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1.
Future Oncol ; 19(26): 1809-1821, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37439564

ABSTRACT

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.


Subject(s)
Colorectal Neoplasms , Patients , Humans , Research Design , Colorectal Neoplasms/therapy
2.
BMJ ; 367: l6384, 2019 11 13.
Article in English | MEDLINE | ID: mdl-31722874
3.
J Forensic Leg Med ; 17(6): 293-7, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20650415

ABSTRACT

The purpose of the study was to determine whether Infrared imaging could play a role in the detection of previous blunt force injury after resolution of skin changes were no longer visible to the human eye. Investigations were performed using an adapted digital camera and the same standard Nikon camera body to photograph the bruises of ten volunteer adult subjects. The same lens was fitted to each camera body and each bruise was photographed until it was no longer possible to identify it with the naked eye. The results of photographing subjects over 6 months demonstrated that the median time the bruises persisted in both groups was approximately between 18 and 19 days. There was no statistically significant difference between groups of bruises photographed with both the infrared digital camera that had been adapted to capture only infrared light, and with the standard camera which had the same lens fitted to it. The two groups of photographs of bruises imaged at the same time with the two cameras were not significantly different with regard to what skin changes could be detected. The use of the near infrared spectrum, with wavelengths that are longer than the human eye can detect, did not reveal significant evidence of bruising after it had faded from view to both the human eye and to a standard camera.


Subject(s)
Contusions/diagnosis , Forensic Medicine/instrumentation , Infrared Rays , Photography/instrumentation , Physical Examination/instrumentation , Biometric Identification , Confidence Intervals , Feasibility Studies , Forensic Medicine/methods , Forensic Medicine/trends , Humans , Kaplan-Meier Estimate , Photography/methods , Physical Examination/methods , Statistics, Nonparametric
4.
J Cataract Refract Surg ; 36(6): 997-1002, 2010 Jun.
Article in English | MEDLINE | ID: mdl-20494773

ABSTRACT

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.


Subject(s)
Electrocoagulation , Keratomileusis, Laser In Situ/methods , Lasers, Excimer/therapeutic use , Presbyopia/surgery , Vision, Monocular/physiology , Astigmatism/physiopathology , Female , Humans , Intraoperative Complications , Male , Middle Aged , Patient Satisfaction , Presbyopia/physiopathology , Refraction, Ocular/physiology , Retreatment , Retrospective Studies , Surveys and Questionnaires , Visual Acuity/physiology
5.
Eur J Obstet Gynecol Reprod Biol ; 142(2): 149-53, 2009 Feb.
Article in English | MEDLINE | ID: mdl-19054602

ABSTRACT

OBJECTIVE: This study was undertaken to document physical injuries and ascertain associated variables in female complainants of sexual assault. STUDY DESIGN: 164 cases of sexual assault between 2002 and 2006 in Belfast were included. 162 women consented to body examination and 153 to genital examination. Data for the study were obtained from the contemporaneous notes of a forensic doctor who examined the victims. RESULTS: Of 164 females, 44% were less than 20 years of age, mean age was 24.2, range 13-74 years; two-thirds reported alcohol consumption prior to assault. Non-genital (body) injury was observed in 61%, genital injury in 39%, both in 20% and 18% had no injury. Body injury was associated with time to examination (OR=4.0, p<0.01), alcohol intake prior to assault (OR=3.33, p<0.001), assault occurring outdoors (OR=3.45, p<0.01), previous sexual intercourse (OR=3.19, p<0.01) and genital injury (OR=2.24, p<0.05). Genital injury was related to acquaintance assault (OR=2.33, p<0.05), time to examination (OR=3.70, p<0.05), reported virgin status (OR=3.03, p<0.01) and absence of hormonal contraception (OR=2.04, p<0.10). CONCLUSION: Almost half the victims of sexual assault were less than 20 years old and injury was detected in over 80%. Time to examination and prior sexual experience were related to genital and body injury. Assault occurring outdoors and alcohol intake were associated with body injury. Genital injury was more frequent in acquaintance assault and victims not using hormonal contraception. Young females drinking alcohol are at a very high risk for sexual assault.


Subject(s)
Genitalia, Female/injuries , Rape/statistics & numerical data , Violence/statistics & numerical data , Wounds and Injuries/epidemiology , Adolescent , Adult , Aged , Female , Humans , Middle Aged , Northern Ireland/epidemiology , Young Adult
6.
J Forensic Leg Med ; 15(8): 497-504, 2008 Nov.
Article in English | MEDLINE | ID: mdl-18926501

ABSTRACT

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.


Subject(s)
Alcohol-Related Disorders/blood , Alcoholic Beverages/poisoning , Crime Victims/statistics & numerical data , Ethanol/blood , Forensic Toxicology/statistics & numerical data , Pharmaceutical Preparations/blood , Sex Offenses/statistics & numerical data , Substance Abuse Detection/statistics & numerical data , Alcohol-Related Disorders/epidemiology , Alcohol-Related Disorders/psychology , Crime Victims/legislation & jurisprudence , Crime Victims/psychology , Ethanol/urine , Female , Forensic Medicine/methods , Humans , Longitudinal Studies , Male , Northern Ireland/epidemiology , Pharmaceutical Preparations/administration & dosage , Pharmaceutical Preparations/urine , Retrospective Studies , Sex Offenses/legislation & jurisprudence , Sex Offenses/psychology , Social Behavior , Substance Abuse Detection/trends , Substance-Related Disorders/epidemiology
7.
Med Sci Law ; 48(2): 117-23, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18533571

ABSTRACT

The interface between forensic physicians and the police ombudsman of Northern Ireland is an area where there is little published research. In particular there has been no attempt to inquire into the role of forensic physicians in the procedures employed to investigate alleged police maltreatment of prisoners at the time of arrest or later in the custodial setting. A questionnaire was distributed to all forensic physicians in Northern Ireland to assess their level of engagement with the ombudsman's office and shed light on the attitudes of forensic physicians to the police ombudsman's handling of the complaints procedure. The results published represent the opinion of the majority of forensic physicians in Northern Ireland and show a broadly supportive attitude to the role of the police ombudsman in the investigation of alleged police officer misconduct. However, a majority of forensic physicians felt that their involvement in the investigative process was an under-used resource.


Subject(s)
Attitude of Health Personnel , Interprofessional Relations , Physicians , Police , Adult , Forensic Medicine , Humans , Ireland , Middle Aged , Surveys and Questionnaires
8.
J Forensic Leg Med ; 15(3): 148-57, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18313009

ABSTRACT

This study reports on 60 cases of suicide in Londonderry, Northern Ireland from January 2000 to December 2005. The research focused on a number of factors associated with the occurrence of suicide. These included age, gender, employment status, method used and possible predisposing factors. Additionally, the seasonality of occurrence was also investigated. Notably, over the period of the study, the number of suicides almost doubled. The results demonstrated that 83.3% of suicides were male. The largest proportion of these, over one third, occurred in men between the ages 21 and 30 years. This high rate of young male suicides was in marked contrast to any other group. The most frequent method of suicide recorded in this study was hanging (55%). The next most frequent methods were drowning (25%) and overdose (13.3%). Three times as many males (6) overdosed compared to females.


Subject(s)
Suicide/statistics & numerical data , Adult , Age Distribution , Aged , Aged, 80 and over , Asphyxia/mortality , Drowning/mortality , Drug Overdose/mortality , Female , Forensic Medicine , Humans , Ireland/epidemiology , Male , Mental Disorders/epidemiology , Methods , Middle Aged , Seasons , Sex Distribution , Unemployment/statistics & numerical data
9.
Invest Ophthalmol Vis Sci ; 48(12): 5616-23, 2007 Dec.
Article in English | MEDLINE | ID: mdl-18055811

ABSTRACT

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.


Subject(s)
Bacteria/isolation & purification , Conjunctiva/microbiology , Dry Eye Syndromes/microbiology , Adult , Aged , Aged, 80 and over , Bacteria/genetics , Bacterial Typing Techniques , Cell Count , DNA Fingerprinting/methods , DNA, Bacterial/analysis , Female , Goblet Cells/pathology , Humans , Male , Meibomian Glands/pathology , Middle Aged , Polymerase Chain Reaction/methods , RNA, Ribosomal, 16S/genetics , Sequence Analysis, DNA
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