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Facilitators and barriers in anorexia nervosa treatment initiation (FABIANA): study protocol for a mixed-methods and multicentre study.

ABSTRACT: BACKGROUND:Anorexia nervosa is a serious disorder, which often takes a chronic course. Early treatment leads to a significantly better prognosis and prevents chronicity. However, existing evidence on facilitators and barriers in anorexia nervosa treatment initiation is scarce. AIMS:Against this background, the FABIANA study (ClinicalTrials.gov Identifier: NCT03713541) aims to (a) identify potentially modifiable facilitators and barriers from the perspectives of adolescent and adult patients with anorexia nervosa, carers and physicians, (b) develop and test an instrument for the combined assessment of multiple key facilitators and barriers, and (c) quantify the effect of potentially modifiable versus non-modifiable key facilitators and barriers on the duration of untreated illness (DUI) in patients with anorexia nervosa. METHOD:FABIANA is an observational, mixed-method-study divided into three consecutive substudies each corresponding to one of the study aims. All three substudies will include female patients with anorexia nervosa aged 14 years and older at the beginning of their first psychotherapeutic anorexia nervosa treatment. The qualitative substudy I and the quantitative substudy III will additionally include carers and involved physicians. The recruitment will take place at 20 cooperating study centres throughout Germany, which provide in-patient or out-patient anorexia nervosa specialist care. The DUI will be calculated based on the month of illness onset as determined in validated interviews on lifetime anorexia nervosa symptoms and the therapist-reported date of treatment initiation. CONCLUSIONS:Strengths and limitations of the retrospective assessment of the DUI will be discussed. The findings of the FABIANA study will contribute to the development of evidence-based early-intervention approaches and the prevention of a chronic course of illness. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03713541. DECLARATION OF INTEREST:None.

SUBMITTER: Kastner D

PROVIDER: S-EPMC6854360 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Facilitators and barriers in anorexia nervosa treatment initiation (FABIANA): study protocol for a mixed-methods and multicentre study.

Kästner Denise D Buchholz Ines I Weigel Angelika A Brunner Romuald R Voderholzer Ulrich U Gumz Antje A Löwe Bernd B

BJPsych open 20191021 6

<h4>Background</h4>Anorexia nervosa is a serious disorder, which often takes a chronic course. Early treatment leads to a significantly better prognosis and prevents chronicity. However, existing evidence on facilitators and barriers in anorexia nervosa treatment initiation is scarce.<h4>Aims</h4>Against this background, the FABIANA study (ClinicalTrials.gov Identifier: NCT03713541) aims to (a) identify potentially modifiable facilitators and barriers from the perspectives of adolescent and adul ...[more]

PMID: 31631825

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Project description:BackgroundA long duration of untreated illness (DUI) is an unfavorable prognostic factor in anorexia nervosa (AN) and is associated with chronic illness progression. Although previous preventive measures aimed at reducing DUI and thus improving short- and long-term treatment outcomes have been partially successful, a better understanding of the factors involved in the sensitive phase prior to treatment initiation is needed. To date, there is no validated instrument available to assess these factors specifically for patients with AN. The FABIANA-project (Facilitators and barriers in anorexia nervosa treatment initiation) aims at identifying predictors of the DUI in order to target preventive measures better in the future. As part of this project, the FABIANA-checklist was developed, based on a multi-informant perspective and a multimodal bottom-up approach. The present study focusses on the process of item generation, item selection and psychometric validation of the checklist.MethodsBased upon a previous qualitative study, an initial set of 73 items was generated for the most frequently mentioned facilitators and barriers of treatment initiation in AN. After a process of consensual rating and cognitive pre-testing, the resulting 25-item version of the FABIANA-checklist was provided to a sample of female patients (N = 75), aged ≥ 14 years with AN that underwent their first psychotherapeutic treatment in the last 12 months. After item analysis, dimensionality of the final version of the FABIANA-checklist was tested by Principal Component Analysis (PCA). We evaluated construct validity assuming correlations with related constructs, such as perceived social support (F-SozU), support in the health care system (PACIC-5A), illness perception and coping (BIPQ).ResultsWe included 54 adult and 21 adolescent patients with AN, aged on average 21.4 years. Average BMI was 15.5 kg/m2, age of onset was 19.2 years and average DUI was 2.25 years. After item analysis, 7 items were excluded. The PCA of the 18-item-FABIANA-checklist yielded six components explaining 62.64% of the total variance. Overall internal consistency was acceptable (Cronbach's α = .76) and construct validity was satisfactory for 14 out of 18 items. Two consistent components emerged: "primary care perceived as supportive and competent" (23.33%) and "emotional and practical support from relatives" (9.98%). With regard to the other components, the heterogeneity of the items led to unsatisfactory internal consistency, single item loading and in part ambiguous interpretability.ConclusionsThe FABIANA-checklist is a valid instrument to assess factors involved in the process of treatment initiation of patients with AN. Psychometrics and dimensionality testing suggests that experienced emotional and practical support from the primary health care system and close relatives are main components. The results indicate that a differentiated assessment at item level is appropriate. In order to quantify the relative importance of the factors and to derive recommendations on early-intervention approaches, the predictive effect of the FABIANA-items on the DUI will be determined in a subsequent study which will further include the perspective of relatives and primary caregivers. Trial registration Clinical Trials.gov Identifier: NCT03713541: https://clinicaltrials.gov/ct2/show/NCT03713541 .

Project description:IntroductionInitiation of injectable therapies in type 2 diabetes (T2D) is often delayed, however the reasons why are not fully understood.MethodsA mixed methods study performed in sequential phases. Phase 1: focus groups with people with T2D (injectable naïve [n = 12] and experienced [n = 5]) and healthcare professionals (HCPs; nurses [n = 5] and general practitioners (GPs) [n = 7]) to understand their perceptions of factors affecting initiation of injectables. Phase 2: video-captured GP consultations (n = 18) with actor-portrayed patient scenarios requiring T2D treatment escalation to observe the initiation in the clinical setting. Phase 3: HCP surveys (n = 87) to explore external validity of the themes identified in a larger sample.ResultsFocus groups identified patients' barriers to initiation; fear, lack of knowledge and misconceptions about diabetes and treatment aims, concerns regarding lifestyle restrictions and social stigma, and feelings of failure. Facilitators included education, good communication, clinician support and competence. HCP barriers included concerns about weight gain and hypoglycaemia, and limited consultation time. In simulated consultations, GPs performed high-quality consultations and recognised the need for injectable initiation in 9/12 consultations where this was the expert recommended option but did not provide support for initiation themselves. Survey results demonstrated HCPs believe injectable initiation should be performed in primary care, although many practitioners reported inability to do so or difficulty in maintaining skills.ConclusionPeople with T2D have varied concerns and educational needs regarding injectables. GPs recognise the need to initiate injectables but lack practical skills and time to address patient concerns and provide education. Primary care nurses also report difficulties in maintaining these skills. Primary care HCPs initiating injectables require additional training to provide practical demonstrations, patient education and how to identify and address concerns. These skills should be concentrated in the hands of a small number of primary care providers to ensure they can maintain their skills.

Project description:BACKGROUND:A large number of mobile health (mHealth) apps have been created to help users to manage their health or receive health care services. Many of these mHealth apps have proven to be helpful for maintaining or improving their users' health. However, many people still choose not to use mHealth apps or only use them for a short period. One of the reasons behind this lack of use is the concern for their health information security and privacy. OBJECTIVE:The goal of this study was to determine the relationship between users' characteristics and their security and privacy concerns and to identify desired security features in mHealth apps, which could reduce these concerns. METHODS:A questionnaire was designed and validated by the research team. This questionnaire was then used to determine mobile app users' security and privacy concerns regarding personal health data in mHealth apps as well as the security features most users' desire. A semistructured interview was used to identify barriers to and facilitators of adopting mHealth apps. RESULTS:In total, 117 randomly selected study participants from a large pool took part in this study and provided responses to the validated questionnaire and the semistructured interview questions. The results indicate that most study participants did have concerns about their privacy when using mHealth apps. They also expressed their preferences regarding several security features in mHealth apps, such as regular password updates, remote wipe, user consent, and access control. An association between their demographic characteristics and their concerns and preferences in security and privacy was identified; however, in most cases, the differences among the different demographic groups were not statistically significant, except for a few very specific aspects. These study participants also indicated that the cost of apps and lack of security features in mHealth apps were barriers for adoption, whereas having free apps, strong but easy-to-use security features, and clear user protection privacy policies might encourage them to use mHealth apps in their health management. CONCLUSIONS:This questionnaire and interview study verified the security and privacy concerns of mHealth app users, identified the desired security and privacy features, and determined specific barriers to and facilitators of users adopting mHealth apps. The results can be used to guide mHealth app developers to create apps that would be welcomed by users.

Dataset Information

Facilitators and barriers in anorexia nervosa treatment initiation (FABIANA): study protocol for a mixed-methods and multicentre study.

Publications

Facilitators and barriers in anorexia nervosa treatment initiation (FABIANA): study protocol for a mixed-methods and multicentre study.

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