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Nevin Manimala Statistics

Development and Validation of Information Technology Scale in Nursing

Appl Clin Inform. 2024 Mar;15(2):220-229. doi: 10.1055/s-0044-1782229. Epub 2024 Mar 20.

ABSTRACT

BACKGROUND: The implementation of information technology (IT) in patient care is on the rise. The nursing workforce should be prepared for using such technology to support the delivery of patient-centered care. The integration of informatics into nursing practice has been progressing at a slower rate than the development of advancements and in which areas nurses use IT is still not clear.

OBJECTIVE: Our objective was to develop a new instrument to determine the usage of IT in nursing practice.

METHODS: A methodological study was conducted with factor analyses. A total of 498 registered nurses in a university hospital (n = 374) and primary care centers (n = 124) participated in the study. A questionnaire consisting demographic characteristics and an item pool with 50 statements were used to collect data. The validity and reliability of the instrument were statistically tested by computing the Keiser-Meier-Olkin (KMO) and Bartlett tests, an exploratory factor analysis, descriptive statistics, Cronbach’s α, and a confirmatory factor analysis.

RESULTS: The instrument extracted eight factors comprising 39 items that explained 55% of the variance: professional autonomy(α = 0.82), data sharing/communication(α = 0.80), data management (α = 0.79), professional development (α = 0.71), administration (α = 0.76), research (α = 0.76), informing (α = 0.68), and classification of interventions (α = 0.75). Total reliability was 0.936. KMO index and a measure of sampling adequacy were high (0.936); the Bartlett test of sphericity was significant (p < 0.005).

CONCLUSION: Study provided the evidence for the factor structure, internal consistency, reliability, and responsiveness of the 39-item “The Information Technology Scale in Nursing.” Further testing of the developed instrument with a larger number of nurses from various backgrounds and different settings is recommended.

PMID:38508655 | DOI:10.1055/s-0044-1782229

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Nevin Manimala Statistics

Self-help friendliness and cooperation with self-help groups among rehabilitation clinics in Germany (KoReS): a mixed-methods study protocol

BMJ Open. 2024 Mar 20;14(3):e083489. doi: 10.1136/bmjopen-2023-083489.

ABSTRACT

INTRODUCTION: Self-help is an important complement to medical rehabilitation for people with chronic diseases and disabilities. It contributes to stabilising rehabilitation success and further coping with disease and disability. Rehabilitation facilities are central in informing and referring patients to self-help groups. However, sustainable cooperation between rehabilitation and self-help, as can be achieved using the concept of self-help friendliness in healthcare, is rare, as is data on the cooperation situation.

METHODS AND ANALYSIS: The KoReS study will examine self-help friendliness and cooperation between rehabilitation clinics and self-help associations in Germany, applying a sequential exploratory mixed-methods design. In the first qualitative phase, problem-centred interviews and focus groups are conducted with representatives of self-help-friendly rehabilitation clinics, members of their cooperating self-help groups and staff of self-help clearinghouses involved based on a purposeful sampling. Qualitative data collected will be analysed through content analysis using MAXQDA. The findings will serve to develop a questionnaire for a quantitative second phase. Cross-sectional online studies will survey staff responsible for self-help in rehabilitation clinics nationwide, representatives of self-help groups and staff of self-help clearinghouses. Quantitative data analysis with SPSS will include descriptive statistics, correlation, subgroup and multiple regression analyses. Additionally, a content analysis of rehabilitation clinics’ websites will evaluate the visibility of self-help in their public relations.

ETHICS AND DISSEMINATION: The University Medical Center Hamburg-Eppendorf Local Psychological Ethics Committee at the Center for Psychosocial Medicine granted ethical approval (reference number LPEK-0648; 10.07.2023). Informed consent will be obtained from all participants. Results dissemination will comprise various formats such as workshops, presentations, homepages and publications for the international scientific community, rehabilitation centres, self-help organisations and the general public in Germany. For relevant stakeholders, practical guides and recommendations to implement self-help friendliness will derive from the results to strengthen patient orientation and cooperation between rehabilitation and self-help to promote the sustainability of rehabilitation processes.

PMID:38508651 | DOI:10.1136/bmjopen-2023-083489

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Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia

BMJ Open. 2024 Mar 19;14(3):e081208. doi: 10.1136/bmjopen-2023-081208.

ABSTRACT

INTRODUCTION: Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.

METHODS AND ANALYSIS: The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.

ETHICS AND DISSEMINATION: The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.

TRIAL REGISTRATION NUMBER: Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

PMID:38508650 | DOI:10.1136/bmjopen-2023-081208

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Relationship between social isolation and glycaemic control of people previously diagnosed with diabetes: secondary analysis from the CHARLS

BMJ Open. 2024 Mar 19;14(3):e076106. doi: 10.1136/bmjopen-2023-076106.

ABSTRACT

OBJECTIVES: Social isolation may affect diabetes self-management. This study aimed to explore the relations between social isolation and glycaemic control in patients with diabetes and to explore lifestyle differences among individuals with different levels of social isolation.

METHODS: The relevant data of 665 people previously diagnosed with diabetes included in the China Health and Retirement Longitudinal Study from 2011 to 2015 were extracted and analysed. The study included patient general information, blood glucose, lipids, glycosylated haemoglobin, social isolation index, health-related lifestyle factors and diabetes-related factors. Differences in metabolic abnormalities and modifiable lifestyles were compared among patients with varying levels of social isolation.

RESULTS: Multiple linear regression analysis demonstrated that among men aged 45-64 years, the high social isolation group had significantly higher glycosylated haemoglobin levels compared with the low isolation group (7.29±1.81 vs 6.59±1.63, p=0.026). A positive correlation was observed between social isolation and blood glucose (β=14.16; 95% CI 2.75 to 25.57; p=0.015) and glycosylated haemoglobin (β=0.35; 95% CI 0.10 to 0.60; p=0.006), indicating that higher social isolation was associated with higher fasting blood glucose and glycosylated haemoglobin levels. However, no significant associations were observed in other age groups. Notably, men aged 45-65 years with high social isolation had higher depression rates (44.10% vs 24.60%, p=0.024), lower engagement in moderate exercise (5.70% vs 23.50%, p=0.019) and shorter 10-minute walks (17.10% vs 36.80%, p=0.027). Differences in other health-related and diabetes-related factors were not statistically significant.

CONCLUSION: Middle-aged men with diabetes with higher social isolation tend to have higher blood glucose and glycosylated haemoglobin levels. This subset of patients requires targeted attention to provide social support from family and friends for improved glycaemic control. If necessary, education on diabetes should be made available to family members and friends.

PMID:38508640 | DOI:10.1136/bmjopen-2023-076106

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Development and applications of the Anaesthetists’ Non-Technical Skills behavioural marker system: a systematic review

BMJ Open. 2024 Mar 20;14(3):e075019. doi: 10.1136/bmjopen-2023-075019.

ABSTRACT

OBJECTIVES: To comprehensively synthesise evidence regarding the validity and reliability of the Anaesthetists’ Non-Technical Skills (ANTS) behavioural marker system and its application as a tool for the training and assessment of non-technical skills to improve patient safety.

DESIGN: Systematic review.

DATA SOURCES: We employed a citation search strategy. The Scopus and Web of Science databases were searched for articles published from 2002 to May 2022.

ELIGIBILITY CRITERIA: English-language publications that applied the ANTS system in a meaningful way, including its use to guide data collection, analysis and reporting.

DATA EXTRACTION AND SYNTHESIS: Study screening, data extraction and quality assessment were performed by two independent reviewers. We appraised the quality of included studies using the Joanna Briggs Institute Critical Appraisal Checklists. A framework analysis approach was used to summarise and synthesise the included articles.

RESULTS: 54 studies were identified. The ANTS system was applied across a wide variety of study objectives, settings and units of analysis. The methods used in these studies varied and included quantitative (n=42), mixed (n=8) and qualitative (n=4) approaches. Most studies (n=47) used the ANTS system to guide data collection. The most commonly reported reliability statistic was inter-rater reliability (n=35). Validity evidence was reported in 51 (94%) studies. The qualitative application outcomes of the ANTS system provided a reference for the analysis and generation of new theories across disciplines.

CONCLUSION: Our results suggest that the ANTS system has been used in a wide range of studies. It is an effective tool for assessing non-technical skills. Investigating the methods by which the ANTS system can be evaluated and implemented for training within clinical environments is anticipated to significantly enhance ongoing enhancements in staff performance and patient safety.

PROSPERO REGISTRATION NUMBER: CRD42022297773.

PMID:38508635 | DOI:10.1136/bmjopen-2023-075019

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SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

BMJ Open. 2024 Mar 20;14(3):e081455. doi: 10.1136/bmjopen-2023-081455.

ABSTRACT

INTRODUCTION: SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

METHODS AND ANALYSIS: The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

ETHICS AND DISSEMINATION: The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05533918 and NCT05533359.

PMID:38508633 | DOI:10.1136/bmjopen-2023-081455

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Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

BMJ Open. 2024 Mar 19;14(3):e075547. doi: 10.1136/bmjopen-2023-075547.

ABSTRACT

OBJECTIVES: To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

DESIGN: Qualitative interviews analysed using thematic analysis.

SETTING AND PARTICIPANTS: Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

RESULTS: Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

CONCLUSIONS: Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

PMID:38508621 | DOI:10.1136/bmjopen-2023-075547

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Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol

BMJ Open. 2024 Mar 19;14(3):e079071. doi: 10.1136/bmjopen-2023-079071.

ABSTRACT

BACKGROUND: Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning-specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

METHODS AND ANALYSIS: We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

ETHICS AND DISSEMINATION: As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

REGISTRATION: https://doi.org/10.17605/OSF.IO/ZHDKR.

PMID:38508618 | DOI:10.1136/bmjopen-2023-079071

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Implementation and Perception of Outpatient Pharmacists Prescribing Hormonal Contraceptives in North Carolina

J Am Pharm Assoc (2003). 2024 Mar 18:102070. doi: 10.1016/j.japh.2024.102070. Online ahead of print.

ABSTRACT

BACKGROUND: North Carolina (NC) House Bill 96, effective February 2022, enabled trained immunizing pharmacists across the state to prescribe hormonal contraceptives (HCs). However, the extent and barriers to deployment are unknown. The purpose of this study was to describe the uptake and challenges from outpatient pharmacists who trained to provide HCs in an outpatient practice to assist others in the implementation of this service.

OBJECTIVES: The primary objective was to estimate the proportion of trained NC pharmacists who provided HCs in an outpatient setting. The secondary objective was to identify barriers during the implementation of this service.

METHODS: This cross-sectional, anonymous, web-based survey was emailed on December 13, 2022 to NC-licensed pharmacists enrolled in the required training. A reminder email was sent on January 10, 2023, with all responses considered up to January 31, 2023. Pharmacists licensed in NC who performed at least 50% of their clinical practice in an outpatient setting were included. The primary endpoint was having prescribed HC (Y/N). All endpoints were analyzed using descriptive statistics.

RESULTS: Of 1,633 pharmacists eligible, 96 completed responses were included in the analysis (5.9%). Training was incomplete in 11/96 (11.5%), and 66/96 (68.8%) completed the training without implementing the service. Of the remaining 19/96 (19.8%) that developed a HC service, 15/96 (15.6%) had prescribed HCs. Among the 15 prescribing pharmacists, all reported positive patient feedback, while 7/15 reported improved job satisfaction. Among all 96 respondents, barriers reported included time constraints (49%) and a lack of appropriate reimbursement (43.8%).

CONCLUSION: Few HC-trained NC outpatient pharmacists are prescribing HCs. Addressing prescribing barriers would potentially expand the scope of this service and further innovate the outpatient pharmacy setting.

PMID:38508518 | DOI:10.1016/j.japh.2024.102070

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Glycemic control among adults with type 1 diabetes during Passover: a pre-post single center study

Can J Diabetes. 2024 Mar 18:S1499-2671(24)00059-5. doi: 10.1016/j.jcjd.2024.03.003. Online ahead of print.

ABSTRACT

BACKGROUND: No data are available regarding glycemic control of patients with type 1 diabetes mellitus (T1D) during Passover.

OBJECTIVE: To assess the effect of Passover on diabetes management and glycemic control in adults with T1D with nutritional changes during Passover (observant) compared with patients who did not change their dietary habits during Passover (non-observant).

METHODS: Observational pre-post study of adult patients with T1D, followed in a diabetes clinic in Israel. Data were downloaded from insulin pumps and CGM for 37 days: 2 weeks before Passover, 9 days of Passover, and 2 weeks thereafter. Differences in percentage of time spent above target (>10.0 mmol/l and >13.9 mmol/l), at target (3.9-10.0 mmol/l) and below target (<3.9mmol/l and <3.0 mmol/l) were compared using paired t-tests or paired signed rank tests.

RESULTS: The study cohort included 43 patients (23 observant, 20 non-observant). The average BG was significantly higher during Passover compared with the period before Passover – in non-observant patients 8.2±1.5 mmol/l and 7.9±1.3 mmol/l (p=0.043), respectively, and in observant patients 8.7±1.6 mmol/l and 8.4±1.6 mmol/l (p=0.048), respectively. Time above range (TAR) 10-13.9 mmol/l was increased in observant patients during Passover, as compared to the period before Passover – 24.9±16.2% and 20.6±12.4% (p=0.04), respectively. The dose of bolus insulin had increased significantly in observant patients – 27.4±13.9 units during Passover, as compared with 24.2±11.2 units before Passover (p=0.02).

CONCLUSIONS: Passover alters glycemic control and insulin needs in Jewish patients with T1D. It is advisable to make specific adjustments to maintain the recommended glycemic control.

PMID:38508514 | DOI:10.1016/j.jcjd.2024.03.003