The Effectiveness of Patient Education on Laparoscopic Surgery Postoperative Outcomes to Determine Whether Direct Coaching Is the Best Approach: Systematic Review of Randomized Controlled Trials.

BACKGROUND: As of 2022, patient adherence to postoperative guidelines can reduce the risk of complications by up to 52.4% following laparoscopic abdominal surgery. With the availability of various preoperative education interventions (POEIs), understanding which POEI results in improvement in patient outcomes across the procedures is imperative. OBJECTIVE: This study aims to determine which POEI could be the most effective on patient outcomes by systematically reviewing all the POEIs reported in the literature. METHODS: In total, 4753 articles investigating various POEIs (eg, videos, presentations, mobile apps, and one-on-one education or coaching) were collected from the PubMed, Embase, and Scopus databases. Inclusion criteria were adult patients undergoing abdominal laparoscopic surgery, randomized controlled trials, and studies that provided postoperative outcomes. Exclusion criteria included studies not published in English and with no outcomes reported. Title and abstract and full-text articles with POEI randomized controlled studies were screened based on the above criteria through a blinded, dual review using Covidence (Veritas Health Innovation). Study quality was assessed through the Cochrane Risk of Bias tool. The included articles were analyzed for educational content, intervention timing, intervention type, and postoperative outcomes appropriate for a particular surgery. RESULTS: Only 17 studies matched our criteria, with 1831 patients undergoing laparoscopic cholecystectomy, bariatric surgery (gastric bypass and gastric sleeve), and colectomy. In total, 15 studies reported a statistically significant improvement in at least 1 patient postoperative outcome. None of these studies were found to have an overall high risk of bias according to Cochrane standards. In total, 41% (7/17) of the included studies using direct individual education improved outcomes in almost all surgery types, while educational videos had the greatest statistically significant impact for anxiety, nausea, and pain postoperatively (P<.01). Direct group education demonstrated significant improvement in weight, BMI, exercise, and depressive symptoms in 33% (2/6) of the laparoscopic gastric bypass studies. CONCLUSIONS: Direct education (individual or group based) positively impacts postoperative laparoscopic surgery outcomes. TRIAL REGISTRATION: PROSPERO CRD42023438698; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=438698.

Walking the talk in digital transformation of regulatory review.

Cloud-based regulatory platforms have the potential to substantially transform how regulatory submissions are developed, transmitted, and reviewed across the full life cycle of drug development. The benefits of cloud-based submission and review include accelerating critical therapies to patients in need globally and efficiency gains for both drug developers and regulators. The key challenge is turning the theoretical promise of cloud-based regulatory platforms into reality to further the application of technology in the regulatory processes. In this publication we outline regulatory policy journeys needed to effect the changes in the external environment that would allow for use of a cloud-based technology, discuss the prerequisites to successfully navigate the policy journeys, and elaborate on future possibilities when adoption of cloud-based regulatory technologies is achieved.

Patient-Reported Outcomes and Factors Impacting Success of the Periacetabular Osteotomy.

Hip dysplasia is a condition affecting both infants and adults, characterized by a shallow acetabulum that does not sufficiently cover the head of the femur. This leads to instability of the hip and elevated levels of mechanical stress around the acetabular rim. A popular procedure for the correction of hip dysplasia is the periacetabular osteotomy (PAO), in which fluoroscopically guided osteotomies around the pelvis are made to allow for repositioning of the acetabulum to fit properly on the femoral head. This systematic review aims to analyze patient factors that impact outcomes, as well as patient-reported outcomes such as the Harris Hip Score (HHS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The patients in this review did not undergo any prior intervention for acetabular hip dysplasia, allowing for an unbiased reporting of outcomes from all included studies. Of studies reporting HHS, the mean preoperative HHS was 68.92 and the mean postoperative HHS was 89.1. Of the study that reported mHHS, the mean preoperative mHHS was 70, and the mean postoperative mHHS was 91. Of the studies reporting WOMAC, the mean preoperative WOMAC was 66, and the mean postoperative WOMAC was 63. Key findings of this review are that of the seven included studies, six achieved a minimally important clinical difference (MCID) based on patient-reported outcomes, and factors impacting outcome are preoperative Tönnis osteoarthritis (OA) grade, pre and postoperative lateral-center edge angle (LCEA), preoperative hip joint congruency, postoperative Tönnis angle, and age. In patients with no prior intervention for hip dysplasia, the PAO is a successful procedure with significant improvement in postoperative patient-reported outcomes. Despite the reported success of the PAO, proper patient selection is vital to avoid early conversions to total hip arthroplasty (THA) and prolonged pain. However, further investigation is prompted regarding the long-term survivorship of the PAO in patients with no prior intervention for hip dysplasia.

Evaluation of the Fracture Liaison Service within the Canadian Healthcare Setting.

Previous studies evaluating fracture liaison service (FLS) programs have found them to be cost-effective, efficient, and reduce the risk of fracture. However, few studies have evaluated the clinical effectiveness of these programs. We compared the patient populations of those referred for osteoporosis management by FLS to those referred by primary care physicians (PCP), within the Canadian healthcare system in the province of Ontario. Specifically, we investigated if a referral from FLS is similarly effective as PCP at identifying patients at risk for future osteoporotic fractures and if osteoporosis therapies have been previously initiated. A retrospective chart review of patients assessed by a single Ontario rheumatology practice affiliated with FLS between January 1, 2014, and December 31, 2017, was performed identifying two groups: those referred by FLS within Hamilton and those referred by their PCP for osteoporosis management. Fracture risk of each patient was determined using FRAX. A total of 573 patients (n = 225 (FLS group) and n = 227 (PCP group)) were evaluated. Between the FLS and PCP groups, there were no significant differences in the absolute 10-year risk of a major osteoporotic fracture (15.6% (SD = 10.2) vs 15.3% (SD = 10.3)) and 10-year risk of hip fracture (4.7% (SD = 8.3) vs 4.7% (SD = 6.8)), respectively. 10.7% of patients referred by FLS and 40.5% of patients referred by their PCP were on osteoporosis medication prior to fracture. Our study suggests that referral from FLS is similarly effective as PCP at identifying patients at risk for future osteoporotic fractures, and clinically effective at identifying the care gap with the previous use of targeted osteoporosis therapies from referral from PCP being low and much lower in those referred by FLS. Interventional programs such as FLS can help close the treatment gap by providing appropriate care to patients that were not previously identified to be at risk for fracture by their primary care physician and initiate proper medical management.

Development and Pilot Testing of a Simulation to Study How Physicians Facilitate Surrogate Decision Making Based on Critically Ill Patients' Values and Preferences.

CONTEXT: There are no evidence-based programs to train physicians to facilitate shared decision making based on incapacitated intensive care unit patients' values and preferences. OBJECTIVES: The objective of this study was to develop a high-fidelity simulation to fill this gap. METHODS: Case development involved six steps: 1) drafting a case about an elderly patient receiving prolonged mechanical ventilation; 2) engaging an expert advisory board to optimize case content; 3) revising the case based on advisory board input; 4) training actors to portray the case patient's daughter; 5) obtaining physician feedback on the simulation; and 6) revising the case based on their feedback. We conducted a cross-sectional pilot study with 50 physicians to assess feasibility and acceptability, defined a priori as an enrollment rate >40 physicians/year, study procedures <75 minutes/participant, >95% actor adherence to standardization rules, and high physician ratings of realism and acceptability. RESULTS: Advisory panel feedback yielded two modifications: 1) refocusing the case on decision making about tracheostomy and percutaneous gastrostomy and 2) making the patient's values more authentic. Physician feedback yielded two additional modifications: 1) reducing how readily the actor divulged the patient's values and 2) making her more emotional. All 50 physicians enrolled in the pilot study over 11 months completed study procedures in <75 minutes. Actor adherence to standardization rules was 95.8%. Physicians' mean ratings of realism and acceptability were 8.4 and 9.1, respectively, on a 10-point scale. CONCLUSION: Simulation is feasible, is acceptable, and can be adequately standardized to study physicians' skills for facilitating surrogate decision making based on an incapacitated intensive care unit patient's values and preferences.

CT imaging signs of surgically proven bowel trauma.

The objective of this study was to determine the incidence and interobserver agreement of individual CT findings as well as the bowel injury prediction score (BIPS) in surgically proven bowel injury after blunt abdominal trauma. This HIPAA-compliant retrospective study was IRB approved and consent was waived. All patients 14 years or older who sustained surgically proven bowel injury after blunt abdominal trauma between 1/1/2004 and 6/30/2015 were included. Admission trauma MDCT scans were independently interpreted by two abdominal fellowship-trained radiologists who recorded the following CT findings: intraperitoneal fluid, mesenteric hematoma/fat stranding, bowel wall thickening/hematoma, active intravenous contrast extravasation, free intraperitoneal air, bowel wall discontinuity, and focal bowel hypoenhancement. Subsequently, the electronic medical records of the included patients, admission abdominal physical exam results, admission white blood cell count, and findings at exploratory laparotomy of the included patients were recorded. Thirty-three patients met the inclusion criteria. The incidence and interobserver agreement of the CT findings were as follows: intraperitoneal fluid 93.9 %, kappa = 0.784 (good); mesenteric hematoma/fat stranding 84.8 %, kappa = 0.718 (good); bowel wall thickening/hematoma 42.4 %, kappa = 0.491 (moderate); active IV contrast extravasation 36.3 %, kappa = 1.00 (perfect); free intraperitoneal air 21.2 %, kappa = 0.904 (very good), bowel wall discontinuity 6.1 %, kappa = 1.00 (perfect); and focal bowel hypoenhancement 6.1 %, kappa = 0.468 (moderate). An absence of the specified CT findings was encountered in 9.1 % with surgically proven bowel injuries (kappa = 1.00, perfect). In our study, 9/16 patients or 56.3 % had a bowel injury prediction score (BIPS) of 2 or more as defined by McNutt et al. (J Trauma Acute Care Surg 78(1):105-111, 2014). The presence of intraperitoneal fluid and mesenteric hematoma/fat stranding are the most common CT findings in bowel injuries proven at laparotomy. A small percentage of patients have no abnormal CT findings. This grading system did not prove to be useful in our study likely due to our inherently small patient population; however, the use of BIPS deserves further investigation as it may help in identifying blunt bowel and mesenteric injury patients with often subtle or nonspecific CT findings.

Early Application of High Cut-Off Haemodialysis for de-Novo Myeloma Nephropathy is Associated with Long-Term Dialysis-Independency and Renal Recovery.

BACKGROUND: Multiple myeloma (MM) is a haematological malignancy associated with kidney injury resulting from cast nephropathy, which can be caused by monoclonal free light chains (FLC). It has been demonstrated that early reduction of FLC can lead to a higher proportion of patients recovering renal function with a better outcome, especially if high cut-off haemodialysis (HCO-HD) combined with chemotherapy is used. PATIENTS AND METHODS: In this study, four cases with MM nephropathy were treated with HCO-HD and chemotherapy at a single institution during the period from August 2009 to August 2011. All of the patients presented with acute renal failure and high serum FLC. All patients underwent a bone marrow biopsy to confirm the diagnosis of MM, according to the WHO criteria. Three patients had de novo MM and one patient had relapsed light chain myeloma disease. All patients underwent HCO-HD concomitantly with specific myeloma therapy once the diagnosis or relapse of MM was established. RESULTS: After a medial follow up of 26 months, (range, 13-36) our data showed that all patients had a significant decrease in serum FLC through HCO-HD, proving the effectiveness of HCO-HD in managing MM. De-novo MM patients restored their renal function and achieved low-level FLC early in the treatment and became dialysis-independent. One patient with relapsed myeloma remained dialysis-dependent. CONCLUSION: In summary, our study suggests that in myeloma nephropathy associated with light-chain MM, HCO-HD should be initiated as early as possible. At the same time a specific MM treatment should be initiated to gain control of the disease and salvage the kidneys in order to achieve dialysis-independency. Further randomized trials to confirm our results are warranted.