• June 15, 2007, RotaTeq (Rotavirus, Live, Oral, Pentavalent Vaccine): Changes to the ADVERSE REACTIONS and POST-MARKETING sections of the product's prescribing information. The ADVERSE REACTIONS section was updated to include six cases of Kawasaki disease that were observed during the Phase 3 clinical trial.
• February 13, 2007, Rotavirus, Live, Oral, Pentavalent Vaccine (RotaTeq): FDA Public Health Notification regarding 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq).

Note from the National Guideline Clearinghouse (NGC) and the Institute for Clinical Systems Improvement (ICSI): For a description of what has changed since the previous version of this guidance, refer to Summary of Changes Report -- October 2007.

This guideline is intended to assist in the prioritization of screening maneuvers, tests and counseling opportunities. It is not intended to diagnose or treat any condition. Consequently, once a health issue or condition has been uncovered, other ICSI guidelines (such as prevention and management of Obesity [Mature Adolescents and Adults] guideline) will take precedence during any further diagnosis and management.

Recommendations for preventive services for children and adolescents are presented in the form of an algorithm with 6 components, accompanied by detailed annotations. An algorithm is provided for Preventive Services for Children and Adolescents. Clinical highlights follow.

Class of evidence (A-D, M, R, X) and conclusion grade (I-III, Not Assignable) definitions are provided at the end of the "Major Recommendations" field.

Preventive services in this guideline are grouped into four groups, based on their evidence of effectiveness and their priority ranking, as follows:

Level I Preventive Services that providers and care systems must deliver (based on best evidence). (Annotation #4)

Level II Preventive Services that providers and care systems should deliver (based on good evidence). (Annotation #5)

Level III Preventive Services for which the evidence is currently incomplete. (Annotation #5a)

Level IV Screening maneuvers that are not supported by evidence. (Annotation #5b)

Table 1: Child Preventive Services That Providers and Care Systems Must Deliver (Based on Best Evidence) (Level I)

Childhood Immunization Series

Routine Immunization Schedule for Infants, Children, and Adolescents

Please check manufacturer for specifications for dosing, as all intervals may not be needed.

Abbreviations: DTaP, diphtheria, tetanus, acellular pertussis; IPV, inactivated poliovirus vaccine; MMR, measles, mumps, and rubella; MMRV, measles, mumps, rubella and varicella vaccine; Hib, Haemophilus influenzae type b; Hep B, hepatitis B; Hep A, hepatitis A; Tdap, tetanus-diphtheria toxoid; tiv, trivalent influenza vaccine

Table 2: Child Preventive Services That Providers and Care Systems Should Deliver (Based on Good Evidence) (Level II)

Abbreviations: BMI, body mass index; SIDS, sudden infant death syndrome

Preventive Services for Which the Evidence Is Currently Incomplete (Level III)

• Blood lead testing
• Clinical breast exam screening
• Dental and periodontal disease counseling
• Developmental/behavioral assessment testing
• Domestic violence and abuse screening and counseling
• Dyslipidemia screening
• Dysplasia of the hip screening
• Hearing screening
• Injury prevention screening
• Iron deficiency screening
• Nutritional counseling
• Preconception counseling
• Pregnancy prevention counseling
• Scoliosis screening
• Secondhand smoke exposure counseling
• Sexually transmitted infection (other than Chlamydia) counseling
• Sexually transmitted infection (other than Chlamydia) screening
• Skin cancer screening and counseling
• Substance abuse: alcohol use screening and counseling
• Undescended testicles screening
• Viral upper respiratory infection prevention counseling

Screening Maneuvers Which Are Not Supported by Evidence (Level IV)

Level IV services are those with low predictive value and/or uncertain beneficial action for true positives.

• Blood chemistry panels
• Child maltreatment screening
• Hemoglobin (for anemia screening)
• Tuberculin skin testing (routine)
• Urinalysis

Clinical Highlights

• All clinic visits—whether acute, chronic, or for preventive service visit—are opportunities for prevention. Incorporate appropriate preventive services at every opportunity. (Annotation #3)
• Assess patients for risk factors at periodic intervals. (Annotation #2)
• Address or initiate child preventive services that providers and care systems must deliver (based on best evidence) (Level 1). (Annotation #4)
  • Childhood immunization series
  • Chlamydia screening
  • Vision screening

Preventive Services for Children and Adolescents Algorithm Annotations

1. System Alerts Patient/Parent or Provider of Needed Preventive Services

   Clinics must determine some way of communicating what has been done, what needs to be done, etc. This may be a paper face sheet in the patient's chart, electronic postcard reminders, or pop-ups on computer screen, for example. The ideal system at a minimum alerts providers, the appointment desk, and others at each contact, and even better if it alerts patient and the health team independent of patient-initiated contact.

   The advent of the electronic health record has supported the trend of providing appropriate preventive services exactly when indicated, therefore lessening the need for the periodic exam as an organizing construct.

2. Perform Risk Stratification and Health Assessment

   In order to provide these services, it is first necessary to know which services are needed by individual patients. This includes both knowing when the last services were provided and what risk factors are present. This information may be most efficiently collected through the use of questionnaires or automated means of combining information from the medical record with patient-collected information. Nursing or reception staff can collect this information, or increasingly it may be collectible through Internet and Web-based technologies. As important as collecting data thoroughly once, though, is having some way to update the information at regular intervals. One-on-one interviews by clinicians are the least efficient way to obtain or update this information.

   See the Support for Implementation section, 'Knowledge Resources: Preventive Risk Assessment Forms' in the original guideline document for sample forms.

3. Use Every Opportunity for Prevention

   Nearly every patient contact for any reason should be used to identify and address preventive service needs.

   Possible examples might include the following:

   • A mother of a 15-month-old patient calls, requesting an appointment for a sore throat; if not contraindicated, this would trigger the scheduler to ask patient about need for immunizations.
   • A father of a five-year-old year patient calls to schedule a routine visit during the fourth quarter of the year. The scheduler/receptionist could ask patient about flu shot status and facilitate the process for completion of this service.
   • A new patient accesses the Internet to schedule a preventive service visit. The interactive system reminds patient to bring or arrange to have mailed his/her medical records. The system also presents an option to complete an automated health-risk assessment form.

   The work group recognizes that urgent or emergent visits may not always present preventive service opportunities.

4. Preventive Services That Providers and Care Systems Must Deliver (Based on Best Evidence). (Level I)

   Level I preventive services are worthy of attention at every visit. Busy clinicians cannot deliver this many services in any single visit. However, with systems in place to track whether or not patients are up-to-date with the high-priority preventive services recommended for their age group, clinicians can offer the high-priority services as opportunities present.

   Childhood Immunization Series

   Refer to Table 1 above for routine immunization schedule for infants, children, and adolescents.

   Counseling Messages

   Educate parents to immunize children according to age appropriate schedule.

   References/Related Guidelines

   See the NGC summary of the ICSI Immunizations guideline for current immunization schedules and annotations to the basic schedule above.

   Chlamydia Screening

   Services

   Routine screening for chlamydia is recommended for all sexually active women aged 25 years and younger.

   Risk factors include:

   • Having new or multiple sex partners
   • Having a prior history of a sexually transmitted infection (STI)
   • Not using condoms consistently and correctly

   Refer to the original guideline document for information on burden of suffering.

   Efficacy

   The most efficacious means of reducing the risk of acquiring sexually transmitted infections through sexual contact is either abstinence from sexual relations or maintenance of a mutually monogamous sexual relationship with an uninfected partner. Condoms have been shown in the laboratory to prevent transmission of chlamydia trachomatis, herpes simplex virus, trichomonas, cytomegalovirus, and human immunodeficiency virus. Even under optimal conditions, however, condoms are not always efficacious in preventing transmission. Condom failures occur at an estimated rate of 10% to 15% either as a result of product failure or as a result of incorrect or inconsistent use.

   Evidence supporting this recommendation is of class: A, R

   Vision Screening

   Service

   Vision screening is recommended for children four years old and younger. Screening should be used to detect amblyopia, atrabismus, and defects in visual activity. By age five, vision screening should be performed in the clinic or school as part of preschool screening.

   Efficacy

   No direct evidence demonstrates that vision screening and early treatment in children leads to improved visual acuity and or other outcomes such as school performance. The U.S. Preventive Services Task Force concluded that effectiveness of screening in preschool children is supported by indirect evidence that screening is effective in identifying strabismus and amblyopia, treatment of strabismus and amblyopia is effective, and more intensive screening leads to improved visual acuity compared to usual screening. A single randomized control trial demonstrated that children randomized to more intensive screening between 8 and 37 months of age had a lower prevalence of severe amblyopia, and at 7.5 years of age lower prevalence of amblyopia after treatment.

   A prospective study of two matched cohorts of over 700 preschool children each in Ontario found that 3% of children screened before entry to school had moderate to severe vision impairment (visual acuity 20/50 or greater) compared to 6% of children in the matched cohort screened 6-12 months later, indicating that effectiveness of treatment is approximately 50%. Those found to have vision problems using the illiterate E screening instrument were referred to their family doctor.

   Counseling Messages

   Normal objective vision screening performed at schools need not be repeated by clinics for average-risk, asymptomatic children.

   Evidence supporting this recommendation is of classes: A, B, R

5. Preventive Services That Providers and Care Systems Should Deliver (Based on Good Evidence (Level II)

   Level II services have been shown to be effective and should be provided whenever possible. If systems/care management teams are successful in keeping patients on time with high-priority services during illness and disease management visits, preventive services in the second group can be delivered.

   Refer to Table 2 above for information on Level II preventive services.

   Cervical Cancer Screening

   Service

   All women should be screened for cervical cancer beginning at age 21 or three years after initiating sexual intercourse, whichever is earlier. Screening should be performed every three years after three consecutive normal Pap smears over five years.

   Human papillomavirus (HPV) testing may be used as an adjunct to Papanicolaou (Pap) smear screening to help minimize unnecessary colposcopies and other interventions.

   Women who have had dysplasia on prior Pap smears should continue with annual screening for five years after the last dysplastic Pap smear; after that, they need only every-three-year screening.

   References/Related Guidelines

   See the NGC summary of the ICSI Initial Management of Abnormal Cervical Cytology (Pap Smear) and HPV Testing guideline.

   Evidence supporting this recommendation is of classes: C, M, R

   Infant Sleep Positioning and Sudden Infant Death Syndrome (SIDS) Counseling

   Service

   Ask how child is positioned for sleep. Inform parents of importance of back-sleeping position. Demonstrate the appropriate sleeping position when the patient is under medical care.

   Refer to the original guideline document for information on efficacy of SIDS counseling and burden of suffering.

   Counseling Message

   Infants should be placed on their back for sleep. Side sleeping is no longer recognized as an alternative position. Parents should be advised about the appropriate sleeping position starting in the newborn nursery. Health care workers should be careful to place babies on their back to demonstrate to parents the appropriate sleeping position. Continued work to educate all potential caregivers of infants should be supported.

   Infant sleep surfaces should be firm and there should be no loose bedding or soft objects around the infant.

   Parents should be encouraged not to smoke, as this has many important health benefits. Smoking during pregnancy has been shown to be associated with increased risk of SIDS.

   A proximate but separate sleeping environment and the use of pacifiers have been recommended. These should be discussed with parents in the context of fully supporting breastfeeding.

   Supporting evidence is of classes: C, D, M, R

   Injury Prevention Counseling: Motor Vehicle Safety Screening and Counseling

   Service

   Ask about the use of car seats, booster seats, and seat belts in the family.

   Ask about helmet use in motorcycle riders.

   Refer to the original guideline document for information on the efficacy of counseling and burden of suffering from motor vehicle injuries.

   Counseling Messages

   Age Group - Birth to 9 Years

   • Install and use federally approved child safety seats.
   • Discuss the fact that infants should face the rear of the vehicle until they are both 1 year of age and 20 lbs, and should not be placed in any seat with an air bag. (Best - middle rear seat).
   • All children under 4 years of age must ride in appropriate car seat.
   • Discuss the fact that children between 4 to 9 years and weighing less than 80 pounds should be in a belt positioning booster seat.

   All Individuals

   • Discuss always wearing a safety belt when driving or riding in a car. Discuss the fact that 50% of death and disability from motor vehicle accidents can be prevented when passengers routinely wear seat belts.
   • Do not drive or ride in a motor vehicle when the driver is under the influence of alcohol or drugs.
   • Discuss the fact that passengers should not ride in cargo areas of any vehicle.
   • The safest way to travel is to ensure that EVERYONE in the vehicle is correctly buckled up and that all children under age 13 ride in the back seat.
   • For air bag safety, drivers should try to maintain at least 10 inches between themselves and the steering wheel. Front passenger seats should be moved as far back as possible.
   • Motorcycle riders should always wear helmets to reduce the risk of head injury.

   Evidence supporting this recommendation is of classes: B, C, M, R

   Neonatal Screening

   Service

   Metabolic screens and other interventions in the first week of life should be performed according to state law.

   Efficacy

   Newborn metabolic screening is designed to detect infants with inborn errors of metabolism. Early identification in many cases can avert a poor outcome for a child with various interventions depending on the condition. Approximately 4,000 infants per year are identified with a condition through the newborn metabolic screening program. Each state varies on the test required to be done by law, but a uniform approach with all states using mass spectrometry is being promoted by a variety national groups (www.mchb.hrsa.gov/screening).

   Counseling Message

   All infants should receive a newborn metabolic screening test prior to hospital discharge, ideally when greater than 24 hours of age. Infants who receive screening before 24 hours of age should receive a repeat test before the second week of age.

   System alerts should provide notice of positive results. Appropriate follow-up services must be provided for any child with a positive test.

   Evidence supporting this recommendation is of class: R

   Obesity Screening

   Service

   Record height, weight, and body mass index (BMI) annually beginning at age two as part of a normal visit schedule. Monitor BMI.

   Refer to the original guideline document for information on efficacy of obesity screening.

   Counseling Messages

   Encourage wholesome eating and physical activity.

   2-18 years

   Encourage:

   • Consumption of fruits, vegetables, whole grains, and low-fat dairy products
   • Limiting total fat, especially saturated, trans fats, and cholesterol
   • Daily participation of 30 to 60 minutes of moderate to vigorous physical activity appropriate for age
   • Regular meals

   Discourage:

   • Foods with added sugars
   • Sweetened beverages
   • Television and video games; limit to one hour per day

   References/Related Guidelines

   http://www.healthierus.gov/

   http://www.mypyramid.gov

   See Knowledge Resources section, "Resources Available" in the original guideline document; ICSI's Technology Assessment Report on Treatment of Obesity in Children and Adolescents; and the NGC summary of ICSI guideline Prevention and Management of Obesity (Mature Adolescents and Adults).

   Evidence supporting this recommendation is of classes: A, B, D, M, R

   Tobacco Use Screening, Prevention, and Intervention in Adolescents

   Service

   Establish tobacco use and secondhand smoke exposure and reassess at every opportunity. (See section on Secondhand Smoke Exposure in the original guideline document).

   Reinforce non-users to continue non-use of tobacco products.

   Offer tobacco cessation services on a regular basis to all patients who use tobacco. (All forms of tobacco should be considered.)

   The key components of successful office tobacco cessation interventions are:

   • Ask about tobacco use and smoke exposure at every opportunity.
   • Advise all users to quit.
   • Assess willingness to make a quit effort.
   • Assist users' willingness to make a quit attempt.
   • Arrange follow-up.

   Refer to the original guideline document for information on efficacy of tobacco use screening.

   Counseling Messages

   For children and adolescents aged 10 years and above and the child or adolescent is using tobacco:

   • Emphasize short-term negative effects of tobacco use.
   • Advise tobacco users to quit.
   • Assess user's willingness to make a quit attempt.
   • Provide counseling depending on readiness-to-quit stage. Provide a motivational intervention if the user is not ready to make a quit effort.
   • Assist in quitting if ready to make a quit effort. Negotiate a quit date. Counsel to support cessation and build abstinence skills. Offer phone line for more assistance.
   • Arrange follow-up to occur soon after the quit date.

   For All Ages

   • If accompanying household member uses tobacco, encourage member to quit. If the member user is interested in quitting, encourage a visit at his or her clinic for more cessation assistance.
   • Provide educational and self-help materials.

   Evidence supporting this recommendation is of class: R

   5a. Preventive Services for Which the Evidence Is Currently Incomplete (Level III)

   Level III services could be left to the judgment of individual medical groups, clinicians and their patients. These services either have insufficient evidence to prove their effectiveness and/or have important harms. For these preventive services in particular, decisions about offering the service should be made on a patient-by-patient basis. It is important to remember that insufficient evidence does not mean the service is not effective, but rather that the current literature is not sufficient to say whether or not the service is effective.

   Please refer to the beginning of the "Major Recommendations" field and to the original guideline document for information on Level III preventive services.

   5b. Screening Maneuvers That Are Not Supported by Evidence (Level IV)

   Level IV services are those with low predictive value and/or uncertain beneficial action for true positives.

   The list of Level IV preventive services is provided at the beginning of "Major Recommendations" field. Please refer to the original guideline document for detailed information on Level IV preventive services.

Definitions:

Classes of Research Reports:

1. Primary Reports of New Data Collection:

   Class A:

   • Randomized, controlled trial

   Class B:

   • Cohort study

   Class C:

   • Non-randomized trial with concurrent or historical controls
   • Case-control study
   • Study of sensitivity and specificity of a diagnostic test
   • Population-based descriptive study

   Class D:

   • Cross-sectional study
   • Case series
   • Case report

2. Reports that Synthesize or Reflect upon Collections of Primary Reports:

   Class M:

   • Meta-analysis
   • Systematic review
   • Decision analysis
   • Cost-effectiveness analysis

   Class R:

   • Consensus statement
   • Consensus report
   • Narrative review

   Class X:

   • Medical opinion

Conclusion Grades:

Grade I: The evidence consists of results from studies of strong design for answering the question addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative results have sufficiently large samples to have adequate statistical power.

Grade II: The evidence consists of results from studies of strong design for answering the question addressed, but there is some uncertainty attached to the conclusion because of inconsistencies among the results from the studies or because of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the question addressed, but the results have been confirmed in separate studies and are consistent with minor exceptions at most.

Grade III: The evidence consists of results from studies of strong design for answering the question addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among the results of different studies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering the question addressed.

Grade Not Assignable: There is no evidence available that directly supports or refutes the conclusion.

A detailed and annotated clinical algorithm is provided for Preventive Services for Children and Adolescents.

ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675; e-mail: icsi.info@icsi.org; Web site: www.icsi.org.

ICSI's conflict of interest policy and procedures are available for review on ICSI's website at www.icsi.org.

Electronic copies: Available from the Institute for Clinical Systems Improvement (ICSI) Web site.

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675; Web site: www.icsi.org; e-mail: icsi.info@icsi.org.

• Preventive services for children and adolescents. Executive summary. Bloomington (MN): Institute for Clinical Systems Improvement, 2006 Oct. 1 p. Electronic copies: Available in Portable Document Format (PDF) from the Institute for Clinical Systems Improvement (ICSI) Web site.
• Appendices A-E of the original guideline document provide various counseling and educational tools, including body mass index (BMI) charts.
• ICSI pocket guidelines. April 2006 edition. Bloomington (MN): Institute for Clinical Systems Improvement, 2006. 298 p.

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675; Web site: www.icsi.org; e-mail: icsi.info@icsi.org.

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