Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions.

Real-world evidence (RWE) research helps determine whether outcomes observed in clinical trials happen in real-life clinical practice. RWE research may help patients receive more appropriate treatment, closer to their needs and wishes. RWE for metastatic colorectal cancer is currently limited. The PROMETCO RWE study is an important example of an ongoing initiative that focuses on patient-reported outcomes in metastatic colorectal cancer. Patients play an active role throughout the RWE research process, including study design, participation and results dissemination. This involvement can encourage greater patient empowerment through active engagement, potentially resulting in various benefits that can lead to improved clinical outcomes. Greater patient engagement can increase involvement in RWE, helping more patients to access the benefits of RWE research. Clinical Trial Registration: NCT03935763 (ClinicalTrials.gov).

Real-world evidence (RWE) research provides information that is essential to improving medical treatment. When it comes to metastatic colorectal cancer ­ cancer that has spread to other parts of the body ­ only a few RWE studies have been conducted. RWE studies, such as the ongoing PROMETCO study in patients with metastatic colorectal cancer, differ from clinical trials in that they include a wider range of people with fewer restrictions on type of treatments received. They can also place more attention to the patients' own opinions. By joining RWE studies, patients are likely to become more interested in their disease and take a more active role in their treatment. In the end, this can help to improve their quality of life and possibly improve the outcomes of their treatment. Doctors need to work in partnership with patients to increase participation in RWE studies.

Femtosecond laser in situ keratomileusis versus conductive keratoplasty to obtain monovision in patients with emmetropic presbyopia.

PURPOSE: To compare visual outcomes, complications, and patient satisfaction after femtosecond laser in situ keratomileusis (LASIK) and conductive keratoplasty (CK). SETTING: Private laser clinics, Reading and Southampton, United Kingdom. METHODS: In this retrospective consecutive single-surgeon comparative study, presbyopic emmetropia was treated with femtosecond LASIK or CK to achieve monovision by targeting -1.50 diopters (D) of myopia in the nondominant eye after a successful monovision contact lens trial. The CK treatments were performed with a ViewPoint CK system using the light-touch technique. The femtosecond LASIK was performed using an IntraLase FS/FS30 and EC-5000 platform with OPDCAT wavefront treatment. RESULTS: The mean spherical equivalent 12 months postoperatively was -1.63 D +/- 0.68 (SD) in the femtosecond LASIK group and -0.97 +/- 0.82 D in the CK group (P<.001). The mean vector value of astigmatism at 12 months was 0.32 +/- 0.32 D and 1.00 +/- 0.75 D, respectively (P<.0001). The mean induced higher-order aberration (HOA) was 0.45 +/- 0.28 microm in the femtosecond LASIK group and 1.13 +/- 0.25 microm in the CK group (P<.0001). The retreatment rate was 3% after femtosecond LASIK and 50% after CK (P<.0001). On a questionnaire administered at 12 months, 20 patients (62.5%) in the femtosecond LASIK group and 11 patients (34.4%) in the CK group reported being satisfied (P = .02). CONCLUSIONS: In emmetropic presbyopic cases, femtosecond LASIK monovision provided stable correction with less induced astigmatism and HOA. Eyes with CK monovision had regression and induced astigmatism.

Alleged drug facilitated sexual assault (DFSA) in Northern Ireland from 1999 to 2005. A study of blood alcohol levels.

Alleged sexual assault cases, identified from the forensic science Northern Ireland (FSNI) database, which had toxicology assays carried out on either blood or urine samples, were examined for the years 1999 up to and including 2005. In 1999 there were 30 toxicology requests while in 2005 there were 51, representing a 70% increase. The percentage of cases containing alcohol, drugs or both increased from 66% in 1999 to 78% in 2005. The estimated average blood alcohol concentration remained broadly similar throughout the spread of years. It was found to be 218mg% (milligrams per 100 millilitres) in 1999 and 217mg% in 2005. The actual number of cases studied within the 12h cut-off time rose from 9 in 1999 to 22 in 2005. The relationship between negative toxicology results and time delay between the alleged assault and forensic sampling was examined. This showed that between 44% and 74% of cases were found to have a time delay of >12h. Some of these cases may therefore represent false negative results. The presence of drugs, either alone or in combination with other drugs, doubled between 1999 and 2005. Increased identification was found with antidepressants, recreational drugs, benzodiazepines and analgesics, some of which were also associated with alcohol consumption. The findings are sufficient to cause alarm for the health and safety of certain individuals and their increased vulnerability to sexual assault in some social settings. Additionally, the legal implications of what constitutes valid consent needs to be considered further in the light of these findings, if attrition rates are to improve.

Ocular pathogen or commensal: a PCR-based study of surface bacterial flora in normal and dry eyes.

PURPOSE: To compare the bacterial population of the ocular surface of normal and dry eye subjects using conventional culture and 16S rDNA PCR. METHODS: Ninety-one subjects were classified as normal (n = 57) or dry eye (n = 34) by using tear break-up time, McMonnies survey, goblet cell density, and meibomian gland assessment. Conventional bacterial culture and broad-range 16S rDNA PCR, cloning, and DNA sequencing were used for bacterial identification. Repeated sampling was performed in a subset of subjects over a 3-month period. The association between goblet cell loss and bacterial counts in a subgroup of subjects was assessed. RESULTS: Most of the bacteria identified by culture were coagulase negative staphylococci, whereas molecular methods demonstrated a considerable number of additional bacteria. Atypical ocular surface bacteria including Rhodococcus erythropolis, Klebsiella oxytoca, and Erwinia sp., were identified in cases of overt inflammation and, surprisingly, on the normal ocular surface. The same bacteria remained on the ocular surface after repeated sampling. Increased bacterial flora was associated with reduced goblet cell density. CONCLUSIONS: Molecular analysis revealed a diverse ocular surface bacterial population. In addition to the normal flora, various potentially pathogenic bacteria were identified. The detection of known pathogens in both normal and dry eyes, with minimal signs of infection, presents a diagnostic dilemma. It remains unknown whether their presence is associated with inflammation and reduced goblet cell density or whether they adversely affect the ocular surface predisposing it to abnormal microbial colonization. In the absence of overt clinical infection, it is unknown whether such results should prompt intervention with therapy.