Neurochirurgische behandeling SB
- Welke neurochirurgische behandeling is bij kinderen met SB geïndiceerd om het lopen te verbeteren of zoveel mogelijk te behouden?
Het onderwerp 'Neurochirurgische behandeling SB' wordt uitgewerkt in verschillende modules. Specifieke aanbevelingen en onderbouwing kunt u vinden in deze (sub)modules.
Onderbouwing
Referenties
- Mokkink, L. B., Terwee, C.B., Patrick, D.L., Alonso, J., Stratford, P.W., Knol, D.L. & de Vet, H.C.W. (2010). The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. . Qual Life Res, 19, 539-549.
- Adviescommissie Richtlijnen (2011). Medisch-specialistische richtlijnen 2.0. . Utrecht: Orde van Medisch Specialisten., 1, 1-.
- Adzick, N.S., Thom, E.A., Spong, C.Y., Brock, J.W. 3rd, Burrows, P.K., Johnson, M.P. (2011). A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med, 364, 993-1004.
- Alman, B.A., Bhandari, M., Wright, J.G. (1996). Function of dislocated hips in children with lower level spina bifida. J Bone Joint Surg Br, 78, 294-8.
- Banit, D.M., Iwinski, H.J. Jr, Talwalkar, V., Johnson, M. (2001). Posterior spinal fusion in paralytic scoliosis and myelomeningocele. J Pediatr Orthop, 21, 117-125.
- Banta, J.V., Park, S.M. (1983). Improvement in pulmonary function in patients having combined anterior and posterior spine fusion for myelomeningocele scoliosis. Spine (Phila Pa 1976), 8, 765-770.
- Bazih, J., Gross, R.H. (1981). Hip surgery in the lumbar level myelomeningocele patient. J Pediatr Orthop, 1, 405-11.
- Bowman, R.M., Mohan, A., Ito J., Seibly, J.M., McLone, D.G. (2009). Tethered cord release: a long-term study in 114 patients. J Neurosurg Pediatr, 3, 181-7.
- Carstens, C., Paul, K., Niethard, F.U., Pfeil, J. (1991). Effect of scoliosis surgery on pulmonary function in patients with myelomeningocele. J Pediatr Orthop, 11, 459-464.
- Cochrane, D.D., Rassekh, S.R., Thiessen, P.N. (1998). Functional deterioration following placode untethering in myelomeningocele. Pediatr Neurosurg, 28, 57-62.
- Danzer, E., Gerdes, M., Bebbington, M.W., Sutton, L.N., Melchionni, J., Adzick, N.S., Johnson, M.P. (2009). Lower extremity neuromotor function and short-term ambulatory potential following in utero myelomeningocele surgery. Fetal Diagn Ther, 25, 47-53.
- Dias, L. (2011). Hip dislocation in spina bifida: when is surgery required and what type of surgery should be performed. Ortop Traumatol Rehabil, 2, 101-3.
- Dunteman, R.C., Vankoski. S.J., & Dias, L,S. (2000). Internal derotation osteotomy of the tibia: pre- and postoperative gait analysis in persons with high sacral myelomenigocele. J Ped Orthop, 20, 623-28.
- Eggink, A. J. (2012). Foetal therapy for spina bifida. Ned Tijdschr Geneeskd, 156, 4924-.
- Frawley, P.A., Broughton, N.S., Menelaus, M.B. (1996). Anterior release for fixed flexion deformity of the hip in spina bifida. J Bone Joint Surg Br, 78, 299-302.
- Gabrieli, A.P., Vankoski, S.J., Dias, L.S., Milani, C., Lourenco, A., Filho, J.L., Novak, R. (2003). Gait analysis in low lumbar myelomeningocele patients with unilateral hip dislocation or subluxation. J Pediatr Orthop, 23, 330-4.
- Georgiadis, G.M., Aronson, D.D. (1990). Posterior transfer of the anterior tibial tendon in children who have a myelomenigocele. J Bone Joint Surg Am, 72, 392-8.
- Heeg, M., Broughton, N.S., Menelaus, M.B. (1998). Bilateral dislocation of the hip in spina bifida: a long-term follow-up study. J Pediatr Orthop, 18, 434-6.
- Herman, J.M., McLone, D.G., Storrs, B.B., Dauser, R.C. (1993). Analysis of 153 patients with myelomeningocele or spinal lipoma reoperated upon for a tethered cord; Presentation management and outcome.. Pediatr Neurosurg, 19, 243-.
- Hoffman, H. J., Taecholarn, C., Hendrick, E. B. (1985). Management of lipomyelomeningoceles; Experience at the Hospital for Sick Children, Toronto. J Neurosurg., 62, 1-8.
- Lorente Molto, F.J., Martínez Garrido, I. (2005). Retrospective review of L3 myelomeningocele in three age groups: should posterolateral iliopsoas transfer still be indicated to stabilize the hip?. J Pediatr Orthop B, 14, 177-84.
- Marshall, P.D., Broughton, N.S., Menelaus, M.B., Graham, H.K. (1996). Surgical release of knee flexion contractures in myelomeningocele. J Bone Joint Surg Br, 78, 912-6.
- Mazur, J., Menelaus, M.B., Dickens, D.R., Doig, W.G. (1986). Efficacy of surgical management for scoliosis in myelomeningocele: correction of deformity and alteration of functional status. J Pediatr Orthop, 6, 568-75.
- Muller, E.B., Nordwall, A., Wendt, L. von (1992). Influence of surgical treatment of scoliosis in children with spina bifida on ambulation and motoric skills. Acta Paediatr, 81, 73-6.
- Osebold, W.R., Mayfield, J.K., Winter, R.B., Moe, J.H. (1982). Surgical treatment of paralytic scoliosis associated with myelomeningocele. J Bone Joint Surg Am, 64, 841-856.
- Parisini, P., Greggi, T., Di Silvestre, M., Giardina, F., Bakaloudis, G. (2002). Surgical treatment of scoliosis in myelomeningocele. Stud Health Technol Inform, 91, 442-447.
- Park, K.B., Park, H.W., Joo, S.Y., Kim, H.W. (2008). Surgical treatment of calcaneal deformity in a select group of patients with myelomenigocele. J Bone Joint Surg Am, 90, 2149-59.
- Schoenmakers, M.A., Gooskens, R.H., Gulmans, V.A., Hanlo, P.W., Vandertop, W.P., Uiterwaal, C.S., Helders, P.J. (2003). Long-term outcome of neurosurgical untethering on neurosegmental motor and ambulation levels. Dev Med Child Neurol, 45, 551-5.
- Stella, G., , Ascani, E., Cervellati, S., Bettini, N., Scarsi, M., Vicini, M., Carbone, M. (1998). Surgical treatment of scoliosis associated with myelomeningocele. . Eur J Pediatr Surg, 8 (1), 22-25.
- Stella, G., Ascani, E., Cervellati, S., Bettini, N., Scarsi, M., Vicini, M., Carbone, M. (1998). Surgical treatment of scoliosis associated with myelomeningocele. Eur J Pediatr Surg, 8 (1), 22-25.
- Stott, N.S., Zionts, L.E., Gronley, J.K., Perry, J. (1996). Tibialis anterior transfer for calcaneal deformity: a postoperative gait analysis. J Pediatr Orthop, 16, 792-8.
- Vankoski, S.J., Michaud, S., Dias, L. (2000). External tibial torsion and the effectiveness of the solid ankle-foot orthoses. Journal of Pediatric Orthopedics, 20 (3), 349-355.
- Wai, K.W., Young. N.L., Feldman. B.M., Badley. E.M., Wright. J.G. (2005). The relationship between function, self-perception and spinal deformity. Implications for treatment of scoliosis in children with spina bifida. J Ped Orthop, 25, 64-9.
- Ward, W.T., Wenger, D.R., Roach, J.W. (1989). Surgical correction of myelomeningocele scoliosis: a critical appraisal of various spinal instrumentation systems. J Pediatr Orthop, 9, 262-268.
Evidence tabellen
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
Study quality |
|
Research question: What are the effects of surgical treatment of gait disorders in children and adolescents with spina bifida? |
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Studies on prenatal surgical treatment |
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Danzer, 2009 |
Type of study: Retrospective study
Country: USA
Source of funding: NIH (National Institute of Health)
|
Inclusion criteria: - Less then 26 weeks of gestation - Confirmed normal karyotype - Absence of associated congenital malformations - Maximum lateral ventricular malformations - Severe Arnold-Chiari II malformation - S1-level lesion or higher - Normal leg movement and absence of talipes deformity.
Exclusion criteria: Not stated
N= 54 (14 eligble patients excluded from fetal surgery due to maternal issues)
Intervention group: Sex: Not stated Gestational age fetal surgery: 23.1 ± 1.4 weeks
Control group: Not applicable
Groups comparable at baseline? Not applicable |
N= 54
Describe intervention: Fetal myelomeningocele (fMMC) closure |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Mean follow-up 45 months (range 30-72 months)
For how many participants were no complete outcome data available?
Detailed neurodevelopmental assessment incompleet in 37%. Other measurements complete.
Control group: Not applicable N (%):%
Reasons for incomplete outcome data described? Not stated
|
Outcome measures and effect size (include 95%CI and p-value if available): Ambulation: 69% walk independently, 24% assisted walkers and 7% wheelchair dependent
Lower Extremity Neuromotor Function: 57.4% better then predicted, 24.1% same as predicted and 18.5% worse as predicted
Predictors of independent walking after fMMC repair: Lower likelihood to walk independent: - Higher-level lesion (>L4, p=0.001) - Development of clubfoot deformity (p=0.026) Not significant associated: - Early fetal intervention (<22 weeks’ gestation) - Higher birth weight - LENF at birth - Need for V-P shunt placement - Improved LENF at birth |
C No control group
Higly selective study population
Young population, results may not reflect long-term LENF and ambulatory status. |
|
Adzick et al. 2011 |
Type of study: Randomized Trial
Country: USA
Source of funding: - Eunice Kennedy Shriver National Institute of Child Health and Human Development - Clinical and Translational Science Awards, National Institutes of Health.
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Inclusion criteria: - Singleton pregnancy - Myelomeningocele with the upper boundary located between T1 and S1 - Evidence of hindbrain herniation - Gestational age of at least 19.0 to 25.9 weeks at randomization - Normal karyotype - U.S. residency - Maternal age of at least 18 years
Exclusion criteria: - Fetal anomaly unrelated to myelomeningocele - Servere kyphosis - Risk of preterm birth (including short cervix and previous preterm birth) - Placental abruption - Body-mass index of 35 or more - Contraindication to surgery (including previous hysterotomy in the active uterine segment)
N= 158
Intervention group: Sex: 55% M/45% F Gestational age at randomization ± SD: 23.6 ± 1.4 weeks
Control group: Sex: 36% M/64% F Gestational age at randomization ± SD: 23.9 ± 1.3 weeks
Groups comparable at baseline? Yes, except fewer female fetuses and lesion level more severe in prenatal-surgery group (p=0.02 for both comparisons). |
N=78
Describe intervention: Prenatal surgery before 26 weeks of gastation |
N=80
Describe control intervention: Standard postnatal repair
|
Endpoint of follow-up: age children of 30 months
For how many participants were no complete outcome data available?
First primary outcome: Intervention group: 12 (15%) Control group: 13 (16.7%)
Second primary outcome: 22 (31.4%) Control group: 27 (42.2%)
Reasons for incomplete outcome data described? Termination of the trial by data and safety monitoring committee, data of 158 patients whose children were evaluated at 12 months.
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Outcome measures and effect size (include 95%CI and p-value if available): - Deaths: 2 perinatal in each group.
Prenatal vs. Postnatal surgery at 12 months: - Fetal or neonatal death, cerebrospinal fluid shunt: 68% vs. 98% (RR: 0.70, 95% CI 0.58-0.84, p<0.001) - Shunt placement: 40% vs. 82% (p<0.001) - Hindbrain hernation: 64% vs. 96% (RR: 0.67, 95% CI: 0.56-0.81, p<0.001) - No significant differences in rates of identification of epidermoid cysts
Prenatal vs. Postnatal surgery at 30 months: - No significant difference in Bayley Mental Development Index (p=0.53) - Difference between motorfunction and anatomical levels (positive values: indicate function is better than expected): 0.58 ±1.94 and -0.69±1.99 (p=0.001) - Able to walk independently: 42% vs. 21% (RR: 2.01, 95CI: 1.16-3.48, p=0.01) - Better motor function - Better parent-reported selfcare(p=0.02) and mobility (0.003) - No significant differences in cognitive scores (p=0.67) |
B Termination of the trial by data and safety monitoring committee.
Young population, results may not reflect long-term ambulatory status
Ambulation secondary outcome |
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Studies on orthopaedic surgical treatment |
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Bowman, 2009 |
Type of study: Prospective cohort
Country: USA
Source of funding: Not stated
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Inclusion criteria: Newborns with myelomeningocele undergone back closure (tethered cord release)
Exclusion criteria: Not stated
N= 114 (502 newborns with myelomeningocele, 114 patients with symptomatic tethered spinal cord)
Intervention group: Sex: 49% M /51% F Mean age ± SD: 7 years (range 7 months – 21.8 years) at time of first untethering Ambulation:
Control group: Not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 114
Describe intervention: Untethering procedure |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Not stated. Mean follow up after initial untethetering (TCR 1) was 12 years (range: 1 month – 21.8 years), after second release (TCR 2) 4.6 years (1.1 - 11.0 years), third (TCR 3) 3.6 years (0.3 - 7.1 years) and fourth (TCR 4) 3.3 years (2.6 – 4.3 years)
For how many participants were no complete outcome data available? All children underwent full evaluation 3 months postoperative and follow-up at yearly basis.
Intervention group: N (%): Control group: N (%):%
Reasons for incomplete outcome data described? Not applicable. |
Outcome measures and effect size (include 95%CI and p-value if available): Scoliosis: 17% showed improvement (mean curve improvement 18˚, range 5-30), 9% stable (curve range 15-46˚) and 24% progreesed (range 44-74˚)
Manual Muscle Test changes: 70% improvement, 28% stable and 2% decline
Lower extremity contracture: 22% improvement, 78% stable
Lower extremity spasticity: 63% improvement, 37% stable
Gait change: 79% improvement, 19% stable and 3% worsened
Back pain: 100% improvement
Urinary changes: 64% improvement, 36% stabilization. |
C No control group
No statistical analysis
|
|
Schoenmakers et al. 2003 |
Type of study: Prospecitive cohort
Country: The Netherlands
Source of funding: Not stated |
Inclusion criteria: - Neurosurgical treatment for tethered cord syndrome - Younger than 18 years of age
Exclusion criteria: Not stated
N=44
Intervention group: Sex: 17 M/ 27 F Mean age ± SD: 6 years and 2 months ± 5 years Ambulation: 22 patients
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 44
Describe intervention: Neurosurgical untethering |
N=0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Mean duration 7 years and 1 month ± 1 year and 8 months.
For how many participants were no complete outcome data available? Not stated
Intervention group: N (%): 0 Control group: N (%):% Not applicable
Reasons for incomplete outcome data described? No
|
Outcome measures and effect size (include 95%CI and p-value if available): 26 patients, 6 weeks to 6 months after surgery, ambulation level stable compared to preoperative Late deterioration of ambulatory status in 5 patients Obesity (OR: 16,7 95%CI 2,1-133,0) and retethering (OR:20,6 95%CI 2,9-143,6) strongly associated with deterioration of ambulatory status, age had no statistically significant influence
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C No control group
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Herman et al., 1993 |
Type of study: Retrospective cohort
Country: USA Source of funding: Not stated |
Inclusion criteria: - Children with myelomeningocele or lipomyelomeningocele - Operated for release of tethered spinal cord between 1981 and 1988
Exclusion criteria: Not stated
N= 153 patients
Intervention group: Lipomyelomeningocele patients (N=53) Sex ratio: 1 M: 1.2 F Mean age (range): 8 years (3-30 years) Ambulation: not stated
Myelomeningocele patients (N=100) Sex ratio: 1 M: 1 F Mean age (range): 6 years (1-19 years) Ambulation: not stated
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 153
Describe intervention: Reoperation for a tethered cord |
N=0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Average of 4 years follow-up
For how many participants were no complete outcome data available?
Intervention group: N (%): Not stated Control group: N (%): not applicable
Reasons for incomplete outcome data described? Not applicable
|
Outcome measures and effect size (include 95%CI and p-value if available): Improvement in gait, increased walking endurance and improved stance noted in 72% of myelomeningocele and 59% of spinal lipoma patients. |
C No control group
Most patients were initial operated at another institution.
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Cochrane et al., 1998 |
Type of study: Retrospective cohort
Country: Canada
Source of funding: Not stated |
Inclusion criteria: - Undergoing secondary cord untethering - Original spina malformation myelomeningecele or hemimyelomengocele - Progressive neurological, urological and/or musculoskeletal deterioration - Etiology of the deterioration was thought to be due to cord tethering - Other etiological possibilities were excluded based on CT myelography or magnetic resonance of the brain and cord.
Exclusion criteria: Not stated
N= 24 patients
Intervention group: Sex: Not stated Mean age (range): 7.8 years (0.72 – 18.2 years) Ambulation: not stated
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 24
Describe intervention: Placode untethering (secondary cord untethering) |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: 3, 12 and 24 months following placode untethering.
For how many participants were no complete outcome data available?
Intervention group: N (%): Not stated Control group: N (%): Not applicable
Reasons for incomplete outcome data described? No.
|
Outcome measures and effect size (include 95%CI and p-value if available): Preoperative: Changes in ambulatory support requirements and/or the pattern of gait occured in 9 patients
Postoperative: Changes in muscle power, tone and range of movement translated into alterations in mobility and ambulatory support requirements in 9 patients of whom 5 were initially improved and 4 were unchanged. |
C No control group
Small sample size
No statistical analysis
|
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Stott et al. 1996 |
Type of study: Retrospective study
Country: USA
Source of funding: Not stated |
Inclusion criteria: - Low-lumbar-level spina bifida - Undergone bilateral transfer of the tibialis anterior to the calcaneus - Agree to undergo clinical and radiographic evaluation and gait analysis as part of the study
Exclusion criteria: Not stated
N=7 (respons: 88%)
Intervention group: Sex: 2 M/ 5 F Mean age and range: 8 years (3-12 years) Ambulation: 100% community ambular
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? not applicable |
N= 7
Describe intervention: Bilateral transfer of the tibialis anterior to the calcaneus
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N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: average of 40 months (range 24-60 months)
For how many participants were no complete outcome data available?
Intervention group: N (%): 7 (100%) Control group: N (%): not applicable
Reasons for incomplete outcome data described? Not applicable
|
Outcome measures and effect size (include 95%CI and p-value if available): - All patients remained community walkers - Improved velocity (compared to laboratory data, age- and sex-matched controls) P<0.01 - Increased stride length (compared to laboratory data, age- and sex-matched controls) P<0.01 - Decreased quadriceps activity at terminal stance with use of braces in free walking (p<0.03) - Decreased energy expenditure when braces were worn (p<0.05) |
D Very small sample size (N=7)
Unclear defined control group. |
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Park et al. 2008 |
Type of study: Retrospective review
Country: South Korea
Source of funding: Not stated |
Inclusion criteria: Not stated
Exclusion criteria: Not stated
N=18
Intervention group: Sex: 7 M/11 F Mean age and range: 7 years, 4 months (4 years 11 months – 14 years and 4 months) Ambulation: 100%
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? not applicable |
N= 18
Describe intervention: Surgical treatment of calcaneal deformity
|
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: average of 47 months
For how many participants were no complete outcome data available?
Intervention group: Not stated
Control group: N (%): not applicable
Reasons for incomplete outcome data described? No
|
Outcome measures and effect size (include 95%CI and p-value if available): - No recurrence or worsening of the deformity was observed in any of the patients, and no other types of foot deformity developed after surgery. - Postoperative kinematic studies showed a significant (p < 0.0001) increase in peak plantar flexion and a significant decrease in peak dorsiflexion force of the ankle in the stance phase of gait. - Peak pressures under the forefoot and midfoot were increased after surgery, and the relative amount of weight-bearing on the heel as compared with the forefoot was shifted toward more equal weight-bearing. - Lless improvement in foot-pressure distribution was observed in patients with increased pelvic rotation before surgery. - Those patients also had decreased knee extension in stance phase and increased hip abduction and pelvic obliquity both before and after surgery in comparison with patients who had normal pelvic rotation. |
C Small sample size
Unclear defined study population. |
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Georgiadis et al. 1990 |
Type of study: Retrospective study
Country: USA
Source of funding: No funding |
Inclusion criteria: Myelomeningocle patients Had posterior transfer of the anterior tibial tendon between 1969 and 1985.
Exclusion criteria: Moved away and could not be contacted
N= 20
Intervention group: Sex: 7 M/13 F Mean age: 4.6 (1.1 – 10.2) years Ambulation: 90% community walkers postoperative
Control group: Not applicable
Groups comparable at baseline? Not applicable |
N= 20
Describe intervention: Posterior transfer of the anterior tibial tendon |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: 6 (2.2 – 17) years
For how many participants were no complete outcome data available? Operative reports were available for 19 of the 20 patients.
Reasons for incomplete outcome data described? No
|
Outcome measures and effect size (include 95%CI and p-value if available): - During follow up: 18 of 20 patients community walkers
|
C Small study population
Preoperative ambulation was not reported
|
|
Schoenmakers et al. 2005 |
Type of study: Prospective cohort
Country: The Netherlands
Source of funding:
|
Inclusion criteria: - Patients with myelomeningocele - Younger than 18 years of age - Surgical treatment for spinal deformities - Willing to participate in study - Informed consent signed by parents
Exclusion criteria: Not stated
N=10
Intervention group: Sex: 3 M/ 7 F patients Mean age ± SD: 9.3 ± 3.4 Ambulation: 4 patients
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 10
Describe intervention: Spinal fusion |
N=0
Describe control intervention: Not applicable
|
Endpoint of follow-up: 18 months after surgery
For how many participants were no complete outcome data available?
Intervention group: N (%): 0
Reasons for incomplete outcome data described? Not applicable
|
Outcome measures and effect size (include 95%CI and p-value if available): - 3 out of 4 patients ambulation level deteriorated after surgery (no longer able to walk) - 2 out of 3 exercise walkers lost ablility to walk - Mean PEDI-scaled scores on functional skills self-care showed nonsignificant tendency towards deteriorate form pre-surgery to 6 months after surgery - 18 months after surgery functional skills on self-care borderline improved (p=0,07) - Caregiver assistence improved on selfcare (p=0,2) and borderline on mobility (p=0,06) from baseline to 18 months - Complications in 8 out of 10 patients |
C Small sample size
No control group
|
|
Müller et al. 1992 |
Type of study: Prospective cohort
Country: Sweden
Source of funding: Bräcke Östergård Research Foundation Folke Bernadotte Foundation Bertha and Félix Neubergh Foundation |
Inclusion criteria: - Patients with myelomeningocele - Born between 1964 and 1979 - Undergone spinal surgery for scoliosis
Exclusion criteria: Not stated
N=14
Intervention group: Sex: 5 M/ 9 F Mean age (range): 12,4 (9-16) Ambulation: presurgery mean score 2 (non functional ambulators)
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? No applicable |
N=14
Describe intervention: Spinal surgery for scoliosis (Harrington, Dwyer or combination) |
N=0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Mean age of children at time of follow up 15,6 years (1020) years Mean time of 3,4 years (1-8 years) between time of surgery and latest clinical examination
For how many participants were no complete outcome data available? Not stated
Intervention group: N (%): Control group: N (%): Not applicable
Reasons for incomplete outcome data described? No |
Outcome measures and effect size (include 95%CI and p-value if available): 57% lost some of their ambulation capacity No influence on activity of daily life
|
C Small sample size
No control group
Incomplete outcome data not described
|
|
Mazur et al. 1986 |
Type of study: Retrospective cohort
Country: Australia
Source of funding: Not stated |
Inclusion criteria: Spina bifida cystica Underwent surgical treatment for paralytic scoliosis between 1974 and 1983
Exclusion criteria: Not stated
N=49
Intervention group A: Sex: 5 M/10 F Mean age ± SD: 11 years and 3 months Ambulation:
Intervention group B: Sex: 4 M/3 F Mean age ± SD: 10 years and 8 months Ambulation:
Intervention group C: Sex: 14 M/13 F Mean age ± SD: 12 years Ambulation:
Control group: Not applicable
Groups comparable at baseline? All 3 groups seemed nearly equivalent in terms of deformity, level of lesion, functional capabilities, age and sex distribution |
Group A: N=15
Describe intervention: Posterior Harrington instrumentation and fusion
Group B: N=7
Describe intervention: Anterior Dwyer fusions
Group C: N=28
Describe intervention: Combined anterior Dwyer and posterior Harrington fusions |
N=0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Group A: 7 years follow up Group B: 4 years and 9 months follow up Group C: 4 years and 1 month follow up
For how many participants were no complete outcome data available?
Intervention group: N (%): 4 (8% loss to follow up)
Control group: not applicable N (%):%
Reasons for incomplete outcome data described? Family relocation or death unrelated to surgery
|
Outcome measures and effect size (include 95%CI and p-value if available): Group A: Ability to ambulate or to me mobile in wheelchair deterioted in 27% No patient improved ambulatory status Group B: Ability to ambulate or to me mobile in wheelchair deterioted in 57% No patient improved ambulatory status
Group C: Ability to ambulate or to me mobile in wheelchair deterioted in 67% No patient improved ambulatory status
|
C Allocation to treatment groups not random
Small number of patients in treatment groups
No control group |
|
Kahanovitz et al. 1981 |
Type of study: Retrospective study
Country: USA
Source of funding: Not stated |
Inclusion criteria: - Patients with myelomeningocele and scoliosis - Minimum age 16 years
Exclusion criteria: - Primary lordosis or kyphosis
N= 39
Intervention group: Sex: Not stated Mean age: 19.9 (range 16.5 – 38) years Ambulation: 48,7 %
Control group: Not applicable
Groups comparable at baseline? Not applicable |
N= 15
Describe intervention: N=12: posterior fusion in situ followed by postoperative immobilization in a Risser cast N=2: posterior fusion and Harrington instrumentation N=1: anterior fusion with Dwyer followed by posterior and Harrington. |
N=0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Not stated.
For how many participants were no complete outcome data available?
Intervention group: N (%): Unknown, not stated
Control group: N (%): Not applicable
Reasons for incomplete outcome data described? No. |
Outcome measures and effect size (include 95%CI and p-value if available): Preoperative vs. Postoperative: - 8 patients maintained functional levels - 1 community ambulator à household ambulator - 4 household ambulators à balanced sitters - 2 balanced sitters à unbalanced sitters |
C Unknown follow-up duration
For 8 patients preoperative function unknown
Small sample size
No randomization. |
|
Wai et al. 2005 |
Type of study: Retrospective study
Country: Canada
Source of funding: Trainee’s Starter Grant from the Hospital for Sick Children’s Research Institute |
Inclusion criteria: - English speaking - Aged 7 to 16 years - Spina bifida cystica and scoliosis
Exclusion criteria: Not had a radiograph of their spine within 6 months or had had an orthopeaedic operative procedure within previous year
N=80
Intervention group: Sex: 38 M/ 42F Mean age: 12.5 (7-16) years Ambulation: 57% non-walker, 10.1% exercise walker, 6.3% household walker, 26.6 community walker
Control group: Not applicable
Groups comparable at baseline? Not applicable |
N= 24
Describe intervention: Spinal stabilization surgery consisting of anterior release and discectomy and posterior instrumentation to the pelvis with segmental unit rod fixation |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Not stated
For how many participants were no complete outcome data available? 19 of 24 children had adequate preoperative radiographs available for comparison (79%).
Reasons for incomplete outcome data described? No
|
Outcome measures and effect size (include 95%CI and p-value if available): Preoperative vs. Postoperative: - Cobb angle: 73.7° (SD: 18) vs. 39.0° (SD: 24.8) (P<0.001) - Sitting Scale: -1,3 (P=0.003) - SBSQ: -11.0 (P=0.002) - Ask: -9.3 (P=0.01) |
C No control group
Small sample size
Limted study population: data not extrapolatable to scoliosis beyond 110° |
|
Marshall et al. 1996 |
Type of study: Prospective study
Country: Australia
Source of funding: Not stated |
Inclusion criteria: Surgical release of knee flexion contractures
Exclusion criteria: Not stated
N=28
Intervention group: Sex: Not stated Mean age (range): 6,4 (3-21) Ambulation: 5 community walkers ntrol group: Not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N=28
Describe intervention: Surgical release of knee flexion contractures
|
N=0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Mean period of follow up 13 years (4-20 years)
For how many participants were no complete outcome data available?
Intervention group: Not stated N (%): Control group: Not applicable N (%):%
Reasons for incomplete outcome data described? No |
Outcome measures and effect size (include 95%CI and p-value if available): The thoracic level group remained non ambulators or non functional ambulators L3/L4 group: 4 non walkers became non functional walkers, 1 non functional walker progessed to household ambulator, 3 household ambulators became community ambulators
|
C Small sample size
No control group
No statistical analysis |
|
Abraham et al. 1977 |
Type of study: Retrospective cohort
Country: Great Brittian
Source of funding: Not stated |
Inclusion criteria: Patients with myelomeningocele treated surgcally for knee flexion contracture
Exclusion criteria: Not stated
N= 76
Intervention group: Sex: 35 M/ 41 F Age range: 2 – 14 years Ambulation: 24%
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 76
Describe intervention: Surgical treatment for flexion contracture of the knee |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Average follow up 4 years with minimum of 1 year
For how many participants were no complete outcome data available?
Intervention group: N (%): Not stated Control group: N (%): Not applicable
Reasons for incomplete outcome data described? No. |
Outcome measures and effect size (include 95%CI and p-value if available): 45 patients were active walkers at follow up compared to 18 before. |
C No control group |
|
Snela et al. 2000 |
Type of study: Retrospective cohort
Country: Germany
Source of funding: Not stated |
Inclusion criteria: Sought consultation between 1980 and 1995 Flexion contracture suitable for correction Exclusion criteria: Not stated
N= 80
Intervention group: Sex: not stated Age range: 2 – 19 years Ambulation: not stated
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 80
Describe intervention: Surgical treatment for flexion contracture of the knee |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Average follow up 5.1 (1.3 – 17 years)
For how many participants were no complete outcome data available?
Intervention group: N (%): Not stated Control group: N (%): Not applicable
Reasons for incomplete outcome data described? No.
|
Outcome measures and effect size (include 95%CI and p-value if available): - 74% very good long term results (full knee extension, flexion contracture <10˚, bracing without problems, daily use braces for standing or walking, walking without braces) - 20% good long term results (knee flexion contracture recurrence up to 30˚, posibility to wear brace, no pressure sore, limited use of brace for standing or walking exercise) - 6% unsatifactory long term result (recurrence of more than 30˚, inability to wear braces for standing and walking exercises) |
C No control group |
|
Dunteman et al. 2000 |
Type of study: Retrospective review
Country: USA
Source of funding: Not stated |
Inclusion criteria: All patients with high sacral level myelomeninggocele who had pre- and postoperative gait analysis with both kinectic and kinematic data as well as surgical correction of external tibial torsion form October 1993 to February 1999.
Exclusion criteria: Not stated
N= 8
Intervention group: Sex: 4 M/ 4 F Mean age ± SD: 12.9 (range 8-20.2) years Ambulation: all ambulatory
Control group: Not applicable
Groups comparable at baseline? Not applicable |
N= 8
Describe intervention: Distal tibia and fibular internal derotation osteotomies |
N= 0
Describe control intervention: Not applicable |
Endpoint of follow-up: 37 months (11-49 months)
For how many participants were no complete outcome data available?
Intervention group: Not stated
Reasons for incomplete outcome data described? Not stated
|
Outcome measures and effect size (include 95%CI and p-value if available): - Improvement in the abnormal internal knee varus moment (P<0.005) - Increase in stance phase knee extension (P<0.01) - Resolution of preoperative knee pain in 3 patiens. |
D Very small sample size (N=8)
No control group
|
|
Alman et al., 1996 |
Type of study: Retrospective cohort
Country: Canada
Source of funding: Medical Research Council Scholarship |
Inclusion criteria: - Patients with spina bifida born between 1974 and 1985 - Bilateral lesions at L3 and L4 - L3 involvement on one side and L4 on the other
Exclusion criteria: Undergone operations in the previous four months
N= 52 (respons 88%)
Intervention group: Sex: 11 M/ 19 F Mean age ± SD: 14.5 (5.8) Ambulation: 26
Control group: Sex: 12 M/ 10 F Mean age ± SD: 16.4 (5.4) Ambulation: 20
Groups comparable at baseline? Trend towards higher levels of motor involvement in conservative group |
N=30
Describe intervention: Operative relocation of the hip |
N=22
Describe control intervention: Conservative
|
Endpoint of follow-up: Not stated
For how many participants were no complete outcome data available?
Intervention group: N (%): Not stated Control group: N (%): Not stated
Reasons for incomplete outcome data described? No.
|
Outcome measures and effect size (include 95%CI and p-value if available): Functional level of walking did not differ significantly (p = 0.05) |
C No random allocation of patients to treatment or control group
Small number of patients
|
|
Lorente Moltó et al., 2005 |
Type of study: Retrospectively cohort
Country: Spain
Source of funding: Not stated |
Inclusion criteria: - Myelomeningocele patients - Diagnosed and treated from neonatal period between october 1975 and march 1992 - L3 paralysis
Exclusion criteria: - Death because neurological complications before adolescence
N= 29
Intervention group: Sex: 17 M/ 12 F Mean age (range): 26.5 months (11 months – 6 years) Ambulation: 11 non-walkers (38%)
Control group: not applicable Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? Not applicable |
N= 29
Describe intervention: Posterolateral iliopsoas transfer. Surgical technique as described by Sharrard. |
N= 0
Describe control intervention: Not applicable
|
Endpoint of follow-up: Mean follow up 21 years (range 11-28 years)
For how many participants were no complete outcome data available?
Intervention group: N (%): Not stated Control group: N (%): Not applicable
Reasons for incomplete outcome data described? No.
|
Outcome measures and effect size (include 95%CI and p-value if available): - At preschool age and in adolescence proportion of effective walkers did not differ significantly (86.2 vs. 75.8%, p=0.315) - All adolescence community ambulators kept ambulatory status in adulthood. |
C No control group
Small number of patients included
Selective population (only L3 paralysis). |
|
Bazih et al., 1981 |
Type of study: Retrospective cohort
Country: USA
Source of funding: Not stated |
Inclusion criteria: - Patients with myelomeningocele - 4 years or older
Exclusion criteria: Not stated
N= 74 patients
Intervention and control group: Sex: 29 M/ 45 F Mean age (range): 10 years and 5 months (4 years and 1 month – 20 years) Ambulation: 28 patients
Control group: Sex: M/F Mean age ± SD: Ambulation:
Groups comparable at baseline? No neurologic features distinguishing operated and nonoperated groups. Operated group older. |
N= 18
Describe intervention: Surgery for specific purpose of attaining reduction in an unstable hip |
N= 56
Describe control intervention: No operation
|
Endpoint of follow-up: Unclear, not stated
For how many participants were no complete outcome data available?
Intervention group: unclear, not stated N (%): Control group: unclear, not stated N (%):%
Reasons for incomplete outcome data described? No.
|
Outcome measures and effect size (include 95%CI and p-value if available): - 16 hips successfully reduced, 13 hips (45%) were redislocated or subluxed. - Little difference between nonoperated and operated groups regarding ambulatory capabilities or the percentage of ambuators with dislocated hip. |
C Small intervention group
Use of historic controls
No random allocation to intervention or control group |
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 18-04-2013
Laatst geautoriseerd : 18-04-2013
Geplande herbeoordeling : 01-01-2019
Uiterlijk in 2018 bepaalt het bestuur van de Nederlandse Vereniging van Revalidatieartsen of deze richtlijn nog actueel is. Zo nodig wordt een nieuwe werkgroep geïnstalleerd om de richtlijn te herzien. De geldigheid van de richtlijn komt eerder te vervallen indien nieuwe ontwikkelingen aanleiding zijn een herzieningstraject te starten.
De Nederlandse Vereniging van Revalidatieartsen is als houder van deze richtlijn de eerstverantwoordelijke voor de actualiteit van deze richtlijn. De andere aan deze richtlijn deelnemende wetenschappelijk verenigingen of gebruikers van de richtlijn, delen de verantwoordelijkheid en informeren de eerstverantwoordelijke over relevante ontwikkelingen binnen hun vakgebied.
Algemene gegevens
Met ondersteuning van de Orde van Medisch Specialisten. De richtlijnontwikkeling werd gefinancierd uit de Kwaliteitsgelden Medisch Specialisten (SKMS).
Doel en doelgroep
Doel
Door de in Nederland bestaande expertise op het gebied van diagnostiek en behandeling van de loopstoornissen bij kinderen met SB en de bestaande wetenschappelijke literatuur over dit onderwerp, is er een vruchtbare bodem ontstaan voor het opstellen van een multidisciplinaire richtlijn. Deze richtlijn geeft concrete aanbevelingen voor het optimaliseren van de multidisciplinaire zorg, ter ondersteuning van de dagelijkse praktijkvoering gericht op het bereiken en behouden van zelfstandig lopen van kinderen met SB en draagt bij aan een realistisch en objectief beeld ten aanzien van hun functionele prognose. Met deze richtlijn streeft men naar het bereiken van uniformiteit met betrekking tot de diagnostiek en behandeling door de diverse medici en paramedici.
Doelgroep
Deze richtlijn is geschreven voor alle leden van de beroepsgroepen die betrokken zijn bij de diagnostiek en behandeling van kinderen met loopstoornissen ten gevolge van SB. Voor kinderen met SB en hun naasten wordt een toegankelijke samenvatting van de richtlijn uitgewerkt.
Samenstelling werkgroep
- Mw. dr. B. Ivanyi-Roelfsema, kinderrevalidatiearts, Nederlandse Vereniging van Revalidatieartsen, voorzitter
- Dr. J. van Aalst, neurochirurg, Nederlandse Vereniging voor Neurochirurgie
- Mw. dr. H.J.G. van den Berg-Emons, onderzoeker, Erasmus Medisch Centrum Rotterdam
- Dr. R.H.J.M. Gooskens, kinderneuroloog, Nederlandse Vereniging voor Kinderneurologie
- Mw. dr. J.F. de Groot, fysiotherapeut/onderzoeker, Koninklijk Nederlands Genootschap voor Fysiotherapie
- Drs. T.H.R de Jong, neurochirurg, Nederlandse Vereniging voor Neurochirurgie
- Mw. dr. C.C.E. de Jong-de Vos van Steenwijk, kinderarts, Nederlandse Vereniging voor Kindergeneeskunde
- Dr. C.G.B. Maathuis, kinderrevalidatiearts, Nederlandse Vereniging van Revalidatieartsen
- Dr. M.J. Nederhand, revalidatiearts, Nederlandse Vereniging van Revalidatieartsen
- C. Th. Noppe, orthopedisch technicus
- Mw. dr. M.A.G.C. Schoenmakers, kinderfysiotherapeut/onderzoeker, Koninklijk Nederlands Genootschap voor Fysiotherapie
- Dr. J.A. van der Sluijs, orthopedisch chirurg, Nederlandse Orthopaedische Vereniging
- Dr. P.A.A. Struijs, orthopedisch chirurg, Nederlandse Orthopaedische Vereniging
- J.M.A. Verheijden, beleidsmedewerker zorg, Vereniging van mensen met spina bifida (BOSK)
Met ondersteuning van:
- Mw. drs. S.B. Muller-Ploeger, junior adviseur afdeling Ondersteuning Professionele Kwaliteit, Orde van Medisch Specialisten
- Mw. dr. N.H.J. van Veen, adviseur afdeling Ondersteuning Professionele Kwaliteit, Orde van Medisch Specialisten
Kernredactie:
- Mw. dr. B. Ivanyi-Roelfsema, kinderrevalidatiearts, Nederlandse Vereniging van Revalidatieartsen
- Mw. dr. N.H.J. van Veen, adviseur afdeling Ondersteuning Professionele Kwaliteit, Orde van Medisch Specialisten
Belangenverklaringen
De werkgroepleden hebben schriftelijk verklaard of ze in de laatste vijf jaar een (financieel ondersteunde) betrekking onderhielden met commerciële bedrijven, organisaties of instellingen die in verband staan met het onderwerp van de richtlijn.
Geen van de werkgroepleden heeft aangegeven belangen te hebben die mogelijk kunnen interfereren met de besluitvorming in de werkgroep ten aanzien van de interpretatie van het wetenschappelijk bewijs en het opstellen van aanbevelingen.
Inbreng patiëntenperspectief
Het perspectief van kinderen en jongeren met SB en hun verzorgers wordt gezien als een waardevolle en essentiële aanvulling bij het tot stand komen van deze richtlijn. In de werkgroep werden zij vertegenwoordigd door een afgevaardigde namens de vereniging van mensen met SB (BOSK).
Implementatie
In de verschillende fasen van de richtlijnontwikkeling is rekening gehouden met de implementatie van de richtlijn en de praktische uitvoerbaarheid van de aanbevelingen. Daarbij werd uitdrukkelijk gelet op factoren die de invoering van de richtlijn in de praktijk kunnen bevorderen of belemmeren.
Na autorisatie zal de richtlijn digitaal worden verspreid onder de relevante beroepsgroepen. Daarnaast zal er een samenvatting van de richtlijn verstuurd worden naar de deelnemende wetenschappelijke verenigingen ter publicatie. Ook zal de richtlijn te downloaden zijn vanaf de website van de Nederlandse Vereniging van Revalidatieartsen: www.revalidatiegeneeskunde.nl.
Werkwijze
AGREE
Deze richtlijn is opgesteld conform de eisen in het rapport ‘Richtlijnen 2.0’ van de adviescommissie Richtlijnen van Orde van Medisch Specialisten. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II), dat een internationaal breed geaccepteerd instrument is voor de beoordeling van de kwaliteit van richtlijnen.
Werkgroep
Voor het ontwikkelen van de richtlijn is in 2010 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van relevante specialismen die betrokken zijn bij de diagnostiek en behandeling van de loopstoornissen bij kinderen met SB (zie hiervoor de samenstelling van de werkgroep).
De leden van de werkgroep zijn door hun beroepsverenigingen gemandateerd voor deelname. De werkgroep werkte gedurende twee jaar aan de totstandkoming van de richtlijn. De leden van de werkgroep schreven in subgroepen teksten die tijdens plenaire vergaderingen werden besproken en na verwerking van de commentaren werden geaccordeerd.
Knelpuntenanalyse, uitgangsvragen en uitkomstmaten
Op basis van de uitkomsten van de knelpuntenanalyse binnen de werkgroep en inventarisatie van vragen en knelpunten middels een focusgroep bijeenkomst met mensen met SB en ouders van kinderen met SB, zijn er concept uitgangsvragen opgesteld. Na onderlinge discussie heeft de werkgroep de definitieve uitgangsvragen vastgesteld.
Voor de uitkomstmaten worden relevante domeinen in relatie tot het lopen op het niveau van functies, activiteiten en participatie van het ICF-CY model door de werkgroep gehanteerd.
Strategie voor zoeken en selecteren van literatuur
Er werd eerst oriënterend gezocht naar bestaande buitenlandse richtlijnen in Medline (OVID), de databases van het Guidelines International Network (GIN), de Kwaliteitskoepel en Artsennet (geen referenties, vanaf 2006) en naar systematische reviews in Medline (OVID) en de Cochrane Library (2 referenties vanaf 2000). Ook werd gezocht naar artikelen over patiëntenperspectief (24 referenties, vanaf 1996). Vervolgens werd voor de afzonderlijke uitgangsvragen aan de hand van specifieke zoektermen gezocht naar gepubliceerde wetenschappelijke studies in de Cochrane Library (Wiley), Embase (Elsevier) en/of Medline (OVID) tot uiterlijk juli 2011.
Tevens werd aanvullend gezocht naar studies aan de hand van de literatuurlijsten van de geselecteerde artikelen.
In eerste instantie werd gezocht naar studies met de hoogste mate van bewijs. Voor het identificeren van mogelijke systematische reviews en gerandomiseerde klinische trials werd gebruik gemaakt van zoekfilters, gebaseerd op de filters die gebruikt worden door het Scottish Intercollegiate Guideline Network (SIGN) (http://www.sign.ac.uk/).
De werkgroepleden selecteerden de via de zoekactie gevonden artikelen op basis van relevantie. De geselecteerde artikelen werden gebruikt om de uitgangsvraag te beantwoorden. De searches werden gelimiteerd op literatuur in het Engels, Nederlands, Frans en Duits. Waar dat niet zo was, is dat vermeld. De databases waarin is gezocht, de zoekactie of gebruikte trefwoorden van de zoekactie en de gehanteerde selectiecriteria zijn te vinden onder 'Zoekverantwoording'.
Beoordelen en samenvatten van de literatuur
Individuele studies werden systematisch beoordeeld, op basis van op voorhand opgestelde methodologische kwaliteitscriteria (zie tabel 3.1 en 3.2). De relevante onderzoeksgegevens van de geselecteerde artikelen zijn overzichtelijk weergegeven in evidence-tabellen, die per module te vinden zijn onder 'Evidence tabellen'. De belangrijkste bevindingen uit de literatuur zijn beschreven in de samenvatting van de literatuur. Het wetenschappelijke bewijs werd samengevat in één of meerdere conclusies, waarbij het niveau van het meest relevante bewijs is weergegeven (zie tabel 3.3).
Tabel 3.1 GRADE bewijsniveaus van interventiestudies
|
Bewijsniveau |
Interventie onderzoek |
|
Hoog (A1) |
RCTs zonder ernstige beperkingen Observationele studies met zeer grote effecten en zonder ernstige beperkingen |
|
Matig (A2) |
RCTs met ernstige beperkingen Observationele studies met grote effecten en zonder ernstige beperkingen |
|
Laag (B) |
RCTs met zeer ernstige beperkingen Observationele studies zonder ernstige beperkingen |
|
Zeer laag (C) |
RCTs met zeer ernstige beperkingen en inconsistente resultaten Observationele studies met ernstige beperkingen Niet-systematische klinische observaties (vb. case series of case reports) |
Tabel 3.2 EBRO bewijsniveaus van diagnostische accuratessestudies en studies naar schade, etiologie of prognose
|
Bewijs niveau |
Diagnostisch accuratesse onderzoek |
Schade of bijwerkingen, etiologie, prognose |
|
A1 |
Meta-analyse van min. 2 onafhankelijk van elkaar uitgevoerde onderzoeken van A2-niveau |
|
|
A2 |
Onderzoek t.o.v. een referentietest (‘gouden standaard’) met tevoren gedefinieerde afkapwaarden en onafhankelijke beoordeling van resultaten, met voldoende grote serie van opeenvolgende patiënten die allen de index- en referentietest hebben gehad |
Prospectief cohort onderzoek van voldoende omvang en follow-up, waarbij adequaat gecontroleerd is voor ‘confounding’ en selectieve follow-up voldoende is uitgesloten. |
|
B |
Onderzoek t.o.v. een referentietest, maar niet met alle kenmerken die onder A2 zijn genoemd |
Prospectief cohort onderzoek, maar niet met alle kenmerken als genoemd onder A2 of retrospectief cohort onderzoek of patiëntcontrole onderzoek |
|
C |
Niet-vergelijkend onderzoek |
|
|
D |
|
Voor prognose: dwarsdoorsnede onderzoek |
Tabel 3.3 Niveau van bewijskracht van de conclusie op basis van de aan de conclusie ten grondslag liggende literatuur
|
Niveau |
Conclusie gebaseerd op |
|
1 |
Voor therapeutische interventiestudies: studies van hoge kwaliteit Voor diagnostisch accuratesse onderzoek of prognose, etiologie of bijwerkingen: onderzoek van niveau A1 of tenminste 2 onafhankelijk van elkaar uitgevoerde onderzoeken van niveau A2 |
|
2 |
Voor therapeutische interventiestudies: studies van matige kwaliteit Voor diagnostisch accuratesse onderzoek of prognose, etiologie of bijwerkingen: 1 onderzoek van niveau A2 of tenminste 2 onafhankelijk van elkaar uitgevoerde onderzoeken van niveau B |
|
3 |
Voor therapeutische interventiestudies: studies van lage kwaliteit Voor diagnostisch accuratesse onderzoek of prognose, etiologie of bijwerkingen: 1 onderzoek van niveau B of tenminste 2 onafhankelijk van elkaar uitgevoerde onderzoeken van niveau C |
|
4 |
Voor therapeutische interventiestudies: studies van zeer lage kwaliteit Voor diagnostisch accuratesse onderzoek of prognose, etiologie of bijwerkingen: 1 onderzoek van niveau C of D |
De methodologische kwaliteit van de studies die de validiteit of betrouwbaarheid onderzochten van meetinstrumenten om het lopen bij kinderen en adolescenten met SB te evalueren werd beoordeeld aan de hand van de COSMIN checklist (Mokkink, 2010). Deze checklist is ontwikkeld en gevalideerd voor het beoordelen van studies die de validiteit en reproduceerbaarheid van meetinstrumenten evalueren.
Overwegingen
Voor een aanbeveling zijn naast het wetenschappelijke bewijs, ook andere aspecten belangrijk, zoals de expertise van de werkgroepleden, patiëntenvoorkeuren, kosten en beschikbaarheid van voorzieningen of organisatorische zaken. Deze aspecten zijn, voor zover niet wetenschappelijk onderzocht, vermeld onder het kopje ‘Overwegingen’.
Formuleren van aanbevelingen
De aanbevelingen geven een antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen.
Indicatorontwikkeling
Er zijn door de werkgroep drie interne kwaliteitsindicatoren ontwikkeld om het toepassen van de richtlijn in de praktijk te volgen en te versterken.
Kennislacunes
Tijdens de ontwikkeling van deze richtlijn is systematisch gezocht naar onderzoek waarvan de resultaten bijdragen aan een antwoord op de uitgangsvragen. Bij elke uitgangsvraag is door de werkgroep nagegaan of er (aanvullend) wetenschappelijk onderzoek gewenst is. Een overzicht van aanbevelingen voor nader/vervolg onderzoek staat in de aanverwant 'Kennislacunes'.
Commentaar- en autorisatiefase
De conceptrichtlijn is aan de betrokken (wetenschappelijke) verenigingen voorgelegd voor commentaar. De commentaren zijn verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren is de conceptrichtlijn op sommige punten aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijn is aan de betrokken (wetenschappelijke) verenigingen voorgelegd voor autorisatie.
Zoekverantwoording
Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.