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1.  Predicting Radiation Pneumonitis after Chemoradiotherapy for Lung Cancer: An International Individual Patient Data Meta-analysis 
Background
Radiation pneumonitis is a dose-limiting toxicity for patients undergoing concurrent chemoradiation therapy (CCRT) for non-small cell lung cancer (NSCLC). We performed an individual patient data meta-analysis to determine factors predictive of clinically significant pneumonitis.
Methods
After a systematic review of the literature, data was obtained on 836 patients who underwent CCRT in Europe, North America and Asia. Patients were randomly divided into training and validation sets (2/3 vs. 1/3 of patients). Factors predictive of symptomatic pneumonitis (grade ≥ 2 by one of several scoring systems) or fatal pneumonitis were evaluated using logistic regression. Recursive partitioning analysis (RPA) was used to define risk groups.
Results
The median radiotherapy dose was 60 Gy, and median follow-up was 2.3 years. Most patients received concurrent cisplatin/etoposide (38%) or carboplatin/paclitaxel (26%). The overall rate of symptomatic pneumonitis was 29.8% (n=249), with fatal pneumonitis in 1.9% (n=16). In the training set, factors predictive of symptomatic pneumonitis were lung volume receiving ≥20 Gy (V20) [OR:1.03 per 1% increase, p=0.008], and carboplatin/paclitaxel chemotherapy [OR:3.33, p<0.001], with a trend for age [OR: 1.24 per decade, p=0.09]; the model remained predictive in the validation set with good discrimination in both datasets (c-statistic>0.65). On RPA, the highest risk of pneumonitis (>50%) was in patients >65 years of age receiving carboplatin/paclitaxel. Predictors of fatal pneumonitis were daily dose >2 Gy, V20, and lower-lobe tumor location.
Conclusions
Several treatment-related risk factors predict the development of symptomatic pneumonitis, and elderly patients who undergo CCRT with carboplatin-paclitaxel chemotherapy are at highest risk. Fatal pneumonitis, although uncommon, is related to dosimetric factors and tumor location.
doi:10.1016/j.ijrobp.2012.04.043
PMCID: PMC3448004  PMID: 22682812
Non-small cell lung cancer; radiotherapy; chemotherapy; pneumonitis
2.  Safety and efficiency assessment of training Canadian cardiac surgery residents to perform aortic valve surgery 
Canadian Journal of Surgery  2013;56(3):180-186.
Background
Research has demonstrated equivalent patient safety outcomes for various cardiac procedures when the primary surgeon was a supervised trainee. However, cardiac surgery cases have become more complex, and the Canadian cardiac surgery education model has undergone some changes. We sought to compare patient safety and efficiency of aortic valve replacement (AVR) between Canadian patients treated by senior cardiac trainees and those treated by certified cardiac surgeons.
Methods
We completed a single-centre, case-matched, prospectively collected and retrospectively analyzed study of AVR. Patients were matched between trainees and consultants for age, sex, New York Heart Association and Canadian Cardiovascular Society status, urgency of operation and diabetes status.
Results
We analyzed 1102 procedures: 624 isolated AVRs and 478 AVRs with coronary artery bypass graft (CABG). For isolated AVR, there was no significant difference in 30-d mortality (p = 0.13) or in major adverse events (p = 0.38) between the groups. In the AVR+CABG group, there was no significant difference in 30-day mortality (p = 0.10) or in the rates of major adverse events (p = 0.37) between the groups. Secondary outcomes (hospital and intensive care unit lengths of stay, valve size and type) did not differ significantly between the groups for isolated AVR or AVR+CABG.
Conclusion
Despite a higher-risk patient population and changes in the cardiac surgery training model, it appears that outcomes are not negatively affected when a senior trainee acts as the primary surgeon in cases of AVR.
doi:10.1503/cjs.033111
PMCID: PMC3672431  PMID: 23484469
3.  Added-value of SPECT/CT to lymphatic mapping and sentinel lymphadenectomy in gynaecological cancers 
Lymphatic mapping and sentinel lymphadenectomy (LM/SL) have been successfully used in pre-treatment nodal staging of gynaecological cancers. We hypothesised the added-value of LM/SL plus SPECT/CT in patients with early stage of cervical cancer and vulvar cancer. A prospective, single-center, diagnostic, open label, active control, non-randomized clinical trial has been conducted in 7 patients with FIGO IA-IB1 cervical cancer and 7 patients with FIGO stage I-II-IIIcN0 vulvar cancer. All patients underwent LM/SL plus SPECT/low-dose CT and complete lymph node dissection (CLND) according to the standard of care. In case of negative hematoxylin-eosin staining, serial sections of the SLNs were analysed by immunohistochemistry and high molecular weight cytokeratin. Primary outcome measures were the detection rate, the sensitivity (SV), the negative predictive value (NPV), the diagnostic accuracy (DA) for anatomic localisation of SLNs, and the impact on management of SPECT/CT guided LM/SL versus CLND. The secondary outcome measure was the patient tolerability and operating time of LM/SL guided SPECT/CT versus CLND. http://clinicaltrials.gov/show/NCT00773071 All 14 patients were enrolled into the 1-day research protocol with dual-tracer LM/SL and SPECT/CT. Additional SLNs were detected on SPECT/CT compared to conventional planar imaging. Hot and cold > 1cm SLNs were detected on SPECT/CT. Detection rate, SV, NPV, DA were 100% in both groups; false negative rate was 0%. Rate of SLN metastases was 28.5% in cervical cancer and 42.9% in vulvar cancer. Impact on treatment was 28.5% and 14.3% in cervical cancer and vulvar cancer patients, respectively. SPECT/CT was well tolerated by all patients and operating time for LM/SL was within 30 min. No adverse events were reported with a time frame of 1-to-3 years. In early stage of gynaecological cancers, SPECT/low-dose CT is technically feasible and of clinical added-value for LM/SL.
PMCID: PMC3601478  PMID: 23526734
LM/SL; SPECT/CT; vulvar cancer; cervical cancer
4.  Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial 
Background:
International guidelines for the management of nonvariceal upper gastrointestinal bleeding have not been widely adopted in clinical practice. We sought to determine whether a national, multifaceted intervention could improve adherence to guidelines, especially for patients at high risk of nonvariceal upper gastrointestinal bleeding.
Methods:
In this randomized trial, we stratified hospitals by region and size and allocated sites to either the control or experimental group. Health care workers in the experimental group were given published guidelines, generic algorithms, stratification scoring systems and written reminders and attended multidisciplinary guideline education groups and case-based workshops. These interventions were implemented over a 12-month period after randomization, with performance feedback and benchmarking. The primary outcome of adherence rates to key guidelines in endoscopic and pharmacologic management, determined by chart review, was adjusted according to site characteristics and possible within-site dependencies. We also report the rates of adherence to other recommendations.
Results:
Forty-three sites were randomized to the experimental (n = 21) or control (n = 22) groups. In our primary analysis, we compared patients before (experimental group: n = 402 patients; control group: n = 424 patients) and after (experimental group: n = 361 patients; control group: n = 389 patients) intervention. Patient-level analysis revealed no significant difference in adherence rates to the guidelines after the intervention (experimental group: 9.8%; control group: 4.8%; p = 0.99) after adjustment for the rate of adherence before the intervention (experimental group: 13.2%; control group: 7.1%). The adherence rates to other guidelines were similar and decreased over time, varying between 5% and 93%.
Interpretation:
This national knowledge translation–based trial suggests poor adherence to guidelines on nonvariceal upper gastrointestinal bleeding. Adherence was not improved by an educational intervention, which highlights both the complexity and poor predictability of attempting to alter the behaviour of health care providers (Trial registration: ClinicalTrials.gov, no. MCT-88113).
doi:10.1503/cmaj.120095
PMCID: PMC3576461  PMID: 23318399
5.  Reducing treatment delay for early intervention: evaluation of a community based crisis helpline 
Background
A limited number of studies have assessed the pathways to care of patients experiencing psychosis for the first time. Helpline/clinic programs may offer patients who are still functional but have potential for crisis an alternative that is free from judgment.
Methods
In this study we report on patient calling a round-the-clock crisis helpline for suicide prevention supported by psychiatric facilities in Mumbai, India. Chi-square and test of mean differences were used to compare outcomes between first-episode patients and those with a previous history.
Results
Within five years, the helpline received 15,169 calls. Of those callers, 2341 (15.4%) experienced suicidal ideation. Two hundred and thirty four patients opting for counseling lasting 12 months agreed to a psychiatric assessment. Of those, 32 were fist time psychosis sufferers, whereas, 54 had previously been psychotic. Of all psychiatric assessments, the clinic received 94 patients with ‘first-episode psychosis’. We found that the duration of illness was significantly shorter (17 vs. 28 months) and suicide attempts were fewer (16 vs. 21) in first-time psychosis sufferers compared to those with a treatment history.
Conclusions
We conclude that some first-episode patients of schizophrenia and other disorders do access services by using helplines. We also argue that helplines may be somewhat immune to stigma, allowing patients a safe alternative when finding help.
doi:10.1186/1744-859X-11-20
PMCID: PMC3416718  PMID: 22827835
Helpline; Stigma; Psychosis; Early intervention; Duration of treatment
6.  Atypical antipsychotics usage in long-term follow-up of first episode schizophrenia 
Indian Journal of Psychiatry  2012;54(3):248-252.
Background:
It is not clear if the role of antipsychotics in long-term clinical and functional recovery from schizophrenia is correlated. The pattern of use is a major aspect of pharmacotherapy in long-term follow-ups of schizophrenia. The aim of this study was to examine patterns of antipsychotic usage in patients with longstanding psychosis and their relationship to social outcomes.
Materials and Methods:
We conducted a cross-sectional study on a cohort from a long-term outcome study. Participants were 116 first episode schizophrenia patients from Mumbai, India, who had more than 80% compliance, as reported by relatives. Patients were assessed on antipsychotic medication use and on clinical and functional parameters.
Results:
There was a high compliance rate (72%). Most patients (77%) used atypical antipsychotics; only 10 (8.6%) patients were taking typical antipsychotics. There were no among-drug differences in the percentage of patients meeting the recommended dose: Clozapine (200–500 mg), Riseperidone (4.0–6.0 mg), Olanzapine (10–20 mg), Quetiapine (400–800 mg), Aripiprazole (15–30 mg), Ziprasidone (120–160 mg); an equivalent dosage of Chlorpromazine (300–600 mg) did not differ amongst any atypical antipsychotic subgroup. Also, we did not find any significant differences in recovery on Clinical Global Impression Severity scale (CGIS), Quality of Life (QOL), or Global Assessment of Functioning (GAF) between groups of antipsychotic drugs.
Conclusion:
This study shows that most patients suffering from schizophrenia, in a long-term follow-up, use prescribed atypical antipsychotics within the recommended limits. Also, the chlorpromazine equivalence dosages do not differ across antipsychotic medications. The outcomes on clinical and functional parameters are also similar across all second-generation antipsychotics.
doi:10.4103/0019-5545.102425
PMCID: PMC3512362  PMID: 23226849
Antipsychotics; long-term outcome; prescribing; schizophrenia
7.  Consolidative high-dose chemotherapy after conventional-dose chemotherapy as first salvage treatment for male patients with metastatic germ cell tumours 
Introduction:
Some men with metastatic germ cell tumours that have progressed after response to initial cisplatin-based combination chemotherapy are cured with conventional dose first salvage chemotherapy (CDCT) – however, many are not. High-dose chemotherapy with autologous stem cell rescue (HDCT) may be of value in these patients. Prognosis has recently been better defined by International Prognostic Factor Study Group (IPFSG) prognostic factors. HDCT after response to CDCT has been offered at our institution over the past two decades. We retrospectively assessed the validity of the IPFSG prognostic factors in our patients and evaluated the value of HDCT.
Methods:
We identified eligible men with metastatic germ cell tumour progressed after at least 3 cycles of cisplatin-based chemotherapy and treated with cisplatin-based CDCT alone or with carboplatin-based HDCT. We also collected their clinical data. Patients were classified into risk groups using IPFSG factors, and progression-free and overall survival factors were analyzed and compared in patients treated with CDCT alone and with HDCT.
Results:
We identified 38 eligible first salvage patients who had received a median of 4 cycles (range, 1 to 7 cycles) of CDCT. Twenty patients received CDCT alone and 18 patients received CDCT plus HDCT. The overall median progression- free survival was 24.6 months (95%CI, 7.3 to 28.7 months) and overall median overall survival was 34.6 months (95%CI, 17.2 to 51.3 months). Distribution by IPFSG category and 2-year progression- free survival and 3-year overall survival rates within each risk category were very similar to the IPFSG results. There were two toxic deaths with CDCT and none with HDCT. Overall, patients treated with CDCT plus HDCT had improved progression- free survival and overall survival.
Conclusions:
The IPFSG prognostic risk factors appeared valid in our patient population. The safety of HDCT with etoposide and carboplatin was confirmed. HDCT was associated with improved progression- free survival and overall survival outcomes, consistent with observations of the IPFSG group. Ideally, the value of optimal HDCT should be determined in comparison to optimal CDCT as first salvage therapy in men with metastatic germ cell tumour with a randomized trial.
doi:10.5489/cuaj.11233
PMCID: PMC3328550  PMID: 22511417
8.  How long can patients with renal cell carcinoma wait for surgery without compromising pathological outcomes? 
Introduction:
Surgical wait times have been shown to be of significance in other malignancies, but limited studies exist in renal cell cancer (RCC). We analyzed surgical waiting time for RCC patients to see if there was an adverse impact on pathological characteristics.
Methods:
Our centre triages RCC patients on the basis of perceived tumour risk. The waiting time for surgery is adjusted stage for stage: clinical T1 at 90 days, T2 at 40 days, T3 and T4 at 30 days. We retrospectively reviewed the charts of 354 patients who underwent surgery for RCC. Patients were assessed for pathological upstaging, positive lymph nodes, tumour recurrence and tumour size within each stage. Analysis was performed, using surgical waiting time as a categorical variable, to test for associations with disease recurrence or adverse pathological characteristics.
Results:
The median time from the first consultation to surgery was 41 days and the mean follow-up was 26.6 months. Waiting time stage for stage was: clinical T1 at 57.12 days, clinical T2 at 36.8 days, clinical T3 and T4 at 30.32 days. On multivariate analysis, pathological tumour size was associated with progression, whereas no significant association was found between waiting time and upstaging. Higher stage tumours, sarcomatoid pathology and clinical evidence of progression were associated with shorter waiting times for early interventions.
Conclusions:
There was no statistically significant evidence for upstaging or progression during the waiting period for our group of patients. The data reinforce previous studies reporting a “safe” period of active surveillance in T1 RCC without affecting their final pathological outcome.
doi:10.5489/cuaj.10035
PMCID: PMC3235220  PMID: 21388587
10.  Persistent suicide risk in clinically improved schizophrenia patients: challenge of the suicidal dimension 
Background
Suicide is a major problem in schizophrenia, estimated to affect 9%–13% of patients. About 25% of schizophrenic patients make at least one suicide attempt in their lifetime. Current outcome measures do not address this problem, even though it affects quality of life and patient safety. The aim of this study was to assess suicidality in long-term clinically improved schizophrenia patients who were treated in a nongovernmental psychiatric treatment centre in Mumbai, India.
Method
Participants were 61 patients out of 200 consecutive hospitalized first-episode patients with schizophrenia diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders who were much improved on the Clinical Global Impression Scale-Improvement (CGI-I) scale at the endpoint of a 10-year follow-up. Clinical assessment tools included the Positive and Negative Syndrome Scale for Schizophrenia, CGI-I, Global Assessment of Functioning, and suicidality.
Results
Many of the patients, although clinically improved, experienced emerging suicidality during the 10-year follow-up period. All of the patients reported significant suicidality (ie, suicide attempts, suicidal crises, or suicidal ideation) at the end of the study, whereas only 83% had reported previous significant suicidality at baseline. No sociodemographic and clinical variables at baseline were predictive of suicidal status at the end of the 10-year follow-up.
Conclusion
Schizophrenia is a complex neurobehavioral disorder that appears to be closely associated with suicidal behavior. Adequate assessment and management of suicidality needs to be a continual process, even in patients who respond well to treatment.
doi:10.2147/NDT.S12044
PMCID: PMC2951746  PMID: 20957123
schizophrenia; suicide risk; prevention
11.  Predictors of long-term outcome of first-episode schizophrenia: A ten-year follow-up study 
Indian Journal of Psychiatry  2010;52(4):320-326.
Objective:
Schizophrenia is a severe mental disorder for which final outcomes continue to be unfavorable. The main objectives of this research were to examine and determine the baseline predictors of outcome status of first-episode schizophrenia in a long-term follow-up of ten years and of recovery ten years later.
Materials and Methods:
The study was carried out in a non-governmental, psychiatric hospital and participants consisted of patients available for assessment ten years following their initial diagnosis. Outcome was assessed on clinical and social parameters. Clinical measures of outcome included psychopathology, hospitalization, and suicidality. Social parameters included quality of life functioning, employability, interpersonal functioning, and the ability to live independently.
Results:
In our sample, mean positive symptoms’ score were reduced by more than 65% between baseline and endpoint. The percentage of reduction in scores of negative symptoms is much less than reduction in positive symptoms. It was observed that only 23-25% patients showed social recovery on two or three different parameters. Additionally, fewer negative symptoms, lower depression scores, and low levels of aggression at baseline predicted good outcome. A higher level of positive symptoms at baseline also predicted recovery. The two social variables that predicted later outcomes were initially high levels of work performance and the ability to live independently at baseline.
Conclusions:
Clinical information is not sufficient to make an accurate prediction of outcome status; rather, outcome depends upon multiple factors (including social parameters). A major implication of this research is the argument for moving toward a comprehensive assessment of outcome and to plan management accordingly. Bringing social outcome measures to the forefront and into the communities will allow for a more patient-centric approach. It also opens newer vistas for addressing the complex interaction of clinical and social parameters.
doi:10.4103/0019-5545.74306
PMCID: PMC3025157  PMID: 21267365
Follow-up studies; outcome assessment; psychosocial factors; schizophrenia; treatment outcome
12.  Impact of body mass index on perioperative outcomes during the learning curve for robot-assisted radical prostatectomy 
Introduction:
Previous studies of robotic-assisted radical prostatectomy (RARP) have suggested that obesity is a risk factor for worse perioperative outcomes. We evaluated whether body mass index (BMI) adversely affected perioperative outcomes.
Methods:
A prospective database of 153 RARP (single surgeon) was analyzed. Obesity was defined as BMI ≥ 30 kg/m2; normal BMI < 25 kg/m2; and overweight as 25 to 30 kg/m2. Two separate analyses were performed: the first 50 cases (the initial learning curve) and the entire cohort of 153 RARP.
Results:
In the initial cohort of 50 cases (14 obese patients), there was no statistically significant difference with regards to operative times, port-placement times and estimated blood loss (EBL). Length of stay (LOS) was longer in the obese group (4.3 vs. 2.9 days); BMI remained an independent predictor of increased LOS on multivariate linear regression analysis (p = 0.002). There was no statistically significant difference in the postoperative outcomes of leak rates, margin rates and incisional herniae. In the entire cohort, when comparing obese patients to those with a normal BMI, there was no statistically significant difference in operative times, EBL, LOS, or immediate postoperative outcomes. However, on multivariate linear regression analysis, BMI was an independent predictor of increased operative time (p = 0.007).
Conclusion:
Obese patients do not have an increased risk of blood loss, positive margins or the postoperative complications of incisional hernia and leak during the learning curve. They do, however, have slightly longer operative times; we also noted an increased LOS in our first 50 cases.
PMCID: PMC2910769  PMID: 20694101
13.  Effects of duration of untreated psychosis on long-term outcome of people hospitalized with first episode schizophrenia 
Indian Journal of Psychiatry  2010;52(2):164-167.
Duration of untreated psychosis (DUP) has emerged as a reliable predictor of outcome but continues to remain under scientific scrutiny. The present study examines the effect of differential periods of DUP on long-term outcome of first episode schizophrenia at Mumbai, India. This research was a prospective, 10-year follow-up naturalistic study. Hospitalized patients of first episode schizophrenia were selected and followed up. Results showed that the mean DUP was higher for a group which showed clinical recovery on Clinical Global Impression Scale [14.0 months (SD=8.0) in recovered and 10.8 months (SD=5.7) in non-recovered group (P=0.091)]. DUP was not found to be significantly associated with any of the end point parameters of good clinical or social outcome. Thus, this study found that DUP alone does not determine outcome status confirming the role of psychopathological heterogeneity.
doi:10.4103/0019-5545.64583
PMCID: PMC2927888  PMID: 20838506
Duration of untreated psychosis; first-episode schizophrenia; long-term outcome
14.  The abilities of improved schizophrenia patients to work and live independently in the community: a 10-year long-term outcome study from Mumbai, India 
Background
The outcome of first episode schizophrenia has several determinants. Socioecological factors, particularly living conditions, migration, community and culture, not only affect the level of risk but also the outcome. Mega cities around the world show a unique socioecological condition that has several challenges for mental health. The present study reports on the long-term status of patients with schizophrenia in such a mega city: Mumbai, India.
Aim
This study aims to reveal the long-term outcome of patients suffering from schizophrenia with special reference to clinical symptoms and social functioning.
Methods
The cohort for this study was drawn from a 10-year follow-up of first episode schizophrenia. Patients having completed 10 years of consistent treatment after first hospitalisation were assessed on psychopathological and recovery criteria. Clinical as well as social parameters of recovery were evaluated. Descriptive statistics with 95% confidence intervals are provided.
Results
Of 200 patients recruited at the beginning of this study, 122 patients (61%) were present in the city of Mumbai at the end of 10-year follow-up study period. Among 122 available patients, 101 patients (50.5%) were included in the assessment at the end of 10-year follow-up study period, 6 patients (3.0%) were excluded from the study due to changed diagnosis, and 15 patients (7.5%) were excluded due to admission into long-term care facilities. This indicates that 107 out of 122 available patients (87.7%) were living in the community with their families. Out of 101 (50.5%) patients assessed at the end of 10 years, 61 patients (30.5%) showed improved recovery on the Clinical Global Impression Scale, 40 patients (20%) revealed no improvement in the recovery, 43 patients (72.9%) were able to live independently, and 24 patients (40%) were able to find employment.
Conclusion
With 10 years of treatment, the recovery rate among schizophrenia patients in Mumbai was 30.5%. Among the patients, 87.7% of patients lived in the community, 72.9% of patients lived independently, and 40% of patients obtained employment. However, 60% of patients were unable to return to work, which highlights the need for continued monitoring and support to prevent the deterioration of health in these patients. It is likely that socioecological factors have played a role in this outcome.
doi:10.1186/1744-859X-8-24
PMCID: PMC2770563  PMID: 19825168
15.  The new cardiac surgery patient: defying previous expectations 
Canadian Journal of Surgery  2006;49(2):117-122.
Background
Studies conducted before 1999 of patients who had coronary artery bypass graft surgery (CABG) have shown a tendency toward increasing preoperative risk factors. This study examines whether this trend of increasing risk in patients who have cardiac surgery has continued since 1999 and whether its effect on mortality and morbidity has changed.
Methods
We prospectively collected data for 2754 patients who had cardiac surgery, divided them into 4 cohorts based on the year of operation (2000–2003) and analyzed the data according to 56 predefined preoperative, operative and postoperative variables.
Results
There were no significant changes in most preoperative risk factors over time, except for significant decreases in the proportion of elective (p = 0.016) and emergency/salvage operations (p < 0.001) and increases in urgent procedures and in the number of patients with congestive heart failure (CHF) (p < 0.001). The proportion of CABG procedures decreased significantly, whereas the proportion of valve, CABG plus valve, and non-CABG surgeries increased. A significant increase in multiarterial graft use and a decrease in off-pump coronary artery bypass procedures were observed. Postoperative complication rates did not change during the 4 years except for a significant decrease in wound infections. No significant changes in overall mortality and mortality across types of procedure were observed. Median observed/expected ratios for expected length of stay in hospital and risk of mortality did not change significantly over time.
Conclusion
Patients' risk factors, except for CHF, did not change from 2000 to 2003. Despite more complicated procedures, the postoperative complication rates did not change except for a decrease in wound infections. These results suggest that the assumption of an inexorably increasing patient risk profile should be re-evaluated.
PMCID: PMC3207536  PMID: 16630423
16.  Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled trial 
Background
Upper respiratory tract infections are a major source of morbidity throughout the world. Extracts of the root of North American ginseng (Panax quinquefolium) have been found to have the potential to modulate both natural and acquired immune responses. We sought to examine the efficacy of an extract of North American ginseng root in preventing colds.
Methods
We conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 323 subjects 18–65 years of age with a history of at least 2 colds in the previous year were recruited from the general population in Edmonton, Alberta. The participants were instructed to take 2 capsules per day of either the North American ginseng extract or a placebo for a period of 4 months. The primary outcome measure was the number of Jackson-verified colds. Secondary variables measured included symptom severity, total number of days of symptoms and duration of all colds. Cold symptoms were scored by subjects using a 4-point scale.
Results
Subjects who did not start treatment were excluded from the analysis (23 in the ginseng group and 21 in the placebo group), leaving 130 in the ginseng group and 149 in the placebo group. The mean number of colds per person was lower in the ginseng group than in the placebo group (0.68 [standard deviation (SD) 0.82] v. 0.93 [SD 0.91], difference 0.25%, 95% confidence interval [CI] 0.04–0.45). The proportion of subjects with 2 or more Jackson-verified colds during the 4-month period (10.0% v. 22.8%, 12.8% difference, 95% CI 4.3–21.3) was significantly lower in the ginseng group than in the placebo group, as were the total symptom score (77.5 [SD 84.6] v. 112.3 [SD 102.5], difference 1.5%, 95% CI 1.2–2.0) and the total number of days cold symptoms were reported (10.8 [SD 9.7] v. 16.5 [SD 13.8] days, difference 1.6%, 95% CI 1.3–2.0) for all colds.
Interpretation
Ingestion of a poly-furanosyl-pyranosyl-saccharide–rich extract of the roots of North American ginseng in a moderate dose over 4 months reduced the mean number of colds per person, the proportion of subjects who experienced 2 or more colds, the severity of symptoms and the number of days cold symptoms were reported.
doi:10.1503/cmaj.1041470
PMCID: PMC1266327  PMID: 16247099
17.  Is obesity a predictor of mortality, morbidity and readmission after cardiac surgery? 
Canadian Journal of Surgery  2004;47(1):34-38.
Introduction
Obesity has been described as a risk factor for the development of coronary artery disease, but it has not been determined whether obesity is associated with adverse outcomes after cardiac surgery. Therefore, we analyzed a large cohort of patients who had undergone cardiac surgery to determine whether obesity is a predictor of mortality, morbidity or early readmission to hospital.
Methods
At the London Health Sciences Centre, an academic tertiary care centre, we prospectively entered data from the cardiac surgical database from July 1999 to April 2002. We collected data on 1310 consecutive, unselected patients who underwent cardiac surgery during that time. We assessed the degree of obesity using the body mass index (BMI), and we prospectively documented the occurrence of 10 major complications after surgery. They included stroke, reoperation for bleeding, life-threatening cardiac arrest or arrhythmia, new renal failure requiring dialysis, septicemia, mediastinitis, sternal dehiscence, respiratory failure, postoperative myocardial infarction and low cardiac output necessitating intra-aortic balloon pump use. Univariable and multivariable analyses were conducted to determine the factors associated with and predictive of postoperative death and major complications.
Results
An increased BMI did not increase the risk of early postoperative death. Furthermore, increased BMI was not a predictor of a patient experiencing any of the major complications, except sternal dehiscence. An increased BMI was associated with a higher likelihood of readmission to hospital within 30 days of discharge.
Conclusion
Obesity was not associated with adverse outcomes after cardiac operations, aside from the increased risks of sternal dehiscence and early hospital readmission.
PMCID: PMC3211805  PMID: 14997923
18.  Health-related quality of life and mobility of patients awaiting elective total hip arthroplasty: a prospective study 
Background
Waits for elective total hip arthroplasty for osteoarthritis are common in publicly funded health care systems, but they may lead to poorer postoperative outcomes and loss of health-related quality of life (HRQOL) through progressive pain and immobility during the wait. These issues have not been examined from the time of referral for surgery. Our primary objective was to test whether a longer wait was associated with poorer postoperative HRQOL.
Methods
Patients needing possible total hip arthroplasty for osteoarthritis were identified upon referral to a surgeon in London, Ont. Outcome measures, including the Western Ontario McMaster (WOMAC) Osteoarthritis Index and mobility in the 6-Minute Walk, were assessed at baseline and every 3–6 months thereafter until at least 3 months after the surgery.
Results
Of 553 potentially eligible patients referred for surgical assessment, 123 were placed on a waiting list for total hip arthroplasty; 114 underwent the procedure, and 99 of them returned for postoperative assessment. No significant differences in HRQOL or mobility were seen postoperatively between patients with short waits and those with long waits (a priori definitions ≤ 6 months and > 6 months respectively). At referral, however, patients with short waits had poorer HRQOL and were less mobile than those with long waits (p = 0.002 for WOMAC Osteoarthritis Index total score, 0.001 for pain, 0.009 for stiffness and 0.008 for function; p = 0.006 for 6-Minute Walk results). Patients with short waits experienced larger gains in these measures from the time of referral until the postoperative assessment than did patients with long waits (p = 0.002 for WOMAC Osteoarthritis Index total score, < 0.001 for pain, 0.005 for stiffness and 0.005 for function; p = 0.06 for 6-Minute Walk results). For patients with long waits, increases in the WOMAC Osteoarthritis Index total score exceeded 10% and losses in walking distance exceeded 30 m from the time of referral to surgery.
Interpretation
The length of wait for elective total hip arthroplasty is not associated with postoperative HRQOL and mobility. However, patients who undergo the procedure within 6 months after referral have greater disability at referral, and realize greater gains in HRQOL and mobility after surgery, than patients waiting more than 6 months. Clinically important losses in HRQOL and mobility occur in patients waiting more than 6 months.
PMCID: PMC134291  PMID: 12427702
19.  Prognostic variables in adult Wilms tumour 
Canadian Journal of Surgery  2008;51(4):252-256.
Objective
To identify outcomes and prognostic variables that predict survival outcomes in adult Wilms tumour patients.
Methods
We collected data on 128 patients with adult Wilms tumour treated between 1973 and 2006. Six cases from our 2 Canadian centres have not been previously reported. We collected data on the remaining 122 patients from published case reports or case series. Analyzed factors included age, sex, favourable or unfavourable histopathology, clinical stage (I, II, III or IV) and chemotherapy and radiotherapy received. The outcomes studied included overall survival (OS) and disease-specific survival (DSS). Univariate analysis with Kaplan–Meier actuarial methodology and multivariate analyses with Cox regression were used to determine outcomes and predictive clinical factors.
Results
The patients' mean age was 26 (range 15–73) years. After a mean follow-up of 54 (range 2–240) months, the OS and DSS of the entire cohort were both 68%. Favourable histopathology predicted superior OS and DSS (both p < 0.001). Higher clinical stage predicted inferior OS and DSS (both p < 0.001).
Conclusion
Adult Wilms tumour has a poorer prognosis than pediatric Wilms tumour. In adults with Wilms tumour, more aggressive patient-and tumour-specific surveillance and adjunctive therapies than those advocated by pediatric National Wilms Tumor Study guidelines may be warranted, especially in patients with an unfavourable histopathology and higher clinical stage.
PMCID: PMC2552940  PMID: 18815646

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