Moffett’s Solution Causes Significantly Greater Postoperative Throat Pain Compared to Cophenylcaine in Sinonasal Surgery

Aim. Preoperative decongestion with Moffett’s solution is routine practice in sinonasal procedures providing an ideal operative field. Anecdotally, it is related to postoperative throat pain, yet a quantitative relationship has not been established. We compare the incidence and severity of postoperative throat pain after application of Moffett’s solution against Cophenylcaine decongestion. Methodology. A total of thirty patients from two consultants were recruited. The intervention arm (twenty) was decongested with Moffett’s solution and the control arm (ten) with Cophenylcaine. The primary outcome was self-reported postoperative throat pain as measured by visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and next morning. Results. There was a significantly higher VAS for throat pain in patients decongested with Moffett’s solution in the early postoperative period (2 hours p=0.03, 4 hours p=0.04). Conclusion. Moffett’s solution is associated with a greater severity of transient postoperative throat pain compared to topical Cophenylcaine. We recommend further studies to identify means to minimise this side effect. Clinical Trial Registration. This paper has been registered with the Australian and New Zealand Clinical Trials Registry under the registration number: ACTRN12619000772145.

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Comparison of IOL Power Calculated by Preoperative Biometry versus Intraoperative Wavefront Aberrometry in Thai Cataract Patients.

10.21203/rs.3.rs-25811/v2 ◽

2020 ◽

Author(s):

Bharkbhum Khambhiphant ◽

Sribenjapanon Thanyaporn

Keyword(s):

Trial Registration ◽

Altman Analysis ◽

Clinical Trial Registration ◽

Bland Altman Analysis ◽

Multifocal Iol ◽

Registration Number ◽

Wavefront Aberrometry ◽

Iol Power ◽

The One ◽

Cataract Patients

Abstract Background: To find agreement between the calculated intraocular lens (IOL) power from using the SRK/T based preoperative biometry and the intraoperative wavefront aberrometry (ORA®) in Thai cataract patients, and to compare the accuracy of each method with the postoperative refraction results.Methods: Eyes that underwent cataract surgery with monofocal or multifocal IOL implantation were enrolled in this prospective study. All eye biometry was measured preoperatively and the ORA intraoperatively. The SRK/T suggested IOL from the preoperative biometry was chosen in all cases. The suggested power and the estimated refraction (EST) from both devices were collected. Bland Altman analysis was used to find the agreement between them. The predicted EST of implanted IOL from both devices were compared with the one-month postoperative SE. Results: The study comprised 97 eyes (79 patients). Of these, 38 eyes (39.2%) had the same suggested IOL power, 36 eyes (37.1%) were within ±0.5D, 20 eyes (20.6%) were within ±1.0D and 3 eyes were beyond ±1.0D. Bland-Altman analysis found the mean difference between IOL power calculated from both devices was 0.39 with LoA of -0.54 to 1.31. The correlation was 98.50% (95%CI 98%- 99.10%). In the same suggested IOL power group, the median difference of EST by preoperative biometry and ORA compared with one-month postoperative SE were -0.08 (95%CI: -0.08, 1.11), and -0.14 (95%CI: -0.88, 1.2), respectively. Conclusions:The ORA and preoperative biometry results were in concordance with each other. The result of preoperative biometry was more accurate than ORA in this study. Trial Registration: The thai clinical trial registration number: TCTR20171005001Registration Date: October 3rd, 2017First Enrollment: November 10th, 2017

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Clinical research about the improved PVP method in treatment of acute osteoporotic vertebral compression fractures

Journal of Orthopaedic Surgery ◽

10.1177/2309499019864667 ◽

2019 ◽

Vol 27 (3) ◽

pp. 230949901986466 ◽

Cited By ~ 3

Author(s):

Yao Zhang ◽

JiPeng Song ◽

Yu Hou ◽

GenAi Zhang ◽

LiXiang Ding

Keyword(s):

Digital Design ◽

Trial Registration ◽

Vertebral Compression Fractures ◽

Clinical Trial Registration ◽

Traditional Group ◽

X Ray ◽

Compression Fractures ◽

Registration Number ◽

Operation Duration ◽

Radiological Dose

Objective: The traditional percutaneous vertebroplasty (PVP) could induce massive radiation and side injuries to the tissues around the fractured centrum. This study was designed to reduce the radiation and damage and improve the treatment efficiency of PVP. Methods: Forty four patients who diagnosed to be acute osteoporotic single vertebral compression fractures were collected and randomly divided into traditional group and improved group, and these two groups were separately treated by the traditional and improved PVP which assisted by the preoperative digital design. The treatment outcome between these two groups was compared and analyzed by Students’ t test and χ 2 test. Results: Compared with the traditional PVP, the improved PVP could significantly reduce the X-ray fluoroscopy times for determining puncture point (14.41 ± 4.00 vs. 6.82 ± 2.15, p < 0.001) and puncture route (22.73 ± 3.89 vs. 13.36 ± 3.39, p < 0.001), the X-ray fluoroscopy times during the operation (76.59 ± 12.4 vs. 34.82 ± 6.74, p < 0.001), operation duration (28.64 ± 7.43 min vs. 15.23 ± 4.4 min, p < 0.001), and total radiological dose (588.85 ± 53.86 cGycm2 vs. 276.5 ± 58.17 cGycm2, p < 0.001). The improved PVP could also significantly decrease the visual analog score at intra-operation (7.68 ± 0.78 vs. 4.50 ± 0.67, p < 0.001) and 1 day after the operation (2.45 ± 0.51 vs. 2.16 ± 0.36, p < 0.05). Besides, the improved PVP could not significantly affect the Oswestry disability index after operation ( p > 0.05). Conclusion: The improved PVP operation could significantly reduce the total radiological dose and X-ray fluoroscopy times, protect the patients and medical staff, and reduce the pain caused by the operation. Trial registration: This trial was registered in China clinical trial registration center and the registration number was ChiCTR-INR-17011557.

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Comparison of IOL Power Calculated by Preoperative Biometry versus Intraoperative Wavefront Aberrometry in Thai Cataract Patients.

10.21203/rs.3.rs-25811/v3 ◽

2020 ◽

Author(s):

Bharkbhum Khambhiphant ◽

Sribenjapanon Thanyaporn

Keyword(s):

Trial Registration ◽

Altman Analysis ◽

Clinical Trial Registration ◽

Bland Altman Analysis ◽

Multifocal Iol ◽

Registration Number ◽

Wavefront Aberrometry ◽

Iol Power ◽

The One ◽

Cataract Patients

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Patient expectations are better for immunotherapy than traditional chemotherapy for cancer

Journal of Cancer Research and Clinical Oncology ◽

10.1007/s00432-020-03336-1 ◽

2020 ◽

Vol 146 (12) ◽

pp. 3189-3198

Author(s):

Andreas Ihrig ◽

Jenniffer Richter ◽

Carsten Grüllich ◽

Leonidas Apostolidis ◽

Peter Horak ◽

...

Keyword(s):

Adverse Effects ◽

Cancer Patients ◽

Checkpoint Inhibitors ◽

Mixed Methods Study ◽

Trial Registration ◽

Risk Awareness ◽

Structured Interviews ◽

Clinical Trial Registration ◽

Registration Number ◽

Advanced Stage Cancer

Abstract Purpose The main aim of the study was to explore the expectations and knowledge of advanced-stage cancer patients about immunotherapy. Methods This mixed methods study included 53 cancer patients on immune checkpoint inhibitors (ICIs), 55 cancer patients undergoing chemotherapy (CT), and 53 non-cancer patients. Participants’ expectations about ICIs and CT were compared. Additional qualitative data were derived from semi-structured interviews. Results Among patients who did not receive ICIs, 63 (58%) had never heard of ICIs and 94 (87%) had large gaps in their knowledge of ICIs. Among ICI patients, 33 (62%) simply described ICIs without errors. ICI perception was positive, regardless of whether respondents received or had heard of ICIs, which became particularly evident when compared to CT. ICIs were rated as more promising, and all adverse effects were expected to be significantly lower than those of CT. Knowledge about ICIs was also limited in the interviewed ICI patients. Some patients reported adverse effects of ICIs that were mostly mild and well-tolerated or easily treated. Conclusions The lack of understanding of ICIs should be improved by activities to increase the knowledge of ICI patients and the general population. In contrast to CT, ICIs invoked fewer negative associations with efficacy and toxicity. Therefore, attention should be paid to risk awareness when educating patients. (Clinical trial registration number: DRKS00011868) Trial Registration: German clinical trials register, www.germanctr.de, number DRKS00011868.

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Outcome of multifaceted interventions for improving the quality of antenatal care in Nigerian referral hospitals

Reproductive Health ◽

10.1186/s12978-020-00997-6 ◽

2020 ◽

Vol 17 (1) ◽

Author(s):

Friday Ebhodaghe Okonofua ◽

Lorretta Favour Chizomam Ntoimo ◽

Bola Ekezue ◽

Victor Ohenhen ◽

Kingsley Agholor ◽

...

Keyword(s):

Clinical Trials ◽

Antenatal Care ◽

Trial Registration ◽

Central Hospital ◽

Referral Hospitals ◽

Registration Number ◽

Multifaceted Interventions ◽

Clinical Trials Registry ◽

And Control

Abstract Background The study was designed as quasi-experimental research to investigate the effectiveness of multifaceted interventions for improving the quality of antenatal care in referral hospitals in Nigeria. Two referral hospitals (the Central Hospital in Benin City, South-South Nigeria, and the General Hospital in Minna) served as intervention sites, while two hospitals in comparable locations, (the Central Hospital Warri and the Suleja Hospital Abuja) were the control hospitals. Methods Intervention activities consisted of the introduction of a strategic plan with the shared vision of reducing maternal mortality by 50% in 1 year in the hospitals; staff training and re-training; the establishment of an automated appointment system; composite health education involving couples and providers; advocacy with policymakers; and the implementation of maternal death reviews and surveillance. These activities were implemented in the intervention hospitals over 21 months (October 2017 to June 2019). Exit interviews of pregnant women at intervention and control sites by trained interviewers were used to assess the quality of antenatal care after their visit, A total of 777 women were interviewed (427 in the intervention sites and 350 in the control sites). Data were analyzed with univariate and multivariate Poisson and logistic regression to determine the extent to which health providers in the clinics completed the 18 signal functions identified in the WHO assessment tool. Results The regression analyses showed the interventions were effective in improving six quality indicators (QIs) for counseling and information sharing. The difference between intervention and control sites on these QIs was significant at < 0.05. On the contrary, the interventions were less effective for maternal and fetal measurements; and disease testing and management QIs. Conclusion The positive effects of the interventions are likely due to the effectiveness of the training and health education components. The lack of intervention impact observed for maternal and fetal measurements may be due to the high workload of care staff and inadequate clinic supplies, which we did not address. We conclude that interventions that address the quality of antenatal care in low-resource settings should focus on improving all elements of care, including adequate staffing and mobilization of material resources. Trial registration This study was registered in the ISRCTN on August 14th, 2020. Trial Registration Number. SRCTN17985403. Retrospective registration. The reason for the retrospective registration is the current non-recognition of the Nigeria Clinical Trials Registry (NCTR); which is currently not an ICMJE or WHO ICTRP approved registry. (This study was registered in the Nigeria Clinical Trials Registry on April 14th, 2016. Trial Registration Number NCTR No: 91540209).

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Point-of-care measurements of blood ketones in newborns

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2018-316293 ◽

2018 ◽

Vol 104 (5) ◽

pp. F544-F546

Author(s):

Deborah L Harris ◽

Philip J Weston ◽

Jane E Harding

Keyword(s):

Point Of Care ◽

Clinical Care ◽

Area Under The Curve ◽

Laboratory Method ◽

Clinical Trial Registration ◽

Paired Samples ◽

Newborn Intensive Care Unit ◽

Registration Number ◽

Beta Hydroxybutyrate ◽

Clinical Trials Registry

ObjectiveBabies may use alternative cerebral fuels including ketones when blood glucose concentrations are low, but laboratory ketone measurements are slow and expensive. Point-of-care measurement of ketone concentrations, if sufficiently accurate, may provide useful information for clinical care.Patients and designEligible babies were 35–42 weeks’ gestation, ≤10 days old and admitted to the newborn intensive care unit. At the time of clinically indicated blood tests, additional samples were taken to measure beta-hydroxybutyrate using a point-of-care analyser and the laboratory method.ResultsOne-hundred and fifty babies had 142 paired samples. Overall point-of-care accuracy was excellent (mean difference 0.00 mmol/L) and precision was moderate (SD 0.18 mmol/L). A point-of-care measurement ≥0.4 mmol/L was highly predictive of a laboratory measurement ≥0.4 mmol/L (area under the curve 0.98).ConclusionPoint-of-care measurement of blood beta-hydroxybutyrate concentrations is sufficiently accurate in newborns to be potentially useful in clinical care.Clinical trial registration numberRegistered with the Australian and New Zealand Clinical Trials Registry ACTRN: 12616000784415. The study was registered before recruitment commenced.

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Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study

Arthritis Research & Therapy ◽

10.1186/s13075-021-02547-2 ◽

2021 ◽

Vol 23 (1) ◽

Author(s):

Yusuke Miyazaki ◽

Kazuhisa Nakano ◽

Shingo Nakayamada ◽

Satoshi Kubo ◽

Shigeru Iwata ◽

...

Keyword(s):

Operating Characteristic ◽

Certolizumab Pegol ◽

Area Under The Curve ◽

Serum Levels ◽

Trial Registration ◽

Clinical Parameters ◽

Characteristic Analysis ◽

Clinical Trial Registration ◽

Registration Number ◽

The Relationship

Abstract Objective To estimate the relationship between serum TNFα, IL-6, and serum CZP levels and the clinical response to CZP in RA patients in the TSUBAME study. Methods One hundred patients with RA who received CZP were enrolled and multiple clinical parameters, serum TNFα, IL-6, and CZP levels, were assessed at 0, 24, and 48 h and 12 weeks after first administration of CZP. Results The CZP therapy significantly improved the DAS28(ESR) at 12 weeks. Serum TNFα and IL-6 levels significantly decreased from baseline at 24 h after the first administration of CZP. Serum TNFα levels at baseline were not related to clinical parameters at baseline and improvement in DAS28(ESR) at week 12 of the CZP therapy. However, serum levels of CZP at 24 h were strongly and negatively correlated with TNFα levels at 24 h, which were negatively correlated with improved rate in DAS28(ESR) at week 12. Only serum levels of TNFα, but not IL-6, at 24 h had a negative correlation with achievement of DAS28(ESR)<2.6 at week 12 by the multivariate analysis (odds ratio 0.01, 95% confidence interval 0.04e−2–0.22, p < 0.01). A receiver operating characteristic analysis was conducted to estimate the achievement of DAS28(ESR)<2.6 at week 12 after the CZP therapy and cut-off value of 0.76 pg/ml for serum levels of TNFα at 24 h was yielded (area under the curve=0.75). DAS28(ESR)<2.6 was achieved at week 12 significantly more patients with lower serum TNF levels (≦0.76 pg/ml) at 24 h than those with higher TNF levels. Conclusions CZP was highly effective in RA patients who had low serum TNFα levels at 24 h after the initial administration of CZP. Therefore, we propose that serum TNFα levels at 24 h could serve as a biomarker predicting effectiveness to CZP at week 12 in patients with RA. Trial registration Clinical trial registration number: UMIN ID:000022831

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DETECT Schools Study Protocol: A Prospective Observational Cohort Surveillance Study Investigating the Impact of COVID-19 in Western Australian Schools

Frontiers in Public Health ◽

10.3389/fpubh.2021.636921 ◽

2021 ◽

Vol 9 ◽

Author(s):

Marianne J. Mullane ◽

Hannah M. Thomas ◽

Melanie Epstein ◽

Joelie Mandzufas ◽

Narelle Mullan ◽

...

Keyword(s):

School Setting ◽

Trial Registration ◽

Surveillance Study ◽

Clinical Trial Registration ◽

School Communities ◽

Peace Of Mind ◽

Psychosocial Wellbeing ◽

Registration Number ◽

Observational Cohort ◽

The Impact

Introduction: Amidst the evolving COVID-19 pandemic, understanding the transmission dynamics of the SARS-CoV-2 virus is key to providing peace of mind for the community and informing policy-making decisions. While available data suggest that school-aged children are not significant spreaders of SARS-CoV-2, the possibility of transmission in schools remains an ongoing concern, especially among an aging teaching workforce. Even in low-prevalence settings, communities must balance the potential risk of transmission with the need for students' ongoing education. Through the roll out of high-throughput school-based SARS-CoV-2 testing, enhanced follow-up for individuals exposed to COVID-19 and wellbeing surveys, this study investigates the dynamics of SARS-CoV-2 transmission and the current psychosocial wellbeing impacts of the pandemic in school communities.Methods: The DETECT Schools Study is a prospective observational cohort surveillance study in 79 schools across Western Australia (WA), Australia. To investigate the incidence, transmission and impact of SARS-CoV-2 in schools, the study comprises three “modules”: Module 1) Spot-testing in schools to screen for asymptomatic SARS-CoV-2; Module 2) Enhanced surveillance of close contacts following the identification of any COVID-19 case to determine the secondary attack rate of SARS-CoV-2 in a school setting; and Module 3) Survey monitoring of school staff, students and their parents to assess psycho-social wellbeing following the first wave of the COVID-19 pandemic in WA.Clinical Trial Registration: Trial registration number: ACTRN12620000922976

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CSF MicroRNAs Reveal Impairment of Angiogenesis and Autophagy in Parkinson Disease

Neurology Genetics ◽

10.1212/nxg.0000000000000633 ◽

2021 ◽

Vol 7 (6) ◽

pp. e633

Author(s):

Alan J. Fowler ◽

Jaeil Ahn ◽

Michaeline Hebron ◽

Timothy Chiu ◽

Reem Ayoub ◽

...

Keyword(s):

Parkinson Disease ◽

Mirna Expression ◽

Trial Registration ◽

Whole Genome ◽

Autophagy Flux ◽

Clinical Trial Registration ◽

Mirna Sequencing ◽

Registration Number ◽

Disease Modifying

Background and ObjectivesWe assessed longitudinal changes in CSF microRNAs (miRNAs) in patients with moderately severe Parkinson disease.MethodsWe used next-generation whole-genome miRNA sequencing to determine CSF miRNA expression in 75 patients with Parkinson disease after single random ascending doses of nilotinib and longitudinal miRNA expression after daily nilotinib, 150 and 300 mg, vs placebo for 1 year.ResultsSignificant changes in the expression of miRNAs that control genes and pathways that regulate angiogenesis, autophagy, and the blood-brain-barrier components, primarily collagen, were observed over 1 year, suggesting impairment of these pathways in Parkinson progression in these patients. Different miRNAs that indicate activation of genes associated with autophagy flux and clearance and angiogenesis were significantly altered in the nilotinib, 300 mg vs 150 mg, or placebo group, and these changes correlated with clinical outcomes. No changes were observed in miRNAs after a single dose of nilotinib vs placebo.DiscussionThis study suggests vascular and autophagy defects in Parkinson progression. Nilotinib, 300 mg, reverses these effects via alteration of miRNA expression, suggesting epigenomic changes that may underlie long-term disease-modifying effects.Trial Registration InformationClinical trial registration number: NCT02954978.

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A160 PREVALENCE OF OUTCOME SWITCHING AMONG PUBLISHED PHASE 3 INTERVENTIONAL TRIALS FOR INFLAMMATORY BOWEL DISEASE THERAPEUTICS

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwab002.158 ◽

2021 ◽

Vol 4 (Supplement_1) ◽

pp. 167-168

Author(s):

R Bansal ◽

R Khan ◽

N Gimpaya ◽

M A Scaffidi ◽

K Elsolh ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Primary Outcome ◽

Randomized Clinical Trials ◽

Pooled Analysis ◽

Trial Registration ◽

Phase 3 ◽

Clinical Trial Registration ◽

Inflammatory Bowel ◽

Secondary Outcomes

Abstract Background Outcome switching is a well-described form of inconsistent reporting in randomized clinical trials (RCTs), wherein pre-specified primary and/or secondary outcomes are changed between trial registration and the publication of results without explanation. This is of particular concern, as the selective publication of results that are favorable will insert bias into the trial’s results and may cast doubt on the veracity of its findings. While it has been investigated in other disciplines, the prevalence of outcome switching has yet to be described among RCTs for inflammatory bowel disease (IBD). Aims To determine the prevalence of correctly reported pre-specified primary and secondary outcomes in published phase 3 interventional RCTs for IBD. Methods We identified all phase 3 interventional trials for IBD with published results using clinicaltrials.gov. We included all results with an associated publication that detailed the results of the trial. We excluded registrations if: only an abstract of the results was available; trial results were only published as a pooled analysis; multiple trial segments were reported collectively; or a publication of the results could not be identified through clinicaltrials.gov or a custom search. Two reviewers extracted all pre-specified primary and secondary outcomes for each trial using the clinical trial registration page that was dated before the commencement of the trial. These outcomes were compared to the outcomes reported in the corresponding journal articles. Any discrepancies were noted, and additional outcomes were extracted. Results We identified a total of 88 phase 3 interventional RCTs for IBD, of which 57 were matched to independent publications of their results. All trials pre-specified a primary outcome, and 50 (87.7%) pre-specified secondary outcomes. 10 (17.5%) of trials did not report some or all primary outcomes, and 19 (33.3%) trials had a change or alteration to the primary outcome. Of the trials that pre-specified secondary outcomes, 16 (28.1%) did not report all pre-specified secondary outcomes. 49 (86.0%) trials added 6 (IQR: 2–8) unspecified secondary outcomes on average. Conclusions Many phase 3 interventional RCTs in IBD either did not report some or all primary outcomes, or altered the primary outcome. Trials routinely reported additional outcomes that were not pre-specified and failed to note that they were added post hoc. Based on these results, we recommend improvements in the reporting of pre-specified outcomes and higher fidelity in order to maintain confidence in trial results. Funding Agencies None

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