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Study protocol for a single-blind, parallel-group, randomised, controlled non-inferiority trial of 4-day intensive versus standard cognitive behavioural therapy for adults with obsessive-compulsive disorder

Por: Ivanova · E. · Fondberg · R. · Flygare · O. · Sannemalm · M. · Asplund · S. · Dahlen · S. · Sampaio · F. · Andersson · E. · Mataix-Cols · D. · Ivanov · V. Z. · Rück · C.
Introduction

Individual cognitive behavioural therapy (CBT) with exposure and response prevention is an effective treatment for obsessive–compulsive disorder (OCD). However, individual CBT is costly and time-consuming, requiring weekly therapy sessions for 3–4 months. A 4-day intensive version of CBT for OCD delivered in group format has been recently developed in Norway (Bergen 4-day treatment, B4DT). B4DT has shown promising results in several uncontrolled and one small, randomised trial, but its non-inferiority to the gold standard treatment has not been established.

Methods and analysis

This single-blind, randomised controlled trial including 120 patients (60 per arm) will compare B4DT to individual CBT. The primary outcome is the blind assessor-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS). We hypothesise that B4DT will be non-inferior to gold standard CBT 15 weeks after treatment start. The non-inferiority margin is set at four points on the Y-BOCS. Secondary outcomes include time to treatment response, cost-effectiveness, response and remission rates, drop-out rates and adverse events.

Ethics and dissemination

This study has been approved by the Swedish Ethical Review Authority. Hypotheses were specified and analysis code published before data collection started. Results from all analyses will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials and Consolidated Health Economic Evaluation Reporting Standards irrespective of outcome.

Trial registration number

NCT05608278.

Development of indicators for avoidable emergency medical service calls by mapping paramedic clinical impression codes to ambulatory care sensitive conditions and mental health conditions in the UK and Canada

Por: Agarwal · G. · Siriwardena · A. N. · McLeod · B. · Spaight · R. · Whitley · G. A. · Ferron · R. · Pirrie · M. · Angeles · R. · Moore · H. · Gussy · M. · EDGE Consortium · Agarwal · Siriwardena · Angeles · Bielska · Brar · Cooper · Ferron · Gussy · Hill · Khunti · Law · McLeod · Moore · P
Objective

Paramedic assessment data have not been used for research on avoidable calls. Paramedic impression codes are designated by paramedics on responding to a 911/999 medical emergency after an assessment of the presenting condition. Ambulatory care sensitive conditions (ACSCs) are non-acute health conditions not needing hospital admission when properly managed. This study aimed to map the paramedic impression codes to ACSCs and mental health conditions for use in future research on avoidable 911/999 calls.

Design

Mapping paramedic impression codes to existing definitions of ACSCs and mental health conditions.

Setting

East Midlands Region, UK and Southern Ontario, Canada.

Participants

Expert panel from the UK-Canada Emergency Calls Data analysis and GEospatial mapping (EDGE) Consortium.

Results

Mapping was iterative first identifying the common ACSCs shared between the two countries then identifying the respective clinical impression codes for each country that mapped to those shared ACSCs as well as to mental health conditions. Experts from the UK-Canada EDGE Consortium contributed to both phases and were able to independently match the codes and then compare results. Clinical impression codes for paramedics in the UK were more extensive than those in Ontario. The mapping revealed some interesting inconsistencies between paramedic impression codes but also demonstrated that it was possible.

Conclusion

This is an important first step in determining the number of ASCSs and mental health conditions that paramedics attend to, and in examining the clinical pathways of these individuals across the health system. This work lays the foundation for international comparative health services research on integrated pathways in primary care and emergency medical services.

Investigating trial design variability in trials of disease-modifying therapies in Parkinsons disease: a scoping review protocol

Por: Zeissler · M.-L. · Boey · T. · Chapman · D. · Rafaloff · G. · Dominey · T. · Raphael · K. G. · Buff · S. · Pai · H. V. · King · E. · Sharpe · P. · OBrien · F. · Carroll · C. B.
Introduction

Parkinson’s disease (PD) is a debilitating neurological disorder for which the identification of disease-modifying interventions represents a major unmet need. Diverse trial designs have attempted to mitigate challenges of population heterogeneity, efficacious symptomatic therapy and lack of outcome measures that are objective and sensitive to change in a disease modification setting. It is not clear whether consensus is emerging regarding trial design choices. Here, we report the protocol of a scoping review that will provide a contemporary update on trial design variability for disease-modifying interventions in PD.

Methods and analysis

The Population, Intervention, Comparator, Outcome and Study design (PICOS) framework will be used to structure the review, inform study selection and analysis. The databases MEDLINE, Web of Science, Cochrane and the trial registry ClinicalTrials.gov will be systematically searched to identify published studies and registry entries in English. Two independent reviewers will screen study titles, abstracts and full text for eligibility, with disagreements being resolved through discussion or by a third reviewer where necessary. Data on general study information, eligibility criteria, outcome measures, trial design, retention and statistically significant findings will be extracted into a standardised form. Extracted data will be presented in a descriptive analysis. We will report our findings using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review extension.

Ethics and dissemination

This work will provide an overview of variation and emerging trends in trial design choices for disease-modifying trials of PD. Due to the nature of this study, there are no ethical or safety considerations. We plan to publish our findings in a peer-reviewed journal.

Researcher‐initiated role play, stimulated recall interview, storycrafting, painting and drawing as research methods to reach children's perspectives in health sciences

Abstract

Aim

To describe the application of selected creative and participatory research methods in nursing science.

Design

Research methodology paper.

Methods

Researcher-initiated role play, stimulated recall interviews, the Storycrafting method, painting and drawing. Altogether, 11 children (5–7 years old) and 12 parents participated in the research.

Results

Each small group (n = 3) acted differently during the data collection. Not every child wanted to play, draw or tell stories, but they all expressed their views through some method. Although the same themes emerged from children's narratives, they could not have been verified by just one method.

Conclusions

Using creative and participatory methods and the principles of studies of child perspectives are applicable ways of conducting research in nursing science. Children must be treated as individuals during the research process, and they must have opportunities to use several communication methods to express their views.

Implications for the profession and patient care

Understanding different ways to interact with children and hear children's views will help nurses to encounter children.

Impact

In this article, we present a valid way of conducting research with children. By following our protocol, nursing research from a child perspective can be implemented.

Reporting Method

Consolidated criteria for reporting qualitative research (COREQ).

Patient Contribution

The child participants were involved in choosing physical places for data collection and the usage and order of the selected methods. Both the children and the adult participants took part in interpreting the research data.

Frontline nurse leaders' competences in evidence‐based healthcare: A scoping review

Abstract

Aim

To identify evidence on frontline nurse leaders' competences in evidence-based healthcare (EBHC) and the instruments measuring these competences.

Design

A scoping review.

Data Sources

The search was conducted in June 2021 and complemented in June 2022. The CINAHL, ProQuest, Medline (Ovid), Scopus, Web of Science databases and MedNar along with the Finnish database Medic were searched.

Review Method

The scoping review was conducted in accordance with the Joanna Briggs institute methodology for scoping reviews. Titles, abstracts and full-text versions were screened independently by two reviewers according to the inclusion criteria. Deductive-inductive content analysis was used to synthesize data.

Results

A total of 3211 articles published between 1997 and 2022 were screened, which resulted in the inclusion of 16 articles. Although frontline nurse leaders had a positive attitude towards EBHC, they had a lack of implementing EBHC competence into practice. Part of the instruments were used in the studies, and only one focused especially on leaders. None of instruments systematically covered all segments of EBHC.

Conclusion

There is a limited understanding of frontline nurse leaders' competence in EBHC. It is important to understand the importance of EBHC in healthcare and invest in the development of its competence at all levels of leaders. Frontline nurse leaders' support is essential for direct care nurses to use EBHC to ensure the quality of care and benefits to patients. Leaders must enhance their own EBHC competence to become role models for direct care nurses. It is also essential to develop valid and reliable instruments to measure leaders' competence covering all EBHC segments. The results can be utilized in the assessment and development of frontline nurse leaders' EBHC competence by planning and producing education and other competence development methods.

Cohort profile: Genetic data in the German Socio-Economic Panel Innovation Sample (SOEP-G)

by Philipp D. Koellinger, Aysu Okbay, Hyeokmoon Kweon, Annemarie Schweinert, Richard Karlsson Linnér, Jan Goebel, David Richte, Lisa Reiber, Bettina Maria Zweck, Daniel W. Belsky, Pietro Biroli, Rui Mata, Elliot M. Tucker-Drob, K. Paige Harden, Gert Wagner, Ralph Hertwig

The German Socio-Economic Panel (SOEP) serves a global research community by providing representative annual longitudinal data of respondents living in private households in Germany. The dataset offers a valuable life course panorama, encompassing living conditions, socioeconomic status, familial connections, personality traits, values, preferences, health, and well-being. To amplify research opportunities further, we have extended the SOEP Innovation Sample (SOEP-IS) by collecting genetic data from 2,598 participants, yielding the first genotyped dataset for Germany based on a representative population sample (SOEP-G). The sample includes 107 full-sibling pairs, 501 parent-offspring pairs, and 152 triads, which overlap with the parent-offspring pairs. Leveraging the results from well-powered genome-wide association studies, we created a repository comprising 66 polygenic indices (PGIs) in the SOEP-G sample. We show that the PGIs for height, BMI, and educational attainment capture 22∼24%, 12∼13%, and 9% of the variance in the respective phenotypes. Using the PGIs for height and BMI, we demonstrate that the considerable increase in average height and the decrease in average BMI in more recent birth cohorts cannot be attributed to genetic shifts within the German population or to age effects alone. These findings suggest an important role of improved environmental conditions in driving these changes. Furthermore, we show that higher values in the PGIs for educational attainment and the highest math class are associated with better self-rated health, illustrating complex relationships between genetics, cognition, behavior, socio-economic status, and health. In summary, the SOEP-G data and the PGI repository we created provide a valuable resource for studying individual differences, inequalities, life-course development, health, and interactions between genetic predispositions and the environment.

Comparison of national and international sedentary behaviour and physical activity guidelines for older adults: A systematic review and quality appraisal with AGREE II

by Amy Huang, Ellen Wang, Stephanie Sanger, Alexandra Papaioannou, Isabel B. Rodrigues

Most older adults 65 years and older accumulate over 8.5 hours/day of sedentary time, which is associated with increased risk of metabolic syndromes and falls. The impact of increased sedentary time in older adults has prompted development of sedentary behaviour guidelines. The purpose of our review was to compare national and international sedentary behaviour and physical activity guidelines for older adults and appraise the quality of guidelines using AGREE II. We conducted our search in Medline, Embase, Global Health, Web of Science, CINAHL, and relevant grey literature. We included the most recent guidelines for older adults written in English. We identified 18 national and international guidelines; ten of the 18 guidelines included sedentary behaviour recommendations while all 18 included physical activity recommendations for older adults. The ten sedentary behaviour guidelines were developed using cohort studies, knowledge users’ opinions, systematic reviews, or other guidelines while the physical activity guidelines were developed using randomized controlled trials, systematic reviews, meta-analysis, and overview of reviews. The definition of sedentary behaviour and the recommendations were inconsistent between the guidelines and were based on very low to low quality and certainty of evidence. All guidelines provided consistent recommendations for aerobic and resistance training; the recommendations were developed using moderate to high quality and certainty of evidence. Only eight physical activity guidelines provided recommendations for balance training and six on flexibility training; the balance training recommendations were consistent between guidelines and based on moderate quality evidence. Further work is needed to develop evidenced-based sedentary behaviour recommendations and flexibility training recommendations for older adults.

Individual, family, and environmental determinants of vision-related quality of life of children and young people with visual impairment

by Ana Šemrov, Valerija Tadić, Mario Cortina-Borja, Jugnoo Sangeeta Rahi, on behalf of The Resilience and Childhood Visual Impairment Study Group

Childhood visual impairment can have a significant impact on an individual’s development. To improve clinical care and develop appropriate psychosocial interventions of these patients, it is necessary to understand the contributing and modifiable factors that both identify individuals in greater need and could be targeted in interventions. Here we investigate the broader individual, family, and environmental factors associated with vision-related quality of life (VQoL) of children and young people with visual impairment (CYP-VI). Data for this cross-sectional study were collected from September 2014 to May 2017 to develop and validate two vision-specific patient-reported outcome measures (PROMs) for CYP-VI. Patients were recruited from 22 hospitals in the United Kingdom and were aged 7–18 years with visual impairment as per WHO criteria. Participants self-completed the two PROMs, VQoL and Functional Vision Questionnaires. Clinical characteristics were extracted from medical records. Their carers provided information on family sociodemographic backgrounds. Associations between the VQoL scores and other factors were examined using Spearman’s correlation, Kruskal-Wallis, Wilcoxon rank-sum tests, and quantile regression models. The sample consisted of 152 CYP-VI (67 females). Better VQoL was significantly associated with better functional vision overall (rSpearman = –0.52), parent-reported absence of additional chronic conditions (dCohen = 0.46), attending mainstream (versus other) school (dCohen = 0.44), higher socio-economic status (rSpearman = 0.17) and higher parental education level (rSpearman = 0.20). No other investigated factors were significantly associated with VQoL. The final quantile regression model included functional vision scores and the presence of additional health condition. Variation in self-reported VQoL in CYP-VI can be partly accounted for by factors relating to the clinical status of the affected child and, more importantly, by non-health-related factors. This needs to be considered in clinical practice when assessing vision-specific outcomes and providing support to CYP-VI, as well as in the development of future interventions.
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