Tools for Measuring Daily Activities in Children: Promoting Independence and Developing a Language for Child Disability

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of Child and Family Health. The new morbidity revisited: a renewed commitment to the psychosocial aspects of pediatric care.Pediatrics. 2001;108:1227–1230

Tools for Measuring Daily

Activities in Children: Promoting

Independence and Developing a

Language for Child Disability

I

n adult medicine, a few widely prevalent chronic medical impairments (eg, atherosclerosis, hyper-tension, arthritis, diabetes, alcohol misuse, and tobacco-related chronic obstructive pulmonary dis-ease) contribute to limitations in work and functional activity. In pediatrics, the diversity of childhood con-ditions and their relatively low prevalence makes a categorical approach to child disability problematic.1

During the past 2 decades, major neonatal, cardiac, oncologic, genetic, and neurologic advances have re-sulted in the increased survival of children with pre-vious life-limiting conditions.2 _{In addition, there is}

increased recognition of the impact of psychosocial risks (teen parents, low birth weight status, child abuse, prenatal illicit substance exposure, lead poi-soning, and poverty) on developmental and social competencies has occurred.3–5_{For this reason and in}

keeping with guidelines of the American Academy of Pediatrics, it benefits pediatric health profession-als to have some surveillance tools for assessing chil-dren’s performance in essential self-care, mobility, communication, and social-learning tasks.6

In this issue ofPediatrics electronic pages, Wong and colleagues7_{examine the use of the Functional}

Inde-pendence Measure for Children (WeeFIM) in 445 Chinese children ages 6 months to 7 years. A key component for understanding how functional activ-ities fit into a framework of childhood disability is the National Center for Medical Rehabilitation Re-search and Institute of Medicine Model of patho-physiology, impairment, functional limitation, dis-ability, and societal limitation.8 –10_{These dimensions}

are illustrated in Table 1 for 3 relatively common disorders: motor disability after very low birth weight status, developmental delays after congenital heart disease, and learning and communication chal-lenges after elevated lead exposure.

Crucial to measuring functional limitations is de-fining essential daily tasks. In the WeeFIM instru-ment, these tasks include self-care activities of feed-ing (usfeed-ing a cup, spoon, and fork), groomfeed-ing (washing face and hands, brushing teeth, combing hair), dressing upper body (shirts/blouses, sweat-ers), dressing lower body (underwear, pants, shoes, and socks), adjusting clothes and wiping after

toilet-ing, and maintaining bladder and bowel continency. Motor items include changing positions from chairs, getting on and off toilets, getting in and out of the bathtub or shower, walking indoors and outdoors, and ascending and descending stairs. Cognitive items include receptive and expressive communica-tion, social interaction with peers, problem-solving, and memory. The list of these activities reflect that during a typical day a child must complete a meal independently using appropriate utensils or be as-sisted in feeding. The child, during a typical day, will wash hands and face, brush teeth, comb hair, or be assisted in these areas. A child, on a typical day, will dress and maintain continency or require assistance or diapers. A child will ambulate indoors and out-doors, get in and out of chairs, on and off toilets, in and out of showers, negotiate stairs, or be assisted with these tasks. Similarly, a child will understand requests, communicate basic needs, take turns and play with friends, carry out a sequence of actions to solve a problem, and remember routines. By speci-fying criterion-specific component tasks that reflect the increasing complexity of developmental matu-rity, the pediatrician can assess the child’s regular and consistent progression toward independence.

In the study by Wong et al, Chinese children were recruited from maternal and child health centers and 2 parochial kindergartens in Hong Kong. The inves-tigators established robust interrater reliability across self-care, motor, and cognitive domains. They also demonstrated highly robust correlations be-tween a child’s age and domain scores reflecting the developmental progress of functional skills. Wong and colleagues also demonstrated that basic mobility (chair transfer) and walking were achieved by 2 years; toileting transfers, stairs, expression, and so-cial interaction were achieved by 31_⁄₂ _{years. At age}

41_⁄₂ _{years, continency independence, getting in and}

out of showers, and dressing were performed inde-pendently. By age 5 years, singing songs, remember-ing routines, problem-solvremember-ing, and wipremember-ing after us-ing the bathroom were independently accomplished. Wong et al also demonstrated some gender and cul-turally specific aspects (eg, presence of maid at home and early attendance in preschool) on performance of functional skills. In keeping with US development studies, girls mastered self-care and communication competencies before boys. Similar to the US WeeFIM standardization, there was no effect of socioeco-nomic status on WeeFIM activities.11

Importantly, the Wong study describes environ-mental supports such as attendance in preschool and the curriculum supports for the precursors of read-ing, writread-ing, and social interaction that take place in Hong Kong. These practices result in advanced self-care independence and social cognition of Chinese preschoolers compared with US preschoolers. Some of this advantage also reflects differences in how quality child care and preschool experiences are or-ganized in Asia compared with the fragmentation and difficulty accessing quality across US child care centers.

Currently pediatric health professionals have sev-eral choices for adaptive-functional instruments.

Received for publication Nov 7, 2001; accepted Nov 8, 2001.

Reprint requests to (M.E.M.) Child Development Center, Rhode Island Hospital, 593 Eddy St, Providence, RI 02903. E-mail: [email protected] PEDIATRICS (ISSN 0031 4005). Copyright © 2002 by the American Acad-emy of Pediatrics.

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These include the Pediatric Evaluation of Disability Inventory, the Vineland Adaptive Behavior Scales, and the Battelle Developmental Inventory.12–14_These

assessment tools are maximum data sets and involve detailed and extensive queries of self-care, mobility, communication, and social items. On average, they require⬎30 minutes of interview time and complex scoring and are not easily suited to tracking over time.15 _{As with all tools, they have the strength of}

systematically describing a child’s performance in daily activities. In addition, the Pediatric Evaluation of Disability Inventory environmental modification and assistance items have direct overlap with WeeFIM, as well as robust correlations, and can be administered in⬍20 minutes.3

Having completed appropriate psychometric

norming, the Chinese version of the WeeFIM can now be used among Chinese children with physical, developmental, genetic, or behavioral impairments. The child’s strengths and challenges can be described so that despite having a risk factor or a medical or psychological impairment, the child’s ability to per-form self-care, self or alternative mobility, spoken, gestural or electronic augmented communication, and appropriate play and learning activities can be assessed. This information will allow the pediatri-cian not only to understand the impact of the disor-der on basic daily activities but to help the family promote functional independence and, when chal-lenges exit, to access family supports. For children who demonstrate core skills in self-care, mobility, communication, and social interaction, pediatricians can prioritize interventions to enhance academic per-formance and social competencies. Our efforts in assessing and monitoring basic functional competen-cies can then help us prioritize our efforts in both disability prevention and when these efforts are not fully realized, optimize functional performance, fam-ily supports, and community participation.

Michael E. Msall, MD Child Development Center

Hasbro Children’s Hospital—Brown Medical School Providence, RI 02903

REFERENCES

1. Stein REK, Silver EJ. Operationalizing a conceptually based noncat-egorical definition: a first look at US children with chronic conditions.

Arch Pediatr Adolesc Med. 1999;153:68 –74

2. Newacheck PW, Strickland B, Shonkoff JP, et al. An epidemiologic profile of children with special health care needs.Pediatrics. 1998;102: 117–123

3. Msall ME, Tremont MR, Ottenbacher KJ. Functional assessment of preschool children: optimizing developmental and family supports in early intervention.Infants Young Child.2001;14:46 – 66

4. Shonkoff J, Phillips D. Neurons to Neighborhoods: The Science of Early Childhood Development.Washington, DC: National Academy of Sciences; 2000

5. Hagan JF Jr. The new morbidity: where the rubber hits the road or the practitioner’s guide to the new morbidity [commentary].Pediatrics. 2001;108:1206 –1210

6. American Academy of Pediatrics, Committee on Children With Disabil-ities. Developmental surveillance and screening of infants and young children.Pediatrics. 2001;108:192–196

7. Wong S, Chan K, Wong W. The functional independence measure (WeeFIM) for Chinese children: The Hong Kong cohort.Pediatrics. 2002;109(2). Available at: http://www.pediatrics.org/cgi/content/ full/109/2/e36 TABLE 1. National Center for Medial Rehabilitation Research and Institute of Medicine Models of Enablement Definitions Diplegic Cerebral Palsy at 18 Months 30-Month-Old With Elevated Lead Congenital Heart Disease at 36 Months Pathophysiology Molecular, biochemical, or cellular mechanisms Vulnerability of periventricular oligodendroglia to ischemia Neurotoxicity of lead, on synaptogenesis, and neurotransmitter functioning Cyanotic congenital heart disease requiring 2 cardiac operations Impairment Loss of structure or function at an organ level 600 g, 26 wk gestation. Periventricular leukomalcia, chronic lung disease, spasticity of lower extremities Delayed vocabulary, risk for educational challenges Developmental delays in gross motor and fine motor coordination and speech articulation Functional limitation Inability of a person to perform an activity normal for peers Unable to long sit, unable to quadriped crawl, limited vocabulary in expressive speech Not talking in sentences, cannot imitate stroke with crayons, cannot solve basic puzzles Difficulty with puzzles. Difficulty with speech being understood by peers and strangers. Functional strengths Activity Ability of a person to impact on their environment Sits with supports, transfers, says “mama, ” follows 1-step request with gesture, finger feeds. Climbs, runs, feeds self with utensils, toilet-trained Communicates basic needs to family members. Likes to have books read to him Disability Participation Expression of functional limitation in a societal context of social roles typical for nondisabled peers Orthopedic monitoring for contractures, bilateral ankle-foot orthoses, supplementary security income, early intervention services Ongoing lead monitoring, access to early head start, access to quality small group early child experiences Access to small group early child education and developmental motor and language intervention Societal limitations Contextual factors Legal, attitudinal, and cultural barriers impacting on community participation Implicit institutional policy that states not ready for developmental speech therapy until walking Ensuring quality housing for all children Waiting lists for preschool speech therapists

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8. National Institutes of Health/National Institute of Child Health and Human Development.Research Plan for the National Center for Medical Rehabilitation Research.Bethesda, MD: National Institutes of Health; 1993. NIH Publ. No. 93-3509

9. Pope AM, Tarlov AR, eds. Disability in America: Toward a National Agenda for Prevention. Washington, DC: National Academy Press; 1991 10. Butler C, Chambers H, Goldstein M, et al. Evaluating research in de-velopmental disabilities: a conceptual framework for reviewing treat-ment outcomes.Dev Med Child Neurol. 1999;41:55–59

11. Msall ME, DiGaudio KM, Duffy LC, LaForest S, Braun S, Granger C. WeeFIM: normative sample of an instrument for tracking functional independence in children.Clin Pediatr. 1994;33:431– 438

12. Haley SM, Coster WJ, Ludlow LH. Pediatric Evaluation of Disability Inventory (PEDI), Version 1.Boston, MA: New England Medical Center-PEDI Research Group; 1992

13. Sparrow S, Balla D, Cicchetti D.Vineland Adaptive Behavior Scales Inter-view Edition: Survey Form Manual.Circle Pines, MN: American Guidance Service; 1984

14. Newborg J, Stock JR, Wnek L. Battelle Developmental Inventory with Recalibrated Technical Data and Norms: Examiner’s Manual.Allen, TX: DLM, LINC Associates; 1984

15. Ottenbacher KJ, Msall ME, Lyon N, et al. The WeeFIM instrument: its utility in detecting change in children with developmental disabilities.

Arch Phys Med Rehab. 2000;81:1317–1326

Nifedipine Labeling Illustrates

the Pediatric Dilemma for

Off-Patent Drugs

ABBREVIATIONS. FDAMA, Food and Drug Administration Modernization Act; NIH, National Institutes of Health; PPRU, Pediatric Pharmacology Research Unit; NICHD, National Institute of Child Health and Human Development; OPD, Orphan Product Development Program.

S

uccess of the 1997 Food and Drug

Administra-tion ModernizaAdministra-tion Act (FDAMA) SecAdministra-tion 111 legislation for labeling and information of drugs for children should propel reenactment of new or similar legislation currently under consideration.1,2

Expanded coverage to off-patent drugs used off-label in children may create incentives sufficient to study old and new pediatric drugs.1,3_{We offer a}

perspec-tive and an example on this issue as rationale for expanded legislation on pharmaceuticals for chil-dren.

The therapeutic orphan status of children is sub-stantiated by off-label drug use.4 – 6_{Recent FDA and}

congressional actions expose 3 categories of thera-peutic orphan drugs distinguished by likely occur-rence of sponsored studies leading to information or labeling1,3,7_:

1. New prescription drugs with requirements for pe-diatric studies under the 1998 FDA Pepe-diatric Rule3

are the most likely to be studied, and then 2. Prescription drugs on the market that are either,

a. On-patent and applicable for exclusivity under

Section 111 of FDAMA legislation,1 _which

thereby offers an incentive to industry, or b. Off-patent but with a product marketed

con-tinually by the original innovator, and lastly 3. Generic or over-the-counter drugs available from

companies other than the original innovator, that show a lack of pediatric information.8 _Notably,

drugs in this category are not addressed by the FDA Pediatric Rule or FDAMA such that little incentive exists for support of clinical trials in children.1,3 _{Many over-the-counter drugs are in}

this category and show a high prevalence of in-sufficient pediatric labeling.9

Drugs in categories 2b and 3 are collectively re-garded as off-patent or as having no exclusivity pro-visions for application of FDAMA.1 _{Some estimate}

that approximately 200 older drugs with pediatric use are trapped in these 2 categories. Categorical distinctions allow assessment of likely support for pediatric studies, and this is an important consider-ation for the proposed legislconsider-ation. For example, with proper incentive, an original innovator marketing an off-patent drug may support pediatric studies more readily than other companies that have only generic interests.

Acquisition of data for use or labeling of a category 2b drug in children is well-illustrated by nifedipine. This drug has been used for approximately 15 years to treat hypertension in children despite a lack of pharmacokinetic data and a pediatric formulation. The immediate release nifedipine preparations by the original innovator and generic forms by numer-ous generic manufacturers (approximately 33) are used for dosing children. These often require tech-niques for removing nifedipine from the capsule, and the majority of these techniques are inefficient, nonreproducible, and difficult to perform in a clini-cal setting. In addition, physicians are unable to in-dividualize accurately the nifedipine dose because of the high nifedipine concentration in the existing for-mulations (29 mg/mL and 44 mg/mL in the 10-mg and 20-mg capsule, respectively). A small variation in volume extracted produces a large error in dose delivered. For example, an infant weighing 2.54 kg and receiving nifedipine at a dose of 0.5 mg/kg would require a dose of 1.27 mg or 0.04 mL. Al-though other agents are available to treat hyperten-sion or hypertensive crisis, nifedipine has been and will likely continue to be used by physicians due to its oral availability, safety profile in children, and reported efficacy (references on request).

This commentary describes 1) background on pe-diatric labeling dilemma with nifedipine; 2) reasons for failed remedial actions despite listing of nifedi-pine on the FDA Pediatric Priority Drug List; 3) interest by the National Institutes of Health (NIH) Pediatric Pharmacology Research Unit (PPRU) Net-work to pursue studies of off-patent drugs and in particular nifedipine; and 4) private sector funding issues. A declined original innovator interest in de-velopment of a pediatric formulation or support of nifedipine studies is characteristic of this dilemma. We remain hopeful that congressional legislation

Received for publication Jul 17, 2001; accepted Nov 8, 2001.

Address correspondence to John T. Wilson, MD, LSUHSC-Shreveport, 1501 Kings Hwy, Shreveport, LA 71130. E-mail: [email protected]

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DOI: 10.1542/peds.109.2.317

2002;109;317

Pediatrics

Michael E. Msall

Developing a Language for Child Disability

Tools for Measuring Daily Activities in Children: Promoting Independence and

Services

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