Context: Global Burden of Disease studies identify hearing loss as the third leading cause of years lived with a disability. Their estimates point to large societal and individual costs from unaddressed hearing difficulties. Workplace noise is an important modifiable risk factor; if addressed, it could significantly reduce the global burden of disease. In practice, providing hearing protection devices (HPDs) is the most common intervention to reduce noise exposure at work. However, lack of fit of HPDs, especially earplugs, can greatly limit their effectiveness. This may be the case for 40% of users. Testing the fit and providing instructions to improve noise attenuation might be effective. In the past two decades, hearing protection fit-test systems have been developed and evaluated in the field. They are called field attenuation estimation systems. They measure the noise attenuation obtained by individual workers using HPDs. If there is a lack of fit, instruction for better fit is provided, and may lead to better noise attenuation obtained by HPDs.

To assess: (1) the effects of field attenuation estimation systems and associated training on the noise attenuation obtained by HPDs compared to no instruction or to less instruction in workers exposed to noise; and (2) whether these interventions promote adherence to HPD use.

We included randomised controlled trials (RCTs), cluster-RCTs, controlled before-after studies (CBAs), and interrupted time-series studies (ITSs) exploring HPD fit testing in workers exposed to noise levels of more than 80 A-weighted decibels (or dBA) who use hearing protection devices. The unit 'dBA' reports on the use of a frequency-weighting filter to adjust sound measurement results to better reflect how human ears process sound. The outcome noise attenuation had to be measured either as a personal attenuation rating (PAR), PAR pass rate, or both. PAR pass rate is the percentage of workers who passed a pre-established level of sufficient attenuation from their HPDs, identified on the basis of their individual noise exposure.

How hearing conservation training format impacts personal attenuation ratings in U.S. Marine Corps Training Recruits.

Abstract:
The purpose of this fit-testing study in the field was to systematically compare three Hearing Protection Device (HPD) fit-training methods and determine whether they differ in the acquisition of HPD fitting skill and resulting amount of earplug attenuation.

Subjects were randomly assigned to receive HPD fit-training using one of three training methods:

US Marine training recruits (

The post-training HPD fit-test passing rate differed by training method, with pass rates ranging from 50% (current) to nearly 92% (eHPD). The difference between group delta PAR values were significantly higher (>9 dB) in both the eHPD and integrated methods compared to the current method.

The HPD fit-training methods that teach "what right feels like" (eHPD and integrated) provided a greater number of trainees with the skill to achieve noise attenuation values required for impulse noise exposures encountered during basic training. The attenuation achieved by those methods was significantly greater than the current training method.

Training in using earplugs or using earplugs with a higher than necessary noise reduction rating? A randomized clinical trial.

Abstract:
Noise-induced hearing loss (NIHL) is one of the most common occupational diseases and the second most common cause of workers' claims for occupational injuries.

Due to high prevalence of NIHL and several reports of improper use of hearing protective devices (HPDs), we conducted this study to compare the effect of face-to-face training in effective use of earplugs with appropriate NRR to overprotection of workers by using earplugs with higher than necessary noise reduction rating (NRR).

In a randomized clinical trial, 150 workers referred to occupational medicine clinic were randomly allocated to three arms---a group wearing earplugs with an NRR of 25 with no training in appropriate use of the device; a group wearing earplugs with an NRR of 25 with training; another group wearing earplugs with an NRR of 30, with no training. Hearing threshold was measured in the study groups by real ear attenuation at threshold (REAT) method. This trial is registered with Australian New Zealand clinical trials Registry, number ACTRN00363175.

The mean ± SD age of the participants was 28 ± 5 (range: 19-39) years. 42% of participants were female. The mean noise attenuation in the group with training was 13.88 dB, significantly higher than those observed in other groups. The highest attenuation was observed in high frequencies (4, 6, and 8 kHz) in the group with training.

Training in appropriate use of earplugs significantly affects the efficacy of earplugs---even more than using an earplug with higher NRR.

Variability of real-world hearing protector attenuation measurements.

Abstract: The attenuation provided by a hearing protection device (HPD) in the field is usually estimated by applying a derating factor to the laboratory-determined noise reduction rating (NRR) of the HPD. However, attenuation is highly dependent on individual-specific HPD fit. Prediction of an individual's attenuation depends on the accuracy of the measurement system and the variability of attenuation over time (e.g. after HPD refitting). Variability in attenuation and attenuation test systems has not been adequately characterized to allow for such an assessment. This study compared attenuation measurements made with two systems, Real-Ear-at-Threshold (REAT) and Microphone-in-Real-Ear (MIRE), on 20 workers using two earplugs (foam and custom-molded). Workers' perceptions of the earplugs were also evaluated. Individuals' attenuation results were summarized as personal attenuation ratings (PARs, similar to NRRs). Variability in PARs from between-subject, within-subject and within-day (i.e. repeated tests on a subject without earplug refitting) differences was assessed and used to present the lower confidence limit, or uncertainty factor (UF), of an average individual's attenuation. The custom-molded earplug PARs achieved a higher mean percentage of labeled attenuation than did the foam earplug with both test systems. The custom-molded earplugs also had higher overall acceptance among workers. MIRE PAR levels were lower than REAT levels for both earplugs, but the relationship between the two test systems was highly variable. The MIRE system had lower within-day variability than the REAT system. One individual's MIRE results were highly influential; removal of these results greatly reduced the UF for the custom-molded earplug/MIRE combination. UFs ranged from 8.8 to 13.5 dB. These findings highlight the importance of evaluating variability in individual-specific protection results for personal protective equipment like HPDs, rather than relying on single measurements.

Relationship between comfort and attenuation measurements for two types of earplugs.

Abstract: Noise-induced hearing loss is almost always preventable if properly fitted hearing protectors are worn to reduce exposure. Many individuals choose not to wear hearing protection because it may interfere with effective communication in the workplace or it may be uncomfortable. Hearing protector comfort has not received the same amount of attention as noise reduction capability. The present study was conducted to evaluate the comfort level of two different types of insert earplugs as well as the attenuation levels achieved by the earplugs. Attenuation levels were obtained with a commercially available earplug fit-test system, and the comfort ratings were obtained by questionnaire. The primary research objective was to determine whether hearing protector comfort was related to measured attenuation values. A linear mixed effects model provided evidence for an inverse relationship between comfort and attenuation.

Acceptance of a semi-custom hearing protector by manufacturing workers.

Noise attenuation of earplugs as measured by hREAT and F-MIRE methods in a Japanese metal manufacturing plant.

Abstract:
The aim of this study was to compare the noise attenuation (NA) properties of earplugs by using the headphone-based real-ear-attenuation-at-threshold (hREAT) and field microphone-in-real-ear (F-MIRE) techniques.

The subjects were 89 male workers (mean age: 44.8 ± 12.1 yr) exposed to noise above 85 dBA (mean noise exposure period: 14.3 ± 11.3 yr) in a Japanese nonferrous metal manufacturing plant. They were confirmed to have pure-tone air-conduction hearing threshold levels (HTLs). The hREAT and F-MIRE NA values were measured by a Rion AG-20A and a 3M E-A-Rfit, respectively.

The NA values could not be measured by hREAT for four workers (hREAT-group). The mean NA of the earplugs for subjects for whom hREAT measurements were possible (hREAT+ group) was 26.0 ± 10.0 dB. The NA of the earplugs could be measured for all subjects using F-MIRE, and the NAs of the hREAT- and hREAT+ groups were 9.5 ± 8.7 and 21.0 ± 7.3 dB. The mean HTL value at 500 Hz to 2 kHz was 45.8 ± 3.1 dB for the hREAT- group, which was significantly lower than the value for the hREAT+ group, 18.0 ± 8.6 dB.

Because there is a difference between the NA values obtained by hREAT and F-MIRE, it may be necessary to compensate for this difference. In addition, workers with hearing loss and the length of the measurement time need to be taken into consideration. Finally the F-MIRE method may be useful for educating workers about using earplugs in noisy workplaces.

[Measurement of real personal noise attenuation using earplugs with the E-A-Rfit system].

Abstract:
The assessment of efficiency of hearing protection devices (HPDs), conducted above statutory limits, must be made using a standardized method while devices are worn; however, standardized and suitable laboratory conditions are difficult to encounter at the workplace. To overcome this problem, there are methods of measurement at the workplace such as "field-microphone-in-real-ear" (F-MIRE).

The study was concerned with the measurement of real noise attenuation using earplugs and a new evaluation system: we checked the difference between "real" attenuation (at workplace) and "theorical" attenuation (reproduced in the laboratory) as stated by the manufacturer.

We used the E-A-Rfit computerized method, which measures the loss of attenuation of earplugs in the ear, calculating the difference of sound pressure between an "outside" microphone and an "inside" one, in relation to the same earplug. The measurements at the workplace were carried out on eight subjects with good hearing levels (aged between 20 and 25 years), who were trained to wear the devices correctly. After the tests carried out with the E-A-Rfit system, which does not require a subjective answer, we obtained graphs and tables showing real noise attenuation.

We propose a comparison between hearing threshold for frequency, personal attenuation rating (PAR) and single number rating (SNR, provided by manufacturer): a difference of 10 dB (PAR 27 db vs. SNR 37 dB) was clearly evident although dissimilar methods were used to obtain such values. The instrument is rapid, simple and objective to use and also allows personalized information and training for every worker.

[Assessment of the impulse noise attenuation by earplugs in metalworking processes].

Abstract:
The aim of the study was to answer the question of whether earplugs provide sufficient protection in the exposure to impulse noise generated during metalworking processes.

The noise generated by die forging hammer and punching machine was characterized. Using an acoustic test fixture, noise parameters (LCpeak, LAmax) under 24 earplugs, foam, winged and no-roll, were measured. Octave band method was used to calculate values of LAeq under earplugs.

It was found that in the case of punching machine the exposure limit value of A-weighted noise exposure level, normalized to an 8-h working day (LEX, 8h = 94.8 dB) of noise present at the workstation, was exceeded, while in the case of die forging hammer both the exposure limit value of this parameter (LEX, 8h = 108.3 dB) and the exposure limit value of peak sound pressure level (LCpeak = 148.9 dB) were exceeded. The assessment of noise parameters (LCpeak, LAmax, LAeq) under earplugs revealed that the noise attenuation can be insufficient, sufficient, or too high.

Earplugs can be suitable hearing protection devices in metalworking processes. Of the 24 earplugs included in this study, 9 provided appropriate noise attenuation in the case of tested die forging hammer and 10 in the case of tested punching machine.

Training on hearing protector insertion improves noise attenuation.

Abstract:
To determine the efficacy of hearing protector insertion by comparing attenuation values measured by objective (MIRE) and subjective (REAT) methods in groups with and without training.

The study included 80 male subjects assigned to experimental (with training) and control (without training) groups. The following procedures were performed: occupational history, objective and subjective assessment of hearing protectors. Only subjects in the experimental group received training and guidance on proper hearing protector insertion.

Attenuation values were significantly higher in the experimental group than in the control group at all frequencies (500, 1000, 2000, and 4000 Hz) investigated through the objective (MIRE) and subjective (REAT) methods. In addition, attenuation values in the control group were lower than those provided by the hearing protector manufacturer.

Both objective and subjective attenuation tests demonstrated the efficacy of training on insertion of hearing protectors because the group that received training on proper hearing protection insertion exhibited higher attenuation values than the untrained group.

Evaluation of the hearing protector in a real work situation using the field-microphone-in-real-ear method.

Abstract: Purpose To evaluate the effectiveness of the attenuation of a hearing protector (HP) in a real work situation using the field-microphone-in-real-ear method (f-MIRE). Methods Eighteen individuals of both genders (mean age of 47.17±8 years) participated in this study. In the workplace, the personal attenuation level of the HP was assessed using the f-MIRE method, followed by orientation about the importance of using the HP, cleaning and storing the device, and training for effective placement. Results The analyses showed a significant statistic attenuation for all of the collected data (total noise, by frequency band and dose) when the noise levels in the lapel microphone and the probe microphone were compared. In the comparison of the attenuation values provided by the manufacturer and those found in this study, we observed higher values for the manufacturer in all frequency bands. No difference was observed for the noise levels in the different activities and times evaluated. Conclusion The findings of this study enabled us to know the personal level of attenuation of the HP during a real work situation, which was within the limits of tolerance. It was also possible to collect information about the environmental noise to which these workers are exposed. We noticed situations where this level exceeded the safety values, and therefore it is recommended the use of the HP. It is important that more studies are conducted using the f-MIRE method, because it may be an ally to assess the effectiveness of the HP attenuation in the workplace.


Context: Magnesium sulphate is a common therapy in perinatal care. Its benefits when given to women at risk of preterm birth for fetal neuroprotection (prevention of cerebral palsy for children) were shown in a 2009 Cochrane review. Internationally, use of magnesium sulphate for preterm cerebral palsy prevention is now recommended practice. As new randomised controlled trials (RCTs) and longer-term follow-up of prior RCTs have since been conducted, this review updates the previously published version.

To assess the effectiveness and safety of magnesium sulphate as a fetal neuroprotective agent when given to women considered to be at risk of preterm birth.

We included RCTs and cluster-RCTs of women at risk of preterm birth that assessed prenatal magnesium sulphate for fetal neuroprotection compared with placebo or no treatment. All methods of administration (intravenous, intramuscular, and oral) were eligible. We did not include studies where magnesium sulphate was used with the primary aim of preterm labour tocolysis, or the prevention and/or treatment of eclampsia.

Umbilical cord serum ionized magnesium level and total pediatric mortality.

Abstract:
To estimate whether higher magnesium levels in umbilical cord blood at delivery are associated with increased total pediatric (fetal + neonatal + postneonatal) mortality.

During the Magnesium and Neurologic Endpoints Trial, in addition to randomizing mothers having preterm labor into arms containing magnesium sulfate, other tocolytic agents, or saline controls, we obtained biologic specimens at delivery, including umbilical cord venous blood on which was determined the serum ionized magnesium level using the AVL 988-4 analyzer (Graz, Austria). Laboratory results were then matched with the pediatric mortalities. The study power was based on the anticipated reductions in neonatal intraventricular hemorrhage related to magnesium usage from 18.9% to 4.4%. For alpha =.05, 1-beta (power)=80%, two tailed, the total number of infants needed would be 140.

Of 149 mothers who gave permission for randomization, ionized magnesium levels were available for 82 children. Seven deaths occurred (one immediately before delivery, three as neonates, and three in the postneonatal period). The median level of ionized magnesium among the seven dead children was 0.76 mmol/L; among the 75 survivors, the median level of ionized magnesium was 0.55 mmol/L (Mann-Whitney U test, P =.03). Using multivariable logistic regression analysis, the association remained statistically significant when controlling for possible confounding factors (adjusted odds ratio 7.7, 95% confidence interval 1.2, 47.6, P =.03).

These findings of a dose response between serum ionized magnesium and deaths in children increase our concern about the improper use of tocolytic magnesium.

Association between maternal serum ionized magnesium levels at delivery and neonatal intraventricular hemorrhage.

Abstract:
To determine whether magnesium sulfate (MgSO(4)) exposure is associated with a reduced risk for neonatal intraventricular hemorrhage (IVH).

In a randomized, controlled trial, women in preterm labor were randomly assigned to receive MgSO(4), "other" tocolytic, or saline control. At delivery, we collected maternal antecubital and umbilical cord blood for determination of serum ionized magnesium levels. Neonatal IVH was diagnosed by cranial ultrasonogram.

Among 144 infants, 24 were diagnosed with IVH. Using crude intention-to-treat analysis, we found that 18% (13/74) of survivors exposed after birth to MgSO(4) had IVH compared with 16% (11/70) of babies who were not exposed. Infants who had IVH were more likely to have been delivered by mothers with higher serum ionized magnesium (Mg) levels (0.75 vs 0.56 mmol/L) (P =.01). Using multivariable logistic regression, we confirmed that higher Mg levels are a significant predictor of neonatal IVH (adjusted odds ratio, 15.8; 95% CI, 1.4-175.0) even when adjusted for birth weight, gestational age, antenatal hemorrhage, and neonatal glucocorticoid exposure.

In mothers with preterm labor, our data indicate that antenatal MgSO(4) exposure may be associated with an increased risk for IVH among their newborns.

Association between the use of antenatal magnesium sulfate in preterm labor and adverse health outcomes in infants.

Abstract:
The purpose of this study was to determine whether the use of antenatal magnesium sulfate prevents adverse outcomes (neonatal intraventricular hemorrhage, periventricular leucomalacia, death, and cerebral palsy).

In a controlled trial, we randomized mothers in preterm labor to magnesium sulfate, "other" tocolytic, or placebo. At delivery, umbilical cord blood was collected for the later determination of serum ionized magnesium levels. Neonatal cranial ultrasound scans were obtained periodically for the diagnosis of intraventricular hemorrhage and periventricular leucomalacia. Among survivors, the diagnosis of cerebral palsy was made at age 18 months.

Children with adverse outcomes had higher umbilical cord magnesium levels at delivery. In regression models that controlled for confounders, which included very low birth weight, magnesium remained a significant risk factor (adjusted odds ratio, 3.7; 95% CI, 1.1-11.9; P =.03).

Contrary to original hypotheses, this randomized trial found that the use of antenatal magnesium sulfate was associated with worse, not better, perinatal outcome in a dose-response fashion.

Components of the systemic fetal inflammatory response syndrome as predictors of impaired neurologic outcomes in children.

Abstract:
The purpose of this study was to compare interleukin-6 and funisitis as predictors of impaired neurologic outcomes in children by performing a secondary analysis on data that were collected prospectively for another purpose.

We examined umbilical cords for funisitis and obtained cord blood for interleukin-6 levels. A psychomotor developmental index score was determined for each child at age 18 months.

The prevalence (46%) of elevated interleukin-6 levels (> or = 10 pg/mL) among children with low psychomotor developmental index scores (<100) was not significantly different from that of children with normal scores (47%). Among children with funisitis (n = 21), the median psychomotor developmental index score was 94; for children without funisitis (n = 92), it was 99 (P <.02). When the data were regressed for confounding, funisitis remained significant (adjusted odds ratio, 1.3; 95% CI, 1.1-1.9). Furthermore, funisitis was a more specific predictor of low psychomotor developmental index scores (P <.001), although elevated interleukin-6 levels were more sensitive.

When used for the prediction of impaired neurologic outcomes in children, funisitis has better specificity and thus a better positive predictive value than does interleukin-6.

Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial.

Abstract:
Prenatal magnesium sulfate may reduce the risk of cerebral palsy or death in very preterm infants.

To determine the effectiveness of magnesium sulfate given for neuroprotection to women at risk of preterm birth before 30 weeks' gestation in preventing pediatric mortality and cerebral palsy.

Randomized controlled trial at 16 tertiary hospitals in Australia and New Zealand with stratification by center and multiple pregnancy. A total of 1062 women with fetuses younger than 30 weeks' gestation for whom birth was planned or expected within 24 hours were enrolled from February 1996 to September 2000 with follow-up of surviving children at a corrected age of 2 years.

Women were randomly assigned to receive a loading infusion of 8 mL (4 g [16 mmol] of 0.5 g/mL of magnesium sulfate solution or isotonic sodium chloride solution [0.9%]) for 20 minutes followed by a maintenance infusion of 2 mL/h for up to 24 hours.

Rates of total pediatric mortality, cerebral palsy, and the combined outcome of death or cerebral palsy at a corrected age of 2 years.

Data were analyzed for 1047 (99%) 2-year survivors. Total pediatric mortality (13.8% vs 17.1%; relative risk [RR], 0.83; 95% confidence interval [CI], 0.64-1.09), cerebral palsy in survivors (6.8% vs 8.2%; RR, 0.83; 95% CI, 0.54-1.27), and combined death or cerebral palsy (19.8% vs 24.0%; RR, 0.83; 95% CI, 0.66-1.03) were less frequent for infants exposed to magnesium sulfate, but none of the differences were statistically significant. Substantial gross motor dysfunction (3.4% vs 6.6%; RR, 0.51; 95% CI, 0.29-0.91) and combined death or substantial gross motor dysfunction (17.0% vs 22.7%; RR, 0.75; 95% CI, 0.59-0.96) were significantly reduced in the magnesium group.

Magnesium sulfate given to women immediately before very preterm birth may improve important pediatric outcomes. No serious harmful effects were seen.

Antenatal risk factors associated with the development of lenticulostriate vasculopathy (LSV) in neonates.

Abstract:
To determine the antenatal risk factors associated with neonatal lenticulostriate vasculopathy (LSV).

Women in preterm labor were randomized to magnesium sulfate (MgSO4), other tocolytic, or saline control. The surviving babies underwent head ultrasounds (HUS) (weeks of life 1, 2, and 4) and periodic developmental examinations (months 4, 8, 12, and 18).

Of 140 infants, 17.1% (24) had neonatal intraventricular hemorrhage (IVH), and 10.0% (14) had LSV (half of the latter (7 of 14) had both IVH and LSV). In a regression model in which other risk factors were controlled for, the association between antenatal exposures to tocolytic MgSO4 >or=50 g and LSV were significant (adjusted odds ratio (OR), 8.3; 95% confidence interval (CI), 1.5 to 45.0; p=0.01).

Based on our data and their analyses, we infer that antenatal exposure to high-dosage, tocolytic MgSO4 may be associated with LSV.

Magnesium sulphate given before very-preterm birth to protect infant brain: the randomised controlled PREMAG trial*.

Abstract:
To evaluate whether magnesium sulphate (MgSO(4)) given to women at risk of very-preterm birth would be neuroprotective in preterm newborns and would prevent neonatal mortality and severe white-matter injury (WMI).

A randomised study.

Eighteen French tertiary hospitals. Population Women with fetuses of gestational age < 33 weeks whose birth was planned or expected within 24 hours were enrolled from July 1997 to July 2003 with follow up of infants until hospital discharge. METHODS Five hundred and seventy-three mothers were randomly assigned to receive a single 40-ml infusion of 0.1 g/ml of MgSO(4) (4 g) solution or isotonic 0.9% saline (placebo) over 30 minutes. This study is registered as an International Standard Randomised Controlled Trial, number 00120588.

The primary endpoints were rates of severe WMI or total mortality before hospital discharge, and their combined outcome. Analyses were based on intention to treat.

After 6 years of enrolment, the trial was stopped. Data from 688 infants were analysed. Comparing infants who received MgSO(4) or placebo, respectively, total mortality (9.4 versus 10.4%; OR: 0.79, 95% CI 0.44-1.44), severe WMI (10.0 versus 11.7%; OR: 0.78, 95% CI 0.47-1.31) and their combined outcomes (16.5 versus 17.9%; OR: 0.86, 95% CI 0.55-1.34) were less frequent for the former, but these differences were not statistically significant. No major maternal adverse effects were observed in the MgSO(4) group.

Although our results are inconclusive, improvements of neonatal outcome obtained with MgSO(4) are of potential clinical significance. More research is needed to assess the protective effect of MgSO(4) alone or in combination with other neuroprotective molecules.

Benefit of magnesium sulfate given before very preterm birth to protect infant brain.

[Effect of magnesium sulphate on mortality and neurologic morbidity of the very-preterm newborn (of less than 33 weeks) with two-year neurological outcome: results of the prospective PREMAG trial].

Abstract:
To evaluate whether magnesium sulphate (MgSO(4)) given to women at risk of very-preterm birth would be neuroprotective in preterm newborns.

In 18 French centres, women with fetuses of gestational age less than 33 weeks whose birth was expected within 24 hours were randomised from 1993 to 2003 with follow-up of infants until two years of age after discharge. They received a single injection of 0.1 mg/l de MgSO(4) (4g) or isotonic 0.9% saline over 30 minutes. This study is registered as an International Standard Randomised Controlled Trial, number 00120588. Analyses were based on intention to treat.

Data from 688 infants were analysed of which 606 were followed up and 10 were lost to follow-up. Comparing infants who received MgSO(4) or placebo, respectively, has shown a decrease of all primary endpoints (total mortality, severe white matter injury and their combined outcome) and of all secondary endpoints (motor dysfunction, cerebral palsy, cognitive dysfunction and their combined outcomes at two years of age) in the MgSO(4) group. The decrease was nearly significant or significant for gross motor dysfunction (OR: 0.65 [0.41-1.02]) and combined criteria: death and cerebral palsy (OR: 0.65 [0.42-1.03]); death and gross motor dysfunction (OR: 0.62 [0.41-0.93]); death, cerebral palsy and cognitive dysfunction (OR: 0.68 [0.47-1.00]). No major maternal adverse effects were observed in the MgSO(4) group.

Given its beneficial effects and safety, the use of prenatal low-dose MgSO(4) for preventing neurodisabilities of very-preterm infants should be discussed either as a stand-alone treatment or as part of a combination treatment, at least in the context of clinical trials.

A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.

Abstract:
Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy.

In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age.

A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event.

Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.)


Context: Collaborative care for severe mental illness (SMI) is a community-based intervention that promotes interdisciplinary working across primary and secondary care. Collaborative care interventions aim to improve the physical and/or mental health care of individuals with SMI. This is an update of a 2013 Cochrane review, based on new searches of the literature, which includes an additional seven studies.

To assess the effectiveness of collaborative care approaches in comparison with standard care (or other non-collaborative care interventions) for people with diagnoses of SMI who are living in the community.

Randomised controlled trials (RCTs) where interventions described as 'collaborative care' were compared with 'standard care' for adults (18+ years) living in the community with a diagnosis of SMI. SMI was defined as schizophrenia, other types of schizophrenia-like psychosis or bipolar affective disorder. The primary outcomes of interest were: quality of life, mental state and psychiatric admissions at 12 months follow-up.

Predictors of outcome in a primary care depression trial.

Abstract:
Previous treatment trials have found that approximately one third of depressed patients have persistent symptoms. We examined whether depression severity, comorbid psychiatric illness, and personality factors might play a role in this lack of response.

Randomized trial of a stepped collaborative care intervention versus usual care.

HMO in Seattle, Wash.

Patients with major depression were stratified into severe (N = 149) and mild to moderate depression (N = 79) groups prior to randomization.

A multifaceted intervention targeting patient, physician, and process of care, using collaborative management by a psychiatrist and primary care physician.

Patients with more severe depression had a higher risk for panic disorder (odds ratio [OR], 5.8), loneliness (OR, 2.6), and childhood emotional abuse (OR, 2.1). Among those with less severe depression, intervention patients showed significantly improved depression outcomes over time compared with those in usual care (z = -3.06, P<.002); however, this difference was not present in the more severely depressed groups (z = 0.61, NS). Although the group with severe depression showed differences between the intervention and control groups from baseline to 3 months that were similar to the group with less severe depression (during the acute phase of the intervention), these differences disappeared by 6 months.

Initial depression severity, comorbid panic disorder, and other psychosocial vulnerabilities were associated with a decreased response to the collaborative care intervention. Although the intervention was appropriate for patients with moderate depression, individuals with higher levels of depression may require a longer continuation phase of therapy in order to achieve optimal depression outcomes.

Integrated medical care for patients with serious psychiatric illness: a randomized trial.

Abstract:
This randomized trial evaluated an integrated model of primary medical care for a cohort of patients with serious mental disorders.

A total of 120 individuals enrolled in a Veterans Affairs (VA) mental health clinic were randomized to receive primary medical care through an integrated care initiative located in the mental health clinic (n = 59) or through the VA general medicine clinic (n = 61). Veterans who obtained care in the integrated care clinic received on-site primary care and case management that emphasized preventive medical care, patient education, and close collaboration with mental health providers to improve access to and continuity of care. Analyses compared health process (use of medical services, quality of care, and satisfaction) and outcomes (health and mental health status and costs) between the groups in the year after randomization.

Patients treated in the integrated care clinic were significantly more likely to have made a primary care visit and had a greater mean number of primary care visits than those in the usual care group. They were more likely to have received 15 of the 17 preventive measures outlined in clinical practice guidelines. Patients assigned to the integrated care clinic had a significantly greater improvement in health as measured by the physical component summary score of the 36-Item Short-Form Health Survey than patients assigned to the general medicine clinic (4.7 points vs -0.3 points, P<.001). There were no significant differences between the 2 groups in any of the measures of mental health symptoms or in total health care costs.

On-site, integrated primary care was associated with improved quality and outcomes of medical care.

Design and implementation of a randomized trial evaluating systematic care for bipolar disorder.

Abstract:
Everyday care of bipolar disorder typically falls short of evidence-based practice. This report describes the design and implementation of a randomized trial evaluating a systematic program to improve quality and continuity of care for bipolar disorder.

Computerized records of a large health plan were used to identify all patients treated for bipolar disorder. Following a baseline diagnostic assessment, eligible and consenting patients were randomly assigned to either continued usual care or a multifaceted intervention program including: development of a collaborative treatment plan, monthly telephone monitoring by a dedicated nurse care manager, feedback of monitoring results and algorithm-based medication recommendations to treating mental health providers, as-needed outreach and care coordination, and a structured psychoeducational group program (the Life Goals Program by Bauer and McBride) delivered by the nurse care manager. Blinded assessments of clinical outcomes, functional outcomes, and treatment process were conducted every 3 months for 24 months.

A total of 441 patients (64% of those eligible) consented to participate and 43% of enrolled patients met criteria for current major depressive episode, manic episode, or hypomanic episode. An additional 39% reported significant subthreshold symptoms, and 18% reported minimal or no current mood symptoms. Of patients assigned to the intervention program, 94% participated in telephone monitoring and 70% attended at least one group session.

In a population-based sample of patients treated for bipolar disorder, approximately two-thirds agreed to participate in a randomized trial comparing alternative treatment strategies. Nearly all patients accepted regular telephone monitoring and over two-thirds joined a structured group program. Future reports will describe clinical effectiveness and cost-effectiveness of the intervention program compared with usual care.

Treating patients with medically unexplained symptoms in primary care.

Abstract:
There are no proven, comprehensive treatments in primary care for patients with medically unexplained symptoms (MUS) even though these patients have high levels of psychosocial distress, medical disability, costs, and utilization. Despite extensive care, these common patients often become worse.

We sought to identify an effective, research-based treatment that can be conducted by primary care personnel.

We used our own experiences and files, consulted with experts, and conducted an extensive review of the literature to identify two things: 1). effective treatments from randomized controlled trials for MUS patients in primary care and in specialty settings; and 2). any type of treatment study in a related area that might inform primary care treatment, for example, depression, provider-patient relationship.

We developed a multidimensional treatment plan by integrating several areas of the literature: collaborative/stepped care, cognitive-behavioral treatment, and the provider-patient relationship. The treatment is designed for primary care personnel (physicians, physician assistants, nurse practitioners) and deployed intensively at the outset; visit intervals are progressively increased as stability and improvement occur.

Providing a comprehensive treatment plan for chronic, high-utilizing MUS patients removes one barrier to treating this common problem effectively in primary care by primary care personnel.

Collaborative care improves health outcomes in older people with depression and arthritis.

Care satisfaction, hope, and life functioning among adults with bipolar disorder: data from the first 1000 participants in the Systematic Treatment Enhancement Program.

Abstract:
The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) is designed to evaluate the longitudinal outcome of patients with bipolar disorder. The STEP-BD disease-management model is built on evidence-based practices and a collaborative care approach designed to maximize specific and nonspecific treatment mechanisms. This prospective study examined the longitudinal relationships between patients' satisfaction with care, levels of hope, and life functioning in the first 1000 patients to enter STEP-BD.

The study used scores from the Care Satisfaction Questionnaire, Beck Hopelessness Scale, Range of Impaired Functioning Tool, Young Mania Rating Scale, and Montgomery-Asberg Depression Rating Scale at 5 time points during a 1-year interval. Analyses tested mediational pathways between care satisfaction, hope, and life functioning, depression, and mania using mixed-effects (random and fixed) regression models.

Increases in care satisfaction were associated with decreased hopelessness (P < .01) but not related to symptoms of depression or mania. Similarly, decreased hopelessness was associated with better life functioning (P < .01) but not related to symptoms of depression or mania. Depression was independently associated with poorer life functioning (P < .0001).

This study provided support for the hypothesized mediational pathway between care satisfaction, hopelessness, and life functioning. Findings suggest that providing care that maximizes patient hope may be important. By so doing, patients might overcome the learned helplessness/hopelessness that often accompanies a cyclical illness and build a realistic illness-management strategy.

Can collaborative care address the needs of low-income Latinas with comorbid depression and cancer? Results from a randomized pilot study.

Abstract: In a pilot study, 55 low-income Latina patients with breast or cervical cancer and comorbid depression were randomly assigned to receive collaborative care as part of the Multifaceted Oncology Depression Program or usual care. Relative to patients in the usual care condition, patients receiving collaborative care were more likely to show>or=50% improvement in depressive symptoms as measured by the Personal Health Questionnaire (OR=4.51, 95% CI=1.07-18.93). Patients in the collaborative care program were also more likely to show improvement in emotional well-being (increase of 2.15) as measured by the Functional Assessment of Cancer Therapy Scale than were those receiving usual care (decrease of 0.50) (group difference=2.65, 95% CI: 0.18-5.12). Despite health system, provider, and patient barriers to care, these initial results suggest that patients in public sector oncology clinics can benefit from onsite depression treatment.

A trial of problem-solving by community mental health nurses for anxiety, depression and life difficulties among general practice patients. The CPN-GP study.

Abstract:
To compare the effectiveness of community mental health nurse (CMHN) problem-solving and generic CMHN care, against usual general practitioner (GP) care in reducing symptoms, alleviating problems, and improving social functioning and quality of life for people living in the community with common mental disorders; and to undertake a cost comparison of each CMHN treatment compared with usual GP care.

A pragmatic, randomised controlled trial with three arms: CMHN problem-solving, generic CMHN care and usual GP care.

General practices in two southern English counties were included in the study. CMHNs were employed by local NHS trusts providing community mental health services.

Participants were GP patients aged 18--65 years with a new episode of anxiety, depression or reaction to life difficulties and had to score at least 3 points on the General Health Questionnaire-12 screening tool. Symptoms had to be present for a minimum of 4 weeks but no longer than 6 months.

Patients were randomised to one of three groups: (1) CMHN problem-solving treatment, (2) generic CMHN treatment, or (3) usual GP care. All three groups of patients remained free to consult their GPs throughout the course of the study, and could be prescribed psychotropic drug treatments.

Patients were assessed at baseline, and 8 weeks and 26 weeks after randomisation. The primary outcome measure was psychological symptoms measured on the Clinical Interview Schedule -- Revised. Other measures included social functioning, health-related quality of life, problem severity and satisfaction. The economic outcomes were evaluated with a cost--utility analysis.

Twenty-four CMHNs were trained to provide problem-solving under supervision, and another 29 were referred patients for generic support. In total, 247 patients were randomised to the three arms of the study, referred by 98 GPs in 62 practices. All three groups of patients were greatly improved by the 8-week follow-up. No significant differences were found between the groups at 8 weeks or 26 weeks in symptoms, social functioning or quality of life. Greater satisfaction with treatment was found in the CMHN groups. CMHN care represented a significant additional health service cost and there were no savings in sickness absence.

The study found that specialist mental health nurse support is no better than support from GPs for patients with anxiety, depression and reactions to life difficulties. The results suggest that healthcare providers could consider adopting policies of restricting referrals of unselected patients with common mental disorders to specialist CMHNs, although there may be other roles in primary care that CMHNs could play effectively. Further research should address the predictors of chronicity in common mental disorders and target extra treatment. More research is also needed into the effectiveness and cost-effectiveness of problem-solving treatment for other disorders, of facilitated self-help treatments for common mental disorders and of CMHN care for people with severe and enduring mental illnesses, as well as the prevention of mental disorders.

Attitudes regarding the collaborative practice model and treatment adherence among individuals with bipolar disorder.

Abstract: An emerging literature suggests that a collaborative care model, in which patients are active managers of their illness within a supportive social environment, is a beneficial approach for individuals with bipolar disorder. One aspect of treatment that is often suboptimal among individuals with bipolar disorder is treatment adherence. Establishing an ideal collaborative model may offer an opportunity to enhance treatment adherence among individuals with bipolar disorder. This paper presents results from a qualitative exploration of patients' attitudes towards the collaborative care model and how individuals with bipolar disorder perceive treatment adherence within the context of the collaborative care model. All participants were actively enrolled in outpatient treatment at a Community Mental Health Center and part of a larger study that evaluated the Life Goals Program, a manual-driven structured group psychotherapy for bipolar disorder that is based on the collaborative practice model. The Life Goals Program is designed to assist individuals to participate more effectively in the management of their bipolar illness and to improve their social and work-related problems. Individuals were queried regarding their opinions on the ingredients for an effective client-provider relationship. Quantitative data were collected on baseline treatment adherence as well. Individuals treated for bipolar disorder in a community mental health clinic identified 12 key elements that they felt were critical ingredients to a positive collaborative experience with their mental health care provider. The authors conceptualized these elements around 3 emerging themes: patient-centered qualities, provider-centered qualities, and interactional qualities. Individuals with bipolar disorder perceived the ideal collaborative model as one in which the individual has specific responsibilities such as coming to appointments and sharing information, whereas the provider likewise has specific responsibilities such as keeping abreast of current "state-of-the-arf" prescribing practices and being a good listener. Treatment adherence was identified as a self-managed responsibility within the larger context of the collaborative model. Individuals with bipolar disorder in this study placed substantial emphasis on the interactional component within the patient-provider relationship, particularly with respect to times when the individual may be more symptomatic and more impaired. It is important that clinicians and care providers gather information related to patients' perceptions of the patient-provider relationship when designing or evaluating services aimed at enhancing treatment adherence.


Context: Respiratory distress occurs in up to 7% of newborns, with respiratory support (RS) provided invasively via an endotracheal (ET) tube or non-invasively via a nasal interface. Invasive ventilation increases the risk of lung injury and chronic lung disease (CLD). Using non-invasive strategies, with or without minimally invasive surfactant, may reduce the need for mechanical ventilation and the risk of lung damage in newborn infants with respiratory distress.

To evaluate the benefits and harms of nasal high-frequency ventilation (nHFV) compared to invasive ventilation via an ET tube or other non-invasive ventilation methods on morbidity and mortality in preterm and term infants with or at risk of respiratory distress.

Randomised controlled trials (RCTs), cluster- or quasi-RCTs of nHFV in newborn infants with respiratory distress compared to invasive or non-invasive ventilation.

Nasal high frequency percussive ventilation versus nasal continuous positive airway pressure in transient tachypnea of the newborn: a pilot randomized controlled trial (NCT00556738).

Abstract:
To determine whether nasal high frequency percussive ventilation (NHFPV) would decrease duration of transient tachypnea of the newborn (TTN) compared to nasal continuous positive airway pressure (NCPAP) in newborn infants.

A prospective, unmasked, randomized, controlled clinical trial was conducted in 46 eligible newborn infants who were hospitalized for TTN in the University Hospital of Bordeaux (France) between 2007 and 2009. Infants born by cesarian section ≥37 GA, ≥2,000 g with diagnosis of TTN and with a transcutaneous saturation <90% at 20 min after birth were eligible. Infants were randomized to either NHFPV or NCPAP. The primary endpoint was a reduction of the duration of TTN. Secondary endpoints were the duration of oxygen therapy and the minimal level required to obtain a saturation between 90% and 96% integrated into an index which included a time factor: [(FiO2 -21)/time of O2 therapy].

In the NHFPV group the duration of TTN was half the time of NCPAP group (105 min ± 20 and 377 min ± 150, respectively; P < 0.0001). There was a significant decrease in duration of oxygen supplementation in the NHFPV group (6.3 min ± 3.3) compared to the NCPAP group (19.1 min ± 8.1; P < 0.001), and a significant decrease in level of oxygen supplementation [(FiO2 -0.21)/time of O2 therapy] in the NHFPV group (0.29 min(-1)  ± 0.16) compared to the NCPAP group (0.46 min(-1)  ± 0.50; P < 0.001). There was no complication and NHFPV was as well tolerated as NCPAP.

NHFPV is well tolerated and more effective than NCPAP in treatment of TTN. NHFPV might be a novel and safe tool to manage TTN. Pediatr Pulmonol.

Non-invasive high-frequency ventilation versus bi-phasic continuous positive airway pressure (BP-CPAP) following CPAP failure in infants <1250 g: a pilot randomized controlled trial.

Abstract:
Non-invasive high-frequency ventilation (NIHFV), a relatively new modality, is gaining popularity despite limited data. We sought to evaluate the effectiveness of NIHFV versus bi-phasic continuous positive airway pressure (BP-CPAP) in preterm infants failing CPAP.

Infants with BW<1250 g on CPAP were randomly assigned to NIHFV or BP-CPAP if they met pre-determined criteria for CPAP failure. Infants were eligible for randomization after 72 h age and until 2000 g. Guidelines for adjustment of settings and criteria for failure of assigned mode were implemented. The primary aim was to assess feasibility of a larger trial. In addition, failure of assigned non-invasive respiratory support (NRS) mode, invasive mechanical ventilation (MV) 72 h and 7 days post-randomization, and bronchopulmonary dysplasia (BPD) were assessed.

Thirty-nine infants were randomized to NIHFV (N=16) or BP-CPAP (N=23). There were no significant differences in mean (s.d.) postmenstrual age (28.6 (1.5) versus 29.0 (2.3) weeks, P=0.47), mean (s.d.) weight at randomization (965.0 (227.0) versus 958.1 (310.4) g, P=0.94) or other baseline demographics between the groups. Failure of assigned NRS mode was lower with NIHFV (37.5 versus 65.2%, P=0.09), although not statistically significant. There were no differences in rates of invasive MV 72 h and 7 days post-randomization or BPD.

NIHFV was not superior to BP-CPAP in this pilot study. Effectiveness of NIHFV needs to be proven in larger multi-center, appropriately powered trials before widespread implementation.

Noninvasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with moderate-severe respiratory distress syndrome: A preliminary report.

Abstract:
The aim of this study was to compare the effect of noninvasive high-frequency oscillatory ventilation (nHFOV) with nasal continuous positive airway pressure (nCPAP) in preterm infants with moderate-severe respiratory distress syndrome (RDS) after surfactant administration via INSURE (intubation, surfactant, extubation) method on the need for invasive mechanical ventilation (IMV).

A total of 81 infants with a gestational age (GA) of 28-34 weeks were eligible and were randomized to nCPAP (n = 42) or to nHFOV (n = 39). The need for IMV was the primary outcome. The incidence of bronchopulmonary dysplasia (BPD), occurrence of intraventricular hemorrhage (IVH), and air leaks, and mortality were considered as secondary outcomes.

A total 76 infants finally completed the study. The need for IMV was significantlylower in the nHFOV group compared with the nCPAP group(24.3% vs 56.4%, P < 0.01). The incidence of IVH, air leaks or BPD was similar between the two groups. In addition, the mortality rate was not statistically different.

In this prospective, randomized controlled study, nHFOV significantly reduced the need for IMV as compared with nCPAP in preterm infants with moderate-severe RDS without increase in adverse effects.

Response to 'Non-invasive high frequency ventilation and the errors from the past: designing simple trials neglecting complex respiratory physiology'.

Effective elimination of carbon dioxide by nasopharyngeal high-frequency ventilation.

Nasal high-frequency ventilation for premature infants.

Abstract:
To assess the use of nasal high-frequency ventilation (HFV) to provide noninvasive ventilatory support for very low birthweight (VLBW) infants.

VLBW infants, >7 days of age on nasal continuous positive airway pressure (CPAP), were placed on nasal HFV for 2 h using the Infant Star high-frequency ventilator (Mallinckrodt, Inc., St. Louis, MO, USA). Mean airway pressure was set to equal the previous level of CPAP, and amplitude was adjusted to obtain chest wall vibration. Capillary blood was sampled before starting HFV and after 2 h to determine change in pH and partial pressure of carbon dioxide (pCO(2)).

Fourteen subjects were studied, 10 males and 4 females. Gestational age was 26-30 weeks (median 27). Age at study was 18-147 days (median 30). Median birth weight was 955 g; median weight at study was 1605 g. Nasal CPAP pressure was 4-7 cm H(2)O (mean 5). Amplitude was 30-60 (median 50). After 2 h, PCO(2) (mean 45 torr) was significantly lower than initial PCO(2) (mean 50 torr) (p = 0.01), and pH had increased significantly (7.40 vs. 7.37, p = 0.04).

Nasal HFV is effective in decreasing pCO(2) in stable premature infants requiring nasal CPAP support. Long-term use of nasal HFV requires further study.

Elective high-frequency oscillatory ventilation in preterm infants with respiratory distress syndrome: an individual patient data meta-analysis.

Abstract:
Despite the considerable amount of evidence from randomized controlled trials and meta-analyses, uncertainty remains regarding the efficacy and safety of high-frequency oscillatory ventilation as compared to conventional ventilation in the early treatment of respiratory distress syndrome in preterm infants. This results in a wide variation in the clinical use of high-frequency oscillatory ventilation for this indication throughout the world. The reasons are an unexplained heterogeneity between trial results and a number of unanswered, clinically important questions. Do infants with different risk profiles respond differently to high-frequency oscillatory ventilation? How does the ventilation strategy affect outcomes? Does the delay--either from birth or from the moment of intubation--to the start of high-frequency oscillation modify the effect of the intervention? Instead of doing new trials, those questions can be addressed by re-analyzing the individual patient data from the existing randomized controlled trials.

A systematic review with meta-analysis based on individual patient data. This involves the central collection, validation and re-analysis of the original individual data from each infant included in each randomized controlled trial addressing this question.The study objective is to estimate the effect of high-frequency oscillatory ventilation on the risk for the combined outcome of death or bronchopulmonary dysplasia or a severe adverse neurological event. In addition, it will explore whether the effect of high-frequency oscillatory ventilation differs by the infant's risk profile, defined by gestational age, intrauterine growth restriction, severity of lung disease at birth and whether or not corticosteroids were given to the mother prior to delivery. Finally, it will explore the importance of effect modifying factors such as the ventilator device, ventilation strategy and the delay to the start of high-frequency ventilation.

An international collaborative group, the PreVILIG Collaboration (Prevention of Ventilator Induced Lung Injury Group), has been formed with the investigators of the original randomized trials to conduct this systematic review. In the field of neonatology, individual patient data meta-analysis has not been used previously. Final results are expected to be available by the end of 2009.

Weaning of neonates from mechanical ventilation by use of nasopharyngeal high-frequency oscillatory ventilation: a preliminary study.

Abstract:
To investigate the feasibility of nasopharyngeal high-frequency oscillatory ventilation (nHFOV) immediately after extubation in difficult-to-wean preterm infants.

This was an observational study of 20 mechanically ventilated neonates [median (range) birth weight 635 (382-1020)g, median gestational age 25.3 (23.7-27.6) weeks] at high risk for extubation failure. Nine infants had failed at least one previous extubation. Fourteen infants were given hydrocortisone. All 20 infants were extubated into nHFOV, with a mean airway pressure of 8 cmH(2)O, an amplitude of 20 cmH(2)O, and a frequency of 10 Hz.

 Infants remained on nHFOV for a median duration of 136.5 (7.0-456.0) h until further weaning to continuous positive airway pressure (n =14) or reintubation (n = 6). Reintubation was performed in 1 of 11 infants who had not experienced any previous extubation, and in five of nine infants who had experienced at least one previous extubation (P < 0.05). PaCO(2) was virtually unchanged from preextubation levels 2 h after extubation, but declined significantly at 32 h from 59.8 (45.0-92.3) mmHg to 50.7 (39.8-74.4) mmHg (P < 0.01). PaCO(2) returned to preextubation levels upon discontinuation of nHFOV.

This small observational study demonstrates that nHFOV can be successfully applied to wean premature infants from ventilator support.

Use of noninvasive high-frequency ventilation in the neonatal intensive care unit: a retrospective review.

Abstract:
The aim of the article is to review the effectiveness of neonatal noninvasive high-frequency ventilation (NIHFV) in preventing endotracheal mechanical ventilation.

Retrospective case series including all 79 instances of NIHFV use at four participating centers between July 2010 and September 2012.

In 73% of cases, NIHFV was used as rescue after another noninvasive mode, and prophylactically (postextubation) in the remainder. In 58% of cases, infants transitioned to another noninvasive mode, without requiring intubation. There were significant reductions in the mean (SD) number of apneas, bradycardias, or desaturations (over 6 hours) (3.2 [0.4] vs. 1.2 [0.3]; p < 0.001), FiO2 (48 [3] vs. 40 [2]%; p < 0.001) and CO2 levels (74 [6] vs. 62 [4] mm Hg; p = 0.025] with NIHFV. No NIHFV-related complications were noted.

NIHFV is a promising NIV mode that may help prevent or delay intubation and deserves further clinical research.


Context: Dengue is a global health problem of high significance, with 3.9 billion people at risk of infection. The geographic expansion of dengue virus (DENV) infection has resulted in increased frequency and severity of the disease, and the number of deaths has increased in recent years. Wolbachia,an intracellular bacterial endosymbiont, has been under investigation for several years as a novel dengue-control strategy. Some dengue vectors (Aedes mosquitoes) can be transinfected with specific strains of Wolbachia, which decreases their fitness (ability to survive and mate) and their ability to reproduce, inhibiting the replication of dengue. Both laboratory and field studies have demonstrated the potential effect of Wolbachia deployments on reducing dengue transmission, and modelling studies have suggested that this may be a self-sustaining strategy for dengue prevention, although long-term effects are yet to be elucidated.

To assess the efficacy of Wolbachia-carrying Aedes speciesdeployments (specifically wMel-, wMelPop-, and wAlbB- strains of Wolbachia) for preventing dengue virus infection.

Randomized controlled trials (RCTs), including cluster-randomized controlled trials (cRCTs), conducted in dengue endemic or epidemic-prone settings were eligible. We sought studies that investigated the impact of Wolbachia-carrying Aedes deployments on epidemiological or entomological dengue-related outcomes, utilizing either the population replacement or population suppression strategy.

Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia.

Abstract:
The AWED (Applying Wolbachia to Eliminate Dengue) trial is a parallel, two-arm, non-blinded cluster randomised controlled trial that is under way in Yogyakarta, Indonesia, with the aim of measuring the efficacy of Wolbachia-infected Aedes aegypti deployments in reducing dengue incidence in an endemic setting. Enrolment began in January 2018 and is ongoing. The original study protocol was published in April 2018. Here, we describe amendments that have been made to the study protocol since commencement of the trial.

The key protocol amendments are (1) a revised study duration with planned end of participant enrolment in August 2020, (2) the addition of new secondary objectives (i) to estimate serotype-specific efficacy of the Wolbachia intervention and (ii) to compare Ae. aegypti abundance in intervention versus untreated clusters, (3) an additional exposure classification for the per-protocol analysis where the Wolbachia exposure index is calculated using only the cluster-level Wolbachia prevalence in the participant's cluster of residence, (4) power re-estimation using a multinomial sampling method that better accounts for randomness in sampling, and (5) the addition of two trial stopping rules to address the potential for persistently low rates of virologically confirmed dengue case enrolment and Wolbachia contamination into untreated clusters. Additional minor changes to the protocol are also described.

The findings from this study will provide the first experimental evidence for the efficacy of Wolbachia in reducing dengue incidence. Enrolment in the trial will conclude this year (2020) and results will be reported shortly thereafter.

ClinicalTrials.gov, identifier: NCT03055585. Registered on 14 February 2017. Last updated 22 March 2020.

The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial.

Abstract:
Dengue and other arboviruses transmitted by Aedes aegypti mosquitoes, including Zika and chikungunya, present an increasing public health challenge in tropical regions. Current vector control strategies have failed to curb disease transmission, but continue to be employed despite the absence of robust evidence for their effectiveness or optimal implementation. The World Mosquito Program has developed a novel approach to arbovirus control using Ae. aegypti stably transfected with Wolbachia bacterium, with a significantly reduced ability to transmit dengue, Zika and chikungunya in laboratory experiments. Modelling predicts this will translate to local elimination of dengue in most epidemiological settings. This study protocol describes the first trial to measure the efficacy of Wolbachia in reducing dengue virus transmission in the field.

The study is a parallel, two-arm, non-blinded cluster randomised controlled trial conducted in a single site in Yogyakarta, Indonesia. The aim is to determine whether large-scale deployment of Wolbachia-infected Ae. aegypti mosquitoes leads to a measurable reduction in dengue incidence in treated versus untreated areas. The primary endpoint is symptomatic, virologically confirmed dengue virus infection of any severity. The 26 km

The findings from this study will provide the first experimental evidence for the efficacy of Wolbachia in reducing dengue incidence. Together with observational evidence that is accumulating from pragmatic deployments of Wolbachia in other field sites, this will provide valuable data to estimate the effectiveness of this novel approach to arbovirus control, inform future cost-effectiveness estimates, and guide plans for large-scale deployments in other endemic settings.

ClinicalTrials.gov, identifier: NCT03055585 . Registered on 14 February 2017.

Reanalysis of cluster randomised trial data to account for exposure misclassification using a per-protocol and complier-restricted approach.

Abstract: The intention-to-treat (ITT) analysis of the Applying Wolbachia to Eliminate Dengue (AWED) trial estimated a protective efficacy of 77.1% for participants resident in areas randomised to receive releases of wMel-infected Aedes aegypti mosquitoes, an emerging dengue preventive intervention. The limiting assumptions of ITT analyses in cluster randomised trials and the mobility of mosquitoes and humans across cluster boundaries indicate the primary analysis is likely to underestimate the full public health benefit. Using spatiotemporally-resolved data on the distribution of Wolbachia mosquitoes and on the mobility of AWED participants (n = 6306), we perform complier-restricted and per-protocol re-examinations of the efficacy of the Wolbachia intervention. Increased intervention efficacy was estimated in all analyses by the refined exposure measures. The complier-restricted analysis returned an estimated efficacy of 80.7% (95% CI 65.9, 89.0) and the per-protocol analysis estimated 82.7% (71.7, 88.4) efficacy when comparing participants with an estimated wMel exposure of

Disruption of spatiotemporal clustering in dengue cases by wMel Wolbachia in Yogyakarta, Indonesia.

Abstract: Dengue exhibits focal clustering in households and neighborhoods, driven by local mosquito population dynamics, human population immunity, and fine scale human and mosquito movement. We tested the hypothesis that spatiotemporal clustering of homotypic dengue cases is disrupted by introduction of the arbovirus-blocking bacterium Wolbachia (wMel-strain) into the Aedes aegypti mosquito population. We analysed 318 serotyped and geolocated dengue cases (and 5921 test-negative controls) from a randomized controlled trial in Yogyakarta, Indonesia of wMel deployments. We find evidence of spatial clustering up to 300 m among the 265 dengue cases (3083 controls) in the untreated trial arm. Participant pairs enrolled within 30 days and 50 m had a 4.7-fold increase (compared to 95% CI on permutation-based null distribution: 0.1, 1.2) in the odds of being homotypic (i.e. potentially transmission-related) as compared to pairs occurring at any distance. In contrast, we find no evidence of spatiotemporal clustering among the 53 dengue cases (2838 controls) resident in the wMel-treated arm. Introgression of wMel Wolbachia into Aedes aegypti mosquito populations interrupts focal dengue virus transmission leading to reduced case incidence; the true intervention effect may be greater than the 77% efficacy measured in the primary analysis of the Yogyakarta trial.

Baseline Characterization of Dengue Epidemiology in Yogyakarta City, Indonesia, before a Randomized Controlled Trial of

Abstract: Dengue is endemic in Indonesia. Here, we describe the epidemiology of dengue in the city of Yogyakarta, Central Java, as a prelude to implementation of a cluster-randomized trial of

Aedes aegypti abundance and insecticide resistance profiles in the Applying Wolbachia to Eliminate Dengue trial.

Abstract: The Applying Wolbachia to Eliminate Dengue (AWED) trial was a parallel cluster randomised trial that demonstrated Wolbachia (wMel) introgression into Ae. aegypti populations reduced dengue incidence. In this predefined substudy, we compared between treatment arms, the relative abundance of Ae. aegypti and Ae. albopictus before, during and after wMel-introgression. Between March 2015 and March 2020, 60,084 BG trap collections yielded 478,254 Ae. aegypti and 17,623 Ae. albopictus. Between treatment arms there was no measurable difference in Ae. aegypti relative abundance before or after wMel-deployments, with a count ratio of 0.96 (95% CI 0.76, 1.21) and 1.00 (95% CI 0.85, 1.17) respectively. More Ae. aegypti were caught per trap per week in the wMel-intervention arm compared to the control arm during wMel deployments (count ratio 1.23 (95% CI 1.03, 1.46)). Between treatment arms there was no measurable difference in the Ae. albopictus population size before, during or after wMel-deployment (overall count ratio 1.10 (95% CI 0.89, 1.35)). We also compared insecticide resistance phenotypes of Ae. aegypti in the first and second years after wMel-deployments. Ae. aegypti field populations from wMel-treated and untreated arms were similarly resistant to malathion (0.8%), permethrin (1.25%) and cyfluthrin (0.15%) in year 1 and year 2 of the trial. In summary, we found no between-arm differences in the relative abundance of Ae. aegypti or Ae. albopictus prior to or after wMel introgression, and no between-arm difference in Ae. aegypti insecticide resistance phenotypes. These data suggest neither Aedes abundance, nor insecticide resistance, confounded the epidemiological outcomes of the AWED trial.

Efficacy of Wolbachia-Infected Mosquito Deployments for the Control of Dengue.

Abstract:
We conducted a cluster-randomized trial involving releases of

After successful introgression of

Introgression of

Field evaluation of the establishment potential of wMelPop Wolbachia in Australia and Vietnam for dengue control.

Abstract:
Introduced Wolbachia bacteria can influence the susceptibility of Aedes aegypti mosquitoes to arboviral infections as well as having detrimental effects on host fitness. Previous field trials demonstrated that the wMel strain of Wolbachia effectively and durably invades Ae. aegypti populations. Here we report on trials of a second strain, wMelPop-PGYP Wolbachia, in field sites in northern Australia (Machans Beach and Babinda) and central Vietnam (Tri Nguyen, Hon Mieu Island), each with contrasting natural Ae. aegypti densities.

Mosquitoes were released at the adult or pupal stages for different lengths of time at the sites depending on changes in Wolbachia frequency as assessed through PCR assays of material collected through Biogents-Sentinel (BG-S) traps and ovitraps. Adult numbers were also monitored through BG-S traps. Changes in Wolbachia frequency were compared across hamlets or house blocks.

Releases of adult wMelPop-Ae. aegypti resulted in the transient invasion of wMelPop in all three field sites. Invasion at the Australian sites was heterogeneous, reflecting a slower rate of invasion in locations where background mosquito numbers were high. In contrast, invasion across Tri Nguyen was relatively uniform. After cessation of releases, the frequency of wMelPop declined in all sites, most rapidly in Babinda and Tri Nguyen. Within Machans Beach the rate of decrease varied among areas, and wMelPop was detected for several months in an area with a relatively low mosquito density.

These findings highlight challenges associated with releasing Wolbachia-Ae. aegypti combinations with low fitness, albeit strong virus interference properties, as a means of sustainable control of dengue virus transmission.

Female Adult Aedes albopictus Suppression by Wolbachia-Infected Male Mosquitoes.

Abstract: Dengue, chikungunya and zika viruses are pathogens with an increasing global impact. In the absence of an approved vaccine or therapy, their management relies on controlling the mosquito vectors. But traditional controls are inadequate, and the range of invasive species such as Aedes albopictus (Asian Tiger Mosquito) is expanding. Genetically modified mosquitoes are being tested, but their use has encountered regulatory barriers and public opposition in some countries. Wolbachia bacteria can cause a form of conditional sterility, which can provide an alternative to genetic modification or irradiation. It is unknown however, whether openly released, artificially infected male Ae. albopictus can competitively mate and sterilize females at a level adequate to suppress a field population. Also, the unintended establishment of Wolbachia at the introduction site could result from horizontal transmission or inadvertent female release. In 2014, an Experimental Use Permit from the United States Environmental Protection Agency approved a pilot field trial in Lexington, Kentucky, USA. Here, we present data showing localized reduction of both egg hatch and adult female numbers. The artificial Wolbachia type was not observed to establish in the field. The results are discussed in relation to the applied use of Wolbachia-infected males as a biopesticide to suppress field populations of Ae. albopictus.

Establishment of Wolbachia Strain wAlbB in Malaysian Populations of Aedes aegypti for Dengue Control.

Abstract: Dengue has enormous health impacts globally. A novel approach to decrease dengue incidence involves the introduction of Wolbachia endosymbionts that block dengue virus transmission into populations of the primary vector mosquito, Aedes aegypti. The wMel Wolbachia strain has previously been trialed in open releases of Ae. aegypti; however, the wAlbB strain has been shown to maintain higher density than wMel at high larval rearing temperatures. Releases of Ae. aegypti mosquitoes carrying wAlbB were carried out in 6 diverse sites in greater Kuala Lumpur, Malaysia, with high endemic dengue transmission. The strain was successfully established and maintained at very high population frequency at some sites or persisted with additional releases following fluctuations at other sites. Based on passive case monitoring, reduced human dengue incidence was observed in the release sites when compared to control sites. The wAlbB strain of Wolbachia provides a promising option as a tool for dengue control, particularly in very hot climates.


Context: Midwives are primary providers of care for childbearing women globally and there is a need to establish whether there are differences in effectiveness between midwife continuity of care models and other models of care. This is an update of a review published in 2016.

To compare the effects of midwife continuity of care models with other models of care for childbearing women and their infants.

All published and unpublished trials in which pregnant women are randomly allocated to midwife continuity of care models or other models of care during pregnancy and birth.

Satisfaction with midwife-managed care in different time periods: a randomised controlled trial of 1299 women.

Abstract:
To compare women's satisfaction with midwife-managed care with 'shared care' over three different time periods.

Randomised controlled trial.

Glasgow Royal Maternity Hospital, Glasgow, UK.

1299 women experiencing normal pregnancy (consent rate: 82%). Six hundred and forty-eight women were randomised to midwife-managed care and 651 to 'shared care'.

Three self-report questionnaires were sent to women's homes. The questionnaires examined: satisfaction with antenatal care at 34-35 weeks' gestation, and satisfaction with intrapartum, hospital- and home-based postnatal care at seven weeks postnatally. The third questionnaire reviewed satisfaction with intrapartum care seven months after delivery.

Women in both groups were satisfied. However, women in the midwife-managed group were more highly satisfied in relation to the dimensions examined: relationships with staff, information transfer, choices and decisions, and social support. The differences between the two groups were evident for all time periods (i.e. antenatal, intrapartum and postnatal periods) and were sustained at seven-month follow-up. This is illustrated in the mean scores for relationships with staff, as measured at 34-35 weeks' gestation (possible range -2; very negative attitudes to 2; very positive attitudes). Women in the midwife-managed group scored a mean of 1.22 compared to 0.74 for the 'shared care' group (mean diff: 0.48; 95% CI: 0.42 to 0.55). While women in both groups were more likely to make positive rather than negative comments in open-ended questions, the midwife-managed group were more likely to make positive comments whereas the 'shared care' group were more likely to make negative comments.

Midwife-managed care for healthy pregnant women which is integrated into existing services improves satisfaction with antenatal, intrapartum and postnatal care.

Incorporating cultural diversity in randomised controlled trials in midwifery.

Abstract: The randomised controlled trial is currently the 'gold standard' that guides health-care practices. The implementation of new models of midwifery care often relies on results from randomised controlled trials. However, many randomised controlled trials exclude women who do not speak English or are designed in such a way that cultural diversity is not facilitated. This can mean that the sample is not representative of the population from which it was drawn or to which it will be applied. Culturally diverse representation can be achieved through a number of strategies. These include utilising health-care interpreters, ensuring materials are translated into common community languages and engaging the local community. These strategies can be used to ensure that the sample in a randomised controlled trial is culturally and linguistically diverse, and representative of the community. We have conducted a randomised controlled trial of a community-based model of midwifery providing continuity of care in a culturally diverse population. A number of issues in the conduct of a trial within a culturally diverse society are discussed in this paper. The trial will be used to illustrate some of the strategies used to ensure that the sample represented the population from which it was drawn.

A randomised study of midwifery caseload care and traditional 'shared-care'.

Abstract:
To evaluate caseload midwifery care in comparison to traditional 'shared care'.

Comparative study with area randomisation.

District general hospital in England.

'Known carer at delivery,' 'normal vaginal delivery' and 'obstetric intervention'.

All pregnant women delivering in the six areas chosen for the study.

A highly significant difference was found between caseload and traditional care groups in terms of level of 'known carer at delivery' (696/770 94.7%; cf. 52/735 (6.7%), p < 0.001). However, no differences in 'normal vaginal delivery' rates were found (542/770 (70%) cf. 509/735 (69%). There were fewer 'obstetric interventions' in the caseload group, particularly epidural analgesia (80/770 (10%) cf. 110/735 (15%) p = 0.01) and oxytocin augmentation (351/77 (46%) cf. 387/735 (53%), p = 0.01). There were no significant differences found in terms of neonatal outcome.

Caseload midwifery results in high levels of 'known carer at delivery' which appears to be associated with a reduction in augmentation and epidural rates but which were not associated with an increase in normal vaginal delivery rate.

The costs of alternative types of routine antenatal care for low-risk women: shared care vs care by general practitioners and community midwives.

Abstract:
To compare the costs to the health service, women and their families of routine antenatal care provided by either traditional obstetrician-led shared care or general practitioner (GP)/community midwife care.

A multicentre randomized controlled trial in 51 general practices linked to nine maternity hospitals in Scotland: 1667 low-risk pregnant women provided information on costs to the health service. 704 of these women provided information on non-health service costs.

GP/midwife antenatal care was found to cost statistically significantly less than shared care. This was the case for investigations carried out at routine antenatal visits (GP/midwife = 87.25 Pounds, shared care = 91.15 Pounds, P = 0.05), staffing costs at routine antenatal visits (GP/midwife = 127.76 Pounds, shared care = 131.09 Pounds, P = 0.001), and non-health service costs incurred by women and their companions (GP/midwife = 118.53 Pounds, shared care = 133.49 Pounds, P = 0.001). While non-routine care in the GP/midwife arm of the trial costs less than in the shared care arm, the difference was not statistically significant (GP/midwife = 83.74 Pounds, shared care = 94.43 Pounds, P = 0.46). The total societal cost of antenatal care was 417.28 Pounds per women in the GP/midwife arm of the trial and 450.19 Pounds in the shared care arm of the trial. This difference was statistically significant (P < 0.001). The application of sensitivity analysis did not change these results.

GP/midwife antenatal care is a satisfactory option for low-risk pregnant women in Scotland provided that clinical outcomes and women's satisfaction are at least the same as those of women with shared care.

A randomized controlled trial comparing midwife-managed care and obstetrician-managed care for women assessed to be at low risk in the initial intrapartum period.

Abstract:
To compare the efficacy of midwife-managed care and obstetrician-managed care for women assessed to be at low risk in the initial intrapartum period.

1,050 women assessed to be at low risk on admission to labour ward in the Prince of Wales Hospital participated in this study. By computer-generated random allocation, 563 (54%) women were assigned to Group A (experimental) under midwifery care, and 487 (46%) women to Group B (control) under obstetrician care. The outcomes and complications between the 2 groups were compared. Data were analyzed by 2 x 2 contingency tables and Chi-square.

150 (26.6%) women in the experimental group were taken over by the obstetricians. 46 (30.7%) women were transferred to obstetrician-management for the preference of epidural analgesia. The other reasons for taken over the remaining 104 (69.3%) women were fetal distress, poor progress of labour, complications in first or second stage of labour. The experimental group had less oxytocic augmentation (Chi-square = 7.49, p = 0.006) and the insertion of intravenous infusion (Chi-square = 5.34, p = 0.02). Both groups had similar outcomes on normal delivery, operative vaginal delivery, caesarean section and complications.

Midwife-managed care is as safe as obstetrician-managed care for women who were assessed to be at low risk in the intrapartum period. Routine visit by obstetrician is not necessary and the midwives are able to detect complications in the course of labour and alert the obstetrician for taking the necessary action.

A randomised controlled trial comparing birthing centre care with delivery suite care in Adelaide, Australia.

Abstract: Birthing centre care offers women with a low risk of complication in pregnancy an alternative to conventional care for the birthing of their baby. It is important these two forms of care are appropriately assessed. A randomised controlled trial comparing the newly opened birthing centre with the established conventional delivery suite was conducted at the then Queen Victoria Hospital, Adelaide, South Australia. The outcomes measured included maternal satisfaction, costs and clinical outcomes both for mother and baby which related to the need for Caesarean section, episiotomy or tear rate and method of feeding. Two hundred and one women attending the hospital's antenatal clinic were randomly allocated to either birthing centre or delivery suite care. One hundred women were allocated to the birthing centre. No differences were found in either group related to clinical outcomes or costs. The only difference in maternal satisfaction was the choice women made for their next birth. More women in the birthing centre group felt they were encouraged to breastfeed immediately after birth. While the numbers in this study were too small to detect any but large differences in outcome, birthing centre care should remain an option for women and further studies undertaken with larger numbers.

Does birth center care during a woman's first pregnancy have any impact on her future reproduction?

Abstract:
Women's experiences of childbirth may affect their future reproduction, and the model of care affects their experiences, suggesting that a causal link may exist between model of care and future reproduction. The study objective was to examine whether the birth center model of care during a woman's first pregnancy affects whether or not she has a second baby, and on the spacing to the next birth.

Between October 1989 and July 1993, a total of 1860 women at low medical risk in early pregnancy, who participated in a randomized controlled trial of in-hospital birth center care versus standard care, gave birth. The 1063 primiparas in the trial, 543 in the birth center group and 520 in the standard care group, were included in a secondary analysis in which women's personal identification codes were linked to the Swedish National Birth Register, which included information about their subsequent birth during the following 7 to 10 years. Time to an event curves were constructed by means of the Kaplan Meier method.

The observation period after the first birth was on average 8.8 years in the birth center group and 8.7 years in the standard care group. No statistical difference was found between the groups in time to second birth, which was 2.85 and 2.82 years, respectively (median; log-rank 1.26; p=0.26).

A woman's model of care, such as birth center care, during her first pregnancy does not seem to be a sufficiently important factor to affect subsequent reproduction in Sweden.

Effectiveness of certified nurse-midwives. A prospective evaluation study.

Abstract: A prospective evaluation study of the effectiveness of the services of certified nurse-midwives demonstrated that in a hospital setting the care of low-risk maternity patients provided by nurse-midwives was as effective as the provided by house staff physicians. A total of 438 low-risk maternity patients were studied. Selected outcomes pertaining to the prenatal period, labor and delivery, and early infancy demonstrated, with two exceptions, no significant differences. The two exceptions were: (1) overcompliance with appointment attendance was more common among the nurse-midwifery group of patients; (2) a higher rate of forceps delivery was reported among the house staff group of patients.

Swedish women's interest in home birth and in-hospital birth center care.

Abstract:
In Sweden, few alternatives to a hospital birth are available, and little is known about consumer interest in alternative birth care. The aim of this study was to determine women's interest in home birth and in-hospital birth center care in Sweden, and to describe the characteristics of these women.

All Swedish-speaking women booked for antenatal care during 3 weeks during 1 year were invited to participate in the study. Three questionnaires, completed after the first booking visit in early pregnancy, at 2 months, and 1 year after the birth, asked about the women's interest in two alternative birth options and a wide range of possible explanatory variables.

Consent to participate in the study was given by 3283 women (71% of all women eligible). The rates of response to the three questionnaires were 94, 88, and 88 percent, respectively. One percent of participants consistently expressed an interest in home birth on all three occasions, and 8 percent expressed an interest in birth center care. A regression analysis showed five factors that were associated with an interest in home birth: a wish to have the baby's siblings (OR 20.2; 95% CI 6.2-66.5) and a female friend (OR 15.2; 95% CI 6.2-37.4) present at the birth, not wanting pharmacological pain relief during labor and birth (OR 4.7; 95% CI 1.4-15.3), low level of education (OR 4.5; 95% CI 1.8-11.4), and dissatisfaction with medical aspects of intrapartum care (OR 3.6; 95% CI 1.4-9.2). An interest in birth center care was associated with experience of being in control during labor and birth (OR 8.3; 95% CI 3.2-21.6), not wanting pharmacological pain relief (OR 2.3; 95% CI 1.3-4.1), and a preference to have a known midwife at the birth (OR 2.2; 95% CI 1.6-2.9).

If Swedish women were offered free choice of place of birth, the home birth rate would be 10 times higher, and the 20 largest hospitals would need to have a birth center. Women interested in alternative models of care view childbirth as a social and natural event, and their needs should be considered.

Antenatal care of low risk obstetric patients by midwives. A randomised controlled trial.

Abstract:
To assess the practicality, acceptability to patients and salary costs of the antenatal care of low risk obstetric patients by midwives.

A randomised controlled trial.

The antenatal clinic at Westmead Hospital, a teaching hospital of the University of Sydney in western Sydney.

From January 1989 until November 1990, 89 women booking for full antenatal care at Westmead Hospital and classified as low risk were randomly allocated to one of two groups. Group 1 (43 patients) had their antenatal care provided by registered midwives. Group 2 (46 patients) had their antenatal care provided by an obstetrician (either Visiting Medical Officer or Staff Specialist) in a routine hospital antenatal clinic.

Patients in the midwives' clinic were seen by an obstetrician at their first visit to the antenatal clinic and again at 30 weeks and at 40 weeks.

These were the salary costs of each clinic and the patients' levels of satisfaction. Maternal and neonatal indicators, delivery details and analgesic requirements were also considered. These indicators were planned before data collection commenced.

The major differences found were a 28% to 68% salary cost saving and that patients cared for by midwives showed appreciation of the continuity of care and information given at the midwives' clinic.

The care of low risk obstetric patients by midwives in a midwives' clinic showed salary cost savings and high patient acceptance.