Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial.

Importance: Implementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal. Objective: To improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival. Design, setting, and participants: This multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with all stages of pancreatic cancer. It took place from May 22, 2018 through July 9, 2020. Data were analyzed from April 1, 2022, through February 1, 2023. It included all patients in the Netherlands with pathologically or clinically diagnosed pancreatic ductal adenocarcinoma. This study reports 1-year follow-up (or shorter in case of deceased patients). Intervention: The 5 best practices included optimal use of perioperative chemotherapy, palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), referral to a dietician, and use of metal stents in patients with biliary obstruction. A 6-week implementation period was completed, in a randomized order, in all 17 Dutch networks for pancreatic cancer care. Main Outcomes and Measures: The primary outcome was 1-year survival. Secondary outcomes included adherence to best practices and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] global health score). Results: Overall, 5887 patients with pancreatic cancer (median age, 72.0 [IQR, 64.0-79.0] years; 50% female) were enrolled, 2641 before and 2939 after implementation of best practices (307 during wash-in period). One-year survival was 24% vs 23% (hazard ratio, 0.98, 95% CI, 0.88-1.08). There was no difference in the use of neoadjuvant chemotherapy (11% vs 11%), adjuvant chemotherapy (48% vs 51%), and referral to a dietician (59% vs 63%), while the use of palliative chemotherapy (24% vs 30%; odds ratio [OR], 1.38; 95% CI, 1.10-1.74), PERT (34% vs 45%; OR, 1.64; 95% CI, 1.28-2.11), and metal biliary stents increased (74% vs 83%; OR, 1.78; 95% CI, 1.13-2.80). The EORTC global health score did not improve (area under the curve, 43.9 vs 42.8; median difference, -1.09, 95% CI, -3.05 to 0.94). Conclusions and Relevance: In this randomized clinical trial, implementation of 5 best practices in pancreatic cancer care did not improve 1-year survival and quality of life. The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options. Trial Registration: ClinicalTrials.gov Identifier: NCT03513705.

Impact of Neoadjuvant Therapy for Pancreatic Cancer: Transatlantic Trend and Postoperative Outcomes Analysis.

BACKGROUND: The introduction of modern chemotherapy a decade ago has led to increased use of neoadjuvant therapy (NAT) in patients with pancreatic ductal adenocarcinoma (PDAC). A recent North American study demonstrated increased use of NAT and improved operative outcomes in patients with PDAC. The aims of this study were to compare the use of NAT and short-term outcomes in patients with PDAC undergoing pancreatoduodenectomy (PD) among registries from the US and Canada, Germany, the Netherlands, and Sweden. STUDY DESIGN: Databases from 2 multicenter (voluntary) and 2 nationwide (mandatory) registries were queried from 2018 to 2020. Patients undergoing PD for PDAC were compared based on the use of upfront surgery vs NAT. Adoption of NAT was measured in each country over time. Thirty-day outcomes, including the composite measure (ideal outcomes), were compared by multivariable analyses. Sensitivity analyses of patients undergoing vascular resection were performed. RESULTS: Overall, 11,402 patients underwent PD for PDAC with 33.7% of patients receiving NAT. The use of NAT increased steadily from 28.3% in 2018 to 38.5% in 2020 (p < 0.0001). However, use of NAT varied widely by country: the US (46.8%), the Netherlands (44.9%), Sweden (11.0%), and Germany (7.8%). On multivariable analysis, NAT was significantly (p < 0.01) associated with reduced rates of serious morbidity, clinically relevant pancreatic fistulae, reoperations, and increased ideal outcomes. These associations remained on sensitivity analysis of patients undergoing vascular resection. CONCLUSIONS: NAT before PD for pancreatic cancer varied widely among 4 Western audits yet increased by 26% during 3 years. NAT was associated with improved short-term outcomes.

Timing of Initiation of Palliative Chemotherapy in Asymptomatic Patients with Metastatic Pancreatic Cancer: An International Expert Survey and Case-Vignette Study.

Background: The use of imaging, in general, and during follow-up after resection of pancreatic cancer, is increasing. Consequently, the number of asymptomatic patients diagnosed with metastatic pancreatic cancer (mPDAC) is increasing. In these patients, palliative systemic therapy is the only tumor-directed treatment option; hence, it is often immediately initiated. However, delaying therapy in asymptomatic palliative patients may preserve quality of life and avoid therapy-related toxicity, but the impact on survival is unknown. This study aimed to gain insight into the current perspectives and clinical decision=making of experts regarding the timing of treatment initiation of patients with asymptomatic mPDAC. Methods: An online survey (13 questions, 9 case-vignettes) was sent to all first and last authors of published clinical trials on mPDAC over the past 10 years and medical oncologists of the Dutch Pancreatic Cancer Group. Inter-rater variability was determined using the Kappa Light test. Differences in the preferred timing of treatment initiation among countries, continents, and years of experience were analyzed using Fisher's exact test. Results: Overall, 78 of 291 (27%) medical oncologists from 15 countries responded (62% from Europe, 23% from North America, and 15% from Asia-Pacific). The majority of respondents (63%) preferred the immediate initiation of chemotherapy following diagnosis. In 3/9 case-vignettes, delayed treatment was favored in specific clinical contexts (i.e., patient with only one small lung metastasis, significant comorbidities, and higher age). A significant degree of inter-rater variability was present within 7/9 case-vignettes. The recommended timing of treatment initiation differed between continents for 2/9 case-vignettes (22%), in 7/9 (77.9%) comparing the Netherlands with other countries, and based on years of experience for 5/9 (56%). Conclusions: Although the response rate was limited, in asymptomatic patients with mPDAC, immediate treatment is most often preferred. Delaying treatment until symptoms occur is considered in patients with limited metastatic disease, more comorbidities, and higher age.

[Nationwide multidisciplinary developments in pancreatic cancer care in the Netherlands]. / Ontwikkelingen in de zorg voor patiënten met pancreascarcinoom.

In the past years several developments have occurred in the care for patients with pancreatic cancer in the Netherlands. New palliative chemotherapy strategies using FOLFRINOX or gemcitabine/nab-paclitaxel were introduced for patients with advanced disease. Due to centralization of pancreatic surgery, introduction of neoadjuvant therapy, and the implementation of standardized postoperative care more patients became enable for resection, postoperative mortality decreased, and survival improved. Within the randomized PREOPANC trial of the Dutch Pancreatic Cancer Group (DPCG), neoadjuvant therapy using chemoradiation for (borderline) resectable pancreatic cancer improved five-year survival from 7% to 21%. Furthermore, due to nationwide training programs, the use of minimally invasive surgery has increased. Regardless of these developments, the survival of patients with pancreatic cancer is still low and 61% of Dutch patients with pancreatic cancer patients do not receive any tumor targeted therapy. The DPCG is active to improve quality of care through auditing, research, guideline development, and education.

Delayed Versus Immediate Start of Chemotherapy in Asymptomatic Patients With Advanced Cancer: A Meta-Analysis.

BACKGROUND: Due to increased use of imaging, advanced stages of cancer are increasingly being diagnosed in an early, asymptomatic phase. Traditionally, chemotherapy is started immediately in these patients. However, a strategy wherein chemotherapy is withheld until symptoms occur may be beneficial for patients in terms of quality of life (QOL). A systematic review regarding optimal timing of chemotherapy including survival and QOL is lacking. METHODS: We systematically searched PubMed, EMBASE, and Cochrane for studies investigating the timing of start of chemotherapy in asymptomatic patients with advanced cancer. Overall survival (OS) was abstracted as primary, QOL, and toxicity as secondary outcomes. A meta-analysis was performed on OS. QOL was described using the global health status derived from the EORTC-QLQ-C30 questionnaire and toxicity as grade 3-4 adverse events. RESULTS: Overall, 919 patients from 4 randomized controlled trials and 1 retrospective study were included. The included studies investigated colorectal cancer (n = 3), ovarian cancer (n = 1), and gastric cancer (n = 1). Pooled analysis demonstrated no significant differences in OS between delayed and immediate start of chemotherapy (pooled HR: 1.05, 95% CI, 0.90-1.22, P = .52). QOL, evaluated in 3 studies, suggested a better QOL in the delayed treatment group. Toxicity, evaluated in 2 studies, did not differ significantly between groups. CONCLUSION: This meta-analysis confirms the need for prospective studies on timing of start of chemotherapy in asymptomatic patients with advanced cancer. The limited evidence available suggests that delayed start of chemotherapy, once symptoms occur, as compared to immediate start in asymptomatic patients does not worsen OS while it may preserve QOL.

Ideal Outcome After Pancreatoduodenectomy: A Transatlantic Evaluation of a Harmonized Composite Outcome Measure.

OBJECTIVE: The aim of this study is to define and assess Ideal Outcome in the national or multicenter registries of North America, Germany, the Netherlands, and Sweden. BACKGROUND: Assessing outcomes after pancreatoduodenectomy among centers and countries requires a broad evaluation that cannot be captured by a single parameter. Previously, 2 composite outcome measures (textbook outcome and optimal pancreatic surgery) for pancreatoduodenectomy have been described from Europe and the United States. These composites were harmonized into ideal outcome (IO). METHODS: This analysis is a transatlantic retrospective study (2018-2020) of patients after pancreatoduodenectomy within the registries from North America, Germany, The Netherlands, and Sweden. After 3 consensus meetings, IO for pancreatoduodenectomy was defined as the absence of all 6 parameters: (1) in-hospital mortality, (2) severe complications-Clavien-Dindo ≥3, (3) postoperative pancreatic fistula-International Study Group of Pancreatic Surgery (ISGPS) grade B/C, (4) reoperation, (5) hospital stay >75th percentile, and (6) readmission. Outcomes were evaluated using relative largest difference (RLD) and absolute largest difference (ALD), and multivariate regression models. RESULTS: Overall, 21,036 patients after pancreatoduodenectomy were included, of whom 11,194 (54%) reached IO. The rate of IO varied between 55% in North America, 53% in Germany, 52% in The Netherlands, and 54% in Sweden (RLD: 1.1, ALD: 3%, P <0.001). Individual components varied with an ALD of 2% length of stay, 4% for in-hospital mortality, 12% severe complications, 10% postoperative pancreatic fistula, 11% reoperation, and 9% readmission. Age, sex, absence of chronic obstructive pulmonary disease, body mass index, performance status, American Society of Anesthesiologists (ASA) score, biliary drainage, absence of vascular resection, and histologic diagnosis were associated with IO. In the subgroup of patients with pancreatic adenocarcinoma, country, and neoadjuvant chemotherapy also was associated with improved IO. CONCLUSIONS: The newly developed composite outcome measure "Ideal Outcome" can be used for auditing and comparing outcomes after pancreatoduodenectomy. The observed differences can be used to guide collaborative initiatives to further improve the outcomes of pancreatic surgery.

Career Needs Assessment for Early Career Academic Surgeons Using a Modified Accelerated Delphi Process.

INTRODUCTION: Over the past 2 decades, physicians' wellbeing has become a topic of interest. It is currently unclear what the current needs are of early career academic surgeons (ECAS). METHODS: Consensus statements on academic needs were developed during a Delphi process, including all presenters from the previous European Surgical Association (ESA) meetings (2018-2022). The Delphi involved (1) a literature review, (2) Delphi form generation, and (3) an accelerated Delphi process. The Delphi form was generated by a steering group that discussed findings identified within the literature. The modified accelerated e-consensus approach included 3 rounds over a 4-week period. Consensus was defined as >80% agreement in any round. RESULTS: Forty respondents completed all 3 rounds of the Delphi. Median age was 37 years (interquartile range 5), and 53% were female. Majority were consultant/attending (52.5%), followed by PhD (22.5%), fellowship (15%), and residency (10%). ECAS was defined as a surgeon in 'development' years of clinical and academic practice relative to their career goals (87.9% agreement). Access to split academic and clinical contracts is desirable (87.5%). Consensus on the factors contributing to ECAS underperformance included: burnout (94.6%), lack of funding (80%), lack of mentorship (80%), and excessive clinical commitments (80%). Desirable factors to support ECAS development included: access to e-learning (90.9%), face-to-face networking opportunities (95%), support for research team development (100%), and specific formal mentorship (93.9%). CONCLUSION: The evolving role and responsibilities of ECAS require increasing strategic support, mentorship, and guidance on structured career planning. This will facilitate workforce sustainability in academic surgery in the future.

The Feasibility, Proficiency, and Mastery Learning Curves in 635 Robotic Pancreatoduodenectomies Following a Multicenter Training Program: "Standing on the Shoulders of Giants".

OBJECTIVE: To assess the feasibility, proficiency, and mastery learning curves for robotic pancreatoduodenectomy (RPD) in "second-generation" RPD centers following a multicenter training program adhering to the IDEAL framework. BACKGROUND: The long learning curves for RPD reported from "pioneering" expert centers may discourage centers interested in starting an RPD program. However, the feasibility, proficiency, and mastery learning curves may be shorter in "second-generation" centers that participated in dedicated RPD training programs, although data are lacking. We report on the learning curves for RPD in "second-generation" centers trained in a dedicated nationwide program. METHODS: Post hoc analysis of all consecutive patients undergoing RPD in 7 centers that participated in the LAELAPS-3 training program, each with a minimum annual volume of 50 pancreatoduodenectomies, using the mandatory Dutch Pancreatic Cancer Audit (March 2016-December 2021). Cumulative sum analysis determined cutoffs for the 3 learning curves: operative time for the feasibility (1) risk-adjusted major complication (Clavien-Dindo grade ≥III) for the proficiency, (2) and textbook outcome for the mastery, (3) learning curve. Outcomes before and after the cutoffs were compared for the proficiency and mastery learning curves. A survey was used to assess changes in practice and the most valued "lessons learned." RESULTS: Overall, 635 RPD were performed by 17 trained surgeons, with a conversion rate of 6.6% (n=42). The median annual volume of RPD per center was 22.5±6.8. From 2016 to 2021, the nationwide annual use of RPD increased from 0% to 23% whereas the use of laparoscopic pancreatoduodenectomy decreased from 15% to 0%. The rate of major complications was 36.9% (n=234), surgical site infection 6.3% (n=40), postoperative pancreatic fistula (grade B/C) 26.9% (n=171), and 30-day/in-hospital mortality 3.5% (n=22). Cutoffs for the feasibility, proficiency, and mastery learning curves were reached at 15, 62, and 84 RPD. Major morbidity and 30-day/in-hospital mortality did not differ significantly before and after the cutoffs for the proficiency and mastery learning curves. Previous experience in laparoscopic pancreatoduodenectomy shortened the feasibility (-12 RPDs, -44%), proficiency (-32 RPDs, -34%), and mastery phase learning curve (-34 RPDs, -23%), but did not improve clinical outcome. CONCLUSIONS: The feasibility, proficiency, and mastery learning curves for RPD at 15, 62, and 84 procedures in "second-generation" centers after a multicenter training program were considerably shorter than previously reported from "pioneering" expert centers. The learning curve cutoffs and prior laparoscopic experience did not impact major morbidity and mortality. These findings demonstrate the safety and value of a nationwide training program for RPD in centers with sufficient volume.

Evidence-Based Medicine Course in Combination With Journal Clubs to Promote Evidence-Based Surgery.

Introduction To provide high-quality surgical care, surgeons must critically appraise medical literature to adapt their clinical practice whenever convincing evidence emerges. This will promote evidence-based surgery (EBS). Over the last decade, we have organized monthly journal clubs (JCs) and more extensive quarterly EBS courses for surgical residents and PhD students, supervised by surgical staff. We evaluated the participation, satisfaction, and knowledge gained by this EBS program, to make the program future-proof and aid other educators. Materials and methods An anonymous digital survey was distributed via email among residents, PhD students, and surgeons of the Amsterdam University Medical Centers' (UMC) surgical department in April 2022. The survey included general questions on EBS education, specific course-oriented questions for the residents and PhD students, and questions about supervision for surgeons. Results The survey was completed by 47 respondents from the surgery department of the Amsterdam UMC University Hospital, of whom 63.8% (n=30) were residents or PhD students and 36.2% (n=17) were surgeons. During one year of the combined EBS course and JCs, the EBS course was attended by 40.0% (n=12) of PhD students and was rated with a mean score of 7.6/10. JCs were attended by 86.6% (n=26) of residents or PhD students and received a mean score of 7.4/10. Reported strengths of the JCs were their easy accessibility and the acquisition of critical appraisal skills and scientific knowledge. A reported point of improvement was to focus more deeply on specific epidemiological topics per meeting. Of the surgeons, 64.7% (n=11) had supervised at least one JC and gave a mean score of 8.5/10. The main reasons to supervise JCs were the distribution of knowledge (45.5%), scientific discussion (36.3%), and contact with PhD students (18.1%). Conclusion Our EBS educational program, including JCs and EBS courses, was well appreciated by residents, PhD students, and staff. This format is advocated for other centers aiming to better implement EBS in surgical practice.

Nationwide Impact of Centralization, Neoadjuvant Therapy, Minimally Invasive Surgery, and Standardized Pathology Reporting on R0 Resection and Overall Survival in Pancreatoduodenectomy for Pancreatic Cancer.

BACKGROUND: Surgeons aim for R0 resection in patients with pancreatic cancer to improve overall survival. However, it is unclear whether recent changes in pancreatic cancer care such as centralization, increased use of neoadjuvant therapy, minimally invasive surgery, and standardized pathology reporting have influenced R0 resections and whether R0 resection remains associated with overall survival. METHODS: This nationwide retrospective cohort study included consecutive patients after pancreatoduodenectomy (PD) for pancreatic cancer from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Database (2009-2019). R0 resection was defined as > 1 mm tumor clearance at the pancreatic, posterior, and vascular resection margins. Completeness of pathology reporting was scored on the basis of six elements: histological diagnosis, tumor origin, radicality, tumor size, extent of invasion, and lymph node examination. RESULTS: Among 2955 patients after PD for pancreatic cancer, the R0 resection rate was 49%. The R0 resection rate decreased from 68 to 43% (2009-2019, P < 0.001). The extent of resections in high-volume hospitals, minimally invasive surgery, neoadjuvant therapy, and complete pathology reports all significantly increased over time. Only complete pathology reporting was independently associated with lower R0 rates (OR 0.76, 95% CI 0.69-0.83, P < 0.001). Higher hospital volume, neoadjuvant therapy, and minimally invasive surgery were not associated with R0. R0 resection remained independently associated with improved overall survival (HR 0.72, 95% CI 0.66-0.79, P < 0.001), as well as in the 214 patients after neoadjuvant treatment (HR 0.61, 95% CI 0.42-0.87, P = 0.007). CONCLUSIONS: The nationwide rate of R0 resections after PD for pancreatic cancer decreased over time, mostly related to more complete pathology reporting. R0 resection remained associated with overall survival.

Tranexamic acid in hip hemiarthroplasty surgery: a systematic review and meta-analysis.

PURPOSE: Anemia is one of the most common complications after hip fracture surgery. Tranexamic acid (TXA) has been considered effective in preventing anemia in total hip arthroplasty, but its role in hemiarthroplasty is debated. The aim of this systematic review was to investigate the efficacy and safety of perioperative TXA for hip hemiarthroplasty. METHODS: A systematic literature search was performed to identify studies comparing adult patients who underwent hemiarthroplasty for a hip fracture with and without perioperative TXA. The primary outcome was transfusion rate. Secondary outcomes included postoperative hemoglobin, length of hospital stay, adverse events (i.e., deep venous thromboses and pulmonary embolism), and 30-day mortality. RESULTS: In total, 13 articles were included, comprising 54,843 patients of whom 14.1% received perioperative TXA. TXA was applied intravenous in ten studies, topical in two studies, one study investigated both. Pooled results showed a significant reduction in transfusion rate (pooled RR: 0.48, 95% CI 0.40-0.58, p < 0.01). Postoperative hemoglobin and length of stay were investigated in nine studies, pooled results showed significant improvement of both outcomes for patients that received TXA. Eleven studies investigated thromboembolic events, and there was no statistical difference in deep venous thromboses (pooled RR: 0.67, 95% CI 0.18-2.56, p = 0.56) or pulmonary embolism (pooled RR: 1.10, 95% CI 0.45-2.68, p = 0.83) among the two groups. There was a significant reduction in 30-day mortality for patients that received TXA. CONCLUSION: TXA can be considered effective and safe for patients undergoing hip hemiarthroplasty, with a reduction in transfusion rate and increase in postoperative hemoglobin, without increasing adverse events. Optimal timing, dosage, and type of administration of TXA remain unclear.

Chyle Leak After Pancreatoduodenectomy: Clinical Impact and Risk Factors in a Nationwide Analysis.

OBJECTIVE: The aim of this study was to assess the clinical impact and risk factors of chyle leak (CL). BACKGROUND: In 2017, the International Study Group for Pancreatic Surgery (ISGPS) published the consensus definition of CL. Multicenter series validating this definition are lacking and previous studies investigating risk factors have used different definitions and showed heterogeneous results. METHODS: This observational cohort study included all consecutive patients after pancreatoduodenectomy in all 19 centers in the mandatory nationwide Dutch Pancreatic Cancer Audit (2017-2019). The primary endpoint was CL (ISGPS grade B/C). Multivariable logistic regression analyses were performed. RESULTS: Overall, 2159 patients after pancreatoduodenectomy were included. The rate of CL was 7.0% (n=152), including 6.9% (n=150) grade B and 0.1% (n=2) grade C. CL was independently associated with a prolonged hospital stay [odds ratio (OR)=2.84, 95% confidence interval (CI): 1.85-4.36, P <0.001] but not with mortality (OR=0.3, 95% CI: 0.0-2.3, P =0.244). In multivariable analyses, independent predictors for CL were vascular resection (OR=2.1, 95% CI: 1.4-3.2, P <0.001) and open surgery (OR=3.5, 95% CI: 1.7-7.2, P =0.001). The number of resected lymph nodes and aortocaval lymph node sampling were not identified as predictors in multivariable analysis. CONCLUSIONS: In this nationwide analysis, the rate of ISGPS grade B/C CL after pancreatoduodenectomy was 7.0%. Although CL is associated with a prolonged hospital stay, the clinical impact is relatively minor in the vast majority (>98%) of patients. Vascular resection and open surgery are predictors of CL.

Alternative Randomized Trial Designs in Surgery: A Systematic Review.

INTRODUCTION: Randomized controlled trials (RCTs) yield the highest level of evidence but are notoriously difficult to perform in surgery. Surgical RCTs may be hampered by slow accrual, the surgical learning curve, and lack of financial support. Alternative RCT designs such as stepped-wedge randomized controlled trials (SW-RCTs), registry-based randomized controlled trials (RB-RCTs), and trials-within-cohorts (TwiCs) may overcome several of these difficulties. This review provides an overview of alternative RCT designs used in surgical research. METHODS: We systematically searched PubMed, EMBASE, and Cochrane Central for surgical SW-RCTs, RB-RCTs, and TwiCs. A surgical RCT was defined as a randomized trial that studied interventions in patients undergoing general surgery, regardless of the affiliation of the corresponding author. Exponential regression analysis was performed to assess time trends. RESULTS: Overall, 41 surgical RCTs using alternative designs were identified, including 17 published final RCT reports and 24 published protocols of ongoing RCTs. These included 25 SW-RCTs (61%), 13 RB-RCTs (32%), and 3 TwiCs (7%). Most of these RCTs were performed in Europe (63%) and within gastrointestinal/oncological surgery (41%). The total number of RCTs using alternative designs exponentially increased over the last 7 years ( P <0.01), with 95% (n=39/41) of the total number published within this time frame. The most reported reasons for using alternative RCT designs were avoidance of contamination for SW-RCTs and generalizability of the trial population for RB-RCTs and TwiCs. CONCLUSIONS: Alternative RCT designs are increasingly used in surgical research, mostly in Europe and within gastrointestinal/oncological surgery. When adequately used, these alternative designs may overcome several difficulties associated with surgical RCTs.

The fear of cancer recurrence and progression in patients with pancreatic cancer.

PURPOSE: It is plausible that patients with pancreatic cancer experience fear of tumor recurrence or progression (FOP). The aim of this study was to compare FOP in patients with pancreatic cancer treated with surgical resection, palliative systemic treatment, or best supportive care (BSC) and analyze the association between quality of life (QoL) and FOP and the effect of FOP on overall survival (OS). METHODS: This study included patients diagnosed with pancreatic cancer between 2015 and 2018, who participated in the Dutch Pancreatic Cancer Project (PACAP). The association between QoL and WOPS was assessed with logistic regression analyses. OS was evaluated using Kaplan-Meier curves with the log-rank tests and multivariable Cox proportional hazard analyses adjusted for clinical covariates and QoL. RESULTS: Of 315 included patients, 111 patients underwent surgical resection, 138 received palliative systemic treatment, and 66 received BSC. Patients who underwent surgical resection had significantly lower WOPS scores (i.e., less FOP) at initial diagnosis compared to patients who received palliative systemic treatment or BSC only (P < 0.001). Better QoL was independently associated with the probability of having a low FOP in the BSC (OR 0.95, 95% CI 0.91-0.98) but not in the surgical resection (OR 0.97, 95% CI 0.94-1.01) and palliative systemic treatment groups (OR 0.97, 95% CI 0.94-1.00). The baseline WOPS score was not independently associated with OS in any of the subgroups. CONCLUSION: Given the distress that FOP evokes, FOP should be explicitly addressed by health care providers when guiding pancreatic cancer patients through their treatment trajectory, especially those receiving palliative treatment or BSC.

Direct discharge from the emergency department of simple stable injuries: a propensity score-adjusted non-inferiority trial.

BACKGROUND: Recent studies suggest a large proportion of musculoskeletal injuries are simple stable injuries (SSIs). The aim of this study was to evaluate whether direct discharge (DD) from the emergency department (ED) of SSIs is non-inferior to 'traditional care' regarding treatment satisfaction and functional outcome, and to compare other patient-reported outcomes (PROMs), patient-reported experiences (PREMs), resource utilization, and adverse outcomes before and after DD. METHODS: This trial compared outcomes for 11 SSIs 6 months before and after the implementation of DD protocols. Pre-DD, patients were treated according to local protocols. Post-DD, patients were discharged directly using removable orthoses, discharge leaflets, smartphone application, and telephone helpline. Participants received a 3-month postinjury PROM/PREM survey to assess treatment satisfaction (Visual Analog Scale, VAS), pain (VAS), functional outcome (four validated questionnaires), and health-related quality of life (HR-QoL; EuroQol-5D). Resource utilization included general practitioner (GP) visit (yes/no), physiotherapist visit (yes/no), return to work/school/sports (days), work/school absenteeism to visit hospital (yes/no), number of hospital visits, and follow-up X-rays. Other outcomes included missed injuries (additionally to SSI) and adverse outcomes (delayed union, non-union). Between-group differences were assessed using propensity score-adjusted regression analyses. Non-inferiority was assessed for satisfaction and functional outcome using predefined margins. RESULTS: 348 (pre-DD) and 371 (post-DD) patients participated; 144 (41.4%) and 153 (41.2%) patients completed the survey. Satisfaction and functional outcome post-DD were non-inferior to traditional care. Mean satisfaction was 8.13 pre-DD and 7.95 post-DD (mean difference: -0.16, p=0.408). Pain, HR-QoL, GP/physiotherapist visits, and return to work/school/sports were comparable before and after DD. Work absenteeism was higher pre-DD (OR 0.110, p<0.001), as well as school absenteeism (OR 0.084, p<0.001). Post-DD, the mean number of hospital visits and X-rays reduced: -1.68 (p<0.001) and -0.26 (p<0.001). Missed injuries occurred once pre-DD versus twice post-DD. There were no adverse outcomes. DISCUSSION: The results of this study confirm several SSIs can be discharged directly from the ED without compromising patient outcome/experience. Future injury-specific trials are needed to conclusively assess non-inferiority of DD. LEVEL OF EVIDENCE: II.