one year after first urinary tract infection: role of dimercaptosuccinic acid scintigraphy.J Pediatr.1996;129:815– 820
14. Rushton HG, Majd M, Jantausch B, Wiedermann BL, Belman AB. Renal scarring following reflux and nonreflux pyelonephritis in children: evaluation with 99mtechnetium-dimercaptosuccinic acid scintigraphy [published erratum appears in J Urol 1992;148:898].J Urol.1992;147: 1327–1332
15. Schoen EJ, Bhatia S, Ray GT, Clapp W, To TT. Transient pseudohypoal-dosteronism with hyponatremia-hyperkalemia in infant urinary tract infection.J Urol.2002;167:680 – 682
16. Rodriguez-Soriano J, Vallo A, Quintela MJ, Oliveros R, Ubetagoyena M. Normokalaemic pseudohypoaldosteronism is present in children with acute pyelonephritis.Acta Paediatr.1992;81:402– 406
17. Melzi ML, Guez S, Sersale G, et al. Acute pyelonephritis as a cause of hyponatremia/hyperkalemia in young infants with urinary tract mal-formations.Pediatr Infect Dis J.1995;14:56 –59
18. Schoen EJ, Wiswell TE, Moses S. New policy on circumcision— cause for concern.Pediatrics.2000;105:620 – 623
19. Adler R, Ottaway MS, Gould S. Circumcision: we have heard from the experts; now let’s hear from the parents.Pediatrics.2001;107(2). Avail-able at: http://www.pediatrics.org/cgi/content/full/107/2/e20 20. Binner SL, Mastrobattista JM, Day MC, Swaim LS, Monga M. Effect of
parental education on decision-making about neonatal circumcision. South Med J.2002;95:457– 461
21. Collins S, Upshaw J, Rutchik S, Ohannessian C, Ortenberg J, Albertsen P. Effects of circumcision on male sexual function: debunking a myth? J Urol.2002;167:2111–2112
22. Fink KS, Carson CC, DeVellis RF. Adult circumcision outcomes study: effect on erectile function, penile sensitivity, sexual activity and satis-faction.J Urol.2002;167:2113–2116
23. Laumann EO, Masi CM, Zuckerman EW. Circumcision in the United States. Prevalence, prophylactic effects, and sexual practice. JAMA. 1997;277:1052–1057
24. Williamson ML, Williamson PS. Women’s preferences for penile cir-cumcision in sexual partners.J Sex Educ Ther.1988 Fall/Winter;14:8 –12
Home Visiting
To the Editor.—
We read with great interest the article by Olds et al1on home visiting by paraprofessionals and nurses. Many of us across the disciplines are indebted to Dr Olds for the seminal work he and his colleagues have conducted over the last several decades dem-onstrating the efficacy of his nurse home visitation program in preventing a broad array of detrimental maternal health, life course, and child developmental outcomes. Dr Olds’ work has been especially instrumental in the field of child abuse and neglect prevention, helping to spur the development of hundreds of pre-ventive home visitation programs across the United States.
The findings reported inPediatricsin September 2002 extend his earlier work by again demonstrating a wide array of positive benefits for mother-child pairs as a result of nurse home visitation, now across 3 different community settings: Elmira, New York, Memphis, Tennessee, and Denver, Colorado. We would like to caution the readers, however, concerning the conclusions they might be tempted to draw from this most recent study, which, on the face of it, appears as if Dr Olds has directly demonstrated the relative efficacy of nurses versus paraprofessionals as home visi-tors, in a way generalizable to other contexts. Dr Olds and col-leagues, themselves, directly caution us, “Because of constraints of sample size and cost, the study was not designed to make direct comparisons between paraprofessionals and nurses.”1
Olds and colleagues attempted to statistically control post hoc for some of the observed nonequivalencies across nurse and para-professional home visitor groups occurring during the study’s implementation, most notably in the substantially greater turn-over that occurred among the paraprofessional home visitors, as well as in a lower intervention dosage paraprofessional home-visited families actually received. However, as reported, a lack of equivalence across the paraprofessional and nurse home visitor groups remains across several additional important factors, pre-venting direct comparisons of nurses versus paraprofessionals without additional, more careful study. Several examples stand out: First, paraprofessional home visitors were substantially younger (mean age⫽33) than nurse home visitors (mean age⫽ 41),2and earlier research has indicated that worker age and
pre-vious work experience are key predictors of service effectiveness assessments.3,4,5
Second, nurses and paraprofessionals received nonequivalent training: “Because nurses were expected to exercise more inde-pendent judgment in helping mothers deal with physical health concerns, the nurses were given more in-depth training on the physical health and development of the mother and child.”6In addition, nurses were provided specific training in “solution-focused” therapy techniques, whereas paraprofessionals were trained in an “alternate problem-solving method.”7
Third, paraprofessionals and nurses implemented different program protocols. Some of these differences were planned,1 while others were unplanned, resulting from paraprofessionals’ discomfort with implementing a protocol that was originally de-signed for nurses.7Such changes resulted in significantly different emphases in the home visit contents delivered across paraprofes-sional and nurse groupings, with nurses providing greater atten-tion to personal health during pregnancy and parenting during infancy,7areas in which outcome differences were found.
Fourth, “a sense of competition emerged between the nurse visitors and paraprofessional home visitors,” where “performance anxiety emerged among the paraprofessionals themselves that paralleled the anxiety they felt in the presence of the nurse home visitors.”2Such competition between treatment groups is a com-mon threat to the internal validity, highlighted in Cook and Campbell’s classic work on quasi-experimental research as “de-moralization in groups receiving less desirable treatments.”8 Given the lack of equivalence on a number of important factors across nurse and paraprofessional home visitor groups, differ-ences reported in the magnitude of effects are difficult to attribute solely to the professional status of the service deliverers.
Rather than noting these as study limitations, Olds and col-leagues suggest that problems in the implementation of their study design were “inherent in paraprofessional programs” (page 493). They proceed to add: “Although other paraprofessional pro-gram models might perform better than the one tested here, the absence of clinically or statistically significant effects for most paraprofessional models tested in randomized trials makes this unlikely” (page 493). Olds and colleagues here do not acknowl-edge the previous studies of paraprofessional home visitors that have reported important intervention effects,9 –11as well as previ-ous studies employing nurses as home visitors that have failed to report significant program effects,12,13leaving the impression that the scientific base has been selectively attended to. A recent meta-analysis has examined home visitation trials targeting parent-child outcomes related to child maltreatment, and has reported that when considering the full array of studies employing nurses and paraprofessionals, program engagement and retention rates are virtually indistinguishable across professional status types, as are observed effect sizes.14
Most limiting for the broader field, the paraprofessionals used in the Denver trial do not appear as representative, holding sub-stantially less academic preparation and relevant prior training than home visitors employed in numerous other home visiting programs operating across the United States. As noted about the Denver trial, “in order to highlight the contrast between parapro-fessional and nurse home visitors . . . [we] refrained from hiring [paraprofessional] applicants who possessed bachelors’ level ed-ucation” (page 80).2Paraprofessionals in the Denver trial held no academic credentials in relevant fields such as nursing, education, psychology, or social work, in direct contrast to paraprofessionals employed in some of the most widely disseminated home visiting programs in the United States, such as those within the Healthy Families America initiative15or those employed in PAT (“Parents as Teachers”) programs.16,17A national study of Healthy Families America home visitors, for example, noted that 81% of the para-professionals held bachelor’s degrees or some college experience, and 10% had post-bachelor’s graduate training. As well, 85% had previous work experience in home visitation programs, most in the field of early childhood and child abuse and neglect, and 75% of the home visitors held specialized educational training in child development, social work, nursing, or education.18
limitations, and placed in the context of the full array of previous rigorously conducted home visitation studies. Taken as a whole, and not attended to selectively, the empirical evidence does not yet clearly indicate that one specific professional status is optimal over others in the delivery of effective preventive home visiting services.
Neil B. Guterman, PhD, MSW* Elizabeth Anisfeld, PhD‡ Mary McCord, MD, MPH‡§
Departments of *Social Work, ‡Pediatrics, and §Public Health
Columbia University New York, NY 10025
REFERENCES
1. Olds DL, Robinson J, O’Brien R, et al. Home visiting by paraprofession-als and by nurses: a randomized, controlled trial.Pediatrics.2002;110: 486 – 496
2. Hiatt SW, Sampson D, Baird D. Paraprofessional home visitation: con-ceptual and pragmatic considerations.J Community Psychol.1997;25: 77–93
3. Quinones MA, Ford JK, Teachout MS. The relationship between work experience and job performance: a conceptual and meta-analytic re-view.Personnel Psychol.1995;48:887– 891
4. Holley WH, Field HS, Holley BB. Age and reactions to jobs: an empirical study of paraprofessional workers,Aging Work.1978;1:33– 40 5. Guterman NB, Jayaratne S. “Responsibility at-risk”: perceptions of
stress, control and professional effectiveness in child welfare direct practitioners.J Soc Serv Res.1994;20:99 –120
6. Korfmacher J, O’Brien R, Hiatt S, Olds D. Differences in program implementation between nurses and paraprofessionals providing home visits during pregnancy and infancy: a randomized trial.Am J Public Health.1999;89:1847–1851
7. Korfmacher J. Examining the service provider in early intervention.Zero to Three.1998;19:17–22
8. Cook TD, Campbell DT.Quasi-Experimentation: Design and Analysis Is-sues for Field Settings.Boston, MA: Houghton Mifflin; 1979
9. Hardy JB, Street R. Family support and parenting education in the home: An effective extension of clinic-based preventive health care service for poor children.J Pediatr.1989;115:927–931
10. Dawson PM, Robinson JL, Butterfield PM, et al. Supporting new parents through home visits: effects on mother-infant interaction. Top Early Child Spec Ed.1990;10:29 – 44
11. Dawson P, Van Doorninck WJ, Robinson JL. Effects of home-based, informal social support on child health.Dev Behav Pediatr.1989;10:63– 67 12. Barkauskas VH. Effectiveness of public health nurse home visits to primaparous mothers and their infants.Am J Public Health.1983;73: 573–580
13. Infante-Rivard C, Filion G, Baumgarten M, et al. A public health home intervention among families of low socioeconomic status.Children’s Health Care.1989;18:102–107
14. Guterman NB.Stopping Child Maltreatment Before It Starts: Emerging Horizons in Early Home Visitation Services.Thousand Oaks, CA: Sage Publications; 2001
15. Prevent Child Abuse America.Healthy Families America: 2000 Profile of Program Sites.Chicago, IL: Prevent Child Abuse America; 2002 16. Wagner MM, Clayton SL. The Parents as Teachers program: results
from two demonstrations.Future Child.1999;9:91–115 17. Winter MM. Parents as teachers.Future Child.1999;9:179 –181 18. Daro D, Winje C.Healthy Families America: Profiles of Pilot Sites. Center on
Child Abuse Prevention Research.Chicago, IL: National Committee to Prevent Child Abuse; 1998
In Reply.—
Guterman, Anisfeld, and McCord urge readers not to overinter-pret the findings of our trial, raise a number of issues regarding the equivalence of the nurses and paraprofessionals, express doubt that challenges with paraprofessional home visitation are as common as we have claimed, and point out that having nurses serve as home visitors does not ensure success. In sorting out our differences, it will be important for readers to note that our group conducted the Denver trial because most paraprofessional home visiting programs tested in randomized trials had produced spo-radic, small effects that rarely were clinically or statistically
sig-nificant.1,2The study was designed to determine whether para-professionals’ performance could be improved if they were given excellent supervision and structured guidelines shown to work in previous trials when delivered by nurses.
We focused the Denver trial on a segment of the paraprofes-sional population that shared many of the social characteristics of the families they served, given the theory that reduced social distance between visitors and families would increase program effectiveness.3,4We included the nurse arm in the trial to help us interpret the success or failure of the paraprofessional program in light of the nurses’ performance and to provide a third test of the Nurse Family Partnership (NFP), as the nurse program is now called.
Guterman et al are concerned about the nonequivalence of the nurses and paraprofessionals. Nonequivalence in the background of the families would constitute bias that challenges the results of the trial (there is none of any consequence in the Denver study). Nonequivalence in the background of the visitors is to be expected in light of the study’s purpose. We explicitly chose paraprofes-sionals whose backgrounds were “closer” to the backgrounds of the families they served, not to the backgrounds of the nurses. Compared with nurses, paraprofessionals thus had different ed-ucational and socioeconomic backgrounds, familiarity with the communities they served, and ages. Moreover, all of the parapro-fessionals were parents compared with 70% of the nurses.5
Our primary objective in hiring paraprofessionals was to re-cruit the best paraprofessional visitors with these backgrounds and to provide them with excellent resources to serve their fami-lies. This included providing them with twice the level of super-vision as the nurses, detailed visit-by-visit guidelines, and a dif-ferent method of promoting parents’ abilities to cope with the demands of becoming parents and living in poverty. The parapro-fessionals’ supervisors decided that the paraprofessionals would function best if they used the “problem-solving” method (a strat-egy used by nurses in our Memphis trial and that was better suited to the paraprofessionals’ lack of formal training in the helping professions) rather than being required to learn the “so-lution-focused” strategies used by nurses in Denver. Moreover, although the paraprofessionals spent less time learning about the physical health aspects of the curriculum, they were taught to encourage the parents to work with their primary care providers in addressing physical health issues.5
These relatively minor, planned differences in the content and methods of working with families were necessary, given the back-grounds of the visitors. Aside from these planned differences, deviations that emerged in the conduct of the program resulted from the unique ways the 2 visitor types used the guidelines, given that visitors and families were free to modify the frequency of visitation and content of the program as needed. As we (Hiatt et al) have noted, the paraprofessional visitors did not feel com-fortable in using the parenting portion of the curriculum because it felt “foreign and unnecessary” to them. Part of their discomfort was attributable to their being expected to “teach” parents how to care for their children, an activity some felt was patronizing.5 Teaching is a natural part of nurses’ roles. This probably accounts for the lower portion of time paraprofessionals, compared with nurses, spent helping parents learn how to care for their children.6 Analyses of time spent on various program content areas, in-cluding parenting, physical health, and environmental health, however, showed that after controlling for other family back-ground characteristics, amount of time spent on specific activities did not account for differences in outcomes between nurse-visited and paraprofessional-visited families; indeed, an increased amount of time spent on helping parents learn how to care for their children was associated with poorer language development in the paraprofessional group—probably a reflection of the para-professionals’ spending more time on this topic with families who especially needed this kind of help.7 Their underemphasis of parenting in conducting the program, by itself, does not account for the paraprofessionals’ negligible effects on child outcomes.
It is interesting that Guterman, Anisfeld, and McCord have failed to acknowledge the major thrust of the article in which we note the paraprofessionals’ performance anxiety: that despite their commitment to and identification with the families they served, a significant portion of the paraprofessional visitors exhibited prob-lems in maintaining appropriate boundaries in working with fam-ilies, in working effectively with one another, and in making good use of the supervision given to them.5These factors, we think, are
more likely to have played a role in explaining the paraprofes-sionals’ underperformance than is their anxiety, which is equally likely to have improved their effectiveness.
Problems with boundaries, working with others in professional ways, and making good use of supervision are common in para-professional programs when visitors share many of the character-istics of the families they serve. The literature supports this con-clusion,8 –10as does our experience in consulting with others who have tested paraprofessional programs (R. Maynard, personal communication, November 2002). Moreover, we believe that nurses have more persuasive power compared with other visitor types during pregnancy and infancy because of their legitimacy and value in the eyes of pregnant women and new parents, who are particularly concerned about physical health issues.
We are thoroughly familiar with the 2 trials Guterman, Anis-feld, and McCord cite as evidence that paraprofessional programs can work. One consists of a trial of a single gifted home visitor who grew up in the Baltimore neighborhood in which she worked, but by the time she served as a home visitor, held a bachelor’s degree.11Is the success observed in this trial a reflection of para-professional programs overall or the unique talents of a single individual? The second trial, conducted in Denver, experienced problems with implementation of the design (treatment-based differences in rates of attrition and a control group that was not entirely randomized) and produced effects of questionable clinical importance (no effects on prenatal health, maternal life-course, and child maltreatment, but improvements in observed interac-tion between mothers and their children— effects limited to dyads in which the mothers were teens and Hispanics).12–14
We have noted in our reviews of home visiting programs that simply hiring nurses to serve as home visitors is insufficient1,2and have referenced the very studies cited by Guterman, Anisfeld, and McCord to support this position. When the outcomes of interest are prenatal health, child maltreatment, childhood injuries, and maternal life course, programs that have used nurses have pro-duced the most dramatic and consistent effects, but only when they follow an effective program model. The NFP tested in the Elmira, Memphis, and Denver trials has produced the largest and most consistent effects on these outcomes of any home visiting program examined to date.15,16
Part of the NFP program model requires that the nurses serve only low-income first-time mothers (and their families)—as they are in need and more likely to be receptive to such services than are higher income and multiparous women. The current trial supports our position that you need at least 2 (and probably 3) components to produce the greatest effects on these outcome domains: 1) an effective program model; 2) the right visitor type; and 3) a target population that is in need and sees the value of the service being offered.
It is difficult, using the kind of meta-analyses conducted by Guterman,17to discern requirements for program success because they consist of combinations of program characteristics. Unless there are large numbers of studies to amply fill the cells in a cross-classification matrix of program models, visitor back-grounds, and population characteristics, such analyses will fail to discriminate the conditions necessary for success. Meta-analysis, in the context of limited samples of studies, is a blunt instrument. Guterman, Anisfeld, and McCord are right that today many home visiting programs, such the Parents as Teachers and Healthy Families America programs, have moved toward recruiting visi-tors with higher educational qualifications. When put to careful tests in randomized, controlled trials, however, these program models have produced few clinically or statistically significant effects.18 –20
Results of other recently reported trials of paraprofessional programs corroborate the small effects detected for the parapro-fessionals in Denver. The Early Head Start programs that con-sisted of home visiting alone produced effects that also were small (typically in the 10%–15% of a standard deviation range at best).21 This work is important because the Head Start visitors were held to very high standards of program implementation, usually had higher educational backgrounds, had caseloads roughly half the size, and were required to visit on a more frequent basis compared with paraprofessionals in the Denver trial.22 Similarly, a well-conducted trial of an augmented version of the Healthy Families America program recently has been completed in San Diego; in this trial, parenting classes and support groups were added to the home visiting intervention, the visitors were required to have a
minimum of an associate’s degree and 4 years of previous work in health and human services, and they were able to retain families in the program at higher rates than most other home visiting programs that use paraprofessionals as home visitors.20This pro-gram produced effects similar to those achieved by paraprofes-sionals in Denver for comparable outcomes.20
We hope that successful paraprofessional program models will be developed, tested, and replicated— especially for segments of the population that have special needs and for whom the evidence is less clear. The Best Beginnings Plus program for substance-abusing parents, tested by Dr Anisfeld,16and another paraprofes-sional program for substance-abusing parents in Seattle,23 for example, may eventually meet these standards. In the meantime, vulnerable families deserve services that have the best chance of helping them and taxpayers deserve investments of public funds in prevention programs proven to work.
David Olds, PhD Lisa Pettitt, PhD Susan Hiatt, PhD John Holmberg, PsyD JoAnn Robinson, PhD Ruth O’Brien, PhD
University of Colorado Denver, CO 80218
Jon Korfmacher, PhD
Erikson Institute Chicago, IL 60611-5627
REFERENCES
1. Olds D, Kitzman H. Can home visitation improve the health of women and children at environmental risk?Pediatrics.1990;86:108 –116 2. Olds DL, Kitzman H. Review of research on home visiting.Future Child.
1993;3:51–92
3. Heins H Jr, Nance N, Ferguson J. Social support in improving perinatal outcome: the resource mothers program. Obstet Gynecol. 1987;70: 263–266
4. Kalafat J, Boroto DR. The paraprofessional movement as a paradigm community psychology endeavor.J Community Psychol.1977;5:3–12 5. Hiatt SW, Sampson D, Baird D. Paraprofessional home visitation:
con-ceptual and pragmatic considerations.J Community Psychol.1997;25:77–92 6. Korfmacher J, O’Brien R, Hiatt S, Olds D. Differences in program implementation between nurses and paraprofessionals in prenatal and infancy home visitation: a randomized trial.Am J Public Health.1999; 89:1847–1851
7. Olds D, O’Brien R, Robinson J, et al.Additional Analyses of Home Visita-tion 2000 Data.Report to the Colorado Trust (grant no. 99030). January 31, 2001
8. Johnson A.The Teenage Parent Home Visitor Services Demonstration: Pro-viding Home Visitor Services to Teen Parents on Welfare: An Analysis of Key Implementation Features.Princeton, NJ: Mathematica Policy Research, Inc; 1999
9. Larner M, Halpern R. Lay home visiting: strengths, tensions, and chal-lenges.Zero to Three.1987;8:1–7
10. Musick J, and Stott F. Paraprofessionals revisited and reconsidered. In: Shonkoff JP, Meisels SJ, eds.Handbook of Early Childhood Intervention. 2nd ed. Cambridge, UK: Cambridge University Press; 2000:439 – 453 11. Hardy J, Street R. Family support and parenting education in the home:
an effective extension of clinic-based preventive health care services for poor children.J Pediatr.1989;115:927–31
12. Dawson P, Robinson JL, Butterfield P, et al. Supporting new parents through home visits: Effects on mother-infant interaction. Top Early Child Spec Ed.1990;10:29 – 44
13. Dawson P, Van Doorninck W, Robinson J. Effects of home-based, in-formal social support on child health.Dev Behav Pediatr.1989;10:63– 67 14. Van Doorninck WJ, Dawson P, Butterfield PM, Alexander HI. Parent-Infant Support Through Lay Health Visitors.Final Report to Maternal and Child Health Service, Bureau of Community Health Services, US Public Health Service, National Institute of Health, Department of Health, Education and Welfare (grant No. MC-R-080398-03-0). March 31, 1990 15. Olds DL. Prenatal and infancy home visiting by nurses: from
random-ized trials to community replication.Prev Sci.2002;3:153–172 16. Olds DL, Robinson J, O’Brien R, et al. Home visiting by nurses and by
17. Guterman NB.Stopping Child Maltreatment Before It Starts: Emerging Horizons in Early Home Visitation Services.Thousand Oaks, CA: Sage Publications; 2001
18. Wagner MM, Clayton SL. The Parents as Teachers Program: results from two demonstrations.Future Child.1999;9:91–115
19. Duggan AK, McFarlane EC, Windham AM, et al. Evaluation of Hawaii’s Healthy Start Program.Future Child.1999 Spring/Summer;9:66–90 20. Landsverk J, Carrilio T, Connelly CD, et al. Healthy Families San Diego
Clinical Trial Technical Report. Child and Adolescent Services Research Center. San Diego Children’s Hospital and Health Center. May 31, 2002 21.Making a Difference in the Lives of Infants and Toddlers and Their Families: The Impacts of Early Head Start, Volume 1: Final Technical Report.June 2002. Child Outcomes Research and Evaluation, Office of Planning, Research, and Evaluation, Administration for Children and Families, and the Head Start Bureau, Administration on Children, Youth and Families, Department of Health and Human Services.
22.Leading the Way: Program Implementation, Volume III.December 2000. Child Outcomes Research and Evaluation, Office of Planning, Research, and Evaluation, Administration for Children and Families, and the Head Start Bureau, Administration on Children, Youth and Families, Department of Health and Human Services.
23. Ernst CC, Grant TM, Streissguth AP, Sampson PD. Intervention with high-risk alcohol and drug-abusing mothers: II. Three-year findings from the Seattle model of paraprofessional advocacy.J Commun Psychol. 1999;27:19 –38
A New Look at Meningomyeloceles
To the Editor.—
Rintoul et al1reviewed the records of 297 patients born after 1983 with an open meningomyelocele whose lesion was closed at their hospital and who were subsequently followed in their spina bifida clinic, to describe clinical outcomes. The authors are to be commended for documenting the results of conscientious and comprehensive care. I have, however, reservations about using their cross-sectional survey for their stated purpose “to serve as a comparison group . . . to assess the efficacy” of in utero (fetal) surgery for meningomyelocele.
First, I do not believe that their rate of placement of a ventricu-loperitoneal (VP) shunt for treatment of hydrocephalus (81%) or that from any cross-sectional survey can serve as a “gold stan-dard” against which the rate of developing hydrocephalus after fetal surgery can be compared. The decision about who among infants with spina bifida and hydrocephalus requires placement of a VP shunt is arbitrary and the prevalence of shunting varies from clinic to clinic. For instance, in a cohort study performed by our clinic some years ago, we found that 95% of patients had been shunted.2Likewise, there is a significant difference in the rate of VP shunt placement in the 2 series of patients who underwent fetal surgery for meningomyelocele, as acknowledged by the au-thors. In the series of patients who had fetal surgery reported from the authors’ institution, reported by Sutton et al,3only 1 of 9 (11%) had VP shunt placement, but Bruner et al,4doing fetal surgery on patients at a slightly more advanced gestational age, shunted 59%. We now follow a patient who had fetal surgery at another hospital and was not shunted there but who had marked ventricular dilatation when seen by us and was shunted subsequently. Be-cause the decision about shunt placement is arbitrary, it would be helpful if objective measures of ventricular dilatation could be used to compare the rate of developing hydrocephalus after fetal surgery to that of patients who had surgery postnatally. Objective measures of ventricular dilatation might include the ratio of the average of the frontal and occipital horn widths to the interparietal distance5or, potentially better yet, the ratio of ventricular volume to intracranial volume, determined by volumetric magnetic reso-nance imaging, at an age equivalent to 40 weeks’ gestation and/or prior to VP shunt placement.
Second, the data presented are not complete enough to use for comparison to determine if fetal surgery reduces the occurrence of Chiari II-related symptoms. The prevalence of a history of symp-toms attributable to the Chiari II malformation was not recorded in the authors’ cross-sectional survey, although they state that 9.4% had undergone posterior fossa decompression and laminec-tomy. Six of the 297 patients (2%) died from Chiari II-related symptoms in their cross-sectional survey. These are lower preva-lences of symptoms and mortality attributable to Chiari II-related
symptoms than reported by us2and by McLone et al.6The au-thors’ better outcome can be substantiated convincingly only by presenting data from a cohort study of consecutively referred patients, all followed forward over time to a preestablished end-point, including those patients whose care was transferred to another hospital.
Third, motor function was not accurately enough determined to use for comparison. McDonald et al,7in a carefully performed study, demonstrated that neurosegmental level was not uniform in individual patients with meningomyelocele and that patients should be “grouped according to the strength of specific muscles rather than by neuro-segmental level.” Further, the authors pre-sented the “best motor level” recorded in the chart, rather than the best (most accurately) determined motor level. In our own clinic, there is sometimes a difference between the 2.
Third, their data are insufficient to control for the confounding effect of method of delivery on motor outcome. Luthy et al8 demonstrated a substantially better motor outcome in patients who were delivered by elective cesarean section before a trial of labor than in those who were delivered vaginally or by cesarean section after a trial of labor. As the authors state, they do not have information about whether cesarean section was performed for their patients before or after a trial of labor. To determine if motor outcome is better after fetal surgery, it is necessary to compare motor outcome to that of infants delivered by elective cesarean section before a trial of labor, since this is “current best practice.” Fourth, the occurrence and age of occurrence of symptomatic tethered cord requiring surgery were not reported by the authors. It is possible that symptomatic tethered cord might be more com-mon in patients who have had fetal surgery than in those whose surgery was postnatal.
Rather than determine the efficacy of fetal surgery by compar-ing outcomes to a cross-sectional survey of patients who had surgery postnatally, it would be far better if a randomized trial was undertaken. New surgical procedures ought to be held to the same standards of proof of efficacy as are required for new med-ical therapies. A randomized trial for this experimental surgery is especially necessary from an ethical standpoint because of the risks to both the fetus and mother, because of the potential risk to future pregnancies (however small), and because of the option for therapeutic abortion. Ideally, outcome should not be determined by the surgeons who performed the fetal surgery, since it is now recognized that surgeons are “stakeholders” in operations that they develop or promulgate; although “the driving force [in de-veloping new surgical procedures is to save lives, there is also the appeal of technical challenge and competition to meet demand.”9 It is likely that the number of centers performing this as of yet unproven surgery will soon increase because all too often in medicine, invention is the mother of necessity. Now, therefore, is the time to organize, seek funding for, and conduct a randomized trial of fetal surgery for meningomyelocele, while it is still done at only a few centers. Comparison of outcomes of fetal surgery for meningomyelocele to any cross-sectional survey will not do to establish efficacy.
Gordon Worley, MD
Neurodevelopmental Pediatrics Myelodysplasia (Spina Bifida) Clinic Duke University Medical Center Durham, NC 27710
REFERENCES
1. Rintoul NE, Sutton LN, Hubbard AM, et al. A new look at meningomyeloceles: functional level, vertebral level, shunting, and the implications for fetal intervention.Pediatrics.2002;109:409 – 413 2. Worley G, Schuster JM, Oakes WJ. Survival at 5 year of a cohort of
newborn infants with myelomeningocele.Dev Med Child Neurol.1996; 38:816 – 822
3. Sutton LN, Adzick NS, Bilaniuk LT. Improvement in hindbrain herni-ation demonstrated by serial fetal magnetic resonance imaging follow-ing fetal surgery for myelomenfollow-ingocele.JAMA.1999;282:1826 –1831 4. Bruner JP, Tulipan N, Paschall RL, et al. Fetal surgery of
myelomenin-gocele and the incidence of shunt-dependent hydrocephalus.JAMA. 1999;282:1819 –1825
5. O’Hayon BB, Drake JM, Ossip MG, et al. Frontal and occipital horn ratio: a linear estimate of ventricular size for multiple imaging modal-ities in pediatric hydrocephalus.Pediatr Neurosurg.1998;29:245–249
DOI: 10.1542/peds.111.6.1491
2003;111;1491
Pediatrics
Neil B. Guterman, Elizabeth Anisfeld and Mary McCord
Home Visiting
Services
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DOI: 10.1542/peds.111.6.1491
2003;111;1491
Pediatrics
Neil B. Guterman, Elizabeth Anisfeld and Mary McCord
Home Visiting
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