scholarly journals Research Waste in ME/CFS

2017 ◽  
Author(s):  
Sonia Lee

AbstractObjectiveTo compare the prevalence of selective reporting in ME/CFS research areas: psychosocial versus cellular.MethodA bias appraisal was conducted on three trials (1x psychosocial and 2x cellular) to compare risk of bias in study design, selection and measurement. The primary outcome compared evidence and justifications in resolving biases by proportions (%) and ORs (Odds Ratio); the secondary outcome determined the proportion (in %) of ME/CFS grants at risk of bias.ResultsNS (cellular study) was twice as likely to present evidence in resolving biases over PACE (psychosocial trial) (OR = 2.16; 65.6% vs 46. 9%), but this difference was not significant (p = 0.13). However, NS was five times more likely to justify biases over PACE (OR = 4.76; 46.9% vs 15. 6%) and this difference was significant (p = 0.0095; p < 0.05). PACE was weak in place (operational aspects 32%) and NS for data practices (37%). The proportion of grants were more biased in PACE (72%) than NS (28%) for evidence, and also more biased in PACE (86%) than NS (14%) for justifications.ConclusionPsychosocial trials on ME/CFS are more likely to engage in selective reporting indicative of research waste than cellular trials. Improvements to place may help reduce these biases, whereas cellular trials may benefit from adopting more translatable data methods. However, these findings are based on two trials. Further risk of bias appraisals are needed to determine the number of trials required to make robust these findings.

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e045343
Author(s):  
Ray Moynihan ◽  
Sharon Sanders ◽  
Zoe A Michaleff ◽  
Anna Mae Scott ◽  
Justin Clark ◽  
...  

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.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rosanna Guarnieri ◽  
Serena Bertoldo ◽  
Michele Cassetta ◽  
Federica Altieri ◽  
Camilla Grenga ◽  
...  

Abstract Background This review evaluates, as a primary outcome, which surgical technique (open vs. closed) and which type of material used for the auxiliaries (elastic vs. metallic) were preferable in terms of periodontal results during the treatment of palatal-impacted canines. The timing of the evaluation of the results was also assessed as a secondary outcome. Methods An electronic search of the literature up to March 2021 was performed on Pubmed, MEDLINE (via Pubmed), EMBASE (via Ovid), Cochrane Reviews and Cochrane Register of Controlled Trials (RCTs) (CENTRAL). The risk of bias evaluation was performed using version 2 of the Cochrane risk of bias tool (RoB 2) for RCTs and the ACROBAT NRSI tool of Cochrane for non-RCTs. Results 11 articles met the inclusion criteria. Only one RCT was assessed as having a low risk of bias and all the non-RCTs were assessed as having a serious risk of bias. This review revealed better periodontal results for the closed technique and metallic auxiliaries. In addition, it revealed that the timing of the evaluation of the results affects the periodontal results with better results obtained 2 years after the end of treatment. Conclusion In the treatment of a palatal-impacted canine, the closed technique and metallic auxiliaries should be preferred in terms of better periodontal results. The timing of the evaluation of the results affects the periodontal results.


2020 ◽  
pp. 088506662094018
Author(s):  
Nasreen Hassoun-Kheir ◽  
Oryan Henig ◽  
Tomer Avni ◽  
Leonard Leibovici ◽  
Mical Paul

Objectives: To assess the effects and safety of β-blockers in hospitalized patients with burns. Methods: A systematic review and meta-analysis of the literature. A broad search was conducted to identify all randomized controlled trials (RCTs) comparing β-blockers to control in hospitalized patients with burns. The primary outcome was 3-month all-cause mortality. Secondary outcomes were clinical patient-relevant end points. We subgrouped results by children/adults and burn severity. Risk of bias was assessed using the individual domain approach. Results: Four RCTs reported in 11 publications were included. Primary outcome of mortality was assessed in children (2 trials, n = 424) and adults (2 trials, n = 148) with severe burns. No significant difference was found between propranolol and control for mortality (risk ratio [RR] = 0.82, 95% CI = 0.48-1.39, 4 trials with broad confidence intervals in adults and children), sepsis (RR = 0.81, 95% CI = 0.46-1.43, 2 trials), and survivors’ length of stay (absolute mean difference = 2.53, 95% CI = −2.58–7.63, 3 trials). There was no significant difference in bradycardia (RR = 1.33, 95% CI = 0.77-2.3, 2 trials), hypotension (RR = 1.26, 95% CI = 0.73-2.17, 3 trials), or cardiac arrhythmia (RR: 2.97, 95% CI: 0.12-71.87, 1 trial). The evidence was graded as very low certainty, due to trial’s internal risk of bias, imprecision, and possible selective reporting. Conclusions: No sufficient evidence was found to support or refute an advantage for β-blocker use in children or adults after burns. Additional studies are needed to create a consensus and formulate practice guidelines on the optimal β-blocker to use, indications for initiation, and duration of treatment.


Author(s):  
Yohei Ishikawa ◽  
Toru Hifumi ◽  
Mitsuyoshi Urashima

Background—This study aimed to explore whether living alone or with a spouse only affects the short-term prognosis of acute ischemic stroke patients. Methods—We conducted a retrospective cohort study of patients with a diagnosis of acute ischemic stroke from April 2014 to February 2019 in Japan. The primary outcome was defined as worsening by at least one grade on the modified Rankin Scale (mRS). The secondary outcome was set as the degree of worsening on the mRS. The outcomes were compared between three groups of patients: (1) those living alone (ALONE), (2) those living with their spouse only (SPOUSE), and (3) OTHERs. Results—In total, 365 patients were included in this study: 111 (30%) ALONE, 133 (36%) SPOUSE, and 121 (33%) OTHERs. Cardiogenic embolisms were observed more frequently in ALONE than in OTHERs. The primary outcome occurred in 88 (79.3%) patients in ALONE and in 96 (72.2%) patients in SPOUSE, both of which were higher than the 72 (59.5%) in OTHERs. After adjusting with 19 variables, the risk of worsening was higher in ALONE (odds ratio (OR): 2.90, 95% confidence interval (CI): 1.50–5.58) and SPOUSE (OR: 1.83, 95% CI: 1.00–3.33) compared with OTHERs. Conclusions—In patients with acute ischemic stroke, not only living alone but also living with a spouse only may be associated with a worse short-term prognosis, independent of other cardiovascular risks.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Stibleichinger ◽  
J Wendt ◽  
F Hofbauer ◽  
G Klappacher

Abstract Background Coronary no-reflow is a potentially lethal complication of percutaneous coronary intervention (PCI). There is a growing body of evidence on how to best prevent this condition by the proper stenting technique and other mechanical measures or adjunctive drug treatments. However, it is still controversial how to tackle coronary no-reflow when it occurs. Purpose We aimed to compare and rank intracoronary agents for acute treatment of coronary no-reflow by considering both indirect and direct evidence from the literature in a network meta-analysis. Methods We searched the databases PubMed, Embase and Central for randomised controlled trials of the acute treatment of coronary no-reflow following primary PCI in patients with ST-elevation myocardial infarction (STEMI) and non-STEMI. Trials with patients suffering from stable angina and/or receiving elective PCI, observational study design and no measure of coronary flow were excluded. Two blinded reviewers independently collected studies, assessed risk of bias with the Cochrane risk of bias tool and extracted data. The primary outcome was a measure of coronary flow immediately following the intervention (TIMI flow grade, TIMI frame count or myocardial bush grade), secondary outcome were major adverse cardiovascular events during follow-up. Pairwise and network meta-analysis were performed using the random-effects model within a frequentist framework. Results 8 studies with a total of 540 participants were identified, including 4 multi-arm studies. This enabled 19 pairwise comparisons of 12 different treatments, all administered via intracoronary route (ADE=adenosine, DIL=diltiazem, DIP=dipyridamole, NIT= nitroglycerin, NPR=nitroprusside, PLA=placebo, TIR=tirofiban, U+V=urokinase combined with verapamil, URA=urapidil, URO=urokinase, VER=verapamil X+T= Xuesaitong combined with tirofiban). Overall, risk of bias in these studies was rated moderate. For graphical representation of the network for the primary outcome, see left panel of the figure. It exhibited a low level of inconsistency and heterogeneity with a global I2 value of 20.9%. Among the different treatments, URA, X+T, and TIR were more effective in re-establishing coronary flow with the caveat that the results of URA depended on one singular trail with a large variance, see right panel of the figure. NIT was even slightly worse than placebo in the primary outcome, the other agents were equivalent with placebo. In terms of major cardiovascular events during follow-up, TIR exhibited a protective effect compared with placebo at borderline statistical significance (OR 0.3843 [95% CI 0.1488; 0.9923]. For URA, data on secondary outcome were not available. Conclusions Urapidil and Tirofiban are potentially effective candidate drugs for larger randomised controlled trials, which are needed to validate the sparse evidence that is available to date on the acute treatment of coronary no-reflow.


BMJ ◽  
2021 ◽  
pp. n2202
Author(s):  
Bartosz Helfer ◽  
Jo Leonardi-Bee ◽  
Alexandra Mundell ◽  
Callum Parr ◽  
Despo Ierodiakonou ◽  
...  

Abstract Objective To systematically review the conduct and reporting of formula trials. Design Systematic review. Data sources Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1 January 2006 to 31 December 2020. Review methods Intervention trials comparing at least two formula products in children less than three years of age were included, but not trials of human breast milk or fortifiers of breast milk. Data were extracted in duplicate and primary outcome data were synthesised for meta-analysis with a random effects model weighted by the inverse variance method. Risk of bias was evaluated with Cochrane risk of bias version 2.0, and risk of undermining breastfeeding was evaluated according to published consensus guidance. Primary outcomes of the trials included in the systematic review were identified from clinical trial registries, protocols, or trial publications. Results 22 201 titles were screened and 307 trials were identified that were published between 2006 and 2020, of which 73 (24%) trials in 13 197 children were prospectively registered. Another 111 unpublished but registered trials in 17 411 children were identified. Detailed analysis was undertaken for 125 trials (23 757 children) published since 2015. Seventeen (14%) of these recently published trials were conducted independently of formula companies, 26 (21%) were prospectively registered with a clear aim and primary outcome, and authors or sponsors shared prospective protocols for 11 (9%) trials. Risk of bias was low in five (4%) and high in 100 (80%) recently published trials, mainly because of inappropriate exclusions from analysis and selective reporting. For 68 recently published superiority trials, a pooled standardised mean difference of 0.51 (range −0.43 to 3.29) was calculated with an asymmetrical funnel plot (Egger’s test P<0.001), which reduced to 0.19 after correction for asymmetry. Primary outcomes were reported by authors as favourable in 86 (69%) trials, and 115 (92%) abstract conclusions were favourable. One of 38 (3%) trials in partially breastfed infants reported adequate support for breastfeeding and 14 of 87 (16%) trials in non-breastfed infants confirmed the decision not to breastfeed was firmly established before enrolment in the trial. Conclusions The results show that formula trials lack independence or transparency, and published outcomes are biased by selective reporting. Systematic review registration PROSPERO 2018 CRD42018091928.


2021 ◽  
Author(s):  
◽  
Robert T Thibault

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.


2014 ◽  
Vol 23 (01) ◽  
pp. 49-55
Author(s):  
L. C. Hofbauer ◽  
D. Felsenberg ◽  
M. Amling ◽  
A. Kurth ◽  
P. Hadji

SummaryIt is important to understand compliance and persistence with medication use in the clinical practice of osteoporosis treatment. The purpose of this work is to describe the “intravenous ibandronate versus oral alendronate” (VIVA) study, a non-interventional trial to assess the compliance and persistence of osteopenic postmenopausal women with treatment via weekly oral alendronate or intravenous ibandronate (Bonviva®) every three months.4477 patients receiving ibandronate 3 mg i. v. quarterly and 1491 patients receiving alendronate 70 mg orally weekly were included in the study. Matched pairs of 901 subjects in each group were also generated. Matching was performed on the basis of age, body mass index, fracture history at study inclusion, prior treatment with bisphosphonates and the number of concomitant disorders. Secondary outcome measures of osteoporosis related fractures, mobility restriction and pain, analgesia, quality of life questionnaires as well as attitudes to medications were assessed. The primary outcome parameters of compliance and persistence will be tracked in these subjects.At baseline, the entire collectives differed significantly on body weight (less in ibandronate group), duration since osteo - porosis diagnosis (longer in ibandronate), and incidence of prior osteoporotic fracture (higher in ibandronate group). The matched-pairs differed only on mobility restriction and quality of life (both worse in ibandronate group).The results from the VIVA study trial will provide scientific rationale for clinical recommendations in the pharmacological treatment of postmenopausal osteoporosis.


2014 ◽  
Vol 23 (2) ◽  
pp. 135-140 ◽  
Author(s):  
Edward W. Holt ◽  
Kidist K. Yimam ◽  
Hanley Ma ◽  
Richard E. Shaw ◽  
Richard A. Sundberg ◽  
...  

Background & Aims: A number of factors have been identified that influence the yield of screeningcolonoscopy. The perceived tolerability of bowel preparation has not been studied as a predictor of quality outcomes in colonoscopy. We aimed to characterize the association between patient-perceived tolerability of bowel preparation and polyp detection during colonoscopy.Methods: We performed a cross-sectional cohort study of 413 consecutive adult patients presenting foroutpatient colonoscopy at two outpatient endoscopy centers at our institution. We developed a standardized questionnaire to assess the patient's experience with bowel preparation. Bowel preparation quality was measured using the validated Ottawa scale and colonoscopic findings were recorded for each patient. The primary outcome was polyp detection and the secondary outcome was the quality of bowel preparation.Results: Patient-reported clarity of effluent during bowel preparation correlated poorly with Ottawa score during colonoscopy, k=0.15. Female gender was an independent risk factor for a poorly tolerated bowel prep (OR 3.93, 95% CI 2.30 - 6.72, p<0.001). Report of a poorly tolerated bowel prep was independently associated with the primary outcome, polyp detection (OR 0.39, 95% CI 0.18 - 0.84, p=0.02) and also with the secondary outcome, lower quality bowel preparation (OR 2.39, 95% CI 1.17 - 4.9, p=0.02).Conclusions: A patient-perceived negative experience with bowel preparation independently predicted both a lower quality bowel preparation and a lower rate of polyp of detection. Assessment of the tolerability of bowel preparation before colonoscopy may be a clinically useful predictor of quality outcomes during colonoscopy.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S49-S50
Author(s):  
Bruce M Jones ◽  
Emily Plauche ◽  
Susan E Smith ◽  
Christopher M Bland

Abstract Background Penicillin allergy reconciliation is an important aspect of antimicrobial stewardship with ~10% of the population reporting a penicillin allergy. Our facility utilizes a Penicillin Allergy Reconciliation Program (PARP) led by an Infectious Diseases (ID) Pharmacist and pharmacy students to identify patients with penicillin allergies to reconcile and intervene when necessary. Information is collected by interview, electronic medical record (EMR) review, prescription outpatient fill history. This study evaluated reconciliations with and without a PARP in patients in a community health system. Methods This was a retrospective study that compared reconciliations performed on adult patients admitted at least once in 2019 with a self-reported penicillin allergy and ID physician consult at a hospital with a PARP (Institution 1) and one without a formal evaluation and intervention program (Institution 2) within the same community health system with same ID physicians. The primary outcome was documented reconciliation of a patient’s penicillin allergy during an inpatient visit in 2019. Reconciliation was defined as an edit or clarification (updating the severity, reaction, or comments section, as well as deleting) to a patient’s penicillin allergy in the EMR. The secondary outcome evaluated the percentage of total and ID consult patients with a penicillin allergy. Results There were 245 patients who met criteria and were included in the study, 113 from Institution 1 and 132 from Institution 2. For the primary outcome, there were 82 (72.6%) reconciliations at Institution 1 and 15 (11.4%) reconciliations at Institution 2 (p &lt; 0.001). Interventions at Institution 1 and 2 resulted in 74 EMR updates and 8 removals and 14 EMR updates and 1 removal, respectively. Reconciliation was performed on the same visit as the ID consult in 59/82 patients (72%) at Institution 1 and 11/15 patients (73.3%) at Institution 2. All reconciliations at Institution 2 were made by pharmacist (10) or nurses (5). For the secondary outcome, 10.9% of patients with an ID consult and 12.6% of all patients admitted in 2019 had a penicillin allergy (p=0.027). Conclusion A PARP led by an ID pharmacist and students was an effective method to perform penicillin allergy reconciliations, even in the presence of active ID consultation. Disclosures Bruce M. Jones, PharmD, BCPS, ALK-Abello (Research Grant or Support)Allergan/Abbvie (Speaker’s Bureau) Christopher M. Bland, PharMD, FCCP, FIDSA, BCPS, ALK Abello, Inc. (Grant/Research Support)Biomerieux (Consultant)Merck (Consultant, Grant/Research Support, Advisor or Review Panel member, Speaker’s Bureau)Tetraphase (Speaker’s Bureau)


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