scholarly journals Errata for trial publications are not uncommon, are frequently not trivial, and can be challenging to access: a retrospective review

2019 ◽  
Vol 107 (2) ◽  
Author(s):  
Kelly Farrah ◽  
Danielle Rabb
Keyword(s):  
Systematic Reviews ◽  
Retrospective Review ◽  
Time Lag ◽  
Bibliographic Databases ◽  
Common Drug Review ◽  
Database Indexing ◽  
Standard Information ◽  
Publication Time ◽  
Inconsistent Database ◽  
Drug Review

Objective: The research sought to determine the prevalence of errata for drug trial publications that are included in systematic reviews, their potential value to reviews, and their accessibility via standard information retrieval methods.Methods: The authors conducted a retrospective review of included studies from forty systematic reviews of drugs evaluated by the Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review (CDR) in 2015. For each article that was included in the systematic reviews, we conducted searches for associated errata using the CDR review report, PubMed, and the journal publishers’ websites. The severity of errors described in errata was evaluated using a three-category scale: trivial, minor, or major. The accessibility of errata was determined by examining inclusion in bibliographic databases, costs of obtaining errata, time lag between article and erratum publication, and correction of online articles.Results: The 40 systematic reviews included 127 articles in total, for which 26 errata were identified. These errata described 38 errors. When classified by severity, 6 errors were major; 20 errors were minor; and 12 errors were trivial. No one database contained all the errata. On average, errata were published 211 days after the original article (range: 15–1,036 days). All were freely available. Over one-third (9/24) of online articles were uncorrected after errata publication.Conclusion: Errata frequently described non-trivial errors that would either impact the interpretation of data in the article or, in fewer cases, impact the conclusions of the study. As such, it seems useful for reviewers to identify errata associated with included studies. However, publication time lag and inconsistent database indexing impair errata accessibility.

scholarly journals Efficacy of perioperative immunonutrition in visceral surgery: an umbrella review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e053851
Author(s):  
Karem Slim ◽  
Flora Badon ◽  
Charles-Hervé Vacheron ◽  
Chadli Dziri ◽  
Thomas Marquillier
Keyword(s):  
Systematic Reviews ◽  
Surgical Site Infections ◽  
Visceral Surgery ◽  
Hospital Length Of Stay ◽  
Bibliographic Databases ◽  
Measurement Tool ◽  
Published Data ◽  
Umbrella Review ◽  
Meta Analyses

IntroductionImmunonutrition (IN) is generally used before major visceral surgery with the intent to reduce postoperative complications, especially infectious ones. However, the conclusions of published meta-analyses are conflicting. The purpose of this review is to synthesise the data of published systematic reviews on the effectiveness of IN.Methods and analysisThis protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols guidelines. This is an umbrella review of systematic reviews comparing IN (delivered orally 5–7 days preoperatively) with normal diet or isocaloric isonitrogenous feeding before visceral surgery performed on any of several viscera (colorectum, stomach, pancreas, liver, oesophagus). We search the systematic reviews included in the main bibliographic databases. To assess the efficacy of IN, several outcomes will be considered: the main outcome is infectious complications (surgical site infections, pulmonary infections or urinary infections) and secondary outcomes are overall morbidity, hospital length of stay and mortality. Identified reviews will be screened by two independent assessors. The methodological quality of relevant included reviews will be assessed using A MeaSurement Tool to Assess systematic Reviews (AMSTAR) instrument. The data extracted from included reviews will be synthesised using the r-Metafor package considering separate groups according to the viscus of interest. Publication bias will be evaluated, and subgroup analyses will be performed according to the quality of studies and preoperative nutritional status.Ethics and disseminationAn umbrella review based on published data from systematic reviews needs no ethical approval. Furthermore, no patient will be involved in the review. Once terminated, the review will be submitted for publication in an open access journal to ensure wide dissemination of the findings.PROSPERO registration numberCRD42021255177.

scholarly journals The Contributions of MEDLINE, Other Bibliographic Databases and Various Search Techniques to NICE Public Health Guidance

2015 ◽  
Vol 10 (1) ◽  
pp. 50 ◽  
Author(s):  
Paul Levay ◽  
Michael Raynor ◽  
Daniel Tuvey
Keyword(s):  
Public Health ◽  
Systematic Reviews ◽  
Spatial Planning ◽  
Grey Literature ◽  
Database Search ◽  
Bibliographic Databases ◽  
Search Techniques ◽  
Different Types ◽  
Health Guidance ◽  
Guidance Development

Abstract Objective – To make recommendations for the National Institute for Health and Care Excellence (NICE) on the factors to consider when choosing databases and search techniques when producing systematic reviews to support public health guidance development. Methods – Retrospective analysis of how the publications included in systematic reviews commissioned by NICE on obesity, spatial planning, and tuberculosis were retrieved. The included publications were checked to see if they were found from searching MEDLINE, another database or through other search techniques. Results – MEDLINE contributed 24.2% of the publications included in the obesity review, none of the publications in the spatial planning review and 72% of those in the tuberculosis review. Other databases accounted for 9.1% of included publications in obesity, 20% in spatial planning and 4% in tuberculosis. Non-database methods provided 42.4% of the included publications in the obesity review, compared to 5% in the spatial planning review and 24% in the tuberculosis review. It was not possible to establish retrospectively how 24.2% of the publications in the obesity review and 75% in the spatial planning review were found. Conclusions – Topic-specific databases and non-database search techniques were useful for tailoring the resources to the review questions. The value of MEDLINE in these reviews was affected by the degree of overlap with clinical topics, the domain of public health, and the need to find grey literature. The factors that NICE considers when planning a systematic search are the multidisciplinary nature of public health and the different types of evidence required.

scholarly journals Evaluating alignment between Canadian Common Drug Review reimbursement recommendations and provincial drug plan listing decisions: an exploratory study

CMAJ Open ◽  
2016 ◽  
Vol 4 (4) ◽  
pp. E674-E678 ◽  
Author(s):  
N. Allen ◽  
S. R. Walker ◽  
L. Liberti ◽  
C. Sehgal ◽  
M. S. Salek
Keyword(s):  
Exploratory Study ◽  
Drug Plan ◽  
Common Drug Review ◽  
Common Drug ◽  
Drug Review

PD24 Data Collection By Patient Groups To Provide Patient Input

2018 ◽  
Vol 34 (S1) ◽  
pp. 137-138 ◽  
Author(s):  
Sarah Berglas ◽  
Tamara Rader ◽  
Helen Mai
Keyword(s):  
Data Collection ◽  
Family Members ◽  
Secondary Data ◽  
Primary Data ◽  
Sampling Frame ◽  
Common Drug Review ◽  
Common Drug ◽  
Personal Experiences ◽  
Patient Groups ◽  
Drug Review

Introduction:The Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review and pan-Canadian Oncology Drug Review programs incorporate perspectives and experiences from patients and family members who might be affected by the resulting funding recommendation. Perspectives are provided by patient groups who use different approaches to gather patient input.Methods:We analyzed a random sample of ninety-three patient input submissions, drawn from a sampling frame of 532 submissions given to CADTH between June 2010 and June 2016. We looked at how groups described their information gathering methods in the original submissions or the published Clinical Guidance Reports.Results:Approaches were categorized according to whether they involved primary (n = 86) or secondary data collection (n = 130) and further sub categorized according to how data was collected. Primary data included: personal experiences, as described by the submission's author (n = 16); surveys conducted specifically for the submission (n=34); and new interviews of patients and family members on disease and drug experiences (n = 36). Half (forty-seven of ninety-three) of the patient input submissions included experiences of one or more patients who had received the drug under review. Secondary data included: published literature (n = 31); existing surveys (n = 27); past conversations with patients and family members (n = 36); experiences of patient group staff interacting with patients and family members (n = 19); and advice from clinical experts (n = 17). Many patient input submissions (sixty-eight out of ninety-three) reported multiple approaches to collect data. Use of two approaches was most common (thirty-seven out of ninety-three) with five or six approaches used in three of ninety-three submissions.Conclusions:Despite resource and timing challenges, many patient groups gather primary data to share with CADTH and find individuals with experience of the drug under review.

scholarly journals An analysis of redactions in Canada’s Common Drug Review Clinical Review Reports and how they relate to the patients’ voice

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015497 ◽  
Author(s):  
Allison Soprovich ◽  
Sylvia El Kurdi ◽  
Dean T Eurich
Keyword(s):  
Clinical Study ◽  
Clinical Review ◽  
Study Data ◽  
Biological Agents ◽  
Common Drug Review ◽  
Common Drug ◽  
Patient Reported ◽  
The Usa ◽  
Review Reports ◽  
Drug Review

ImportanceCanada’s Common Drug Review (CDR) evaluates drug data from published and unpublished research, as well as input from patient groups, to recommend provincial coverage. Currently, the CDR process gives manufacturers the opportunity to redact information in the final publicly available report. Patients often have strong feelings regarding the efficacy, harms, health-related quality of life (HRQL), and cost associated with the drugs under review and their redacted data. Highlighting Canada’s approach will hopefully build on the growing international concern regarding transparency of clinical study data.ObjectiveThe purpose was to objectively examine and classify completed, publicly available CDR-Clinical Review Reports (CRR) for redactions, and compare them to the patients’ reported interests as patient-centred outcomes.MethodsTwo independent reviewers searched for and examined publicly available CDR-CRR from November 2013-September 2016 through the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database. Both reviewers separately classified the redactions and patient-reported interests into the following categories: efficacy, harms, HRQL and costs. All discrepancies were rectified by consensus involving a third reviewer.ResultsFifty-two completed CDR-CRR were reviewed. 48 (92%) included patient-reported interests and 40 (77%) had redactions classified in the following categories: efficacy (75%), costs (48%), harms (38%), HRQL (23%). 89% of redactions were outcomes identified as patient-reported interests (69% efficacy, 42% harms, 36% cost, 33% HRQL). When examining drug characteristics, biological agents were statistically associated with increased odds of redactions with respect to either efficacy (OR 3.4, 95% CI 1.0 to 11.6) or harms (OR 3.5, 95% CI 1.02 to 12.4) compared with non-biological agents.ConclusionsWhether data from the CDR-CRR used in the decision-making should be fully disclosed to the public is controversial. Our findings suggest clinical data (efficacy, harms, HRQL) matters to patients and should be publicly available within the CDR-CRR. Canada trails Europe and the USA regarding the transparency of clinical study data. This lack of transparency relates to the patient voice, and limits movement towards patient-centred care and patient-engaged research, restricting real-world value measurement.

scholarly journals ACTIVITIES OF THE PAN-CANADIAN PHARMACEUTICAL ALLIANCE: AN OBSERVATIONAL ANALYSIS

2018 ◽  
Vol 25 (2) ◽  
pp. e12-e22
Author(s):  
Angela Rocchi ◽  
Fergal Mills
Keyword(s):  
Health Technology ◽  
Incremental Cost Effectiveness Ratio ◽  
Cost Effectiveness Ratio ◽  
Common Drug Review ◽  
Common Drug ◽  
The Common ◽  
Time Required ◽  
Drug Review ◽  
Public Drug

Background The pan-Canadian Pharmaceutical Alliance (pCPA) was established in 2010 to negotiate confidential prices for drugs coming forward from Canada’s centralized health technology assessment (HTA) agency reviews, on behalf of the participating public drug plans. Objective To analyze the activities of the pCPA, to determine: alignment of HTA agency recommendations and pCPA negotiation decisions; the role of health economics in pCPA activities; and patterns of implicit prioritization. Methods The analysis was based on the archive of drugs handled through the pCPA, as posted on its website. The period of observation was from inception to August 31, 2017. HTA recommendations were sourced from the websites of the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review. Descriptive and statistical analyses were conducted. Results The dataset contained 206 drug-indication pairings. There was close but imperfect alignment between HTA agency recommendations and the pCPA’s decisions to negotiate; deviations occurred only with CDR-reviewed drugs. The median incremental cost-effectiveness ratio of negotiated drugs was $168K/QALY for oncology drugs, but $70K/QALY for non-oncology drugs. The time to initiate negotiations was dramatically shorter for oncology versus non-oncology drugs (mean 54 versus 263 days) and also differed between therapeutic areas at CDR. The time required for PCPA activity was surprisingly similar for drugs recommended without a price condition and for those conditional on a price reduction.

VP30 Evaluation Of CINAHL In Six Systematic Reviews On Maternal Care

2019 ◽  
Vol 35 (S1) ◽  
pp. 83-83
Author(s):  
Inga Overesch ◽  
Dorothea Sow ◽  
Elke Hausner ◽  
Nina Peterwerth
Keyword(s):  
Feasibility Study ◽  
Systematic Reviews ◽  
Maternal Care ◽  
Information Sources ◽  
Reference Lists ◽  
Journal Article ◽  
Bibliographic Databases ◽  
Randomized Controlled ◽  
Subject Specific ◽  
Study Type

IntroductionInformation retrieval for systematic reviews (SRs) should include sensitive searches in several bibliographic databases. In addition to standard databases (i.e., MEDLINE, Embase and CENTRAL), researchers might consider subject-specific ones. In the fields of nursing and midwifery, a SR would typically include CINAHL as a subject-specific database. The aim of this study was to analyze the number and relevance of references retrieved from CINAHL in six SRs on maternal care.MethodsWe conducted a retrospective analysis of six SRs (e.g., benefit of intrapartum ultrasound or one-to-one care during labor). The study type was limited to randomized controlled trials (RCTs) in all but three SRs. In all cases, MEDLINE, Embase, CENTRAL and CINAHL were searched for primary studies. Further information sources (e.g., study registries and reference lists of SRs) were also considered. The proportion of the additional number of hits and studies included from CINAHL as well as the corresponding number of participants were calculated.ResultsOverall, the reviewers screened 12,013 references from bibliographic databases and identified forty relevant studies. CINAHL contained 2,643 (22 percent) of the references. In five out of six SRs, no additional studies were identified in CINAHL. In the remaining SR on birthing positions, the reviewers included thirteen RCTs of which one was a feasibility study with 68 participants indexed only in CINAHL. This corresponds to 0.9 percent of the women participating in all thirteen RCTs (n = 7,861). However, this study was cited in a journal article on a subsequent RCT that was identified and included via MEDLINE and ClinicalTrials.gov.ConclusionsIt is not necessary to search CINAHL in SRs on maternal care if standard databases and further information sources are considered. An additional study from CINAHL was included in one out of six SRs, a small feasibility study that could have been identified without CINAHL via a subsequent RCT.

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