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  1. Hayano W, Kerscher M, Day D, Ogilvie A, Pavicic T, Lim T, et al.
    Aesthet Surg J, 2023 Apr 13.
    PMID: 37052953 DOI: 10.1093/asj/sjad103
    BACKGROUND: The use of validated scales is still considered the gold standard in evaluating the severity of an aesthetic facial condition.

    OBJECTIVES: The objective of this investigation was to create and validate 5-point photo numeric scales which assess perioral lines and marionette lines.

    METHODS: A medical team created two different novel 5-point photonumeric scale for the assessment of perioral lines and marionette lines. Eleven international raters were involved in the digital validation, while 4 raters performed a live validation.

    RESULTS: For the Croma Static Perioral Lines-Assessment Scale digital inter-rater ICCs were 0.88 [95% CI: 0.85-0.91] in the first rating and 0.87 [0.83-0.90] in the second rating. The digital intra-rater ICCs were 0.90 [95% CI: 0.87-0.92]. In the live rating, the inter-rater ICCs were 0.89 [95% CI: 0.85-0.93] in the first rating and 0.91 [95% CI: 0.87-0.93] in the second rating with an intra-rater ICC of 0.91 [95% CI: 0.88-0.95]. For the Croma Marionette Lines-Assessment scale the digital rating inter-rater ICCs were 0.85 [95% CI: 0.81-0.89] in the first rating and 0.87 [95% CI: 0.84-0.90] in the second rating with an intra-rater ICC of 0.89 [95% CI: 0.88-0.91]. In the live rating, the inter-rater ICCs were 0.73 [95% CI: 0.54-0.83] in the first rating and 0.79 [95% CI: 0.65-0.87] in the second rating with an intra-rater ICC of 0.88 [95% CI: 0.83-0.94].

    CONCLUSIONS: It is to be concluded that the Croma Static Perioral Lines-Assessment Scale and the Croma Marionette Lines-Assessment Scale have exceptional inter- and intra-rater agreements to be justifiably used in the clinical and study setting for all ethnic groups.

  2. Kerscher M, Green J, Day D, Ogilvie A, Pavicic T, Lim T, et al.
    Aesthet Surg J, 2023 Feb 25.
    PMID: 36840504 DOI: 10.1093/asj/sjad041
    BACKGROUND: A scarcity of scales which assess platysmal bands, wrinkles in the décolleté, and horizontal necklines in the digital and live setting exist.

    OBJECTIVES: The objective of this investigation was to create and validate 5-point photo numeric scales which assess horizontal necklines, platysmal bands and wrinkles in the décolleté.

    METHODS: A medical team created 3 different novel 5-point photonumeric scale for the assessment of horizontal necklines, platysmal bands and décolleté wrinkling. Eleven international raters were involved in the digital validation, while 4 raters performed a live validation.

    RESULTS: The Croma Horizontal Neck Line - Assessment Scale showed substantial inter-rater agreement and almost perfect intra-rater agreement in the digital and live validations. The Croma Platysmal Bands-Assessment Scale showed substantial intra-rater agreement in both, digital and live validations. For the décolleté, a static and a dynamic scale was created and validated. The Croma Static Décolleté Wrinkling-Assessment Scale showed substantial and almost perfect inter-rater agreement in the digital validation and live-validation, respectively, while the intra-rater agreement was in both almost perfect. The Croma Dynamic Décolleté Wrinkling-Assessment Scale showed almost perfect agreement in both validation settings for both, inter-and intra-rater agreement.

    CONCLUSIONS: The Croma Horizontal Neck Line - Assessment Scale, the Croma Static and Dynamic Décolleté Wrinkling-Assessment Scales have sufficient inter and intrarater agreements to be justifiably used in the clinical and study setting.

  3. Loong HH, Shimizu T, Prawira A, Tan AC, Tran B, Day D, et al.
    ESMO Open, 2023 Aug;8(4):101586.
    PMID: 37356359 DOI: 10.1016/j.esmoop.2023.101586
    INTRODUCTION: Next-generation sequencing (NGS) diagnostics have shown clinical utility in predicting survival benefits in patients with certain cancer types who are undergoing targeted drug therapies. Currently, there are no guidelines or recommendations for the use of NGS in patients with metastatic cancer from an Asian perspective. In this article, we present the Asia-Pacific Oncology Drug Development Consortium (APODDC) recommendations for the clinical use of NGS in metastatic cancers.

    METHODS: The APODDC set up a group of experts in the field of clinical cancer genomics to (i) understand the current NGS landscape for metastatic cancers in the Asia-Pacific (APAC) region; (ii) discuss key challenges in the adoption of NGS testing in clinical practice; and (iii) adapt/modify the European Society for Medical Oncology guidelines for local use. Nine cancer types [breast cancer (BC), gastric cancer (GC), nasopharyngeal cancer (NPC), ovarian cancer (OC), prostate cancer, lung cancer, and colorectal cancer (CRC) as well as cholangiocarcinoma and hepatocellular carcinoma (HCC)] were identified, and the applicability of NGS was evaluated in daily practice and/or clinical research. Asian ethnicity, accessibility of NGS testing, reimbursement, and socioeconomic and local practice characteristics were taken into consideration.

    RESULTS: The APODDC recommends NGS testing in metastatic non-small-cell lung cancer (NSCLC). Routine NGS testing is not recommended in metastatic BC, GC, and NPC as well as cholangiocarcinoma and HCC. The group suggested that patients with epithelial OC may be offered germline and/or somatic genetic testing for BReast CAncer gene 1 (BRCA1), BRCA2, and other OC susceptibility genes. Access to poly (ADP-ribose) polymerase inhibitors is required for NGS to be of clinical utility in prostate cancer. Allele-specific PCR or a small-panel multiplex-gene NGS was suggested to identify key alterations in CRC.

    CONCLUSION: This document offers practical guidance on the clinical utility of NGS in specific cancer indications from an Asian perspective.

  4. Ouyang M, Faigle R, Wang X, Johnson B, Summers D, Khatri P, et al.
    Cerebrovasc Dis, 2024;53(5):635-642.
    PMID: 37883934 DOI: 10.1159/000534706
    INTRODUCTION: Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low risk of symptomatic intracerebral hemorrhage (sICH) and other complications.

    METHODS: OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe, and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically stable adult patients with mild AIS (defined by a NIHSS <10) who do not require intensive care within 2 h post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, USA, and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7,200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 min for 2 h, 2 hourly (vs. every 30 min) for 8 h, and 4 hourly (vs. every 1 h) until 24 h, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH, and serious adverse events.

    CONCLUSION: OPTIMISTmain will provide level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS.

  5. Ouyang M, González F, Montalbano M, Pruski A, Jan S, Wang X, et al.
    Cerebrovasc Dis, 2025;54(1):96-104.
    PMID: 38442704 DOI: 10.1159/000538136
    INTRODUCTION: The ongoing OPTIMISTmain study, an international, multicenter, stepped-wedge cluster randomized trial, aims to determine effectiveness and safety of low-intensity versus standard monitoring in thrombolysis-treated patients with mild-to-moderate acute ischemic stroke (AIS). An embedded process evaluation explored integration and impact of the intervention on care processes at participating US sites.

    METHODS: A mixed-methods approach with quantitative and qualitative data was collected between September 2021 and November 2022. Implementer surveys were undertaken at pre- and post-intervention phases to understand the perceptions of low-intensity monitoring strategy. A sample of stroke care nurses were invited to participate in semi-structured interviews at an early stage of post-intervention. Qualitative data were analyzed deductively using the normalization process theory; quantitative data were tabulated.

    RESULTS: Interviews with 21 nurses at 8 hospitals have shown low-intensity monitoring was well accepted as there were less time constraints and reduced workload for each patient. There were initial safety concerns over missing deteriorating patients and difficulties in changing established routines. Proper training, education, and communication, and changing the habits and culture of care, were key elements to successfully adopting the new monitoring care into routine practice. Similar results were found in the post-intervention survey (42 nurses from 13 hospitals). Nurses reported time being freed up to provide patient education (56%), daily living care (50%), early mobilization (26%), mood/cognition assessment (44%), and other aspects (i.e., communication, family support).

    CONCLUSIONS: Low-intensity monitoring for patients with mild-to-moderate AIS, facilitated by appropriate education and organizational support, appears feasible and acceptable at US hospitals.

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