BackgroundParental concerns about their children’s development can be used as an indicator of developmental risk. We undertook a systematic review of the prevalence of parents’ concerns as an indicator of developmental risk, measured by the Parents’ Evaluation of Developmental Status (PEDS) and associated risk factors.MethodsElectronic databases, bibliographies and websites were searched and experts contacted. Studies were screened for eligibility and study characteristics were extracted independently by two authors. A summary estimate for prevalence was derived. Meta-regression examined the impact of study characteristics and quality. Meta-analysis was used to derive pooled estimates of the impact of biological and psychosocial risk factors on the odds of parental concerns indicating high developmental risk.ResultsThirty seven studies were identified with a total of 210,242 subjects. Overall 13.8% (95% CI 10.9 -16.8%) of parents had concerns indicating their child was at high developmental risk and 19.8% (95% CI 16.7-22.9%) had concerns indicating their child was at moderate developmental risk. Male gender, low birth weight, poor/fair child health rating, poor maternal mental health, lower socioeconomic status (SES), minority ethnicity, not being read to, a lack of access to health care and not having health insurance were significantly associated with parental concerns indicating a high developmental risk.ConclusionsThe prevalence of parental concerns measured with the PEDS indicating developmental risk is substantial. There is increased prevalence associated with biological and psychosocial adversity.Trial registrationPROSPERO Registration: CRD42012003215.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2431-14-231) contains supplementary material, which is available to authorized users.