Endoscopic measurement of hiatal hernias: is it reliable and does it have a clinical impact? Results from a large prospective database.

OBJECTIVES: The aim of our study was to compare the results of endoscopy and manometry with regard to the presence and longitudinal size of hiatal hernias using a cohort of patients with PPI-refractory reflux symptoms. In addition, we aimed to investigate the clinical relevance of hiatal hernias and their size in relation to the occurrence of GERD. METHODS: Five hundred patients with suspected GERD due to typical reflux symptoms (heartburn and regurgitation) and inadequate response to PPI therapy underwent standardized screening at a reflux center. After 2 weeks of PPI withdrawal, all patients underwent endoscopy, 24-h pH impedance measurement, and high-resolution manometry (HRM). Both endoscopy and HRM results were available for 487 patients. RESULTS: There was a high correlation between the endoscopic and manometric measured longitudinal size of hernias (rho = .768 (p < .001)). Absolute differences differ on a small effect basis (Cohen's d = 0.23). The presence of hernias increases significantly with the severity of GERD, regardless of whether the hernia was diagnosed by endoscopy or manometry. CONCLUSION: In summary, endoscopically and manometrically measured hiatal hernia size are highly significantly correlated. Patients with refractory reflux symptoms and a hernia size of 4 cm are very likely to have GERD. In the future, this finding could greatly simplify the diagnosis of GERD.

Decision aid and cost compensation influence uptake of PSA-based early detection without affecting decisional conflict: a cluster randomised trial.

International guidelines recommend to inform men about the benefits and harms of prostate specific antigen (PSA) based early detection of prostate cancer. This study investigates the influence of a transactional decision aid (DA) or cost compensation (CC) for a PSA test on the decisional behaviour of men. Prospective, cluster-randomised trial to compare two interventions in a 2 × 2 factorial design: DA versus counselling as usual, and CC versus noCC for PSA-testing. 90 cluster-randomised physicians in the administrative district of Muenster, Germany recruited 962 participants aged 55-69 yrs. in 2018. Primary endpoint: the influence of the DA and CC on the decisional conflict. Secondary endpoints: factors which altered the involvement of the men regarding their decision to take a PSA-test. The primary endpoint was analysed by a multivariate regression model. The choice to take the PSA test was increased by CC and reduced by the DA, the latter also reduced PSA uptake in men who were offered CC. The DA led to an increase of the median knowledge about early detection, changed willingness to perform a PSA test without increasing the level of shared decision, giving participants a stronger feeling of having made the decision by themselves. The DA did not alter the decisional conflict, as it was very low in all study groups. DA reduced and CC increased the PSA uptake. The DA seemed to have a greater impact on the participants than CC, as it led to fewer PSA tests even if CC was granted.Trial registration: German Clinical Trial Register (Deutsches Register Klinischer Studien DRKS00007687). Registered: 06/05/2015. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007687 .

Delivering the unexpected-Information needs for PSA screening from Men's perspective: A qualitative study.

BACKGROUND: Making decisions about PSA screening tests is challenging, as it requires both knowledge of the possible benefits and harms of screening and an individual assessment of the patient's values. Our research explores how much and what information men perceive to be necessary with regard to screening for prostate cancer. OBJECTIVE: To explore men's information and associated needs for decision making in PSA testing. DESIGN: Qualitative interview study. SETTING AND PARTICIPANTS: We interviewed 32 men (aged 55-69) about their decision making on PSA screening following counselling with a Decision Aid at their GP's or urologist's practice in Germany. MAIN OUTCOME MEASURES: Men's expressed needs for decision making in PSA testing. METHODS: All interviews were transcribed verbatim and analysed by framework analysis. RESULTS: Comprehensive pre-screening counselling is needed. For the men in our study, information about test (in)accuracy, the benefit-harm balance and consequences of the test were relevant and surprising. Additional needs were for interpretation support, a take-home summary and time for deliberation. For several men, their physician's attitude was of interest. After being well-informed, most men felt empowered to make a preference-based decision on their own. DISCUSSION: Men were surprised by what they learned, especially regarding the accuracy and possible harms of screening. There is large variation in the breadth and depth of information needed, and some controversy regarding the consequences of testing. CONCLUSION AND PATIENT CONTRIBUTION: A core set of information should be offered before men make their first PSA screening decision. Information about biopsy and associated side-effects could follow in a short form, with details only on request. Knowledge about a high rate of false-positive test results beforehand might help men handle a suspicious test result.

Increased risk for cancer after stroke at a young age: etiological relevance or incidental finding?

BACKGROUND: Etiological factors, such as a malignant disease, in young stroke patients are often neglected. Therefore, in this study, we aimed to investigate the risk of developing cancer in young stroke survivors. METHODS: The current case-control study sample included patients who received an initial ischemic stroke diagnosis documented in the Disease Analyzer database (IQVIA), which compiles data such as risk factors, drug prescriptions, and diagnoses obtained from general practitioners and specialists. RESULTS: The stroke and non-stroke groups included 18,668 patients each; each group had 2836 (15.3%) participants ≤ 55 years. The cancer incidence in the stroke group over the age of 55 years was higher than in the younger subgroup (29.4% versus 17.3%). The proportions of cancer patients within 10 years of follow-up were higher in the stroke group versus the non-stroke group, as well as in the subgroup of patients aged ≤ 55 versus patients > 55 years (17.3% versus 9.5% and 29.4% versus 24.9%, respectively). The calculated hazard ratio for developing cancer within 10 years of follow-up was higher in the younger stroke population (≤ 55 years) than in the older population (hazard ratio: 1.47 (CI 1.18-1.83) versus 1.17 (CI 1.10-1.25). CONCLUSION: In our cohort, young individuals aged ≤ 55 years who suffered a stroke had twice as high risk for developing cancer within 10 years after the index event compared to the control group. Stroke might have implication regarding the subsequent development of cancer and vice versa.

Development and Prospective Randomized Evaluation of a Decision Aid for Prostate-specific Antigen-based Early Detection of Prostate Cancer in Men Aged Between 55 and 69Yr: The PSAInForm Trial.

For men interested in early detection of prostate cancer, the potential impact on decisional conflict of a decision aid with or without cost compensation for the prostate-specific antigen test will be investigated.

Budget impact analysis of drugs for ultra-orphan non-oncological diseases in Europe.

BACKGROUND/AIM: Ultra-orphan diseases (UODs) have been defined by a prevalence of less than 1 per 50,000 persons. However, little is known about budget impact of ultra-orphan drugs. METHODS: For analysis, the budget impact analysis (BIA) had a time horizon of 10 years (2012-2021) and a pan-European payer's perspective, based on prevalence data for UODs for which patented drugs are available and/or for which drugs are in clinical development. RESULTS: A total of 18 drugs under patent protection or orphan drug designation for non-oncological UODs were identified. Furthermore, 29 ultra-orphan drugs for non-oncological diseases under development that have the potential of reaching the market by 2021 were found. Total budget impact over 10 years was estimated to be €15,660 and €4965 million for approved and pipeline ultra-orphan drugs, respectively (total: €20,625 million). CONCLUSION: The analysis does not support concerns regarding an uncontrolled growth in expenditures for drugs for UODs.