To document the rate of surgical ligation of a patent ductus arteriosus (PDA) in extremely premature infants who had received more than one course of indomethacin. Outcomes were compared among three subgroups (ligation, further indomethacin and no further treatment) of infants who received at least one course of indomethacin, and between two subgroups (one course of indomethacin and more than one course) among infants who underwent ligation.
A retrospective chart review of all 23 weeks+0 days to 26 weeks+6 days’ gestational age infants with a PDA born between 1994 and 2005 was performed. Secondary outcomes were compared among the subgroups.
The final study population consisted of 196 extremely premature infants with a PDA. The rate of surgical ligation in the 88 infants who received more than one course of indomethacin was 64%. The ligation subgroup, in comparison with the no further treatment subgroup, spent a greater median time on mechanical ventilation (39 versus 29 days, P<0.001) and in hospital (115 versus 92 days P=0.002), while trending toward lower mortality (18% versus 40%, P=0.07). The PDA closed following the first course of indomethacin in only 20% of infants.
A majority of extremely premature infants receiving more than one course of indomethacin underwent surgical ligation. Repeated indomethacin courses were generally well tolerated, but were mostly unsuccessful. Ligation appears to have potential risks and benefits. A randomized trial should be performed after studies define a hemodynamically significant PDA that will result in morbidity and/or mortality unless treated.
Ductus arteriosus, patent; Indomethacin; Infant, premature; Ligation
Ensuring access to timely and appropriate primary healthcare for people living in poverty is an issue facing all countries, even those with universal healthcare systems. The transformation of healthcare practices and organization could be improved by involving key stakeholders from the community and the healthcare system in the development of research interventions. The aim of this project is to stimulate changes in healthcare organizations and practices by encouraging collaboration between care teams and people living in poverty. Our objectives are twofold: 1) to identify actions required to promote the adoption of professional practices oriented toward social competence in primary care teams; and 2) to examine factors that would encourage the inclusion of people living in poverty in the process of developing social competence in healthcare organizations.
This study will use a participatory action research design applied in healthcare organizations. Participatory research is an increasingly recognized approach that is helpful for involving the people for whom the research results are intended. Our research team consists of 19 non-academic researchers, 11 academic researchers and six partners. A steering committee composed of academic researchers and stakeholders will have a decision-making role at each step, including knowledge dissemination and recommendations for new interventions. In this project we will adopt a multiphase approach and will use a variety of methods, including photovoice, group discussions and interviews.
The proposed study will be one of only a few using participatory research in primary care to foster changes aimed at enhancing quality and access to care for people living in poverty. To our knowledge this will be the first study to use photovoice in healthcare organizations to promote new interventions. Our project includes partners who are targeted for practice changes and improvements in delivering primary care to persons living in poverty. By involving knowledge users, including service recipients, our study is more likely to produce a transformation of professional practices and encourage healthcare organizations to take into account the needs of persons living in poverty.
Participatory research; Poverty; Primary care; Photovoice; Knowledge transfer
Fractures associated with bone fragility in older adults signal the potential for secondary fracture. Fragility fractures often precipitate further decline in health and loss of mobility, with high associated costs for patients, families, society and the healthcare system. Promptly initiating a coordinated, comprehensive pharmacological bone health and falls prevention program post-fracture may improve osteoporosis treatment compliance; and reduce rates of falls and secondary fractures, and associated morbidity, mortality and costs.
This pragmatic, controlled trial at 11 hospital sites in eight regions in Quebec, Canada, will recruit community-dwelling patients over age 50 who have sustained a fragility fracture to an intervention coordinated program or to standard care, according to the site. Site study coordinators will identify and recruit 1,596 participants for each study arm. Coordinators at intervention sites will facilitate continuity of care for bone health, and arrange fall prevention programs including physical exercise. The intervention teams include medical bone specialists, primary care physicians, pharmacists, nurses, rehabilitation clinicians, and community program organizers.
The primary outcome of this study is the incidence of secondary fragility fractures within an 18-month follow-up period. Secondary outcomes include initiation and compliance with bone health medication; time to first fall and number of clinically significant falls; fall-related hospitalization and mortality; physical activity; quality of life; fragility fracture-related costs; admission to a long term care facility; participants’ perceptions of care integration, expectations and satisfaction with the program; and participants’ compliance with the fall prevention program. Finally, professionals at intervention sites will participate in focus groups to identify barriers and facilitating factors for the integrated fragility fracture prevention program.
This integrated program will facilitate knowledge translation and dissemination via the following: involvement of various collaborators during the development and set-up of the integrated program; distribution of pamphlets about osteoporosis and fall prevention strategies to primary care physicians in the intervention group and patients in the control group; participation in evaluation activities; and eventual dissemination of study results.
Clinical Trial.Gov NCT01745068
Study ID number
CIHR grant # 267395
Fragility fracture; Osteoporosis; Fall prevention; Integrated program; Interorganizational collaboration; Canada; Controlled trial; Evaluation
As complementary and alternative medicine (CAM) has developed extensively, uncertainty about the appropriateness of the terms CAM and other CAM-related terms has grown both in the research and practice communities. Various terms and definitions have been proposed over the last three decades, highlighting how little agreement exits in the field. Contextual use of current terms and their respective definitions needs to be discussed and addressed.
Relying upon the results of a large international Delphi survey on the adequacy of the term CAM, a focus group of 13 international experts in the field of CAM was held. A forum was also set up for 28 international experts to discuss and refine proposed definitions of both CAM and integrative healthcare (IHC) terms. Audio recordings of the meeting and forum discussion threads were analyzed using interpretive description.
Multiple terms to describe the therapies, products, and disciplines often referred to as CAM, were considered. Even though participants generally agreed there is a lack of optimal definitions for popular CAM-related umbrella terms and that all terms that have so far been introduced are to some extent problematic, CAM and IHC remained the most popular and accepted terms by far. The names of the specific disciplines were also deemed adequate in certain contexts. Focus group participants clarified the context in which those three terms are appropriate. Existing and emergent definitions of both CAM and integrative healthcare terms were discussed.
CAM and other related terms could be used more effectively, provided they are used in the proper context. It appears difficult for the time being to reach a consensus on the definition of the term CAM due to the uncertainty of the positioning of CAM in the contemporary healthcare systems. While umbrella terms such as CAM and IHC are useful in the context of research, policy making and education, relevant stakeholders should limit the use of those terms.
Definition; Term; Focus group; International experts; Integrative healthcare
In Canada, antimicrobial treatment is the most common approach for acute otitis media. The aim of the present study was to compare the cost effectiveness of treatment with amoxicillin versus a watch-and-wait approach (WAIT) within a Canadian pediatric setting. Four hundred eighty-eight children, six months to five years of age, who participated in a randomized controlled trial were included in the study. The average medication costs per patient were higher for the amoxicillin group ($17.26) than for the WAIT group ($4.33). However, both health care ($148.44 versus $162.48) and patient costs ($23.50 versus $31.87) were greater for the WAIT group. The mean cost of treatment for the amoxicillin group was $189.20, compared with $198.68 for the WAIT group. Amoxicillin may be cost effective in treating children with acute otitis media. The potential development of antimicrobial resistance was not addressed in the present study.
Acute otitis media; Cost effectiveness; Economic analysis; Randomized controlled trial
Several changes to medication safety practices were proposed in a pediatric hospital, including changing the period of patient observation after administration of opioids and limiting the availability of various concentrations of morphine in the patient care unit.
To document and review postoperative pain management for children on a surgical ward, specifically with regard to intermittent IV bolus administration of morphine, to help in assessing the impact of the proposed nursing practice changes.
Data were collected from records for narcotics and controlled drugs for the surgical ward over a 3-month period (April to June 2006). For each patient, data had been recorded for up to 7 consecutive days after surgery. A patient’s data were included in the review if he or she had received at least 2 doses of morphine by IV bolus, except for the review of weight-based dosing pattern (mg/kg), for which all patients who had received at least one dose of IV morphine were included.
Charts for 193 patients were audited. Of these, 163 patients (84.5%) had recieved up to 0.1 mg/kg per dose, and 53 (27.5%) had received only one dose of morphine. Among patients who received more than one dose, the median dose was 0.080 mg/kg on day 1, with a decrease by day 5 to 0.065 mg/kg. Most patients received morphine over the first 2 days after surgery. The median time elapsed between doses was 4.3 h on day 1 and 6.2 h on day 2. Of the 1020 doses included in the analysis, most (801 [78.5%]) were 4 mg or less.
The intermittent administration of IV bolus doses of morphine at the study hospital followed common standards for the treatment of postoperative pain. Most doses were no more than 4 mg. On the basis of this information, only 2-mg vials of morphine are now stocked on the ward. The hospital’s change in monitoring practices will increase the surveillance of patients receiving IV bolus doses of morphine.
morphine; medication safety; pediatrics; morphine; sécurité des médicaments; pédiatrie
Several studies show that colonoscopies are technically more difficult to perform in women than men, especially in women who have undergone abdominal and gynecological surgeries. A review of the literature indicates an increased rate of noncompletion of colonoscopies in most cases; however, no studies have investigated the procedural complication rate, sedation requirements and perception of pain in colonoscopies.
To determine whether women who have undergone a previous hysterectomy have a higher noncompletion rate when undergoing a colonoscopy, and to assess whether there is a higher percentage of complications. Furthermore, the present study also aimed to ascertain whether these women required more sedation and whether their perception of pain is greater than that of women who did not undergo previous abdominal surgeries.
The present study was a prospective cohort study of women, 45 to 80 years of age, who underwent colonoscopy (n=508). A total of 229 patients were eligible for the study; they completed a questionnaire, and were subsequently divided into control and hysterectomy groups. Gastroenterologists performed all procedures. After colonoscopy, the patient and endoscopist completed a pain perception questionnaire. Cecal intubation rates were also recorded.
No significant difference for cecal intubation rates were detected between the two groups (95.7% and 98.7% in hysterectomy and control groups, respectively; P=0.176). The crude OR for the success rate was 0.29 (95% CI 0.05 to 1.90). There was no significant difference between groups regarding sedation or the type of colonoscope. No correlation between the gastroenterologists’ evaluation of pain and patients’ pain was observed.
Hysterectomy did not significantly diminish the cecal intubation rate, and there was no detectable difference in pain perception or sedative dose. Colonoscopy remains an excellent screening and diagnostic tool for all women.
Cecal intubation; Colonoscopy; Hysterectomy; Pain; Sedation; Women
To examine assessment and treatment profiles of adolescent patients with anorexia nervosa and eating disorder not otherwise specified who received olanzapine as compared with an untreated matched sample.
A retrospective, matched-groups comparison study was completed. Medical files of 86 female patients treated in the eating disorder program at the Children's Hospital of Eastern Ontario were examined. Patients treated with olanzapine were initially identified through chart review and then matched to a diagnosis, age, and, when possible, treatment group that served as the active comparator. Weight gain was examined in a sample of 22 inpatients.
Patients treated with olanzapine displayed greater evidence of psychopathology and medical compromise at the time of first assessment compared with those not treated. Rate of weight gain was not statistically different between groups when olanzapine was started during inpatient admissions. Medication effect on eating disorder cognitions could not be assessed given the presence of multiple confounders relating to treatment. Notable side effects included sedation and dyslipidemia in 56% of patients.
Despite our best attempts at matching olanzapine-treated subjects with a control sample, analysis revealed significant differences between groups, suggesting greater illness severity in those augmented with olanzapine. Given these inherent differences, we were unable to draw any firm conclusions regarding the potential efficacy of olanzapine. Factors associated with the prescription of adjunctive pharmacotherapy in this cohort appear to be linked to illness severity, acuity, and associated comorbidity. The observed side-effect profile indicates the need for more consistent predrug screening and for closer monitoring during treatment.
Biomedical and Complementary and Alternative Medicine (CAM) academic and clinical communities have yet to arrive at a common understanding of what Integrative healthcare (IHC) is and how it is practiced. The Models of Team Health Care Practice (MTHP) framework is a conceptual representation of seven possible practice models of health care within which teams of practitioners could elect to practice IHC, from an organizational perspective. The models range from parallel practice at one end to integrative practice at the other end. Models differ theoretically, based on a series of hypotheses. To date, this framework has not been empirically validated. This paper aims to test nine hypotheses in an attempt to validate the MTHP framework.
Secondary analysis of two studies carried out by the same research team was conducted, using a mixed methods approach. Data were collected from both biomedical and CAM practitioners working in Canadian IHC clinics. The secondary analysis is based on 21 participants in the qualitative study and 87 in the quantitative study.
We identified three groups among the initial seven models in the MTHP framework. Differences between practitioners working in different practice models were found chiefly between those who thought that their clinics represented an integrative model, versus those who perceived their clinics to represent a parallel or consultative model. Of the scales used in the analysis, only the process of information sharing varied significantly across all three groups of models.
The MTHP framework should be used with caution to guide the evaluation of the impact of team-oriented practice models on both subjective and objective outcomes of IHC. Groups of models may be more useful, because clinics may not "fit" under a single model when more than one model of collaboration occurs at a single site. The addition of a hypothesis regarding power relationships between practitioners should be considered. Further validation is required so that integrative practice models are well described with appropriate terminology, thus facilitating the work of health care practitioners, managers, policy makers and researchers.
To examine the breastfeeding prevalence among infants aged three and six months who were previously hospitalized because of hyperbilirubinemia, and to determine whether jaundice in newborn infants increases the risk of breastfeeding discontinuation.
Surveys were mailed to mothers of all eligible infants admitted over a two-and-a-half year period to the paediatric ward of a tertiary care children’s hospital with a diagnosis of hyperbilirubinemia. A total of 127 mother-patient pairs were included in the study. Breastfeeding rates at three and six months were compared with those of a city-wide survey (Infant Care Survey) conducted by Ottawa’s Public Health Department. Risk factors for early breastfeeding discontinuation were examined.
Breastfeeding rates at three and six months were not different between the study group and those reported in the Infant Care Survey (75.5% in the study group versus 71.2% in the Infant Care Survey group, at three months; and 59.1% in the study group versus 50.8% of the Infant Care Survey group, at six months). None of the previously reported risk factors for early weaning had an impact on breastfeeding duration in the study population.
Breastfeeding rates following the discharge of infants diagnosed with jaundice were not significantly different from those reported for the general population. Different patient characteristics may have inflated the breastfeeding rates in the study population, as evidenced by a very high education level among the mothers of enrolled patients. Larger prospective studies in diverse populations are needed to determine the rates of early breastfeeding discontinuation in jaundiced infants.
Breastfeeding; Hyperbilirubinemia; Infants; Jaundice
La littérature suggère l'hypothèse d'une santé différentielle des francophones en situation minoritaire au Canada. L'effet de minorité sur la santé perçue a été mesuré à l'aide des Enquêtes sur la santé dans les collectivités canadiennes (ESCC) de 2001 et 2003. Une analyse de régression logistique multivariée séquentielle montre que les francophones minoritaires – hommes et femmes – sont plus enclins à déclarer une moins bonne santé que les anglophones majoritaires. Contrairement aux femmes, cette disparité chez les hommes demeure significative même lorsque nous ajustons pour certains grands déterminants de la santé. L'étude illustre que l'action des déterminants de santé peut être ainsi modulée par le rapport minoritaire/majoritaire. Les inégalités ainsi révélées appellent à une réflexion sur les politiques d'accès linguistique aux soins de santé.
To quantify the frequency and types of in-office emergencies seen by FPs.
A retrospective descriptive analysis of the frequency and types of in-office emergencies seen by FPs was done using the City of Ottawa Emergency Medical Services database.
Community medical offices in the Ottawa, Ont, region during a 3-year period (2004 to 2006).
All patients for whom an ambulance was called to a medical office or clinic during the study period.
MAIN OUTCOME MEASURES
Number of emergency calls from FPs’ offices, primary complaints, seasonal variation, distance to the nearest emergency facility, and patients’ demographic characteristics.
A total of 3033 code 04 (life-threatening) emergency calls were received from FPs’ offices during the study period. Demographic analysis of the calls showed that 91.3% of calls were regarding adult patients with an average age of 51.5 years. There was an overall statistically significant difference in the sex of the patients presenting (P < .001), but it was attributable to calls about genitourinary emergencies, which were almost all for women. The most common type of emergency reported was cardiovascular complaints. Of the 992 cardiovascular emergencies, 74.3% were complaints of ischemic chest pain.
There is a great burden on the health care system from emergency calls, with continued unpreparedness from FPs. Clearly, FPs must take seriously the risk of being unprepared for in-office emergencies. Dissemination strategies must be developed so that the guidelines that have been developed can be effectively implemented in FP offices across the country.
Integrative health care (IHC) has become a popular term used in practice and research to define the blending of complementary and alternative medicine (CAM) and conventional care as an innovative approach to health care delivery.
Purpose and objectives
To conduct a bibliometric analysis to develop a better understanding of the evolution of the concept of IHC in the CAM field.
All articles on IHC published between 1915 and 2008 indexed in the ISI web of knowledge database were retrieved. Title and abstract review were conducted to determine eligibility. Inclusion criteria included a research report and integration of CAM and conventional therapies. A second review of the full papers will be conducted to determine the final article sample, which will be analyzed using a rigorous bibliometric analysis approach.
Three thousand and five articles were retrieved and 35% met the inclusion criteria in the first screening round. Descriptive and relational bibliometric indicators will be presented, including the volume of research by year, keywords used, impact of the publication and collaboration amongst researchers.
Discussion and conclusion
Application of a bibliometric analysis allows for a broad and focused overview of the IHC literature within its historical and cultural context, and evaluation of the research output and its impact.
bibliometrics; complementary and alternative medicine (CAM)
To reduce the risk of medication errors in paediatric patients, the Canadian Council on Health Services Accreditation endorsed the standardization and limiting of drug concentrations available within an organization.
Standard concentrations (SCs) were implemented in the emergency department, operating room and paediatric intensive care unit at the Children’s Hospital of Eastern Ontario in Ottawa, Ontario. The change in practice involved addressing concerns raised during stakeholder consultations, developing a computer program, and educating and testing staff in the new method. The software for SC selection and infusion rate calculation featured redundant inputs, a ‘deviation’ column comparing the prescribed and infused doses, and a printout of patient information that also facilitated dose verification back-calculation.
The major barrier to acceptance of SCs was possible fluid overload in lower weight patients. Thus, infusions received by 48 successive infants in the paediatric intensive care unit were compared with theoretical SC infusions. Volumes were not significantly increased, and there was no trend toward proportionally larger volumes in lower weight patients. Medication error reporting was very low before implementation, and SC errors remained low; new online reporting led to higher reporting of other errors after implementation. A survey indicated excellent staff acceptance and beliefs that patient safety and continuity of care were improved.
SCs were successfully instituted with computer support, in lieu of ‘smart pumps,’ across multiple critical care units in a paediatric institution. The initial program is being expanded to 40 continuous infusion drugs, plus paediatric advanced life support bolus medications.
Critical care; High-alert medications; Intravenous; Medication safety; Paediatrics; Standard concentrations
Housing is a key determinant of child and youth health. A significant number of Canadian children and youth are living in housing need, but information regarding the housing status of children and youth in the Ottawa, Ontario, community is lacking.
To examine the housing status of children and youth accessing emergency health services at the Children’s Hospital of Eastern Ontario (Ottawa, Ontario), and the factors associated with housing status.
Youth and families of children registered at the Children’s Hospital of Eastern Ontario’s emergency department were offered a questionnaire. Affordability, adequacy, suitability and stability of housing were evaluated through self-reporting. Housing need was defined as an inability to meet one or more of these criteria. Associations among housing and household composition, demographics and weight-for-age percentiles were examined.
One thousand three hundred sixty surveys were completed. Fifty-four per cent of respondents (663 of 1224) were living in housing need, including 33% of respondents (381 of 1166) who were living in unaffordable housing. Single-parent families (OR 2.82), families with six or more members (OR 2.51) and families who rented (OR 5.27) were more likely to be living in housing need. Children and youth with a primary care physician were more likely to be living in stable housing (OR 0.41). Unsuitable housing was associated with extreme weight-forage percentiles (OR 1.90).
More than one-half of the children and youth in the present study were living in housing need. Health care providers have a responsibility to identify and understand the determinants of health of their patients, including housing, and to work for the improved health of their patients and their communities.
Community medicine; Determinants of health; Housing; Public health
Established noninvasive pharmacologic means of alleviating pain and anxiety in children undergoing intravenous cannulation are time-consuming, and thus impractical for routine use in the emergency department. Vapocoolant sprays provide transient skin anesthesia within seconds of application. We compared the effect of a new vapocoolant spray to placebo on pain due to intravenous cannulation in children.
In this double-blind randomized controlled trial, which we conducted between June 1 and Sept. 12, 2006, 80 children aged 6–12 years received either vapocoolant spray or placebo before cannulation. Children rated their pain using a 100-mm colour visual analogue scale. Secondary outcomes included success rate on first attempt at cannulation and pain ratings by the children's parents, nurses and child life specialists.
We found a modest but significant reduction in pain with the use of vapocoolant spray (mean difference 19 mm, 95% confidence interval [CI] 6–32 mm; p < 0.01). Cannulation on first attempt was more often successful with the use of vapocoolant spray (85.0%) than with placebo (62.5%) (mean difference 22.5%, 95% CI 3.2%–39.9%; p = 0.03). The number needed to treat to prevent 1 cannulation failure was 5 (95% CI 3–32). Parents (p = 0.04), nurses (p = 0.01) and child life specialists (p < 0.01) considered the children's pain to be reduced with the use of vapocoolant spray.
The vapocoolant spray in our study quickly and effectively reduced pain due to intravenous cannulation in children and improved the success rate of cannulation. It is an important option to reduce childhood procedural pain in emergency situations, especially when time precludes traditional interventions.
(http://ClinicalTrials.gov trial register no. NCT00130650.)
To explore factors affecting collaboration between family physicians and psychologists.
Mailed French-language survey.
Family physicians practising in the area of the Réseau des services de santé en français de l’Est de l’Ontario.
MAIN OUTCOME MEASURES
Physicians’ knowledge and understanding of the qualifications of psychologists and the regulations governing their profession; beliefs regarding the effectiveness of psychological treatments; views on the integration of psychologists into primary care; and factors affecting referrals to psychologists.
Of 457 surveys sent, 118 were returned and analyzed (27% of surveys delivered). Most family physicians were well aware that there were evidence-based psychological interventions for mental health and personal difficulties, and some knew that psychological interventions could help with physical conditions. Physicians had some knowledge about the qualifications and training of psychologists. Many physicians reported being uncomfortable providing counseling themselves owing to time constraints, the perception that they were inadequately trained for such work, and personal preferences. The largest barrier to referring patients to psychologists was cost, since services were not covered by public health insurance. Some physicians were deterred from referring by previous experience of not receiving feedback on patients from psychologists. Increased access to clinical psychologists through collaborative care was considered a desirable goal for primary health care.
Family physicians know that there are evidence-based psychological interventions for mental health issues. Psychologists need to communicate better about their credentials and what they can offer, and share their professional opinions and recommendations on referred patients. Physicians would welcome practice-based psychological services and integrated interdisciplinary collaboration as recommended by the Kirby and Romanow commissions, but such collaboration is hampered by the lack of public health insurance coverage.
Anorexia Nervosa (AN) is a serious, debilitating condition that causes significant physical, emotional, and functional impairment. The condition is characterized by destructive weight loss behaviours and a refusal to maintain body weight at or above a minimally normal weight for age and height. AN often develops in adolescence and is a predominantly female disorder. Treatment for AN typically involves medical, nutritional and psychological interventions. Pharmacotherapy is also often used; however, the literature on the effectiveness of these drugs in a pediatric population is very limited. Olanzapine, which is an 'atypical' antipsychotic, is becoming more widespread in the treatment of AN. Olanzapine is hypothesized to facilitate weight gain, while decreasing levels of agitation and decreasing resistance to treatment in young women with AN. This randomized, double-blind placebo-controlled trial seeks to examine the effectiveness and safety of olanzapine in female youth with AN.
Adolescent females between the ages of 12 and 17 diagnosed with AN (either restricting or binge/purge type) or Eating Disorder Not Otherwise Specified with a Body Mass Index of less than or equal to 17.5, will be offered inclusion in the study. Patients will be randomly assigned to receive either olanzapine or placebo. Patients assigned to receive olanzapine will start at a low dose of 1.25 mg/day for three days, followed by 2.5 mg/day for four days, 5 mg/day for one week, then 7.5 mg/day (the target dose chosen) for 10 weeks. After 10 weeks at 7.5 mg the medication will be tapered and discontinued over a period of two weeks. The effectiveness of olanzapine versus placebo will be determined by investigating the change from baseline on measures of eating attitudes and behaviors, depression and anxiety, and change in Body Mass Index at week 12, and after a follow-up period at week 40. It is anticipated that 67 participants will be recruited over two years to complete enrollment.
Randomized controlled trials designed to measure the safety and effectiveness of olanzapine in comparison to placebo are desperately needed, particularly in the adolescent population.
Current Controlled Trials ISRCTN23032339
Based on regional and anecdotal reports, there is concern that vitamin D–deficiency rickets is persistent in Canada despite guidelines for its prevention. We sought to determine the incidence and clinical characteristics of vitamin D–deficiency rickets among children living in Canada.
A total of 2325 Canadian pediatricians were surveyed monthly from July 1, 2002, to June 30, 2004, through the Canadian Paediatric Surveillance Program to determine the incidence, geographic distribution and clinical profiles of confirmed cases of vitamin D-deficiency rickets. We calculated incidence rates based on the number of confirmed cases over the product of the length of the study period (2 years) and the estimates of the population by age group.
There were 104 confirmed cases of vitamin D–deficiency rickets during the study period. The overall annual incidence rate was 2.9 cases per 100 000. The incidence rates were highest among children residing in the the north (Yukon Territory, Northwest Territories and Nunavut). The mean age at diagnosis was 1.4 years (standard deviation [SD] 0.9, min–max 2 weeks–6.3 years). Sixty-eight children (65%) had lived in urban areas most of their lives, and 57 (55%) of the cases were identified in Ontario. Ninety-two (89%) of the children had intermediate or darker skin. Ninety-eight (94%) had been breast-fed, and 3 children (2.9%) had been fed standard infant formula. None of the breast-fed infants had received vitamin D supplementation according to current guidelines (400 IU/d). Maternal risk factors included limited sun exposure and a lack of vitamin D from diet or supplements during pregnancy and lactation. The majority of children showed clinically important morbidity at diagnosis, including hypocalcemic seizures (20 cases, 19%).
Vitamin D–deficiency rickets is persistent in Canada, particularly among children who reside in the north and among infants with darker skin who are breast-fed without appropriate vitamin D supplementation. Since there were no reported cases of breast-fed children having received regular vitamin D (400 IU/d) from birth who developed rickets, the current guidelines for rickets prevention can be effective but are not being consistently implemented. The exception appears to be infants, including those fed standard infant formula, born to mothers with a profound vitamin D deficiency, in which case the current guidelines may not be adequate to rescue infants from the vitamin D-deficient state.
Procedural pain relief is sub-optimal in neonates. Topical tetracaine provides pain relief in children. Evidence of its efficacy and safety in neonates is limited. The objective of this study was to assess the efficacy and safety of topical tetracaine on the pain response of neonates during a venipuncture.
Medically stable infants greater than or equal to 24 weeks gestation, requiring a venipuncture, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. Participants received oral sucrose if they met local eligibility criteria. The venipuncture was performed according to a standard protocol. A medium effect size in the pain score (corresponding to about 2 point difference in the PIPP score) was considered clinically significant, leading to a sample size of 142 infants, with 80% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test.
One hundred and forty two infants were included, 33 +/- 4 weeks gestation, 2100 +/- 900 grams and 6 +/- 3 days of age. There was almost no difference in PIPP scores at 1 minute between groups (mean difference -0.09; 95% confidence interval [CI]: -1.68 to 1.50; P = . 91). Similarly, there were no differences in PIPP scores during the 2nd, 3rd and 4th minute. Duration of cry did not differ between the groups (median difference, 0; 95% CI, -3 to 0; P = . 84). The majority of infants in both groups received sucrose 24%. Sucrose had a significant effect on the PIPP score, as assessed by an ANOVA model (p = 0.0026). Local skin erythema was observed transiently in 11 infants (7 in the tetracaine and 4 in the placebo group). No serious side effect was observed.
Tetracaine did not significantly decrease procedural pain in infants undergoing a venipuncture, when used in combination with routine sucrose administration.
We studied the effects of access to point-of-care medical evidence in a computerised physician order entry system (CPOE) on management and clinical outcome of children with bronchiolitis.
This was a before-after study that took place in a Canadian tertiary care paediatric teaching hospital. The intervention was a clinical evidence module (CEM) for bronchiolitis management, adapted from Clinical Evidence (BMJ Publishing Group) and integrated into the hospital CPOE. CPOE users were medical trainees under the supervision of staff physicians working in the infant ward. Use of antibiotics, bronchodilators and corticosteroids; disease severity; length of hospital admission; and trainee use and perception of the CEM were measured before and after CEM introduction.
334 paediatric inpatients age 2 weeks to 2 years, with a clinical diagnosis of bronchiolitis; 147 children the year preceding and 187 children the year following introduction of a Clinical Evidence Module (CEM). The percentage of patients receiving antibiotics fell from 35% to 22% (relative decrease 37%) following the introduction of the CEM (p = 0.016). Bronchodilator use was high but following the CEM patients no longer received more than one variety. Steroid usage and length of hospitalisation were low and unaffected. Trainees found the CEM to be educational.
Readily accessible clinical evidence at the point of care was associated with a significant decrease in antibiotic use and an end to multiple bronchodilator use. The majority of physician trainees found the CEM to be a useful educational tool.
Procedural pain relief is sub-optimal in infants, especially small and vulnerable ones. Tetracaine gel 4% (Ametop®, Smith-Nephew) provides pain relief in children and larger infants, but its efficacy in smaller infants and for peripherally inserted central catheters (PICC) remains uncertain. The objective of this trial was to assess the safety and efficacy of tetracaine gel on the pain response of very low birth weight (VLBW) infants during insertion of a PICC.
Medically stable infants greater than or equal to 24 weeks gestation, requiring a non-urgent PICC, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. The PICC was inserted according to a standard protocol. Pain was assessed using the Premature Infant Pain Profile (PIPP). A 3-point change in the pain score was considered clinically significant, leading to a sample size of 54 infants, with 90% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test.
Fifty-four infants were included, 27 +/- 2 weeks gestation, 916 +/- 292 grams and 6.5 +/- 3.2 days of age. Baseline characteristics were similar between groups. The mean PIPP score in the first minute was 10.88 in the treatment group as compared to 11.74 in the placebo group (difference 0.86, 95% CI -1.86, 3.58). Median duration of crying in non-intubated infants was 181 seconds in the tetracaine group compared to 68 seconds in the placebo group (difference -78, 95% CI -539, 117). Local skin erythema was observed transiently in 4 infants (3 in the treatment and 1 in the placebo group). No serious harms were observed.
Tetracaine 4% when applied for 30 minutes was not beneficial in decreasing procedural pain associated with a PICC in very small infants.
Coagulase negative staphylococcus (CONS) is the main cause of late-onset sepsis in Neonatal Intensive Care Units (NICU). Although CONS rarely causes fulminant sepsis, vancomycin is frequently used as empiric therapy. Indiscriminate use of vancomycin has been linked to the emergence of vancomycin resistant organisms. The objective of this study was to compare duration of CONS sepsis and mortality before and after implementation of a policy of selective vancomycin use and compare use of vancomycin between the 2 time periods.
A retrospective study was conducted of infants ≥4 days old, experiencing signs of sepsis with a first positive blood culture for CONS, during two 12-month periods. Late-onset sepsis was treated empirically with vancomycin and gentamicin during period 1, and cloxacillin and gentamicin during period 2. The confidence interval method was used to assess non-inferiority of the outcomes between the two study groups.
There were 45 episodes of CONS sepsis during period 1 and 37 during period 2. Duration of sepsis was similar between periods (hazard ratio of 1.00, 95%CI: 0.64, 1.57). One death during period 2 was possibly related to CONS sepsis versus none in period 1. Vancomycin was used in 97.8% of episodes in period 1 versus 81.1% of episodes in period 2.
Although we failed to show non-inferiority of duration of sepsis in the cloxacillin and gentamicin group compared to the vancomycin and gentamicin group, duration of sepsis was clinically similar. Restricting vancomycin for confirmed cases of CONS sepsis resistant to oxacillin appears effective and safe, and significantly reduces vancomycin use in the NICU.