Background and purpose: Tailored, language-appropriate information is fundamental for children and their families in paediatric oncology, influencing both the quality of care and clinical outcomes. Yet, for families who speak another language, interpreter services are not used to the extent necessary to ensure equitable and patient-safe communication. Knowledge about how healthcare professionals (HCPs) (registered nurses [RNs] and medical doctors [MDs]) experience and manage interpreter use is limited. To address this gap, this study aimed to explore the obstacles to interpreter use in Nordic paediatric oncology care and to examine the challenges HCPs experience during interpreter‑mediated conversations. Participants/materials and methods: A cross-sectional multicentre survey study involving 453 RNs and MDs from 20 paediatric oncology centres across the Nordic region. The Communication over Language Barriers Questionnaire was used in each country’s majority language. Descriptive and non-parametric analyses were used to summarise and compare the data between countries and professions. Group differences were tested using Pearson’s chi-square or Fisher–Freeman–Halton exact tests, with p < 0.05 considered significant. Results: Time constraints in acute but also in planned care situations were identified as the most common obstacles to interpreter use. In addition, when using interpreters, the respondents sometimes or often experienced challenges such as uncertainty about the accuracy of the interpretation and about patients’ understanding of the given information. Interpretation: To ensure equitable, safe, and person‑centred care for children and their families, there is an emergent need for improved communication strategies and a need for better organisational support, easier interpreter access, and stronger systems for quality-assured interpreter services across the Nordic region.
Background and purpose: Abemaciclib in addition to adjuvant endocrine therapy for hormone receptor positive (HR+) breast cancer improves disease free survival (IDFS) and overall survival (OS). However, treatment-related adverse events may lead to early discontinuation. Sahlgrenska University Hospital implemented a gradual increase in initial dosing, with the intention to improve tolerability and adherence. Patient/material and methods: This retrospective observational study described adherence, tolerability and healthcare utilization associated with a gradual dose increase of adjuvant abemaciclib. A total of 69 patients aged 31–81 years were treated at Sahlgrenska University Hospital between 1st of April 2023 and 1st of April 2025 with cut-off September 5th, 2025. Clinical encounters and treatment outcomes were extracted from medical records and analyzed using descriptive statistics. Results: Patients were older and had worse Eastern Cooperative Oncology Group status compared with the monarchE registrational trial. At 12 and 26 weeks, 34 patients (49%) and 25 patients (36%) remained on the full dose of abemaciclib, respectively. Overall, 65 patients (94.2%) and 58 patients (84%) remained on treatment at any dose at 12 and 26 weeks. Treatment discontinuation was mainly driven by low grade adverse events (grade 1–2). During the study period 1069 clinical encounters were recorded; 15 patients (22%) had at least one emergency care encounter and seven (10%) required hospital admission. Interpretation: The gradual dose increase strategy resulted in fewer patients maintaining the full dose at 12 weeks compared with monarchE and TRADE trials, while overall treatment persistence remained high. Treatment discontinuation was primarily driven by cumulative low-grade toxicity and healthcare utilization was considerable.
Background and purpose: Since the introduction of sentinel lymph node biopsy, nodal assessment has expanded to nearly all women with endometrial cancer. However, evidence on the prognostic significance of isolated tumor cells (ITCs) and nodal tumor burden remains limited. We therefore investigated the association of ITCs and nodal tumor burden with survival. Patients and methods: This cohort study included women with endometrial cancer who underwent surgery in Region Stockholm–Gotland, Sweden, between 2010 and 2024, and either underwent sentinel lymph node biopsy or were registered as having lymph node metastases (FIGO stage IIIC). Nodal dissemination was categorized as bulky, macro-, micro-metastases, or ITCs. Overall survival (OS) and cancer-specific survival (CSS) were evaluated using multivariable Cox regression in two separate analyses: (1) ITCs versus node-negative patients and (2) nodal tumor burden (bulky, macro-, micro-metastases) among node-positive patients. Results: Among 1219 patients, 310 (25%) had nodal dissemination, including 250 with nodal metastases and 60 with ITCs. No significant difference in OS was observed between patients with ITCs and node-negative patients (Hazard ratio [HR] 1.94, 95% confidence interval [CI] 0.75–5.06). Adjuvant therapy was more frequent among patients with ITCs (47% vs. 11%). In patients with nodal metastases, no clear OS differences were observed by nodal burden. Compared with micrometastases, survival was similar for macrometastases (HR 0.95, 95% CI 0.50–1.81) and bulky metastases (HR 1.19, 95% CI 0.64–2.21). Age > 68 years and p53 mutation were associated with worse survival. CSS analyses yielded similar findings, with no significant differences observed in either comparison. Interpretation: Neither ITCs nor greater nodal burden was clearly associated with survival after adjustment for clinical and molecular factors. Survival appeared to be influenced by patient and tumor characteristics, although estimates were imprecise and modest associations cannot be excluded.
BACKGROUND AND PURPOSE:This study examined whether theory-based education increases cervical cancer screening among underserved women. METHODS:Seven databases (PubMed, Embase, Scopus, Web of Science, Cochrane Library, CINAHL, and PsycINFO) were systematically searched for studies published between January 2005 and November 2025. A total of 1,200 records were identified; after duplicate removal, 900 titles and abstracts were screened, and 200 full-text articles were assessed. Fourteen studies met inclusion criteria for qualitative synthesis, and 12 trials contributed extractable binary outcome data for meta-analysis, including one study with two distinct intervention arms. The primary outcome was screening uptake (Pap smear, visual inspection with acetic acid [VIA], or human papillomavirus [HPV] testing). Data extraction and quality appraisal followed PRISMA 2020 and Joanna Briggs Institute guidance. Pooled odds ratios (ORs) were calculated using DerSimonian-Laird random-effects models with Hartung-Knapp adjustment, and heterogeneity, prediction intervals, small-study effects, and certainty of evidence (GRADE) were evaluated. RESULTS:Structured educational interventions significantly increased screening uptake compared with usual care or minimal information (OR = 4.41; 95% confidence interval [CI]: 2.21-8.80). Subgroup analyses showed substantial effects in both high-income (OR = 3.46; 95% CI: 1.43-8.36) and middle-income settings (OR = 6.55; 95% CI: 2.74-15.63). Interventions frequently incorporated behavioral frameworks, such as the Health Belief Model, Protection Motivation Theory, and BASNEF model, and were often culturally tailored or delivered through community-embedded formats. INTERPRETATION:Integrating such interventions into national and local screening programs represents an effective and equitable strategy to reduce disparities in cervical cancer prevention.
Background and purpose: To compare follow-up preferences and health-related quality of life between newly operated endometrial cancer patients and those already enrolled in a traditional hospital-based follow-up program, and to explore whether preferences differ depending on follow-up experience. Patient/material and methods: In this prospective cross-sectional study, patients who underwent primary surgery for endometrial cancer in northern Sweden were included. Group 1 consisted of newly operated patients recruited before entering follow-up, and Group 2 included patients already participating in the standard hospital-based follow-up program. Participants completed questionnaires on sociodemographic characteristics, follow-up preferences, and quality of life (EORTC QLQ-C30). Clinical data were obtained from medical records. The primary outcome was follow-up preference; secondary outcomes included quality of life and associations with clinical and demographic variables. Results: Of the 121 invited patients, 92 (76%) responded, and 90 were included in the analysis (48 in Group 1; 42 in Group 2). The groups were comparable in baseline characteristics. Newly operated patients demonstrated more diverse follow-up preferences, with 51.1% preferring physician-led hospital visits compared to 82.9% in Group 2 (p = 0.035). Global quality of life did not differ significantly (p = 0.165), although Group 1 reported lower functional scores, particularly in role and emotional functioning. Appetite loss was the only symptom that differed significantly between groups. Interpretation: Newly operated patients are more open to alternative follow-up models despite similar overall quality of life. Integrating patient preferences into follow-up care may enhance personalization and sustainability.
Background and purpose: Human papillomavirus (HPV) causes multiple cancers. Understanding HPV-related cancer burden may help implement effective strategies for cancer prevention. The aim was to examine incidence and survival trends of eight HPV-related cancer sites in Estonia and estimate the number of cases attributable to HPV. Patient/material and methods: The Estonian Cancer Registry provided data on all cases of eight HPV-related cancer sites diagnosed in Estonia during 1995–2022. Age-standardized incidence trends were analyzed using joinpoint regression, estimating annual percentage change (APC). The number of HPV-attributable cases was estimated using internationally derived site-specific attributable fractions, as tumor HPV status was not available. Five-year relative survival ratios were calculated from national life tables. Results: In all, 11,266 cases of HPV-related cancer sites were diagnosed, of which 6,263 were estimated to be attributable to HPV; over 40% occurred before age 55. In women, estimated average annual number of HPV-attributable cases nearly quadrupled for oropharyngeal cancer (OPC) and tripled for anal cancer. A significant increase in OPC and anal cancer incidence was observed among women (APC 10.0 and 3.8, respectively). Cervical cancer incidence declined after 2012 (APC –5.6). Survival improved for OPC in men (from 13 to 44%) and vaginal cancer in women (from 45 to 73%). Interpretation: HPV-related cancer patterns in Estonia are shifting from cervical to non-cervical cancers. Increasing oropharyngeal and anal cancer incidence highlights the need for prevention strategies beyond cervical screening alone. Strengthening HPV vaccination uptake and sustaining organized cervical screening are critical for reducing future cancer burden.
Background and purpose: Volumetric modulated arc therapy (VMAT) plans often involve small and irregular beam apertures (i.e. high complexity), which can pose challenges for accurate dose calculations. The aim of this study was to investigate plausible dose calculation errors for VMAT plans of various complexity. Patient/material and methods: Twenty patient cases, each with three VMAT plans of different complexities (i.e. 60 plans in total), were included. All plans were calculated using six different dose calculation methods. It was assumed that greater differences between calculations reflect increased difficulty in accurately estimating dose. Basic performances of the six calculation methods were evaluated based on static fields. Three-dimensional distributions of voxel-wise two standard deviations (2SDs) in percent of local voxel dose were visually evaluated. 2SD volume histograms were analyzed as well as the mean (2SDMean) and maximum 2SD within 2 cm3 (2SD2cc) for different regions of interest. Results: Higher 2SD values were generally found outside the planning target volume (PTV) compared to inside, particularly in low dose and buildup regions. Average (per treatment site) 2SDMean/2SD2cc values were 0.9–1.2%/1.8–5.1% in the PTV and 1.8–3.1/8.4–18.7% for the region 1 cm outside the PTV. For organs of interest, 2SDMean/2SD2cc values were larger than the equivalent values in the PTV, with highest values up to 5/15% observed for the prostate cases. Interpretation: Variations between dose calculation methods were larger in organs of interest than in the PTVs. Differences in 2SD distributions between the patient cases were generally larger than differences between the complexity levels.
Background and purpose: Palliative immune checkpoint inhibitor (pICI) treatment has improved overall survival (OS) in many solid tumours during the last decades. However, the survival benefits are based on fit patients included in the clinical trials, all with Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1. Data on survival in PS 2-3 patients are limited. This study aimed to compare OS according to ECOG PS at the initiation of pICI in real world data. Patient/material and methods: ICI has been recorded in the Swedish National Cancer Drug Registries since 2010. Palliative ICI treatment in the Southeastern region, Sweden, from 2010 until April 2025 were included. Survival probability and median overall survival (mOS) were calculated. Results: A total of 1956 patients had received at least one pICI treatment, for lung cancer (n = 854), melanoma (n = 443), renal carcinoma (n = 218) and urothelial carcinoma (n = 127). PS 2 or higher was reported in 28.9% and 80.6% received ICI only (no chemotherapy). mOS was in PS 0-1 patients 23.4 months, in PS 2 patients 9.6 months and in PS 3 patients 3.8 months. Death within 90 days occurred in 45.7% of PS 3 patients. Interpretation: Less fit patients are commonly treated with pICI, and PS seems an important predictive factor for palliative ICI regardless of cancer subtype. In our data, mOS is particularly short in PS 3 patients, suggesting to refrain from treatment. mOS is shorter in PS 2 patients than in PS 0-1, warranting individual considerations in treatment decisions. Better tools to guide treatment decisions for PS 2 patients are desirable.
Background and purpose: It has generally been established that younger breast cancer patients exhibit unfavorable biology and poorer prognosis. However, previous studies have not consistently demonstrated differences between younger and older patients. The objective of this study, therefore, was to compare pathological characteristics and prognosis in young patients (age ≤ 40 years) with early breast cancer with those of older patients (age ≥ 55 years). Patients/material and methods: Individuals diagnosed with early breast cancer (age ≤ 40 years) and those ≥ 55 years of age, who were treated at two hospitals between June 2003 and December 2019, were identified. Oncological outcomes, including recurrence-free survival (RFS), distant RFS (DRFS), and locoregional RFS (LRRFS), were compared between two groups. Kaplan–Meier survival curves and the Cox proportional hazards model were used to evaluate. Results: Data from 288 young (≤ 40 years) and 830 older (≥ 55 years) patients were included. Pathologically, younger patients exhibited a higher prevalence of high-grade tumors. There was no significant difference in RFS and DRFS between the younger and older patient groups (RFS: hazard ratio 1.11 [95% confidence intervals (CI) 0.74–1.66]; P = 0.613; DRFS: hazard ratio 1.03 [95% CI 0.65–1.62]; P = 0.897). However, LRRFS was unfavorable in younger patients (hazard ratio, 2.15; 95% CI, 1.03–4.49; P = 0.043). Subgroup analysis revealed a significant difference in LRRFS among hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients (hazard ratio 4.04 [95% CI 1.17–13.97]; P = 0.027); however, no significant difference was observed in other subtypes. Interpretation: Younger patients with breast cancer exhibited a higher frequency of high-grade tumors, although no differences were observed in RFS and DRFS. However, locoregional recurrence was more common among younger patients, especially HR-positive/HER2-negative breast cancer.
Background and purpose: National radiotherapy (RT) data infrastructures are emerging to support treatment quality assurance and outcome research. However, prospective nationwide integration of full DICOM-RT data with toxicity and patient-reported outcome measures (PROMs) remains uncommon. KaSARi (Key advances in Standardizing, Automating, and predicting Risks in RT) was established to create national research infrastructure for prospective RT data collection and integration in Finland. Materials and methods: KaSARi is a prospective, consent-based multicenter cohort infrastructure involving Finnish university and central hospitals. All adult patients receiving RT are eligible. DICOM-RT datasets from treatment planning and oncology information systems are linked to clinician-graded toxicity, PROMs and relevant clinical variables. The infrastructure builds on previously validated multi-institutional DICOM workflows and follows FAIR (Findable, Accessible, Interoperable, Reusable) data principles. Predefined work packages support data harmonization, scalable data processing and enable downstream applications such as AI-based segmentation, dose prediction, and outcome modeling. Results: Patient recruitment started in May 2025. By February 2026, 221 patients had been enrolled at the coordinating center, initially including breast cancer patients and subsequently expanding to all RT indications. Recruitment at a second center began in November 2025, with 37 patients enrolled. The infrastructure is projected to include approximately 29,000 patients over 15 years. Integration of dosimetric, clinical and PROM data is progressing through a phased national implementation as additional centers join the network. Interpretation: KaSARi represents a national infrastructure prospectively integrating full DICOM-RT data-sets with clinician-graded toxicity and PROMs across all RT indications within a unified research protocol. The study provides a foundation for nationwide outcome modeling, harmonization of RT practices and development and validation of data-driven AI-based methods.
Background and purpose: Although exercise is recommended for cancer patients, its acute effects on tumour blood flow (TBF) have not been quantified in humans. As TBF may influence tumour progression and treatment efficacy, we assessed its circulatory responses in malignant lymphoma during exercise using dynamic PET imaging. Patient/material and methods: Eight patients with Hodgkin or non-Hodgkin lymphoma underwent thoracic [¹⁵O]H₂O positron emission tomography/computed tomography (PET/CT) at rest and during 10 min of supine cycling (Borg RPE 11–16). TBF and its heterogeneity, tumour blood volume (TBV), mean transit time (MTT), and vascular resistance were quantified in eight index and three secondary tumours. Results: Baseline TBF in index tumours was high (mean 57.6 mL/dL/min; range 30.3–105.0). During exercise, TBF (mean 48.1 ± 16.1 mL/dL/min), its heterogeneity and MTT did not change significantly. However, TBV decreased (p = 0.038), and vascular resistance tended to increase (p = 0.055). TBF change correlated positively with age (r = 0.73, p = 0.04) and negatively with tumour volume (r = –0.67, p = 0.02), but not with heart rate or power output. Secondary tumours showed similar exercise responses, with lower absolute TBF (p = 0.02). Interpretation: This study demonstrates the feasibility of using [¹⁵O]H₂O PET/CT to quantify TBF in lymphoma patients in real time during acute exercise. Baseline TBF is remarkably high in lymphoma tumours, and responses to acute exercise are variable, tending to decline in younger patients and larger tumours, while vascular resistance tended to increase.
BACKGROUND AND PURPOSE:This study evaluates volumetric modulated arc therapy (VMAT) as a potential alternative to three-dimensional conformal radiotherapy (3D-CRT) for whole-breast radiotherapy (RT) with simultaneous-integrated boost (SIB). Patient/material and methods: Ten left-sided breast cancer patients previously treated in our institution (whole breast with SIB) were selected. Clinical plans were generated using tangential field-in-field 3D-CRT technique. VMAT plans were retrospectively created. Dosimetric evaluation was performed according to our clinical guidelines. A robustness evaluation of the 3D-CRT and VMAT plans against simulated anatomical and setup uncertainties was also performed. Differences between techniques were analysed using a two-sided Wilcoxon signed-rank test with a significance level of 0.05. RESULTS:Both the 3D-CRT and VMAT plans fulfilled the clinical requirements for target volumes and organs at risk. VMAT plans showed a median increase in heart mean dose of 10.8%, compared to 3D-CRT (p < 0.05). Heart maximum dose was reduced by up to 56.7% with VMAT (p < 0.05), offering a clinically meaningful advantage. For the ipsilateral lung, no significant difference in mean dose was observed, V16Gy was significantly lower and V4Gy was significantly increased with VMAT. VMAT plans improved dose conformity to the boost planning target volume, (p < 0.05). Median monitor units (MU) values of 371 MU (359-466 MU) vs 927 MU (752-1018 MU) were obtained with 3D-CRT and VMAT. VMAT remained robust to simulated uncertainties for whole-breast but showed greater sensitivity in the boost volume. INTERPRETATION:VMAT was a feasible alternative to 3D-CRT for whole-breast RT with SIB, improving boost dose-conformity and reducing maximum heart dose. However, VMAT requires careful dosimetric evaluation and robustness assessment.
BACKGROUND AND PURPOSE:Optimal postoperative follow-up for high-risk cutaneous melanomas (CM) is unclear. We aimed to evaluate disease recurrences in patients with stage III CM before modern adjuvant therapies. Patient/material and methods: Three hundred and fifty patients with a median follow-up of 8.9 years at Helsinki University Hospital Comprehensive Cancer Center after complete resection of stage IIIA-D CM between 2008 and 2017 were identified. Information on baseline characteristics, recurrence patterns and survival were collected from electronic medical records. RESULTS:One hundred and ninety patients (54.3%) developed disease recurrence with 258 recurrence events documented. Local recurrence occurred in 14.5, 27.0, 32.3 and 44.4% and distant metastases in 21.7, 40.5, 52.4 and 83.3% of patients with stage IIIA, IIIB, IIID and IIID, respectively. Median recurrence-free survival was not reached and 7.4 years in stage IIIA and IIIB compared to 2.9 and 0.9 years in IIIC and IIID. Routine computed tomography (CT) imaging revealed 51% of all recurrences and 64% of distant meta-stases. 13.2% of distant recurrences involved skin and soft tissues, 31.4 lungs, 34.0 other visceral organs and 21.5% brain. First recurrences occurred mostly during the first 2 years of follow-up (59.5-100% in stage IIIB-D) except for stage IIIA (45.0%). Most of recurrences detected by patients (58.0%), physical exams or ultrasound (76.1%) and routine CT (61.2%) occurred during the first 2 years. INTERPRETATION:High rate of recurrences and distant metastases supports routine physical exams and CT particularly during the first years of postoperative follow-up, especially in stage IIIB-D CM.
BACKGROUND AND PURPOSE:This study examined lung cancer patients' diagnostic pathways, focusing on first healthcare contact, general practice events, referral choice, and stage at diagnosis. PATIENTS AND METHODS:General practices in three Danish regions participated in a retrospective survey of medical records for patients diagnosed with lung cancer between March 2019 and February 2021. General practitioners completed a questionnaire on initial contact, symptom presentation, diagnostic events and first referral. Socioeconomic data and tumor stage were retrieved from national registers. Associations between symptom presentation and diagnostic events were analysed. RESULTS:Among 1069 patients, 72% had initial contact in general practice, 22% at a hospital and 5% with out-of-hours care. Of patients starting in general practice (n = 766), 36% presented specific cancer symptoms, 48% non-specific symptoms, 9% both and 7% were asymptomatic. Diagnostic events included hesitation to seek care (10%), declining investigation or non-adherence (4%) and initial management for another disease (33%). Men were more likely to decline investigation or fail to follow-up (odds ratio [OR] 4.32; 95% confidence interval 1.75-10.65). Non-specific symptoms increased the odds of referral for another condition (OR 1.48) or another cancer type (OR 2.99). Most patients were first referred to imaging (48%), whereas 16% entered a cancer care pathway and 18% were acutely hospitalised. Advanced stage was common (80%) and more likely among acutely hospitalised patients (OR 2.68). INTERPRETATION:Most lung cancer patients present first in general practice. Non-specific symptoms are frequent and pose challenges for timely diagnosis.
BACKGROUND AND PURPOSE:The introduction of immune checkpoint inhibitors (ICIs) into the treatment of patients with metastatic or recurrent cervical cancer has been shown to significantly prolong survival. In this study, we examined the clinical outcomes and tolerability of treatment with ICIs in patients with metastatic or recurrent cervical cancer in a real-world setting in Norway. Patient/material and methods: This retrospective cohort study included patients treated with an ICI in combination with chemotherapy or as single agent at Oslo University Hospital between 2016 and 2024. The primary oncological endpoint was progression-free survival (PFS). Secondary endpoints include overall survival (OS) as well as tolerability. RESULTS:We included 57 patients with a median age of 53 years and a median follow-up of 15.2 months. Thirty-five patients were treated with an ICI in combination with chemotherapy (cohort 1), and or an ICI alone (n = 22) (cohort 2). Forty-six patients (81%) were treated for recurrent disease. In cohort 1, the median PFS was 12.4 months (95% CI: 9.0-15.7), and the median OS was 27.5 months (95% CI: 18.0-37.1). In cohort 2, the median PFS was 3.7 months (95% CI: 2.4-5.0), and the median OS was 9.3 months (95% CI: 4.3-14.4). Nine patients (16%) discontinued treatment due to toxicity. INTERPRETATION:Our real-world data on the use of ICIs alone or in combination showed antitumour efficacy comparable to that reported in clinical studies in patients with advanced or recurrent cervical cancer. Our discontinuation rate highlights that toxicity management and mitigation are paramount when novel drugs are introduced in clinical algorithms.
BACKGROUND AND PURPOSE:Locoregional tumor control is strongly associated with survival for non-small cell lung cancer, emphasizing the importance of precise radiotherapy delivery. This study aims to evaluate a traffic light adaptation protocol regarding target coverage, protocol performance and patient outcomes. MATERIAL AND METHODS:From 2019 to 2022, we prospectively enrolled inoperable non-small cell lung cancer patients. We acquired daily cone-beam computed tomography and traffic light registrations, classifying anatomical changes and need of action. Using repeated computed tomography (rCT) in week 1 and 3 for dosimetric evaluation, we recalculated clinical target volume (CTV) D98% and V95% with and without adaptation, and compared traffic light registrations with the actual dose distribution. Protocol performance was evaluated by the sensitivity and specificity in detecting CTV V95% < 98%. RESULTS:Among 45 patients with complete registrations, baseline shift and tumor shrinkage were most common changes, leading to corrections from bone to tumor match in 37.8% and replanning in 13.3% of patients. Among 38 patients with at least one rCT, 15.8% would have received insufficient CTV coverage without adaptation. Protocol sensitivity, specificity and balanced accuracy were 83.3, 88.6, and 85.7%, respectively. For 38 stage II-III patients, median overall survival was 43.5 months (95% confidence interval [CI]: 32.9-54.1), median time to locoregional failure 27.4 months (95% CI: 0-61.8) and median estimated time to distant failure 30.7 months (CI not estimated due to censoring). INTERPRETATION:The protocol identified relevant changes, improving target coverage without increasing organ at risk doses. With appropriate training, protocol performance was good, and clinical outcomes were consistent with international results.
