An Adaptation, Extension and Pre-Testing of an Interactive Decision Aid for Men Diagnosed with Localized Prostate Cancer in Iceland: A Mixed-Method Study.

In this study an interactive decision aid (DA) for men diagnosed with localized prostate cancer was adapted, extended and pre-tested. The DA's prototype was based on a literature review and other empirically tested DAs. Semi-structured interviews with 12 men (age 65-80) diagnosed with localized prostate cancer were conducted to get feedback on content, usability, and the DA's layout. The interviews were analyzed using thematic analysis and themes were identified using deductive and inductive coding. Participants found the accessibility of the information and the explicit values clarification tool helpful. Four themes were identified: (1) usability and design, (2) content and knowledge, (3) deciding factors of decision-making, and (4) social support. Participants valued receiving extensive and realistic information on surgery/radiation therapy side effects and getting unbiased presentations of treatment options. Following the thematic analysis, the DA was revised and tested in a survey among 11 newly diagnosed prostate cancer patients (age 60-74). The participants valued the DA and found it helpful when making a treatment decision, and all reported that they would recommend it to others making a prostate cancer treatment decision. The DA is currently being tested in a randomized clinical trial (RCT). This is the first DA developed for prostate cancer patients in Iceland and if the results of the RCT show that it is more effective than standard care in assisting newly diagnosed patients with their treatment decision, the DA can be easily translated and adapted to cultures similar to Iceland such as the Nordic countries.

How Much Information Do Icelandic Men Receive on Pros and Cons of Prostate-Specific Antigen Testing Prior to Undergoing Testing?

Prostate-specific antigen (PSA) testing for asymptomatic men is neither encouraged nor discouraged in most countries; however, shared decision-making is emphasized prior to PSA testing. The objective of this study was to examine to what extent Icelandic men receive information about the pros and cons of PSA testing. Furthermore, to explore if patient-provider communication about pros and cons of PSA testing has improved in the last decade during which time more emphasis has been placed on shared decision-making. All Icelandic men diagnosed with prostate cancer in the years 2015 to 2020 were invited to participate, and a total of 471 out of 1002 men participated (response rate 47.0%). Participants' age ranged from 51 to 95 years (M = 71.9, SD = 7.3). Only half of the men received information about the pros and cons of PSA testing, a third did not receive any information prior to testing and, alarmingly, 22.2% of the men did not even know that they were being tested. A majority of the participants lacked knowledge about the testing with half of the men reporting that they had no knowledge about pros and cons of PSA testing prior to testing. The findings have major public health relevance as they indicate that information provided prior to PSA testing continue to be deficient and that there is a pressing need for interventions that educate men about the benefits and limitations of PSA testing before men undergo medical procedures that can seriously affect their quality of life.

Transition from open to robotically assisted approach on radical prostatectomies in Iceland. A nationwide, population-based study.

OBJECTIVES: In January 2015, radical prostatectomies (RPs) in Iceland changed almost entirely from being performed as open (ORP) to robotically assisted (RARP). This study assesses early surgical and short-term oncological outcome after ORP and RARP and evaluates the safety of transition between the two surgical techniques. METHODS: The study population involved 160/163 (98%) of all radical prostatectomies performed in Iceland between January 2013 and April 2016. Data on patients was collected retrospectively from medical records. Early surgical and short-term oncological outcomes were compared between the two surgical techniques. RESULTS: The ORP and RARP cohorts were comparable with respect to all clinical and pathological variables, except for median prostate volume, which was 45 mL in the ORP cohort and 37 mL in the RARP cohort (p = 0.03). Intraoperative blood loss was higher, hospital stay longer, catheterization time longer, and risk of complications within 30 days of surgery higher after ORP than RARP (p < 0.01). The operative time, positive surgical margin rate and recurrence free survival, within two years, was comparable between the two surgical techniques. CONCLUSIONS: The transition from ORP to RARP in Iceland was safe and resulted in improved early surgical outcome. However, no conclusion can be drawn from this study regarding oncological outcome, due to short follow up and a small sample size.

Long-term adverse effects after retropubic and robot-assisted radical prostatectomy. Nationwide, population-based study.

BACKGROUND AND OBJECTIVES: Surgery for prostate cancer is associated with adverse effects. We studied long-term risk of adverse effects after retropubic (RRP) and robot-assisted radical prostatectomy (RARP). METHODS: In the National Prostate Cancer Register of Sweden, men who had undergone radical prostatectomy (RP) between 2004 and 2014 were identified. Diagnoses and procedures indicating adverse postoperative effects were retrieved from the National Patient Register. Relative risk (RR) of adverse effects after RARP versus RRP was calculated in multivariable analyses adjusting for year of surgery, hospital surgical volume, T stage, Gleason grade, PSA level at diagnosis, patient age, comorbidity, and educational level. RESULTS: A total of 11 212 men underwent RRP and 8500 RARP. Risk of anastomotic stricture was lower after RARP than RRP, RR for diagnoses 0.51 (95%CI = 0.42-0.63) and RR for procedures 0.46 (95%CI = 0.38-0.55). Risk of inguinal hernia was similar after RARP and RRP but risk of incisional hernia was higher after RARP, RR for diagnoses 1.48 (95%CI = 1.01-2.16), and RR for procedures 1.52 (95%CI = 1.02-2.26). CONCLUSIONS: The postoperative risk profile for RARP and RRP was quite similar. However, risk of anastomotic stricture was lower and risk of incisional hernia higher after RARP.

Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study.

OBJECTIVE: The aim of this study was to assess the risk of serious adverse effects after radiotherapy (RT) with curative intention and radical prostatectomy (RP). MATERIALS AND METHODS: Men who were diagnosed with prostate cancer between 1997 and 2012 and underwent curative treatment were selected from the Prostate Cancer data Base Sweden. For each included man, five prostate cancer-free controls, matched for birth year and county of residency, were randomly selected. In total, 12,534 men underwent RT, 24,886 underwent RP and 186,624 were controls. Adverse effects were defined according to surgical and diagnostic codes in the National Patient Registry. The relative risk (RR) of adverse effects up to 12 years after treatment was compared to controls and the risk was subsequently compared between RT and RP in multivariable analyses. RESULTS: Men with intermediate- and localized high-risk cancer who underwent curative treatment had an increased risk of adverse effects during the full study period compared to controls: the RR of undergoing a procedures after RT was 2.64 [95% confidence interval (CI) 2.56-2.73] and after RP 2.05 (95% CI 2.00-2.10). The risk remained elevated 10-12 years after treatment. For all risk categories of prostate cancer, the risk of surgical procedures for urinary incontinence was higher after RP (RR 23.64, 95% CI 11.71-47.74), whereas risk of other procedures on the lower urinary tract and gastrointestinal tract or abdominal wall was higher after RT (RR 1.67, 95% CI 1.44-1.94, and RR 1.86, 95% CI 1.70-2.02, respectively). CONCLUSION: The risk of serious adverse effects after curative treatment for prostate cancer remained significantly elevated up to 12 years after treatment.

Rehospitalization after radical prostatectomy in a nationwide, population based study.

PURPOSE: We investigated hospital readmission frequency during the 90 days after radical prostatectomy and assessed the readmission risk associated with potentially related variables. MATERIALS AND METHODS: Using the population based, nationwide PCBaSe (Prostate Cancer data Base Sweden) we identified men diagnosed with incident prostate cancer between 2000 and 2011 who underwent radical prostatectomy as primary treatment. We used logistic regression analysis to examine the association of the risk of 90-day postoperative readmission with surgical method, calendar period, tumor risk category, hospital case load and patient characteristics. RESULTS: During 90 postoperative days 2,317 of the 24,122 men (10%) identified were nonelectively readmitted, specifically 10% after retropubic, 9% after robot-assisted and 11% after laparoscopic radical prostatectomy. The range in readmission frequency among hospitals was 0% to 35%. Higher readmission risk was associated with the early calendar period (2009 to 2011 vs 2000 to 2002 OR 0.71, 95% CI 0.61-0.83), greater age (70 or greater vs less than 60 years OR 1.17, 95% CI 1.00-1.36), higher risk category (high vs low OR 1.78, 95% CI 1.57-2.03), high comorbidity (Charlson comorbidity index 3 or greater vs 0 OR 1.77, 95% CI 1.29-2.44) and low hospital surgical volume (150 or greater vs fewer than 30 radical prostatectomies per year OR 0.70, 95% CI 0.60-0.81). CONCLUSIONS: Readmission rates after different radical prostatectomy methods were similar, ranging from 9% to 11%, with wide variation among hospitals. Readmission rates can be used as an indicator of perioperative care quality but potential confounders must be adjusted to avoid bias.

Information on pros and cons of prostate-specific antigen testing to men prior to blood draw: a study from the National Prostate Cancer Register (NPCR) of Sweden.

OBJECTIVE: Recent guidelines on serum testing of prostate-specific antigen (PSA) levels in asymptomatic men emphasize the importance of an informed decision. This study assessed the proportion of men who had received written or oral information on the possible consequences of testing of serum levels of PSA before blood draw. MATERIAL AND METHODS: From the National Prostate Cancer Register (NPCR) in Sweden, 600 men per year were randomly selected out of all men with T1c prostate cancer who were diagnosed in the work-up of a PSA test as a part of health examination in 2006-2008. In a mailed questionnaire these men were asked whether and how they had been informed about the pros and cons of a PSA test prior to blood draw. RESULTS: In total, 1621 out of 1800 men (90.1%) responded to the questionnaire; 39/1563 (2.5%) reported that they had received only written information before testing, 179/1563 (11.5%) had received both oral and written information, 763/1563 (48.8%) had received oral information only, 423/1563 (27.1%) had not received any information and 159/1563 (10.2%) were not aware of that a PSA test had been performed. CONCLUSIONS: The proportion of men who had received written information on the pros and cons of a PSA test before blood draw in the setting of a health examination was low. Improved routines for giving information to the patient before a PSA test are warranted.

Ventilator-associated pneumonia in the pediatric intensive care unit: characterizing the problem and implementing a sustainable solution.

OBJECTIVES: To characterize ventilator-associated pneumonia (VAP) in our pediatric intensive care unit (PICU), implement an evidence-based pediatric VAP prevention bundle, and reduce VAP rates. STUDY DESIGN: The setting is a 25-bed PICU in a 475-bed free-standing pediatric academic medical center. VAP was diagnosed according to Centers for Disease Control and National Nosocomial Infections Surveillance System definitions. A pediatric VAP prevention bundle was established and implemented. Baseline VAP rates were compared with implementation and post-bundle-implementation periods. RESULTS: VAP is significantly associated with increased PICU length of stay, mechanical ventilator days, and mortality rates (length of stay VAP 19.5+/-15.0 vs non-VAP 7.5+/-9.2, P< .001; ventilator days VAP 16.3+/-14.7 vs non-VAP 5.3+/-8.4, P< .001; mortality VAP 19.1% vs non-VAP 7.2%, P= .01). The VAP rate was reduced from 5.6 (baseline) to 0.3 infections per 1000 ventilator days after bundle implementation; P< .0001. Subglottic/tracheal stenosis, trauma, and tracheostomy are significantly associated with VAP. CONCLUSIONS: PICU VAP is associated with increased morbidity and mortality rates. A multidisciplinary improvement team can implement a sustainable pediatric-specific VAP prevention bundle, resulting in VAP rate reduction.

Inhaled nitric oxide for premature infants with severe respiratory failure.

BACKGROUND: Inhaled nitric oxide is a controversial treatment for premature infants with severe respiratory failure. We conducted a multicenter, randomized, blinded, controlled trial to determine whether inhaled nitric oxide reduced the rate of death or bronchopulmonary dysplasia in such infants. METHODS: We randomly assigned 420 neonates, born at less than 34 weeks of gestation, with a birth weight of 401 to 1500 g, and with respiratory failure more than four hours after treatment with surfactant to receive placebo (simulated flow) or inhaled nitric oxide (5 to 10 ppm). Infants with a response (an increase in the partial pressure of arterial oxygen of more than 10 mm Hg) were weaned according to protocol. Treatment with study gas was discontinued in infants who did not have a response. RESULTS: The rate of death or bronchopulmonary dysplasia was 80 percent in the nitric oxide group, as compared with 82 percent in the placebo group (relative risk, 0.97; 95 percent confidence interval, 0.86 to 1.06; P=0.52), and the rate of bronchopulmonary dysplasia was 60 percent versus 68 percent (relative risk, 0.90; 95 percent confidence interval, 0.75 to 1.08; P=0.26). There were no significant differences in the rates of severe intracranial hemorrhage or periventricular leukomalacia. Post hoc analyses suggest that rates of death and bronchopulmonary dysplasia are reduced for infants with a birth weight greater than 1000 g, whereas infants weighing 1000 g or less who are treated with inhaled nitric oxide have higher mortality and increased rates of severe intracranial hemorrhage. CONCLUSIONS: The use of inhaled nitric oxide in critically ill premature infants weighing less than 1500 g does not decrease the rates of death or bronchopulmonary dysplasia. Further trials are required to determine whether inhaled nitric oxide benefits infants with a birth weight of 1000 g or more.