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  1. Article ; Online: A randomized trial of expedited intra-arrest transfer versus more extended on-scene resuscitation for refractory out of hospital cardiac arrest: Rationale and design of the EVIDENCE trial.

    Burns, Brian / Marschner, Ian / Eggins, Renee / Buscher, Hergen / Morton, Rachael L / Bendall, Jason / Keech, Anthony / Dennis, Mark

    American heart journal

    2023  Volume 267, Page(s) 22–32

    Abstract: Background: Refractory Out of Hospital Cardiac Arrest (r-OHCA) is common and the benefit versus harm of intra-arrest transport of patients to hospital is not clear.: Objective: To assess the rate of survival to hospital discharge in adult patients ... ...

    Abstract Background: Refractory Out of Hospital Cardiac Arrest (r-OHCA) is common and the benefit versus harm of intra-arrest transport of patients to hospital is not clear.
    Objective: To assess the rate of survival to hospital discharge in adult patients with r-OHCA, initial rhythm pulseless ventricular tachycardia (VT)/ventricular fibrillation (VF) or Pulseless Electrical Activity (PEA) treated with 1 of 2 locally accepted standards of care:
    Hypothesis: We hypothesize that expedited transport from scene in r-OHCA improves survival with favorable neurological status/outcome.
    Methods/design: Phase III, multi-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial with contemporaneous registry of patient ineligible for the clinical trial. Eligible patients for inclusion are adults with witnessed r-OHCA; estimated age 18 to 70, assumed medical cause with immediate bystander cardiopulmonary resuscitation (CPR); initial rhythm of VF/pulseless VT, or PEA; no return of spontaneous circulation following 3 shocks and/or 15 minutes of professional on-scene resuscitation; with mechanical CPR available. Two hundred patients will be randomized in a 1:1 ratio to either expedited transport from scene or ongoing ALS at the scene of cardiac arrest.
    Setting: Two urban regions in NSW Australia.
    Outcomes: Primary: survival to hospital discharge with cerebral performance category (CPC) 1 or 2. Secondary: safety, survival, prognostic factors, use of ECMO supported CPR and functional assessment at hospital discharge and 4 weeks and 6 months, quality of life, healthcare use and cost-effectiveness.
    Conclusions: The EVIDENCE trial will determine the potential risks and benefits of an expedited transport from scene of cardiac arrest.
    MeSH term(s) Adolescent ; Adult ; Aged ; Humans ; Middle Aged ; Young Adult ; Cardiopulmonary Resuscitation ; Emergency Medical Services ; Out-of-Hospital Cardiac Arrest/therapy ; Prospective Studies ; Quality of Life ; Tachycardia, Ventricular
    Language English
    Publishing date 2023-10-21
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 80026-0
    ISSN 1097-6744 ; 0002-8703
    ISSN (online) 1097-6744
    ISSN 0002-8703
    DOI 10.1016/j.ahj.2023.10.003
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  2. Article ; Online: SCORE: a randomised controlled trial evaluating shared care (general practitioner and oncologist) follow-up compared to usual oncologist follow-up for survivors of colorectal cancer.

    Jefford, Michael / Emery, Jon D / James Martin, Andrew / De Abreu Lourenco, Richard / Lisy, Karolina / Grunfeld, Eva / Mohamed, Mustafa Abdi / King, Dorothy / Tebbutt, Niall C / Lee, Margaret / Mehrnejad, Ashkan / Burgess, Adele / Marker, Julie / Eggins, Renee / Carrello, Joseph / Thomas, Hayley / Schofield, Penelope

    EClinicalMedicine

    2023  Volume 66, Page(s) 102346

    Abstract: Background: SCORE is the first randomised controlled trial (RCT) to examine shared oncologist and general practitioner (GP) follow-up for survivors of colorectal cancer (CRC). SCORE aimed to show that shared care (SC) was non-inferior to usual care (UC) ...

    Abstract Background: SCORE is the first randomised controlled trial (RCT) to examine shared oncologist and general practitioner (GP) follow-up for survivors of colorectal cancer (CRC). SCORE aimed to show that shared care (SC) was non-inferior to usual care (UC) on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months.
    Methods: The study recruited patients from five public hospitals in Melbourne, Australia between February 2017 and May 2021. Patients post curative intent treatment for stage I-III CRC underwent 1:1 randomisation to SC and UC. SC replaced two oncologist visits with GP visits and included a survivorship care plan and primary care management guidelines. Assessments were at baseline, 6 and 12 months. Difference between groups on GHQ-QoL to 12 months was estimated from a mixed model for repeated measures (MMRM), with a non-inferiority margin (NIM) of -10 points. Secondary endpoints included quality of life (QoL); patient perceptions of care; costs and clinical care processes (CEA tests, recurrences). Registration ACTRN12617000004369p.
    Findings: 150 consenting patients were randomised to SC (N = 74) or UC (N = 76); 11 GPs declined. The mean (SD) GHQ-QoL scores at 12 months were 72 (20.2) for SC versus 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 month and 12 month follow-up was 69 for SC and 73 for UC, mean difference -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. There was no clear evidence of differences on other QoL, unmet needs or satisfaction scales. At 12 months, the majority preferred SC (40/63; 63%) in the SC group, with equal preference for SC (22/62; 35%) and specialist care (22/62; 35%) in UC group. CEA completion was higher in SC. Recurrences similar between arms. Patients in SC on average incurred USD314 less in health costs versus UC patients.
    Interpretation: SC seems to be an appropriate and cost-effective model of follow-up for CRC survivors.
    Funding: Victorian Cancer Agency and Cancer Australia.
    Language English
    Publishing date 2023-11-30
    Publishing country England
    Document type Journal Article
    ISSN 2589-5370
    ISSN (online) 2589-5370
    DOI 10.1016/j.eclinm.2023.102346
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  3. Article ; Online: Supportive care needs and psychosocial outcomes of rural versus urban women with breast cancer.

    Eggins, Renee / Fowler, Helen / Cameron, Jessica / Aitken, Joanne F / Youl, Philippa / Turrell, Gavin / Chambers, Suzanne K / Dunn, Jeff / Pyke, Chris / Baade, Peter D / Goodwin, Belinda

    Psycho-oncology

    2022  Volume 31, Issue 11, Page(s) 1951–1957

    Abstract: Objective: To identify whether supportive care needs vary according to remoteness and area-level socio-economic status and to identify the combinations of socio-demographic, area-level and health factors that are associated with poorer quality of life, ... ...

    Abstract Objective: To identify whether supportive care needs vary according to remoteness and area-level socio-economic status and to identify the combinations of socio-demographic, area-level and health factors that are associated with poorer quality of life, psychological distress and severity of unmet supportive care needs.
    Methods: Cross sectional data was collected from women with a breast cancer diagnosis (n = 2635) in Queensland, Australia, through a telephone survey including socio-demographic, health, psychosocial and supportive care needs measures. Hierarchical regression and cluster analyses were applied to assess the predictors of unmet need and psychosocial outcomes and to identify socio-demographic and health status profiles of women, comparing their level of unmet needs and psychosocial outcomes.
    Results: Women living in outer regional areas reported the highest severity of unmet need in the patient care domain. Greater unmet need for health systems and information and patient care was also evident for those in moderately and most disadvantaged areas. Three clusters were identified reflecting (1) older women with poorer health and lower education (19%); (2) younger educated women with better health and private insurance (61%); and (3) physically active women with localised cancer who had completed treatment (20%). Poorer outcomes were evident in the first two of these clusters.
    Conclusions: This better understanding of the combinations of characteristics associated with poorer psychosocial outcomes and higher unmet need can be used to identify women with higher supportive care needs early and to target interventions.
    MeSH term(s) Female ; Humans ; Aged ; Breast Neoplasms/psychology ; Quality of Life/psychology ; Social Support ; Cross-Sectional Studies ; Surveys and Questionnaires ; Health Services Needs and Demand
    Language English
    Publishing date 2022-07-16
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1118536-3
    ISSN 1099-1611 ; 1057-9249
    ISSN (online) 1099-1611
    ISSN 1057-9249
    DOI 10.1002/pon.5977
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    Zs.A 3550: Show issues Location:
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  4. Article ; Online: Patient-Reported Bowel, Urinary, and Sexual Outcomes After Laparoscopic-Assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial (ALaCart).

    Mercieca-Bebber, Rebecca / Eggins, Renee / Brown, Kilian / Gebski, Val J / Brewer, Kate / Lai, Lenna / Bailey, Lisa / Solomon, Michael J / Lumley, John W / Hewett, Peter / Clouston, Andrew D / Wilson, Kate / Hague, Wendy / Hayes, Julian / White, Stephen / Morgan, Matt / Simes, R John / Stevenson, Andrew R L

    Annals of surgery

    2022  Volume 277, Issue 3, Page(s) 449–455

    Abstract: Objective: The aim of this study was to compare patient-reported urinary, bowel, and sexual functioning of ALaCaRT Trial participants randomized to open or laparoscopic surgery for rectal cancer.: Summary background data: The primary endpoint, ... ...

    Abstract Objective: The aim of this study was to compare patient-reported urinary, bowel, and sexual functioning of ALaCaRT Trial participants randomized to open or laparoscopic surgery for rectal cancer.
    Summary background data: The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established.
    Methods: Participants completed QLQ-CR29 at baseline, 3, and 12 months post-surgery. Additionally, women completed Rosen's Female Sexual Functioning Index (FSFI). Men completed the International Index of Erectile Function (IIEF) and QLQ-PR25. We compared the proportions of participants in each group who experienced moderate/severe symptoms/dysfunction at each time-point and compared mean difference scores from baseline to 12 months between groups. All analyses were intention-to-treat. Sexual functioning analyses included only the participants who expressed sexual interest at baseline.
    Results: Baseline PRO compliance of 475 randomized participants was 88%. At 12 months, a lower proportion of open surgery participants experienced moderate-severe fecal incontinence and sore skin, compared to Laparoscopic participants, and a lower proportion of men randomized to open surgery experienced moderate-severe urinary symptoms. There were no differences at 3 months for bowel or urinary symptoms. Sexual functioning among sexually interested participants was similar between groups at 3 and 12 months; however, a lower proportion of women reported moderate to severe sexual dissatisfaction at 3 months in the open as compared to the laparoscopic group, (Rebecca.mercieca@sydney.edu.au., 95% CI 0.03-0.39).
    Discussion: Despite the slightly lower proportions of open surgery participants self-reporting moderate-severe symptoms for 3 of 16 urinary/bowel domains, and lack of differences in sexual domains, it remains difficult to recommend one surgical approach over another for rectal resection.
    MeSH term(s) Male ; Female ; Humans ; Rectal Neoplasms/surgery ; Rectum/surgery ; Proctectomy/adverse effects ; Laparoscopy ; Patient Reported Outcome Measures
    Language English
    Publishing date 2022-02-15
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 340-2
    ISSN 1528-1140 ; 0003-4932
    ISSN (online) 1528-1140
    ISSN 0003-4932
    DOI 10.1097/SLA.0000000000005412
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  5. Article ; Online: Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients.

    Allen, Nicholas C / Martin, Andrew J / Snaidr, Victoria A / Eggins, Renee / Chong, Alvin H / Fernandéz-Peñas, Pablo / Gin, Douglas / Sidhu, Shireen / Paddon, Vanessa L / Banney, Leith A / Lim, Adrian / Upjohn, Edward / Schaider, Helmut / Ganhewa, Aparna D / Nguyen, Jennifer / McKenzie, Catriona A / Prakash, Saurabh / McLean, Catriona / Lochhead, Alistair /
    Ibbetson, Jan / Dettrick, Andrew / Landgren, Anthony / Allnutt, Katherine J / Allison, Clare / Davenport, Rachael B / Mumford, Blake P / Wong, Brittany / Stagg, Brendan / Tedman, Alexander / Gribbin, Hannah / Edwards, Harrison A / De Rosa, Nicholas / Stewart, Thomas / Doolan, Brent J / Kok, Yonatan / Simpson, Kate / Low, Zhi M / Kovitwanichkanont, Tom / Scolyer, Richard A / Dhillon, Haryana M / Vardy, Janette L / Chadban, Steven J / Bowen, David G / Chen, Andrew C / Damian, Diona L

    The New England journal of medicine

    2023  Volume 388, Issue 9, Page(s) 804–812

    Abstract: Background: Immunosuppressed organ-transplant recipients have an increased incidence of, and mortality from, skin cancer. Nicotinamide (vitamin B: Methods: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, organ-transplant recipients who ... ...

    Abstract Background: Immunosuppressed organ-transplant recipients have an increased incidence of, and mortality from, skin cancer. Nicotinamide (vitamin B
    Methods: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, organ-transplant recipients who had had at least two keratinocyte cancers in the past 5 years to receive 500 mg of nicotinamide or placebo twice daily for 12 months. Participants were examined for skin lesions by dermatologists at 3-month intervals for 12 months. The primary end point was the number of new keratinocyte cancers during the 12-month intervention period. Secondary end points included the numbers of squamous-cell and basal-cell carcinomas during the 12-month intervention period, the number of actinic keratoses until 6 months after randomization, safety, and quality of life.
    Results: A total of 158 participants were enrolled, with 79 assigned to the nicotinamide group and 79 to the placebo group. The trial was stopped early owing to poor recruitment. At 12 months, there were 207 new keratinocyte cancers in the nicotinamide group and 210 in the placebo group (rate ratio, 1.0; 95% confidence interval, 0.8 to 1.3; P = 0.96). No significant between-group differences in squamous-cell and basal-cell carcinoma counts, actinic keratosis counts, or quality-of-life scores were observed. Adverse events and changes in blood or urine laboratory variables were similar in the two groups.
    Conclusions: In this 12-month, placebo-controlled trial, oral nicotinamide therapy did not lead to lower numbers of keratinocyte cancers or actinic keratoses in immunosuppressed solid-organ transplant recipients. (Funded by the National Health and Medical Research Council; ONTRANS Australian New Zealand Clinical Trials Registry number, ACTRN12617000599370.).
    MeSH term(s) Humans ; Australia ; Carcinoma, Basal Cell/etiology ; Carcinoma, Basal Cell/prevention & control ; Carcinoma, Squamous Cell/etiology ; Carcinoma, Squamous Cell/prevention & control ; Chemoprevention ; Keratosis, Actinic/etiology ; Keratosis, Actinic/prevention & control ; Niacinamide/administration & dosage ; Niacinamide/therapeutic use ; Quality of Life ; Skin Neoplasms/etiology ; Skin Neoplasms/prevention & control ; Transplant Recipients ; Immunocompromised Host ; Organ Transplantation/adverse effects ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/therapeutic use ; Ultraviolet Rays/adverse effects
    Chemical Substances Niacinamide (25X51I8RD4) ; Antineoplastic Agents
    Language English
    Publishing date 2023-03-01
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa2203086
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