Double-blinded, randomised, placebo-controlled trial of convalescent plasma for COVID-19: analyses by neutralising antibodies homologous to recipients' variants.

INTRODUCTION: Convalescent plasma (CP) emerged as potential treatment for COVID-19 early in the pandemic. While efficacy in hospitalised patients has been lacklustre, CP may be beneficial at the first stages of disease. Despite multiple new variants emerging, no trials have involved analyses on variant-specific antibody titres of CP. METHODS: We recruited hospitalised COVID-19 patients within 10 days of symptom onset and, employing a double-blinded approach, randomised them to receive 200 ml convalescent plasma with high (HCP) or low (LCP) neutralising antibody (NAb) titre against the ancestral strain (Wuhan-like variant) or placebo in 1:1:1 ratio. Primary endpoints comprised intubation, corticosteroids for symptom aggravation, and safety assessed as serious adverse events. For a preplanned ad hoc analysis, the patients were regrouped by infused CP's NAb titers to variants infecting the recipients i.e. by titres of homologous HCP (hHCP) or LCP (hLCP). RESULTS: Of the 57 patients, 18 received HCP, 19 LCP and 20 placebo, all groups smaller than planned. No significant differences were found for primary endpoints. In ad hoc analysis, hHCPrecipients needed significantly less respiratory support, and appeared to be given corticosteroids less frequently (1/14; 7.1%) than those receiving hLCP (9/23; 39.1%) or placebo (8/20; 40%), (p = 0.077). DISCUSSION: Our double-blinded, placebo-controlled CP therapy trial remained underpowered and does not allow any firm conclusions for early-stage hospitalised COVID-19 patients. Interestingly, however, regrouping by homologous - recipients' variant-specific - CP titres suggested benefits for hHCP. We encourage similar re-analysis of ongoing/previous larger CP studies. TRIAL REGISTRATION: ClinTrials.gov identifier: NCT0473040.

Functional results of total-knee arthroplasty versus medial unicompartmental arthroplasty: two-year results of a randomised, assessor-blinded multicentre trial.

OBJECTIVE: The primary objective of the trial was to assess the clinical effectiveness of medial unicompartmental knee arthroplasty versus total knee arthroplasty in patients with isolated medial osteoarthritis of the knee. DESIGN: Prospective, randomised, 2 years, assessor-blind, multicentre, superiority trial. SETTING: The patients were enrolled between December 2015 and May 2018 from the outpatient clinics of three public high-volume arthroplasty hospitals (Finland). PARTICIPANTS: We recruited 143 patients with symptomatic-isolated medial osteoarthritis of the knee needing an arthroplasty procedure. All the patients were suitable for both unicompartmental and total knee arthroplasties. Population was selected as the end-stage-isolated medial osteoarthritis. INTERVENTIONS: All patients, randomized 1:1, received a medial unicompartmental arthroplasty or a total knee arthroplasty through a similar midline skin incision. Patients were blinded to the type of arthroplasty for the whole 2 years of follow-up. MAIN OUTCOME MEASURES: Primary outcome measure was between-group differences in the Oxford Knee Score (OKS) and secondary outcome Knee injury and Osteoarthritis Score (KOOS) at 2 years postoperatively. The changes within and between the groups were analysed with analysis of variance for repeated measurements. RESULTS: The primary outcome was comparable for medial unicompartmental arthroplasty and total knee arthroplasty at 2 years. The mean difference in the OKS between the groups was 1.6 points (95% CI -0.7 to 3.9). In the KOOS subscales, the mean difference between the groups was 0.1 points (95% CI -4.8 to 5.0) for pain, 7.8 points (95% CI 1.5 to 14.0) for symptoms, 4.3 points (95% CI -0.6 to 9.2) for function in daily living, 4.3 points (95% CI -3.0 to 11.6) for function in sports, and 2.1 points (95% CI -4.8 to 9.1) for knee-related quality of life. CONCLUSIONS: The recovery after unicompartmental knee arthroplasty was faster compared with total knee arthroplasty, but unicompartmental arthroplasty did not provide a better patient-reported outcome at 2 years. TRIAL REGISTRATION NUMBER: NCT02481427.

The efficacy of probiotics and/or n-3 long-chain polyunsaturated fatty acids intervention on maternal prenatal and postnatal depressive and anxiety symptoms among overweight and obese women.

BACKGROUND: Maternal depression and anxiety may endanger well-being of both mother and child. We investigated the efficacy of probiotics and/or fish oil (FO) in modifying pre- and postnatal depressive and anxiety symptoms. Symptom trajectories were identified and the influence of lifestyle factors on symptoms was evaluated. METHODS: Overweight women (n = 439) were randomized to intervention groups (probiotics+FO, probiotics+placebo, FO+placebo, placebo+placebo) from early pregnancy until six months postpartum, and assessed for depressive and anxiety symptoms with Edinburgh Postnatal Depression Scale (EPDS) and Anxiety subscale of Symptoms Checklist (SCL-90) at early and late pregnancy and three, six and 12 months postpartum. Latent growth mixture modeling was used to model the symptom courses. Dietary quality and physical activity were assessed with validated indices. RESULTS: Symptom scores were generally low. Statistically significant intervention effect was seen during pregnancy (p = 0.017): EPDS scores increased (by 1.11 points) in the FO+probiotics group and decreased (by 0.85 points) in the FO+placebo group. At 12 months postpartum, FO+placebo group had lower EPDS scores compared to probiotics+placebo group (p = 0.039). No differences in SCL scores were seen in response to the intervention. Irrespective of the intervention, three depressive and two anxiety symptoms trajectories were identified. Dietary quality correlated negatively with depressive symptoms in early pregnancy and six months postpartum and with anxiety symptoms in early pregnancy. Perinatal events including mother-reported colic were related to symptoms. LIMITATIONS: Secondary outcomes of the primary trial. CONCLUSIONS: Intervention had a modest impact on depressive symptoms. Diet and obstetric events were associated with depressive and anxiety symptoms.

Characteristics of clinically node negative breast cancer patients needing preoperative MRI.

BACKGROUND: International guidelines do not recommend magnetic resonance imaging (MRI) for all breast cancer patients at primary diagnostics. This study aimed to understand which patient or tumor characteristics are associated with the use of MRI. The role of MRI among other preoperative imaging methods in clinically node negative breast cancer was studied. MATERIAL AND METHODS: Patient and tumor characteristics were analyzed in association with the use of MRI by multivariable logistic regression analysis in 461 patients. Primary tumor size was compared between MRI, mammography (MGR), ultrasound (US) and histopathology by Spearman correlation. The delays in surgery and diagnosis were analyzed among patients with or without MRI, and axillary reoperations were evaluated. RESULTS: Age (p < 0.0001), primary operation method (p < 0.0001), tumor histology (p < 0.0001) and HER2 status (p = 0.0064) were associated with the use of MRI. Spearman correlations between tumor size in histopathology and the difference in tumor size between histopathology and imaging methods were 0.52 in MGR, 0.66 in US and 0.36 in MRI (p < 0.0001 for all). A seven-day delay in surgical treatment was observed among patients with MRI compared to patients without MRI (p < 0.0001). Axillary reoperation rates were similar in patients with or without MRI (p = 0.57). CONCLUSION: Patient selection through prearranged characterization is important in deciding on optimal candidates for preoperative MRI among breast cancer patients. MRI causes moderate delays in primary breast cancer surgery. Preoperative MRI is useful in the evaluation of tumor size but might be insufficient in detecting lymph node metastases.

Prolonged injury symptoms and later visits to psychiatric care after mild traumatic brain injury in school-age.

OBJECTIVE: To investigate demographic and pre-injury factors in Finnish school-aged children admitted to pediatric neurology services after mild traumatic brain injury (mTBI). The relation of these factors to prolonged injury symptoms and later visits into psychiatric care was assessed. METHODS: Demographic information, pre-injury learning status, and neuropsychological test results of 120 patients aged 7-16 years were retrospectively collected from the hospital medical records. Data were compared with self- or parent-reported injury symptoms at 1-3 months post-injury and later visits to psychiatric care. RESULTS: According to medical records, 14.2% of the children with mTBI had a diagnosed neurobehavioral or psychiatric condition pre-injury. Additionally, 53.3% of the children had some neurobehavioral or psychiatric concerns or traits prior to the injury. Over half (56.7%) of the children studied were symptomatic at 1-3 months following the injury. Female gender and presence of prolonged symptoms were predictive for later visit into psychiatric care. CONCLUSIONS: Pre-injury neurobehavioral or psychiatric problems may predict prolonged injury symptoms following pediatric mTBI. In this retrospective patient series, prolonged symptoms and female gender seem to predict the need for later psychiatric care. Monitoring the recovery of children with mTBI and pre-injury risk factors is important for timely interventions.

Healthy learning mind - Effectiveness of a mindfulness program on mental health compared to a relaxation program and teaching as usual in schools: A cluster-randomised controlled trial.

BACKGROUND: Mindfulness-Based Interventions (MBIs) have shown promising effects on mental health among children and adolescents, but high-quality studies examining the topic are lacking. The present study assessed the effects of MBI on mental health in school-setting in an extensive randomised controlled trial. METHODS: Finnish school children and adolescents (N = 3519), aged 12-15 years (6th to 8th graders), from 56 schools were randomized into a 9 week MBI group, and control groups with a relaxation program or teaching as usual. The primary outcomes were resilience, socio-emotional functioning, and depressive symptoms at baseline, at completion of the programs at 9 weeks (T9), and at follow-up at 26 weeks (T26). RESULTS: Overall, mindfulness did not show more beneficial effects on the primary outcomes compared to the controls except for resilience for which a positive intervention effect was found at T9 in all participants (ß=1.18, SE 0.57, p = 0.04) as compared to the relaxation group. In addition, in gender and grade related analyses, MBI lowered depressive symptoms in girls at T26 (ß=-0.49, SE 0.21, p = 0.02) and improved socio-emotional functioning at T9 (ß=-1.37, SE 0.69, p = 0.049) and at T26 (ß=-1.71, SE 0.73, p = 0.02) among 7th graders as compared to relaxation. LIMITATIONS: The inactive control group was smaller than the intervention and active control groups, reducing statistical power. CONCLUSIONS: A short 9-week MBI in school-setting provides slight benefits over a relaxation program and teaching as usual. Future research should investigate whether embedding regular mindfulness-based practice in curriculums could intensify the effects.

The effect of low-dose aspirin on serum placental growth factor levels in a high-risk PREDO cohort.

OBJECTIVES: Our first aim was to study the longitudinal changes of serum placental growth factor (PlGF) concentration between 12+0 and 28+0 weeks of gestation in the prospective PREDO cohort. Our second aim was to study the effect of low-dose acetylsalicylic acid (LDA; 100 mg/day), started before the 14th week of gestation, on PlGF concentration. STUDY DESIGN: Blood samples were collected at 12+0-14+0, 18+0-20+0 and 26+0-28+0 weeks of gestation in 101 women without and 309 with clinical risk factors for pre-eclampsia. Risk-women were divided into two groups: to those who had medium risk for pre-eclampsia and to those who had high risk for pre-eclampsia. Finally there were seven groups according to risk, treatment (no prevention/placebo/LDA) and outcome measure pre-eclampsia. Longitudinal changes in the PlGF concentration between groups were compared. To investigate the effect of LDA on serum PlGF concentration, placebo (N = 62) and LDA (N = 61) groups were compared. A repeated measures ANOVA was used to analyze differences in PlGF levels between the groups. RESULTS: The increase in serum PlGF concentration was higher in LDA than in placebo group (time × group effect, p = 0.046). The increase in serum PlGF concentration during pregnancy was lower in high-risk women who had placebo and developed pre-eclampsia and in medium-risk women who developed pre-eclampsia compared to the other women (time × group effect, p < 0.001). There were no differences in PlGF change between low-risk women, medium-risk women who did not develop pre-eclampsia, high-risk women in the placebo group without pre-eclampsia and high-risk women in the LDA group with and without pre-eclampsia (p = 0.15). CONCLUSIONS: Our finding suggests an association between LDA started before 14 weeks of gestation and higher increase in serum PlGF concentration.

Dreaming and awareness during dexmedetomidine- and propofol-induced unresponsiveness.

BACKGROUND: Experiences during anaesthetic-induced unresponsiveness have previously been investigated by interviews after recovery. To explore whether experiences occur during drug administration, we interviewed participants during target-controlled infusion (TCI) of dexmedetomidine or propofol and after recovery. METHODS: Healthy participants received dexmedetomidine (n=23) or propofol (n=24) in stepwise increments until loss of responsiveness (LOR1). During TCI we attempted to arouse them for interview (return of responsiveness, ROR1). After the interview, if unresponsiveness ensued with the same dose (LOR2), the procedure was repeated (ROR2). Finally, the concentration was increased 1.5-fold to achieve presumable loss of consciousness (LOC), infusion terminated, and the participants interviewed upon recovery (ROR3). An emotional sound stimulus was presented during LORs and LOC, and memory for stimuli was assessed with recognition task after recovery. Interview transcripts were content analysed. RESULTS: Of participants receiving dexmedetomidine, 18/23 were arousable from LOR1 and LOR2. Of participants receiving propofol, 10/24 were arousable from LOR1 and two of four were arousable from LOR2. Of 93 interviews performed, 84% included experiences from periods of unresponsiveness (dexmedetomidine 90%, propofol 74%). Internally generated experiences (dreaming) were present in 86% of reports from unresponsive periods, while externally generated experiences (awareness) were rare and linked to brief arousals. No within drug differences in the prevalence or content of experiences during infusion vs after recovery were observed, but participants receiving dexmedetomidine reported dreaming and awareness more often. Participants receiving dexmedetomidine recognised the emotional sounds better than participants receiving propofol (42% vs 15%), but none reported references to sounds spontaneously. CONCLUSION: Anaesthetic-induced unresponsiveness does not induce unconsciousness or necessarily even disconnectedness. CLINICAL TRIAL REGISTRATION: NCT01889004.

Comparative effects of dexmedetomidine, propofol, sevoflurane, and S-ketamine on regional cerebral glucose metabolism in humans: a positron emission tomography study.

INTRODUCTION: The highly selective α2-agonist dexmedetomidine has become a popular sedative for neurointensive care patients. However, earlier studies have raised concern that dexmedetomidine might reduce cerebral blood flow without a concomitant decrease in metabolism. Here, we compared the effects of dexmedetomidine on the regional cerebral metabolic rate of glucose (CMRglu) with three commonly used anaesthetic drugs at equi-sedative doses. METHODS: One hundred and sixty healthy male subjects were randomised to EC50 for verbal command of dexmedetomidine (1.5 ng ml-1; n=40), propofol (1.7 µg ml-1; n=40), sevoflurane (0.9% end-tidal; n=40) or S-ketamine (0.75 µg ml-1; n=20) or placebo (n=20). Anaesthetics were administered using target-controlled infusion or vapouriser with end-tidal monitoring. 18F-labelled fluorodeoxyglucose was administered 20 min after commencement of anaesthetic administration, and high-resolution positron emission tomography with arterial blood activity samples was used to quantify absolute CMRglu for whole brain and 15 brain regions. RESULTS: At the time of [F18]fluorodeoxyglucose injection, 55% of dexmedetomidine, 45% of propofol, 85% of sevoflurane, 45% of S-ketamine, and 0% of placebo subjects were unresponsive. Whole brain CMRglu was 63%, 71%, 71%, and 96% of placebo in the dexmedetomidine, propofol, sevoflurane, and S-ketamine groups, respectively (P<0.001 between the groups). The lowest CMRglu was observed in nearly all brain regions with dexmedetomidine (P<0.05 compared with all other groups). With S-ketamine, CMRglu did not differ from placebo. CONCLUSIONS: At equi-sedative doses in humans, potency in reducing CMRglu was dexmedetomidine>propofol>ketamine=placebo. These findings alleviate concerns for dexmedetomidine-induced vasoconstriction and cerebral ischaemia. CLINICAL TRIAL REGISTRATION: NCT02624401.

The impact of probiotics and n-3 long-chain polyunsaturated fatty acids on intestinal permeability in pregnancy: a randomised clinical trial.

A disruption in intestinal barrier integrity may predispose individuals to metabolic aberrations, particularly during the vulnerable period of pregnancy. We investigated whether intestinal permeability, as measured by serum zonulin concentration, changes over the duration of pregnancy and whether this change is reflected in lipopolysaccharide (LPS) activity. Second, we tested in a randomised double-blind placebo controlled clinical trial the impact of consuming dietary probiotics and/or long chain polyunsaturated fatty acid (LC-PUFA) supplements in lowering serum zonulin concentration and LPS activity. The probiotic supplement was a combination of two bacteria, Bifidobacterium animalis ssp. lactis 420 and Lactobacillus rhamnosus HN001. This study included 200 overweight pregnant women participating in an on-going study; participants were randomised to consume either (1) probiotics, (2) LC-PUFA, (3) probiotics and LC-PUFA, or (4) placebo for each supplement. Blood samples were obtained at early, the baseline, and late pregnancy (mean 14 and 35 weeks of gestation, respectively). Serum zonulin concentration increased from early (mean (standard deviation): 62.7 (12.9) ng/ml) to late pregnancy by 5.3 (95%CI 3.7-6.9) ng/ml, and LPS activity increased from (0.16 (0.04) EU/ml) by 0.04 (95%CI 0.03-0.05) EU/ml. No differences among the intervention groups were detected in the change from early to late pregnancy in serum zonulin concentration (P=0.8) or LPS activity (P=0.2). The change in serum zonulin concentration during the pregnancy was associated with the weeks of follow up (r=0.25, P<0.001). Serum LPS activity was correlated with higher maternal weight gain (r=0.19, P=0.008). As a conclusion, intestinal permeability increased with the progression of pregnancy in overweight and obese women and was reflected in LPS activity. No efficacy of supplementation with probiotics and/or LC-PUFA was demonstrated in pregnancy-induced changes in serum zonulin concentration or LPS activity.

Systematic Screening of Adverse Reactions to Metal Debris after Recap-M2A-Magnum Metal-on-Metal Total Hip Arthroplasty.

BACKGROUND AND AIMS: An adverse reaction to metal debris is a known complication after large diameter head metal-on-metal total hip arthroplasty. However, the failure rate varies depending on the implant design. Therefore, we investigated the prevalence of adverse reaction to metal debris, as well as the symptoms and risk factors after undergoing a ReCap-M2a-Magnum large diameter head metal-on-metal total hip arthroplasty. MATERIALS AND METHODS: Between 2005 and 2012, 1188 patients (1329 hips) underwent ReCap-M2a-Magnum total hip arthroplasty at our institution. Systematic screening for adverse reaction to metal debris was arranged using the Oxford Hip Score questionnaire, hip and pelvic radiographs, and assessments of the serum chromium and cobalt ion levels. Clinical evaluation and magnetic resonance imaging were performed for the symptomatic patients, as well as those with either chromium or cobalt ion levels ⩾5 µg/L. The prevalence of adverse reaction to metal debris after ReCap-M2a-Magnum total hip arthroplasty was assessed, and the risk factors for adverse reaction to metal debris were evaluated using logistic regression. The mean follow-up time was 5.2 (0.003-9.1) years. This study was an extension of a previous study conducted at our institution with 80 patients. RESULTS: In total, 33 patients (33 hips, 2.5% of all hips) required a revision operation due to adverse reaction to metal debris. Moreover, 157 hips exhibited definitive adverse reaction to metal debris, but a revision operation was not performed (157 of 1329 hips, 11.8% of all hips). Overall, 190 out of 1329 (14.3%) hips had definitive adverse reaction to metal debris. Pain, subluxation sensation, clicking, swelling, a small head size, and a fair/poor Oxford Hip Score were associated with definitive adverse reaction to metal debris. CONCLUSION: We found a high prevalence of adverse reaction to metal debris in the ReCap-M2a-Magnum total hip arthroplasty patients in this study; however, most of the patients did not require revision operations.

Evaluation of serum zonulin for use as an early predictor for gestational diabetes.

Diet has an important role in regulating intestinal permeability and subsequently the risk for metabolic disorders. In this observational study, we examined whether serum intestinal permeability marker zonulin, could be used as a predictor for gestational diabetes mellitus (GDM). Serum zonulin concentration was measured in early pregnancy in overweight or obese pregnant women (n=88) at risk for developing GDM. Serum zonulin was associated with higher odds of GDM (adjusted OR for 1 ng ml-1 increase in zonulin: 1.08, 95% CI: 1.02-1.15; P=0.009), diagnosed by a 2-h 75-g oral glucose tolerance test at late pregnancy. The optimal cutoff value was 43.3 ng ml-1, with sensitivity of 88% (95% CI: 71-100%) and specificity of 47% (95% CI: 33-58%). The area under the ROC-curve was 0.67 (95% CI: 0.54-0.81). Our results show an association between increased early-pregnancy serum zonulin concentration and GDM, suggesting zonulin as a possible predictor for GDM.

Improved Survival in Male Melanoma Patients in the Era of Sentinel Node Biopsy.

BACKGROUND AND AIMS: Sentinel node biopsy is a standard method for nodal staging in patients with clinically localized cutaneous melanoma, but the survival advantage of sentinel node biopsy remains unsolved. The aim of this case-control study was to investigate the survival benefit of sentinel node biopsy. MATERIALS AND METHODS: A total of 305 prospective melanoma patients undergoing sentinel node biopsy were compared with 616 retrospective control patients with clinically localized melanoma whom have not undergone sentinel node biopsy. Survival differences were calculated with the median follow-up time of 71 months in sentinel node biopsy patients and 74 months in control patients. Analyses were calculated overall and separately in males and females. RESULTS: Overall, there were no differences in relapse-free survival or cancer-specific survival between sentinel node biopsy patients and control patients. Male sentinel node biopsy patients had significantly higher relapse-free survival ( P = 0.021) and cancer-specific survival ( P = 0.024) than control patients. In females, no differences were found. Cancer-specific survival rates at 5 years were 87.8% in sentinel node biopsy patients and 85.2% in controls overall with 88.3% in male sentinel node biopsy patients and 80.6% in male controls and 87.3% in female sentinel node biopsy patients and 89.8% in female controls. CONCLUSION: Sentinel node biopsy did not improve survival in melanoma patients overall. While females had no differences in survival, males had significantly improved relapse-free survival and cancer-specific survival following sentinel node biopsy.

Distinct regulation of tonsillar immune response in virus infection.

BACKGROUND: The relationships between tonsillar immune responses, and viral infection and allergy are incompletely known. OBJECTIVE: To study intratonsillar/nasopharyngeal virus detections and in vivo expressions of T-cell- and innate immune response-specific cytokines, transcription factors, and type I/II/III interferons in human tonsils. METHODS: Palatine tonsil samples were obtained from 143 elective tonsillectomy patients. Adenovirus, bocavirus-1, coronavirus, enteroviruses, influenza virus, metapneumovirus, parainfluenza virus, rhinovirus, and respiratory syncytial virus were detected using PCR. The mRNA expression levels of IFN-α, IFN-ß, IFN-γ, IL-10, IL-13, IL-17, IL-28, IL-29, IL-37, TGF-ß, FOXP3, GATA3, RORC2, and Tbet were directly analyzed by quantitative RT-PCR. RESULTS: Fifty percentage of subjects reported allergy, 59% had ≥1 nasopharyngeal viruses, and 24% had ≥1 intratonsillar viruses. Tonsillar virus detection showed a strong negative association with age; especially rhinovirus or parainfluenza virus detection showed positive association with IFN-γ and Tbet expressions. IL-37 expression was positively associated with atopic dermatitis, whereas IFN-α, IL-13, IL-28, and Tbet expressions were negatively associated with allergic diseases. Network analyses demonstrated strongly polarized clusters of immune regulatory (IL-10, IL-17, TGF-ß, FOXP3, GATA3, RORC2, Tbet) and antiviral (IFN-α, IFN-ß, IL-28, IL-29) genes. These two clusters became more distinctive in the presence of viral infection or allergy. A negative correlation between antiviral cytokines and IL-10, IL-17, IL-37, FOXP3, and RORC2 was observed only in the presence of viruses, and interestingly, IL-13 strongly correlated with antiviral cytokines. CONCLUSIONS: Tonsillar cytokine expression is closely related to existing viral infections, age, and allergic illnesses and shows distinct clusters between antiviral and immune regulatory genes.

Comparison of short-term outcome of laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: A prospective randomized controlled multicenter SLEEVEPASS study with 6-month follow-up.

BACKGROUND AND AIMS: The long-term efficacy of laparoscopic Roux-en-Y gastric bypass in the treatment of morbid obesity has already been demonstrated. Laparoscopic sleeve gastrectomy has shown promising short-term results, but the long-term efficacy is still unclear. The aim of this prospective randomized multicenter study is to compare the results of Roux-en-Y gastric bypass and sleeve gastrectomy. MATERIAL AND METHODS: A total of 240 morbidly obese patients were randomized to undergo either Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point of study was weight loss, and the secondary end points were resolution of comorbidities and morbidity. The short-term results at 6 months were analyzed. RESULTS: The mean excess weight loss at 6 months was 49.2% in the sleeve gastrectomy group and 52.9% in the Roux-en-Y gastric bypass group (p = 0.086). Type 2 diabetes was resolved or improved in 84.3% of patients in the sleeve gastrectomy group and 93.3% in the Roux-en-Y gastric bypass group (p = 0.585). The corresponding results for arterial hypertension were 76.8% and 81.9% (p = 0.707) and for hypercholesterolemia 64.1% and 69.0% (p = 0.485). There was no mortality at 6 months. There was one major complication following sleeve gastrectomy and two after Roux-en-Y gastric bypass (p = 0.531). Eight sleeve gastrectomy patients and 11 Roux-en-Y gastric bypass patients had minor complications (p = 0.403). CONCLUSION: The short-term results of sleeve gastrectomy and Roux-en-Y gastric bypass regarding weight loss, resolution of obesity-related comorbidities and complications were not different at 6 months.

Hip resurfacing arthroplasty versus large-diameter head metal-on-metal total hip arthroplasty: comparison of three designs from the Finnish Arthroplasty Register.

BACKGROUND AND AIMS: Large headed metal-on-metal total hip arthroplasty may produce more metal ions than hip resurfacing arthroplasty. Increased metal-ion levels may be associated with higher revision rates due to adverse reaction to metal debris. The purpose of our study was to compare the survivorship of three hip resurfacing arthroplasty designs with their analogous cementless large-diameter head metal-on-metal total hip arthroplasties. MATERIAL AND METHODS: Based on data obtained from the Finnish Arthroplasty Register, the revision risks of three metal-on-metal hip resurfacing arthroplasty/total hip arthroplasty design couples performed during 2001-2011 were analyzed using the Cox regression model. RESULTS: In the Cox regression analysis for compared design pairs adjusted for age, gender, operated side, head size, diagnosis, and implant, there was no statistically significant difference in revision risk between ReCap hip resurfacing arthroplasty and Bimetric/ReCap total hip arthroplasty (risk ratio = 1.43, confidence interval = 0.95-2.14, p = 0.09) or between Birmingham hip resurfacing arthroplasty and Synergy/Birmingham hip resurfacing total hip arthroplasty (risk ratio = 1.35, confidence interval = 0.75-2.43, p = 0.31). However, the revision risk of Corail and Summit/articular surface replacement total hip arthroplasty (ASR HRA) was significantly increased compared to ASR HRA. (risk ratio = 0.73, confidence interval = 0.54-0.98, p = 0.04). CONCLUSION: We conclude that the short-term revision risk of large headed metal-on-metal total hip arthroplasties was not increased compared to analogous hip resurfacing arthroplasties in two out of three devices studied at a nationwide level. There may be implant-related factors having an effect on the success of single manufacturer devices. However, more information on the incidence of adverse soft-tissue reactions in these patient cohorts is needed.

Experience of structural onlay allografts for the treatment of bone deficiency in revision total hip arthroplasty.

BACKGROUND AND AIMS: Loss of femoral bone stock in elective revision total hip arthroplasty poses unique and substantial challenges. Structural onlay allografts may provide mechanical stability for the cementless revision prosthesis and increase bone stock. MATERIAL AND METHODS: At least one cortical onlay allograft was used in 40 elective total hip arthroplasty revisions (40 patients) to reconstruct femoral bone defects. The operations were performed between January 1999 and August 2010 in the Turku University Hospital, Finland. The mean follow-up time was 52 months (range: 12-125 months). RESULTS: The allografts were incorporated into the bone tissue in 37 of 40 (92.5%) patients. Cementless revision stems healed in 36 of 40 (90.0%) patients, but these patients were not exactly the same patients whose allografts were successfully incorporated. One or more surgical complications were experienced by 14 of 40 (35.0%) patients during follow-up. In all, 4 of 40 (10.0%) patients (all women) had hip infections during follow-up. Of the 7 patients with rheumatoid arthritis, 4 (57.1%) had at least one complication. CONCLUSIONS: The use of the cortical onlay allografts provides a feasible option for restoring the integrity of the proximal femur in revision total hip arthroplasty, but the complication rate is high, particularly in female patients with rheumatoid arthritis.

Hearing aid compliance in the elderly.

OBJECTIVES: A decreasing but still substantial proportion of elderly persons with hearing aids use them only occasionally. Because the prevalence of age-related hearing loss is increasing, it is important for the hearing rehabilitation process to be effective. The aim of this study was to use a mailed questionnaire to evaluate the rate of hearing aid use and the reasons for minimal use or nonuse. METHODS: Questions about hearing aid use and associated problems were included in a survey of hearing mailed to 4,067 people in age cohorts of 70, 75, 80 and 85 years in an industrialized urban community in Finland. RESULTS: In this sample of 249 hearing aid users, 55.4% used their hearing aid daily, and 27.3% used it > 6 hours a day. The percentage of subjects who never used their hearing aid was 10.7%. Use of hearing aids tended to decline with advancing age. The most common reasons for minimal use were disturbing background noise, acoustic feedback problems, battery cost, and a lack of motivation to use the hearing aid. CONCLUSIONS: Compliance with hearing aid use by the elderly is increasing, but a significant proportion of hearing aids are still used only occasionally or never. We discuss methods to improve compliance in this patient group. Our results may be used to reexamine existing procedures for fitting hearing aids for counseling, which may increase patient compliance with hearing aids, leading to greater benefits from their use.

Metformin vs. insulin in gestational diabetes. A randomized study characterizing metformin patients needing additional insulin.

AIMS: We compared metformin with insulin as treatment of gestational diabetes mellitus (GDM). Furthermore, we aimed to characterize metformin-treated patients needing additional insulin to achieve prespecified glucose targets. METHODS: We conducted a single centre randomized controlled study with non-inferiority design comparing metformin and insulin in the treatment of 217 GDM patients having birth weight as primary outcome variable. RESULTS: There were no significant differences in mean birth weight expressed in grams [+15 (90% confidence interval (CI): -121 to 89)] or SD units [+0.04 (90% CI: -0.27 to 0.18)] between the metformin and insulin groups. There were no significant differences in neonatal or maternal data between the groups. Only 23 (20.9%) of the 110 patients in the metformin group needed additional insulin. Compared with the patients on metformin only, those needing additional insulin were older (p = 0.04), their oral glucose tolerance test had been performed earlier and diabetes therapy started earlier in gestation (p = 0.01 and p = 0.004, respectively). The risk for additional insulin was 4.6-fold in women with baseline serum fructosamine concentration above median compared with those below median. CONCLUSIONS: Metformin is an effective alternative to insulin in the treatment of GDM patients. Serum fructosamine may help in predicting the adequacy of metformin treatment alone.

Soluble urokinase-type plasminogen activator receptor in patients with suspected infection in the emergency room: a prospective cohort study.

OBJECTIVES: The soluble form of urokinase-type plasminogen activator (suPAR) was evaluated as an early prognostic marker of sepsis in patients with suspected infection. DESIGN: A single-centre prospective cohort study. METHODS: The cohort comprised 539 patients in the emergency department with suspected infection: 59 without systemic inflammatory response syndrome (SIRS) and without bacterial infection (group 1), 68 with bacterial infection and without SIRS (group 2), 54 with SIRS and without bacterial infection (group 3), 309 with sepsis (SIRS and bacterial infection) and without organ failure (group 4) and 49 with severe sepsis (SIRS, bacterial infection and organ failure) (group 5). suPAR was measured on admission using a commercial solid-phase enzyme-linked immunosorbent assay. RESULTS: The median soluble form of the receptor (suPAR) concentrations in groups 1-5 were 4.7, 5.0, 4.4, 4.8 and 7.9 ng mL(-1) , respectively (P < 0.001). The levels were significantly higher in nonsurvivors compared with survivors (8.3 vs. 4.9 ng mL(-1) , P < 0.001) and in patients with severe sepsis (group 5) compared with those in the other groups (7.9 vs. 4.8 ng mL(-1) , P < 0.001). Area under the receiver operating characteristics curve (AUC(ROC) ) for the prediction of case fatality was 0.79 (95% confidence interval [CI]: 0.72-0.86, P < 0.0001) and 0.75 for severe sepsis (95% CI: 0.68-0.81, P < 0.0001). At a cut-off level of 6.4 ng mL(-1) , suPAR had 76% sensitivity and 69% specificity for fatal disease; at a cut-off level of 6.6 ng mL(-1) , the sensitivity and specificity for severe sepsis were 67% and 72%, respectively. In multivariate models, high suPAR remained an independent predictor of case fatality and severe sepsis after adjusting for potential confounders. CONCLUSIONS: A high suPAR level predicts case fatality and severe sepsis in patients with suspected infection.