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  1. Article: Correction: Validating the Safe and Effective Use of a Neurorehabilitation System (InTandem) to Improve Walking in the Chronic Stroke Population: Usability Study.

    Smayda, Kirsten Elisabeth / Cooper, Sarah Hodsdon / Leyden, Katie / Ulaszek, Jackie / Ferko, Nicole / Dobrin, Annamaria

    JMIR rehabilitation and assistive technologies

    2024  Volume 11, Page(s) e56041

    Abstract: This corrects the article DOI: 10.2196/50438.]. ...

    Abstract [This corrects the article DOI: 10.2196/50438.].
    Language English
    Publishing date 2024-02-21
    Publishing country Canada
    Document type Published Erratum
    ZDB-ID 2798120-4
    ISSN 2369-2529
    ISSN 2369-2529
    DOI 10.2196/56041
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Corneal Outcomes Following Cataract Surgery Using Ophthalmic Viscosurgical Devices Composed of Chondroitin Sulfate-Hyaluronic Acid: A Systematic Review and Meta-Analysis.

    Hsiao, Chia-Wen / Cheng, Hang / Ghafouri, Rana / Ferko, Nicole C / Ayres, Brandon D

    Clinical ophthalmology (Auckland, N.Z.)

    2023  Volume 17, Page(s) 2083–2096

    Abstract: Background: Ophthalmic viscosurgical devices (OVDs) are commonly used during cataract surgery to protect the corneal endothelium. A systematic literature review and meta-analysis were conducted to assess the clinical evidence of OVDs composed of ... ...

    Abstract Background: Ophthalmic viscosurgical devices (OVDs) are commonly used during cataract surgery to protect the corneal endothelium. A systematic literature review and meta-analysis were conducted to assess the clinical evidence of OVDs composed of chondroitin sulfate-hyaluronic acid (CS-HA) versus other OVDs in maintaining endothelial cell density (ECD) and corneal thickness (CT).
    Methods: MEDLINE and EMBASE databases were searched from 2000 to 2020. Randomized controlled trials (RCTs, N ≥ 20 per group) comparing an OVD containing CS-HA (ie, VISCOAT
    Results: A total of 966 abstracts were screened, and data were extracted from 12 RCTs. Meta-analyses using a random-effects model revealed significantly lower percent (%) decrease in ECD for CS-HA OVDs compared to both HA-only (MD: -4.10%; 95% CI: -5.81 to -2.40; p < 0.0001; 9 studies) and HPMC (MD: -6.47%; 95% CI: -10.41 to -2.52; p = 0.001; 2 studies) products. Similarly, % CT increase was significantly lower with CS-HA than with HA-only OVDs (MD: -3.22%; 95% CI: -6.24% to -0.20%; p = 0.04; 4 studies). However, there were no significant differences when comparing % CT change between CS-HA and HPMC OVDs (MD: 2.65%; 95% CI: -0.43% to 0.95%; p = 0.4; 2 studies).
    Conclusion: CS-HA OVDs lead to less postoperative loss of endothelial cells and may better protect corneal endothelium during cataract surgery, relative to other OVDs. Future randomized studies may be needed to solidify these findings.
    Language English
    Publishing date 2023-07-24
    Publishing country New Zealand
    Document type Journal Article ; Review
    ISSN 1177-5467
    ISSN 1177-5467
    DOI 10.2147/OPTH.S419863
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Validating the Safe and Effective Use of a Neurorehabilitation System (InTandem) to Improve Walking in the Chronic Stroke Population: Usability Study.

    Smayda, Kirsten Elisabeth / Cooper, Sarah Hodsdon / Leyden, Katie / Ulaszek, Jackie / Ferko, Nicole / Dobrin, Annamaria

    JMIR rehabilitation and assistive technologies

    2023  Volume 10, Page(s) e50438

    Abstract: Background: Persistent walking impairment following a stroke is common. Although rehabilitative interventions exist, few exist for use at home in the chronic phase of stroke recovery. InTandem (MedRhythms, Inc) is a neurorehabilitation system intended ... ...

    Abstract Background: Persistent walking impairment following a stroke is common. Although rehabilitative interventions exist, few exist for use at home in the chronic phase of stroke recovery. InTandem (MedRhythms, Inc) is a neurorehabilitation system intended to improve walking and community ambulation in adults with chronic stroke walking impairment.
    Objective: Using design best practices and human factors engineering principles, the research presented here was conducted to validate the safe and effective use of InTandem.
    Methods: In total, 15 participants in the chronic phase of stroke recovery (≥6 months after stroke) participated in this validation study. Participants were scored on 8 simulated use tasks, 4 knowledge assessments, and 7 comprehension assessments in a simulated home environment. The number and types of use errors, close calls, and operational difficulties were evaluated. Analyses of task performances, participant behaviors, and follow-up interviews were conducted to determine the root cause of use errors and difficulties.
    Results: During this validation study, 93% (14/15) of participants were able to successfully complete the critical tasks associated with the simulated use of the InTandem system. Following simulated use task assessments, participants' knowledge and comprehension of the instructions for use and key safety information were evaluated. Overall, participants were able to find and correctly interpret information in the materials in order to answer the knowledge assessment questions. During the comprehension assessment, participants understood warning statements associated with critical tasks presented in the instructions for use. Across the entire study, 3 "use errors" and 1 "success with difficulty" were recorded. No adverse events, including slips, trips, or falls, occurred in this study.
    Conclusions: In this validation study, people in the chronic phase of stroke recovery were able to safely and effectively use InTandem in the intended use environment. This validation study contributes to the overall understanding of residual use-related risks of InTandem in consideration of the established benefits.
    Language English
    Publishing date 2023-11-20
    Publishing country Canada
    Document type Journal Article
    ZDB-ID 2798120-4
    ISSN 2369-2529
    ISSN 2369-2529
    DOI 10.2196/50438
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Reduced Hospital Costs for Ultrasound-guided Vacuum-assisted Excision Compared with Open Surgery in Patients with Benign Breast Masses and High-risk Lesions.

    Whitworth, Pat / Hogan, Andrew / Ferko, Nicole / Son, Daniel / Wang, Faye / Xiong, Yan / Suri, Himanshu / Barclay, Ben

    Journal of breast imaging

    2024  Volume 2, Issue 5, Page(s) 452–461

    Abstract: Objective: Benign breast masses represent a substantial proportion of breast cancer screening results and may require multiple follow-up visits and biopsy. Even with a preceding benign core biopsy, benign masses have been excised via open surgery for a ... ...

    Abstract Objective: Benign breast masses represent a substantial proportion of breast cancer screening results and may require multiple follow-up visits and biopsy. Even with a preceding benign core biopsy, benign masses have been excised via open surgery for a variety of reasons. This study compared the procedural costs of US-guided vacuum-assisted excision (US-VAE) versus open surgical excisions for benign breast masses and high-risk lesions (HRL).
    Methods: In this retrospective cohort study, female outpatients receiving US-VAE or open excision of benign breast masses between 2015 and 2018 were identified within the Premier Healthcare Database. A secondary analysis was conducted for patients with HRLs. Propensity score matching and multivariate regression adjusted for patient demographics, encounter level covariates, and hospital characteristics. The total procedural costs were reported from a hospital perspective.
    Results: A total of 33 724 patients underwent excisions for benign breast masses (8481 US-VAE and 25 242 open surgery). Procedural costs were significantly lower in unmatched patients who received US-VAE ($1350) versus open surgery ($3045) (P < 0.0001). After matching, a total of 5499 discharges were included in each group, with similar findings for US-VAE ($1348) versus open surgery ($3101) (P < 0.0001). A secondary analysis of matched HRL patients (41 discharges in each group) also showed significantly lower procedural costs with US-VAE ($1620) versus open surgery ($3870) (P < 0.0001).
    Conclusion: Among patients with benign breast masses or HRLs, US-VAE was associated with significantly lower procedural costs versus open surgery. If excision is performed and expected clinical outcomes are equal, US-VAE is preferable to reduce costs without compromising the quality of care.
    Language English
    Publishing date 2024-02-29
    Publishing country United States
    Document type Journal Article
    ISSN 2631-6129
    ISSN (online) 2631-6129
    DOI 10.1093/jbi/wbaa055
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Economic and healthcare resource utilization assessments of PET imaging in Coronary Artery Disease diagnosis: a systematic review and discussion of opportunities for future economic evaluations.

    Ferko, Nicole / Priest, Stacey / Almuallem, Lamees / Walczyk Mooradally, Alicyia / Wang, Di / Oliva Ramirez, Abril / Szabo, Erika / Cabra, Arturo

    Journal of medical economics

    2024  Volume 27, Issue 1, Page(s) 715–729

    Abstract: Aims: This systematic literature review (SLR) consolidated economic and healthcare resource utilization (HCRU) evidence for positron emission tomography (PET) and single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to ... ...

    Abstract Aims: This systematic literature review (SLR) consolidated economic and healthcare resource utilization (HCRU) evidence for positron emission tomography (PET) and single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to inform future economic evaluations.
    Materials and methods: An electronic search was conducted in MEDLINE, Embase, and Cochrane databases from 2012-2022. Economic and HCRU studies in adults who underwent PET- or SPECT-MPI for coronary artery disease (CAD) diagnosis were eligible. A qualitative methodological assessment of existing economic evaluations, HCRU, and downstream cardiac outcomes was completed. Exploratory meta-analyses of clinical outcomes were performed.
    Results: The search yielded 13,439 results, with 71 records included. Economic evaluations and comparative clinical trials were limited in number and outcome types (HCRU, downstream cardiac outcomes, and diagnostic performance) assessed. No studies included all outcome types and only one economic evaluation linked diagnostic performance to HCRU. The meta-analyses of comparative studies demonstrated significantly higher rates of early- and late-invasive coronary angiography and revascularization for PET- compared to SPECT-MPI; however, the rate of repeat testing was lower with PET-MPI. The rate of acute myocardial infarction was lower, albeit non-significant with PET- vs. SPECT-MPI.
    Limitations and conclusions: This SLR identified economic and HCRU evaluations following PET- and SPECT-MPI for CAD diagnosis and determined that existing studies do not capture all pertinent outcome parameters or link diagnostic performance to downstream HCRU and cardiac outcomes, thus, resulting in simplified assessments of CAD burden. A limitation of this work relates to heterogeneity in study designs, patient populations, and follow-up times of existing studies. Resultingly, it was challenging to pool data in meta-analyses. Overall, this work provides a foundation for the development of comprehensive economic models for PET- and SPECT-MPI in CAD diagnosis, which should link diagnostic outcomes to HCRU and downstream cardiac events to capture the full CAD scope.
    MeSH term(s) Humans ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/economics ; Positron-Emission Tomography/economics ; Tomography, Emission-Computed, Single-Photon/economics ; Cost-Benefit Analysis ; Myocardial Perfusion Imaging/economics ; Patient Acceptance of Health Care/statistics & numerical data
    Language English
    Publishing date 2024-05-06
    Publishing country England
    Document type Systematic Review ; Journal Article
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.1080/13696998.2024.2345507
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Process for Consensus Statements on Lumbar Total Disc Replacement.

    Ferko, Nicole / Hollmann, Sarah

    Spine

    2017  Volume 42 Suppl 24, Page(s) S101–S102

    Abstract: Consensus statements regarding the evidence-base for lumbar total disc replacement, as it pertains to payer decision-making, were developed through a modified-Delphi technique involving 17 spine surgeons and a former payer medical director. The Delphi ... ...

    Abstract : Consensus statements regarding the evidence-base for lumbar total disc replacement, as it pertains to payer decision-making, were developed through a modified-Delphi technique involving 17 spine surgeons and a former payer medical director. The Delphi process involved one round of anonymous survey and one round with a face-to-face meeting. The survey was a 51-item, electronically administered questionnaire to determine level of agreement with proposed statements on the evidence for lumbar total disc replacement and to provide additional diagnosis and management practice information for further deliberations. A subset of the proposed statements was discussed at the face-to-face meeting to identify reasons for disagreement, revise wording, and obtain consensus. The meeting involved presentation of the current evidence base for lumbar total disc replacement, as well as three themed sessions that were moderated by surgeons on the panel. The voting processes during meeting deliberations remained anonymous. Consensus was defined as ≥ 90% agreement. Consensus was reached on 11 statements, divided into themes that focused on patient eligibility and diagnosis, evidence criteria for coverage decisions, clinical evidence, and budgetary implications.
    MeSH term(s) Consensus ; Decision Making ; Delivery of Health Care ; Delphi Technique ; Humans ; Lumbar Vertebrae/surgery ; Surveys and Questionnaires ; Total Disc Replacement/methods ; Total Disc Replacement/trends
    Language English
    Publishing date 2017-11-23
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 752024-4
    ISSN 1528-1159 ; 0362-2436
    ISSN (online) 1528-1159
    ISSN 0362-2436
    DOI 10.1097/BRS.0000000000002452
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  7. Article ; Online: A Comparison of Microwave Ablation and Cryoablation for the Treatment of Renal Cell Carcinoma: A Systematic Literature Review and Meta-analysis.

    McClure, Timothy / Lansing, Austin / Ferko, Nicole / Wright, George / Ghosh, Sudip K / Raza, Sajjad / Kalsekar, Iftekhar / Clarke, Kerise / Talenfeld, Adam

    Urology

    2023  Volume 180, Page(s) 1–8

    Abstract: Objective: To conduct a systematic review and meta-analysis comparing microwave ablation (MWA) and cryoablation for renal cell carcinoma (RCC).: Methods: The systematic search was performed in MEDLINE, Embase, and Cochrane databases. Studies ... ...

    Abstract Objective: To conduct a systematic review and meta-analysis comparing microwave ablation (MWA) and cryoablation for renal cell carcinoma (RCC).
    Methods: The systematic search was performed in MEDLINE, Embase, and Cochrane databases. Studies published in English from January 2006 to February 2022 that assessed adults with primary RCC who received MWA or cryoablation were included. Study arms from RCTs, comparative observational, and single-arm studies were eligible. The outcomes included local tumor recurrence (LTR), overall survival, disease-free survival, overall/major complications, procedure/ablation time, 1- to 3-month primary technique efficacy, and technical success. Single-arm meta-analyses were performed using the random effects model. Sensitivity analyses excluding low-quality studies assessed using the MINORs scale were performed. Univariable and multivariable examined the effects of prognostic factors.
    Results: Baseline characteristics were similar between groups and mean tumor size for MWA and cryoablation were 2.74 and 2.69 cm. Single-arm meta-analyses were similar for LTR and secondary outcomes between cryoablation and MWA. Ablation time was significantly shorter with MWA than with cryoablation (meta-regression weighted mean difference 24.55 minutes, 95% confidence interval -31.71, -17.38, P < .0001). One-year LTR was significantly lower with MWA than cryoablation (odds ratio 0.33, 95% confidence interval 0.10-0.93, P = .04). There were no significant differences for other outcomes.
    Conclusion: MWA provides significantly improved 1-year LTR and ablation time compared with cryoablation for patients with RCC. Other outcomes appeared similar or favorable for MWA; however, results were not statistically significant. MWA of primary RCC is as safe and effective as cryoablation, which should be confirmed with future comparative studies.
    MeSH term(s) Adult ; Humans ; Carcinoma, Renal Cell/surgery ; Cryosurgery/methods ; Microwaves/therapeutic use ; Treatment Outcome ; Kidney Neoplasms/surgery ; Catheter Ablation/methods ; Retrospective Studies
    Language English
    Publishing date 2023-06-17
    Publishing country United States
    Document type Meta-Analysis ; Systematic Review ; Journal Article ; Review
    ZDB-ID 192062-5
    ISSN 1527-9995 ; 0090-4295
    ISSN (online) 1527-9995
    ISSN 0090-4295
    DOI 10.1016/j.urology.2023.06.001
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  8. Article: Successful Implementation of Femtosecond Laser-Assisted Cataract Surgery: A Real-World Economic Analysis.

    George, David S / Ainslie-Garcia, Margaret H / Ferko, Nicole C / Cheng, Hang

    Clinical ophthalmology (Auckland, N.Z.)

    2021  Volume 15, Page(s) 923–929

    Abstract: Purpose: To calculate the minimum number of Femtosecond laser-assisted cataract surgery (FLACS) procedures required per month to pay off the fixed investment cost over 5 years to achieve break-even.: Setting: A rural ophthalmology practice located in ...

    Abstract Purpose: To calculate the minimum number of Femtosecond laser-assisted cataract surgery (FLACS) procedures required per month to pay off the fixed investment cost over 5 years to achieve break-even.
    Setting: A rural ophthalmology practice located in the mid-West United States.
    Design: An economic analysis, based on real-world, retrospectively collected data over 12 months, from an ambulatory surgical care perspective.
    Methods: FLACS was initiated in 2017 with the LenSx
    Results: The clinic performed 2717 cataract surgeries in the 12-month period, with 1304 (48%) of patients converting to FLACS. Of FLACS procedures, 613 (47%) selected an advanced-technology intraocular lens (AT-IOL; eg, toric or lifestyle IOL), and the remaining patients selected a monofocal IOL with laser astigmatism correction. FLACS increased AT-IOL use by 113 procedures (23%) compared to volumes in the year prior to FLACS. Overall, FLACS was predicted to be profitable, with only 13 cases required per month to break even in 5 years. If both facility and physician fees are considered revenue, only eight cases per month are required to break-even in 5 years.
    Conclusion: The practice experienced a greater-than-anticipated conversion to FLACS and increased selection of AT-IOLs, well above the break-even volume required, contributing to a rapid return on their investment.
    Language English
    Publishing date 2021-03-02
    Publishing country New Zealand
    Document type Journal Article
    ISSN 1177-5467
    ISSN 1177-5467
    DOI 10.2147/OPTH.S293111
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Incidence and Resolution Strategies for Early-Onset Postoperative Leg Pain Following Lumbar Total Disc Replacement.

    Guyer, Richard D / Ferko, Nicole / Bonner, Ashley / Situ, Aaron / Ohnmeiss, Donna D

    International journal of spine surgery

    2021  Volume 15, Issue 5, Page(s) 978–987

    Abstract: Background: Lumbar total disc replacement (TDR) has produced results similar or superior to fusion in treating symptomatic disc degeneration. Some patients have reported onset of leg pain early after surgery. Little information is available specifically ...

    Abstract Background: Lumbar total disc replacement (TDR) has produced results similar or superior to fusion in treating symptomatic disc degeneration. Some patients have reported onset of leg pain early after surgery. Little information is available specifically on this problem. The purpose of this study was to investigate the incidence of early-onset postoperative leg pain following lumbar TDR and to describe strategies for its treatment.
    Methods: The study was based on a post hoc analysis of prospectively collected adverse event data from 283 patients in the activL Food and Drug Administration investigational device exemption study. Early-onset leg pain was defined as occurring between 0 and 4 weeks postprocedure, and the baseline visual analog scale score in the affected leg(s) was <25 (of 100). The treatment types these patients received were analyzed.
    Results: Among 283 patients, 26 (9.2%) had an early-onset leg pain event. The majority of these events resolved (20/26, 76.9%). Of those resolving, 55% (11/20) did so within 3 months. Most patients received at least 1 drug treatment for leg pain (92.3%). Of those receiving drug therapy, the most common type was neurogenic (61.5%), followed by narcotics (46.2%). Steroid use was prescribed in 30.8%. The majority of resolved cases were not on narcotics and resolved with neurogenic drugs. Three patients went on to have surgery, none of whom benefited from it. Age, body mass index, and baseline disability scores were predictive of time to resolution.
    Conclusion: Early-onset postoperative leg pain occurred in approximately 10% of lumbar TDR patients. The majority of events resolved, often within 3 months. Treatment with conservative care, including medication(s), was more effective in resolving symptoms rather than surgery.
    Clinical relevance: This study provides useful information for providers and patients on the incidence, treatment, and resolution of leg pain with onset after lumbar TDR and not related to direct neural compression identified by imaging.
    Level of evidence: 2.
    Language English
    Publishing date 2021-09-22
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2211-4599
    ISSN 2211-4599
    DOI 10.14444/8128
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: A device category economic model of electrosurgery technologies across procedure types: a U.S. hospital budget impact analysis.

    Ferko, Nicole / Wright, George W J / Syed, Imran / Naoumtchik, Elena / Tommaselli, Giovanni A / Gangoli, Gaurav

    Journal of medical economics

    2021  Volume 24, Issue 1, Page(s) 524–535

    Abstract: Aims: The electrosurgical technology category is used widely, with a diverse spectrum of devices designed for different surgical needs. Historically, hospitals are supplied with electrosurgical devices from several manufacturers, and those devices are ... ...

    Abstract Aims: The electrosurgical technology category is used widely, with a diverse spectrum of devices designed for different surgical needs. Historically, hospitals are supplied with electrosurgical devices from several manufacturers, and those devices are often evaluated separately; it may be more efficient to evaluate the category holistically. This study assessed the health economic impact of adopting an electrosurgical device-category from a single manufacturer.
    Methods: A budget impact model was developed from a U.S. hospital perspective. The uptake of electrosurgical devices from EES (Ethicon Electrosurgery), including ultrasonic, advanced bipolar, smoke evacuators, and reusable dispersive electrodes were compared with similar MED (Medical Energy Devices) from multiple manufacturers. It was assumed that an average hospital performed 10,000 annual procedures 80% of which involved electrosurgery. Current utilization assumed 100% MED use, including advanced energy, conventional smoke mitigation options (e.g. ventilation, masks), and single-use disposable dispersive electrode devices. Future utilization assumed 100% EES use, including advanced energy devices, smoke evacuators (i.e. 80% uptake), and reusable dispersive electrodes. Surgical specialties included colorectal, bariatric, gynecology, thoracic and general surgery. Systematic reviews, network meta-analyses, and meta-regressions informed operating room (OR) time, hospital stay, and transfusion model inputs. Costs were assigned to model parameters, and price parity was assumed for advanced energy devices. The costs of disposables for dispersive electrodes and smoke-evacuators were included.
    Results: The base-case analysis, which assessed the adoption of EES instead of MED for an average U.S. hospital predicted an annual savings of $824,760 ($101 per procedure). Savings were attributable to associated reductions with EES in OR time, days of hospital stay, and volume of disposable electrodes. Sensitivity analyses were consistent with these base-case findings.
    Conclusions: Category-wide adoption of electrosurgical devices from a single manufacturer demonstrated economic advantages compared with disaggregated product uptake. Future research should focus on informing comparisons of innovative electrosurgical devices.
    MeSH term(s) Budgets ; Cost-Benefit Analysis ; Electrosurgery/economics ; Electrosurgery/instrumentation ; Financial Management, Hospital/economics ; Humans ; Length of Stay ; Models, Economic ; Operative Time ; Surgical Procedures, Operative/classification ; Surgical Procedures, Operative/economics ; Technology Assessment, Biomedical
    Language English
    Publishing date 2021-05-04
    Publishing country England
    Document type Journal Article
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.1080/13696998.2021.1915626
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