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Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.
Address reprint requests to: Stuart D. Shelton, MD, Darnall Loop, Department of Obstetrics and Gynecology, Darnall Army Community Hospital, Ft. Hood, TX 76544-5063. E-mail: email@example.com
The opinions and assertions contained herein are the private views of the authors and not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.
Received May 9, 2000. Received in revised form August 8, 2000. Accepted October 5, 2000.
Objective: To assess the effect of repeated courses of betamethasone on birth weight and head circumference.
Methods: We conducted a historical cohort study of inpatients receiving betamethasone therapy over 5 years. We compared birth weights and head circumferences of infants whose mothers received one course of betamethasone with those of infants whose mothers received multiple courses. Multiple regression analysis was used to adjust for potential confounding variables. Sufficient power (80%) existed to detect a 20% difference between the groups (α = 0.05).
Results: Mean birth weights (±SD) were 1717 ± 707 g in the single-course group (n = 107) and 1783 ± 647 g in the multiple-course group (n = 45) (P = .59, Student t-test). Mean head circumference was 28.2 ± 3.6 cm in the single-course group and 29.2 ± 2.9 cm in the multiple-course group (P = .15, Student t-test). In regression analysis, birth weights (1757 g and 1752 g) and head circumferences (28.5 cm and 29.0 cm) did not differ significantly different between the single-course and multiple-course groups.
Conclusion: Multiple courses of betamethasone do not reduce birth weight or head circumference in neonates compared with single-course therapy.
As reported by Liggins and Howie almost 30 years ago,1 corticosteroids enhance fetal lung maturity and thereby reduce both the incidence and severity of the neonatal respiratory distress syndrome. Additional benefits of corticosteroids include reductions in intraventricular hemorrhage, necrotizing enterocolitis, and neonatal mortality.2 Despite these benefits, controversy exists regarding management of the woman who is undelivered 7 days after steroid therapy but is still at risk for preterm delivery. In this instance, the risks and benefits of repeated dosing remain unsettled.
A 1994 ACOG Committee Opinion3 stated that further study was needed to establish the safety and benefit of repeated doses of corticosteroids in preterm patients. Although little human information was presented over the next 4 years, a 1998 revised committee opinion held that routine repeated dosing should be abandoned and replaced with rescue therapy on an as-needed basis.4 This recommendation was based on possible adverse fetal or maternal effects with repeated doses, as seen in animal studies. Johnson et al5 reported that repeated doses of betamethasone resulted in a 24% reduction in birth weight and a 15% reduction of brain size in preterm offspring of rhesus monkeys compared with controls. Ikegami et al6 administered repeated doses of betamethasone or saline to sheep and noted a progressive reduction in birth weight in the groups that received betamethasone. Both of these studies5,6 involved deliveries of preterm animals. Other studies of animal models have confirmed a reduction in neonatal birth weight7,8 or brain size9 in fetuses before or at term who were exposed to repeated doses of antenatal corticosteroids. Only one of these studies7 evaluated long-term postnatal growth and found no difference in subsequent body weight of mice exposed to multiple doses of betamethasone compared with controls.
In contrast to animal data, few studies are available on the effect of repeated doses of antenatal corticosteroids on human fetal growth,10–12 and the conclusions of these studies are not in agreement. Pratt et al10 found no significant effect of multiple doses of betamethasone on birth weight, whereas French et al11 and Banks et al12 noted a reduction in birth weight of infants exposed to multiple doses of antenatal betamethasone.
We sought to evaluate the effect of repeated doses of an antenatal corticosteroid, betamethasone, on birth weight and head circumference; the latter was chosen as an indirect index of brain size. We postulated that repeated doses of antenatal betamethasone would result in a reduction in neonatal birth weight and head circumference compared with single-dose therapy.
In accordance with our institutional review board guidelines, a historical cohort study was conducted by reviewing obstetric inpatient records for patients admitted between the gestational ages of 24 0/7 to 36 6/7 weeks to Duke University Medical Center from January 1991 through December 1995. We used a computer-generated list of women admitted before term that was based on International Classification of Diseases, Ninth Revision, codes to identify records for review. All patients receiving betamethasone were eligible for analysis. We excluded patients admitted before term in whom betamethasone was not used. Other exclusion criteria were fetal anomalies, multiple gestations, steroid use for other medical conditions, or insufficient data (ie, birth weight or head circumference not available). Maternal demographic information, number and timing of betamethasone doses, and clinical outcomes were recorded. Neonatal records were reviewed and neonatal birth weight, head circumference, and sex were noted.
Patients were divided into two groups for analysis according to whether they received one or multiple courses of therapy. A single course of betamethasone was defined as two 12-mg doses administered intramuscularly 24 hours apart. Administration of more than two doses qualified as multiple courses. Patients who received one of the two doses that made up a single course were analyzed in the single-course group.
Dichotomous variables were analyzed by using the χ2 or Fisher exact test, and continuous variables were analyzed by using the Student t-test. Multiple regression analysis controlling for gestational age at birth, race, sex, alcohol use, illicit drug use, and tobacco use was used to compare birth weights and head circumferences between groups. For all tests, statistical significance was set at P < .05 using a two-tailed test. Analyses were performed by using SAS software (SAS Institute, Cary, NC).
We identified 472 women with preterm admissions and reviewed their records. Of these, 320 were excluded: Two hundred fifty-one received no betamethasone, 38 had multiple gestations, 27 had insufficient data, 2 had fetal anomalies, and 2 had other steroid use. The most common reason that a woman delivering before term did not receive betamethasone was advanced preterm labor at time of admission.
After exclusion criteria were applied, 152 patients remained for study analysis; of these women, 107 received one course of betamethasone and 45 received multiple courses of therapy. Among patients receiving multiple courses, 28 received two courses, 4 received three courses, 5 received four courses, 2 received five courses, 5 received six courses, and 1 received seven courses.
The incidence of tobacco and alcohol use differed significantly between the groups. Patients receiving multiple courses of betamethasone were less likely to smoke tobacco or drink alcohol (Table 1). The groups did not differ with respect to pregnancy complications, such as diabetes or hypertensive disorders.
The groups did not differ significantly with respect to gestational age at delivery, birth weight, or head circumference; in contrast, gestational age at the time of the initial treatment with betamethasone differed significantly (Table 2). After multiple regression analysis controlling for gestational age at birth, sex, race, tobacco use, alcohol use, and illicit drug use, the groups still did not differ significantly.
Our retrospective analysis demonstrated that birth weight and head circumference in fetuses exposed to multiple courses of betamethasone did not differ significantly from those in fetuses exposed to a single course. Our results are consistent with those of Pratt et al,10 who found no significant difference in birth weights of infants exposed to one or multiple courses of betamethasone. Their analysis, like ours, was retrospective and therefore subject to the same potential problems.
In contrast to our results and the findings of Pratt et al,10 other investigators noted decreased birth weights of human fetuses exposed to multiple doses of betamethasone.11,12 However, in the study by Banks et al,12 the difference in birth weights between the single-course group and the multiple-course group was only 39 g. French et al11 found a 9% reduction in birth weight with multiple doses, but this translated into only a 122-g difference. The clinical significance of such small reductions in birth weight depends on the gestational age at which it was detected, and they are not likely to impact neonatal outcome, except in extremely low birth weight infants.
We recommend caution in interpreting the results of all these studies, since retrospective investigations are inherently subject to data collection bias. The persons who performed the chart reviews for our study were not blinded to the study objective and were therefore potentially subject to ascertainment bias. Although we used regression analysis to control for possible confounding variables, the multiple factors affecting growth make comparison of groups difficult. Additional factors that affect neonatal birth weight may exist but were not included in our regression model.
Several possible explanations account for our finding of no difference in birth weights or head circumferences between groups. First, a type II error may have occurred; that is, a difference actually existed, but we did not find it because of the small sample. Retrospectively, we determined that we had 80% power to detect a 20% difference in birth weights between the groups at an α level of 0.05. Therefore, a smaller difference in birth weight may be present that was not detected by our analysis. Sufficient power to detect a 10% difference in birth weights between groups would require quadrupling the size of each group. This would not be possible using patients from our institution, since we began to decrease our use of multiple steroid courses in the years after this study. In addition, a 10% reduction in birth weight is unlikely to have clinical significance, except perhaps at birth weights less than 750 g. A second reason for lack of difference in birth weight and head circumference between the single-course and multiple-course groups may be that the reduction seen in animal models was due to differences in steroid doses or in animal versus human response to steroids. Finally, we may not have found a difference because repeated courses of antenatal betamethasone do not adversely affect fetal growth.
The conclusions drawn from our study must be limited to effects on growth outcomes. We did not examine possible beneficial effects of multiple courses of betamethasone. We also did not address other potential deleterious effects of multiple courses of betamethasone, such as fetal adrenal suppression or increased risk of maternal or fetal infection. Finally, our study examined only short-term effects of betamethasone on fetal growth and not potential long-term effects of multiple steroid courses on growth and development.
Although we did not find a reduction in birth weight or head circumference in fetuses exposed to multiple courses of betamethasone, we believe that concern about possible adverse effects of repeated courses of corticosteroids is legitimate. In the absence of clear evidence to show that repeated doses provide benefits above those of single-course therapy, we feel that is incumbent on the provider to prove that multiple doses are not harmful.
Consideration of repeated administration of corticosteroids to women who are undelivered but remain at risk for preterm delivery 7 days after a course of antenatal corticosteroids should take into account the risks as well as the benefits of such therapy. Until prospective studies specifically designed to evaluate the risks and benefits of multiple courses of antenatal corticosteroids are performed, we are limited to animal and retrospective human analyses. Although our study results provide some reassurance about the safety of repeated courses of antenatal betamethasone, until clinical benefit for repeated doses can be shown or no other possible adverse effects are found, caution should be exercised when considering repeated dosing of corticosteroids.
This article has been cited 4 time(s).
© 2001 The American College of Obstetricians and Gynecologists
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Save money on batteries with the AC adapter! The lightweight and long power cord on the AC Adapter allows you to plug in and use your Mighty Bright light just about anywhere. For use with: HammerHead, XtraFlex2, Duet2, Triple LED, Vusion, and Stage/Pedal Board lights.
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• Not compatible with Floor Light and Magnifier
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subset: commoncrawl


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P!nk: Miley Cyrus Is Talented & Beautiful, But Her VMAs Performance Was 'Tacky'
It seems like everyone is chiming in about what they thought about Miley Cyrus' MTV Video Music Awards (VMAs) performance last month.
The former Disney star hit the stage with Robin Thicke to sing his hit track "Blurred Lines," but her "twerking" dance moves and flesh-colored bikini resulted in hundreds of complaints to The Federal Communications Commission.
Pop star P!nk wasn't too impressed with the performance and believes Cyrus' raunchy new image doesn't do justice to her talent and ability.
She told E! ""I think it's tacky... She's really freaking talented. She's beautiful. She can sing her as** off and to go up there and do that? She's cheating herself and she's cheating the rest of us. She can do what she wants. People can like it if they want. I'm not going to buy it.
"She can do better. I've seen her do better... I twerk all the time like a mofo (sic). There's a place for that and it's not on stage."


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Human adventure is an activity which involves risk, danger or exciting experiences and often used to refer to activities with some potential for physical danger, such as skydiving, mountain climbing, breaking and entering, committing misdemeanours, and participating in extreme sports etc.
Recently I watched one extremely crazy video of a man with a bicycle. Whole time I am terrified that he is going to die and almost had a heart attack.
Watch this amazing video of incredible talent.


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Quality and color are great and looks so good with my gray walls. So glad I found it at Rugs Direct.


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alright first off thanks Coleman for giving Sundov some props haha. Like the top symbol-record thing but the match up is a little big.
on that note its the return of my MATCH UP PREVIEW. Heres the Key (+) good for us (-) bad for us (e) even....pretty simple here we go MAGIC-KNICKS edition...
CENTERS Kurt Thomas vs Kelvin Cato--Cato does have a 2 inch height advantage here BUT thats going to happen in most to every game the knicks play with Kurt as center. We have been playing the last 3 games with Kurt undersized by 2-4 inches but guess what boys we WON the last three games. Cato outweighs Thomas by a good margin almost 50 lbs and thats where I see are advantage. Kurt mite not oversize or outpower, or out block (1.6 per game) Cato but he surely will beat him to the punch. Kurt also averages 4.5 ppg and a little less than 3 rpg more here....RATING (+)
POWERFORWARDS Mike Sweetney vs Dwight Howard--Sophmore vs Rookie. Another situation where we get outsized this one by 3 inches. Now Sweetney will overpower this kid BUT clearly doesnt have any advantage. Dwight Howard unlike Cato has that quickness to back up his size. Cant really go by average stats because Howard has been a year rounded starter but when starting they average around the same in points and rebounds. Sweetney will have a tough time defending Howard and getting shots off (1.6 blocks per game)...Sweetney will foul out early unless he comes up with a game plan in defending him before hand....RATING (-)
SMALLFORWARDS Tim Thomas vs Grant Hill--In stats Hill overwhelmingly concurs Thomas. But Tim does have everything working in his favor. If he plays how he has been and defends as he could and has been this will be a sure cut plus for the team. Tim is 2 inches taller, has a much wider wingspan and is flat out more athletic. Not to state the obvious (but thats what im doing here haha) Hills knees/age will catch up with him and theres no way he can match up with the athleticism of a one Tim Thomas. you cant rule out the possiblity of Grant Hill succeeding in this match up hes overcome a lot and is a great player BUT this for now is a rare....RATING (+)
SHOOTINGGUARDS Jamal Crawford vs Doug Christie. Not a horribly uneven match up. Crawford beats Christie in ppg 11+ more on average. Christie definitly is a good defender and good at the steals BUT we have to take in a account that Crawford is a remarkable ball handler (my second favorite right behind my boy Skip to My Lou, thats a shot out haha). So where Christie excels Crawford excels on the opposite side. I think if crawford does what i honestly thinks he does best and drives to the lane and breaks down his opponent hes got this one. Im just afraid with Christies defense Craw mite get scared and go for the lazy, run and gun, out of the blue shot that were used to that gets him that 39fg%....was going to go even here but....RATING (+)
POINT GUARDS Stephon Marbury vs Steve Francis. I LOVE let me reitirrate that LOVE watching them play each other. Even before Steph was a Knick I think they push eachother to the limit and defend, try to one up eachother every time they play. Its a pleasure watching much like an Iverson/Marbury matchup but to another degree. Not saying Francis is better than Iverson by any means BUT if your familiar with the Steph/Steve matchups your with me on this. Both have similar stats, similar size. Just will be a pleasure to watch simple as that, and even though Francis is still not 100%....RATING (e)
on the starting line ups were going out there under sized (5 inches all together) and out rebounded (6.3 rpg) ...BUT according to this unsignificant tally lol, well win this game...this here is the rubber match 1-1 this season...this will (knock on wood or ) but this will make the series 2-1 and the knicks 4th consecutive win!!!!


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9 posts tagged with Nutrition and sugar.
Displaying 1 through 9 of 9. Subscribe:
Given the Taubes/Lustig view on sugar, why not use dextrose everywhere?
If we assume the (increasingly accepted) view that sugar, in any decent quantity, is a highly unhealthy thing to eat, and that the main culprit is actually fructose, is there any good reason to not aggressively replace sugar or HFCS with dextrose? [more inside]
Sugar, sugar... aw, honey, honey 🎶
Really brief, dumb question about nutrition: How bad is sugar for you if you're not overweight/obese or diabetic? [more inside]
Nutrition and health aspects of white versus wheat bread
Most people have heard the mantra that wheat bread is "good" but white bread is bad. However, virtually all commercial wheat breads contain added sugars in some form (molasses, etc.) while it is possible to obtain commercial white breads with zero added sugars (e.g. scali or Italian bread) and sugar is meant to be "bad" for us, contributing to cancer, obesity and diabetes. From a scientific or evidence standpoint, how do the relative merits of sugarless white and whole wheat breads stack up assuming one buys the best quality option from each category?
Insulin, sugar and the food pyramid
Our sugar and carbohydrate consumption causes our bodies to store the glucose as fat. Why does the food pyramid tell us to eat more of that food? [more inside]
What happens when I eat a bunch of sugar and then go to bed?
Are there any nutritionists that can weigh in on what exactly occurs when I eat a bunch of sugar immediately before going to bed? [more inside]
Sugar, spice, and everything nice, but mostly sugar. Is that what little girls die of?
How bad is it, really, to have a sugar addiction? [more inside]
Sweet, sweet candy
What are some (at least slightly) healthy alternatives to muffins, pudding, cupcakes and chocolate? Everybody I know favours savoury -- but I favour the sweet stuff! My attempts to eat well eventually derail because while I have lots of healthy savoury options, I've got no healthy sweet options. [more inside]
Gimme' some of that sweet sweet...
How much sugar do I consume every year without my knowledge? [more inside]
How much sugar is too much for a toddler?
How much sugar is too much for a toddler? [more inside]
Page: 1


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3 Reviews
It isn't your brother's pant anymore.
Airblaster equipped the My Brothers Pant with zippers at each inseam for ventilated airflow. Zippered ankle gussets allow easy access to the protective boot gaiters. Reinforced with ripstop, the cuffs stay strong for multiple seasons. This pant also has adjustable tabs at the waist so you don't lose your pants while riding.
- Membrane 15k/10k
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- Ripstop reinforced kickpatches
- Built-in waist adjustment
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Airblaster My Brothers Pant
Tech Specs
Nailed it.
- Familiarity: I've put it through the wringer
- Fit: True to size
- Size Bought: Medium
Bought these babies after comparing all the best brands. These are not your typical snow pants, they are made from a stretchy blend fabric that feels a bit like corduroy denim. My jacket was soaked after a day in the powder but these pants kept out the snow and the cold. Did I mention that they fit great too? Real women have hips and these fit my hips and thighs with a slight flare and a 33in inseam. Did I mention the loads of compliments I got?! I'd buy these again in a heartbeat. Thanks Airblaster!
Love these pants
- Familiarity: I've put it through the wringer
- Fit: True to size
I've had three pairs of these pants, and I like them because of the fit. They've got the slouchy tight fit that I want in a ski pant. The only thing I don't really like in the updated version is that they've cut the pants so that the hips balloon out a little bit, but I don't mind because you can't see it underneath my coat. I have used both the medium and smalls. I'm 5'5", 125lb, athletic build. The mediums definitely sag a bit, but still have the slim fit around the legs. The smalls are tight through the legs and fit perfectly around my waist. It's hard to find ski pants that have the perfect balance of slim and saggy fit. I always buy the same pair! LOVE the fit.
Single stitch weak cotton outer seem
- Familiarity: I've used it several times
Quality material , good fit but if you brush by a branch the seam will go from boot to hip, very dissapointed with company response ? single stitch with poor quality cotton ,not a winning combo, rider since 87
What is the inseam on these?
I ordered Medium, which has a 33in inseam.


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Mumford & Sons Bassist Ted Dwane Shares Post-Brain Surgery Photo, Thanks Fans For Support
Mumford & Sons bassist Ted Dwane, who underwent brain surgery last week to remove a blood clot, is doing well, recovering at home since his release from the hospital on Friday.
The band posted a photo of Ted on its website (and on Twitter & Facebook) with a message from the ailing musician, "Bear with a sore head! Thanks so much for all the well wishing, it seems to be working! I'm home," he wrote to fans.
The photo shows Ted with his hair shaved off (the beard's still intact!) and a visible cut on his head where the surgery was performed.
Last week the band was forced to cancel their headlining appearance at this year's Bonnaroo Festival, along with two more dates, and singer Jack Johnson filled in, dedicating his entire set to Dwane and covering the band's single "The Cave."
"We want to dedicate this whole set to Ted Dwane and all of Mumford & Sons," Johnson said.
The singer was scheduled to make an appearance with band ALO during the event, but got the call at the last minute. He said aside from guesting with ALO he was also anticipating seeing Mumford & Sons' set.


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Total Attendance at the meeting was 16.
The meeting opened with a History Channel video on robotics.
Jake hosted the giveaways and literture handouts. Among the goodies this time were some nice DC motors and a LOT of little plastic containers.
The next item on the agenda was the line tracing contest. The group decided that, instead of a single contest event, the line tracing contest should be made into a long term robotics "badge" so to speak. Members were encouraged to build their robots over the coming months, bring them in when they need help, or when they would like to demonstrate their abilities. Jim also demonstrated his line tracing robot, and the group was amused by its attempts to follow a masking tape line that we stuck on the floor.
Jake then spoke about the upcoming Robo Expo being hosted by Mondo*Tronics (www.RobotStore.com) to be held Sept. 20 at the Hyatt hotel in Cambridge, Mass. Mondo is looking for people to man the exhibits and demo their lastest creations. Curt indicated that he would put the map on the club web site.
Jeff Bachiochi from Circuit Cellar indicated that he was willing to trade books for subscriptions.
This led into a discussion of ordering books from A.K. Peters as a club project in order to build a sharing library. Members were encouraged to put together a book list and a parts list so that in the future we could place such a group order.
Mike M. talked about the motor driver boards that he recently purchased for his home butler robot. Being a little to big to bring along, Mike showed the club photos of how this robot is progressing.
Mike talked about his aspirations for a fire fighting robot. He brought in a base and some various motors and asked the group for their thoughts.
This led into a short talk on stepper motors given by Jake.
The meeting was capped by a free-for-all discussion and excerpts from the Trinity video (from the robot's point of view).
The meeting ajourned at 3:45pm.


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Eastern Division reaches CPS3 goal
American Cancer Society board of directors member, Dr. Arnold Baskies (center, holding plaque) and Virtua staff made CPS3 a success in South Jersey.
Study goal surpassed six months ahead of schedule
Last week, the American Cancer Society's Eastern Division (New York and New Jersey) became the first Division to surpass its Cancer Prevention Study-3 (CPS-3) enrollment goal. And they did it six months ahead of schedule.
A total of 24,717 enrolled participants put us over the top! What makes this success all the more sweet is that all of the remaining planned enrollments will help ensure the organization reaches its nationwide goal of 300,000 people enrolled. Thank you to everyone who enrolled, volunteered, or helped spread the word about community enrollments.
What makes this success all the more inspiring is the story behind it. Last November, as Hurricane Sandy pounded the Northeastern United States, Eastern cancelled enrollments expected to bring in 2,500 new participants. Despite the catastrophic effects from the storm in New Jersey and New York, staff and volunteers did not waiver in their commitment to our mission and to CPS-3. They stood ready in 2013 to make up for lost time and were more determined than ever to make their goal. Staff was driven by a mantra first shared by Kris Kim, senior vice president for operations and soon-to-be the Division's executive vice president, "We cannot be the first generation to fail the next."
The friends, family, and neighbors that these volunteers and staff members helped enroll are equally as dedicated to the life-saving study. In fact, one participant was so determined to enroll that despite being hospitalized for a broken hip, she had her nurses bring her to the hospital enrollment site in a wheelchair so she would not miss out on being a part of cancer's last stand.
Danielle Heller, regional community mission manager in the Hudson Valley, said it best in a note she sent to Dr. Alpa Patel, the strategic director of CPS-3: "CPS-3 has to be one of the most exciting and rewarding initiatives I have ever been involved in. As my two daughters play with their Barbie dolls, who they claim are 'cancer fighting superhero women,' I know the work I am doing at ACS is having a tremendous impact on their lives and the lives of so many others. Very few people get to wake up each day and fight for something they believe in. All of us involved in CPS-3 are a part of the next wave of cancer answers. Our legacy will be experienced by all generations to come. Now that is a good day at work!"


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The W3C is a curious beast. While moral in the sense that it evangelizes open standards and accessibility, it is strangely amoral in its obedience to member vendor whim and its insistence on the one true path of W3C-blessed technologies. Both of the topics I tackle this week are results in a way of that latter tendency. In this column I revisit the validation thread on XML-DEV, shaking the "one true way" assumptions on schema usage, and take a swipe at the latest SOAP specifications.
Fallacies of Validation
I am exceedingly grateful to Roger Costello who has taken the threads of discussion about validation covered last week and summarized them on XML-DEV under a series of posts entitled "Fallacies of Validation." Never one to look a gift horse in the mouth, I'll focus on Costello's summary.
In his most recent revision, Costello identifies seven fallacies.
Fallacy of "the Schema"
Drawing from comments from Michael Kay and Len Bullard, Costello notes that a system needn't have just a single schema.
Both Michael and Len are stating that in a system there should be numerous schemas. This is a big mindshift for me. I admit being trapped into thinking that there should be a single schema.
Fallacy of Schema Locality
Costello says that this issue arises when schemas encode local customs, but end up being used in a global scenario. I'm not sure this is a fallacy, but it's certainly a trap.
Fallacy of Requisite Validation
This might equally be called the fallacy of overaggressive validation. There are situations where validation doesn't win the system much and ends up inconveniencing others. Quoting Michael Kay talking about postal address validation:
The strategy (validating the user's address) assumes that you know better than your customers what constitutes a valid address. Let's face it, you don't, and you never will. A much better strategy is to let them (the user) express their address in their own terms.
Fallacy of Validation as a Pass/Fail Operation
This is a particularly intriguing point, as it flies in the face of traditional DTD and schema validation. Costello reproduces the argument here from Mary Holstege:
[Many people think that validation is a pass/fail operation.] Not so, although lots of people are still stuck in that way of thinking, including, alas, a lot of the vendors. The schema design goes to great pains to make it possible to do things like this, for example: validate a document against a tight schema, and then ask questions of the result such as "show me all the item counts that failed validation because they were too high."
So this is a failure of vendor implementation, not W3C XML Schema? Rick Jelliffe says it's more a systematic problem with grammar-based approaches to validation. His Schematron technology offers a rule-based approach which doesn't suffer from the same issue.
Fallacy of a Universal Validation Language
Regular readers of XML.com will perhaps already grasp this. Costello cites Dave Pawson's observation that the Atom format can't be validated against a single schema -- not even with Relax NG!
Whether this is a wise decision on Atom's part is another matter.
Fallacy of Closed System Validation
The XML schema version of Murphy's Law. This one is summed up nicely in Costello's words:
Many people imagine that they can create a monolithic, invariant schema because "there's just me and my well-known trading partners." This statement fails to recognize the existence of a changing world; more precisely, a changing ecosystem.
Fallacy that Validation is Exclusively for Constraint Checking
This one is somewhat related to fallacy #4. Costello writes:
I suspect that many people have the same mentality that I have regarding validation: "An XML instance document arrives, I forward it to a validator tool, if the validator tool doesn't complain then forward the instance to some software to process it. If there's an error then discard the instance."
He goes on to observe that validation can play other roles in a system, such as a starting point for messages and events that cause subsequent system action, rather than merely errors.
Another theme Costello picks out is using schema validation results to mediate evolution in a system. Validation messages can be used to adapt the behavior of a system, rather than blindly assuming the user is wrong.
A really useful summary. While some of the "fallacies" are perhaps better framed as anti-patterns, I think everyone who uses a schema with XML should read them in order to broaden their thinking about validation and its uses.
Soapy Susurration
News comes my way from the W3C of a new rash of web service specifications. I tell you, not even King CORBA in all its glory was clothed with specs such as these!
Chiefly amusing among the three specifications marching toward Candidate Recommendation status at the W3C is the Resource Representation SOAP Header Block. Before even looking at the specification, something smells a little strange about this. Chapter 2, verse 21 of the Book of REST teaches us that a resource representation is what you get when you retrieve content by resolving a URI. In everyday life, a resource representation is what you get in response to an HTTP request.
It is then with an element of fear I look to see what this specification can possibly contain. The introduction is plain enough:
This document describes the semantics and serialization of a SOAP header block for carrying resource representations in SOAP messages.
I am afraid this does not calm my nerves much. Are we then headed toward the re-encapsulation of HTTP in, erm, SOAP? The example at the end of section 4.1 seems to confirm this. The example includes a PNG image, base-64 encoded, in the header, and an XML body that refers to that image by URI. The example itself also gets amusingly close to being RDF.
This specification seems to be the final resolution of SOAP with Attachments. The circle is now complete! I now confidently predict that it will not be long before we find entire SOAP messages themselves encoded in base 64 and carried around in the headers of other SOAP messages. To further my amusement, I offer this challenge: If one can be found in the wild before XML 2004 this year, I will buy the finder a drink at the conference bar.
I will spare you further expostulation about what's wrong with HTTP anyway for such things, and the lunacy of using XML as a general container for any media type; and, actually, what about BEEP, which solved this problem years ago?
Instead, a little ditty adequately sums up my feelings. With apologies to De Morgan:
SOAP specs have little specs upon their backs to spite 'em
And little specs have lesser specs, and so ad infinitum.
Births, Deaths, and Marriages
The latest announcements from the XML-DEV mailing list.
- XULNews.com Live
Source for news on the Mozilla XUL user interface technology. Web interface to the xul-announce mailing list.
- Orbeon.org: Open Source XML-Based Integration
If you look behind the buzzwords, the exciting thing here is an open source XForms implementation.
- Topologi Professional Edition 2.1
Rick Jelliffe's editor for the markup professional. Hard to beat.
- XForms link directory
Useful-looking bunch of XForms links.
- SSYN: Alternative to Data-centric XML and YAML
The latest chapter in the attempt by Python programmers to remodel XML in their own image.
- XMLmind XML Editor V2.7
XML editor, kitchen sink, and lifestyle assistant adds support for many image formats, including SVG, command-line access to editor functions, and plugin enhancements.
Also in XML-Deviant
You don't get much more nostalgic than this ... proving XML-DEV is educational in every way, I learned my new word of the week: bloviate ... 126 messages to XML-DEV last week, Len rating 25% (happily the blog isn't getting all the attention) ... adherence to schemas causes trouble, from Venezuela to an English coal shed.
Schema as editing guide
2004-09-03 01:09:53
I like this article, because it shows some practicality (?). Let me add another side : editorial document point of vue.
I am a XML document professional, and the main use I have always seen on DTDs was editing guideline (and constraint). This is a way to ensure the document follow a certain model, therefore providing all the information you will need to use or publish this document afterward.
Now I know Schema were created more for Data exchange than document encoding. But I believe this is still a point to be looked upon : The schema is, for me, a way to guide a generic tool (editor, code generator, interface generator) for a suitable interaction with the user.
So more than validation (which I frankly don't care about that much : better produce a correct instance than refuse a incorrect one afterward), Schema should be seen as guidelines.
As for SOAP, I'd like someone to point out for me in which functionnal perspective it is better than REST-style interface...


text: An epitome of classic beauty, this brilliantly carved lantern is surely a heartthrob. You donŐt need a power cut as a reason for its use. Just place it casually on the porch and keep counting the upcoming compliments and appreciation that follow from around everywhere. A heat resistant glass shade placed tactfully in the centre of this metallic piece, the product definitely makes you feel proud. The lantern is further tinted with a warm shade of blue which adds to its tranquility. The color blue is known as a symbol of calmness and serenity and thatŐs exactly what this lantern does to its surrounding. When lit, the lantern fills the entire ambience with splendor and warmth and when not in use it can be a great piece of decoration. The small ring on the top of the lantern ensures comfortable hanging of the lantern at your desired place. So, go on immerse yourself in the glow of this scintillating lantern. It comes with a dimension of


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After being placed in script oblivion, it appears that the feature film adaptation of the classic animated series (and inspiration for Adult Swim's Venture Brothers) Jonny Quest may be getting resurrected. IESB has recently reported that Zac Effron and Dwayne "The Rock" Johnson will star in the upcoming adaptation. It's to be titled The Adventures of Jonny Quest. Set to direct will be Andy Fickman, who recently directed Johnson in the family-friendly Sci-Fi film, Race to Witch Mountain (he also let his freak flag fly with Reefer Madness: The Musical.)
Naysayer's Argument: This is generally news that falls in the "God, no!" and "WGAF?" categories. Do I care about Jonny Quest? Not really. I caught it every now and then as a kid, but it certainly did not help define my life. You may be asking yourself, "What possible value could this film have?"
After all, we have Zac Effron, star of those obnoxious High School Musical movies (or was it Cheetah Girls? I always confuse those things.) He will be playing Jonny, the main character, who traditionally is supposed to be 12-years old. We have The Rock playing Race Bannon, who is hot and cold in his roles -- possibly set to make a fool of himself -- even worse than he did in Doom. And there's the yet-to-be-cast, Hadji. Is he going to be some bad Fisher Stevens-esque Indian stereotype in a turban? How about an over-the-top CGI version of the pug, Bandit? And again...Jonny Quest???
Well, there's no hating happening here. Let's put this film into perspective, then:
I think it's safe to say that no one cares about the retconning of the Jonny Quest story. If Jonny is a teenager or in his early 20's, then cool. Who wants to see a 12-year old going around playing superhero?
Giving credit where credit is due, when The Rock is on, he is ON. When I think back to films that get by with pure chemistry, I think of The Rock with Seann William Scott in The Rundown. On paper, it was a run-of-the-mill action flick which allowed Vince McMahon to showcase his then-employee in film. It turned out to be a legitimately funny film with great action. This was largely due to the character dynamic created by Johnson and Scott. The same type of chemistry is possible to recreate (maybe even top) with this Jonny Quest project. We can take the sarcastic atmosphere that worked with the Venture Brothers,and give it more of a legitimate jump. I can already see The Rock as team strongman -- Race Bannon -- stuck in the uncomfortable wilderness, ripping on the pretty boy Effron and his "nerdy scientist" father, Dr. Quest. All this, amid some decent action. That is a film I would go to see.
On the Hadji issue, it's not necessary to be a purist and make him wear the turban and Nehru jacket, but let's not be pressured by modern-day political correctness. At the end of the day, if the Hadji character happens to wear a turban, then he does. (Breaking News: Some people from India actually wear them.) It's silly to think that by doing that, it implies that they think "all Indians wear turbans." You can be authentic to the source material without being one step away from putting a Slurpee in his hand. Great characters are never stereotypes.
Cliff Notes: Don't be so quick to poo-poo this project. It has potential, and I am all for it, if done right.


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A few minutes with Dr. Nugent will reveal some certainties.
He is passionate about and uniquely skilled at caring for children with heart defects, both in the clinic and through research. He has an encyclopedic understanding of how the heart works. And he is not from Texas.
"I'm from Melbourne, Australia," he says in his quintessential Aussie accent. "I moved to the United States 13 years ago and have been here ever since."
Dr. Nugent came to America for a fellowship at Boston Children's Hospital and Harvard Medical School, where he learned about pediatric interventional cardiology from some of the leading minds in the field.
He has applied that knowledge for the benefit of patients like Anthony Herman (read his Rhythm of the Heart story) for the past five years at Children's Medical Center. And he's convinced that the The Heart Center at Children's cares for children with heart conditions as well as anywhere in the world.
"I was once told that the measure of a good program isn't a survey but instead where the doctors in the program would choose to send their own children," Dr. Nugent says. "I wouldn't hesitate one second to send my children to The Heart Center at Children's if they had a heart problem."


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Nachega, Jean Bf; Hislop, Michaelc; Dowdy, David Wd; Gallant, Joel Ed,e; Chaisson, Richard Ea,d,e; Regensberg, Leonc; Maartens, Garyb
A typographical error was published in the article 'Efavirenz versus nevirapine-based initial treatment of HIV infection: clinical and virological outcomes in Southern African adults' by Nachega J.B. et al.[1] which appeared on pp. 2117–2126 of AIDS, Volume 22, issue 16.
The affiliations and correspondence address of the first author were not complete. Please see the corrected information below:
Efavirenz versus nevirapine-based initial treatment of HIV infection: clinical and virological outcomes in Southern African adults
Jean B. Nachegaa,b, Michael Hislopc, David W. Dowdyd, Joel E. Gallantd,e, Richard E. Chaissona,d,e, Leon Regensbergc, and Gary Maartensb
aDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Global Disease Epidemiology and Control Program, Baltimore, Maryland, USA, bDepartment of Medicine, Division of Clinical Pharmacology, Groote Schuur Hospital, University of Cape Town, cAid for AIDS Disease Management Program Ltd., Cape Town, South Africa, dDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health and eDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Correspondence to Professor Jean B. Nachega, MD, PhD, Director, Center for Infectious Diseases, Faculty of Health Sciences, Stellenbosch University, Teaching Building, 5th Floor, Room 5012, Tygerberg Campus, Cape Town, South Africa.
E-mail: firstname.lastname@example.com or email@example.com
November 12, 2008.
aDepartment of International Health, Johns Hopkins Bloomberg School of Public Health Global Disease Epidemiology and Control Program, Baltimore, Maryland, USA
bDepartment of Medicine, Division of Clinical Pharmacology, Groote Schuur Hospital, University of Cape Town, South Africa
cAid for AIDS Disease Management Program Ltd., Cape Town, South Africa
dDepartment of Epidemiology, USA
eDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
fDepartment of Internal Medicine and Center for Infectious Disease, Stellenbosch University, Cape Town, South Africa.
Received 5 April, 2008
Revised 30 June, 2008
Accepted 9 July, 2008
Correspondence to Professor Jean B. Nachega, MD, PhD, Director, Center for Infectious Diseases, Faculty of Health Sciences, Stellenbosch University, Teaching Building, 5th Floor, Room 5012, Tygerberg Campus, Cape Town, South Africa. E-mail: firstname.lastname@example.com or email@example.com
Objective: To determine the effectiveness of efavirenz versus nevirapine in initial antiretroviral therapy regimens for adults in sub-Saharan Africa.
Design: Observational cohort study.
Methods: Study participants were 2817 HIV-infected, highly active antiretroviral therapy-naive adults who began nevirapine-based or efavirenz-based highly active antiretroviral therapy between January 1998 and September 2004 via a private-sector HIV/AIDS program in nine countries of southern Africa. The primary outcome was time to virologic failure (two measurements of viral loads ≥400 copies/ml). Secondary outcomes included all-cause mortality, time to viral load less than 400 copies/ml, pharmacy-claim adherence, and discontinuation of nevirapine or efavirenz without virologic failure.
Results: The median follow-up period was 2.0 years (interquartile range 1.2–2.6). Patients started on nevirapine were significantly less likely than those started on efavirenz to achieve high adherence, whether defined as 100% (30.2 versus 38.1%, P < 0.002) or more than 90% (44.8 versus 49.4%, P < 0.02) pharmacy-claim adherence. In a multivariate analysis, patients on nevirapine had greater risk of virologic failure [hazard ratio (HR 1.52; 95% confidence interval (CI) 1.24–1.86)], death (2.17; 1.31–3.60), and regimen discontinuation (1.67; 1.32–2.11). Switching from nevirapine to efavirenz had no significant virologic effect, whereas switching from efavirenz to nevirapine resulted in significantly slower time to suppression (hazard ratio 0.58, 95% confidence interval 0.35–0.93) and faster time to failure (hazard ratio 3.92; 95% confidence interval 1.61–9.55) than remaining on efavirenz.
Conclusion: In initial highly active antiretroviral therapy regimens, efavirenz was associated with superior virologic and clinical outcomes than nevirapine, suggesting that efavirenz might be the preferred nonnucleoside reverse transcriptase inhibitor in resource-limited settings. However, its higher cost and potential teratogenicity are important barriers to implementation.
WHO recommends that initial highly active antiretroviral therapy (HAART) regimens in resource-limited settings include a nonnucleoside reverse transcriptase inhibitor (NNRTI) – specifically efavirenz or nevirapine [1,2]. Despite the drugs' widespread use, direct comparisons of their effectiveness are limited and conflicting [3–6]. Currently, efavirenz is recommended over nevirapine for initial treatment by both the US Department of Health and Human Services [7] and the International AIDS Society-USA guidelines [8] based on efavirenz's more favorable toxicity profile and efficacy data [5,9–12]. However, a WHO survey found that most (67%) countries in sub-Saharan Africa recommended nevirapine-based regimens for first-line therapy because it costs less and is available in generic fixed-dose combination regimens [13,14]. Strong evidence that efavirenz produces more favorable virologic and clinical outcomes in a resource-limited population might influence recommendations as well as speed efforts to reduce the cost of efavirenz or to develop a generic efavirenz-containing fixed-dose combination regimen for use in such settings.
A preliminary analysis by our group suggested better virologic outcomes might exist for patients treated initially with efavirenz rather than with nevirapine [15]. However, that analysis was limited by a lack of clinical outcomes data, including mortality and change-in-therapy data. Also, in the earlier study we could only perform limited analyses of relative contributions of efavirenz and nevirapine on virologic outcomes, as the primary variable was adherence, not NNRTI choice.
We now report the results of a primary analysis of virologic and clinical outcomes by initial NNRTI in a large observational cohort study of adults in southern Africa.
We evaluated records from HIV-1-infected adults enrolled in Aid for AIDS, a private sector, employer-subsidized, disease-management program. Although the majority of patients originate from South Africa, this program operates in nine countries of southern Africa, described in detail elsewhere [16]. This program does not manage clinics, but reviews HAART prescription requests from patients' private medical practitioners according to clinical guidelines [17], and manages doctor's reimbursements. HAART and laboratory tests are fully covered by the patient's medical insurance fund (MIF).
In Aid for AIDS, patients become eligible for HAART with either a documented CD4 cell count less than 350 cells/μl on two occasions or a clinical confirmation of an AIDS-defining illness. The treating physician decides whether to prescribe efavirenz-based or nevirapine-based HAART, but efavirenz is required for those patients on rifampicin for tuberculosis. Nevirapine is required for women of childbearing potential who do not commit to using two reliable methods of contraception (e.g., condoms and hormonal contraceptives) because of the risk of teratogenicity with efavirenz [18–20]. HAART is dispensed monthly via a pharmacy of the patient's choice. For reimbursement, patients submit a claim containing the date dispensed, the specific medication regimen, and the quantity supplied. Reimbursement requires no patient copayment. In this population, short-course HAART is standard policy for prevention of mother-to-child transmission (pMTCT) of HIV; single-dose nevirapine was never used [17].
Aid for AIDS systematically collects demographic, laboratory, and clinical data at baseline and during enrollment and recommends semiannual measurement of CD4 cell count and viral load, but physicians choose the timing and the laboratory in which these tests are performed. Physicians are asked to use the same laboratory for follow-up measurements, but the assays used are not recorded. During follow-up, deaths were identified by notification from the attending medical practitioner, the hospital case manager (for in-hospital deaths), the medical fund administrator, or a family member. Patients who left their MIF or whose MIF changed to a different disease-management program were censored as 'lost to follow-up' at the date of departure.
For this study, we included all Aid for AIDS participants who met the following criteria: the participants who were qualified for and claimed at least 1 month of HAART between January 1998 and September 2004; who used an initial regimen containing either efavirenz or nevirapine and two nucleoside reverse transcriptase inhibitors (NRTIs); who were at least 18 years old at HAART initiation; who had no mention of prior HAART therapy in the medical record provided by the medical practitioner or attending physician; who had no viral load less than 400 copies/ml prior to HAART initiation; and who had at least one follow-up viral-load measurement 30–365 days after initiating HAART.
The primary exposure variable for the current analysis was the initial NNRTI used. Patients were defined as being on efavirenz-based or nevirapine-based HAART from the first pharmacy claim authorized until authorization for that drug lapsed for 30 days, another NNRTI or protease inhibitor was prescribed and authorized by Aid for AIDS, or study end (1 September 2004).
The primary outcome was time to virologic failure, defined as two separate (consecutive or nonconsecutive) measurements of viral load 400 copies/ml at least, each more than 6 months after HAART initiation, or switch to another NNRTI or protease inhibitor after at least one such measurement. Patients who had a single viral load more than 400 copies/ml and who died or were subsequently lost to follow-up or censored were not eligible to be 'virologic failures', except in the time-to-failure analyses for those patients who switched regimens. Secondary outcomes included time to all-cause mortality, time to viral-load suppression less than 400 copies/ml, and discontinuation of initial NNRTI without virologic failure. During the follow-up period, deaths were identified as noted above. Potential confounders evaluated are shown in Table 1.
Pharmacy-claim adherence was expressed as a percentage, calculated as the number of months with HAART claims submitted divided by the number of complete months from HAART commencement to death, withdrawal from Aid for AIDS, or study end, with the result multiplied by 100. Depending on the analysis, pharmacy-claim adherence was analyzed as a binary variable with a cut-off of 100, 90, or 80%; or in discrete predefined strata; or as a continuous variable for more than 50% adherence. Of note, adherence based on pharmacy data has been validated with medication electronic monitor system (MEMS caps) adherence [21] and therapeutic drug levels [22,23], and it reliably predicts virologic success [5,17,24–26], drug resistance [27], and survival [16,28,29].
Differences in baseline characteristics were assessed with two-sample Student's t tests (continuous variables with normal distributions on visual inspection), Wilcoxon rank-sum (other continuous variables), and χ2 tests (categorical variables). Kaplan–Meier plots were used to estimate outcome probability according to initial NNRTI and adherence status (100 versus <100%; >90 versus <90%; >80 versus <80%). Cox proportional hazards regression was used to model the individual and simultaneous effects of the initial NNRTI, baseline variables, and pharmacy-claim adherence on time to virologic failure, viral suppression, and regimen discontinuation. Plots of −log[−log(survival)] against log(analysis time) and analyses of scaled Schoenfeld residuals were used to assess the proportionality assumption (P = 0.67 for efavirenz versus nevirapine on time to virologic failure). All available variables were included a priori in multivariate models and were stratified into discrete categories: sex (male/female), race (black/other), CD4 cell count (≤50, 51–200, or >200 cells/μl), viral load (> or <5 log10 copies/ml), prior history of antiretroviral therapy for pMTCT (yes/no), initial NRTI combination (zidovudine/lamivudine, stavudine/lamivudine, stavudine/didanosine, or zidovudine/didanosine), and date of HAART initiation (in four calendar-year strata). Interactions were tested by including multiplicative terms in regression models. All P-values reported are exact and two-tailed, with a value of less than 0.05 considered statistically significant. Statistical analyses were performed using STATA Release 8.0 (Stata Corporation, College Station, Texas, USA).
The present study was approved by the University of Cape Town Research Ethics Committee, the Johns Hopkins University, Bloomberg School of Public Health's Committee on Human Research, and by the Aid for AIDS Clinical Advisory Committee, Cape Town, South Africa.
Of 2817 patients meeting inclusion criteria, 1822 (64.7%) were started on efavirenz and 995 (35.5%) on nevirapine (Table 1). Compared with patients started on efavirenz, those on nevirapine were significantly younger, were more likely to be female, were less immunosuppressed (median CD4 cell counts: 171 cells/μl, on nevirapine; 136 cells/μl, on efavirenz), had lower viral loads at baseline (median 5.1 log10 copies/ml, on nevirapine, versus 5.2, on efavirenz), started treatment earlier in calendar time, and were more likely to receive zidovudine/lamivudine (P < 0.01 for all comparisons; Table 1).
The two groups did not differ in frequency of viral-load measurements [median 1.08 per year, interquartile range (IQR) 0.59–1.60, for nevirapine; 1.10, 0.71–1.58, for efavirenz; P = 0.15] or time to first post-HAART viral-load measurement (median 122 days, IQR 92–209, for nevirapine; 114 days, 92–204, for efavirenz; P = 0.19). Women with baseline CD4 cell counts 250 cells/μl at least were more likely to be started on nevirapine (n = 157, 23.4%) than efavirenz (n = 203, 18.5%). Exclusion of these patients did not materially change results.
Median (IQR) length of follow-up was 1.9 (1.0–2.6) years for the nevirapine group and 2.0 (1.3–2.6) years for patients started on efavirenz (P = 0.006 for difference; Table 1). During this time, patients started on nevirapine were significantly less likely than those on efavirenz to achieve high adherence, whether defined as 100% (30.2 versus 38.1%, P < 0.002) or more than 90% (44.8 versus 49.4%, P < 0.02). Patients started on nevirapine were also more likely to experience virologic failure (20.4 versus 13.8%) and NNRTI discontinuation without virologic failure (15.4 versus 8.9%). Crude proportions of patients who died (2.3% for nevirapine versus 1.8% for efavirenz) or were lost to follow-up (10.4 versus 11.6%) were comparable (Fig. 1), as was the median (IQR) gain in CD4 cell count among 510 patients who had a CD4 cell count measurement between 9 and 15 months post-HAART while still on their initial NNRTI regimen [gain of 173 cells/μl (94–283) on nevirapine versus 168 (72–310) on efavirenz].
After adjusting for other variables, patients started on efavirenz had a significantly shorter time to virologic suppression (<400 copies/ml) than did those treated with nevirapine [median: 4.8 months versus 5.5 months, respectively; multivariate hazard ratio (HR) 1.27, 95% confidence interval (CI) 1.15–1.40] (Table 2). Similarly, patients started on nevirapine were more likely to experience virologic failure than those on efavirenz (HR 1.52, 1.24–1.86, P < 0.001). Exclusion of patients with only one viral-load measurement from analyses of virologic failure did not materially impact our findings (HR 1.65, 1.34–2.02). Other variables significantly associated with faster time to virologic failure in multivariate analysis included lower baseline CD4 cell counts (HR 1.52, 1.16–1.99, P = 0.004, for ≤50 versus >200 cells/μl), initial use of stavudine/didanosine (HR 1.48, 1.15–1.91, P = 0.001, versus zidovudine/lamivudine) or zidovudine/didanosine (HR 2.35, 1.07–5.18, P = 0.03), calendar year of HAART initiation (HR 1.57, 1.29–1.90, P < 0.001, per later year), and pharmacy-claim adherence (HR 11.74, 8.48–16.25, P < 0.001, for <50 versus 100% adherence).
The increased risk of virologic failure associated with nevirapine was restricted to patients with less than 90% adherence in univariate analysis (Fig. 2); however, a test for interaction between NNRTI and adherence was not statistically significant (P = 0.37), and an increased risk of failure on nevirapine was observed in all patients after adjustment for potential confounders (multivariate HR 1.46, 1.17–1.84, for <90% adherence; 1.63, 1.04–2.54, for ≥90% adherence). Patients initially treated with nevirapine also had a significantly higher risk of both death (multivariate HR 2.17, 1.31–3.60, P < 0.001) and of NNRTI discontinuation in the absence of virologic failure (multivariate HR 1.67, 1.32–2.11, P < 0.001) than did patients initially treated with efavirenz. In an analysis that did not censor individuals at the date of stopping/switching NNRTI (i.e., using baseline regimen alone), the association between NNRTI regimen and risk of virologic failure was attenuated (multivariate HR 1.20, 0.97–1.48, P = 0.10).
In a secondary analysis, we compared outcomes in patients who switched from efavirenz to nevirapine or vice versa, excluding patients who had no viral-load measurement after switch or who switched NNRTI after achieving virologic suppression and subsequently experiencing virologic failure (viral load ≥400 copies/ml). Of 177 eligible patients, 54 (34.2%) switched, whereas virologically suppressed (last known viral-load measurement <400 copies/ml). Of these 54, four of 18 (22.2%) who switched from nevirapine to efavirenz had a single viral-load measurement 400 copies/ml at least, and none experienced virologic failure, as defined here, over a median 0.81 (IQR 0.65–1.49) years of follow-up. By contrast, nine of the 36 patients (25.0%) who switched from efavirenz to nevirapine had at least one viral-load measurement 400 copies/ml at least, and five (13.9%) experienced virologic failure over a median 0.93 (IQR 0.53–1.40) years of follow-up. In time-to-event analysis, the univariate hazard of virologic failure was 3.92 (95% CI 1.61–9.55) for patients who switched to nevirapine compared with those who remained on efavirenz.
The remaining 123 (65.8%) of 177 patients switched NNRTIs before achieving known virologic suppression (Fig. 1); 78 (63.4%) of these had no viral-load measurement between HAART initiation and NNRTI switch. After adjusting for confounders, including time to next viral-load measurement, those patients switching from nevirapine to efavirenz before virologic suppression had a chance of subsequent suppression comparable with those remaining on nevirapine (HR 0.86, 95% CI 0.65–1.13). In contrast, those switching from efavirenz to nevirapine before virologic suppression achieved suppression significantly more slowly than those who remained on efavirenz (HR 0.58, 95% CI 0.35–0.93) (Fig. 3).
The present observational study from a private-sector HIV/AIDS disease-management program in southern Africa has shown that initial use of nevirapine was associated with a 52% greater risk of virologic failure and more than double risk of all-cause mortality compared with efavirenz, after adjusting for many potential confounders in a population for whom short-course HAART, not single-dose nevirapine, was the standard of care for pMTCT.
These data are consistent with comparable studies from the developed world. The Antiretroviral Therapy Cohort Collaboration (ART-CC), which combined data from 12 HIV/AIDS cohort studies, found that patients who started with nevirapine-based regimens were approximately twice as likely at 6 months to have a detectable viral load or to die than those started on efavirenz [4]. However, the ART-CC study could not control for adherence, perhaps the most important determinant of treatment outcome. A study of Veterans Affairs patients (97% male) in the United States did examine adherence and also reported worse virologic and immunologic outcomes with nevirapine than with efavirenz [5]. However, this Veterans Affairs study did not evaluate virologic failure after initial suppression and did not report clinical outcomes [5]. Only two clinical trials have directly compared efavirenz and nevirapine. A small trial in Spain (n = 64) showed no significant difference in the proportion of patients achieving virologic suppression at 48 weeks after starting either nevirapine (64%) or efavirenz (74%) (P = 0.43) [30]. In the larger 2NN trial [3], nevirapine was associated with more serious toxicities and did not satisfy protocol criteria for noninferiority. In addition, among South African participants in 2NN, rates of failure of nevirapine-based (50.0%) and efavirenz-based regimens (38.3%) [3], defined as virologic failure or NNRTI switch, were comparable with the present study's rates of failure to complete follow-up on the initial NNRTI regimen (48.4 and 36.2%, respectively).
Although informative, the results of our secondary analyses on the effects of switching from efavirenz to nevirapine or from nevirapine to efavirenz must be interpreted with caution, given the limited sample size, the low frequency of viral-load measurement, and the confounding potential of physician prescribing patterns (e.g., lead-in dose escalation of nevirapine when switching from efavirenz to nevirapine leading to subtherapeutic nevirapine concentrations due to enzyme induction by residual efavirenz [31]). It would also be helpful to know the clinical indications used for switching regimens, but this information was not available in this database.
Efavirenz's observed advantages have important clinical and public health implications, particularly for resource-limited settings. However, other factors must be weighed, including nevirapine's lower cost, its different side-effect profile, its requirement for more careful clinical and laboratory monitoring [32–34], and its potential for complex drug interactions (e.g., with rifampicin) [35,36]. Furthermore, the currently unquantified teratogenicity of efavirenz [37] should be weighed against the increased risk of virologic failure on nevirapine. A formal cost-effectiveness comparison may be helpful.
The current study has some limitations. First, both unmeasured confounding and bias are risks with any observational study. Of particular concern is selection bias: patients more likely to adhere to HAART may be more likely to be prescribed efavirenz. Temporal bias may also be important, as physicians were more likely to prescribe nevirapine earlier in the study, and adherence counseling and monitoring may have improved over time. Our analysis, however, showed that virologic outcomes did not improve. Additional limitations include small sample size for secondary analyses of clinical outcome and NNRTI switch; measurement of adherence using pharmacy claims alone; exclusion of patients with limited follow-up; a relatively short follow-up period, and the potentially limited generalizability from a private-sector program.
Given the rapid roll out of antiretroviral programs worldwide and the frequent use of first-line nevirapine-based HAART in such programs, the assumption that efavirenz and nevirapine are equally effective needs to be reassessed. There is a critical need for a large, randomized, clinical trial to definitively compare the outcomes of efavirenz and nevirapine, and for acceleration of efforts to develop lower cost formulations of efavirenz, including generic, fixed-dose combinations.
Author contributions: conception and design, J.B.N., R.E.C., G.M.; analysis and interpretation of the data, J.B.N., M.H., L.R., J.G., D.W.D., R.E.C.; drafting of the article, J.B.N., D.W.D., J.G., G.M.; critical revision of the article for important intellectual content, J.B.N., J.G., D.W.D., R.E.C., G.M.; final approval of the article, J.B.N., D.W.D., J.G., M.H., R.E.C., L.R., G.M.; provision of study materials or patients, M.H., L.R.; statistical expertise, J.B.N., D.W.D.; and administrative, technical, or logistic support, R.E.C., L.R.
We are grateful to Joanna Downer, PhD; Roderick Graham, MA; Julio Montaner, MD; Steven Deeks, MD; and Mark Van-Natta, MHS, for critical reading of this manuscript. This paper was given in part as an oral presentation at the 14th Conference on Retroviruses and Opportunistic Infections, 25–28 February 2007, Los Angeles, California, USA (MonOrAb#31). J.B.N. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
J.B.N., R.E.C., and G.M. acknowledge research support from the National Institute of Allergy and Infectious Diseases (NIAID), United States National Institutes of Health (NIH), AI 5535901 and AI 016137. J.B.N. is the recipient of an NIAID/NIH Mentored Patient-Oriented Research Career Award K23 AI068582-01. D.D. is supported by the NIH Medical Scientist Training Program Award 5 T32 GMO7309. The funders had no input into the results or presentation of the results reported in this manuscript.
Conflict of interest: consultant: R.E.C. (Bristol-Myers Squibb). Consultant and/or honorarium: J.B.N. (GlaxoSmithKline, Merck-Sharp-Dohme) and G.M. (Merck-Sharp-Dohme). Grants received: G.M. (Merck-Sharp-Dohme). Other: J.B.N. (Aspen Pharmaceuticals); J.E.G.: Grants/Research Support (Gilead Sciences, GlaxoSmithKline, Merck, Pfizer, Roche, Tibotec), consultant and/or honorarium (Bristol Myers Squibb, Gilead Sciences, Roche, Abbott Laboratories, GlaxoSmithKline, Merck, Schering Plough, Pfizer, and Tibotec).
Sources of support: The work described herein was funded by the National Institute of Allergy and Infectious Diseases of the US National Institutes of Health (NIH) and the NIH Medical Scientist Training Program.
This article has been cited 2 time(s).
efavirenz; effectiveness; highly active antiretroviral therapy; nevirapine; Southern Africa
© 2008 Lippincott Williams & Wilkins, Inc.
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Carleton Summer Science Institute
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Dear CSSI Students and Families,
It is a real pleasure to welcome you to the Carleton Summer Science Institute (CSSI). From the early conceptual stages to the final assembly of faculty, courses, and research experiences, this program has given us the opportunity to think hard about what we do in our disciplines and why. That is, we asked ourselves the question: what are the most important ideas our particular discipline offers society? The courses will introduce you to a few key concepts in our fields. Due to the overwhelming interest in the CSSI program we are excited to offer two sessions again this year. Though the scientific topics will differ between the two sessions, the opportunity for you to receive a rewarding educational experience will be the same.
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Please join us for the seventh Carleton Summer Science Institute. We have put together an exciting, fun, and hopefully rewarding three weeks of course work and research meant to challenge your assumptions in a rich, supportive intellectual environment.
Jennifer Wolff, Associate Professor of Biology
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Carleton College has long upheld a tradition of providing equal opportunity to all people. The following nondiscrimination statement is stipulated in the Minnesota State Statutes: As required by state and federal law, Carleton College does not discriminate on the basis of race, color, creed, religion, sex, national origin, marital status, sexual orientation, status with regard to public assistance, age, or disability in providing employment or in its educational programs and activities.


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Home List of Titles Ageing and thermal degradation of plasma polymerised thin films derived from Lavandula angustifolia essential oil
Please use this identifier to cite or link to this item: http://hdl.handle.net/1959.3/155063
- Title
- Ageing and thermal degradation of plasma polymerised thin films derived from Lavandula angustifolia essential oil
- Author(s)
- Easton, C. D.; Jacob, M. V.
- Abstract
- The ageing and thermal degradation of polymer thin films derived from the essential oil of Lavandula angustifolia (LA) fabricated using plasma polymerisation were investigated. Spectroscopic ellipsometry and Fourier transform infrared (FTIR) spectroscopy were employed to monitor the optical parameters, thickness and chemical structure of the polyLA films fabricated at various RF powers over a period of 1400 h. The bulk of the degradation under ambient conditions was found to occur within the first 100 h after fabrication. The thermal degradation of the polyLA films was also investigated using the ellipsometry and FTIR. An increase in thermal stability was found for films fabricated at increased RF power levels. Between 200 and 300 °C, the properties indicate that a phase change occurs in the material. Samples annealed up to 405 °C demonstrated minimal residue, with retention ranging between 0.47 and 2.2%. A tuneable degradation onset temperature and minimal residue post-anneal demonstrate that the polyLA films are excellent candidates for sacrificial material in air gap fabrication.
- Publication type
- Journal article
- Source
- Polymer Degradation and Stability, Vol. 94, no. 4 (Apr 2009), pp. 597-603
- Publication year
- 2009
- FOR Code(s)
- 0303 Macromolecular and Materials Chemistry; 0904 Chemical Engineering; 0912 Materials Engineering
- Keyword(s)
- Ellipsometry; Fourier transform infrared spectroscopy; FTIR; Oxidation; Plasma polymers; Sacrificial materials
- Publisher
- Elsevier
- 0141-3910
- Publisher URL
- Copyright
- Copyright © 2009 Elsevier Ltd. All rights reserved.
- Peer reviewed