no a-priori outcomes defined
Test performance, sensititvity, specivicity, psychometric properties (reliability, validity, responsiveness), patient outcome after test result (p. 3ff + 21)
no a-priori outcomes defined
no a-priori outcomes defined
no a-priori outcomes defined
a. Efficacy: Mortality/Survival, pre-ulcer lesions, time to foot ulcer, foot ulceration, amputation, time to amputation, mobility restriction, long-term mobility, general functioning, quality of life, independence, healing, deformity (p. 3)
no a-priori outcomes defined
Healing rates, durations of treatment (including debridement) needed to achieve healing, quality of life measures (including quality of life if wounds heal only partially) (p. 3)
no a-priori outcomes defined
a. Efficacy: Mortality/Survival, pre-ulcer lesions, time to foot ulcer, foot ulceration, amputation, time to amputation, mobility restriction, long-term mobility, general functioning, quality of life, independence, healing, deformity (p. 3)
a. Safety: Safety outcomes, including adverse events (diabetic ketoacidosis, severe hypoglycaemia)or complications (infections, pump malfunction);<br>b. efficacy and effectiveness outcomes include glycaemic control (e.g., glycosylated haemoglobin), patient satisfaction and quality of life, secondary complications of diabetes, neuro-cognitive function and behaviour changes in children if applicable, pregnancy outcomes if applicable (p. 48)
no a-priori outcomes defined
a. Efficacy: Mortality, morbidity (symptom burden, symptom improvement, time to healing), quality of life (patient-based outcomes, such as cosmetic appearance, QoL or depression scores), resource use (e.g. length of hospital stay), return to normal activities, recurrence and tumour response measures<br>b. Safety: Adverse events (ulceration of the underlying tissues, haemoptysis, scarring, carcinogenicity, oesophageal strictures, cardiac complications, nausea, inflammation, pain, constipation) (p. 8)
Discard rates of non-viable kidneys, delayed graft function (DGF) (incidence and duration) is defined as the need for dialysis in the first 7 days following transplantation, primary non-function (incidence): PNF is defined as the state of a graft that has never functioned post-transplant, graft rejection rates, graft function (glomerular filtration rate, serum creatinine concentration, urinary output), patient survival, graft survival, health-related quality of life, cost-effectiveness (p.13)
a. Efficacy: mortality, side effects, long term survival (-overall, -cancer-specific, -without metastasis, -without second treatment, -without biochemical or disease relapse), long-term side effects, quality of life (p. 6)<br>b. Safety: Operative and postoperative complications (p. 6)
a. Efficacy: Clinical (surrogate parameters): PSA-kinetics, histology; patient-relevant outcomes: 5-year survival, disease-free survival, overall survival, quality of life<br>b. Safety: Morbidity: acute/ chronic urinary dysfunction, urinary incontinence, strictures/ stenosis (bladder neck, ureter), erectile dysfunction, recto-urethral fistula, chronic pain, mortality (p. 13)
a. Efficacy: Primary - mortality/survival, ulceration, amputation, recurrence rates, mobility restriction, quality of life, independence, long term mobility, healing,<br>Secondary - Percentage healing, general functioning, deformity and pre-ulcer lesions, hospitalisation, average length of stay<br>b. Saftey: harms, side effects (p. 497)
Efficacy and safety, risk of clinical myocardial infarctions (p. 6)
- Outcome measures for communication needs and function such as Client Oriented Scale of Improvement (COSI), Expected consequences of Hearing Aid Ownership (ECHO)<br>- Self-report measures such as Abbreviated Profile of Hearing Aid Benefit (APHAB), haring
Benefits in everyday life i.e. quality of life, communication abilities, adherence data, reference, and willingness-to-pay (p. 26)