Surgery for persistent otitis media with effusion: generalizability of results from the UK trial (TARGET). Trial of Alternative Regimens in Glue Ear Treatment.

TARGET (Trial of Alternative Regimens in Glue Ear Treatment) is a multicentre UK randomized controlled trial (RCT) comparing bilateral ventilation tubes with and without adjuvant adenoidectomy against non-surgical management in children with bilateral, persistent otitis media with effusion (OME). This paper compares the recruited and randomized children with those that, although eligible, were not included in the RCT for various reasons. This is necessary to identify any potential bias in the overall estimate of treatment effectiveness. At the first visit, 1315 children with OME satisfied the criteria of age (3 years 3 months-6 years 9 months), no previous ear or adenoid surgery, tympanometric evidence of fluid (bilateral B or B + C2) and a hearing loss (conductive loss in both ears of > or =20 dBHL). Of these children, 151 (11%) were not followed up because of overriding concern and 70 (5%) because of parental refusal. Of the 506 children eligible for randomization, because of persistence over 12 weeks of watchful waiting of bilateral OME with the same criteria, 20 (4%) were not randomized because of overriding concern and 75 (15%) because of parental refusal. The distribution of the potential effect modifiers was determined for each group. At the first visit, the only significant differences (P < 0.05), comparing those not recruited because of overriding concern with those recruited, were in respect of sex (61% girls compared with 52% boys) and hearing level (34.6 compared with 33.0 dBHL). At the second visit, the only significant difference involved less frequent upper respiratory tract infections (URTIs) in children whose parents refused to allow randomization (8% compared with 18% had had episodic URTI more often than once every 3 months). It is probable that the findings from the TARGET trial will translate to the entire clinic population in this age group as long as they meet the same audiometric and tympanometric criteria. The differences found can be handled by presentation of disaggregated results

Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children : a systematic review

Background Randomised controlled trials (RCTs) are recommended as the ‘gold standard’ in evaluating health care interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children. Aim To identify predictors of recruitment and retention in RCTs involving children. Methods A systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0–12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists. Results Twenty-eight studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socioeconomic status (SES)) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child’s illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research. Conclusion Parent characteristics may predict participation of children and their families to RCTs; however, there was a lack of consensus. Whilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention