Biomedical subjects

A Willan

Publications and source records attributed to A Willan.

At least 19 recordsLinked to original sources

PubMed2004

A survey of Canadian practitioners regarding the management of the hypertensive disorders of pregnancy.

BACKGROUND: How Canadian practitioners are managing the hypertensive disorders of pregnancy (HDP) is not known, particularly in relation to the 1997 guidelines published by the Canadian Hypertension Society (CHS). METHODS: A survey, with French and English versions (and covering diagnosis, evaluation, and management of pregnancy hypertension), was mailed to all members of the Society of Obstetricians and Gynaecologists of Canada (SOGC) (N = 1757, including obstetricians, family doctors practicing obstetrics, and midwives). Additionally, internists [i.e., all nephrologists (N = 191) and a random sample of 25% of general internists (N = 450)] registered with the Royal College of Physicians and Surgeons of Canada were sampled. The survey was distributed in two mailings and one reminder card. Data were entered into Microsoft Access, and Graph Pad Prism used to summarize responses [N (%)]. Differences in practice between specialties were examined, with a Bonferroni correction used to calculate a significant p value based on the number of comparisons and alpha of 0.05. RESULTS: Respondents numbered 1187 (49.5%), with 466 not informative for the purpose of the study (due to retirement, or practices that do not include pregnant women with hypertension). The final analysis included 721 completed surveys. For all types of HDP, most internists, family doctors, and midwives initiate nonpharmacological therapy (most common advice to quit work) at dBP 80-89 mmHg (i.e., primary prevention). Only for preeclampsia do obstetricians most frequently use this threshold; otherwise, dBP 90-99 mmHg is usually chosen. For nonsevere hypertension, antihypertensive drug therapy (most commonly methyldopa or labetalol) is started by most practitioners at dBP 90-99 mmHg, although obstetricians are more likely to choose a higher threshold (p < 0.0001). There is little agreement about dBP treatment goal; most internists and family doctors normalize dBP, whereas obstetricians appear to be divided on dBP goals of 80-89 (46-51%) vs. 90-99 mmHg (41-44%) for all HDP (p = 0.66). Severe hypertension is commonly treated with parenteral hydralazine, labetalol, or magnesium sulphate. Short-acting or sustained release nifedipine is used rarely/never by most practitioners. Approximately one-third of obstetricians and family doctors use diazepam to treat eclampsia. The vast majority use MgSO4 prophylactically in women with preeclampsia. INTERPRETATION: This survey has clarified current stated management of women with HDP, and identified the need for both research into the dBP treatment goal that optimizes pregnancy outcomes among women with HDP, and translation of definitive studies into clinical practice.

Antihypertensive Agents↗

PubMed2004

A survey of canadian practitioners regarding diagnosis and evaluation of the hypertensive disorders of pregnancy.

BACKGROUND: How Canadian practitioners are diagnosing and managing the hypertensive disorders of pregnancy (HDP), particularly in relation to the 1997 recommendations published by the Canadian Hypertension Society (CHS), is not known. METHODS: A survey, with French and English versions (and covering diagnosis, evaluation, and management of pregnancy hypertension), was mailed to all members of the Society of Obstetricians and Gynaecologists of Canada (SOGC) (N = 1757, including obstetricians, family doctors practicing obstetrics, and midwives). Additionally, internists [i.e., all nephrologists (N = 191) and a random sample of 25% of general internists (N = 450)] registered with the Royal College of Physicians and Surgeons of Canada were sampled. The survey was distributed in two mailings and one reminder card. Data were entered into Microsoft Access, and Graph Pad Prism used to summarize responses [N (%)]. Differences in practice between specialties were examined, with a Bonferonni correction used to calculate a significant p value based on the number of comparisons and alpha of 0.05. RESULTS: Respondents numbered 1187 (49.5%), with 466 not informative for the purpose of the study (due to retirement, or practices that do not include pregnant women with hypertension). The final analysis included 721 completed surveys. Most (609, 84.5% of) respondents take blood pressure (BP) with women in the sitting position, and use a mercury sphygmomanometer (79%) and the 5th Korotkoff (61%) sound to designate diastolic BP (dBP). To monitor pregnancies complicated by preeclampsia, most clinicians use the proposed laboratory tests of maternal well-being (usually at least once/week), fetal well-being [nonstress test (NST, at least once/week), and ultrasonographic studies (once weekly to every two weeks)]. There is general agreement that women with preeclampsia should be delivered for uncontrolled hypertension, end-organ dysfunction, or fetal compromise (nonreassuring NST, severe oligohydramnios, biophysical profile < 4, estimated fetal weight < 5th centile, and reversed end-diastolic flow by umbilical artery Doppler velocimetry). Less consensus was seen for delivery for preeclampsia at > 34 weeks, mild asymptomatic HELLP syndrome, hyperreflexia, and absent end-diastolic flow by umbilical artery Doppler velocimetry. INTERPRETATION: This survey has clarified the current state of practice with respect to the diagnosis and evaluation of women with all types of HDP. In particular, we have identified areas of potential variability in BP measurement, and provided data on the feasibility of enrolling women with sub types of preeclampsia into intervention studies aimed at prolonging pregnancy.

Biomarkers↗

PubMed2002

Interventions to reduce unintended pregnancies among adolescents: systematic review of randomised controlled trials.

OBJECTIVE: To review the effectiveness of primary prevention strategies aimed at delaying sexual intercourse, improving use of birth control, and reducing incidence of unintended pregnancy in adolescents. DATA SOURCES: 12 electronic bibliographic databases, 10 key journals, citations of relevant articles, and contact with authors. STUDY SELECTION: 26 trials described in 22 published and unpublished reports that randomised adolescents to an intervention or a control group (alternate intervention or nothing). DATA EXTRACTION: Two independent reviewers assessed methodological quality and abstracted data. DATA SYNTHESIS: The interventions did not delay initiation of sexual intercourse in young women (pooled odds ratio 1.12; 95% confidence interval 0.96 to 1.30) or young men (0.99; 0.84 to 1.16); did not improve use of birth control by young women at every intercourse (0.95; 0.69 to 1.30) or at last intercourse (1.05; 0.50 to 2.19) or by young men at every intercourse (0.90; 0.70 to 1.16) or at last intercourse (1.25; 0.99 to 1.59); and did not reduce pregnancy rates in young women (1.04; 0.78 to 1.40). Four abstinence programmes and one school based sex education programme were associated with an increase in number of pregnancies among partners of young male participants (1.54; 1.03 to 2.29). There were significantly fewer pregnancies in young women who received a multifaceted programme (0.41; 0.20 to 0.83), though baseline differences in this study favoured the intervention. CONCLUSIONS: Primary prevention strategies evaluated to date do not delay the initiation of sexual intercourse, improve use of birth control among young men and women, or reduce the number of pregnancies in young women.

Adolescent↗

PubMed2001

Cost-effectiveness of the implantable cardioverter-defibrillator: results from the Canadian Implantable Defibrillator Study (CIDS).

BACKGROUND: In the Canadian Implantable Defibrillator Study (CIDS), we assessed the cost-effectiveness of the implantable cardioverter-defibrillator (ICD) in reducing the risk of death in survivors of previous ventricular tachycardia (VT) or fibrillation (VF). METHODS AND RESULTS: Healthcare resource use was collected prospectively on the first 430 patients enrolled in CIDS (n=212 ICD, n=218 amiodarone). Mean cost per patient, adjusted for censoring, was computed for each group based on initial therapy assignment. Incremental cost-effectiveness of ICD therapy was computed as the ratio of the difference in cost (ICD minus amiodarone) to the difference in life expectancy (both discounted at 3% per year). All costs are in 1999 Canadian dollars (C$1 approximately US$0.65). Over 6.3 years, mean cost per patient in the ICD group was C$87 715 versus C$38 600 in the amiodarone group (difference C$49 115; 95% CI C$25 502 to C$69 508). Life expectancy for the ICD group was 4.58 years versus 4.35 years for amiodarone (difference 0.23, 95% CI -0.09 to 0.55), for incremental cost-effectiveness of ICD therapy of C$213 543 per life-year gained. ICD benefit was greater in patients with low left ventricular ejection fraction (<35%), and cost-effectiveness in this group was more attractive (C$108 484). Alternative extrapolations of survival benefit and costs to 12 years indicated cost-effectiveness in the range of C$100 000 to C$150 000 per life-year gained. CONCLUSIONS: At C$213 543, the value for the money offered by ICD therapy is not attractive by currently accepted standards. Further research is warranted to identify the indications and patient subgroups for whom ICDs are a cost-effective use of resources.

Cost-Benefit Analysis↗

PubMed2001

The randomized placebo-phase design for clinical trials.

Randomized controlled trials are the criterion standard method for evaluating the effectiveness of medical treatments. There are situations, however, where the possibility of being in the control group in a randomized controlled trial is unacceptable to potential subjects or their physicians. This lack of acceptance is a reason for poor accrual. We developed and validated a new clinical trial design for survival data that may allay concerns about not receiving an investigational product and should be more acceptable. Called the randomized placebo-phase design, this new design asks whether, on average, those subjects who begin active treatment sooner respond sooner than those who begin it later. Using Monte Carlo computer simulations, we demonstrated that the design is valid and may offer advantages over traditional randomized controlled trials in some situations. The randomized placebo-phase design may be especially useful when highly potent therapies for rare diseases are tested or when accrual may be otherwise difficult.

Humans↗

PubMed2001

Multiple courses of antenatal corticosteroids: a systematic review and meta-analysis.

OBJECTIVE: To assess the effects of multiple courses of antenatal corticosteroids on perinatal and neonatal death and neonatal, infant, and maternal disease. METHODS: MEDLINE and Embase were searched for human studies published in English. Studies that compared multiple courses of antenatal corticosteroids versus a single course were included if they were published in full and were controlled for gestational age at birth. Meta-analyses (odds ratio and 95% confidence interval) were undertaken when possible. RESULTS: Eight observational studies were included. Selection bias was present in all studies. Multiple courses of antenatal corticosteroids were associated with a decreased risk of respiratory distress syndrome (odds ratio, 0.79; 95% confidence interval, 0.64 to 0.98) and patent ductus arteriosus (odds ratio, 0.56; 95% confidence interval, 0.35 to 0.90) and were associated with an increased risk of endometritis (odds ratio, 3.42; 95% confidence interval, 1.92 to 6.11). There was no significant effect on other neonatal and maternal outcomes. CONCLUSION: It is not possible to establish the true effects of multiple courses of antenatal corticosteroids by a review of the results of observational studies because of the effect of confounding variables. Randomized controlled trials are needed to address this important issue.

Adrenal Cortex Hormones↗

PubMed2000

Effect of smoking cessation on mortality after myocardial infarction: meta-analysis of cohort studies.

OBJECTIVE: To determine the effect of smoking cessation on mortality after myocardial infarction. DATA SOURCES: English- and non-English-language articles published from 1966 through 1996 retrieved using keyword searches of MEDLINE and EMBASE supplemented by letters to authors and searching bibliographies of reviews. STUDY SELECTION: Selection of relevant abstracts and articles was performed by 2 independent reviewers. Articles were chosen that reported the results of cohort studies examining mortality in patients who quit vs continued smoking after myocardial infarction. DATA EXTRACTION: Mortality data were extracted from the selected articles by 2 independent reviewers. DATA SYNTHESIS: Twelve studies were included containing data on 5878 patients. The studies took place in 6 countries between 1949 and 1988. Duration of follow-up ranged from 2 to 10 years. All studies showed a mortality benefit associated with smoking cessation. The combined odds ratio based on a random effects model for death after myocardial infarction in those who quit smoking was 0.54 (95% confidence interval, 0.46-0.62). Relative risk reductions across studies ranged from 15% to 61%. The number needed to quit smoking to save 1 life is 13 assuming a mortality rate of 20% in continuing smokers. The mortality benefit was consistent regardless of sex, duration of follow-up, study site, and time period. CONCLUSION: Results of several cohort studies suggest that smoking cessation after myocardial infarction is associated with a significant decrease in mortality.

Age Factors↗

PubMed2000

Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial.

CONTEXT: Although advance directives are commonly used in the community, little is known about the effects of their systematic implementation. OBJECTIVES: To examine the effect of systematically implementing an advance directive in nursing homes on patient and family satisfaction with involvement in decision making and on health care costs. DESIGN: Randomized controlled trial conducted June 1, 1994, to August 31, 1998. SETTING AND PARTICIPANTS: A total of 1292 residents in 6 Ontario nursing homes with more than 100 residents each. INTERVENTION: The Let Me Decide advance directive program included educating staff in local hospitals and nursing homes, residents, and families about advance directives and offering competent residents or next-of-kin of mentally incompetent residents an advance directive that provided a range of health care choices for life-threatening illness, cardiac arrest, and nutrition. The 6 nursing homes were pair-matched on key characteristics, and 1 home per pair was randomized to take part in the program. Control nursing homes continued with prior policies concerning advance directives. MAIN OUTCOME MEASURES: Residents' and families' satisfaction with health care and health care services utilization over 18 months, compared between intervention and control nursing homes. RESULTS: Of 527 participating residents in intervention nursing homes, 49% of competent residents and 78% of families of incompetent residents completed advance directives. Satisfaction was not significantly different in intervention and control nursing homes. The mean difference (scale, 1-7) between intervention and control homes was -0.16 (95 % confidence interval [CI], -0.41 to 0.10) for competent residents and 0.07 (95% CI, -0.08 to 0.23) for families of incompetent residents. Intervention nursing homes reported fewer hospitalizations per resident (mean, 0.27 vs 0.48; P = .001) and less resource use (average total cost per patient, Can $3490 vs Can $5239; P = .01) than control nursing homes. Proportion of deaths in intervention (24%) and control (28%) nursing homes were similar (P = .20). CONCLUSION: Our data suggest that systematic implementation of a program to increase use of advance directives reduces health care services utilization without affecting satisfaction or mortality.

Advance Directives↗

PubMed2000

Will the use of low-molecular-weight heparin (enoxaparin) in patients with acute coronary syndrome save costs in Canada?

BACKGROUND: One-year follow-up data from the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events (ESSENCE) trial show that use of low-molecular-weight heparin (enoxaparin) compared with unfractionated heparin in patients hospitalized with unstable angina or non-Q-wave myocardial infarction is associated with a 10% reduction in the cumulative 1-year risk of death, myocardial infarction, or recurrent angina. Given the higher acquisition cost of enoxaparin relative to unfractionated heparin, we assessed whether the reduced use of revascularization procedures and related care makes enoxaparin a cost-saving therapy in Canada. METHODS AND RESULTS: We analyzed cumulative 1-year resource use data on the 1259 ESSENCE patients enrolled in Canadian centers (40% of the total ESSENCE sample). Patient-specific data on use of drugs, diagnostic cardiac catheterization, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, and hospital days were available from the initial hospital stay and cumulative to 1 year. Hospital resources were costed with the use of data from a teaching hospital in southern Ontario that is a participant in the Ontario Case Costing Project. During the initial hospital stay, use of enoxaparin was associated with reduced use of diagnostic catheterization and revascularization procedures, with the largest effect being reduced use of percutaneous transluminal coronary angioplasty (15.0% vs 10.6%; P =.03). At 1 year, the reduced risk and costs of revascularization more than offset increased drug costs for enoxaparin, producing a cost-saving per patient of $1485 (95% confidence interval $-93 to $3167; P =.06). Sensitivity analysis with lower hospital per diem costs from a community hospital in Ontario still predicts cost savings of $1075 per patient over a period of 1 year. CONCLUSIONS: The acquisition and administration cost of enoxaparin is higher than for unfractionated heparin ($101 vs $39), but in patients with acute coronary syndrome, the reduced need for hospitalization and revascularization over a period of 1 year more than offsets this initial difference in cost. Evidence from this Canadian substudy of ESSENCE supports the view that enoxaparin is less costly and more effective than unfractionated heparin in this indication.

Adult↗

PubMed2000

Prelabor rupture of the membranes at term: expectant management at home or in hospital? The TermPROM Study Group.

OBJECTIVE: To determine whether adverse effects of expectant management for premature rupture of membranes (PROM) at term and patient satisfaction were greater if women were managed at home rather than in a hospital. METHODS: We undertook a secondary analysis of data from the International TermPROM Study for women managed expectantly at home or in a hospital. Using multiple logistic regression analyses, we determined the effect of home and hospital management and controlled for differences in baseline characteristics, in measures of maternal and neonatal infections and rates of cesarean. RESULTS: Six hundred fifty-three women (39.1%) were managed at home, and 1017 (60.9%) in a hospital. Management at home, compared with in a hospital, increased risk of nulliparas needing antibiotics before delivery (odds ratio [OR] 1.52 95% confidence interval [CI] 1.04, 2.24, P =.03), those not colonized with group B streptococcus having cesareans (OR 1.48 95% CI 1.03, 2. 14, P =.04), and neonatal infections (OR 1.97 95% CI 1.00, 3.90, P =. 05). More multiparas managed at home said they would participate in the study again (OR 1.80 95% CI 1.27, 2.54, P <.001). CONCLUSION: Expectant management at home, rather than in a hospital, might increase the likelihood of some adverse outcomes.

Adult↗

PubMed2000

Randomized trials versus observational studies in adolescent pregnancy prevention.

The objective of this study is to compare the results of randomized trials and observational studies of interventions to prevent adolescent pregnancy. We identified published and unpublished reports through computerized searches of CATLINE, CINAHL, CONFERENCE PAPERS INDEX, DISSERTATION ABSTRACTS ONLINE, EMBASE, ERIC, MEDLINE, NTIS, POPLINE, PsycINFO, and SOCIOLOGICAL ABSTRACTS; manual searches of eight relevant journals; reference lists from primary articles; and contact with content experts. We included randomized trials and observational studies that evaluated the impact of primary prevention interventions including sex education classes, school-based clinics, free-standing clinics, physician/nurse practitioner practice-based service, improved access, and community-based programs on four outcomes: sexual intercourse, birth control use, responsible sexual behavior, or pregnancy in adolescents. One investigator abstracted the data and a second conducted a detailed review of the abstraction. We identified 13 randomized trials and 17 observational studies. We generated estimates of the impact of the interventions separately for males and females for all four outcomes for both observational studies and randomized trials. For six of the eight outcomes the summary odds ratios for the observational studies showed a significant intervention benefit (P<0.05) while the randomized trials did not show a benefit for any outcome in either females or males. The difference between the results of the observational studies and randomized trials was statistically significant in two of the eight outcomes (P<0.05 for initiation of intercourse and pregnancy in females). Observational studies yield systematically greater estimates of treatment effects than randomized trials of adolescent pregnancy prevention interventions. Public policy or individual patient treatment decisions should be based on observational studies only when randomized trials are unavailable and only with careful consideration of possible biases.

Adolescent↗

PubMed1999

Economic evaluation of outpatient treatment with low-molecular-weight heparin for proximal vein thrombosis.

BACKGROUND: The safety and efficacy of taking low-molecular-weight heparin at home was previously demonstrated in a clinical trial in which patients with acute proximal deep vein thrombosis were randomized to receive either intravenous standard heparin in the hospital or subcutaneous low-molecular-weight heparin administered primarily at home. Treatment in the home has the potential to substantially reduce the cost to the health care system. METHODS: To conduct an economic evaluation we prospectively collected data on resource use and health-related quality of life (Medical Outcomes Study Short-Form 36) on the 300 patients who formed the trial stratum presenting with proximal vein thrombosis as outpatients, of whom 151 received standard heparin and 149 received low-molecular-weight heparin. The primary viewpoint of the analysis was societal, and costs included health care costs, patient travel costs, and productivity costs as a result of time off work. Costs were assessed over a period of 3 months from randomization. Quality of life was assessed as the change in Short-Form 36 domain scores from baseline to day 7 for each treatment group. All costs are reported in 1997 Canadian dollars. RESULTS: There were 11 recurrent thromboembolic events and 1 bleed in the 151 patients who received standard heparin; the corresponding data for the 149 patients receiving low-molecular-weight heparin were 10 and 4, respectively. The mean cost per patient who received standard heparin was Can $5323 compared with Can $2278 for low-molecular-weight heparin, a total societal cost savings per patient using low-molecular-weight heparin of Can $3045 (95% confidence interval, Can $2012-$4050). There was no difference in quality of life between the 2 groups except for the domain of social functioning, where a greater improvement from baseline to day 7 was observed for the low-molecular-weight heparin group vs the standard heparin group (P =.005). CONCLUSIONS: For patients with acute proximal deep vein thrombosis, treatment at home with low-molecular-weight heparin is less costly than hospital-based treatment with standard heparin. The economic evidence in favor of outpatient treatment with low-molecular-weight heparin exhibits dominance; a situation of reduced cost is created with no compromise in clinical outcomes or patients' quality of life.

Adult↗

PubMed1999

Mastectomy or lumpectomy? Helping women make informed choices.

PURPOSE: To develop an instrument to help clinicians inform their patients about surgical treatment options for the treatment of breast cancer and to evaluate the impact of the instrument on the clinical encounter. METHODS: We developed an instrument, called the Decision Board, to present information regarding the benefits and risks of breast-conserving therapy (lumpectomy plus radiation therapy) and mastectomy to women with early-stage breast cancer to enable them to express a preference for the type of surgery. Seven surgeons from different communities in Ontario administered the instrument to women with newly diagnosed clinical stage I or II breast cancer over an 18-month period. Patients and surgeons were interviewed regarding acceptability of the instrument. The rates of breast-conserving surgery performed by surgeons before and after the introduction of the instrument were compared. RESULTS: The Decision Board was administered to 175 patients; 98% reported that the Decision Board was easy to understand, and 81% indicated that it helped them make a decision. The average score on a true/false test of comprehension was 11.8 of 14 (84%) (range, 6 to 14). Surgeons found the Decision Board to be helpful in presenting information to patients in 91% of consultations. The rate of breast-conserving surgery decreased when the Decision Board was introduced (88% v 73%, P =.001) CONCLUSION: The Decision Board is a simple method to improve communication and facilitate shared decision making. It was well accepted by patients and surgeons and easily applied in the community.

Adult↗

PubMed1999

Economic evaluation of long-term management strategies for erosive oesophagitis.

OBJECTIVE: To compare the expected costs and outcomes of alternative strategies for the management of patients with erosive oesophagitis. DESIGN: There were 3 components to the overall analytic approach. First, a decision model was constructed to compare expected costs and outcomes of 6 management strategies. Second, principles of quantitative literature review and meta-analysis were used to determine probabilities of clinical events (i.e. oesophagitis healing and recurrence). Finally, principles of cost-effectiveness analysis were used to compare treatment alternatives in terms of dominance and incremental cost effectiveness. The viewpoint for the study was that of a provincial government payer for healthcare over a 1-year period. MAIN OUTCOME MEASURES AND RESULTS: Healing rates were significantly higher for proton pump inhibitors (PPI) [p < 0.001]. Recurrence rates were significantly higher for intermittent therapy (placebo) and lower for regular dose PPI (p < 0.001). Maintenance prokinetic agent (PA) is dominated (i.e. more costly and less effective) and step-down maintenance PPI is dominated through principles of extended dominance. The 'efficient frontier' is represented by: maintenance H2-receptor antagonist (H2RA), intermittent PPI, step-down maintenance H2RA and maintenance PPI. CONCLUSIONS: The price of H2RA is a key factor influencing whether step-down maintenance PPI forms part of, or is contained within, the 'efficient frontier' of long term management for erosive oesophagitis.

Costs and Cost Analysis↗

PubMed1998

Evaluation of a patient file folder to improve the dissemination of written information materials for cancer patients.

BACKGROUND: Many cancer centers make available to patients written information material to supplement verbal information provided by clinicians. Randomized trials have demonstrated that providing such information can increase patient knowledge and satisfaction. However, little data are available regarding effective means of dissemination of such materials. The purpose of this study was to determine whether providing patients with a personal file folder after their first clinic appointment would improve the dissemination of written information materials and increase patient satisfaction. METHODS: A before/after study was performed. Consecutive patients with newly diagnosed cancer attending the Hamilton Regional Cancer Centre were selected randomly and interviewed by telephone within 1-2 weeks of the first clinic appointment regarding the number of information pamphlets received, patient satisfaction, and general preference for written information materials. The preintervention evaluation (T1) occurred over a 4-month period followed by the introduction of the personal file folder into the clinical practice. Six weeks after its introduction, the postintervention (T2) evaluation took place over the ensuing 4 months. RESULTS: A total of 300 patients completed the evaluation (150 each in T1 and T2). Responding patients in the two time periods were comparable with respect to background demographic variables. The mean number of information pamphlets received by patients increased with the introduction of the personal file folder from 2.4+/-2.0 standard deviations (SD) in T1 to 3.6+/-2.5 SD in T2 (P=0.0001). The percentage of patients planned for treatment who received treatment-related information increased from 36% (42 of 116 patients) in T1 to 65% (68 of 105 patients) in T2 (P=0.002). Mean patient satisfaction increased from 3.3+/-1.1 SD to 3.8+/-1.0 SD over the 2 time periods (P=0.0001). The majority of patients (87%) believed it was important to receive written information materials. CONCLUSIONS: The patient file folder increased the dissemination of written information materials and currently is being incorporated into routine practice.

Attitude↗

PubMed1998

Impact of age and cranial irradiation on radiographic skeletal pathology in children with acute lymphoblastic leukemia.

BACKGROUND: Symptomatic osteopenia is a common form of morbidity in children with acute lymphoblastic leukemia (ALL) before, during, and after treatment. A causal role for corticosteroids has been proposed, but other investigators have suggested that cranial irradiation is an important factor contributing to this disorder. PROCEDURE: In this study of children with ALL, all of whom received steroids, skeletal morbidity was assessed radiographically by an observer who was blinded to the ages of the children, their risk categorization (and related treatment), and the timing of the assessments with respect to the administration of therapy. DISCUSSION: Skeletal morbidity was most prevalent in older subjects who had been given cranial radiotherapy. However, there was no difference in the frequency of fractures in two groups of younger children (< or = 9 years of age), one irradiated and the other not. CONCLUSIONS: It is likely that corticosteroid therapy plays an important part in the pathogenesis of this disorder. The role played by cranial irradiation is much less certain.

Age Factors↗

PubMed1997

Evaluation of an educational program to prevent adolescent pregnancy.

The authors evaluated the effectiveness of a school-based sex education program in decreasing rates of sexual intercourse, improving birth control use, and decreasing the incidence of pregnancies among teenagers 16 years of age and younger. Twenty-one schools received either the McMaster Teen Program or the conventional didactic sex education program. Preprogram, the mean age of the students was 12.6 years. There were no statistically significant differences between groups in time to first sexual activity for males, chi 2(1) = 2.93, p = 0.09; time to first sexual activity for females, chi 2(1) = 0.50, p = 0.48; and time to first pregnancy, chi 2(1) = 1.90, p = 0.17. Significantly more experimental group males reported always using birth control at year 1 (difference 8.9%; 95% confidence interval [CI] = 0.4, 17.4). Limitations of the program that may have influenced the results were the exclusion of contraception information and its short duration.

Adolescent↗

PubMed1996

Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group.

BACKGROUND: Breast-conservation surgery is now commonly used to treat breast cancer. Postoperative breast irradiation reduces cancer recurrence in the breast. There is still controversy concerning the necessity of irradiation of the breast in all patients. PURPOSE: We present an update of results from a randomized clinical trial designed to examine the efficacy of breast irradiation following conservation surgery in the treatment of women with axillary lymph node-negative breast cancer. The patients were enrolled from April 1984 through February 1989. Initial results were published in 1992 after a median follow-up time of 43 months. It was reported that recurrence of cancer in the breast occurred in 5.5% of the patients who received breast irradiation compared with 25.7% of those who did not. No difference in survival was detected between the two treatment groups. Now that the median patient follow-up has reached 7.6 years, the trial end points have been re-examined and an attempt has again been made to identify a group of patients at low risk for recurrence of cancer in the breast. METHODS: Eight hundred thirty-seven patients with node-negative breast cancer were randomly assigned to receive either radiation therapy (n = 416) or no radiation therapy (n = 421) following lumpectomy and axillary lymph node dissection. The cumulative local recurrence rate as a first event, distant recurrence (i.e., occurrence of metastasis) rate, and overall mortality rate for the treatment groups were described by the Kaplan-Meier method and compared with the use of the logrank test. The Cox proportional hazards model was used to adjust the observed treatment effect for the influence of various prognostic factors (patient age, tumor size, estrogen receptor level, and tumor histology) at study entry on the outcomes of local breast recurrence, distant recurrence, and overall mortality. All P values resulted from the use of two-tailed statistical tests. RESULTS: One hundred forty eight (35%) of the nonirradiated patients and 47 (11%) of the irradiated patients developed recurrent cancer in the breast (relative risk for patients in the former versus the latter group = 4.0; 95% confidence interval = 2.83-5.65; P < .0001). Ninety-nine (24%) of the patients in the former group have died compared with 87 (21%) in the latter group. Age (< 50 years), tumor size (> 2 cm), and tumor nuclear grade (poor) continued to be important predictors for local breast relapse. On the basis of these factors, we were unable to identify a subgroup of patients with a very low risk for local breast cancer recurrence. Tumor nuclear grade, as previously reported, and tumor size were important predictors for mortality. CONCLUSIONS: Breast irradiation was shown to reduce cancer recurrence in the breast, but there was no statistically significant reduction in mortality. A subgroup of patients with a very low risk for local breast recurrence who might not require radiation therapy was not identified.

Adult↗