Determining the Level of Statistician Participation on Canadian-Based Research Ethics Boards
In: IRB: ethics & human research, Band 27, Heft 2, S. 11
ISSN: 2326-2222
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In: IRB: ethics & human research, Band 27, Heft 2, S. 11
ISSN: 2326-2222
In: Qualitative report: an online journal dedicated to qualitative research and critical inquiry
ISSN: 1052-0147
A new group of medically fragile young adults are graduating from pediatric palliative care programs with limited expectations to live beyond early adulthood, and no comparable adult services to support their complex needs. Accessing this population is difficult because of the complexity of their conditions, the extensive personal and equipment supports that limit feasibility for travel, and divergent communication abilities. Therefore, we undertook a descriptive case study using an asynchronous modification of an online focus group, a bulletin board focus group (BBFG). The greatest strengths of the BBFG are the appeal of this methodology for young adults and the multi day focus group becomes both a community and an intervention. An important limitation of this method was participant follow through on discussion threads. This BBFG provided rich and varied types of data, and very positive participant experiences.
In: African Journal of Disability, Band 11
ISSN: 2226-7220
Background: Physical rehabilitation interventions address functional deficits caused by impairments that affect someone's performance. Whilst rehabilitation is important, it is assumed that these services are either minimal or nonexistent in low-resource settings. Our data expand on the data from the Situation Assessment of Rehabilitation in the Republic of Rwanda report to describe rehabilitation services and who access them at public and semiprivate facilities (primarily funded by the private sector).Objectives: This article describes the use of the outpatient physical rehabilitation services across nine health facilities, the characteristics of adults attending these health facilities and some of the facilitators and barriers they encounter when attending rehabilitation.Method: Data were collected between September and December 2018 from the heads of departments and adult patients attending outpatient rehabilitation services funded by the government, international nongovernmental organisations or faith-based organisations.Results: Two hundred and thirteen adults were recruited from nine facilities. There is a sixfold difference in the number of rehabilitation personnel between public and semiprivate hospitals in these facilities' catchment areas. However, most participants were recruited at public facilities (186 [87%]), primarily with physical disorders. Patients reported that family support (94%) was the most crucial facilitator for attending rehabilitation, whilst transportation cost (96%) was a significant barrier.Conclusion: Rehabilitation service availability for Rwandan adults with disabilities is limited. Whilst family support helps patients attend rehabilitation, transportation costs remain a significant barrier to people attending rehabilitation. Strategies to address these issues include developing triage protocols, training community health workers and families.Contribution: Data on rehabilitation service provision in Rwanda and most African countries are either non-existent or very limited. These data contain important information regarding the services provided and the people who used them across different health facilities (public versus private) and urban versus rural settings). To improve rehabilitation service provision, we first need to understand the current situation. These data are an important step to better understanding rehabilitation in Rwanda.
In: Research on social work practice, Band 26, Heft 2, S. 168-179
ISSN: 1552-7581
Objective: To evaluate whether the addition of a wraparound facilitator to regular child protection services improved child and family functioning over 20 months. Method: A single blind randomized controlled trial with concealment and stratification across three sites ( N = 135 eligible families with substantiated maltreatment). Results: Based on 2 × 2 mixed analysis of variance and intention to treat, both groups improved in child impairments, d = −.60 [−.81, −.39], caregiver psychological distress, d = −.33 [−.52, −.13], and family resources, d = .44 [.27, .62]. No measurable benefit was associated with the intervention (e.g., child impairments, d = .14 [−.12, .52]). However, treatment fidelity analysis revealed that many components of wraparound were either missing or present in both groups. Conclusions: The presence of a facilitator alone did not appear to improve child or family functioning if the various components of wraparound were not adequately implemented.
In: Journal of the International AIDS Society, Band 16, Heft 1
ISSN: 1758-2652
IntroductionGuidelines in resource‐poor settings have progressively included interventions to reduce postnatal HIV transmission through breast milk. In addition to HIV‐free survival, infant growth and non‐HIV infections should be considered. Determining the effect of these interventions on infant growth and non‐HIV infections will inform healthcare decisions about feeding HIV‐exposed infants. We synthesize findings from studies comparing breast to formula feeding, early weaning to standard‐duration breastfeeding, breastfeeding with extended antiretroviral (ARV) to short‐course ARV prophylaxis, and alternative preparations of infant formula to standard formula in HIV‐exposed infants, focusing on infant growth and non‐HIV infectious morbidity outcomes. The review objectives were to collate and appraise evidence of interventions to reduce postnatal vertical HIV transmission, and to estimate their effect on growth and non‐HIV infections from birth to two years of age among HIV‐exposed infants.MethodsWe searched PubMed, SCOPUS, and Cochrane CENTRAL Controlled Trials Register. We included randomized trials and prospective cohort studies. Two authors independently extracted data and evaluated risk of bias. Rate ratios and mean differences were used as effect measures for dichotomous and continuous outcomes, respectively. Where pooling was possible, we used fixed‐effects meta‐analysis to pool results across studies. Quality of evidence was assessed using the GRADE approach.Results and discussionProspective cohort studies comparing breast‐ versus formula‐fed HIV‐exposed infants found breastfeeding to be protective against diarrhoea in early life [risk ratio (RR)=0.31; 95% confidence interval (CI)=0.13 to 0.74]. The effect of breastfeeding against diarrhoea [hazard ratio (HR)=0.74; 95% CI=0.57 to 0.97] and respiratory infections (HR=0.65; 95% CI=0.41 to 1.00) was significant through two years of age. The only randomized controlled trial (RCT) available showed that breastfeeding tended to be protective against malnutrition (RR=0.63; 95% CI=0.36 to 1.12). We found no statistically significant differences in the rates of non‐HIV infections or malnutrition between breast‐fed infants in the extended and short‐course ARV prophylaxis groups.ConclusionsLow to moderate quality evidence suggests breastfeeding may improve growth and non‐HIV infection outcomes of HIV‐exposed infants. Extended ARV prophylaxis does not appear to increase the risk for HIV‐exposed infants for adverse growth or non‐HIV infections compared to short‐course ARV prophylaxis.
In: Child abuse & neglect: the international journal ; official journal of the International Society for the Prevention of Child Abuse and Neglect, Band 36, Heft 4, S. 308-322
ISSN: 1873-7757
INTRODUCTION: The COVID-19 pandemic has driven unprecedented social and economic reform in efforts to curb the impact of disease. Governments worldwide have legislated non-essential service shutdowns and adapted essential service provision in order to minimise face-to-face contact. We anticipate major consequences resulting from such policies, with marginalised populations expected to bear the greatest burden of such measures, especially those with substance use disorders (SUDs). METHODS AND ANALYSIS: We aim to conduct (1) a scoping review to summarise the available evidence evaluating the impact of the COVID-19 pandemic on patients with SUDs, and (2) an evidence map to visually plot and categorise the current available evidence evaluating the impact of COVID-19 on patients with SUDs to identify gaps in addressing high-risk populations. ETHICS AND DISSEMINATION: Ethics approval is not required for this scoping review as we plan to review publicly available data. This is part of a multistep project, whereby we intend to use the findings generated from this review in combination with data from an ongoing prospective cohort study our team is leading, encompassing over 2000 patients with SUDs receiving medication-assisted therapy in Ontario prior to and during the COVID-19 pandemic.
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Background The role of the human microbiome in health and disease is an emerging and important area of research; however, there is a concern that African populations are under-represented in human microbiome studies. We, therefore, conducted a systematic survey of African human microbiome studies to provide an overview and identify research gaps. Our secondary objectives were: (i) to determine the number of peer-reviewed publications; (ii) to identify the extent to which the researches focused on diseases identified by the World Health Organization [WHO] State of Health in the African Region Report as being the leading causes of morbidity and mortality in 2018; (iii) to describe the extent and pattern of collaborations between researchers in Africa and the rest of the world; and (iv) to identify leadership and funders of the studies. Methodology We systematically searched Medline via PubMed, Scopus, CINAHL, Academic Search Premier, Africa-Wide Information through EBSCOhost, and Web of Science from inception through to 1st April 2020. We included studies that characterized samples from African populations using next-generation sequencing approaches. Two reviewers independently conducted the literature search, title and abstract, and full-text screening, as well as data extraction. Results We included 168 studies out of 5515 records retrieved. Most studies were published in PLoS One (13%; 22/168), and samples were collected from 33 of the 54 African countries. The country where most studies were conducted was South Africa (27/168), followed by Kenya (23/168) and Uganda (18/168). 26.8% (45/168) focused on diseases of significant public health concern in Africa. Collaboration between scientists from the United States of America and Africa was most common (96/168). The first and/or last authors of 79.8% of studies were not affiliated with institutions in Africa. Major funders were the United States of America National Institutes of Health (45.2%; 76/168), Bill and Melinda Gates Foundation (17.8%; 30/168), and the European Union (11.9%; 20/168). Conclusions There are significant gaps in microbiome research in Africa, especially those focusing on diseases of public health importance. There is a need for local leadership, capacity building, intra-continental collaboration, and national government investment in microbiome research within Africa. Video Abstract
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During the development of this work we presented our thinking at workshops and open meetings and would like to thank all participants for their valuable input and views: Society for Clinical Trials May 2013 Boston; Clinical Trials Methodology Conference Edinburgh November 2013; Royal Statistical Society October 2013; UK National Institute for Health Research (NIHR) Research Design Service London and South East March 2014 London; UK NIHR statisticians April 2015 London; Society for Academic Primary Care Annual Scientific Meeting July 2015 Oxford; HSRPP Health Services Research and Pharmacy Practice Conference April 2016. We also thank Colin Begg for feedback on the proposed items to be included in the guidelines during the two day consensus meeting in Oxford. Funding: We received grants from Queen Mary University of London (£7495), University of Sheffield (£8000), NIHR RDS London and South East (£2000), NIHR Statisticians Group (£2400), and Chief Scientist Office Scotland (£1000). CLC (nee Coleman) was funded by a National Institute for Health Research (NIHR) research methods fellowship. This article presents independent research partly funded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Marion Campbell works at the Health Services Research Unit, University of Aberdeen, and the Unit receives core funding from the Scottish Government Health and Social Care Directorates; however, the opinions expressed are those of the authors alone. The funders had no role in this study. ; Peer reviewed ; Publisher PDF
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In: Journal of the International AIDS Society, Band 21, Heft 11
ISSN: 1758-2652
AbstractIntroductionWhen measuring the success of HIV programmes to retain patients in care, few studies distinguish between retention in clinic (individual returns to the same clinic) and retention in care (individual is active in care at initial site or elsewhere). The objectives of this study were to quantify retention in clinic versus retention in care and determine risk factors associated with attrition from care in low‐income settings in Nairobi, Kenya.MethodsBetween April 2013 and June 2015, adults testing positive for HIV were recruited at two comprehensive care clinics in informal urban settlements. Participants were followed from the time of a positive HIV test for up to 14 months. Participants who did not return to the clinic for their 12‐month appointment between 10 and 14 months after their baseline visit were traced by telephone or community outreach to determine whether they were still receiving HIV care. We used generalized linear regression to determine the association between clinical and socio‐demographic factors and attrition from care at 12 months.ResultsOf the 1068 individuals screened for study participation, 775 individuals newly presenting to HIV care were included in this study. Between 10 and 14 months, 486 participants (62.7%, 95% confidence intervals [CI], 59.2% to 66.1%) returned to the clinic for their 12‐month appointment (retained in clinic). After telephone tracing and community outreach, an additional 123 of 289 participants were found to be active in care at other HIV clinics (42.6%, 95% CI, 36.8% to 48.5%). Overall, 609 (78.6%, 95% CI, 75.7% to 81.5%) participants were retained in care at any HIV clinic at 12 months. Participants in higher baseline CD4 count categories were more likely to be retained than those whose baseline CD4 count was <200 cells/mm3.ConclusionsRetention in clinic substantially underestimated retention in care 12 months after presenting to care in this high‐prevalence and low‐income urban setting. Improved systems to track patients between clinics are required to accurately estimate retention in care in resource‐limited settings. Although the proportion of patients retained in care was greater than expected, interventions to improve retention in care are needed to meet global targets to end the AIDS epidemic.
In: Crisis: the journal of crisis intervention and suicide prevention, Band 36, Heft 4, S. 231-240
ISSN: 2151-2396
Abstract. Background: For decades we have understood the risk factors for suicide in the general population but have fallen short in understanding what distinguishes the risk for suicide among patients with serious psychiatric conditions. Aims: This prompted us to investigate risk factors for suicidal behavior among psychiatric inpatients. Method: We reviewed all psychiatric hospital admissions (2008–2011) to a centralized psychiatric hospital in Ontario, Canada. Using multivariable logistic regression we evaluated the association between potential risk factors and lifetime history of suicidal behavior, and constructed a model and clinical risk score to predict a history of this behavior. Results: The final risk prediction model for suicidal behavior among psychiatric patients (n = 2,597) included age (in three categories: 60–69 [OR = 0.74, 95% CI = 0.73–0.76], 70–79 [OR = 0.45, 95% CI = 0.44–0.46], 80+ [OR = 0.31, 95% CI = 0.30–.31]), substance use disorder (OR = 1.30, 95% CI = 1.27–1.32), mood disorder (OR = 1.49, 95% CI = 1.47–1.52), personality disorder (OR = 2.30, 95% CI = 2.25–2.36), psychiatric disorders due to general medical condition (OR = 0.52, 95% CI = 0.50–0.55), and schizophrenia (OR = 0.42, 95% CI = 0.41–0.43). The risk score constructed from the risk prediction model ranges from −9 (lowest risk, 0% predicted probability of suicidal behavior) to +5 (highest risk, 97% predicted probability). Conclusion: Risk estimation may help guide intensive screening and treatment efforts of psychiatric patients with high risk of suicidal behavior.
In: Research on social work practice, Band 29, Heft 1, S. 10-18
ISSN: 1552-7581
Purpose: Major depressive disorder is the leading cause of disability worldwide. This study is part of a mixed methods pilot trial, exploring the effectiveness, acceptability, and feasibility of providing behavioral activation (BA) treatment in a group format. Methods: Using an applied, descriptive approach, qualitative data were collected from individual interviews (18) and focus groups (5) at multiple data points throughout the trial and feedback given to group facilitators, who adapted the program accordingly. Results: Group BA is an effective and acceptable treatment format when a client-centered, flexible approach is utilized. This contrasted with findings from the comparison intervention, a peer support group, from which participants reported no benefit. Conclusions: Group BA is beneficial in a fiscally responsible evidenced-based health-care culture. Comparator groups need to be carefully selected. Engaging patient and clinician perspectives when designing and implementing new clinical interventions is vital in informing future research and social work practice.
In: Health services insights, Band 16, S. 117863292311665
ISSN: 1178-6329
When conducting randomised clinical trials, the choice of methodology and statistical analyses will influence the results. If the planned methodology is not of optimal quality and predefined in detail, there is a risk of biased trial results and interpretation. Even though clinical trial methodology is already at a very high standard, there are many trials that deliver biased results due to the implementation of inadequate methodology, poor data quality and erroneous or biased analyses. To increase the internal and external validity of randomised clinical trial results, several international institutions within clinical intervention research have formed The Centre for Statistical and Methodological Excellence (CESAME). Based on international consensus, the CESAME initiative will develop recommendations for the proper methodological planning, conduct and analysis of clinical intervention research. CESAME aims to increase the validity of randomised clinical trial results which will ultimately benefit patients worldwide across medical specialities. The work of CESAME will be performed within 3 closely interconnected pillars: (1) planning randomised clinical trials; (2) conducting randomised clinical trials; and (3) analysing randomised clinical trials.
In: Research on social work practice, Band 28, Heft 5, S. 577-584
ISSN: 1552-7581
Purpose: This systematic survey evaluates the completeness of reporting in pilot and feasibility randomized controlled trials investigating behavioral interventions based on the Consolidated Standards of Reporting Trials (CONSORT) extension for pilot trials. Methods: The authors searched Medline/Pubmed and randomly selected 100 articles from 2012 through 2016 to determine the proportion of reported CONSORT extension items. They examined study factors related to reporting, including year and country of publication, psychotherapy intervention, multiple centers, industry funding, and journal endorsement of CONSORT. Results: The authors found that the mean reporting score on the CONSORT extension was 51.6% ( SD = 15.1). Studies of psychotherapy interventions had significantly higher reporting scores than other interventions (incidence rate ratio = 1.10, 95% confidence interval: 1.01–1.20). Conclusions: Our findings indicate that current reporting quality is suboptimal. Many included trials failed to provide rationale for piloting, assess feasibility objectives, or indicate clear progression to a future large trial. Reporting quality should be reevaluated following uptake of the 2016 CONSORT extension for pilot trials.
In: Research on social work practice, Band 28, Heft 5, S. 538-545
ISSN: 1552-7581
Behavioral and social sciences randomized controlled trials (BSSTs) have a significant role in life sciences. Choosing an appropriate control or comparator group for BSSTs is critical, to provide true intervention effects. The objective of this study was to determine the types of control groups used in BSSTs, and the rationale provided to justify these choices. We conducted a systematic survey of BSST protocols published between January 2012 and October 2016 in the Cochrane Library and Medline databases. We randomly selected 200 protocols. The study selection and data extraction were performed independently in duplicate. The most frequent control groups were active concurrent (97/200, 48.5%), and no treatment concurrent controls (88/200, 44.0%). The majority of studies (71.5%) did not provide justification for comparators choice. We concluded that BSSTs trials compare interventions to active and no treatment controls however the majority of trials lacked rationale for the selection of the study comparator.