The EMBARC European Bronchiectasis Registry: protocol for an international observational study

Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies.The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1) a clinical history consistent with bronchiectasis; and 2) computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1) bronchiectasis due to known cystic fibrosis; 2) age <18 years; and 3) patients who are unable or unwilling to provide informed consent.The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications.The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials.

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BronchUK: Protocol for an observational cohort study and biobank in bronchiectasis

ERJ Open Research ◽

10.1183/23120541.00775-2020 ◽

2021 ◽

pp. 00775-2020

Author(s):

Anthony De Soyza ◽

Philip Mawson ◽

Adam T. Hill ◽

Stuart Elborn ◽

Judy M. Bradley ◽

...

Keyword(s):

Cohort Study ◽

Patient Outcomes ◽

Large Scale ◽

Research Collaboration ◽

Clinical History ◽

Observational Cohort Study ◽

Disease Area ◽

Exclusion Criteria ◽

Observational Cohort

Bronchiectasis has been a largely overlooked disease area in respiratory medicine. This is reflected by a shortage of large-scale studies and lack of approved therapies, in turn leading to a variation of treatment across centres. BronchUK (Bronchiectasis observational cohort and biobank UK) is a multicentre, prospective, observational cohort study working collaboratively with the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project. The inclusion criterion for patients entering the study is a clinical history consistent with bronchiectasis and computed tomography (CT) demonstrating bronchiectasis. Main exclusion criteria are 1) patients unable to provide informed consent, 2) bronchiectasis due to known cystic fibrosis or where bronchiectasis is not the main or codominant respiratory disease, 3) age <18 years, and 4) prior lung transplantation for bronchiectasis. The study is aligned to standard UK NHS practice with an aim to recruit a minimum of 1,500 patients from across at least nine secondary care centres. Patient data collected at baseline includes demographics, aetiology testing, comorbidities, lung function, radiology, treatments, microbiology, and quality of life. Patients are followed up annually for a maximum of five years and, where able, blood and/or sputa samples are collected and stored in a central biobank. BronchUK aims to collect robust longitudinal data that can be used for analysis into current NHS practice and patient outcomes, and to become an integral resource to better inform future interventional studies in bronchiectasis.

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Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-020-03176-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yaping Wang ◽

Bin Liu ◽

Xiuqiong Fu ◽

Tiejun Tong ◽

Zhiling Yu

Keyword(s):

Relapse Rate ◽

Large Scale ◽

Primary Outcome ◽

Response Rate ◽

Meta Analysis ◽

Risk Of Bias ◽

Efficacy And Safety ◽

History Of ◽

Non Ulcer Dyspepsia

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

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An examination of the quality of social and environmental disclosures by Nigerian oil companies

Corporate Governance ◽

10.1108/cg-05-2015-0065 ◽

2016 ◽

Vol 16 (2) ◽

pp. 400-419 ◽

Cited By ~ 5

Author(s):

Odhiambo Odera ◽

Albert Scott ◽

Jeff Gow

Keyword(s):

Large Scale ◽

Health And Safety ◽

Annual Reports ◽

Content Type ◽

Oil Companies ◽

Environmental Disclosures ◽

Oil Company ◽

A Company ◽

Tests For Normality

Purpose This study seeks to examine the quantity and quality of social and environmental disclosures (SEDs) of Nigerian oil companies. The study aims to analyse SED activities as reported by the oil companies in their annual reports. Design/methodology/approach The study analyses annual reports through content analysis. SED quantity is measured by alternative two units: number of sentences and number of pages. A two-point scale system to assess SED quality is used as follows: 1 = if SED is quantitative and reports specific activities of a company concerning its social and environmental responsibility; 0 = otherwise. Correlation analysis is performed among the different SED categories to identify the relationships among them. Kolmongrov–Smirnov and Shapiro–Wilk tests for normality are utilised. Findings SED activities are reported by most of the companies, and by quantity, employee information is found to be the most common type of disclosure. SED quantity and quality in the environment category is found to be overwhelmingly low despite the large-scale public concern expressed about the levels of the environmental degradation caused by oil company operations. Research limitations/implications The data collected for this study are based on one country, which controls diversity but limits the generalizability of the findings. The study is limited by the sample which includes mainly quoted companies, as they are believed to make improved disclosures because of their investor orientation and statutory obligations. Originality/value The study extends SED research by focusing on social disclosures such as employee-, community- and health- and safety-related disclosures. The study also investigates the motivations of SED providers and establishes a link between stakeholder demands/engagement and the level of disclosure.

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Baseline characteristics of postmenopausal women with osteoporosis treated with teriparatide in a real-world setting in Latin America: a subregional analysis from the Asia and Latin America Fracture Observational Study (ALAFOS)

Advances in Rheumatology ◽

10.1186/s42358-019-0088-2 ◽

2019 ◽

Vol 59 (1) ◽

Cited By ~ 2

Author(s):

Joao L. Cunha-Borges ◽

Guillermo Meléndez Mier ◽

Noemí Casas ◽

Adriana Medina ◽

Jose Fernando Molina ◽

...

Keyword(s):

Latin America ◽

Observational Study ◽

Postmenopausal Women ◽

Latin American ◽

Real World Setting ◽

Related Quality ◽

Health Related ◽

History Of ◽

Fracture History

Abstract Background Osteoporosis is a major healthcare concern in Latin America. Factors such as changing demographics, fragmented healthcare systems, and financial considerations may result in a huge increase in the burden of osteoporosis in this region. The aim of this article is to describe the baseline clinical characteristics and fracture history of patients who are prescribed teriparatide in normal clinical practice in Latin America. Methods We conducted a prospective, multinational, observational study (the Asia and Latin America Fracture Observational Study [ALAFOS]) in 20 countries worldwide to assess the incidence of fractures in postmenopausal women with osteoporosis receiving teriparatide as a part of routine clinical practice in a real-world setting. In this subregional analysis of the ALAFOS study, we report the clinical characteristics, fracture history, risk factors for osteoporosis, comorbidities, previous osteoporosis therapies and health-related quality of life measures at baseline for patients from the four participant Latin American countries: Argentina, Brazil, Colombia, and Mexico. Results The Latin America subregional cohort included 546 postmenopausal women (mean [SD] age: 71.0 [10.1] years; range: 40–94 years), constituting 18% of the ALAFOS total population. The baseline mean (SD) bone mineral density T-scores were − 3.02 (1.23) at the lumbar spine and − 2.31 (0.96) at the femoral neck; 62.8% of patients had a history of low trauma fracture after the age of 40 years and 39.7% of patients had experienced ≥1 fall in the past year. Osteoporosis medications were used by 70.9% of patients before initiating teriparatide. The median (Q1, Q3) EQ-5D-5 L Visual Analog Scale (VAS) scores for perceived health status at baseline was 70 (50, 80). The mean (SD) worst back pain numeric rating scale score for the overall Latin American cohort was 4.3 (3.4) at baseline. Conclusions This baseline analysis of the Latin America subregion of the ALAFOS study indicates that patients who are prescribed teriparatide in the four participant countries had severe osteoporosis and high prevalence of fractures. They also had back pain and poor health-related quality of life. The proportions of patients with severe or extreme problems on the EQ-5D-5 L individual domains were lower than those in the overall ALAFOS study population.

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Misunderstandings in ART Triadic Interactions: A Qualitative Comparison of First and Follow-Up Visits

Frontiers in Psychology ◽

10.3389/fpsyg.2021.641998 ◽

2021 ◽

Vol 12 ◽

Author(s):

Maria Grazia Rossi ◽

Elena Vegni ◽

Julia Menichetti

Keyword(s):

Clinical History ◽

History Taking ◽

Qualitative Comparison ◽

Triadic Interactions ◽

Complex Interactions ◽

Weak Evidence ◽

History Of ◽

The Moment

BackgroundMisunderstandings in medical interactions can compromise the quality of communication and affect self-management, especially in complex interactions like those in the assisted reproductive technology (ART) field. This study aimed to detect and describe misunderstandings in ART triadic visits. We compared first and follow-up visits for frequency, type, speakers, and topics leading to misunderstandings.MethodsWe purposively sampled 20 triadic interactions from a corpus of 85 visits. We used a previously developed coding scheme to detect different types of misunderstandings (i.e., with strong, acceptable, and weak evidence). We analyzed also the different topics leading to strong misunderstandings (direct expressions of lack of understanding, pragmatic alternative understandings, semantic alternative understandings) to provide insights about the contents of the consultation that may need particular attention and care.FindingsWe detected an overall number of 1078 misunderstandings in the 20 selected visits. First visits contained almost two-third of the misunderstandings (n = 680, 63%). First visits were particularly rich in misunderstandings with acceptable evidence (e.g., clarifications and checks for understanding), compared to follow-up visits. In first visits, doctors’ turns more frequently than couples’ turns contained misunderstandings, while in follow-up visits it was the other way around. Looking at the couple, the majority of the misunderstandings were expressed by the woman (n = 241, 22%) rather than by the man (n = 194, 18%). However, when weighting for their number of turns, 9% of the men’s turns included an expression of misunderstanding, compared to the 7% of the women’s turns. Finally, more than half of the misunderstandings with strong evidence were about history-taking and treatment-related topics, and while the history-taking ones were particularly frequent in first visits the treatment-related ones were more present in follow-up visits.DiscussionFindings indicate that first visits may deserve particular attention to avoid misunderstandings, as they are the moment where a shared understanding can be harder to reach. In particular, misunderstandings happening in first visits seem mostly related to physicians having to reconstruct the clinical history of patients, while those in the follow-up visits seem to reflect residual and unsolved doubts from the couple, especially concerning treatments.

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Investigation of predictors of interest in a brief mindfulness-based intervention and its effects in patients with psoriasis at a rehabilitation clinic (SkinMind): an observational study and randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033952 ◽

2020 ◽

Vol 10 (9) ◽

pp. e033952

Author(s):

Laura Stadtmüller ◽

Markus Eckardt ◽

Christoph Zick ◽

Joerg Kupfer ◽

Christina Schut

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Observational Study ◽

Controlled Trial ◽

Present Moment ◽

Self Compassion ◽

Study Results ◽

Randomised Controlled ◽

Rehabilitation Clinic

IntroductionPsoriasis (PS) is a chronic inflammatory skin disease accompanied by reduced quality of life. Mindfulness is the ability to focus on the present moment without evaluation. Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life. However, it remained unclear what distinguishes patients with PS interested in psychological interventions from those without interest and whether also a shorter, namely 2-week mindfulness-based intervention is beneficial in this patient group. This will be investigated with this study.Methods and analysesData will be collected at a rehabilitation clinic in Germany. The study is divided into two parts: study 1a is an observational study. Its aim is to investigate whether sociodemographic, skin-related and psychological factors are significant predictors of interest in a brief psychological intervention in 127 patients with PS. Study 1b is a randomised controlled trial, in which 60 patients (retrieved from study 1a) will be randomised to an intervention or control group (treatment as usual). The main outcome variables are mindfulness and self-compassion. In addition, mediation analyses will be used in an explorative manner to test whether there is a relationship between mindfulness/self-compassion and the severity of PS and whether it is mediated by itch catastrophising and fear of negative evaluation (first model) or perceived stress (second model).Ethics and disseminationThe study protocol has been approved by the University of Giessen. Study results will be disseminated by publication of the results at (inter) national conferences and in scientific journals.Trial registration numbersDRKS00017426 and DRKS00017429.

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Retreatment with Bendamustine-Bortezomib-Dexamethasone in a Patient with Relapsed/Refractory Multiple Myeloma

Case Reports in Hematology ◽

10.1155/2016/6745286 ◽

2016 ◽

Vol 2016 ◽

pp. 1-3

Author(s):

Claudio Cerchione ◽

Davide Nappi ◽

Maria Di Perna ◽

Irene Zacheo ◽

Anna Emanuele Pareto ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Myeloma ◽

Clinical History ◽

Correct Choice ◽

Refractory Multiple Myeloma ◽

Effective Option ◽

Heavily Pretreated ◽

History Of ◽

Previously Treated

The clinical management of relapsed/refractory multiple myeloma and the correct choice of the most suitable therapy in heavily pretreated and fragile patients are tough clinical issues for clinicians. In advanced phases of disease, the choice of available therapies becomes very poor, and the retreatment with previously adopted and effective therapy, although unpredictable, could be an effective option. In this report, we describe the clinical history of a patient, previously treated with 9 lines of therapy, refractory to bortezomib and IMIDs, for whom the retreatment with bendamustine resulted in a stable disease with good quality of life.

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Baseline Characteristics of a National French E-Cohort of Hidradenitis Suppurativa in ComPaRe and Comparison with Other Large Hidradenitis Suppurativa Cohorts

Dermatology ◽

10.1159/000513447 ◽

2021 ◽

pp. 1-11

Author(s):

Morgane Condamina ◽

Laetitia Penso ◽

Viet-Thi Tran ◽

Claire Hotz ◽

Philippe Guillem ◽

...

Keyword(s):

Quality Of Life ◽

Hidradenitis Suppurativa ◽

Real Life ◽

Epidemiological Studies ◽

Scientific Data ◽

Disease Stage ◽

Treatment History ◽

Patient Reported ◽

History Of

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition substantially impacting patients’ quality of life; the pathogenesis remains unclear, and treatment is complex and not yet standardized. Observational data are increasingly being used to evaluate therapeutics in “real-life” interventions, and the development of e-cohorts is offering new tools for epidemiological studies at the population level. Objective: The aim of this study was to describe the clinical characteristics and treatment history of HS participants in the Community of Patients for Research (ComPaRe) cohort and to compare these to other cohorts. Methods: We performed a cross-sectional study of the baseline data of HS participants in ComPaRe, an e-cohort of patients with chronic diseases. Data were collected using patient-reported questionnaires about clinical-demographic aspects, quality of life, and treatment history. Results: A total of 396 participants (339 females, 57 males) were included (mean age 38 years); 83 (21%) had a family history of HS, 227 (57.3%) were current smokers, and 241 (60.9%) were overweight or obese. Most of the participants declared a Hurley stage II (n = 263, 66.4%) or III (n = 76, 20.3%). The breast was more frequently affected in women than men (37.5 vs. 5.3%, p < 0.0001), whereas the dorsal region was more frequently affected in men (39.5 vs. 10.9%, p < 0.0001). Increased disease stage was associated with obesity (25.9 vs. 33.8 vs. 51.3%, p = 0.02) and some HS localizations (genital [p < 0.005], pubis [p < 0.007], gluteal fold [p = 0.02], and groin [p < 0.0001]). The most frequently prescribed treatments were oral antibiotics (n = 362, 91.4%), especially amoxicillin-clavulanic acid and cyclins. Less than 10% of participants received biologics. Most of these results were consistent with previously published cohorts. Conclusion: Recruitment of participants by such a web platform can be a faster way to get relevant scientific data for a wide variety of patients that could be used for epidemiological studies and to evaluate therapeutics in “real-life” interventions.

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How reliable are randomised controlled trials for studying the relationship between diet and disease? A narrative review

British Journal Of Nutrition ◽

10.1017/s0007114516002129 ◽

2016 ◽

Vol 116 (3) ◽

pp. 381-389 ◽

Cited By ~ 7

Author(s):

Norman J. Temple

Keyword(s):

Cohort Studies ◽

Randomised Controlled Trials ◽

Critical Evaluation ◽

Epidemiological Studies ◽

Dietary Factors ◽

Controlled Trials ◽

Large Numbers ◽

History Of ◽

Randomised Controlled

AbstractLarge numbers of randomised controlled trials (RCT) have been carried out in order to investigate diet–disease relationships. This article examines eight sets of studies and compares the findings with those from epidemiological studies (cohort studies in seven of the cases). The studies cover the role of dietary factors in blood pressure, body weight, cancer and heart disease. In some cases, the findings from the two types of study are consistent, whereas in other cases the findings appear to be in conflict. A critical evaluation of this evidence suggests factors that may account for conflicting findings. Very often RCT recruit subjects with a history of the disease under study (or at high risk of it) and have a follow-up of only a few weeks or months. Cohort studies, in contrast, typically recruit healthy subjects and have a follow-up of 5–15 years. Owing to these differences, findings from RCT are not necessarily more reliable than those from well-designed prospective cohort studies. We cannot assume that the results of RCT can be freely applied beyond the specific features of the studies.

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A Body of One’s Own: From Self-Cutting to the Cuts of Separation in an Adolescent Suffering From Traumatic Early Abandonments

Journal of the American Psychoanalytic Association ◽

10.1177/0003065121993231 ◽

2021 ◽

Vol 69 (1) ◽

pp. 109-135

Author(s):

Laura Balottin ◽

Luca Quagelli ◽

Maria Vittoria Costantini

Keyword(s):

Young Patient ◽

Adolescent Girl ◽

Clinical History ◽

Traumatic Experiences ◽

Self And Other ◽

Complex Process ◽

History Of ◽

The Relationship

The treatment of adolescents suffering from early traumatic experiences inescapably involves the encounter with patients’ concrete use of their bodies and actions. The clinical history of an adolescent girl reveals the relationship between traumatic transgenerational abandonments and self-cutting in the transference-countertransference relationship. Initially the patient’s body and actions were the only way to communicate experiences that could not be conveyed in words and represented: the “skin for two” of the original psychosomatic envelope needed to be wounded, cut, broken concretely. The establishment of a boundary between internal and external, self and other, is the result of a complex process with roots in the quality of the encounter with the object. Gradually, in the encounter with the analyst, the young patient may construct a tenuous possibility of differentiation and begin to access the first outline of a representation of loss.

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