Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Randomized controlled trial to prevent excessive weight gain in pregnant women. Maternal carbohydrate intake and pregnancy outcome. Global report on preterm birth and stillbirth (3 of 7): evidence for effectiveness of interventions. Quality of reporting of randomized, controlled trials in cerebral palsy. The health impacts of housing-led regeneration: a prospective controlled study. Burn pain and anxiety: the use of music relaxation during rehabilitation. Randomized controlled trials in pediatric surgery: could we do better? The quality of reporting of randomized controlled trials in solid organ transplantation. Quality of reporting in randomized trials published in high-quality surgical journals. Reporting of sample size calculation in randomised controlled trials: review.
Excessive weight gain during pregnancy is a major risk factor for postpartum weight retention and future weight gain and obesity in women, but few adequately powered randomized controlled trials have examined the efficacy of a behavioral weight-control intervention during pregnancy.
                This study examined whether a behavioral intervention during pregnancy could decrease the proportion of women who exceeded the 1990 Institute of Medicine (IOM) recommendations for gestational weight gains and increase the proportion of women who returned to pregravid weights by 6 mo postpartum.
                This study was a randomized, assessor-blind, controlled trial. Participants were pregnant (13.5 wk gestation), normal-weight (NW; n = 201) and overweight or obese (OW/OB; n = 200) women whose average age was 28.8 y. Participants were randomly assigned within the 1990 IOM weight category (NW compared with OW/OB) to standard care (n = 200) or to a behavioral intervention to prevent excessive gestational weight gain (n = 201). The intervention included one face-to-face visit; weekly mailed materials that promoted an appropriate weight gain, healthy eating, and exercise; individual graphs of weight gain; and telephone-based feedback. The retention at the 6-mo postpartum assessment was 82%.
                Intent-to-treat analyses showed that the intervention, compared with standard care, decreased the percentage of NW women who exceeded IOM recommendations (40.2% compared with 52.1%; P = 0.003) and increased the percentages of NW and OW/OB women who returned to their pregravid weights or below by 6 mo postpartum (30.7% compared with 18.7%; P = 0.005).
                A low-intensity behavioral intervention during pregnancy reduced excessive gestational weight gains in NW women and prevented postpartum weight retention in NW and OW/OB women. This trial was registered at clinicaltrials.gov as NCT01117961. The Institute of Medicine (IOM) recommends that normal-weight women (BMI (body mass index) of 19.8-26.0) gain 25-35 lb (11.4-15.9 kg) during pregnancy, and that overweight women (BMI of 26.1-29.0) gain 15-25 lbs (6.8-11.4 kg). A significant number of normal-weight women and an even greater proportion of overweight women exceed these guidelines, which increases postpartum weight retention and may contribute to the development of obesity.
                To determine whether a stepped care, behavioral intervention will decrease the percentage of women who gain more than the IOM recommendation.
                Randomized controlled trial comparing a stepped-care behavioral intervention with usual care. Women (n=120) who had a BMI>19.8, age>18 and <20 weeks gestation were recruited from a hospital-based clinic serving low-income women and randomized by race and BMI category to the intervention or control group. The intervention group received education about weight gain, healthy eating, and exercise and individual graphs of their weight gain. Those exceeding weight gain goals were given more intensive intervention. Women were followed through pregnancy to their first postpartum clinic visit. The main outcome measure was weight gain during pregnancy categorized as above the IOM recommendations vs below or within the IOM recommendations.
                The intervention significantly decreased the percentage of normal-weight women who exceeded the IOM recommendations (33 vs 58%, P<0.05). There was a non-significant (P=0.09) effect in the opposite direction among overweight women (59% of intervention and 32% of control gained more than recommended). Postpartum weight retention was strongly related to weight gain during pregnancy (r=0.89).
                The intervention reduced excessive weight gain during pregnancy among normal weight women. Experimental evidence indicates that the primary maternal environmental factor that regulates feto-placental growth is substrate delivery to the placental site, which is the product of maternal substrate levels and the rate of placental-bed blood flow. Thus, maternal factors which change either substrate level or flow alter feto-placental growth rate. The best-studied substrate in human pregnancy is glucose, and there is a direct relationship between maternal blood glucose levels and size at birth. Altering the type of carbohydrate eaten (high- v. low-glycaemic sources) changes postprandial glucose and insulin responses in both pregnant and non-pregnant women, and a consistent change in the type of carbohydrate eaten during pregnancy influences both the rate of feto-placental growth and maternal weight gain. Eating primarily high-glycaemic carbohydrate results in feto-placental overgrowth and excessive maternal weight gain, while intake of low-glycaemic carbohydrate produces infants with birth weights between the 25th and the 50th percentile and normal maternal weight gain. The calculated difference in energy retention with similar total energy intakes is of the order of 80,000 kJ. Preliminary information from subsequent metabolic studies indicates that the mechanisms involved include changes in: daily digestible energy requirements (i.e. metabolic efficiency), substrate utilization (glucose oxidation v. lipid oxidation), and insulin resistance and sensitivity. Thus, altering the source of maternal dietary carbohydrate may prove to be a valuable tool in the management of pregnancies at risk for anomalous feto-placental growth and for the prevention and/or treatment of obesity and insulin resistance in the non-pregnant state. Interventions directed toward mothers before and during pregnancy and childbirth may help reduce preterm births and stillbirths. Survival of preterm newborns may also be improved with interventions given during these times or soon after birth. This comprehensive review assesses existing interventions for low- and middle-income countries (LMICs).
                Approximately 2,000 intervention studies were systematically evaluated through December 31, 2008. They addressed preterm birth or low birth weight; stillbirth or perinatal mortality; and management of preterm newborns. Out of 82 identified interventions, 49 were relevant to LMICs and had reasonable amounts of evidence, and therefore selected for in-depth reviews. Each was classified and assessed by the quality of available evidence and its potential to treat or prevent preterm birth and stillbirth. Impacts on other maternal, fetal, newborn or child health outcomes were also considered. Assessments were based on an adaptation of the Grades of Recommendation Assessment, Development and Evaluation criteria.
                Most interventions require additional research to improve the quality of evidence. Others had little evidence of benefit and should be discontinued. The following are supported by moderate- to high-quality evidence and strongly recommended for LMICs: Two interventions prevent preterm births--smoking cessation and progesterone. Eight interventions prevent stillbirths--balanced protein energy supplementation, screening and treatment of syphilis, intermittant presumptive treatment for malaria during pregnancy, insecticide-treated mosquito nets, birth preparedness, emergency obstetric care, cesarean section for breech presentation, and elective induction for post-term delivery. Eleven interventions improve survival of preterm newborns--prophylactic steroids in preterm labor, antibiotics for PROM, vitamin K supplementation at delivery, case management of neonatal sepsis and pneumonia, delayed cord clamping, room air (vs. 100% oxygen) for resuscitation, hospital-based kangaroo mother care, early breastfeeding, thermal care, and surfactant therapy and application of continued distending pressure to the lungs for respiratory distress syndrome
                The research paradigm for discovery science and intervention development must be balanced to address prevention as well as improve morbidity and mortality in all settings. This review also reveals significant gaps in current knowledge of interventions spanning the continuum of maternal and fetal outcomes, and the critical need to generate further high-quality evidence for promising interventions. In conducting reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy, the assessment of trials can be hampered by problems in reporting. Therefore, we set out to evaluate trial reporting by using the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations.
                Randomized, controlled trials published in 1990 or later were identified in literature searches for reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy. Two independent reviewers evaluated the trial reporting by using a modified 33-item Consolidated Standards of Reporting Trials checklist.
                We identified 15 randomized, controlled trials. Almost half (48%) of the applicable items were reported adequately. Inadequate reporting was found in the following items: outcome measures, sample-size determination, details of the sequence generation, allocation concealment and implementation of the randomization, success of assessor blinding, recruitment and follow-up dates, intention-to-treat analysis, precision of the effect size, co-interventions, and adverse events.
                Only a small number of sufficiently reported trials were found. Because nearly all items had been described in at least 1 article, high-quality reporting seems feasible. Assessment of trials depends on appropriate reporting, and poor reporting jeopardizes judgments on the clinical implications. Authors of randomized, controlled trials are encouraged to follow the Consolidated Standards of Reporting Trials criteria. There is a clear need to improve the quality of reporting of trials in this field. To evaluate self-reported changes in housing quality and health associated with housing-led area regeneration.
                A prospective study over 1 year using structured interviews with 50 households who moved to new housing and with 50 matched controls who did not move.
                Residents of two social rented housing schemes in the West of Scotland.
                Small but not statistically significant increases in levels of "excellent" or "good" self-reported health status were found in both groups. Both intervention and control groups experienced reductions in problems related to warmth, but no significant change in how they felt about their house.
                It is feasible to conduct prospective controlled studies to evaluate the health effects of housing improvement using matched control groups. The absence of marked improvement in health after moving to new housing might be due to the small sample size or to the limited potential to improve health through this intervention alone. Pain and anxiety are well-documented problems during the rehabilitation of patients with burns. This study examined the effect of music on anxiety and pain during range of motion. Eleven subjects with partial-thickness or deeper burns were randomly assigned to a control group (without music intervention) or experimental group (with music intervention). Vital signs, pain, and anxiety were recorded before and after treatments. There was no difference in pretest and posttest anxiety across the groups; however, there was a difference in anxiety between the groups. Conversely, there was a difference in pretest and posttest pain across the groups but no difference in pain between the groups. Results showed no significant reduction in anxiety and pain during therapy with music relaxation. Limitations included nonhomogenous groups, small sample size, potentially unrepresentative sample, variation in exercise protocol, and small musical selection. Further research is recommended. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved. Randomized controlled trials (RCTs) of interventions provide the highest level of evidence about efficacy but their value either alone or within a meta-analysis is dependent on its methodological quality. For this reason recent RCTs in organ transplantation were assessed for quality. RCTs published between 2004 and 2006 (n = 332) were assessed, after excluding duplicate and nonEnglish reports. Quality was evaluated using the Jadad score plus allocation concealment and intention to treat analysis. We noted journal type, journal author instructions, funding source, sample size and number and location of study centres. Around one-third of RCTs had a Jadad score of 3 or greater (indication of a methodologically good quality trial) and the other two parameters were satisfied in just over one third. Although the majority of trials were published in speciality journals the quality of those published in general journals was superior. Commercially sponsored trials were of better quality as were multicentre trials in contrast to single centre trials. Overall quality of reporting of RCTs in organ transplantation is poor and as RCTs provide the highest level of evidence in evaluations of interventions there needs to be a concerted effort within the transplant community to improve the standards of RCTs. Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements.
                We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event-related, and specific nonpharmacologic criteria.
                Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score > or = 3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event-related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively.
                Quality of reporting of generic methodologic, adverse-event-related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria. To assess quality of reporting of sample size calculation, ascertain accuracy of calculations, and determine the relevance of assumptions made when calculating sample size in randomised controlled trials.
                Review.
                We searched MEDLINE for all primary reports of two arm parallel group randomised controlled trials of superiority with a single primary outcome published in six high impact factor general medical journals between 1 January 2005 and 31 December 2006. All extra material related to design of trials (other articles, online material, online trial registration) was systematically assessed. Data extracted by use of a standardised form included parameters required for sample size calculation and corresponding data reported in results sections of articles. We checked completeness of reporting of the sample size calculation, systematically replicated the sample size calculation to assess its accuracy, then quantified discrepancies between a priori hypothesised parameters necessary for calculation and a posteriori estimates.
                Of the 215 selected articles, 10 (5%) did not report any sample size calculation and 92 (43%) did not report all the required parameters. The difference between the sample size reported in the article and the replicated sample size calculation was greater than 10% in 47 (30%) of the 157 reports that gave enough data to recalculate the sample size. The difference between the assumptions for the control group and the observed data was greater than 30% in 31% (n=45) of articles and greater than 50% in 17% (n=24). Only 73 trials (34%) reported all data required to calculate the sample size, had an accurate calculation, and used accurate assumptions for the control group.
                Sample size calculation is still inadequately reported, often erroneous, and based on assumptions that are frequently inaccurate. Such a situation raises questions about how sample size is calculated in randomised controlled trials.
There is not enough evidence to recommend any intervention for preventing excessive weight gain during pregnancy, due to the significant methodological limitations of included studies and the small observed effect sizes. More high-quality randomised controlled trials with adequate sample sizes are required to evaluate the effectiveness of potential interventions.