no a-priori outcomes defined
no a-priori outcomes defined
Mortality due to CHD, all-cause mortality, and morbidity measures such as hospitalisation, change in angina severity classification (CCS classification), change in heart failure severity classification (NYHAclassification), diuretic dose (in heart failure), exercise duration on treadmill, time to 1-minute ST segment depression, peak oxygen consumption [volume of oxygen uptake (VO2)] and health-related quality of life (HRQoL) (p. 5)
Mortality, haemorrhage postoperatively/ post-tonsillectomy: primary or immediate (<24h) and secondary or delayed (>24h) (p. 1)
a. Efficacy: Specialist Advisers: Patient survival, tumour response on follow-up imaging, local tumour control, time to disease progression, improvement in health-related quality of life, reduction in tumour-related symptoms<br>b. Safety: Specialist Adviser: Anecdotal adverse event of sepsis, theoretical adverse events such as tumour seeding, bronchopleural fistula, residual necrotic tissue and changes such as fibrosis (p. 3ff)
a. Efficacy: Special Advisers: Increase in overall and relapse-free patient survival, local tumour control, tumour response, improved response rates<br>b. Safety: Special Advisers: Theoretical adverse events such as damage to major arteries or veins, bowel injury (stomach, duodenum, or small or large bowel), pancreatic leak, sepsis, infection or abscess, haemorrhage (p. 3ff)
a. Efficacy: Specialist Advisers: Local tumour control, time to progression, patient survival<br>b. Safety: Specialist Adviser: Theoretical adverse events such as damage to surrounding organs, minor bleeding, sepsis and ureteric stricture (p. 3ff)
a. Efficacy: Prognostic outcomes: Observed risk of clinical outcomes (eg mortality/survival, ulcer healing, time to healing, amputation, time to amputation, mobility restriction, general functioning, quality of life, independence)<br>Diagnostic accuracy: Sensitvity, specificity, positive and negative likelihood ratios, positive and negative predivtive values, doagnostic odds ratio, ROC curves, accuracy (p. 77)
no a-priori outcomes defined
no a-priori outcomes defined
no a-priori outcomes defined
a. Efficacy: technical success of catheter insertion and drainage procedure, resolution of symptoms (bloating, nausea, acid reflux, reduced appetite, negative perception of body image and resulting psychological distress), quality of life outcomes, drainage frequency, resource use outcomes (for example re-admission rates, re-interventions and duration of hospital stay)<br>b. Safety: adverse events (catheter site infections, peritonitis, catheter occlusion, haemorrhage or bowel perforation when the device is inserted) (p. 6)
Efficacy: mortality, morbidity, QoL (p. 14ff)
a. Safety: physical harms from testing, e.g. allergy to electrode adhesive<br>b. Efficacy patient relevant: survival/mortality rate, resolution/reduction of symptoms (e.g. snoring excessive daytime sleepiness, witnessed apnoea episodes), disease specific quality of life Surrogate: respiratory events, number of apnoeas or hypopnoeas (e.g. AHI, RDI), oxygen saturation (e.g. ODI), sleep time and efficiency (e.g. sleep stage duration/quality), control of morbidities (e.g. hypertension, HbA1c control, heart failure outcomes) (p. 43ff/114), Diagnostic accuracy: sensitivity specificity, accuracy, negative predictive value, positive predictive value, area under the curve (AUC), positive likelihood ratio, negative likelihood ratio, level of agreement, diagnostic odds ratio, summary receiver operator characteristic curve (p. 47)
Efficacy: mortality, morbidity, QoL (p. 14ff)
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)
Primary - Retinal detachment (RD) in the eye(s) exposed to prophylactic intervention, Secondary - Adverse events relating to the intervention, blindness (by self-assessment, or being registered or legally blind), time to RD, presence and type of lesions or retinal tears (as these may constitute a precursor for RD) (p. 8)
no a-priori outcomes defined
no a-priori outcomes defined
a. Efficacy: Postoperative limb alignment, Length of time to revision, Recovery times/length of stay in hospital, Patient satisfaction: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) functional knee score; Oxford knee score; Crosby & Insall score; Knee Society Score; Short-Form-36 (SF-36) Health Survey; Bartlett Patellar Score; pain (Visual Analogue Scale); quality of life<br>b. Safety: Infection/fracture through pin site, Complication rates, Blood loss, Thromboembolic effect, Revision rate, economics: Duration of surgery/case (p. 9)