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Pilot cluster randomised trial of an evidence-based intervention to reduce avoidable hospital admissions in nursing home residents (Better Health in Residents of Care Homes with Nursing--BHiRCH-NH Study)

Por: Sampson · E. L. · Feast · A. · Blighe · A. · Froggatt · K. · Hunter · R. · Marston · L. · McCormack · B. · Nurock · S. · Panca · M. · Powell · C. · Rait · G. · Robinson · L. · Woodward-Carlton · B. · Young · J. · Downs · M.
Objectives

To pilot a complex intervention to support healthcare and improve early detection and treatment for common health conditions experienced by nursing home (NH) residents.

Design

Pilot cluster randomised controlled trial.

Setting

14 NHs (7 intervention, 7 control) in London and West Yorkshire.

Participants

NH residents, their family carers and staff.

Intervention

Complex intervention to support healthcare and improve early detection and treatment of urinary tract and respiratory infections, chronic heart failure and dehydration, comprising: (1) ‘Stop and Watch (S&W)’ early warning tool for changes in physical health, (2) condition-specific care pathway and (3) Situation, Background, Assessment and Recommendation tool to enhance communication with primary care. Implementation was supported by Practice Development Champions, a Practice Development Support Group and regular telephone coaching with external facilitators.

Outcome measures

Data on NH (quality ratings, size, ownership), residents, family carers and staff demographics during the month prior to intervention and subsequently, numbers of admissions, accident and emergency visits, and unscheduled general practitioner visits monthly for 6 months during intervention. We collected data on how the intervention was used, healthcare resource use and quality of life data for economic evaluation. We assessed recruitment and retention, and whether a full trial was warranted.

Results

We recruited 14 NHs, 148 staff, 95 family carers and 245 residents. We retained the majority of participants recruited (95%). 15% of residents had an unplanned hospital admission for one of the four study conditions. We were able to collect sufficient questionnaire data (all over 96% complete). No NH implemented intervention tools as planned. Only 16 S&W forms and 8 care pathways were completed. There was no evidence of harm.

Conclusions

Recruitment, retention and data collection processes were effective but the intervention not implemented. A full trial is not warranted.

Trial registration number

ISRCTN74109734 (https://doi.org/10.1186/ISRCTN74109734).

Original protocol

BMJ Open. 2019;9(5):e026510. doi:10.1136/bmjopen-2018-026510.

Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol

Por: Blankestijn · P. J. · Fischer · K. I. · Barth · C. · Cromm · K. · Canaud · B. · Davenport · A. · Grobbee · D. E. · Hegbrant · J. · Roes · K. C. · Rose · M. · Strippoli · G. F. · Vernooij · R. W. · Woodward · M. · de Wit · G. A. · Bots · M. L.
Introduction

End-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD.

Methods and analysis

This international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years’ follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.

Ethics and dissemination

The CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.

Trial registration number

Netherlands National Trial Register (NTR 7138).

Understanding on the association between informal caregiver characteristics and cognitive function of adults with cancer: a scoping review protocol

Por: Yang · Y. · Rushton · S. · Woodward · A. · Hendrix · C.
Introduction

Adults with cancer frequently report symptoms such as decline in cognitive function throughout the trajectory of illness. Patients with cognitive deficits need support and assistance from their informal caregivers and often rely on them to manage their symptoms based on their degree of deficits. Patients spend a significant amount of time with their informal caregivers and become interdependent with each other. In spite of their interdependence, it is unclear whether patients’ cognitive outcomes (ie, cognitive function) are associated with their informal caregivers. Therefore, the body of literature related to the association between caregiver characteristics and cognitive function of adults with cancer needs to be fully mapped with assessment for knowledge gaps.

Methods and analysis

Methods for this scoping review was informed by the framework proposed by Arksey and O’Malley. Seven electronic databases will be searched: (1) PubMed (MEDLINE), (2) CINAHL, (3) Embase, (4) PsycINFO, (5) Scopus, (6) Sociological Abstracts and (7) ProQuest dissertation abstracts. In addition, the search for grey literature will include the conference abstracts available through Embase, Scopus and Sociological abstracts as well as dissertations available in ProQuest dissertations. All retrieved citations will be independently screened by two authors and eligibility will be determined based on inclusion and exclusion criteria at title and abstract level. Studies meeting inclusion criteria, will be screened at full text level by two reviewers followed by abstraction of included studies. Eligible studies will be collated, summarised and reported using the data charting form that research team developed.

Ethics and dissemination

This scoping review does not require ethics approval. Results of this scoping review will be disseminated via conference presentation and/or publication in a scientific journal.

Development of a 'universal-reporter outcome measure (UROM) for patient and healthcare professional completion: a mixed methods study demonstrating a novel concept for optimal questionnaire design

Por: Macefield · R. · Brookes · S. · Blazeby · J. · Avery · K. · On behalf of the Bluebelle Study Group* · Andronis · Blencowe · Calvert · Coast · Draycott · Donovan · Gooberman-Hill · Longman · Mathers · Pinkney · Reeves · Rogers · Torrance · Woodward · Ashton · Clayton · Clout · Dum
Objectives

To describe the novel concept of, and methods for developing, a ‘universal-reporter’ outcome measure (UROM); a single questionnaire for completion by patients and/or healthcare professionals (HCPs) when views on the same subject are required.

Design

A mixed methods study with three phases—phase I: identification of relevant content domains from existing clinical tools, patient questionnaires and in-depth interviews with multistakeholders; phase II: item development using a novel approach that considered plain language in conjunction with medical terminology; and phase III: pretesting with multistakeholders using cognitive interviews.

Setting

A case study in surgical wound assessment undertaken in two UK hospital trusts and one university setting.

Participants

Patients who had recently undergone general abdominal surgery and healthcare professionals involved in post-surgical wound care.

Results

Phase I: In the example case study, 19 relevant content domains were identified from two clinical tools, two patient questionnaires and 19 multistakeholder interviews (nine patients, 10 HCPs). Phase II: Domains were operationalised into items and subitems (secondary components to collect further information, if relevant). The version after pretesting had 16 items, five of which included further subitems. Plain language in conjunction with medical terminology was applicable in nine (27%) items/subitems. Phase III: Pretesting with 28 patients and 14 HCPs found that the UROM was acceptable to both respondent groups. An unanticipated secondary finding of the study was that the combined use of plain language and medical terminology during questionnaire development may be a useful, novel technique for evaluating item interpretation and thereby identifying items with inadequate content validity.

Conclusion

UROMs are a novel approach to outcome assessment that are acceptable to both patients and HCPs. Combining plain language and medical terminology during item development is a recommended technique to improve accuracy of item interpretation and content validity during questionnaire design. More work is needed to further validate this novel approach and explore the application of UROMs to other settings.

Perspectives of time: a qualitative study of the experiences of parents of critically ill newborns in the neonatal nursery in North Queensland interviewed several years after the admission

Por: Ireland · S. · Ray · R. A. · Larkins · S. · Woodward · L.
Design

A qualitative study informed by grounded theory principles to explore the experiences of parents who had extremely preterm or babies with antenatally diagnosed life-threatening diagnoses who were cared for in a regional tertiary neonatal unit. The study was conducted when the child was old enough to be diagnosed with long-term neurodevelopmental or medical sequelae.

Setting

North Queensland is a large area in Eastern Australia of 500 000 km2, which is served by one tertiary neonatal unit.

Participants

Seventeen families representing 21 extremely preterm babies and one baby with congenital malformations who was not expected to survive prior to delivery (but did) were interviewed using grounded theory principles. Interviews were coded and themes derived.

Results

Parents who recollect their neonatal experiences from 3 to 7 years after the baby was cared for in the neonatal intensive care described negative themes of grief and loss, guilt and disempowerment. Positive enhancers of care included parental strengths, religion and culture, family supports and neonatal unit practices. Novel findings included that prior pregnancy loss and infertility formed part of the narrative for parents, and hope was engendered by religion for parents who did not usually have a religious faith.

Conclusions

An understanding of both the negative aspects of neonatal care and the positive enhancers is necessary to improve the neonatal experience for parents. Parents are able to contextualise their previous neonatal experiences within both the long-term outcome for the child and their own life history.

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