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Vericiguat is indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in patients with heart failure and reduced ejection fraction (HFrEF) following a recent worsening event. The aim of the VICTOR trial was to assess the effect of vericiguat in patients with HFrEF without recent heart failure worsening. In this double-blind, placebo-controlled, phase 3 trial, conducted at 482 sites across 36 countries, patients aged 18 years or older with HFrEF (left ventricular ejection fraction of ≤40%) without heart failure hospitalisation within 6 months or outpatient intravenous diuretic use within 3 months before randomisation were randomly assigned (1:1) using an intervention randomisation system with interactive response technology to oral vericiguat (target 10 mg dose) or matching placebo. The primary composite endpoint was time to cardiovascular death or heart failure hospitalisation. Efficacy endpoints were assessed in the intention-to-treat population. Adverse events were assessed in all randomly assigned patients who received at least one dose of study drug (safety population). This trial is registered with ClinicalTrials.gov, NCT05093933, and is complete. Between Nov 2, 2021, and Dec 21, 2023, 10 921 patients were screened and 6105 were randomly assigned: 3053 to vericiguat and 3052 to placebo. The median age was 68·0 years (IQR 61·0–75·0), 1440 (23·6%) patients were women, 4665 (76·4%) were men, 3934 (64·4%) were White, and 2899 (47·5%) had no previous hospitalisation for heart failure. During a median follow-up of 18·5 months (IQR 13·6–24·7), primary outcome events occurred in 549 (18·0%) patients in the vericiguat group and 584 (19·1%) patients in the placebo group (hazard ratio [HR] 0·93 [95% CI 0·83–1·04]; p=0·22). As prespecified in the protocol, because the primary endpoint was not statistically significant, all analyses of secondary and exploratory endpoints are considered nominal. Cardiovascular death occurred in 292 (9·6%) patients in the vericiguat group and 346 (11·3%) patients in the placebo group (HR 0·83 [95% CI 0·71–0·97]). Hospitalisation for heart failure occurred in 348 (11·4%) patients in the vericiguat group and in 362 (11·9%) patients in the placebo group (HR 0·95 [95% CI 0·82–1·10]). Serious adverse events occurred in 717 (23·5%) of 3049 patients in the vericiguat group and 751 (24·6%) of 3049 patients in the placebo group. The most common adverse event was symptomatic hypotension (345 [11·3%] patients in the vericiguat group and 281 [9·2%] in the placebo group). All-cause death occurred in 377 (12·3%) patients in the vericiguat group and 440 (14·4%) patients in the placebo group (HR 0·84 [95% CI 0·74–0·97]). Among patients with HFrEF and no recent worsening, vericiguat did not reduce the risk of a composite endpoint of time to cardiovascular death or heart failure hospitalisation. Fewer cardiovascular deaths were observed in the vericiguat group than in the placebo group. Merck Sharp & Dohme (a subsidiary of Merck) and Bayer.

Following completion of the VICTORIA trial, vericiguat was approved for the treatment of worsening heart failure with reduced ejection fraction (HFrEF) and received a class IIb recommendation in European and North American guidelines. The subsequent VICTOR trial evaluated the use of vericiguat in patients with HFrEF and no recent worsening. We aimed to assess the effect of vericiguat on clinical endpoints through pooled analyses of patient-level data from the VICTORIA and VICTOR trials. This prespecified, pooled individual participant-level analysis was conducted on data from two trials: VICTORIA, which was active from Sept 25, 2016, to Sept 2, 2019 in 42 countries, and VICTOR, which was active from Nov 2, 2021, to Feb 5, 2025 in 36 countries. The VICTORIA trial enrolled adult (aged ≥18 years) participants with HFrEF with recent worsening (defined as either hospitalisation for heart failure within the previous 6 months or outpatient use of intravenous diuretics within the previous 3 months) and increased NT-proBNP concentrations; the VICTOR trial had similar eligibility criteria but participants had no recent worsening of heart failure. Participants in both trials received contemporary background guideline-directed heart failure therapy as appropriate. The primary endpoint was a composite endpoint of cardiovascular death or hospitalisation for heart failure (also assessed individually). This study is registered with PROSPERO, CRD420251065636. Data from 11 155 patients (5050 in the VICTORIA trial and 6105 in the VICTOR trial) were included in the pooled analysis. The primary endpoint of cardiovascular death or hospitalisation for heart failure occurred in 1446 (25·9%) of 5579 patients in the vericiguat group and 1556 (27·9%) of 5576 patients in the placebo group (hazard ratio [HR] 0·91 [95% CI 0·85–0·98]; p=0·0088), with similar reductions in its individual components of cardiovascular death (0·89 [0·80–0·98]; p=0·020) and hospitalisation for heart failure (0·92 [0·84–1·00]; p=0·043) as first events. Vericiguat reduced the risk of hospitalisation for heart failure and cardiovascular death in patients with HFrEF across a broad range of clinical severity, including those receiving contemporary guideline-directed medical therapy. Vericiguat might be suitable as an additional treatment option for selected patients with HFrEF. Merck Sharp & Dohme (a subsidiary of Merck) and Bayer.

ObjectiveTo describe the comorbidities in children with cerebral palsy (CP) and determine the characteristics associated with different impairments.DesignCross-sectional study.SettingTertiary care referral centre in India.PatientsBetween April 2018 and May 2022, all children aged 2–18 years with a confirmed diagnosis of CP were enrolled by systematic random sampling. Data on antenatal, birth and postnatal risk factors, clinical evaluation and investigations (neuroimaging and genetic/metabolic workup) were recorded.Main outcome measuresPrevalence of the co-occurring impairments was determined using clinical evaluation or investigations as indicated.ResultsOf the 436 children screened, 384 participated (spastic CP=214 (55.7%) (spastic hemiplegic=52 (13.5%); spastic diplegia=70 (18.2%); spastic quadriplegia=92 (24%)), dyskinetic CP=58 (15.1%) and mixed CP=110 (28.6%)). A primary antenatal/perinatal/neonatal and postneonatal risk factor was identified in 32 (8.3%), 320 (83.3%) and 26 (6.8%) patients, respectively. Prevalent comorbidities (the test used) included visual impairment (clinical assessment and visual evoked potential)=357/383(93.2%), hearing impairment (brainstem-evoked response audiometry)=113 (30%), no understanding of any communication (MacArthur Communicative Development Inventory)=137 (36%), cognitive impairment (Vineland scale of social maturity)=341 (88.8%), severe gastrointestinal dysfunction (clinical evaluation/interview)=90 (23%), significant pain (non-communicating children’s pain checklist)=230 (60%), epilepsy=245 (64%), drug-resistant epilepsy=163 (42.4%), sleep impairment (Children’s Sleep Habits Questionnaire)=176/290(60.7%) and behavioural abnormalities (Childhood behaviour checklist)=165 (43%). Overall, hemiparetic and diplegic CP and Gross Motor Function Classification System ≤3 were predictive of lesser co-occurring impairment.ConclusionCP children have a high burden of comorbidities, which increase with increasing functional impairment. This calls for urgent actions to prioritise opportunities to prevent risk factors associated with CP and organise existing resources to identify and manage co-occurring impairments.Trial registration numberCTRI/2018/07/014819.

Background: The aim of this study was to examine and appreciate characteristics of malpractice lawsuits brought against interventional pain specialists. Objectives: To examine and appreciate characteristics of malpractice lawsuits brought against interventional pain specialists. Study Design: Retrospective review. Setting: Jury verdicts and settlement reports of state and federal malpractice cases involving interventional pain practitioners from January 1, 1988, to January 1, 2018 were gathered from the Westlaw online legal database. Methods: Jury verdicts and settlement reports of state and federal malpractice cases involving interventional pain practitioners from January 1, 1988, to January 1, 2018 were gathered from the Westlaw online legal database. Data collected for each case included year, state, patient age, patient gender, defendant specialty, legal outcome, award amount, alleged cause of malpractice, and factors in plaintiff’s decision to file. After elimination of duplicates and applying inclusion/ exclusion criteria to our initial search yielding over 1,500 cases, a total of 82 cases were included in this study. Results: A total of 57.3% of cases resulted in a jury verdict in favor of the defendant, whereas 41.5% favored the plaintiff. When comparing cases that were performed in the operating room to cases performed outside the operating room, we found the jury verdicts to favor the plaintiff 83.3% of the time for operating room procedures (P = 0.003). In other words, interventional pain practitioners were more likely to be found at fault for complications from procedures performed in the operating room. To eliminate confounders, a logistical regression was performed and confirmed operating room procedures were an independent predictor of a verdict awarded to the plaintiff (P = 0.008). The median amount awarded to the plaintiff for all cases was$333,000, and the single highest award amount was $ 36,636,288. The median payout for operating room procedures was $450,000 (P = 0.010), which was significantly different from the median payout for nonoperating room procedures. Procedure categorization demonstrated a statistically significant difference in jury verdicts (P = 0.01411) and procedural error was the leading reason for pursuing litigation, followed by lack of informed consent and unnecessary procedure performed. Limitations: There is more than one database that captures medicolegal claims brought against practitioners. Westlaw, which has been previously utilized by other studies, is only one of them and the extent to which overlap exists in unclear. For each, data input are not necessarily consistent and data capture are not complete. As a result, there could exist a skew toward more severe complications and the details of individual cases likely vary. During data extraction, we found that all details of the procedure were not always included. For example, not all cases specified the type of injectate utilized for epidural injection (i.e., local anesthetic, steroid, mixture, and others) or route of injection (i.e., transforaminal vs. interlaminar). Moreover, as previously mentioned, cases that are settled out of court or finalized prior to trial are not necessarily reported by the Westlaw database, and therefore were not always included in our data search. Conclusions: Overall, interventional pain medicine physicians were favored by jury verdicts for malpractice claims. However, when filtering by procedure or setting, jury verdicts favored the plaintiff in some cases. Key words: Interventional pain, medical, malpractice, anesthesiology

BackgroundThe internet has had an enormous influence on the field of medicine. In this regard, Statista, a market and consumer data company, estimated in 2019 that more than half the world’s population (>four billion people) were active internet users. Accessing the World Wide Web has become the second nature for most. In the medical field, many patients look to the internet for information regarding certain procedures. The purpose of this study, therefore, was to assess the readability level of more than 492 online sources with information on a wide array of interventional pain procedures.ObjectiveThe aim is to determine the readability of online patient educational materials for interventional pain procedures.Study designThis is a retrospective review.MethodsWe downloaded and reformatted to plain text 492 internet-based patient educational materials for 17 different interventional pain procedures. Plain text was processed using Readability Studio (Oleander Software Ltd., Vandalia, Ohio, USA), which employs 10 quantitative readability scales that are widely used and accepted in the medical literature.ResultsThe software determined the average reading level (or grade level) of the 492 online sources we examined to be 12.1, with a range of 10.9 to 13.LimitationsGoogle is not the only online search engine patients utilize for information, and the top links for each search could change over time. Also, some patients prefer videos rather than text to learn about their disease and treatment options. Finally, depending on their provider, the links that patients are directed to may be significantly more or less readable.ConclusionsThe average American adult reads at the eighth grade level. The National Institutes of Health and the American Medical Association have recommended education materials be made available at the third to seventh grade level. Our analysis shows patient educational materials found online for interventional pain procedures to be overly technical, with an average reading level (or grade level) of 12.1.