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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 AstraZeneca. L.V. is a current employee of Moderna. S.B.H. is a current employee of the Enigma Biomedical Group. The remaining authors declare no competing interests. | 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 utility values for health states reported by patients, derived from assessments by the general public. We hypothesized that language problems and other nonmotor deficits are not captured as well as motor deficits by this system. We aimed to quantify the association between disabling neurologic deficits and the EQ-5D dimension scores and the utility score in patients with ischemic stroke. | 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 logistic regression and Tobit regression, respectively. The explained variance of each model was estimated with Nagelkerke pseudo-R | 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 the variance in all EQ-5D dimension scores and the utility score. In the utility score, 8.9% of the variance was explained by neglect, 10.0% by aphasia, 10.8% by hemianopia, and 17.5%–24.1% by limb paresis. | 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-)effectiveness of treatments and interventions. | 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 endovascular treatment plus intravenous thrombolysis compared with that of intravenous thrombolysis alone. | 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 treatment of the patient and who were blinded to treatment assignment. Information was obtained from the patient, if possible, and a proxy. For this study, we used the EQ-5D dimension scores as indicated by the patient. If not available, we used the EQ-5D dimension scores as indicated by their proxy. For some patients, EQ-5D dimension scores for both an in-person and telephone assessment were available. In those cases, the scores from the in-person assessment were used. | 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 regression. For the EQ-5D utility score, censoring from above takes place, which means cases with a value at or above some threshold (i.e., utility of 1), all take on the value of that threshold, so that true value might be equal to the threshold, but it might also be higher.Missing data were imputed by multiple imputation by chained equations based on relevant covariates including outcomes. | 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 score (eFigure 1, | 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; 10, dysarthria; and 11, extinction and inattention.In the sensitivity analysis, 441 EQ-5D assessments were completed by patients and 386 EQ-5D assessments were completed by proxies (eFigure 2, | 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. This study showed that the explained variance of neurologic deficits was lower on the dimensions pain/discomfort and anxiety/depression than on the other EQ-5D dimension scores and the utility score. Motor deficits caused by limb paresis explained more of the variance on the EQ-5D dimension scores and the utility score than other nonmotor deficits such as hemianopia, aphasia, and neglect.Our results are in line with previous research showing that the EQ-5D dimensions mobility, self-care, and usual activities were more strongly correlated with the modified Rankin scale and Barthel index than the EQ-5D dimensions pain/discomfort and anxiety/depression in patients with ischemic stroke.We used the NIHSS to quantify the association between neurologic deficits and the EQ-5D dimension scores and the utility score. Although the NIHSS and the EQ-5D are instruments with different purposes, one can imagine that disabling neurologic deficits should be reflected in the EQ-5D to a certain extent. We expected that the dimensions pain/discomfort and anxiety/depression would be influenced by aphasia because we assumed aphasia may limit participation, might cause anxiety, and might cause cognitive and emotional discomfort.Quality of life can be measured with generic measures or disease-specific measures, such as the Stroke-Specific Quality of Life, Stroke Impact Scale or STATIS-Stroke for ischemic stroke.This study has some limitations. The study population consisted mainly of patients with anterior circulation ischemic stroke. Therefore, only a few patients had ataxia, and we cannot draw any conclusions about the association between ataxia and the EQ-5D. We expect that ataxia does substantially influence the EQ-5D, especially on the dimensions mobility, self-care, and usual-activities, but this should be confirmed in future research. In our study, patients with missing values on the NIHSS and/or EQ-5D at 90 days had worse outcomes compared with patients without missing values. It is worrisome that missing values on the NIHSS and/or EQ-5D might be associated with outcomes. However, because we used multiple imputation based on relevant covariates including outcomes, which provides less biased estimates compared with excluding those patients, we expect that those missing values did not influence our results.To conclude, 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-)effectiveness of treatments and interventions. | 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 treatment in the endovascular group. EKOS, Concentric Medical, and Cordis supplied study catheters during protocol versions 1–3. In the United States, IMS III trial investigator meeting support was provided in part by Genentech, EKOS, and Concentric Medical. In Europe, IMS III trial investigator meeting support was provided in part by Boehringer Ingelheim. | 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 research, all paid to institution. P. Khatri reports grant funding from the NIH and Cerenovus and consulting fees from Lumosa, Bayer, Diamedica, and Basking Biosciences. The other authors report no relevant disclosures. Go to | 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 benefit and thus the sample size. This belief is misguided — when the purpose of the trial is to test the null hypothesis of no treatment benefit, the only role that the minimum important difference should be given is in determining whether the sample size should be zero, that is, whether the trial should be conducted at all.The true power of the trial depends on the true benefit, so the calculated sample size will result in a true power close to the target power used in the calculation only if the assumed benefit is close to the true benefit. Hence, the assumed benefit should be set to a value that is considered a realistic estimate of the true benefit. If a trial designed using a realistic value for the assumed benefit is unlikely to demonstrate that a meaningful benefit exists, the trial should not be conducted. Any attempt to reconcile discrepancies between the realistic estimate of benefit and the minimum important difference when setting the assumed benefit merely conflates a valid sample size calculation with one based on faulty inputs and leads to a true power that fails to match the target power.When calculating sample size, trial designers should focus efforts on determining reasonable estimates of the true benefit, not on what magnitude of benefit is judged important. | 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) effect size, (2) use an estimate obtained from previous studies (possibly pilot studies), (3) elicit a value from experts, (4) use a value that is considered a realistic benefit, and (5) use a value that represents the minimum important difference (MID). What constitutes a MID often is not well-defined, but criteria typically are anchored to the notions of the smallest benefit that would be of interest to stakeholders or the benefit that would need to be observed to justify a change in practice. The minimum clinically important difference (MCID) (or simply clinically important difference (CID), when the connection with a minimum value is implied) often is used synonymously with the MID. This commentary does not summarize the extensive literature discussing the advantages and shortcomings of the various approaches, but instead focuses on the (mis-)use of the MID and the central role of the realistic benefit. Unless noted otherwise, it is assumed throughout that the null hypothesis being tested is that the true benefit is zero.The DELTA | 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 assumed benefit based on the MID. Although the primary aim of the sample size calculation is to ensure that the trial will generate sufficient information, a fundamental requirement is that the calculation must be For example, suppose we set the sample size based on an assumed benefit to 4 units, reflecting our best estimate for the true benefit. If indeed, the true benefit is near 4 units, then the true power of the trial will match the target power. Now suppose that a 1-unit benefit is considered important. We should be satisfied that our trial likely will yield reasonably strong evidence that the intervention provides an important benefit and proceed using this sample size. We should not change the assumed effect to 1 unit; that would increase the sample size by a factor of 16 and result in an overpowered (and potentially a too-large-to-be-feasible) trial. Conversely, suppose that the minimum important benefit is 8 units. We should acknowledge that the trial is highly unlikely to show that the intervention produces a meaningful benefit and simply abandon the trial. We should not change the assumed effect size to 8 units; this would decrease the calculated sample size by a factor of 4 and result in an underpowered trial that even more surely will not show a meaningful benefit. Any attempt to reconcile discrepancies in judgments between what is important and what is realistic (e.g., by taking the minimum or an in-between value) to obtain a value for the assumed benefit conflates the goal of ensuring sufficient information with the requirement that the calculation be valid and leads to a sample size that addresses neither. This argument does not imply that only one value for the realistic benefit should be considered, given the uncertainty about the true benefit, but judgments about what is an important benefit should not be used to inform judgments about what is a realistic benefit. | 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 example, the risks of adopting a treatment effect estimate from a pilot study because it has large uncertainty notwithstanding, it would be counterproductive to ignore this information altogether. Because different sources, types, and amounts of information may need to be considered, each with uncertain levels of relevance, developing a universally applicable synthesis process may not be practical. However, identifying such a process is not as important as ensuring that whatever process is undertaken, it considers the task thoroughly and is reported transparently (as advocated in the DELTAIt is not reasonable to expect that trial designers are able to choose with confidence a single value for the assumed benefit, so a range of values should be considered. But again, for the results to be meaningful, this range must reflect realistic values, not what values are considered important. When insufficient evidence is available to judge what would be a realistic assumed benefit, an adaptive trial design incorporating sample size re-estimation would be appropriate, rather than attempting to fix a sample size based on an assumed benefit which may be far from the truth. | 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 into consideration merely leads to an invalid sample size calculation. The minimum important difference should play no role in setting the sample size; however, to provide support for conducting the trial, trialists should report on the minimum important difference and provide the rationale for why the realistic benefit is expected to be (substantially) greater than the minimum important difference. | 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 of Dentistry Research Center, KSAU, CDRC No (FR0626). | 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 indications of fractures, which if found were excluded. Forty teeth which met the inclusion criteria were disinfected with 5.25% sodium hypochlorite for 30 min and stored in normal saline at room temperature until further use. | 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-angle handpiece Ti-Max Z900L (NSK, Nakanishi Inc., Tochigi, Japan) at a speed range of 320,000–400,000 rpm with a round-end tapered diamond (Bur # TR-14, ISO 198/022, Mani Inc., Tokyo, Japan), which was replaced by a new one for each tooth. The final tooth preparations had the following dimensions: 3 mm wide isthmus; 2 mm wide box at the gingival third and 4 mm occlusal width. The apical depth of the boxes in Group B was prepared 2 mm above the level of CEJ, and for Groups C and D, it was prepared 2 mm and 4 mm below the CEJ, respectively. For etching the dentin, 37% phosphoric acid gel (Prime-Dent, Chicago, IL, USA) was used for 15 s and rinsed with water. The excess water was then carefully removed by a brief burst of air, leaving the dentine and enamel surface slightly moist with a shiny surface. A fully saturated brush was used to apply the bonding agent (Bonding resin, Prime-Dent, Chicago, IL, USA) on the etched surface in two consecutive coats; it was air dried for 10 s and light-cured using an LED curing light (Smart lite max, Dentsply Caulk, Milford, DE, USA) for another 10 s on both the occlusal and proximal surfaces. The rest of the cavity in all samples was filled incrementally using a microhybrid composite, Filtek Z250 (3M ESPE, St. Paul, MN, USA), followed by light curing for 20 s.Based on current principles of tooth preparation, for all-ceramic zirconia crowns, the occlusal surfaces were reduced by 2.0 mm, with a function-cusp bevel. A circumferential reduction by 1.0 mm was conducted, with the margins terminating at the CEJ. The final preparation had an axial wall taper of 6 to 8 degrees. The preparations were carried out using a flat-end long tapered diamond (Bur # TF-14, ISO 172/023, Mani Inc., Japan) with a highspeed contra-angle handpiece Ti-Max Z900L (NSK, Nakanishi Inc., Tochigi, Japan). | 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 zirconia bur and a Cercon disc (DeguDent GmbH, Germany) containing 94.5% pure zirconium. To attain full strength, sintering was accomplished in the dental lab in a Cercon heat plus P8 machine (Dentsply Sirona, NC, USA) set at 8 h and 30 min by a dental technician with a sintering device Cercon Heat (DeguDent GmbH, Germany). The visually unacceptable teeth and those with margin damages were rejected, and another coping was made as needed. The intaglio surface of the Zi crowns were pretreated, mechanically, through air blasting with alumina oxide and cleaned with an alkaline agent, Ivoclean (ivoclar vivadent, Schaan, Liechtenstein), before cementation. | 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 after cleaning the excess cement beyond the margins. | 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 along the long axis of the tooth ( | 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 it is well tolerated, both clinically and histologically [In the present study, a traditional hybrid composite was used for the DME, as it is known to reduce marginal gap formation. The use of other materials such as glass ionomers, resin-modified glass ionomers and smart dentin replacement (SDR) bulk-fill composites for DME have also provided acceptable results with regards to FR, marginal adaptation and microleakage [The comparison of IRs such as onlays, overlays/partial crowns and full crowns have been extensively studied in the literature, with the majority of these studies reporting them to have clinical efficacy in excess of 93% [The FR of posterior teeth was determined previously to be in the range of 1120–2500 N [Research on the effects of DME on FR among indirect CAD/CAM restorations have generally focused on teeth with inlays, onlays, overlays and endocrowns. Most of these studies reported that the use of DME did not significantly impact the FR of teeth [The type and site of fracture was visually evaluated. Failure type was classified based on the adaptation and modification from previous studies, as “restorable” for those with visible cracks and fracture lines on the zirconia crowns and “unrestorable” for those in which the fractures were seen below the CEJ [Under the limitations of this study, DME under normal depths (2 mm) rarely influenced the FR of teeth, except when the tooth structure was severely compromised, as in Group D. However, the load required to fracture the crowned teeth decreased as the extension of DME apical to the CEJ increased, thus rejecting the null hypothesis. Most of the samples failed unfavorably under maximum load. Nevertheless, more importantly, from a clinical point of view, the load required to fracture these samples far exceeded the maximum recorded biting force in posterior teeth, which is in the range of 800–1000 N [In spite of the perceived advantages in this study, it has some limitations; a. The ease in performing the DME, especially where the distance to the crown margins is greater than 2 mm, might not be established in clinical settings without STA violations. b. Natural teeth variances in strength and morphology when compared to the dyes used in some of the other studies could have an influence on the results. c. The fracture of the teeth/MZi crown assembly was evaluated visually in this study; a more detailed fractographic evaluation would have provided precise details regarding the initiation and causes of cracks. The future trends in research will change the ever-evolving material choices for direct restorations and the development of monolith crowns using newer CAD/CAM technologies, which will help establish an ideal restorative choice, esthetically and functionally. | 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 resistance. However, caution should be undertaken in MOD preparations where the distance between the DME and the crown margins reaches 4 mm. Although unfavorable failures were common in this study, the load required to fracture all the samples, regardless of the DME margins, far exceeded the maximum recorded biting force. | 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 Alqahtani); data curation, M.B.M.; writing—original draft preparation, M.B.M.; writing—review and editing, M.B.M., M.A., A.R. and A.A. (Anas Aljarad); visualization, R.A. and A.A. (Abdulrhman Alanazi); supervision, A.R.; project administration, A.S. and A.M. All authors have read and agreed to the published version of the manuscript. | 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, Supracrestal connective tissue attachment; Zi, Zirconia. | 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 findings into routine cancer care. In this quantitative study, we examined the level of organisational readiness of cancer services preparing to implement a clinical pathway for the screening, assessment, and management of anxiety and depression in adult cancer patients (the ADAPT CP) within a cluster randomised controlled trial and sought to identify staff- and service-level factors associated with organisational readiness. | 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 scale. Data collection included staff demographic and professional characteristics, and their perception of the ADAPT CP using a set of 13 study-specific survey items. Service characteristics were captured using a site profile audit form and workflows during site engagement. | 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 the ADAPT CP in one treatment modality, those opting for four treatment modalities had significantly higher organisational readiness scores. Staff in administrative/technical support/non-clinical roles had significantly higher organisational readiness scores compared to psychosocial staff. Higher organisational readiness scores were also significantly related to more positive perceptions of the ADAPT CP. | 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 staff to implement change, effectively communicating the value of the change, and taking a whole-of-service approach to implementing the change. Future longitudinal studies may identify factors associated with ongoing readiness and engagement prior to implementation. | 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 impacting implementation in a number of frameworks, is organisational readiness for change [When organisational readiness is high, individuals within the organisation are more motivated to implement the change, and display greater persistence when faced with challenges [To address this gap, our team recently examined factors associated with organisational readiness for implementing a clinical pathway for the screening, assessment, and management of anxiety and depression in adult cancer patients (the ADAPT CP) [The current study extends on the interim analysis by: 1) examining organisational readiness across all 12 services, and 2) using a quantitative approach to assess a range of factors that may impact organisational readiness. The ORIC allowed us to examine two of the four factors proposed by Holt et al. [What is the level of organisational readiness of the 12 cancer services prior to the implementation of the ADAPT CP, as measured by the ORIC?Which staff- and service-level factors are associated with perceived readiness to implement the ADAPT CP?Previous findings suggest that an adequate number of psychosocial staff, having procedures in place for the provision of psychosocial care (e.g., processes for identifying the psychosocial needs of patients), and being trained in providing psychosocial care are perceived as facilitators to implementing psychosocial programs within oncology services [ | 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) to determine the level of implementation effort required to successfully introduce the ADAPT CP. Participating services were cluster randomised, stratified by service size, to the core versus enhanced implementation strategy which was utilised by the research team for 12 months during which services implemented the ADAPT CP as part of routine care. Data for the primary study are reported elsewhere [ | 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). Services were excluded if they were unable to commit to the study process (e.g., endorsing and enabling staff to participate in training for the ADAPT CP, engaging in a 3-month tailoring period prior to implementation), or did not have Wi-Fi/broadband/internet to support the use of a web-based portal that had been created to support implementation (ADAPT Portal).Study participants were staff at the 12 cancer services who were employed on an ongoing (≥ 6 months) basis. Staff in roles that provide clinical, administrative, or technical/managerial support to the cancer service were identified through an organisational chart mapping exercise during site engagement and were invited to participate in this study and give informed consent. Participants included staff who would or would not be directly involved in the application of the ADAPT CP, to gauge a range of perceptions from a broader organisational perspective. | 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 treatment modality (e.g., medical oncology department, surgical oncology department) or streams (e.g., breast cancer, haematology) to implement the ADAPT CP. Staff were then provided with training to familiarise them with the ADAPT CP and the ADAPT Portal.An email containing a link to a REDCap [ | 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 ADAPT CP and the research team, perceived workload/burden of implementing the ADAPT CP, as well as perceived support from leaders and the availability of resources required to implement the ADAPT CP. Level of agreement with each statement was indicated using a 5-point Likert scale ranging from strongly agree to strongly disagree. Based on a factor analysis conducted on these items [Individual demographic and professional characteristics were also elicited. Information collected included age, gender, role, employment status, and years in current employment. | 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 patients over a 12-month period (< 100, ≥ 100), history of psychosocial screening (yes, no), and clinical load of psychosocial staff (number of new patients per 1.0 full-time equivalent of psychosocial staff). Decisions pertaining to the number of streams (1, 2, ≥ 3) and treatment modalities (1–4; medical, radiation, surgical, or haematological oncology) in which to implement the ADAPT trial were captured in the workflows during the site engagement meetings with team leaders (for more detail, see: [The study was approved by the Sydney Local Health District Human Research Ethics Committee, Protocol X16-0378 HREC/16/RPAH/522. | 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 an exploratory factor analysis. Factors were extracted if they had an eigenvalue > 1 and item loadings were identified using a varimax rotation (with Kaiser normalisation). For ease of interpretability of the rotated factor loadings, an item was considered to load onto a factor if it loaded at least 0.40, and was less than 0.40 for the other factors [Based on the literature and an understanding of the services implementing the ADAPT CP, a number of staff- and service-level factors were identified as having potential to influence staff perceptions of their service’s readiness to implement the ADAPT CP. The staff-level factors identified were: age, gender, role, employment status, length of time in current role, and each survey respondents’ For regression analyses, a minimum of 10 participants per predictor is required to produce reliable results [With the aim of developing a model with predictors that provide the best explanation for the outcome variable, a backward elimination regression was conducted. The initial, full model contained all significant predictors from the univariate regression analyses with variables eliminated from the model, starting with the predictor having the highest non-significant p-value (i.e., The assumptions of multiple regression were also checked. The REDCap survey data was extracted using Microsoft Excel. All analyses were performed using Stata, version 17.0. | 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 prior to implementation to recruit champions, tailoring of the clinical pathway (e.g., identify existing referral pathways, integrate the clinical pathway into workflows), staff training, and awareness raising activities. Alternatively, there may have been sample bias, with services readier to implement the ADAPT CP more likely to agree to participate in the study. While perceived readiness was relatively high, there remains an opportunity to further increase readiness and identify the generalisable learnings about what influences readiness for use in other contexts.Holt et al. [We hypothesised that factors relating to psychosocial staff or the psychosocial care of patients would be associated with organisational readiness. Our hypothesis was only partly supported because, aside from staff role (which included staff in psychosocial roles) emerging as a significant predictor of organisational readiness, history of psychosocial screening, and clinical load of psychosocial staff were not significant predictors.Staff in administrative, technical support and non-clinical roles had significantly higher organisational readiness scores compared to psychosocial staff. As the focus of the ADAPT CP was on the identification and management of distress and anxiety and depression in patients, this finding was surprising given the experience of psychosocial staff in providing psychological care. However, psychosocial staff may have felt more responsible for, and burdened by, the ADAPT CP than other staff, and thus less ready for this change. While the aim was for the ADAPT CP to be a multidisciplinary, whole-of-service initiative, with staff across various roles playing an important part in enacting the ADAPT CP within their service, across most services, more roles were allocated to psychosocial staff by lead team members [Positive attitudes toward the acceptability and appropriateness of the ADAPT CP were also associated with higher levels of perceived organisational readiness. Indeed, Weiner [Organisational readiness scores were significantly higher for services which implemented the ADAPT CP in four treatment modalities versus one. This suggests that staff who were confident in their service’s ability to implement the ADAPT CP were also confident to apply it in more than one treatment modality. As noted in a previous qualitative study which examined the rationale for what and why decisions were made to tailor the ADAPT CP across the 12 cancer services [There are some potential limitations of the present study. The first is related to the survey response rates. In this study, few staff completed the surveys relative to the number of surveys sent. We cannot rule out the possibility that those who completed the survey may have been more engaged with the ADAPT program and held more positive views of the ADAPT CP, potentially introducing some level of bias. Thus, the high perceived benefit scores reported may not be representative of all staffs’ views. Additionally, as part of the larger program of work, the ORIC scale was also administered at the midpoint and endpoint of the implementation period (Additional file Second, we were able to examine only 2 out of the 4 types of factors proposed by Holt and colleagues as being influential to organisational readiness (staff and service-level factors) [This study did, however, have several strengths, including the size and complexity of the trial, its focus on organisational readiness both from a quantitative perspective here, and a qualitative perspective in our earlier paper [In conclusion, this study identified a high level of readiness for implementing an anxiety/depression CP in routine cancer care, in 12 cancer services. Factors associated with organisational readiness for change suggested the importance of adequately resourcing and supporting staff to implement change, effectively communicating the value of the change, and taking a whole-of-service approach to change. However, a potential sample bias may exist, therefore caution is needed in interpretating the results and assuming generalisability of the results. Future studies of complex multi-component interventions trials that test implementation strategies are needed to identify additional factors that may be associated with readiness and engagement with change processes. | 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. The first draft of the manuscript was written by Mona Faris. The manuscript was edited by all authors. All authors have reviewed and approved the final manuscript submitted for publication. | 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 loupes among surgeons. However, research in this area, particularly among surgeons, is sparse. This study examines the impact of prismatic loupes on surgeons’ physical workload, musculoskeletal discomfort, and performance during simulated surgical tasks. | 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 muscle activity of the cervical erector spinae (CES), upper trapezius (UT), and lumbar erector spinae (LES) for each pair of loupes. The secondary outcomes included performance (completion time and errors), perceived body-part discomfort, and subjective evaluation of the three pairs of loupes. | 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 in the forward-bending neck and conjointly amplifies the cervical loading (Dentists and dental hygienists work with bending neck and trunk with hands working in a constrained site (The studies on prismatic loupes of low angulation (4.6°) reported significant head and neck flexion reduction among the intervention group in the short-term experiment (The prismatic loupes with a high angulation (90°), were reported to decrease the head tilt by 20°, which was an equivalent 0° head flexion, border-line the limit of the action level range; this may lead to over-correction or even backward extension of the head (Overall, it is worthwhile to study the effects of prismatic loupes with varying angulations on physical workload, discomfort, and workability.Despite of the recent development of commercially available prismatic loupes for surgeons [e.g., (Lastly, it has been reported that the usage of surgical loupe is associated with increased neck/shoulder muscle activation (Hence, further studies are needed to investigate the feasibility of using prismatic loupes to reduce surgeons’ physical workload and to evaluate the effects of different angulations of the loupes. This study aimed to compare two types of new prismatic loupes with traditional loupes, regarding surgeons’ physical workload, perceived physical discomfort, surgical performance and subjective evaluation in simulated surgical tasks. | 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 the limited availability of eligible participants, the sample size was determined to the fullest extent that the circumstances allowed. Information regarding age, sex, stature, weight, and surgical experience was collected. Each participant was examined by an optician. After the experiment, each participant was provided with one pair of prismatic loupes of their choice, which they can continue using in their daily work. The study was approved by the Regional Ethics Review Board in Stockholm (Dnr: 2020–02161, extended from Dnr: 2014/1120–31). The trial was registered under the number ISRCTN34385943 in the ISRCTN registry. All participants gave their informed consent to participate in the study. | 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) prismatic loupes (HOYA Technosurgical, Tokyo, Japan) with an angulation of 48° in the prism and magnification power of 2.5. The LT loupes were custom-made and custom-adjusted for each participant, and the frame provided a fixed forward inclination of 20°. In comparison, the HT loupes were ready-made (not custom-made) with an adjustable inclination angle of the frame up to 30° and were adjusted to fit each participant’s needs before the laboratory trial. | 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), basic suture (BS), and precision cutting (PC) which were depicted in details in the | 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 were recorded by four inertial measurement units (IMUs) (AX6, Axivity Ltd., Newcastle, UK) at 25 Hz in the same positions as a previous study (The muscle activities were recorded bilaterally by surface electromyography (EMG) using bipolar electrodes with a gel (Ag/AgCl electrodes, N-00-S/25, Ambu A/S, Copenhagen, Denmark) and a logger (Mobi8, from TMSi, Oldenzaal, The Netherlands) with a sampling rate of 1,024 Hz per channel and a 24-bit AD-convertor. The electrodes for the CES were placed bilaterally, with one at the C2–C3 level on the upper part of the trapezius and the other 3 cm caudally (Positions of EMG electrodes on the cervical erector spinae, upper trapezius, and lumbar erector spinae.To obtain muscle activity, the EMG data were first computed as root mean square (RMS) values of every 1/8 s epoch after a digital bandpass filter (30–400 Hz) ( | 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 pair of loupes. For the indirect comparison, a 5-point Likert-type scale (from –2, very bad, to +2, very good) was employed to measure the overall visual function, image brightness, spatial orientation, and image depth, and a 4-point scale (from –3, severe, to 0, nothing) was used for assessing double vision, headache, and nausea (The perceived discomfort was assessed by Borg’s CR-10 scale for the neck, right shoulder, left shoulder, upper back, and lower back (Subjective evaluation of the user experience contained two parts – a single-choice question on the preferred loupes and an open question asking for any comments on the three pairs of loupes were included (see Additionally, surgical performance was assessed by task completion time and counting the number of surgical errors. The errors were rated by two independent surgeon examiners. An error was counted when the participant missed one dot or did not go through one dot in the suture for BS and when the participant cut outside the black line for PC. Errors were not counted in PT. | 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 6, e.g., a rank of [1, 1, 2] would be normalized to [1.5, 1.5, 3]. The number of surgical errors was calculated as the average value of the two examiners.All quantitative measures of each task were compared separately across three types of loupes (own, LT, and HT), and they were matched on the individual level. The normality and sphericity of the dataset of each measure were checked by the Shapiro–Wilk test and Mauchly’s test. Since the normality and the sphericity of most measures did not fulfill the criteria, the Friedman test was used to test the overall significance of the differences in each measure of each task between the three pairs of loupes (own, LT, and HT). | PMC10803506 |
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