We describe the rationale and protocol for a randomized noninferiority controlled trial (RCT) to determine if the Flexi-T380(+) copper intrauterine contraceptive device (IUD) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use, NovaT-200, when placed immediately after a first-trimester abortion.
Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380(+) IUD, a device for which no current evidence on expulsion or effectiveness rates is available, or the Nova-T200 IUD, the only other brand of copper IUD available in Canada at the time of study initiation. The primary outcome measure is IUD expulsion rate at 1 year. Secondary outcomes include: pregnancy rate, method continuation rate, complication rates (infection, perforation), and satisfaction with contraceptive method. A non-intervention group of consenting women choosing a range of other post-abortion contraception methods, including no contraception, will be included for comparison of secondary outcomes. Web-based contraception satisfaction questionnaires, clinical records, and government-linked health administrative databases will be used to assess primary and secondary outcomes.
The RCT design, combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry, and hospital records, offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada, in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options. We highlight considerations of design, implementation, and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion.
ClinicalTrials.gov Identifier NCT01174225
Contraception; Intrauterine device; Intrauterine device expulsion; Contraception effectiveness; Abortion-induced; Therapeutic abortion; Non-inferiority trial; Randomized controlled trial; Canada
Identifying adverse events and near misses is essential to improving safety in the health care system. Patients are capable of reliably identifying and reporting adverse events. The effect of a patient safety reporting system used by families of pediatric inpatients on reporting of adverse events by health care providers has not previously been investigated.
Between Nov. 1, 2008, and Nov. 30, 2009, families of children discharged from a single ward of British Columbia’s Children’s Hospital were asked to respond to a questionnaire about adverse events and near misses during the hospital stay. Rates of reporting by health care providers for this period were compared with rates for the previous year. Family reports for specific incidents were matched with reports by health care providers to determine overlap.
A total of 544 familes responded to the questionnaire. The estimated absolute increase in reports by health care providers per 100 admissions was 0.5% (95% confidence interval −1.8% to 2.7%). A total of 321 events were identified in 201 of the 544 family reports. Of these, 153 (48%) were determined to represent legitimate patient safety concerns. Only 8 (2.5%) of the adverse events reported by families were also reported by health care providers.
The introduction of a family-based system for reporting adverse events involving pediatric inpatients, administered at the time of discharge, did not change rates of reporting of adverse events and near misses by health care providers. Most reports submitted by families were not duplicated in the reporting system for health care providers, which suggests that families and staff members view safety-related events differently. However, almost half of the family reports represented legitimate patient safety concerns. Families appeared capable of providing valuable information for improving the safety of pediatric inpatients.
The objective was to conduct a program evaluation of the Centre for Healthy Weights—Shapedown BC (CHW-SB), a family-centered, multidisciplinary program for obese children, by assessing the change in weight trajectories from program intake to completion. Secondary outcomes included changes in clinical, biochemical and psychological parameters, and in physical activity (PA) levels. The CHW-SB program was evaluated over 10 weeks. Data collection included anthropometric, metabolic, PA and psychological measures. Longitudinal mixed effects regression was performed to evaluate weight change from Phase 1 (before program on waitlist) to Phase 2 (during program). 238 children <18 years of age were referred to the program of which 119 were eligible for participation. There was a significant decrease in weight trajectory in children following program entry. Participants experienced an average .89% monthly increase before program entry, compared to a .37% monthly decline afterwards, a drop of 1.26% (p < 0.0001, 95%CI 1.08 to 1.44). zBMI (2.26 ± 0.33 to 2.20 ± 0.36, p < 0.001), waist circumference (99 ± 15.7 to 97 ± 16 cm, p < 0.0001) and fasting insulin (137 ± 94.8 to 121 ± 83.4 pmol/L, p < 0.001) also decreased in participants who attended the final visit. Significant improvements were seen in all measures of PA, self-concept, and anxiety. CHW-SB, a government-funded program, is the first obesity-treatment program to be evaluated in Canada. While short-term evaluation revealed significant improvements in adiposity, PA, and psychological measures, the lack of full follow-up is a limitation in interpreting the clinical effectiveness of this program, as drop-out may be associated with lack of success in meeting program goals. These data also emphasize the need for ongoing evaluation to assess the long-term implications of this unique program and ultimately optimize utilization of governmental resources.
obesity; weight loss; BMI reduction; children; prevention; treatment; intervention
To assess if birth at less than 26 weeks gestation is an important predictor of brain microstructure maturation as determined by using diffusion tensor imaging.
We performed serial MRI and diffusion tensor imaging in 176 infants born at < 33 weeks gestation. Diffusion parameters were calculated for white and gray matter regions. Linear regression for repeated measures was used to assess the effect of extremely premature birth on brain maturation.
In white matter, fractional anisotropy increased by 0.008 per week (95% CI 0.007-0.009, p=<0.0001) and mean diffusivity decreased by 0.021 mm2/sec per week, (95% CI -0.24 to -0.018, p=<0.0001). Birth at < 26 weeks was associated with lower white matter fractional anisotropy (-0.01, 95% CI -0.018 to -0.003, p=0.008) but this effect was eliminated when co-morbid conditions were added to the model. Moderate-severe brain injury was associated with decreased mean white matter fractional anisotropy (-0.012, 95% CI -0.02 to -0.004, p=0.002).
Brain microstructure maturation as measured serially in premature infants is independent of extremely premature birth. Brain injury and co-morbid conditions may be the important determinants of microstructure maturation.
Infant, premature; Magnetic resonance imaging; Diffusion tensor imaging
To identify factors that mediate or moderate the effects of exercise on postmenopausal sex hormone concentrations.
Postmenopausal women were randomized to 12 months of aerobic exercise for 200 min/week (n = 160) or to a control group (n = 160). Intention-to-treat analyses were performed using general linear models with sex hormone concentrations at 6 and 12 months as the outcome. Mediation by adiposity and insulin was investigated by examining changes in effect estimates after adjustment for changes in these factors over 12 months. Moderation was studied as the interaction between group assignment and eight baseline characteristics.
Intervention effects on sex hormone–binding globulin (SHBG) and estradiol changes were attenuated with adjustment for change in overall body fat, while there was less attenuation adjusting for intra-abdominal fat change. Intervention effects on SHBG levels were unaffected by adjustment for insulin change. Significant interactions were identified between treatment and physical fitness (for SHBG and testosterone) and age (for testosterone), implying subgroup differences in intervention effect.
Our data suggest that overall fat loss partially mediated exercise-induced changes in estradiol and SHBG concentrations. No previous RCT in postmenopausal women has studied moderators of exercise-induced sex hormone changes; therefore, future studies are needed to corroborate our results.
Exercise; Gonadal steroid hormones; Sex hormone–binding globulin; Randomized controlled trial; Breast neoplasms
We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.
Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014.
The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.
Current Controlled Trials ISRCTN19506752
Physical activity is a known modifiable lifestyle means for reducing postmenopausal breast cancer risk, but the biologic mechanisms are not well understood. Metabolic factors may be involved. In this study, we aimed to determine the effects of exercise on insulin resistance (IR) indicators, IGF1, and adipokines in postmenopausal women. The Alberta Physical Activity and Breast Cancer Prevention Trial was a two-armed randomized controlled trial in postmenopausal, inactive, cancer-free women. A year-long aerobic exercise intervention of 225 min/week (n=160) was compared with a control group asked to maintain usual activity levels (n=160). Baseline, 6- and 12-month serum levels of insulin, glucose, IGF1, IGF-binding protein 3 (IGFBP3), adiponectin, and leptin were assayed, and after data collection, homeostasis model assessment of IR (HOMA-IR) scores were calculated. Intention-to-treat analyses were performed using linear mixed models. The treatment effect ratio (TER) of exercisers to controls was calculated. Data were available on 308 (96.3%) women at 6 months and 310 (96.9%) women at 12 months. Across the study period, statistically significant reductions in insulin (TER=0.87, 95% confidence interval (95% CI)=0.81–0.93), HOMA-IR (TER=0.86, 95% CI=0.80–0.93), and leptin (TER=0.82, 95% CI=0.78–0.87), and an increase in the adiponectin/leptin ratio (TER=1.21, 95% CI=1.13–1.28) were observed in the exercise group compared with the control group. No significant differences were observed for glucose, IGF1, IGFBP3, adiponectin or the IGF1/IGFBP3 ratio. Previously inactive postmenopausal women who engaged in a moderate-to-vigorous intensity exercise program experienced changes in insulin, HOMA-IR, leptin, and adiponectin/leptin that might decrease the risk for postmenopausal breast cancer.
The Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial examined the influence of aerobic exercise on biologic factors that are associated with breast cancer risk. Mammographic density, a secondary outcome, is reported here.
The ALPHA Trial was a parallel group randomized controlled trial conducted between May 2003 and July 2007. Postmenopausal, sedentary women aged 50 to 74 years (n = 320) were evenly randomized to aerobic exercise (45 minutes, 5 days per week) or control (usual lifestyle) for one year. Dense fibroglandular tissue and nondense fatty tissue were measured from mammograms at baseline and one year using computer-assisted thresholding software for area measurements and a new technique that relies on the calibration of mammography units with a tissue-equivalent phantom for volumetric measurements.
Nondense volume decreased in the exercise group relative to the control group (difference between groups = −38.5 cm3; 95% confidence interval = −61.6 to 15.4; P = 0.001). Changes in total body fat accounted for this decrease. Changes in dense area and dense volume, measures that have previously been associated with breast cancer risk, were not significantly different between the groups (P ≥ 0.36).
To achieve changes in mammographic measures may require more exercise or a study population with higher baseline levels of sex hormones or a wider range of mammographic density. The data from this study, however, suggest that the protective effect of exercise on breast cancer risk may operate through a mechanism other than mammographic density.
Physical activity; mammographic density; breast cancer; postmenopausal women; randomized controlled trial
To examine FPs’ attitudes toward birth for those providing intrapartum care (IPC) and those providing only antepartum care (APC).
National, cross-sectional Web- and paper-based survey.
A total of 897 Canadian FPs: 503 providing both IPC and APC (FPIs), 252 providing only APC but who previously provided IPC (FPPs), and 142 providing only APC who never provided IPC (FPNs).
Main outcome measures
Respondents’ views (measured on a 5-point Likert scale) on routine electronic fetal monitoring, epidural analgesia, routine episiotomy, doulas, pelvic floor benefits of cesarean section, approaches to reducing cesarean section rates, maternal choice and the mother’s role in her own child’s birth, care providers’ fears of vaginal birth for themselves or their partners, and safety by mode or place of birth.
Results showed that FPIs and FPPs were more likely than FPNs were to take additional training or advanced life support courses. The FPIs consistently demonstrated more positive attitudes toward vaginal birth than did the other 2 groups. The FPPs and FPNs showed significantly more agreement with use of routine electronic fetal monitoring and routine epidural analgesia (P < .001). The FPIs displayed significantly more acceptance of doulas (P < .001) and more disagreement with the pelvic floor benefits of cesarean section than other FPs did (P < .001). The FPIs were significantly less fearful of vaginal birth for themselves or their partners than were FPPs and FPNs (P < .001). All FP groups agreed on rejection of elective cesarean section, in the absence of indications, for themselves or their partners and on support for vaginal birth in the presence of uterine scar. While all FP groups supported licensed midwifery, three-quarters thought home birth was more dangerous than hospital birth and showed ambivalence toward birth plans. Only 7.8% of FPIs would choose obstetricians for their own or their partners’ maternity care.
The FPIs had a more positive, evidence-based view of birth. It is likely that FPs providing only APC are influencing women in their practices toward a relatively negative view of birth before referral to obstetricians, FPIs, or midwives for the actual birth. The relatively negative views of birth held by FPs providing only APC need to be addressed in family practice education and in continuing education.
We examined how an aerobic exercise intervention influenced circulating estradiol, estrone, sex hormone–binding globulin (SHBG), androstenedione, and testosterone levels, which may be involved in the association between physical activity and breast cancer risk.
A two-center, two-arm randomized controlled trial of exercise was conducted in 320 postmenopausal, sedentary women age 50 to 74 years. Participants were randomly assigned to a 1-year aerobic exercise intervention of 225 min/wk (n = 160) or to a control group who maintained their usual level of activity (n = 160). Baseline, 6-month, and 12-month assessments of estrone, estradiol, androstenedione, and testosterone were quantified by radioimmunoassay after extraction, and SHBG was quantified by an immunometric assay. Intent-to-treat analyses were performed using linear mixed models.
Blood data were available on 309 women (96.6%) at 12 months. Women in the intervention group exercised an average of 3.6 d/wk for 178 min/wk. At 12 months, statistically significant reductions in estradiol (treatment effect ratio [TER] = 0.93; 95% CI, 0.88 to 0.98) and free estradiol (TER = 0.91; 95% CI, 0.87 to 0.96) and increases in SHBG (TER = 1.04; 95% CI, 1.02 to 1.07) were observed in the exercise group compared with the control group. No significant differences in estrone, androstenedione, and testosterone levels were observed between exercisers and controls at 12 months.
This trial found that previously sedentary postmenopausal women can adhere to a moderate- to vigorous-intensity exercise program that results in changes in estradiol and SHBG concentrations that are consistent with a lower risk for postmenopausal breast cancer.
Children with progressive metabolic, neurological, or chromosomal conditions and their families anticipate an unknown lifespan, endure unstable and often painful symptoms, and cope with erratic emotional and spiritual crises as the condition progresses along an uncertain trajectory towards death. Much is known about the genetics and pathophysiology of these diseases, but very little has been documented about the trajectory of symptoms for children with these conditions or the associated experience of their families. A longitudinal study design will help to close this gap in knowledge.
Charting the Territory is a longitudinal descriptive, correlational study currently underway with children 0-19 years who are diagnosed with progressive neurological, metabolic, or chromosomal conditions and their families. The purpose of the study is to determine and document the clinical progression of the condition and the associated bio-psychosocial-spiritual experiences of the parents and siblings age 7-18 years. Approximately 300 families, both newly diagnosed children and those with established conditions, are being recruited in six Canadian cities. Children and their families are being followed for a minimum of 18 months, depending on when they enroll in the study. Family data collection will continue after the child's death if the child dies during the study period. Data collection includes monthly parental assessment of the child's symptoms; an annual functional assessment of the child; and completion of established instruments every 6 months by parents to assess family functioning, marital satisfaction, health status, anxiety, depression, stress, burden, grief, spirituality, and growth, and by siblings to assess coping and health. Impact of participation on parents is assessed after 1 year and at the end of the study. Chart reviews are conducted at enrollment and at the conclusion of the study or at the time of the child's death.
Knowledge developed from this study will provide some of the first-ever detailed descriptions of the clinical symptom trajectory of these non-curable progressive conditions and the bio-psychosocial-spiritual aspects for families, from diagnosis through bereavement. Information about developing and implementing this study may be useful to other researchers who are interested in designing a longitudinal study.
Plasma levels of the inflammatory biomarker C-reactive protein (CRP) predict cardiovascular risk and may represent a target for treating and/or monitoring risk-reduction strategies. The effect of angiotensin-converting enzyme inhibitors on CRP levels has not been adequately studied.
A total of 264 men and women, with CRP levels of 2 mg/L or greater and no history of cardiovascular disease, were enrolled in a 12-week randomized, double-blind, placebo-controlled study. Participants were randomly assigned to receive 10 mg/day of ramipril (n=132) or placebo (n=132) for 12 weeks. The main outcome measure was the change in CRP levels from baseline to 12 weeks in the ramipril- versus placebo-treated patients.
The mean (± SD) age was 53±9 years (60% men). Baseline demographics were similar between the volunteers allocated to receive either placebo or ramipril. The geometric mean CRP at baseline was 3.84 mg/L (95% CI 3.62 mg/L to 4.06 mg/L). The percentage change in geometric mean CRP values over 12 weeks was −13.2% (95% CI −22.3% to −3.2%) in the placebo group compared with −21.1% (95% CI −29.9% to −11.2%) in the ramipril group (P nonsignificant), indicating no significant reduction in the primary end point of the trial.
A 12-week ramipril treatment protocol for healthy middle-aged volunteers did not lower CRP levels compared with placebo. However, because of the inherent variability of CRP levels, a much larger study is required to exclude a small treatment effect.
ACE inhibitors; CRP; Risk factors
Approximately one-quarter of all Canadian children will seek emergency care in any given year, with the two most common medical problems affecting children in the emergency department (ED) being acute respiratory illness and injury. Treatment for some medical conditions in the ED remains controversial due to a lack of strong supporting evidence.
The purpose of this paper is to describe a multi-centre team grant in pediatric emergency medicine (PEM) that has been recently funded by the Canadian Institutes of Health Research (CIHR). This program of research integrates clinical research (in the areas of acute respiratory illness and injury) and knowledge translation (KT). This initiative includes seven distinct projects that address the objective to generate new evidence for clinical care and KT in the pediatric ED. Five of the seven research projects in this team grant make significant contributions to knowledge development in KT science, and these contributions are the focus of this paper.
The research designs employed in this program include: cross-sectional surveys, randomized controlled trials (RCTs), quasi-experimental designs with interrupted time-series analysis and staggered implementation strategies, and qualitative designs.
This team grant provides unique opportunities for making important KT methodological developments, with a particular focus on developing a better theoretical understanding of the causal mechanisms and effect modifiers of different KT interventions.
To estimate the minimal clinically important difference (MCID) of seven measures of fatigue in rheumatoid arthritis.
Study Design and Setting
A cross-sectional study design based on inter-individual comparisons was used. Six to eight subjects participated in a single meeting and completed seven fatigue questionnaires (nine sessions were organized and 61 subjects participated). After completion of the questionnaires, the subjects had five one-on-one 10-minute conversations with different people in the group to discuss their fatigue. After each conversation, each patient compared their fatigue to their conversational partner’s on a global rating. Ratings were compared to the scores of the fatigue measures to estimate the MCID. Both non-parametric and linear regression analyses were used.
Non-parametric estimates for the MCID relative to “little more fatigue” tended to be smaller than those for “little less fatigue”. The global MCIDs estimated by linear regression were: FSS 20.2, VT 14.8, MAF 18.7, MFI 16.6, FACIT–F 15.9, CFS 9.9, RS 19.7, for normalized scores (0 to 100). The standardized MCIDs for the seven measures were roughly similar (0.67 to 0.76).
These estimates of MCID will help to interpret changes observed in a fatigue score and will be critical in estimating sample size requirements.
minimal clinically important difference; sample size requirement; fatigue; rheumatoid arthritis; health status; interpretation
Shaken baby syndrome often occurs after shaking in response to crying bouts. We questioned whether the use of the educational materials from the Period of PURPLE Crying program would change maternal knowledge and behaviour related to shaking.
We performed a randomized controlled trial in which 1279 mothers received materials from the Period of PURPLE Crying program or control materials during a home visit by a nurse by 2 weeks after the birth of their child. At 5 weeks, the mothers completed a diary to record their behaviour and their infants' behaviour. Two months after giving birth, the mothers completed a telephone survey to assess their knowledge and behaviour.
The mean score (range 0–100 points) for knowledge about infant crying was greater among mothers who received the PURPLE materials (63.8 points) than among mothers who received the control materials (58.4 points) (difference 5.4 points, 95% confidence interval [CI] 4.1 to 6.5 points). The mean scores were similar for both groups for shaking knowledge and reported maternal responses to crying, inconsolable crying and self-talk responses. Compared with mothers who received control materials, mothers who received the PURPLE materials reported sharing information about walking away if frustrated more often (51.5% v. 38.5%, difference 13.0%, 95% CI 6.9% to 19.2%), the dangers of shaking (49.3% v. 36.4%, difference 12.9%, 95% CI 6.8% to 19.0%), and infant crying (67.6% v. 60.0%, difference 7.6%, 95% CI 1.7% to 13.5%). Walking away during inconsolable crying was significantly higher among mothers who received the PURPLE materials than among those who received control materials (0.067 v. 0.039 events per day, rate ratio 1.7, 95% CI 1.1 to 2.6).
The receipt of the Period of PURPLE Crying materials led to higher maternal scores for knowledge about infant crying and for some behaviours considered to be important for the prevention of shaking. (ClinicalTrials.gov trial register no. NCT00175422.)
Secondary prevention medications in cardiac patients improve outcomes. However, prescription rates for these drugs and long-term adherence are suboptimal.
To determine whether an enhanced secondary prevention program improves outcomes.
Hospitalized patients with indications for secondary prevention medications were randomly assigned to either usual care or an intervention arm, in which an intensive program was used to optimize prescription rates and long-term adherence. Follow-up was 19 months.
A total of 2643 patients were randomly assigned in the study; 1342 patients were assigned to usual care and 1301 patients were assigned to the intervention arm. Prescription rates were near optimal except for lipid-lowering medications. Rehospitalization rates per 100 patients were 136.2 and 132.6 over 19 months in the usual care and intervention groups, respectively (P=0.59). Total days in hospital per patient were similar (10.9 days in the usual care group versus 10.2 days in the intervention group; P not significant). Crude mortality was 6.2% and 5.5% in the usual care and intervention groups, respectively, with no significant difference (P=0.15) in overall survival. Post hoc analysis suggested that after the study team became experienced, days in hospital per patient were reduced by the program (11.1±0.91 and 8.9±0.61 in the usual care and intervention groups, respectively; P<0.05).
The intervention program failed to improve outcomes in the present study. One explanation for these results is the near optimal physician compliance with guidelines in both groups. It is also possible that a substantial learning curve for the staff was involved, as suggested by the reduction in total days in hospital in the intervention patients during the second part of the study.
Guideline adherence; Secondary prevention
To examine injury mortality rates in Native and non-Native children in the province of Alberta, Canada, over a 10-year period, temporal trends in injury mortality rates (Native vs. non-Native), as well as relative risks of injury mortality (Native vs. non-Native) by injury mechanism and intent, were calculated.
An observational, population-based study design was used. Mortality data were obtained from provincial vital statistics, with injury deaths identified using external injury codes (E-codes). The relative risk (RR) of injury mortality (Native vs. non-Native) along with 95% confidence intervals (CIs) were calculated. Stratified analyses and Poisson regression modeling were used to calculate adjusted relative risk.
Injury mortality rates declined over the study period, with no difference in the rate of decline between Native and non-Native children. The adjusted relative risk for all-cause injury death (Native vs. non-Native) was 4.6 (95% CI 4.1 to 5.2). The adjusted relative risks (Native vs. non-Native) by injury intent categories were: unintentional injuries, 4.0 (95% CI 3.5 to 4.6); suicide, 6.6 (95% CI 5.2 to 8.5); and homicide, 5.1 (95% CI 3.0 to 8.5). Injury mortality rates were consistently higher for Native children across all injury mechanism categories. The largest relative risks (Native vs. non-Native) were pedestrian injury (RR=17.0), accidental poisoning (RR=15.4), homicide by piercing objects (RR=15.4), and suicide by hanging (RR=13.5).
The burden of injury mortality is significantly greater in Native children compared with non-Native children. Therefore, injury prevention strategies that target both intentional and unintentional injuries are needed.
Postoperative complications are a significant source of morbidity and mortality. There are limited studies, however, assessing the impact of common postoperative complications on health care resource utilization.
To assess the association of clinically important postoperative complications with total hospital costs and length of stay (LOS) in patients undergoing noncardiac surgery.
We determined total hospital costs and LOS in all patients admitted to a single tertiary care center between July 1, 1996 and March 31, 1998 using a detailed administrative hospital discharge database. Total hospital costs and LOS were adjusted for preoperative and surgical characteristics.
Of 7,457 patients who underwent noncardiac surgery, 6.9% developed at least 1 of the postoperative complications. These complications increased hospital costs by 78% (95% confidence interval [CI]: 68% to 90%) and LOS by 114% (95% CI: 100% to 130%) after adjustment for patient preoperative and surgical characteristics. Postoperative pneumonia was the most common complication (3%) and was associated with a 55% increase in hospital costs (95% CI: 42% to 69%) and an 89% increase in LOS (95% CI: 70% to 109%).
Postoperative complications consume considerable health care resources. Initiatives targeting prevention of these events could significantly reduce overall costs of care and improve patient quality of care.
perioperative; surgery; cost; complications
Several studies have suggested an association between periodontal disease and prematurity but this finding has not been consistently observed.
Case control study. Cases (n = 50) were women who had delivered after spontaneous preterm labor at <35 weeks gestation. Two groups of controls (n = 101) were recruited: women who were undelivered but at a preterm gestation and women who delivered at term. A standard, clinical, periodontal examination was performed and gingival crevicular fluid was obtained from standardized locations and tested for neutrophil elastase along with the bacterial enzymes gingipain and dipeptidylpeptidase. Data were analyzed with Fisher's exact tests, ANOVA and multivariate logistic regression.
There was no difference in the proportion of sites with significant attachment loss (≥3 mm): Cases-3.2%, Controls-2.2% p = 0.21. The gingival crevicular fluid concentrations of elastase and gingipain were elevated in cases vs. controls 238.8 uU/ul vs. 159.6 uU/ul p = .007 and 2.70 uU/ul vs. 1.56 uU/ul p = .001. On multivariate analysis, the mean log concentration of elastase, but not of gingipain, remained a significant predictor of preterm labor p = .0.015.
We found no evidence that clinical periodontal disease is associated with spontaneous preterm birth. Elevated gingival crevicular fluid levels of elastase were associated with preterm birth but further research is needed before this can be assumed to be a causal relationship.
The optimal management of croup – a common respiratory illness in young children – is well established. In particular, treatment with corticosteroids has been shown to significantly reduce the rate and duration of intubation, hospitalization, and return to care for on-going croup symptoms. Furthermore treatment with a single dose of corticosteroids does not appear to result in any significant adverse outcomes, and yields overall cost-savings for both families and the health care system.
However, as has been shown with many other diseases, there is a significant gap between what we know and what we do. The overall aim of this study is to identify, from a societal perspective, the costs and associated benefits of three strategies for implementing a practice guideline that addresses the management of croup.
We propose to use a matched pair cluster trial in 24 Alberta hospitals randomized into three intervention groups. We will use mixed methods to assess outcomes including linkage and analysis of administrative databases obtained from Alberta Health and Wellness, retrospective medical chart audit, and prospective telephone surveys of the parents of children diagnosed to have croup. The intervention strategies to be compared will be mailing of printed educational materials (low intensity intervention), mailing plus a combination of interactive educational meetings, educational outreach visits, and reminders (intermediate intensity intervention), and a combination of mailing, interactive sessions, outreach visits, reminders plus identification of local opinion leaders and establishment of local consensus processes (high intensity intervention). The primary objective is to determine which of the three intervention strategies are most effective at lowering the rate of hospital days per 1,000 disease episodes. Secondary objectives are to determine which of the three dissemination strategies are most effective at increasing the use of therapies of known benefit. An economic analysis will be conducted to determine which of the three intervention strategies will most effectively reduce total societal costs including all health care costs, costs borne by the family, and costs stemming from the strategies for disseminating guidelines.
Reports of the use of psyllium, largely in hypercholesterolemic men, have suggested that it lowers serum cholesterol as a result of the binding of bile acids in the intestinal lumen. Widespread advertisements have claimed an association between the use of soluble fibre from psyllium seed husk and a reduced risk of coronary heart disease. Given the purported mechanism of cholesterol-lowering by psyllium, we hypothesized that there would be a greater effect when psyllium is taken with breakfast than when taken at bedtime. Secondarily, we expected to confirm a cholesterol-lowering effect of psyllium in subjects with "average" cholesterol levels.
Sixteen men and 47 women ranging in age from 18 to 77 years [mean 53 +/- 13] with LDL cholesterol levels that were normal or slightly elevated but acceptable for subjects at low risk of coronary artery disease were recruited from general gastroenterology and low risk lipid clinics. Following a one month dietary stabilization period, they received an average daily dose of 12.7 g of psyllium hydrophilic mucilloid, in randomized order, for 8 weeks in the morning and 8 weeks in the evening. Change from baseline was determined for serum total cholesterol, LDL, HDL and triglycerides.
Total cholesterol for the "AM first" group at baseline, 8 and 16 weeks was 5.76, 5.77 and 5.80 mmol/L and for the "PM first" group the corresponding values were 5.47, 5.61 and 5.57 mmol/L. No effect on any lipid parameter was demonstrated for the group as a whole or in any sub-group analysis.
The timing of psyllium administration had no effect on cholesterol-lowering and, in fact, no cholesterol-lowering was observed. Conclusions regarding the effectiveness of psyllium for the prevention of heart disease in the population at large may be premature.
To determine the frequency with which commonly coded clinical variables are complications, as opposed to baseline comorbidities, and to compare the results of 2 risk-adjusted outcome analyses for coronary artery bypass graft surgery for which we either (a) ignored, or (b) used the available “diagnosis-type indicator.”
Analysis of existing administrative data.
Twenty-three Canadian hospitals.
A total of 50,357 coronary artery bypass graft surgery cases.
MEASUREMENTS AND MAIN RESULTS
Among 21 clinical variables whose definitions involve the diagnosis-type indicator, 14 were predominantly (≥97%) baseline risk factors when present. Seven variables were often complication diagnoses: renal disease (when present, 13% coded as complications), recent myocardial infarction (15%), peptic ulcer disease (15%), congestive heart failure (17%), cerebrovascular disease (26%), hemiplegia (34%), and severe liver disease (35%). The results of risk adjustment analyses predicting in-hospital mortality differed when the diagnosis-type indicator was either used or ignored, and as a result, adjusted hospital mortality rates and rankings changed, often dramatically, with rankings increasing for 10 hospitals, decreasing for 9 hospitals, and remaining the same for only 4 hospitals.
The results of analyses performed using the diagnosis-type indicator in Canadian administrative data differ considerably from analyses that ignore the indicator. The widespread introduction of such an indicator should be considered in other countries, because risk-adjustment analyses performed without a diagnosis-type indicator may yield misleading results.
administrative data; risk adjustment; complications; comorbidities; coronary artery bypass graft surgery
The authors discuss a rarely diagnosed, common clinical entity, not discussed in the English medical literature. Anusitis causes anal pain and bleeding more often than hemorrhoids. Many patients with anusitis are wrongly diagnosed as having hemorrhoids, and some even have a hemorrhoidectomy with poor results. Anusitis is defined and described. A new treatment method is presented. It is important to consider anusitis as a distinct entity and to differentiate it from hemorrhoids, proctitis, and pruritus ani.