[Show abstract][Hide abstract] ABSTRACT: Background
Acute diarrhea and acute gastroenteritis (AD/AGE) are common among children in low- and middle-income countries (LMIC) and high-income countries (HIC). Supportive therapy including maintaining feeding, prevention of dehydration, and use of oral rehydration solution (ORS), is the mainstay of treatment in all children. Several additional treatments aiming to reduce the episode duration have been compared to placebo, but the differences in effectiveness among them are unknown.
Methods and analysis
We will conduct a systematic review of all randomized controlled trials evaluating the use of zinc, vitamin A, probiotics, prebiotics, synbiotics, racecadotril, smectite, and fermented and lactose-free milk/formula for AD/AGE treatment in children. The primary outcomes are diarrhea duration and mortality. Secondary outcomes are diarrhea lasting 3 or 7 days, stool frequency, treatment failure, hospitalizations, and adverse events. We will search MEDLINE, Ovid EMBASE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), and LILACS through Ovid, as well as grey literature resources. Two reviewers will independently screen titles and abstracts, review full texts, extract information, and assess the risk of bias (ROB) and the confidence in the estimate (with the grading of recommendations, assessment, development, and evaluation [GRADE] approach). Results will be summarized narratively and statistically. Subgroup analysis according to HIC vs. LMIC, age, nutrition status, and ROB is planned. We will perform a Bayesian network meta-analysis to combine the pooled direct and indirect treatment effect estimates for each outcome, if adequate data is available.
This is the first systematic review and network meta-analysis that aims to determine the relative effectiveness of pharmacological and nutritional treatments for reducing the duration of AD/AGE in children. The results will help to reduce the uncertainty of the effectiveness of the interventions, find knowledge gaps, and/or encourage further research for other therapeutic options.
Systematic review registration
PROSPERO registration number: CRD42015023778.
Full-text · Article · Dec 2016 · Systematic Reviews
[Show abstract][Hide abstract] ABSTRACT: Background Steroids are often combined with local anesthetic (LA) and injected to reduce pain associated with various chronic non-cancer pain (CNCP) complaints. The biological rationale behind injection of a steroid solution is unclear, and it is uncertain whether the addition of steroids offers any additional benefits over injection of LA alone. We propose to conduct a systematic review and meta-analysis to summarize the evidence for using steroids and LA vs. LA alone in the treatment of CNCP. Methods An experienced librarian will perform a comprehensive search of EMBASE, MEDLINE, and the Cochrane Central Registry of Controlled Trials (CENTRAL) databases with search terms for clinical indications, LA, and steroid agents. We will review bibliographies of all relevant published reviews in the last 5 years for additional studies. Eligible trials will be published in English and randomly allocate patients with CNCP to treatment with steroid and LA injection therapy or injection with LA alone. We will use the guidelines published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes that we collect and present. Teams of reviewers will independently and in duplicate assess trial eligibility, abstract data, and assess risk of bias among eligible trials. We will prioritize intention to treat analysis and, when possible, pool outcomes across trials using random effects models. We will report our findings as risk differences, weighted mean differences, or standardized mean differences for individual outcomes. Further, to ensure interpretability of our results, we will present risk differences and measures of relative effect for pain reduction based on anchor-based minimally important clinical differences. We will conduct a priori defined subgroup analyses and use the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system to evaluate the certainty of the evidence on an outcome-by-outcome basis. Discussion Our review will evaluate both the effectiveness and the adverse events associated with steroid plus LA vs. LA alone for CNCP, evaluate the quality of the evidence using the GRADE approach, and prioritize patient-important outcomes guided by IMMPACT recommendations. Our results will facilitate evidence-based management of patients with chronic non-cancer pain and identify key areas for future research. Trial registration PROSPERO CRD42015020614
Full-text · Article · Feb 2016 · Systematic Reviews
[Show abstract][Hide abstract] ABSTRACT: Background:
Chronic pain is implicated as a risk factor for illicit opioid use among patients with opioid addiction treated with methadone. However, there exists conflicting evidence that supports and refutes this claim. These discrepancies may stem from the large variability in pain measurement reported across studies.
We aim to determine the clinical and demographic characteristics of patients reporting pain and evaluate the prognostic value of different pain classification measures in a sample of opioid addiction patients.
Multi-center prospective cohort study.
Methadone maintenance treatment facilities for managing patients with opioid addiction.
This study includes participants from the Genetics of Opioid Addiction (GENOA) prospective cohort study. We assessed the prognostic value of different pain measures for predicting opioid relapse. Pain measures include the Brief Pain Inventory (BPI) and patients' response to a direct pain question all study participants were asked from the GENOA case report form (CRF) "are you currently experiencing or have been diagnosed with chronic pain?" Performance characteristics of the GENOA CRF pain measure was estimated with sensitivity and specificity using the BPI as the gold standard reference. Prognostic value was assessed using pain classification as the primary independent variable in an adjusted analysis using 1) the percentage of positive opioid urine screens and 2) high-risk opioid use (= 50% positive opioid urine screens) as the dependent variables in a linear and logistic regression analyses, respectively.
Among participants eligible for inclusion (n = 444) the BPI was found to be highly sensitive, classifying a large number of GENOA participants with pain (n = 281 of the 297 classified with pain, 94.6%) in comparison to the GENOA CRF (n = 154 of 297 classified with pain, 51.8%). Participants concordantly classified as having pain according to the GENOA CRF and BPI were found to have an estimated 7.79% increase in positive opioid urine screens (estimated coefficient: 7.79; 95%CI 0.74, 14.85: P = 0.031) and a 4 times greater odds (odds ratio [OR]: 4.10 P = 0.008; 95%CI: 1.44, 11.63) of engaging in a "high risk" level of illicit opioids use. The prognostic relevance of pain classification was not maintained for the additional participants classified by the BPI (n = 143 discordant).
These results suggest that while the BPI may be more sensitive in capturing pain among patients with opioid addiction, this tool is of less value for predicting the impact of pain on illicit opioid use for opioid addiction patients on methadone maintenance treatment. The GENOA CRF showed high predictive ability, whereby patients classified according to the GENOA CRF are at serious risk for opioid relapse. Using the appropriate tool to assess pain in opioid addiction may serve to improve the current detection and management of comorbid pain.
We caution the interpretation of these result since they are still reflective of participants already maintained on an opioid substitution therapy (OST), which can largely differ from patients who drop out of methadone maintenance treatment (MMT) or never seek treatment altogether.
[Show abstract][Hide abstract] ABSTRACT: Background: Chronic kidney disease-mineral and bone disorders (CKD-MBD) have been associated with poor health outcomes, including diminished quality and length of life. Standard management for CKD-MBD includes phosphate-restricted diet, active vitamin D, vitamin D analogs, and phosphate binders. Persistently elevated parathyroid hormone (PTH) levels may require the addition of Cinacalcet hydrochloride (cinacalcet) which sensitizes calcium receptors on the parathyroid glands. The objective of this systematic review is to compare the effect of cinacalcet versus standard treatment in patients with CKD-MBD. Methods/design: Data sources will include MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, and Web of Science from 1996 to June 2015. Teams of two reviewers will, independently and in duplicate, screen titles and abstracts and potentially eligible full text reports to determine eligibility, and subsequently abstract data and assess risk of bias in eligible trials. We will calculate the effect estimates (risk ratios or mean differences) and 95 % confidence intervals, as well as statistical measures of variability in results across studies using random effect models for patient-important and intermediate outcomes. We will use the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to rate the quality of evidence about estimates of effect on an outcome-by-outcome basis. We will present our results with a GRADE summary table. Discussion: Our review will explore the effect of cinacalcet versus standard treatment in patients with CKD-MBD. The results of this systematic review will help guide management of this patient population, and identify targets for future research. Systematic review registration: PROSPERO CRD42015020318 http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015020318.
Full-text · Article · Jan 2016 · Systematic Reviews
[Show abstract][Hide abstract] ABSTRACT: Introduction Studies indicate substandard diagnostic care, delayed and missed diagnosis as some of the contributing factors to maternal mortality. The clinical impact of point-of-care (POC) diagnostics has been shown in the monitoring and treatment of a variety of infectious diseases, including HIV/AIDS and tuberculosis. The objective of this systematic review is to investigate the impact of POC diagnostics on maternal outcomes for HIV-infected women.
Methods We will conduct a systematic review to evaluate the impact of POC diagnostics for improving desired healthcare outcomes for HIV-infected women. The search strategy will involve electronic databases including: Cochrane Infectious Disease Group Specialised Register; Cochrane Central Register of Control Trials, published in The Cochrane Library; PubMed; EBSCOhost and LILACS. The studies will be mapped in 2 stages: stage 1 will map studies descriptively by focus and method; stage 2 will involve additional inclusion criteria, quality assessment and data extraction undertaken by 2 reviewers in parallel. Evidence will be synthesised using relevant systematic research tools: meta-analysis and subgroup analysis will be conducted using RevMan and Stata 13 will be used for meta-regressions. We will follow recommendations described in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the Cochrane Handbook for Intervention Reviews.
Ethics and dissemination We anticipate finding a large number of studies on POC diagnostic interventions on maternal outcomes in HIV-infected women, which, once summarised, will be useful to guide future diagnostic interventions. The protocol for the systematic review has been registered in PROSPERO. The study will be disseminated electronically and in print. It will also be presented to conferences related to HIV/AIDS, POC diagnostics and maternal health.
Trial registration number PROSPERO CRD42014015439.
[Show abstract][Hide abstract] ABSTRACT: A randomized controlled clinical trial is the best way to minimize bias in ascertaining treatment effects, but the credibility of the results of a trial depends on the validity of the methods used to analyze the data, and the conditions under which such methods produce valid answers. A sensitivity analysis is a method to determine the robustness of trial findings by examining the extent to which results are affected by changes in methods, models, values of unmeasured variables, or assumptions. The goal of a sensitivity analysis is to identify results that are most dependent on questionable or unsupported assumptions. In this article, we briefly review the current use of sensitivity analyses in a random sample of published nutrition literature and provide a guide on the use of sensitivity analyses in randomized trials as to when to consider them, what to consider when planning them, and different methods of implementing them. We propose an 8-step strategy for improving the approach to conducting and reporting sensitivity analyses in nutrition-based trials.
Full-text · Article · Dec 2015 · American Journal of Clinical Nutrition
[Show abstract][Hide abstract] ABSTRACT: . Web-based learning (WBL) is increasingly used in medical education; however, residency training programs often lack guidance on its implementation. We describe how the use of feasibility studies can guide the use of WBL in anesthesia residency training.
. Two case-based WBL emergency airway management modules were developed for self-directed use by anesthesia residents. The feasibility of using this educational modality was assessed using a single cohort pretest/posttest design. Outcome measures included user recruitment and retention rate, perceptions of educational value, and knowledge improvement. The differences between pre- and postmodule test scores and survey Likert scores were analysed using the paired
. Recruitment and retention rates were 90% and 65%, respectively. User-friendliness of the modules was rated highly. There was a significant improvement in perceptions of the value of WBL in the postsurvey. There was a significant knowledge improvement of 29% in the postmodule test.
. Feasibility studies can help guide appropriate use of WBL in curricula. While our study supported the potential feasibility of emergency airway management modules for training, collaboration with other anesthesia residency programs may enable more efficient development, implementation, and evaluation of this resource-intensive modality in anesthesia education and practice.
Preview · Article · Dec 2015 · Anesthesiology Research and Practice
[Show abstract][Hide abstract] ABSTRACT: Background:
Remote ischemic preconditioning is a simple therapy that may reduce cardiac and kidney injury. We undertook a randomized controlled trial to evaluate the effect of this therapy on markers of heart and kidney injury after cardiac surgery.
Patients at high risk of death within 30 days after cardiac surgery were randomly assigned to undergo remote ischemic preconditioning or a sham procedure after induction of anesthesia. The preconditioning therapy was three 5-minute cycles of thigh ischemia, with 5 minutes of reperfusion between cycles. The sham procedure was identical except that ischemia was not induced. The primary outcome was peak creatine kinase- myocardial band (CK-MB) within 24 hours after surgery (expressed as multiples of the upper limit of normal, with log transformation). The secondary outcome was change in creatinine level within 4 days after surgery (expressed as log-transformed micromoles per litre). Patient-important outcomes were assessed up to 6 months after randomization.
We randomly assigned 128 patients to remote ischemic preconditioning and 130 to the sham therapy. There were no significant differences in postoperative CK-MB (absolute mean difference 0.15, 95% confidence interval [CI] -0.07 to 0.36) or creatinine (absolute mean difference 0.06, 95% CI -0.10 to 0.23). Other outcomes did not differ significantly for remote ischemic preconditioning relative to the sham therapy: for myocardial infarction, relative risk (RR) 1.35 (95% CI 0.85 to 2.17); for acute kidney injury, RR 1.10 (95% CI 0.68 to 1.78); for stroke, RR 1.02 (95% CI 0.34 to 3.07); and for death, RR 1.47 (95% CI 0.65 to 3.31).
Remote ischemic preconditioning did not reduce myocardial or kidney injury during cardiac surgery. This type of therapy is unlikely to substantially improve patient-important outcomes in cardiac surgery.
ClinicalTrials.gov, no. NCT01071265.
Full-text · Article · Dec 2015 · Canadian Medical Association Journal
[Show abstract][Hide abstract] ABSTRACT: Suicidal behavior is a growing public health concern resulting in morbidity and premature death. Although certain factors such as age, sex, and psychiatric disorders have been consistently reported to be associated with suicidal behavior, other factors including biological markers, diet, and physical activity may also influence suicidal behavior. The purpose of this pilot study was to evaluate the feasibility of conducting a full-scale study to identify the conventional and novel risk factors of suicidal behavior in individuals who made a recent suicide attempt.
This pilot study was a case-control study of participants with recent (within 1 month of admission) suicide attempts admitted to hospital and compared to two control groups: 1) psychiatric inpatient participants without a history of suicide attempts and 2) community-based controls. We collected information on demographic variables, circumstances of suicide attempts (for cases), medical and psychiatric diagnoses, behavioral patterns, physical measurements, and social factors. Blood and urine samples were also collected for biological markers. Feasibility outcomes are as follows: 1) 50 % of all eligible cases will consent to participate, 2) 50 cases and 100 controls per year can be recruited, and 3) at least 80 % of the participants will provide blood samples for DNA and biological markers.
We recruited 179 participants in total; 51 cases, 57 psychiatric controls without suicide attempt, and 71 non-psychiatric controls in Hamilton, Ontario. Recruitment rate was 70 % (213/304), and we obtained urine and blood specimens from 90 % (191/213) of participants. Questionnaire completion rates were high, and data quality was very good with few data-related queries to resolve. We learned that cases tended to be hospitalized for long periods of time and the suicide attempt occurred more than a month ago in many of the cases; therefore, we expanded our inclusion criterion related to timing of suicide attempt to 3 months instead of 1 month.
The study procedures needed certain modifications including extending the time between suicide attempt and date of recruitment, and more detailed questionnaires related to diet were necessary while other questionnaires such as social support needed to be shortened. Overall, this study showed that it is feasible to conduct a larger-scale study.
[Show abstract][Hide abstract] ABSTRACT: The lumbar transversus abdominis plane (TAP) block has become an optional part of multimodal analgesia following several abdominal surgeries. There remains a lack of consensus regarding the extent of dermatomal blockade following lumber TAP block, as well as the optimal local anesthetic volumes and concentrations. The objectives of this pilot trial were to assess the feasibility of conducting a similar full-scale trial and gather information on relevant clinical outcomes, namely whether greater local anesthetic volumes would lead to more cephalad dermatomal blockade.
The study was a prospective, double-blinded pilot randomized controlled trial (RCT) with three arms, each representing different local anesthetic volumes: 20 ml 0.5% ropivacaine, 30 ml 0.33% ropivacaine, and 40 ml 0.25% ropivacaine. We planned to recruit 30 females undergoing total abdominal hysterectomy for non-malignant pathology, who would then receive bilateral ultrasound-guided midaxillary TAP blocks at the completion of surgery. Randomized patients would be followed for 48 h post-block and would receive multimodal analgesia. The primary outcomes were measurements of patient recruitment and safety, to inform the feasibility of a larger trial. The main secondary outcome was the clinically pertinent endpoint of dermatomal blockade, which was assessed by loss of sensation to ice and pinprick.
Our target sample size was reached in 8 months, and the recruitment rate was 52% (31/60). A total of 58 TAP blocks were performed among 29 patients. All but one of the patients who received interventions were successfully followed and assessed up to 48 h. No patient safety-related adverse events were reported during the study period. The mean highest dermatome blocked in each group at any time point was T8. The 20 ml 0.5% ropivacaine group achieved a T9–L1 block that lasted for 48 h. The 30 ml 0.33% ropivacaine group had a sensory block from T9–L1 that regressed to T10–T12 between 24 and 48 h. The 40 ml 0.25% ropivacaine group reported an initial sensory block from T9–T12 that regressed by 24 h to include only the T12 dermatome.
This pilot study demonstrated that the study design is feasible and safe to be carried to a full-scale RCT. The preliminary clinical findings showed that increasing the volume, while maintaining a constant dose, of local anesthetic does not appear to extend the height of dermatomal blockade following midaxillary TAP block. This finding needs to be confirmed in future studies.
ClinicalTrials.gov registration is: NCT01307215.
[Show abstract][Hide abstract] ABSTRACT: Background
The consequences of opioid relapse among patients being treated with opioid substitution treatment (OST) are serious and can result in abnormal cardiovascular function, overdose, and mortality. Chronic pain is a major risk factor for opioid relapse within the addiction treatment setting. There exist a number of opioid maintenance therapies including methadone, buprenorphine, naltrexone, and levomethadyl acetate (LAAM), of which the mediating effects of pain on treatment attrition, substance use behavior, and social functioning may differ across therapies. We aim to 1) evaluate the impact of pain on the treatment outcomes of addiction patients being managed with OST and 2) identify the most recently published opioid maintenance treatment guidelines from the United States, Canada, and the UK to determine how the evidence is being translated into clinical practice.
The authors will search Medline, EMBASE, PubMed, PsycINFO, Web of Science, Cochrane Database of Systematic Reviews, ProQuest Dissertations and theses Database, Cochrane Central Register of Controlled Trials (CENTRAL), World Health Organization International Clinical Trials Registry Platform Search Portal, and the National Institutes for Health Clinical Trials Registry. We will search www.guidelines.gov and the National Institute for Care and Excellence (NICE) databases to identify the most recently published OST guidelines. All screening and data extraction will be completed in duplicate. Provided the data are suitable, we will perform a multiple treatment comparison using Bayesian meta-analytic methods to produce summary statistics estimating the effect of chronic pain on all OSTs. Our primary outcome is substance use behavior, which includes opioid and non-opioid substance use. We will also evaluate secondary endpoints such as treatment retention, general physical health, intervention adherence, personal and social functioning, as well as psychiatric symptoms.
This review will capture the experience of treatment outcomes for a sub-population of opioid addiction patients and provide an opportunity to distinguish the best quality guidelines for OST. If chronic pain truly does result in negative consequences for opioid addiction patients, it is important we identify which OSTs are most appropriate for chronic pain patients as well as ensure the treatment guidelines incorporate this information.
Systematic review registration
PROSPERO CRD42014014015 http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014014015#.VS1Qw1wkKGM
Full-text · Article · Dec 2015 · Systematic Reviews
[Show abstract][Hide abstract] ABSTRACT: Background
Polycystic ovarian syndrome (PCOS) is a common reproductive endocrine disease that is seen among adolescent women. Currently, there is limited evidence to support treatment options leading to considerable variation in practice among healthcare specialists. The objective of this study is to review and synthesize all the available evidence on treatment options for PCOS among adolescent women.
We will conduct a systematic review of all randomized controlled trials evaluating the use of metformin, oral contraceptive pills as monotherapy, or as combination with pioglitazone, spironolactone, flutamide, and lifestyle interventions in the treatment of PCOS in adolescent women ages 11 to 19 years. The primary outcome measures are menstrual regulation and change hirsutism scores. The secondary outcome measures include acne scores, prevalence of dysglycaemia, BMI, lipid profile, total testosterone level, and adverse events. We will perform literature searches through Ovid Medline, Ovid Embase, and Cochrane Central Register of Controlled Trials (CENTRAL), and gray literature resources. Two reviewers will independently screen titles and abstracts of identified citations, review the full texts of potentially eligible trials, extract information from eligible trials, and assess the risk of bias and quality of the evidence independently. Results of this review will be summarized narratively and quantitatively as appropriate. We will perform a multiple treatment comparison using network meta-analysis to estimate the pooled direct and indirect effects for all PCOS interventions on outcomes if adequate data is available.
PCOS treatment poses a clinical challenge to the patients and physicians. This is the first systematic review and network meta-analysis for PCOS treatment in adolescents. We expect that our results will help improve patient care, unify the treatment approaches among specialists, and encourage research for other therapeutic options.
Systematic review registration
Full-text · Article · Dec 2015 · Systematic Reviews
[Show abstract][Hide abstract] ABSTRACT: The heritability of opioid use disorder has been widely investigated; however, the influence of specific genes on methadone treatment outcomes is not well understood. The association between response to methadone treatment and genes that are involved in substance use behaviors and reward mechanisms is poorly understood, despite evidence suggesting their contribution to opioid use disorder. The aim of this study was to investigate the effect of brain-derived neurotrophic factor (BDNF) and dopamine receptor D2 (DRD2) polymorphisms on continued opioid use among patients on methadone treatment for opioid use disorder.
BDNF 196G>A (rs6265) and DRD2-241A>G (rs1799978) genetic variants were examined in patients with opioid use disorder who were recruited from methadone treatment clinics across Southern Ontario, Canada. We collected demographic information, substance use history, blood for genetic analysis, and urine to measure opioid use. We used regression analysis to examine the association between continued opioid use and genetic variants, adjusting for age, sex, ethnicity, methadone dose, duration in treatment, and number of urine screens.
Among 240 patients treated with methadone for opioid use disorder, 36.3 percent (n = 87) and 11.3 percent (n = 27) had at least one risk allele for rs6265 and rs1799978, respectively. These genetic variants were not significantly associated with continued opioid use while on methadone maintenance treatment [rs6265: odds ratio (OR) = 1.37, 95 % confidence interval (CI) = 0.792, 2.371, p = 0.264; rs1799978: OR 1.27, 95 % CI 0.511, 3.182, p = 0.603].
Despite an association of BDNF rs6265 and DRD2 rs1799978 with addictive behaviors, these variants were not associated with continued illicit opioid use in patients treated with methadone. Problematic use of opioids throughout treatment with methadone may be attributed to nongenetic factors or a polygenic effect requiring further exploration. Additional research should focus on investigating these findings in larger samples and different populations.
Full-text · Article · Dec 2015 · Addiction science & clinical practice
[Show abstract][Hide abstract] ABSTRACT: Pneumonia is responsible for a large proportion of hospital admissions and antibiotic utilization. Physician adherence to evidence-based pneumonia management guidelines is poor. Antimicrobial stewardship programs (ASPs) are an effective intervention to mitigate against unwarranted variation from these guidelines. Despite this benefit, ASPs have not been shown to reduce the length of stay of hospitalized patients with pneumonia. In immune-competent adult patients admitted to a hospital ward with a diagnosis of community-acquired pneumonia, does a multi-faceted ASP utilizing prospective chart audit and feedback reduce the length of stay, compared with usual care, without increasing the risk of death or readmission 30 days after discharge from hospital?
Starting on 1 April 2013, all consecutive immune-competent adult patients (>18 years old) admitted to a hospital ward with a positive febrile respiratory illness screening questionnaire and a diagnosis of pneumonia by the attending physician will be eligible for inclusion in this non-randomized study. All eligible patients who fulfill the ASP review criteria will undergo a prospective chart audit, followed by an ASP recommendation provided to the attending physician. The attending physician is responsible for implementing or rejecting the ASP recommendation. This is a modified stepped-wedge design with a baseline data collection period of 3 months, followed by non-random sequential introduction of the ASP intervention on each of four hospital wards in a single community-based, academic-affiliated 339-bed acute-care hospital in Barrie, ON, Canada. The primary outcome measure is hospital length of stay; secondary outcome measures include days and duration of antibiotic therapy, and inadvertent adverse outcomes of 30 day post-discharge mortality and hospital readmission rates. Differences in outcome measures will be assessed using extended Cox regression analysis. Time to ASP intervention is included as a time-dependent covariate in the final model, to account for time-dependent bias.
By designing a pragmatic clinical trial with unique design and analytic features, we not only expect to demonstrate the effectiveness of a real-world ASP, but also provide a model for program evaluation that can be used more broadly to improve patient safety and quality of care.
ClinicalTrials.gov NCT02264756 .
[Show abstract][Hide abstract] ABSTRACT: Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA.
Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program.
The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback.
Clinicaltrials.gov Identifier NCT02045771.
Hamilton Integrated Research Ethics Board (HiREB) number: 14–042.
[Show abstract][Hide abstract] ABSTRACT: Background
Despite the growing numbers of men and women with opioid use disorder in Canada, sex-specific issues in treatment have not been re-examined in the current population of patients with opioid addiction. We aimed to evaluate sex differences in substance use, health, and social functioning among men and women currently receiving methadone treatment for opioid use disorder in Ontario, Canada.
We recruited 503 participants with opioid dependence disorder receiving methadone maintenance treatment. We collected data on demographics, treatment characteristics, psychiatric history, addiction severity, and drug use patterns through urinalysis. We performed adjusted univariate analyses and logistic regression to identify distinct factors affecting men and women.
Among our sample of 54 % (n = 266) men and 46 % women (n = 226) with mean age 38.3 years, less than half of participants were employed (35.6 %) and married (31.8 %) and had completed a high school education (27.9 %). Compared to men, women had frequent physical and psychological health problems, family history of psychiatric illness, and childcare responsibilities and began using opioids through a physician prescription. Men had higher rates of employment, cigarette smoking, and cannabis use compared to women.
Our results have revealed different patterns of substance use, health, and social functioning among men and women currently receiving methadone treatment for opioid addiction in Ontario, Canada. This information can be used to develop an integrative treatment regimen that caters to the individual needs of men and women, as well as to inform methadone treatment protocols to include specialized services (including vocational counseling, childcare and parenting assistance, medical assistance, relationship or domestic violence counseling, etc.) and increase their availability and accessibility on a larger scale.
Full-text · Article · Dec 2015 · Biology of Sex Differences
[Show abstract][Hide abstract] ABSTRACT: Investigating the cumulative rate of deficits and the change of a frailty index (FI) chronologically is helpful in clinical and research settings in the elderly. However, limited evidence for the change of frailty before and after some nonfatal adverse health event such as a major osteoporotic fracture (MOF) is available. Data from the Global Longitudinal Study of Osteoporosis in Women 3-year Hamilton cohort were used in this study. The changes of FI before and after onset of MOF were compared between the women with and without incident MOF. We also evaluated the relationship between risk of MOF, falls and death and the change of FI and the absolute FI measures. There were 3,985 women included in this study (mean age: 69.4 years). The change of FI was significantly larger in the women with MOF than those without MOF at Year 1 (0.085 vs. 0.067, p-value = 0.036) and Year 2 (0.080 vs. 0.052, p-value = 0.042) post-baseline. The FI change was not significantly related with risk of MOF independently of age. However the absolute FI measures were significantly associated with increased risk of MOF, falls and death independently of age. In summary, the increase of the FI is significantly larger in the elderly women experiencing a MOF than their peer controls, indicating their worsening frailty and greater deficit accumulation after a MOF. Measures of the FI change may aid in the understanding of cumulative aging nature in the elderly and serve as an instrument for intervention planning and assessment. This article is protected by copyright. All rights reserved.
Full-text · Article · Nov 2015 · Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research
[Show abstract][Hide abstract] ABSTRACT: Introduction:
Clinical prediction rules have been validated and widely used in patients with atrial fibrillation (AF) to predict stroke and major bleeding. However, these prediction rules were not developed in the same population, and do not provide the key information that patients and prescribers need at the time anticoagulants are being considered-what is the individual patient-specific risk of both benefit (decreased stroke) and harm (increased major bleeding). In this study, our primary objective is to develop and validate a prediction model for patients' individual combined benefit and harm outcomes (stroke, major bleeding and neither event) with and without warfarin therapy. Our secondary outcome is all-cause mortality.
Methods and analysis:
We will use data from the Kaiser Permanente Colorado (KPCO) anticoagulation management databases and electronic medical records. Patients with a primary or secondary diagnosis during an ambulatory KPCO medical office visit, emergency department visit, or inpatient stay between 1 January 2005 and 31 December 2012 with no AF diagnosis in the previous 180 days will be included. Patients' demographic characteristics, laboratory data, comorbidities, warfarin medication data and concurrent use of medication will be used to construct the prediction model. For primary outcomes (stroke with no major bleeding, and major bleeding with no stroke), we will perform polytomous logistic regression to develop a prediction model for patients' individual combined benefit and harm outcomes, taking neither event group as the reference group. As regards death, we will use Cox proportional hazards regression analysis to build a prediction model for all-cause mortality.
Ethics and dissemination:
This study has been approved by the KPCO Institutional Review Board and the Hamilton Integrated Research Ethics Board. Results from this study will be published in a peer-reviewed journal electronically and in print. The prediction models may aid in patient-physician shared decision-making when they are considering warfarin therapy.