Standardisation of crown-rump length measurement.

Correct estimation of gestational age is essential for any study of ultrasound biometry and for everyday clinical practice. However, inconsistency in pregnancy dating may occur through differences in measurement methods or errors during measurement. In the INTERGROWTH-21(st) Project, pregnancies are dated by the last menstrual period, provided that it is certain and associated with a regular menstrual cycle, and the gestational age by dates concurs with a first-trimester ultrasound crown-rump length (CRL) estimation. Hence, there was a need to standardise CRL measurement methodology across the study sites in this international, multicentre project to avoid systematic differences in dating. To achieve uniformity we undertook the following steps: the ultrasound technique was standardised by disseminating an illustrated, operating manual describing CRL plane landmarks and calliper application, and posters describing the correct acquisition technique were disseminated for quick reference. To ensure that all ultrasonographers understood the methodology, they forwarded a log-book to the INTERGROWTH-21(st) Ultrasound Coordinating Unit, containing the answers to a written test on the manual material and five images of a correctly acquired CRL. Interpretation of CRL was also standardised by ensuring that the same CRL regression formula was used across all study sites. These methods should minimise potential systematic errors in dating associated with pooling data from different health institutions, and represent a model for standardising CRL measurement in future studies.

Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project.

The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards.

Standardisation and quality control of ultrasound measurements taken in the INTERGROWTH-21st Project.

Meticulous standardisation and ongoing monitoring of adherence to measurement protocols during data collection are essential to ensure consistency and to minimise systematic error in multicentre studies. Strict ultrasound fetal biometric measurement protocols are used in the INTERGROWTH-21(st) Project so that data of the highest quality from different centres can be compared and potentially pooled. A central Ultrasound Quality Unit (USQU) has been set up to oversee this process. After initial training and standardisation, the USQU monitors the performance of all ultrasonographers involved in the project by continuously assessing the quality of the images and the consistency of the measurements produced. Ultrasonographers are identified when they exceed preset maximum allowable differences. Corrective action is then taken in the form of retraining or simply advice regarding changes in practice. This paper describes the procedures used, which can form a model for research settings involving ultrasound measurements.

Managing data for the international, multicentre INTERGROWTH-21st Project.

The INTERGROWTH-21(st) Project data management was structured incorporating both a centralised and decentralised system for the eight study centres, which all used the same database and standardised data collection instruments, manuals and processes. Each centre was responsible for the entry and validation of their country-specific data, which were entered onto a centralised system maintained by the Data Coordinating Unit in Oxford. A comprehensive data management system was designed to handle the very large volumes of data. It contained internal validations to prevent incorrect and inconsistent values being captured, and allowed online data entry by local Data Management Units, as well as real-time management of recruitment and data collection by the Data Coordinating Unit in Oxford. To maintain data integrity, only the Data Coordinating Unit in Oxford had access to all the eight centres' data, which were continually monitored. All queries identified were raised with the relevant local data manager for verification and correction, if necessary. The system automatically logged an audit trail of all updates to the database with the date and name of the person who made the changes. These rigorous processes ensured that the data collected in the INTERGROWTH-21(st) Project were of exceptionally high quality.

Intra- and interobserver variability in fetal ultrasound measurements.

OBJECTIVE: To assess intra- and interobserver variability of fetal biometry measurements throughout pregnancy. METHODS: A total of 175 scans (of 140 fetuses) were prospectively performed at 14-41 weeks of gestation ensuring an even distribution throughout gestation. From among three experienced sonographers, a pair of observers independently acquired a duplicate set of seven standard measurements for each fetus. Differences between and within observers were expressed in measurement units (mm), as a percentage of fetal dimensions and as gestational age-specific Z-scores. For all comparisons, Bland-Altman plots were used to quantify limits of agreement. RESULTS: When using measurement units (mm) to express differences, both intra- and interobserver variability increased with gestational age. However, when measurement of variability took into account the increasing fetal size and was expressed as a percentage or Z-score, it remained constant throughout gestation. When expressed as a percentage or Z-score, the 95% limits of agreement for intraobserver difference for head circumference (HC) were ± 3.0% or 0.67; they were ± 5.3% or 0.90 and ± 6.6% or 0.94 for abdominal circumference (AC) and femur length (FL), respectively. The corresponding values for interobserver differences were ± 4.9% or 0.99 for HC, ± 8.8% or 1.35 for AC and ± 11.1% or 1.43 for FL. CONCLUSIONS: Although intra- and interobserver variability increases with advancing gestation when expressed in millimeters, both are constant as a percentage of the fetal dimensions or when reported as a Z-score. Thus, measurement variability should be considered when interpreting fetal growth rates.

Standardization of fetal ultrasound biometry measurements: improving the quality and consistency of measurements.

OBJECTIVE: To assess whether a standardization exercise prior to commencing a fetal growth study involving multiple sonographers can reduce interobserver variation. METHODS: In preparation for an international study assessing fetal growth, nine experienced sonographers from eight countries participated in a standardization exercise consisting of theoretical and practical sessions. Each performed a set of seven standard fetal measurements on pregnant volunteers at 20-37 weeks' gestation, and these were repeated by the lead sonographer; all measurements were taken in a blinded fashion. After this the sonographers had hands-on practice and feedback sessions on other volunteers. This process was repeated three times. Measurement differences between sonographers and the lead sonographer, expressed as a gestational-age-specific Z-score, between the first and third scans were compared using the Wilcoxon signed ranks test, and variance was assessed using Pitman's test. Interobserver agreement was also assessed using the intraclass correlation coefficient (ICC), and all images were scored for quality in a blinded fashion. RESULTS: At baseline the level of agreement and image scoring were high. A significant reduction in the differences between sonographers and the lead sonographer were seen for fetal biometry overall (head circumference, abdominal circumference and femur length) between the first and third scans (median Z-scores, 0.46 and 0.24; P = 0.005), and a reduction in the variance was also observed (P < 0.001). The ICCs for measurement pairs for every fetal measurement showed a clear trend of increasing ICC (better agreement) with consecutive training scan sessions, although no improvement in image scores was seen. CONCLUSION: Even for experienced sonographers, a standardization exercise before starting a study of fetal biometry can improve consistency of measurements. This could be of relevance for studies assessing fetal growth in multicenter sites.

Morphologic significance of bifid uvula.

Bifid uvula is often regarded as a marker for submucous cleft palate although this relationship has not been fully confirmed. The reason for the tacitly assumed connection between these two anomalies has, in part, been perpetuated by the generally accepted definition of submucous cleft palate as the triad of bifid uvula, notching of the hard palate, and muscular diastasis of the soft palate. Recently, investigations have provided evidence of more subtle manifestations of submucous cleft palate by the use of nasopharyngoscopic examination of the palate and pharynx. It has been determined that submucous cleft palate can occur even when a peroral examination shows an intact uvula. This finding places the "marker" relationship in question. In order to determine the frequency of association between bifid uvula and submucous clefting, a total ascertainment of children with bifid uvula from a suburban pediatric practice was examined nasopharyngoscopically. It was determined that in all but two cases, children with bifid uvula had some or all of the landmarks of submucous cleft palate. Several of the children were found to have velopharyngeal insufficiency and mildly hypernasal speech. This finding prompts caution in the recommendation of adenoidectomy in the presence of bifid uvula.

Recruiting physicians without inviting trouble.

Many hospitals use physician recruitment strategies--generally assistance or employment strategies--to ensure medical staff loyalty. Although these strategies appeal to both hospitals and physicians, they are becoming increasingly problematic. Over the past three years, the government has issued pronouncements that question their legality. Thus any hospital considering physician recruitment strategies would be wise to evaluate them in light of various legal issues. such as reimbursement, nonprofit taxation, corporate practice of medicine, and certificate-of-need statutes. The consequences of failing to consider these issues can be ominous. The penalties for violating the proscribed remuneration provision of the Medicare act can include a fine, imprisonment, suspension from the Medicare and Medicaid programs, or loss of license. Payment issues can result in reduced reimbursement levels. Nonprofit taxation issues can trigger the loss of tax exemption. As a result of the corporate practice of medicine, a physician recruitment strategy may not be reimbursable by third-party payers or may even constitute the unauthorized practice of medicine. Finally, in some states, physician recruitment may trigger certificate-of-need review.

Regularity of unit length boosts statistical learning in verbal and nonverbal artificial languages.

Humans have remarkable statistical learning abilities for verbal speech-like materials and for nonverbal music-like materials. Statistical learning has been shown with artificial languages (AL) that consist of the concatenation of nonsense word-like units into a continuous stream. These ALs contain no cues to unit boundaries other than the transitional probabilities between events, which are high within a unit and low between units. Most AL studies have used units of regular lengths. In the present study, the ALs were based on the same statistical structures but differed in unit length regularity (i.e., whether they were made out of units of regular vs. irregular lengths) and in materials (i.e., syllables vs. musical timbres), to allow us to investigate the influence of unit length regularity on domain-general statistical learning. In addition to better performance for verbal than for nonverbal materials, the findings revealed an effect of unit length regularity, with better performance for languages with regular- (vs. irregular-) length units. This unit length regularity effect suggests the influence of dynamic attentional processes (as proposed by the dynamic attending theory; Large & Jones (Psychological Review 106: 119-159, 1999)) on domain-general statistical learning.

Shared structural and temporal integration resources for music and arithmetic processing.

While previous research has investigated the relationship either between language and music processing or between language and arithmetic processing, the present study investigated the relationship between music and arithmetic processing. Rule-governed number series, with the final number being a correct or incorrect series ending, were visually presented in synchrony with musical sequences, with the final chord functioning as the expected tonic or the less-expected subdominant chord (i.e., tonal function manipulation). Participants were asked to judge the correctness of the final number as quickly and accurately as possible. The results revealed an interaction between the processing of series ending and the processing of the task-irrelevant chords' tonal function, thus suggesting that music and arithmetic processing share cognitive resources. These findings are discussed in terms of general temporal and structural integration resources for linguistic and non-linguistic rule-governed sequences.