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Ultrasonography in screening for developmental dysplasia of the hip in
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     1 Centre for Reviews and Dissemination, University of York, York YO10 5DD, 2 Horten Centre, University of Zurich, Zurich, Switzerland

    Correspondence to: N F Woolacott nw11@york.ac.uk

    Objective To assess the accuracy and effectiveness of the screening of all newborn infants for developmental dysplasia of the hip (DDH) using ultrasound imaging, as is standard practice in some European countries but not in the United Kingdom, the United States, or Scandinavia.

    Design Systematic review.

    Data sources Twenty three medical, economic, and grey literature databases (to March 2004), with no limitations of design or language; some references were provided by experts.

    Selection of studies Only diagnostic accuracy studies and comparative studies conducted in an unselected newborn population were eligible for the review. Two reviewers independently selected the studies and performed the quality assessment.

    Results The review identified one diagnostic accuracy study, and this was of limited quality. In this study the reference standard was treatment up to age of 8 months or an abnormal ultrasound finding at age 8 months. Ultrasound screening had a sensitivity of 88.5% (95% confidence interval 84.1% to 92.1%), specificity of 96.7% (96.4% to 97.4%), a positive predictive value of 61.6% and a negative predictive value of 99.4%. Ten studies evaluated the impact of ultrasound in screening, but these too had various methodological weaknesses, limiting the reliability of their findings. Compared with clinical screening, general ultrasound screening in newborns may increase overall treatment rates, but ultrasound screening seems to be associated with shorter and less intrusive treatment.

    Conclusions Clear evidence is lacking either for or against general ultrasound screening of newborn infants for DDH. Studies that investigate the natural course of the disorder, the optimal treatment for DDH, and the best strategy for ultrasound screening are needed.

    The term developmental dysplasia of the hip (DDH) refers to an abnormal relation between the femoral head and the acetabulum. At birth the femoral head and the acetabulum are mainly cartilaginous, and a normal adult hip joint depends on their correct development. During the newborn period unstable hips are common, but most of these develop normally.1 If subluxation or dislocation persists, anatomic changes develop, and eventually the correct positioning of the femoral head within the acetabulum (reduction) can be achieved only with surgery. Early detection of DDH can enable less invasive and potentially more effective corrective procedures.

    Various screening strategies are available for early detection and treatment of DDH. Clinical screening of newborns includes ascertainment of the medical history (family history, pregnancy) and a clinical examination using Ortolani and Barlow manoeuvres. With ultrasound screening, an imaging technique developed by, in particular, Graf,2 Harcke,3 and Terjesen,4 5 cartilage can be visualised, and this allows detection of abnormal positioning of the femoral head within the acetabulum, instability, and dysplasia at a very young age. The timing of the ultrasound screening is an ongoing focus of debate6: some argue that all newborns should be screened within the first week of life,7 whereas others favour screening after two or three months because at an earlier age most hips with abnormal ultrasound findings subsequently develop normally.8 Early non-invasive interventions in newborns or infants suspected of being at risk of DDH after clinical or ultrasound screening, include broad diapering, splinting, overhead extensions, or the Pavlik harness.9 10 However, evidence on the effectiveness of these interventions is scarce.11

    Some believe that DDH detected on ultrasonography should be treated very early or should be followed up intensively. The assumption of proponents of ultrasound screening is that untreated cases will have an adverse outcome,7 whereas others believe that the risk of overtreatment is considerable and that the cost-benefit equation for ultrasound screening is not favourable enough.10 12 Consequently, the screening of all newborn infants at birth for DDH using ultrasound imaging is standard practice in some European countries, such as Germany and Switzerland, but has not been accepted in the United Kingdom, the United States, or Scandinavia.13 14 Therefore, we conducted a systematic review to determine the diagnostic accuracy of ultrasonography for detecting DDH in a unselected population of newborns and to assess the impact of ultrasound screening of newborn infants.

    Methods

    Literature search and study selection

    The literature search using the terms "ultrasonography", "hip dysplasia", and "new-born" (with their synonyms and closely related words) involved a range of 23 medical, economic, and grey literature databases including Medline, Embase, Biosis, Science Citation Index, the Cochrane controlled trials register, plus five websites. All searches were last updated in March 2004. The searches were not limited by study design or by language. We identified further studies by examining the reference lists of all included articles. In addition, some literature was provided by Swiss Federal Office for Social Security (which commissioned this review) and by individual experts. The full list of sources and the search strategy is available from the authors.

    Two reviewers (NFW, MAP) independently appraised each reference according to the inclusion and exclusion criteria. Any disagreements were resolved by consensus. Studies eligible for inclusion were diagnostic accuracy studies in an unselected newborn population or studies comparing an ultrasound screening regimen with another screening strategy that reported on outcomes such as overall treatment rates, rates of operative intervention, rates of abduction splinting, rate of delayed diagnosis, time to treatment, duration of treatment, rate of treatment complications, false diagnostic labelling, and any long term functional outcomes (such as osteoarthritis). To avoid any spectrum bias that may arise from the selection of participants15 we aimed to review only studies of an unselected population of newborns, rather than infants with suspected or frank DDH or notable risk factors for DDH.

    Data extraction and analysis

    We extracted data on to predesigned forms. All relevant data were extracted by one reviewer (NFW) and independently checked for accuracy by a second reviewer (MAP). We did not have a general policy of contacting authors for study details because the time allowed by the commissioning body was limited. We did, however, request specific data for two trials where the total for the screened population was required,16 17 but these data were unavailable. Diagnostic accuracy studies were assessed for quality using the QUADAS checklist.18 For studies evaluating the impact of ultrasound screening on therapeutic decisions or patient outcomes, or on both, we created a checklist, which related to very general issues of study quality; this was done by combining the main elements of the checklists for cohort and randomised controlled studies given in a report by the NHS Centre for Reviews and Dissemination.19 Two reviewers independently assessed the quality of included studies and agreed on quality scoring in consensus. The included studies were combined in a narrative synthesis and treatment differences calculated (mean differences or absolute risk differences) with 95% confidence intervals. Findings were not pooled statistically because of the diversity of study designs, ultrasound techniques, and therapeutic management.

    Results

    The search strategy generated 787 references. We selected 188 studies for full text assessment, of which 10 met the inclusion criteria. Of the excluded studies, about three quarters had not been conducted in a general (unselected) population of newborn infants, and about a quarter included unselected newborns but had no control group.

    Diagnostic accuracy

    We identified one study that evaluated the diagnostic accuracy of ultrasound (table 1).20 The index test was ultrasonography at the age of 1, 2, and 3 months, and the reference standard was defined by the decision to treat or by an abnormal ultrasound finding at the age of 8 months. The quality of the study (see table A on bmj.com) was limited because the reference test might not have correctly classified patients and was not independent of the index test. Because the reference test was the end of follow-up and therefore encompassed decision to treat at any age, some treated infants might have resolved spontaneously; such cases represent overtreatment. The calculated sensitivity of ultrasonography was 88.5% (95% confidence interval 84.1% to 92.1%), the specificity 96.7% (96.4% to 97.4%), the positive likelihood ratio 29.1, the negative likelihood ratio 0.12, the positive predictive value 61.6%, and the negative predictive value 99.4%.

    Table 1 Characteristics of included studies of ultrasound screening in unselected newborns

    Impact of ultrasound screening

    We identified two randomised controlled trials (RCTs)21 22 and eight non-randomised studies comparing ultrasound screening of newborns with another screening regimen (table 1). One of these studies was the diagnostic accuracy study described earlier.20 The ultrasonography was done with Graf's basic technique in six studies,17 20 23-26 with a modified technique after Terjesen27 in three,21 22 28 and with a modified technique after Harcke29 in one study.16 The level of experience of the examiners could not be compared between the studies because experience was described in only two studies.16 21 The overall quality of the included studies was limited. Even the two RCTs21 22 were of limited quality: one was found to have an allocation to treatment that was not truly random,21 and in neither RCT were assessors blind to screening group. The main biases inherent in the studies are summarised in table 1 (further details of the quality assessment are in table B on bmj.com). The main findings of the studies are given in table 2.

    Table 2 Results of the 10 studies included in the review

    Treatment rate

    Both RCTs21 22 and all but one of the other five studies that reported overall treatment rate17 20 24-26 found an increase associated with general ultrasound screening. However, ultrasound screening was associated with a reduction in surgical procedures or inpatient treatment for the correction of DDH.16 17 20 23

    Duration of treatment

    Two studies reported effects on treatment duration. One, conducted in Poland, used broad diapering, splinting, and, where necessary, overhead extensions as treatment and reported a reduction in treatment duration from 11.6 (standard deviation 6.5) months to 7.8 (3.7) months after the introduction of ultrasonogrpahy.24 The other study, conducted in Jordan, involved treatment with the Pavlik harness; it found that ultrasound screening at birth was associated with a shorter mean treatment duration (1.16 months) than screening at age 3-4 months of age (mean treatment duration 2.9 months).25

    Rate of developmental dysplasia of the hip diagnosed late

    Three studies defined "late" diagnosis as diagnosis after age 1 month.21 22 28 In two of these studies the rate of late diagnosed DDH after clinical screening plus ultrasonography was compared with that seen with clinical screening alone, with prevalences per 1000 of 1.4 (95% confidence interval 0.18 to 3.39) versus 2.6 (1.0 to 4.19),21 and 0.7 (0 to 1.41) versus 2.6 (1.8 to 3.39).28 Two of the studies (both RCTs) compared general ultrasound screening with clinical screening plus selective ultrasound screening and reported higher rates with selective screening, but in neither study was the difference significant.21 22 The differences between studies may be explained partly by the small absolute number of cases from which the rates are calculated, but they may also be a reflection of an increasing level of expertise with ultrasound imaging over time (the study with the lowest rates being the most recent study).

    In the study by Roovers et al, in which "late" was defined as at or after age 8 months, the number of cases of DDH missed by the two screening programmes (that is, those identified only at the reference test) was 17 (0.8%) with clinical screening compared with 31 (0.6%) with ultrasound screening20; this difference was not significant (-0.2%; -0.75% to 0.17%).

    Discussion

    Kocher MS. Ultrasonographic screening for developmental dysplasia of the hip: an epidemiologic analysis (part I). Am J Orthop 2000;29: 929-33.

    Graf R. Classification of hip joint dysplasia by means of sonography. Arch Orthop Trauma Surg 1984;102: 248-55.

    Harcke HT, Grissom LE. Performing dynamic sonography of the infant hip. AJR Am J Roentgenol 1990;155: 837-44.

    Terjesen T, Runden TO, Tangerud A. Ultrasonography and radiography of the hip in infants. Acta Orthop Scand 1989;60: 651-60.

    Terjesen T. Ultrasound as the primary imaging method in the diagnosis of hip dysplasia in children aged < 2 years. J Pediatr Orthop B 1996;5: 123-8.

    Wientroub S, Grill F. Ultrasonography in developmental dysplasia of the hip. J Bone Joint Surg Am 2000;82a: 1004-18.

    Graf R, Tschauner C, Klapsch W. Progress in prevention of late developmental dislocation of the hip by sonographic newborn hip screening—results of a comparative follow-up-study. J Pediatr Orthop B 1993;2: 115-21.

    Marks DS, Clegg J, al Chalabi AN. Routine ultrasound screening for neonatal hip instability. Can it abolish late-presenting congenital dislocation of the hip? J Bone Joint Surg Br 1994;76: 534-8.

    Suzuki S. Ultrasound and the Pavlik harness in CDH. J Bone Joint Surg Br 1993;75: 483-7.

    Patel H. Preventive health care, 2001 update: screening and management of developmental dysplasia of the hip in newborns. CMAJ 2001;164: 1669-77.

    Elbourne D, Dezateux C, Arthur R, Clarke NM, Gray A, King A, et al. Ultrasonography in the diagnosis and management of developmental hip dysplasia (UK hip trial): clinical and economic results of a multicentre randomised controlled trial. Lancet 2002;360: 2009-17.

    American Academy of Pediatrics. Clinical practice guideline: early detection of developmental dysplasia of the hip. Pediatrics 2000;105: 896-905.

    Gunther KP, Stoll S, Schmitz A, Niethard FU, Altenhofen L, Melzer C, et al. Erste Ergebnisse aus der Evaluationsstudie des sonographischen Huftscreenings in der Bundesrepublik Deutschland . Z Orthop Ihre Grenzgeb 1998;136: 508-12.

    Kohler G, Hell AK. Experiences in diagnosis and treatment of hip dislocation and dysplasia in populations screened by the ultrasound method of Graf. Swiss Med Wkly 2003;133: 484-7.

    Whiting P, Rutjes A, Reitsma J, Glas AS, Bossuyt P, Kleijnen J. Sources of variation and bias in studies of diagnostic accuracy: a systematic review. Ann Intern Med 2004;140: 189-202.

    Clegg J, Bache CE, Raut VV. Financial justification for routine ultrasound screening of the neonatal hip. J Bone Joint Surg Br 1999;81: 852-7.

    Grill F, Muller D. Ergebnisse des Huftultraschallscreenings in ?sterreich . Orthopade 1997;26: 25-32.

    Whiting P, Rutjes A, Reitsma J, Bossuyt P, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003;3(1): 25.

    NHS Centre for Reviews and Dissemination. Undertaking systematic reviews of research on effectiveness: CRD's guidance for carrying out or commissioning reviews. 2nd ed. York: NHS CRD, 2001. (Report No 4.)

    Roovers EA, Boere-Boonekamp MM, Castelein RM, Zielhuis GA, Kerkhoff AHM. Effectiveness of ultrasound screening for developmental dysplasia of the hip. Arch Dis Child Fetal Neonatal Ed 2005;90: F25-30.

    Rosendahl K, Markestad T, Lie RT. Ultrasound screening for developmental dysplasia of the hip in the neonate: the effect on treatment rate and prevalence of late cases. Pediatrics 1994;94: 47-52.

    Holen K, Tegander A, Bredland T, Johansen O, Saether O, Eik-Nes S, et al. Universal or selective screening of the neonatal hip using ultrasound? A prospective, randomised trial of 15 529 newborn infants. J Bone Joint Surg 2002;84B: 886-90.

    Eggl H, Krismer M, Klestil T, Frischhut B. Auswirkungen des Hüftsonographiescreenings. Eine epidemiologische Studie . Orthopade 1993;22: 277-9.

    Maj S, Sosnierz A. Ocena programu wczesnego rozpoznawania wrodzonej dysplazji biodra z wykorzystaniem badania ultrasonograficznego . Pol Tyg Lek 1989;44: 916-7.

    Malkawi H, Tadros F, Khasawneh Z, Al Asir B. Simple or stress sonographic hip screening in the newborn versus simple hip screening at the age of three to four months. Saudi Med J 1997;18: 507-11.

    Krolo I, Viskovic K, Kozic S, Marotti M, Klaric-Custovic R, Banak-Zahtila N, et al. The advancement in the early diagnostics of developmental hip dysplasia in infants—the role of ultrasound screening. Coll Antropol 2003;27: 627-34.

    Tegnander A, Terjesen T, Bredland T, Holen KJ. Incidence of late-diagnosed hip-dysplasia after different screening methods in newborns. J Pediatr Orthop B 1994;3: 86-8.

    Terjesen T, Bredland T, Berg V. Ultrasound for hip assessment in the newborn. J Bone Joint Surg Br 1989;71: 767-73.

    Harcke HT, Clarke NM, Lee MS, Borns PF, MacEwen GD. Examination of the infant hip with real time ultrasonography. J Ultrasound Med 1984;4: 131-7.

    Tegnander A, Holen KJ, Terjesen T. The natural history of hip abnormalities detected by ultrasound in clinically normal newborns: a 6-8 year radiographic follow-up study of 93 children. Acta Orthop Scand 1999;70: 335-7.

    Von Kries R, Ihme N, Oberle D, Lorani A, Stark R, Altenhofen L, et al. Effect of ultrasound screening on the rate of first operative procedures for developmental hip dysplasia in Germany. Lancet 2003;362: 1883-7.

    Puhan M, Woolacott N, Kleijnen J, Steurer J. Observational studies on ultrasound screening for developmental dysplasia of the hip in newborns—a systematic review. Ultraschall in der Medizin 2003;24: 377-82.

    Cox SL, Kernohan WG. They cannot sit properly or move around: seating and mobility during treatment for developmental dysplasia of the hip in children. Pediatr Rehabil 1998;2: 129-34.

    Gardner F, Dezateux C, Elbourne D, Gray A, King A, Quinn A, et al. The hip trial: psychosocial consequences for mothers of using ultrasound to manage infants with developmental hip dysplasia. Arch Dis Child Fetal Neonatal Ed 2005;90: 17-24.

    Dezateux C, Brown J, Arthur R, Karnon J, Parnaby A. Performance, treatment pathways, and effects of alternative policy options for screening for developmental dysplasia of the hip in the United Kingdom. Arch Dis Child 2003;88: 753-9.

    Roovers EA, Boere-Boonekamp MM, Zielhuis GA, Kerkhoff AHM. The best strategy to perform ultrasound screening for developmental dysplasia of the hip. In: Roovers EA. Post-neonatal ultrasound screening for developmental dysplasia of the hip. A study of cost-effectiveness in the Netherlands . Enschede, Netherlands: University of Twente, 2004: 55-66.(Nerys F Woolacott, research fellow1, Mil)