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Πέμπτη 5 Νοεμβρίου 2020

Treatment patterns and medication adherence among newly diagnosed patients with migraine: a drug utilisation study

Alexandros G.Sfakianakis shared this article with you from Inoreader
Objectives

Prophylactic drugs currently used for migraine treatment are not specific. Furthermore, few studies in existing literature describe drugs utilisation patterns and adherence to migraine prophylactic treatment. This study is aimed to describe utilisation patterns of migraine drugs, evaluate adherence to prophylactic medications and investigate drug-related costs.

Design

Retrospective population-based study using an administrative health-related database.

Setting

Primary care setting in the Campania region, Southern Italy.

Participants

This study was carried out between 1 January 2016 and 31 December 2018, involving 12 894 subjects with any primary or secondary hospital discharge with migraine diagnosis, or at least two medical dispensations of migraine-specific acute or prophylactic medications (triptans or pizotifen). Subjects were classified into four treatment cohorts: no treatment, acute, prophylactic and both acute and prophylactic. Subjects were followed-up for 1 year.

Outcome measures

Utilisation patterns of migraine drugs at treatment initiation; adherence to prophylactic treatment; discontinuation, restart and switching rates; annual migraine drug costs per patient.

Results

Overall, 81.1% of subjects received acute treatment as their initial migraine treatment regimen, 10.7% prophylactic treatment, 8.2% both acute and prophylactic treatment. 599 patients were treated prophylactically; of these, 26.2% adhered to their initial treatment while 73.8% reported interruptions in treatment. Among the latter, 46.4% of patients discontinued the treatment completely within 103 days (IQR 89.0), 31% restarted treatment 46 days after interruption (IQR 60.0) and 22.6% switched to another treatment within 98 days (IQR 57.5) (p<0.001). The median annual cost of drugs per patient was 103 for those treated acutely, 75 for those treated prophylactically, 163 for those treated both.

Conclusions

Migraine treatment with acute medications is still prevalent in Italy; only few patients received prophylactic treatment with poor adherence to treatment. These findings reflect an unmet need for improved prophylactic therapies in order to provide a better disease management.

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Effects of exergames training on postural balance in patients who had a chronic stroke: study protocol for a randomised controlled trial

Alexandros G.Sfakianakis shared this article with you from Inoreader
Introduction

Exergames training, as an additional therapy to standard care, has been widely used for motor recovery after patients who had a stroke, and it is a valuable and positive tool in the rehabilitation of this population. This study describes a single-blind randomised clinical trial that will aim to investigate the effects of exergames training on postural balance in patients with chronic stroke.

Methods and analysis

Forty-two individuals with chronic stroke (>6 months), aged 20–75 years, will be randomised into two groups: the experimental group, which will be subjected to an exergames protocol, and control group, which will undergo a kinesiotherapy protocol. Both protocols are based on postural balance. The intervention will consist of 40-minute sessions two times per week for 10 consecutive weeks. The volunteers will be evaluated before the treatment, at the end of the interventions and 8 weeks thereafter. The primary outcome will be postural balance (Berg Balance Scale, Functional Reach Test, Timed Up and Go test and Centre of Pressure variables) and secondary outcomes will include gait (6 m timed walk and Kinovea Software), cortical activation patterns (electroencephalography Emotiv EPOC), functional independence (Functional Independence Measure), quality of life (Stroke-Specific Quality of Life Scale) and motivation (Intrinsic Motivation Inventory).

Ethics and dissemination

This protocol was approved by the Ethics Committee of the Federal University of Rio Grande do Norte (number 3.434.350). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.

Trial registration number

Brazilian Registry of Clinical Trials (RBR-78v9hx).

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'10% of your medical students will cause 90% of your problems: a prospective correlational study

Alexandros G.Sfakianakis shared this article with you from Inoreader
Objectives

Our aim was to explore the relationship between medical student Conscientiousness Index scores and indicators of later clinical performance held in the UK Medical Education Database (UKMED). Objectives were to determine whether conscientiousness in first-year and second-year medical students predicts later performance in medical school and in early practice. Policy implications would permit targeted remediation where necessary or aid in selection.

Design

A prospective correlational study.

Setting

A single UK medical school and early years of practice, 2005–2018.

Participants

The data were obtained from the UKMED on 858 students. Full outcome data was available for variable numbers of participants, as described in the text.

Main outcome measures

Scores on the UK Foundation Programme Office's Situational Judgement Test (SJT) and Educational Performance Measure (EPM), the Prescribing Safety Assessment (PSA) and Annual Review of Competency Progression (ARCP) outcomes.

Results

Linear regression analysis shows Conscientiousness Index scores significantly correlate with pregraduate and postgraduate performance variables: SJT scores (R=0.373, R2=0.139, B=0.066, p<0.001, n=539); PSA scores (R=0.249, R2=0.062, B=0.343, p<0.001, n=462); EPM decile scores for the first (lowest) decile are significantly lower than the remaining 90% (p=0.003, n=539), as are PSA scores (p<0.001, n=463), and ARCP year 2 scores (p=0.019, n=517). The OR that students in the first decile fail to achieve the optimum ARCP outcome is 1.6126 (CI: 1.1400 to 2.2809, p=0.0069, n=618).

Conclusions

Conscientiousness Index scores in years 1 and 2 of medical school have predictive value for later performance in knowledge, skills and clinical practice. This trait could be used either for selection or for targeted remediation to avoid potential problems in the future.

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TOP-ID: a Delphi technique-guided development of a prescription and deprescription tool for adults with intellectual disabilities

Alexandros G.Sfakianakis shared this article with you from Inoreader
Objectives

Adults with an intellectual disability (AWID) are often polymedicated because of somatic and psychiatric health problems. Besides, they may display challenging behaviours, leading to off-label prescription of psychotropic drugs, without efficacy and with numerous adverse effects. In this context, a prescription/deprescription tool (Tool for Optimising Prescription in Intellectual Disability/TOP-ID) was developed to improve the care of AWID. This paper describes how TOP-ID was designed.

Design

Four-step consensus-based process involving a review of the literature, eight semistructured interviews and a two-round Delphi process.

Setting

Seventeen general practices and university and general hospitals from Belgium, France and Switzerland.

Participants

Eighteen French-speaking physicians from different domains of expertise participated in the Delphi process.

Primary and secondary outcome measures

For the Delphi iteration process, consensus was defined as at least a 65% agreement between the experts.

Results

Two rounds were needed for the Delphi process. Eighty-one items of the tool were submitted to 18 out of 35 recruited French-speaking experts during the first round. Sixty-nine per cent of the items reached a rate of agreement of 65% or more in that round. Thirteen questions were reformulated and resubmitted for the second Delphi iteration round. All of the statements reached a rate of agreement of 65% or more in the second round.

Conclusion

TOP-ID is the first prescription–deprescription tool developed specifically for AWIDs in French. It is intended to help prescribers document patient care in order to reduce prescription errors and to improve safety. The next steps of the project include the development of an electronic version of TOP-ID and a utility study.

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Mindfulness-based cognitive therapy experiences in youth with inflammatory bowel disease and depression: findings from a mixed methods qualitative study

Alexandros G.Sfakianakis shared this article with you from Inoreader
Objectives

Mindfulness-based cognitive therapy (MBCT) is effective in treating psychosocial comorbidities in inflammatory bowel disease (IBD); however, there have been no qualitative studies of MBCT experiences among youth with IBD. We aimed to examine the experiences of youth with IBD and depression who completed an adapted MBCT group programme, and the impact of common psychotherapy and group factors.

Design

This mixed method qualitative study, nested within a randomised controlled trial (RCT) of MBCT for youth with IBD, employed thematic analysis of qualitative data from three focus groups and open-ended survey questions.

Setting

The study was conducted in the outpatient department of a tertiary hospital for young adults in Brisbane, Australia.

Participants

Out of sixty-four adolescents and young adults recruited to the RCT of MBCT for youth with IBD and depression, 29 completed the MBCT evaluation survey and 19 attended the focus groups.

Results

Four key themes emerged: 'connectedness and shared understanding', 'growing in wisdom', 'therapeutic alliance' and 'barriers to mindfulness practice'. Participants described MBCT experiences as healing and transformative with the themes of connectedness, growing in wisdom and therapeutic alliance laying the foundation for therapeutic change. Main barriers included fatigue, depression, time and travel constraints.

Conclusions

The study identified key themes facilitating the process of therapeutic change within the MBCT programme for youth with IBD and elucidated common and group psychotherapy factors underlying the key themes. Participants perceived connecting with peers as essential for learning mindfulness skills which in turn strengthened the connection. Study findings will facilitate interpretation of the results of the RCT of MBCT in youth with IBD and inform the design of future studies of MBCT in this cohort.

Trial registration number

ACTRN12617000876392; Results.

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WeChat-based health education to improve health knowledge in three major infectious diseases among residents: a multicentre case-controlled protocol

Alexandros G.Sfakianakis shared this article with you from Inoreader
Introduction

Health literacy (HL) in infectious diseases is inadequate in China. Since the first nationwide survey of HL conducted in China, great efforts have been made. However, the rate of HL in infectious diseases was 16.06% in 2017. In contrast, with an HL rate of 15.85% in 2008, no significant effect was observed over 10 years. With an increasing number of internet users, we aim to assess the effects of WeChat-based health education for the promotion of partial HL-health knowledge in infectious diseases.

Methods and analysis

A total of 2160 residents aged 15–69 years old will be enrolled in this study. The primary outcome measures will be the rate of health knowledge in infectious disease. The follow-up period is 3 years.

Ethics and dissemination

The study protocol was approved by the Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University. The findings of this study will be submitted to a peer-reviewed journal.

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Co-production of an educational package for the universal human papillomavirus (HPV) vaccination programme tailored for schools with low uptake: a participatory study protocol

Alexandros G.Sfakianakis shared this article with you from Inoreader
Aim

To co-produce with young people an educational package about the human papillomavirus (HPV) vaccine that is tailored to increase vaccine uptake in schools and populations with lower uptake.

Introduction

Persistent infection with HPV can result in cancers affecting men and especially women. From September 2019, the English-schools-based HPV vaccination programme was expanded to include young men (in addition to young women) aged 12–13 years. Some young people attending schools with lower uptake of the vaccine have unmet information needs. We hypothesise that mechanisms to address information needs and increase young people's autonomy in consent procedures will result in higher uptake.

Methods and analysis

The Medical Research Council's framework for development and evaluation of complex interventions will inform intervention development. Recruitment of young people aged 12–15 years and key stakeholders (National Health Service commissioners, school staff, immunisation nurses and youth workers/practitioners) will be facilitated through existing links with healthcare organisations, schools and youth organisations in areas with lower uptake of the HPV vaccination programme. The proposed research will comprise three phases: (1) a rapid review of adolescent immunisation materials and preliminary qualitative interviews with young people and key stakeholders, (2) theory development and co-production of HPV vaccine communication materials through an iterative process with young people and (iii) testing delivery mechanisms and acceptability of the educational package in four schools with lower uptake.

Ethics and dissemination

The University of Bristol's Faculty of Health Sciences and London School of Hygiene and Tropical Medicine's Research Ethics Committees provided approvals for the study. A dissemination event for young people and key stakeholders and webinar with the National Immunisation Network will be organised. The study findings will be published in peer-reviewed journals and presented at conferences. Recommendations for a future larger scale study will be made.

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Rationale and study protocol of the Physical Activity and Dietary intervention in women with OVArian cancer (PADOVA) study: a randomised controlled trial to evaluate effectiveness of a tailored exercise and dietary intervention on body composition, physical function and fatigue in women with ovarian cancer undergoing chemotherapy

Alexandros G.Sfakianakis shared this article with you from Inoreader
Introduction

As a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising quality of life. Exercise and dietary interventions can positively influence body composition, physical fitness and function, and fatigue in patients with cancer. However, there are no data from randomised controlled trials on the effectiveness of exercise and dietary interventions in patients with ovarian cancer. Due to a complex disease trajectory, a relatively poor survival and distinct disease-induced and treatment-induced side effects, it is unclear whether exercise and dietary interventions that were shown to be feasible and effective in other types of cancer produce comparable results in patients with ovarian cancer. The aim of this article is to present the design of the multicentre randomised controlled Physical Activity and Dietary intervention in OVArian cancer trial and to describe how the exercise and dietary intervention is tailored to specific comorbidities and disease-induced and treatment-induced adverse effects in patients with ovarian cancer.

Methods and analysis

Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line (neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy. Primary outcomes are body composition, physical function and fatigue. Outcome measures will be assessed before the start of chemotherapy, 3 weeks after completion of chemotherapy and 12 weeks later. The exercise and dietary intervention was tailored to ovarian cancer-specific comorbidities and adverse effects of ovarian cancer and its treatment following the i3-S strategy.

Ethics and dissemination

This study has been approved by the medical ethical committee of the Amsterdam UMC (reference: 018). Results of the study will be published in international peer-reviewed journals.

Trial registration number

Netherlands Trial Registry (NTR6300).

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Clinical communication in inflammatory bowel disease: a systematic literature review protocol

Alexandros G.Sfakianakis shared this article with you from Inoreader
Introduction

Evidence regarding effective communication between clinicians and patients with inflammatory bowel disease (IBD) is limited. Studies that investigate clinical communication in IBD are much fewer in number than studies that investigate the perceptions of patients and clinicians about communication in clinical encounters. The current review aims to identify, organise and summarise systematically what is currently known about (1) the characteristics of interactions between clinicians who manage IBD and patients with IBD, and (2) how clinical discussion affects health outcomes in IBD.

Methods and analysis

Scopus, PubMed, Embase, Communication Abstracts, Health & Society, Linguistics and Language Behavior Abstracts and PsycINFO will be systematically searched for studies that investigate the characteristics of IBD clinical interactions during recorded consultations, from earliest available dates within each database to May 2020. A specifically developed quality assessment tool, grounded in linguistic theory, will be used to critically assess the evidence. In addition, a data extraction template will be developed and utilised to provide a description of the characteristics of IBD clinical communication as well as an estimation of its effect on health outcomes in a narrative synthesis.

Ethics and dissemination

Ethical review and approval is not required for this systematic review as no primary data will be collected. The results will be published in peer-reviewed journals and presented at academic conferences.

PROSPERO registration number

International Prospective Register of Systematic Reviews (PROSPERO) on 28 April 2020 (registration number: CRD42020169657).

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Incidence and Predictors of Structural Valve Deterioration after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Background. Transcatheter aortic valve replacement (TAVR), widely used as an alternative therapy in patients with severe aortic stenosis, is expected to be offered to low-risk patents with a longer life expectancy. The durability of transcatheter aortic valve is becoming of increasing importance. Method. PubMed, Embase, and Cochrane CENTRAL from the inception to March 2020 were systematically screened for studies reporting on structural valve deterioration (SVD) in TAVR patients. Incidence of SVD was diagnosed according to the latest European consensus as the primary end point. Predictors of SVD evaluated at multivariable analysis and cumulative incidence function (CIF) of SVD were the secondary end point. Result. Twelve studies encompassing 10031 patients evaluating the incidence of SVD were included, wit h a follow-up between 1 and 8 years. The pooled incidence of SVD was 4.93% (95% CI, 2.75%–7.70%, I2 = 96%) at 1 year and 8.97% (95% CI, 6.89%–11.29%, I2 = 86%) in the long term (≥5 years). Subgroup analysis was performed to identify the valve type that may result in partial heterogeneity. SVD was more frequent in patents with a valve diameter of 5 years), occurring more commonly in renal dysfunction patients, with small valve diameter and without OAC exposure. There may be an underestimation of the incidence if we assume death as a competing risk.
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Rejuvenated Circulating Endothelial Progenitor Cells and Nitric Oxide in Premenopausal Women with Hyperhomocysteinemia

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Hyperhomocysteinemia (HHcy) induced endothelial dysfunction is associated with disturbance in circulating endothelial progenitor cells (EPCs). Nevertheless, whether this unfavorable effect of HHcy on circulating EPCs also exists in premenopausal women is still unknown. Therefore, this leaves an area for the investigation of the difference on the number and activity of circulating EPCs in premenopausal women with hyperhomocysteinemia and its underlying mechanism. The number of circulating EPCs was measured by fluorescence-activated cell sorter analysis, as well as DiI-acLDL and lectin fluorescent staining. The migration and proliferation of circulating were evaluated by the Transwell chamber assay and MTT. Additionally, the endothelial function and levels of nitric oxide (NO), VEGF, and GM-CSF in plasma and cu lture medium were determined. The number or activity of circulating EPCs and flow-mediated dilatation (FMD) in premenopausal women with or without HHcy were higher than those in postmenopausal women. However, no significant effect of HHcy on the number or activity of circulating EPCs in premenopausal women was observed. A similar alteration in NO level between the four groups was observed. There was a correlation between FMD and the number or activity of EPCs, as well as NO level in plasma or secretion by EPCs. For the first time, our findings illuminated the quantitive or qualitative alterations of circulating EPCs and endothelial function in premenopausal patients with HHcy are preserved, which was associated with retained NO production. The recuperated endothelial repair capacity is possibly the potential mechanism interpreting cardiovascular protection in premenopausal women with HHcy.
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