Home-based screening for biliary atresia using infant stool colour cards: a large-scale prospective cohort study and cost-effectiveness analysis.

OBJECTIVE: Biliary atresia (BA), a leading cause of paediatric liver failure and liver transplantation, manifests by three weeks of life as jaundice with acholic stools. Poor outcomes due to delayed diagnosis remain a problem worldwide. We evaluated and assessed the cost-effectiveness of methods of introducing a BA Infant Stool Colour Card (ISCC) screening programme in Canada. SETTING AND METHODS: A prospective study at BC Women's Hospital recruited consecutive healthy newborns through six incrementally more intensive screening approaches. Under the baseline "passive" strategy, families received ISCCs at maternity, with instructions to monitor infant stool colour daily and return the ISCC by mail at age 30 days. Additional strategies were: ISCC mailed to family physician; reminder letters or telephone calls to families or physicians. Random telephone surveys of ISCC non-returners assessed total card utilization. Primary outcome was ISCC utilization rate expressed as a composite outcome of the ISCC return rate and non-returned ISCC use. Markov modelling was used to predict incremental costs and life years gained from screening (passive and reminder), compared with no screening, over a 10-year time horizon. RESULTS: 6,187 families were enrolled. Card utilization rates in the passive screening strategy were estimated at 60-94%. For a Canadian population, the increase in cost for passive screening, compared with no screening, is $213,584 and the gain in life years is 9.7 ($22,000 per life-year gained). CONCLUSIONS: A BA ISCC screening programme targeting families of newborns is feasible in Canada. Passive distribution of ISCC at maternity is potentially effective and highly cost-effective.

Painful neuropathic disorders: an analysis of the Régie de l'Assurance Maladie du Québec database.

BACKGROUND/OBJECTIVE: Painful neuropathic disorders (PNDs) refer to neurological disorders involving nerves in which pain is a predominant symptom. In most cases, PNDs involve the peripheral nerves. Treatment of PNDs is likely to use large health care resources. However, little is known about the economic burden of PNDs in Canada. METHOD: The present study was performed using data from a random sample of patients covered by the Régie de l'Assurance Maladie du Quebec drug plan. Subjects with a diagnosis of a peripheral PND were identified. Comorbidities, pain-related medication use and resource utilization were compared between PND patients and control patients without PNDs matched for age and sex in a 1:1 ratio. RESULTS: A total of 4912 patients with PNDs were identified. A higher level of comorbidities was found in the PND group (Von Korff chronic disease score 3.91 versus 2.54; P<0.001). The proportion of users of pain-related medications was significantly higher in the PND cohort than in the control group (chi-squared; P<0.001). The average annual number of physician visits was also significantly higher in the PND group than in the control group (14.7 versus 6.4; P<0.001). From a health ministry perspective, costs of health care resources were significantly higher in the PND group (4,163 dollars versus 1,846 dollars; P<0.001). The proportion of potentially inappropriate medications was 34% among those 65 years of age or older. CONCLUSIONS: PNDs are associated with a higher level of comorbidities, higher medical resources utilization and higher health care costs than non-PND conditions.

Promotion of breastfeeding intervention trial (PROBIT): a cluster-randomized trial in the Republic of Belarus. Design, follow-up, and data validation.

This paper summarizes the objectives, design, follow-up, and data validation of a cluster-randomized trial of a breastfeeding promotion intervention modeled on the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI). Thirty-four hospitals and their affiliated polyclinics in the Republic of Belarus were randomized to receive BFHI training of medical, midwifery, and nursing staffs (experimental group) or to continue their routine practices (control group). All breastfeeding mother-infant dyads were considered eligible for inclusion in the study if the infant was singleton, born at > or = 37 weeks gestation, weighed > or = 2500 grams at birth, and had a 5-minute Apgar score > or = 5, and neither mother nor infant had a medical condition for which breastfeeding was contraindicated. One experimental and one control site refused to accept their randomized allocation and dropped out of the trial. A total of 17,795 mothers were recruited at the 32 remaining sites, and their infants were followed up at 1, 2, 3, 6, 9, and 12 months of age. To our knowledge, this is the largest randomized trial ever undertaken in area of human milk and lactation. Monitoring visits of all experimental and control maternity hospitals and polyclinics were undertaken prior to recruitment and twice more during recruitment and follow-up to ensure compliance with the randomized allocation. Major study outcomes include the occurrence of > or = 1 episode of gastrointestinal infection, > or = 2 respiratory infections, and the duration of breastfeeding, and are analyzed according to randomized allocation ("intention to treat"). One of the 32 remaining study sites was dropped from the trial because of apparently falsified follow-up data, as suggested by an unrealistically low incidence of infection and unrealistically long duration of breastfeeding, and as confirmed by subsequent data audit of polyclinic charts and interviews with mothers of 64 randomly-selected study infants at the site. Smaller random audits at each of the remaining sites showed extremely high concordance between the PROBIT data forms and both the polyclinic charts and maternal interviews, with no evident difference in under- or over-reporting in experimental vs control sites. Of the 17,046 infants recruited from the 31 participating study sites, 16,491 (96.7%) completed the study and only 555 (3.3%) were lost to follow-up. PROBIT's results should help inform decision-making for clinicians, hospitals, industry, and governments concerning the support, protection, and promotion of breastfeeding.

Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality Assessment.

Monitoring vaccine safety is a complex and shared responsibility. It can be carried out in many ways, one of which is the reporting of individual cases of adverse reactions thought to be due to vaccination. The task is difficult because ascribing causality to an individual case report is fraught with challenges. A standardized evaluation instrument--known as the causality assessment form--was therefore developed for use by an expert advisory committee to facilitate the process. By following the several sections in this form, the members of the committee are taken through a series of points to establish causality. These points include the basic criteria for causation such as biological plausibility, the time elapsed between the vaccine administration and the onset of the adverse event, and whether other factors (drugs, chemicals or underlying disease) could account for the adverse symptoms. The form concludes with a consensus assessment of causality, a commentary about the assessment, and advice for further study or follow-up. This method of assessing the more serious cases of adverse reaction reported to vaccination has proven useful in evaluating ongoing safety of vaccines in Canada. Through analyses such as this, new signals can be identified and investigated further.

Coordination of primary health care for back pain. A randomized controlled trial.

STUDY DESIGN: A randomized controlled trial comparing usual care with a program for the coordination of primary health care (CORE) for the treatment of subacute low-back pain patients. OBJECTIVES: To measure the effectiveness of the CORE program as a mean for implementing clinical practice guidelines for low-back pain in an urban community. SUMMARY OF BACKGROUND DATA: Clinical practice guidelines have been developed for primary care physicians and patients on the clinical management of low-back pain. The implementation of the guidelines in a large community is difficult with the multiplicity of medical and nonmedical back care providers and products. The CORE program was designed to make the guidelines fit in this complex environment. METHODS: One hundred ten workers compensated for low-back pain for 4 to 8 weeks in metropolitan Montreal were randomized in two groups: usual care (N = 56) and the CORE program (N = 54). Coordination of primary health care was performed by two primary care physicians and a nurse in liaison with the treating physicians, and included a complete examination, recommendations for the clinical management, and support to carry out the recommendations. All workers were followed for 6 months. Back pain and functional status were assessed at baseline, 3 months, and 6 months. RESULTS: In the 6-month follow-up, the CORE group returned to work 6.6 days (standard error = 8.9) quicker than the control group, a difference that was not statistically significant. However, the CORE group showed a sustained improvement in pain and functional status with two-fold differences at the end of the 6 months of follow-up. This represented nine points on the Oswestry scale (P = 0.02) and 12 points on the Quebec Back Pain Disability Scale (P = 0.01). The CORE group also used three times less specialized imaging tests of the spine at 3 months (P < 0.01) and exercised twice as much at 6 months (P < 0.05) than the controls. CONCLUSIONS: The therapeutic results for workers with low-back pain could be improved by implementing the clinical practice guidelines with primary care physicians in a large community, without delaying the return to work. The CORE intervention for back pain patients is highly relevant to primary care practice. It is simple in its application, flexible to accommodate physicians' and- patients' preferences in health care, and it is effective on patients' clinical outcome.

Estimation of direct and indirect costs because of common infections in toddlers attending day care centers.

OBJECTIVE: To describe both the direct and the indirect costs of illness in a closely followed cohort of toddlers attending day care centers (DCCs) in Québec, Canada. METHODS: Fifty-two DCCs participated in the study. Parents were invited to fill in a calendar on which they would indicate the occurrence of colds, diarrhea, and vomiting, in addition to any actions taken with respect to this occurrence. The participating parents were called biweekly to report the information. The costs reported in this article are based on a period of 6 months of follow-up. The direct costs included medication and visits to a physician whereas indirect costs included alternative care provided by a family member, a babysitter, or an employed parent who missed work. RESULTS: Two hundred seventy-three toddlers were followed from 35 to 182 days during the study period. During a 6-month period, the adjusted average costs per child for medication and consultation were $47.47 (standard deviation [SD] = 52.76) and $49.10 (SD = 51.34), respectively, whereas they amount to $11.51 (SD = 51.19) for care by a babysitter, $35.68 (SD = 94.74) for care by a family member, and $117.12 (SD = 210.29) for a parent missing work (when using opportunity cost). The overall adjusted average total costs per child incurred to the parents and society was $260.70 (SD = 301.25). CONCLUSIONS: The originality of this study was to comprehensively include all costs associated with the care of an ill child attending DCCs. Future research should aim at finding economical ways to decrease illness frequency in toddlers attending day care centers and subsequently the costs they incur.

A comparison of parametric and nonparametric approaches to ROC analysis of quantitative diagnostic tests.

Receiver operating characteristic (ROC) analysis, which yields indices of accuracy such as the area under the curve (AUC), is increasingly being used to evaluate the performances of diagnostic tests that produce results on continuous scales. Both parametric and nonparametric ROC approaches are available to assess the discriminant capacity of such tests, but there are no clear guidelines as to the merits of each, particularly with non-binormal data. Investigators may worry that when data are non-Gaussian, estimates of diagnostic accuracy based on a binormal model may be distorted. The authors conducted a Monte Carlo simulation study to compare the bias and sampling variability in the estimates of the AUCs derived from parametric and nonparametric procedures. Each approach was assessed in data sets generated from various configurations of pairs of overlapping distributions; these included the binormal model and non-binormal pairs of distributions where one or both pair members were mixtures of Gaussian (MG) distributions with different degrees of departures from binormality. The biases in the estimates of the AUCs were found to be very small for both parametric and nonparametric procedures. The two approaches yielded very close estimates of the AUCs and the corresponding sampling variability even when data were generated from non-binormal models. Thus, for a wide range of distributions, concern about bias or imprecision of the estimates of the AUC should not be a major factor in choosing between the nonparametric and parametric approaches.

An effect model for the assessment of drug benefit: example of antiarrhythmic drugs in postmyocardial infarction patients.

An effect model is a function that defines the relationship between the clinical efficacy of a treatment and specific covariates. The simplest effect model defines the probability of failure in treated patients as a linear function of the probability for these patients if they received no treatment. We used this approach to explore the effects of Class I antiarrhythmic agents in patients after myocardial infarction. Evidence from one large trial, the Cardiac Arrhythmic Suppression Trial (CAST), and the pooling of data from several smaller trials suggests that these agents have harmful effects in postmyocardial infarction patients. The relevance of results from pooled data is dependent on the homogeneity of the trials and is assessed by a heterogeneity test that is dependent on the analytical method used, i.e., odds ratio or rate difference methods, which correspond to two different effect models. We have developed an effect model that considers both iatrogenic effects of these drugs, i.e., depression of ventricular function and arrhythmogenic effects. When applied to the data from 13 published trials (including CAST), we found that these drugs may be beneficial in high-risk patients (with a 1-year mortality rate of > or = 15%) and that the background lethal iatrogenic effect is likely to affect low- and very low-risk patients (1-year mortality rate of < or = 5%). The accuracy of the proposed model was confirmed with use of the results from the recent CAST II study.

[Current day-care structures for young children. Social and economic aspect based on the situation in the Rhône district]. / Structures actuelles d'accueil permanent pour jeunes enfants. Aspect social et économique à la lumière de la situation dans le département du Rhône.

The French public day-care system is intended for children under the age of 3. All structures are under the supervision of the "protection maternelle et infantile" (mother and child health service) and, before opening, must have the agreement of the Conseil général (department council). In the Rhône department (main town: Lyon) in 1990, 5020 children under the age of 3, from a total of 67,500, were in public daycare. The public daycare system complies with about 21% of all requests for child care. Recently, family day nurseries have developed more rapidly than collective daycare, being more flexible and less expensive. The costs for running a day nursery are shared between parents (28%), municipality (50%), national social support (20%) and other fundings (2%).

[Care of non-severe acute diarrhea in infants: a socioeconomic approach]. / Prise en charge des diarrhées aiguës non graves du nourrisson: approche socio-économique.

During a period of 3 months, 267 children with non severe acute diarrhea (NSAD) were treated by one of four modalities of care: in the private office of a general practitioner (n = 58), or of a paediatrician (n = 109), in a hospital emergency service (n = 62), or as hospital inpatients (n = 38). The socio-economic status and the cost of treatment for each of these children was subsequently assessed. The children admitted to hospital were mainly referred by hospital out-patient departments (47%) and general practitioners (37%) who, unlike paediatricians, care for more socially disadvantaged patients. The main reason for hospitalization was the presence of diarrhea with vomiting (55%). Several measures are proposed to redefine the role of the hospital and to improve cooperation with doctors in office practice, which would reduce both the number of hospitalizations due to NSAD and the length of hospital stay. Since the cost of treating NSAD hospital is 60 time greater than care at home, these measures are economically important.