1.A practical guide to understanding, using and including patient reported outcomes in clinical trials in ovarian cancer.
Michelle K WILSON ; Rebecca MERCIECA-BEBBER ; Michael FRIEDLANDER
Journal of Gynecologic Oncology 2018;29(5):e81-
Health related quality of life (HRQOL) is a key priority for patients with ovarian cancer as there is significant morbidity associated with the disease and the treatment. It is therefore essential to include measures of HRQOL and patient reported outcomes (PROs) in all clinical trials and ideally report them in the initial manuscript. The results of these analyses help interpret the primary trial endpoints which are typically progression free survival and overall survival from the perspective of the patients, but can also assist with regulatory approval of new drugs and inform future patients regarding the potential benefits and downsides of the treatment as well as help support clinical recommendations. Including PROs in clinical trials allows patient-defined clinical benefits to be assessed in parallel to traditional survival outcomes to provide a more holistic overview and aid in the interpretation of the trial results. Given the importance of these instruments in clinical trials, greater effort is required to improve the appropriate inclusion, quality of analyses and reporting of PROs. It is also essential that all clinicians understand the intricacies of the selection, implementation and interpretation of these measures of HRQOL and PRO's and how important their contribution is to clinical trials as well as clinical practice. This review is a practical guide for clinicians to gain a better understanding of PROs and how they can be incorporated into ovarian cancer trials.
Disease-Free Survival
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Humans
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Ovarian Neoplasms*
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Quality of Life
2.Transient Obstructive Hydrocephalus due to Intraventricular Hemorrhage: A Case Report and Review of Literature.
Eriks A LUSIS ; Ananth K VELLIMANA ; Wilson Z RAY ; Michael R CHICOINE ; Sarah C JOST
Journal of Clinical Neurology 2013;9(3):192-195
BACKGROUND: Acute transient obstructive hydrocephalus is rare in adults. We describe a patient with intraventricular hemorrhage (IVH) who experienced the delayed development of acute transient hydrocephalus. CASE REPORT: A 33-year-old man with a previously diagnosed Spetzler-Martin Grade 5 arteriovenous malformation presented with severe headache, which was found to be due to IVH. Forty hours after presentation he developed significant obstructive hydrocephalus due to the thrombus migrating to the cerebral aqueduct, and a ventriculostomy placement was planned. However, shortly thereafter his headache began to improve spontaneously. Within 4 hours after onset the headache had completely resolved, and an interval head CT scan revealed resolution of hydrocephalus. CONCLUSIONS: In patients with IVH, acute obstructive hydrocephalus can develop at any time after the ictus. Though a delayed presentation of acute but transient obstructive hydrocephalus is unusual, it is important to be aware of this scenario and ensure that deterioration secondary to thrombus migration and subsequent obstructive hydrocephalus do not occur.
Adult
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Arteriovenous Malformations
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Cerebral Aqueduct
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Dietary Sucrose
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Head
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Headache
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Hemorrhage
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Humans
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Hydrocephalus
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Thrombosis
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Ventriculostomy
3.The Utility of Somatosensory Evoked Potential Monitoring During Cervical Spine Surgery: How Often Does It Prompt Intervention and Affect Outcome?.
Michael S ROH ; Tracy J WILSON-HOLDEN ; Anne M PADBERG ; Jong Beom PARK ; K DANIEL RIEW
Asian Spine Journal 2007;1(1):43-47
STUDY DESIGN: Retrospective review of the results of somatosensory evoked potentials (SSEP) performed in cervical spine surgery. PURPOSE: To evaluate the utility of spinal cord monitoring during cervical spine surgery in a single surgeon's practice, based on how often it prompted an intraoperative intervention. OVERVIEW OF LITERATURE: Intraoperative monitoring during cervical spine surgery is not a universally accepted standard of care. This is due in part to the paucity of literature regarding the impact of monitoring on patient management or outcome. METHODS: SSEP for tibial, median, and ulnar nerves were monitored in 809 consecutive cervical spine operations performed by a single surgeon. The average patient age was 52 years (range, 2 to 88 years), with 472 males and 339 females. Cases were screened for significant degradation or loss of SSEP data. Specific attention was paid to 1) what interventions were performed in response to the SSEP degradation with subsequent improvement, and 2) whether SSEP changes corresponded with postoperative neurological deficits. RESULTS: Seventeen of 809 patients (2.1%) had SSEP degradation that met warning criteria and therefore prompted intervention. Release of shoulder tape (8) or traction (4) most often resulted in SSEP improvement. Failure of SSEP data to return to within acceptable limits of baseline was associated with neurological deficit (p=0.04). Two patients awoke with new postoperative neurological deficits, which resolved in 6 hours and 2 months respectively. Patients with ossification of the posterior longitudinal ligament (OPLL) were at seven-fold greater risk of intraoperative SSEP degradation. CONCLUSIONS: SSEP monitoring in this surgical population proved sensitive to perioperative factors which may increase the risk of postoperative neurologic deficit, and probably prevented neurological deficits in 15 of 809 patients (1.9%). Improvement in data following intervention appears to correlate well with unchanged neurologic status. Experience with intraoperative monitoring in this patient series has led to incorporation of these techniques as a standard of care in cervical spine surgeries performed by this surgeon.
Evoked Potentials, Somatosensory*
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Female
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Humans
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Longitudinal Ligaments
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Male
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Monitoring, Intraoperative
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Neurologic Manifestations
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Retrospective Studies
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Shoulder
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Spinal Cord
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Spine*
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Standard of Care
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Traction
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Ulnar Nerve
4.Interfacial modulus mapping of layered dental ceramics using nanoindentation.
Antonios L THEOCHAROPOULOS ; Andrew J BUSHBY ; Ken MY P'NG ; Rory M WILSON ; K Elizabeth TANNER ; Michael J CATTELL
The Journal of Advanced Prosthodontics 2016;8(6):479-488
PURPOSE: The aim of this study was to test the modulus of elasticity (E) across the interfaces of yttria stabilized zirconia (YTZP) / veneer multilayers using nanoindentation. MATERIALS AND METHODS: YTZP core material (KaVo-Everest, Germany) specimens were either coated with a liner (IPS e.max ZirLiner, Ivoclar-Vivadent) (Type-1) or left as-sintered (Type-2) and subsequently veneered with a pressable glass-ceramic (IPS e.max ZirPress, Ivoclar-Vivadent). A 5 µm (nominal tip diameter) spherical indenter was used with a UMIS CSIRO 2000 (ASI, Canberra, Australia) nanoindenter system to test E across the exposed and polished interfaces of both specimen types. The multiple point load – partial unload method was used for E determination. All materials used were characterized using Scanning Electron Microscopy (SEM) and X – ray powder diffraction (XRD). E mappings of the areas tested were produced from the nanoindentation data. RESULTS: A significantly (P<.05) lower E value between Type-1 and Type-2 specimens at a distance of 40 µm in the veneer material was associated with the liner. XRD and SEM characterization of the zirconia sample showed a fine grained bulk tetragonal phase. IPS e-max ZirPress and IPS e-max ZirLiner materials were characterized as amorphous. CONCLUSION: The liner between the YTZP core and the heat pressed veneer may act as a weak link in this dental multilayer due to its significantly (P<.05) lower E. The present study has shown nanoindentation using spherical indentation and the multiple point load - partial unload method to be reliable predictors of E and useful evaluation tools for layered dental ceramic interfaces.
Ceramics*
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Elastic Modulus
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Hot Temperature
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Methods
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Microscopy, Electron, Scanning
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Powder Diffraction
5.Schistosome eggs have a direct role in the induction of basophils capable of a high level of IL-4 production: Comparative study of single- and bisexual infection of Schistosoma mansoni in vivo
William K. Anyan ; Takashi Kumagai ; Rieko F. Shimogawara ; Takenori Seki ; Nobuaki Akao ; Kazushige Obata ; Bethel Kwansa-Bentum ; Kwabena Mante Bosompem ; Daniel A Boakye ; Michael D. Wilson ; Hajime Karasuyama ; Nobuo Ohta
Tropical Medicine and Health 2010;38(1):13-22
Immunobiological roles of schistosome eggs during murine experimental infection were investigated with special reference to the induction of basophilic leukocytes. After single- or bisexual infection with Schistosoma mansoni in BALB⁄c mice, splenomegaly and liver granulomas were observed only in bisexual infection in parallel with deposition of mature parasite eggs. Comparison of the kinetics of basophil response revealed a marked increase in number in the bone marrow of mice with bisexual infection at the 7th week post infection as opposed to a marginal increase in single- sex infections. In the spleen, bimodal response was observed in the basophil responses; a small but repeatable peak at the 4th week after infection, increasing again at the 8th week, which corresponded to the initiation and maturation of parasite eggs in the affected organs of infected mice. The same time course was observed for IL-4 production by the splenocytes from mice of bisexual infection. To obtain more concrete evidence of the role of eggs in the induction of basophils, we tested using the intravenous egg injection model. Injection of eggs induced basophilia, and it was accompanied by the up-regulation of IL-4 production in splenocytes from the 8th day. Basophils induced in this model showed a high level of IL-4 production confirmed by flow cytometry, while faint levels of IL-4 production were observed for CD4+ T cells at this time point. In addition, we demonstrate that egg deposition is the trigger of basophil induction and activation in the murine experimental model of S. mansoni infection, which might play an essential role in the initiation of Th1⁄2 conversion during the course of S. mansoni infection in vivo.
6.Medium-term mortality after hip fractures and COVID-19: A prospective multi-centre UK study.
Gareth CHAN ; Ashish NARANG ; Arash AFRAMIAN ; Zaid ALI ; Joseph BRIDGEMAN ; Alastair CARR ; Laura CHAPMAN ; Henry GOODIER ; Catrin MORGAN ; Chang PARK ; Sarah SEXTON ; Kapil SUGAND ; Thomas WALTON ; Michael WILSON ; Ajay BELGAUMKAR ; Kieran GALLAGHER ; Koushik GHOSH ; Charles GIBBONS ; Joshua JACOB ; Andrew KEIGHTLEY ; Zuhair NAWAZ ; Khaled SARRAF ; Christopher WAKELING ; William KIEFFER ; Benedict ROGERS
Chinese Journal of Traumatology 2022;25(3):161-165
PURPOSE:
The COVID-19 pandemic has caused 1.4 million deaths globally and is associated with a 3-4 times increase in 30-day mortality after a fragility hip fracture with concurrent COVID-19 infection. Typically, death from COVID-19 infection occurs between 15 and 22 days after the onset of symptoms, but this period can extend up to 8 weeks. This study aimed to assess the impact of concurrent COVID-19 infection on 120-day mortality after a fragility hip fracture.
METHODS:
A multi-centre prospective study across 10 hospitals treating 8% of the annual burden of hip fractures in England between 1st March and 30th April, 2020 was performed. Patients whose surgical treatment was payable through the National Health Service Best Practice Tariff mechanism for "fragility hip fractures" were included in the study. Patients' 120-day mortality was assessed relative to their peri-operative COVID-19 status. Statistical analysis was performed using SPSS version 27.
RESULTS:
A total of 746 patients were included in this study, of which 87 (11.7%) were COVID-19 positive. Mortality rates at 30- and 120-day were significantly higher for COVID-19 positive patients relative to COVID-19 negative patients (p < 0.001). However, mortality rates between 31 and 120-day were not significantly different (p = 0.107), 16.1% and 9.4% respectively for COVID-19 positive and negative patients, odds ratio 1.855 (95% CI 0.865-3.978).
CONCLUSION
Hip fracture patients with concurrent COVID-19 infection, provided that they are alive at day-31 after injury, have no significant difference in 120-day mortality. Despite the growing awareness and concern of "long-COVID" and its widespread prevalence, this does not appear to increase medium-term mortality rates after a hip fracture.
COVID-19
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Hip Fractures/surgery*
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Humans
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Pandemics
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Prospective Studies
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Retrospective Studies
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State Medicine
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United Kingdom/epidemiology*