a. Efficacy: Primary - symptom score, Secondary - urodynamic (peak urine flow rate, mean urine flow rate, total voided volume, residual volume, detrusor pressure), prostate size, quality of life score<br>b. Safety: Complications: intraoperative complications, co-interventions, clot retention, cardiovascular events, transurethral resection syndrome, blood transfusion, septicaemia, urinary retention, recatheterisation, urinary tract infection (including epididymitis), irritative urinary symptoms, incontinence, retrograde ejaculation, erectile dysfunction, stricture, reoperation rate, mortality (p. 24)
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 of procedure, sequence of use, harms of intervention (p. 4ff)
Successful revascularisation, occurrence of restenosis, avoidance of major adverse cardiac events, including death, myocardial infarction and stroke, restenosis (measuring late lumen loss, presence of coronary stenosis greater than 50% = binary restenosis) (p. 6)
Effect on wound healing (healing time, reduction of wound surface, skin graft healing time), length of stay in hospital, mortality, side effects or complications (p. 2)
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)
a. Efficacy: Evidence of bridging on radiograph (3 out of 4 cortices bridged), fracture healing time, return to painless weight bearing, avoidance of further surgery<br>b. Safety: device-related adverse events (p. 6)
Risks inherent in these technologies, the qualifications required to use the devices (p. xii)
no a-priori outcomes defined
Efficacy, healing (radiological/clinical), stability of the bone, loss-of-reduction, function/quality of life, complications related to fracture (pain, infection, reinterventions rate) (p. 28,65)
a. Safety: Primary - major complications (migration, oesophageal/gastrointestinal obstruction or perforation); minor complications (gastric erosion, ulceration, nausea, electrolytic abnormalities), Secondary - technical failure, bursting of the balloon (p. 48)<br>b. Effectiveness: Primary - short- and long-term weight loss, BMI, waist size, skinfold thickness, fat free mass, quality of life, mortality (all cause), obesity-related co-morbidities, Secondary - technical failure (p. 63)
no a-priori outcomes defined
Primary- Number of women cured, number of women cured or improved (this outcome is henceforth referred to in the text as improvement), adverse events, condition-specific (and generic measures of health-related) quality of life, Secondary - Quantification of symptoms (number of incontinent episodes over24 hours, number of pad changes over 24 hours, mean volume or weight of urine loss on pad test, number of micturitions over 24 hours), participant satisfaction or desire for further treatment, Long-term data (number of women having incontinence surgery, return of symptoms/recurrence), socioeconomic measures, other intermediate, explanatory or treatment specific outcomes (measure of pelvic floor muscle function, treatment adherence, volume and type of fluid intake or change in body mass index) (p. 32)
Primary- Number of women cured, number of women cured or improved (this outcome is henceforth referred to in the text as improvement), adverse events, condition-specific (and generic measures of health-related) quality of life, Secondary - Quantification of symptoms (number of incontinent episodes over24 hours, number of pad changes over 24 hours, mean volume or weight of urine loss on pad test, number of micturitions over 24 hours), participant satisfaction or desire for further treatment, Long-term data (number of women having incontinence surgery, return of symptoms/recurrence), socioeconomic measures, other intermediate, explanatory or treatment specific outcomes (measure of pelvic floor muscle function, treatment adherence, volume and type of fluid intake or change in body mass index) (p. 32)
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)
Risks inherent in these technologies, the qualifications required to use the devices (p. xii)
Primary - Level of satisfaction, Secondary – Surrogate Outcomes for Satisfaction: Major problem resolved/improvement of health state/menstrual symptoms successfully treated/degree of recommendation, bleeding scores, amenorrhoea rate, heavy bleeding rate, EQ-5D utility score, SF-36 scores, postoperative pain score, time to return to work/normal activities/sexual activity, discontinuing use of Mirena (p. 12ff)
a. Efficacy: Specialist advisers key efficacy outcomes: survival, duration of mechanical ventilation, intensive care unit stay, total hospital stay, reduction in ventilation volume pressure and carbon dioxide removal)<br>b. Safety: Specialist advisers key safety outcomes: Vascular access damage, bleeding (including intracerebral haemorrhage), infection and complications requiring major surgery. theoretical adverse events = gas embolism, haemolysis and heparin-induced thrombocytopenia (p. 5)
a. Efficacy: clinical neurological status after 3 months, overall survival (1-3 months), clinical neurological status after 1 month, surrogate: successful recanalization of the intracerebral artery<br>b. Safety: Rate of symptomatic intracerebral bleeding, device-related complications (p. 13)