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Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.
This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.
This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.
To evaluate midwives' level of stress and burnout during the COVID-19 Omicron phase in Italy. Secondary aims were to explore the impact of the pandemic on midwives' personal dimensions and professional activities and potential supporting strategies.
A mixed-methods study was undertaken from July to December 2022.
Data were collected using a national online observational survey. Descriptive and inferential analyses were performed to evaluate stress, burnout and the impact of the pandemic on personal and professional dimensions. A deductive qualitative approach was used to analyse open-ended responses, that were merged with quantitative data following a convergent mixed-methods approach.
A total of 1944 midwives participated in the survey. The stress summary score mean was 10.34, and 562 midwives (28.91%) experienced burnout. The intention to reduce working hours was reported by 202 midwives (10.39%), with 60.40% (n = 122) of them experiencing burnout. The intention to leave clinical practice within the following 2 years was reported by 239 (12.29%), with 68.20% (n = 163) of them experiencing burnout. All the personal dimensions and professional activities considered were defined by more than half of midwives as being impacted ‘Moderately’ or ‘To a great extent’ by pandemic. Stress and burnout frequencies increased when the midwives' perception of the pandemic effects was higher. Potential supporting strategies described by midwives as the most important in increasing their ability to cope with the pandemic were ‘Women's awareness of the midwives' role’ (n = 1072; 55.14%) and ‘Family and friends' emotional support’ (n = 746; 38.38%).
Our findings suggested strategies to support a positive and safe working environment for midwives during a pandemic emergency, with potential transferability to similar contexts when human resources are lacking. It is recommended that maternity services provide the necessary resources for a safe and supportive working environment to prevent high stress levels and chronic burnout.
Studies conducted during the first COVID-19 pandemic wave showed an increased level of stress, anxiety, burnout, post-traumatic stress disorder and depression experienced by healthcare professionals; moreover, midwives experienced drastic changes in care pathways and policies with struggles identified when providing high-quality woman-centred care following pandemic restrictions. Although it is recommended, there is lack of knowledge about long-term psychological effects of COVID-19 for midwives. Our study highlights that during the Omicron wave midwives experienced a high level of stress and burnout with an impact on individual dimensions and professional activities. Their stress and burnout were influenced by several factors, including restrictions in place, lack of organizational acknowledgement, work overload and need for extra childcare cover. Maternity services should provide the necessary resources for a safe and supportive working environment to prevent high stress levels and chronic burnout. Recommendations on how to facilitate this are suggested.
During the writing process, we referred to ‘The Strengthening the Reporting of Observational Studies Epidemiology Statement’, the guidelines for reporting observational studies from the Equator network.
No patient or public contribution.
Work overload conditions negatively impacted on the quality of maternity services. Improving organizational aspects, reducing working hours, promoting family and friends' emotional support and improving women's awareness of midwife's role were the main strategies reported by midwives. These suggestions for ensuring a positive and safe working environment for midwives during a pandemic emergency could potentially be applied to similar situations where human resources are lacking.
Head and neck cancer is the eighth most common cancer in the UK. Current standard of care treatment for patients with recurrent/metastatic squamous cell head and neck carcinoma (HNSCC) is platinum-based chemotherapy combined with the anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, cetuximab. However, most patients will have poor median overall survival (OS) of 6–9 months despite treatment. HNSCC tumours exhibit an immune landscape poised to respond to immunotherapeutic approaches, with most tumours expressing the immunosuppressive receptor programmed death-ligand 1 (PD-L1). We undertook the current study to determine the safety and efficacy of avelumab, a monoclonal antibody targeting the interaction between PD-L1 and its receptor on cytotoxic T-cells, in combination with cetuximab.
This is a multi-centre, single-arm dose de-escalation phase II safety and efficacy study of avelumab combined with cetuximab; the study was to progress to a randomised phase II trial, however, the study will now complete after the safety run-in component. Up to 16 participants with histologically/cytologically recurrent/metastatic squamous cell carcinoma (including HNSCC) who have not received cetuximab previously will be recruited. All patients will receive 10 mg/kg avelumab and cetuximab (500, 400 or 300 mg/m2 depending on the cohort open at time of registration) on days 1 and 15 of 4-week cycles for up to 1 year, (avelumab not given cycle 1 day 1). A modified continual reassessment method will be used to determine dose de-escalation. The primary objective is to establish the safety of the combination and to determine the optimum dose of cetuximab. Secondary objectives include assessing evidence of antitumour activity by evaluating response rates and disease control rates at 6 and 12 months as well as progression-free and OS.
Approval granted by City and East REC (18/LO/0021). Findings will be published in peer-reviewed journals and disseminated at conferences.
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