scholarly journals Estimating the prevalence of discrepancies between study registrations and publications: A systematic review and meta-analyses

2021 ◽  
Author(s):  
◽  
Robert T Thibault
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Prediction Interval ◽  
Secondary Outcome ◽  
Selective Reporting ◽  
Study Protocols ◽  
Clinical Literature ◽  
Research Findings ◽  
Meta Analyses ◽  
Almost All

Background. Prospectively registering study plans in a permanent time-stamped and publicly accessible document is becoming more common across disciplines and aims to improve the trustworthiness of research findings. Selective reporting persists, however, when researchers deviate from their registered plans without disclosure. This systematic review aims to estimate the prevalence of undisclosed discrepancies between prospectively registered study plans and their associated publication. We further aim to identify the research disciplines where these discrepancies have been observed, whether interventions to reduce discrepancies have been conducted, and gaps in the literature. Methods. On 15 December 2019, we searched Scopus and Web of Knowledge for articles that included quantitative data about discrepancies between registrations or study protocols and their associated publications. We used random-effects meta-analyses to synthesize the results. Results. We reviewed k = 89 articles, including k = 70 that report on primary outcome discrepancies from n = 6314 studies and, k = 22 that report on secondary outcome discrepancies from n = 1436 studies. Meta-analyses indicate that between 10% to 68% (95% prediction interval) of studies contain at least one primary outcome discrepancy and between 13% to 95% (95% prediction interval) contain at least one secondary outcome discrepancy. Almost all articles assessed clinical literature, and there was considerable heterogeneity, resulting in wide prediction intervals. We identified only one article that attempted to correct discrepancies. Discussion. Many articles did not include information on whether discrepancies were disclosed, which version of a registration they compared publications to, and whether the registration was prospective. Thus, our estimates represent discrepancies broadly, rather than our target of undisclosed discrepancies between prospectively registered study plans and their associated publications. Discrepancies are common and reduce the trustworthiness of medical research. Interventions to reduce discrepancies could prove valuable. Registration. osf.io/ktmdg. Protocol amendments are listed in Supplementary Material A.

scholarly journals Impact of COVID-19 pandemic on utilisation of healthcare services: a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e045343
Author(s):  
Ray Moynihan ◽  
Sharon Sanders ◽  
Zoe A Michaleff ◽  
Anna Mae Scott ◽  
Justin Clark ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Unmet Need ◽  
Healthcare Utilisation ◽  
Healthcare Services ◽  
Risk Of Bias ◽  
Secondary Outcome ◽  
Severe Illness ◽  
Service Utilisation ◽  
Registration Number

ObjectivesTo determine the extent and nature of changes in utilisation of healthcare services during COVID-19 pandemic.DesignSystematic review.EligibilityEligible studies compared utilisation of services during COVID-19 pandemic to at least one comparable period in prior years. Services included visits, admissions, diagnostics and therapeutics. Studies were excluded if from single centres or studied only patients with COVID-19.Data sourcesPubMed, Embase, Cochrane COVID-19 Study Register and preprints were searched, without language restrictions, until 10 August, using detailed searches with key concepts including COVID-19, health services and impact.Data analysisRisk of bias was assessed by adapting the Risk of Bias in Non-randomised Studies of Interventions tool, and a Cochrane Effective Practice and Organization of Care tool. Results were analysed using descriptive statistics, graphical figures and narrative synthesis.Outcome measuresPrimary outcome was change in service utilisation between prepandemic and pandemic periods. Secondary outcome was the change in proportions of users of healthcare services with milder or more severe illness (eg, triage scores).Results3097 unique references were identified, and 81 studies across 20 countries included, reporting on >11 million services prepandemic and 6.9 million during pandemic. For the primary outcome, there were 143 estimates of changes, with a median 37% reduction in services overall (IQR −51% to −20%), comprising median reductions for visits of 42% (−53% to −32%), admissions 28% (−40% to −17%), diagnostics 31% (−53% to −24%) and for therapeutics 30% (−57% to −19%). Among 35 studies reporting secondary outcomes, there were 60 estimates, with 27 (45%) reporting larger reductions in utilisation among people with a milder spectrum of illness, and 33 (55%) reporting no difference.ConclusionsHealthcare utilisation decreased by about a third during the pandemic, with considerable variation, and with greater reductions among people with less severe illness. While addressing unmet need remains a priority, studies of health impacts of reductions may help health systems reduce unnecessary care in the postpandemic recovery.PROSPERO registration numberCRD42020203729.

scholarly journals Association between insulin resistance and post-ischaemic stroke outcome in patients without diabetes: protocol for a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044771
Author(s):  
Jeremiah Hadwen ◽  
Woojin Kim ◽  
Brian Dewar ◽  
Tim Ramsay ◽  
Alexandra Davis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Insulin Resistance ◽  
Ischaemic Stroke ◽  
Functional Outcome ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Stroke Outcome ◽  
Post Stroke ◽  
Meta Analyses

IntroductionInsulin resistance is an independent risk factor for atherosclerosis, coronary artery disease and ischaemic stroke. Currently, insulin resistance is not usually included in post-stroke risk stratification. This systematic review and meta-analysis intends to determine if available scientific knowledge supports an association between insulin resistance and post-stroke outcomes in patients without diabetes.Methods and analysisThe authors will conduct a literature search in Medline, Embase, Web of Science and Cochrane Central. The review will include studies that assess the association between elevated insulin homeostasis model of insulin resistance (HOMA-IR) and post-stroke outcome (functional outcome and recurrent stroke). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines will be used. The primary outcome will be post-stroke functional outcome (Modified Rankin Scale), and the secondary outcome will be recurrent ischaemic stroke. Comparison of outcome will be made between highest and lowest HOMA-IR range (as defined in each article included in this systematic review). Risk of bias will be assessed qualitatively. Meta-analysis will be performed if sufficient homogeneity exists between studies. Heterogeneity of outcomes will be assessed by I².Ethics and disseminationNo human or animal subjects or samples were/will be used. The results will be published in a peer-reviewed journal, and will be disseminated at local and international neurology conferences.PROSPERO registration numberCRD42020173608.

scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review

10.2196/15309 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15309
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

Background Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. Objective This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. Methods To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. Results Scoping review and pilot data extraction are under way, and the results are expected by March 2020. Conclusions It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. Trial Registration PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 International Registered Report Identifier (IRRID) DERR1-10.2196/15309

scholarly journals Association of Functional Dyspepsia with Depression and Anxiety: A Systematic Review

2021 ◽  
Author(s):  
Tasia Esterita ◽  
Sheilla Dewi ◽  
Felicia Grizelda Suryatenggara ◽  
Glenardi Glenardi
Keyword(s):  
Systematic Review ◽  
Functional Dyspepsia ◽  
Assessment Tools ◽  
Depression And Anxiety ◽  
Questionnaire Assessment ◽  
Prevalence Of Depression ◽  
Choice Of Treatment ◽  
Meta Analyses ◽  
Almost All

Background and Aims: Functional dyspepsia (FD) symptoms may lead to depression or anxiety in affected individuals and vice versa. These individuals often have more serious somatic symptoms, longer disease recovery time, and tend to consume more medical resources and health care costs. Therefore, recognition of depression and anxiety is crucial to improve clinical outcome in FD patients. The aim of this study is to systematically review the association of functional dyspepsia with depression and anxiety. Methods: This systematic review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. A Literature search was carried out with PubMed and ProQuest databases from 1 January 2010 to 5 October 2020. The outcomes of interest were association of functional dyspepsia with depression and anxiety. The quality of each study was assessed using the Joanna Briggs Institute (JBI) tool. Results: A total of 13 studies involving 14,076 subjects were included in this review. Almost all of the studies showed that prevalence of depression or anxiety is higher in patients with FD compared to controls. This is implied by a higher mean score on the depression and anxiety questionnaire assessment tools or a positive correlation in the odds ratio. FD is known to affect more females than males, but psychological links were stronger in males. Moreover, prevalence of depression and anxiety symptoms in patients with refractory FD (63.3% and 61.5%) was higher compared to non-refractory FD (20.9% and 23.3%) and healthy patients (10% and 10%). Conclusion: There is a significant association of FD with depression and anxiety. Thus, identifying psychological factors in FD patients is essential to help clinicians determine the best choice of treatment and improve the prognosis and quality of life of the patients.

scholarly journals Can nurses improve self-management among pediatric patients? A systematic review and meta-analysis

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
A Mele ◽  
A Nardi ◽  
G P Prencipe ◽  
G Migliara ◽  
A Massimi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Educational Intervention ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Educational Interventions ◽  
Risk Of Bias ◽  
Ed Visits ◽  
Meta Analyses ◽  
Almost All

Abstract Background Few studies report educational interventions for pediatric patients with asthma or diabetes type 1 as a fundamental instrument to engage them and improve their health. The aim of this systematic review and meta-analysis was to synthesize evidence about behavioral changes in life style, disease management and clinical outcome in pediatric patients after a structured educational intervention delivered by nurses. Methods A systematic review of the literature was carried out in MEDLINE, Scopus and CINHAL including only RCTs. Methodological quality of the studies was assessed using Cochrane tool. Meta-analyses on HbA1c reduction for diabetes and hospitalization, emergency department (ED) visits and medication for asthma were carried-out. Results Of the 3559 papers initially retrieved, 5 regarding diabetes and 19 asthma met the inclusion criteria for the systematic review and 14 for the meta-analyses. Included studies were highly heterogeneous in terms of type of intervention and follow-up duration. Almost all the studies showed an improvement but only few were statistically significant. All studies regarding diabetes showed a low risk of bias (only one RCTs had a high risk of bias in one domain), while almost all RCTs on asthma showed a high risk of bias. The pooled mean differences in favor of the experimental groups were: HBA1c -0.02 (IC95%: -0.26 - 0.22), Hospitalization 0.58 (IC95%: 0.19 - 1.78), Medication -0.10 (IC95%: -0.43 - 0.23), ED Visits 0.82 (IC95%: 0.44 - 1.54). Conclusions There is a general agreement about the central role of educational intervention delivered by nurses to pediatric patients and the assessment of the behavioral changes after educational interventions is strongly recommended in pediatric population. However, more efforts are requested in designing studies on patients with asthma and to program more appropriate follow-up and periodic recall in order to engage pediatric patients in the management of their own chronic disease. Key messages educational intervention delivered by nurses to pediatric patients with asthma or diabetes type 1 as a fundamental instrument to engage them. more efforts are requested in designing studies on patients with asthma and to program more appropriate follow-up and periodic recall in order to engage pediatric patients.

scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review (Preprint)

2019 ◽  
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

BACKGROUND Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. OBJECTIVE This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. METHODS To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. RESULTS Scoping review and pilot data extraction are under way, and the results are expected by March 2020. CONCLUSIONS It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. CLINICALTRIAL PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15309

scholarly journals Incidence of Fatal Anaphylaxis: A Systematic Review of Observational Studies

2021 ◽  
Vol 32 (4) ◽  
Author(s):  
S Perez-Codesido ◽  
A Rosado-Ingelmo ◽  
M Privitera-Torres ◽  
E Pérez Fernández ◽  
A Nieto-Nieto ◽  
...  
Keyword(s):  
Systematic Review ◽  
Death Rate ◽  
Observational Studies ◽  
Web Of Science ◽  
Research Strategy ◽  
Hymenoptera Venom ◽  
Prospective Cohort Studies ◽  
Meta Analyses ◽  
Almost All ◽  
Fatal Anaphylaxis

Background: Fatal anaphylaxis is very rare, with an incidence ranging from 0.5 to 1 deaths per million person-years. Objective: Based on a systematic review, we aimed to explain differences in the reported incidence of fatal anaphylaxis based on the methodological and demographic factors addressed in the various studies. Methods: We searched PubMed/MEDLINE, EMBASE, and the Web of Science for relevant retrospective and prospective cohort studies and registry studies that had assessed the anaphylaxis death rate for the population of a country or for an administrative region. The research strategy was based on combining “anaphylaxis” with “death”, “study design”, and “main outcomes” (incidence). Results: A total of 46 studies met the study criteria and included 16,541 deaths. The range of the anaphylaxis mortality rate for all causes of anaphylaxis was 0.002-2.51 deaths per million person-years. Fatal anaphylaxis due to food (range 0.002-0.29) was rarer than deaths due to drugs (range 0.004-0.56) or Hymenoptera venom (range 0.02-0.61). The frequency of deaths due to anaphylaxis by drugs increased during the study period (IRR per year, 1.02, 95%CI 1.00-1.04). We detected considerable heterogeneity in almost all of the meta-analyses carried out. Conclusion: The incidence of fatal anaphylaxis is very low and differs according to the various subgroups analyzed. The studies were very heterogeneous. Fatal anaphylaxis due to food seems to be less common than fatal anaphylaxis due to drugs or Hymenoptera venom.

scholarly journals Self-concept in poor readers: a systematic review and meta-analysis

PeerJ ◽  
2020 ◽  
Vol 8 ◽  
pp. e8772 ◽  
Author(s):  
Genevieve M. McArthur ◽  
Nicola Filardi ◽  
Deanna A. Francis ◽  
Mark E. Boyes ◽  
Nicholas A. Badcock
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Strong Association ◽  
Physical Appearance ◽  
Self Concept ◽  
Poor Reading ◽  
Quality Of Evidence ◽  
Secondary Outcomes ◽  
Meta Analyses

Background The aims of this systematic review and meta-analyses were to determine if there is a statistically reliable association between poor reading and poor self-concept, and if such an association is moderated by domain of self-concept, type of reading impairment, or contextual factors including age, gender, reading instruction, and school environment. Methodology We searched 10 key databases for published and unpublished studies, as well as reference lists of included studies, and studies that cited included studies. We calculated standardised mean differences (SMDs) and 95% confidence intervals for one primary outcome (average self-concept) and 10 secondary outcomes (10 domains of self-concept). We assessed the data for risk of bias, heterogeneity, sensitivity, reporting bias, and quality of evidence. Results Thirteen studies with 3,348 participants met our selection criteria. Meta-analyses revealed statistically significant SMDs for average self-concept (−0.57) and five domains of self-concept (reading/writing/spelling: −1.03; academic: −0.67; math: −0.64; behaviour: −0.32; physical appearance: −0.28). The quality of evidence for the primary outcome was moderate, and for secondary outcomes was low, due to lack of data. Conclusions These outcomes suggest a probable moderate association between poor reading and average self-concept; a possible strong association between poor reading and reading-writing-spelling self-concept; and possible moderate associations between poor reading and self-concept in the self-concept domains of academia, mathematics, behaviour, and physical appearance.

Sign in / Sign up

Export Citation Format

Share Document