Final Research Plan

Adolescent Idiopathic Scoliosis: Screening

January 07, 2016

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Panel 1

The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from October 1 until October 28, 2015 at 5:00 p.m., ET.

Text Description.

The figure shows the analytic framework for screening for adolescent idiopathic scoliosis. On the left side, the population represented is asymptomatic children and adolescents ages 10 to 18 years. In the direct pathway, Key Question 1 has an arrow from screening to a) the intermediate outcome of curve severity and b) the health outcomes of morbidity, mortality, quality of life, and functioning. In the indirect pathway, Key Question 2 has an arrow from the population to “idiopathic scoliosis,” which represents screening test accuracy. Treatment has a line to a) the intermediate outcome and b) the health outcomes (Key Question 3). Between the “intermediate outcomes” and “health outcomes” boxes there is a dotted line with no arrows denoting the association marked as Key Question 4. The Key Questions on harms are represented with curved arrows at the bottom of the figure (Key Questions 5 and 6).

  1. Does screening for adolescent idiopathic scoliosis improve: a) health outcomes and b) the degree of abnormal spinal curvature in childhood or adulthood?
  2. What is the accuracy of screening for adolescent idiopathic scoliosis?
  3. Does treatment of adolescent idiopathic scoliosis that has a Cobb angle of less than 50° at diagnosis improve: a) health outcomes and b) the degree of spinal curvature in childhood or adulthood?
  4. What is the association between severity of spinal curvature in adolescence and health outcomes in adulthood?
  5. What are the harms of screening for adolescent idiopathic scoliosis?
  6. What are the harms of treatment of adolescent idiopathic scoliosis that has a Cobb angle of less than 50° at diagnosis?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
Populations KQs 1, 2, 5: Asymptomatic children and adolescents ages 10 to 18 years

KQs 3, 6: Screen-detected children and adolescents ages 10 to 18 years who are diagnosed with adolescent idiopathic scoliosis that has a Cobb angle of 10° to 50°

KQ 4: Children and adolescents ages 10 to 18 years who are diagnosed with adolescent idiopathic scoliosis that has a Cobb angle of ≥10°		 Persons with scoliosis of:
  • Neuromuscular etiology (e.g., cerebral palsy, myelomeningocele, muscular dystrophy, spinal muscular atrophy, spina bifida, spinal cord injuries)
  • Congenital etiology (e.g., hemivertebrae, failure of segmentation)
  • Mesenchymal/syndromic etiology (e.g., Marfan syndrome, mucopolysaccharidosis, osteogenesis imperfecta, inflammatory diseases, postoperative)
  • Early-onset idiopathic etiology (infantile [ages 0 to 3 years] or juvenile [ages 4 to 9 years])
Settings
  • Primary care or generalizable to primary care
  • School-based screening programs
  • Countries categorized as “High” on the Human Development Index (as defined by the United Nations Development Programme)
 Specialty care (e.g., surgical clinics and clinics for conditions known to be associated with scoliosis) and other settings with a symptomatic population
Screening tests KQs 1, 2, 5: Forward bend test (with or without scoliometer/inclinometer), surface topography, or other methods (e.g., back-contour device), followed by x-ray for confirmation

KQ 2: Studies with a reference standard

 KQs 1, 2, 5: X-ray alone
Treatments KQs 3, 6:
  • Surgery
  • Nonoperative treatment, including but not limited to: bracing, physical therapy/exercise therapy, and electrical muscle stimulation
  
Comparison KQs 1, 2, 5: Usual care

KQs 3, 6: Observation, usual care

 KQs 1, 2, 5: Studies with no comparator

KQs 3, 6: Comparative effectiveness studies
Harms KQ 5: Any screening harms, including but not limited to: labeling, radiation exposure

KQ 6: Any treatment harms, including but not limited to: psychosocial harms, physiological harms, functioning, or pain

 KQs 5, 6: Studies with no comparator
Outcomes Intermediate outcomes in childhood or adulthood: Severity of spinal curvature

Health outcomes in childhood or adulthood:

  • Morbidity (e.g., pulmonary symptoms, hypertension, lumbar radiculopathy)
  • Quality of life
  • Functional outcomes (e.g., pain, musculoskeletal function, activity restriction)
  • Mortality
  
Study design KQs 1–4: Randomized, controlled trials; controlled trials; cohort studies

KQs 5, 6: Randomized, controlled trials; controlled trials; cohort studies; case series

 All KQs: Studies rated as poor quality

KQs 1–4: Case series, cost effectiveness studies, qualitative study designs

The draft research plan was posted for public comment from October 1 to October 28, 2015. In response to public comment, the USPSTF made a few minor changes. For Key Question 4, the upper bound of 50° was removed from the included population; the USPSTF also changed “Cobb angle” to “severity of spinal curvature” to ensure that relevant studies utilizing 3-dimensional imaging would not be excluded. The USPSTF clarified that both intermediate and health outcomes will include outcomes experienced in childhood or adulthood. Finally, the USPSTF removed studies assessing “selective screening” from the list of excluded screening tests.