title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Competing interests | M.S., J.K., J.O’G., E.H., J.C., D.G., Y.L. and H.H. are employees and shareholders of Biogen. E.R., R.R., L.V., A.M.R. and S.B.H. are former employees and shareholders of Biogen. E.R. is a current employee of Takeda Pharmaceuticals. R.R. is a current employee of Vigil Neuroscience. A.M.R. is a current employee of Astra... | PMC10724064 | ||
References | PMC10724064 | |||
Background and Objectives | motor deficits, nonmotor deficits, neurologic deficits | ISCHEMIC STROKE | Go to The Article Processing Charge was funded by the authors.Submitted and externally peer reviewed. The handling editor was Editor-in-Chief José Merino, MD, MPhil, FAAN.The EuroQol Group 5-Dimension Self-Reported Questionnaire (EQ-5D) is a well-established instrument to assess quality of life and generates generic ut... | PMC10065207 |
Methods | neurologic deficits, Stroke | REGRESSION, STROKE | We used data of the Interventional Management of Stroke III trial. Missing data were imputed by multiple imputation. The association between neurologic deficits (individual NIH Stroke Scale [NIHSS] item scores) and the EQ-5D-3L (5 three-level dimension scores and utility score) at 90 days was assessed with ordinal logi... | PMC10065207 |
Results | sensory loss, dysarthria, paresis, hemianopia, aphasia | HEMIANOPIA, PARESIS, FACIAL PALSY | In total, 525 surviving patients were included. Complete data on both the NIHSS and EQ-5D were available for 481/525 (91.6%) patients. At 90 days, 161/491 (32.8%) patients had aphasia and 226/491 (46.0%) patients had paresis of at least 1 limb. Limb paresis, facial palsy, sensory loss, and dysarthria explained most of ... | PMC10065207 |
Discussion | neurologic deficits, paresis, hemianopia, nonmotor deficits, ischemic stroke, aphasia | HEMIANOPIA, PARESIS, ISCHEMIC STROKE | The impact of neurologic deficits on the EQ-5D in patients with ischemic stroke is mostly due to limb paresis, while the EQ-5D is less sensitive to other nonmotor deficits such as hemianopia, aphasia, and neglect. This may lead to overestimation of quality of life and, consequently, underestimation of the (cost-)effect... | PMC10065207 |
Methods | PMC10065207 | |||
Data | Stroke | STROKE | We used data from the Interventional Management of Stroke (IMS) III trial. This trial had data on the NIHSS and the EQ-5D at the same time point, 3 months after inclusion. The IMS III trial was a phase 3, multicenter, open-label clinical trial with blinded outcome assessment that evaluated the efficacy and safety of en... | PMC10065207 |
Standard Protocol Approvals, Registrations, and Patient Consents | The IMS III trial was approved by the ethics committee and research board of each participating center. Written informed consent was obtained from patients or their legal representative before enrollment in the trial. The IMS III trial was registered at | PMC10065207 | ||
NIHSS | neurologic deficit | The NIHSS is a 15-item neurologic examination scale, ranging from 0 to 42, with higher scores indicating more severe neurologic deficit. | PMC10065207 | |
EQ-5D | anxiety/depression | In the IMS III trial, the EQ-5D with 3 levels was used. The EQ-5D consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.Assessment of the EQ-5D dimension scores was performed at 90 days after inclusion by study investigators who were not directly involved with acute tr... | PMC10065207 | |
Statistical Analysis | neurologic deficits | REGRESSION | Clinical characteristics of patients according to availability of the NIHSS and EQ-5D at 90 days were compared using descriptive statistics. We assessed the association between neurologic deficits (NIHSS sum score and individual NIHSS item scores) and each EQ-5D dimension score with univariable ordinal logistic regress... | PMC10065207 |
Data Availability | Anonymized trial data and methods that support our finding are available upon request ( | PMC10065207 | ||
Results | Among the 525 surviving patients included in this study, 481/525 (91.6%) patients had complete data on both the NIHSS and EQ-5D ( | PMC10065207 | ||
Flowchart of IMS III Patients Selected for Analysis | Stroke | STROKE | EQ-5D = EuroQol Group 5-Dimension Self-Report Questionnaire; IMS = Interventional Management of Stroke; NIHSS = NIH Stroke Scale.Characteristics of Patients at Baseline and Outcomes at 90 Days by Availability of NIHSS and EQ-5D AssessmentPatients with higher NIHSS scores reported more problems on each EQ-5D dimension s... | PMC10065207 |
Explained Variance of the NIHSS Sum Score on the EQ-5D Dimension Scores and on the Utility Score | sensory loss, dysarthria, paresis, Stroke | PARESIS, FACIAL PALSY, STROKE | EQ-5D = EuroQol Group 5-Dimension Self-Report Questionnaire; NIHSS = NIH Stroke Scale.Limb paresis, facial palsy, sensory loss, and dysarthria explained most of the variance in all EQ-5D dimension scores and the utility score ( | PMC10065207 |
Explained Variance of NIHSS Items on the EQ-5D Dimension Scores and on the Utility Score | dysarthria, ataxia, Stroke | FACIAL PALSY, STROKE | EQ-5D = EuroQol Group 5-Dimension Self-Report Questionnaire; NIHSS = NIH Stroke Scale; 1a, level of consciousness (LOC); 1b, LOC questions; 1c, LOC commands; 2, best gaze; 3, visual; 4, facial palsy; 5, motor arm left (a) and right (b); 6, motor leg left (a) and right (b); 7, limb ataxia; 8, sensory; 9, best language; ... | PMC10065207 |
Discussion | anxiety/depression, anxiety, motor deficits, neurologic deficits, paresis, nonmotor deficits, hemianopia, Stroke, ataxia, ischemic stroke, aphasia | HEMIANOPIA, PARESIS, STROKE, ISCHEMIC STROKE | We quantified the association between disabling neurologic deficits measured with the NIHSS and the 5 EQ-5D dimension scores and the EQ-5D utility score in patients who had an ischemic stroke. We hypothesized that language problems and other nonmotor deficits are not captured as well as motor deficits by this system. T... | PMC10065207 |
Acknowledgment | The authors thank the IMS III investigators for their help and for providing access to their data.Editorial, page CME Course: | PMC10065207 | ||
Study Funding | Neurologic Disorders, Stroke | NEUROLOGIC DISORDERS, STROKE | The IMS III trial was funded by the NIH and National Institute of Neurologic Disorders and Stroke, grant numbers: University of Cincinnati (U01NS052220) and Medical University of South Carolina (U01NS054630 and U01NS077304). Genentech supplied the study drug used for intra-arterial tissue-type plasminogen activator tre... | PMC10065207 |
Disclosure | P. | HEART, BRAIN | D. Dippel reports funding from the Dutch Heart Foundation, Brain Foundation Netherlands, The Netherlands Organization for Health Research and Development, Health Holland Top Sector Life Sciences & Health, and unrestricted grants from Penumbra Inc., Stryker, Medtronic, Thrombolytic Science, LLC, and Cerenovus for resear... | PMC10065207 |
Authors | PMC10065207 | |||
Glossary | Strokeinterquartile rangeNIH Stroke | EuroQol Group 5-Dimension Self-Reported QuestionnaireInterventional Management of Strokeinterquartile rangeNIH Stroke Scale | PMC10065207 | |
References | PMC10065207 | |||
Keywords | Performing a sample size calculation for a randomized controlled trial requires specifying an assumed benefit (that is, the mean improvement in outcomes due to the intervention) and a target power. There is a widespread belief that judgments about the minimum important difference should be used when setting the assumed... | PMC9847050 | ||
Background | When calculating the required sample size for a definitive randomized controlled trial, an assumed benefit (that is, the mean improvement in outcomes due to the intervention) must be specified. In broad terms, the main approaches to setting the assumed benefit include (1) select a value for Cohen’s (standardized) effec... | PMC9847050 | ||
What is wrong with using the MID? | The primary motivation for considering the MID when setting the assumed benefit is the notion that this will help to ensure that the trial can determine whether a meaningfully important benefit exists. Chuang-Stein et al. [However, there is a more fundamental problem than choosing the wrong numerical value for the assu... | PMC9847050 | ||
How should the realistic benefit be determined? | As summarized in the DELTAAll of the foregoing concerns are valid, but ultimately, a value for the realistic effect must be chosen. This judgment should be made through thoughtful consideration of the trial context and all available evidence—information should not be discarded simply because it is not “ideal.” For exam... | PMC9847050 | ||
Conclusion | When the trial’s null hypothesis is no treatment benefit, the best way to ensure the true trial power matches the target power is by setting the assumed benefit to a realistic estimate of the true benefit in the sample size calculation. Attempting to adjust that sample size by taking the minimum important difference in... | PMC9847050 | ||
Acknowledgements | The author is grateful to the two anonymous reviewers for constructive comments that substantially improved the content of this article. | PMC9847050 | ||
Author’s contributions | HW is the sole author of this work. The author read and approved the final manuscript. | PMC9847050 | ||
Author’s information | HW is an Associate Professor in the School of Population & Public Health at the University of British Columbia (UBC), the Associate Head of Methodology at the CIHR Canadian HIV Trials Network, and the Biostatistics Program Head at the UBC Centre for Health Evaluation and Outcome Sciences. | PMC9847050 | ||
Funding | None | PMC9847050 | ||
Availability of data and materials | Not applicable | PMC9847050 | ||
Declarations | PMC9847050 | |||
Ethics approval and consent to participate | Not applicable. | PMC9847050 | ||
Consent for publication | Not applicable. | PMC9847050 | ||
Competing interests | The author declares that he has no competing interests. | PMC9847050 | ||
References | PMC9847050 | |||
2. Materials and Methods | PMC10144512 | |||
2.1. Study Design | This experimental study was performed in the College of Dentistry, Prince Sattam bin Abdulaziz University (PSAU), Al Kharj, and the College of Dentistry, King Saud Bin Abdulaziz University (KSAU), Riyadh, after obtaining ethical approval from the Institutional Review Board, PSAU, IRB No (PSAU2021011), and the College o... | PMC10144512 | ||
2.2. Sample Collection | fractures, orthodontic | Non-carious maxillary premolars with all cusps and walls intact, freshly extracted for orthodontic reasons, were collected from the specialist clinic, PSAU. These teeth were inspected using a stereomicroscope (RX-100, Hirox, Tokyo, Japan) at 16× magnification for the presence of any deformities, craze lines or indicati... | PMC10144512 | |
2.3. Description of the Experimental Groups | Selected teeth were divided into four groups, A–D, comprising of ten teeth each, allotted in a random order. All the teeth received full-contour crowns using CAD-CAM technology; however, groups would be differentiated based on the depth of DME from crown margins ( | PMC10144512 | ||
2.4. Tooth Preparation | dentine, tooth | CAVITY, GROUP B | Orthodontic resin (Ortho-Resin, DeguDent GmbH, Hanau, Germany) was used to cover the roots of the teeth up to 5 mm below the CEJ. The preparation of samples was performed by one investigator to maintain uniformity. The proximal box preparations (mesial or/and distal) were conducted using a using a high-speed contra-ang... | PMC10144512 |
2.5. Fabrication of Crowns | HT | HEAT | All samples were digitally scanned using the Cercon eye scanner (DeguDent GmbH, Hanau, Germany) and designed by the software of Cercon art 3.2 (DeguDent GmbH, Germany) to receive Cercon HT full-contoured crowns. The milling process was accomplished with a Cercon Xpert machine (DeguDent GmbH, Germany) after selecting a ... | PMC10144512 |
2.6. Cementation | The cementation of the crowns was conducted using an A2 shade, dual-cure, self-adhesive resin cement, RelyX U200 (3M, St. Paul, MN, USA), under a constant load of 20 N. The load was applied using a surveyor assembly machine to ensure equal pressure over the crowns, which were then light-cured for 20 secs per surface af... | PMC10144512 | ||
2.7. Aging | The aging of the samples to stimulate clinical conditions was conducted in a thermocycling machine (SD Mechnotronik THE 1100, Feldkirchen-Westerham, Germany). The samples were placed in a 10 × 10 open specimen basket and subjected to 5000 cycles in a water bath at (5 to 55 °C) for 30 s/cycle and a 5 s transfer time. | PMC10144512 | ||
2.8. Fracture Test | fracture, tooth | Samples were subjected to a fracture test using the MTS 810 Universal Testing Machine (Eden Prairie, MN, USA). After mounting the samples on a metal base at a vertical angle, a stainless-steel flat-load cell was used, making sure that it contacted both the cusps before the force was applied in a vertical direction alon... | PMC10144512 | |
2.9. Statistical Analysis | ANOVA was used for the statistical analysis of the data. The comparative evaluation of the means was performed using the Tukey HSD post hoc test. A calculated | PMC10144512 | ||
4. Discussion | fracture, fractures, caries, tooth | CARIES | Modern restorative dentistry aims to preserve healthy dentition and replace missing tooth structures conservatively [Additionally, complete caries removal can also lead to the establishment of deep subgingival margins, which are often difficult to restore [Studies on the effect of DME on the periodontium indicate that ... | PMC10144512 |
5. Conclusions | fracture, tooth | The loss of tooth structure, especially the marginal ridges, adversely affects the strength of teeth, even if supported by high-strength full-contour Zi crowns. The DME technique is suitable for use when deep margins are encountered, and the length of the DME-to-crown margins does not significantly impact its fracture ... | PMC10144512 | |
Author Contributions | Conceptualization, A.R., A.A. (Abdullah Alqahtani), A.A. (Abdulrhman Alanazi) and A.M.; methodology, A.M., A.R., A.A. (Abdullah Alqahtani), A.M. and K.A.; software, A.M.; validation, A.R., K.A. and A.M.; formal analysis, R.A., A.S. and A.A. (Anas Aljarad); investigation, A.S. and M.A.; resources, A.A. (Abdullah Alqahta... | PMC10144512 | ||
Institutional Review Board Statement | This research was conducted in accordance with the Declaration of Helsinki and approved by the Institutional review board, PSAU, IRB No (PSAU2021011)) dated November 2021 and KSAU, CDRC No (FR0626). | PMC10144512 | ||
Informed Consent Statement | Not applicable. | PMC10144512 | ||
Data Availability Statement | Available on request. | PMC10144512 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10144512 | ||
Abbreviations | Fracture | CEJ, Cemento-enamel junction; DME, Deep marginal elevation; FEA, Finite-element analysis; FR, Fracture resistance; IR, Indirect restorations; LED, Light-emitting diode; MOD, Mesio-occluso-distal; MPa, Megapascals; MZi, Monolith Zirconia; N, Newtons; SCL, Surgical crown lengthening; SDR, Smart dentin replacement; STA, S... | PMC10144512 | |
Background | cancer, depression, adult cancer, anxiety | CANCER | Organisational readiness is recognised as a key factor impacting the successful translation of research findings into practice. Within psycho-oncology, measuring organisational readiness and understanding factors impacting organisational readiness is crucial as it is often challenging to implement evidence-based findin... | PMC10426102 |
Methods | cancer | CANCER | Multidisciplinary staff across 12 Australian cancer services were identified. Their perceptions of their services’ readiness to implement the ADAPT CP in the cancer stream or treatment modality selected within their service was assessed prior to implementation using the Organizational Readiness for Implementing Change ... | PMC10426102 |
Results | REGRESSION | Fourteen staff- and service-level factors were identified as potentially impacting organisational readiness. To identify factors that best explained organisational readiness, separate univariate analyses were conducted for each factor, followed by a backward elimination regression. Compared to services that implemented... | PMC10426102 | |
Conclusions | depression, anxiety | Readiness to implement an anxiety and depression clinical pathway within 12 oncology services was high. This may be attributed to the extensive engagement with services prior to implementation. The factors associated with organisational readiness highlight the importance of ensuring adequate resourcing and supporting s... | PMC10426102 | |
Trial registration | The ADAPT RCT was registered prospectively with the ANZCTR on 22/03/2017. Trial ID ACTRN12617000411347.
| PMC10426102 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12913-023-09829-2. | PMC10426102 | ||
Keywords | PMC10426102 | |||
Introduction | depression, adult cancer, cancer, anxiety | CANCER | Many effective evidence-based innovations (e.g., interventions, guidelines, clinical pathways) have been developed, yet, translating evidence into practice is often slow; it takes on average 17 years for evidence-based interventions to become part of routine health care [One such facilitator, recognised as a key factor... | PMC10426102 |
Method | PMC10426102 | |||
Study design and setting | cancer | CANCER | The ADAPT cluster randomised controlled trial (RCT) was implemented in 12 cancer services across New South Wales (NSW), Australia over a 12-month period. Sites were recruited between November 2017 and December 2020. The primary aim of the cluster RCT was to evaluate two implementation strategies (core versus enhanced) ... | PMC10426102 |
Participating services and staff | cancer, tumour | CANCER, TUMOUR | Eligible services were those that provide cancer care to at least 100 patients per year in New South Wales (NSW), Australia, and operate in a public and/or private healthcare system. Participating sites could be whole services or selected departments within those services (e.g., tumour streams or treatment modalities).... | PMC10426102 |
Study procedure | BREAST CANCER | In each service prior to implementation, one or more champion(s) was identified, and a multidisciplinary lead team was appointed, who engaged with the research team during 6–8 engagement meetings to tailor the ADAPT CP according to service resources, preferences, and existing workflows. Services also decided which trea... | PMC10426102 | |
Measures | PMC10426102 | |||
Staff readiness, attitudes and characteristics | depression, anxiety | The Organizational Readiness for Implementing Change (ORIC) scale [Perceptions of the ADAPT CP were captured using a set of 13 study-specific items assessing the: perceived need for and importance of an anxiety and depression clinical pathway (CP) for patients and for the organisation, credibility of the evidence-based... | PMC10426102 | |
Site characteristics and workflows | Champions at each service completed a site profile audit to capture information about characteristics of the service. Information collected of relevance to the current study included site location (inner regional, major city), service type (public, private or mixed), hospital size as determined by the number of new pat... | PMC10426102 | ||
Data analysis | REGRESSION | Descriptive statistics in the form of means, frequencies, and proportions were used to summarise service and staff characteristics, and the ORIC and additional study-specific survey item responses.To determine how the ORIC items would be grouped and used in the analyses, the latent structure of the ORIC was assessed in... | PMC10426102 | |
Results | PMC10426102 | |||
Survey responses | There were 139 staff surveys returned at T0, with response rates across sites ranging from 13–40% (median = 27%). These response rates reflect high staff turnover, staff being on leave, and clinical workload. Of the returned surveys, 33 were excluded due to: missing ORIC items ( | PMC10426102 | ||
Survey scales | PMC10426102 | |||
ORIC | An exploratory factor analysis was conducted using the T0 ORIC results. A single factor was identified (eigenvalue = 7.96). As we were unable to replicate the two-factor structure of the ORIC as in Shea et al. [Mean ORIC ratings and the standard deviation for each item, averaged across services | PMC10426102 | ||
Additional study-specific items | An exploratory factor analysis was conducted on the 13 study-specific additional items to assess their latent structure (see: [For the two factors identified, namely, | PMC10426102 | ||
Identifying significant predictors of organisational readiness | PMC10426102 | |||
Discussion | anxiety/depression CP, depression, cancer, anxiety | CANCER, POSITIVE | This study examined staff perceptions of their service’s level of readiness to implement the ADAPT CP, and identified factors associated with organisational readiness. As measured by the ORIC scale, readiness to implement change was relatively high, which may be attributed to the extensive engagement with services prio... | PMC10426102 |
Authors’ contributions | All the authors made substantial contributions to the manuscript. The study concept and design were developed by Joanne Shaw, Phyllis Butow, Heather Shepherd, and Mona Faris. Data extraction and preparation was performed by Mona Faris. Statistical analyses were performed by Mona Faris, Patrick Kelly, and Joanne Shaw. T... | PMC10426102 | ||
Funding | Cancer | CANCER | This program of research is funded by a Cancer Institute NSW Translational Program Grant: 14/TPG/1–02, awarded to Phyllis Butow. The funding body had no role in the design of this study and will have no role in its enactment. | PMC10426102 |
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10426102 | ||
Declarations | PMC10426102 | |||
Ethics approval and consent to participate | Ethics approval was obtained for the study from the Sydney Local Health District Human Research Ethics Committee, Protocol X16-0378HREC/16/RPAH/522. All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all participants. | PMC10426102 | ||
Consent for publication | Not applicable. | PMC10426102 | ||
Competing interests | The authors declare they have no competing interests. | PMC10426102 | ||
References | PMC10426102 | |||
Introduction | CNR | NECK DISORDER | Edited by: Mario Fargnoli, Mercatorum University, ItalyReviewed by: Charls Erik Halder, Global Health Specialist, BangladeshLucia Vigoroso, National Research Council (CNR), ItalyRecently developed prismatic loupes may mitigate the high physical workload and risk of neck disorders associated with traditional surgical lo... | PMC10803506 |
Materials and methods | HT | SECONDARY | Nineteen out of twenty recruited surgeons performed three tasks in a fixed-order with their own loupes and both low-tilt (LT) and high-tilt (HT) prismatic loupes, in a randomized order. The primary outcomes were the median inclination angles and velocities of the head, trunk, and upper arms, along with the median muscl... | PMC10803506 |
Results | lower head inclinations, HT | Using prismatic loupes, either LT or HT, compared with the surgeons’ own loupes yielded lower head inclinations (all | PMC10803506 | |
Discussion | The results indicate that prismatic loupes can reduce physical workload in the neck during simulated surgical task, with no significant difference in surgical errors. Future studies are needed to investigate the long-term effects of prismatic loupes among surgeons. | PMC10803506 | ||
Introduction | head flexion, angulation, head and neck flexion reduction, low angulation, Work-related musculoskeletal disorders, WMSDs | BENDING | Work-related musculoskeletal disorders (WMSDs) are prevalent among surgeons, irrespective of their surgical modalities and specialties (As demonstrated in a previous study, among other factors such as high neck bending angles and precision work requirements, the weight of surgical loupes adds to the torque that impacts... | PMC10803506 |
Materials and methods | PMC10803506 | |||
Participants | stature | Twenty surgeons with at least 2 years of experience in endocrine, head and neck, or vascular surgeries were recruited from a Swedish academic hospital; the effective sample size was 19 due to dropouts. The selection of surgical specialties was based on the similarity in surgical postures and the use of loupes. Due to t... | PMC10803506 | |
Surgical loupes | angulation, HT | Three types of loupes were used in this study: the surgeons’ own traditional nonprismatic loupes (own) with a typical magnification power of 2.5, low-tilt (LT) prismatic loupes (Optergo AB, Mölnlycke, Sweden) with a 15° angulation of the optical axis in the prism and magnification power of 3.0, and high-tilt (HT) prism... | PMC10803506 | |
Study design and settings | This randomized, controlled crossover study was conducted at a clinical training center with an individually adjusted surgical light and table height; surgeons adjusted the light and height according to their habits and likings. The participants performed three representative simulated surgical tasks, peg transfer (PT)... | PMC10803506 | ||
Primary outcome measures | bipolar | The primary outcome measures were the physical workload of the surgeons, including postures and angular velocities of the head, trunk, and upper arms, and the muscular activity of the cervical erector spinae (CES), upper trapezius (UT), and lumbar erector spinae (LES).Postural data of the head, trunk, and upper arms we... | PMC10803506 | |
Secondary outcome measures | nausea, headache | DOUBLE VISION | The perceived visual quality, body-part discomfort, and subjective evaluation of the user experience was evaluated by a survey after the trial of each loupe and at the end of the whole experiment.The perceived visual quality was measured by a survey that contains indirect and direct comparison after the use of each pai... | PMC10803506 |
Data processing and statistical analysis | HT | The postures and muscle activities were summarized as the 10th, 50th, and 90th percentiles of all data within each task, with each pair of loupes for each participant. For the angular velocities, only the 50th percentile was used (Equal ranks in the final survey were normalized so that the sum of all ranks remained at ... | PMC10803506 |
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