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Subgroup analyses and patterns of multiple sclerosis health service utilisation: A cluster analysis.Multiple Sclerosis Journal -... 2024Previous investigations of multiple sclerosis (MS)-related healthcare have focused on utilisation of specific individual health services (e.g. hospital care,...
BACKGROUND
Previous investigations of multiple sclerosis (MS)-related healthcare have focused on utilisation of specific individual health services (e.g. hospital care, office-based neurologists) by people with MS (PwMS). Meanwhile, little is known about possible patterns of utilisation across health services and their potential differences across patient characteristics.
OBJECTIVE
To comprehensively analyse and identify patterns of MS-related health service utilisation and detect patient characteristics explaining such patterns.
METHODS
In 2021, we invited all PwMS insured by the largest insurance company in Lower Saxony, Germany, to take part in an online survey. We merged respondents' survey and health insurance claims data. We analysed MS-related health service utilisation and defined individual characteristics for subgroup analyses based on Andersen's Behavioural Model. We executed non-parametric missing value imputation and conducted hierarchical clustering to find patterns in health service utilisation.
RESULTS
Of 6928 PwMS, 1935 responded to our survey and 1803 were included in the cluster analysis. We identified four distinct health service utilisation clusters: (1) regular users (n = 1130), (2) assistive care users (n = 443), (3) low users (n = 195) and (4) special services users (n = 35). Clusters differ by patient characteristics (e.g. age, impairment).
CONCLUSION
Our findings highlight the complexity of MS-related health service utilisation and provide relevant stakeholders with information allowing them to tailor healthcare planning according to utilisation patterns.
PubMed: 38910839
DOI: 10.1177/20552173241260151 -
BMJ Open Jun 2024Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require...
PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations (the PERISCOPE trial) - a study protocol for a pragmatic, UK multicentre, superiority randomised controlled trial with an internal pilot, economic evaluation and nested qualitative study.
INTRODUCTION
Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT).
METHODS AND ANALYSIS
PERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients' and clinicians' acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively.
ETHICS AND DISSEMINATION
Ethical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period.
TRIAL REGISTRATION NUMBER
ISRCTN17691638.
Topics: Humans; Orthopedic Procedures; United Kingdom; Antirheumatic Agents; Pragmatic Clinical Trials as Topic; Perioperative Care; Qualitative Research; Multicenter Studies as Topic; Pilot Projects; Cost-Benefit Analysis; Biological Products
PubMed: 38910007
DOI: 10.1136/bmjopen-2024-084997 -
BMJ Open Jun 2024Participation in bowel cancer screening is lower in regions where there is high ethnic diversity and/or socioeconomic deprivation. Interventions, such as text message... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
Comparing the effectiveness and cost-effectiveness of text-message reminders and telephone patient navigation to improve the uptake of faecal immunochemical test screening among non-responders in London: a randomised controlled trial protocol.
INTRODUCTION
Participation in bowel cancer screening is lower in regions where there is high ethnic diversity and/or socioeconomic deprivation. Interventions, such as text message reminders and patient navigation (PN), have the potential to increase participation in these areas. As such, there is interest in the comparative effectiveness of these interventions to increase bowel cancer screening participation, as well as their relative cost-effectiveness.
METHODS AND ANALYSIS
This study will use a three-arm randomised controlled trial design to compare the effectiveness and cost-effectiveness of text message reminders and PN to increase the uptake of bowel cancer screening in London. Participants will be individuals who have not returned a completed faecal immunochemical test kit within 13 weeks of receiving a routine invitation from the London bowel cancer screening hub. Participants will be randomised (in a 1:1:1 ratio) to receive either (1) usual care (ie, 'no intervention'), (2) a text message reminder at 13 weeks, followed by repeated text message reminders at 15, 17 and 19 weeks (in the event of non-response) or (3) a text message reminder at 13 weeks, followed by PN telephone calls at 15, 17 and 19 weeks in the event of non-response. The primary endpoint will be participation in bowel cancer screening, defined as 'the return of a completed kit by week 24'. Statistical analysis will use multivariate logistic regression and will incorporate pairwise comparisons of all three groups, adjusted for multiple testing.
ETHICS AND DISSEMINATION
Approvals to conduct the research have been obtained from University College London's Joint Research Office (Ref: 150666), the Screening Research, Innovation and Development Advisory Committee ('RIDAC', Ref: 2223 014 BCSP Kerrison), the Health Research Authority (Ref: 22/WM/0212) and the Confidentiality Advisory Group (Ref: 22/CAG/0140). Results will be conveyed to stakeholders, notably those managing the screening programme and published in peer-reviewed journals/presented at academic conferences.
TRIAL REGISTRATION NUMBER
ISRCTN17245519.
Topics: Humans; Text Messaging; London; Cost-Benefit Analysis; Early Detection of Cancer; Reminder Systems; Occult Blood; Colorectal Neoplasms; Telephone; Patient Navigation; Randomized Controlled Trials as Topic
PubMed: 38909999
DOI: 10.1136/bmjopen-2023-079482 -
Alzheimer's Research & Therapy Jun 2024Aim of this study was to detect predictors of better adherence to the AgeWell.de-intervention, a two-year randomized multi-domain lifestyle intervention against... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Aim of this study was to detect predictors of better adherence to the AgeWell.de-intervention, a two-year randomized multi-domain lifestyle intervention against cognitive decline.
METHODS
Data of 317 intervention group-participants comprising a risk group for dementia (Cardiovascular Risk Factors, Ageing and Dementia (CAIDE) score of ≥ 9; mean age 68.9 years, 49.5% women) from the AgeWell.de intervention study were analysed. Regression models with four blocks of predictors (sociodemographic, cognitive and psychosocial, lifestyle factors and chronic conditions) were run on adherence to the components of nutrition, enhancement of social and physical activity and cognitive training. Adherence to each component was operationalised by assessing the degree of goal achievement per component at up to seven time points during the intervention period, measured using a 5-point Likert scale (mean score of goal achievement).
RESULTS
Increasing age was negatively associated with adherence, while higher education positively predicted adherence. Participants with better mental state (Montreal Cognitive Assessment (MoCA)-score > 25) at baseline and higher self-efficacy adhered better. Diabetes and cardiovascular conditions were not associated with adherence, whereas smoking negatively affected adherence. Highest education and quitting smoking in the past were the only predictors associated with all four intervention components.
CONCLUSION
Results identified predictors for better and worse adherence. Particularly self-efficacy seems to be of considerable influence on adherence. This should be considered when designing future intervention trials.
TRIAL REGISTRATION
German Clinical Trials Register (ref. number: DRKS00013555).
Topics: Humans; Female; Male; Aged; Cognitive Dysfunction; Self Efficacy; Life Style; Patient Compliance; Middle Aged; Exercise; Dementia; Aged, 80 and over
PubMed: 38909256
DOI: 10.1186/s13195-024-01499-4 -
Trials Jun 2024Adverse events suffer from poor reporting within randomised controlled trials, despite them being crucial to the evaluation of a treatment. A recent update to the...
Adverse events suffer from poor reporting within randomised controlled trials, despite them being crucial to the evaluation of a treatment. A recent update to the CONSORT harms checklist aims to improve reporting by providing structure and consistency to the information presented. We propose an extension wherein harms would be reported in conjunction with effectiveness outcome(s) rather than in silo to provide a more complete picture of the evidence acquired within a trial. Benefit-risk methods are designed to simultaneously consider both benefits and risks, and therefore, we believe these methods could be implemented to improve the prominence of adverse events when reporting trials. The aim of this article is to use case studies to demonstrate the practical utility of benefit-risk methods to present adverse events results alongside effectiveness results. Two randomised controlled trials have been selected as case studies, the Option-DM trial and the SANAD II trial. Using a previous review, a shortlist of 17 benefit-risk methods which could potentially be used for reporting RCTs was created. From this shortlist, three benefit-risk methods are applied across the two case studies. We selected these methods for their usefulness to achieve the aim of this paper and which are commonly used in the literature. The methods selected were the Benefit-Risk Action Team (BRAT) Framework, net clinical benefit (NCB), and the Outcome Measures in Rheumatology (OMERACT) 3 × 3 table. Results using the benefit-risk method added further context and detail to the clinical summaries made from the trials. In the case of the SANAD II trial, the clinicians concluded that despite the primary outcome being improved by the treatment, the increase in adverse events negated the improvement and the treatment was therefore not recommended. The benefit-risk methods applied to this case study outlined the data that this decision was based on in a clear and transparent way. Using benefit-risk methods to report the results of trials can increase the prominence of adverse event results by presenting them alongside the primary efficacy/effectiveness outcomes. This ensures that all the factors which would be used to determine whether a treatment would be recommended are transparent to the reader.
Topics: Humans; Randomized Controlled Trials as Topic; Risk Assessment; Research Design; Treatment Outcome; Checklist; Risk Factors; Drug-Related Side Effects and Adverse Reactions
PubMed: 38909232
DOI: 10.1186/s13063-024-08228-0 -
Clinical Lung Cancer May 2024It is unclear whether the sequential administration of programmed death (PD)-1/programmed death-ligand 1 (PD-L1) inhibitors and epidermal growth factor receptor-tyrosine...
Interstitial Pneumonitis Following Sequential Administration of Programmed Death-1/Programmed Death-Ligand1 Inhibitors and Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors For Non-Small Cell Lung Cancer: A Matched-Pair Cohort Study Using a Nationwide Inpatient Database.
BACKGROUND
It is unclear whether the sequential administration of programmed death (PD)-1/programmed death-ligand 1 (PD-L1) inhibitors and epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is associated with the development of severe interstitial pneumonitis (IP).
PATIENTS AND METHODS
We identified 69,107 eligible patients with non-small cell lung cancer (NSCLC) from a Japanese national inpatient database, who initiated EGFR-TKI therapy. The study population was divided into the PD-1/PD-L1 inhibitor and non-prior PD-1/PD-L1 groups based on PD-1/PD-L1 administration before EGFR-TKI therapy. We conducted 1:4 matched-pair cohort analyses (n = 9,725) to compare the incidence of IP and in-hospital mortality within 90 days of administration of EGFR-TKI between the two groups after adjusting for the clinical background. Furthermore, we performed subgroup analyses categorized according to the duration of prior PD-1/PD-L1 inhibitor use.
RESULTS
IP occurred in 4.4% of patients in the matched-pair cohort. PD-1/PD-L1 inhibitor-use before EGFR-TKI therapy was significantly associated with IP (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.34-2.38) and in-hospital mortality (OR, 2.10; 95% CI, 1.72-2.55). Prior PD-1/PD-L1 inhibitor use in an interval of <6 months before EGFR-TKI administration was associated with a higher risk of IP than EGFR-TKI administration without prior PD-1/PD-L1 inhibitor. In-hospital mortality was higher in patients with prior PD-1/PD-L1 inhibitor use than that in those without prior PD-1/PD-L1 inhibitor use, irrespective of the treatment duration.
CONCLUSION
Sequential use of PD-1/PD-L1 inhibitors and EGFR-TKIs in patients with non-small cell lung cancer was significantly associated with IP compared to EGFR-TKIs without prior PD-1/PD-L1 inhibitor administration.
PubMed: 38909011
DOI: 10.1016/j.cllc.2024.04.012 -
BMJ Open Jun 2024Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of...
OBJECTIVE
Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan.
METHODS
This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020.
RESULTS
This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs.
CONCLUSIONS
This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.
Topics: Humans; Japan; Depressive Disorder, Major; Cross-Sectional Studies; Drug Industry; Conflict of Interest; Bipolar Disorder; Practice Guidelines as Topic; Disclosure; Authorship
PubMed: 38908845
DOI: 10.1136/bmjopen-2024-086396 -
BMJ Open Jun 2024Climate change poses a major threat to our health, livelihoods and the planet. In 2020, the UK National Health Service (NHS) committed to reducing its Scope 1, 2 and 3...
INTRODUCTION
Climate change poses a major threat to our health, livelihoods and the planet. In 2020, the UK National Health Service (NHS) committed to reducing its Scope 1, 2 and 3 emissions to reach net zero by 2045. Although a net zero NHS would help to limit the consequences of climate change, little is known about the UK general public's values and preferences for the proposed service changes needed to reach net zero.
METHODS
This study will elicit the public's preferences for actions to help achieve net zero NHS in England and Scotland using a discrete choice experiment (DCE). The DCE attributes and levels describe actions that can be taken by the NHS across key areas: buildings and estates, outdoor space, travel and transport, provision of care, goods and services and food and catering. The survey was designed using online think-aloud interviews with 17 members of the public. Two versions of the survey will be administered to a sample of up to 2200 respondents. One will include a payment vehicle as income tax increases. We will estimate the relative importance of each attribute and, for the former survey, the monetary trade-offs which individuals are willing to make between attributes. Where possible, we will match both samples to gauge preference robustness with the inclusion of the monetary payment. We will test whether respondents' preferences differ based on their socioeconomic circumstances and attitudes toward the NHS and climate change.
ETHICS AND DISSEMINATION
The University of Aberdeen's School of Medicine, Medical Sciences and Nutrition Ethics Research Board has approved the study (reference: SERB/690090). All participants will provide informed consent. Results will be submitted to peer-reviewed publications and presented at relevant conferences and seminars. A lay summary of the research will be published on the Health Economics Research Unit website.
Topics: Humans; Scotland; Climate Change; England; State Medicine; Choice Behavior; Surveys and Questionnaires; Public Opinion; Consumer Behavior; Research Design; Female; Male
PubMed: 38908844
DOI: 10.1136/bmjopen-2023-082863 -
Social Science & Medicine (1982) Jun 2024The Quality of Care Experience Aged Care Consumers (QCE-ACC) is a new preference-based instrument recently adopted by the Australian government nationally as a new...
The Quality of Care Experience Aged Care Consumers (QCE-ACC) is a new preference-based instrument recently adopted by the Australian government nationally as a new quality indicator for aged care. This study employed a discrete choice experiment (DCE) approach to develop an aged care user-specific value set for the QCE-ACC instrument. This is crucial for establishing the relative importance of key QCE-ACC dimensions for informing quality assessment and economic evaluation in aged care. We further empirically compared the preferences of aged care recipients and non-aged care recipients amongst the older Australian population (65 years and above) for quality of care experience using the QCE-ACC. A total of 201 older people (age 74.2 ± 6.2; 59.7% female) receiving aged care services completed the DCE survey between August and September 2022. The comparison of relative importance indicated some divergence in the preferences between the aged care recipients and non-aged care recipients. Amongst aged care recipients, being treated with "Respect & Dignity" was the most important quality of care experience defining dimension, with "Health & Wellbeing" ranked second and "Skills & Training" (of staff) ranked third. However, within non-aged care recipients, "Skills Training" (of staff) was considered the most important quality of care dimension. Distinction in the QCE-ACC utility weights distributions and mean values were also observed, suggesting that aged care recipients may have different opinions about the quality of aged care compared to those who have not accessed aged care services. The findings shed light on the unique preferences of aged care recipients, indicating that aged care recipients and non-aged care recipients' preferences for quality of aged care are not interchangeable. The value set developed in this study is specifically tailored for assessing the quality of aged care using the QCE-ACC instrument from the perspective of aged care users in Australia.
PubMed: 38908090
DOI: 10.1016/j.socscimed.2024.117054 -
BMC Nursing Jun 2024The lack of professional identity can impede the transition from nursing students to qualified nurses and exacerbate the shortage of health care professionals....
BACKGROUND
The lack of professional identity can impede the transition from nursing students to qualified nurses and exacerbate the shortage of health care professionals. Personality is important to resilience-building and professional identity development in nursing students. However, the associations among personality, resilience, and professional identity are less explored. The study aims to identify latent subtypes of personality, to evaluate the mediating role of resilience between personality and professional identity in nursing students, and to provide practical guidance for educators' subsequent interventions with nursing students' professional identity.
METHODS
1397 nursing students were recruited from Be Resilient to Nursing Career (BRNC) between October 2020 and April 2022 by cluster sampling from 4 universities in China. NEO Five-Factor Inventory, 10-item Connor-Davidson Resilience Scale, and Professional Identity Questionnaire for Undergraduate Students were administered. Analyses of latent profiles and mediations were performed.
RESULTS
Three latent personality types were identified: Over-sensitivity (35.4%), Ordinary (53.8%), and Flexibility (10.8%). Nursing role model was found to be a significant indicator of personality (Ordinary as ref, Over-sensitivity: OR = 0.73, 95% CI: 0.57-0.93, P = 0.010; Flexibility: OR = 1.85, 95% CI: 1.29-2.65, P = 0.001). The association between personality portraits and professional identity were significantly mediated by resilience (P < 0.05).
CONCLUSIONS
There exists heterogeneity in nursing students' personality. Resilience plays a significant role in mediating the relationship between personality and professional identity.
PubMed: 38907353
DOI: 10.1186/s12912-024-02007-7