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Ayer — Abril 19th 2024Tus fuentes RSS

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

Por: Gumber · L. · Agbeleye · O. · Inskip · A. · Fairbairn · R. · Still · M. · Ouma · L. · Lozano-Kuehne · J. · Bardgett · M. · Isaacs · J. D. · Wason · J. M. · Craig · D. · Pratt · A. G.
Objective

International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.

Design

Systematic review.

Data sources

Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.

Eligibility criteria

All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.

Data extraction and synthesis

Search results were independently screened by at least two reviewers and data were extracted into a proforma.

Results

38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.

Conclusions

International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.

Open science framework registration number

osf-registrations-yvtjb-v1.

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Reporting form and content of research priorities identified in knee osteoarthritis clinical practice guidelines: a methodological literature analysis

Por: Gao · Y. · Liu · Z. · Cao · R. · Feng · Y. · Tao · L. · Su · C. · Guan · X. · Fang · R. · Deng · Y. · Xiang · W. · Fei · Y.
Objectives

Clinical practice guideline (CPG) developers conduct systematic summaries of research evidence, providing them great capacity and ability to identify research priorities. We systematically analysed the reporting form and content of research priorities in CPGs related to knee osteoarthritis (KOA) to provide a valuable reference for guideline developers and clinicians.

Design

A methodological literature analysis was done and the characteristics of the reporting form and the content of the research priorities identified in KOA CPGs were summarised.

Data sources

Six databases (PubMed, Embase, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang and Chinese Biomedical Literature Database) were searched for CPGs published from 1 January 2017 to 4 December 2022. The official websites of 40 authoritative orthopaedic societies, rheumatology societies and guideline development organisations were additionally searched.

Eligibility criteria

We included all KOA CPGs published in English or Chinese from 1 January 2017 that included at least one recommendation for KOA. We excluded duplicate publications, older versions of CPGs as well as guidance documents for guideline development.

Data extraction and synthesis

Reviewers worked in pairs and independently screened and extracted the data. Descriptive statistics were used, and absolute frequencies and proportions of related items were calculated.

Results

187 research priorities reported in 41 KOA CPGs were identified. 24 CPGs reported research priorities, of which 17 (41.5%) presented overall research priorities for the entire guideline rather than for specific recommendations. 110 (58.8%) research priorities were put forward due to lack of evidence. Meanwhile, more than 70% of the research priorities reflected the P (population) and I (intervention) structural elements, with 135 (72.2%) and 146 (78.1%), respectively. More than half of the research priorities (118, 63.8%) revolved around evaluating the efficacy of interventions. Research priorities primarily focused on physical activity (32, 17.3%), physical therapy (30, 16.2%), surgical therapy (27, 14.6%) and pharmacological treatment (26, 14.1%).

Conclusions

Research priorities reported in KOA CPGs mainly focused on evaluating non-pharmacological interventions. There exists considerable room for improvement for a comprehensive and standardised generation and reporting of research priorities in KOA CPGs.

Using interoperable nursing care data to improve outcomes for multiple traumas patients with Impaired Physical Mobility

Abstract

Aim(s)

To demonstrate how interoperable nursing care data can be used by nurses to create a more holistic understanding of the healthcare needs of multiple traumas patients with Impaired Physical Mobility. By proposing and validating linkages for the nursing diagnosis of Impaired Physical Mobility in multiple trauma patients by mapping to the Nursing Outcomes Classification (NOC) and Nursing Interventions Classification (NIC) equivalent terms using free-text nursing documentation.

Design

A descriptive cross-sectional design, combining quantitative analysis of interoperable data sets and the Kappa's coefficient score with qualitative insights from cross-mapping methodology and nursing professionals' consensus.

Methods

Cross-mapping methodology was conducted in a Brazilian Level 1 Trauma Center using de-identified records of adult patients with a confirmed medical diagnosis of multiple traumas and Impaired Physical Mobility (a nursing diagnosis). The hospital nursing free-text records were mapped to NANDA-I, NIC, NOC and NNN linkages were identified. The data records were retrieved for admissions from September to October 2020 and involved medical and nursing records. Three expert nurses evaluated the cross-mapping and linkage results using a 4-point Likert-type scale and Kappa's coefficient.

Results

The de-identified records of 44 patients were evaluated and then were mapped to three NOCs related to nurses care planning: (0001) Endurance; (0204) Immobility Consequences: Physiological, and (0208) Mobility and 13 interventions and 32 interrelated activities: (6486) Environmental Management: Safety; (0840) Positioning; (3200) Aspiration Precautions; (1400) Pain Management; (0940) Traction/Immobilization Care; (3540) Pressure Ulcer Prevention; (3584) Skincare: Topical Treatment; (1100) Nutrition Management; (3660) Wound Care; (1804) Self-Care Assistance: Toileting; (1801) Self-Care Assistance: Bathing/Hygiene; (4130) Fluid Monitoring; and (4200) Intravenous Therapy. The final version of the constructed NNN Linkages identified 37 NOCs and 41 NICs.

Conclusion

These valid NNN linkages for patients with multiple traumas can serve as a valuable resource that enables nurses, who face multiple time constraints, to make informed decisions efficiently. This approach of using evidence-based linkages like the one developed in this research holds high potential for improving patient's safety and outcomes.

No Patient or Public Contribution

In this study, there was no direct involvement of patients, service users, caregivers or public members in the design, conduct, analysis and interpretation of data or preparation of the manuscript. The study focused solely on analysing existing de-identified medical and nursing records to propose and validate linkages for nursing diagnoses.

Factors associated with health behaviours among stroke survivors: A mixed‐methods study using COM‐B model

Abstract

Aims

To identify factors associated with health behaviours among stroke survivors, through a multi-centre study.

Design

A sequential mixed methods design.

Methods

In the quantitative research phase, a total of 350 participants were recruited through multi-stage sampling from December 2022 to June 2023. General information questionnaires, The Stroke Prevention Knowledge Questionnaire (SPKQ), Short Form Health Belief Model Scale (SF-HBMS), Health Promoting Lifestyle Profile (HPLPII), and the WHOQOL-BREF (World Health Organization Quality of Life Questionnaire, Brief Version) were distributed across five tertiary hospitals in Henan province, China. For the qualitative research component, semi-structured interviews were conducted to explore the barriers and facilitators of health behaviour. This study adheres to the GRAMMS guidelines.

Results

A total of 315 participants (90.0%) completed the survey. Identified barriers to health behaviour included residing in rural areas, higher scores on the Charlson Comorbidity Index (CCI) and mRS, as well as lower scores on SPKQ, SF-HBMS and WHOQOL-BREF. Twenty-four individuals participated in qualitative interviews. Twenty-eight themes were identified and categorised by frequency, covering areas such as knowledge, skills, intentions, social influences, social/professional role and identity, environmental context and resources, beliefs about capabilities, beliefs about consequences and behavioural regulation. Both quantitative and qualitative data suggested that health behaviour among stroke survivors is at a moderate level, and the identified barrier factors can be mapped into the COM-B model (Capability, Opportunity, Motivation and Behaviour).

Conclusion

The study indicates that key barriers to health behaviour among stroke survivors align with the COM-B model. These identified factors should be carefully considered in the planning of future systematic interventions aimed at improving health behaviours among stroke survivors.

Patient or Public Contribution

Patients were invited to completed questionnaires in the study and semi-structured interviews. The investigators provided explanation of this study’ content, purpose and addressed issues during the data collection.

A concurrent mixed‐method study exploring the experiences of interprofessional collaboration among Canadian midwives and obstetricians

Abstract

Aim

This study explores the experiences of interprofessional collaboration of Canadian midwives and obstetricians from midwives' perspective.

Design

A concurrent mixed-methods approach that combined a small validation study and qualitative thematic analysis was used to provide evidence of the nature and importance of collaboration between Registered Midwives (RMs) and obstetricians.

Method

Eighteen RMs across Canada completed a demographic survey and the Midwifery-Obstetrician Collaboration (MOC) scale in 2023. The quantitative analyses were conducted to assess the reliability of the Midwifery-Obstetrician Collaboration (MOC) and accumulate preliminary evidence to support its validity. Semi-structured interviews were conducted with 13 participants. After completing the interviews, themes were identified using thematic analysis.

Results

The primary themes identified were knowledge of midwifery scope affects collaboration, collaboration is necessary for effective patient care, midwife-physician collaboration is impacted by power differentials and hierarchies, and proposed methods to improve physician-midwife collaboration. Although a small sample size did not permit extensive statistical testing, the quantitative results supported the reliability of the MOC scale. In addition, a strong correlation between the MOC and the communication subscale of the Inter-Professional Collaboration (IPC) scale provided evidence of the MOC's concurrent validity as a measure of collaboration between midwives and physicians.

Conclusion

This study provides support for the Midwifery-Obstetrics Collaboration (MOC) Scale as an assessment tool to evaluate collaboration between midwives and OB/GYNs in obstetrics care. While the 18 RMs recruited for this study provided a fulsome analysis for the qualitative portion, a larger study is necessary to provide more extensive quantitative analysis to validate the MOC scale for continued use among RMs and OBs.

Implications

The implications of this study are to foster strong interprofessional relationships between midwives and OBs and to improve the health outcomes of pregnant women and newborns.

Reporting Method

The authors adhered to Consolidated criteria for reporting qualitative research (COREQ).

Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders

Por: Clohessy · S. · Arvanitis · T. N. · Rashid · U. · Craddock · C. · Evans · M. · Toro · C. T. · Elliott · M. T.
Objective

The COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used across all stages of clinical research by stakeholders in clinical, health and social care research and investigate their experience using digital tools.

Design

Two online surveys followed by semistructured interviews were conducted. Interviews were audiorecorded, transcribed and analysed thematically.

Setting, participants

To explore the digital tools used since the pandemic, survey participants (researchers and related staff (n=41), research and development staff (n=25)), needed to have worked on clinical, health or social care research studies over the past 2 years (2020–2022) in an employing organisation based in the West Midlands region of England (due to funding from a regional clinical research network (CRN)). Survey participants had the opportunity to participate in an online qualitative interview to explore their experiences of digital tools in greater depth (n=8).

Results

Six themes were identified in the qualitative interviews: ‘definition of a digital tool in clinical research’; ‘impact of the COVID-19 pandemic’; ‘perceived benefits/drawbacks of digital tools’; ‘selection of a digital tool’; ‘barriers and overcoming barriers’ and ‘future digital tool use’. The context of each theme is discussed, based on the interview results.

Conclusions

Findings demonstrate how digital tools are becoming embedded in clinical research, as well as the breadth of tools used across different research stages. The majority of participants viewed the tools positively, noting their ability to enhance research efficiency. Several considerations were highlighted; concerns about digital exclusion; need for collaboration with digital expertise/clinical staff, research on tool effectiveness and recommendations to aid future tool selection. There is a need for the development of resources to help optimise the selection and use of appropriate digital tools for clinical research staff and participants.

Factors impacting nursing assistants to accept a delegation in the acute care settings: A mixed method study

Abstract

Aims

To investigate the experience of nursing assistants being delegated nursing tasks by registered nurses.

Design

Mixed method explanatory sequential design.

Methods

A total of 79 nursing assistants working in an acute hospital in Australia completed surveys that aimed to identify their experience of working with nurses and the activities they were delegated. The survey data were analysed using descriptive statistics. Interviews with 11 nursing assistants were conducted and analysed using Braun and Clarke's thematic analysis. Results were triangulated to provide a richer understanding of the phenomena.

Results

Most nursing assistants felt supported completing delegated care activities. However, there was confusion around their scope of practice, some felt overworked and believed that they did not have the right to refuse a delegation. Factors impacting the nursing assistant's decision to accept a delegation included the attitude of the nurses, wanting to be part of the team and the culture of the ward. Nursing assistants who were studying to be nurses felt more supported than those who were not.

Conclusions

Delegation is a two-way relationship and both parties need to be cognisant of their roles and responsibilities to ensure safe and effective nursing care is provided. Incorrectly accepting or refusing delegated activities may impact patient safety.

Implications for the profession and/or patient care

Highlights the need for implementing strategies to support safe delegation practices between the registered and unregulated workforce to promote patient safety.

Impact

Describes the experiences of nursing assistants working in the acute care environment when accepting delegated care from nurses. Reports a range of factors that inhibit or facilitate effective delegation practices between nurses and nursing assistants. Provides evidence to support the need for stronger education and policy development regarding delegation practices between nurses and unregulated staff.

Reporting method

Complied with the APA Style JARS-MIXED reporting criteria for mixed method research.

Patient or public contribution

No patient or public contribution.

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

Por: Chatters · R. · Dimairo · M. · Cooper · C. · Ditta · S. · Woodward · J. · Biggs · K. · Ogunleye · D. · Thistlethwaite · F. · Yap · C. · Rothman · A.
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.

Inter-reviewer reliability of human literature reviewing and implications for the introduction of machine-assisted systematic reviews: a mixed-methods review

Por: Hanegraaf · P. · Wondimu · A. · Mosselman · J. J. · de Jong · R. · Abogunrin · S. · Queiros · L. · Lane · M. · Postma · M. J. · Boersma · C. · van der Schans · J.
Objectives

Our main objective is to assess the inter-reviewer reliability (IRR) reported in published systematic literature reviews (SLRs). Our secondary objective is to determine the expected IRR by authors of SLRs for both human and machine-assisted reviews.

Methods

We performed a review of SLRs of randomised controlled trials using the PubMed and Embase databases. Data were extracted on IRR by means of Cohen’s kappa score of abstract/title screening, full-text screening and data extraction in combination with review team size, items screened and the quality of the review was assessed with the A MeaSurement Tool to Assess systematic Reviews 2. In addition, we performed a survey of authors of SLRs on their expectations of machine learning automation and human performed IRR in SLRs.

Results

After removal of duplicates, 836 articles were screened for abstract, and 413 were screened full text. In total, 45 eligible articles were included. The average Cohen’s kappa score reported was 0.82 (SD=0.11, n=12) for abstract screening, 0.77 (SD=0.18, n=14) for full-text screening, 0.86 (SD=0.07, n=15) for the whole screening process and 0.88 (SD=0.08, n=16) for data extraction. No association was observed between the IRR reported and review team size, items screened and quality of the SLR. The survey (n=37) showed overlapping expected Cohen’s kappa values ranging between approximately 0.6–0.9 for either human or machine learning-assisted SLRs. No trend was observed between reviewer experience and expected IRR. Authors expect a higher-than-average IRR for machine learning-assisted SLR compared with human based SLR in both screening and data extraction.

Conclusion

Currently, it is not common to report on IRR in the scientific literature for either human and machine learning-assisted SLRs. This mixed-methods review gives first guidance on the human IRR benchmark, which could be used as a minimal threshold for IRR in machine learning-assisted SLRs.

PROSPERO registration number

CRD42023386706.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Por: Wilkinson · J. · Heal · C. · Antoniou · G. A. · Flemyng · E. · Alfirevic · Z. · Avenell · A. · Barbour · G. · Brown · N. J. L. · Carlisle · J. · Clarke · M. · Dicker · P. · Dumville · J. C. · Grey · A. · Grohmann · S. · Gurrin · L. · Hayden · J. A. · Heathers · J. · Hunter · K. E. · Lasser
Introduction

Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.

Methods and analysis

The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.

Ethics and dissemination

The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Development of a supportive care framework for breast cancer survivor's unmet needs: A modified Delphi study

Abstract

Aim

To establish a supportive care framework for addressing unmet needs among breast cancer survivors, providing practical guidance for healthcare providers to assess and manage these needs, ultimately enhancing the health outcomes and quality of life of breast cancer survivors.

Design

We conducted a two-round Delphi survey to gather expert opinions regarding the unmet needs supportive care framework for breast cancer survivors.

Methods

Initial framework identification and inquiry questionnaire creation was achieved via literature search and expert group discussions, which included 15 experts from nursing practice, clinical medicine, nursing management and nursing education was conducted using a Delphi survey. To establish consensus, a two-round Delphi poll was done, using criteria based on the mean (≥4.0), coefficient of variation (CV < 0.25) and percentage for entire score (≥20%).

Results

Experts reached a consensus, leading to six care modules, and 28 care entries: Tumour Detection Support (three care entries), Management of Complications of Antitumor Therapy (seven care entries), Healthy Lifestyle Management (five care entries), Sexual and Fertility Support (four care entries), Psychosocial Support (four care entries) and Resource and Linkage Support (five care entries).

Conclusion

To address breast cancer survivors' unmet needs, a supportive framework was developed to actively enhance their health outcomes. However, further refinement and feasibility testing using mobile devices or artificial intelligence are required.

Implications for the Profession and Patient Care

This pioneering framework prioritises addressing unmet needs and equips healthcare providers to assess and manage these needs effectively, facilitating the implementation of programs aimed at improving the well-being of breast cancer survivors.

Reporting Method

This study was guided by a modified guideline for the Conducting and Reporting of Delphi Studies (CREDES) (Palliative Medicine, 31(8), 684, 2017).

Patient or Public Contribution

No Patient or Public Contribution.

Trial and protocol registration

The Delphi study methodology does not require registration.

Enhancing blood pressure management protocol implementation in patients with acute intracerebral haemorrhage through a nursing‐led approach: A retrospective cohort study

Abstract

Aim

To evaluate the impact of nurse care changes in implementing a blood pressure management protocol on achieving rapid, intensive and sustained blood pressure reduction in acute intracerebral haemorrhage patients.

Design

Retrospective cohort study of prospectively collected data over 6 years.

Methods

Intracerebral haemorrhage patients within 6 h and systolic blood pressure ≥ 150 mmHg followed a rapid (starting treatment at computed tomography suite with a target achievement goal of ≤60 min), intensive (target systolic blood pressure < 140 mmHg) and sustained (maintaining target stability for 24 h) blood pressure management plan. We differentiated six periods: P1, stroke nurse at computed tomography suite (baseline period); P2, antihypertensive titration by stroke nurse; P3, retraining by neurologists; P4, integration of a stroke advanced practice nurse; P5, after COVID-19 impact; and P6, retraining by stroke advanced practice nurse. Outcomes included first-hour target achievement (primary outcome), tomography-to-treatment and treatment-to-target times, first-hour maximum dose of antihypertensive treatment and 6-h and 24-h systolic blood pressure variability.

Results

Compared to P1, antihypertensive titration by stroke nurses (P2) reduced treatment-to-target time and increased the rate of first-hour target achievement, retraining of stroke nurses by neurologists (P3) maintained a higher rate of first-hour target achievement and the integration of a stroke advanced practice nurse (P4) reduced both 6-h and 24-h systolic blood pressure variability. However, 6-h systolic blood pressure variability increased from P4 to P5 following the impact of the COVID-19 pandemic. Finally, compared to P1, retraining of stroke nurses by stroke advanced practice nurse (P6) reduced tomography-to-treatment time and increased the first-hour maximum dose of antihypertensive treatment.

Conclusion

Changes in nursing care and continuous education can significantly enhance the time metrics and blood pressure outcomes in acute intracerebral haemorrhage patients.

Reporting Method

STROBE guidelines.

Patient and Public Contribution

No Patient or Public Contribution.

Risk factors of post‐operative diarrhoea in patients with pancreatic cancer after neoadjuvant chemotherapy: A retrospective cohort study

Abstract

Background

Post-operative diarrhoea is a common adverse event after pancreatic surgery. While the risk factors for this condition have been identified, the increasing trend of administering chemotherapy before surgery might change these factors. This study aimed to identify the risk factors of post-operative diarrhoea in patients with pancreatic ductal adenocarcinoma (PDAC) who underwent neoadjuvant chemotherapy.

Design

A retrospective cohort study.

Methods

Patients who underwent neoadjuvant chemotherapy and pancreatectomy because of PDAC between 2021 and 2023 were included. The preoperative characteristics of, operative details of and post-operative outcomes in patients with and without post-operative diarrhoea were collected and compared. The independent risk factors of post-operative diarrhoea were identified using logistic regression analysis. STROBE checklist was used.

Results

Post-operative diarrhoea occurred in 65 out of 145 (44.8%) patients during hospitalization. Elevated white blood cell count, advanced tumour stage, and late abdominal drain removal were independent risk factors for post-operative diarrhoea (p < .001, p = .006 and p = .009, respectively).

Conclusions

Some perioperative factors influence post-operative diarrhoea in patients who undergo neoadjuvant chemotherapy. More attention should be paid to patients at a higher risk of post-operative diarrhoea, with an emphasis on high-quality management for these patients.

Reaching consensus on the definition of person‐centred handover practices in emergency departments: A modified online Delphi

Abstract

Aim

To reach consensus on the definition and attributes of ‘person-centred handover practices’ in emergency departments.

Background

Handover practices between emergency care practitioners and healthcare professionals in emergency departments are important and should be conducted meticulously. Person-centred handover practices may enhance the delivery of person-centred care in emergency departments.

Design

A three-round online Delphi survey.

Methods

Nine experts participated in a three round Delphi survey. The expert panel comprised experts from nine countries. Quantitative data were descriptively analysed, and qualitative data were thematically analysed. A consensus of 80% had to be reached before an attribute and definition could be accepted.

Results

Experts reached a consensus of 79% in round one, 95% in round two and 95% in round three. A final set of six attributes were agreed upon and the final concept definition was formulated.

Conclusion

Person-centred handover practices have not been implemented in emergency departments. Yet, person-centred handover practices may enhance the delivery of person-centred care, which has multiple benefits for patients and healthcare practitioners.

Implications for the profession and/or patient care

Person-centred care is not generally implemented in emergency departments. Person-centred handover practices can lead to person-centred care. Handover practices in emergency departments are a high-risk activity. Despite numerous calls to standardise and improve handover practices, they remain a problem. Developing a standardised definition could be a first step towards implementing person-centred handover practices in emergency departments.

Reporting method

The study adhered to the relevant EQUATOR reporting guidelines: Guidance on Conducting and Reporting Delphi Studies (CREDES) checklist.

Impact (Addressing)

Improve handover practices and patient care. Improve person-centred care in emergency departments.

Patient or public contribution

Emergency care practitioners and nurses experienced in handover practices and/or person-centred care, working in clinical and academic fields, participated in the study by sharing their expert knowledge during each of the Delphi rounds.

An mHealth application for chronic vascular access: A multi‐method evaluation

Abstract

Background

Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose.

Aim

In this study, we evaluated the utility, usability and feasibility of children, families and adults requiring long-term intravenous therapy using a recently developed mobile health application (App), intravenous (IV) Passport.

Design

Multi-site, parallel, multi-method, prospective cohort study.

Methods

A multi-site, multi-method study was carried out in 2020–2021, with 46 participants (20 adults, 26 children/family) reporting on their experiences surrounding the use of the IV Passport for up to 6 months.

Results

Overall, utility rates were acceptable, with 78.3% (N = 36) using the IV Passport over the follow-up period, with high rates of planned future use for those still active in the project (N = 21; 73%), especially in the child/family cohort (N = 13; 100%). Acceptability rates were high (9/10; IQR 6.5–10), with the IV Passport primarily used for documenting new devices and complications. Thematic analysis revealed three main themes (and multiple subthemes) in the qualitative data: Advocacy for healthcare needs, Complexity of healthcare and App design and functionality.

Conclusion

Several recommendations were made to improve the end-user experience including ‘how to’ instructions; and scheduling functionality for routine care.

Implications for the Profession and/or Patient Care

The IV Passport can be safely and appropriately integrated into healthcare, to support consumers.

Impact

Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians.

Reporting Method

Not applicable.

Patient Contribution

Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.

Construction of an instrument to enable the assessment of the risk of falls in older outpatients: A quantitative methodological study

Abstract

Objectives

To develop an instrument to facilitate the risk assessment of falls in older outpatients.

Design

A quantitative methodological study using the cross-sectional data.

Methods

This study enrolled 1988 older participants who underwent comprehensive geriatric assessment (CGA) in an outpatient clinic from May 2020 to November 2022. The history of any falls (≥1 falls in a year) and recurrent falls (≥2 falls in a year) were investigated. Potential risk factors of falls were selected by stepwise logistic regression, and a screening tool was constructed based on nomogram. The tool performance was compared with two reference tools (Fried Frailty Phenotype; CGA with 10 items, CGA-10) by using receiver operating curves, sensitivity (Sen), specificity (Spe), and area under the curve (AUC).

Results

Age, unintentional weight loss, depression measured by the Patient Health Questionnaire-2, muscle strength measured by the five times sit-to-stand test, and stand balance measured by semi- and full-tandem standing were the most important risk factors for falls. A fall risk screening tool was constructed with the six measurements (FRST-6). FRST-6 showed the best AUC (Sen, Spe) of 0.75 (Sen = 0.72, Spe = 0.69) for recurrent falls and 0.65 (Sen = 0.74, Spe = 0.48) for any falls. FRST-6 was comparable to CGA-10 and outperformed FFP in performance.

Conclusions

Age, depression, weight loss, gait, and balance were important risk factors of falls. The FRST-6 tool based on these factors showed acceptable performance in risk stratification.

Impact

Performing a multifactorial assessment in primary care clinics is urgent for falls prevention. The FRST-6 provides a simple and practical way for falls risk screening. With this tool, healthcare professionals can efficiently identify patients at risk of falling and make appropriate recommendations in resource-limited settings.

Patient or Public Contribution

No patient or public contribution was received, due to our study design.

How do patients with rheumatoid arthritis perceive their self‐care and self‐care support? A mixed‐method study

Abstract

Aim

To explore self-care and needs and preferences towards tailored self-care support of patients with rheumatoid arthritis at the outpatient clinic.

Design

A sequential explanatory mixed method design.

Methods

The Self-Care of Chronic Illness Inventory questionnaire, two focus groups and six semi-structured interviews were conducted between November 2021 and April 2023. Questionnaires of 107 patients were descriptively analysed. Subsequently, 11 patients and 2 healthcare professionals participated in the focus groups and 6 patients in the interviews, which were thematically analysed.

Results

Quantitative and qualitative data corresponded and showed that patients perform various self-care activities at an adequate level and have strategies to exert control and reduce symptoms. One key theme emerged: ‘Not only being the person with rheumatoid arthritis’ (RA) as patients primarily aim to get on with their lives. Nine subthemes covered self-care activities for maintaining health including staying physically active, finding the right medication and dose and adapting their diet. Patients differed in how they self-monitored their symptoms. Recognizing symptoms and finding strategies to manage symptoms included the process of body listening in which patient seek and try different strategies to find what works for them and incorporate routines. Patients experienced positive effects of a warm or cold environment. Patients felt the need for practical and emotional support from others and preferred having credible information.

Conclusion

Patients perform adequate self-care including a diversity of self-care activities to get on with their lives and have strategies to reduce and control the symptoms and impact of RA.

Implications

Tailoring self-care support to patients' individual needs and preferences is necessary to help patients cope with the erratic nature of the disease and maintain their quality of life. Healthcare providers need to provide practical and emotional support and use credible information to allow patients to make self-care decisions to manage their lives.

Reporting Methods

Quantitative finding are reported according to the STROBE guidelines and qualitative finding are reported according to the COREQ guidelines.

What Does This Paper Add

Patients perform various self-care activities at an adequate level and have strategies to exert control and reduce symptoms. Patients primarily aim to continue their lives and not being seen as the person with rheumatoid arthritis. Healthcare professionals need to provide practical and emotional support and use credible information to inform patients' self-care decision-making.

Patient or Public Contribution

No patient or public contribution.

Engaging people with lived experiences on community advisory boards in community-based participatory research: a scoping review protocol

Por: Nelson · G. · Kettaneh · H. · Knox · B. · Purkey · E. · Chan-Nguyen · S. · Jenkins · M. · Bayoumi · I.
Introduction

Community-based participatory research (CBPR) is a collaborative research approach that equally engages researchers and community stakeholders throughout all steps of the research process to facilitate social change and increase research relevance. Community advisory boards (CABs) are a CBPR tool in which individuals with lived experience and community organisations are integrated into the research process and ensure the work aligns with community priorities. We seek to (1) explore the best practices for the recruitment and engagement of people with lived experiences on CABs and (2) identify the scope of literature on minimising power dynamics between organisations and community members with lived experience who work on CABs together.

Methods and analysis

This scoping review will follow the Arksey and O’Malley methodological framework, informed by Levac et al, and will be reported using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. Detailed and robust search strategies have been developed for Embase, Medline and PsychINFO. Grey literature references and reference lists of included articles published between 1 January 1990 and 30 March 2023 will be considered. Two reviewers will independently screen references in two successive stages of title/abstract and full-text screening. Conflicts will be decided by consensus or a third reviewer. Thematic analysis will be applied in three phases: open coding, axial coding and abstraction. Extracted data will be recorded and presented in a tabular format and/or graphical summaries, with a descriptive overview discussing how the research findings relate to the research questions. At this time, a preliminary search of peer-reviewed and grey literature has been conducted. Search results for peer-reviewed literature have been uploaded to Covidence for review and appraisal for relevance.

Ethics and dissemination

Formal ethics approval is not required for this review. Review findings will inform ongoing and future CBPR community advisory board dynamics.

Registration

The protocol has been registered prospectively on the Open Science Framework (https://doi.org/10.17605/OSF.IO/QF5D3)

Struggling in the dehumanized world of COVID—An exploratory mixed‐methods study of frontline healthcare workers' experiences

Abstract

Aim

To explore healthcare workers' experiences of the changed caring reality during the COVID-19 pandemic in Sweden.

Design

An online fully mixed-methods design.

Methods

A web-based self-reported questionnaire with fixed and open-ended answers collected data from March to April 2021, analysed in three steps. First, free-text questions were analysed by qualitative content analysis. Then quantitative linear regression analyses using models covering stress and coping mechanisms were conducted. Finally, a meta-inference of qualitative and quantitative data emerged a new comprehensive understanding. The COREQ guidelines were used for reporting.

Results

Meta-inferenced results of quantitative and qualitative findings show the pandemic was a traumatic experience for healthcare workers. Main theme; When work became a frightening experience in a dehumanized reality, comprised four themes: Entering unprepared into a frightful, incomprehensible world; Sacrificing moral values and harbouring dilemmas in isolation; Lack of clear management; and Reorient in togetherness and find meaning in a changed reality. Qualitative results comprised four categories; Working in a dehumanized world; Living in betrayal of ones' own conscience; Lack of structure in a chaotic time and Regaining vitality together. Subdimensions comprehensibility and meaningfulness were associated significantly with post-traumatic stress disorder in multiple regression analysis. In multiple regression analysis, sense of coherence was the most prominent coping strategy.

Conclusions

Forcing oneself to perform beyond one's limit, sacrificing moral values and lacking management was a traumatic experience to healthcare workers during the pandemic. Reorienting as a way of coping was possible in togetherness with colleagues. There is an urgency of interventions to meet the needs among healthcare workers who took on a frontline role during the COVID-19 pandemic and to prevent mental health illness in future crisis.

Patient or Public Contribution

No patient or public contribution.

Summary

The pandemic outbreak exposed frontline healthcare workers to unparallelled stress shown as negative for their mental health in several meta-analyses and systematic reviews. In-depth understanding on experiences and how symptoms of post-traumatic stress disorder relate to coping mechanisms have been scarcely explored. This study contributes to understanding on healthcare workers' experiences and the relation between lower sense of coherence and increased risk of developing symptoms of post-traumatic stress disorder.

Implications for Practice/Policy

This study might guide how to prepare for resilience in future emergencies.

Key elements to support primary healthcare nurses to thrive at work: A mixed‐methods sequential explanatory study

Abstract

Aim

Develop evidence-based recommendations for managers to support primary healthcare nurses to thrive at work.

Design

A mixed-methods sequential explanatory design.

Methods

National data were collected in 2020 via an e-survey based on a meta-analysis of antecedents of thriving from 213 primary healthcare nurses across New Zealand. Structural equation modelling analysis identified the key factors supporting primary healthcare nurses to thrive. This informed a second open-ended e-survey in 2022 of 19 nurses from one primary healthcare organization. The thematic analysis provided recommendations for improving management strategies to support thriving primary healthcare nurses.

Results

The vitality component of thriving significantly reduced burnout and intention to leave organization and profession. In contrast, the learning component of thriving had a significant positive effect on burnout. The key factors that support thriving at work are empowering leadership and perceived organizational supports (decreases burnout and intention to leave organization and profession through enhanced vitality). Recommendations for improving thriving were made in eight key areas: communication, effective management, professional development, scope of practice, autonomy, effective orientation, reward and work–life balance.

Conclusions

Vitality is important in reducing burnout and turnover intentions. While learning was identified as increasing burnout, professional development and training for managers were identified as essential. Hence, the vitality dimension of the thriving at work construct should be studied at the dimension level, but more research is needed into the impact of learning on thriving over time. Primary healthcare nurses have identified that empowering leadership and perceived organizational support are critical factors in supporting them to thrive, and they provide specific recommendations for managers to improve these factors in the clinical setting.

No Patient or Public Contribution

This study collected data from Registered Nurses only.

What Is Already Known

A plethora of existing research focuses on resilience in nurses rather than thriving at work. Enabling employees to thrive at work contributes to improved well-being and sustainable organizational performance.

What This Paper Adds

Empowering leadership and perceived organizational support are the key factors that support primary healthcare nurses to thrive at work. The vitality dimension of the thriving at work construct should be studied at the dimension level, and further research is needed into the impact of learning on thriving over time. Primary healthcare nurses recommend that managers focus on improving communication, management efficiency, professional development, scope of practice, autonomy, orientation, reward and work–life balance.

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