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BACKGROUND: The role of adjuvant treatment in the intermediate-risk group of patients with early-stage cervical cancer is controversial and is supported by a single randomized Gynecologic Oncology Group (GOG) 92 study performed more than 20 years ago. Recent retrospective studies have shown excellent local control in this group of patients after radical surgery with no additional adjuvant treatment. PRIMARY OBJECTIVE: To evaluate if adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with intermediate-risk cervical cancer. STUDY HYPOTHESIS: Radical surgery alone is non-inferior to the combined treatment of radical surgery followed by adjuvant (chemo)radiation in disease-free survival in patients with intermediate-risk cervical cancer. TRIAL DESIGN: This is a phase III, international, multicenter, randomized, non-inferiority trial in which patients with intermediate-risk cervical cancer will be randomized 1:1 into arm A, with no additional treatment after radical surgery, and arm B, receiving adjuvant external beam radiotherapy±brachytherapy ± concomitant chemotherapy. Patient data will be collected over 3 years post-randomization of the last enrolled patient for primary endpoint analysis or for 6 years for the overall survival analysis. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients with intermediate-risk early-stage cervical cancer (IB1-IIA), defined as lymph node-negative patients with a combination of negative prognostic factors (tumor size >4 cm; tumor size >2 cm and lymphovascular space invasion; deep stromal invasion >2/3; or tumor-free distance <3 mm) with squamous cell carcinoma or human papillomavirus (HPV)-related adenocarcinoma, are eligible for the trial. PRIMARY ENDPOINT: Disease-free survival defined as time from randomization to recurrence diagnosis. SAMPLE SIZE: 514 patients from up to 90 sites will be randomized. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: It is estimated that the accrual will be completed by 2027 (with 3 additional years of follow-up) and primary endpoint results will be published by 2031. Estimated trial completion is by 2034. TRIAL REGISTRATION: NCT04989647.
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INTRODUCTION: A deeper understanding of personality specifics in military personnel may increase the efficacy of health care professionals in this field. Changes in modern warfare require army officers to make decisions in complicated situations with increasing levels of autonomy. Character is traditionally regarded as a key quality in these dynamics. However, it remains unclear which character strengths are conducive to effective leadership in the military. The present study aims at mapping Czech Army cadets' and professional soldiers' perceptions of the character strengths of those officers, who they consider the best they served under. The study also examined how these perceptions vary across soldiers at different stages of their careers and how much they overlap with the same soldiers' ratings of their own strengths. In addition, a regression analysis, to outline combinations of strengths for various aspects of character-based leadership, was performed. MATERIALS AND METHODS: Respondents (N = 199) were recruited from three different subpopulations of the Czech Army-serving members of two reconnaissance units (N = 38), and 1st (N = 81) and 5th (N = 80) year cadets at the University of Defense. They rated the character strengths of chosen officers and themselves on the Character Strengths Leadership Inventory and the Values in Action Inventory of Strengths Revised. This study was approved by the units' commanding officer and the representatives of the University of Defense. RESULTS: Subordinates rated honesty, leadership, perspective, teamwork, fairness, creativity, love of learning, and zest highest in their chosen officers. These officers' mean profiles strongly correlated in all the three groups (rs = .82-.86). The mean correlation between officers' and respondents' self-reported strengths was not strong (rs = .18). Multiple regression models of the perception of an officer's success, success of their team, them as a leadership example, and them as having a good character, most frequently, involved fairness, honesty, kindness, and social intelligence, while forgiveness was negatively associated with these parameters. CONCLUSIONS: The present study achieved its aims. First, it suggests the officers' character strengths that tend to be most valued by their subordinates among Czech Army cadets and soldiers serving in reconnaissance units. Second, the strong overlap of best officers' character profiles in all groups suggests that this perception may remain stable throughout a soldier's career. Third, the relationship between chosen officers' and respondents' self-reported strengths was negligible, suggesting that the perception of officer's strengths may not be an individual's projection. Fourth, regression models of character-based leadership proposed a combination of character strengths that may contribute to the officer's perceived efficacy. Compared to other studies, the sample included both cadets and military professionals with a proportional number of females being included. These results imply that health care practitioners working with military clients may benefit from the acknowledgment of their specific character strengths, most notably honesty and fairness, while providing care to this population.
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BACKGROUND: Outcome measurement is an essential part of the evaluation of palliative care and the measurements need to be reliable, valid and adapted to the culture in which they are used. The Integrated Palliative Outcome Scale (IPOS) is a widely used tool for assessing personal-level outcomes in palliative care. The aim of this study was to provide Czech version of IPOS and assess its psychometric properties. METHODS: Patients receiving palliative care in hospice or hospitals completed the IPOS. The reliability of Czech IPOS was tested with Cronbach alpha (for internal consistency), the intraclass correlation coefficient for total IPOS score and weighted Kappa (for test-retest reliability of individual items). Factor analysis was used for elucidating the construct (Exploratory Factor Analysis). Convergent validity was tested with correlation analysis (Spearman correlation) in a part of the sample, who completed also the Edmonton Symptom Assessment System (ESAS) and the Palliative Performance Scale (PPS). RESULTS: The sample consisted of 140 patients (mean age 72; 90 women; 81% oncological disease). The Cronbach alpha was 0.789; intraclass correlation was 0.88. The correlations of IPOS with ESAS was R = 0.4 and PPS R = - 0.2. Exploratory factor analysis revealed a 2-factor solution on our data. The first factor covers emotional and information needs and the second factor covers physical symptoms. CONCLUSION: Czech IPOS has very good reliability regarding both internal consistency and test-retest reliability. Together with an item analysis results, we can conclude that the Czech adaptation of the tool was successful. The convergent validity needs to be assessed on the larger sample and the proposed 2-factor internal structure of the questionnaire has to be confirmed by using CFA.
