Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial).

BACKGROUND: The rate of incisional hernia after closure of a temporary loop ileostomy is significant. Synthetic meshes are still commonly avoided in contaminated wounds. The Preloop trial was a multicentre RCT designed to evaluate the benefits of synthetic mesh in incisional hernia prevention, and its safety for use in a contaminated surgical site compared with biological mesh. METHODS: Study patients who underwent closure of a loop ileostomy after anterior resection for rectal cancer were assigned to receive either retrorectus synthetic or biological mesh to prevent incisional hernia. The primary outcomes were surgical-site infections within 30 days, and clinical or radiological incisional hernia incidence at 10 months. Secondary outcomes were reoperation rate, operating time, duration of hospital stay, other complications within 30 days of surgery, 5-year quality of life measured by RAND-36, and incisional hernia incidence within 5 years of follow-up. RESULTS: Between November 2018 and September 2021, 102 patients were randomised, of whom 97 received the intended allocation. At 10-month follow-up, 90 patients had undergone clinical evaluation and 88 radiological evaluation. One patient in each group (2 per cent) had a clinical diagnosis of incisional hernia (P = 0.950) and one further patient in each group had a CT-confirmed incisional hernia (P = 0.949). The number of other complications, reoperation rate, operating time, and duration of hospital stay did not differ between the study groups. CONCLUSION: Synthetic mesh appeared comparable to biological mesh in efficacy and safety for incisional hernia prevention at the time of loop ileostomy closure. REGISTRATION NUMBER: NCT03445936 (http://www.clinicaltrials.gov).

Unresponsive Low Mixed Venous Oxygen Saturation During Early Intensive Care Unit Stay is Associated With Increased Risk of Organ Dysfunction After Cardiac Surgery: A Single-Center Retrospective Study.

OBJECTIVES: The aim of the study was to determine if unresponsive mixed venous oxygen saturation (SvO2) values during early postoperative hours are associated with postoperative organ dysfunction. DESIGN: A single-center retrospective observational study. SETTING: A university hospital. PARTICIPANTS: A total of 6,282 adult patients requiring cardiac surgery who underwent surgery in a University Hospital from 2007 to 2020. INTERVENTIONS: A pulmonary artery catheter was used to gather SvO2 samples after surgery at admission to the intensive care unit (ICU) and 4 hours later. For the analysis, patients were divided into 4 groups according to their SvO2 values. The rate of organ dysfunctions categorized according to the SOFA score was then studied among these subgroups. MEASUREMENTS AND MAIN RESULTS: The crude mortality rate for the cohort at 1 year was 4.3%. Multiple organ dysfunction syndrome (MODS) was present in 33.0% of patients in the early postoperative phase. During the 4-hour initial treatment period, 43% of the 931 patients with low SvO2 on admission responded to goal-directed therapy to increase SvO2 >60%; whereas, in 57% of the 931 patients, the low SvO2 was sustained. According to the adjusted logistic regression analyses, the odds ratio for MODS (4.23 [95% CI 3.41-5.25]), renal- replacement therapy (4.97 [95% CI 3.28-7.52]), time on a ventilator (2.34 [95% CI 2.17-2.52]), and vasoactive-inotropic score >30 (3.62 [95% CI 2.96-4.43]) were the highest in the group with sustained low SvO2. CONCLUSIONS: Patients with SvO2 <60% at ICU admission and 4 hours later had the greatest risk of postoperative MODS. Responsiveness to a goal-directed therapy protocol targeting maintaining or increasing SvO2 ≥60% at and after ICU admission may be beneficial.

Reliability of Bioreactance and Pulse-Power Analysis in Measuring Cardiac Index During Open Abdominal Aortic Surgery.

OBJECTIVE: To investigate the accuracy, precision, and trending ability of noninvasive bioreactance-based Starling SV and the mini invasive pulse-power device LiDCOrapid as compared to thermodilution cardiac output (TDCO) as measured by pulmonary artery catheter when assessing cardiac index (CIx) in the setting of elective open abdominal aortic (AA) surgery. DESIGN: A prospective method-comparison study. SETTING: Oulu University Hospital, Finland. PARTICIPANTS: Forty patients undergoing elective open abdominal aortic surgery. INTERVENTIONS: Intraoperative CI measurements were obtained simultaneously with TDCO and the study monitors, resulting in 627 measurement pairs with Starling SV and 497 with LiDCOrapid. MEASUREMENTS AND MAIN RESULTS: The Bland-Altman method was used to investigate the agreement among the devices, and four-quadrant plots with error grids were used to assess trending ability. The agreement between TDCO and Starling SV was associated with a bias of 0.18 L/min/m2 (95% confidence interval [CI] = 0.13 to 0.23), wide limits of agreement (LOA = -1.12 to 1.47 L/min/m2), and a percentage error (PE) of 63.7 (95% CI = 52.4-71.0). The agreement between TDCO and LiDCOrapid was associated with a bias of -0.15 L/min/m2 (95% CI = -0.21 to -0.09), wide LOA (-1.56 to 1.37), and a PE of 68.7 (95% CI = 54.9-79.6). The trending ability of neither device was sufficient. CONCLUSION: The CI measurements achieved with Starling SV and LiDCOrapid were not interchangeable with TDCO, and the ability to track changes in CI was poor. These results do not support the use of either study device in monitoring CI during open AA surgery.

Prevalence of Acetabular Dysplasia at a Mean age of 18 Years After Treatment for Neonatal hip Instability.

BACKGROUND: The long-term radiological outcomes after the treatment of neonatal hip instability (NHI) in developmental dysplasia of the hip are unclear. Therefore, the prevalence of acetabular dysplasia at a mean age of 18 years after treatment was investigated. The relationship between acetabular dysplasia and hip discomfort has also been poorly established. Therefore, the differences in pain, hip-related quality of life (QOL), and hip impingement tests in hips with and without acetabular dysplasia were assessed. METHODS: All 127 patients treated for NHI from 1995 to 2001 at the study hospital and meeting the inclusion criteria were invited to participate in this population-based follow-up. Of these individuals, 88 (69.3%) participated. The lateral center-edge angle (LCEA), Sharp's angle (SA), and acetabular head index (AHI) were calculated for both hips from pelvic anterior-posterior radiographs. The Copenhagen Hip and Groin Outcome Score (HAGOS) questionnaire was completed for both hips separately; the total score, pain, and QOL subscores were calculated; and the impingement test was performed. RESULTS: The prevalence of acetabular dysplasia, defined as an LCEA <20°, was 3.4%. Only the mean AHI (81.1%, SD 5.3) differed (-5.08, 95% CI -5.77 to -4.38, P <0.001) from previously described gender-specific and side-specific means, whereas the mean LCEA and SA did not. The odds ratio for a positive hip impingement test was 2.8 (95% CI: 1.11-7.05, P = 0.029) for hips with an LCEA <25° compared to hips with LCEA ≥25°. The hips with an SA ≥45° had a mean of 7.8 points lower for the HAGOS pain subscore (95% CI: 4.2-11.4, P <0.001) and a mean of 6.1 points lower for the HAGOS QOL subscore (95% CI: 2.1-10.2, P = 0.003) compared with hips with an SA <45°. CONCLUSIONS: The prevalence of acetabular dysplasia was low after treatment for NHI. Acetabular dysplasia seems to be as common in the general population as for those treated for NHI based on the LCEA. Only an SA ≥45° resulted in slightly more pain and lower hip-related QOL.

Postoperative complications after displaced intra-articular calcaneal fracture operations.

BACKGROUND: The objective was to compare postoperative complications in the management of displaced intra articular calcaneal fractures (DIACF) between two groups; the open reduction and internal fixation (ORIF) group versus the percutaneous fixation (PF) group. METHODS: A total of 243 DIACFs were diagnosed and 127 of them received operations either with ORIF 75 (59.1 %) or PF 52 (40.9 %) between 2004 and 2018. Postoperative complications, radiological Sanders's classification and improvement of Böhler's angle were analyzed. RESULTS: Early complication rate (<6 weeks), rate of deep wound infections and wound edge necrosis were significantly better in PF than in ORIF patient group. There were no significant differences in late complications (>6 weeks from operation) nor in improvement of Böhler's angle. CONCLUSION: Complication rate is lower when using PF technique while fracture reduction remains the same compared to the ORIF. LEVEL OF EVIDENCE: IV retrospective cohort study at a single institution.

Impact of cholangitis on survival of patients with malignant biliary obstruction treated with percutaneous transhepatic biliary drainage.

PURPOSE: To evaluate the impact of cholangitis on survival of patients with gastrointestinal cancer and malignant biliary obstruction treated with percutaneous transhepatic biliary drainage (PTBD). METHODS: A retrospective registry study was performed at a tertiary center from 2000 to 2016 in Northern Finland. RESULTS: The study included 588 patients, 258 (43.9%) patients with pancreatic cancer, 222 (37.7%) with biliary tract cancer, and 108 (18.4%) with metastasis from gastrointestinal cancers. Patient mean age was 70 years, range 26 - 93 years. There were 288 [49.0%] women. The 30-day mortality rate was 30.8% for 156 patients with cholangitis before PTBD, 19.5% for 215 patients with cholangitis after PTBD and 25.8% for 217 patients without cholangitis (P = 0.039). The median survival was 1.8 months for patients with cholangitis before PTBD, 3.0 months for patients with cholangitis after PTBD, and 3.2 months for patients without cholangitis (P = 0.002). The hazard ratio (HR) for 1-year mortality for patients with cholangitis before PTBD was 1.3 (95% CI 1.06 - 1.67, P = 0.015) compared to patients with cholangitis after PTBD. After successful PTBD, 54 out of 291 patients received chemotherapy; the median survival was 5.2 months with cholangitis before PTBD, 9.4 months with cholangitis after PTBD and 15.3 months without cholangitis. CONCLUSION: In gastrointestinal cancers with malignant biliary obstruction, survival is poorer if cholangitis occurs before PTBD compared to cholangitis after PTBD. An oncologist's consultation is essential for assessing the possibility of chemotherapy in successfully treated PTBD patients, because of the notable survival benefit.

Changes in transcranial near-infrared spectroscopy values reflect changes in cardiac index during cardiac surgery.

To determine whether changes in transcranial near-infrared spectroscopy (NIRS) values reflect changes in cardiac index (CI) in adult cardiac surgical patients. Single-center prospective post hoc analysis. University hospital. One hundred and twenty-four adult patients undergoing cardiac surgery. In each patient, several CI measurements were taken, and NIRS values were collected simultaneously. We used a hierarchical linear regression model to assess the association between NIRS values and CI. We calculated a crude model with NIRS as the only factor included, and an adjusted model, where mean arterial pressure, end-tidal CO2 , and oxygen saturation were used as confounding factors. A total of 1301 pairs of NIRS and CI values were collected. The analysis of separate NIRS and CI pairs revealed a poor association, which was not statistically significant when adjusted with the chosen confounders. However, when the changes in NIRS from baseline or from the previous measurement were compared to those of CI, a clinically and statistically significant association between NIRS and CI was observed also in the adjusted model. Compared to the baseline and to the previous measurement, respectively, the regression coefficients with 95% confidence intervals were 0.048 (0.041-0.056) and 0.064 (0.055-0.073) in off-pump coronary artery bypass patients and 0.022 (0.016-0.029) and 0.026 (0.020-0.033) in patients who underwent cardiopulmonary bypass. In an unselected cardiac surgical population, the changes in NIRS values reflect those in CI, especially in off-pump coronary artery bypass patients. In this single-center post hoc analysis of data from a prospectively collected database of cardiac surgery patients, paired measurements of cardiac output and NIRS revealed that while there was a no correlation between individual paired measurements, a small correlation was found in changes in the two measurements from baseline values. This highlights a potential to utilize changes in NIRS from baseline to suggest changes in cardiac output in cardiac surgical populations.

Reliability of bioreactance and pulse power analysis in measuring cardiac index during cytoreductive abdominal surgery with hyperthermic intraperitoneal chemotherapy (HIPEC).

PURPOSE: Various malignancies with peritoneal carcinomatosis are treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). The hemodynamic instability resulting from fluid balance alterations during the procedure necessitates reliable hemodynamic monitoring. The aim of the study was to compare the accuracy, precision and trending ability of two less invasive hemodynamic monitors, bioreactance-based Starling SV and pulse power device LiDCOrapid with bolus thermodilution technique with pulmonary artery catheter in the setting of cytoreductive surgery with HIPEC. METHODS: Thirty-one patients scheduled for cytoreductive surgery were recruited. Twenty-three of them proceeded to HIPEC and were included to the study. Altogether 439 and 430 intraoperative bolus thermodilution injections were compared to simultaneous cardiac index readings obtained with Starling SV and LiDCOrapid, respectively. Bland-Altman method, four-quadrant plots and error grids were used to assess the agreement of the devices. RESULTS: Comparing Starling SV with bolus thermodilution, the bias was acceptable (0.13 l min- 1 m- 2, 95% CI 0.05 to 0.20), but the limits of agreement were wide (- 1.55 to 1.71 l min- 1 m- 2) and the percentage error was high (60.0%). Comparing LiDCOrapid with bolus thermodilution, the bias was acceptable (- 0.26 l min- 1 m- 2, 95% CI - 0.34 to - 0.18), but the limits of agreement were wide (- 1.99 to 1.39 l min- 1 m- 2) and the percentage error was high (57.1%). Trending ability was inadequate with both devices. CONCLUSION: Starling SV and LiDCOrapid were not interchangeable with bolus thermodilution technique limiting their usefulness in the setting of cytoreductive surgery with HIPEC.

Synthetic mesh versus biological mesh to prevent incisional hernia after loop-ileostomy closure: a randomized feasibility trial.

BACKGROUND: Incisional hernia is a frequent complication after loop-ileostomy closure, rationalizing hernia prevention. Biological meshes have been widely used in contaminated surgical sites instead of synthetic meshes in fear of mesh related complications. However, previous studies on meshes does not support this practice. The aim of Preloop trial was to study the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. METHODS: The Preloop randomized, feasibility trial was conducted from April 2018 until November 2021 in four hospitals in Finland. The trial enrolled 102 patients with temporary loop-ileostomy after anterior resection for rectal cancer. The study patients were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene Macro™, Medtronic) (SM) or a biological mesh (Permacol™, Medtronic) (BM) to the retrorectus space at ileostomy closure. The primary end points were rate of surgical site infections (SSI) at 30-day follow-up and incisional hernia rate during 10 months' follow-up period. RESULTS: Of 102 patients randomized, 97 received the intended allocation. At 30-day follow-up, 94 (97%) patients were evaluated. In the SM group, 1/46 (2%) had SSI. Uneventful recovery was reported in 38/46 (86%) in SM group. In the BM group, 2/48 (4%) had SSI (p > 0.90) and in 43/48 (90%) uneventful recovery was reported. The mesh was removed from one patient in both groups (p > 0.90). CONCLUSIONS: Both a synthetic mesh and biological mesh were safe in terms of SSI after loop-ileostomy closure. Hernia prevention efficacy will be published after the study patients have completed the 10 months' follow-up.

X-ray video defaecography is superior to magnetic resonance defaecography in the imaging of defaecation disorders.

AIM: The aim of this work was to study the technical success and diagnostic capability of magnetic resonance defaecography (MRD) compared with video defaecography (VD). METHOD: Sixty four women with defaecation disorders underwent both MRD and x-ray VD over 1 year. The assessment by two radiologists in consensus was retrospective and blinded. The technical success of straining and evacuation was evaluated subjectively. The presence of enterocele, intussusception, rectocele and dyssynergic defaecation was analysed according to established criteria, with VD as the standard of reference. RESULTS: It was found that 62/64 (96.9%) VD studies were technically fully diagnostic compared with 29/64 (45.3%) for MRD. The number of partially diagnostic studies was 1/64 (1.6%) for VD versus 21/64 (32.8%) for MRD, with 1/64 (1.6%) (VD) and 14/64 (21.9%) (MRD) being nondiagnostic. Thirty enteroceles were observed by VD compared with seven in MRD with moderate agreement (κ = 0.41). Altogether 53 intussusceptions were observed by VD compared with 27 by MRD with poor agreement (κ = -0.10 and κ = 0.02 in recto-rectal and recto-anal intussusception, respectively). Moderate agreement (κ = 0.47) was observed in diagnosing rectocele, with 47 cases by VD and 29 by MRD. Dyssynergic defaecation was observed in three patients by VD and in 11 patients by MRD, with slight agreement (κ = 0.14). CONCLUSION: The technical success and diagnostic capabilities of VD are better than those of MRD. VD remains the method of choice in the imaging of defaecation disorders.

Visual outcomes of observation, macular laser and anti-VEGF in diabetic macular edema in type 1 diabetes: a real-world study.

BACKGROUND: The treatment for diabetic macular edema (DME) has revolutionized during the last 15 years after the introduction of intravitreal anti-VEGF agents. The aim of the current study is to evaluate the real-world visual outcomes of diabetic macular edema (DME) treatment in patients with type 1 diabetes (T1D) in long-term follow-up. METHODS: A real-world, descriptive, population-based cohort and follow-up of all patients with T1D and DME in 2006-2020 in 34 communities of the Northern Ostrobothnia Hospital District. The main outcome measures included age, gender, duration of T1D at the onset of DME, stage of retinopathy, treatment of DME (observation, laser, intravitreal treatments, combination), and visual outcomes. RESULTS: A total of 304 eyes of 206 T1D patients with DME were included. 75% (n=155) had non-proliferative diabetic retinopathy during the onset of DME. 15% of the cases were observed, 33% had macular laser, 41% intravitreal anti-VEGF and 12% combination of laser and intravitreal injections. Patients in anti-VEGF and in combination groups gained 4.9 and 5.5 ETDRS letters after the initial DME episode (p<0.001 and p<0.001), and the long-term visual improvements were 4.1 and 5.1 ETDRS letters (p<0.001 and p<0.001), respectively. In observation and laser groups the initial gain of 0.1 (p>0.90) and loss of 0.4 ETDRS letter (p=0.61), respectively, was noted. After the follow-up, a 3.7 ETDRS letter decrease was documented in the observation group (p>0.90) and a 1.1 (p=0.14) ETDRS letter decline in the laser group of patients. At the beginning of treatment, eyes subjected to anti-VEGF alone or in combination with laser had lower visual acuity compared to eyes subjected to observation or macular laser. The average of a 6.1±4.8 anti-VEGF injections were needed to dry DME. Visual impairment due to DME decreased from 2.4% to 1.0% during the 15-year period. CONCLUSIONS: Anti-VEGF alone or in combination with macular laser seems to be beneficial in terms of visual outcomes and treatment stability in T1D patients with central DME. Moreover, satisfying long-term visual outcomes were achieved with anti-VEGF treatment in a real-world setting.

Association of low mixed venous oxygen saturations during early ICU stay with increased 30-day and 1-year mortality after cardiac surgery: a single-center retrospective study.

BACKGROUND: Low postoperative mixed venous oxygen saturation (SvO2) values have been linked to poor outcomes after cardiac surgery. The present study was designed to assess whether SvO2 values of < 60% at intensive care unit (ICU) admission and 4 h after admission are associated with increased mortality after cardiac surgery. METHODS: During the years 2007-2020, 7046 patients (74.4% male; median age, 68 years [interquartile range, 60-74]) underwent cardiac surgery at an academic medical center in Finland. All patients were monitored with a pulmonary artery catheter. SvO2 values were obtained at ICU admission and 4 h later. Patients were divided into four groups for analyses: SvO2 ≥ 60% at ICU admission and 4 h later; SvO2 ≥ 60% at admission but < 60% at 4 h; SvO2 < 60% at admission but ≥ 60% at 4 h; and SvO2 < 60% at both ICU admission and 4 h later. Kaplan-Meier survival curves, Cox regression models, and receiver operating characteristic curve analysis were used to assess differences among groups in 30-day and 1-year mortality. RESULTS: In the overall cohort, 52.9% underwent coronary artery bypass grafting (CABG), 29.1% valvular surgery, 12.1% combined CABG and valvular procedures, 3.5% surgery of the ascending aorta or aortic dissection, and 2.4% other cardiac surgery. The 1-year crude mortality was 4.3%. The best outcomes were associated with SvO2 ≥ 60% at both ICU admission and 4 h later. Hazard ratios for 1-year mortality were highest among patients with SvO2 < 60% at both ICU admission and 4 h later, regardless of surgical subgroup. CONCLUSION: SvO2 values < 60% at ICU admission and 4 h after admission are associated with increased 30-day and 1-year mortality after cardiac surgery. Goal-directed therapy protocols targeting SvO2 ≥ 60% may be beneficial. Prospective studies are needed to confirm these observational findings.

Accuracy, Precision, and Trending Ability of Perioperative Central Venous Oxygen Saturation Compared to Mixed Venous Oxygen Saturation in Unselected Cardiac Surgical Patients.

OBJECTIVE: To determine whether central venous oxygen saturation (ScvO2) measurements could be used interchangeably with mixed venous oxygen saturation (SvO2) measurements in adult cardiac surgery patients. DESIGN: A single-center prospective observational study. SETTING: A university hospital. PARTICIPANTS: Eighty-five adult patients undergoing cardiac surgery. INTERVENTIONS: The study authors compared the oxygen saturations in 590 pairs of venous blood samples drawn from the pulmonary artery catheter (PAC) at three different time points during surgery and four different time points in the intensive care unit. They compared samples obtained from the distal pulmonary artery line (SvO2) to those drawn from the proximal central venous line of the PAC (ScvO2) with the Bland-Altman test and the four-quadrant method. MEASUREMENTS AND MAIN RESULTS: The mean bias between SvO2 and ScvO2 was -1.9 (95% confidence interval [CI], -2.3 to -1.5) and the limits of agreement (LOA) were -11.5 to 7.6 (95% CI, -12.5 to -10.7 and 6.8-8.5, respectively). The percentage error (PE) was 13.2%. Based on the four-quadrant plot, only 50% of the measurement pairs were in agreement, indicating deficient trending ability. CONCLUSION: ScvO2 values showed acceptable accuracy as the mean bias was low. The precision was inadequate; although the PE was acceptable, the LOA were wide. Trending ability was inadequate. The authors cannot recommend the use of ScvO2 values interchangeably with SvO2 measurements in the management of adult cardiac surgery patients.

Reliability of Bioreactance and Pulse-Power Analysis in Measuring Cardiac Index in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass.

OBJECTIVES: Less-invasive and continuous cardiac output monitors recently have been developed to monitor patient hemodynamics. The aim of this study was to compare the accuracy, precision, and trending ability of noninvasive bioreactance-based Starling SV and miniinvasive pulse-power device LiDCOrapid to bolus thermodilution technique with a pulmonary artery catheter (TDCO) when measuring cardiac index in the setting of cardiac surgery with cardiopulmonary bypass (CPB). DESIGN: A prospective method-comparison study. SETTING: Oulu University Hospital, Finland. PARTICIPANTS: Twenty patients undergoing cardiac surgery with CPB. INTERVENTIONS: Cardiac index measurements were obtained simultaneously with TDCO intraoperatively and postoperatively, resulting in 498 measurements with Starling SV and 444 with LiDCOrapid. MEASUREMENTS AND MAIN RESULTS: The authors used the Bland-Altman method to investigate the agreement between the devices and four-quadrant plots with error grids to assess the trending ability. The agreement between TDCO and Starling SV was qualified with a bias of 0.43 L/min/m2 (95% confidence interval [CI], 0.37-0.50), wide limits of agreement (LOA, -1.07 to 1.94 L/min/m2), and a percentage error (PE) of 66.3%. The agreement between TDCO and LiDCOrapid was qualified, with a bias of 0.22 L/min/m2 (95% CI 0.16-0.27), wide LOA (-0.93 to 1.43), and a PE of 53.2%. With both devices, trending ability was insufficient. CONCLUSION: The reliability of bioreactance-based Starling SV and pulse-power analyzer LiDCOrapid was not interchangeable with TDCO, thus limiting their usefulness in cardiac surgery with CPB.

Artificial intelligence-enhanced care pathway planning and scheduling system: content validity assessment of required functionalities.

BACKGROUND: Artificial intelligence (AI) and machine learning are transforming the optimization of clinical and patient workflows in healthcare. There is a need for research to specify clinical requirements for AI-enhanced care pathway planning and scheduling systems to improve human-AI interaction in machine learning applications. The aim of this study was to assess content validity and prioritize the most relevant functionalities of an AI-enhanced care pathway planning and scheduling system. METHODS: A prospective content validity assessment was conducted in five university hospitals in three different countries using an electronic survey. The content of the survey was formed from clinical requirements, which were formulated into generic statements of required AI functionalities. The relevancy of each statement was evaluated using a content validity index. In addition, weighted ranking points were calculated to prioritize the most relevant functionalities of an AI-enhanced care pathway planning and scheduling system. RESULTS: A total of 50 responses were received from clinical professionals from three European countries. An item-level content validity index ranged from 0.42 to 0.96. 45% of the generic statements were considered good. The highest ranked functionalities for an AI-enhanced care pathway planning and scheduling system were related to risk assessment, patient profiling, and resources. The highest ranked functionalities for the user interface were related to the explainability of machine learning models. CONCLUSION: This study provided a comprehensive list of functionalities that can be used to design future AI-enhanced solutions and evaluate the designed solutions against requirements. The relevance of statements concerning the AI functionalities were considered somewhat relevant, which might be due to the low level or organizational readiness for AI in healthcare.

Quality of life in head and neck cancer patients at 5 years after free flap reconstruction: a significant decline during the follow-up.

PURPOSE: Free flap reconstructions following head and neck tumor resection are known to involve more than 50% rate of complications and other adverse events and up to 50% mortality during a 5-year follow-up. We aimed to examine the difference in the long-term quality of life (QoL) between the 2-year and 5-year assessments after free flap surgery for cancer of the head and neck. METHODS: A total of 28 of the 39 eligible patients responded to the survey. QoL was assessed at 5 years after operation and compared with the assessment performed at 2 years after the operation using RAND-36, EORTC-C30 and H&N-35, and SWAL-QOL tools. RESULTS: The criteria for poor QoL using RAND-36 tool was met in 11 (39.3%) patients in contrast to 4 (14.3%, P = 0.003) patients in the 2-year assessment. EORTC-C30 global score was decreased from 83.9 (SD16.4) to 64.6 (SD 24.0, P < 0.001) during the follow-up. In both RAND-36 and EORTC-C30 surveys, decline was found in physical and role functioning together with energy and emotional well-being domains. SWAL-QOL showed poor swallowing-related QoL in both assessments. CONCLUSION: We found a significant decline in QoL during a 5-year follow-up after free flap surgery for cancer of the head and neck.

The impact of cardiovascular diseases on hearing deterioration: a 13-year follow-up study.

OBJECTIVE: To study the impact of cardiovascular diseases (CVDs) on hearing deterioration among ageing adults in a longitudinal setting. Furthermore, to describe the pure tone threshold changes at the 0.125-8 kHz frequency range over 13 years. DESIGN: A population-based follow-up study. STUDY SAMPLE: A random sample of 850 adults, of whom 559 participated in the follow-up study. Otological examination, a structured interview, and pure tone audiometry were conducted. Multivariate regression models were used to estimate the effect of CVD (participants had at least one cardiovascular condition) on hearing deterioration of the better ear hearing level (BEHL), defined as a change in the pure-tone average (PTA) of the frequencies 0.5, 1, 2, and 4 kHz and separately at the lower (0.125, 0.25, and 0.5 kHz) and higher (4, 6, and 8 kHz) frequencies. RESULTS: In the multivariable-adjusted analysis, the BEHL change at 13 years was 0.7 dB greater among participants with CVD (p = 0.3). The mean BEHL change during the 13-year follow-up was 12.0 dB (95% CI 11.4-12.6) among all participants. CONCLUSIONS: No significant association between CVD and hearing threshold changes was found.

Case control study investigating the clinical utility of NPWT in the perineal region following abdominoperineal resection for rectal adenocarcinoma: a single center study.

BACKGROUND: Perineal wound complications are common after abdominoperineal resection (APR) for rectal adenocarcinoma. Delayed wound healing may postpone postoperative adjuvant therapy and, therefore, lead to a worse survival rate. Negative-pressure wound therapy (NPWT) has been suggested to improve healing, but research on this subject is limited. METHODS: The aim of this study was to assess whether NPWT reduces surgical site infections (SSI) after APR for rectal adenocarcinoma when the closure is performed with a biological mesh and a local flap. A total of 21 consecutive patients had an NPWT device (Avelle, Convatec™) applied to the perineal wound. The study patients were compared to a historical cohort in a case-control setting in relation to age, body mass index, tumor stage, and length of neoadjuvant radiotherapy. The primary outcome was the surgical site infection rate. The secondary outcomes were the wound complication rate, the severity of wound complications measured by the Clavien-Dindo classification, length of hospital stay, and surgical revision rate. RESULTS: The SSI rate was 33% (7/21) in the NPWT group and 48% (10/21) in the control group, p = 0.55. The overall wound complication rate was 62% (13/21) in NPWT patients and 67% (14/21) in the control group, p > 0.90. The length of hospital stay was 15 days in the NPWT group and 13 in the control group, p = 0.34. The wound severity according to the Clavien-Dindo classification was 3b in 29% (6/21) of the NPWT group and in 38% (8/21) of the control group. A surgical revision had to be performed in 29% (6/21) of the cases in the NPWT group and 38% (8/21) in the control group, p = 0.73. CONCLUSION: NPWT did not statistically decrease surgical site infections or reduce wound complication severity in perineal wounds after APR in this case-control study. The results may be explained by technical difficulties in applying NPWT in the perineum, especially in female patients. NPWT devices should be further developed to suit the perineal anatomy before their full effect can be assessed. Trial registration The study was registered as a prospective registry study (266/2018, registered 15th of November 2018).

Bioreactance and fourth-generation pulse contour methods in monitoring cardiac index during off-pump coronary artery bypass surgery.

The pulmonary artery catheter (PAC) is considered the gold standard for cardiac index monitoring. Recently new and less invasive methods to assess cardiac performance have been developed. The aim of our study was to assess the reliability of a non-invasive monitor utilizing bioreactance (Starling SV) and a non-calibrated mini-invasive pulse contour device (FloTrac/EV1000, fourth-generation software) compared to bolus thermodilution technique with PAC (TDCO) during off-pump coronary artery bypass surgery (OPCAB). In this prospective study, 579 simultaneous intra- and postoperative cardiac index measurements obtained with Starling SV, FloTrac/EV1000 and TDCO were compared in 20 patients undergoing OPCAB. The agreement of data was investigated by Bland-Altman plots, while trending ability was assessed by four-quadrant plots with error grids. In comparison with TDCO, Starling SV was associated with a bias of 0.13 L min-1 m-2 (95% confidence interval, 95% CI, 0.07 to 0.18), wide limits of agreement (LOA, - 1.23 to 1.51 L min-1 m-2), a percentage error (PE) of 60.7%, and poor trending ability. In comparison with TDCO, FloTrac was associated with a bias of 0.01 L min-1 m-2 (95% CI - 0.05 to 0.06), wide LOA (- 1.27 to 1.29 L min-1 m-2), a PE of 56.8% and poor trending ability. Both Starling SV and fourth-generation FloTrac showed acceptable mean bias but imprecision due to wide LOA and high PE, and poor trending ability. These findings indicate limited reliability in monitoring cardiac index in patients undergoing OPCAB.

Syndesmosis fixation in supination-external rotation ankle fractures. Long-Term results of a prospective randomised study.

BACKROUND: The clinical relevance and treatment of syndesmosis injury in supination-external rotation (SER) ankle fractures are controversial. METHODS: After malleolar fixation 24 SER 4 ankle fracture patients with unstable syndesmosis in external rotation stress test were randomised to syndesmosis transfixation with a screw (13 patients) or no fixation (11 patients). Mean follow-up time was 9.7 years (range, 8.9-11.0). The primary outcome measure was the Olerud-Molander Ankle Outcome Score (OMAS). Secondary outcome measures included ankle mortise congruity and degenerative osteoarthritis, 100-mm visual analogue scale for function and pain, RAND 36-Item Health Survey, and range of motion. RESULTS: Mean OMAS in the syndesmosis transfixation group was 87.3 (SD 15.5) and in the no-syndesmosis-fixation group 89.0 (SD 16.0) (difference between means 1.8, 95% CI -10.4-14.0, P = 0.76). There were no differences between the two groups in secondary outcome measures. CONCLUSION: With the numbers available, SER 4 ankle fractures with unstable syndesmosis can be treated with malleolar fixation only, with good to excellent long-term functional outcome.