Wasifa Zarin

Utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol

Introduction Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products. Methods and analysis Our review conduct will follow the Joanna Briggs Institute scoping review methods manual. Literature searches were conducted in MEDLINE, EMBASE and the Cochrane Library from inception to 13 May 2016. Additional sources included searches of study registries, conference abstracts, dissertations, as well as websites of international regulatory authorities (eg, Food and Drug Administration (FDA), the WHO, European Medicines Agency). Search results will be supplemented by scanning the references of relevant reviews. We will include all publication types including published articles, editorials, websites and book sections that describe use of social media and crowd-sourced data for surveillance of adverse events associated with health products. Two reviewers will perform study selection and data abstraction independently, and discrepancies will be resolved through discussion. Data analysis will involve quantitative (eg, frequencies) and qualitative (eg, content analysis) methods. Dissemination The summary of results will be sent to Health Canada, who commissioned the review, and other relevant policymakers involved with the Drug Safety and Effectiveness Network. We will compile and circulate a 1-page policy brief and host a 1-day stakeholder meeting to discuss the implications, key messages and finalise the knowledge translation strategy. Findings from this review will ultimately inform the design and development of a data analytics platform for social media and crowd-sourced data for pharmacovigilance in Canada and internationally. Registration details Our protocol was registered prospectively with the Open Science Framework (https://osf.io/kv9hu/).

Effectiveness of different compression-to-ventilation methods for cardiopulmonary resuscitation: A systematic review

AIM To compare the effectiveness of different compression-to-ventilation methods during cardiopulmonary resuscitation (CPR) in patients with cardiac arrest. METHODS We searched MEDLINE and Cochrane Central Register of Controlled Trials from inception until January 2016. We included experimental, quasi-experimental, and observational studies that compared different chest compression-to-ventilation ratios during CPR for all patients and assessed at least one of the following outcomes: favourable neurological outcomes, survival, return of spontaneous circulation (ROSC), and quality of life. Two reviewers independently screened literature search results, abstracted data, and appraised the risk of bias. Random-effects meta-analyses were conducted separately for randomised and non-randomised studies, as well as study characteristics, such as CPR provider. RESULTS After screening 5703 titles and abstracts and 229 full-text articles, we included 41 studies, of which 13 were companion reports. For adults receiving bystander or dispatcher-instructed CPR, no significant differences were observed across all comparisons and outcomes. Significantly less adults receiving bystander-initiated or plus dispatcher-instructed compression-only CPR experienced favourable neurological outcomes, survival, and ROSC compared to CPR 30:2 (compression-to-ventilation) in un-adjusted analyses in a large cohort study. Evidence from emergency medical service (EMS) CPR providers showed significantly more adults receiving CPR 30:2 experiencing improved favourable neurological outcomes and survival versus those receiving CPR 15:2. Significantly more children receiving CPR 15:2 or 30:2 experienced favourable neurological outcomes, survival, and greater ROSC compared to compression-only CPR. However, for children <1 years of age, no significant differences were observed between CPR 15:2 or 30:2 and compression-only CPR. CONCLUSIONS Our results demonstrated that for adults, CPR 30:2 is associated with better survival and favourable neurological outcomes when compared to CPR 15:2. For children, more patients receiving CPR with either 15:2 or 30:2 compression-to ventilation ratio experienced favourable neurological function, survival, and ROSC when compared to CO-CPR for children of all ages, but for children <1years of age, no statistically significant differences were observed.

Study protocol for a scoping review on rehabilitation scoping reviews

Introduction: Scoping reviews are increasingly popular in rehabilitation. However, significant variability in scoping review conduct and reporting currently exists, limiting potential for the methodology to advance rehabilitation research, practice and policy. Our aim is to conduct a scoping review of rehabilitation scoping reviews in order to examine the current volume, yearly distribution, proportion, scope and methodological practices involved in the conduct of scoping reviews in rehabilitation. Key areas of methodological improvement will be described. Methods and analysis: We will undertake the review using the Arksey and O’Malley scoping review methodology. Our search will involve two phases. The first will combine a previously conducted scoping review of scoping reviews (not distinct to rehabilitation, with data current to July 2014) together with a rehabilitation keyword search in PubMed. Articles found in the first phase search will undergo a full text review. The second phase will include an update of the previously conducted scoping review of scoping reviews (July 2014 to current). This update will include the search of nine electronic databases, followed by title and abstract screening as well as a full text review. All screening and extraction will be performed independently by two authors. Articles will be included if they are scoping reviews within the field of rehabilitation. A consultation exercise with key targets will inform plans to improve rehabilitation scoping reviews. Ethics and dissemination: Ethics will be required for the consultation phase of our scoping review. Dissemination will include peer-reviewed publication and conferences in rehabilitation-specific contexts.

Evaluative reports on medical malpractice policies in obstetrics: a rapid scoping review

BackgroundThe clinical specialty of obstetrics is under particular scrutiny with increasing litigation costs and unnecessary tests and procedures done in attempts to prevent litigation. We aimed to identify reports evaluating or comparing the effectiveness of medical liability reforms and quality improvement strategies in improving litigation-related outcomes in obstetrics.MethodsWe conducted a rapid scoping review with a 6-week timeline. MEDLINE, EMBASE, LexisNexis Academic, the Legal Scholarship Network, Justis, LegalTrac, QuickLaw, and HeinOnline were searched for publications in English from 2004 until June 2015. The selection criteria for screening were established a priori and pilot-tested. We included reports comparing or evaluating the impact of obstetrics-related medical liability reforms and quality improvement strategies on cost containment and litigation settlement across all countries. All levels of screening were done by two reviewers independently, and discrepancies were resolved by a third reviewer. In addition, two reviewers independently extracted relevant data using a pre-tested form, and discrepancies were resolved by a third reviewer. The results were summarized descriptively.ResultsThe search resulted in 2729 citations, of which 14 reports met our eligibility criteria. Several initiatives for improving the medical malpractice litigation system were found, including no-fault approaches, patient safety policy initiatives, communication and resolution, caps on compensation and attorney fees, alternative payment system and liabilities, and limitations on litigation.ConclusionsOnly a few litigation policies in obstetrics were evaluated or compared. Included documents showed that initiatives to reduce medical malpractice litigation could be associated with a decrease in adverse and malpractice events. However, due to heterogeneous settings (e.g., economic structure, healthcare system) and variation in the outcomes reported, the advantages and disadvantages of initiatives may vary.

Prevention and management of unprofessional behaviour among adults in the workplace: A scoping review

Background Unprofessional behaviour is a challenge in academic medicine. Given that faculty are role models for trainees, it is critical to identify strategies to manage these behaviours. A scoping review was conducted to identify interventions to prevent and manage unprofessional behaviour in any workplace or professional setting. Methods A search of 14 electronic databases was conducted in March 2016, reference lists of relevant systematic reviews were scanned, and grey literature was searched to identify relevant studies. Experimental and quasi-experimental studies that reported on interventions to prevent or manage unprofessional behaviours were included. Studies that reported impact on any outcome were eligible. Two reviewers independently screened articles and completed data abstraction. Qualitative analysis of the definitions of unprofessional behaviour was conducted. Data were charted to describe the study, participant, intervention and outcome characteristics. Results 12,482 citations were retrieved; 23 studies with 11,025 participants were included. The studies were 12 uncontrolled before and after studies, 6 controlled before and after studies, 2 cluster-randomised controlled trials (RCTs), 1 RCT, 1 non-randomised controlled trial and 1 quasi-RCT. Four constructs were identified in the definitions of unprofessional behaviour: verbal and/or non-verbal acts, repeated acts, power imbalance, and unwelcome behaviour. Interventions most commonly targeted individuals (22 studies, 95.7%) rather than organisations (4 studies, 17.4%). Most studies (21 studies, 91.3%) focused on increasing awareness. The most frequently targeted behaviour change was sexual harassment (4 of 7 studies). Discussion Several interventions appear promising in addressing unprofessional behaviour. Most of the studies included single component, in-person education sessions targeting individuals and increasing awareness of unprofessional behaviour. Fewer studies targeted the institutional culture or addressed behaviour change.

Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis

Abstract Objective To compare the efficacy, effectiveness, and safety of the herpes zoster live attenuated vaccine with the herpes zoster adjuvant recombinant subunit vaccine or placebo for adults aged 50 and older. Design Systematic review with bayesian meta-analysis and network meta-analysis. Data sources Medline, Embase, and Cochrane Library (inception to January 2017), grey literature, and reference lists of included studies. Eligibility criteria for study selection Experimental, quasi-experimental, and observational studies that compared the live attenuated vaccine with the adjuvant recombinant subunit vaccine, placebo, or no vaccine in adults aged 50 and older. Relevant outcomes were incidence of herpes zoster (primary outcome), herpes zoster ophthalmicus, post-herpetic neuralgia, quality of life, adverse events, and death. Results 27 studies (22 randomised controlled trials) including 2 044 504 patients, along with 18 companion reports, were included after screening 2037 titles and abstracts, followed by 175 full text articles. Network meta-analysis of five randomised controlled trials found no statistically significant differences between the live attenuated vaccine and placebo for incidence of laboratory confirmed herpes zoster. The adjuvant recombinant subunit vaccine, however, was statistically superior to both the live attenuated vaccine (vaccine efficacy 85%, 95% credible interval 31% to 98%) and placebo (94%, 79% to 98%). Network meta-analysis of 11 randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more adverse events at injection sites than the live attenuated vaccine (relative risk 1.79, 95% credible interval 1.05 to 2.34; risk difference 30%, 95% credible interval 2% to 51%) and placebo (5.63, 3.57 to 7.29 and 53%, 30% to 73%, respectively). Network meta-analysis of nine randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more systemic adverse events than placebo (2.28, 1.45 to 3.65 and 20%, 6% to 40%, respectively). Conclusions Using the adjuvant recombinant subunit vaccine might prevent more cases of herpes zoster than using the live attenuated vaccine, but the adjuvant recombinant subunit vaccine also carries a greater risk of adverse events at injection sites. Protocol registration Prospero CRD42017056389.

Correction to: Engaging policy-makers, health system managers, and policy analysts in the knowledge synthesis process: a scoping review

Following the publication of the original article [1], it was brought to our attention that the letter ‘l’ was unfortunately omitted from the word ‘health’ in the article’s title.

Patient safety initiatives in obstetrics: a rapid review

Objectives This review was commissioned by WHO, South Africa-Country office because of an exponential increase in medical litigation claims related to patient safety in obstetrical care in the country. A rapid review was conducted to examine the effectiveness of quality improvement (QI) strategies on maternal and newborn patient safety outcomes, risk of litigation and burden of associated costs. Design A rapid review of the literature was conducted to provide decision-makers with timely evidence. Medical and legal databases (eg, MEDLINE, Embase, LexisNexis Academic, etc) and reference lists of relevant studies were searched. Two reviewers independently performed study selection, abstracted data and appraised risk of bias. Results were summarised narratively. Interventions We included randomised clinical trials (RCTs) of QI strategies targeting health systems (eg, team changes) and healthcare providers (eg, clinician education) to improve the safety of women and their newborns. Eligible studies were limited to trials published in English between 2004 and 2015. Primary and secondary outcome measures RCTs reporting on patient safety outcomes (eg, stillbirths, mortality and caesarean sections), litigation claims and associated costs were included. Results The search yielded 4793 citations, of which 10 RCTs met our eligibility criteria and provided information on over 500 000 participants. The results are presented by QI strategy, which varied from one study to another. Studies including provider education alone (one RCT), provider education in combination with audit and feedback (two RCTs) or clinician reminders (one RCT), as well as provider education with patient education and audit and feedback (one RCT), reported some improvements to patient safety outcomes. None of the studies reported on litigation claims or the associated costs. Conclusions Our results suggest that provider education and other QI strategy combinations targeting healthcare providers may improve the safety of women and their newborns during childbirth.