Reporting of drug trial funding sources and author financial conflicts of interest in Cochrane and non-Cochrane meta-analyses: a cross-sectional study

ObjectiveTo (1) investigate the extent to which recently published meta-analyses report trial funding, author–industry financial ties and author–industry employment from included randomised controlled trials (RCTs), comparing Cochrane and non-Cochrane meta-analyses; (2) examine characteristics of meta-analyses independently associated with reporting funding sources of included RCTs; and (3) compare reporting among recently published Cochrane meta-analyses to Cochrane reviews published in 2010.DesignReview of consecutive sample of recently published meta-analyses.Data sourcesMEDLINE database via PubMed searched on 19 October 2018.Eligibility criteria for selecting articlesWe selected the 250 most recent meta-analyses listed in PubMed that included a documented search of at least one database, statistically combined results from ≥2 RCTs and evaluated the effects of a drug or class of drugs.Results90 of 107 (84%) Cochrane meta-analyses reported funding sources for some or all included trials compared with 21 of 143 (15%) non-Cochrane meta-analyses, a difference of 69% (95% CI 59% to 77%). Percent reporting was also higher for Cochrane meta-analyses compared with non-Cochrane meta-analyses for trial author–industry financial ties (44% versus 1%; 95% CI for difference 33% to 52%) and employment (17% versus 1%; 95% CI for difference 9% to 24%). In multivariable analysis, compared with Cochrane meta-analyses, the odds ratio (OR) for reporting trial funding was ≤0.11 for all other journal category and impact factor combinations. Compared with Cochrane reviews from 2010, reporting of funding sources of included RCTs among recently published Cochrane meta-analyses improved by 54% (95% CI 42% to 63%), and reporting of trial author–industry financial ties and employment improved by 37% (95% CI 26% to 47%) and 10% (95% CI 2% to 19%).ConclusionsReporting of trial funding sources, trial author–industry financial ties and trial author–industry employment in Cochrane meta-analyses has improved since 2010 and is higher than in non-Cochrane meta-analyses.

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Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study

BMJ ◽

10.1136/bmj.e5155 ◽

2012 ◽

Vol 345 (aug16 3) ◽

pp. e5155-e5155 ◽

Cited By ~ 32

Author(s):

M. Roseman ◽

E. H. Turner ◽

J. Lexchin ◽

J. C. Coyne ◽

L. A. Bero ◽

...

Keyword(s):

Conflicts Of Interest ◽

Cross Sectional Study ◽

Drug Trials ◽

Sectional Study ◽

Cross Sectional ◽

Cochrane Reviews

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AB0898-HPR WICH FACTORS ARE RELATED TO PAINFUL EXPERIENCE IN PATIENTS AFFECTED BY CHRONIC INFLAMMATORY RHEUMATIC DISEASE DURING THE COVID-19 PANDEMIC?

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.4073 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1472.2-1472

Author(s):

T. El Joumani ◽

H. Rkain ◽

T. Fatima Zahrae ◽

H. Kenza ◽

R. Abouqal ◽

...

Keyword(s):

Psychological Impact ◽

Multivariable Analysis ◽

Cross Sectional Study ◽

Sectional Study ◽

Quality Of Sleep ◽

Cross Sectional ◽

Therapeutic Adherence ◽

Factors Associated ◽

Painful Experience

Objectives:To evaluate the effect of containment, during the Covid-19 pandemic, on the pain of patients with CIRD, and to analyze the factors associated with the experience of pain.Methods:A cross-sectional study was conducted among patients with rheumatic diseases using a questionnaire providing information on patients and disease characteristics. Impact of COVID-19 on This is a cross-sectional study that consecutively includedPatients were asked to assess the global pain which they had experienced before and during the containment period, using a single Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (greatest pain).Statistical Analysis System IBM SPSS Statistics V20.0.0 was used to analyze the study data.We performed univariate then multivariate analysis to search any related factors to pain perception during to quarantines. Qualitative values were analyzed by the chi2 test. Quantitative values were analyzed by the Student test when the measures were normally distributed or by nonparametric test (Mann–Whitney U) when the measures were not normally distributed (Kolmogorov–Smirnov test was used to test normality).Results:Among the 350 patients who answered to the questionnaire online, rheumatoid arthritis represented 62.3%, spondyloarthropathy 34.3% and undifferentiated CIRD 3.4%.Pain experience caused by the CIRD during the containment was reported by 79.1% of patients.The level of pain, using the VAS of Pain increased significantly during the COVID-19 pandemic (4,6 ± 2,8 and 5,4 ± 3 before and during the containment; p<0.001).In multivariate analysis, the factors implicated in pain were the negative impact of Coronavirus on access to rheumatologic care, discontinuation of therapeutic adherence, the disturbed quality of sleep and the negative psychological impact (table 1).Table 1: Summarize multivariable analysis of factors associated with painful experience related to CIRD during containement.Table 1.Multivariable analysis of factors associated with painful experience related to CIRD during containementPImpact on monitoring0.05Impact on therapeutic adherence<0.001Quality of sleep disturbed0.001Negative psychological impact0.02Conclusion:This survey showed the that the COVID-19 pandemic have incresed painful experience in CIRD patients. Factors influencing painful experience should be taken into account to help patients to cope with their chronic rheumatism and this global health crisis.Disclosure of Interests:None declared

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Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2018-022233 ◽

2018 ◽

Vol 8 (9) ◽

pp. e022233 ◽

Cited By ~ 27

Author(s):

Amanda Jane Blatch-Jones ◽

Wei Pek ◽

Emma Kirkpatrick ◽

Martin Ashton-Key

Keyword(s):

Feasibility Study ◽

Randomised Controlled Trials ◽

Feasibility Studies ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Group 2 ◽

Randomised Controlled ◽

Pilot Feasibility Study ◽

Group 1

ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed weretesting recruitment(100% in both groups),feasibility(83%, 100%) andsuggestions for further study/investigation(83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study wheretesting recruitment(50%, 73%) andfeasibility(42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study wheretesting recruitment(93%, 100%) andfeasibility(44%, 92%) were the most common study elements reported.Conclusions‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

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A cross-sectional study of all clinicians’ conflict of interest disclosures to NHS hospital employers in England 2015-2016

BMJ Open ◽

10.1136/bmjopen-2017-019952 ◽

2018 ◽

Vol 8 (3) ◽

pp. e019952 ◽

Cited By ~ 4

Author(s):

Harriet Ruth Feldman ◽

Nicholas J DeVito ◽

Jonathan Mendel ◽

David E Carroll ◽

Ben Goldacre

Keyword(s):

Conflict Of Interest ◽

Conflicts Of Interest ◽

Current System ◽

Tertiary Care ◽

Cross Sectional Study ◽

Freedom Of Information ◽

Sectional Study ◽

Cross Sectional ◽

The Gift ◽

The Uk

ObjectiveWe set out to document how NHS trusts in the UK record and share disclosures of conflict of interest by their employees.DesignCross-sectional study of responses to a Freedom of Information Act request for Gifts and Hospitality Registers.SettingNHS Trusts (secondary/tertiary care organisations) in England.Participants236 Trusts were contacted, of which 217 responded.Main outcome measuresWe assessed all disclosures for completeness and openness, scoring them for achieving each of five measures of transparency.Results185 Trusts (78%) provided a register. 71 Trusts did not respond within the 28 day time limit required by the FoIA. Most COI registers were incomplete by design, and did not contain the information necessary to assess conflicts of interest. 126/185 (68%) did not record the names of recipients. 47/185 (25%) did not record the cash value of the gift or hospitality. Only 31/185 registers (16%) contained the names of recipients, the names of donors, and the cash amounts received. 18/185 (10%) contained none of: recipient name, donor name, and cash amount. Only 15 Trusts had their disclosure register publicly available online (6%). We generated a transparency index assessing whether each Trust met the following criteria: responded on time; provided a register; had a register with fields identifying donor, recipient, and cash amount; provided a register in a format that allowed further analysis; and had their register publicly available online. Mean attainment was 1.9/5; no NHS trust met all five criteria.ConclusionOverall, recording of employees’ conflicts of interest by NHS trusts is poor. None of the NHS Trusts in England met all transparency criteria. 19 did not respond to our FoIA requests, 51 did not provide a Gifts and Hospitality Register and only 31 of the registers provided contained enough information to assess employees’ conflicts of interest. Despite obligations on healthcare professionals to disclose conflicts of interest, and on organisations to record these, the current system for logging and tracking such disclosures is not functioning adequately. We propose a simple national template for reporting conflicts of interest, modelled on the US ‘Sunshine Act’.

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Non-Cochrane vs. Cochrane reviews were twice as likely to have positive conclusion statements: cross-sectional study

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2008.08.008 ◽

2009 ◽

Vol 62 (4) ◽

pp. 380-386.e1 ◽

Cited By ~ 50

Author(s):

Andrea C. Tricco ◽

Jennifer Tetzlaff ◽

Ba' Pham ◽

Jamie Brehaut ◽

David Moher

Keyword(s):

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Cochrane Reviews

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Prevalence of Gaucher Disease (GD) in Patients with Unknown Cause of Splenomegaly and/or Thrombocytopenia in Saudi Arabia: A Multicenter Cross-sectional Study Protocol (Preprint)

10.2196/preprints.28607 ◽

2021 ◽

Author(s):

Abdulelah Qadi ◽

Aly Ezzat ◽

Ayman Al Hejazi ◽

Fahad Al Abbas ◽

Ghaleb Elyamany ◽

...

Keyword(s):

Saudi Arabia ◽

Gaucher Disease ◽

Cross Sectional Study ◽

Primary Objective ◽

High Risk Group ◽

Acid Sphingomyelinase ◽

Lysosomal Storage ◽

Sectional Study ◽

Eligibility Criteria ◽

Cross Sectional

UNSTRUCTURED Background: Gaucher disease (GD) is the commonest form of Lysosomal storage disorders that are characterized by the accumulation of glucosylceramide within the lysosomes of cells that are ordinarily degraded to glucose and lipid components. The primary objective of this study is to determine the prevalence of Gaucher Disease in a high-risk group (defined as patients with splenomegaly and/or thrombocytopenia of unknown cause). Methods: The present multicenter, cross-sectional, study will include patients presenting with signs of splenomegaly and/or thrombocytopenia over a period of 12 months with no definitive cause. Eligible patients will be assessed for acid β-glucosidase and acid sphingomyelinase enzymes activity using dried blood spot (DBS) samples. A total of 400 patients from Saudi Arabia who fulfill the eligibility criteria will be enrolled in the study. Discussion: Saudi Arabia is the largest country in the Arabian Peninsula, with a population of more than 28 million. Despite healthcare being free to Saudi citizens, a number of potential barriers to healthcare access and individual healthcare-seeking have been reported. While Gaucher disease is a rare disease, its incidence in Saudi Arabia appears to be higher than other parts of the world. Nevertheless, no previous nationwide study was conducted to provide reliable data regarding the incidence and characteristics of Saudi patients with Gaucher Disease. There is a scarcity in the published literature regarding the treatment patterns and outcomes of Gaucher Disease in Saudi Arabia as well.

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Magnitude of Uncontrolled Hypertension and Associated Factors among Adult Hypertensive Patients in Public Hospitals of Central Zone, Tigray, Ethiopia: A Cross-sectional Study 2018

10.21203/rs.2.14404/v1 ◽

2019 ◽

Author(s):

Assefa Iyasu Negash ◽

Desta Siyoum ◽

Tsega Hailemariam ◽

Berihu Hailu Kidanu ◽

Gebreamlak Gebremdhin Gebremeskel ◽

...

Keyword(s):

Antihypertensive Medication ◽

Multivariable Analysis ◽

Central Zone ◽

Cross Sectional Study ◽

Public Hospitals ◽

Uncontrolled Hypertension ◽

Sectional Study ◽

Cross Sectional ◽

Hypertensive Patients ◽

Co Morbidity

Abstract Background: - Uncontrolled hypertension is if SBP is ≥140 mm Hg and/or DBP ≥90 mm Hg for general hypertensive population or if SBP ≥130 mm Hg and/or DBP ≥80 mm Hg in patients with established diabetes mellitus or chronic kidney disease based on the average of two or more properly measured, seated, BP readings on each of two or more office visits. The aim of this study was to assess the magnitude of uncontrolled hypertension and associated factors among adult hypertensive patients in public hospitals of central zone, Tigray, Ethiopia, 2018. Methods:- A hospital based cross sectional study design was used. The study population was all sampled adult hypertensive patients who had follow up in public hospitals of central zone, Tigray and the data collection period was from March 01 to April 30, 2018. About 421 study participants were selected using systematic random sampling. Interviewer administered structured questionnaire, chart review checklist and measurements were used. The collected data was checked for its completeness manually and then entered and cleaned in to epi data version 3.1 and exported to Statistical packages for social science version 22 for analysis. Bivariate and multivariable analyses were done to identify factors of uncontrolled hypertension. Then those variables significant at p<0.25 with the outcome variable in bivariate analysis were selected for multivariable analysis and odds ratio with 95% confidence level was computed and p-value < 0.05 was described as a significant association in multivariable analysis. Result: - Among 421 respondents about 177(42%) had uncontrolled hypertension. Co-morbidity [AOR=0.36, (0.205, 0.631)], five to ten years duration of medication taken [AOR=0.398, (0.218, 0.725)], side effect of medication [AOR=0.542, (0.339, 0.866)] and medication adherence [AOR=4.092, (2.419, 6.924)] were significantly associated with uncontrolled hypertension. Conclusion: - In this study the magnitude of uncontrolled hypertension was high. Co-morbidity, antihypertensive medication taken for long duration, side effect of antihypertensive medication and non adherence to antihypertensive medication shows statistical association with uncontrolled hypertension.

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Pattern of Chemotherapy-Related Adverse Effects Among Adult Patients With Cancer Treated at Gondar University Referral Hospital, Ethiopia: A Cross-Sectional Study

Journal of Global Oncology ◽

10.1200/jgo.18.70000 ◽

2018 ◽

Vol 4 (Supplement 1) ◽

pp. 15s-15s

Author(s):

Sewunet Admasu Belachew ◽

Daniel Asfaw Erku ◽

Abebe Basazn Mekuria ◽

Begashaw Melaku Gebresillassie

Keyword(s):

Health Care Professionals ◽

Conflicts Of Interest ◽

Tertiary Care ◽

Cross Sectional Study ◽

Chemotherapeutic Agents ◽

Referral Hospital ◽

Categorical Variables ◽

Sectional Study ◽

Cross Sectional ◽

Patients With Cancer

Abstract 32 Purpose Adverse drug reactions (ADRs) are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology pharmacovigilance essential. The objective of the current study was to assess the pattern of ADRs that occur in patients with cancer who were treated with chemotherapy in a tertiary care teaching hospital in Ethiopia. Methods A cross-sectional study over a 2-year period from September 2013 to August 2015 was conducted in patients with cancer who underwent chemotherapy at Gondar University Referral Hospital Oncology Center. Data were collected directly from patients and their medical case files. Reported ADRs were assessed for causality using the WHO causality assessment scale and Naranjo’s algorithm. Severities of the reported reactions were also assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). Pearson’s χ2 test was used to examine the association between two categorical variables. Results A total of 815 ADRs were identified from 203 patients who were included in the study. The most commonly occurring ADRs were nausea and vomiting (18.9%), infections (16.7%), neutropenia (14.7%), fever and/or chills (11.3%), and anemia (9.3%). Platinum compounds (31.4%) were the most common group of drugs that caused ADRs. Of reported ADRs, 65.8% were grades 3 to 4 (severe level), 29.9% were grades 1 to 2 (mild level), and 4.3% were grade 5 (toxic level). Significant association was found between age, number of chemotherapeutic agents, and dose of chemotherapy with the occurrence of grades 3 to 5 toxicity. Conclusion The high incidence of chemotherapy-related ADRs among patients with cancer is of concern. Establishing an effective ADR monitoring and reporting system—oncopharmacovigilance—and creating awareness among health care professionals of the importance of ADR reporting may help prevent the problem. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST No COIs from the authors.

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