SIR–The paper by Harris et al.1 describes the Harris Infant Neuromotor Test (HINT), an assessment of infant motor function developed by the first author. The stated purpose of the HINT is ‘to differentiate atypical from typical motor development in infants aged 2.5 to 12.5 months.’ Hence, this first report of the predictive validity of the HINT deserves careful review. Unfortunately, the article lacks key information, so the reader is unable to evaluate the study procedures, or to determine the clinical validity of the HINT. Demographic and birth characteristics are presented for 144 infants, recruited as a convenience sample of 58-term and 86 at-risk infants. However, the authors report attrition of 21% prior to their primary outcome at 2 years and 50% prior to outcome at 3 years. This implies the predictive validity is actually based on outcome of 114 infants at 2 years and 72 infants at 3 years. But, these participants are not described and the numbers are ambiguous. Tables III and IV indicate that the predictive validity results are based on a sample of 144; the ROC curves in the online supplemental materials indicate 13 missing participants at 2-year outcome. The authors discuss attrition as a limitation but conclude that the ‘considerable’ attrition in their study was not a problem because the statistically significant findings indicate adequate power. However, they do not address attrition as a source of selection bias which can seriously undermine the validity of an epidemiological study. As stated in the resource cited by the authors,2 to address attrition in long-term follow-up studies researchers should, ‘provide clear, unambiguous information on the flow of subjects through the study/cohort at each stage.’ The article by Harris et al. does not clearly describe the evolution of the study sample, nor of the participants at each end-point. The reference cited further advises researchers to ‘provide baseline characteristics for those seen and not seen at follow-up for each intervention group.’2 Harris et al. do not compare the characteristics of participants who were evaluated to those who were lost to follow-up. This information is required because it is likely that accurate prediction of developmental outcome would be more challenging for those infants who were not maintained in the study, due to a higher prevalence of confounding influences. Indeed, in the discussion the authors note a differential rate of attrition between the typical and atypical infants. If this report of predictive validity of the HINT is based only on follow-up of the infants who represented greater developmental stability relative to the source population, this bias should be noted. The authors do not provide explicit information about the outcome status of the participants. Since the key predictive measures (sensitivity, specificity, predictive values) are based on the proportion of participants with normal or abnormal outcomes, it is necessary for readers to know the a priori operational definitions of outcome, as well as the actual developmental outcome of all participants. The authors do not define the outcome criteria in the Method section. The titles for Tables III and IV suggest two levels of outcome measures based on Bayley-II scores; however, the readers are never informed of the outcomes of the individual study participants. The authors note that ‘only two infants showed significant BSID-II motor delays at age 2.’ No report is given of the number of infants who exhibited mild delay at age 2 years, or of the outcome status at 3 years. Finally, the authors claim that their sample is ‘representative of … the US population in terms of ethnic origin’ (and ‘generalizeable’), based on reported 79% Caucasian infants in their sample deemed comparable to 77% white race in the United States. In studies of health outcomes in the US, it is not standard practice to categorize participants simply as ‘white’ or ‘non-white’ because these designations may comprise very different racial/ethnic groups (Hispanic, Asian, African-American, Native American). It is unlikely that a sample of infants in British Columbia is racially comparable to the demographics of the USA. The authors should simply provide the racial/ethnic identity of their participants (not given) and allow the reader to determine the generalizability of the findings. Harris et al. are to be commended for conducting a longitudinal study over a period of 3 years in an effort to demonstrate long-term predictive validity of the HINT. Inclusion of the information missing from this article regarding the study participants and procedures would enable the reader to accurately evaluate the predictive value of this new tool.
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