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REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Tuberculosis infection and hypertension: prevalence estimates from the US National Health and Nutrition Examination Survey

Por: Salindri · A. D. · Auld · S. C. · Gujral · U. P. · Urbina · E. M. · Andrews · J. R. · Huaman · M. A. · Magee · M. J.
Objectives

Tuberculosis infection (TBI) is marked by dynamic host–pathogen interactions with persistent low-grade inflammation and is associated with increased risk of cardiovascular diseases (CVD) including acute coronary syndrome, myocardial infarction and stroke. However, few studies assess the relationship between TBI and hypertension, an intermediate of CVD. We sought to determine the association between TBI and hypertension using data representative of the adult US population.

Methods

We performed cross-sectional analyses using data from the 2011–2012 US National Health and Nutrition Examination Survey (NHANES). Eligible participants included adults with valid QuantiFERON-TB Gold In-Tube (QFT-GIT) test results who also had blood pressure measures and no history of TB disease. TBI was defined by a positive QFT-GIT. We defined hypertension by either elevated measured blood pressure levels (ie, systolic ≥130 mm Hg or diastolic ≥80 mm Hg) or known hypertension indications (ie, self-reported previous diagnosis or use of antihypertensive medications). Analyses were performed using robust quasi-Poisson regressions and accounted for the stratified probability sampling design of NHANES.

Results

The overall prevalence of TBI was 5.7% (95% CI 4.7% to 6.7%) and hypertension was present among 48.9% (95% CI 45.2% to 52.7%) of participants. The prevalence of hypertension was higher among those with TBI (58.5%, 95% CI 52.4% to 64.5%) than those without TBI (48.3%, 95% CI 44.5% to 52.1%) (prevalence ratio (PR) 1.2, 95% CI 1.1 to 1.3). However, after adjusting for confounders, the prevalence of hypertension was similar for those with and without TBI (adjusted PR 1.0, 95% CI 1.0 to 1.1). The unadjusted prevalence of hypertension was higher among those with TBI versus no TBI, especially among individuals without CVD risk factors including those with normal body mass index (PR 1.6, 95% CI 1.2 to 2.0), euglycaemia (PR 1.3, 95% CI 1.1 to 1.5) or non-smokers (PR 1.2, 95% CI 1.1 to 1.4).

Conclusions

More than half of adults with TBI in the USA had hypertension. Importantly, we observed a relationship between TBI and hypertension among those without established CVD risk factors.

Summary

The prevalence of hypertension was high (59%) among adults with TBI in the USA. In addition, we found that the prevalence of hypertension was significantly higher among adults with positive QFT without established hypertension risk factors.

Nurse and midwife involvement in task‐sharing and telehealth service delivery models in primary care: A scoping review

Abstract

Aim

To synthesise and map current evidence on nurse and midwife involvement in task-sharing service delivery, including both face-to-face and telehealth models, in primary care.

Design

This scoping review was informed by the Joanna Briggs Institute (JBI) Methodology for Scoping Reviews.

Data Source/Review Methods

Five databases (Ovid MEDLINE, Embase, PubMed, CINAHL and Cochrane Library) were searched from inception to 16 January 2024, and articles were screened for inclusion in Covidence by three authors. Findings were mapped according to the research questions and review outcomes such as characteristics of models, health and economic outcomes, and the feasibility and acceptability of nurse-led models.

Results

One hundred peer-reviewed articles (as 99 studies) were deemed eligible for inclusion. Task-sharing models existed for a range of conditions, particularly diabetes and hypertension. Nurse-led models allowed nurses to work to the extent of their practice scope, were acceptable to patients and providers, and improved health outcomes. Models can be cost-effective, and increase system efficiencies with supportive training, clinical set-up and regulatory systems. Some limitations to telehealth models are described, including technological issues, time burden and concerns around accessibility for patients with lower technological literacy.

Conclusion

Nurse-led models can improve health, economic and service delivery outcomes in primary care and are acceptable to patients and providers. Appropriate training, funding and regulatory systems are essential for task-sharing models with nurses to be feasible and effective.

Impact

Nurse-led models are one strategy to improve health equity and access; however, there is a scarcity of literature on what these models look like and how they work in the primary care setting. Evidence suggests these models can also improve health outcomes, are perceived to be feasible and acceptable, and can be cost-effective. Increased utilisation of nurse-led models should be considered to address health system challenges and improve access to essential primary healthcare services globally.

Reporting Method

This review is reported against the PRISMA-ScR criteria.

Patient or Public Contribution

No patient or public contribution.

Protocol registration

The study protocol is published in BJGP Open (Moulton et al., 2022).

‘Towards a conceptualization of nurses’ support of hospitalised patients' self‐management—A modified Delphi study’

Abstract

Aim

To determine patients', nurses' and researchers' opinions on the appropriateness and completeness of the proposed conceptualization of nurses' support of hospitalised patients' self-management.

Design

A modified Delphi study.

Methods

We conducted a two-round Delphi survey. The panel group consisted of patients, nurses and researchers. The conceptualization of nurses' support of hospitalised patients' self-management presented in the first Delphi round was based on previous research, including a scoping review of the literature. Data was analysed between both rounds and after the second round. Results are reported in accordance with the guidance on Conducting and Reporting Delphi Studies (CREDES).

Results

In the first round all activities of the proposed conceptualization were considered appropriate to support the patients' self-management. Panel members' comments led to the textual adjustment of 19 activities, the development of 15 new activities, and three general questions related to self-management support during hospitalisation. In the second round the modified and the newly added activities were also deemed appropriate. The clarification statements raised in the first Delphi round were accepted, although questions remained about the wording of the activities and about what is and what is not self-management support.

Conclusion

After textual adjustments and the addition of some activities, the proposed conceptualization of nurses' support in patients' self-management while hospitalised have been considered appropriate and complete. Nevertheless, questions about the scope of this concept still remains. The results provide a starting point for further discussion and the development of self-management programs aimed at the hospitalised patient.

Implication for the profession and/or patient care

The results can be considered as a starting point for practice to discuss the concept of nurses' support for hospitalised patients' self-management and develop, implement and research self-management programs specific for their patient population.

Reporting Method

Results are reported in accordance with the guidance on Conducting and Reporting Delphi Studies (CREDES).

Patient or Public Contribution

Patients were involved as expert panellist in this Delphi study.

Impact statement

What problem did the study address?

Self-management support during hospitalisation is understudied, which undermines the development of evidence-based interventions.

What were the main findings?

A panel, consisting of patients, nurses and researchers, agreed on the appropriateness of a conceptualization of nurses' support of inpatients' self-management, and identified some points for discussion, mainly related to the boundaries of the concept self-management.

Where and on whom will the research have an impact?

This study is crucial for generating conceptual understanding of how nurses support patients' self-management during hospitalisation. This is necessary for policy, clinical practice, education, and research on this topic.

The Listening Guide: Illustrating an underused voice‐centred methodology to foreground underrepresented research populations

Abstract

Aim

To highlight the value of utilizing the Listening Guide methodology for nursing research and provide an exemplar applying this methodology to explore a novel concept in an underrepresented group—inner strength in persons newly diagnosed with mild cognitive impairment along with their care partners.

Design

Methodology discussion paper.

Methods

The exemplar study used the Listening Guide methods for data elicitation and analysis. Methods included adaptations for the study population and novice qualitative researchers.

Results

The Listening Guide methodology with adaptations enabled the research team to centre the voices of persons living with mild cognitive impairment, highlight an abstract phenomenon and attend to the influences of the sociopolitical context. Further, this methodology helped address common challenges emerging qualitative researchers encounter, including understanding methods of application, engaging reflexively and immersing in the data.

Conclusion

The Listening Guide is a voice-centred qualitative methodology that is well suited to foreground the experiences of groups underrepresented in research and explore emerging phenomena.

Implications for Nursing

Nurses are central to striving for health equity. The Listening Guide methodology offers a valuable and accessible research tool to understand the experiences and needs of underrepresented groups and shape healthcare in response.

Impact

The Listening Guide methodology can be broadly applied to research with persons with mild cognitive impairment, and other underrepresented groups, to explore other phenomena beyond inner strength and move the science forward in representing the perspectives of groups underrepresented by research.

Patient or Public Contribution

Persons living with cognitive impairment and their care partners participated in study conceptualization, interview guide development, methods development and dissemination plans.

Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L.
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

Attrition from longitudinal ageing studies and performance across domains of cognitive functioning: an individual participant data meta-analysis

Por: Hernandez · R. · Jin · H. · Lee · P.-J. · Schneider · S. · Junghaenel · D. U. · Stone · A. A. · Meijer · E. · Gao · H. · Maupin · D. · Zelinski · E. M.
Objectives

This paper examined the magnitude of differences in performance across domains of cognitive functioning between participants who attrited from studies and those who did not, using data from longitudinal ageing studies where multiple cognitive tests were administered.

Design

Individual participant data meta-analysis.

Participants

Data are from 10 epidemiological longitudinal studies on ageing (total n=209 518) from several Western countries (UK, USA, Mexico, etc). Each study had multiple waves of data (range of 2–17 waves), with multiple cognitive tests administered at each wave (range of 4–17 tests). Only waves with cognitive tests and information on participant dropout at the immediate next wave for adults aged 50 years or older were used in the meta-analysis.

Measures

For each pair of consecutive study waves, we compared the difference in cognitive scores (Cohen’s d) between participants who dropped out at the next study wave and those who remained. Note that our operationalisation of dropout was inclusive of all causes (eg, mortality). The proportion of participant dropout at each wave was also computed.

Results

The average proportion of dropouts between consecutive study waves was 0.26 (0.18 to 0.34). People who attrited were found to have significantly lower levels of cognitive functioning in all domains (at the wave 2–3 years before attrition) compared with those who did not attrit, with small-to-medium effect sizes (overall d=0.37 (0.30 to 0.43)).

Conclusions

Older adults who attrited from longitudinal ageing studies had lower cognitive functioning (assessed at the timepoint before attrition) across all domains as compared with individuals who remained. Cognitive functioning differences may contribute to selection bias in longitudinal ageing studies, impeding accurate conclusions in developmental research. In addition, examining the functional capabilities of attriters may be valuable for determining whether attriters experience functional limitations requiring healthcare attention.

Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Por: Brittain · G. · Petrie · J. · Duffy · K. E. M. · Glover · R. · Hullock · K. · Papaioannou · D. · Roldan · E. · Beecher · C. · Bursnall · M. · Ciccarelli · O. · Coles · A. J. · Cooper · C. · Giovannoni · G. · Gabriel · I. · Kazmi · M. · Kyriakou · C. · Nicholas · R. · Paling · D. · Peniket
Introduction

Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis

StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination

The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number

ISRCTN88667898.

Use of herbal medicine during pregnancy and associated factors among pregnant women with access to public healthcare in west Shewa zone, Central Ethiopia: sequential mixed-method study

Por: Bekele · G. G. · Woldeyes · B. S. · Taye · G. M. · Kebede · E. M. · Gebremichael · D. Y.
Objective

This study was aimed at assessing the prevalence of herbal drug use among pregnant women with access to modern medicine and associated factors in public health facilities in the west Shewa zone, Oromia regional state, Ethiopia.

Design

A sequential mixed-method study approach was carried out among pregnant women and other stakeholders.

Setting

This study was conducted at public health facilities, including 3 public hospitals and 20 health centres, in the west Shewa zone of Ethiopia.

Participants

A systematically selected sample of 411 pregnant women was participated in the quantitative study. For the qualitative method, focus group discussions and in-depth interviews were conducted among pregnant women attending antenatal care and key informants using an interview guide until data saturation was achieved.

Primary outcome

For outcome variables, the respondents were asked if they used any herbal medicine during their current pregnancy. It was then recorded as 0=no and 1=yes.

Results

The prevalence of herbal medicines was found to be 19.7%. The most commonly used herbal medicines were Zingiber officinale, Ocimum gratissimum, Eucalyptus globules, Allium sativum and Rutacha lepensis. Herbal medicine use during pregnancy was significantly associated with older maternal age (adjusted OR (AOR) 2.4, 95% CI 1.2 to 5.1), urban residence (AOR 2.3, 95% CI 1.3 to 3.7) and second trimester of pregnancy (AOR 2.3, 95% CI 1.3 to 4.5).

Conclusions

In this study, one in five pregnant women uses herbal medicine, which is relatively low. Sociodemographic factors and the duration of pregnancy affected the utilisation of herbal drugs during pregnancy. The most common herbals used by pregnant women were intended to treat minor disorders of pregnancy and medical disorders such as hypertension.

Pharmacogenomics of poor drug metabolism in greyhounds: Canine P450 oxidoreductase genetic variation, breed heterogeneity, and functional characterization

by Stephanie E. Martinez, Amit V. Pandey, Tania E. Perez Jimenez, Zhaohui Zhu, Michael H. Court

Greyhounds metabolize cytochrome P450 (CYP) 2B11 substrates more slowly than other dog breeds. However, CYP2B11 gene variants associated with decreased CYP2B11 expression do not fully explain reduced CYP2B11 activity in this breed. P450 oxidoreductase (POR) is an essential redox partner for all CYPs. POR protein variants can enhance or repress CYP enzyme function in a CYP isoform and substrate dependent manner. The study objectives were to identify POR protein variants in greyhounds and determine their effect on coexpressed CYP2B11 and CYP2D15 enzyme function. Gene sequencing identified two missense variants (Glu315Gln and Asp570Glu) forming four alleles, POR-H1 (reference), POR-H2 (570Glu), POR-H3 (315Gln, 570Glu) and POR-H4 (315Gln). Out of 68 dog breeds surveyed, POR-H2 was widely distributed across multiple breeds, while POR-H3 was largely restricted to greyhounds and Scottish deerhounds (35% allele frequencies), and POR-H4 was rare. Three-dimensional protein structure modelling indicated significant effects of Glu315Gln (but not Asp570Glu) on protein flexibility through loss of a salt bridge between Glu315 and Arg519. Recombinant POR-H1 (reference) and each POR variant (H2-H4) were expressed alone or with CYP2B11 or CYP2D15 in insect cells. No substantial effects on POR protein expression or enzyme activity (cytochrome c reduction) were observed for any POR variant (versus POR-H1) when expressed alone or with CYP2B11 or CYP2D15. Furthermore, there were no effects on CYP2B11 or CYP2D15 protein expression, or on CYP2D15 enzyme kinetics by any POR variant (versus POR-H1). However, Vmax values for 7-benzyloxyresorufin, propofol and bupropion oxidation by CYP2B11 were significantly reduced by coexpression with POR-H3 (by 34–37%) and POR-H4 (by 65–72%) compared with POR-H1. Km values were unaffected. Our results indicate that the Glu315Gln mutation (common to POR-H3 and POR-H4) reduces CYP2B11 enzyme function without affecting at least one other major canine hepatic P450 (CYP2D15). Additional in vivo studies are warranted to confirm these findings.

Use of removable support boot versus cast for early mobilisation after ankle fracture surgery: cost-effectiveness analysis and qualitative findings of the Ankle Recovery Trial (ART)

Por: Baji · P. · Barbosa · E. C. · Heaslip · V. · Sangar · B. · Tbaily · L. · Martin · R. · Docherty · S. · Allen · H. · Hayward · C. · Marques · E. M. R.
Objectives

To estimate the cost-effectiveness of using a removable boot versus a cast following ankle fracture from the National Health Service and Personal Social Services (NHS+PSS) payer and societal perspectives and explore the impact of both treatments on participants’ activities of daily living.

Design

Cost-effectiveness analyses and qualitative interviews performed alongside a pragmatic multicentre randomised controlled trial.

Setting

Eight UK NHS secondary care trusts.

Participants

243 participants (60.5% female, on average 48.2 years of age (SD 16.4)) with ankle fracture. Qualitative interviews with 16 participants. Interventions removable air boot versus plaster cast 2 weeks after surgery weight bearing as able with group-specific exercises.

Primary and secondary outcome measures

Quality-adjusted life years (QALYs) estimated from the EQ-5D-5L questionnaire, costs and incremental net monetary benefit statistics measured 12 weeks after surgery, for a society willing-to-pay £20 000 per QALY.

Results

Care in the boot group cost, on average, £88 (95% CI £22 to £155) per patient more than in the plaster group from the NHS+PSS perspective. When including all societal costs, the boot saved, on average, £676 per patient (95% CI –£337 to £1689). Although there was no evidence of a QALY difference between the groups (–0.0020 (95% CI –0.0067 to 0.0026)), the qualitative findings suggest participants felt the boot enhanced their quality of life. Patients in the boot felt more independent and empowered to take on family responsibilities and social activities.

Conclusions

While the removable boot is slightly more expensive than plaster cast for the NHS+PSS payer at 12 weeks after surgery, it reduces productivity losses and the need for informal care while empowering patients. Given that differences in QALYs and costs to the NHS are small, the decision to use a boot or plaster following ankle surgery could be left to patients’ and clinicians’ preferences.

Trial registration number

ISRCTN15497399, South Central—Hampshire A Research Ethics Committee (reference 14/SC/1409).

Qualitative interview study of strategies to support healthcare personnel mental health through an occupational health lens

Por: Brown-Johnson · C. · DeShields · C. · McCaa · M. · Connell · N. · Giannitrapani · S. N. · Thanassi · W. · Yano · E. M. · Singer · S. J. · Lorenz · K. A. · Giannitrapani · K.
Background

Employee Occupational Health (‘occupational health’) clinicians have expansive perspectives of the experience of healthcare personnel. Integrating mental health into the purview of occupational health is a newer approach that could combat historical limitations of healthcare personnel mental health programmes, which have been isolated and underused.

Objective

We aimed to document innovation and opportunities for supporting healthcare personnel mental health through occupational health clinicians. This work was part of a national qualitative needs assessment of employee occupational health clinicians during COVID-19 who were very much at the centre of organisational responses.

Design

This qualitative needs assessment included key informant interviews obtained using snowball sampling methods.

Participants

We interviewed 43 US Veterans Health Administration occupational health clinicians from 29 facilities.

Approach

This analysis focused on personnel mental health needs and opportunities, using consensus coding of interview transcripts and modified member checking.

Key results

Three major opportunities to support mental health through occupational health involved: (1) expanded mental health needs of healthcare personnel, including opportunities to support work-related concerns (eg, traumatic deployments), home-based concerns and bereavement (eg, working with chaplains); (2) leveraging expanded roles and protocols to address healthcare personnel mental health concerns, including opportunities in expanding occupational health roles, cross-disciplinary partnerships (eg, with employee assistance programmes (EAP)) and process/protocol (eg, acute suicidal ideation pathways) and (3) need for supporting occupational health clinicians’ own mental health, including opportunities to address overwork/burn-out with adequate staffing/resources.

Conclusions

Occupational health can enact strategies to support personnel mental health: to structurally sustain attention, use social cognition tools (eg, suicidality protocols or expanded job descriptions); to leverage distributed attention, enhance interdisciplinary collaboration (eg, chaplains for bereavement support or EAP) and to equip systems with resources and allow for flexibility during crises, including increased staffing.

Efficient assessment of brain fog and fatigue: Development of the Fatigue and Altered Cognition Scale (FACs)

by Timothy R. Elliott, Yu-Yu Hsiao, Kathleen Randolph, Randall J. Urban, Melinda Sheffield-Moore, Richard B. Pyles, Brent E. Masel, Tamara Wexler, Traver J. Wright

Debilitating symptoms of fatigue and accompanying “brain fog” are observed among patients with various chronic health conditions. Unfortunately, an efficient and psychometrically sound instrument to assess these co-occurring symptoms is unavailable. Here, we report the development and initial psychometric properties of the Fatigue and Altered Cognition Scale (the FACs), a measure of self-reported central fatigue and brain fog. Traumatic brain injury (TBI) was chosen to model and develop the FACs due to research team expertise and established links between TBI and the symptom complex. Potential items were generated by researchers and clinicians with experience treating these symptoms, drawing from relevant literature and review of patient responses to measures from past and current TBI studies. The 20 candidate items for the FACs—ten each to assess altered cognition (i.e., brain fog) and central fatigue–were formatted on an electronic visual analogue response scale (eVAS) via an online survey. Demographic information and history of TBI were obtained. A total of 519 participants consented and provided usable data (average age = 40.23 years; 73% female), 204 of whom self-reported a history of TBI (75% reported mild TBI). Internal consistency and reliability values were calculated. Confirmatory factor analysis (CFA) examined the presumed two-factor structure of the FACs and a one-factor solution for comparison. A measurement invariance test of the two latent constructs (altered cognition, fatigue) among participants with and without TBI was conducted. All items demonstrated normal distribution. Cronbach’s alpha coefficients indicated good internal consistency for both factors (α’s = .95). Omega reliability values were favorable (α’s = .95). CFA supported the presumed two-factor model and item loadings which outperformed the one-factor model. Measurement invariance found the two-factor structure was consistent between the two groups. Implications of these findings, study limitations, and potential use of the FACs in clinical research and practice are discussed.

Patients perspectives on tapering programmes for prescription opioid use disorder: a qualitative study

Por: Davies · L. E. M. · Koster · E. S. · Damen · K. F. · Beurmanjer · H. · van Dam · V. W. · Bouvy · M. L. · Schellekens · A. F.
Objectives

Approximately 10% of chronic pain patients who receive opioids develop an opioid use disorder (OUD). Tapering programmes for these patients show high drop-out rates. Insight into chronic pain patients’ experiences with tapering programmes for prescription OUD could help improve such programmes. Therefore, we investigated the perspectives of chronic pain patients with prescription OUD to identify facilitators and barriers to initiate and complete a specialised OUD tapering programme.

Design

A qualitative study using semi-structured interviews on experiences with initiation and completion of opioid tapering was audio recorded, transcribed and subject to directed content analysis.

Setting

This study was conducted in two facilities with specialised opioid tapering programmes in the Netherlands.

Participants

Twenty-five adults with chronic pain undergoing treatment for prescription OUD participated.

Results

Participants indicated that tapering is a personal process, where willingness and motivation to taper, perceived (medical) support and pain coping strategies have an impact on the tapering outcome. The opportunity to join a medical-assisted tapering programme, shared decision-making regarding tapering pace, tapering location, and receiving medical and psychological support facilitated completion of an opioid tapering programme.

Conclusions

According to patients, a successful treatment of prescription OUD requires a patient-centred approach that combines personal treatment goals with shared decision-making on opioid tapering. Referral to a specialised tapering programme that incorporates opioid rotation, non-judgmental attitudes, and psychological support can create a safe and supportive environment, fostering successful tapering and recovery.

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

Rebels with a cause? How norm violations shape dominance, prestige, and influence granting

by Gerben A. van Kleef, Florian Wanders, Annelies E. M. van Vianen, Rohan L. Dunham, Xinkai Du, Astrid C. Homan

Norms play an important role in upholding orderly and well-functioning societies. Indeed, violations of norms can undermine social coordination and stability. Much is known about the antecedents of norm violations, but their social consequences are poorly understood. In particular, it remains unclear when and how norm violators gain or lose influence in groups. Some studies found that norm violators elicit negative responses that curtail their influence in groups, whereas other studies documented positive consequences that enhance violators’ influence. We propose that the complex relationship between norm violation and influence can be understood by considering that norm violations differentially shape perceptions of dominance and prestige, which tend to have opposite effects on voluntary influence granting, depending on the type of norm that is violated. We first provide correlational (Study 1) and causal (Study 2) evidence that norm violations are associated with dominance, and norm abidance with prestige. We then examine how dominance, prestige, and resultant influence granting are shaped by whether local group norms and/or global community norms are violated. In Study 3, protagonists who violated global (university) norms but followed local (sorority/fraternity) norms were more strongly endorsed as leaders than protagonists who followed global norms but violated local norms, because the former were perceived not only as high on dominance but also on prestige. In Study 4, popular high-school students were remembered as violating global (school) norms while abiding by local (peer) norms. In Study 5, individuals who violated global (organizational) norms while abiding by local (team) norms were assigned more leadership tasks when global and local norms conflicted (making violators “rebels with a cause”) than when norms did not conflict, because the former situation inspired greater prestige. We discuss implications for the social dynamics of norms, hierarchy development, and leader emergence.

Investigating the ability to adhere to cardiometabolic medications with different properties: a retrospective cohort study of >500 000 patients in the USA

Por: Lauffenburger · J. C. · Tesfaye · H. · Solomon · D. H. · Antman · E. M. · Glynn · R. J. · Lee · S. B. · Tong · A. · Choudhry · N. K.
Objective

Poor medication adherence remains highly prevalent and adversely affects health outcomes. Patients frequently describe properties of the pills themselves, like size and shape, as barriers, but this has not been evaluated objectively. We sought to determine the extent to which oral medication properties thought to be influential translate into lower objectively-measured adherence.

Design

Retrospective cohort study.

Setting

US nationwide commercial claims database, 2016–2019.

Participants

Among patients initiating first-line hypertension, diabetes or hyperlipidaemia treatment based on clinical guidelines, we measured pill size, shape, colour and flavouring, number of pills/day and fixed-dose combination status as properties.

Outcome measures

Outcomes included discontinuation after the first fill (ie, never filling again over a minimum of 1-year follow-up) and long-term non-adherence (1-year proportion of days covered

Results

Across 604 323 patients, 14.6% discontinued after filling once (ie, were non-persistent), and 54.0% were non-adherent over 1-year follow-up. Large pill size was associated with non-adherence, except for thiazides (eg, metformin adjusted OR (aOR): 1.12, 95% CI: 1.06 to 1.18). Greater pill burden was associated with a higher risk of non-adherence across all classes (eg, metformin aOR: 1.58, 95% CI: 1.53 to 1.64 for two pills/day). Taking less than one pill/day was also associated with higher risk of non-adherence and non-persistence (eg, non-persistence statin aOR: 1.29, 95% CI: 1.20 to 1.38). Pill shape, colour, flavouring and combination status were associated with mixed effects across classes.

Conclusions

Pill burden and pill size are key properties affecting adherence for almost all classes; others, like size and combination, could modestly affect medication adherence. Clinical interventions could screen patients for potential intolerance to medication and potentially implement more convenient dosing schedules.

(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.

Disease decreases variation in host community structure in an old-field grassland

by Rita L. Grunberg, Fletcher W. Halliday, Robert W. Heckman, Brooklynn N. Joyner, Kayleigh R. O’Keeffe, Charles E. Mitchell

Disease may drive variation in host community structure by modifying the interplay of deterministic and stochastic processes that shape communities. For instance, deterministic processes like ecological selection can benefit species less impacted by disease. When communities have higher levels of disease and disease consistently selects for certain host species, this can reduce variation in host community composition. On the other hand, when host communities are less impacted by disease and selection is weaker, stochastic processes (e.g., drift, dispersal) may play a bigger role in host community structure, which can increase variation among communities. While effects of disease on host community structure have been quantified in field experiments, few have addressed the role of disease in modulating variation in structure among host communities. To address this, we conducted a field experiment spanning three years, using a tractable system: foliar fungal pathogens in an old-field grassland community dominated by the grass Lolium arundinaceum, tall fescue. We reduced foliar fungal disease burden in replicate host communities (experimental plots in intact vegetation) in three fungicide regimens that varied in the seasonal duration of fungicide treatment and included a fungicide-free control. We measured host diversity, biomass, and variation in community structure among replicate communities. Disease reduction generally decreased plant richness and increased aboveground biomass relative to communities experiencing ambient levels of disease. These changes in richness and aboveground biomass were consistent across years despite changes in structure of the plant communities over the experiment’s three years. Importantly, disease reduction amplified host community variation, suggesting that disease diminished the degree to which host communities were structured by stochastic processes. These results of experimental disease reduction both highlight the potential importance of stochastic processes in plant communities and reveal the potential for disease to regulate variation in host community structure.

Elopement: Evidence‐based mitigation and management

Abstract

Background

Elopement jeopardizes patient safety, affects the hospital's reputation, and results in financial ramifications. In an academic community hospital, executive leadership approached a team of nurse leaders for expertise following the elopement of a vulnerable patient.

Aim of the Initiative

The team's goal was to identify evidence-based strategies to mitigate future elopement events. Following an extensive literature review and gap analysis, the organization recognized opportunities pertaining to elopement management, including patient assessment, prevention strategies, and facility-wide response when events occur. The nurse leader team thoroughly searched current literature to answer the Population, Intervention, Comparison, and Outcome (i.e., PICO) questions of interest. Following a critical appraisal of 55 articles, 26 were utilized to make practice change recommendations. The body of evidence included a variety of age groups and diagnoses.

Implementation Plan

After the synthesis of the literature, the team provided recommendations to the organization. These recommendations included the assessment of patient-specific risks and the implementation of elopement prevention measures as fundamental elements for incidence reduction. The team partnered with multidisciplinary stakeholders for the revision of policies, processes, and electronic medical record documentation.

Outcomes

The organization monitored elopement events and the duration of each event throughout the phases of implementation. Pre-implementation data, collected from January to June 2021, demonstrated 34 individual elopement cases lasting an average of 118 min each. In comparison, post-implementation data collected during the same time frame in 2022 found only 12 events lasting an average of 24 min each.

Implications for Practice

The organization implemented evidence-based recommendations to standardize the facility's approach to elopement. With structured assessment, precautions, and response, the organization demonstrated a notable decline in the number and duration of elopement events. Hardwiring processes, analyzing data, and adjusting expectations within an evidence-based framework should assist the organization's drive to further enhance patient safety surrounding elopement events.

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