The Best Services Trial (BeST?): a cluster randomised controlled trial comparing the clinical and cost-effectiveness of New Orleans Intervention Model with services as usual (SAU) for infants and young children entering care.

BACKGROUND: Abused and neglected children are at increased risk of health problems throughout life, but negative effects may be ameliorated by nurturing family care. It is not known whether it is better to place these children permanently with substitute (foster or adoptive) families or to attempt to reform their birth families. Previously, we conducted a feasibility randomised controlled trial (RCT) of the New Orleans Intervention Model (NIM) for children aged 0-60 months coming into foster care in Glasgow. NIM is delivered by a multidisciplinary health and social care team and offers families, whose child has been taken into foster care, a structured assessment of family relationships followed by a trial of treatment aiming to improve family functioning. A recommendation is then made for the child to return home or for adoption. In the feasibility RCT, families were willing to be randomised to NIM or optimised social work services as usual and equipoise was maintained. Here we present the protocol of a substantive RCT of NIM including a new London site. METHODS: The study is a multi-site, pragmatic, single-blind, parallel group, cluster randomised controlled superiority trial with an allocation ratio of 1:1. We plan to recruit approximately 390 families across the sites, including those recruited in our feasibility RCT. They will be randomly allocated to NIM or optimised services as usual and followed up to 2.5 years post-randomisation. The principal outcome measure will be child mental health, and secondary outcomes will be child quality of life, the time taken for the child to be placed in permanent care (rehabilitation home or adoption) and the quality of the relationship with the primary caregiver. DISCUSSION: The study is novel in that infant mental health professionals rarely have a role in judicial decisions about children's care placements, and RCTs are rare in the judicial context. The trial will allow us to determine whether NIM is clinically and cost-effective in the UK and findings may have important implications for the use of mental health assessment and treatment as part of the decision-making about children in the care system.

Estimation of the risk of tubal factor infertility associated with genital chlamydial infection in women: a statistical modelling study.

OBJECTIVES: Using a statistical modelling approach, our study aim is to determine reliable age-related estimates of the risk of all-cause tubal factor infertility (TFI) following past or current chlamydial infection in women in Scotland. METHOD: Using data from several sources, a Markov-Chain Monte Carlo model was used to estimate the age-related risk of TFI given genital chlamydia infection at any time. The analysis is based on the probability of a woman ever having chlamydial infection, ever having TFI and ever having a previous chlamydial infection given a diagnosis of TFI. The model was programmed and evaluated using WinBugs14. RESULTS: By the age 44 years, the overall risk of a woman having at least a single chlamydial infection is estimated at 42.9% (95% credible interval 30.0, 59.0%). The risk of a woman having TFI increased from 0.5% in those aged 16-19 years to 0.8% in those aged 40-44. The overall estimated probability of TFI, based on lifetime infertility, given a past or current chlamydial infection, is relatively consistent across all five age groups from 16-44 years, being 0.9% among those aged 25-29 and 1.4% in those aged 35-39; The estimates were found to be sensitive to the definition of infertility, with the estimate increasing from 1.3% in the youngest age group to 2.8% and 4.5% for 24-month primary infertility and primary or secondary infertility, respectively. CONCLUSIONS: At the population level, the likelihood of all-cause TFI in those with past or current chlamydial infection is low. These findings have relevance both at the policy level, in the development of control programmes, and also at an individual level, particularly for clinicians supporting women undergoing testing or with a positive diagnosis.

Modelling consultation rates in infancy: influence of maternal and infant characteristics, feeding type and consultation history.

BACKGROUND: Severity of illness, sociodemographic factors, and breastfeeding have been identified as predictors of consultation rates in infants, and prescriptions for antibiotics have been found to increase future consultation rates in older children. The Baby Check trial (1996-1998) provided detailed information about consultations for 935 babies during their first 6 months. AIMS: To investigate potential predictors of consultation rates in babies. DESIGN OF STUDY: A 6-month cohort study of newborn babies originally enrolled into a randomised controlled trial. Maternal and infant characteristics were collected from hospital discharge records. Primary care consultation data for each baby were collected by case note review. SETTING: Thirteen general practices in Glasgow. METHOD: Multilevel models were used to analyse the number of consultations for each baby during its first 26 weeks, dependent upon the baby's age, the calendar month, maternal and infant characteristics, and previous consultations. RESULTS: The strongest predictors of consultation rates were previous consultations, particularly during the preceding week. Breastfed babies and those with older mothers consulted less often. A multilevel model was better than a fixed effects model, with considerable variation in consultation rates between babies. CONCLUSION: Infants' consultation rates over time can be analysed using multilevel models, if details of primary care consultations are available. These models can incorporate the effects of fixed variables and those that change during the follow-up period. Our findings add to previous research linking breastfeeding with reduced morbidity in infancy, and for that reason breastfeeding should continue to be promoted in primary care.