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Cardiovascular Risk Factors
Published in Nicole M. Farmer, Andres Victor Ardisson Korat, Cooking for Health and Disease Prevention, 2022
Consumption of a Mediterranean diet is associated with a lower risk of CVD. The PREDIMED trial involved the randomization of 7,447 participants between 55 and 80 years of age who were at high cardiovascular risk to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. After a median follow-up of 4.8 years, the PREDIMED study found that consumption of the intervention diets led to a significant reduction in cardiovascular-related events (stroke) (Estruch et al., 2018). However, all three diets led to a decrease in SBP, with the Mediterranean diets leading to further decrease in DBP than the low-fat control diet (Toledo et al., 2013).
Meta-Analysis of Dose-Response Relationships
Published in Christopher H. Schmid, Theo Stijnen, Ian R. White, Handbook of Meta-Analysis, 2020
Nicola Orsini, Donna Spiegelman
Here, we compare a dose-response analysis of multiple prospective studies based on individual participant data with that of the summarized data. For illustrative purposes, we use data from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute. The SEER program provides data about cancer statistics from several population-based registries in the USA (http://seer.cancer.gov) from San Francisco-Oakland, Connecticut, Metropolitan Detroit, Hawaii, Iowa, New Mexico, Seattle, Utah, and Metropolitan Atlanta that here are considered as different studies. Analysis are based on nine studies of prognostic factors for breast cancer survival including a total of 84,404 women. Year of breast cancer diagnosis ranged from 1988 to 1997. During 554,812 person-years, 8520 women died from breast cancer. Median follow-up time was about six years in all of the studies. The same source of data has been used to illustrate dose-response meta-analysis of individual participant data using fractional polynomials (Sauerbrei and Royston, 2011).
Endarterectomy for Asymptomatic Carotid Artery Stenosis
Published in Juan Carlos Jimenez, Samuel Eric Wilson, 50 Landmark Papers Every Vascular and Endovascular Surgeon Should Know, 2020
Juan Carlos Jimenez, Samuel Eric Wilson
Follow-Up Patients were entered between December 1987 and December 1993. Publication of results occurred in 1995.1 After randomization the patients were seen at 1 month and then at 3-month intervals alternating between telephone and clinic visits. At conclusion of the study, the median follow-up interval was 2.7 years with 4,657 patient years of observation.
Is PSA Still the Best Predictor for Biochemical Recurrence after Radical Prostatectomy in High-Risk Prostate Cancer?
Published in Journal of Investigative Surgery, 2022
Serkan Akan, Numan Doğu Güner, Caner Ediz, Aytaç Şahin, Ayhan Verit
A total of 102 patients aged between 52 and 75 years were enrolled in the study. Mean age of the patients was 64.12 ± 4.55 years old. Minimum, maximum, and mean tPSA levels were 2.1 ng/ml, 61 ng/ml, and 19.74 ± 13.34 ng/ml, respectively. Mean MPCI was 33.65 ± 22.78%, and MPCI ranged from 5% to 100%. At the third month, minimum, maximum, and mean tPSA levels were 0, 18.7 ng/ml, and 0.35 ± 1.90 ng/ml, respectively. Mean PV was 51.63 ± 24.12 cc with a minimum and maximum PV of 17 cc and 142 cc. Minimum, maximum, and mean PSA-D levels were 0.06 ng/ml/cc, 1.69 ng/ml/cc, and 0.44 ± 0.37 ng/ml/cc, respectively. Mean follow-up was 66.51 ± 34.98 months, median follow-up was 54 months, and duration of follow-up ranged from 11 months to 180 months. Minimum, maximum, mean, and median BCR-free survivals were 3 months, 168 months, 43.03 ± 31.44 months, and 27 months, respectively.
Characteristics and outcomes of participants in colorectal cancer biomarker trials versus a real-world cohort
Published in Acta Oncologica, 2021
Siavash Foroughi, Hui-li Wong, Jeanne Tie, Rachel Wong, Margaret Lee, Belinda Lee, Ian Jones, Iain Skinner, Antony W. Burgess, Peter Gibbs
Median follow-up was calculated using the reverse Kaplan–Meier method. Overall survival (OS) and disease-free survival (DFS) were estimated using Kaplan–Meier curves to illustrate survival outcomes in real-world and trial participants. OS was defined as the time from surgery to all-cause death, censored at the date of the last review. DFS was defined as the time from surgery to recurrence or all-cause death. Survival outcomes were not analyzed for the RCTs as these studies are still recruiting. Univariable and multivariable Cox proportional hazards analyses were performed to assess the relationship between survival and the clinical characteristics of patients. A two-tailed p-value of 0.01 was considered statistically significant. Analyses were conducted in STATA 12.1 (StataCorp LP, College Station, Texas, USA).
Unsafe testosterone-based dosing regimen of androgen deprivation therapy in patients with locally advanced or metastatic prostate cancer: a prematurely ended randomized controlled trial (MIDAS-trial)
Published in Acta Oncologica, 2021
Midas B. Mulder, Erwin Birnie, Caroline van Dijck – van Boetzelaer, Gert-Jan van de Geijn, Egbert Boevé, Elsbeth M. Westerman, Paul Hamberg
There are several strengths to note in this MIDAS trial. First, this is the first randomized controlled trial testing the testosterone-based dosing regimen. Second, despite the fact that the study was prematurely ended we achieved a good median follow up in the control and interventional group. Treatment compliance among patients starting treatment was good due to the fact that the goserelin injections were administered at home. Finally, this trial adds evidence that prolonging the dosing interval to once every 4 months keeps testosterone low and prevents for antineoplastic medication overuse. There are also some limitation to our study. The most important limitation is the fact that we measured the testosterone levels every 4 weeks in the intervention group. If testosterone levels had been measured more frequently, we might have detected the rapid rise in testosterone level without reaching supracastrate levels. However, at this time the clinical opinion is that a short rise in testosterone level above the castrate level has no clinical implication. Furthermore, we did not measure patients satisfaction with the new dosing regimen.