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Role of patient characteristics in adherence to first-line treatment guidelines in breast, lung and prostate cancer: insights from the Nordic healthcare system

Por: Sandström · N. · Leppälä · E. · Jekunen · A. · Johansson · M. · Andersen · H.
Objectives

This study investigates the influence of socioeconomic status, health literacy, and numeracy on treatment decisions and the occurrence of adverse events in patients with breast, lung, and prostate cancer within a Nordic healthcare setting.

Design

A follow-up to a cross-sectional, mixed-methods, single-centre study.

Setting

A Nordic, tertiary cancer clinic.

Participants

A total of 244 participants with breast, lung and prostate cancer were initially identified, of which 138 first-line treatment participants were eligible for this study. First-line treatment participants (n=138) surpassed the expected cases (n=108).

Interventions

Not applicable as this was an observational study.

Primary and secondary outcome measures

The study’s primary endpoint was the rate of guideline adherence. The secondary endpoint involved assessing treatment toxicity in the form of adverse events.

Results

Guideline-adherent treatment was observed in 114 (82.6%) cases. First-line treatment selection appeared uninfluenced by participants’ education, occupation, income or self-reported health literacy. A minority (3.6%) experienced difficulties following treatment instructions, primarily with oral cancer medications.

Conclusions

The findings indicated lesser cancer health disparities regarding guideline adherence and treatment toxicity within the Nordic healthcare framework. A causal connection may not be established; however, the findings contribute to discourse on equitable cancer health provision.

Factors associated with changes in walking performance in individuals 3 months after stroke or TIA: secondary analyses from a randomised controlled trial of SMS-delivered training instructions in Sweden

Por: Vahlberg · B. M. · Eriksson · S. · Holmbäck · U. · Lundström · E.
Objectives

This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA.

Design

Cross-sectional study with post hoc analysis of a randomised controlled study.

Setting

University Hospital, Sweden.

Participants

79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test.

Intervention

The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care.

Outcome measures

Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test.

Results

Multiple regression analyses showed that age (standardised beta –0.33, 95% CI –3.8 to –1.05, p

Conclusions

Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.

Trial registration number

NCT02902367.

BioMEL: a translational research biobank of melanocytic lesions and melanoma

Por: Helkkula · T. · Christensen · G. · Ingvar · C. · Isaksson · K. · Harbst · K. · Persson · B. · Ingvar · A. · Hafström · A. · Carneiro · A. · Gaspar · V. · Jönsson · G. · Nielsen · K.
Introduction

Diagnosing invasive cutaneous melanoma (CM) can be challenging due to subjectivity in distinguishing equivocal nevi, melanoma in situ and thin CMs. The underlying molecular mechanisms of progression from nevus to melanoma must be better understood. Identifying biomarkers for treatment response, diagnostics and prognostics is crucial. Using biomedical data from biobanks and population-based healthcare data, translational research can improve patient care by implementing evidence-based findings. The BioMEL biobank is a prospective, multicentre, large-scale biomedical database on equivocal nevi and all stages of primary melanoma to metastases. Its purpose is to serve as a translational resource, enabling researchers to uncover objective molecular, genotypic, phenotypic and structural differences in nevi and all stages of melanoma. The main objective is to leverage BioMEL to significantly improve diagnostics, prognostics and therapy outcomes of patients with melanoma.

Methods and analysis

The BioMEL biobank contains biological samples, epidemiological information and medical data from adult patients who receive routine care for melanoma. BioMEL is focused on primary and metastatic melanoma, but equivocal pigmented lesions such as clinically atypical nevi and melanoma in situ are also included. BioMEL data are gathered by questionnaires, blood sampling, tumour imaging, tissue sampling, medical records and histopathological reports.

Ethics and dissemination

The BioMEL biobank project is approved by the national Swedish Ethical Review Authority (Dnr. 2013/101, 2013/339, 2020/00469, 2021/01432 and 2022/02421-02). The datasets generated are not publicly available due to regulations related to the ethical review authority.

Trial registration number

NCT05446155.

Self-Management Analysis in Chronic Conditions (SMACC) checklist: an international consensus-based tool to develop, compare and evaluate self-management support programmes

Por: Moreels · T. · Cruyt · E. · De Baets · S. · Andries · L. · Arts-Tielemans · M. · Rodriguez-Bailon · M. · Bergström · A. · Boete · K. · Bormans · I. · Costa · U. · Declercq · H. · Dekelver · S. · Dekyvere · V. · Delooz · E. · Engels · C. · Helderweirt · S. · Jarrey · M. · Lenaerts · A.
Objectives

The Self-Management Analysis in Chronic Conditions (SMACC) checklist was developed as a guidance tool to support the development, comparison and evaluation of self-management support programmes for persons with a chronic condition. The checklist was based on a previously performed concept analysis of self-management. The aim of this study was to validate its content using an international Delphi study and to deliver a final version.

Design

A two-round Delphi study was conducted between October 2022 and January 2023. Using the researchers’ networks, professionals with research or clinical expertise in self-management support and chronic conditions were recruited via online purposive snowball sampling. Participants were asked to score each item of the checklist (16 items total) on 3 content validity indicators: (1) clarity and comprehensibility, (2) relevance and importance and (3) degree of alignment with the overall goal of the checklist to promote adequate and comprehensive self-management support programmes. A consensus threshold of 75% agreement was used. The participants were also asked general questions about the checklist as a whole and were asked to provide feedback considering its refinement.

Results

Fifty-four professionals with an average 14.5 years of experience participated in round 1, 48 with an average 12.5 years of experience participated in round 2. The majority of professionals were from Western Europe. For the majority of items consensus was reached after round 1. In round 2, 3 of the 4 remaining items reached consensus, 1 last item was retained based on highly recurring feedback.

Conclusions

The SMACC checklist was considered a valid and comprehensive tool to aid the development, evaluation and comparison of self-management support programmes. It was acknowledged as a useful instrument to supplement existing frameworks and was seen as feasible to implement in both research and clinical settings. Further validation in the field, with input from patients and peer experts, will be valuable.

Patient experience of a virtual reality calm room in a psychiatric inpatient care setting in Sweden: a qualitative study with inpatients

Por: Ilioudi · M. · Wallström · S. · Steingrimsson · S. · Lindner · P. · Thunström · A. O. · Ali · L.
Objective

Calm rooms have been developed and implemented in psychiatric inpatient care settings to offer patients a dedicated space for relaxation in a convenient and safe environment. Recent technology developments have enabled virtual reality (VR) equivalents of calm rooms that can be feasibly deployed in psychiatric care settings. While research has shown VR environments to be efficacious in inducing relaxation, little is known how these virtual calm rooms are perceived by patients. The aim of this study was to elucidate patient experiences of using a VR calm room in a psychiatric inpatient setting.

Design

Qualitative interview study. Semi-structured interviews were analysed using qualitive inductive content analysis, which focuses on the interpretation of texts for making replicable and valid inferences.

Setting

Swedish hospital psychiatric inpatient care setting with a wireless, three degrees-of-freedom VR head-mounted display running a calm room application simulating nature environment.

Participants

20 adult patients (12 women) with bipolar disorder (n=18) or unipolar depression (n=2).

Results

Participants experienced the use of the VR calm room as having a positive impact on them, inducing awareness, calmness and well-being. They were thankful to be offered a non-pharmacological alternative for anxiety relief. Participants also expressed that they had some concerns about how they would react emotionally before using the VR device. However, after use, they highlighted that their overall experience was positive. They also expressed that they could see potential for further development of VR technology in psychiatric care.

Conclusions

VR technology has the potential to solve pressing logistic issues in offering calm rooms in psychiatric inpatient care. VR calm rooms appear to be appreciated by psychiatric inpatients, who value their accessibility, convenience and variety of modalities offered. Participants perceived an increase in their well-being after use.

ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden--a phase III randomised double-blinded placebo-controll

Por: Rodriguez-Wallberg · K. A. · Nilsson · H. P. · Bergh · J. · Malmros · J. · Ljungman · P. · Foukakis · T. · Stragliotto · C. L. · Friman · E. I. · Linderholm · B. · Valachis · A. · Andersson · A. · Harrysson · S. · Vennström · L. · Frisk · P. · Mörse · H. · Eloranta · S.
Background

Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.

Methods and analysis

A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14–42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer.

Ethics and dissemination

This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database.

Study registration

The National Institutional review board in Sweden dnr:2021–03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253.

Trial registration number

NCT05328258; EudraCT number:2020-004780-71.

Make My Day: primary prevention of stroke using engaging everyday activities as a mediator of sustainable health - a randomised controlled trial and process evaluation protocol

Por: Patomella · A.-H. · Guidetti · S. · Hagströmer · M. · Olsson · C. B. · Jakobsson · E. · Nilsson · G. H. · Akesson · E. · Asaba · E.
Introduction

The individual, societal and economic benefits of stroke prevention are high. Even though most risk factors can be reduced by changes to lifestyle habits, maintaining new and healthy activity patterns has been shown to be challenging.

The aim of the study is to evaluate the impact of an interdisciplinary team-based, mHealth-supported prevention intervention on persons at risk for stroke. The intervention is mediated by engaging everyday activities that promote health. An additional aim is to describe a process evaluation that serves to increase knowledge about how the programme leads to potential change by studying the implementation process and mechanisms of impact.

Methods and analysis

The study will be a randomised controlled trial including 104 persons at risk for stroke. Persons at risk of stroke (n=52) will be randomised to an mHealth-supported stroke prevention programme. Controls will have ordinary primary healthcare (PHC) services. The 10-week programme will be conducted at PHC clinics, combining group meetings and online resources to support self-management of lifestyle change using engaging everyday activities as a mediator. Primary outcomes are stroke risk, lifestyle habits and participation in health-promoting activities. Assessments will be performed at baseline and at follow-up (11 weeks and 12 months). The effects of the programme will be analysed using inferential statistics. Implementation will be analysed using qualitative and quantitative methods.

Ethics and dissemination

The study has been approved by the Swedish Ethical Review Authority. Study results will be disseminated in peer-reviewed journals and at regional and international conferences targeting mixed audiences.

Trial registration number

NCT05279508.

School health professionals understanding of culture: a scoping review protocol

Por: Wahlström · E. · Landerdahl Stridsberg · S. · Larsson · C. · Stier · J.
Introduction

Culture is highlighted in previous research as important in encounters where health professionals and children do not share a language or culture. In these encounters, culture is described as mainly related to the child, whereas the health professionals’ understanding of their own culture as impacting the encounter tends to be left out. To clarify how culture is understood and conceptualised among professionals, it is of relevance to collate previous research on health professionals’ understanding of culture. In the scoping review that this protocol describes, we aim to focus on the context of the school health services, being a context accessible to many children in their everyday life. The aim of the review will be to identify, describe and analyse previous research concerning school health professionals’ (ie, school nurses, school social workers, school doctors and school psychologists) understanding of culture.

Methods and analysis

This scoping review will be guided by the methodology described by Peters et al and Khalil et al. Searches will be conducted in Scopus, PubMed, Cinahl Plus, SocIndex, Sociological Abstracts, Social Services Abstracts, APA PsycInfo, APA PsycArticles, Web of Science and Applied Social Sciences Index & Abstracts (ASSIA). Any published scientific papers focusing on school health professionals’ understanding of culture (conceptualised through a variety of related terms) and school health services conducted within the last 10 years (2013–2023) will be included. Two reviewers will independently screen all titles and abstracts for inclusion. Two reviewers will conduct the screening of full-text documents and the extraction of information. Qualitative content analysis as well as discourse analysis will be employed.

Ethics and dissemination

Ethical approval is not required for this study. The findings will be disseminated through peer review publication as well as presentation at conferences and to relevant stakeholders.

Accelerometer derived physical activity and subclinical coronary and carotid atherosclerosis: cross-sectional analyses in 22 703 middle-aged men and women in the SCAPIS study

Por: Ekblom-Bak · E. · Börjesson · M. · Ekblom · O. · Angeras · O. · Bergman · F. · Berntsson · C. · Carlhäll · C.-J. · Engström · G. · Engvall · J. · Fagman · E. · Flinck · A. · Johansson · P. · Jujic · A. · Kero · T. · Lind · L. · Mannila · M. · Ostenfeld · E. · Persson · A. · Persson
Objectives

The aim included investigation of the associations between sedentary (SED), low-intensity physical activity (LIPA), moderate-to-vigorous intensity PA (MVPA) and the prevalence of subclinical atherosclerosis in both coronaries and carotids and the estimated difference in prevalence by theoretical reallocation of time in different PA behaviours.

Design

Cross-sectional.

Setting

Multisite study at university hospitals.

Participants

A total of 22 670 participants without cardiovascular disease (51% women, 57.4 years, SD 4.3) from the population-based Swedish CArdioPulmonary bioImage study were included. SED, LIPA and MVPA were assessed by hip-worn accelerometer.

Primary and secondary outcomes

Any and significant subclinical coronary atherosclerosis (CA), Coronary Artery Calcium Score (CACS) and carotid atherosclerosis (CarA) were derived from imaging data from coronary CT angiography and carotid ultrasound.

Results

High daily SED (>70% 10.5 hours/day) associated with a higher OR 1.44 (95% CI 1.09 to 1.91), for significant CA, and with lower OR 0.77 (95% CI 0.63 to 0.95), for significant CarA. High LIPA (>55% 8 hours/day) associated with lower OR for significant CA 0.70 (95% CI 0.51 to 0.96), and CACS, 0.71 (95% CI 0.51 to 0.97), but with higher OR for CarA 1.41 (95% CI 1.12 to 1.76). MVPA above reference level, >2% 20 min/day, associated with lower OR for significant CA (OR range 0.61–0.67), CACS (OR range 0.71–0.75) and CarA (OR range 0.72–0.79). Theoretical replacement of 30 min of SED into an equal amount of MVPA associated with lower OR for significant CA, especially in participants with high SED 0.84 (95% CI 0.76 to 0.96) or low MVPA 0.51 (0.36 to 0.73).

Conclusions

MVPA was associated with a lower risk for significant atherosclerosis in both coronaries and carotids, while the association varied in strength and direction for SED and LIPA, respectively. If causal, clinical implications include avoiding high levels of daily SED and low levels of MVPA to reduce the risk of developing significant subclinical atherosclerosis.

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the e

Por: Engdahl · J. · Straat · K. · Isaksson · E. · Rooth · E. · Svennberg · E. · Norrving · B. · Euler · M. v. · Hellqvist · K. · Gu · W. · Ström · J. O. · Själander · S. · Eriksson · M. · Asberg · S. · Wester · P.
Introduction

Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.

Methods and analysis

AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.

Ethics and dissemination

Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.

Trial registration number

NCT05134454.

Association between anxiety and depression and all-cause mortality: a 50-year follow-up of the Population Study of Women in Gothenburg, Sweden

Por: von Below · A. · Hällström · T. · Sundh · V. · Björkelund · C. · Hange · D.
Objectives

This study aimed to examine the association between anxiety disorders and/or major depression disorder (ADs/MDD) and all-cause mortality in a 50-year perspective and to examine specific risk and health factors that may influence such an association.

Design

Observational population study, 1968–2019.

Setting

The Population Study of Women in Gothenburg, Sweden (PSWG).

Participants

In 1968–1969, 899 (out of 1462) women from PSWG were selected according to date of birth for a psychiatric investigation, including diagnostic evaluation. Eight hundred (89%) were accepted. Twenty-two women were excluded. Of the 778 included, 135 participants (17.4 %) had solely ADs, 32 (4.1%) had solely MDD and 25 (3.2%) had comorbid AD/MDD.

Primary and secondary outcome measures

Associations between ADs, MDD, comorbid AD/MDD and all-cause mortality with adjustments for potential confounding factors. Differences between the groups concerning health and risk factors and their association with mortality.

Results

In a fully adjusted model, ADs were non-significantly associated with all-cause mortality (HR 1.17, 95% CI 0.98 to 1.41). When examining age during risk time as separate intervals, a significant association between mortality and AD was seen in the group of participants who died at the age of 65–80 years (HR 1.70, 95% CI 1.26 to 2.29). In the younger or older age interval, the association did not reach significance at the 95% level of confidence. Among confounding factors, smoking and physical activity were the strongest contributors. The association between smoking and mortality tended to be further increased in the group with ADs versus the group without such disorders (HR 2.10, 95% CI 1.60 to 2.75 and HR 1.82, 95% CI 1.56 to 2.12, respectively).

Conclusions

This study suggests potential links between ADs, age and mortality among women with 50 years of follow-up, but does not provide definitive conclusions due to the borderline significance of the results.

Treatment of schizotypal disorder: a protocol for a systematic review of the evidence and recommendations for clinical practice

Por: Gundersen · K. B. · Rasmussen · A. R. · Sandström · K. O. · Albert · N. · Polari · A. · Ebdrup · B. H. · Nelson · B. · Glenthoj · L. B.
Introduction

Schizotypal disorder is associated with a high level of disability at an individual level and high societal costs. However, clinical recommendations for the treatment of schizotypal disorder are scarce and based on limited evidence. This review aims to synthesise the current evidence on treatment for schizotypal disorder making recommendations for clinical practice.

Methods and analysis

This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic literature search will be performed in PsychArticles, Embase, Medline and Cochrane Central Register of Controlled Trials. Additionally, we will search for relevant articles manually. Inclusion criteria are published studies including individuals diagnosed with schizotypal personality disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria, or schizotypal disorder according to International Classification of Diseases (ICD) criteria. We will include interventional studies comprising any pharmacological and non-pharmacological treatment trials for patients with schizotypal disorder, and all relevant outcome measures will be reported. Risk of bias will be assessed by Cochrane risk-of-bias tools. Data will be synthesised using narrative or thematic analysis and, if suitable, through meta-analysis.

Ethics and dissemination

No original data will be collected as part of this study and ethics approval is, therefore, not applicable. The results will be disseminated through peer-reviewed publication and presented at international scientific meetings. We will aim at submitting the final paper for publication within 4 months of completion of analyses. Furthermore, this systematic review will inform clinicians and researchers on the current state of evidence on treatment for schizotypal disorder. Findings may guide proposals for further research and potentially guide recommendations for clinical practice using the Grading of Recommendations Assessment, Development and Evaluation.

PROSPERO registration number

CRD42022375001.

Associations between the Abilitator, a self-reported measurement tool of work ability and functioning, and national register-based indicators of health and employment

Por: Kausto · J. · Gluschkoff · K. · Poutanen · J. · Wikström · M. · Joensuu · M.
Objectives

The Abilitator is a recently developed self-reported measurement tool for work ability and functioning of people in a weak labour market position. The aim of this study was to describe how self-reported information gathered with the Abilitator corresponds to information drawn from national registers.

Design, setting and participants

Participants (n=669, mean age 44 years, 55% women) took part in the Work Ability Programme (2020–2023) that provided services for unemployed people with reduced work ability. They filled in the Abilitator questionnaire at the start of the service. Register-based data on participants’ health, income and received benefits was drawn from national registers. We evaluated how the different types of indicators concurred.

Results

Statistically significant correlations (from weak to moderate) were found between different domains of the Abilitator and register-based data. Also, participants’ health status (information on mental health or musculoskeletal disorders) was displayed coherently in the results of the Abilitator. Overall, diagnosed mental health disorders distinguished participants’ Abilitator responses more strongly than diagnosed musculoskeletal disorders.

Conclusions

These findings provide further evidence on the applicability of the Abilitator as an instrument to evaluate work ability and functioning of people outside the work force.

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