Venous thromboembolism (VTE) is a major global cause of morbidity and mortality. Low molecular weight heparin (LMWH) and fondaparinux (FDP) are frequently used to treat and prevent VTE and have a ...variety of safety and practical advantages over other anticoagulants, including use in outpatient settings. These medications are commonly listed on drug formularies, which act as a gateway for health plan prescription coverage by outlining the circumstances under which patients will be covered for specific drugs and drug products. Because patient access to medications is impacted by the nature of their listing on formularies, they must be rigorously reviewed and modernized as new evidence emerges.
As part of a broader drug class review team, we completed a systematic review of clinical practice guidelines to determine whether the recommendations they reported aligned with the indications listed for the coverage of LMWH and FDP in an outpatient drug formulary. Guideline quality was assessed using the Appraisal of Guidelines for Research & Evaluation (AGREE) II tool. Recommendation matrices were used to systematically compare, categorize, and summarize included recommendations.
Twenty-seven guidelines were included from which 168 eligible recommendations were identified. Generally, AGREE II domains were adequately addressed; however, domain five (applicability) was poorly addressed. Most recommendations were based on moderate- to low-quality/limited evidence and reported on the use of LMWHs generally; few reported on specific agents.
Our findings contributed to the recommendation that the formulary listing for LMWH and FDP be streamlined to include coverage for specific outpatient indications. The paucity of available evidence on the comparative efficacy of specific LMWH agents against each other and FDP limited agent-specific listing recommendations, highlighting the need for high-quality comparative studies on this topic.
Background. Back pain is a common problem and a major cause of disability and health care utilization. Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments ...(acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain. Data Sources. Records without language restriction from various databases up to February 2010. Data Extraction. The efficacy outcomes of interest were pain intensity and disability. Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature. Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments.
This study is to perform a systematic review of existing guidance on quality of reporting and methodology for systematic reviews of diagnostic test accuracy (DTA) in order to compile a list of ...potential items that might be included in a reporting guideline for such reviews: Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Diagnostic Test Accuracy (PRISMA-DTA).
Study protocol published on EQUATOR website. Articles in full text or abstract form that reported on any aspect of reporting systematic reviews of diagnostic test accuracy were eligible for inclusion. We used the Ovid platform to search Ovid MEDLINE®, Ovid MEDLINE® In-Process & Other Non-Indexed Citations and Embase Classic+Embase through May 5, 2016. The Cochrane Methodology Register in the Cochrane Library (Wiley version) was also searched. Title and abstract screening followed by full-text screening of all search results was performed independently by two investigators. Guideline organization websites, published guidance statements, and the Cochrane Handbook for Diagnostic Test Accuracy were also searched. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Standards for Reporting Diagnostic Accuracy (STARD) were assessed independently by two investigators for relevant items.
The literature searched yielded 6967 results; 386 were included after title and abstract screening and 203 after full-text screening. After reviewing the existing literature and guidance documents, a preliminary list of 64 items was compiled into the following categories: title (three items); introduction (two items); methods (35 items); results (13 items); discussion (nine items), and disclosure (two items).
Items on the methods and reporting of DTA systematic reviews in the present systematic review will provide a basis for generating a PRISMA extension for DTA systematic reviews.
Guidelines recommend that individuals with opioid use disorder (OUD) receive pharmacological and psychosocial interventions; however, the most appropriate psychosocial intervention is not known. In ...collaboration with people with lived experience, clinicians, and policy makers, we sought to assess the relative benefits of psychosocial interventions as an adjunct to opioid agonist therapy (OAT) among persons with OUD.
A review protocol was registered a priori (CRD42018090761), and a comprehensive search for randomized controlled trials (RCT) was conducted from database inception to June 2020 in MEDLINE, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials. Established methods for study selection and data extraction were used. Primary outcomes were treatment retention and opioid use (measured by urinalysis for opioid use and opioid abstinence outcomes). Odds ratios were estimated using network meta-analyses (NMA) as appropriate based on available evidence, and in remaining cases alternative approaches to synthesis were used.
Seventy-two RCTs met the inclusion criteria. Risk of bias evaluations commonly identified study limitations and poor reporting with regard to methods used for allocation concealment and selective outcome reporting. Due to inconsistency in reporting of outcome measures, only 48 RCTs (20 unique interventions, 5,404 participants) were included for NMA of treatment retention, where statistically significant differences were found when psychosocial interventions were used as an adjunct to OAT as compared to OAT-only. The addition of rewards-based interventions such as contingency management (alone or with community reinforcement approach) to OAT was superior to OAT-only. Few statistically significant differences between psychosocial interventions were identified among any other pairwise comparisons. Heterogeneity in reporting formats precluded an NMA for opioid use. A structured synthesis was undertaken for the remaining outcomes which included opioid use (n = 18 studies) and opioid abstinence (n = 35 studies), where the majority of studies found no significant difference between OAT plus psychosocial interventions as compared to OAT-only.
This systematic review offers a comprehensive synthesis of the available evidence and the limitations of current trials of psychosocial interventions applied as an adjunct to OAT for OUD. Clinicians and health services may wish to consider integrating contingency management in addition to OAT for OUD in their settings to improve treatment retention. Aside from treatment retention, few differences were consistently found between psychosocial interventions adjunctive to OAT and OAT-only. There is a need for high-quality RCTs to establish more definitive conclusions.
PROSPERO registration CRD42018090761.
A rapid review, guided by a protocol, was conducted to inform development of the World Health Organization's guideline on personal protective equipment in the context of the ongoing (2013-present) ...Western African filovirus disease outbreak, with a focus on health care workers directly caring for patients with Ebola or Marburg virus diseases.
Electronic databases and grey literature sources were searched. Eligibility criteria initially included comparative studies on Ebola and Marburg virus diseases reported in English or French, but criteria were expanded to studies on other viral hemorrhagic fevers and non-comparative designs due to the paucity of studies. After title and abstract screening (two people to exclude), full-text reports of potentially relevant articles were assessed in duplicate. Fifty-seven percent of extraction information was verified. The Grading of Recommendations Assessment, Development and Evaluation framework was used to inform the quality of evidence assessments.
Thirty non-comparative studies (8 related to Ebola virus disease) were located, and 27 provided data on viral transmission. Reporting of personal protective equipment components and infection prevention and control protocols was generally poor.
Insufficient evidence exists to draw conclusions regarding the comparative effectiveness of various types of personal protective equipment. Additional research is urgently needed to determine optimal PPE for health care workers caring for patients with filovirus.
Background
Liver biopsy remains the gold standard for the diagnosis of liver fibrosis, but its use as a diagnostic tool is limited by its invasive nature and high cost.
Objective
The aim of this ...study was to systematically review the cost‐effectiveness of transient elastography (TE) with and without controlled attenuation parameter (CAP) for the diagnosis of liver fibrosis or steatosis in patients with hepatitis B, hepatitis C, alcoholic liver disease and non‐alcoholic fatty liver disease.
Methods
An economic literature search was performed. Eligibility criteria included systematic reviews, health technology assessments or economic evaluations of TE compared to liver biopsy and other non‐invasive tests. After screening, full‐text reports of potentially relevant articles were assessed in duplicate. The methodological quality of the included studies was also appraised.
Results
The database search yielded 253 records; four cost‐effectiveness and four cost‐utility studies were included. The methodological quality of the included studies varies. High‐quality cost‐effectiveness studies not only suggested that TE is less costly but also less accurate than liver biopsy. The incremental cost‐effectiveness ratio (ICER) of TE improves with a greater level of diagnostic accuracy and a higher degree of liver fibrosis. High‐quality cost‐utility studies indicated that TE is a cost‐effective alternative to biopsy with ICER between $9000 and $14 000 per QALY for patients with hepatitis C. We did not find studies that assessed the cost‐effectiveness of TE with CAP for the diagnosis of liver steatosis.
Conclusions
Transient elastography is an economically attractive alternative to liver biopsy and other non‐invasive diagnostic tests especially for patients with a higher degree of liver fibrosis.
Abstract
Introduction
Older adults with hip fracture often require extensive post-surgery care across multiple sectors, making follow-up care even more important to ensure an ideal recovery. With the ...increased adoption of technology, patient-clinician digital health interventions can potentially improve post-surgery outcomes of hip fracture patients by helping them and their caregivers better understand the various aspects of their care, post-hip fracture surgery. The purpose of this study was to examine the available literature on the impact of hip fracture-specific, patient-clinician digital health interventions on patient outcomes and health care delivery processes. We also aimed to identify the barriers and enablers to the uptake and implementation of these technologies and to provide strategies for improved use of these digital health interventions.
Methods
We conducted a scoping review following the six stages of Arksey and O’Malley’s framework and following the PRISMA-ScR reporting format. Searches were conducted in five databases. In addition to hand searching for relevant studies from the references of all included studies, we also conducted a grey literature search to identify relevant primary studies. Screening of titles and abstracts as well as full texts were performed independently by two reviewers. Two reviewers also performed the data extraction of the included studies.
Results
After screening 3,638 records, 20 articles met the criteria and 1 article was identified through hand searching. Various patient-clinician digital health interventions were described including telehealth /telerehabilitation programs (
n
= 6), care transition /follow-up interventions (
n
= 5), online resources (
n
= 2), and wearable devices /sensor monitoring (
n
= 1). Outcomes were varied and included functional status, gait/mobility, quality of life, psychological factors, satisfaction, survival/complications, caregiver outcomes, compliance, technology-user interactions, and feedback on the use of the digital health interventions. For clinicians, a key barrier to the use of the digital health interventions was the
acceptability of the technology
. However, the
usefulness of the digital health intervention
by clinicians was seen as both a barrier and an enabler. For patients and caregivers, all the themes were seen as both a barrier and an enabler depending on the study. These themes included: 1)
availability and access,
2)
usability
, 3)
knowledge and skills
, 4)
acceptability
, and 5)
usefulness of the digital health intervention.
Conclusion
Many behavioural factors affect the use of patient-clinician digital health interventions. However, a specific attention should be focused on the acceptability of the technology by the clinicians to encourage uptake of the digital health interventions. The results of this scoping review can help to better understand the factors that may be targeted to increase the use of these technologies by clinicians, patients, and caregivers.
IntroductionData regarding the safety of drugs and vaccines in pregnant women are typically unavailable before licensure. Pregnancy exposure registries (PERs) are an important source of postmarketing ...safety information. PERs in low-income and middle-income countries (LMICs) are uncommon but can provide valuable safety data regarding their distinct contexts and will become more relevant as the introduction and use of new drugs and vaccines in pregnancy increase worldwide. Strategies to support PERs in LMICs must be based on a better understanding of their current status. We developed a scoping review protocol to assess the landscape of PERs that operate in LMICs and characterise their strengths and challenges.Methods and analysisThis scoping review protocol follows the Joanna Briggs Institute manual for scoping reviews. The search strategy will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. We will search PubMed, Embase, CINAHL and WHO’s Global Index Medicus, as well as the reference lists of retrieved full-text records, for articles published between 2000 and 2022 that describe PERs or other resources that systematically record exposures to medical products during pregnancy and maternal and infant outcomes in LMICs. Title and abstracts will be screened by two authors and data extracted using a standardised form. We will undertake a grey literature search using Google Scholar and targeted websites. We will distribute an online survey to selected experts and conduct semistructured interviews with key informants. Identified PERs will be summarised in tables and analysed.Ethics and disseminationEthical approval is not required for this activity, as it was determined not to involve human subjects research. Findings will be submitted to an open access peer-reviewed journal and may be presented at conferences, with underlying data and other materials made publicly available.
ObjectiveDetermine the effectiveness of digital mental health interventions for individuals with a concomitant chronic disease.DesignWe conducted a rapid review of systematic reviews. Two reviewers ...independently conducted study selection and risk of bias evaluation. A standardised extraction form was used. Data are reported narratively.InterventionsWe included systematic reviews of digital health interventions aiming to prevent, detect or manage mental health problems in individuals with a pre-existing chronic disease, including chronic mental health illnesses, published in 2010 or after.Main outcome measureReports on mental health outcomes (eg, anxiety symptoms and depression symptoms).ResultsWe included 35 reviews, totalling 702 primary studies with a total sample of 50 692 participants. We structured the results in four population clusters: (1) chronic diseases, (2) cancer, (3) mental health and (4) children and youth. For populations presenting a chronic disease or cancer, health provider directed digital interventions (eg, web-based consultation, internet cognitive–behavioural therapy) are effective and safe. Further analyses are required in order to provide stronger recommendations regarding relevance for specific population (such as children and youth). Web-based interventions and email were the modes of administration that had the most reports of improvement. Virtual reality, smartphone applications and patient portal had limited reports of improvement.ConclusionsDigital technologies could be used to prevent and manage mental health problems in people living with chronic conditions, with consideration for the age group and type of technology used.
Abstract
Background
Depression affects an individual’s physical health and mental well-being and, in pregnant and postpartum women, has specific adverse short- and long-term effects on maternal, ...child, and family health. The aim of these two systematic reviews is to identify evidence on the benefits and harms of screening for depression compared to no screening in the general adult and pregnant and postpartum populations in primary care or non-mental health clinic settings. These reviews will inform recommendations by the Canadian Task Force on Preventive Health Care.
Methods
We searched MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library using a randomized controlled trial filter, where applicable, October 4, 2018, and updated to May 11, 2020. We also searched for gray literature (e.g., websites of organizations of health professionals and patients). Study selection for depression screening trials was performed first on title and abstract, followed by full-text screening. Data extraction, assessment of the risk of bias using the Cochrane risk of bias tool, and application of Grading of Recommendations Assessment, Development and Evaluation were performed by one reviewer and validated by a second reviewer.
Results
A total of three trials were included. All three trials were included in the general adult review, while one of the three trials was included in the pregnant and postpartum review. We did not pool results due to substantial differences between studies and high risk of bias. In the general adult review, the first trial (
n
= 1001) evaluated whether screening for depression in adults with acute coronary syndrome compared to usual care improves health-related quality of life, depression symptoms, or harms of screening at 6, 12, and 18 months. There were little to no differences between the groups at 18 months for the outcomes. The second trial included adults (
n
= 1412) undergoing initial consultation for osteoarthritis, evaluated for depression and general health (mental and physical) after initial consultation and at 3, 6, and 12 months. The physical component score was statistically significantly lower (worse health) in the screened group at 6 months; however, this difference was not significant at 3 or at 12 months. There were no clinically important or statistically significant differences for other outcomes between groups at any time. The third trial (included in both reviews) reported on 462 postpartum women. At 6 months postpartum, fewer women in the screening group were identified as possibly depressed compared to the control group (RR 0.59, 95% confidence interval (CI) 0.39 to 0.89) and mean EPDS scores were also statistically significantly lower in the screened group (standardized mean difference 0.34 lower (95% CI 0.15 to 0.52 lower)). All other outcomes did not differ between groups at follow-up. There were serious concerns about the cut-offs used for the questionnaire used to screen, diagnostic confirmation, selective outcome reporting, and the reported magnitude of effects.
Discussion
There are limitations of the evidence included in the reviews. There was moderate certainty in the evidence from one trial that screening for depression in the general adult population in primary care or non-mental health clinic settings likely results in little to no difference on reported outcomes; however, the evidence was uncertain from the other two included trials. The evidence is very uncertain about the effect of screening for depression in pregnant or postpartum women in primary care or non-mental health clinic settings. Well-conducted and better-reported trials are needed that meet the screening trial criteria used in this review.
Systematic review registration
Both protocols have been registered in the International Prospective Registry of Systematic Reviews (PROSPERO) adult:
CRD42018099690
; pregnancy and postpartum:
CRD42018099689
and published (
https://systematicreviewsjournal.biomedcentral.com/track/pdf/10.1186/s13643-018-0930-3
).
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