Dynamics of Perceived Barriers to Change Physical Activity and Eating Habits in Adults Before and During a Lifestyle Intervention in a Primary Care Setting: A Mixed Methods Approach.

BACKGROUND: There is scarcity of data exploring the dynamics of barriers to changing physical activity (PA) and eating habits during a lifestyle intervention in a primary care setting. The aim of the present study was to investigate barriers to lifestyle change before and during a primary care lifestyle intervention in adults with different sociodemographic backgrounds. METHODS: Barriers to healthy eating and PA were assessed in 114 adults (age = 55 ± 9 years) using a questionnaire before inclusion in the intervention. During the lifestyle intervention, factors perceived as obstacles to reach goals for PA and healthy eating habits were collected using focus group interviews in a sub-sample of 25 adults and analyzed using thematic analysis. RESULTS: At least 1 barrier to changing eating and PA habits was reported in 65% and 67% of the population, respectively, without differences due to sex, place of birth, and educational level. Before entering the lifestyle intervention, intrapersonal factors including lack of willpower and lack of enjoyment were the dominant barriers to PA and healthy eating, irrespective of place of birth, sex, and education level. In contrast, environmental factors such as lack of support from family and work-related constraints emerged as important barriers to overcome during the action phase of the lifestyle intervention. CONCLUSIONS: The present study highlights the dynamics of barriers to changing PA and eating habits in a primary care lifestyle intervention, emphasizing the need for barrier assessment during the different phases of an intervention to tailor support activities for successful lifestyle behavioral change.

Adherence to the physical activity guideline beyond the recommended minimum weekly amount: impacts on indicators of physical function in older adults.

Introduction: The extent to which additional health benefits of accumulating twice the minimum amount of time in moderate-to-vigorous physical activity (MVPA) affects indicators of physical function in older adults is unclear. Therefore, the aim of the present study was to assess indicators of physical function in older adults who accumulate at least 150 but less than 300 min/week of MVPA compared to those accumulating at least 300 min/week. Methods: Indicators of physical function, including handgrip strength, 5 times sit-to-stand test (5-STS), squat jump and 6-min walk test (6MWT) were assessed in a sample of 193 older men (n = 71, 67 ± 2 years), and women (n = 122, 67 ± 2 years), who all accumulated at least 150 weekly minutes of MVPA. Time in MVPA was assessed by accelerometry during 1 week and engagement in muscle strengthening activities (MSA) was assessed by self-report. Protein intake was assessed by a food-frequency-questionnaire. Participants were classified as physically active (≥150 but <300 min of MVPA per week) or as highly physically active (≥300 min of MVPA per week). Results: Factorial analysis of variance revealed that older adults accumulating at least 300 min of MVPA per week had a significantly (p < 0.05) better 6MWT performance and overall physical function compared to the less active group. These findings remained significant after further adjustment for MSA, sex, waist circumference and protein intake. In contrast, no significant differences in indicators of muscle strength were observed between the two groups. Discussion: Adherence to twice the recommended minimum amount of weekly MVPA time is related to a better physical function, evidenced by a better walking performance compared to adherence to the minimum weekly amount of MVPA. This finding emphasizes the benefits of accumulating daily MVPA beyond the minimum recommended amount to optimize the ability to perform activities of daily living, thus reducing the burden of physical disability and related health-care costs.

Real-world long-term effects on blood pressure and other cardiovascular risk factors for patients in digital therapeutics.

PURPOSE: Hypertension is a leading causeof premature death worldwide and a major public health problem. This study investigated the long-term effects (>1 year) of digital hypertension monitoring by home blood pressure (HBP) measurements in combination with individualized remote treatment via a Swedish Digital Therapeutics platform in a large patient population. METHODS: The primary endpoint, HBP, and exploratory endpoints, BMI, alcohol consumption, stress level, physical activity, and smoking, were assessed every 3 months for 540 and 360 days, respectively, in 7752 Swedish primary hypertension patients. Patients received individualized medical treatments and lifestyle advice via asynchronous text-based communication in an app. Changes from baseline in endpoints were calculated for the whole population and for subgroups defined by baseline SBP ≥135 (high SBP), 125-135 (suboptimal SBP), 115-125 (optimal SBP), and <115 mmHg (low SBP). RESULTS: After 360 days of treatment, the whole population showed a significant increase of 57% (from 37 to 58%) in the proportion of patients with controlled SBP (i.e. SBP of 115-135 mmHg). The largest reduction in SBP of 13.8 mmHg was observed for the high SBP subgroup, whereas for the low SBP subgroup, SBP increased by 13.4 mmHg. BP improved most in the first three months, and for both the high and low BP subgroups, the improvement continued during the 540-day study period. Significant beneficial changes were also observed for some exploratory endpoints including BMI and smoking. CONCLUSIONS: In conclusion, the digital therapeutics platform was associated with significant improvement in BP control and associated risk factors, which were maintained over a longer period.

Cost-Effectiveness of Once-Weekly Semaglutide 1 mg versus Canagliflozin 300 mg in Patients with Type 2 Diabetes Mellitus in a Canadian Setting.

OBJECTIVE: Our objective was to evaluate the long-term cost-effectiveness of once-weekly semaglutide 1 mg versus once-daily canagliflozin 300 mg in patients with type 2 diabetes mellitus (T2DM) uncontrolled with metformin from the healthcare payer and societal perspectives in Canada. METHODS: Head-to-head data from the SUSTAIN 8 randomised trial (NCT03136484) were extrapolated over 40 years using economic simulation modelling. The cost-effectiveness of once-weekly semaglutide 1 mg versus canagliflozin 300 mg for treating T2DM was estimated using the Swedish Institute for Health Economics-Diabetes Cohort Model (IHE-DCM) and the Economic and Health Outcomes Model of T2DM (ECHO-T2DM). Unit costs and disutility weights capturing treatments and key macro- and microvascular complications were sourced from the literature to best match the Canadian setting. A probabilistic base-case simulation and sensitivity analyses were conducted. RESULTS: Once-weekly semaglutide 1 mg was associated with reductions in macro- and microvascular complications, yielding incremental cost-effectiveness ratios (ICERs) of (Canadian dollars [CAD]) CAD16,392 and 18,098 per incremental quality-adjusted life-year (QALY) gained versus canagliflozin 300 mg for IHE-DCM and ECHO-T2DM, respectively, from a healthcare payer perspective. Accounting for productivity loss as well, ICERs were CAD14,127 and 13,188 per QALY gained for IHE-DCM and ECHO-T2DM, respectively, from a societal perspective. Sensitivity analyses confirmed that the base-case results were robust to changes in input parameters and assumptions used. CONCLUSIONS: At a willingness-to-pay threshold of CAD50,000 per QALY gained, once-weekly semaglutide 1 mg was cost-effective over 40 years versus once-daily canagliflozin 300 mg for the treatment of T2DM in patients failing to maintain glycemic control with metformin alone.

Benefits of Fruit and Vegetable Consumption on Prevalence of Metabolic Syndrome Are Independent of Physical Activity Behaviors in Older Adults.

Although consumption of fruits and vegetables (FV) is suggested to reduce metabolic risk, there is a paucity of studies taking advantage of objectively assessed physical activity (PA) behaviors when exploring links between FV intake and metabolic syndrome (MetS) in older adults. The aim of the present study was to determine the relationship between FV intake and MetS prevalence in a population of older community-dwelling adults, while considering time spent being sedentary and health-enhancing PA. Prevalence of MetS was determined in a population of 93 men and 152 women (age: 65-70 years). FV intake was determined by self-report and PA behaviors (time spent in moderate-to-vigorous PA (MVPA) and in sedentary) were assessed by accelerometry. Likelihood of having MetS by FV intake was determined using logistic regression with stepwise backward elimination including age, sex, educational level, total energy intake, adherence to MVPA guideline and total sedentary time as covariates. A main finding was that lower FV intakes were significantly related to higher prevalence of MetS (odds ratio [OR]: 1.23; 95% confidence interval [CI]: 1.03-1.47) after considering potential influences by covariates. Additionally, we found that lower intake of vegetables but not fruits was significantly related to higher prevalence of MetS (OR: 1.47; 95%CI: 1.04-2.07). In conclusion, lower intakes of FV in general, and of vegetables in particular, significantly increased likelihood of MetS, regardless of time spent sedentary and adherence to the MVPA guideline. From a public health perspective, our findings emphasize adequate intakes of FV as an independent contributor to metabolic health status in older adults.

Randomized Controlled Trial for Promotion of Healthy Eating in Older Adults by Increasing Consumption of Plant-Based Foods: Effect on Inflammatory Biomarkers.

To what extent the intake of fruit and vegetables (FV) influences inflammatory status remains elusive, particularly in older populations. The aim of the present study was to determine the effect of increased FV intake for 16 weeks on circulating biomarkers of inflammation in a population of older men and women. Sixty-six participants (65-70 years) randomly assigned to either FV or control (CON) groups were instructed to increase FV intake to five servings per day through nutritional counseling (FV) or to maintain habitual diet (CON). Dietary intake and physical activity level (PA) were determined using food frequency questionnaire and accelerometers, respectively, at the start and end of the intervention. C-reactive protein (CRP), interleukin 6 (IL-6), IL-18, macrophage inflammatory protein-1α (MIP-1α), MIP-1ß, tumor necrosis factor-α (TNF-α), TNF-related apoptosis-inducing ligand (TRAIL), TNF-related activation-induced cytokine (TRANCE), and C-X3-C motif chemokine ligand-1 (CX3CL1, or fractalkine) were analyzed. The FV group significantly increased daily FV intake (from 2.2 ± 1.3 to 4.2 ± 1.8 servings/day), with no change in CON. Waist circumference and PA level were unchanged by the intervention. Interaction effects (time × group, p < 0.05) for TRAIL, TRANCE, and CX3CL1 denoting a significant decrease (p < 0.05) in FV but not in CON were observed. No corresponding effects on CRP, IL6, TNF-α, MIP-1α, and ß and IL-18 were observed. The present study demonstrates the influence of increased FV consumption on levels of some inflammatory biomarkers in a population of older adults. Future work is warranted to examine the clinical implications of FV-induced alterations in these inflammatory biomarkers.

Associations between Circulating Inflammatory Biomarkers and Indicators of Muscle Health in Older Men and Women.

Systemic inflammation is believed to contribute to declining muscle health during aging. The present study aims to examine associations between indicators of muscle health and pro- and anti-inflammatory biomarkers in older men and women, while also considering the impacts of physical activity and protein intake. An assessment of skeletal muscle index (SMI) by bioelectrical impedance analysis, handgrip strength, and 5-sit-to-stand time, using standardized procedures, was conducted in a population of older men (n = 90) and women (n = 148) aged 65-70 years. The inflammatory biomarkers C-reactive protein (CRP), fibrinogen, interleukin (IL)-6, IL-10, IL-18, tumor necrosis factor (TNF)-α, monocyte chemoattractant protein-1, and macrophage inflammatory protein-1α were assessed in blood samples. Data were analyzed and stratified according to biological sex using multiple linear regression models. In older women, SMI was inversely associated with the pro-inflammatory markers CRP (ß = -0.372; p < 0.05), fibrinogen (ß = -0.376; p < 0.05), and IL-6 (ß = -0.369; p < 0.05). Importantly, these associations were independent of abdominal adiposity (waist circumference), protein intake, physical activity level, as well as any adherence to muscle strengthening guidelines (≥2 sessions/week). In contrast, no corresponding associations were observed in men. In conclusion, our findings indicate the detrimental influence of a pro-inflammatory environment on muscle health regardless of important lifestyle-related factors in older women. However, the lack of such associations in older men highlights the importance of considering biological sex when examining the complex interaction between the systemic inflammatory environment and muscle health.

Beneficial Role of Replacing Dietary Saturated Fatty Acids with Polyunsaturated Fatty Acids in the Prevention of Sarcopenia: Findings from the NU-AGE Cohort.

Dietary fat subtypes may play an important role in the regulation of muscle mass and function during ageing. The aim of the present study was to determine the impact of isocaloric macronutrient substitutions, including different fat subtypes, on sarcopenia risk in older men and women, while accounting for physical activity (PA) and metabolic risk. A total of 986 participants, aged 65-79 years, completed a 7-day food record and wore an accelerometer for a week. A continuous sex-specific sarcopenia risk score (SRS), including skeletal muscle mass assessed by dual-energy X-ray absorptiometry (DXA) and handgrip strength, was derived. The impact of the isocaloric replacement of saturated fatty acids (SFAs) by either mono- (MUFAs) or poly-unsaturated (PUFAs) fatty acids on SRS was determined using regression analysis based on the whole sample and stratified by adherence to a recommended protein intake (1.1 g/BW). Isocaloric reduction of SFAs for the benefit of PUFAs was associated with a lower SRS in the whole population, and in those with a protein intake below 1.1 g/BW, after accounting for age, smoking habits, metabolic disturbances, and adherence to PA guidelines. The present study highlighted the potential of promoting healthy diets with optimised fat subtype distribution in the prevention of sarcopenia in older adults.

Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data.

INTRODUCTION: The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study showed that compared with placebo, canagliflozin 100 mg significantly reduced the risk of major cardiovascular events and adverse renal outcomes in patients with diabetic kidney disease (DKD). We developed a simulation model that can be used to estimate the long-term health and economic consequences of DKD treatment interventions for patients matching the CREDENCE study population. METHODS: The CREDENCE Economic Model of DKD (CREDEM-DKD) was developed using patient-level data from CREDENCE (which recruited patients with estimated glomerular filtration rate 30 to < 90 mL/min/1.73 m2, urinary albumin to creatinine ratio > 300-5000 mg/g, and taking the maximum tolerated dose of a renin-angiotensin-aldosterone system inhibitor). Risk prediction equations were fit for start of maintenance dialysis, doubling of serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. A micro-simulation model was constructed using these risk equations combined with user-definable kidney transplant event risks. Internal validation was performed by loading the model to replicate the CREDENCE study and comparing predictions with trial Kaplan-Meier estimate curves. External validation was performed by loading the model to replicate a subgroup of the CANagliflozin cardioVascular Assessment Study (CANVAS) Program with patient characteristics that would have qualified for inclusion in CREDENCE. RESULTS: Risk prediction equations generally fit well and exhibited good concordance, especially for the placebo arm. In the canagliflozin arm, modest underprediction was observed for myocardial infarction, along with overprediction of dialysis, doubling of serum creatinine, and all-cause mortality. Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68). The model performed well in internal and external validation exercises. CONCLUSION: CREDEM-DKD is an important new tool in the evaluation of treatment interventions in the DKD population. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02065791.

Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant).

INTRODUCTION: Healthy dietary patterns and physical activity (PA) represent important lifestyle behaviors with considerable potential to influence on age-related metabolic health. Yet, data on the combined effects of these lifestyle behaviors on metabolic health including low-grade systemic inflammation in aging populations remain scarce. Therefore, this protocol describes a randomized controlled trial aiming to examine the impacts of healthy dietary patterns alone or combined with PA on metabolic health in middle-aged and older men and women. MATERIAL AND METHODS: The ORUDIET study is a 3-arm randomized controlled 16-week trial: Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON). The trial is open label, randomized with allocation concealment, parallel groups with passive controls. Participants without overt disease aged between 55 and 70 years, with BMI below 35, a current intake of a maximum of 1 serving of fruit and vegetable per day, and noncompliance to PA guidelines are eligible for inclusion. Participants in HD are instructed to increase fruit and vegetable intake to 5 servings per day (equivalent to 500 g). Participants in HD-PA receive the same dietary intervention as the HD and are additionally instructed to engage in moderate-to-vigorous physical activities for at least 150 minutes per week. The primary study outcomes are changes in metabolic and inflammatory health biomarkers. Secondary outcomes are changes in body composition and perceived health. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethical review board in Uppsala, Sweden. The results will be published in peer-reviewed journals and disseminated in national and international conferences. TRIAL REGISTRATION NUMBER: NCT04062682 Pre-results.

Patient-controlled sedation with propofol for endoscopic procedures-A cost analysis.

BACKGROUND: Patient-controlled sedation (PCS) with propofol accompanied by a bedside nurse anaesthetist is an alternative sedation method for endoscopic procedures compared with midazolam administered by a nurse or endoscopist. Increasing costs in health care demands an economic perspective when introducing alternative methods. We applied a hospital perspective on a cost analysis comparing different methods of sedation and the resource use that were expected to affect cost differences related to the sedation. METHODS: Based on two randomised previous studies, the direct costs were determined for different sedation methods during two advanced endoscopic procedures: endoscopic retrograde cholangiopancreatography (ERCP) and flexible bronchoscopy including endobronchial ultrasound. ERCP comparisons were made between midazolam sedation by the endoscopic team, PCS with a bedside nurse anaesthetist and propofol sedation administered by a nurse anaesthetist. Bronchoscopy comparisons were made between midazolam sedation by the endoscopic team and PCS with a bedside nurse anaesthetist, categorised by premedication morphine-scopolamine or glycopyrronium. RESULTS: Propofol PCS with a bedside nurse anaesthetist resulted in lower costs per patient for sedation for both ERCP (233 USD) and bronchoscopy (premedication morphine-scopolamine 267 USD, premedication glycopyrronium 269 USD) compared with midazolam (ERCP 425 USD, bronchoscopy 337 USD). Aborted procedures that needed to be repeated and prolonged hospital stays significantly increased the cost for the midazolam groups. CONCLUSION: Propofol PCS with a bedside nurse anaesthetist reduces the direct sedation costs for ERCP and bronchoscopy procedures compared with midazolam sedation.

Patient-controlled Sedation During Flexible Bronchoscopy: A Randomized Controlled Trial.

BACKGROUND: Patient-controlled sedation (PCS) is a documented method for endoscopic procedures considered to facilitate early recovery. Limited data have been reported, however, on its use during flexible bronchoscopy (FB). METHODS: This study hypothesized that PCS with propofol during FB would facilitate early recovery, with similar bronchoscopist and patient satisfaction compared with nurse-controlled sedation (NCS) with midazolam. A total of 150 patients were randomized 1:1:1 into a control group (premedication with morphine-scopolamine and NCS with midazolam), PCS-MS group (premedication with morphine-scopolamine and PCS with propofol), and PCS-G group (premedication with glycopyrronium and PCS with propofol). RESULTS: The procedures included transbronchial biopsy, transbronchial needle aspiration, cryotherapy/biopsy, and/or multistation endobronchial ultrasound. FB duration values in median (range) were 40 (10 to 80), 39 (12 to 68), and 44 (10 to 82) minutes for the groups NCS, PCS-MS, and PCS-G, respectively. An overall 81% of the patients in the combined PCS groups were ready for discharge (modified Post Anaesthetic Discharge Scoring System, score 10) 2 hours after bronchoscopy compared with 40% in the control group (P<0.0001). Between PCS groups, 96% of the PCS-G group patients were ready for discharge compared with 65% in the PCS-MS group (P=0.0002) at 2 hours. Bronchoscopists' and patients' satisfaction scores were high in all groups. Postdischarge quality scores showed no differences among the groups. CONCLUSION: PCS with propofol during FB is feasible, as it shortened recovery time without compromising procedure conditions for bronchoscopists or patients. A rapid postsedation stabilization of vital signs facilitates surveillance before the patient leaves the hospital.

Evaluation of a fiber-optic technique for recording intramuscular pressure in the human leg.

To evaluate a forward-sensing fiber-optic pressure technique for recording of intramuscular pressure (IMP) in the human leg and investigate factors that may influence IMP measurements used in diagnosing compartment syndromes. IMP in the tibialis anterior muscle was recorded simultaneously by a fiber-optic technique and needle-injection technique in 12 legs of 7 healthy subjects. Both measurement catheters were placed in parallel with the muscle fibers to the same depth, as verified by sonography. IMP recordings were performed at rest before, during and after applying a model of abnormally elevated IMP (simulated compartment syndrome). IMP was elevated by venous obstruction induced by a thigh tourniquet of a casted leg. IMP was also measured during injections of 0.1 ml of saline into the muscle through the catheters. IMP at baseline was 5.1 (SD = 2.6) mmHg measured with the fiber-optic technique and 7.1 (SD = 2.5) mmHg with the needle-injection technique (p < 0.001). It increased to 48.5 (SD = 6.9) mmHg and 47.6 (SD = 6.6) mmHg respectively, during simulated compartment syndrome. IMP increased significantly following injection of 0.1 ml of saline, measured by both techniques. It remained increased 1 min after injection. The fiber-optic technique was able to record pulse-synchronous IMP oscillations. The fiber-optic technique may be used for IMP measurements in a muscle with both normal and abnormally elevated IMP. It has good dynamic properties allowing for measurement of IMP oscillations. Saline injection used with needle-injection systems to ensure catheter patency compromises IMP readings at least one minute after injection.

Influence of combined resistance training and healthy diet on muscle mass in healthy elderly women: a randomized controlled trial.

The delivery of efficient nonpharmacological treatment to prevent the loss of muscle mass in older adults is a major challenge, and information on the combined effects of training and diet is particularly important. Here we aimed to evaluate the effects of 24 wk of resistance training combined with a healthy dietary approach (n-6/n-3 ratio < 2) in a population of healthy and physically active older women (65-70 years). The three-armed randomized controlled trial included a resistance training + healthy diet group (RT-HD), a resistance training group (RT), and controls (CON). All subjects included in the study were physically active and had low levels of serum inflammatory markers. In accordance with the dietary goals, the n-6/n-3 ratio dietary intake significantly decreased only in RT-HD by 42%. An increase in 1 repetition maximum in leg extension occurred in RT (+20.4%) and RT-HD (+20.8%), but not in CON. Interestingly, leg lean mass significantly increased only in RT-HD (+1.8%). While there were no changes in serum C-reactive protein and IL-6 levels, a significant decrease in serum level of the pro-inflammatory precursor arachidonic acid (-5.3 ± 9.4%) together with an increase in serum n-3 docosahexaenoic acid (+8.3%) occurred only in RT-HD. Altogether, this study demonstrates that the effects of resistance training on muscle mass in healthy older adults can be optimized by the adoption of a healthy diet.

The impact of length and location of positive margins in predicting biochemical recurrence after robot-assisted radical prostatectomy with a minimum follow-up of 5 years.

OBJECTIVE: To evaluate the role of positive surgical margin (PSM) size/focality and location in relation to risk of biochemical recurrence (BCR) after robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: Clinicopathological data were collected from 904 patients who underwent RARP at a single European institution from 2002 to 2006. PSM status after RARP was defined as cancer cells at the inked margin, and was stratified by size/focality and location. The outcome variable was BCR, defined as a postoperative PSA level of ≥0.2 ng/mL. We modelled clinicopathological covariates including PSM size/focality and location using Cox proportional hazards regression. In subgroup analyses, we assessed the effect of PSM size and location at different pathological stages and grades of disease. RESULTS: Compared with negative SM, a PSM of >3 mm/multifocal was associated with an increased risk of BCR in the entire cohort (hazard ratio [HR] 2.84, 95% confidence interval 1.76-4.59), while unifocal PSMs of ≤3 mm were not significantly associated with BCR. In subgroup analyses, the negative impact of >3 mm/multifocal PSM appeared greatest in those with lower postoperative stage and grade of disease. The prognostic role of PSM location was unconfirmed, although data indicated that posterolateral PSMs may be of lower significance in RARP patients. The study is limited by lack of central pathology review, and lack of statistical adjustment for tumour volume, lymph node status, and surgeon volume. CONCLUSION: We found that men with >3 mm/multifocal PSMs have a higher risk of BCR than those with unifocal PSMs of ≤3 mm or negative SMs, especially if they have lower risk disease. Posterolateral margins may be of little significance in a RARP population.

A multinational, multi-institutional study comparing positive surgical margin rates among 22393 open, laparoscopic, and robot-assisted radical prostatectomy patients.

BACKGROUND: Positive surgical margins (PSMs) are a known risk factor for biochemical recurrence in patients with prostate cancer (PCa) and are potentially affected by surgical technique and volume. OBJECTIVE: To investigate whether radical prostatectomy (RP) modality and volume affect PSM rates. DESIGN, SETTING, AND PARTICIPANTS: Fourteen institutions in Europe, the United States, and Australia were invited to participate in this study, all of which retrospectively provided margins data on 9778 open RP, 4918 laparoscopic RP, and 7697 robotic RP patients operated on between January 2000 and October 2011. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: The outcome measure was PSM rate. Multivariable logistic regression analyses and propensity score methods identified odds ratios for risk of a PSM for one modality compared with another, after adjustment for age, preoperative prostate-specific antigen, postoperative Gleason score, pathologic stage, and year of surgery. Classic adjustment using standard covariates was also implemented to compare PSM rates based on center volume for each minimally invasive surgical cohort. RESULTS AND LIMITATIONS: Open RP patients had higher-risk PCa at time of surgery on average and were operated on earlier in the study time period on average, compared with minimally invasive cohorts. Crude margin rates were lowest for robotic RP (13.8%), intermediate for laparoscopic RP (16.3%), and highest for open RP (22.8%); significant differences persisted, although were ameliorated, after statistical adjustments. Lower-volume centers had increased risks of PSM compared with the highest-volume center for both laparoscopic RP and robotic RP. The study is limited by its nonrandomized nature; missing data across covariates, especially year of surgery in many of the open cohort cases; lack of standardized histologic processing and central pathology review; and lack of information regarding potential confounders such as patient comorbidity, nerve-sparing status, lymph node status, tumor volume, and individual surgeon caseload. CONCLUSIONS: This multinational, multi-institutional study of 22 393 patients after RP suggests that PSM rates might be lower after minimally invasive techniques than after open RP and that PSM rates are affected by center volume in laparoscopic and robotic cases. PATIENT SUMMARY: In this study, we compared the effectiveness of different types of surgery for prostate cancer by looking at the rates of cancer cells left at the margins of what was removed in the operations. We compared open, keyhole, and robotic surgery from many centers across the globe and found that robotic and keyhole operations appeared to have lower margin rates than open surgeries. How many cases a center and surgeon do seems to affect this rate for both robotic and keyhole procedures.

Robot-assisted intracorporeal formation of the ileal neobladder.

We are celebrating the 10th anniversary of robot-assisted laparoscopic radical cystectomy (RARC) with urinary diversion (UD), and it seems that this operation is successfully following the footsteps of robot-assisted laparoscopic radical prostatectomy. Until now, approximately 1000 RARCs have been recorded; of them, only 102 were performed totally intracorporeally with a formation of an ileal neobladder. Despite the small numbers, morbidity and functional outcomes seem to be acceptable, when compared with the gold standard-the open procedure. It is imperative that in a challenging procedure such as this, the console surgeon follow a standardized protocol of all surgical steps to ensure the optimal results. In this article, we are sharing Karolinska's experience and discuss all perioperative issues along with ways of dealing with tricky cases.

Biochemical recurrence after robot-assisted radical prostatectomy in a European single-centre cohort with a minimum follow-up time of 5 years.

BACKGROUND: Robot-assisted radical prostatectomy (RARP) is an increasingly commonly used surgical treatment option for prostate cancer (PCa); however, its longer-term oncologic results remain uncertain. OBJECTIVE: To report biochemical recurrence-free survival (BRFS) outcomes for men who underwent RARP ≥5 yr ago at a single European centre. DESIGN, SETTING, AND PARTICIPANTS: A total of 944 patients underwent RARP as monotherapy for PCa from January 2002 to December 2006 at Karolinska University Hospital, Stockholm, Sweden. Standard clinicopathologic variables were recorded and entered into a secure, ethics-approved database made up of those men with registered domiciles in Stockholm. The median follow-up time was 6.3 yr (interquartile range: 5.6-7.2). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The outcome of this study was biochemical recurrence (BCR), defined as a confirmed prostate-specific antigen (PSA) of ≥0.2 ng/ml. Kaplan-Meier survival plots with log-rank tests, as well as Cox univariable and multivariable regression analyses, were used to determine BRFS estimates and determine predictors of PSA relapse, respectively. RESULTS AND LIMITATIONS: The BRFS for the entire cohort at median follow-up was 84.8% (95% confidence interval [CI], 82.2-87.1); estimates at 5, 7, and 9 yr were 87.1% (95% CI, 84.8-89.2), 84.5% (95% CI, 81.8-86.8), and 82.6% (95% CI, 79.0-85.6), respectively. Nine and 19 patients died of PCa and other causes, respectively, giving end-of-follow-up Kaplan-Meier survival estimates of 98.0% (95% CI, 95.5-99.1) and 94.1% (95% CI, 90.4-96.4), respectively. Preoperative PSA >10, postoperative Gleason sum ≥4 + 3, pathologic T3 disease, positive surgical margin status, and lower surgeon volume were associated with increased risk of BCR on multivariable analysis. This study is limited by a lack of nodal status and tumour volume, which may have confounded our findings. CONCLUSIONS: This case series from a single, high-volume, European centre demonstrates that RARP has satisfactory medium-term BRFS. Further follow-up is necessary to determine how this finding will translate into cancer-specific and overall survival outcomes.

Robotic cystectomy: surgical technique.

OBJECTIVE: • The aim of this report is to describe our surgical technique of robotic assisted radical cystectomy (RARC) with totally intracorporeal urinary diversion in patients with urinary bladder cancer. PATIENTS AND METHODS: • A total of 45 patients (7 women and 38 men) with high-grade and/or muscle-invasive urothelial cancer of the bladder underwent RARC and intracorporeal urinary diversion at our department. • Orthotopic ileal neobladder was performed in 36 patients and ileal conduit was performed in 9 patients. RESULT: • Except in two patients that operation was converted to open surgery during the reconstruction of the orthotopic neobladder, the procedure was performed totally intracorporeal. • The operations time, estimated blood loss and length for hospital stay were decreased over the time. CONCLUSION: • RARC with totally intracorporeal urinary diversion is feasible.