Authors' objectives:

The objective of this research was to evaluate the effectiveness, clinical impact and cost-effectiveness of ultrasound in screening of newborns for developmental dysplasia of the hip (DDH).

Authors' results and conclusions: The search strategy generated 787 references. A total of 195 papers were of potential interest and of these 188 were obtained and appraised for inclusion in the review. A total of 63 references describing 62 studies were included in the review. These comprised 11 papers: one study of diagnostic accuracy, 10 studies on the impact of ultrasound in screening for newborns for DDH, four economic evaluations and 47 descriptions of clinical experience. The one study of diagnostic accuracy was a prospective cohort study conducted in the Eastern Netherlands between 1 September 1998 and 30 November 1999. The ultrasound screening programme involved ultrasound imaging at the age of one, two and three months, with a reference test performed at eight months. Only children with sustained physical abnormality were referred for further diagnostic work-up and, where necessary, treatment. This study was flawed due to the choice of reference standard. In addition to those children who had an abnormal result at the reference test at eight months, infants were diagnosed with DDH if they were deemed to require treatment at any stage in the screening process. Thus, an unknown number of children treated during the screening program may in fact have been instances of overtreatment, and the sensitivity was likely to have been overestimated. The results from this study generated the following values: the sensitivity of ultrasound was 88.5%; the specificity was 96.7%; the positive likelihood ratio was 29.1; the negative likelihood ratio was 0.12; the positive predictive value (PPV) was 61.6%; the negative predictive value (NPV) was 99.4%; and the diagnostic odds ratio was 245.8. The studies that evaluated the impact of ultrasound in screening newborn infants for DDH on the therapeutic decisions and on patient outcomes were of poor overall quality. Only two were randomised controlled trials (RCT) of limited quality, the others were mostly retrospective observational studies with historical controls. The populations included in the studies came from seven countries (Austria, Jordan, Norway, Poland, the UK, the Netherlands and Croatia) all from various periods between 1980 and 2001. The findings from one RCT indicated that general ultrasound screening of newborns at birth for DDH appears to result in the overtreatment at a rate of around 16 infants per 1000 screened. This result was reflected in the findings of observational studies. General ultrasound screening of newborns at birth for DDH reduced the number of cases of DDH late detected by 1 to 2 per 1000 when this was defined as diagnosed after one month of age but not when defined as after eight months of age. Both RCTs found that general ultrasound screening was not statistically significantly better at reducing the number of cases of DDH diagnosed after one month of age than was selective ultrasound screening (in which only those infants with known risk factors for DDH are examined with ultrasound). General ultrasound screening of newborns at birth or one month resulted in 1 to 2 fewer cases per 1000 requiring treatment with open or closed reduction or other in-patient treatment. The need for an operative intervention may be recognised earlier with ultrasound, rather than clinical screening (reduced from 12 months to 7 months in one study) and ultrasound screening may be associated with a shorter treatment duration (1.74 months in one study). Only one comparative study of Graf's methodology conducted in the context of general newborn screening for DDH was identified. The findings did not indicate any meaningful difference between the utility of the two imaging techniques studied.

Authors' recommendations: Ultrasound imaging performed initially at age one month appears to be a sensitive diagnostic screening test. However, better quality diagnostic accuracy studies are required. General screening of newborns at birth or at one month of age for DDH using ultrasound rather than clinical examination appears to increase overall treatment rates and may be associated with overtreatment. General ultrasound screening of newborns may reduce the severity and invasiveness of the treatments required for DDH. There is no evidence that ultrasound screening reduces the number of clinically relevant cases of DDH diagnosed late. Limited evidence indicates that general ultrasound screening of newborns offers little, if any increased benefit over selective use of ultrasound imaging. There are no reliable data relating to the possible adverse consequences associated with general ultrasound screening of newborns for DDH or any associated treatments. Further research is required. Few economic evaluation data are available and these are of limited value due to the quality of the clinical data upon which they are based. Overall the cost of ultrasound screening of newborns for DDH may be comparable to or better than that of other screening programmes There is a lack of evidence. Studies that address the questions relating to the true course of DDH, the effects of treatment, and the accuracy of ultrasound screening are required.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.york.ac.uk/inst/crd/CRD_Reports/crdreport28.pdf

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: University of York

Contact Address: University of York, York, Y01 5DD, United Kingdom. Tel: +44 1904 321040, Fax: +44 1904 321041,

Contact Name: crd@york.ac.uk

Contact Email: crd@york.ac.uk

Copyright: Centre for Reviews and Dissemination