Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

The European Journal of Health Economics - The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by...     

The impact on quality of life of diet restrictions and disease symptoms associated with phenylketonuria: a time trade-off and discrete choice experiment study

The European Journal of Health Economics - Phenylketonuria (PKU) is a metabolic disorder leading to a deficiency in the metabolism of phenylalanine (Phe). Elevated Phe levels in the blood, tissue...     

Infection by CagA-Positive Helicobacter pylori Strains and Bone Fragility: A Prospective Cohort Study

Helicobacter pylori (HP) infection is a common and persistent disorder acting as a major cofactor for the development of upper gastrointestinal diseases and several extraintestinal disorders including osteoporosis. However, no prospective study assessed the effects of HP on bone health and fracture risk. We performed a HP screening in a population-based cohort of 1149 adults followed prospectively for up to 11 years. The presence of HP infection was assessed by serologic testing for serum antibodies to HP and the cytotoxin associated gene-A (CagA). The prevalence of HP infection did not differ among individuals with normal bone mineral density (BMD), osteoporosis, and osteopenia. However, HP infection by CagA-positive strains was significantly increased in osteoporotic (30%) and osteopenic (26%) patients respect to subjects with normal BMD (21%). Moreover, anti-CagA antibody levels were significantly and negatively associated with lumbar and femoral BMD. Consistent with these associations, patients affected by CagA-positive strains had a more than fivefold increased risk to sustain a clinical vertebral fracture (HR 5.27; 95% CI, 2.23–12.63; p < .0001) and a double risk to sustain a nonvertebral incident fracture (HR 2.09; 95% CI, 1.27–2.46; p < .005). Reduced estrogen and ghrelin levels, together with an impaired bone turnover balance after the meal were also observed in carriers of CagA-positive HP infection. HP infection by strains expressing CagA may be considered a risk factor for osteoporosis and fractures. Further studies are required to clarify in more detail the underlying pathogenetic mechanisms of this association. © 2020 American Society for Bone and Mineral Research (ASBMR).     

A comparative study of portal vein embolization versus radiation lobectomy with Yttrium-90 micropheres in preparation for liver resection for initially unresectable hepatocellular carcinoma

BackgroundPortal vein embolization before liver resection is considered the therapy of choice for patients with inadequate future liver remnants. The concept of radioembolization with Yttrium-90 to achieve the same goal has limited data.MethodsWe retrospectively compared patients who underwent portal vein embolization and Yttrium-90 lobectomy before resection of hepatocellular carcinoma in patients with chronic liver disease.ResultsSeventy-three patients underwent portal vein embolization and 22 patients underwent Yttrium-90. Forty-seven percent of patients before portal vein embolization required additional procedures for tumor control, and 27% of patients after Yttrium-90 required additional procedure to mainly induce further hypertrophy. Both therapies achieved the goal of future liver remnants >40%, but the degree of hypertrophy was significantly higher in Yttrium-90 patients (63% for Yttrium-90, 36% for portal vein embolization, P < .01). Tumor response was significantly better with Yttrium-90, achieving complete response in 50% of patients. Resectability rate was higher after portal vein embolization (85% for portal vein embolization, 64% for Yttrium-90, P = .03). Tumor progression was the most common reason precluding surgery. Complete tumor control was the reason not to pursue surgery in 18% of patients after Yttrium-90.ConclusionBoth preoperative portal vein embolization and Yttrium-90, increases liver resectability rates by inducing hypertrophy of future liver remnants in patients with hepatocellular carcinoma and chronic liver disease. Yttrium-90 lobectomy achieved better tumor control and provided more time to assess therapy response, optimizing the indication for surgery.     

Clinical Significance of De Novo Malignancy After Liver Transplant: A Single-Center Study

BackgroundSeveral studies have reported that solid organ transplant recipients have a high risk for malignant tumors because the suppressed immune system fails in preventing malignant transformations. De novo malignancy after transplantation is the most common cause of death in the late period after liver transplant (LT). This study investigated the clinical significance of de novo malignancy after LT, and it is the largest study based in Korea to report long-term follow-up results associated with de novo malignancy after LT.MethodsData of 1793 adults who underwent LT in Seoul National University Hospital were retrospectively collected, and medical charts and data from the Ministry of Public Administration and Security were reviewed to examine the causes of death and de novo malignancy status. The Fisher exact test and Kaplan-Meier survival analysis were used to analyze the data.ResultsOf the 1793 recipients, 27 died of de novo malignancies. Of 875 hepatocellular carcinoma (HCC) patients, 12 died, and of 918 non-HCC patients, 15 died. De novo malignancy was the main cause of death at 5 years after LT but was not in the initial 5 years. In Korea the most common cancers that developed after LT were gastric cancer (21.4%) and lymphoma (14.3%). De novo HCC in non-HCC cases was found in 2 patients.ConclusionDe novo malignancy is a key factor affecting long-term survival after LT. Therefore, regular screening and education are important for improving long-term survival and quality of life in these patients after LT.     

An analysis of the ergonomic risk of surgical trainees and experienced surgeons during laparoscopic procedures

BackgroundWork-related musculoskeletal injuries have been increasingly recognized to affect surgeons. It is unknown whether such injuries also affect surgical trainees. The purpose of this study was to assess the ergonomic risk of surgical trainees as compared with that of experienced surgeons.MethodsErgonomic data were recorded from 9 surgeons and 11 trainees. Biomechanical loads during surgery were assessed using motion tracking sensors and electromyography sensors. Demanding and static positions of the trunk, neck, right/left shoulder, as well as activity from the deltoid and trapezius muscles bilaterally were recorded. In addition, participants reported their perceived discomfort on validated questionnaires.ResultsA total of 87 laparoscopic general surgery cases (48 attendings and 39 trainees) were observed. Both trainees and attendings spent a similarly high percentage of each case in static (>60%) and demanding positions (>5%). Even though residents reported overall more discomfort, all participants shared similar ergonomic risk with the exception of trainees’ trunk being more static (odds ratio: –11.42, P = .006).ConclusionSurgeons are prone to ergonomic risk. Trainees are exposed to similar postural ergonomic risk as surgeons but report more discomfort and, given that musculoskeletal injuries are cumulative over time, the focus should be on interventions to reduce ergonomic risk in the operating room.     

Evaluation of the Relationship Between Aspects of Medical Complexity and Work Relative Value Units (wRVUs) for Foot and Ankle Surgical Procedures

Work relative value units (wRVUs) have been assigned to current procedural terminology codes in an effort to help establish physician compensation. However, the ability of these to accurately and efficiently capture the time, technical, and perioperative managerial aspects required of various procedures has recently been called into question for several surgical subspecialties. Therefore, the objective of this investigation was to evaluate various measures of medical complexity against wRVUs for foot and ankle surgical procedures. The 2018 American College of Surgeons National Surgical Quality Improvement Program database was utilized to identify and extract data related to the perioperative medical complexity of 16 foot and ankle surgical current procedural terminology codes. We observed a “weak” positive relationship between wRVUs and operation time as defined by a correlation coefficient of 0.234 (p < .001). Other variables associated with medical complexity in the perioperative period were found to significantly vary between wRVUs categories, but these differences were neither consistently nor directly associated with assigned relative values. We conclude that wRVUs might not always represent an efficient means for determining compensation for foot and ankle surgical procedures.     

Thyroid Dermopathy Treatment of the Foot in the Setting of Graves Hyperthyroidism

Graves’ hyperthyroidism is one of the most common autoimmune diseases, caused by autoantibodies acting against the thyrotropin receptor. Extra-thyroid manifestations include ophthalmopathy, acropachy, and dermopathy, which accounts for 4% to 13% of clinical presentations. This is a case study of a 55-year-old female who presented with recurrent soft tissue mass formation over the dorsal right foot. The patient underwent a soft tissue mass excisional biopsy and the pathology report revealed a soft tissue mass secondary to thyroid dermopathy. Given her history of soft tissue recurrence and previous diagnosis, the patient underwent both excisional biopsy and radiation treatment with success. After 1 year of follow-up, the patient had completely healed without complication. This case demonstrates a multidisciplinary approach for clinical diagnosis and treatment.     

How does yoga reduce stress? A clinical trial testing psychological mechanisms

Yoga interventions can reduce stress, but the mechanisms underlying that stress reduction remain largely unidentified. Understanding how yoga works is essential to optimizing interventions. The present study tested five potential psychosocial mechanisms (increased mindfulness, interoceptive awareness, spiritual well-being, self-compassion and self-control) that have been proposed to explain yoga's impact on stress. Forty-two participants (62% female; 64% White) in a yoga program for stress reduction completed surveys at baseline (T1), mid-intervention (T2) and post-intervention (12 weeks; T3). We measured two aspects of stress, perceived stress and stress reactivity. Changes were assessed with paired t-tests; associations between changes in mechanisms were tested in residual change models. Only stress reactivity decreased, on average, from T1 to T3. Except for self-compassion, all psychosocial mechanisms increased from T1 to T3, with minimal changes from T2 to T3. Except for self-control, increases in each mechanism were strongly associated with decreases in both measures of stress between T1 and T2 and decreases in perceived stress from T1 to T3 (all p's < 0.05). Increased psychosocial resources are associated with stress reduction. Yoga interventions targeting these resources may show stronger stress reduction effects. Future research should test these linkages more rigorously using active comparison groups and larger samples.