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Increased risk of cesarean delivery with advancing maternal age: indications and associated factors in nulliparous women.

OBJECTIVE: To investigate factors that contribute to the increased risk of cesarean delivery with advancing maternal age. STUDY DESIGN: We reviewed demographic and ante- and intrapartum variables from a data set of term, nulliparous women who delivered at Brigham and Women's Hospital in 1998 (n = 3715). RESULTS: Cesarean delivery rates increased with advancing maternal age (< 25 years, 11.6%; > or = 40 years, 43.1%). Older women were more likely to have cesarean delivery without labor (< 25 years, 3.6%; > or = 40 years, 21.1%). Malpresentation and prior myomectomy were the indications for cesarean delivery without labor that were more prevalent in our older population as compared to our younger population. Even among women with spontaneous or induced labor, cesarean delivery rates increased with maternal age (< 25 years, 8.3%; > or = 40 years, 30.6%). Cesarean delivery rates were higher with induced labor, and rates of induction rose directly and continuously with maternal age, especially the rate of elective induction. Cesarean delivery for failure to progress or fetal distress was more common among older parturients, regardless of whether labor was spontaneous or induced. Among women who underwent cesarean delivery because of failure to progress, use of oxytocin and length of labor did not vary with age. CONCLUSIONS: Older women are at higher risk for cesarean delivery in part because they are more likely to have cesarean delivery without labor. However, even among those women who labor, older women are more likely to undergo cesarean delivery, regardless of whether labor is spontaneous or induced. Part of the higher rate among older women who labor is explained by a higher rate of induction, particularly elective induction. Among women in both spontaneous and induced labor, cesarean delivery for the diagnoses of failure to progress and fetal distress was more frequent in older patients, although management of labor dystocia for these patients was similar to that for younger patients.

Adult↗

Predictions for the decision-to-delivery interval for emergency cesarean sections in Norway.

BACKGROUND: To explain the variation in decision-to-delivery intervals in emergency cesarean sections in Norway. METHODS: A seven-month prospective registration of all emergency cesareans provided by 24 maternity units. The clinician in charge filled in a predesigned form for each delivery that obtained detailed information about obstetric history, the pregnancy, indication, the date and time of delivery, decision-to-delivery interval, seniority of the surgeon, and neonatal outcome until hospital discharge. To take account of the clustered nature of our observations, data were analyzed by multilevel regression. RESULTS: 1,511 singleton emergency cesarean sections with known decision-to-delivery interval were included. The average decision-to-delivery interval for all emergency cesarean sections was 52.4 min, for acute cesarean sections 58.7 min, and for urgent emergency operations 11.8 min. Most of the decision-to-delivery interval variation was at patient level, not between departments. Several significant decision-to-delivery interval predictors were identified: 1. abruptio placentae (-54 min), umbilical cord prolapse (-37 min), and fetal stress (-35 min); 2. general anesthesia (versus regional) (-15 min), 3. cesarean sections performed during night-time (-10 min), 4. seniority of the surgeon (-6 min), and 5. cervical opening (for each cm: -6 min). CONCLUSIONS: The variance in the decision-to-delivery interval was mainly explained by the different nature of the cesarean sections. The most important predictors, which all acted to reduce decision-to-delivery interval, were the three indications abruptio placentae, cord prolapse, and fetal stress. Sections performed during night-time had significantly reduced decision-to-delivery interval. The size of the maternal units as measured by number of deliveries per year was not a significant predictor.

Abruptio Placentae↗

A prospective study of vaginal pH as a predictor of preterm delivery.

OBJECTIVE: To test the usefulness of vaginal pH determinations in the prediction of the risk of preterm delivery at or before 36 weeks of gestation. METHODS: This was a prospective study of asymptomatic pregnant women. Vaginal pH was determined using pH paper in a sterile speculum examination during prenatal visits. Patients were followed to delivery and hospital records were reviewed to extract obstetric information. A total of 308 women agreed to participate and met the criteria for enrolment. Preterm delivery was defined as delivery at or prior to 36 weeks of gestation. Abnormal pH was defined as a pH of > 5.0. RESULTS: Abnormal vaginal pH was associated with increased risk of preterm delivery, (OR 3.3, 95% CI 1.15, 9.2; p = 0.02). In the first trimester, an abnormal vaginal pH was not associated with preterm delivery (p = 0.3). After the first trimester, a vaginal pH of 5.0 or greater was associated with increased risk of preterm delivery (OR 9.6, 95% CI 2.0, 45.5; p = 0.001) as well as delivering an infant of less than 2500 g (OR 3.1, 95% CI 1.2, 7.8; p = 0.015). History of a previous preterm delivery was associated with increased risk of preterm delivery (OR 6.2, 95% CI 1.6, 23.7; p = 0.02). A logistic regression model used to control for a history of preterm delivery and race showed abnormal vaginal pH to remain as an independent predictor of preterm delivery (p = 0.01). CONCLUSIONS: High vaginal pH (> or = 5.0) identified women at risk for preterm delivery.

Adult↗

Heterogeneity of perinatal outcomes in the preterm delivery syndrome.

OBJECTIVE: Our aim was to document the differential neonatal morbidity and intrapartum and neonatal mortality of subgroups of preterm delivery. METHODS: This analysis included 38,319 singleton pregnancies, of which 3,304 (8.6%) were preterm deliveries (less than 37 completed weeks) enrolled in the World Health Organization randomized trial of a new antenatal care model. We classified them as preterm deliveries after spontaneous initiation of labor, either with or without maternal obstetric and medical complications; preterm deliveries after prelabor spontaneous rupture of amniotic membranes (PROM), either with or without obstetric and medical complications; and medically indicated preterm deliveries with maternal obstetric and medical complications. Severe neonatal morbidity and neonatal mortality were the primary outcomes. RESULTS: Fifty-six percent of all preterm deliveries were spontaneous, without maternal complications. Small for gestational age was increased only among the medically indicated preterm delivery group (22.3%). Very early preterm delivery (less than 32 weeks of gestation) was highest among PROM with complications (37%). For intrapartum fetal death and neonatal death, after adjusting by gestational age and other confounding variables, we found that the obstetric and medical complications preceding preterm delivery predicted the different risk levels. Conversely, for severe neonatal morbidity the clinical presentation, ie, PROM or medically indicated, predicted the increased risk. CONCLUSION: There are differential neonatal outcomes among preterm deliveries according to clinical presentation, pregnancy complications, gestational age at delivery, and its association with small for gestational age. This syndromic nature of the condition should be considered if preterm delivery is to be fully understood and thus reduced.

Adolescent↗

Misoprostol for second-trimester pregnancy termination in women with a prior cesarean delivery.

OBJECTIVE: To evaluate the use of misoprostol in second-trimester abortion in women with prior cesarean deliveries. METHODS: A review of women with prior cesarean deliveries undergoing abortion at 14-28 weeks of gestation for a fetal anomaly over a 7.5-year period. Outcome data were compared with a contemporaneous cohort of women with unscarred uteri undergoing the same procedure. Misoprostol was used to induce abortion in all cases, and a variety of dosage regimens were used, the most frequent being 400 mug vaginally every 6 hours (71.3%). RESULTS: During the study period, 720 consecutive women underwent a second-trimester abortion for a fetal anomaly using misoprostol. One hundred one women (14%) had at least 1 prior cesarean delivery: 78 women had 1, 19 women had 2, and 4 women had 3 prior cesarean deliveries. Women with a prior cesarean birth were significantly older (30 years [interquartile range 26-35] versus 33 years [29-37], no cesarean delivery versus cesarean delivery, P = < .001) and of increased parity. The median gestational age at delivery was 19.4 weeks (interquartile range 18-20.7) versus 19.3 weeks (17.7-21), no cesarean delivery versus cesarean delivery, P = .48. The presence of a prior uterine scar did not impact upon abortion duration (16.6 hours [12.1-23.8] versus 14.5 hours [11.4-21.4], no cesarean delivery versus cesarean delivery, P = .07). No differences in blood loss, major hemorrhage, or blood transfusion occurred. There was no case of uterine rupture or hysterectomy. CONCLUSION: In second-trimester abortion, the use of misoprostol in women with prior cesarean delivery was not associated with an excess of complications compared with women with unscarred uteri. LEVEL OF EVIDENCE: II-2.

Abortion, Therapeutic↗

Does progesterone treatment influence risk factors for recurrent preterm delivery?

OBJECTIVE: To examine how demographic and pregnancy characteristics can affect the risk of recurrent preterm delivery and the how the effectiveness of progesterone treatment for prevention alters these relationships. METHODS: This was a secondary analysis of a randomized trial of 17alpha-hydroxyprogesterone caproate to prevent recurrent preterm delivery in women at risk. Associations of risk factors for preterm delivery (less than 37 completed weeks of gestation) were examined separately for the women in the 17alpha-hydroxyprogesterone caproate (n = 310) and placebo (n = 153) groups. RESULTS: Univariate analysis found that the number of previous preterm deliveries and whether the penultimate delivery was preterm were significant risk factors for preterm delivery in both the placebo and progesterone groups. High body mass index was protective of preterm birth in the placebo group. Multivariate analysis found progesterone treatment to cancel the risk of more than 1 previous preterm delivery, but not the risk associated with the penultimate pregnancy delivered preterm. Obesity was associated with lower risk for preterm delivery in the placebo group but not in the women treated with progesterone. CONCLUSION: The use of 17alpha-hydroxyprogesterone caproate in women with a previous preterm delivery reduces the overall risk of preterm delivery and changes the epidemiology of risk factors for recurrent preterm delivery. In particular, these data suggest that 17alpha-hydroxyprogesterone caproate reduces the risk of a history of more than 1 preterm delivery. LEVEL OF EVIDENCE: I.

17 alpha-Hydroxyprogesterone Caproate↗

Maternal morbidity associated with cesarean delivery without labor compared with induction of labor at term.

OBJECTIVE: To estimate the maternal morbidity associated with cesarean deliveries performed at term without labor compared with morbidity associated with induction of labor at term. METHODS: A 15-year population-based cohort study (1988-2002) using the Nova Scotia Atlee Perinatal Database compared maternal outcomes in nulliparous women delivering by cesarean delivery without labor and nulliparous women at term undergoing induction of labor for planned vaginal delivery with singleton, cephalic presentation. RESULTS: A total of 5,779 pregnancies satisfied inclusion and exclusion criteria, 879 of which were cesarean deliveries without labor. There were no maternal deaths. There was no difference in wound infection, puerperal febrile morbidity, blood transfusion or intraoperative trauma. After controlling for potential confounders, women undergoing cesarean delivery without labor were less likely to have complications of early postpartum hemorrhage (relative risk 0.61, 95% confidence interval 0.42-0.88, number needed to treat 32) and composite maternal morbidity (relative risk 0.71, 95% confidence interval 0.52-0.95, number needed to treat 34) compared with women undergoing induction of labor. Subgroup analyses of maternal outcomes after induction of labor in women by method of delivery were also performed and demonstrated additional risks of traumatic morbidity after induction of labor. The highest morbidity was found in the assisted vaginal delivery and cesarean delivery in labor groups. CONCLUSION: Early postpartum hemorrhage and composite maternal morbidity were decreased in cesarean delivery without labor compared with induction of labor. Hemorrhagic and traumatic morbidities with labor induction are increased after assisted vaginal delivery and cesarean delivery in labor compared with cesarean delivery without labor.

Adult↗

Repeat cesarean delivery: what indications are recorded in the medical chart?

BACKGROUND: National surveillance estimates reported a troubling 63 percent decline in the rate of vaginal birth after cesarean delivery (VBAC) from 1996 (28.3%) to 2003 (10.6%), with subsequent rising rates of repeat cesarean delivery. The study objective was to examine patterns of documented indications for repeat cesarean delivery in women with and without labor. METHODS: We conducted a population-based validation study of 19 nonfederal short-stay hospitals in Washington state. Of the 4,541 women who had live births in 2000, 11 percent (n = 493) had repeat cesarean without labor and 3 percent (n = 138) had repeat cesarean with labor. Incidence of medical conditions and pregnancy complications, patterns of documented indications for repeat cesarean delivery, and perioperative complications in relation to repeat cesarean delivery with and without labor were calculated. RESULTS: Of the 493 women who underwent a repeat cesarean delivery without labor, "elective"(36%) and "maternal request"(18%) were the most common indications. Indications for maternal medical conditions (3.0%) were uncommon. Among the 138 women with repeat cesarean delivery with labor, 60.1 percent had failure to progress, 24.6 percent a non-reassuring fetal heart rate, 8.0 percent cephalopelvic disproportion, and 7.2 percent maternal request during labor. Fetal indications were less common (5.8%). Breech, failed vacuum, abruptio placentae, maternal complications, and failed forceps were all indicated less than 5.0 percent. Women's perioperative complications did not vary significantly between women without and with labor. Regardless of a woman's labor status, nearly 10 percent of women with repeat cesarean delivery had no documented indication as to why a cesarean delivery was performed. CONCLUSIONS: "Elective" and "maternal request" were common indications among women undergoing repeat cesarean delivery without labor, and nearly 10 percent of women had undocumented indications for repeat cesarean delivery in their medical record. Improvements in standardization of indication nomenclature and documentation of indication are especially important for understanding falling VBAC rates. Future research should examine how clinicians and women anticipate, discuss, and make decisions about childbirth after a previous cesarean delivery within the context of actual antepartum care.

Adult↗

Detection of fetal fibronectin as a predictor of preterm delivery in high risk asymptomatic pregnancies.

OBJECTIVE: The study was designed to determine whether fetal fibronectin would predict delivery before 37 weeks in women at high risk of preterm delivery. STUDY METHODS: Forty-three women considered at risk of preterm delivery were recruited antenatally into a blind longitudinal study. Quantitative assays of fetal fibronectin were obtained from sequential high vaginal swabs taken fortnightly from 24 to 34 weeks of gestation. Fibronectin concentrations of 0.05 microgram/ml or more were considered as positive. RESULTS: Results were calculated by swab and by subject. The sensitivity of an individual fibronectin swab in predicting preterm delivery within 14 days of testing was 71% and the specificity was 93%. The overall positive predictive value was 31% and the negative predictive value was 99%. The sensitivity of the fibronectin swab in predicting delivery before 37 weeks was 17% and the specificity was 93%. The positive predictive value was 50% and the negative predictive value was 73%. For a woman who has had a positive swab the sensitivity in predicting preterm delivery within 14 days of testing was 80% and the specificity was 83%; a woman was counted as positive only if the final swab was positive and preceded delivery by not more than 14 days. The positive predictive value was 36% and the negative predictive value was 97%. For a woman who has had a positive swab the sensitivity in predicting delivery before 37 weeks was 54%. The specificity, the positive predictive value and the negative predictive value were 85%, 64% and 79%, respectively. Women were counted as positive if any swab in the sampling sequence was positive. Fibronectin swabbing when calculated by patient did predict preterm delivery within 14 days of testing (P=0.01) and before 37 weeks (P=0.01). Analysis of the accuracy of predicting delivery from 7 to 28 days after sampling revealed that the best prediction for delivery was within the following 14 days. CONCLUSION: Serial fetal fibronectin assessment from 24 to 34 weeks of gestation anticipated preterm delivery within 14 days of testing and before 37 weeks for high risk asymptomatic women. Such testing should be performed every two weeks.

Adult↗

Does a second delivery increase the risk of anal incontinence?

OBJECTIVE: To evaluate the prevalence of anal incontinence and anal sphincter defects after a first vaginal delivery and assess the effect of a second delivery. DESIGN: Prospective cohort study using postal questionnaires assessing incontinence to flatus and stools at three and thirty months postnatally and anal endosonography at three months following delivery. SETTING: Recruitment was from the antenatal clinic at the University Hospitals of Geneva, Switzerland. POPULATION: One hundred women with a vaginal delivery of their first child. MAIN OUTCOME MEASURES: Prevalence of anal incontinence and anal sphincter defects. RESULTS: Anal incontinence was reported by 16/92 (17%) of women at three months after delivery and by 11/77 (14%) at 30 months. At that time, 5/54 (9%) with no further delivery reported incontinence, compared with 6/ 23 (26%) of those who had had another delivery (RR 2.8, 95% CI 1.0-8.3). Anal sphincter defects were diagnosed by endosonography in 46/87 (53%) women and were associated with reported incontinence at both three months (RR 1.9; 95% CI 1.4-2.6) and 30 months (RR 1.9: 95% CI 1.3-2.8) after delivery. The prevalence of anal incontinence at 30 months was highest (5/13, 39%) among those in whom a sphincter defect was diagnosed by endosonography after their first delivery and with a second delivery. CONCLUSION: Anal incontinence after childbirth is associated with defects of the anal sphincter diagnosed by endosonography. Subsequent deliveries increase the risk of incontinence, particularly among women with a sphincter defect diagnosed after the first delivery.

Adult↗

S-relaxin as a predictor of preterm delivery in women with symptoms of preterm labour.

OBJECTIVE: To evaluate whether serum relaxin (S-relaxin) can predict spontaneous delivery before 34 weeks of gestation in high risk pregnancies. DESIGN: A prospective cohort study. SETTING: Calculated sample size was reached over a two-year period, during which 9507 women gave birth. Of these, 157 healthy women were eligible for the study as they were admitted with symptoms of delivery before 34 weeks of gestation. Ninety-three women were included. Overall participation rate was 59%. POPULATION: Healthy women with singleton pregnancies with symptoms of delivery before 34 weeks of gestation. METHODS: S-relaxin was measured using a standard sandwich ELISA. MAIN OUTCOME MEASURES: End points were preterm delivery before 34 weeks of gestation and delivery within three days from initiation of symptoms. The best possible prediction of preterm delivery was established using logistic regression for risk factors individually associated with preterm delivery before 34 weeks of gestation. S-relaxin was dichotomised to obtain best possible fit and then entered into the model. The same analyses were done for delivery within three days. RESULTS: Median S-relaxin levels varied significantly in the women with preterm prelabour rupture of membranes (PPROM) (316 pg/mL), contractions (222 pg/mL) or ripe cervices (203 pg/mL) (P < 0.05). S-relaxin above the 80th centile (> or = 300 pg/mL) was associated with an increased risk of preterm delivery [crude OR = 4.8; (95% CI: 1.9-12)]. Likelihood ratio of a positive test is 2.6 (1.5-4.9) and S-relaxin resulted in a post-test probability of preterm delivery of 0.72, compared with a pre-test probability of 0.49. S-relaxin contributed to the identification of delivery within three days [adj. OR = 11 (95% CI: 1.8-64)]. CONCLUSION: S-relaxin may be a useful predictor in women with symptoms of delivery before 34 weeks of gestation.

Body Mass Index↗

Home delivery and newborn care practices among urban women in western Nepal: a questionnaire survey.

BACKGROUND: About 98% of newborn deaths occur in developing countries, where most newborns deaths occur at home. In Nepal, approximately, 90% of deliveries take place at home. Information about reasons for delivering at home and newborn care practices in urban areas of Nepal is lacking and such information will be useful for policy makers. METHODS: A cross-sectional survey was carried out in the immunisation clinics of Pokhara city, western Nepal during January and February, 2006. Two trained health workers administered a semi-structured questionnaire to the mothers who had delivered at home. RESULTS: A total of 240 mothers were interviewed. Planned home deliveries were 140 (58.3%) and 100 (41.7%) were unplanned. Only 6.2% of deliveries had a skilled birth attendant present and 38 (15.8%) mothers gave birth alone. Only 46 (16.2%) women had used a clean home delivery kit and only 92 (38.3%) birth attendants had washed their hands. The umbilical cord was cut after expulsion of placenta in 154 (64.2%) deliveries and cord was cut using a new/boiled blade in 217 (90.4%) deliveries. Mustard oil was applied to the umbilical cord in 53 (22.1%) deliveries. Birth place was heated throughout the delivery in 88 (64.2%) deliveries. Only 100 (45.8%) newborns were wrapped within 10 minutes and 233 (97.1%) were wrapped within 30 minutes. Majority (93.8%) of the newborns were given a bath soon after birth. Mustard oil massage of the newborns was a common practice (144, 60%). Sixteen (10.8%) mothers did not feed colostrum to their babies. Prelacteal feeds were given to 37(15.2%) newborns. Initiation rates of breast-feeding were 57.9% within one hour and 85.4% within 24 hours. Main reasons cited for delivering at home were 'preference' (25.7%), 'ease and convenience' (21.4%) for planned deliveries while 'precipitate labor' (51%), 'lack of transportation' (18%) and 'lack of escort' during labor (11%) were cited for the unplanned ones. CONCLUSION: High-risk home delivery and newborn care practices are common in urban population also. In-depth qualitative studies are needed to explore the reasons for delivering at home. Community-based interventions are required to improve the number of families engaging a skilled attendant and hygiene during delivery. The high-risk traditional newborn care practices like delayed wrapping, bathing, mustard oil massage, prelacteal feeding and discarding colostrum need to be addressed by culturally acceptable community-based health education programmes.

Journal Article↗

A quantitative study of IMRT delivery effects in commercial planning systems for the case of oesophagus and prostate tumours.

This study focuses on understanding the impact of intensity-modulated radiotherapy (IMRT) delivery effects when applied to plans generated by commercial treatment-planning systems such as Pinnacle (ADAC Laboratories Inc.) and CadPlan/Helios (Varian Medical Systems). These commercial planning systems have had several version upgrades (with improvements in the optimization algorithm), but the IMRT delivery effects have not been incorporated into the optimization process. IMRT delivery effects include head-scatter fluence from IMRT fields, transmission through leaves and the effect of the rounded shape of the leaf ends. They are usually accounted for after optimization when leaf sequencing the "optimal" fluence profiles, to derive the delivered fluence profile. The study was divided into two main parts: (a) analysing the dose distribution within the planning-target volume (PTV), produced by each of the commercial treatment-planning systems, after the delivered fluence had been renormalized to deliver the correct dose to the PTV; and (b) studying the impact of the IMRT delivery technique on the surrounding critical organs such as the spinal cord, lungs, rectum, bladder etc. The study was performed for tumours of (i) the oesophagus and (ii) the prostate and pelvic nodes. An oesophagus case was planned with the Pinnacle planning system for IMRT delivery, via multiple-static fields (MSF) and compensators, using the Elekta SL25 with a multileaf collimator (MLC) component. A prostate and pelvic nodes IMRT plan was performed with the Cadplan/Helios system for a dynamic delivery (DMLC) using the Varian 120-leaf Millennium MLC. In these commercial planning systems, since IMRT delivery effects are not included into the optimization process, fluence renormalization is required such that the median delivered PTV dose equals the initial prescribed PTV dose. In preparing the optimum fluence profile for delivery, the PTV dose has been "smeared" by the IMRT delivery techniques. In the case of the oesophagus, the critical organ, spinal cord, received a greater dose than initially planned, due to the delivery effects. The increase in the spinal cord dose is of the order of 2-3 Gy. In the case of the prostate and pelvic nodes, the IMRT delivery effects led to an increase of approximately 2 Gy in the dose delivered to the secondary PTV, the pelvic nodes. In addition to this, the small bowel, rectum and bladder received an increased dose of the order of 2-3 Gy to 50% of their total volume. IMRT delivery techniques strongly influence the delivered dose distributions for the oesophagus and prostate/pelvic nodes tumour sites and these effects are not yet accounted for in the Pinnacle and the CadPlan/Helios planning systems. Currently, they must be taken into account during the optimization stage by altering the dose limits accepted during optimization so that the final (sequenced) dose is within the constraints.

Algorithms↗

From concept to application: the impact of a community-wide intervention to improve the delivery of preventive services to children.

OBJECTIVE: To improve health outcomes of children, the US Maternal and Child Health Bureau has recommended more effective organization of preventive services within primary care practices and more coordination between practices and community-based agencies. However, applying these recommendations in communities is challenging because they require both more complex systems of care delivery within organizations and more complex interactions between them. To improve the way that preventive health care services are organized and delivered in 1 community, we designed, implemented, and assessed the impact of a health care system-level approach, which involved addressing multiple care delivery processes, at multiple levels in the community, the practice, and the family. Our objective was to improve the processes of preventive services delivery to all children in a defined geographic community, with particular attention to health outcomes for low-income mothers and infants. DESIGN: Observational intervention study in 1 North Carolina county (population 182 000) involving low- income pregnant mothers and their infants, primary care practices, and departments of health and mental health. An interrupted time-series design was used to assess rates of preventive services in office practices before and after the intervention, and a historical cohort design was used to compare maternal and child health outcomes for women enrolled in an intensive home visiting program with women who sought prenatal care during the 9 months before the program's initiation. Outcomes were assessed when the infants reached 12 months of age. INTERVENTIONS: Our primary objective was to achieve changes in the process of care delivery at the level of the clinical interaction between care providers and patients that would lead to improved health and developmental outcomes for families. We selected interventions that were directed toward major risk factors (eg, poverty, ineffective care systems for preventive care in office practices) and for which there was existing evidence of efficacy. The interventions involved community-, practice-, and family-level strategies to improve processes of care delivery to families and children. The objectives of the community-level intervention were: 1) to achieve policy level changes that would result in changes in resources available at the level of clinical care, 2) to engage multiple practice organizations in the intervention to achieve an effect on most, if not all, families in the community, and 3) to enhance communication between, among, and within public and private practice organizations to improve coordination and avoid duplication of services. The objective of the practice-level interventions was to overcome specific barriers in the process of care delivery so that preventive services could be effectively delivered. To assist the health department in implementing the family-level intervention, we provided assistance in hiring and training staff and ongoing consultation on staff supervision, including the use of structured protocols for care delivery, and regular feedback data about implementation of the program. Interventions with primary care practices focused on the design of the delivery system within the office and the use of teamwork and data in an "office systems" approach to improving clinical preventive care. All practices (N = 8) that enrolled at least 5 infants/month received help in assessing performance and developing systems (eg, preventive services flow sheets) for preventive services delivery. Family-level interventions addressed the process of care delivery to high-risk pregnant women (<100% poverty) and their infants. Mothers were recruited for the home visiting intervention when they first sought prenatal care at the community health center, the county's largest provider of prenatal care to underserved women. The home visiting intervention involved teams of nurses and educators and involved 2 to 4 visits per month through the infant's first year of life to provide parental education on fetal and infant health and development, enhance parents' informal support systems, and link parents with needed health and human services. We included training in injury prevention and discipline, and home visitors assisted mothers in obtaining care from one of the primary care offices. RESULTS: There were high levels of participation, changes in the organization of the delivery system, and improvements in preventive health outcomes. Agencies cooperated in joint contracting, staff training, and defining program eligibility. All 8 eligible practices agreed to participate and 7/8 implemented at least 1 new office system element. Of eligible women, 89% agreed to participate, and outcome data were available on 80% (180/225). After adjusting for differences in baseline characteristics, intervention group women were significantly more likely than comparison group women to use contraceptives (69% vs 47%), not smoke tobacco (27% vs 54%) and have a safe and stimulating home environment for their children. Intervention group children were more likely to have had an appropriate number of well-child care visits (57% vs 37%) and less likely to be injured (2% vs 7%). Intervention mothers also received Aid to Families with Dependent Children for fewer months after the birth of their child (7.7 months vs 11.3 months). CONCLUSIONS: We observed a number of positive effects at all 3 levels of intervention. Policy-level changes at the state and community led to lasting changes in the organization and financing of care, which enabled changes in clinical services to take place. These changes have now been expanded beyond this community to other communities in the state. We were also able to engage multiple practice organizations, reduce duplication, and improve the coordination of care. Changes in the process of preventive services delivery were noted in participating practices. Finally, the outcomes of the family-level intervention were comparable in direction and magnitude to the outcomes of previous randomized trials of the intervention. All the changes were achieved over a relatively brief 3-year study period, and many have been sustained since the project was completed. Tiered, interrelated interventions directed at an entire population of mothers and children hold promise to improve the effectiveness and outcomes of health care for families and children.

Adult↗

Special problems in aerosol delivery: neonatal and pediatric considerations.

Identification of the determinants of efficient aerosol delivery and the specific challenges of aerosol delivery to infants and children can facilitate a systematic approach to optimize aerosol delivery to this population. There are inherent anatomical, physiologic, pathophysiologic, and technical limitations of aerosol efficiency in infants and young children. Nevertheless, one can enhance aerosol efficiency through application of sound principles of aerosol delivery and by exerting control over factors that are amenable to intervention. Improvements in aerosol formulations and delivery systems are being made that will enhance efficiency, decrease risk, and reduce waste and cost. Attention to aerosol particle size (1-3 microm mass median aerodynamic diameter and geometric standard deviation < 2 microm), and the concentration of this respirable particle fraction produced by an aerosol system may enhance delivery through endotracheal tubes and to the lower respiratory tract in infants and children with low V(T) and low inspiratory rates. Attention to the choice of delivery system and to details of proper MDI technique (shaking, priming, immediate actuation, and avoiding multiple actuations prior to inhalation), choice of the aerosol spacer and patient interface (type of face mask, endotracheal tube, mouthpiece), spacer cleaning, and consideration of the medicine to be aerosolized (solution or suspension, viscosity) permit adjustment of the aerosol regimen to optimize delivery. All the patient-related, system-related, and operator-dependent considerations combined can greatly impact aerosol delivery efficacy and improve therapeutic response. Therefore, education and motivation of medical personnel, parents and caregivers, and patients regarding factors that influence aerosol efficiency and teaching of proper technique must be prioritized in order to improve aerosol delivery. Aerosol therapy to all patients, especially infants and young children, would be well served if we had a clear understanding of the efficiency and functional differences among the various drugs and devices. These are substantive issues with daily therapeutic impact that have received increasingly outspoken concern over the past decade by aerosol scientists and clinicians. These issues must be given due attention by drug and device manufacturers as well as by regulatory agencies. The medication, the device, and the conditions under which they are tested must be considered together and studied as thoroughly as the medications themselves with respect to total output and particle size distribution. As noted by Bisgaard, medication dose recommendations are useless unless the device and technique used are specified. Medication dose recommendation could be facilitated by setting equivalent standards for generic and brand-name medications and devices. In addition, standardization of in vitro models with better replicas of infants' and children's anatomy (oropharynx, upper airways), and better in vitro lung models, plus utilization of realistic breathing patterns of infants and children will improve in vitro prediction of the in vivo dose delivered to lower airways. This would greatly facilitate selection of delivery systems under specific circumstances for infants and children of various ages). Safety profile, therapeutic efficacy, and efficiency of aerosolized medications delivered to infants and children need to be rigorously studied. This is particularly true for medications with potentially great benefit but possible adverse effects, such as inhaled glucocorticoid therapy in extremely premature infants. Common sense, ethics, and due respect for the same high standard of approval requirements of adults and older children should motivate further research in understanding and improving aerosol delivery in infants and young children.

Aerosols↗

Development of a model for sustainable delivery of outreach allied health services to remote north-west Queensland, Australia.

INTRODUCTION: Development of sustainable multidisciplinary services in north-west Queensland, Australia, is challenged by large distances, culturally diverse communities, a prolonged wet season, a history of poor retention of allied health professionals (AHPs), and high prevalence of chronic disease. In 2001, the Northern Queensland Rural Division of General Practice drew on wide community consultation and recent research into the recruitment and retention of AHPs to develop a Model for delivery of outreach allied health services operating within a primary healthcare framework. AIM: to develop a Model of allied health service delivery using the principles of primary healthcare, to meet the needs of 11 culturally diverse (indigenous, non-indigenous and mixed) remote communities, in an area of over 373 000 km2. METHODS: The development of the outreach Model of allied-health service delivery occurred over four stages: (1) Formulation of a planning matrix as the outcome of a workshop to identify the core components; (2) Environmental scan including mapping of existing allied health services and identification of gaps in service delivery; community consultation to assist in the gap analysis of service delivery, identification health priorities at a local level, and provision of context as to how services should be provided; analysis of available morbidity, mortality data and screening data; (3) Desktop analysis of previous research into the recruitment and retention of allied health professionals, and determination of a 'reasonable' level of service delivery in rural and remote areas; and (4) Synthesis of information to develop options or a Model of service delivery. RESULTS: The environmental scan indicated the need for a raft of AHPs to address chronic disease and injury in the target communities, including the disciplines of physiotherapy, podiatry, dietetics, occupational therapy, speech pathology and psychology. The Model of service delivery sought to provide services in a form appropriate to communities (ie regular and reliable), with duration of visit providing opportunities for case conferencing and inservice education with resident health professionals and workers. A range of strategies were developed to support the recruitment and retention of allied health professionals, including working and travelling in functional teams; orientation to remote practice; schedules that recognize the need for time back at base, and utilisation of aircraft to minimise travel time; employment packages recognizing isolated and remote practice, professional development, postgraduate study, professional and clinical mentoring; financial subsidies for housing and childcare. A hub-and-spoke model of service delivery was developed with functional teams visiting each community on a 6-weekly rotation for 2-3 days/community per rotation, dependent on population. The duration of visit would promote opportunities for community development, training therapy assistants to promote continuity of care, and health promotion activities within the primary healthcare framework under which the service would operate. Integration and coordination with existing resident health and community services, and visiting services, was considered through the development of a 6 month calendar of service delivery, and Memoranda of Understanding with state health services to allow access to clinics and client records. CONCLUSION: The planning matrix informed and underpinned the final form of the outreach Model of service delivery. The process described enabled the development of a Model for delivering allied health services in a remote rural area that considered the burden of disease, context for service delivery addressing community concerns with visiting services, recruitment and retention of health professionals and integration with resident and visiting health and community services. The strategies employed provide a template for allied health service development in rural and remote areas internationally.

Journal Article↗

Evaluation of an extension set for intermittent intravenous drug delivery to infants.

An intravenous administration set designed for delivery of drug doses to pediatric patients was tested in vitro for the effect of fluid density and flow rate on drug delivery, and delivery of drug by this extension set was compared in vivo with delivery by other methods. Gentamicin (as the sulfate salt) and penicillin G potassium were used to represent low-density and high-density drugs, respectively; a 1-mL solution of each drug, labeled with carbon 14, was tested with each of two primary infusion solutions: 0.45% sodium chloride injection and 10% dextrose injection. The drug dose was injected via a port into a piston-containing chamber from which an equivalent amount of the primary fluid was displaced. Serial samples collected from the end of the filter-containing extension set were analyzed for drug concentration using a liquid scintillation technique. In 12 infants receiving i.v. gentamicin, this delivery method was compared in a randomized crossover trial with delivery by a syringe pump and by i.v. push. Each delivery system was used on one of three consecutive days, and serum gentamicin concentrations were measured by enzyme-multiplied immunoassay. The time required for in vitro delivery of the dose was dependent on flow rate. Density of the drug solution or the primary i.v. fluid did not significantly affect drug delivery. Serum gentamicin concentrations were not significantly different for the three delivery methods, but variability of drug delivery was greatest with the pediatric extension set. This pediatric extension set provides accurate and reliable drug delivery at primary infusion flow rates slower than 10 mL/hr when the drug dosage volume is 2-3 mL or less.

Evaluation Studies as Topic↗

Identification of the critical oxygen delivery for anaerobic metabolism in critically ill septic and nonseptic humans.

OBJECTIVES: To determine the critical oxygen delivery threshold for anaerobic metabolism and to compare its value between septic and nonseptic critically ill patients. DESIGN: Cohort analytic study, consecutive sample. SETTING: Two tertiary care medical and surgical intensive care units in university hospitals. PATIENTS: Nine septic and nine nonseptic critically ill humans. A diagnosis of sepsis was established by the presence of sepsis syndrome, positive cultures obtained within 48 hours of study, and autopsy evidence of a source of infection. METHODS AND INTERVENTIONS: The O2 consumption (determined by indirect calorimetry), O2 delivery (calculated from the Fick equation), and concentration of arterial plasma lactate were simultaneously determined at 5- to 20-minute intervals while life support was discontinued. MAIN OUTCOME MEASURES: Critical O2 delivery, critical O2 extraction ratio, and maximal O2 extraction ratio. RESULTS: In all septic and eight nonseptic patients, O2 delivery and O2 consumption displayed a biphasic relationship over the range of O2 delivery studied. There were no differences in critical O2 delivery threshold (3.8 +/- 1.5 vs 4.5 +/- 1.3 mL.min-1 x kg-1; P > .28), critical O2 extraction ratio (0.61 +/- 0.05 vs 0.59 +/- 0.16; P > .64), and maximal O2 extraction ratio (0.74 +/- 0.08 vs 0.80 +/- 0.11; P > .29) between septic and nonseptic patients. These data have greater than 90% power to detect a difference of 2 mL.min-1 x kg-1 in the critical O2 delivery and 0.1 in the critical and maximal O2 extraction ratios between the septic and nonseptic groups. CONCLUSIONS: The critical O2 delivery for anaerobic metabolism was identified from the biphasic relationship between O2 delivery and O2 consumption in individual humans. The critical O2 delivery is considerably lower than previously reported in humans with the use of pooled group data. Sepsis does not alter the critical O2 delivery for anaerobic metabolism or tissue O2 extraction ability. Interventions to increase O2 delivery to supranormal levels in critically ill humans in the hope of increasing O2 consumption may be inappropriate.

Adult↗