主要结果指标
1. Percentage of participants with disease status reported as one of the categorical descriptions at Baseline [at Baseline]
Only patients with disease status reported as one of the five categorical descriptions below are included in this observation:
fully active/able to carry on all pre-disease activities without restriction (0)
restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work (1)
ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities (2)
capable of only limited self care, confined to bed/chair >50% of waking hours (3)
completely disabled, cannot carry on any selfcare, totally confined to bed or chair (4)
dead (5)
2. Percentage of participants with disease status reported as one of the categorical descriptions at 12 Months [at 12 Months]
Only patients with disease status reported as one of the five categorical descriptions below are included in this observation:
fully active/able to carry on all pre-disease activities without restriction (0)
restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work (1)
ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities (2)
capable of only limited self care, confined to bed/chair >50% of waking hours (3)
completely disabled, cannot carry on any selfcare, totally confined to bed or chair (4)
dead (5)
3. Percentage of participants with disease status reported as one of the categorical descriptions at 24 Months [at 24 Months]
Only patients with disease status reported as one of the five categorical descriptions below are included in this observation:
fully active/able to carry on all pre-disease activities without restriction (0)
restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work (1)
ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities (2)
capable of only limited self care, confined to bed/chair >50% of waking hours (3)
completely disabled, cannot carry on any selfcare, totally confined to bed or chair (4)
dead (5)
次要成果指标
1. Mean Number of Referrals or Specialist Visits to Assess the Health Resource Utilization in Patients with Diffuse TGCT through 24 Months [at Baseline, 12 Months, 24 Months]
Categories: Baseline, 12 Months, 24 Months
2. Mean Brief Pain Inventory (BPI) Average Interference Score From Baseline through 24 Months [Baseline, 6, 12, 18 and 24 months]
The BPI short form is a 5 minutes self administered questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. The change from baseline at each time point reflects the month X value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Categories (scores on a scale): at Baseline, at Month 6, at Month 12, at Month 18 and at Month 24
3. Mean Worst Stiffness Score from Baseline through 24 Months [Baseline, 6, 12, 18 and 24 months]
The Worst Stiffness numerical rating scale (NRS) is a one-item self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine").
Categories (scores on a scale): at Baseline, at Month 6, at Month 12, at Month 18 and at Month 24
4. Mean PROMIS Physical Function Score from Baseline through 24 Months [Baseline, 6, 12, 18 and 24 months]
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures, developed by the US Department of Health and Human Services, that evaluates and monitors physical, mental, and social health. Physical function items relevant to the assessment of lower and upper limb function are to be selected from the PROMIS physical function item bank. Items assessing lower limb function will be administered to subjects with lower extremity tumors, and items assessing upper limb function will be administered to subjects with upper extremity tumors. The results from both sets of items will be combined and analyzed together.
Categories (scores on a scale): at Baseline, at Month 6, at Month 12, at Month 18 and at Month 24
5. Mean Scores on the EuroQol Questionnaire (EQ) of 5 Dimensions (5D) on a Standardized 5-level (5L) Descriptive Health Status Scale (EQ-5D-5L), from Baseline through 24 Months [Baseline, 6, 12, 18 and 24 months]
The EQ-5D questionnaire is made up for two components; health state description and evaluation.
The EQ-5D-5L is the health state description for measuring health status. The descriptive system comprises the 5 dimensions of mobility, self care, usual activities, pain/discomfort, and anxiety/depression. The participants self-rate each dimension on a 5-point, categorical scale: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Categories (scores on a scale): at Baseline, at Month 6, at Month 12, at Month 18 and at Month 24
6. Mean Scores on the EQ-5D Visual Analogue Scale (EQ VAS) Evaluation, from Baseline through 24 Months [Baseline, 6, 12, 18 and 24 months]
The EQ-5D questionnaire is made up for two components; health state description and evaluation.
The EQ VAS is the evaluation that records the respondent's self-rated health on a 20 cm vertical, VAS with ends labeled "the best health you can imagine" and "the worst health you can imagine".
Categories (scores on a scale): at Baseline, at Month 6, at Month 12, at Month 18 and at Month 24
