BACKGROUND: Heterogenous outcome reporting in non-muscle-invasive bladder cancer (NMIBC) effectiveness trials of adjuvant intervention after transurethral resection (TURBT) has been noted in systematic reviews (SRs). This hinders comparing results across trials, combining them in meta-analyses, and evidence-based decision-making for patients and clinicians. OBJECTIVE: We aimed to systematically review the extent of reporting and definition heterogeneity. METHODS: We included randomized controlled trials (RCTs) identified from SRs comparing adjuvant treatments after TURBT or TURBT alone in patients with NMIBC (with or without carcinoma in situ) published between 2000–2020. Abstracts and full texts were screened independently by two reviewers. Data were extracted by one reviewer and checked by another. RESULTS: We screened 807 abstracts; from 15 SRs, 57 RCTs were included. Verbatim outcome names were coded to standard outcome names and organised using the Williamson and Clarke taxonomy. Recurrence (98%), progression (74%), treatment response (in CIS studies) (40%), and adverse events (77%) were frequently reported across studies. However, overall (33%) and cancer-specific (33%) survival, treatment completion (17%) and treatment change (37%) were less often reported. Quality of Life (3%) and economic outcomes (2%) were rarely reported. Heterogeneity was evident throughout, particularly in the definitions of progression and recurrence, and how CIS patients were handled in the analysis of studies with predominantly papillary patients, highlighting further issues with the definition of recurrence and progression vs treatment response for CIS patients. Data reporting was also inconsistent, with some trials reporting event rates at various time-points and others reporting time-to-event with or without Hazard Ratios. Adverse events were inconsistently reported. QoL data was absent in most trials. CONCLUSIONS: Heterogenous outcome reporting is evident in NMIBC effectiveness trials. This has profound implications for meta-analyses, SRs and evidence-based treatment decisions. A core outcome set is required to reduce heterogeneity. PATIENT SUMMARY: This systematic review found inconsistencies in outcome definitions and reporting, pointing out the urgent need for a core outcome set to help improve evidence-based treatment decisions. Keywords:
SUMMARY Episodes of atrial fibrillation that occurred after meals developed in a 60 year old man with a history of ischaemic heart disease. The attacks were precipitated by precursors and metabolites of tyramine and tyramine containing foods and drinks, in the absence of monoamine oxidase inhibitors. The patient has remained free of atrial fibrillation for the past twelve months on a diet that does not contain tyramine. Case reportIn 1980, at the age of 56 years, our patient was admitted to the hospital with central chest pain radiating to the left arm and in fast atrial fibrillation. Electrocardiography showed Q waves and ST segment elevation in the anterior chest leads V1-V5, and the plasma activity of the cardiac enzymes was increased, confirming the diagnosis of acute anterior myocardial infarction with atrial fibrillation. A few hours later acute left ventricular failure developed. He was treated with digoxin, diuretics, and anticoagulants. He quickly improved and recovered and sinus rhythm returned. He was transferred from the coronary care unit to the medical ward where he convalesced for 10 days and made a good recovery. Investigations-that is full blood count, urea and electrolyte concentration, liver function and thyroid function tests-were normal. He was discharged home in sinus rhythm on the above drugs.He had a history of migraine in his twenties, which had been successfully treated by his general practitioner. There was no history of palpitation or heart disease nor of any psychiatric illness. He was married with three children and was a non-smoker. He drank two pints of beer a night and was not on any drugs. His father had died of heart disease at the age of seventy but there was no other relevant family history.Two months later when he was reviewed in the outpatient clinic his condition was good, he was in sinus rhythm, and he was not in heart failure. he was referred to the hospital after he developed attacks of palpitation and dyspnoea, and clinical examination disclosed atrial fibrillation and left ventricular failure, which were confirmed by electrocardiogram and chest x ray respectively. The dose of digoxin was increased to 250 dg/day and diuretics were started. He improved and was subsequently reviewed in the clinic and found to be in a stable condition and in sinus rhythm with a heart rate of 64 beats/min; the attacks of palpitation had become less frequent.In May 1983 during one of his clinic reviews he mentioned for the first time that some of the attacks of palpitation occurred after meals. When he was questioned more closely about foods he suspected he identified cheese, chocolate, red wine, and bananas. Later after he had been asked to note his food more closely, he mentioned that broad beans and some tinned food with preservatives had also precipitated palpitation. Urinary concentrations of catecholamines and 5-hydroxyindolacetic acid were normal, however.Th-ere was clearly some connection between the foods he mentioned and the palpitation which was not prevented by digoxin. A change...
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