Epidural analgesia associated with low-dose oxytocin augmentation increases cesarean births: A critical look at the external validity of randomized trials

2007 ◽  
Vol 2007 ◽  
pp. 177
Author(s):  
D.H. Chestnut
2016 ◽  
Vol 41 (4) ◽  
pp. 357-388 ◽  
Author(s):  
Elizabeth A. Stuart ◽  
Anna Rhodes

Background: Given increasing concerns about the relevance of research to policy and practice, there is growing interest in assessing and enhancing the external validity of randomized trials: determining how useful a given randomized trial is for informing a policy question for a specific target population. Objectives: This article highlights recent advances in assessing and enhancing external validity, with a focus on the data needed to make ex post statistical adjustments to enhance the applicability of experimental findings to populations potentially different from their study sample. Research design: We use a case study to illustrate how to generalize treatment effect estimates from a randomized trial sample to a target population, in particular comparing the sample of children in a randomized trial of a supplemental program for Head Start centers (the Research-Based, Developmentally Informed study) to the national population of children eligible for Head Start, as represented in the Head Start Impact Study. Results: For this case study, common data elements between the trial sample and population were limited, making reliable generalization from the trial sample to the population challenging. Conclusions: To answer important questions about external validity, more publicly available data are needed. In addition, future studies should make an effort to collect measures similar to those in other data sets. Measure comparability between population data sets and randomized trials that use samples of convenience will greatly enhance the range of research and policy relevant questions that can be answered.


2002 ◽  
Vol 97 (6) ◽  
pp. 1576-1581 ◽  
Author(s):  
Jeremy Davies ◽  
Roshan Fernando ◽  
Andrew McLeod ◽  
Sonia Verma ◽  
Philip Found

Background The safety of mobilization following low-dose regional analgesia in parturients remains controversial. Previous studies have demonstrated preserved balance function despite clinically elicited sensory deficits. The aim of this study was to use the Balance Master 6.1, a device capable of real-time analysis of ambulation, to score the performance of basic maneuvers following initiation of low-dose combined spinal-epidural analgesia in laboring women compared with pregnant and nonpregnant controls. Methods Using the Balance Master, balance function during the performance of several simple tasks, including walking and standing up from a sitting position, was evaluated in a prospective, controlled, observational study with 50 laboring women after combined spinal-epidural analgesia compared with 50 pregnant and 50 nonpregnant controls. Results Nonpregnant women scored significantly better results in 6 of the 13 measured balance function parameters compared with both the combined spinal-epidural and pregnant control groups. Compared with the nonpregnant subjects, the pregnant groups generated less force standing up from the sitting position (P < 0.0001), walked more slowly (P = 0.0067), and took shorter steps (P < 0.0001). They also took longer to step up onto and over a 20-cm-high obstacle (P < 0.0001), and they generated less force while stepping up. Initial spinal analgesia in laboring women did not significantly affect performance in comparison to the pregnant controls. Thirty-four percent of women in the combined spinal-epidural group required supplemental epidural analgesia following the initial spinal injection (n = 17) before testing; they had significantly impaired balance function in four tests compared with those receiving a spinal injection only (n = 33). Conclusions Being pregnant at term significantly affects balance function, although initial low-dose spinal-epidural analgesia does not impair function further. Subsequent supplemental epidural analgesia may have a detrimental effect on balance, but properly designed studies are awaited to confirm this. This study supports the practice of allowing laboring women with initial low-dose spinal-epidural analgesia to ambulate, but indicates that further studies need to be conducted on the effects of subsequent epidural supplementation.


Acute Pain ◽  
1997 ◽  
Vol 1 (1) ◽  
pp. 27-32 ◽  
Author(s):  
David A Sidebotham ◽  
Kevin Russell ◽  
Monique R Dijkhuizen ◽  
Peter Tester ◽  
Stephan A Schug

2018 ◽  
Vol 38 (3) ◽  
pp. 157-158
Author(s):  
R. Vedagiri Sai ◽  
S.I. Singh ◽  
F. Qasem ◽  
D. Nguyen ◽  
S. Dhir ◽  
...  

1999 ◽  
Vol 91 (2) ◽  
pp. 436-441 ◽  
Author(s):  
Anthony E. Pickering ◽  
Martin G. Parry ◽  
Basil Ousta ◽  
Roshan Fernando

Background Low-dose combined spinal-epidural analgesia in labor has proved popular with women because lower-limb motor power is preserved, allowing ambulation. However, there has been debate about the safety of allowing women to walk following low-dose regional analgesia because of somatosensory impairment. The authors undertook a prospective controlled observational study using computerized dynamic posturography to examine balance function in pregnant women after combined spinal-epidural analgesia. Methods The authors performed posturographic testing on 44 women in labor after institution of regional analgesia and compared them with a control group of 44 pregnant women. A separate group of six women were tested both before and after combined spinal-epidural analgesia. Results Neurologic examination after regional analgesia showed two parturients (4%) to have motor weakness (excluded from posturography). Four women (9%) had clinical dorsal column sensory loss; these women all completed posturography. The spinal-epidural analgesia group showed a small, statistically significant reduction in one of six posturographic sensory-organization tests; however, this difference was functionally minor. There were no other differences in posturography between the control and spinal-epidural groups. Similar results were found in the paired study, in which there was minimal change in balance function after spinal-epidural analgesia. Conclusions This is the first study to objectively examine the effect of spinal-epidural analgesia on balance function. Using computerized dynamic posturography, the authors were unable to find any functional impairment of balance function after spinal-epidural ambulatory analgesia in women in labor who had no clinical evidence of motor block.


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