Antifungal prophylaxis for prevention of COVID-19-associated pulmonary aspergillosis in critically ill patients: an observational study

Abstract Background Coronavirus disease 19 (COVID-19)-associated pulmonary aspergillosis (CAPA) emerged as important fungal complications in patients with COVID-19-associated severe acute respiratory failure (ARF). Whether mould active antifungal prophylaxis (MAFP) can prevent CAPA remains elusive so far. Methods In this observational study, we included all consecutive patients admitted to intensive care units with COVID-19-associated ARF between September 1, 2020, and May 1, 2021. We compared patients with versus without antifungal prophylaxis with respect to CAPA incidence (primary outcome) and mortality (secondary outcome). Propensity score adjustment was performed to account for any imbalances in baseline characteristics. CAPA cases were classified according to European Confederation of Medical Mycology (ECMM)/International Society of Human and Animal Mycoses (ISHAM) consensus criteria. Results We included 132 patients, of whom 75 (57%) received antifungal prophylaxis (98% posaconazole). Ten CAPA cases were diagnosed, after a median of 6 days following ICU admission. Of those, 9 CAPA cases were recorded in the non-prophylaxis group and one in the prophylaxis group, respectively. However, no difference in 30-day ICU mortality could be observed. Thirty-day CAPA incidence estimates were 1.4% (95% CI 0.2–9.7) in the MAFP group and 17.5% (95% CI 9.6–31.4) in the group without MAFP (p = 0.002). The respective subdistributional hazard ratio (sHR) for CAPA incidence comparing the MAFP versus no MAFP group was of 0.08 (95% CI 0.01–0.63; p = 0.017). Conclusion In ICU patients with COVID-19 ARF, antifungal prophylaxis was associated with significantly reduced CAPA incidence, but this did not translate into improved survival. Randomized controlled trials are warranted to evaluate the efficacy and safety of MAFP with respect to CAPA incidence and clinical outcomes.

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Rationale, baseline characteristics and methodology of the non-interventional VIVA study in postmenopausal osteoporosis

Osteologie/Osteology ◽

10.1055/s-0037-1620027 ◽

2014 ◽

Vol 23 (01) ◽

pp. 49-55

Author(s):

L. C. Hofbauer ◽

D. Felsenberg ◽

M. Amling ◽

A. Kurth ◽

P. Hadji

Keyword(s):

Quality Of Life ◽

Postmenopausal Osteoporosis ◽

Primary Outcome ◽

Osteoporosis Treatment ◽

Secondary Outcome ◽

Matched Pairs ◽

Fracture History ◽

Baseline Characteristics ◽

Study Inclusion

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.

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OP0010 EFFECTIVENESS OF THE MAKING IT WORK™ PROGRAM AT IMPROVING PRESENTEEISM AND WORK CESSATION IN WORKERS WITH INFLAMMATORY ARTHRITIS – RESULTS OF A RANDOMIZED CONTROLLED TRIAL

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2383 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 7.1-8

Author(s):

A. Luquini ◽

Y. Zheng ◽

H. Xie ◽

C. Backman ◽

P. Rogers ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Work Disability ◽

Inflammatory Arthritis ◽

Missing Values ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Mixed Effect ◽

Randomized Controlled ◽

Baseline Characteristics

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

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Abstract 202: Endovascular Therapy for Acute Ischemic Stroke With Distal Large Vessel Occlusion in the Anterior Circulation

Stroke ◽

10.1161/str.47.suppl_1.202 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Amrou Sarraj ◽

Navdeep Sangha ◽

Muhammad Shazam Hussain ◽

Dolora Wisco ◽

Nirav Vora ◽

...

Keyword(s):

Endovascular Therapy ◽

Primary Outcome ◽

Large Vessel ◽

Secondary Outcome ◽

Large Vessel Occlusion ◽

Anterior Circulation ◽

Vessel Occlusion ◽

Good Outcome ◽

Baseline Characteristics ◽

Iv Tpa

Introduction: Five RCTs demonstrated the superiority of endovascular therapy (EVT) over best medical management (MM) for acute ischemic strokes (AIS) with large vessel occlusion (LVO) in the anterior circulation. Patients with M2 occlusions, however, were underrepresented (95 randomized; 51 EVT treated). Evidence from RCTs of the benefit of EVT for M2 occlusions is lacking, as reflected in the recent AHA guidelines. Methods: A retrospective cohort was pooled from 10 academic centers from 1/12 to 4/15 of AIS patients with LVO isolated to M2 presenting within 8 hours from last known normal (LKN). Patients were divided into EVT and MM groups. Primary outcome was 90 day mRS (good outcome 0-2); secondary outcome was sICH. Logistic regression compared the 2 groups. Univariate and multivariate analyses evaluated predictors of good outcome in the EVT group. Results: Figure 1 shows participating centers, 522 patients (288 EVT and 234 MM) were identified. Table (1) shows baseline characteristics. MM treated patients were older and had higher IV tPA treatment rates, otherwise the 2 groups were balanced. 62.7 % EVT patients had mRS 0-2 at 90 days compared to 35.4 % MM (figure 2). EVT patients had 3 times the odds of good outcome as compared to MM patients (OR: 3.1, 95% CI:2.1-4.4, P <0.001) even after adjustment for age, NIHSS, ASPECTS, IV tPA and LKN to door time (OR: 3.2, 95%CI: 2-5.2, P<0.001). sICH rate was 5.6 %, which was not statistically different than the MM group (table 1, P=0.1). Age, NIHSS, good ASPECTS, LKN to reperfusion time and successful reperfusion mTICI ≥ 2b were independent predictors of good outcome in EVT patients. There was a linear relationship between good outcome and time LKN to reperfusion (Figure 3). Conclusion: Despite inherent limitations of its retrospective design, our study suggests that EVT may be effective and safe for distal LVO (M2) relative to best MM. A trial randomizing M2 occlusions to EVT vs. MM is warranted to confirm these findings.

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A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

Multiple Sclerosis Journal ◽

10.1177/135245859500100210 ◽

1995 ◽

Vol 1 (2) ◽

pp. 118-135 ◽

Cited By ~ 64

Author(s):

LD Jacobs ◽

DL Cookfair ◽

RA Rudick ◽

RM Herndon ◽

J R Richert ◽

...

Keyword(s):

Primary Outcome ◽

Interferon Beta ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Phase Iii ◽

Secondary Outcome ◽

Recombinant Interferon ◽

Study Population ◽

The Mean ◽

Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

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Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04748-7 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Feng Bin Lin ◽

◽

Shi Da Chen ◽

Yun He Song ◽

Wei Wang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Intraocular Pressure ◽

High Myopia ◽

Primary Outcome ◽

Controlled Trial ◽

Secondary Outcome ◽

Rank Test ◽

Inner Plexiform Layer ◽

Randomized Controlled ◽

The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

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Results of the ADIUVO Study, the First Randomized Trial on Adjuvant Mitotane in Adrenocortical Carcinoma Patients

Journal of the Endocrine Society ◽

10.1210/jendso/bvab048.336 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

pp. A166-A167

Author(s):

Massimo Terzolo ◽

Martin Fassnacht ◽

Paola Perotti ◽

Rossella Libe ◽

André Lacroix ◽

...

Keyword(s):

Observational Study ◽

Adrenocortical Carcinoma ◽

Multivariable Analysis ◽

Stage I ◽

Controlled Study ◽

Intermediate Risk ◽

Ki 67 ◽

Risk Of Recurrence ◽

Randomized Controlled ◽

Baseline Characteristics

Abstract Background: The ESE-ENSAT guidelines on the management of adrenocortical carcinoma (ACC) suggest adjuvant mitotane for patients at high risk of recurrence following radical surgery. This indication has a limited evidence base, lacking results from randomized controlled trials. No suggestion for or against adjuvant mitotane in low-risk patients was given, since studies did not stratify patients for prognosis. The randomized controlled study ADIUVO compared the efficacy of adjuvant mitotane treatment vs. observation in prolonging recurrence-free survival (RFS) in ACC patients at low-intermediate risk of recurrence. Methods: The main inclusion criteria were: stage I-III ACC, R0 surgery, and Ki-67 ≤10%. Patients were randomly assigned 1:1 to adjuvant mitotane (MIT) or observation (OBS). The primary endpoint of the study was RFS. Patients who refused randomization were offered inclusion in the ADIUVO OBSERVATIONAL study. In this prospective, observational study, patients were managed as in the ADIUVO study. A total of 91 patients were enrolled in ADIUVO, 45 in the MIT and 46 in the OBS arm. Baseline characteristics of patients were perfectly matched between the 2 arms: median age, 51 vs. 50.5 years; female, 73% vs. 67%; stage I, 20% vs. 26%; stage II, 67% vs. 63%, stage III, 13% vs. 11%; ACC secretion 44% vs. 36%; Weiss 5 vs. 5; respectively. In ADIUVO OBSERVATIONAL, 42 patients were treated with mitotane and 53 were untreated. Baseline characteristics of patients were matched between the 2 groups and with MIT and OBS groups in ADIUVO. Thus, the ADIUVO OBSERVATIONAL cohorts could be analyzed in parallel to those of ADIUVO. Results: In the ADIUVO study, recurrences were 8 in the MIT and 11 in the OBS arm, while deaths were 2 and 5, respectively. RFS and overall survival (OS) did not significantly differ between the 2 arms. Tumor size was a predictor of RFS in multivariable analysis. In the OBS arm, the HR for recurrence was 1.321 (95%CI, 0.55–3.32, p=0.54) and HR for death 2.171 (95%CI, 0.52–12.12, p=0.29). The survival analysis in the ADIUVO OBSERVATIONAL study confirmed the findings of ADIUVO. Given the outcome of both studies, the NNT is 55. Conclusions: ACC patients at low-intermediate risk of recurrence after surgery are a minority; however, they show a far better prognosis than expected (5-year RFS is about 75%) and do not benefit significantly from adjuvant mitotane. The results of the ADIUVO study do not support routine use of adjuvant mitotane in this subset of patients, who may thus avoid a potentially toxic treatment. This is an important step toward personalization of ACC care.

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Side Effects of Intravenous Patient-Controlled Analgesia with Remifentanil Compared with Intermittent Epidural Bolus for Labour Analgesia – A Randomized Controlled Trial

PRILOZI ◽

10.2478/prilozi-2020-0009 ◽

2019 ◽

Vol 40 (3) ◽

pp. 99-108

Author(s):

Dafina Karadjova ◽

Mirjana Shosholcheva ◽

Еmilija Ivanov ◽

Аtanas Sivevski ◽

Ivo Kjaev ◽

...

Keyword(s):

Side Effects ◽

Epidural Analgesia ◽

Primary Outcome ◽

Controlled Trial ◽

Secondary Outcome ◽

Patient Controlled Analgesia ◽

Obstetric Anaesthesia ◽

Randomized Controlled ◽

Significant Difference ◽

Remifentanil Group

Abstract Introduction: Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery. Material and methods: This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety. Results: The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group. Conclusion: PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.

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Association between potentially inappropriate medications at discharge and unplanned readmissions among hospitalised elderly patients at a single centre in Japan: a prospective observational study

BMJ Open ◽

10.1136/bmjopen-2019-032574 ◽

2019 ◽

Vol 9 (11) ◽

pp. e032574 ◽

Cited By ~ 4

Author(s):

Junpei Komagamine ◽

Taku Yabuki ◽

Masaki Kobayashi

Keyword(s):

Observational Study ◽

Elderly Patients ◽

Prospective Observational Study ◽

Primary Outcome ◽

Secondary Outcome ◽

Unplanned Readmission ◽

Potentially Inappropriate Medications ◽

Patient Age ◽

Patient Âgé ◽

Increased Risk

ObjectiveTo determine the prevalence of potentially inappropriate medication (PIM) use at admission and discharge among hospitalised elderly patients and evaluate the association between PIMs at discharge and unplanned readmission in Japan.DesignA prospective observational study conducted by using electronic medical records.ParticipantsAll consecutive patients aged 65 years or older who were admitted to the internal medicine ward were included. Patients who were electively admitted for diagnostic procedures were excluded.Main outcome measuresThe primary outcome was 30-day unplanned readmissions. The secondary outcome was the prevalence of any PIM use at admission and discharge. PIMs were defined based on the Beers Criteria. The association between any PIM use at discharge and the primary outcome was evaluated by using logistic regression.ResultsSeven hundred thirty-nine eligible patients were included in this study. The median patient age was 82 years (IQR 74–88); 389 (52.6%) were women, and the median Charlson Comorbidity Index was 2 (IQR 0–3). The proportions of patients taking any PIMs at admission and discharge were 47.2% and 32.2%, respectively. Of all the patients, 39 (5.3%) were readmitted within 30 days after discharge for the index hospitalisation. The use of PIMs at discharge was not associated with an increased risk of 30-day readmission (OR 0.93; 95% CI 0.46 to 1.87). This result did not change after adjusting for patient age, sex, number of medications, duration of hospital stay and comorbidities (OR 0.78; 95% CI 0.36 to 1.66).ConclusionThe prevalence of any PIM use at discharge was high among hospitalised elderly patients in a Japanese hospital. Although the use of PIMs at discharge was not associated with an increased risk of unplanned readmission, given a lack of power of this study due to a low event rate, further studies investigating this association are needed.Trial registration numberUMIN000027189.

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Ultrasonographic needle tip tracking for in-plane infraclavicular brachialis plexus blocks: a randomized controlled volunteer study

Regional Anesthesia and Pain Medicine ◽

10.1136/rapm-2020-101349 ◽

2020 ◽

Vol 45 (8) ◽

pp. 634-639

Author(s):

Trine Kåsine ◽

Luis Romundstad ◽

L A Rosseland ◽

Morten Wang Fagerland ◽

Paul Kessler ◽

...

Keyword(s):

Primary Outcome ◽

New Technology ◽

Onset Time ◽

Piezoelectric Sensor ◽

Secondary Outcome ◽

Procedure Time ◽

Ultrasound Guided ◽

Hand Motion ◽

Randomized Controlled ◽

Volunteer Study

BackgroundOnvision is a new technology for needle tip detection and tracking in ultrasound-guided regional anesthesia. The system consists of a piezoelectric sensor close to the needle tip and an electronic console integrated in the ultrasound system. The needle tip is visualized by a green circle on the ultrasound screen. The aim of the study was to investigate the effect of the new needle tip tracking technology on in-plane infraclavicular plexus blocks.MethodsThe study was a randomized, controlled, observer blinded cross-over trial in 26 healthy volunteers. Two specialists in anesthesiology performed an ultrasound-guided infraclavicular lateral sagittal brachial plexus block with and without needle tip tracking. Primary outcome was procedure time, measured from insertion of the needle until local anesthesia injection was completed. Secondary outcome measures included the number of hand movements and path lengths (assessed by hand motion analysis), block success rate, onset time and duration, discomfort experienced by the volunteers, and the anesthesiologists’ confidence as to whether their block would be successful or not.ResultsMean (SD) procedure time was 183.0 (56.1) s with and 206.8 (56.2) s without needle tip tracking (p=0.16). There were no significant differences in any of the secondary outcomes. Two volunteers’ experienced Horner syndrome after blocks without needle tip tracking. No other adverse events occurred during the study.ConclusionOur study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.Trial registration numberNCT03631914

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Reporting and interpretation of results from clinical trials that did not claim a treatment difference

10.31219/osf.io/725sz ◽

2018 ◽

Author(s):

Simon Gates

Keyword(s):

Primary Outcome ◽

High Impact ◽

Secondary Outcome ◽

Controlled Trials ◽

Treatment Benefit ◽

Treatment Difference ◽

Randomized Controlled ◽

Significant Difference ◽

Treatment Comparisons ◽

Randomised Controlled

Objectives: To describe and summarise the reporting of “non-significant” results in randomized controlled trials (RCTs), and to estimate how commonly trial reports make erroneous claims of no treatment difference based on a non-statistically significant result.Design: Retrospective survey of published RCTs.Setting: Four high impact factor general medical journals, published between June 2016 and June 2017.Participants: Reports of randomised controlled trials that did not find a difference between the interventions they compared.Interventions: Not an interventional study.Primary and secondary outcome measures: We recorded the way each trial’s results for its primary outcome or outcomes were described in the Results and Conclusions sections of the Abstract, using a 10-category classification. We estimated the proportion of papers that made claims that were not justified by the results, or were open to multiple interpretations.Results: Eighty-five trial reports were included, reporting 111 treatment comparisons. The majority of papers made unjustified or confusing statements. In the Results section of abstracts, for 55/111 comparisons (49.5%) the study’s results were re-stated, without interpretation, and 34/111 (30.6%) stated that there was not a statistically significant difference. In the conclusions, 61/111 treatment comparisons (55%) stated that there was no treatment benefit, 14/111 (12.6%) that there was no significant benefit, and 13/111 (11.7%) that there was no significant difference. Conclusions: Despite decades of warnings, the error of concluding a lack of treatment benefit from a non-statistically significant result remains common.

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