Generalizability of trial results based on randomized versus nonrandomized allocation of OME infants to ventilation tubes or watchful waiting. Otitis media and tympanostomy tube insertion during the first three years of life: developmental outcomes at the age of four years. A randomized clinical trial of home intervention for children with failure to thrive. Training in complementary feeding counselling of healthcare workers and its influence on maternal behaviours and child growth: a cluster-randomized controlled trial in Lahore, Pakistan. A practice-based intervention to enhance quality of care in the first 3 years of life: the Healthy Steps for Young Children Program. Enhancing ventilation in homes of children with asthma: pragmatic randomised controlled trial. Screening elderly people in primary care: a randomized controlled trial. The effect of ventilation tubes on language development in infants with otitis media with effusion: A randomized trial. Randomised controlled trial of treatment of unilateral visual impairment detected at preschool vision screening.
The objective was to study the generalizability of trial results by comparing randomized patients to eligible but nonrandomized patients who received the same management. Implementation of trial results is only justifiable when the results can be generalized to the total domain population. The design was a multicentre randomized controlled trial on the effect of early screening and treatment with ventilation tubes on infants with otitis media with effusion. Randomized (n = 187) and nonrandomized eligible patients (n = 133) were followed up. The study population comprised children who were detected by auditory screening at the age of 9-12 months and who were subsequently diagnosed with persistent bilateral otitis media with effusion for 4-6 months. A significant difference was found in the distribution of some prognostic factors: more randomized children had older siblings, did not attend day care and had mothers with a lower educational level than the nonrandomized children. These factors, however, did not modify the outcome. No differences were found in mean hearing levels between the randomized and nonrandomized children: in both the randomized and nonrandomized children ventilation tubes improved the hearing level, especially after 6 months. However, in the long term (12 months), the hearing levels were equal again. The results of the randomized and nonrandomized patients were comparable. The results of this trial appear to be generalizable to the total domain population. The procedure of following up both randomized and nonrandomized patients is recommended when there is concern about selective participation and reduced generalizability. In a long-term, prospective study, we set out to determine whether otitis media in the first 3 years of life persisting for periods currently considered developmentally threatening actually results in later impairments of children's cognitive, language, speech, or psychosocial development; whether prompt insertion of tympanostomy tubes prevents or lessens any such impairments; and whether, irrespective of causality, associations exist between persistent early-life otitis media and later developmental impairments. This report describes findings in study participants at the age of 4 years.
                We enrolled 6350 healthy infants from 2 to 61 days of age at urban hospitals and 2 small-town/rural and 4 suburban private pediatric practices. We regularly evaluated the children for the presence of middle-ear effusion (MEE) throughout their first 3 years of life by pneumatic otoscopy, supplemented by tympanometry; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. In the clinical trial component of the study, we randomly assigned 429 children who met specified minimum criteria regarding the persistence of MEE to undergo tympanostomy tube insertion either promptly or after a defined extended period if MEE remained present. In the associational component of the study, we selected a representative sample of 241 children who ranged from having no MEE to having MEE the cumulative duration of which fell just short of meeting randomization criteria for the clinical trial. In 397 (92.5%) of the children in the clinical trial and in 234 (97.1%) of the children in the representative sample, we assessed cognitive, language, speech, and psychosocial development at the age of 4 years, using formal tests, conversational samples, and parent questionnaires.
                In children in the randomized clinical trial, there were no statistically significant differences in mean (+/-standard deviation) scores (higher denotes more favorable) favoring the early-treatment group over the late-treatment group on the General Cognitive Index of the McCarthy Scales of Children's Abilities (97 +/- 14 and 98 +/- 14, respectively); the Peabody Picture Vocabulary Test-Revised, a measure of receptive language (90 +/- 15 vs 92 +/- 16); the Nonword Repetition Test, a measure of phonological memory (66 +/- 12 vs 70 +/- 12); the Number of Different Words, a measure of word diversity (150 +/- 34 vs 150 +/- 31); the Mean Length of Utterance in Morphemes, a measure of sentence length and grammatical complexity (3.4 +/- 0.8 vs 3.4 +/- 0.7); or the Percentage of Consonants Correct-Revised, a measure of speech-sound production (92 +/- 5 vs 93 +/- 5). There were also no significant differences in ratings (higher denotes less favorable) on the Parenting Stress Index-Short Form (Total Stress scores: 68 +/- 18 vs 65 +/- 17) or the Child Behavior Checklist (Total Problem T scores: 50 +/- 10 vs 49 +/- 10). In the associational component of the study, correlations between the children's durations of MEE and their developmental outcomes were generally weak and, in most instances, nonsignificant. Exceptions, after adjustment for sociodemographic variables and for hearing thresholds at the time of developmental testing, consisted of a significant negative correlation between children's cumulative durations of MEE in their first 3 years of life and scores on the McCarthy Verbal subscale, and significant positive correlations between durations of MEE and scores on 2 measures of parent-child stress. The percentage of variance in these scores explained by time with MEE beyond that explained by sociodemographic variables ranged from 1.6% to 3.3%. In both the randomized clinical trial and the associational component, sociodemographic variables seemed to be the most important factors influencing developmental outcomes, and in both components, the results at 4 years of age were consistent with the results that had been obtained at 3 years of age.
                In otherwise healthy children who are younger than 3 years and have persistent MEE within the duration limits that we studied, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at 4 years of age. In such children, persistent MEE within the duration limits that we studied is negligibly associated with and probably does not affect developmental outcomes at 4 years of age. To evaluate the efficacy of a home-based intervention on the growth and development of children with nonorganic failure to thrive (NOFTT).
                Randomized clinical trial.
                The NOFTT sample included 130 children (mean age, 12.7 months; SD, 6.4) recruited from urban pediatric primary care clinics serving low income families. All children were younger than 25 months with weight for age below the fifth percentile. Eligibility criteria included gestational age of at least 36 weeks, birth weight appropriate for gestational age, and no significant history of perinatal complications, congenital disorders, chronic illnesses, or developmental disabilities. Children were randomized into two groups: clinic plus home intervention (HI) (n = 64) or clinic only (n = 66). There were no group differences in children's age, gender, race, or growth parameters, or on any of the family background variables. Most children were raised by single, African-American mothers who received public assistance. Eighty-nine percent of the families (116 of 130) completed the 1-year evaluation.
                All children received services in a multidisciplinary growth and nutrition clinic. A community-based agency provided the home intervention. Families in the HI group were scheduled to receive weekly home visits for 1 year by lay home visitors, supervised by a community health nurse. The intervention provided maternal support and promoted parenting, child development, use of informal and formal resources, and parent advocacy.
                Growth was measured by standard procedures and converted to z scores for weight for height and height for age to assess wasting and stunting. Cognitive and motor development were measured with the Bayley Scales of Infant Development, and language development was measured by the Receptive/Expressive Emergent Language Scale. Both scales were administered at recruitment and at the 12-month follow-up. Parent-child interaction was measured by observing mothers and children during feeding at recruitment and at the 12-month follow-up, and the quality of the home was measured by the Home Observation Measure of the Environment 18 months after recruitment.
                Repeated-measures multivariate analyses of covariance were used to examine changes in children's growth and development and parent-child interaction. Analyses of covariance were used to examine the quality of the home. Independent variables were intervention status and age at recruitment (1.0 to 12.0 vs 12.1 to 24.9 months). Maternal education was a covariate in all analyses. When changes in developmental status and parent-child interaction were examined, weight for height and height for age at recruitment were included as covariates.
                Children's weight for age, weight for height, and height for age improved significantly during the 12-month study period, regardless of intervention status. Children in the HI group had better receptive language over time and more child-oriented home environments than children in the clinic-only group. The impact of intervention status on cognitive development varied as a function of children's ages at recruitment, with younger children showing beneficial effects of home intervention. There were no changes in motor development associated with intervention status. During the study period, children gained skills in interactive competence during feeding, and their parents became more controlling during feeding, but differences were not associated with intervention status.
                Findings support a cautious optimism regarding home intervention during the first year of life provided by trained lay home visitors. Early home intervention can promote a nurturant home environment effectively and can reduce the developmental delays often experienced by low income, urban infants with NOFTT: Subsequent investigations of home intervention should consider alternative options for toddlers with NOFTT: Malnutrition is common among children aged 6-24 months in developing countries. It increases the risk of mortality. Interventions to improve infant-feeding hold the promise of reducing malnutrition among these children. A study in Brazil has shown the success of training in communication and counselling skills among health workers in improving the nutritional status of young children. Questions were raised whether the method used in the study in Brazil would also be effective when applied in other countries. The aim of the present study was to reduce growth faltering in young children through proper nutrition-promotion techniques. The objective of the study was to determine the efficacy of training health workers in nutrition counselling in enhancing their communication skills and performance, improving feeding practices, and reducing growth faltering in children aged 6-24 months. A cluster-randomized controlled trial was carried out. The method used in this study was a replica of the method in a similar study in Pelotas, Brazil. Forty health centres were paired, and one centre of each pair was randomly allocated to the intervention group, and the other to the control group. The Integrated Management of Childhood Illness (IMCI) module-'Counsel the mother'-was used for training health workers in the health centres in the intervention group. Data from 36 paired health centres and 375 mothers and their children aged 6-24 months recruited from these health centres following consultation with health workers were included in analysis. Independent observers, masked to the intervention status, examined the performance of health workers within the first month after training. Mother-child pairs were visited at home within two weeks, 45 days, and 180 days after recruitment. Information was recorded on the feeding practices, recall of the recommendations of health workers, and sociodemographic variables at these home-visits. Weight and length of the child were measured at each contact. The communication skills and consultation performance of health workers were significantly better in the intervention group than in the control group. The mothers' recall of the recommendation of health workers and reported infant-feeding practices were also significantly better in the intervention group than in the control group, even 180 days after the recruitment consultation. Growth faltering was less in the intervention group, with the largest effect observed among children in the age-group of 12 + months. These results indicate that training in IMCI feeding counselling can enhance the communication skills and performance of health workers. Improved feeding practices of counselled mothers can, in turn, reduce growth faltering in their children. There is growing concern regarding the quality of health care available in the United States for young children, and specific limitations have been noted in developmental and behavioral services provided for children in the first 3 years of life.
                To determine the impact of the Healthy Steps for Young Children Program on quality of early childhood health care and parenting practices.
                Prospective controlled clinical trial enrolling participants between September 1996 and November 1998 at 6 randomization and 9 quasi-experimental sites across the United States. Participants were 5565 children enrolled at birth and followed up through age 3 years.
                Incorporation of developmental specialists and enhanced developmental services into pediatric care in participants' first 3 years of life.
                Quality of care was operationalized across 4 domains: effectiveness (eg, families received > or =4 Healthy Steps-related services or discussed >6 anticipatory guidance topics), patient-centeredness (eg, families were satisfied with care provided), timeliness (eg, children received timely well-child visits and vaccinations), and efficiency (eg, families remained at the practice for > or =20 months). Parenting outcomes included response to child misbehavior (eg, use of severe discipline) and practices to promote child development and safety (eg, mothers at risk for depression discussed their sadness with someone at the practice).
                Of the 5565 enrolled families, 3737 (67.2%) responded to an interview at 30 to 33 months (usual care, 1716 families; Healthy Steps, 2021 families). Families who participated in the Healthy Steps Program had greater odds of receiving 4 or more Healthy Steps-related services (for randomization and quasi-experimental sites, respectively: odds ratio [OR], 16.90 [95% confidence interval [CI], 12.78 to 22.34] and OR, 23.05 [95% CI, 17.38 to 30.58]), of discussing more than 6 anticipatory guidance topics (OR, 8.56 [95% CI, 6.47 to 11.32] and OR, 12.31 [95% CI, 9.35 to 16.19]), of being highly satisfied with care provided (eg, someone in the practice went out of the way for them) (OR, 2.06 [95% CI, 1.64 to 2.58] and OR, 2.11 [95% CI, 1.72 to 2.59]), of receiving timely well-child visits and vaccinations (eg, age-appropriate 1-month visit) (OR, 1.98 [95% CI, 1.08 to 3.62] and OR, 2.11 [95% CI, 1.16 to 3.85]), and of remaining at the practice for 20 months or longer (OR, 2.02 [95% CI, 1.61 to 2.55] and OR, 1.75 [95% CI, 1.43 to 2.15]). They also had reduced odds of using severe discipline (eg, slapping in face or spanking with object) (OR, 0.82 [95% CI, 0.54 to 1.26] and OR, 0.67 [95% CI, 0.46 to 0.97]). Among mothers considered at risk for depression, those who participated in the Healthy Steps Program had greater odds of discussing their sadness with someone at the practice (OR, 0.95 [95% CI, 0.56 to 1.63] and OR, 2.82 [95% CI, 1.57 to 5.08]).
                Universal, practice-based interventions can enhance quality of care for families of young children and can improve selected parenting practices. Few robust studies have tested whether enhancing housing also improves health.
                To evaluate the effectiveness of installing ventilation systems, and central heating where necessary, in the homes of children with moderate or severe asthma.
                Pragmatic randomised controlled trial (RCT) in homes within Wrexham County Borough, Wales, UK.
                A pragmatic RCT was carried out, of a tailored package of housing improvements providing adequate ventilation and temperature, following inspection by a housing officer. One hundred and ninety-two children with asthma aged 5 to 14 years, identified from general practice registers, were randomised to receive this package, either immediately or a year after recruitment. At baseline, and after 4 and 12 months, parents reported their child's asthma-specific and generic quality of life, and days off school.
                The package improved parent-reported asthma-specific quality of life significantly at both 4 and 12 months. At 12 months, this showed an adjusted mean difference between groups of 7.1 points (95% confidence interval [CI] = 2.8 to 11.4, P= 0.001): a moderate standardised effect size of 0.42. The generic quality-of-life scale showed reported physical problems were significantly reduced at 4 months, but not quite at 12 months, when the mean difference was 4.5 (95% CI = -0.2 to 9.1, P= 0.061). The improvement in psychosocial quality of life at 12 months was not significant, with a mean difference of 2.2 (95% CI = -1.9 to 6.4, P= 0.292). Parent-reported school attendance improved, but not significantly.
                This novel and pragmatic trial, with integrated economic evaluation, found that tailored improvement of the housing of children with moderate to severe asthma significantly increases parent-reported asthma-related quality of life and reduces physical problems. Collaborative housing initiatives have potential to improve health. A randomized controlled trial was carried out to test the effectiveness of a screening programme carried out by nurses for elderly people aged 75 years and over in a general practice. A total of 151 people were randomly allocated to the test group and 145 to the control group. The test group received a home visit from a nurse at which an assessment lasting 45 minutes was made of: activities of daily living, social functioning, sensory functions, mental and emotional problems, current medical problems, blood pressure, urinalysis, haemoglobin level and compliance with medication. Both groups completed a selection of items from four health indices before and 20 months after the intervention. At follow up, the test group scored significantly better than the control group on a morale scale. However, this trial provided no evidence for better resolution of physical problems or finding activities of daily living easier in the test group compared with the control group. It is suggested that the main benefit of such a screening process is that the special attention and education provided improves adaptation to old age and awareness of the support systems available. The government has proposed an annual review of elderly people in their own home and this study suggests that the objectives of this scheme should be clarified. To study the effectiveness of ventilation tubes on the language development in infants with persistent otitis media with effusion (OME). All existing studies addressed children 3 years of age or older. Currently, OME is detected and treated with ventilation tubes at a younger age. Because of the critical relationship between age, hearing, and language development, we conducted a study of the effects of ventilation tubes on language development in infants 1 to 2 years old with persistent OME.
                A multicenter, randomized, controlled trial (embedded in a cohort) with 2 treatment arms: 1) treatment with ventilation tubes (VT group; n = 93); or 2) with a period of watchful waiting (WW group; n = 94). Hearing loss and expressive and comprehensive language were assessed every 6 months, while tympanometry and otoscopy were performed every 3 months. Other factors with potential influence on language development were also included: adenoidectomy, hospital, attending day care, sex, age at randomization, educational level of the mother, upper respiratory infections, and the native country of the parents and older siblings. The trial was designed to allow for the detection of a mean difference in language development of 3 months or more between children allocated to the VT and WW groups.
                No relevant differences were found in expressive or comprehensive language between the 2 groups after adjustment for educational level of the mother, IQ of the child, and differences at baseline. A principal component analysis showed that in the VT group, the children with frequent complaints improved 1.6 months more in comprehensive language than those with no or some complaints. The children with favorable language stimulation, however, did not improve more than the children with less favorable stimulation. No differences were found for expressive language among the various clusters. The probability to improve >3 months in comprehensive language was.48 (95% confidence interval [CI]:.29-.68) for children with highly educated mothers versus.09 (95% CI:.02-.30) for children whose mothers had a low educational level. In the WW group, these changes were.30 (95% CI:.14-.53) and.14 (95% CI:.04-.35), respectively. The probability to improve >4 months in expressive language was.52 (95% CI:.32-.71) for children with highly educated mothers versus.06 (95% CI:.01-.31) for children whose mothers had a low educational level. In the WW group these changes were.42 (95% CI:.23-.64) and.11 (95% CI:.03-.35), respectively. In addition, there were delays in expressive language in both groups compared with their age expected values. The comprehensive language of the children who were effusion-free during the follow-up (n = 54) improved 1.5 months (95% CI: -.2-3.2) more than that of the children who had persistent effusion during the entire follow-up (n = 28). No differences were found for expressive language development. Disregarding the intervention contrast, improvements in hearing seemed to be related to improvements in language development, especially in verbal comprehension.
                In this study, we used the Reynell, Schlichting, and Lexi tests to study the relation between early persistent OME and language development. These tests are directly related to normal language, widely accepted, and validated. It cannot be ruled out that more specific measures such as auditory perception tests would have produced more differences between groups, but the focus was on general language development. A total of 10 children in the WW group received treatment with ventilation tubes during follow-up. A further 11 children dropped out during the trial. A sensitivity analysis with the 10 children who received ventilation tubes did not change the results, and baseline differences were not found between the 11 children who dropped out and those who completed the trial.
                In the total group of infants with persistent OME, ventilation tubes did not h To test the efficacy of treatment for unilateral visual loss detected by preschool vision screening and the extent to which effectiveness varies with initial severity.
                Randomised controlled trial of full treatment with glasses and patching, if required, compared with glasses only or no treatment. Masked assessment of best corrected acuity after one year of follow up.
                Eight UK eye departments.
                177 children aged 3-5 years with mild to moderate unilateral impairment of acuity (6/9 to 6/36) detected by screening.
                Children in the full and glasses treatment groups had incrementally better visual acuity at follow up than children who received no treatment, but the mean treatment effect between full and no treatment was equivalent to only one line on a Snellen chart (0.11 log units; 95% confidence interval 0.050 to 0.171; P < 0.0001). The effects of treatment depended on initial acuity: full treatment showed a substantial effect in the moderate acuity group (6/36 to 6/18 at recruitment) and no significant effect in the mild acuity group (6/9 to 6/12 at recruitment) (P = 0.006 for linear regression interaction term). For 64 children with moderate acuity loss the treatment effect was 0.20 log units, equivalent to one to two lines on a Snellen chart. When all children had received treatment, six months after the end of the trial, there was no significant difference in acuity between the groups.
                Treatment is worth while in children with the poorest acuity, but in children with mild (6/9 to 6/12) unilateral acuity loss there was little benefit. Delay in treatment until the age of 5 did not seem to influence effectiveness.
The identified randomised trials do not show an important benefit on language development and behaviour from screening of the general population of asymptomatic children in the first four years of life for OME. However, these trials were all conducted in developed countries. Evidence generated in the developed world, where children may enjoy better nutrition, better living conditions and less severe and different infections, may not be applicable to children in developing countries. The screening aspect of some of these studies was aimed primarily at identifying suitable children in whom to evaluate the effects of treatment, rather than to evaluate the effects of screening programmes. Younger children and children with milder disease may have been included in these treatment trials compared to children who are offered treatment in pragmatic settings.