Τετάρτη 11 Νοεμβρίου 2020

Development of a risk prediction model of potentially avoidable readmission for patients hospitalised with community-acquired pneumonia: study protocol and population

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Introduction

30-day readmission rate is considered an adverse outcome reflecting suboptimal quality of care during index hospitalisation for community-acquired pneumonia (CAP). However, potentially avoidable readmission would be a more relevant metric than all-cause readmission for tracking quality of hospital care for CAP. The objectives of this study are (1) to estimate potentially avoidable 30-day readmission rate and (2) to develop a risk prediction model intended to identify potentially avoidable readmissions for CAP.

Methods and analysis

The study population consists of consecutive patients admitted in two hospitals from the community or nursing home setting with pneumonia. To qualify for inclusion, patients must have a primary or secondary discharge diagnosis code of pneumonia. Data sources include routinely collected administrative claims data as part of diagnosis-related group prospective payment system and structured chart reviews. The main outcome measure is potentially avoidable readmission within 30 days of discharge from index hospitalisation. The likelihood that a readmission is potentially avoidable will be quantified using latent class analysis based on independent structured reviews performed by four panellists. We will use a two-stage approach to develop a claims data-based model intended to identify potentially avoidable readmissions. The first stage implies deriving a clinical model based on data collected through retrospective chart review only. In the second stage, the predictors comprising the me dical record model will be translated into International Classification of Diseases, 10th revision discharge diagnosis codes in order to obtain a claim data-based risk model.

The study sample consists of 1150 hospital stays with a diagnosis of CAP. 30-day index hospital readmission rate is 17.5%.

Ethics and dissemination

The protocol was reviewed by the Comité de Protection des Personnes Sud Est V (IRB#6705). Efforts will be made to release the primary study results within 6 months of data collection completion.

Trial registration number

ClinicalTrials.gov Registry (NCT02833259).

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Development and validity testing of the Adolescent Health Literacy Questionnaire (AHLQ): Protocol for a mixed methods study within the Irish school setting

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Introduction

Health literacy research has focused predominantly on the adult population, and much less is understood about this concept from an adolescent perspective. The tools currently available to measure adolescent health literacy have been adapted from adult versions. This limits their applicability to young people because of the developmental characteristics that impact on adolescents' behaviour, including impulse control and judgement skills. This protocol describes the intended development and validity testing of a questionnaire to measure health literacy in adolescents.

Methods and analysis

This protocol describes this mixed methods study that has three phases: the first phase will involve grounded research with adolescents using qualitative group interviews, co-design and concept mapping workshops to understand what health and healthy behaviours mean to adolescents and to explore their health literacy needs and the potential domains for the questionnaire. The draft health literacy domains identified will be presented to the youth advisory panel, and the questionnaire will be altered based on their feedback. Cognitive pretesting of the questionnaire items will also be conducted. Phase 2 will involve piloting the questionnaire to a two-stage random sample of young people in five urban and rural schools in Ireland. Test–retest reliability will be conducted using Pearson correlation coefficient. Confirmatory factor analysis will also be conducted to analyse the psychometric properties of the questionnaire. Phase 3 will involve the questionnaire being rolled out to a n ationally representative sample of adolescents (n=6052) in Ireland to assess their levels of health literacy.

Ethics and dissemination

Ethical approval to conduct this study has been granted from the University College Dublin Human Research Ethics Committee – Sciences (LS-20–08). Informed assent from adolescents and informed consent from parents/guardians will be sought. The findings of this research will be disseminated at national and international conferences, as well as through publication in peer-reviewed journals.

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Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Introduction

Aphasia is a common language disorder acquired after stroke that reduces the quality of life of affected patients. The impairment is frequently accompanied by a deficit in cognitive functions. The state-of-the-art therapy is speech and language therapy but recent findings highlight positive effects of high-frequency therapy. Telerehabilitation has the potential to enable high-frequency therapy for patients at home. This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training. We hypothesise that patients training with high-frequency teleSLT will show higher improvement in language functions and quality of life compared with patients with high-frequency tele-rehabilitative cognitive training (teleCT).

Methods and analysis

This study is a randomised controlled, evaluator-blinded multicentre superiority trial comparing the outcomes following either high-frequency teleSLT or teleCT. A total of 100 outpatients with aphasia will be recruited and assigned in a 1:1 ratio stratified by trial site and severity of impairment to one of two parallel groups. Both groups will train over a period of 4 weeks for 2 hours per day. Patients in the experimental condition will devote 80% of their training time to teleSLT and the remaining 20% (24 min/day) to teleCT, vice versa for patients in the control condition. The primary outcome measure is the understandability of verbal communication on the Amsterdam Nijmegen Everyday Language Test and secondary outcome measures are intelligibility of the verbal communication, impairment of receptive and expressive language functions, confrontation naming. Other outcomes measures are quality of life and acceptance (usability and subjective experience) of the teleSLT system.

Ethics and dissemination

This study is approved by the Ethics Committee Bern (ID 2016-01577). Results will be submitted to a peer-reviewed journal.

Trial registration number

NCT03228264.

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Discontinuing antidepressant medication after mindfulness-based cognitive therapy: a mixed-methods study exploring predictors and outcomes of different discontinuation trajectories, and its facilitators and barriers

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Objectives

This study aimed to explore predictors and outcomes associated with different trajectories of discontinuing antidepressant medication (ADM), in recurrently depressed individuals after participation in mindfulness-based cognitive therapy (MBCT). Facilitators and barriers of discontinuation were explored qualitatively.

Design

Mixed-methods study combining quantitative and qualitative data, drawn from a randomised controlled trial.

Setting

Twelve secondary and tertiary psychiatric outpatient clinics in the Netherlands.

Participants

Recurrently depressed individuals (N=226) who had been using ADM for at least 6 months and in partial or full remission. Regardless of trial condition, we made post-hoc classifications of patients' actual discontinuation trajectories: full discontinuation (n=82), partial discontinuation (n=34) and no discontinuation (n=110) of ADM within 6 months after baseline. A subset of patients (n=15) and physicians (n=7) were interviewed to examine facilitators and barriers of discontinuation.

Interventions

All participants were offered MBCT, which consisted of eight weekly sessions in a group.

Primary and secondary outcome measures

Demographic and clinical predictors of successful discontinuation within 6 months, relapse risk within 15 months associated with different discontinuation trajectories, and barriers and facilitators of discontinuation.

Results

Of the 128 patients assigned to MBCT with discontinuation, only 68 (53%) fully discontinued ADM within 6 months, and 17 (13%) discontinued partially. Predictors of full discontinuation were female sex, being employed and lower levels of depression. Relapse risk was lower after no discontinuation (45%) or partial discontinuation (38%), compared with full discontinuation (66%) (p=0.02). Facilitators and barriers of discontinuation were clustered within five themes: (1) pre-existing beliefs about depression, medication and tapering; (2) current experience with ADM; (3) life circumstances; (4) clinical support and (5) mindfulness.

Conclusions

Discontinuing antidepressants appears to be difficult, stressing the need to support patients and physicians in this process. MBCT may offer one of these forms of support.

Trial registration number

ClinicalTrials.gov Registry (NCT00928980); post-results.

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Effectiveness of deep electroacupuncture with strong deqi and shallow electroacupuncture with no deqi for lumbar disk herniation: study protocol for a randomised controlled trial

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Introduction

Lumbar disk herniation (LDH) is a common cause of low back pain and dysfunction. Studies have shown that electroacupuncture (EA) can achieve pain relief in patients with LDH. However, there is a lack of evidence regarding the effectiveness of deep EA with strong deqi and shallow EA with no deqi in patients with LDH. This study aims to evaluate the effectiveness of deep EA with strong deqi and shallow EA with no deqi in the treatment of LDH.

Methods and analysis

In this randomised controlled trial, patients with LDH who have low back pain with or without radiculopathy for at least 12 weeks will be enrolled. In total, 44 patients will be recruited from the Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China. Patients will be randomised into the deep EA group and the shallow EA group in a ratio of 1:1 and will be administered 12 sessions of EA treatment (three times a week for 4 weeks, 20 min for each session). The follow-up duration will be 4 weeks. Low back pain intensity and leg pain intensity (in patients with radicular pain) measured using the Visual Analogue Scale (VAS) will be assessed as the primary outcomes. Function (measured using the Roland-Morris Disability Questionnaire), quality of life (measured using the EuroQol Five-Dimensional Five-Level Questionnaire) and patient-evaluated therapeutic effect will be assessed as the secondary outcomes. Patients' expectations of EA, the success of the blin ding method and safety will also be evaluated. Statistical analyses will be followed by the intention-to-treat analysis.

Ethics and dissemination

This study was approved by the Ethics Committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine (approval number: 2019-XS-ZB06). Study results will be disseminated through publication in an open access journal.

Trial registration number

ChiCTR-1900026518.

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TThe Modification of Diet, Exercise and Lifestyle (MODEL) randomised controlled trial in Australian adults: protocol for a mixed-method process evaluation

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Introduction

The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on 'healthful' improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.

Methods and analysis

The overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing 'healthful' behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.

Ethics and dissemination

The MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.

Trial registration number

ACTRN12618001087246.

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Assessing the benefits on quality of life of a multicomponent intervention for fibromyalgia syndrome in primary care: patients and health professionals appraisals: a qualitative study protocol

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Introduction

Fibromyalgia syndrome (FMS) is a complex condition still scarcely understood and with ambiguity when prescribing treatment. Both patients and healthcare providers can supply valuable information for the development of new treatment strategies. The qualitative narrative analysis of participant's accounts is potentially helpful to reveal new insights about their opinions, needs, and experiences and, consequently, to model healthcare interventions accurately. International treatment guidelines suggest a promising future for multicomponent intervention (MI) approaches for FMS. This study aims to assess the benefits of a MI for patients with FMS in the context of primary care (PC) in Terres de L'Ebre, Catalonia (Spain). Furthermore, it is intended to detect the overall perception of effectiveness and to understand patients' lived experience and its impact on the quality of life.

Method and analysis

Qualitative research from a socioconstructivism paradigm perspective and a Hermeneutic Phenomenological method. For data collection, four focus group discussions (FGDs) of 8–12 people (2 FGDs of patients and 2 of professionals) and 10–12 key informant interviews with the participants in the MI group will be carried out. All the information will be recorded and verbatim transcribed to perform an interpretive thematic analysis.

Ethics and dissemination

This study protocol has been approved by the Clinical Research Ethics Committee from the IDIAPJGol Institute, on 25 April 2018 (code P18/068), according to the Declaration of Helsinki/Tokyo. All participants will receive oral/written information about the study, and they will be required to sign an informed consent sheet. Data anonymity will be guaranteed. Dissemination will be carried out through publications in scientific journals, presentations in academic meetings, workshops and through the local and national media.

Trial registration number

ClinicalTrials.gov: NCT04049006; Pre-results.

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Current status of radioligand therapy and positron-emission tomography with prostate-specific membrane antigen

Alexandros G.Sfakianakis shared this article with you from Inoreader

Abstract

Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein highly expressed by prostate cancer cells. PSMA-based radioligand therapy (RLT) emerged as a promising therapeutic option for prostate cancer in the early 2000s, and has been clinically validated with great enthusiasm during these past two decades. Last year, the European Association of Nuclear Medicine (EANM) published the procedure guidelines for the safe clinical practice of Lutetium-177 (177Lu)-labelled PSMA RLT. In addition, PSMA RLT with alpha-ray-emitting radioisotopes has been also developed recently. Following the clinical use of 177Lu-PSMA RLT, PSMA-targeted positron-emission tomography (PET) with Gallium-68 (68Ga) has been performed inevitably for "theranostics" for the last decade; prostate cancer is going to be treated with PSMA-RLT based on the diagnosis by PSMA-PET. Furthermore, the diagnostic usefulness of 68Ga-PSMA PET has bee n documented in various diseases beyond prostate cancer more recently. Regrettably, Japan is behind European countries and the United States in this field, and has just made a belated start of their clinical trials. In this review article, we briefly overviewed the current status of PSMA RLT and PSMA PET. We hope that this topic will be a particular focus of attention for most ANM readers in Japan, and that our efforts will help to facilitate the early approval of PSMA RLT and PSMA PET by the Japanese government even if only slightly.

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[ASAP] Microenvironment-Triggered Degradable Hydrogel for Imaging Diagnosis and Combined Treatment of Intraocular Choroidal Melanoma

Alexandros G.Sfakianakis shared this article with you from Inoreader

TOC Graphic

ACS Nano
DOI: 10.1021/acsnano.0c06000
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Flow‐diverting stents in the treatment of peripheral and visceral artery aneurysms

Alexandros G.Sfakianakis shared this article with you from Inoreader

Abstract

Objective

This meta‐analysis aims to evaluate the safety and efficacy of flow‐diverting stents (FDS) in treating peripheral and visceral artery aneurysms (PAA/VAAs).

Background

Though rare, PAA/VAAs can represent a life‐threatening condition due to their propensity of rupture. The FDS emerges as a new solution to exclude these aneurysms while maintaining collateral branches, but convincing evidence is lacking on its clinical effectiveness.

Methods

A systematic literature search was performed to identify studies related to FDS in treating PAA/VAAs. The preferred reporting items for systematic reviews and meta‐analyses (PRISMA) statement was applied to guide the data extraction, quality assessment, and synthesis of outcomes of interest. Random effect models were applied to calculate the event rates of major endpoints. OpenMeta[Analyst] software was used for statistical analysis.

Results

Of 130 records screened, 10 cohort studies (including 220 patients, average age: 66.0 years, 78.4% male) were enrolled in the meta‐analysis. Pooled data suggested a technical success rate of 98.5% (95% CI: 97.0–100%). During a mean follow‐up period of 14.1 months, 93.6% (95% CI: 88.6–98.5%) side branches remained patent, 89.8% (95% CI: 84.3–95.3%) aneurysms were totally thrombosed, whereas shrinkage/stabilization of the aneurysm was documented in 93.4% (95% CI: 88.4–98.4%) cases. The primary stent patency rate was estimated to be 87.9% (95% CI: 81.0–94.8%). Overall clinical success was achieved in 83.2% (95% CI: 74.4–92.0%) patients.

Conclusions

The FDS features a potential advantage of preserving side branches while inducing sac thrombosis and aneurysm shrinkage/stabilization. Further prospective, comparative studies in larger patient cohorts are anticipated to draw a robust conclusion.

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Usefulness of updated logistic clinical SYNTAX score based on MI‐SYNTAX score in patients with ST‐elevation myocardial infarction

Alexandros G.Sfakianakis shared this article with you from Inoreader

Abstract

Objectives

To compare the predictive performances of the prewiring, postwiring MI‐SYNTAX scores, prewiring, and postwiring Updated Logistic Clinical SYNTAX score (LCSS) for 2‐year all‐cause mortality post percutaneous coronary intervention (PCI) in ST‐elevation myocardial infarction (STEMI) patients.

Background

In patients with STEMI and undergoing primary PCI, coronary stenosis(es) distal to the culprit lesion is often observed after the restoration of coronary flow. To address comprehensively the complex coronary anatomy in these patients, prewiring and postwiring MI‐SYNTAX scores have been reported in the literature. Furthermore, to enable individualized risk estimation for long‐term all‐cause mortality, the Updated LCSS has been developed by combining the anatomical SYNTAX score and clinical factors.

Methods

In the randomized GLOBAL LEADERS trial, anatomical SYNTAX score analysis was performed by an independent angiographic corelab for the first 4,000 consecutive patients as a prespecified analysis; of these, 545 presented with STEMI. The efficacy of the mortality predictions of the four scores at 2 years were evaluated based on their discrimination and calibration abilities.

Results

Complete data was available in 512 patients (93.9%). When the patients were stratified into two groups based on the median of the scores, the prewiring and postwiring Updated LCSSs demonstrated that the high‐score groups were associated with higher rates of 2‐year all‐cause mortality compared to the low‐score groups (6.6 vs. 1.2%; log‐rank p = .001 and 6.6 vs. 1.2%; log‐rank p = .001, respectively). There were no statistically significant differences for predicting the mortality between the prewiring (area under the curve [AUC] 0.625), postwiring MI‐SYNTAX score (AUC 0.614), prewiring (AUC 0.755), and postwiring Updated LCSS (AUC 0.757). In the integrated discrimination improvement (IDI), the prewiring MI‐SYNTAX score had a better discrimination for the mortality than the postwiring MI‐SYNTAX score (IDI ‐0.0082; p = .029). The four scores had acceptable calibration abilities for 2‐year all‐cause mortality.

Conclusions

The prewiring Updated LCSS predicts long‐term all‐cause mortality with clearly useful discrimination and acceptable calibration. Since the postwiring MI‐SYNTAX score does not improve mortality prediction, the prewiring MI‐SYNTAX score may be preferred for the 2‐year mortality prediction using the Updated LCSS.

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