scholarly journals The PRolaCT studies — a study protocol for a combined randomised clinical trial and observational cohort study design in prolactinoma

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ingrid M. Zandbergen ◽  
Amir H. Zamanipoor Najafabadi ◽  
Iris C. M. Pelsma ◽  
M. Elske van den Akker-van Marle ◽  
Peter H. L. T. Bisschop ◽  
...  
Keyword(s):  
Cohort Study ◽  
Standard Care ◽  
Randomised Clinical Trial ◽  
Observational Cohort Study ◽  
Treatment Preference ◽  
Current Standard ◽  
Non Invasive ◽  
Cohort Study Design ◽  
Observational Cohort ◽  
Invasive Prolactinoma

Abstract Background First-line treatment for prolactinomas is a medical treatment with dopamine agonists (DAs), which effectively control hyperprolactinaemia in most patients, although post-withdrawal remission rates are approximately 34%. Therefore, many patients require prolonged DA treatment, while side effects negatively impact health-related quality of life (HRQoL). Endoscopic transsphenoidal resection is reserved for patients with severe side effects, or with DA-resistant prolactinoma. Surgery has a good safety profile and high probability of remission and may thus deserve a more prominent place in prolactinoma treatment. The hypothesis for this study is that early or upfront surgical resection is superior to DA treatment both in terms of HRQoL and remission rate in patients with a non-invasive prolactinoma of limited size. Methods We present a combined randomised clinical trial and observational cohort study design, which comprises three unblinded randomised controlled trials (RCTs; PRolaCT-1, PRolaCT-2, PRolaCT-3), and an observational study arm (PRolaCT-O) that compare neurosurgical counselling, and potential subsequent endoscopic transsphenoidal adenoma resection, with current standard care. Patients with a non-invasive prolactinoma (< 25 mm) will be eligible for one of three RCTs based on the duration of pre-treatment with DAs: PRolaCT-1: newly diagnosed, treatment-naïve patients; PRolaCT-2: patients with limited duration of DA treatment (4–6 months); and PRolaCT-3: patients with persisting prolactinoma after DA treatment for > 2 years. PRolaCT-O will include patients who decline randomisation, due to e.g. a clear treatment preference. Primary outcomes are disease remission after 36 months and HRQoL after 12 months. Discussion Early or upfront surgical resection for patients with a limited-sized prolactinoma may be a reasonable alternative to the current standard practice of DA treatment, which we will investigate in three RCTs and an observational cohort study. Within the three RCTs, patients will be randomised between neurosurgical counselling and standard care. The observational study arm will recruit patients who refuse randomisation and have a pronounced treatment preference. PRolaCT will collect randomised and observational data, which may facilitate a more individually tailored practice of evidence-based medicine. Trial registration US National Library of Medicine registry (ClinicalTrials.gov) NCT04107480. Registered on 27 September 2019, registered retrospectively (by 2 months).

scholarly journals Non-invasive hemodynamic profiling of patients undergoing hemodialysis - a multicenter observational cohort study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Keren Doenyas-Barak ◽  
Marcia H. F. G. de Abreu ◽  
Lucas E. Borges ◽  
Helcio A. Tavares Filho ◽  
Feng Yunlin ◽  
...  
Keyword(s):  
Cohort Study ◽  
Observational Cohort Study ◽  
Non Invasive ◽  
Observational Cohort

scholarly journals Protocol for the WARM Hearts study: examining cardiovascular disease risk in middle-aged and older women - a prospective, observational cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044227
Author(s):  
Alexandra V Rose ◽  
Kevin F Boreskie ◽  
Jacqueline L Hay ◽  
Liam Thompson ◽  
Rakesh C Arora ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Risk Assessment ◽  
Cohort Study ◽  
Disease Risk ◽  
Cardiovascular Disease Risk ◽  
Observational Cohort Study ◽  
Moderate Intensity ◽  
Cvd Risk ◽  
Non Invasive ◽  
Observational Cohort

IntroductionCardiovascular disease (CVD) is a leading cause of death in women. Novel approaches to detect early signs of elevated CVD risk in women are needed. Enhancement of traditional CVD risk assessment approaches through the addition of procedures to assess physical function or frailty as well as novel biomarkers of cardiovascular, gut and muscle health could improve early identification. The Women’s Advanced Risk-assessment in Manitoba (WARM) Hearts study will examine the use of novel non-invasive assessments and biomarkers to identify women who are at elevated risk for adverse cardiovascular events.Methods and analysisOne thousand women 55 years of age or older will be recruited and screened by the WARM Hearts observational, cohort study. The two screening appointments will include assessments of medical history, gender variables, body composition, cognition, frailty status, functional fitness, physical activity levels, nutritional status, quality of life questionnaires, sleep behaviour, resting blood pressure (BP), BP response to moderate-intensity exercise, a non-invasive measure of arterial stiffness and heart rate variability. Blood sample analysis will be used to assess lipid and novel biomarker profiles and stool samples will support the characterisation of gut microbiota. The incidence of the adverse cardiovascular outcomes will be assessed 5 years after screening to compare WARM Hearts approaches to the Framingham Risk Score, the current clinical standard of assessing CVD risk in Canada.Ethics and disseminationThe University of Manitoba Health Research Ethics Board (7 October 2019) and the St Boniface Hospital Research Review Committee (7 October 2019) approved the trial (Ethics Number HS22576 (H2019:063)). Recruitment started 10 October 2020. Data gathered from the WARM Hearts study will be published in peer-reviewed journals and presented at national and international conferences. Knowledge translation strategies will be created to share our findings with stakeholders who are positioned to implement evidence-informed CVD risk assessment programming.Trial registration numberNCT03938155.

Cost of care for prostate cancer patients: An observational cohort study comparing clinical trials to standard care.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 184-184
Author(s):  
B. Jones ◽  
R. Syme ◽  
M. Eliasziw ◽  
B. J. Eigl
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Cohort Study ◽  
Cancer Patients ◽  
Resource Utilization ◽  
Standard Care ◽  
Standard Of Care ◽  
Observational Cohort Study ◽  
Observational Cohort ◽  
The Cost

184 Background: Monetary support of clinical trials is a fundamental necessity for improving treatment and prevention methods; however, current economic data pertaining to the per-patient costs of treating prostate cancer are limited. A concurrent lack of certainty regarding the cost requirements of standard care patients makes it difficult for healthcare professionals and policy makers to generate informed decisions regarding budgets and funding needs. Prostate cancer clinical trials are facing a national funding crisis due to the perception that patients enrolled in clinical trials consume more resources than patients receiving standard care. Methods: A retrospective observational cohort study was conducted to examine the costs incurred by prostate cancer patients at the Tom Baker Cancer Center over one year. Costs for 36 patients enrolled in one of nine cancer trials were compared with costs for 36 matched control subjects who received standard care. Resource utilization was tracked using medical charts and quantified by prices listed in the TBCC's 2009 Clinical Trials Budget template. Results: No evidence was found to support a difference in overall resource utilization between clinical trial patients and standard of care patients (Paired two-tailed t- test, N= 36, p =0.90). There was, however, variability in the types of resources used by each patient population, indicating that, while trial patients may take up significantly more clinic time (p =0.04), undergo more tests and procedures (p < 0.001) and require more diagnostic imaging (p = 0.01), standard care patients are more likely to receive costly interventions such as radiation therapy (p =0.06). Pharmaceutical costs have not yet been included in the analysis and could drastically alter the final results. Conclusions: This study revealed differences in the cost distribution of clinical trials patients versus standard of care patients, which could be used by administrators to improve budgeting and time allocation. The lack of difference in overall cost may be helpful to research advocates attempting to encourage centers to take on more trials. Further analysis is required before definitive conclusions can be drawn. No significant financial relationships to disclose.

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