Primary - Efficacy of glycaemic control, extent this effect is maintained, Secondary - Compliance, satisfaction, quality of life (p. 11ff)
Reducing symptoms, reducing requirement for nutritional support or hospitalisation, improving quality of life (p. 1)
no a-priori outcomes defined
a. Efficacy: Observed risk of ulcer and amputation, diagnostic accuracy (Sensitivity, Specificity, positive and negative likelihood ratios, PPV, NPV, diagnostic odds ratios, ROC-curves, accuracy (p. 11)
Treatment outcome, quality of life, self-esteem, attitude to health, malocclusion, health behaviour, patient participation, patient satisfaction, patient compliance, tooth ankylosis, tooth eruption, tooth ectopic, tooth impacted, tooth injuries, tooth loss, tooth resorption, tooth unerupted, diastema, multiple and congenital abnormalities, jaw malformation, cleft lip or cleft palate or cleft face, tooth disease (p. 21ff)
a. Efficacy: Primary - Subjective sleepiness as assessed by the Epworth Sleepiness Scale, objective sleepiness as assessed by the Maintenance of Wakefulness Test, Osler test, Multiple Sleep Latency Test or equivalent measure Secondary - Blood pressure, cardiovascular disease (e.g. myocardial infarction, stroke), accidents (e.g. driving, occupational), quality of life, mood, anxiety and depression, simulated driving performance, neuropsychological functioning, apnoea–hypopnoea index /desaturation rate,<br>b. Safety: Any complications or adverse effects of treatment (p. 10)
a. Efficacy: Snoring recording and/or acoustic analysis of snoring sound (snoring, sleep disturbance and daytime sleepiness, mean snoring volume, snoring index, percentage of sleep time spent in loud snoring, maximal sound intensity, snore energy ratio), polysomnography (PSG) (apnoea/hypopnoea index (events/hour), apnoea index (AI; events/hour), duration of obstructive respiratory pattern (minutes), oxygen saturation of arterial blood (SaO2) nadir, sleep efficiency (percentage of time asleep compared with time spent in bed) and total sleep time), modified PSG or oximetry outcomes, cephalometric radiographs or MRI scans of palatal length or width, Epworth Sleepiness Scale/symptoms of daytime sleepiness, patient and partner questionnaires and/or linear analogue scales related to snoring severity (it is recognised that patient reported snoring outcomes are of dubious validity as patients will only be able to report on what they have been told by their bed partners), patient and partner questionnaires and/or linear analogue scales related to quality of life, questionnaires and/or linear analogue scales related to sleep quality of bed partner, need for further repeat procedures<br>b. Safety: short- and long-term complications of treatment (e.g. nasal reflux on swallowing, temporal mandibular joint pain, pain, speech, swallowing difficulties and pharyngeal irritation (p. 11ff)
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)
Safety, efficacy, diagnostic performance (p. 2)
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
- 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
a. Safety: Primary - catheter related bloodstream infection, Secondary–colonisation, clinical symptoms, local clinical signs, death<br>b. Efficacy: Primary - Catheter-related bloodstream infection avoided, case detected (p. 7)
no a-priori outcomes defined
a. Efficacy: Primary - Morbidity, mortality, quality of life, Impact on patient management: treatment instigated, treatment avoided, investigations avoided, Secondary - Length of hospital stay, length of intensive care stay (p. 30)<br>b. Safety: pulmonary artery rupture (fatal/non-fatal), other complications (pneumothorax, bleeding, arrhythmia, infection, insertion complications, surgery) (p. 30)
Primary - Efficacy of glycaemic control, extent this effect is maintained, Secondary - Compliance, satisfaction, quality of life (p. 11ff)
no a-priori outcomes defined
no a-priori outcomes defined
a. Efficacy: Union rate, time to fracture union, function, pain, quality of life<br>b. Safety: Morbidity (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)