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  • Oxford University Press (OUP)  (17)
  • 2020-2024  (17)
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  • Oxford University Press (OUP)  (17)
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  • 2020-2024  (17)
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  • 1
    Online Resource
    Online Resource
    Quality of reporting of robot-assisted cholecystectomy in relation to the IDEAL recommendations: systematic review
    Oxford University Press (OUP) ; 2022
    In:  BJS Open Vol. 6, No. 5 ( 2022-09-02)
    Details
    In: BJS Open, Oxford University Press (OUP), Vol. 6, No. 5 ( 2022-09-02)
    Abstract: Robotic cholecystectomy (RC) is a recent innovation in minimally invasive gallbladder surgery. The IDEAL (idea, development, exploration, assessment, long-term study) framework aims to provide a safe method for evaluating innovative procedures. This study aimed to understand how RC was introduced, in accordance with IDEAL guidelines. Methods Systematic searches were used to identify studies reporting RC. Eligible studies were classified according to IDEAL stage and data were collected on general study characteristics, patient selection, governance procedures, surgeon/centre expertise, and outcome reporting. Results Of 1425 abstracts screened, 90 studies were included (5 case reports, 38 case series, 44 non-randomized comparative studies, and 3 randomized clinical trials). Sixty-four were single-centre and 15 were prospective. No authors described their work in the context of IDEAL. One study was classified as IDEAL stage 1, 43 as IDEAL 2a, 43 as IDEAL 2b, and three as IDEAL 3. Sixty-four and 51 provided inclusion and exclusion criteria respectively. Ethical approval was reported in 51 and conflicts of interest in 34. Only 21 reported provision of training for surgeons in RC. A total of 864 outcomes were reported; 198 were used in only one study. Only 30 reported a follow-up interval which, in 13, was 1 month or less. Conclusion The IDEAL framework was not followed during the adoption of RC. Few studies were conducted within a research setting, many were retrospective, and outcomes were heterogeneous. There is a need to implement appropriate tools to facilitate the incremental evaluation and reporting of surgical innovation.
    Type of Medium: Online Resource
    ISSN: 2474-9842
    URL: Article
    DOI: 10.1093/bjsopen/zrac116
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2902033-5
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  • 2
    Online Resource
    Online Resource
    Surgical site infections after emergency hernia repair: substudy from the Management of Acutely Symptomatic Hernia (MASH) study
    Oxford University Press (OUP) ; 2023
    In:  BJS Open Vol. 7, No. 1 ( 2023-01-06)
    Details
    In: BJS Open, Oxford University Press (OUP), Vol. 7, No. 1 ( 2023-01-06)
    Abstract: Acutely symptomatic abdominal wall and groin hernias (ASH) are a common acute surgical presentation. There are limited data to guide decisions related to surgical repair technique and use of antibiotics, which can be driven by increased risk of surgical site infection (SSI) in this group. This study aims to report rates of SSI following ASH repair and explore the use of patient-reported outcome measure reporting in this setting. Methods An 18-week, UK-based, multicentre prospective cohort study (NCT04197271) recruited adults with ASH. This study reports operatively managed patients. Data on patient characteristics, inpatient management, quality of life, complications, and wound healing (Bluebelle score) were collected. Descriptive analyses were performed to estimate event rates of SSI and regression analysis explored the relationship between Bluebelle scores and SSI. The 30 and 90-day follow-up visits assessed complications and quality of life. Results The MASH study recruited 273 patients, of whom 218 were eligible for this study, 87.2 per cent who underwent open repair. Mesh was used in 123 patients (50.8 per cent). Pre- and postoperative antibiotics were given in 163 (67.4 per cent) and 28 (11.5 per cent) patients respectively. There were 26 reported SSIs (11.9 per cent). Increased BMI, incisional, femoral, and umbilical hernia were associated with higher rates of SSI (P = 0.006). In 238 patients, there was a difference in healthy utility values at 90 days between patients with and without SSI (P = 0.025). Also, when analysing 191 patients with Bluebelle scores, those who developed an SSI had higher Bluebelle values (P & lt; 0.001). Conclusion SSI is frequent in repair of acutely symptomatic hernia and correlates with BMI and site of hernia.
    Type of Medium: Online Resource
    ISSN: 2474-9842
    URL: Article
    DOI: 10.1093/bjsopen/zrac155
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2902033-5
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  • 3
    Online Resource
    Online Resource
    Management of Acutely Symptomatic Hernia (MASH) study
    Oxford University Press (OUP) ; 2022
    In:  British Journal of Surgery Vol. 109, No. 8 ( 2022-07-15), p. 754-762
    Details
    In: British Journal of Surgery, Oxford University Press (OUP), Vol. 109, No. 8 ( 2022-07-15), p. 754-762
    Abstract: Acutely symptomatic abdominal wall and groin hernias are a common reason for acute surgical hospital admissions. There are limited data to guide the treatment of these patients. This study aimed to assess outcomes of emergency hernia surgery and identify common management strategies, to improve care for these high-risk patients. Methods A 20-week, national multicentre, collaborative, prospective cohort study (NCT04197271) recruited adults with acutely symptomatic abdominal wall and groin hernias across the UK. Data on patient characteristics, inpatient management, quality of life, complications, and wound healing were collected. Follow-up telephone calls at 30 and 90 days were used to assessed complications and quality of life. Descriptive analyses were undertaken to describe the population and outcomes. Results Twenty-three hospitals recruited 272 eligible patients. Inguinal (37.8 per cent) and umbilical (37.1 per cent) hernias were the most common. Some 13.9 per cent were awaiting elective surgery and 12.8 per cent had previously declined intervention. CT was performed in 47.1 per cent and 81.3 per cent underwent surgical management. Open repairs were carried out in 93.5 per cent, and 92.5 per cent of these were performed under general anaesthesia. Four of 13 laparoscopic procedures were converted to open surgery. Mesh was used in 55.1 per cent of repairs, typically synthetic non-absorbable (87.4 per cent). Complications were infrequent; surgical-site infection (9.4 per cent), delirium (3.2 per cent), and pneumonia (2.3 per cent) were the most common. The 90-day mortality rate was 4.9 per cent. Immediate surgical management was associated with a significant improvement in quality of life at 30 days (median score 0.73–0.82). Conclusion There is variation in the investigation, management, and surgical technique used to treat acutely symptomatic abdominal wall and groin hernias in the UK. The optimal management strategy for specific acute presentations remains to be established. Presented to the Association of Surgeons in Training Conference, Birmingham, UK, March 2021, the Association of Surgeons of Great Britain and Ireland Congress, May 2021, the World Society of Emergency Surgery, Edinburgh, UK, September 2021, and the European Hernia Society Congress, Copenhagen, Denmark, October 2021.
    Type of Medium: Online Resource
    ISSN: 0007-1323 , 1365-2168
    URL: Article
    DOI: 10.1093/bjs/znac107
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2006309-X
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  • 4
    Online Resource
    Online Resource
    Association between preadmission frailty and care level at discharge in older adults undergoing emergency laparotomy
    Oxford University Press (OUP) ; 2020
    In:  British Journal of Surgery Vol. 107, No. 3 ( 2020-01-23), p. 218-226
    Details
    In: British Journal of Surgery, Oxford University Press (OUP), Vol. 107, No. 3 ( 2020-01-23), p. 218-226
    Abstract: Older adults undergoing emergency abdominal surgery have significantly poorer outcomes than younger adults. For those who survive, the level of care required on discharge from hospital is unknown and such information could guide decision-making. The ELF (Emergency Laparotomy and Frailty) study aimed to determine whether preoperative frailty in older adults was associated with increased dependence at the time of discharge. Methods The ELF study was a UK-wide multicentre prospective cohort study of older patients (65 years or more) undergoing emergency laparotomy during March and June 2017. The objective was to establish whether preoperative frailty was associated with increased care level at discharge compared with preoperative care level. The analysis used a multilevel logistic regression adjusted for preadmission frailty, patient age, sex and care level. Results A total of 934 patients were included from 49 hospitals. Mean(s.d.) age was 76·2(6·8) years, with 57·6 per cent women; 20·2 per cent were frail. Some 37·4 per cent of older adults had an increased care level at discharge. Increasing frailty was associated with increased discharge care level, with greater predictive power than age. The adjusted odds ratio for an increase in care level was 4·48 (95 per cent c.i. 2·03 to 9·91) for apparently vulnerable patients (Clinical Frailty Score (CFS) 4), 5·94 (2·54 to 13·90) for those mildly frail (CFS 5) and 7·88 (2·97 to 20·79) for those moderately or severely frail (CFS 6 or 7), compared with patients who were fit. Conclusion Over 37 per cent of older adults undergoing emergency laparotomy required increased care at discharge. Frailty scoring was a significant predictor, and should be integrated into all acute surgical units to aid shared decision-making and discharge planning.
    Type of Medium: Online Resource
    ISSN: 0007-1323 , 1365-2168
    URL: Article
    DOI: 10.1002/bjs.11392
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 5
    Online Resource
    Online Resource
    Cardiac and cardiometabolic phenotyping of trastuzumab-mediated cardiotoxicity: a secondary analysis of the MANTICORE trial
    Oxford University Press (OUP) ; 2022
    In:  European Heart Journal - Cardiovascular Pharmacotherapy Vol. 8, No. 2 ( 2022-02-16), p. 130-139
    Details
    In: European Heart Journal - Cardiovascular Pharmacotherapy, Oxford University Press (OUP), Vol. 8, No. 2 ( 2022-02-16), p. 130-139
    Abstract: An improved understanding of the pathophysiology of trastuzumab-mediated cardiotoxicity is required to improve outcomes of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. We aimed to characterize the cardiac and cardiometabolic phenotype of trastuzumab-mediated toxicity and potential interactions with cardiac pharmacotherapy. Methods and results This study was an analysis of serial magnetic resonance imaging (MRI) and circulating biomarker data acquired from patients with HER2-positive early-stage breast cancer participating in a randomized-controlled clinical trial for the pharmaco-prevention of trastuzumab-associated cardiotoxicity. Circulating biomarkers (B-type natriuretic peptide, troponin I, MMP-2 and -9, GDF-15, neuregulin-1, and IGF-1) and MRI of cardiac structure and function and abdominal fat distribution were acquired prior to trastuzumab, post-cycle 4 and post-cycle 17. Ninety-four participants (51 ± 8 years) completed the study with 30 on placebo, 33 on perindopril, and 31 on bisoprolol. Post-cycle 4, global longitudinal strain deteriorated from baseline in both placebo (+2.0 ± 2.7%, P = 0.002) and perindopril (+0.9 ± 2.5%, P = 0.04), but not with bisoprolol (−0.2 ± 2.1%, P = 0.55). In all groups combined, extracellular volume fraction and GDF-15 increased post-cycle 4 (+1.3 ± 4.4%, P = 0.004; +130 ± 150%, P ≤ 0.001, respectively). However, no significant change in troponin I was detected throughout trastuzumab. In all groups combined, visceral and intermuscular fat volume increased post-cycle 4 (+7 ± 17%, P = 0.02, +8 ± 23%, P = 0.02, respectively), while muscle volume and IGF-1 decreased from post-cycle 4 to 17 (−2 ± 10%, P = 0.008, -18 ± 28%, P  & lt; 0.001, respectively). Conclusion Trastuzumab results in impaired cardiac function and early myocardial inflammation. Trastuzumab is also associated with deleterious changes to the cardiometabolic phenotype which may contribute to the increased cardiovascular risk in this population.
    Type of Medium: Online Resource
    ISSN: 2055-6837 , 2055-6845
    URL: Article
    DOI: 10.1093/ehjcvp/pvab016
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2808613-2
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  • 6
    Online Resource
    Online Resource
    Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial
    Oxford University Press (OUP) ; 2022
    In:  The Journal of Infectious Diseases Vol. 226, No. 9 ( 2022-11-01), p. 1537-1544
    Details
    In: The Journal of Infectious Diseases, Oxford University Press (OUP), Vol. 226, No. 9 ( 2022-11-01), p. 1537-1544
    Abstract: Rotarix (GlaxoSmithKline) oral rotavirus vaccine is licensed as 2 doses in the first 6 months of life. In settings with high child mortality rates, clinical protection conferred by 2 doses of Rotarix is reduced. We assessed vaccine immune response when an additional dose of Rotarix was given to Australian Aboriginal children 6 to  & lt;12 months old. Methods ORVAC is a 2-stage, double-blind, randomized, placebo-controlled trial. Australian Aboriginal children 6 to  & lt;12 months old who had received 1 or 2 prior doses of Rotarix rotavirus vaccine were randomized 1:1 to receive an additional dose of Rotarix or matched placebo. The primary immunological end point was seroresponse defined as an anti-rotavirus immunoglobulin A level ≥20 AU/mL, 28–56 days after the additional dose of Rotarix or placebo. Results Between March 2018 and August 2020, a total of 253 infants were enrolled. Of these, 178 infants (70%) had analyzable serological results after follow-up; 89 were randomized to receive Rotarix, and 89 to receive placebo. The proportion with seroresponse was 85% after Rotarix compared with 72% after placebo. There were no occurrences of intussusception or any serious adverse events. Conclusions An additional dose of Rotarix administered to Australian Aboriginal infants 6 to  & lt;12 months old increased the proportion with a vaccine seroresponse. Clinical Trials Registration NCT02941107.
    Type of Medium: Online Resource
    ISSN: 0022-1899 , 1537-6613
    URL: Article
    DOI: 10.1093/infdis/jiac038
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 1473843-0
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  • 7
    Online Resource
    Online Resource
    Development of a core outcome set for cutaneous squamous cell carcinoma trials: identification of core domains and outcomes*
    Oxford University Press (OUP) ; 2021
    In:  British Journal of Dermatology Vol. 184, No. 6 ( 2021-06), p. 1113-1122
    Details
    In: British Journal of Dermatology, Oxford University Press (OUP), Vol. 184, No. 6 ( 2021-06), p. 1113-1122
    Type of Medium: Online Resource
    ISSN: 0007-0963 , 1365-2133
    URL: Issue
    URL: Article
    DOI: 10.1111/bjd.v184.6
    DOI: 10.1111/bjd.19693
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2004086-6
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  • 8
    Online Resource
    Online Resource
    Updated Living Systematic Review and Meta-analysis of Controlled Trials of Mesenchymal Stromal Cells to Treat COVID-19: A Framework for Accelerated Synthesis of Trial Evidence for Rapid Approval—FASTER Approval
    Oxford University Press (OUP) ; 2022
    In:  Stem Cells Translational Medicine Vol. 11, No. 7 ( 2022-07-20), p. 675-687
    Details
    In: Stem Cells Translational Medicine, Oxford University Press (OUP), Vol. 11, No. 7 ( 2022-07-20), p. 675-687
    Abstract: Mesenchymal stromal cells (MSCs) may reduce mortality in patients with COVID-19; however, early evidence is based on few studies with marked interstudy heterogeneity. The second iteration of our living systematic review and meta-analysis evaluates a framework needed for synthesizing evidence from high-quality studies to accelerate consideration for approval. Methods A systematic search of the literature was conducted on November 15, 2021, to identify all English-language, full-text, and controlled clinical studies examining MSCs to treat COVID-19 (PROSPERO: CRD42021225431). Findings Eleven studies were identified (403 patients with severe and/or critical COVID-19, including 207 given MSCs and 196 controls). All 11 studies reported mortality and were pooled through random-effects meta-analysis. MSCs decreased relative risk of death at study endpoint (RR: 0.50 [95% CI, 0.34-0.75]) and RR of death at 28 days after treatment (0.19 [95% CI] , 0.05-0.78) compared to controls. MSCs also decreased length of hospital stay (mean difference (MD: −3.97 days [95% CI, −6.09 to −1.85], n = 5 studies) and increased oxygenation levels at study endpoint compared to controls (MD: 105.62 mmHg O2 [95% CI, 73.9-137.3,] , n = 3 studies). Only 2 of 11 studies reported on all International Society for Cellular Therapy (ISCT) criteria for MSC characterization. Included randomized controlled trials were found to have some concerns (n = 2) to low (n = 4) risk of bias (RoB), while all non-randomized studies were found to have moderate (n = 5) RoB. Interpretation Our updated living systematic review concludes that MSCs can likely reduce mortality in patients with severe or critical COVID-19. A master protocol based on our Faster Approval framework appears necessary to facilitate the more accelerated accumulation of high-quality evidence that would reduce RoB, improve consistency in product characterization, and standardize outcome reporting.
    Type of Medium: Online Resource
    ISSN: 2157-6564 , 2157-6580
    URL: Article
    DOI: 10.1093/stcltm/szac038
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2642270-0
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  • 9
    Online Resource
    Online Resource
    A Higher Antibody Response Is Generated With a 6- to 7-Week (vs Standard) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine Dosing Interval
    Oxford University Press (OUP) ; 2022
    In:  Clinical Infectious Diseases Vol. 75, No. 1 ( 2022-08-24), p. e888-e891
    Details
    In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 75, No. 1 ( 2022-08-24), p. e888-e891
    Abstract: The optimal dosing interval for severe acute respiratory syndrome coronavirus 2 vaccines remains controversial. In this prospective study, we compared serology results of paramedics vaccinated with mRNA vaccines at the recommended short (17–28 days) vs long (42–49 days) interval. We found that a long dosing interval resulted in higher spike, receptor binding domain, and spike N terminal domain antibody concentrations.
    Type of Medium: Online Resource
    ISSN: 1058-4838 , 1537-6591
    URL: Article
    DOI: 10.1093/cid/ciab938
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2002229-3
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  • 10
    Online Resource
    Online Resource
    1174 The Reporting of Centre and Surgeon Experience in Studies of Robot Assisted Cholecystectomy: A Systematic Review
    Oxford University Press (OUP) ; 2021
    In:  British Journal of Surgery Vol. 108, No. Supplement_6 ( 2021-10-11)
    Details
    In: British Journal of Surgery, Oxford University Press (OUP), Vol. 108, No. Supplement_6 ( 2021-10-11)
    Abstract: Over 90% of cholecystectomies are performed using minimally invasive techniques. Robotic cholecystectomy (RC) has been developed to overcome technical limitations of laparoscopy, including improved range of movement and visualisation. Despite becoming increasingly widespread, the safety and efficacy of RC remain unestablished. This review aims to analyse the quality assurance reporting through centre and surgeon expertise in RC. Method A systematic search was conducted to identify all published studies reporting RC. Data on quality assurance measures were collected, including: centres involved, surgeons’ experience and training. Results Of the 1425 abstracts screened, 90 full-text papers were included. Sixty-four studies (71%) were single institutions. Of the thirty studies (33%) reporting centre type, 28 were conducted in specialist/regional/tertiary centres. Only four stated their caseload of RC. No studies described pre-specified criteria or minimum experience required for a surgeon to participate. Fifty-two (58%) reported the number of surgeons operating and 13 (14%) stated surgeons’ training grade. Two quantified previous RC experience, 7 stated prior laparoscopic experience. Only 21 (23%) described training prior to the surgeons’ first in-human procedure; animal based (n = 12), simulation (n = 12), observation (n = 4), lab-based (n = 3). Specific mentorship was reported in 8 studies, and 13 described dual operating. Conclusions Little information was provided about the experience and training of operating surgeons, making it difficult to ascertain whether replicable techniques were utilised which would allow development of a learning curve. This highlights the need for better transparency when reporting surgical innovation, to ensure the safe, evidence-based adoption of new technologies into clinical practice.
    Type of Medium: Online Resource
    ISSN: 0007-1323 , 1365-2168
    URL: Article
    DOI: 10.1093/bjs/znab259.811
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2006309-X
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