Objectives: To ensure reliable, valid assessments of patients' Health-Related Quality of Life (HRQOL), it is important to use psychometrically robust instruments. In the context of rare diseases, such as metastatic MCC (mMCC), disease-specific instruments are often not available, so instruments from related diseases are used. Previously, the psychometric performance of FACT-M was documented in a cohort of patients with mMCC whose disease progressed after chemotherapy. This study aims to confirm the psychometric performance of FACT-M in patients with mMCC who were either treatment naive or had previously received chemotherapy. Methods: Based on a previously published qualitative analysis, it was confirmed that patients with mMCC, whether treatment naive or previously treated, had similar experiences and concepts associated with their disease. Patient-report outcomes (PRO) data were pooled (n=173) from the single-arm, phase 2 JAVELIN Merkel 200 trial (NCT02155647) from part A (previously treated, n=70) and part B (treatment naive, n=103). Cronbach a was used to assess internal consistency reliability. Convergent validity was assessed using correlations with EQ-5D items. Knowngroups validity was explored using ECOG performance status (PS) 0 vs 1. Results: Cronbach a for all FACT-M scales was excellent, ranging between 0.80 (emotional well-being) and 0.95 (FACT-M total score). As expected, FACT-M subscale scores generally correlated highest with EQ-5D items that measured similar constructs, suggesting good concurrent validity. Known-groups validity analyses showed that the FACT-M differentiated well between ECOG PS 0 and 1. For all subscales, patients with ECOG PS=1 had worse scores compared to ECOG PS=0, with p,0.05 except for social well-being. Conclusions: In the context of rare diseases, which often have limited data available for instrument validation, this analysis confirmed the previously established psychometric performance of FACT-M in patients with mMCC regardless of prior treatment status, reaffirming its suitability for this patient population.
Background: Clavicle fractures are representing 2.6% of total body fractures. The common fracture is the midshaft fracture of the clavicle. The outcomes of non-operative treatment are not preferred nowadays, so the trend to surgical treatment of these fractures has grown.
The aim of the work:The current study aimed to compare the outcomes of conservative and operative treatment of displaced midshaft clavicular fractures with plate fixation to clarify the merits and possible disadvantages of each method.Patients and Methods: Twenty patients as a convenient sample were included. These patients were subdivided into two groups, group I for conservative treatment and group II for operative treatment with plate fixation. All patients will be subjected to complete history taking, clinical, general &local examination, a standard anteroposterior view of the clavicle was done and follow up average 6 months.Results: At the end of follow up period, according to Constant Shoulder Score (CSS), 11 patients had excellent results (CSS: < 11), 4 patients had good results (CSS: 11-20), 3 patients had fair results (CSS: 21-30), 2 patients had poor results (CSS: >30). Pain VAS was significantly higher in group I compared with group II. There is a significant difference found between the groups as regard (outcome, pain VAS, the strength of abduction and the extent of internal rotation) P value < 0.05. There is no significant difference found between the groups as regard (socio-demographic data, comorbidities, fracture characteristics, fractures classification, degree of forward flexion, degree of lateral elevation and extent of lateral rotation) P value >0.05.
Conclusion:Operative treatment with plate fixation is better than conservative treatment in management of pain, high union rate, good functional outcomes and greater patients satisfactory after displaced mid shaft clavicular fractures.
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