no a-priori outcomes defined
Primary - Efficacy of glycaemic control, extent this effect is maintained, Secondary - Compliance, satisfaction, quality of life (p. 11ff)
clinical efficacy, relapse of head or neck cancer, mortality, incidence of treated persons (p. 4ff)
Toxicity outcomes for women by high-intermediate endometrial cancer
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)
a. Efficacy: Specialist Advisers key efficacy outcomes: Electrical isolation of 'all pulmonary veins' or 'all 4 pulmonary veins', procedure duration, freedom from atrial fibrillation, avoidance of repeat procedures and reduced use of anti -arrhythmic drugs<br>b. Safety: Specialist Advisers theoretical adverse events include death, atrio-oesophageal fistula permanent phrenic nerve palsy, damage to structures anatomically close to pulmonary veins, deep vein thrombosis (p. 3ff)
a. Safety: Adverse physical health outcomes as a consequence of the procedures (p. 82)<br>b. Efficacy: Primary – reduction in tear production, quality of life, Secondary – reoperation (p. 82)
a. Efficacy: Quality of life, complete wound closure, time to complete wound healing (skin closure without drainage or dressing requirements), improvements in wound care (infection, impact on the incidence of other problems, such as sepsis, edema, or amputation), satisfaction with treatment, duration of treatment, and survival, Intermediate outcomes: time to 50% reduction of wound volume, percent change in wound volume, and improved wound condition<br>b. Safety: Pain, bleeding, infection/ bacterial load, other complications, mortality (p. 50ff)
no a-priori outcomes defined
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)
Test performance, sensititvity, specivicity, psychometric properties (reliability, validity, responsiveness), patient outcome after test result (p. 3ff + 21)
no a-priori outcomes defined
a. Efficacy: Death (PAC monitoring in critical care settings), length of hospital stay, length of ICU stay, medical morbidities (e.g. cardiac or pulmonary events), duration of ventilation, quality of life using any quality of life measure of symptom relief, optimization of treatment (p. 12)<br>b. Safety: Associated with PAC use: Pneumothorax, bleeding, arrhythmia, infection, insertion complications, death, urgent surgery (p. 12)
a. Efficacy: CO2-Elimination, oxygenation, duration of mechanical ventilation, duration of intensive care, mortality, 6-months disability-free survival<br>b. Safety: complications (p. 9)
safety and efficacy/effectiveness of treating atrial fibrillation (p. 11) effect on heart rhythm, symptoms, quality of life, occurrence of complications, survival (p. 14)
no a-priori outcomes defined
Incidence of patient return electrode site burns, incidence of alternative site burns, incidence of post-operative pressure ulcers, use of the device in certain patient subgroups (p. 8)
no a-priori outcomes defined
a. Efficacy: Specialist Advisers key efficacy outcomes: Improved gait, reduction in effort when walking, reduction in pain and discomfort, reduction in falls, return to work and other quality of life outcomes<br>b. Safety: Specialist Advisers: Anecdotal adverse events including increase in seizure incidence among patients with epilepsy, autonomic dysreflexia in patients with spinal cord injuries, problems with computed tomography (CT) or magnetic resonance imaging (MRI) scanning with implanted electrodes, increases in spasticity or spasms, infection when using implanted systems, and skin intolerance; theoretical adverse events such as muscle fibrillation, problems caused by faulty equipment, or problems when treating pregnant women or patients who have a pacemaker (p. 2)
Early and delayed complications, patient satisfaction, quality of life, functionality, successful insertion rate (p. 1)