Men have a higher risk of death from COVID-19 than women and androgens facilitate entrance of the SARS-CoV-2 virus into respiratory epithelial cells. Thus, androgen deprivation therapy may reduce ...infection rates and improve outcomes for COVID-19. In the spring of 2020, Sweden was highly affected by COVID-19. The aim was to estimate the impact of androgen deprivation therapy on mortality from COVID-19 in men with prevalent prostate cancer by comparing all-cause mortality in the spring of 2020 to that in previous years. Using the Prostate Cancer data Base Sweden all men with prostate cancer on March 1 each year in 2015-2020 were followed until June 30 the same year. Exposure to androgen deprivation therapy was ascertained from filled prescriptions for bicalutamide monotherapy, gonadotropin-releasing hormone agonists (GnRH), or bilateral orchidectomy. A total of 9,822 men died in March-June in the years 2015-2020, of whom 5,034 men were on androgen deprivation therapy. There was an excess mortality in 2020 vs previous years in all men. The crude relative mortality rate ratio for 2020 vs 2015-2019 was 0.93 (95% confidence interval (CI) 0.83 to 1.04) in men on GnRH, and 0.90 (95% CI 0.78 to 1.05) in men on bicalutamide monotherapy. After multivariable adjustment these ratios were attenuated to 1.00 (95% CI 0.89 to 1.12) and 0.97 (95% CI 0.84 to 1.12), respectively. When restricting the analysis to the regions with the highest incidence of COVID-19 or to the time period between 2 April to 10 June when mortality in 2020 was increased >30% compared to previous years, the results were similar to the main analysis. In this large national population-based cohort of men with prevalent prostate cancer, there was no clear evidence in support for an effect of androgen deprivation therapy on COVID-19 mortality.
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The aim of this study was to assess time on treatment with abiraterone and enzalutamide, two androgen receptor targeted (ART) drugs, the impact on time on treatment of time interval without drug ...supply between prescription fillings, and adherence to treatment.
By use of data from The National Prostate Cancer Register, The Prescribed Drug Registry and the Patient Registry, time on treatment with the abiraterone and enzalutamide was analyzed in all men with castration resistant prostate cancer (CRPC) in Sweden 2015-2019. Three time intervals between consecutive fillings, i.e. time without drug supply, were assessed. Adherence to the treatment was evaluated by use of the Medication Possession Ratio. Kaplan Meier analysis and multivariable Cox regression model were used to assess factors affecting time on treatment.
Between January 2015 and October 2019, 1803 men filled a prescription for abiraterone and 4 534 men filled a prescription for enzalutamide. With a time interval of 30 days or less between two fillings, median time on treatment was 4.9 months (IQR 2.6-11.7) for abiraterone and 8.0 months (IQR 3.6-16.4) for enzalutamide. In sensitivity analyses, allowing for no more than 14 days without drug supply between fillings, median time on treatment was 3.9 months (IQR 2.1-9.0) for abiraterone and 5.9 months (IQR 2.8-12.1) for enzalutamide. Allowing for any time period without drug between fillings, median time on treatment was 5.7 months (IQR 2.7-14.0) for abiraterone and 9.8 months (IQR 4.4-21.0) for enzalutamide. Adherence to treatment was above 90% for both drugs.
Time on treatment with abiraterone and enzalutamide was shorter in clinical practice than in randomized controlled trials and varied almost two-fold with time interval without drug. Adherence to treatment was high. The main limitation of our study was the lack of data on use of chemotherapy.
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The main aim of the study was to determine the impact of diagnostic activity and life expectancy on the lifetime risk of a prostate cancer diagnosis. We used a state transition simulation model based ...on Swedish population-based data to simulate life trajectories for 2,000,000 men from age 40 to 100 in order to estimate the lifetime risk of a prostate cancer diagnosis. Risk estimates were determined by the level of diagnostic activity and estimated life expectancy. Higher exposure to diagnostic activity resulted in more prostate cancer diagnoses. This was especially true for men diagnosed with low or intermediate grade disease. Men exposed to high diagnostic compared to low diagnostic activity had a five-fold increased lifetime risk (22% vs. 5%) of being diagnosed with a low or intermediate-risk prostate cancer and half the risk of being diagnosed with a high-risk prostate cancer (6% vs. 13%). Men with a long life expectancy had a higher lifetime risk of a prostate cancer diagnosis both overall (21% vs. 15%) and in all risk categories when compared to men with a short life expectancy. The lifetime risk of a prostate cancer diagnosis is strongly influenced by diagnostic activity and to a lesser degree by life expectancy.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The main aim of the study was to determine the impact of diagnostic activity and life expectancy on the lifetime risk of a prostate cancer diagnosis. We used a state transition simulation model based ...on Swedish population-based data to simulate life trajectories for 2,000,000 men from age 40 to 100 in order to estimate the lifetime risk of a prostate cancer diagnosis. Risk estimates were determined by the level of diagnostic activity and estimated life expectancy. Higher exposure to diagnostic activity resulted in more prostate cancer diagnoses. This was especially true for men diagnosed with low or intermediate grade disease. Men exposed to high diagnostic compared to low diagnostic activity had a five-fold increased lifetime risk (22% vs. 5%) of being diagnosed with a low or intermediate-risk prostate cancer and half the risk of being diagnosed with a high-risk prostate cancer (6% vs. 13%). Men with a long life expectancy had a higher lifetime risk of a prostate cancer diagnosis both overall (21% vs. 15%) and in all risk categories when compared to men with a short life expectancy. The lifetime risk of a prostate cancer diagnosis is strongly influenced by diagnostic activity and to a lesser degree by life expectancy.
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It has been suggested that hypogonadism increases the risk for inguinal hernia (IH). The aim of this study was to investigate any association between androgen deprivation therapy (ADT) for prostate ...cancer and increased risk for IH. The study population in this population-based nested case-control study was based on data from the Prostate Cancer Database Sweden. The cohort included all men with prostate cancer who had not received curative treatment. Men who had been diagnosed or had undergone IH repair (n = 1,324) were cases and controls, where not diagnosed, nor operated on for IH, matched only on birth year (n = 13,240). Conditional multivariate logistic regression models were used to assess any temporal association between ADT and IH, adjusting for marital status, education level, prostate cancer risk category, Charlson Comorbidity Index, ADT, time since prostate cancer diagnosis, and primary prostate cancer treatment. Odds ratio (OR) for diagnosis/repair of IH 0 to 1 year from start of ADT was 0.5 (95% confidence interval CI = 0.38, 0.68); between 1 and 3 years after, the OR was 0.35 (95% CI = 0.26, 0.47); between 3 and 5 years after, the OR was 0.39 (95% CI = 0.26, 0.56); between 5 and 7 years after, the OR was 0.6 (95% CI = 0.41, 0.97); and >9 years after, the OR was 3.68 (95% CI = 2.45, 5.53). The marked increase in OR for IH after 9 years of ADT supports the hypothesis that low testosterone levels increase the risk for IH. The low risk for IH during the first 8 years on ADT is likely caused by selection of men with advanced cancer unlikely to be diagnosed or treated for IH.
Aim
This study aimed to explore the experiences of being a clinical research nurse (CRN), in Sweden.
Design
A qualitative study analysing individual interview data.
Methods
Interviews with 10 ...participants were conducted in April 2017 and repeated with five participants in May 2022. A semi‐structured interview guide was used to cover topics such as experiences of working in a new role and professional challenges related to the role. The transcribed interviews were analysed inductively using qualitative content analysis.
Results
The main theme revealed that the CRNs experienced their work role as being like a hub in a wheel, using an ethical compass, but without real power. The six themes identified showed that CRNs worked independently and relied on clinical experiences as nurses but needed more education. They not only had a sense of duty but also too large responsibilities. Furthermore, they viewed their work as valuable and important. However, they needed an accentuated ethical compass and were also affected by power relations that negatively impacted work.
Conclusion
Working as a CRN means being in a central position and working independently, which requires diverse skills and competencies. CRNs, however, face and manage complex ethical and practical challenges without real power. They experience huge responsibilities but need education and acknowledgement, indicating a need for improvement. This is an important message to stakeholders and managers about the necessity of taking adequate action to support CRNs who are crucial resources in clinical research.
Patient or Public Contribution
No patient or public contribution.
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The aim was to describe epidemiological and medical aspects of 449 cases of traumatic brain injury (TBI) from a well-defined geographical area with a population of 137,000 inhabitants. An episode of ...disturbed consciousness was a prerequisite for inclusion in the study. The incidence of TBI was 354/100,000 inhabitants. Median age was 23 years, range 0-91 years; 55% were men and 45% were women; 33% children 0-14 years, 50% adults 15-64 years, and 17% elderly persons 65-91 years old. Severity classification was based on Glasgow Coma Scale (GCS) on arrival; mild TBI 97% (GCS 13-15), moderate 1% (GCS 9-12), and severe 2% (GCS 3-8). The most common injury events were falls (55%) and vehicle-related events (30%). The percentage of falls was high among children and elderly persons but among adults vehicle-related injury events were also prominent. At least 17% of all patients were under the influence of alcohol, especially adult male bicyclists. CT was performed on 163 cases (36%) revealing 34 cases with intracranial hemorrhage (ICH) which is 21% of the examined or 8% of all the injured. The rate of ICH increased with increasing age (from 3% among children to 17% among the elderly persons) and also increased with decreasing GCS from 6% in the group of mild TBI to 60% among those with severe TBI. Attention should be directed to acute management of mild TBI in order to detect potentially dangerous ICH as well as to preventive actions against falls and vehicle related accidents.
Objectives:
The aim was to describe the patients’ experience of undergoing prostatic artery embolization.
Methods:
A retrospective qualitative interview study was undertaken with 15 patients of mean ...age 73 years who had undergone prostatic artery embolization with a median duration of 210 min at two medium sized hospitals in Sweden. The reasons for conducting prostatic artery embolization were clean intermittent catheterization (n = 4), lower urinary tract symptoms (n = 10) or haematuria (n = 1). Data were collected through individual, semi-structured telephone interviews 1–12 months after treatment and analysed using qualitative content analysis.
Results:
Four categories with sub-categories were formulated to describe the results: a diverse experience; ability to control the situation; resumption of everyday activities and range of opinions regarding efficacy of outcomes. Overall, the patients described the procedure as painless, easy and interesting and reported that while the procedure can be stressful, a calm atmosphere contributed to achieving a good experience. Limitations on access to reliable information before, during and after the procedure were highlighted as a major issue. Practical ideas for improving patient comfort during the procedure were suggested. Improved communications between treatment staff and patients were also highlighted. Most patients could resume everyday activities, some felt tired and bruising caused unnecessary worry for a few. Regarding functional outcome, some patients described substantial improvement in urine flow while others were satisfied with regaining undisturbed night sleep. Those with less effect were considering transurethral resection of the prostate as a future option. Self-enrolment to the treatment and long median operation time may have influenced the results.
Conclusions:
From the patients’ perspective, prostatic artery embolization is a well-tolerated method for treating benign prostate hyperplacia.
Aim
To explore the role of CRNs in Sweden and differences in competences and tasks, using the Clinical Trial Nursing Questionnaire – Swedish version (CTNQ‐SWE).
Design
A cross‐sectional survey.
...Methods
Participants were identified through strategic sampling. Data were analysed by descriptive and comparative statistics.
Results
The respondents were experienced nurses who felt proficient in their role, they felt more acceptance by the principal investigators than by nursing colleagues. A majority of CRNs are involved in all procedures specified in the CTNQ‐SWE. The most often performed tasks, also rated as the most important by the CRNs, concerned informed consent and management of investigational products. The education was often informal: with a lack of job descriptions and professional development plans. Need of formal specialist education was expressed.
Conclusions
Knowledge about the role description can be used by clinical research enterprise internationally and healthcare organizations aiming to support CRNs in their role.
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The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on ...the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization.
Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority.
Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden.
Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19.
The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion).
Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + "standard of care": "standard of care"). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) BLINDING (MASKING): This is an open-label trial.
The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total.
The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021.
Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601 , registered June 8, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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