6 research outputs found

    Health practitioners' readiness to address domestic violence and abuse:A qualitative meta-synthesis

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    Health practitioners play an important role in identifying and responding to domestic violence and abuse (DVA). Despite a large amount of evidence about barriers and facilitators influencing health practitioners' care of survivors of DVA, evidence about their readiness to address DVA has not been synthesised. This article reports a meta-synthesis of qualitative studies exploring the research question: What do health practitioners perceive enhances their readiness to address domestic violence and abuse? Multiple data bases were searched in June 2018. Inclusion criteria included: qualitative design; population of health practitioners in clinical settings; and a focus on intimate partner violence. Two reviewers independently screened articles and findings from included papers were synthesised according to the method of thematic synthesis. Forty-seven articles were included in the final sample, spanning 41 individual studies, four systematic reviews and two theses between the years of 1992 and 2018; mostly from high income countries. Five themes were identified as enhancing readiness of health practitioners to address DVA: Having a commitment; Adopting an advocacy approach; Trusting the relationship; Collaborating with a team; and Being supported by the health system. We then propose a health practitioners' readiness framework called the CATCH Model (Commitment, Advocacy, Trust, Collaboration, Health system support). Applying this model to health practitioners' different readiness for change (using Stage of Change framework) allows us to tailor facilitating strategies in the health setting to enable greater readiness to deal with intimate partner abuse

    Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: A retrospective cohort study.

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    PURPOSE: Real-World Data (RWD) studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice for novel cancer drugs. However, few studies have systematically appraised their quality or compared outcomes to pivotal trials. METHODS: All RWD studies (2010-2019) for drugs approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) from 2010 to 2015 for solid organ tumours in the non-curative setting were identified. Quality assessment was undertaken using the Newcastle Ottawa Scale. Survival differences between each RWD study and the pivotal trial were determined using a related sample Wilcoxon signed-rank test. RESULTS: 293 RWD studies for 45 of the 57 drug indications approved by the FDA/EMA were identified. The most common tumour types were prostate cancer (29%, n = 86) and melanoma (15%, n = 43). A quarter of the studies had industry funding. No high-quality studies were identified, and 78% were low quality. Comparative survival analysis between RWD and pivotal trials was possible for 224 studies (37 drug indications). Differences in median survival between the RWD studies and their corresponding trial ranged from -32 months to 21 months (IQR -4·2 months to 1·6 months). Low-quality studies were more likely to report superior survival outcomes (23%) compared to higher quality studies (8%) (p = 0.02). CONCLUSION: RWD study quality for novel cancer drugs is low and of insufficient rigour to inform reimbursement decisions and clinical practice. RWD studies seeking publication should provide a completed quality assessment tool on submission. Greater investment in properly designed RWD studies is required

    Personal barriers to addressing intimate partner abuse: a qualitative meta-synthesis of healthcare practitioners’ experiences

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    Background: Healthcare practitioners (HCPs) play a crucial role in recognising, responding to, and supporting female patients experiencing intimate partner abuse (IPA). However, research consistently identifies barriers they perceive prevent them from doing this work effectively. These barriers can be system-based (e.g. lack of time or training) or personal/individual. This review of qualitative evidence aims to synthesise the personal barriers that impact HCPs’ responses to IPA. Methods: Five databases were searched in March 2020. Studies needed to utilise qualitative methods for both data collection and analysis and be published between 2010 and 2020 in order to qualify for inclusion; however, we considered any type of healthcare setting in any country. Article screening, data extraction and methodological appraisal using a modified version of the Critical Appraisal Skills Program checklist for qualitative studies were undertaken by at least two independent reviewers. Data analysis drew on Thomas and Harden’s thematic synthesis approach. Results: Twenty-nine studies conducted in 20 countries informed the final review. A variety of HCPs and settings were represented. Three themes were developed that describe the personal barriers experienced by HCPs: I can’t interfere (which describes the belief that IPA is a “private matter” and HCPs’ fears of causing harm by intervening); I don’t have control (highlighting HCPs’ frustration when women do not follow their advice); and I won’t take responsibility (which illuminates beliefs that addressing IPA should be someone else’s job). Conclusion: This review highlights the need for training to address personal issues in addition to structural or organisational barriers. Education and training for HCPs needs to: encourage reflection on their own values to reinforce their commitment to addressing IPA; teach HCPs to relinquish the need to control outcomes so that they can adopt an advocacy approach; and support HCPs’ trust in the critical role they can play in responding. Future research should explore effective ways to do this within the context of complex healthcare organisations

    Safety and Treatment Outcomes of Nivolumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Retrospective Multicenter Cohort Study.

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    Nivolumab is an anti-PD-1 monoclonal antibody currently used as immunotherapy for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) with evidence of disease progression after platinum-based chemotherapy. This study evaluates real-world safety and treatment outcomes of non-trial nivolumab use. A retrospective multicenter cohort study of patients with recurrent/metastatic HNSCC treated with nivolumab between January 2017 and March 2020 was performed. Overall, 123 patients were included. The median age was 64 years, the majority of patients were male (80.5%) and had a smoking history (69.9%). Primary outcomes included overall response rate (ORR) of 19.3%, median progression-free survival (PFS) of 3.9 months, 1-year PFS rate of 16.8%, a median overall survival (OS) of 6.5 months and 1-year OS rate of 28.6%. These results are comparable to the CHECKMATE-141 study. Of 27 patients who had PD-L1 status tested, positive PD-L1 status did not significantly affect PFS ( = 0.86) or OS ( = 0.84). Nivolumab was well tolerated with only 15.1% experiencing immune-related toxicities (IRT) and only 6.7% of patients stopping due to toxicity. The occurrence of IRT appeared to significantly affect PFS ( = 0.01) but not OS ( = 0.07). Nivolumab in recurrent/metastatic HNSCC is well tolerated and may be more efficacious in patients who develop IRT

    Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial

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    Background: Respiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity. Methods: PRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545. Findings: Between Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8\ub71%) of 2396 patients in the CPAP group and 197 (8\ub72%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1\ub701 [95% CI 0\ub781-1\ub724]; p=0\ub795). 200 (8\ub79%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3\ub75%] of 2241 patients), oronasal dryness (43 [1\ub79%]), excessive air leak (36 [1\ub76%]), vomiting (26 [1\ub72%]), and pain (24 [1\ub71%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability. Interpretation: In this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended

    Students' participation in collaborative research should be recognised

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    Letter to the editor
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