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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.

Understanding nurses' experience of climate change and then climate action in Western Canada

Abstract

Aim

To understand nurses' personal and professional experiences with the heat dome, drought and forest fires of 2021 and how those events impacted their perspectives on climate action.

Design

A naturalistic inquiry using qualitative description.

Method

Twelve nurses from the interior of British Columbia, Canada, were interviewed using a semi-structured interview guide. Thematic analysis was employed. No patient or public involvement.

Results

Data analysis yielded three themes to describe nurses' perspective on climate change: health impacts; climate action and system influences. These experiences contributed to nurses' beliefs about climate change, how to take climate action in their personal lives and their challenges enacting climate action in their workplace settings.

Conclusions

Nurses' challenges with enacting environmentally responsible practices in their workplace highlight the need for engagement throughout institutions in supporting environmentally friendly initiatives.

Impact

The importance of system-level changes in healthcare institutions for planetary health.

Clinical and cost-effectiveness of DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people living with dementia and their carers: a study protocol for a parallel multicentre randomised controlled trial

Por: Rapaport · P. · Amador · S. · Adeleke · M. · Banerjee · S. · Barber · J. · Charlesworth · G. · Clarke · C. · Connell · C. · Espie · C. · Gonzalez · L. · Horsley · R. · Hunter · R. · Kyle · S. D. · Manela · M. · Morris · S. · Pikett · L. · Raczek · M. · Thornton · E. · Walker · Z. · Webster
Introduction

Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives’ sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care.

Methods and analysis

We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1–2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation.

Ethics and dissemination

London—Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention.

Trial registration number

ISRCTN13072268.

The role of nursing care continuity report in predicting length of hospital stay in older people: A retrospective cohort study

Abstract

Background

The Nursing Care Continuity Report (NCCR) is a tool for evaluating the quality of nursing care during hospital admission.

Aim

To explore the role of the NCCR in predicting longer length of stay (LOS) in older adults (≥65 years) admitted to a tertiary hospital and determine possible clinical differences at discharge between patients who had a short LOS (≤7 days) and a prolonged LOS (>7 days).

Research Design and Setting

A retrospective cohort study was conducted including all patients with a completed NCCR admitted to the hospital between 2015 and 2019. Sociodemographic data, risk of pressure injuries, level of dependence, presence and intensity of pain, and presence and type of pressure injury were the variables registered in the NCCR.

Results

A total of 41,354 patients were included in this study, with a mean age of 78 years, of whom 47% were female. At admission, 21% of patients were at potential risk of developing pressure ulcers. Age, admission to the internal or respiratory medicine unit, and having at least medium risk of developing pressure ulcers were the predictors of prolonged LOS using a random sample of 950 patients. At discharge, patients with prolonged LOS presented higher risk of pressure ulcers and a higher level of dependency and were more likely to present hospital-acquired pressure ulcers.

Conclusions

Older adults from the internal or respiratory medicine unit who exhibited higher risk of pressure ulcers were related to a prolonged LOS, a higher level of dependency, and hospital-acquired ulcers at hospital discharge.

Relevance to Clinical Practice

Identifying clinical data that have a greater relationship with LOS could be a useful tool for nursing management and for the implementation of strategies to prevent adverse events during hospitalisation.

No Patient or Public Contribution

No direct patient contact was made during the data collection.

Have interventions aimed at assisting general practitioners in facilitating earlier diagnosis of type 1 diabetes in children been successful? A systematic review protocol

Por: Beccia · C. · Hunter · B. · Birkic · V. · White · M. · Manski-Nankervis · J.-A.
Background

Early diagnosis of type 1 diabetes in children is critical to prevent deterioration to diabetic ketoacidosis (DKA), a state where the body’s insulin levels are critically low resulting in the use of fat for fuel and the accumulation of ketones. DKA is a life-threatening emergency where dehydration and cerebral oedema can quickly develop and lead to death. Despite treatment, DKA also has harmful impacts on cognition and brain development. Most children admitted to a hospital with DKA see their general practitioner in the week leading up to their admission. A delay in referral from general practice can result in delays in commencing lifesaving insulin therapy. Prior systematic reviews have explored publicity campaign interventions aimed at recognising type 1 diabetes earlier; however, no reviews have explored these interventions targeted at reducing the delay after presentation to the general practitioner. This systematic review aims to summarise interventions that target the diagnostic delay emerging from general practice and to evaluate their effectiveness in reducing DKA admissions.

Methods

Six databases (Ovid (MEDLINE), Web of Science, EMBASE, CINAHL, Evidence-Based Medicine Reviews (EBMR) and Google Scholar) will be searched to identify studies exploring interventions to reduce diagnostic delay in children with type 1 diabetes, and hence DKA, in general practice. The primary outcome will be the number of DKA admissions to a hospital following a delay in general practice. The secondary outcome will be the behaviour of general practitioners with respect to urgent referral of children with type 1 diabetes. Title, abstract and full-text screening for exclusion and inclusion of publications will be completed by two independent reviewers. Any risks of bias within individual studies will be assessed by two independent reviewers, using the Risk Of Bias In Non-Randomized Studies of Interventions tool. Our confidence in the overall body of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation.

Ethics and dissemination

The systematic review will be disseminated via publication and potentially in conference presentations. Ethics is not required for a systematic review of secondary data.

PROSPERO registration number

CRD42023412504

The meaning of preparedness for informal caregivers of older adults: A concept analysis

Abstract

Aim

To examine the concept of preparedness over time in research with informal caregivers of older adults.

Design

Concept analysis.

Methods

Rodgers' evolutionary method of concept analysis was used to guide this theoretical paper due to the dynamic nature of preparedness, which is influenced by both context and time. Using Rodgers' inductive approach, concept elements were derived from a content analysis of included studies. In the final step, to generate hypotheses and implications regarding the concept, the conceptual structure of preparedness of informal caregivers of older adults was connected to a theoretical problem in the nursing discipline using the Caregiving Stress Process Framework.

Data Sources

Four databases (EBSCO CINAHL, Ovid MEDLINE, Ovid PsycINFO and Scopus) were searched in November 2022 and updated in September 2023. No date limits were set for searching, as the intent was to analyse possible variations of the concept over time.

Results

The attributes of preparedness include self-confidence, having knowledge, skills and abilities to perform daily tasks, handling emotions and developed over time. These attributes can be compared with the stressors outlined in the Caregiving Stress Process Framework (i.e., the moment the caregiver identifies some ‘stressor’; something that prevents them from feeling confident in their preparedness).

Conclusion

The concept of preparedness of informal caregivers of older adults is defined as caregiver's self-confidence about their current competence related to the knowledge, skills and abilities to perform daily tasks, and to handle emotions over time. To link the concept to a theoretical perspective, we propose adaptations to a well-known theory, the Caregiving Stress Process Framework. Future research on caregiving preparedness needs to avoid circular definitions and work with the attributes of preparedness to support caregivers.

Implications for the Profession and/or Patient Care

This paper contributes to the development of interventions that focus on the health and preparedness of informal caregivers of older adults. Clarifying the concept of preparedness helps nurses to support caregivers since it is then known which aspects are included in the preparedness of caregivers (e.g., daily tasks and handling emotions). A more fulsome understanding of preparedness supports us to see beyond stressors of caregiving.

Impact

This study addresses informal caregivers of older adults' preparedness to provide care. We synthesized existing definitions that have been used in research with this population to propose a robust conceptualization of the concept of preparedness, which contributes to better understanding of how preparedness can be supported.

Reporting Method

We were unable to locate a reporting method related to this kind of work (concept analysis).

Patient or Public Contribution

Not applicable as no new data generated.

Decision‐making experiences related to mastectomy: A descriptive qualitative study

Abstract

Aim

To obtain an in-depth understanding of women's decision-making experiences related to mastectomy.

Design

A descriptive qualitative interview study.

Methods

Individual semi-structured interviews were conducted face-to-face with 27 Chinese women with breast cancer who underwent mastectomy at two tertiary hospitals in mainland China between September 2020 and December 2021 after obtaining the appropriate ethical approvals. Interviews were conducted in Mandarin. Data were analysed using inductive content analysis.

Results

Mean age of participants was 48 years (range 31–70). Most participants had low education, low monthly family income, had a partner and health insurance, had been diagnosed with early breast cancer, and had not undergone reconstructive surgery. Six categories related to decision-making experiences emerged: (1) Emotions affecting decision-making, (2) Information seeking for decision-making, (3) Beliefs about mastectomy and the breast, (4) Participation in decision-making, (5) People who influence decision-making, and (6) Post-decision reflection. Participants did not mention the role of nurses in their decision-making process for mastectomy.

Conclusions

This study adds valuable insights into the limited evidence on women's experience with decision-making about mastectomy from a Chinese perspective, which is important given the continuing high prevalence of mastectomy in many regions. Future studies from other countries and ethnic groups are recommended to gain diverse knowledge.

Impact

The findings of this study are useful for nurses and other healthcare professionals in the multidisciplinary team to better support women with breast cancer in their decision-making process regarding mastectomy. The findings could inform future interventions to support treatment decision-making and may be relevant to women living in similar socio-medical contexts to those in mainland China.

Reporting Method

The study was reported following the Standards for Reporting Qualitative Research checklist.

Patient or Public Contribution

No patient or public contribution.

Time for You: A process evaluation of the rapid implementation of a multi-level mental health support intervention for frontline workers during the COVID-19 pandemic

by Bryan McCann, Simon C. Hunter, Kareena McAloney-Kocaman, Paul McCarthy, Jan Smith, Eileen Calveley

The coronavirus (COVID-19) pandemic had wide-ranging negative impacts on mental health. The pandemic also placed extraordinary strain on frontline workers who were required to continue working and putting themselves at risk to provide essential services at a time when their normal support mechanisms may not have been available. This paper presents an evaluation of the Time for You service, a rapidly developed and implemented intervention aimed at providing frontline workers with quick access to flexible online mental health support. Time for You provided service users with three service options: self-guided online cognitive behavioural therapy (CBT) resources; guided engagement with online CBT resources; 1–1 psychological therapy with trainee sport and exercise psychologists and trainee health psychologists. A process evaluation informed by the Consolidated Framework for Implementation Research considered service fidelity, adaptations, perceived impact, reach, barriers, and facilitators. Interviews with project managers (n = 5), delivery staff (n = 10), and service users (n = 14) explored perceptions of the service implementation and outcomes, supported by data regarding engagement with the online CBT platform (n = 217). Findings indicated that service users valued the flexibility of the service and the speed with which they were able to access support. The support offered by Trainee Psychologists was perceived to be of high quality, and the service was perceived by service users to have improved mental health and wellbeing. The rapid implementation contributed to issues regarding appropriate service user screening that led to trainee psychologists being unable to provide the service users with the support they needed as the presenting issues were outside of trainees’ competencies. Overall, the findings suggest that interventions offering flexible, online psychological support to frontline workers can be an effective model for future interventions. Trainee psychologists are also able to play an important role in delivering such services when clear screening processes are in place.
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