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Self-administration medication errors at home and its predictors among illiterate and low-literate community-dwelling older adults with polypharmacy: A negative binomial hierarchical regression

by Nafiseh Ghassab-Abdollahi, Haidar Nadrian, Elnaz Shaseb, Narges Kheirollahi, Mina Hashemiparast

Background

Older adults with polypharmacy are more prone to medication errors. People with low educational attainment have more difficulties in taking their medications.

Objectives

This study aimed to identify the extent of medication self-administration errors (MSEs) and the contributing factors among illiterate and low-literate community-dwelling older adults with polypharmacy.

Method

The present cross-sectional study was conducted among people aged 60 and above. The data were collected using the sociodemographic, clinical, and Belief about Medicines Questionnaires (BMQ). To determine the extent of MSE, a medication error checklist was used. The negative binomial hierarchical regression model in the five blocks was performed.

Results

The final sample size was 276 people. The frequency of MSEs in the last 6 months was 69.2%. Sixteen percent of participants had made four or more mistakes. The most common MSEs were forgetting, improper taking of medications with food, improper timing, incorrect dosage (lower dose), and forgetting the doctor’s instructions. Near 18% of participants reported adverse events following their mistakes. The significant predictors of MSEs were being completely illiterate (p = 0.021), the higher number of doctor visits per year (p = 0.014), irregularly seeing doctors (p Conclusion

Despite the high prevalence of MSEs among older patients, practical strategies to deal with them at their homes have not been established among health systems. MSE as a multifactorial event can be caused by a collection of internal and external factors. Further studies to identify the role of patients, clinicians, procedures, and systems in developing MSEs as interconnected components are needed.

Evidence-informed and consensus-based statements about SAFEty of Physical Agent Modalities Practice in physiotherapy and rehabilitation medicine (SAFE PAMP): a national Delphi of healthcare scientific societies

Por: Gianola · S. · Bargeri · S. · Pellicciari · L. · Gambazza · S. · Rossettini · G. · Fulvio · A. · Genovese · V. · Benedini · M. · Proverbio · E. · Cecchetto · S. · Castellini · G. · Turolla · A. · SAFE PAMP Collaborators · Torresetti · Masturzo · Berliri · Roselli · Vercelli · Scorcu
Objective

A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs.

Study design and setting

A RAND-modified Delphi Rounds’ survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%.

Results

Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17–36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups.

Conclusions

The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol

Por: Merolla · A. · De Lorenzo · R. · Ferrannini · G. · Renzi · C. · Ulivi · F. · Bazzigaluppi · E. · Lampasona · V. · Bosi · E.
Introduction

Chronic autoimmune (type 1 diabetes and coeliac disease) and metabolic/cardiovascular (type 2 diabetes, dyslipidaemia, hypertension) diseases are highly prevalent across all age ranges representing a major public health burden. Universal screening for prediction/early identification of these conditions is a potential tool for reducing their impact on the general population. The aim of this study is to assess whether universal screening using capillary blood sampling is feasible at a population-based level.

Methods and analysis

This is a low-risk interventional, single-centre, pilot study for a population-based screening programme denominated UNISCREEN. Participants are volunteers aged 1–100 who reside in the town of Cantalupo (Milan, Italy) undergoing: (1) interview collecting demographics, anthropometrics and medical history; (2) capillary blood collection for measurement of type 1 diabetes and coeliac disease-specific autoantibodies and immediate measurement of glucose, glycated haemoglobin and lipid panel by point-of-care devices; (3) venous blood sampling to confirm autoantibody-positivity; (4) blood pressure measurement; (5) fulfilment of a feasibility and acceptability questionnaire. The outcomes are the assessment of feasibility and acceptability of capillary blood screening, the prevalence of presymptomatic type 1 diabetes and undiagnosed coeliac disease, distribution of glucose categories, lipid panel and estimate of cardiovascular risk in the study population. With approximately 3000 inhabitants, the screened population is expected to encompass at least half of its size, approaching nearly 1500 individuals.

Ethics and dissemination

This protocol and the informed consent forms have been reviewed and approved by the San Raffaele Hospital Ethics Committee (approval number: 131/INT/2022). Written informed consent is obtained from all study participants or their parents if aged

Conclusions

If proven feasible and acceptable, this universal screening model would pave the way for larger-scale programmes, providing an opportunity for the implementation of innovative public health programmes in the general population.

Trial registration number

NCT05841719.

Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerou

Por: Hartman · T. J. · Christie · J. · Wilson · A. · Ziegler · T. R. · Methe · B. · Flanders · W. D. · Rolls · B. J. · Loye Eberhart · B. · Li · J. V. · Huneault · H. · Cousineau · B. · Perez · M. R. · O'Keefe · S. J. D.
Introduction

Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).

Methods/design

This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1–3 and one meal/day in months 4–6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1–2 pounds per week.

Ethics and dissemination

The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).

Trial registration number

NCT04780477.

Stress appraisal in the workplace and its associations with productivity and mood: Insights from a multimodal machine learning analysis

by Mohamad Awada, Burcin Becerik Gerber, Gale M. Lucas, Shawn C. Roll

Previous studies have primarily focused on predicting stress arousal, encompassing physiological, behavioral, and psychological responses to stressors, while neglecting the examination of stress appraisal. Stress appraisal involves the cognitive evaluation of a situation as stressful or non-stressful, and as a threat/pressure or a challenge/opportunity. In this study, we investigated several research questions related to the association between states of stress appraisal (i.e., boredom, eustress, coexisting eustress-distress, distress) and various factors such as stress levels, mood, productivity, physiological and behavioral responses, as well as the most effective ML algorithms and data signals for predicting stress appraisal. The results support the Yerkes-Dodson law, showing that a moderate stress level is associated with increased productivity and positive mood, while low and high levels of stress are related to decreased productivity and negative mood, with distress overpowering eustress when they coexist. Changes in stress appraisal relative to physiological and behavioral features were examined through the lenses of stress arousal, activity engagement, and performance. An XGBOOST model achieved the best prediction accuracies of stress appraisal, reaching 82.78% when combining physiological and behavioral features and 79.55% using only the physiological dataset. The small accuracy difference of 3% indicates that physiological data alone may be adequate to accurately predict stress appraisal, and the feature importance results identified electrodermal activity, skin temperature, and blood volume pulse as the most useful physiologic features. Implementing these models within work environments can serve as a foundation for designing workplace policies, practices, and stress management strategies that prioritize the promotion of eustress while reducing distress and boredom. Such efforts can foster a supportive work environment to enhance employee well-being and productivity.

Long COVID in long-term care: a rapid realist review

Por: Fyffe · I. · Sorensen · J. · Carroll · S. · MacPhee · M. · Andrews-Paul · A. · Crooks · V. A. · Freeman · S. · Davison · K. · Walls · J. · Berndt · A. · Shams · B. · Sivan · M. · Mithani · A.
Objectives

The goals of this rapid realist review were to ask: (a) what are the key mechanisms that drive successful interventions for long COVID in long-term care (LTC) and (b) what are the critical contexts that determine whether the mechanisms produce the intended outcomes?

Design

Rapid realist review.

Data sources

Medline, CINAHL, Embase, PsycINFO and Web of Science for peer-reviewed literature and Google for grey literature were searched up to 23 February 2023.

Eligibility criteria

We included sources focused on interventions, persons in LTC, long COVID or post-acute phase at least 4 weeks following initial COVID-19 infection and ones that had a connection with source materials.

Data extraction and synthesis

Three independent reviewers searched, screened and coded studies. Two independent moderators resolved conflicts. A data extraction tool organised relevant data into context-mechanism-outcome configurations using realist methodology. Twenty-one sources provided 51 intervention data excerpts used to develop our programme theory. Synthesised findings were presented to a reference group and expert panel for confirmatory purposes.

Results

Fifteen peer-reviewed articles and six grey literature sources were eligible for inclusion. Eleven context-mechanism-outcome configurations identify those contextual factors and underlying mechanisms associated with desired outcomes, such as clinical care processes and policies that ensure timely access to requisite resources for quality care delivery, and resident-centred assessments and care planning to address resident preferences and needs. The underlying mechanisms associated with enhanced outcomes for LTC long COVID survivors were: awareness, accountability, vigilance and empathetic listening.

Conclusions

Although the LTC sector struggles with organisational capacity issues, they should be aware that comprehensively assessing and monitoring COVID-19 survivors and providing timely interventions to those with long COVID is imperative. This is due to the greater care needs of residents with long COVID, and coordinated efficient care is required to optimise their quality of life.

Incorporating usability evaluation into iterative development of an online platform to support research participation in Parkinsons disease: a mixed methods protocol

Por: Chapman · R. · Zeissler · M.-L. · Meinert · E. · Mullin · S. · Whipps · S. · Whipps · J. · Hockey · K. · Hockey · P. · Carroll · C. B.
Introduction

Many people with Parkinson’s (PwP) are not given the opportunity or do not have adequate access to participate in clinical research. To address this, we have codeveloped with users an online platform that connects PwP to clinical studies in their local area. It enables site staff to communicate with potential participants and aims to increase the participation of the Parkinson’s community in research. This protocol outlines the mixed methods study protocol for the usability testing of the platform.

Methods and analysis

We will seek user input to finalise the platform’s design, which will then be deployed in a limited launch for beta testing. The beta version will be used as a recruitment tool for up to three studies with multiple UK sites. Usability data will be collected from the three intended user groups: PwP, care partners acting on their behalf and site study coordinators. Usability questionnaires and website analytics will be used to capture user experience quantitatively, and a purposive sample of users will be invited to provide further feedback via semistructured interviews. Quantitative data will be analysed using descriptive statistics, and a thematic analysis undertaken for interview data. Data from this study will inform future platform iterations.

Ethics and dissemination

Ethical approval was obtained from the University of Plymouth (3291; 3 May 2022). We will share our findings via a ‘Latest News’ section within the platform, presentations, conference meetings and national PwP networks.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

A cohort study on the biochemical and haematological parameters of Italian blood donors as possible risk factors of COVID-19 infection and severe disease in the pre- and post-Omicron period

by Chiara Marraccini, Lucia Merolle, Davide Schiroli, Agnese Razzoli, Gaia Gavioli, Barbara Iotti, Roberto Baricchi, Marta Ottone, Pamela Mancuso, Paolo Giorgi Rossi

To investigate the association between biochemical and blood parameters collected before the pandemic in a large cohort of Italian blood donors with the risk of infection and severe disease. We also focused on the differences between the pre- and post-Omicron spread in Italy (i.e., pre- and post-January 01, 2022) on the observed associations. We conducted an observational cohort study on 13750 blood donors was conducted using data archived up to 5 years before the pandemic. A t-test or chi-squared test was used to compare differences between groups. Hazard ratios with 95% confidence intervals for SARS-CoV-2 infection and severe disease were estimated using Cox proportional hazards models. Subgroup analyses stratified by sex, age and epidemic phase of first infection (pre- and post-Omicron spread) were examined. We confirmed a protective effect of groups B and O, while groups A and AB had a higher likelihood of infection and severe disease. However, these associations were only significant in the pre-Omicron period. We found an opposite behavior after Omicron spread, with the O phenotype having a higher probability of infection. When stratified by variant, A antigen appeared to protect against Omicron infection, whereas it was associated with an increased risk of infection by earlier variants. We were able to stratify for the SARS CoV-2 dominant variant, which revealed a causal association between blood group and probability of infection, as evidenced by the strong effect modification observed between the pre- and post-Omicron spread. The mechanism by which group A acts on the probability of infection should consider this strong effect modification.

Angiotensin II in liver transplantation (AngLT-1): protocol of a randomised, double-blind, placebo-controlled trial

Por: Bokoch · M. P. · Tran · A. T. · Brinson · E. L. · Marcus · S. G. · Reddy · M. · Sun · E. · Roll · G. R. · Pardo · M. · Fields · S. · Adelmann · D. · Kothari · R. P. · Legrand · M.
Introduction

Catecholamine vasopressors such as norepinephrine are the standard drugs used to maintain mean arterial pressure during liver transplantation. At high doses, catecholamines may impair organ perfusion. Angiotensin II is a peptide vasoconstrictor that may improve renal perfusion pressure and glomerular filtration rate, a haemodynamic profile that could reduce acute kidney injury. Angiotensin II is approved for vasodilatory shock but has not been rigorously evaluated for treatment of hypotension during liver transplantation. The objective is to assess the efficacy of angiotensin II as a second-line vasopressor infusion during liver transplantation. This trial will establish the efficacy of angiotensin II in decreasing the dose of norepinephrine to maintain adequate blood pressure. Completion of this study will allow design of a follow-up, multicentre trial powered to detect a reduction of organ injury in liver transplantation.

Methods and analysis

This is a double-blind, randomised clinical trial. Eligible subjects are adults with a Model for End-Stage Liver Disease Sodium Score ≥25 undergoing deceased donor liver transplantation. Subjects are randomised 1:1 to receive angiotensin II or saline placebo as the second-line vasopressor infusion. The study drug infusion is initiated on reaching a norepinephrine dose of 0.05 µg kg-1 min-1 and titrated per protocol. The primary outcome is the dose of norepinephrine required to maintain a mean arterial pressure ≥65 mm Hg. Secondary outcomes include vasopressin or epinephrine requirement and duration of hypotension. Safety outcomes include incidence of thromboembolism within 48 hours of the end of surgery and severe hypertension. An intention-to-treat analysis will be performed for all randomised subjects receiving the study drug. The total dose of norepinephrine will be compared between the two arms by a one-tailed Mann-Whitney U test.

Ethics and dissemination

The trial protocol was approved by the local Institutional Review Board (#20–30948). Results will be posted on ClinicalTrials.gov and published in a peer-reviewed journal.

Trial registration number

ClinicalTrials.govNCT04901169

Phenomenography: an alternative to the usual qualitative method

Por: Rolls · K.
Introduction

Phenomenography is a method of exploring the phenomenon of interest by examining how a group of individuals experience said phenomenon, uncovering the similarities and differences of this shared experience. The purpose of this paper is to outline the case for phenomenography as a research method ideally suited to explore the complex problems encountered by nurses and midwives within their everyday practice.

Research paradigm

Phenomenography emerged in the mid-1970s from the landmark study by Marton and Saljo1 2 where they endeavoured to explain why students at the same university and course arrived at different solutions for the same problems. Phenomenography is a second-order perspective because it focuses on participants and is concerned with understanding the collective view rather than understanding an experience through multiple individual experiences. A key assumption is that individual experiences are ‘logically related’ when phenomena they experience are the...

Primary care in Northern Ontario for transgender people in the context of the COVID‐19 pandemic: A qualitative secondary analysis

Abstract

Purpose

To examine changes to primary care practice for transgender clients resulting from government mandated public health measures in response to COVID-19 in Northern Ontario.

Design

Secondary analysis of qualitative data using interview transcripts from a dataset that included 15 interviews conducted between October 2020 and April 2021.

Methods

The dataset came from a convergent mixed method study exploring the delivery of primary care services to transgender individuals in Northern Ontario. Qualitative interviews with primary care practitioners including nurse practitioners, nurses, physicians, social workers, psychotherapists, and pharmacists providing care for transgender people in Northern Ontario were included in the secondary analysis.

Results

Fifteen primary care practitioner providing care to transgender individuals in Northern Ontario participated in the parent study. Practitioners described their understanding of the effect of the early stages of the COVID-19 pandemic changes on their practice and the care experience for their transgender patients. Two themes were identified and described by participants: (1) a change in the delivery of care; and (2) barriers and facilitators to care.

Conclusions

Practitioners' primary care experiences in the early waves of COVID suggest the integral use of telehealth in Northern Ontario transgender care. Nurses working in advance practice and nurse practitioners are essential in providing continuity of care for their transgender clients.

Clinical relevance/Significance

Identification of initial practice changes for the primary care of trans people will illuminate avenues for further research. The urban, rural, and remote practice settings in Northern Ontario provide an opportunity for increasing access for gender diverse people in these areas and for developing increased understanding of uptake of telemedicine practice. Nurses are integral to primary care for transgender patients in Northern Ontario.

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