A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

<p>Abstract</p> <p>Background</p> <p>Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.</p> <p>Methods</p> <p>We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.</p> <p>Results</p> <p>110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.</p> <p>Conclusions</p> <p>Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.</p

Cool-season annual pastures with clovers to supplement wintering beef cows nursing calves

<p>Abstract</p> <p>In December of 3 years, 87 beef cows with nursing calves (594 ± 9.8 kg; calving season, September to November) at side were stratified by body condition score, body weight, cow age, and calf gender and divided randomly into 6 groups assigned to 1 of 6 cool-season annual pastures (0.45 ha/cow) that had been interseeded into a dormant common bermudagrass (<it>Cynodon dactylon</it> [L.] Pers.)/bahiagrass (<it>Paspalum notatum</it> Flugge) sod. Pastures contained 1 of the following 3 seeding mixtures (2 pastures/mixture): 1) wheat (<it>Triticum aestivum</it> L.) and ryegrass (<it>Lolium multiflorum</it> Lam., <b>WRG</b>), 2) wheat and ryegrass plus red clover (<it>Trifolium pretense</it> L., <b>WRR</b>), or 3) wheat and ryegrass plus white (<it>Trifolium repens</it> L.) and crimson clovers (<it>Trifolium incarnatum</it> L., <b>WRW</b>). All groups had <it>ad libitum</it> access to grass hay (12% crude protein; 58% total digestible nutrients). The second week in December, cow estrous cycles were synchronized and artificially inseminated. In late December, a bull was placed with each group for 60-d. Data were analyzed with an analysis of variance using a mixed model containing treatment as the fixed effect and year as the random effect. Body weight and condition scores did not differ (<it>P</it> ≥ 0.27) among cows between February and June. Calf birth weights or average daily gain did not differ (<it>P</it> ≥ 0.17) among treatments; however, calves grazing pastures with clovers did tend (<it>P</it> = 0.06) to weigh more than calves grazing grass only. Weaning weight per cow exposed to a bull was greater (<it>P</it> = 0.02) for WRR and WRW than WRG. Cows grazing winter-annual pastures containing clovers tended to wean more calf body weight per cow exposed to a bull than cows grazing the grass only pastures.</p

Resources, violence and the telluric geographies of small wars

A growing literature debates the proposition that insurgency in ‘small wars’ is primarily driven by opportunities to exploit or loot abundant natural resource and by feasibility factors. While recent studies on the geography of opportunity, feasibility and predation have qualified some of these broad claims, the literature is still in need of a better understanding of the micro-geographies of small wars. Through a critical discussion of this literature, I will argue for an analytics of ‘telluric geographies’ that studies the geography of rule, violence and affect in small wars