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Antipsychotics for Parkinsons disease: a protocol for a systematic review with network meta-analysis and trial sequential analysis

Por: Petersen · J. J. · Kamp · C. B. · Juul · S. · Bjerg · J. L. · Sillassen · C. D. B. · Faltermeier · P. · Salvesen · L. · Hejl · A.-M. · Bech · S. · Lokkegaard · A. · Jakobsen · J. C.
Introduction

Parkinson’s disease is a neurological disease with a rising incidence and prevalence. Patients with Parkinson’s disease may receive antipsychotics, for example, due to Parkinson’s disease psychosis. Parkinson’s disease psychosis is characterised by visual hallucinations and other psychotic symptoms. To date, no systematic review has evaluated the effects of antipsychotics in patients with Parkinson’s disease. Therefore, this review aims to assess the beneficial and harmful effects of antipsychotics for Parkinson’s disease.

Methods and analysis

This is a protocol for a systematic review. A search specialist will perform a search in major medical databases (eg, MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica database), CENTRAL (Cochrane Central Register of Controlled Trials)) and clinical trial registries. Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will be included. Two review authors will independently extract data and conduct risk of bias assessments with the Cochrane Risk of Bias tool—V.2. Primary outcomes will be all-cause mortality, serious adverse events and significant falls. Secondary outcomes will be hospitalisations, non-serious adverse events, Unified Parkinson’s Disease Rating Scale total score and psychotic symptoms using any valid symptom scale. Data will be synthesised by aggregate meta-analysis, trial sequential analysis and network meta-analysis. Several subgroup analyses are planned. An eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by GRADE (Grading of Recommendations Assessment, Development and Evaluations) and CiNeMA (Confidence in Network Meta-Analysis) approach.

Ethics and dissemination

This protocol does not include results, and ethics approval is not required for the project. The findings from the systematic review will be published in international peer-reviewed scientific journals.

PROSPERO registration number

PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.

Short-term versus long-term psychotherapy for borderline personality disorder: a protocol for an individual patient data pooled analysis of two randomised clinical trials

Por: Juul · S. · McMain · S. · Olsen · M. H. · Chapman · A. · Pereira Ribeiro · J. · Storebo · O. J. · Kuo · J. · Hestbaek · E. · Kamp · C. B. · Rishede · M. · Frandsen · F. W. · Bo · S. · Poulsen · S. · Sorensen · P. · Bateman · A. · Simonsen · S. · Jakobsen · J. C.
Background

The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.

Methods

An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0–49 compared with 50–100).

Ethics and dissemination

The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.

PROSPERO registration number

CRD42024612840.

Protocol for the development of a transdiagnostic core outcome set for mental health disorders in adults: the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative

Por: Juul · S. · Faltermeier · P. · Petersen · J. J. · Siddiqui · F. · Kamp · C. B. · Thabane · L. · Samaan · Z. · Mbuagbaw · L. · Horowitz · M. · Moncrieff · J. · Hengartner · M. P. · Olsen · M. H. · Hermann · R. · Moller · M. H. · Gluud · C. · Jakobsen · J. C.
Introduction

Mental health problems are important causes of disability and economic costs worldwide. Randomised clinical trials examining the treatment of mental health disorders measure heterogeneous outcomes, causing difficulties in data synthesis, interpretation and translation into clinical practice. The aim of the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative is to develop an overarching, transdiagnostic research-based and consensus-based core outcome set for adult mental health disorders.

Methods and analysis

The development of the PIO-Psych transdiagnostic core outcome set will include three phases: (1) a systematic scoping review of the literature to develop the initial list of outcomes for the Delphi study; (2) a Delphi study in three rounds including people with lived experience of mental health disorders and their relatives, clinicians, researchers and others (administrators, mental healthcare policymakers, philosophers); (3) a hybrid consensus meeting to agree on the final overarching, transdiagnostic core outcome set and corresponding time points of assessment of each outcome.

Ethics and dissemination

Ethical approval is not applicable to this study according to the Research Ethics Committee of the Capital Region of Denmark, as it is not an interventional study. All data will be reported anonymously, and it will not be possible to identify study participants. Results will be disseminated via stakeholder and research networks and peer-reviewed publications.

Trial registration details

The PIO-Psych Initiative was pre-registered with COMET (Core Outcome Measures for Effectiveness Trials) on 17 May 2024 (https://www.comet-initiative.org/Studies/Details/3125).

Patients' perspectives of the digital counselling competence of healthcare professionals—A qualitative descriptive study

Abstract

Aim

To describe the perspectives of patients using digital services on the digital counselling competence of healthcare professionals.

Design

A descriptive qualitative interview study.

Methods

The analysed data were collected in Finland during the spring of 2023 via 11 individual, semi-structured interviews from participants who had received video-mediated counselling. The interviews were carried out online through Microsoft Teams and adhered to an interview guide using main and ancillary questions. The data were analysed using inductive content analysis.

Results

The patients' perspectives of healthcare professionals' digital counselling competence were related to five categories: (1) competence in preparing for video-mediated counselling, (2) digital competence in implementing the video-mediated counselling, (3) competence in interacting with the patient during the video-mediated counselling, (4) competence in supporting the patient's self-management in video-mediated counselling and (5) competence in self-development as a digital counsellor.

Conclusion

The results of this study indicate that healthcare professionals need to possess a wide range of digital counselling competencies when providing video-mediated counselling. This study thus lays the groundwork for future studies of patients' perspectives of healthcare professionals' digital counselling competence.

Implications for the Profession and/or Patient Care

The results of this study can be used to develop healthcare professionals' digital counselling competence and patient-centered care. The presented insights can also be used to map further research topics.

Reporting Method

The Consolidated criteria for reporting qualitative research (COREQ) checklist was used when reporting the results.

Patient or Public Contribution

Patients who had experience in using digital services participated in the data collection of this study.

Impact

What problem did the study address? Healthcare professionals may well need to develop new competencies as counselling is increasingly moving to digital environments. What were the main findings? The main areas of digital counselling competence that emerged from the patients' perspectives were competence in preparing for video-mediated counselling, digital competence, competence in interacting with the patient, competence in supporting self-management and competence in self-development as a digital counsellor. Where and on whom will the research have an impact? The research can be used to build and develop healthcare professionals' digital counselling competence, as well as improve the delivery of patient-centered care.

‘We had conversations we wouldn't have had otherwise’—Exploring home‐dwelling people with dementia and family members' experiences of deliberating on ethical issues in a literature‐based intervention

Abstract

Aim

To explore home-dwelling people with dementia and family members' perceptions of the feasibility and acceptability of an intervention using dementia-related literature excerpts to facilitate conversations on ethical issues related to living with dementia.

Background

Ethical issues in dementia care emerge throughout the illness. In the early stages, they may involve decisions about disclosing the illness to the family, shifting roles and responsibilities, and considerations of transitioning to a nursing home. Addressing ethical issues and providing adequate support to home-dwelling people with dementia and their families are often lacking.

Design

An exploratory-descriptive qualitative study.

Methods

We conducted eight interviews with 14 home-dwelling persons with dementia and their family caregivers. Six were dyadic interviews, and two were individual interviews with family caregivers. We analysed the interview data using template analysis. We adhered to the COREQ checklist in reporting this study.

Results

Using excerpts from dementia-related literature was a feasible and acceptable way of initiating discussions on ethical issues among home-dwelling persons with dementia and family caregivers. However, engaging the families of newly diagnosed individuals was challenging due to emotional distress. The intervention provided peer support, including identifying with others and sharing experiences. Moreover, participating couples found intimacy and relational attunement through shared reflections.

Conclusion

Based on the findings, it appears that the participants in this study felt that using excerpts from dementia-related literature to deliberate on ethical issues was feasible and acceptable. Deliberating on ethical issues with peers and family caregivers offers valuable social support and opportunities for strengthening relationships.

Implications for patient care

This study makes an important contribution by providing valuable insights into how ethical issues related to living with dementia can be addressed using related literature and suggests how the intervention can be integrated into existing care initiatives for home-dwelling people with dementia and their families.

Reporting method

We have adhered to relevant EQUATOR guidelines with the COREQ reporting method.

Patient or public contribution

A healthcare professional working as a so-called dementia coordinator (a title used in the Danish context) was involved in the conduct of this study by being responsible for the recruitment of home-dwelling people with dementia and their family members. Moreover, she had joint responsibility for facilitating the intervention along with the first author.

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