AIMS AND METHODS: A randomised controlled, non-blinded, cross-over study involving 38 patients (with colostomies and ileostomies) compared the test device to a similar device from the same manufacturer but without the tape border. The main objective was to assess wear time for non-inferiority as a measure of efficacy. Secondary efficacy assessment included peristomal skin condition using the DET (discolouration, erosion and tissue growth) score and patient acceptability, which was assessed through questionnaires using Likert-scale options. Safety was assessed according to the incidence and intensity of device-related adverse events, and the condition of the peristomal skin.
RESULTS AND CONCLUSION: Analysis of results in the per-protocol population showed an average wear time of 4.5 days for both devices and demonstrated non-inferiority. DET scores were similar in both groups, and both had low rates of device-related adverse events, all of which related to peristomal skin. Patients said the devices were user friendly. While the two devices are similar, some patients may find one with an adhesive tape more suited to their needs.
METHODS: In this cross-over study, study participants were randomized to perform the initial peak expiratory flow (PEF) measurement in either standing or sitting position. The highest of three readings in each position were compared using paired t-test. A mean difference of
METHODS: This was a randomized crossover trial in a simulated clinical setting to compare the SÜPEVAC unit with standard hospital wall suction. Twenty-two fellows of the Australasian College for Emergency Medicine, the Australian and New Zealand College of Anaesthetists, or the College of Intensive Care Medicine were recruited. Outcomes were assessed via a structured survey and measuring the time to view the glottis.
RESULTS: This study found there was no significant difference between the SÜPEVAC unit and wall suction with regard to suction time (P = .762; 95% confidence interval, -0.683 to 0.338) or qualitative assessment via the survey.
CONCLUSIONS: The SÜPEVAC unit is comparable with wall suction in a clinical setting. Further research is warranted.
MATERIALS AND METHODS: A randomised prospective crossover study was designed to compare the AR Gynae endotrainer versus Karl Storz SZABO-BERCI-SACKIER laparoscopic trainer as a tool for training gynaecology laparoscopic skills. Participants were assigned to perform two specially designed tasks used for laparoscopic training using both endotrainers. All subjects evaluated both simulators concerning their performance by the use of a questionnaire comparing: design, ports placement, visibility, ergonomics, triangulation of movement, fulcrum effect, depth perception, ambidexterity, resources for training, and resources for teaching. The overall score was defined as the median value obtained. The ability and time taken for participants to complete the tasks using both endotrainers were also compared. A total of 26 participants were enrolled in this study, including 13 Masters's students from the Department of Obstetrics & Gynaecology and 13 Masters's students from the Department of Surgery, Hospital Universiti Sains Malaysia (HUSM), Kelantan, Malaysia.
RESULTS: A better performance was observed with AR Gynae as compared to Karl Storz endotrainer in five out of ten items evaluated in the questionnaire. Additionally, the overall score of AR Gynae endotrainer (median of 3.98) was comparable to that of Karl Storz endotrainer (median of 3.91) with p=0.519. For the items design and resources for teaching, the evaluation for AR Gynae endotrainer was significantly higher with p-values of 0.003 and 0.032, respectively. All participants were able to complete both tasks using both endotrainers. The time taken to complete both tasks was comparable on both endotrainers. Also, the AR Gynae endotrainer was cheaper.
CONCLUSIONS: The AR Gynae endotrainer was found to be a convenient and cost-effective laparoscopic simulator for gynaecology laparoscopic training and was comparable to the established Karl Storz SZABO-BERCI-SACKIER laparoscopic trainer.
METHODS: Records were identified by searching MEDLINE, EMBASE, PubMed, CINAHL, ClinicalTrials.gov, ISRCTN, CENTRAL, WHO ICTRP and the NIHR UK clinical trials gateway. The search included records published from 1946 to March 2020. Included studies were those as follows: (a) recruiting adults aged 18 years or older diagnosed with SSD of average threshold severity worse than 70 dB HL in the worse-hearing ear and normal (or near-normal) hearing in the better-hearing ear, (b) evaluating interventions to restore bilateral and/or binaural hearing and (c) enrolling those adults in a controlled trial, before-and-after study or cross-over study. Studies that fell just short of the participant eligibility criteria were included in a separate sensitivity analysis.
RESULTS: Ninety-six studies were included (72 full inclusion, 24 sensitivity analysis). For fully included studies, 37 exclusively evaluated interventions to re-establish bilateral hearing and 29 exclusively evaluated interventions to restore binaural hearing. Overall, 520 outcome domains were identified (350 primary and 170 secondary). Speech-related outcome domains were the most common (74% of studies), followed by spatial-related domains (60% of studies). A total of 344 unique outcome instruments were reported. Speech-related outcome domains were measured by 73 different instruments and spatial-related domains by 43 different instruments. There was considerable variability in duration of follow-up, ranging from acute (baseline) testing to 10 years after the intervention. The sensitivity analysis identified no additional outcome domains.
CONCLUSIONS: This review identified large variability in the reporting of outcome domains and instruments in studies evaluating the therapeutic benefits and harms of SSD interventions. Reports frequently omitted information on what domains the study intended to assess, and on what instruments were used to measure which domains.
TRIAL REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): Registration Number CRD42018084274 . Registered on 13 March 2018, last revised on 7th of May 2019.
RESULTS: The GI of the calamansi drink tested was calculated as 37, a value within the range of low GI foods. Trial registration Clinical Trials identifier NCT04462016; Retrospectively registered on July 1, 2020.
SUBJECTS AND METHODS: Twenty-six second-year undergraduate audiology students participated. A cross-over study design was used. All students initially attended two hours of seminar and role-play sessions. They were then divided into three types of training, 1) SP training (Group A), 2) SP with feedback (Group B), and 3) a non-additional training group (Group C). After two training sessions, the students changed their types of training to, 1) Group A and C: SP training with feedback, and 2) Group B: non-additional training. All the groups were assessed at three points: 1) pre-test, 2) intermediate, and 3) post-test. The normalized median score differences between and within the respective groups were analysed using non-parametric tests at 95% confidence intervals.
RESULTS: Groups with additional SP trainings (with and without feedback) showed a significantly higher normalized gain score than no training group (p<0.05).
CONCLUSIONS: The SP training (with/ without feedback) is a beneficial learning tool for history taking to students in audiology major.
MATERIALS AND METHODS: In this trial, a total of 56 eligible subjects were randomly assigned to the fasting group and the postprandial group. The two groups were given 250 mg of the test and reference preparation, respectively. Liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was applied to determine the plasma concentration of cefalexin. PhoenixWinNonlin software (V7.0) was used to calculate the pharmacokinetic parameters of cefalexin using the non-compartmental model (NCA), and the bioequivalence and safety results were calculated by SAS (V9.4) software.
RESULTS: The main pharmacokinetic parameters of the test and reference preparations were as follows, the fasting group: Cmax 12.59 ± 2.65 μg/mL, 12.72 ± 2.28 μg/mL; AUC0-8h 20.43 ± 3.47 h×μg/mL, 20.66 ± 3.38 h×μg/mL; AUC0-∞ 20.77 ± 3.53 h×μg/mL, 21.02 ± 3.45 h×μg/mL; the postprandial group: Cmax 5.25 ± 0.94 μg/mL, 5.23 ± 0.80 μg/mL; AUC0-10h 16.92 ± 2.03 h×μg/mL, 17.09 ± 2.31 h×μg/mL; AUC0-∞ 17.33 ± 2.09 h×μg/mL, 17.67 ± 2.45 h×μg/mL.
CONCLUSION: The 90% confidence intervals of geometric mean ratios of test preparation and reference preparation were calculated, and the 90% confidence intervals of geometric mean ratios of Cmax, AUC0-10h, and AUC0-∞ were within the 80.00% ~ 125.00% range in both groups. Both Cmax and AUC met the pre-determined criteria for assuming bioequivalence. The test and reference products were bioequivalent after administration under fasting as well as under fed conditions in healthy Chinese subjects. This study may suggest that successful generic versions of cefalexin not only guarantee the market supply of such drugs but can also improve the safety and effectiveness and quality controllability of cefalexin through a new process and a new drug composition ratio.
MATERIALS AND METHODS: A randomized, 2-treatment, 2-period, 2-sequence, single dose, crossover with a washout period of 2 weeks, was conducted in 24 healthy Thai male volunteers. Blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h following drug administration. Plasma concentrations of risperidone and 9-hydroxyrisperidone were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of risperidone and 9-hydroxyrisperidone were determined using a non-compartmental model.
RESULTS: The geometric means ratios (%) and 90% confidence interval (CI) of the test and reference products for the log-transformed pharmacokinetic parameters, Cmax, AUC0-t and AUC0-inf of risperidone were 104.49 % (92.79% - 117.66%), 100.96 % (92.15% - 110.61 %) and 97.99 % (90.72% - 105.85%). The 90% CI of geometric means ratios of the test and reference products for the log-transformed pharmacokinetic parameters, Cmax, AUC0-t and AUC0-inf of 9-hydroxyrisperidone were 97.00%, 96.97% and 97.49%.
CONCLUSIONS: The 90% CI for the geometric means ratios (test/reference) of the log-trasformed Cmax, AUC0-t and AUC0-inf of risperidone and its major active metabolite were within the bioequivalence acceptance criteria of 80% - 125% of the US-FDA.