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Παρασκευή 27 Νοεμβρίου 2020

Experiences of Venous Leg Ulcer persons following an individualised nurse-led education: protocol for a qualitative study using a constructivist grounded theory approach

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Introduction

Venous leg ulcers are slow-healing wounds with a high risk of recurrences. To prevent recurrences and promote healing, different nurse-led educational interventions have been developed. The impact of these interventions on self-management is ambiguous. Also, how persons with a venous leg ulcer experiences these educational sessions are poorly described.

Aim

This study protocol presents the methodology to provide a comprehensive explanation of participants' journeys—of how they experience their individualised education sessions concerning self-management.

Methods and analysis

A constructivist grounded theory approach according to Charmaz involving 30 participants will be used. Data will be collected through semistructured face-to-face interviews. Interviews will be transcribed verbatim and analysed with initial and focus coding using MAXQDA. Data collection and data analysis will occur iteratively, focusing on constant comparison to obtain well-developed categories. Categories will be reinforced using existent literature.

Ethics and dissemination

This pre-results study is embedded in a clinical trial (NCT04019340) and approved by ethical committee of the canton of Geneva (CCER: 2019-01964). A theory will emerge from participants' journeys informing future education sessions for patients with venous leg ulcers. The findings will be disseminated through peer-reviewed publications and communications.

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Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in de novo stage IV breast cancer patients: study protocol of the i-GO study

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Introduction

In breast cancer, local tumour control is thought to be optimised by administering higher local levels of cytotoxic chemotherapy, in particular doxorubicin. However, systemic administration of higher dosages of doxorubicin is hampered by its toxic side effects. In this study, we aim to increase doxorubicin deposition in the primary breast tumour without changing systemic doxorubicin concentration and thus without interfering with systemic efficacy and toxicity. This is to be achieved by combining Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox, Celsion Corporation, Lawrenceville, NJ, USA) with mild local hyperthermia, induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). When heated above 39.5°C, LTLD releases a high concentration of doxorubicin intravascularly within seconds. In the absence of hyperthermia, LTLD leads to a similar biodistribution and antitumour efficacy compared with conventional doxorubicin.

Methods and analysis

This is a single-arm phase I study in 12 chemotherapy-naïve patients with de novo stage IV HER2-negative breast cancer. Previous endocrine treatment is allowed. Study treatment consists of up to six cycles of LTLD at 21-day intervals, administered during MR-HIFU-induced hyperthermia to the primary tumour. We will aim for 60 min of hyperthermia at 40°C–42°C using a dedicated MR-HIFU breast system (Profound Medical, Mississauga, Canada). Afterwards, intravenous cyclophosphamide will be administered. Primary endpoints are safety, tolerability and feasibility. The secondary endpoint is efficacy, assessed by radiological response.

This approach could lead to optimal loco-regional control with less extensive or even no surgery, in de novo stage IV patients and in stage II/III patients allocated to receive neoadjuvant chemotherapy.

Ethics and dissemination

This study has obtained ethical approval by the Medical Research Ethics Committee Utrecht (Protocol NL67422.041.18, METC number 18-702). Informed consent will be obtained from all patients before study participation. Results will be published in an academic peer-reviewed journal.

Trial registration numbers

NCT03749850, EudraCT 2015-005582-23.

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Open-label, single-centre, cluster-randomised controlled trial to Evaluate the Potential Impact of Computerisedantimicrobial stewardship (EPIC) on the antimicrobial use after cardiovascular surgeries: EPIC trial study original protocol

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Introduction

Inappropriate antimicrobial use increases the prevalence of antimicrobial-resistant bacteria. Surgeons are reluctant to implement recommendations of guidelines in clinical practice. Antimicrobial stewardship (AMS) is effective in antimicrobial management, but it remains labour intensive. The computerised decision support system (CDSS) has been identified as an effective way to enable key elements of AMS in clinical settings. However, insufficient evidence is available to evaluate the efficacy of computerised AMS in surgical settings.

Methods and analysis

The Evaluate of the Potential Impact of Computerised AMS trial is an open-label, single-centre, two-arm, cluster-randomised, controlled trial, which aims to determine whether a multicomponent CDSS intervention reduces overall antimicrobial use after cardiovascular surgeries compared with usual clinical care in a specialty hospital with a big volume of cardiovascular surgeries. Eighteen cardiovascular surgical teams will be randomised 1:1 to either the intervention or the control arm. The intervention will consist of (1) re-evaluation alerts and decision support for the duration of antimicrobial treatment decision, (2) re-evaluation alerts and decision support for the choice of antimicrobial, (3) quality control audit and feedback. The primary outcome will be the overall systemic antimicrobial use measured in days of therapy (DOT) per admission and DOT per 1000 patient-days over the whole intervention period (6 months). Secondary outcomes include a series of indices to evaluate ant imicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption, and user compliance and satisfaction.

Ethics and dissemination

The Ethics Committee in Fuwai Hospital approved this study (2020-1329). The results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT04328090.

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Associations between multimorbidity and glycaemia (HbA1c) in people with type 2 diabetes: cross-sectional study in Australian general practice

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Objectives

To explore the prevalence of multimorbidity as well as individual and combinations of long-term conditions (LTCs) in people with type 2 diabetes (T2D) attending Australian general practice, using electronic health record (EHR) data. We also examine the association between multimorbidity condition count (total/concordant(T2D related)/discordant(unrelated)) and glycaemia (glycated haemoglobin, HbA1c).

Design

Cross-sectional study.

Setting

Australian general practice.

Participants

69 718 people with T2D with a general practice encounter between 2013 and 2015 captured in the MedicineInsight database (EHR Data from 557 general practices and >3.8 million Australian patients).

Primary and secondary outcome measures

Prevalence of multimorbidity, individual and combinations of LTCs. Multivariable linear regression models used to examine associations between multimorbidity counts and HbA1c (%).

Results

Mean (SD) age 66.42 (12.70) years, 46.1% female and mean (SD) HbA1c 7.1 (1.4)%. More than 90% of participants with T2D were living with multimorbidity. Discordant conditions were more prevalent (83.4%) than concordant conditions (69.9 %). The three most prevalent discordant conditions were: painful conditions (55.4%), dyspepsia (31.6%) and depression (22.8%). The three most prevalent concordant conditions were hypertension (61.4%), coronary heart disease (17.1%) and chronic kidney disease (8.5%). The three most common combinations of conditions were: painful conditions and hypertension (38.8%), painful conditions and dyspepsia (23.1%) and hypertension and dyspepsia (22.7%). We found no associations between any multimorbidity counts (total, concordant and discordant) or combinations and HbA1c.

Conclusions

Multimorbidity was common in our cohort of people with T2D attending Australian general practice, but was not associated with glycaemia. Although we did not explore mortality in this study, our results suggest that the increased mortality in those with multimorbidity and T2D observed in other studies may not be linked to glycaemia. Interestingly, discordant conditions were more prevalent than concordant conditions with painful conditions being the second most common comorbidity. Better understanding of the implications of different patterns of multimorbidity in people with T2D will allow more effective tailored care.

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Estimation of minimally important difference of the EQ-5D-5L utility scores among patients with either hypertension or diabetes or both: a cross-sectional study in Hong Kong

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Objective

To estimate and report the minimally important difference (MID) of the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L) using the Hong Kong (HK) utility score among patients with either hypertension or diabetes or both.

Design

Data were analysed using secondary data analysis based on a cross-sectional study assessing patients' experiences in HK.

Setting

A representative sample was recruited from 26 specialist outpatient clinics in HK.

Participants

We analysed data from 2231 and 662 patients who reported having hypertension or diabetes alone, respectively, and 874 patients had these two diseases.

Intervention

An instrument-defined approach was applied to estimate MID stratified according to sex and age for the three subpopulations.

Results

The overall MID (oMID) estimates were 0.089, 0.086 and 0.089 for patients with hypertension or diabetes alone and with these two diseases, respectively. The adjusted MID (aMID) estimate was smaller than the oMID, and the improved MID was larger than the deteriorated MID. Women had larger oMID but smaller aMID than men. Younger respondents had larger aMID than older respondents. Effect sizes ranged from 0.30 to 0.503, which fit our preset criteria.

Conclusion

Four types of MID of the EQ-5D utility score for patients with hypertension or diabetes alone and with these two diseases were reported. Variations in the MID estimates should be further explored in other populations or using different statistical methods.

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Systematic Review of Hemostatic Agents used in Vascular Surgery

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Hemostatic agents are routinely used in vascular surgery to complement proper suture techniques and decrease the risk of peri-operative bleeding. A relative lack of comparative research studies leave surgeons with the option of choosing hemostatic agents based on their personal experience. This review highlights the efficacy and safety of hemostatic agents and categorizes them according to their primary mechanism of action and cost.
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Fenestrated versus debranching TEVAR for endovascular treatment of distal aortic arch and descending aortic lesions

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Cervical debranching followed by thoracic endovascular aortic repair (TEVAR) is well-established for treating aortic arch lesions, but total endovascular repair with fenestrated endografts has not been adequately studied. This is a comparison of the two techniques.
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A systematic review and meta-analysis of combined carotid endarterectomy with ipsilateral proximal intervention (the hybrid approach) for tandem carotid artery lesions

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The safety and effectiveness of using the hybrid approach to treat tandem carotid lesions is controversial, and the clinical significance of technical variants on perioperative outcomes has not been evaluated. This meta-analysis was performed to evaluate the technique, safety, effectiveness and long-term outcomes of the hybrid approach.
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Patients aged >=65 years dispositions during ambulance assignments, including factors associated with non-conveyance to hospital: a longitudinal and comparative study

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Objectives

Patients ≥65 years old represent 30%–50% of all ambulance assignments (AAs), and the knowledge of which care level they are disposed to is limited and diverging. The aim of this study was therefore to describe and compare characteristics of patients' aged ≥65 years dispositions during AA, including determining changes over time and factors associated with non-conveyance to hospitals.

Design

A longitudinal and comparative database study.

Setting

Ambulance service in a Swedish region.

Participants

32 085 AAs with patients ≥65 years old during the years 2014, 2016 and 2018. Exclusion criteria: AAs with interhospital patient transfers and lack of patients' dispositions data.

Outcome measures

Dependent factors: conveyance and non-conveyance to hospitals. Independent factors: age, sex, symptom, triage level, scene, time, day and season.

Results

The majority (n=29 060; 90.6%) of patients' dispositions during AA were conveyance to hospitals. In total, the most common symptoms were circulatory (n=4953; 15.5%) and respiratory (n=4529; 14.1%). A significant increase, p<0.01, of non-conveyance to hospitals was shown during 2014 and 2018, from 801 (7.8%) to 1295 (11.4%). Increasing age was associated with decreasing odds of non-conveyance, 85–89 years (OR=0.85, 95 % CI=0.72 to 0.99) and 90 years or older (OR=0.80, 95 % CI=0.68 to 0.93). Several factors were associated with non-conveyance, for example, symptoms of diabetes (OR=8.57, 95 % CI=5.99 to 12.26) and mental disorders (OR=5.71, 95 % CI=3.85 to 8.48) in comparison with infections.

Conclusions

The study demonstrates several patient characteristics, and factors associated with non-conveyance to hospitals, such as age, symptom, triage level, scene, time, day and season. The increasing non-conveyance trend highlights the importance of further studies on optimal care levels for patients ≥65 years old.

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