Published online June 1, 2006
PEDIATRICS Vol. 117 No. 6 June 2006, pp. 2080-2092 (doi:10.1542/peds.2005-1904)
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Quality-of-Care Indicators for the Neurodevelopmental Follow-up of Very Low Birth Weight Children: Results of an Expert Panel Process

C. Jason Wang, MD, MPhila,b, Elizabeth A. McGlynn, PhDa, Robert H. Brook, MD, ScDa,c,,d, Carol H. Leonard, PhDe, Robert E. Piecuch, MDe, Steven I. Hsuehf and Mark A. Schuster, MD, PhDa,b,,d

a RAND Health, Santa Monica, California
b Department of Pediatrics, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California
c Division of General Internal Medicine, Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angles, California
d Department of Health Services, School of Public Health, University of California, Los Angeles, Los Angeles, California
e Department of Pediatrics, University of California, San Francisco, San Francisco, California
f University of California, Los Angeles, Los Angeles, California


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE. To develop a set of quality indicators for the neurodevelopmental follow-up care of very low birth weight (VLBW; <1500 g) children.

METHODS. We reviewed the scientific literature on predictors of neurodevelopmental outcomes for VLBW children and the clinical practice guidelines relevant to their care after hospital discharge. An expert panel with members nominated by the American Academy of Pediatrics, the National Institute of Child Health and Human Development, the Vermont Oxford Network, and the California Children's Service was convened. We used a modified Delphi method to evaluate and select the quality-of-care indicators.

RESULTS. The panel recommended a total of 70 indicators in 5 postdischarge follow-up areas: general care; physical health; vision, hearing, speech, and language; developmental and behavioral assessment; and psychosocial issues. Of these, 58 (83%) indicators were in preventive care, 5 (7%) were in acute care, and 7 (10%) were in chronic care.

CONCLUSION. The quality indicators cover follow-up care for VLBW infants with various medical conditions. Given the elevated rates of long-term neurodevelopmental disabilities and the potential impact of poor health care, this new set of indicators provides an opportunity to assess and monitor the quality of follow-up care with the ultimate aim of improving the quality of care for this high-risk population.

Key Words: low birth weight • quality of care

Abbreviations: VLBW—very low birth weight • NBW—normal birth weight • VON—Vermont Oxford Network

Each year in the United States, 40000 children are born with very low birth weight (VLBW; <1500 g), with almost all born prematurely.1, 2 In the past 2 decades, advances in neonatal intensive care medicine have reduced the mortality of VLBW infants. In 1988, 74% of VLBW infants survived until discharge to home or a long-term-care facility, compared with 80% in 1991 and 84% in 1995.3

VLBW infants represent a heterogeneous group with varying degrees of medical and social risks.4 Although some have normal growth and development, others have mild to severe developmental abnormalities. For example, VLBW children are at significantly increased risk for neurosensory problems (eg, vision, hearing, and speech impairments). Visual impairments are common, and their prevalence increases with decreasing gestational age.5–10 Compared with normal birth weight (NBW) children, VLBW children face a 2 to 3 times greater risk for ophthalmic morbidity (impaired visual acuity, strabismus, color vision defects, and visual field defects).10, 11 VLBW infants also have an increased risk for hearing loss,12–15 speech and language delays,12, 15–22 and behavioral and attentional disorders.12, 22–31 Approximately 6% to 20% of VLBW children have cerebral palsy and related neurologic disability, compared with lower rates among NBW children.12, 32 Infants with bronchopulmonary dysplasia (with prolonged ventilation), history of severe intracranial hemorrhage, and cerebral white matter damage are particularly at risk for poor neurodevelopmental outcomes.12, 33, 34 Even VLBW children who seem "healthy" in childhood may have greater limitations in activities of daily living during adolescence.11 VLBW children at a 20-year follow-up had lower mean IQs, lower academic achievement scores, higher neurosensory impairment rates, and subnormal height, compared with NBW peers.35 Rates of adverse outcomes increase as birth weight decreases.32

Timely access and quality of care are especially important for VLBW children. Interventions such as providing antibodies to prevent respiratory syncytial virus,36, 37 treating eye disease,12, 38–43 and offering cognitive/behavioral therapy44–49 are effective in preventing or ameliorating negative sequelae of prematurity and of VLBW in randomized, controlled trials. The National Institute of Child Health and Human Development, the National Institute of Neurological Disorders and Stroke, and the Centers for Disease Control and Prevention sponsored in 2002 a workshop that established follow-up guidelines for high-risk infants.50

Although many studies have noted gaps in the quality of care that is provided in the United States,51–54 we know of no published studies on quality of care for VLBW infants after discharge. This gap may be attributable to the lack of quality assessment instruments for this population and the challenge of tracking their complex care.32

Measuring quality of care can lead to improvement in care. For example, when the Joint Commission on Accreditation of Healthcare Organizations implemented standardized performance measures to track the performance of 3000 accredited US hospitals, consistent improvement was observed, especially among hospitals that initially had a low level of performance.55 Most performance measures that are used to assess the quality of medical care rely on process measures, which assess what health care providers did for the patient and how well they did it.56 It has been shown that process-of-care measures are related to health outcomes. For example, vulnerable older patients who receive higher quality of care that is assessed with process measures have lower mortality.57

In this article, we describe our development of a set of quality-of-care indicators for the neurodevelopmental follow-up care of VLBW children. We aimed to cover a wide range of areas that are important for the care of VLBW infants with various medical conditions.


   METHODS
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 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Development of Indicators
The research team reviewed the scientific literature on clinical predictors, screening, and treatment for VLBW children. To identify systematically published literature, we searched the PubMed database from January 1966 through March 2003, using the following terms: low birth weight, neonatal intensive care unit graduates, neonatal intensive care unit follow-up, and quality of care for very low birth weight infants. To augment our search, we included searches of prominent authors in this field. We screened article titles to select abstracts to assess and then reviewed full-text articles that seemed appropriate. We also considered articles that were cited in the Agency for Healthcare Research and Quality Evidence Report, Criteria for Determining Disability in Infants and Children: Low Birth Weight.12 We reviewed a total of 437 articles. We also gathered the clinical practice guidelines that are relevant to the assessments and interventions of VLBW infants' common medical conditions.

Next, we drafted a set of potential quality-of-care indicators. An indicator was drafted if (1) it measured an intervention or a treatment with potential health benefits for the patient, (2) it was supported by adequate scientific evidence or professional consensus, (3) it covered care that is under the control or influence of the health care provider or organization, and (4) it covered information that typically is found in the medical record or information whose absence from the record could be considered a marker for poor quality.58 For each indicator, we adopted the quality-of-evidence scheme from the Canadian Task Force on Periodic Health Examination to note the highest level of evidence supporting the process: (1) randomized, controlled trial; (2) nonrandomized, controlled trial, cohort or case-control study, or multiple time series; or (3) descriptive study or expert opinion.59

Expert Panel
A 10-member expert panel was selected on the basis of nominations from the American Academy of Pediatrics Committee on the Fetus and Newborn, the California Children's Service, National Institute of Child Health and Human Development, and the Vermont Oxford Network (VON). The research team contacted nominees to determine their interest and availability at the time of the scheduled meeting. The selected panelists included 2 general pediatricians (1 from private practice, 1 from an academic setting), 4 neonatologists who are involved in VLBW follow-up, 1 psychologist, 2 behavioral/developmental pediatricians, and 1 maternal and child health researcher. See the Appendix for names and affiliations.


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  		APPENDIX VLBW Expert Panel

 
A modified Delphi method was used to rate the indicators.39 This process consisted of 1 round of anonymous ratings of the indicators by the panel, a face-to-face panel discussion, and a second round of anonymous ratings immediately after the panel discussions. It is a structured approach to expert panel deliberations that does not require consensus.

In the first round, panelists were sent the literature reviews, a list of candidate indicators, a glossary of terms, and rating sheets. They were asked to rate each indicator separately for validity and for feasibility on a 9-point scale (1 = low, 9 = high) and return their ratings to the research team before the face-to-face meeting. The panel was instructed to give an indicator a high validity score if there is adequate scientific evidence or professional consensus supporting the indicator, there are identifiable health benefits for patients who receive the specified care, clinicians or health plans with higher rates of adherence would be considered higher quality providers, and a high proportion of the determinants of adherence are under the clinician's or health plan's influence. Similarly, a high feasibility score was given if the average medical record is likely to contain information that is needed to determine adherence, estimates of adherence on the basis of medical record data are likely to be reliable, and failure to document information that is relevant to the indicator is itself a marker of poor quality. In addition to rating the indicators, panelists were asked to comment on the indicators and suggest revisions.58

The panel met on June 12 to 13, 2003, at RAND. At the beginning of the meeting, the panelists received the results of the first round of scoring so that they could compare their ratings with those of other panelists. The results that were given to each panelist showed the distribution of ratings for each indicator (without revealing the ratings of individual panelists), the median rating, and a caret on the rating sheet indicating the panelist's own initial rating on the indicators.

During the meeting, the panelists discussed the indicators and initial ratings and explored reasons for disagreements. The research team was present to answer questions about the literature review and the initial indicators. Some initial indicators were removed during the discussions by consensus; others were modified, and new ones were added. The panelists rerated the revised set of indicators anonymously during the meeting (the second round). The panel also asked the research team to proceed with development of draft indicators on specific aspects of "physical health" that had not been included in the initial set. Final ratings of these physical health indicators were obtained from the panel by mail.

Analysis of Ratings
We used the following scoring criteria to evaluate panel ratings: indicators were accepted when they received a median validity score of 7 or higher and had a median feasibility score of 4 or higher. Indicators were eliminated if substantial disagreement, defined as at least 3 votes in the 1 to 3 range and at least 3 votes in the 7 to 9 range, existed.56

The research team analyzed the final set of indicators by type of care (preventive, acute, and chronic), function of care (screening, diagnosis, treatment, and follow-up), and modality of care (history, physical examination, tests/evaluations, interventions, and returns and referrals). Preventive indicators include primary interventions such as immunizations or injury prevention counseling. Acute care indicators relate to the spectrum of care for conditions that have a time-limited course. Chronic care indicators apply to conditions that last 3 months or more and cause significant morbidity.58


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Figure 1 details the indicator development process. In the first round, 93 indicators were developed in 7 follow-up areas: general care; vision; neurologic disability and cerebral palsy; hearing, speech, and language; behavior and function; learning disability and cognitive deficits; and psychosocial issues.


Figure 1
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  		FIGURE 1 Indicator selection process: 69% (48 indicators) of the final 70 indicators came from the initial set of 93 indicators that were drafted by the research team (some of these indicators were revised by the expert panel), and 31% (22 indicators) were added during rounds 2 and 3 of the indicator selection process.

 
During the panel meeting, 22 indicators were revised, 42 indicators were deleted, and 19 new indicators were added by consensus. Among the remaining 70 rerated during the panel meeting, 9 were removed (4 for low validity, 1 for substantial disagreement on validity, and 4 for substantial disagreement on feasibility scores), resulting in 61 indicators that we deemed suitable for quality-of-care assessment.

For the "physical health" indicators, the panel rated all items as "valid" and "feasible" with significant agreement during the first round of ratings; a second round of rating for these indicators was deemed unnecessary by panel consensus. This process added 9 indicators to the list, resulting in a final set of 70 indicators.

Tables 1 to 5 list the 70 indicators in 5 areas: 19 indicators cover general care (Table 1); 9 cover physical health (Table 2); 18 cover vision, hearing, speech, and language (Table 3); 19 cover developmental and behavioral assessment (Table 4); and 5 cover psychosocial assessment (Table 5). Table 6 is a glossary of terms that were used in the indicator set.


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  		TABLE 1 Quality-of-Care Indicators: General Care

 

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  		TABLE 5 Quality-of-Care Indicators: Psychosocial Assessment

 

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  		TABLE 2 Quality-of-Care Indicators: Physical Health

 

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  		TABLE 3 Quality-of-Care Indicators: Vision, Hearing, and Speech and Language

 

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  		TABLE 4 Quality-of-Care Indicators: Developmental and Behavioral Assessment

 

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  		TABLE 6 Glossary of Terms

 
Emphasizing the importance of continuity of care from the hospital to the primary care setting, 17 of the 19 indicators in the general care category pertain to this area. For example, indicator 1 specifies inclusion of a discharge summary in the primary care provider's medical record, and indicators 2 through 17 specify particular elements in the discharge summary. The panel also recommended routine measurements for weight, height, and head circumference (indicators 18 and 19).

Physical health indicators cover areas of counseling and prevention for sudden infant death syndrome (indicators 20 and 21), respiratory syncytial virus immunoglobulin therapy (indicator 22), and appropriate use of oxygen therapy (indicators 23–26) for VLBW children with chronic lung disease, as well as measures to prevent failure to thrive (indictor 27) and anemia (indicator 28). In the area of vision, hearing, speech, and language, the expert panel emphasizes the importance of early detection of and treatment for ophthalmologic abnormalities (indicators 29–37), speech and language delays (indicators 38–42), and hearing problems (indicators 43–46), which often are found in VLBW children. For developmental and behavioral follow-up, various screening tests and formal evaluation are recommended for VLBW infants (indicators 47–60 and 64–65), with recommendations for subsequent interventions if abnormalities are suspected (indicators 61–63). Finally, the panel suggested indicators on psychosocial assessments, including the need for documentation of family demographic characteristics and risk factors (indicators 66–69) and requirements for provider follow-up if social risks are suspected (indicator 70).

Table 7 shows the distribution of indicators by care type, function, modality, and applicable age. The panel recommended 58 (83%) preventive care indicators, 5 (7%) acute care indicators, and 7 (10%) chronic care indicators. The distribution by function was as follows: 29 (41%) indicators pertain to screening, 20 (29%) pertain to diagnosis, 5 (7%) pertain to treatment, and 16 (23%) pertain to follow-up. The indicators deal with specific aspects of the patient history (39%), physical examination (11%), special tests/evaluations (30%), specific interventions (eg, medications/nutritional intake, counseling, physical therapy, occupational therapy, speech therapy, educational interventions; 10%), and patient returns or referrals (eg, general follow- up visit, or referral to subspecialists; 10%). Eighty-four percent of the indicators are applicable to children who are younger than 3 years, the period when follow-up efforts are most extensive.


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  		TABLE 7 Indicator Items by Type, Function Modality, and Age

 

   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
The quality-of-care indicators developed through this multidisciplinary expert panel process cover a wide range of areas that are important for VLBW infants with various medical conditions. These indicators are designed to assess the overall quality of follow-up care for this high-risk population. Low adherence to the recommended indicators can reflect a breakdown anywhere in the system, eg, deficiency in provider knowledge, lack of coordination among providers, lack of communication with the child's family regarding the importance of timely intervention(s), complications in the referral or reimbursement system within a health plan, or lack of local specialty providers in the child's health care network.32, 60–62

This set of indicators is based on expert review of available evidence. Given the high costs of health care for VLBW infants63 and their elevated rates of long-term neurodevelopmental disabilities, it is surprising that there have been no systematic studies of the quality of their posthospital care. Moreover, a large proportion of VLBW children are enrolled in Medicaid,63 and children and adolescents who are enrolled in Medicaid have been found to receive worse care than children who are enrolled in commercial health plans.52, 64, 65 Therefore, federally supported Title V programs could require states to provide quality-of-care assessments for VLBW infants' follow-up care as a condition of receiving federal funding. It has been shown that public reporting of quality-of-care data can improve patient outcomes. For example, the risk-adjusted mortality rates for coronary bypass surgery have declined significantly in New York State since the New York State Cardiac Reporting System was introduced.66, 67

Many VLBW infants are followed through high-risk infant follow-up programs that are run by NICUs in major hospitals; however, as these children grow or move away from the areas that are served by the hospitals, routine follow-up ceases for many. Because most general pediatricians care for so few of these children in their practices, they may not be aware of the neurodevelopmental risks that VLBW children face or of the guidelines that cover follow-up.

Educating providers in quality improvement techniques and developing measurement and feedback systems have the potential to greatly improve health care for VLBW children.68 The development of a child health services infrastructure that supports quality by simplifying and strengthening links among primary care clinicians and specialists, allied health providers, and social services, as well as schools, community organizations, and governments, would be important.68 This integration of information can assist health departments, health plans, and school systems in organizing and planning for developmental surveillance and intervention programs. Such a system also would allow health services researchers to study how quality is changing over time.

The VON, for example, has already established a NICU database that contains detailed, uniform clinical and treatment information on all infants who have birth weights of 401 to 1500 g and are born at member institutions or admitted within 28 days of birth.69 An expanded VON or development of parallel networks could provide a platform for monitoring follow-up care and assist in compiling information on the quality of care that is delivered.

During the indicator development process, issues frequently arose regarding who should perform particular elements of the care. For some services, the experts believed that quality depended on a specific type of provider (eg, ophthalmologist); for others, experts deliberately left the decision open to allow more flexibility, knowing that the availability of specialists and practice conditions may vary across communities.

It is important to emphasize that this set of indicators focuses specifically on the neurodevelopmental follow-up of VLBW infants and is not meant to cover all aspects of follow-up care. For example, functional status measurements are important for VLBW infants: 1 study found that 35% of 1- to 4-year-old VLBW NICU graduates were limited in at least 1 age-appropriate activity of daily living.70 However, although the panel considered it important to measure functional status, they unanimously decided to exclude indicators for such measurements at this time, because the currently available functional status assessment methods have not yet been validated for routine clinical use.

Most of the evidence that is available for the expert panel was level III evidence (ie, based on opinion or descriptive studies). However, when stronger evidence is lacking, expert opinion can offer valid guidance through the use of the modified Delphi panel process.71–73 It is our hope that the current set of indicators that were developed through the expert panel process can also inform directions for future clinical trials that aim to improve follow-up care for VLBW infants. As stronger clinical evidence becomes available for follow-up care, our initial set of indicators may yield to revisions that are based on that evidence. In the meantime, researchers and quality improvement personnel can begin to measure the quality of follow-up care that is provided to VLBW infants; examine and understand important factors that contribute to adherence to recommended care; and suggest opportunities for clinical efforts, research studies, and policy interventions.


   ACKNOWLEDGMENTS
 
This work was supported by the Robert Wood Johnson Clinical Scholars Program at University of California, Los Angeles, and by the Centers for Disease Control and Prevention grants U48/CCU915773 and U48/DP000056 (Dr Schuster, principal investigator).

We thank Charles Mercier, MD, Paul Shekelle, MD, PhD, and Barry Zuckerman, MD, for review of our initial draft of indicators and Colleen Carey and Sydne Newberry, PhD, for editorial assistance.


   FOOTNOTES
 
Accepted Nov 29, 2005.

Address correspondence to C. Jason Wang, MD, RAND Corporation, 1776 Main St, Santa Monica, CA 90407-2138. E-mail: jasonw{at}rand.org

The authors have indicated they have no financial relationships relevant to this article to disclose.


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