Economic evaluations of medical devices in paediatrics: a systematic review and a quality appraisal of the literature.

BACKGROUND: Although economic evaluations (EEs) have been increasingly applied to medical devices, little discussion has been conducted on how the different health realities of specific populations may impact the application of methods and the ensuing results. This is particularly relevant for pediatric populations, as most EEs on devices are conducted in adults, with specific aspects related to the uniqueness of child health often being overlooked. This study provides a review of the published EEs on devices used in paediatrics, assessing the quality of reporting, and summarising methodological challenges. METHODS: A systematic literature search was performed to identify peer-reviewed publications on the economic value of devices used in paediatrics in the form of full EEs (comparing both costs and consequences of two or more devices). After the removal of duplicates, article titles and abstracts were screened. The remaining full-text articles were retrieved and assessed for inclusion. In-vitro diagnostic devices were not considered in this review. Study descriptive and methodological characteristics were extracted using a structured template. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist was used to assess the quality of reporting. A narrative synthesis of the results was conducted followed by a critical discussion on the main challenges found in the literature. RESULTS: 39 full EEs were eligible for review. Most studies were conducted in high-income countries (67%) and focused on high-risk therapeutic devices (72%). Studies comprised 25 cost-utility analyses, 13 cost-effectiveness analyses and 1 cost-benefit analysis. Most of the studies considered a lifetime horizon (41%) and a health system perspective (36%). Compliance with the CHEERS 2022 items varied among the studies. CONCLUSIONS: Despite the scant body of evidence on EEs focusing on devices in paediatrics results highlight the need to improve the quality of reporting and advance methods that can explicitly incorporate the multiple impacts related to the use of devices with distinct characteristics, as well as consider specific child health realities. The design of innovative participatory approaches and instruments for measuring outcomes meaningful to children and their families should be sought in future research.

Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia.

Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work on PV. This initiative was put in practice by our Inserm-ANRS MIE PV department in two distinct multinational European consortia with 19 participating countries: conect4children (c4c) for paediatrics research and EU-Response for Covid-19 platform trials. The centralized PV system consists of some key procedures to harmonize the complex safety processes, creation of a local safety officer (LSO) network and centralization of all safety activities. The key procedures described the safety management plan for each trial and how tasks were shared and delegated between all stakeholders. Processing of serious adverse events (SAEs) in a unique database guaranteed the full control of the safety data and continuous evaluation of the risk-benefit ratio. The LSO network participated in efficient regulatory compliance across multiple countries. In total, there were 1312 SAEs in EU-Response and 83 SAEs in c4c in the four trials. We present here the lessons learnt from our experience in four clinical trials. We managed heterogeneous European local requirements and implemented efficient communication with all trial teams. Our approach builds capacity for PV that can be used by multiple academic sponsors.

Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov.

BACKGROUND: Data monitoring committees advise on clinical trial conduct through appraisal of emerging data to ensure participant safety and scientific integrity. While consideration of their use is recommended for trials performed with vulnerable populations, previous research has shown that data monitoring committees are reported infrequently in publications of pediatric randomized controlled trials. We aimed to assess the frequency of reported data monitoring committee adoption in ClinicalTrials.gov registry records and to examine the influence of key trial characteristics. METHODS: We conducted a cross-sectional data analysis of all randomized controlled trials performed exclusively in a pediatric population and registered in ClinicalTrials.gov between 2008 and 2021. We used the Access to Aggregate Content of ClinicalTrials.gov database to retrieve publicly available information on trial characteristics and data on safety results. Abstracted data included reported trial design and conduct parameters, population and intervention characteristics, reasons for prematurely halting, serious adverse events, and mortality outcomes. We performed descriptive analyses on the collected data and explored the influence of clinical, methodological, and operational trial characteristics on the reported adoption of data monitoring committees. RESULTS: We identified 13,928 pediatric randomized controlled trial records, of which 39.7% reported adopting a data monitoring committee, 49.0% reported not adopting a data monitoring committee, and 11.3% did not answer on this item. While the number of registered pediatric trials has been increasing since 2008, we found no clear time trend in the reported adoption of data monitoring committees. Data monitoring committees were more common in multicenter trials (50.6% vs 36.9% for single-center), multinational trials (60.2% vs 38.7% for single-country), National Institutes of Health-funded (60.3% vs 40.1% for industry-funded or 37.5% for other funders), and placebo-controlled (47.6% vs 37.5% for other types of control groups). Data monitoring committees were also more common among trials enrolling younger participants, trials employing blinding techniques, and larger trials. Data monitoring committees were more common in trials with at least one serious adverse event (52.6% vs 38.4% for those without) as well as for trials with reported deaths (70.3% vs 38.9% for trials without reported deaths). In all, 4.9% were listed as halted prematurely, most often due to low accrual rates. Trials with a data monitoring committee were more often halted for reasons related to scientific data than trials without a data monitoring committee (15.7% vs 7.3%). CONCLUSION: According to registry records, the use of data monitoring committees in pediatric randomized controlled trials was more frequent than previously reported in reviews of published trial reports. The use of data monitoring committees varied across key clinical and trial characteristics based on which their use is recommended. Data monitoring committees may still be underutilized in pediatric trials, and reporting of this item could be improved.

Modified triple Kessler with least risk of elongation among Achilles tendon repair techniques: a systematic review and network meta-analysis of human cadaveric studies.

PURPOSE: Current treatment recommendations emphasize early loading, with preservation of tendon length and physiologic tension. The objective of this systematic review and network meta-analysis was to compare failure load and elongation after cyclic loading of Achilles tendon repair techniques at time-zero. METHODS: The databases PubMed, CENTRAL and Web of Science were searched for all published in-vitro studies comparing Achilles tendon repair techniques, or augmentation with autografts/biomaterials, and reports of failure load or elongation after cyclic loading. Only studies using human cadaveric Achilles tendons and matched pairs, or randomized specimen allocation, were selected for quantitative synthesis. A network meta-analysis per primary outcome was performed. Results were summarized as P score rankings and their validity was assessed using statistical methods. RESULTS: Sixteen studies, comprising 367 tendon repairs, were included. The following repair techniques were used (n = number of studies): Krackow (n = 8), Achillon (n = 4), double Krackow (n = 3), Bunnell (n = 3), Percutaneous Achilles Repair System (n = 3), Percutaneous Achilles Repair System Midsubstance (n = 2), Kessler (n = 3), double Kessler (n = 1), modified triple Kessler (n = 1), triple bundle (n = 1), a multifilament stainless steel cable-crimp technique (n = 1) and a double loop knot stitch (n = 1). Five studies assessed augmentation with autografts/biomaterials. Regarding the failure load, biomaterial augmented Krackow repairs occupied the first four positions in the ranking, followed by the multifilament stainless steel cable-crimp and Percutaneous Achilles Repair System Midsubstance techniques. Concerning elongation after cyclic loading, the triple Kessler was ranked first, followed by the Achillon and Percutaneous Achilles Repair System Midsubstance techniques. A negligible correlation between ranks was found (rs = 0.11; p = 0.75n.s.), meaning that a higher repair tensile strength is not necessarily related to improved performance in regard to avoidance of elongation. CONCLUSION: In the failure load network meta-analysis, biomaterial augmented Krackow repairs ranked highest, but noticeable statistical heterogeneity was found. Regarding elongation with cyclic loading, the modified triple Kessler stitch showed the highest probability of ranking first. LEVEL OF EVIDENCE: Level IV.

Systematic reviews and meta-analysis published in indexed Portuguese medical journals: time trends and critical appraisal.

INTRODUCTION: Over the last years, the number of systematic reviews published is steadily increasing due to the global interest in this type of evidence synthesis. However, little is known about the characteristics of this research published in Portuguese medical journals. This study aims to evaluate the publication trends and overall quality of these systematic reviews. MATERIAL AND METHODS: This was a methodological study. We aimed the most visible Portuguese medical journals indexed in MEDLINE. Systematic reviews were identified through an electronic search (through PUBMED). We included systematic reviews published up to August 2020. Systematic reviews selection and data extraction were done independently by three authors. The overall quality critical appraisal using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2) was independently assessed by three authors. Disagreements were solved by consensus. RESULTS: Sixty-six systematic reviews published in 5 Portuguese medical journals were included. Most (n = 53; 80.3%) were systematic reviews without meta-analysis. Up to 2010 there was a steady increase in the number of systematic reviews published, followed by a period of great variability of publication, ranging from 1 to 10 in a given year. According to the systematic reviews' typology, most have been predominantly conducted to assess the effectiveness/efficacy of health interventions (n = 27; 40.9%). General and Internal Medicine (n = 20; 30.3%) was the most addressed field. Most systematic reviews (n = 46; 69.7%) were rated as being of "critically low-quality". CONCLUSIONS: There were consistent flaws in the methodological quality report of the systematic reviews included, particularly in establishing a prior protocol and not assessing the potential impact of the risk of bias on the results. Through the years, the number of systematic reviews published increased, yet their quality is suboptimal. There is a need to improve the reporting of systematic reviews in Portuguese medical journals, which can be achieved by better adherence to quality checklists/tools.

The sham effect of invasive interventions in chronic coronary syndromes: a systematic review and meta-analysis.

BACKGROUND: Some patients with chronic coronary syndromes undergo invasive procedures but the efficacy of such interventions remains to be robustly established by randomised sham-controlled trials (RCTs). PURPOSE: To determine the sham effect in patients with chronic coronary syndromes enrolled in RCTs by performing a systematic review and meta-analysis. METHODS: In April 2022, we performed a literature search for published patient-blind RCTs (CENTRAL, MEDLINE®, PsycINFO, and reference lists) with sham procedures, reporting the pre-post effects in the invasive sham arm among patients with Canadian cardiovascular society (CCS) angina or angina equivalents. RESULTS: 16 RCTs were included with 546 patients in the sham arm. Pooled results showed that sham interventions were associated with: improvement of 7% (95% CI 2-11%; I2 = 0%) in exercise time; decrease of 0.78 (95% CI - 1.10 to - 0.47; I2 = 75%) in CCS angina class; decrease of 53% (95% CI 24-71%; I2 = 96%) and 25% (95% CI 20-29%; I2 = 0%) in anginal episodes and nitroglycerine (NTG) use, respectively. Pooled results also showed an improvement in the physical functioning, angina frequency, treatment satisfaction, and disease perception domains of the Seattle Angina Questionnaire (SAQ). CONCLUSION: Sham interventions in patients with chronic coronary syndromes were associated with a significant decrease in anginal episodes, NTG use, and CCS angina class and increased SAQ quality of life and exercise time. These results highlight the need for previous non sham-controlled trials to be interpreted with caution, and the importance of new invasive interventions to be evaluated versus a sham procedure.

Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research: A Pan-European and Canadian Snapshot in Time.

OBJECTIVE: To capture the early effects of the coronavirus disease 2019 (COVID-19) pandemic on pediatric clinical research. STUDY DESIGN: Pediatric clinical research networks from 20 countries and 50 of their affiliated research sites completed two surveys over one month from early May to early June 2020. Networks liaised with their affiliated sites and contributed to the interpretation of results through pan-European group discussions. Based on first detection dates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), countries formed 1 early detecting and 1 late detecting cluster. We tested the hypothesis that this clustering influenced clinical research. RESULTS: Research sites were first impacted by the pandemic in mid-March 2020 (March 16 ± 10 days, the same date as lockdown initiation; P = .99). From first impact up until early June, site initiation and feasibility analysis processes were affected for >50% of the sites. Staff were redirected to COVID-19 research for 44% of the sites, and 75.5% of sites were involved in pediatric COVID-19 research (only 6.3% reported COVID-19 cases in their other pediatric trials). Mitigation strategies were used differently between the early and late detecting country clusters and between countries with and without a pediatric COVID-19 research taskforce. Positive effects include the development of teleworking capacities. CONCLUSIONS: Through this collaborative effort from pediatric research networks, we found that pediatric trials were affected and conducted with a range of unequally applied mitigations across countries during the pandemic. The global impact might be greater than captured. In a context where clinical research is increasingly multinational, this report reveals the importance of collaboration between national networks.

Nebulization procedures for children with unknown viral status during the COVID-19 pandemic.

During the Covid19 pandemic there has been much discussion about in-hospital procedures that may generate aerosols. One such procedure, that has led to confusion and concern, is nebulisation of children. In this paper, we discuss the evidence around whether nebulisation procedures generate aerosols, and offer strategies around nebulisation of children with asthma.

A Systematic Review of Clinical Practice Guidelines for the Diagnosis and Management of Bronchiolitis.

BACKGROUND: Bronchiolitis is the leading cause of hospital admission for respiratory disease among infants aged <1 year. Clinical practice guidelines can benefit patients by reducing the performance of unnecessary tests, hospital admissions, and treatment with lack of a supportive evidence base. This review aimed to identify current clinical practice guidelines worldwide, appraise their methodological quality, and discuss variability across guidelines for the diagnosis and management of bronchiolitis. METHODS: A systematic literature review of electronic databases EMBASE, Global Health, and Medline was performed. Manual searches of the gray literature, national pediatric society websites, and guideline-focused databases were performed, and select international experts were contacted to identify additional guidelines. The Appraisal of Guidelines for Research and Evaluation assessment tool was used by 2 independent reviewers to appraise each guideline. RESULTS: Thirty-two clinical practice guidelines met the selection criteria. Quality assessment revealed significant shortcomings in a number of guidelines, including lack of systematic processes in formulating guidelines, failure to state conflicts of interest, and lack of consultation with families of affected children. There was widespread agreement about a number of aspects, such as avoidance of the use of unnecessary diagnostic tests, risk factors for severe disease, indicators for hospital admission, discharge criteria, and nosocomial infection control. However, there was variability, even within areas of consensus, over specific recommendations, such as variable thresholds for oxygen therapy. Guidelines showed significant variability in recommendations for the pharmacological management of bronchiolitis, with conflicting recommendations over whether use of nebulized epinephrine, hypertonic saline, or bronchodilators should be routinely trialled. CONCLUSIONS: Future guidelines should aim to be compliant with international standards for clinical guidelines to improve their quality and clarity and to promote their adoption into practice. Variable recommendations between guidelines may reflect the evolving evidence base for bronchiolitis management, and platforms should be created to understand this variability and promote evidence-based recommendations.

The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years.

OBJECTIVES: For child health randomized controlled trials (RCTs) published in 2012, we aimed to describe design and reporting characteristics and evaluate changes since 2007; assess the association between trial design and registration and risk of bias (RoB); and assess the association between RoB and effect size. STUDY DESIGN: For 300 RCTs, we extracted design and reporting characteristics and assessed RoB. We assessed 5-year changes in design and reporting (based on 300 RCTs we had previously analyzed) using the Fisher exact test. We tested for associations between design and reporting characteristics and overall RoB and registration using the Fisher exact, Cochran-Armitage, Kruskal-Wallis, and Jonckheere-Terpstra tests. We pooled effect sizes and tested for differences by RoB using the χ2 test for subgroups in meta-analysis. RESULTS: The 2012 and 2007 RCTs differed with respect to many design and reporting characteristics. From 2007 to 2012, RoB did not change for random sequence generation and improved for allocation concealment (P < .001). Fewer 2012 RCTs were rated high overall RoB and more were rated unclear (P = .03). Only 7.3% of 2012 RCTs were rated low overall RoB. Trial registration doubled from 2007 to 2012 (23% to 46%) (P < .001) and was associated with lower RoB (P = .009). Effect size did not differ by RoB (P = .43) CONCLUSIONS: Random sequence generation and allocation concealment were not often reported, and selective reporting was prevalent. Measures to increase trialists' awareness and application of existing reporting guidance, and the prospective registration of RCTs is needed to improve the trustworthiness of findings from this field.

Block Copolymers as Dispersants for Single-Walled Carbon Nanotubes: Modes of Surface Attachment and Role of Block Polydispersity.

When using amphiphilic polymers to exfoliate and disperse carbon nanotubes in water, the balance between the hydrophobic and hydrophilic moieties is critical and nontrivial. Here, we investigate the mode of surface attachment of a triblock copolymer, Pluronics F127, composed of a central hydrophobic polypropylene oxide block flanked by hydrophilic polyethylene oxide blocks, onto single-walled carbon nanotubes (SWNTs). Crucially, we analyze the composition in dispersant of both the as-obtained dispersion (the supernatant) and the precipitate-containing undispersed materials. For this, we combine the carefully obtained data from 1H NMR peak intensities and self-diffusion and thermogravimetric analysis. The molecular motions behind the observed NMR features are clarified. We find that the hydrophobic blocks attach to the dispersed SWNT surface and remain significantly immobilized leading to 1H NMR signal loss. On the other hand, the hydrophilic blocks remain highly mobile and thus readily detectable by NMR. The dispersant is shown to possess significant block polydispersity that has a large effect on dispersibility. Polymers with large hydrophobic blocks adsorb on the surface of the carbonaceous particles that precipitate, indicating that although a larger hydrophobic block is good for enhancing adsorption, it may be less effective in dispersing the tubes. A model is also proposed that consistently explains our observations in SWNT dispersions and some contradicting findings obtained previously in carbon nanohorn dispersions. Overall, our findings help elucidating the molecular picture of the dispersion process for SWNTs and are of interest when looking for more effective (i.e., well-balanced) polymeric dispersants.

A descriptive analysis of non-Cochrane child-relevant systematic reviews published in 2014.

BACKGROUND: Consumers, clinicians, policymakers and researchers require high quality evidence to guide decision-making in child health. Though Cochrane systematic reviews (SRs) are a well-established source of evidence, little is known about the characteristics of non-Cochrane child-relevant SRs. To complement published descriptions of Cochrane SRs, we aimed to characterize the epidemiologic, methodological, and reporting qualities of non-Cochrane child-relevant SRs published in 2014. METHODS: English-language child-relevant SRs of quantitative primary research published outside the Cochrane Library in 2014 were eligible for this descriptive analysis. A research librarian searched MEDLINE, CINAHL, Web of Science, and PubMed in August 2015. A single reviewer screened articles for inclusion; a second verified the excluded studies. Reviewers extracted: general characteristics of the review; included study characteristics; methodological approaches. We performed univariate analyses and presented the findings narratively. RESULTS: We identified 1598 child-relevant SRs containing a median (IQR) 19 (11, 33) studies. These originated primarily from high-income countries (n = 1247, 78.0%) and spanned 47 of the 53 Cochrane Review Groups. Most synthesized therapeutic (n = 753, 47.1%) or epidemiologic (n = 701, 43.8%) evidence. Though 39.3% (n = 628) of SRs included evidence related to children only, few were published in pediatric-specific journals (n = 283, 17.7%). Reporting quality seemed poor based on the items we assessed; few reviews mentioned an a-priori protocol (n = 246, 15.4%) or registration (n = 111, 6.9%), and only 23.4% (n = 374) specified a primary outcome. Many SRs relied solely on evidence from non-RCTs (n = 796, 49.8%). Less than two-thirds (n = 953, 59.6%) appraised the quality of included studies and assessments of the certainty of the body of evidence were rare (n = 102, 6.4%). CONCLUSIONS: Child-relevant Cochrane SRs are a known source of high quality evidence in pediatrics. There exists, however, an abundance of evidence from non-Cochrane SRs that may be complementary. Our findings show that high-quality non-Cochrane SRs may not be practical nor easy for knowledge users to find. Improvements are needed to ensure that evidence syntheses published outside of the Cochrane Library adhere to the high standard of conduct and reporting characteristic of Cochrane SRs.

Comparison of nuisance parameters in pediatric versus adult randomized trials: a meta-epidemiologic empirical evaluation.

BACKGROUND: We wished to compare the nuisance parameters of pediatric vs. adult randomized-trials (RCTs) and determine if the latter can be used in sample size computations of the former. METHODS: In this meta-epidemiologic empirical evaluation we examined meta-analyses from the Cochrane Database of Systematic-Reviews, with at least one pediatric-RCT and at least one adult-RCT. Within each meta-analysis of binary efficacy-outcomes, we calculated the pooled-control-group event-rate (CER) across separately all pediatric and adult-trials, using random-effect models and subsequently calculated the control-group event-rate risk-ratio (CER-RR) of the pooled-pediatric-CERs vs. adult-CERs. Within each meta-analysis with continuous outcomes we calculated the pooled-control-group effect standard deviation (CE-SD) across separately all pediatric and adult-trials and subsequently calculated the CE-SD-ratio of the pooled-pediatric-CE-SDs vs. adult-CE-SDs. We then calculated across all meta-analyses the pooled-CER-RRs and pooled-CE-SD-ratios (primary endpoints) and the pooled-magnitude of effect-sizes of CER-RRs and CE-SD-ratios using REMs. A ratio < 1 indicates that pediatric trials have smaller nuisance parameters than adult trials. RESULTS: We analyzed 208 meta-analyses (135 for binary-outcomes, 73 for continuous-outcomes). For binary outcomes, pediatric-RCTs had on average 10% smaller CERs than adult-RCTs (summary-CE-RR: 0.90; 95% CI: 0.83, 0.98). For mortality outcomes the summary-CE-RR was 0.48 (95% CIs: 0.31, 0.74). For continuous outcomes, pediatric-RCTs had on average 26% smaller CE-SDs than adult-RCTs (summary-CE-SD-ratio: 0.74). CONCLUSIONS: Clinically relevant differences in nuisance parameters between pediatric and adult trials were detected. These differences have implications for design of future studies. Extrapolation of nuisance parameters for sample-sizes calculations from adult-trials to pediatric-trials should be cautiously done.

Evaluation of AMSTAR to assess the methodological quality of systematic reviews in overviews of reviews of healthcare interventions.

BACKGROUND: Overviews of reviews (overviews) compile information from multiple systematic reviews (SRs) to provide a single synthesis of relevant evidence for decision-making. It is recommended that authors assess and report the methodological quality of SRs in overviews-for example, using A MeaSurement Tool to Assess systematic Reviews (AMSTAR). Currently, there is variation in whether and how overview authors assess and report SR quality, and limited guidance is available. Our objectives were to: examine methodological considerations involved in using AMSTAR to assess the quality of Cochrane and non-Cochrane SRs in overviews of healthcare interventions; identify challenges (and develop potential decision rules) when using AMSTAR in overviews; and examine the potential impact of considering methodological quality when making inclusion decisions in overviews. METHODS: We selected seven overviews of healthcare interventions and included all SRs meeting each overview's inclusion criteria. For each SR, two reviewers independently conducted AMSTAR assessments with consensus and discussed challenges encountered. We also examined the correlation between AMSTAR assessments and SR results/conclusions. RESULTS: Ninety-five SRs were included (30 Cochrane, 65 non-Cochrane). Mean AMSTAR assessments (9.6/11 vs. 5.5/11; p < 0.001) and inter-rater reliability (AC1 statistic: 0.84 vs. 0.69; "almost perfect" vs. "substantial" using the Landis & Koch criteria) were higher for Cochrane compared to non-Cochrane SRs. Four challenges were identified when applying AMSTAR in overviews: the scope of the SRs and overviews often differed; SRs examining similar topics sometimes made different methodological decisions; reporting of non-Cochrane SRs was sometimes poor; and some non-Cochrane SRs included other SRs as well as primary studies. Decision rules were developed to address each challenge. We found no evidence that AMSTAR assessments were correlated with SR results/conclusions. CONCLUSIONS: Results indicate that the AMSTAR tool can be used successfully in overviews that include Cochrane and non-Cochrane SRs, though decision rules may be useful to circumvent common challenges. Findings support existing recommendations that quality assessments of SRs in overviews be conducted independently, in duplicate, with a process for consensus. Results also suggest that using methodological quality to guide inclusion decisions (e.g., to exclude poorly conducted and reported SRs) may not introduce bias into the overview process.

Effectiveness of needle and syringe Programmes in people who inject drugs - An overview of systematic reviews.

BACKGROUND: Needle and syringe programmes (NSP) are a critical component of harm reduction interventions among people who inject drugs (PWID). Our primary objective was to summarize the evidence on the effectiveness of NSP for PWID in reducing blood-borne infection transmission and injecting risk behaviours (IRB). METHODS: We conducted an overview of systematic reviews that included PWID (excluding prisons and consumption rooms), addressed community-based NSP, and provided estimates of the effect regarding incidence/prevalence of Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV), Hepatitis B virus (HBV) and bacteremia/sepsis, and/or measures of IRB. Systematic literature searches were undertaken on relevant databases, including EMBASE, MEDLINE, and PsychINFO (up to May 2015). For each review we identified relevant studies and extracted data on methods, and findings, including risk of bias and quality of evidence assessed by review authors. We evaluated the risk of bias of each systematic review using the ROBIS tool. We categorized reviews by reported outcomes and use of meta-analysis; no additional statistical analysis was performed. RESULTS: We included thirteen systematic reviews with 133 relevant unique studies published between 1989 and 2012. Reported outcomes related to HIV (n = 9), HCV (n = 8) and IRB (n = 6). Methods used varied at all levels of design and conduct, with four reviews performing meta-analysis. Only two reviews were considered to have low risk of bias using the ROBIS tool, and most included studies were evaluated as having low methodological quality by review authors. We found that NSP was effective in reducing HIV transmission and IRB among PWID, while there were mixed results regarding a reduction of HCV infection. Full harm reduction interventions provided at structural level and in multi-component programmes, as well as high level of coverage, were more beneficial. CONCLUSIONS: The heterogeneity and the overall low quality of evidence highlights the need for future community-level studies of adequate design to support these results. TRIAL REGISTRATION: The protocol of this systematic review was registered in Prospective Register of Systematic Reviews (PROSPERO 2015: CRD42015026145 ).

Descriptive analysis of cochrane child-relevant systematic reviews: an update and comparison between 2009 and 2013.

BACKGROUND: Systematic reviews support health systems and clinical decision-making by identifying and summarizing all existing studies on a particular topic. In 2009, a comprehensive description of child-relevant systematic reviews published in the Cochrane Database of Systematic Reviews was compiled. This study aims to provide an update, and to describe these systematic reviews according to their content and methodological approaches. METHODS: All child-relevant systematic reviews published by the Cochrane Collaboration in the Cochrane Database of Systematic Reviews (CDSR) as of March, 2013 were identified and described in relation to their content and methodological approaches. This step equated to an update of the Child Health Field Review Register (CHFRR). The content of the updated CHFRR was compared to the published 2009 CHFRR description regarding clinical and methodological characteristics, using bivariate analyses. As the Cochrane Collaboration has recognized that disease burden should guide research prioritization, we extracted data from the Global and National Burden of Diseases and Injuries Among Children and Adolescents Between 1990 and 2013 study in order to map the distribution of the burden of disease in child health to the distribution of evidence across Review Groups in the CHFRR. RESULTS: Of the 5,520 potential Cochrane systematic reviews identified, 1,293 (23.4%) were child-relevant (an increase of 24% since 2009). Overall, these reviews included 16,738 primary studies. The most commonly represented Review Groups were Airways (11.5%), Cystic Fibrosis and Genetic Diseases (7.9%), Acute Respiratory Infections (7.8%), Developmental, Psychological and Learning Problems (6.7%), and Infectious Diseases (6.2%). Corresponding authors were most often from Europe (51%), North America (15%), and Australia (15%). The majority of systematic reviews examined pharmacological interventions alone (52% compared to 59% in 2009). Out of 611 reviews that were assessed as up-to-date, GRADE was used in 204 (35%) reviews to assess the overall quality of the evidence, which was often moderate (35.6%) or low (37.8%) for primary outcomes. Ninety percent of reviews that were assessed as up to date used the Cochrane Risk of Bias tool, or a modified version, to assess methodological quality. Most reviews conducted one or more meta-analyses (73%). Among the 25 leading causes of death globally, the Review Groups associated with the largest number of causes were: 1) Infectious Diseases, 2) Anaesthesia, Critical, and Emergency Care, 3) Injuries, 4) Pregnancy and Childbirth (PC), and 5) Neonatal. There were large discrepancies between the number of causes of mortality that each Review Group was associated with and the total amount of evidence each Review Group contributed to the CHFRR. Ninety-eight percent of the causes of mortality in 2013 were from developing nations, but only 224 (17.3%) reviews had corresponding authors from developing countries. CONCLUSION: The content and methodological characteristics of child-relevant systematic reviews in the Cochrane CHFRR have been described in detail. There were modest advances in methods between 2009 and 2013. Systematic reviews contained in the CDSR offer an important resource for researcher's, clinicians and policy makers by synthesizing an extensive body of primary research. Further content analysis will allow the identification of clinical topics of greatest priority for future systematic reviews in child health.

Outcomes in Child Health: Exploring the Use of Social Media to Engage Parents in Patient-Centered Outcomes Research.

BACKGROUND: With the rapid growth of technology and its improved accessibility globally, social media is gaining an increasingly important role in health care. Patients are frequently engaging with social media to access information, share content, and interact with others in online health communities. However, the use of social media as a stakeholder engagement strategy has been minimally explored, and effective methods for involving participants in research on the identification of patient-centered outcomes remain unknown. OBJECTIVE: The aim of this study was to evaluate the process of using social media to engage parents in identifying patient-centered outcomes, using acute respiratory infections in children as an example to gauge feasibility. METHODS: We conducted a process evaluation of a two-phase Web-based strategy to engage parents in research on patient-centered outcomes. In the first phase, we developed a website and study-specific Facebook and Twitter accounts to recruit parents to complete a Web-based survey identifying patient-centered outcomes. In the second phase, we used Facebook to host discussion with parents based on the survey results. The reach of social media as an engagement strategy and the characteristics of the population recruited were assessed. RESULTS: During the first phase, there were 5027 visits to the survey site, 110 participants completed the survey, 553 unique users visited the study website (675 visits), the Facebook page received 104 likes, and the Twitter account gained 52 followers over the 14-week study period. Most survey respondents identified Facebook (51.8%, 57/110) or a friend (45.5%, 50/110) as their source of referral. It was found that 70.0% (77/110) of respondents resided in Canada, in urban centers (92.7%, 102/110), and 88.2% (97/110) had a college or university degree or higher. The median year of birth was 1978 and 90.0% (99/110) were female. Most survey responses (88.2%, 97/110) were completed during the first month of the study. In the second phase, 4 parents participated in the discussion, our Facebook page gained 43 followers, and our posts reached 5866 users. Mirroring the first phase, most followers were female (79%, 34/43), between 35 and 44 years (49%, 21/43), and resided in Canada (98%, 42/43). User engagement was variable, with no clear patterns emerging in timing, topic, or type of post. CONCLUSIONS: Most participants were highly educated, urban dwelling, and female, limiting diversity and representativeness. The source of referral for most survey respondents was through Facebook or a friend, suggesting the importance of personal connections in the dissemination and uptake of information. User engagement with the Facebook-based discussion threads was inconsistent and difficult to initiate. Although there is substantial interest in the use of social media as a component of an effective patient engagement strategy, challenges regarding participant engagement, representativeness, obtaining buy-in, and resources required must be carefully considered.

Social Media for the Dissemination of Cochrane Child Health Evidence: Evaluation Study.

BACKGROUND: Health care providers value ready access to reliable synthesized information to support point-of-care decision making. Web-based communities, facilitated by the adoption of social media tools such as Facebook, Twitter, and YouTube, are increasingly being used for knowledge dissemination, bridging the gap between knowledge generation and synthesis and knowledge implementation. OBJECTIVE: Our objective was to implement and evaluate a structured social media strategy, using multiple platforms, to disseminate Cochrane Child Health evidence to health care providers caring for children. METHODS: Our social media strategy had three components: daily "tweets" using the Cochrane Child Health Twitter account, weekly WordPress blog posts, and a monthly journal club on Twitter ("tweet chat"). Each tweet, blog, and journal club shared Cochrane evidence on a child health topic. We evaluated the strategy through (1) Twitter and blog site analytics, (2) traceable link (Bitly) statistics, (3) Altmetric.com scores for promoted evidence, and (4) participant feedback. We also tracked the resources required to write the blog, tweet content, and manage the strategy. RESULTS: The 22-week social media strategy ran between November 2014 and April 2015. We created 25 blog posts, sent 585 tweets, and hosted 3 tweet chats. Monthly blog visits and views and Twitter account followers increased over time. During the study period, the blog received 2555 visitors and 3967 page views from a geographically diverse audience of health care providers, academics, and health care organizations. In total, 183 traceable Bitly links received 3463 clicks, and the Twitter account gained 469 new followers. The most visited and viewed blog posts included gastrointestinal topics (lactose avoidance), research on respiratory conditions (honey for cough and treatments for asthma), and maternal newborn care (skin-to-skin contact). On Twitter, popular topics were related to public health (vaccination) and pain management. We collected Altmetric.com scores for 61 studies promoted during the study period and recorded an average increase of 11 points. Research staff (n=3) contributed approximately 433 hours to promotion activities and planning (6.5 hours each per week) to implement the social media strategy, and study investigators reviewed all content (blog posts and tweets). CONCLUSIONS: This study provides empirical evidence on the use of a coordinated social media strategy for the dissemination of evidence to professionals providing health services to children and youth. The results and lessons learned from our study provide guidance for future knowledge dissemination activities using social media tools.

A systematic review of the characteristics and validity of monitoring technologies to assess Parkinson's disease.

BACKGROUND: There is growing interest in having objective assessment of health-related outcomes using technology-based devices that provide unbiased measurements which can be used in clinical practice and scientific research. Many studies have investigated the clinical manifestations of Parkinson's disease using such devices. However, clinimetric properties and clinical validation vary among the different devices. METHODS: Given such heterogeneity, we sought to perform a systematic review in order to (i) list, (ii) compare and (iii) classify technological-based devices used to measure motor function in individuals with Parkinson's disease into three groups, namely wearable, non-wearable and hybrid devices. A systematic literature search of the PubMed database resulted in the inclusion of 168 studies. These studies were grouped based on the type of device used. For each device we reviewed availability, use, reliability, validity, and sensitivity to change. The devices were then classified as (i) 'recommended', (ii) 'suggested' or (iii) 'listed' based on the following criteria: (1) used in the assessment of Parkinson's disease (yes/no), (2) used in published studies by people other than the developers (yes/no), and (3) successful clinimetric testing (yes/no). RESULTS: Seventy-three devices were identified, 22 were wearable, 38 were non-wearable, and 13 were hybrid devices. In accordance with our classification method, 9 devices were 'recommended', 34 devices were 'suggested', and 30 devices were classified as 'listed'. Within the wearable devices group, the Mobility Lab sensors from Ambulatory Parkinson's Disease Monitoring (APDM), Physilog®, StepWatch 3, TriTrac RT3 Triaxial accelerometer, McRoberts DynaPort, and Axivity (AX3) were classified as 'recommended'. Within the non-wearable devices group, the Nintendo Wii Balance Board and GAITRite® gait analysis system were classified as 'recommended'. Within the hybrid devices group only the Kinesia® system was classified as 'recommended'.