Other Outcome Variables (other + outcome_variable)

Distribution by Scientific Domains


Selected Abstracts


A randomised prospective clinical trial into the effect of infant orthopaedics on maxillary arch dimensions in unilateral cleft lip and palate (Dutchcleft)

EUROPEAN JOURNAL OF ORAL SCIENCES, Issue 5 2001
Charlotte Prahl
Aim of the study was to evaluate the effect of infant orthopaedics (IO) on maxillary dimensions in infants with unilateral cleft lip and palate (UCLP). The study design was a prospective two-arm randomised controlled trial in parallel with three participating academic Cleft Palate Centres. Treatment was assigned by means of a computerised balanced allocation method. One group (IO+) wore passive maxillary plates during the first year of life, the other group (IO,) did not. Maxillary casts, made at birth, and at 15, 24, 48, 78 wk were digitised three-dimensionally. Before lip closure alveolar, midpalatal and posterior cleft width reduced significantly more in IO(+) than in IO(,). After lip closure, the alveolar cleft width reduced significantly more in IO(,). Until soft palate closure the slope of the palatal vault flattened significantly by IO. It is concluded that IO only has a temporary effect on maxillary arch dimensions that does not last beyond surgical soft palate closure. Therefore, infant orthopaedics as a tool to improve maxillary arch form could be abandoned. However, other outcome variables like facial and dental appearance, speech outcome, and cost-effectiveness need to be investigated further in order to assess the comprehensive effect of infant orthopaedics. [source]


A modelling strategy for the analysis of clinical trials with partly missing longitudinal data

INTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 3 2003
Ian R. White
Abstract Standard statistical analyses of randomized controlled trials with partially missing outcome data often exclude valuable information from individuals with incomplete follow-up. This may lead to biased estimates of the intervention effect and loss of precision. We consider a randomized trial with a repeatedly measured outcome, in which the value of the outcome on the final occasion is of primary interest. We propose a modelling strategy in which the model is successively extended to include baseline values of the outcome, then intermediate values of the outcome, and finally values of other outcome variables. Likelihood-based estimation of random effects models is used, allowing the incorporation of data from individuals with some missing outcomes. Each estimated intervention effect is free of non-response bias under a different missing-at-random assumption. These assumptions become more plausible as the more complex models are fitted, so we propose using the trend in estimated intervention effects to assess the nature of any non-response bias. The methods are applied to data from a trial comparing intensive case management with standard case management for severely psychotic patients. All models give similar estimates of the intervention effect and we conclude that non-response bias is likely to be small. Copyright © 2003 Whurr Publishers Ltd. [source]


Assessing Drinking Outcomes in Alcohol Treatment Efficacy Studies: Selecting a Yardstick of Success

ALCOHOLISM, Issue 10 2003
Linda Carter Sobell
Background: Although the number of alcohol treatment efficacy trials has mushroomed, there is no consensus on how best to measure outcomes. To advance the goal of establishing cross-trial consistency in measuring outcomes in clinical efficacy studies, the National Institute on Alcohol Abuse and Alcoholism convened a panel of experts and charged them with exploring, debating, and, ultimately, selecting a "sentinel" or "optimal" outcome measure to be used in future alcohol treatment studies. The goal of this article, one in a series of several presented at the National Institute on Alcohol Abuse and Alcoholism conference, is to discuss (1) the rationale underlying selection of an optimal outcome measure, (2) the necessary characteristics of an optimal outcome measure, (3) the utility of selecting an optimal measure, and (4) which drinking assessment methods could be used to collect data to portray the optimal outcome measure. Methods: At a minimum, the criteria for an "optimal" measure include that it be psychometrically sound. In addition, it should have considerable currency in the field, thereby increasing its prospects for adoption. The measure should also be consistent with the concepts of greatest interest and relevance to the field (e.g., directly reflect the fundamental goal of alcohol treatment). In light of these highly desired features, percent of days heavy drinking was chosen at the conference as a practical and relevant measure of alcohol treatment outcome. Conclusions: Percent of days heavy drinking should be the optimal measure of alcohol treatment outcome. Currently, daily drinking estimation methods are the most useful for gathering data that can reflect the optimal measure. In addition, data gathered by daily drinking estimation methods can be used to study a variety of other outcome variables of interest to clinical researchers. [source]


The effect of learning curve on the outcome of caesarean section

BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 11 2006
WY Fok
Objective, To evaluate the operative outcomes when trainees first perform caesarean sections independently. Design, A retrospective study in a tertiary obstetric unit. Population, Five hundred caesarean sections, which represented the first 50 caesarean sections performed independently by each of ten trainees, were studied. Methods, The effect of learning curve on outcome was analysed. Main outcome measures, Total operative time, incision-to-delivery interval, operative blood loss, Apgar score, cord arterial pH, incidence of neonatal intensive care unit admission, postoperative complication rates and duration of hospitalisation. Results, The mean operative time for the first five cases by trainees was 52.2 ± 11.4 minutes. It progressively decreased and reached 39.6 ± 8.4 minutes for the 46th to 50th cases. The operative time was significantly longer in the first 15 caesarean sections (P < 0.05). Moreover, the incision-to-delivery interval was also longer during the first five cases (P= 0.02). Besides the time of the operation, the trend for operative blood loss stabilised after the first ten caesarean sections (P < 0.05). Otherwise, there were no significant differences among other outcome variables. Conclusion, This study shows that trainees need to perform 10,15 caesarean sections before their skills become more proficient. Senior obstetricians may need to provide guidance to the trainees during their first independent 15 caesarean sections. [source]