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What are best practices for involving family caregivers in interventions aimed at responsive behaviour stemming from unmet needs of people with dementia in nursing homes: a scoping review

Objectives

This study aimed to determine best practices for involving family caregivers in interventions aimed at preventing and reducing responsive behaviour stemming from unmet needs, including pain.

Design

Scoping review, reported according to the Preferred Reporting Items for Systematic Reviews, Meta-Analyses extension for Scoping Reviews reporting guideline.

Data sources

PubMed, Embase, Emcare, Web of Science, COCHRANE Library, PsycINFO, Academic Search Premier and Cinahl searched up to 23 July 2023.

Eligibility criteria

Studies reporting on family involvement in interventions for nursing home residents with dementia were included.

Data extraction and synthesis

Two researchers independently extracted the data, followed by a content analysis.

Results

Of the 1486 records screened, 20 studies were included. Family caregivers were involved in interventions aimed at planning care, life review (eg, documentation of life experiences of their relative), and selecting activities for their relative. Family caregivers preferred an active role in developing optimal care for their relative. Drivers of success and barriers to family involvement centred around three themes: (1) communication between all involved; (2) prerequisites (organisational and other conditions) and (3) personal circumstances (family’s coping and skills).

Conclusion

Best practices for involving family caregivers in interventions aimed at addressing responsive behaviour in residents with dementia concerned those interventions in which family caregivers were given an important role in managing responsive behaviour. This means that, in order to achieve an active role of family caregivers in the whole care process, their needs must be taken into account.

Trial registration number

The protocol of the review was regisered at OSF; https://osf.io/twcfq

ARCHERY: a prospective observational study of artificial intelligence-based radiotherapy treatment planning for cervical, head and neck and prostate cancer - study protocol

Por: Aggarwal · A. · Court · L. E. · Hoskin · P. · Jacques · I. · Kroiss · M. · Laskar · S. · Lievens · Y. · Mallick · I. · Abdul Malik · R. · Miles · E. · Mohamad · I. · Murphy · C. · Nankivell · M. · Parkes · J. · Parmar · M. · Roach · C. · Simonds · H. · Torode · J. · Vanderstraeten · B. · Lan
Introduction

Fifty per cent of patients with cancer require radiotherapy during their disease course, however, only 10%–40% of patients in low-income and middle-income countries (LMICs) have access to it. A shortfall in specialised workforce has been identified as the most significant barrier to expanding radiotherapy capacity. Artificial intelligence (AI)-based software has been developed to automate both the delineation of anatomical target structures and the definition of the position, size and shape of the radiation beams. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy.

Methods

ARCHERY is a non-randomised prospective study to evaluate the quality and economic impact of AI-based automated radiotherapy treatment planning for cervical, head and neck, and prostate cancers, which are endemic in LMICs, and for which radiotherapy is the primary curative treatment modality. The sample size of 990 patients (330 for each cancer type) has been calculated based on an estimated 95% treatment plan acceptability rate. Time and cost savings will be analysed as secondary outcome measures using the time-driven activity-based costing model. The 48-month study will take place in six public sector cancer hospitals in India (n=2), Jordan (n=1), Malaysia (n=1) and South Africa (n=2) to support implementation of the software in LMICs.

Ethics and dissemination

The study has received ethical approval from University College London (UCL) and each of the six study sites. If the study objectives are met, the AI-based software will be offered as a not-for-profit web service to public sector state hospitals in LMICs to support expansion of high quality radiotherapy capacity, improving access to and affordability of this key modality of cancer cure and control. Public and policy engagement plans will involve patients as key partners.

Optimising HIV care using information obtained from PROMs: protocol for an observational study

Por: Moody · K. · Nieuwkerk · P. T. · Bedert · M. · Nellen · J. F. · Weijsenfeld · A. · Sigaloff · K. C. E. · Laan · L. · Bruins · C. · van Oers · H. · Haverman · L. · Geerlings · S. E. · Van der Valk · M.
Introduction

Successful antiviral therapy has transformed HIV infection into a chronic condition, where optimising quality of life (QoL) has become essential for successful lifelong treatment. Patient-reported outcome measures (PROMs) can signal potential physical and mental health problems related to QoL. This study aims to determine whether PROMs in routine clinical care improve quality of care as experienced by people with HIV (PWH).

Methods and analysis

We report the protocol of a multicentre longitudinal cohort studying PWH at Amsterdam University Medical Centres in the Netherlands. PROMs are offered annually to patients via the patient portal of the electronic health record. Domains include anxiety, depression, fatigue, sleep disturbances, social isolation, physical functioning, stigma, post-traumatic stress disorder, adherence, drug and alcohol use and screening questions for sexual health and issues related to finances, housing and migration status. Our intervention comprises (1) patients’ completion of PROMs, (2) discussion of PROMs scores during annual consultations and (3) documentation of follow-up actions in an individualised care plan, if indicated. The primary endpoint will be patient-experienced quality of care, measured by the Patient Assessment of Chronic Illness Care, Short Form (PACIC-S). Patients will provide measurements at baseline, year 1 and year 2. We will explore change over time in PACIC-S and PROMs scores and examine the sociodemographical and HIV-specific characteristics of subgroups of patients who participated in all or only part of the intervention to ascertain whether benefit has been achieved from our intervention in all subgroups.

Ethics and dissemination

Patients provide consent for the analysis of data collected as part of routine clinical care to the AIDS Therapy Evaluation in the Netherlands study (ATHENA) cohort through mechanisms described in Boender et al. Additional ethical approval for the analysis of these data is not required under the ATHENA cohort protocol. The results will be presented at national and international academic meetings and submitted to peer-reviewed journals for publication.

Statistical methods applied for the assessment of the HIV cascade and continuum of care: a systematic scoping review

Por: Kalinjuma · A. V. · Glass · T. R. · Masanja · H. · Weisser · M. · Msengwa · A. S. · Vanobberghen · F. · Otwombe · K.
Objectives

This scoping review aims to identify and synthesise existing statistical methods used to assess the progress of HIV treatment programmes in terms of the HIV cascade and continuum of care among people living with HIV (PLHIV).

Design

Systematic scoping review.

Data sources

Published articles were retrieved from PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) Complete and Excerpta Medica dataBASE (EMBASE) databases between April and July 2022. We also strategically search using the Google Scholar search engine and reference lists of published articles.

Eligibility criteria

This scoping review included original English articles that estimated and described the HIV cascade and continuum of care progress in PLHIV. The review considered quantitative articles that evaluated either HIV care cascade progress in terms of the Joint United Nations Programme on HIV and AIDS targets or the dynamics of engagement in HIV care.

Data extraction and synthesis

The first author and the librarian developed database search queries and screened the retrieved titles and abstracts. Two independent reviewers and the first author extracted data using a standardised data extraction tool. The data analysis was descriptive and the findings are presented in tables and visuals.

Results

This review included 300 articles. Cross-sectional study design methods were the most commonly used to assess the HIV care cascade (n=279, 93%). In cross-sectional and longitudinal studies, the majority used proportions to describe individuals at each cascade stage (276/279 (99%) and 20/21 (95%), respectively). In longitudinal studies, the time spent in cascade stages, transition probabilities and cumulative incidence functions was estimated. The logistic regression model was common in both cross-sectional (101/279, 36%) and longitudinal studies (7/21, 33%). Of the 21 articles that used a longitudinal design, six articles used multistate models, which included non-parametric, parametric, continuous-time, time-homogeneous and discrete-time multistate Markov models.

Conclusions

Most literature on the HIV cascade and continuum of care arises from cross-sectional studies. The use of longitudinal study design methods in the HIV cascade is growing because such methods can provide additional information about transition dynamics along the cascade. Therefore, a methodological guide for applying different types of longitudinal design methods to the HIV continuum of care assessments is warranted.

Organisation and delivery of supportive services for patients with prostate cancer in the National Health Service in England and Wales: a national cross-sectional hospital survey and latent class analysis

Por: Dodkins · J. · Cook · A. · Morris · M. · Nossiter · J. · Prust · S. · Waller · S. · van der Meulen · J. · Aggarwal · A. · Clarke · N. · Payne · H. A.
Objectives

We assessed how often National Health Service (NHS) hospitals reported that they had specific supportive services for patients with prostate cancer available onsite, including nursing support, sexual function and urinary continence services, psychological and genetic counselling, and oncogeriatric services. We identified groups of hospitals with similar patterns of supportive services.

Design/setting

We conducted an organisational survey in 2021 of all NHS hospitals providing prostate cancer services in England and Wales. Latent class analysis grouped hospitals with similar patterns of supportive services.

Results

In 138 hospitals, an advanced prostate cancer nurse was available in 125 hospitals (90.6%), 107 (77.5%) had a clinical nurse specialist (CNS) attending all clinics, 103 (75.7%) had sexual function services, 111 (81.6%) had continence services and 93 (69.4%) psychological counselling. The availability of genetic counselling (41 hospitals, 30.6%) and oncogeriatric services (15 hospitals, 11.0%) was lower. The hospitals could be divided into three groups. The first and largest group of 85 hospitals provided the most comprehensive supportive services onsite: all hospitals had a CNS attending all clinics, 84 (98.8%) sexual function services and 73 (85.9%) continence services. A key characteristic of the second group of 31 hospitals was that none had a CNS attending all clinics. A key characteristic of the third group of 22 hospitals was that none had sexual function services available. The hospitals in the largest group were more likely to run joint clinics (p

Conclusions

There is considerable variation in supportive services for prostate cancer available onsite in NHS hospitals in England and Wales. Availability of genetic counselling and oncogeriatric services is low. The different patterns of supportive services among hospitals demonstrate that initiatives to improve the availability of the entire range of supportive services to all patients should be carefully targeted.

Maternal serum levels of prokineticin-1 related to pregnancy complications and metformin use in women with polycystic ovary syndrome: a post hoc analysis of two prospective, randomised, placebo-controlled trials

Por: Ujvari · D. · Trouva · A. · Hirschberg · A. L. · Vanky · E.
Objective

Serum prokineticin-1 (s-PROK1) in the second and third trimester of pregnancy is positively correlated to preeclampsia, intrauterine growth restriction (IUGR) and preterm delivery. Women with polycystic ovary syndrome (PCOS) are prone to these adverse pregnancy outcomes. However, the contribution of PROK1 to the development of pregnancy complications and the effect of metformin and hyperandrogenism on s-PROK1 in PCOS have not been studied previously.

Design

This work is a post hoc analysis of two prospective, randomised, placebo-controlled trials.

Setting

Pregnant women with PCOS were included from 11 study centres in Norway.

Participants

From 313 women, 264 participated in the present study after exclusions due to dropouts or insufficient serum samples.

Intervention

Women with PCOS were randomly administered with metformin or placebo, from first trimester to delivery.

Primary and secondary outcome measures

s-PROK1 was analysed using ELISA at gestational week 19 and related to pregnancy complications, fasting insulin levels, homoeostatic model assessment for insulin resistance (HOMA-IR), testosterone, or androstenedione levels, metformin use, PCOS phenotype and hyperandrogenism.

Results

Maternal s-PROK1 in the second trimester did not predict pregnancy-induced hypertension, pre-eclampsia or late miscarriage/preterm delivery in women with PCOS. However, s-PROK1 was lower in women who used metformin before inclusion, both in those randomised to metformin and to placebo, compared with those who did not. s-PROK1 was also lower in those who used metformin both at conception and during pregnancy compared with those who used metformin from inclusion or did not use metformin at all. s-PROK1 was lower in hyperandrogenic compared with normo-androgenic women with PCOS.

Conclusions

Maternal s-PROK1 in the second trimester did not predict pregnancy complications in PCOS. Those who used metformin at conception and/or during pregnancy had lower s-PROK1. PCOS women with hyperandrogenism exhibited lower s-PROK1 compared with normo-adrogenic phenotypes.

Trial registration number

NCT03259919 and NCT00159536.

Assessment of cervical softening and the prediction of preterm birth (STIPP): protocol for a prospective cohort study

Por: Breuking · S. · Oudijk · M. A. · van Eekelen · R. · de Boer · M. A. · Pajkrt · E. · Hermans · F.
Introduction

Preterm birth (PTB) is among the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is key to enable obstetric healthcare professionals to apply interventions that improve perinatal and childhood outcomes. Serial transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB and identify those at high risk for a recurrent PTB. Cervical length measurement, fetal fibronectin test or a combination of both can be used to identify women at high risk of PTB presenting with symptoms of threatened PTB. The predictive capacity of these methods can be improved. Cervical softening is a precursor of cervical shortening, effacement and dilatation and could be a new marker to identify women a high risk of PTB. However, the predictive value of cervical softening to predict spontaneous PTB still needs to be determined.

Methods and analysis

This is a single-centre, prospective cohort study, conducted at the Amsterdam University Medical Centers in the Netherlands. Cervical softening will be investigated with a non-invasive CE-marked device called the Pregnolia System. This device has been developed to evaluate consistency of the cervix based on tissue elasticity. Two different cohorts will be investigated. The first cohort includes women with a history of spontaneous PTB

Ethics and dissemination

The study is approved by the Medical Ethics Committee of Amsterdam UMC (METC2022.0226). All patients will give oral and written informed consent prior to study entry. Results will be disseminated via a peer-reviewed journal.

Trial registration number

NCT05477381.

What is the aetiology of dysnatraemia in COVID-19 and how is this related to outcomes in patients admitted during earlier and later COVID-19 waves? A multicentre, retrospective observational study in 11 Dutch hospitals

Por: de Haan · L. · ten Wolde · M. · Beudel · M. · Olde Engberink · R. H. G. · Appelman · B. · Haspels-Hogervorst · E. K. · Rusch · D. · Gritters van den Oever · N. C. · Simsek · S. · Paternotte · N. · van den Bergh · J. P. · Wyers · C. E. · de Kruif · M. D. · Dormans · T. · Moeniralam
Objectives

To evaluate the relationship among dysnatraemia at hospital presentation and duration of admission, risk of intensive care unit (ICU) admission and all-cause mortality and to assess the underlying pathophysiological mechanism of hyponatraemia in patients with COVID-19. Our hypothesis is that both hyponatraemia and hypernatraemia at presentation are associated with adverse outcomes.

Design

Observational study.

Setting

Secondary care; 11 Dutch hospitals (2 university and 9 general hospitals).

Participants

An analysis was performed within the retrospective multicentre cohort study COVIDPredict. 7811 patients were included (60% men, 40% women) between 24 February 2020 and 9 August 2022. Patients who were ≥18 years with PCR-confirmed COVID-19 or CT with COVID-19 reporting and data system score≥4 and alternative diagnosis were included. Patients were excluded when serum sodium levels at presentation were not registered in the database or when they had been transferred from another participating hospital.

Outcome measures

We studied demographics, medical history, symptoms and outcomes. Patients were stratified according to serum sodium concentration and urinary sodium excretion.

Results

Hyponatraemia was present in 2677 (34.2%) patients and hypernatraemia in 126 (1.6%) patients. Patients with hyponatraemia presented more frequently with diarrhoea, lower blood pressure and tachycardia. Hyponatraemia was, despite a higher risk for ICU admission (OR 1.27 (1.11–1.46; p

Conclusions

Hypernatraemia at presentation was associated with adverse outcomes in patients with COVID-19. Hypovolaemic hyponatraemia was found to be the most common aetiology of hyponatraemia. Hyponatraemia of unknown aetiology was associated with a higher risk for ICU admission and intubation and longer duration of admission.

Workplace-based learning about health promotion in individual patient care: a scoping review

Por: Verhees · M. J. M. · Engbers · R. · Landstra · A. M. · Bremer · A. E. · van de Pol · M. · Laan · R. F. J. M. · Assendelft · W. J. J.
Objective

To outline current knowledge regarding workplace-based learning about health promotion in individual patient care.

Design

Scoping review.

Data sources

PubMed, ERIC, CINAHL and Web of Science from January 2000 to August 2023.

Eligibility criteria

We included articles about learning (activities) for healthcare professionals (in training), about health promotion in individual patient care and in the context of workplace-based learning.

Data extraction and synthesis

The studies were evaluated using a charting template and were analysed thematically using a template based on Designable Elements of Learning Environments model.

Results

From 7159 studies, we included 31 that described evaluations of workplace-based learning about health promotion, around a variety of health promotion topics, for different health professions. In the articles, health promotion was operationalised as knowledge, skills or attitudes related to specific lifestyle factors or more broadly, with concepts such as health literacy, advocacy and social determinants of health. We assembled an overview of spatial and instrumental, social, epistemic and temporal elements of learning environments in which health promotion is learnt.

Conclusions

The studies included in our analysis varied greatly in their approach to health promotion topics and the evaluation of learning outcomes. Our findings suggest the importance of providing opportunities for health profession learners to engage in authentic practice situations and address potential challenges they may experience translating related theory into practice. Additionally, our results highlight the need for conscious and articulated integration of health promotion in curricula and assessment structures. We recommend the exploration of opportunities for health profession students, professionals and patients to learn about health promotion together. Additionally, we see potential in using participatory research methods to study future health promotion learning.

Study registration

Open Science Framework, https://doi.org/10.17605/OSF.IO/6QPTV.

Infographic summaries for clinical practice guidelines: results from user testing of the BMJ Rapid Recommendations in primary care

Por: Van Bostraeten · P. · Aertgeerts · B. · Bekkering · G. E. · Delvaux · N. · Dijckmans · C. · Ostyn · E. · Soontjens · W. · Matthysen · W. · Haers · A. · Vanheeswyck · M. · Vandekendelaere · A. · Van der Auwera · N. · Schenk · N. · Stahl-Timmins · W. · Agoritsas · T. · Vermandere · M.
Objectives

Infographics have the potential to enhance knowledge translation and implementation of clinical practice guidelines at the point of care. They can provide a synoptic view of recommendations, their rationale and supporting evidence. They should be understandable and easy to use. Little evaluation of these infographics regarding user experience has taken place. We explored general practitioners’ experiences with five selected BMJ Rapid Recommendation infographics suited for primary care.

Methods

An iterative, qualitative user testing design was applied on two consecutive groups of 10 general practitioners for five selected infographics. The physicians used the infographics before clinical encounters and we performed hybrid think-aloud interviews afterwards. 20 interviews were analysed using the Qualitative Analysis Guide of Leuven.

Results

Many clinicians reported that the infographics were simple and rewarding to use, time-efficient and easy to understand. They were perceived as innovative and their knowledge basis as trustworthy and supportive for decision-making. The interactive, expandable format was preferred over a static version as general practitioners focused mainly on the core message. Rapid access through the electronic health record was highly desirable. The main issues were about the use of complex scales and terminology. Understanding terminology related to evidence appraisal as well as the interpretation of statistics and unfamiliar scales remained difficult, despite the infographics.

Conclusions

General practitioners perceive infographics as useful tools for guideline translation and implementation in primary care. They offer information in an enjoyable and user friendly format and are used mainly for rapid, tailored and just in time information retrieval. We recommend future infographic producers to provide information as concise as possible, carefully define the core message and explore ways to enhance the understandability of statistics and difficult concepts related to evidence appraisal.

Trial registration number

MP011977.

What works for and what hinders deimplementation of low-value care in emergency medicine practice? A scoping review

Por: Gangathimmaiah · V. · Drever · N. · Evans · R. · Moodley · N. · Sen Gupta · T. · Cardona · M. · Carlisle · K.
Objectives

Low-value care can harm patients and healthcare systems. Despite a decade of global endeavours, low value care has persisted. Identification of barriers and enablers is essential for effective deimplementation of low-value care. This scoping review is an evidence summary of barriers, enablers and features of effective interventions for deimplementation of low-value care in emergency medicine practice worldwide.

Design

A mixed-methods scoping review was conducted using the Arksey and O’Malley framework.

Data sources

Medline, CINAHL, Embase, EMCare, Scopus and grey literature were searched from inception to 5 December 2022.

Eligibility criteria

Primary studies which employed qualitative, quantitative or mixed-methods approaches to explore deimplementation of low-value care in an EM setting and reported barriers, enablers or interventions were included. Reviews, protocols, perspectives, comments, opinions, editorials, letters to editors, news articles, books, chapters, policies, guidelines and animal studies were excluded. No language limits were applied.

Data extraction and synthesis

Study selection, data collection and quality assessment were performed by two independent reviewers. Barriers, enablers and interventions were mapped to the domains of the Theoretical Domains Framework. The Mixed Methods Appraisal Tool was used for quality assessment.

Results

The search yielded 167 studies. A majority were quantitative studies (90%, 150/167) that evaluated interventions (86%, 143/167). Limited provider abilities, diagnostic uncertainty, lack of provider insight, time constraints, fear of litigation, and patient expectations were the key barriers. Enablers included leadership commitment, provider engagement, provider training, performance feedback to providers and shared decision-making with patients. Interventions included one or more of the following facets: education, stakeholder engagement, audit and feedback, clinical decision support, nudge, clinical champions and training. Multifaceted interventions were more likely to be effective than single-faceted interventions. Effectiveness of multifaceted interventions was influenced by fidelity of the intervention facets. Use of behavioural change theories such as the Theoretical Domains Framework in the published studies appeared to enhance the effectiveness of interventions to deimplement low-value care.

Conclusion

High-fidelity, multifaceted interventions that incorporated education, stakeholder engagement, audit/feedback and clinical decision support, were administered daily and lasted longer than 1 year were most effective in achieving deimplementation of low-value care in emergency departments. This review contributes the best available evidence to date, but further rigorous, theory-informed, qualitative and mixed-methods studies are needed to supplement the growing body of evidence to effectively deimplement low-value care in emergency medicine practice.

Perceptions of conflicting information about long-term medications: a qualitative in-depth interview study of patients with chronic diseases in the Swiss ambulatory care system

Por: Santos · B. · Blondon · K. S. · Sottas · M. · Carpenter · D. · Backes · C. · Van Gessel · E. · Schneider · M. P.
Objective

Patients with multiple long-term conditions visit various healthcare professionals and are exposed to medication information from various sources causing an increased risk of patients perceiving contradictory medication information. The aims of this study are to: (1) characterise conflicting medication information perceived by patients with long-term conditions, (2) better understand the related impact on patients’ medication self-management and healthcare system navigation and (3) explore ways in which such events could be prevented.

Design

This study was conducted through qualitative semistructured interviews. Data were analysed using thematic analysis.

Setting

Community pharmacies and medical centres in Geneva, Switzerland.

Participants

This study included outpatients from April 2019 to February 2020. Patients were included after participating in a quantitative survey of perceived conflicting information about medications for long-term diseases.

Methods

Semistructured audiotaped interviews of 20 to 60 min following a pre-established interview guide to explore participants’ perceptions of conflicting information. Interviews were transcribed verbatim, and a thematic analysis was conducted with inductive and deductive coding using MAXQDA (2018, Release 18.2.3).

Results

Twenty-two patients were interviewed, until data saturation, mentioning indication or need for a medication as the main topic of conflicting information between two healthcare professionals. Perceived conflicting information often resulted from insufficient information provided and poor communication leading to confusion, doubts and medication non-adherence. Patients expected more information and more interprofessional communication on their medications. As a result of conflicting information, most participants learnt or were learning to take an active role and become partners of the healthcare providers.

Conclusion

The need to strengthen and improve communication and interprofessional collaborative practice among healthcare professionals and with the patient is emerging to increase the quality and consistency of information about medications, and consequently, to ensure better use and experience of medications.

Interventions to reduce interpersonal stigma towards patients with a mental dysregulation for ambulance and emergency department healthcare professionals: review protocol for an integrative review

Por: Van de Glind · G. · Galenkamp · N. · Bleijenberg · N. · Schoonhoven · L. · Scheepers · F. E. · Crilly · J. · van Veen · M. · Ham · W. H. W.
Introduction

Worldwide, there is an increase in the extent and severity of mental illness. Exacerbation of somatic complaints in this group of people can result in recurring ambulance and emergency department care. The care of patients with a mental dysregulation (ie, experiencing a mental health problem and disproportionate feelings like fear, anger, sadness or confusion, possibly with associated behaviours) can be complex and challenging in the emergency care context, possibly evoking a wide variety of feelings, ranging from worry or pity to annoyance and frustration in emergency care staff members. This in return may lead to stigma towards patients with a mental dysregulation seeking emergency care. Interventions have been developed impacting attitude and behaviour and minimising stigma held by healthcare professionals. However, these interventions are not explicitly aimed at the emergency care context nor do these represent perspectives of healthcare professionals working within this context. Therefore, the aim of the proposed review is to gain insight into interventions targeting healthcare professionals, which minimise stigma including beliefs, attitudes and behaviour towards patients with a mental dysregulation within the emergency care context.

Methods and analysis

The protocol for a systematic integrative review is presented, using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols recommendations. A systematic search was performed on 13 July 2023. Study selection and data extraction will be performed by two independent reviewers. In each step, an expert with lived experience will comment on process and results. Software applications RefWorks-ProQuest, Rayyan and ATLAS.ti will be used to enhance the quality of the review and transparency of process and results.

Ethics and dissemination

No ethical approval or safety considerations are required for this review. The proposed review will be submitted to a relevant international journal. Results will be presented at relevant medical scientific conferences.

PROSPERO registration number

CRD42023390664 (https://www.crd.york.ac.uk/prospero/).

(Cost-)effectiveness of an individualised risk prediction tool (PERSARC) on patients knowledge and decisional conflict among soft-tissue sarcomas patients: protocol for a parallel cluster randomised trial (the VALUE-PERSARC study)

Introduction

Current treatment decision-making in high-grade soft-tissue sarcoma (STS) care is not informed by individualised risks for different treatment options and patients’ preferences. Risk prediction tools may provide patients and professionals insight in personalised risks and benefits for different treatment options and thereby potentially increase patients’ knowledge and reduce decisional conflict. The VALUE-PERSARC study aims to assess the (cost-)effectiveness of a personalised risk assessment tool (PERSARC) to increase patients’ knowledge about risks and benefits of treatment options and to reduce decisional conflict in comparison with usual care in high-grade extremity STS patients.

Methods

The VALUE-PERSARC study is a parallel cluster randomised control trial that aims to include at least 120 primarily diagnosed high-grade extremity STS patients in 6 Dutch hospitals. Eligible patients (≥18 years) are those without a treatment plan and treated with curative intent. Patients with sarcoma subtypes or treatment options not mentioned in PERSARC are unable to participate. Hospitals will be randomised between usual care (control) or care with the use of PERSARC (intervention). In the intervention condition, PERSARC will be used by STS professionals in multidisciplinary tumour boards to guide treatment advice and in patient consultations, where the oncological/orthopaedic surgeon informs the patient about his/her diagnosis and discusses benefits and harms of all relevant treatment options. The primary outcomes are patients’ knowledge about risks and benefits of treatment options and decisional conflict (Decisional Conflict Scale) 1 week after the treatment decision has been made. Secondary outcomes will be evaluated using questionnaires, 1 week and 3, 6 and 12 months after the treatment decision. Data will be analysed following an intention-to-treat approach using a linear mixed model and taking into account clustering of patients within hospitals.

Ethics and dissemination

The Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) approved this protocol (NL76563.058.21). The results of this study will be reported in a peer-review journal.

Trial registration number

NL9160, NCT05741944.

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