OBJECTIVES: We described the ROB profile of neonatal RCTs published since the 1950s.
METHODS: We analyzed individual studies within the Cochrane Neonatal reviews published up to December 2016. We extracted the reviewers' judgments on the ROB domains including random sequence generation, allocation concealment, blinding, incomplete outcome data, and selective reporting. We evaluated blinding of personnel in trials in which blinding was considered feasible.
RESULTS: We assessed 1980 RCTs published between 1952 and 2016 from 294 Cochrane Neonatal systematic reviews, with full ROB assessments performed in 848 trials (42.8%). Among the ROB domains, the highest proportion of trials (73%) were judged as satisfactory ("low risk") in handling incomplete outcome data, while fewest trials achieved blinding of outcome assessor (38.4%). In the last 6 decades, a progressive increase has been observed in the proportion of trials that were rated as low risk in random sequence generation, allocation concealment, and selective reporting. However, blinding was achieved in less than half of the trials with no clear improvement across decades (23-44% since the 1980s).
CONCLUSIONS: Despite steady improvement in the overall quality of neonatal RCTs over the last 6 decades, blinding remained unsatisfactory in the majority of the trials.
METHODS: Detailed, retrospective clinico-pathological analysis of potentially malignant lesions undergoing malignant transformation, from a 590 patient cohort treated by interventional laser surgery and followed for a mean of 7.3 years, was undertaken. Clinical outcome was documented at study census date (31 December 2014).
RESULTS: A total of 99 patients (16.8%) developed cancer: 71 (12%) seen "unexpectedly" upon excision and 28 (4.8%) progressing to malignancy at a median of 87.3 months post-surgery. Thirty "unexpected" excisions were micro-invasive (42.3%) arising primarily in severely dysplastic precursors (75%) at ventro-lateral tongue and floor of mouth sites (54.5%); 1 patient (1.4%) had a cancer-related death, whilst 58 (81.7%) were disease free. A total of 19 of 28 "progressive" cancers (67.9%) arose at new sites, with erythroleukoplakia a significant predictor of malignancy (P = .0019). Nine (32.1%) developed at the same precursor site, with 6 (77.7%) on the ventro-lateral tongue and floor of mouth. Three (10.7%) were micro-invasive, 9 patients (32.1%) died from metastatic disease and 12 (42.9%) were disease free (P < .001).
CONCLUSION: Squamous carcinoma may arise at the site of a precursor lesion as transformation or new-site development via field cancerisation. Whilst interventional surgery facilitates early diagnosis and treatment of occult disease, thus reducing risk from same-site transformation, new-site cancer is a significant long-term risk for patients with potentially malignant disorder.
METHODOLOGY: This was a cross-sectional observational study done from November 2017 until December 2017 at ED Hospital Sultan Abdul Halim (HSAH), a 650-bedded tertiary hospital in the state of Kedah. All patients that were triaged to red zone, age 18 years and above, and involved in intra-hospital transfer to critical coronary unit, intensive care unit and wards were included. All cases were documented in proforma by the accompanying staff.
RESULTS: Among the 170 critically ill patients, only 29 patients (17.1%) experienced adverse events during intra-hospital transfer. The adverse events seen were hypotension (12.4%), desaturation (3.5%) and dislodged peripheral line (2.4%). Cardiorespiratory related diagnosis was the commonest presentation. Intra-hospital transfer during morning shift and evening shift has 79.5% (b=-1.59, OR=0.21, 95% CI: 0.06, 0.69, p=0.011) and 75.6% ((b=-1.41, OR=0.24, 95% CI: 0.08, 0.73, p=0.012) lesser odds of experiencing adverse events compare to night shift. Patients with vasopressor/inotropes had 9 times higher odds of experiencing adverse events during transportation, compared to patients with no vasopressor/inotropes (b=2.27, OR=9.70, 95% CI: 3.39, 27.72, p<0.001).
CONCLUSIONS: Critical care patients who are involved in intrahospital transfer were at risk of adverse events such as hypotension, desaturation and dislodge peripheral line. Risk identification and maintaining level of care is important to minimize the adverse events during transfer. Patients had higher rates of adverse events if they were transferred during night shifts and on inotropic/vasopressor support.