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  1. Article ; Online: A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT.

    Daniels, Jane / Dixon, Emily F / Gill, Alicia / Bishop, Jon / D'Amico, Maria / Ahmed, Khaled / Dodds, Julie / Tryposkiadis, Kostas / Wilks, Mark / Millar, Michael / Husain, Shahid / Gray, Jim / Whiley, Angela / Moore, Patrick V / Munetsi, Ruvimbo L / Hemming, Karla / Roberts, Tracy / Plumb, Jane / Deeks, Jonathan /
    Khan, Khalid S / Thangaratinam, Shakila

    Health technology assessment (Winchester, England)

    2022  Volume 26, Issue 12, Page(s) 1–82

    Abstract: Background: Mother-to-baby transmission of group B : Objectives: We investigated if intrapartum antibiotic prophylaxis directed by a rapid intrapartum test reduces maternal and neonatal antibiotic use, compared with usual care (i.e. risk factor- ... ...

    Abstract Background: Mother-to-baby transmission of group B
    Objectives: We investigated if intrapartum antibiotic prophylaxis directed by a rapid intrapartum test reduces maternal and neonatal antibiotic use, compared with usual care (i.e. risk factor-directed antibiotics), among women with risk factors for vertical group B
    Design: An unblinded cluster randomised controlled trial with a nested test accuracy study, an economic evaluation and a microbiology substudy.
    Setting: UK maternity units were randomised to either a strategy of rapid test or usual care.
    Participants: Vaginal and rectal swabs were taken from women with risk factors for vertical group B
    Main outcome measures: Primary outcomes were rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B
    Results: Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units and 906 mothers (951 babies) participated in usual-care units. There were no differences in the rates of intrapartum antibiotic prophylaxis for preventing early-onset group B
    Conclusions: The Group B Streptococcus 2 (GBS2) trial found no evidence that the rapid test reduces the rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B
    Future work: The role of routine testing for prevention of neonatal infection requires evaluation in a randomised controlled trial.
    Trial registration: Current Controlled Trials ISRCTN74746075.
    Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
    MeSH term(s) Anti-Bacterial Agents/therapeutic use ; Antibiotic Prophylaxis ; Cost-Benefit Analysis ; Female ; Humans ; Infant, Newborn ; Mothers ; Pregnancy ; Streptococcal Infections/diagnosis ; Streptococcal Infections/drug therapy ; Streptococcal Infections/prevention & control ; Streptococcus agalactiae
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2022-02-23
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2006765-3
    ISSN 2046-4924 ; 1366-5278
    ISSN (online) 2046-4924
    ISSN 1366-5278
    DOI 10.3310/BICF1187
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC): a pilot study to assess feasibility of a large multicentre trial.

    Yeung, Joyce / Middleton, Lee / Tryposkiadis, Kostas / Kerr, Amy / Daniels, Jane / Naidu, Babu / Melody, Teresa / Goebel, Andreas / Wilson, Matthew / Kumar, Sajith / Szentgyorgyi, Lajos / Flanagan, Sarah / Shah, Rajesh / Worrall, Antony / Gao, Fang

    BMJ open

    2019  Volume 9, Issue 7, Page(s) e023679

    Abstract: Objectives: Thoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. ... ...

    Abstract Objectives: Thoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. The specific objective of this pilot study was to assess the feasibility of conducting a larger trial to determine whether PVB at thoracotomy is more effective in reducing CPTP compared with TEB.
    Design: A randomised, parallel, external pilot study was conducted to assess whether a large randomised trial of TEB and PVB with CPTP as the primary outcome is feasible.
    Setting: Two adult thoracic centres in the UK.
    Participants: All adult patients admitted for elective open thoracotomy. Participants were excluded if they were American Society of Anesthesiologists physical status IV or V; or if there is contraindication to local anaesthetics; infection near the proposed puncture site; coagulation/thoracic spine disorders; required chest wall resection or emergency thoracic surgery or had a previous thoracotomy.
    Results: All patients presenting for thoracotomy were screened over a 12-month period with 194 found to be eligible. Of these, 69 (36%) were randomised (95% CI 29% to 42%). Discounting five participants who died, 54 of 64 participants (84%) returned questionnaire booklets at 6 months. The number of participants indicating at least a moderate level of chest pain at 6 months was lower with PVB but with high levels of uncertainty (RR: 0.7; 95% CI 0.3 to 1.7 for worst pain; RR: 0.3; 95% CI 0.0 to 2.8 for average pain). There were no safety concerns.
    Conclusions: A large, multicentre randomised controlled trial of PVB versus TEB is feasible as it is possible to randomise and follow up participants with high fidelity. Pain scores were lower on average with PVB compared with TEB but a much larger trial is required to confirm this reliably.
    Trial registration number: ISRCTN45041624.
    MeSH term(s) Adult ; Aged ; Analgesia, Epidural/methods ; Chronic Pain/therapy ; Feasibility Studies ; Female ; Humans ; Lung Neoplasms/surgery ; Male ; Middle Aged ; Nerve Block/methods ; Pain Measurement ; Pain, Postoperative/therapy ; Pilot Projects ; Thoracic Vertebrae ; Thoracotomy/adverse effects ; Treatment Outcome
    Language English
    Publishing date 2019-07-09
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2018-023679
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Randomised controlled pilot study to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: TOPIC feasibility study protocol.

    Yeung, Joyce / Melody, Teresa / Kerr, Amy / Naidu, Babu / Middleton, Lee / Tryposkiadis, Kostas / Daniels, Jane / Gao, Fang

    BMJ open

    2016  Volume 6, Issue 12, Page(s) e012735

    Abstract: Introduction: Open chest surgery (thoracotomy) is considered the most painful of surgical procedures. Forceful wound retraction, costochondral dislocation, posterior costovertebral ligament disruption, intercostal nerve trauma and wound movement during ... ...

    Abstract Introduction: Open chest surgery (thoracotomy) is considered the most painful of surgical procedures. Forceful wound retraction, costochondral dislocation, posterior costovertebral ligament disruption, intercostal nerve trauma and wound movement during respiration combine to produce an acute, severe postoperative pain insult and persistent chronic pain many months after surgery is common. Three recent systematic reviews conclude that unilateral continuous paravertebral blockade (PVB) provides analgesia at least equivalent to thoracic epidural blockade (TEB) in the postoperative period, has a lower failure rate, and symptom relief that lasted months. Crucially, PVB may reduce the development of subsequent chronic pain by intercostal nerve protection or decreased nociceptive input. The overall aim is to determine in patients who undergo thoracotomy whether perioperative PVB results in reducing chronic post-thoracotomy pain (CPTP) compared with TEB. This pilot study will evaluate feasibility of a substantive trial.
    Methods and analysis: TOPIC is a randomised controlled trial comparing the effectiveness of TEB and PVB in reducing CPTP. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 2 adult thoracic centres, Heart of England NHS Foundation Trust (HEFT) and University Hospital of South Manchester NHS Foundation Trust (UHSM). The primary objective is to establish the number of patients randomised as a proportion of those eligible. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will primarily take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.
    Ethics and dissemination: The study has obtained ethical approval from NHS Research Ethics Committee (REC number 14/EM/1280). Dissemination plan includes: informing patients and health professionals; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full HTA application dependent on the success of the study.
    Trial registration number: ISRCTN45041624; Pre-results.
    MeSH term(s) Analgesia, Epidural ; Chronic Pain/drug therapy ; Feasibility Studies ; Humans ; Nerve Block ; Pain, Postoperative/drug therapy ; Pilot Projects ; Research Design ; Single-Blind Method ; Thoracic Vertebrae ; Thoracotomy/adverse effects
    Language English
    Publishing date 2016-12-01
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2016-012735
    Database MEDical Literature Analysis and Retrieval System OnLINE

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