of symbols/signs produced (follow-up 10.5 months; Better indicated by lower values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | - | - | mean (SD) 50.6 higher (42.9) | VERY LOW | CRITICAL |
| Number of symbols/signs produced (follow-up 1.5; Better indicated by lower values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | very serious3 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | - | - | mean (SD) 109 higher (69.9) | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 1 due to participants not comparable at baseline for: ‘measures of physical handicap, non-verbal IQ and language comprehension and expression’.
- 2
not calculable.
- 3
evidence was downgraded by 2 due to attrition bias - groups not comparable for availability of outcome data
Table 13GRADE profile for Makaton intervention
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Makaton | Control | Relative (95% CI) | Absolute | ||
| Number of symbols/signs understood (follow-up 10.5 months; Better indicated by higher values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | - | - | mean 34.4 (27.9) higher (0 to 0 higher) | VERY LOW | CRITICAL |
| Number of symbols/signs understood (follow-up 1.5 years; Better indicated by higher values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 14 | - | - | mean 72.1 (46.1) higher (0 to 0 higher) | VERY LOW | CRITICAL |
| Number of symbols/signs produced (follow-up 10.5 months; Better indicated by higher values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | - | - | mean 28.2 (25.6) higher (0 to 0 higher) | VERY LOW | CRITICAL |
| Number of symbols/signs produced (follow-up 1.5 years; Better indicated by higher values) | ||||||||||||
| 1 (Udwin and Yule 1990) | observational studies | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 14 | - | - | mean 65.1 (46.2) higher (0 to 0 higher) | VERY LOW | CRITICAL |
- 1
evidence downgraded by 1 due to participants not comparable at baseline for: ‘measures of physical handicap, non-verbal IQ and language comprehension and expression’.
- 2
not calculable.
Table 14GRADE profile for ‘My Turn to Speak’ training vs no training for teachers/assistants
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | ‘My Turn to Speak’ training (workshops) | No training | Relative (95% CI) | Absolute | ||
| Change in quality of facilitation of children’s communication by adults (teachers and assistants) (follow-up 1 months; Better indicated by lower values)1 | ||||||||||||
| 1 (McConachie and Pennington, 1997) | observational study | no serious risk of bias | N/A | no serious indirectness | NC2 | none | 19 | 10 | - | NC3 | VERY LOW | CRITICAL |
| Change in quality of facilitation of children’s communication by adults (teachers and assistants) (follow-up 4 months; Better indicated by lower values)1 | ||||||||||||
| 1 (McConachie and Pennington, 1997) | observational study | serious4 | N/A | no serious indirectness | NC2 | none | 9 | 4 | - | NC5 | VERY LOW | CRITICAL |
- 1
facilitation of communication by n = 34 teachers and assistants with n = 9 students who had CP and used AAC (2 used VOCAs)
- 2
raw data was not available for both groups to calculate mean difference and imprecision.
- 3
raw data was not available for both groups to calculate mean difference. No significant difference in quality of facilitation of children’s communication in participant group reported (Chi squared = 1.62, not significant).
- 4
evidence was downgraded by 1 due to attrition bias - loss of follow-up in comparison group and unavailability of data in intervention group.
- 5
raw data was not available for both groups to calculate mean difference. Significant improvement in quality of facilitation of children’s communication in participant group reported but no significant difference in comparison group.
Table 15GRADE profile for Dynavox2c vs Alphatalker
| Quality assessment | Error rate in 7 participants | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Dynavox2c (dual level display) | Alphatalker (single level display) | Relative (95% CI) | Absolute | ||
| Error rate in test 1 among 7 CP participants1 (measured with: errors ÷ number of possible correct responses; Better indicated by lower values) | ||||||||||||
| 1 (Hochstein 2003) | observational study2 | no serious risk of bias | N/A | no serious indirectness | NC | none | Median 0.59 (range 0.22 to 0.78) | Median 0.19 (range 0.09 to 0.44) | - | NC2 | LOW | IMPORTANT |
| Error rate in test 2 among 7 CP participants1 (measured with: errors ÷ number of possible correct responses; Better indicated by lower values) | ||||||||||||
| 1 (Hochstein 2003) | observational study2 | no serious risk of bias | N/A | no serious indirectness | NC | none | Median 0.50 (range 0.13 to 0.72) | Median 0.19 (range 0.06 to 0.38) | - | NC2 | LOW | IMPORTANT |
- 1
case-control (controls were non-CP participants, results not reported here). 7 CP participants used both Dynavox2c and Alphatalker.
- 2
absolute effect not calculable.
H.14. Managing saliva control
Table 16GRADE profile for comparison of Botulinum versus Placebo for drooling
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Botulinum toxin A | Placebo | Relative (95% CI) | Absolute | ||
| Reduction of frequency and severity of drooling (measured with: Total TSG scale at 4 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Lin 2008) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | NC2 | none | N=6 Mean=5.17 | N=7 Mean=6.71 | - | MD=1.54 lower P<0.01 | VERY LOW | CRITICAL |
| Frequency of drooling (measured with: Frequency section only of TSG scale at 4 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Alrefai 2009) | randomised trials | serious3 | no serious inconsistency | no serious indirectness | NC2 | none | N=11 Median=3 | N=13 Median=4 | - | MD=NC P<0.05 | LOW | CRITICAL |
| Severity of drooling (measured with: Severity section of TSG scale at 4 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Alrefai 2009) | randomised trials | serious3 | no serious inconsistency | no serious indirectness | NC2 | none | N=11 Median=4 | N=13 Median=5 | - | MD=NC P<0.05 | LOW | CRITICAL |
| Reduction of frequency and severity of drooling (measured with: Subjective drooling scale at 4 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Wu 2011) | randomised trials | serious4 | no serious inconsistency | no serious indirectness | NC2 | none | N=10 Mean=NR | N=10 Mean=NR | - | MD=NC P>0.05 | LOW | CRITICAL |
| Reduction of frequency and severity of drooling (measured with: Salivary flow, mL/min at 4 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Wu 2011) | randomised trials | serious4 | no serious inconsistency | no serious indirectness | NC2 | none | N=10 Mean=NR | N=10 Mean=NR | - | MD=NC P=0.037 | LOW | CRITICAL |
| Adverse effects: swallowing problems (assessed with: Reported by parents or carers) | ||||||||||||
| 2 (Alrefai 2009; Wu 2011) | randomised trials | very serious4,5 | no serious inconsistency | no serious indirectness | NA | none | 2/21 (9.5%) | 0/23 (0%) | NC | NC | LOW | CRITICAL |
| 0% | - | |||||||||||
| Adverse effects: breathing problems - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | CRITICAL | |
| Health-related quality of life - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | CRITICAL | |
| Psychological wellbeing - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | IMPORTANT | |
MD mean difference; NA not applicable; NC not calculable; NR non reported; P p-value
- 1
evidence was downgraded by 2 due to selection bias: authors state ‘randomly assigned’ but insufficient information to permit judgement; concealment of allocation unclear. Performance bias: states ‘double-blind’ but the blinding of the person delivering treatment to group is unknown; Unclear if children were blinded to treatment as well. Attrition bias: no information on whether there were withdrawals from treatment, and no adverse effects were reported. Detection bias: unclear from the paper if investigators taking outcome measures are blinded to treatment allocation. It was not possible to calculate imprecision due to lack of information reported in the paper (no 95% CI and SD).
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded.
- 3
evidence was downgraded by 1 due to selection bias: ‘each patient was given a number and a registered nurse, independent from the investigator assigned the patients to the treatment or placebo group’ unclear if the numbers given had a non-random component; unclear allocation concealment because of lack of information. Performance bias: low risk. Attrition bias: data on 16 people only provided although 24 received the first injection. No data provided for outcomes at 4 months. Detection bias: unclear if parents and carers taking outcome measures were blinded to allocation as well. It was not possible to calculate imprecision due to lack of information reported in the paper (no 95% CI and ranges).
- 4
evidence was downgraded by 1 due to selection bias: unclear as the sequence generation is unspecified as well as concealment of allocation is unspecified. Performance bias: low risk. Attrition bias: low risk. Detection bias: low risk. It was not possible to calculate imprecision due to lack of information reported in the paper (no 95% CI, means and SD).
- 5
evidence was downgraded by 2 due to selection bias: ‘each patient was given a number and a registered nurse, independent from the investigator assigned the patients to the treatment or placebo group’ unclear if the numbers given had a non-random component; unclear allocation concealment because of lack of information. Performance bias: person delivering the treatment and patients were blinded to treatment allocation. Attrition bias: data on 16 people only provided although 24 received the first injection. No data provided for outcomes at 4 months. Detection bias: unclear if parents and carers taking outcome measures were blinded to allocation as well.
Table 17GRADE profile for comparison of Botulinum versus no treatment for drooling
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Botulinum | No treatment | Relative (95% CI) | Absolute | ||
| Reduction of frequency and severity of drooling (measured with: Total TSG scale at 4 weeks - medium dose; Better indicated by lower values) | ||||||||||||
| 1 (Basciani 2011) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | NC2 | none | N=7 (BoNT-B) | N=7 | - | MD=5.143 lower P<0.001 | VERY LOW | CRITICAL |
| Reduction of frequency and severity of drooling (measured with: Total TSG scale at 4 weeks - high dose; Better indicated by lower values) | ||||||||||||
| 1 (Basciani 2011) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | NC2 | none | N=7 (BoNT-B) | N=7 | - | MD=5.714 lower P<0.001 | VERY LOW | CRITICAL |
| Reduction of frequency and severity of drooling (measured with: Drooling impact scale at 4 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Reid 2008) | randomised trials | serious3 | no serious inconsistency | no serious indirectness | no serious imprecision | none | N=13 Mean(SD)=34.29(14.96) (Botulinum toxin A) | N=18 Mean(SD)=61.74(12.35) | - | MD=27.38 lower (−17.44 to −37.31) | MODERATE | CRITICAL |
| Adverse effects: swallowing problems (assessed with: Diary reports and communication from the parents) | ||||||||||||
| 1 (Basciani 2011) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | NA | none | 2/7 (28.6%) in the high dose group only | 0/7 (0%) | NC | NC | LOW | CRITICAL |
| 0% | - | |||||||||||
| Adverse effects: breathing problems - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | ||
| Health-related quality of life - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | CRITICAL | |
| Psychological wellbeing - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | IMPORTANT | |
MD mean difference; NA not applicable; NC not calculable; NR non reported; p-value
- 1
evidence downgraded by 2 due to selection bias: concealment of allocation not reported; groups haven’t been compared at baseline; Performance bias: this is a trial comparing treatment against no treatment and no information is reported on other types of care provided; the study is not blinded; Attrition bias: low dose group had 1 lost at follow-up, medium dose group had 1, control group had 1. No intention to treat analysis reported; Detection bias: the study is not blinded. It was not possible to calculate imprecision due to lack of information reported (No. of participants in each arm not reported).
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded.
- 3
evidence was downgraded by 1 due to selection bias: low risk; Performance bias: person delivering treatment was not blinded. Also, children, carers and parents were not blinded to intervention; Attrition bias: outcome measures for baseline and 1 month post baseline for CP group only available to review authors. No outcomes available at 2-6 months and at 1 year for CP group; Detection bias: investigators taken outcomes measures were not blinded to intervention.
Table 18GRADE profile for comparison of Anticholinergic drug versus Placebo for drooling
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Anticholinergic drug | Placebo | Relative (95% CI) | Absolute | ||
| Reduction of frequency and severity of drooling (measured with: Total TSG scale at 8 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Mier 2000) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | NC2 | none | N=NR Mean=1.85 (glycopyrrolate) | N=NR Mean=6.83 | - | MD=4.98 lower P<0.001 | VERY LOW | CRITICAL |
| Reduction of frequency and severity of drooling (measured with: Improvement in the mTDS scale at 8 weeks; Better indicated by higher values) | ||||||||||||
| 1 (Zeller 2012) | randomised trials | very serious3 | no serious inconsistency | no serious indirectness | serious imprecision7 | none | N=19 Mean (SD)=3.94 (1.95) (glycopyrrolate) | N=17 Mean (SD)=0.71 (2.14) | - | MD=3.23 higher (1.89 to 4.57) P<0.0001 | VERY LOW | CRITICAL |
| Reduction of frequency and severity of drooling (measured with: TDS scale at 2 weeks; Better indicated by lower values) | ||||||||||||
| 1 (Camp-Bruno 1989) | randomised trials | very serious4 | no serious inconsistency | no serious indirectness5,6 | NC2 | none | N=10 Mean=2.38 (benztropine) | N=10 Mean=3.53 | - | MD=1.15 lower P≤0.001 | VERY LOW | CRITICAL |
| Adverse effects: visual problems - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | CRITICAL | |
| Adverse effects: constipation | ||||||||||||
| 1 (Zeller 2012) | randomised trials | very serious3 | no serious inconsistency | no serious indirectness5,6 | very serious8 | none | 6/20 (30%) | 4/18 (22.2%) | RR 1.35 (0.45 to 4.03) | 78 more per 1000 (from 122 fewer to 673 more) | VERY LOW | CRITICAL |
| 0% | - | |||||||||||
| Health-related quality of life - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | CRITICAL | |
| Psychological wellbeing - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | IMPORTANT | |
MD mean difference; NA not applicable; NC not calculable; NR non reported; P p-value
- 1
evidence was downgraded by 2 due to selection bias: authors do not specify how many participants have been randomised in each group; concealment of allocation not reported; groups haven’t been compared at baseline; Performance bias: blinding of person delivering the treatment and patients receiving the treatment. However, parents reported to know when their child was receiving the intervention because of the dramatic improvement in drooling; Attrition bias: data from 12 children who commenced the study (and have been randomised) were not included in the final analysis. No outcome measures reported for those 12 children. Therefore, authors reported outcomes only on the children who completed the study; Detection bias: Not clear whether the person doing the physical examination for side effects was blind to the intervention. It was not possible to calculate imprecision due to lack of information reported (the study doesn’t report No. of participants in each arm).
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded.
- 3
evidence was downgraded by 2 due to selection bias: unclear as the sequence generation is unspecified as well as concealment of allocation is unspecified; Performance bias: the study is reported to be double-blind but it is also said that ‘as patients receiving placebo would be expected to continue drooling chronically, caregivers of this group were encouraged to keep patients in the study until at least the end of 4-week titration period’; Attrition bias: safety and efficacy populations are different (2 participants not included in the efficacy analysis); Detection bias: study reported to be double-blind but lack of information on this.
- 4
evidence was downgraded by 2 due to selection bias: unclear risk as no information provided on the sequence generation process, nor on the allocation concealment; Performance and Detection bias: unclear risk, as the study is reported to be “double-blind” but unclear if all staff involved in taking outcome measures were blinded to intervention; Attrition bias: high risk as 7 children were eliminated from the study but no details were given regarding the point at which they were excluded. Three patients developed side effects to drug and were excluded on that basis. No data provided for these participants.. It was not possible to calculate imprecision due to lack of information reported (the study doesn’t report SD).
- 5
population considered in the study: children with CP and other neurological disorders (study hasn’t been downgraded for Indirectness).
- 6
study was carried out in a school setting.
- 7
evidence was downgraded by 1 due to serious imprecision as 95% CI crossed one default MID.
- 8
evidence was downgraded by 2 due to very serious imprecision as 95% CI crossed two default MID.
Table 19GRADE profile for comparison of Behaviour therapy and usual care for drooling
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Behavioural therapy | Usual care | Relative (95% CI) | Absolute | ||
| Frequency of drooling (measured with: Each drooling episode over a period of 20 minute was recorded.; Better indicated by lower values) | ||||||||||||
| 1 (Sethy 2011) | randomised trials | serious1 | NA | no serious indirectness | no serious imprecision | none | N=12 Mean(SD)=5.67(3.17) | N=13 Mean(SD)=21.38(2.60) | - | MD=15.71 lower (−17.99 to −13.43) | MODERATE | CRITICAL |
| Health-related quality of life - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | CRITICAL | |
| Psychological wellbeing - not reported | ||||||||||||
| 0 | - | - | - | - | - | none | - | - | - | - | IMPORTANT | |
MD mean difference; NA not applicable; NC not calculable; NR non reported; p-value; SD standard deviation.
- 1
evidence was downgraded by 1 due to selection bias: low risk; Performance bias: patients and carers are not blind to study allocation; Attrition bias: low risk; Detection bias: low risk.
Table 20GRADE Profile for Botulinum versus surgery
| Quality assessment | No of patients = 19 | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Pre- | Post- | Relative (95% CI) | Absolute | ||
| Drooling quotient after botulinum (follow-up 8 weeks; measured with: the percentage of time a person drools and was measured by a speech and language therapist; Better indicated by lower values) | ||||||||||||
| 1 (Scheffer 2010) | observational studies | Very serious1 | NA | no serious indirectness | no serious imprecision | none | - | - | - | MD 11.8 lower (2.6 to 21.0 higher) | VERY LOW | CRITICAL |
| Drooling quotient after botulinum (follow-up 32 weeks; measured with: the percentage of time a person drools and was measured by a speech and language therapist; Better indicated by lower values) | ||||||||||||
| 1 (Scheffer 2010) | observational studies | Very serious1 | NA | no serious indirectness | serious2 | none | - | - | - | MD 7.5 lower (0.1 to 14.8 higher) | VERY LOW | CRITICAL |
| Drooling quotient after surgery (follow-up 8 weeks; measured with: the percentage of time a person drools and was measured by a speech and language therapist; Better indicated by lower values) | ||||||||||||
| 1 (Scheffer 2010) | observational studies | Very serious1 | NA | no serious indirectness | no serious imprecision | none | - | - | - | MD 18.0 lower (10.5 to 25.6 higher) | VERY LOW | CRITICAL |
| Drooling quotient after surgery (follow-up 32 weeks; measured with: the percentage of time a person drools and was measured by a speech and language therapist; Better indicated by lower values) | ||||||||||||
| 1 (Scheffer 2010) | observational studies | Very serious1 | NA | no serious indirectness | no serious imprecision | none | - | - | - | MD 23.4 lower (14.2 to 32.6 higher) | VERY LOW | CRITICAL |
MD mean difference; NA not applicable; NC not calculable; NR non reported; P p-value; SD standard deviation.
- 1
evidence was downgraded by 2 due to selection bias: only children who initially underwent botulinum treatment were selected for surgical treatment; attrition bias: n=3, n=2, and n=5 observations lost at follow-up; Confounding was not reported; small sample size. In addition, the authors state that a 6 months ‘at least’ washout period was observed in order to avoid a carry-over effect, however with 6 months there is an overlap between the two interventions of 2 months (therefore a carry-over effect is possible from BoNT-A to surgery).
- 2
evidence was downgraded by 1 due to serious imprecision as 95% CI crossed one default MID.
Table 21GRADE profile for transdermal hyoscine hydrobromide compared to glycopyrrolate
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Transdermal hyoscine hydrobromide | glycopyrrolate | Relative (95% CI) | Absolute | ||
| Reduction of frequency and severity of drooling (follow-up 4 weeks; measured with: Drooling impact score (DIS); range of scores: 0-100; Better indicated by lower values) | ||||||||||||
| 1 (Parr 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 41 | 29 | - | MD 6.80 higher (1.05 lower to 14.65 higher) | LOW | CRITICAL |
| reduction of frequency and severity of drooling (follow-up 12 weeks; measured with: DIS; range of scores: 0-100; Better indicated by lower values) | ||||||||||||
| 1 (Parr 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 38 | 33 | - | MD 7.20 higher (1.36 lower to 15.76 higher) | LOW | CRITICAL |
| reduction of frequency and severity of drooling (follow-up 4 weeks; measured with: DSFS; Better indicated by lower values) | ||||||||||||
| 1 (Parr 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious3 | none | 0 | - | - | MD 0.4 higher (0 to 0 higher) | LOW | CRITICAL |
| reduction of frequency and severity of drooling (Copy) (follow-up 12 weeks; measured with: DSFS; Better indicated by lower values) | ||||||||||||
| 1 (Parr 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious3 | none | 0 | - | - | MD 0 higher (0 to 0 higher) | LOW | CRITICAL |
| adverse effect - constipation | ||||||||||||
| 1 (Parr 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 5/47 (10.6%) | 12/38 (31.6%) | RR 0.33 (0.1301 to 0.8725) | 212 fewer per 1000 (from 40 fewer to 275 fewer) | LOW | CRITICAL |
| 0% | - | |||||||||||
- 1
evidence was downgraded by 1 due to high risk of performance bias (participants, families, and trial clinicians not blind to treatment allocation).
- 2
evidence was downgraded by 1 due to serious imprecision as the 95% CI crossed one MID.
- 3
imprecision could not be calculated due to lack of information reported. Evidence downgraded by 1.
H.15. Risk factors for low bone mineral density
Not applicable for this review
H.16. Prevention of reduced bone mineral density
Table 11GRADE profile for increased time spent on standing frame versus usual time
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Increased time spent on standing frame | Usual time on standing frame | Relative (95% CI) | Absolute | ||
| Change in the vertebral vTBMD (follow-up 9 months; measured with: DEXA scan (mg/cm3); Better indicated by higher values) | ||||||||||||
| 1 (Caulton 2004) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 13 | 13 | - | mean 8.91 higher (2.4 to 15.41 higher) | LOW | CRITICAL |
| Change in the proximal tibial TBMD (follow-up 9 months; measured with: DEXA scan (mg/cm3); Better indicated by higher values) | ||||||||||||
| 1 (Caulton 2004) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 13 | 13 | - | mean 0.85 lower (16.83 lower to 15.13 higher) | MODERATE | CRITICAL |
- 1
evidence was downgraded by 1 due to lack of blinding.
- 2
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
Table 12GRADE profile for whole-body vibration versus usual physiotherapy
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Whole-body vibration + usual physiotherapy | Usual physiotherapy | Relative (95% CI) | Absolute | ||
| Lumbar spine areal BMD (mg/cm3) (follow-up 6 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Ruck 2010) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Median (IQ range) = 0.013 (0.005 to 0.022) | Median (IQ range) = 0.010 (0.001 to 0.055) | - | P value = 0.89 | LOW | CRITICAL |
| Distal femur region 1 areal BMD (mg/cm3) (follow-up 6 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Ruck 2010) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Median (IQ range) = 0.032 (0.003 to 0.099) | Median (IQ range) = −0.046 (−0.107 to 0.003) | - | P value = 0.11 | LOW | CRITICAL |
| Distal femur region 2 (mg/cm3) (follow-up 6 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Ruck 2010) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Median (IQ range) = −0.002 (−0.041 to 0.024) | Median (IQ range) = 0.020 (−0.107 to 0.042) | - | P value = 0.41 | LOW | CRITICAL |
| Distal femur region 3 areal BMD (mg/cm3) (follow-up 6 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Ruck 2010) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Median (IQ range) = −0.026 (−0.076 to −0.015) | Median (IQ range) = 0.034 (−0.019 to 0.041) | - | P value = 0.03 | LOW | CRITICAL |
- 1
evidence was downgraded by 1 due to high performance bias.
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded by 1.
Table 13GRADE profile for home-based virtual cycling versus usual physical activity
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Home-based virtual cycling training | Usual and general physical activity at home | Relative (95% CI) | Absolute | ||
| Lumbar areal BMD (g/cm3) (follow-up 12 weeks; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Chen 2013) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Mean±SD = 0.583±0.136 | Mean±SD = 0.583±0.140 | - | P value = 0.357 | VERY LOW | CRITICAL |
| Femur areal BMD (g/cm3) (follow-up 12 weeks; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Chen 2013) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Mean±SD = 0.744±0.097 | Mean±SD = 0.73±0.124 | - | P value = 0.022 | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 2 due to high selection bias and high performance bias.
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded.
Table 14GRADE profile for physical activity program versus usual life style habits
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Physical activity program (weight bearing) | Usual life style habits | Relative (95% CI) | Absolute | ||
| % change in proximal femur BMC (g) (follow-up 8 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Chad 1999) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 11.5% | 3.5% | - | P = 0.08 | VERY LOW | CRITICAL |
| % change in femural neck BMC (g) (follow-up 8 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Chad 1999) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 9.6% | -5.8% | - | P = 0.03 | VERY LOW | CRITICAL |
| % change in femoral neck vBMD (g/cm3) (follow-up 8 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Chad 1999) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 5.6% | -6.3% | - | P = 0.02 | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 2 due to high selection bias and high performance bias.
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded.
Table 15GRADE profile for vitamin D only versus vitamin D + biphosphonates
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Vitamin D | Vitamin D + biphosphonates | Relative (95% CI) | Absolute | ||
| BMD pre versus post treatment in Monotherapy group (follow-up 6 months; measured with: DEXA scans; Better indicated by higher values) | ||||||||||||
| 1 (Iwasaki 2008) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | - | - | - | P value = 0.003 | VERY LOW | CRITICAL |
| BMD pre versus post treatment in Polytherapy group (follow-up 6 months; measured with: DEXA scans; Better indicated by higher values) | ||||||||||||
| 1 (Iwasaki 2008) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | - | - | - | P value = 0.0035 | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 2 due to high selection bias and high detection bias.
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded by 1.
Table 16GRADE profile for calcium + vitamin D versus observation only
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Pre-treatment | Post-treatment | Relative (95% CI) | Absolute | ||
| BMD in intervention group, g/cm2 (follow-up 9 months; measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Jekovec-Vrhovsek 2000) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Mean±SD = 0.383±0.175 | Mean±SD = 0.476±0.199 | - | P <0.001 | VERY LOW | CRITICAL |
| BMD in control group, g/cm2 (follow-up 9 months; measured with: DEXA scan; Better indicated by lower values) | ||||||||||||
| 1 (Jekovec-Vrhovsek 2000) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Mean±SD = 0.393±0.077 | Mean±SD = 0.315±0.109 | - | P value = 0.013 | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 2 due to moderate selection bias, weak study design, confounders not included in analysis, no blinding.
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded by 1.
Table 17GRADE profile for pamidronate versus placebo
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Biphosphonates | Placebo | Relative (95% CI) | Absolute | ||
| % change in distal femur region 1 (follow-up 1 years; measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Henderson 2002) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 7 | 7 | - | MD 80.0 higher (37.19 to 122.28 higher) | LOW | |
| % change in distal femur region 2 (follow-up 1 years; measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Henderson 2002) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 7 | 7 | - | MD 27.0 higher (8.93 to 45.07 higher) | LOW | CRITICAL |
| % change in distal femur region 3 (follow-up 1 years; measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Henderson 2002) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 7 | 6 | - | MD 12.0 higher (1.85 lower to 25.85 higher) | LOW | CRITICAL |
| % change in lumbar spine (follow-up 1 years; measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Henderson 2002) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 7 | 7 | - | MD 18.0 higher (6.57 to 29.42 higher) | LOW | CRITICAL |
- 1
evidence was downgraded by 1 due to high selection bias.
- 2
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
Table 18GRADE profile for gastrostomy pre- and after intervention
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Pre-intervention | Post-intervention | Relative (95% CI) | Absolute | ||
| BMC, g (measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Arrowsmith 2010) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Median (IQ range) = 469 (374 to 632) | Median (IQ range) = 626 (509 to 736) | - | P<0.05 | VERY LOW | CRITICAL |
| BMC for age, SDS (measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Arroswmith 2010) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Median (IQ range) = −2.3 (−3.3 to −1.7) | Median (IQ range) = −2.5 (−3.6 to −1.7) | - | P ns | VERY LOW | |
| BMC for height SDS (measured with: DEXA scan; Better indicated by higher values) | ||||||||||||
| 1 (Arroswmith 2010) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | Median (IQ range) = −0.6 (−1.0 to −0.1) | Median (IQ range) = −1.1 (−1.5 to −0.3) | - | P ns | VERY LOW | |
- 1
evidence was downgraded by 2 due to weak selection bias, weak study design, confounders not fully assessed in analysis, no blinding.
- 2
imprecision could not be calculated due to lack of information reported in the paper. Study has been downgraded by 1.
H.17. Causes of pain, distress, discomfort and sleep disturbance
Not applicable for this review
H.18. Assessment of pain, distress, discomfort and sleep disturbances
Not applicable for this review
H.19. Management of pain, distress and discomfort
Not applicable for this review
H.20. Management of sleep disturbances
Table 22GRADE profile for clinical evidence profile: sleep positioning systems
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Sleep positioning systems | No sleep positioning systems | Relative (95% CI) | Absolute | ||
| Sleep latency (measured with: the time it took the child to fall asleep once put to bed (minutes); Better indicated by lower values) | ||||||||||||
| 1 | randomised trials | no serious risk of bias | very serious1 | no serious indirectness | serious2,3 | none | 21 | 21 | Limited data. A small number of established users of sleep positioning systems showed no significant difference in sleep quality indicators. | not pooled | VERY LOW | CRITICAL |
| Sleep efficiency (measured with: % of time in bed actually asleep; Better indicated by lower values) | ||||||||||||
| 1 | randomised trials | no serious risk of bias | very serious1 | no serious indirectness | serious3 | none | 21 | 21 | Limited data. A small number of established users of sleep positioning systems showed no significant difference in sleep quality indicators. | not pooled | VERY LOW | CRITICAL |
- 1
authors state that meta-analysis was not performed due to heterogeneity between the included studies given differences in measurement tools, experimental location, choice of metric, age of participants, type of motor disorder, position adopted in sleep positioning system, history of seizures, GMFCS level, and type of sleep positioning system used. Evidence was downgraded by 2 given high heterogeneity and because a ransom effect model was rejected given the small sample sizes and number of studies.
- 2
Not calculable.
- 3
although no pooled estimate was presented, 95% CI of the single estimates in the studies are very wide. Given the small sample sizes involved, it is likely that meta-analysis would have still not reduced the wide range in confidence intervals.
Table 23GRADE profile for clinical evidence profile: melatonin versus placebo
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Melatonin | Placebo | Relative (95% CI) | Absolute | ||
| total night time sleep (measured with: sleep diaries; Better indicated by higher values) | ||||||||||||
| 4 (Coppola 2004; Dodge 2001; Wasdell 2008; Appleton 2012) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | none | 146 | 154 | - | MD 30.01 higher (12.29 to 47.72 higher) | HIGH | CRITICAL |
| total night time sleep (measured with: actigraphy; Better indicated by higher values) | ||||||||||||
| 2 (Wasdell 2008; Appleton 2012); | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 80 | 79 | - | MD 14.51 higher (7.69 lower to 36.72 higher) | MODERATE | CRITICAL |
| sleep latency (measured with: sleep diaries; Better indicated by lower values) | ||||||||||||
| 4 (Coppola 2004; Dodge 2001; Wasdell 2008; Appleton 2012) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 146 | 151 | - | MD 32.73 lower (43.37 to 22.09 lower) | MODERATE | CRITICAL |
| sleep latency (measured with: actigraphy; Better indicated by lower values) | ||||||||||||
| 2 (Wasdell 2008; Appleton 2012); | randomised trials | no serious risk of bias | serious2 | no serious indirectness | serious1 | none | 74 | 75 | - | MD 29.91 lower (42.16 to 17.66 lower) | LOW | CRITICAL |
| night wakes (measured with: sleep diaries; Better indicated by lower values) | ||||||||||||
| 3 (Coppola 2004; Dodge 2001; Wasdell 2008; Appleton 2012) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | none | 95 | 95 | - | MD 0.01 higher (0.28 lower to 0.3 higher) | HIGH | CRITICAL |
| night wakes (measured with: actigraphy; Better indicated by lower values) | ||||||||||||
| 1 (Wasdell 2008) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 50 | 50 | - | MD 0.45 higher (1.56 lower to 2.46 higher) | MODERATE | CRITICAL |
| night wakes (measured with: CSDI score; range of scores: 0-12; Better indicated by lower values) | ||||||||||||
| 1 (Appleton 2012) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 60 | 65 | - | MD 1.00 lower (1.83 to 0.16 lower) | MODERATE | CRITICAL |
| quality of life of the parent (measured with: Family Impact Module of the PedsQL; range of scores: 0-100; Better indicated by lower values) | ||||||||||||
| 1 (Appleton 2012) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | none | 64 | 69 | - | MD 3.57 higher (0.86 lower to 8 higher) | HIGH | IMPORTANT |
- 1
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
- 2
evidence was downgraded by 1 due to serious heterogeneity (chi-squared p<0.1, I-squared inconsistency statistic of 50%-74.99%) and no plausible explanation was found with sensitivity or subgroup analysis
H.21. Assessment of mental health problems
Not applicable for this review
H.22. Management of mental health problems
Table 24GRADE profile for SSTP compared to WL for mental health problems in cerebral palsy
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | SSTP | WL | Relative (95% CI) | Absolute | ||
| ECBI intensity (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 15.43 higher (0.78 to 30.08 higher) | LOW | CRITICAL |
| ECBI problem (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 6.04 higher (2.20 to 9.89 higher) | LOW | CRITICAL |
| SDQ emotional symptoms (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 1.33 higher (0.45 to 2.21 higher) | LOW | CRITICAL |
| SDQ conduct problems (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 0.85 higher (0.23 lower to 1.72 higher) | LOW | CRITICAL |
| SDQ hyperactivity (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 0.73 higher (0.40 lower to 1.86 higher) | LOW | CRITICAL |
| SDQ peer problems (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 0.77 higher (0.10 lower to 1.65 higher) | LOW | CRITICAL |
| SDQ prosocial (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 0.44 lower (1.68 lower to 0.78 higher) | LOW | CRITICAL |
| SDQ impact (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 20 | 22 | - | MD 0.67 higher (1.14 lower to 2.50 higher) | LOW | CRITICAL |
SDQ Strengths and Difficulties Questionnaire; ECBI Eyberg Child Behaviour Inventory; WL waiting list; SSTP Stepping Stones Triple P; ACT parent Acceptance and Commitment Therapy; MD mean difference; NC not calculable due to data reporting not allowing for calculation of MIDs.
- 1
evidence was downgraded by 1 dues to unclear blinding of participants and investigators
- 2
majority of evidence has only 1 indirect aspect of PICO (intervention not clearly specified in the protocol)
Table 25GRADE profile for SSTP + ACT versus WL for mental health problems in cerebral palsy
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | SSTP + ACT | WL | Relative (95% CI) | Absolute | ||
| DASS depression (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 5.33 higher (0 to 0 higher) | LOW | CRITICAL |
| DASS stress (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 5.50 higher (0 to 0 higher) | LOW | CRITICAL |
| CP-QOL acceptance (Better indicated by lower values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 9.01 lower (0 to 0 higher) | LOW | CRITICAL |
| CP-QOL functioning (Better indicated by lower values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 8.72 lower (0 to 0 higher) | LOW | CRITICAL |
| ECBI intensity (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 24.12 higher (10.22 to 38.03 higher) | LOW | CRITICAL |
| ECBI problem (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 8.30 higher (4.63 to 11.97 higher) | LOW | CRITICAL |
| SDQ emotional symptoms (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 0.37 higher (0.46 lower to 1.21 higher) | LOW | CRITICAL |
| SDQ conduct problems (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 0.43 higher (0.41 lower to 1.26 higher) | LOW | CRITICAL |
| SDQ hyperactivity (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 1.66 higher (0.55 to 2.77 higher) | LOW | CRITICAL |
| SDQ peer problems (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 0.64 higher (0.18 lower to 1.46 higher) | LOW | CRITICAL |
| SDQ prosocial (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 0.16 lower (1.33 lower to 0.78 higher) | LOW | CRITICAL |
| SDQ impact (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 22 | - | MD 1.00 higher (0.66 lower to 2.67 higher) | LOW | CRITICAL |
SDQ Strengths and Difficulties Questionnaire; ECBI Eyberg Child Behaviour Inventory; WL waiting list; SSTP Stepping Stones Triple P; ACT parent Acceptance and Commitment Therapy; MD mean difference; NC not calculable due to data reporting not allowing for calculation of MIDs..
- 1
evidence was downgraded by 1 dues to unclear blinding of participants and investigators
- 2
majority of evidence has only 1 indirect aspect of PICO (intervention not clearly specified in the protocol)
Table 26GRADE profile for SSTP + ACT compared to SSTP only for mental health problems in cerebral palsy
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | SSTP + ACT | SSTP only | Relative (95% CI) | Absolute | ||
| ECBI intensity (Better indicated by lower values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 8.69 higher (5.65 lower to 23.04 higher) | LOW | CRITICAL |
| ECBI problem (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 2.26 higher (1.61 lower to 6.12 higher) | LOW | CRITICAL |
| SDQ emotional symptoms (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 0.95 lower (1.81 to 0.09 lower) | LOW | CRITICAL |
| SDQ conduct problems (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 0.42 lower (1.28 lower to 0.44 higher) | LOW | CRITICAL |
| SDQ hyperactivity (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 0.93 higher (0.17 lower to 2.04 higher) | LOW | CRITICAL |
| SDQ peer problems (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 0.13 lower (0.98 lower to 0.61 higher) | LOW | CRITICAL |
| SDQ prosocial (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 0.29 higher (0.91 lower to 1.49 higher) | LOW | CRITICAL |
| SDQ impact (Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | NC | none | 23 | 20 | - | MD 0.33 higher (1.42 lower to 2.07 higher) | LOW | CRITICAL |
SDQ Strengths and Difficulties Questionnaire; ECBI Eyberg Child Behaviour Inventory; WL waiting list; SSTP Stepping Stones Triple P; ACT parent Acceptance and Commitment Therapy; MD mean difference; NC not calculable due to data reporting not allowing for calculation of MIDs..
- 1
evidence was downgraded by 1 dues to unclear blinding of participants and investigators
- 2
majority of evidence has only 1 indirect aspect of PICO (intervention not clearly specified in the protocol)
Table 27GRADE profile for SSTP + ACT compared to SSTP only at 6 months follow up for mental health problems in cerebral palsy
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | SSTP + ACT | SSTP only | Relative (95% CI) | Absolute | ||
| ECBI intensity (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | serious3 | none | 12 | 16 | - | MD 15.3 lower (36.74 lower to 6.14 higher) | VERY LOW | CRITICAL |
| ECBI problem (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | serious1 | no serious indirectness | serious2 | none | 12 | 16 | - | MD 2.61 lower (7.32 lower to 2.1 higher) | VERY LOW | CRITICAL |
| SDQ emotional symptoms (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | very serious4 | none | 12 | 16 | - | MD 0.08 higher (1.04 lower to 1.2 higher) | VERY LOW | CRITICAL |
| SDQ conduct problems (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | serious3 | none | 12 | 16 | - | MD 0.31 higher (0.46 lower to 1.08 higher) | VERY LOW | CRITICAL |
| SDQ hyperactivity (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | serious3 | none | 12 | 16 | - | MD 0.36 lower (2.17 lower to 1.45 higher) | VERY LOW | CRITICAL |
| SDQ peer problems (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | serious3 | none | 12 | 16 | - | MD 0.78 lower (2.14 lower to 0.58 higher) | VERY LOW | CRITICAL |
| SDQ prosocial (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | very serious4 | none | 12 | 16 | - | MD 0.26 lower (2.26 lower to 1.74 higher) | VERY LOW | CRITICAL |
| SDQ impact (follow-up 6 months; Better indicated by higher values) | ||||||||||||
| 1 (Whittingham 2014) | randomised trials | serious1 | no serious inconsistency | serious2 | serious3 | none | 12 | 16 | - | MD 0.67 lower (1.67 lower to 0.33 higher) | VERY LOW | CRITICAL |
SDQ Strengths and Difficulties Questionnaire; ECBI Eyberg Child Behaviour Inventory; WL waiting list; SSTP Stepping Stones Triple P; ACT parent Acceptance and Commitment Therapy; MD mean difference; NC not calculable.
- 1
evidence was downgraded by 1 dues to unclear blinding of participants and investigators
- 2
majority of evidence has only 1 indirect aspect of PICO (intervention not clearly specified in the protocol)
- 3
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
- 4
evidence was downgraded by 2 due to very serious imprecision as 95%CI crossed two default MIDs
H.23. Management of sensory and perceptual difficulties
Table 28GRADE profile for sensory-perceptual motor training vs home-based programme
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Sensory-perceptual motor training | Home-based programme | Relative (95% CI) | Absolute | ||
| Individual versus group - double tactile stimuli perception DTS (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 1 lower (2.99 lower to 0.99 higher) | VERY LOW | CRITICAL |
| Individual versus group - localization of tactile stimuli LTS (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 1.29 higher (2.49 lower to 5.07 higher) | VERY LOW | CRITICAL |
| Individual versus group - graphestesia GRA (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 16 | 16 | - | MD 0.25 lower (1.49 lower to 0.99 higher) | VERY LOW | CRITICAL |
| Individual versus group - kinaesthesia KIN (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 11.68 lower (20.51 to 2.85 lower) | VERY LOW | CRITICAL |
| Individual versus group - finger identification FI (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 1.44 higher (0.42 lower to 3.3 higher) | VERY LOW | CRITICAL |
| Individual versus group - manual form perception MFP (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 16 | 16 | - | MD 0.06 higher (0.3 lower to 0.42 higher) | VERY LOW | CRITICAL |
| Individual versus group - design copying DC (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 16 | 16 | - | MD 0.06 higher (1.27 lower to 1.39 higher) | VERY LOW | CRITICAL |
| Individual versus group - position in space PS (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 0.38 higher (1.16 lower to 1.92 higher) | VERY LOW | CRITICAL |
| Individual versus group - imitation of posture IP (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 0.62 higher (0.62 lower to 1.86 higher) | VERY LOW | CRITICAL |
| Individual versus group - motor accuracy MAC (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 4.48 lower (15.77 lower to 6.81 higher) | VERY LOW | CRITICAL |
| Individual versus group - right-left discrimination RLD (measured with: The Ayres Southern California Sensory Integration Test (SCSIT); Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 16 | 16 | - | MD 1.25 lower (3.14 lower to 0.64 higher) | VERY LOW | CRITICAL |
| Individual versus group - physical activity test PA (Better indicated by lower values) | ||||||||||||
| 1 (Bumin 2001) | observational studies | very serious1 | no serious inconsistency | no serious indirectness | very serious3 | none | 16 | 16 | - | MD 7.31 lower (19.34 lower to 4.72 higher) | VERY LOW | CRITICAL |
- 1
evidence was downgraded by 2 due to moderate selection bias, weak study design, unclear blinding, weak data collection methods, moderate attrition bias, unclear intervention integrity.
- 2
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
- 3
evidence was downgraded by 2 due to very serious imprecision as 95%CI crossed two default MIDs
Table 29GRADE profile for child-focused vs context-focused approach
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Child-focused | context-focused approach | Relative (95% CI) | Absolute | ||
| paediatric evaluation of disability inventory (PEDI) - Self-care (functional skill scale) at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 71 | 57 | - | MD 2.49 higher (3.25 lower to 8.23 higher) | LOW | CRITICAL |
| paediatric evaluation of disability inventory (PEDI) - Self-care (functional skill scale) at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 71 | 57 | - | MD 0.11 higher (6.22 lower to 6.44 higher) | MODERATE | CRITICAL |
| paediatric evaluation of disability inventory (PEDI) - Self-care (caregiver assistance scale) at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.58 lower (9.2 lower to 8.04 higher) | MODERATE | CRITICAL |
| paediatric evaluation of disability inventory (PEDI) - Self-care (caregiver assistance scale) at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 1.28 higher (7.78 lower to 10.34 higher) | MODERATE | CRITICAL |
| paediatric evaluation of disability inventory (PEDI) - Mobility (functional skill scale) at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 1.17 higher (7.27 lower to 9.61 higher) | MODERATE | CRITICAL |
| paediatric evaluation of disability inventory (PEDI) - Mobility (functional skill scale) at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 1.52 higher (7.26 lower to 10.3 higher) | MODERATE | CRITICAL |
| paediatric evaluation of disability inventory (PEDI) - Mobility (caregiver assistance scale) at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.42 higher (9.64 lower to 10.48 higher) | MODERATE | CRITICAL |
| paediatric evaluation of disability inventory (PEDI) - Mobility (caregiver assistance scale) at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 3.18 higher (7.25 lower to 13.61 higher) | MODERATE | CRITICAL |
| Gross Motor Function Measure (GMFM) (Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 1.44 lower (16.63 lower to 13.75 higher) | MODERATE | CRITICAL |
| Gross Motor Function Measure (GMFM) - at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 71 | 57 | - | MD 2.73 higher (2.33 lower to 7.79 higher) | LOW | CRITICAL |
| family empowerment scale (FES) - at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 71 | 57 | - | MD 0.07 higher (0.1 lower to 0.24 higher) | LOW | CRITICAL |
| family empowerment scale (FES) - at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 71 | 57 | - | MD 0.15 higher (0.01 lower to 0.31 higher) | LOW | CRITICAL |
| assessment of preschool children’s participation - ACPC play at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.08 higher (0.45 lower to 0.61 higher) | MODERATE | CRITICAL |
| assessment of preschool children’s participation - ACPC play at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.18 lower (0.7 lower to 0.34 higher) | MODERATE | CRITICAL |
| assessment of preschool children’s participation - ACPC skill development at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.05 lower (0.45 lower to 0.35 higher) | MODERATE | CRITICAL |
| assessment of preschool children’s participation - ACPC skill development at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.02 higher (0.36 lower to 0.4 higher) | MODERATE | CRITICAL |
| assessment of preschool children’s participation - ACPC social activities at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0 higher (0.36 lower to 0.36 higher) | MODERATE | CRITICAL |
| assessment of preschool children’s participation - ACPC social activities at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.02 higher (0.33 lower to 0.37 higher) | MODERATE | CRITICAL |
| assessment of preschool children’s participation - ACPC active physical activities at 6 mo (follow-up 6 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.07 higher (0.35 lower to 0.49 higher) | MODERATE | CRITICAL |
| assessment of preschool children’s participation - ACPC active physical activities at 9 mo (follow-up 9 months; Better indicated by lower values) | ||||||||||||
| 1 (Law 2011) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none | 71 | 57 | - | MD 0.09 higher (0.39 lower to 0.57 higher) | MODERATE | CRITICAL |
- 1
evidence was downgraded by 1 due to high level of performance bias and moderate level of detection bias.
- 2
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
Table 30GRADE profile for web-based multimodal therapy vs standard care
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Web-based multimodal therapy | standard care | Relative (95% CI) | Absolute | ||
| Assessment of Motor and Process Skills (AMPS) - motor skills (follow-up 3 months; Better indicated by lower values) | ||||||||||||
| 1 (James 2015) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 51 | 51 | - | MD 0.27 higher (0.02 to 0.52 higher) | LOW | CRITICAL |
| Assessment of Motor and Process Skills (AMPS) - processing skills (follow-up 3 months; Better indicated by lower values) | ||||||||||||
| 1 (James 2015) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 51 | 51 | - | MD 0.31 higher (0.14 to 0.48 higher) | LOW | CRITICAL |
| Canadian Occupational Performance Measure (COPM) (follow-up 3 months; Better indicated by lower values) | ||||||||||||
| 1 (James 2015) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 51 | 51 | - | MD 1.28 higher (0.68 to 1.88 higher) | LOW | CRITICAL |
| Test of Visual Perceptual Skill (non-motor) 3rd edition (TVPS-3) (follow-up 3 months; Better indicated by lower values) | ||||||||||||
| 1 (James 2015) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 51 | 51 | - | MD 8.83 higher (1.83 to 15.83 higher) | LOW | CRITICAL |
- 1
evidence was downgraded by 1 due to unclear/unknown performance bias and detection bias.
- 2
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
Table 31GRADE profile for hand-arm intensive manual therapy vs hand-arm intensive manual therapy + tactile training
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Hand-arm intensive manual therapy | hand-arm intensive manual therapy + tactile training | Relative (95% CI) | Absolute | ||
| Grating Orientation Task (GOT) (Better indicated by lower values) | ||||||||||||
| 1 (Kuo 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 10 | 10 | - | MD 0.46 higher (0.06 to 0.86 higher) | LOW | CRITICAL |
| Sterognosis (Better indicated by lower values) | ||||||||||||
| 1 (Kuo 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 10 | 10 | - | MD 1.17 lower (2.41 lower to 0.07 higher) | LOW | CRITICAL |
| Two-point discrimination thumb, mm (TPD) (Better indicated by lower values) | ||||||||||||
| 1 (Kuo 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 10 | 10 | - | MD 0.03 higher (0.04 lower to 0.1 higher) | LOW | CRITICAL |
| Semmes-Weinstein monofilaments (SWM) (Better indicated by lower values) | ||||||||||||
| 1 (Kuo 2016) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | serious2 | none | 10 | 10 | - | MD 1.1 lower (2.98 lower to 0.78 higher) | LOW | CRITICAL |
- 1
evidence was downgraded by 1 due to unclear/unknown performance bias, attrition bias, and detection bias.
- 2
evidence was downgraded by 1 due to serious imprecision as 95%CI crossed one default MID
H.24. Other comorbidities in cerebral palsy
Not applicable for this review
H.25. Social care needs
Not applicable for this review
H.26. Transition to adult services
Not applicable for this review
- Risk factors
- Causes of cerebral palsy
- Clinical and developmental manifestations of cerebral palsy
- Red flags for other neurological disorders
- MRI and identification of causes of cerebral palsy
- MRI and prognosis of cerebral pasly
- Prognosis for walking, talking and life expectancy
- Information and support
- Assessment of eating, drinking and swallowing difficulties
- Management of eating, drinking and swallowing difficulties
- Optimising nutritional status
- Improving speech, language and communication: Speech intelligibility
- Improving speech, language and communication: Communication systems
- Managing saliva control
- Risk factors for low bone mineral density
- Prevention of reduced bone mineral density
- Causes of pain, distress, discomfort and sleep disturbance
- Assessment of pain, distress, discomfort and sleep disturbances
- Management of pain, distress and discomfort
- Management of sleep disturbances
- Assessment of mental health problems
- Management of mental health problems
- Management of sensory and perceptual difficulties
- Other comorbidities in cerebral palsy
- Social care needs
- Transition to adult services
- GRADE Tables - Cerebral palsy in under 25s: assessment and managementGRADE Tables - Cerebral palsy in under 25s: assessment and management
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