Conectar
To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.
Qualitative interviews analysed using thematic analysis.
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).
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.
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.
To explore the acceptability of an optimised physiotherapy (OPTimisE) intervention for people with lateral elbow tendinopathy (LET) and feasibility of comparing it to usual care in a randomised controlled trial.
Semistructured interviews, analysed using thematic analysis and mapped onto the COM-B model of behaviour change.
Conducted as part of the OPTimisE Pilot & Feasibility randomised controlled trial within physiotherapy departments in the United Kingdom National Health Service.
17 patients with LET (purposively sampled to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation) and all 8 physiotherapists involved as treating clinicians or site principal investigators.
Four themes were identified. First, participants reported the OPTimisE intervention as acceptable. Second, differences between the OPTimisE intervention and usual care were identified, including the use of an orthosis, holistic advice/education including modifiable risk factors, forearm stretches, general upper body strengthening and a more prescriptive exercise-dosing regimen. Third, participants provided feedback related to the trial resources, which were viewed positively, but identified language translation as a need. Fourth, feedback related to trial processes identified the need for changes to outcome collection and reduction of administrative burden. From the perspective of adopting the OPTimisE intervention, we found evidence that participants were able to change their behaviour. Considering the findings through the lens of the COM-B model, the intervention is likely to be deliverable in practice and the trial can be delivered at scale with some additional support for physiotherapists.
Overall, the OPTimisE intervention was found to be different to usual care and acceptable to patients and physiotherapists. The study highlighted the need to refine trial processes and resources prior to a full-scale trial, to reduce administrative burden, increase support for physiotherapists, improve return rate of outcome questionnaires and provide language translation.
ISRCTN database 19 July 2021. https://www.isrctn.com/ISRCTN64444585.
Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia.
KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness.
The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings.
To explore perceptions and attitudes of African immigrants (Ghanaians, Nigerians, Liberians, and Sierra Leoneans) in the Baltimore-Washington, DC, metropolitan area toward cardiovascular health.
This was a qualitative study among African immigrants recruited from religious and community-based organizations in the Baltimore-Washington metro area. A purposive sample of 66 African immigrants originally from Ghana, Nigeria, Liberia, and Sierra Leone completed a sociodemographic survey and participated in focus group discussions. Focus group data were analysed using qualitative description to develop emergent themes.
A total of 66 African immigrants with a mean (±standard deviation) age of 51 (±11.8) years participated in the focus group discussions. Fifty percent were women, 91% had at least a bachelor's degree, 84% were employed, 80% had health insurance, and 75% were married/cohabitating. The majority of the participants (74%) had lived in the US for 10 years or more, 44% of them had hypertension, and 12% had diabetes. Findings from the focus group discussions revealed: gender differences in descriptions of cardiovascular health and healthiness, an emotional response associated with cardiovascular disease (evoking fear and anxiety and associated with family secrecy), positive and negative lifestyle changes after migration, cardiovascular screening behaviours, and facilitators and barriers to cardiovascular disease prevention practices and heart-healthy lifestyle.
Participants understood health to be a holistic state of well-being. Secrecy in disclosing their cardiovascular disease diagnoses informed by historical socio-cultural belief systems, perceived racial discrimination by healthcare providers, communication and health literacy barriers, economic barriers of holding multiple jobs and the exorbitant cost of heart-healthy foods were identified as some barriers to achieving optimal cardiovascular health in this immigrant population.
Our study expanded on the body of knowledge on African immigrants' perceptions and attitudes toward cardiovascular health. Addressing this knowledge gap will provide important intervention opportunities targeted at improving cardiovascular health outcomes in this population.
No patient or public contribution.
Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.
StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.
The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.
Coexisting multiple health conditions is common among older people, a population that is increasing globally. The potential for polypharmacy, adverse events, drug interactions and development of additional health conditions complicates prescribing decisions for these patients. Artificial intelligence (AI)-generated decision-making tools may help guide clinical decisions in the context of multiple health conditions, by determining which of the multiple medication options is best. This study aims to explore the perceptions of healthcare professionals (HCPs) and patients on the use of AI in the management of multiple health conditions.
A qualitative study will be conducted using semistructured interviews. Adults (≥18 years) with multiple health conditions living in the West Midlands of England and HCPs with experience in caring for patients with multiple health conditions will be eligible and purposively sampled. Patients will be identified from Clinical Practice Research Datalink (CPRD) Aurum; CPRD will contact general practitioners who will in turn, send a letter to patients inviting them to take part. Eligible HCPs will be recruited through British HCP bodies and known contacts. Up to 30 patients and 30 HCPs will be recruited, until data saturation is achieved. Interviews will be in-person or virtual, audio recorded and transcribed verbatim. The topic guide is designed to explore participants’ attitudes towards AI-informed clinical decision-making to augment clinician-directed decision-making, the perceived advantages and disadvantages of both methods and attitudes towards risk management. Case vignettes comprising a common decision pathway for patients with multiple health conditions will be presented during each interview to invite participants’ opinions on how their experiences compare. Data will be analysed thematically using the Framework Method.
This study has been approved by the National Health Service Research Ethics Committee (Reference: 22/SC/0210). Written informed consent or verbal consent will be obtained prior to each interview. The findings from this study will be disseminated through peer-reviewed publications, conferences and lay summaries.
Closed incision negative pressure therapy (ciNPT) system use compared with standard of care dressings (SOC) on surgical site infection (SSI) in cardiac surgery was assessed. A systematic literature review was conducted. Risk ratios (RR) and random effects models were used to assess ciNPT with foam dressing (ciNPT-F) or multilayer absorbent dressing (ciNPT-MLA) versus SOC. Health economic models were developed to assess potential per patient cost savings. Eight studies were included in the ciNPT-F analysis and four studies were included in the ciNPT-MLA analysis. For ciNPT-F, a significant reduction in SSI incidence was observed (RR: 0.507, 95% confidence interval [CI]: 0.362, 0.709; p < 0.001). High-risk study analysis reported significant SSI reduction with ciNPT-F use (RR: 0.390, 95% CI: 0.205, 0.741; p = 0.004). For ciNPT-MLA, no significant difference in SSI rates were reported (RR: 0.672, 95% CI: 0.276, 1.635; p = 0.381). Health economic modelling estimated a per patient cost savings of $554 for all patients and $3242 for the high-risk population with ciNPT-F use. Health economic modelling suggests ciNPT-F may provide a cost-effective solution for sternotomy incision management. However, limited high-quality literature exists. More high-quality evidence is needed to fully assess the impact of ciNPT use following cardiac surgery.
This study aimed to evaluate the prospective cost-effectiveness of the Identification and Referral to Improve Safety plus (IRIS+) intervention compared with usual care using feasibility data derived from seven UK general practice sites.
A cost–utility analysis was conducted to assess the potential cost-effectiveness of IRIS+, an enhanced model of the UK’s usual care. IRIS+ assisted primary care staff in identifying, documenting and referring not only women, but also men and children who may have experienced domestic violence/abuse as victims, perpetrators or both. A perpetrator group programme was not part of the intervention per se but was linked to the IRIS+ intervention via a referral pathway and signposting. A Markov model was constructed from a societal perspective to estimate mean incremental costs and quality-adjusted life years (QALYs) of IRIS+ compared with to usual care over a 10-year time horizon.
The IRIS+ intervention saved £92 per patient and produced QALY gains of 0.003. The incremental net monetary benefit was positive (£145) and the IRIS+ intervention was cost-effective in 55% of simulations at a cost-effectiveness threshold of £20 000 per QALY.
The IRIS+ intervention could be cost-effective or even cost saving from a societal perspective in the UK, though there are large uncertainties, reflected in the confidence intervals and simulation results.
This study aims to map existing literature describing how people with lived experience of self-harm have engaged in codesigning self-harm interventions, understand barriers and facilitators to this engagement, and how the meaningfulness of codesign has been evaluated.
Scoping review by Joanna Briggs Institute methodology. A protocol was published online (http://dx.doi.org/10.17605/OSF.IO/P52UD).
PubMed, Embase, PsycINFO, Web of Science, Cochrane Library, PROSPERO, ClinicalTrials.gov and relevant websites were searched on 24 December 2022 (repeated 4 November 2023).
We included studies where individuals with lived experience of self-harm (first-hand or caregiver) have codesigned self-harm interventions.
Results were screened at title and abstract level, then full-text level by two researchers independently. Prespecified data were extracted, charted and sorted into themes.
We included 22 codesigned interventions across mobile health, educational settings, prisons and emergency departments. Involvement varied from designing content to multistage involvement in planning, delivery and dissemination. Included papers described the contribution of 159 female, 39 male and 21 transgender or gender diverse codesigners. Few studies included contributors from a minoritised ethnic or LGBTQIA+ group. Six studies evaluated how meaningfully people with lived experience were engaged in codesign: by documenting the impact of contributions on intervention design or through postdesign reflections. Barriers included difficulties recruiting inclusively, making time for meaningful engagement in stretched services and safeguarding concerns for codesigners. Explicit processes for ensuring safety and well-being, flexible schedules, and adequate funding facilitated codesign.
To realise the potential of codesign to improve self-harm interventions, people with lived experience must be representative of those who use services. This requires processes that reassure potential contributors and referrers that codesigners will be safeguarded, remunerated, and their contributions used and valued.
by Marla Beauchamp, Renata Kirkwood, Cody Cooper, Matthew Brown, K. Bruce Newbold, Darren Scott, on behalf of the MacM3 team
There is growing interest in identifying valid and reliable methods for detecting early mobility limitations in aging populations. A multi-sensor approach that combines accelerometry with Global Positioning System (GPS) devices could provide valuable insights into late-life mobility decline; however, this innovative approach requires more investigation. We conducted a series of two experiments with 25 older participants (66.2±8.5 years) to determine the validity of a GPS enabled smartwatch (TicWatch S2 and Pro 3 Ultra GPS) and separate accelerometer (ActiGraph wGT3X-BT) to collect movement, navigation and body posture data relevant to mobility. In experiment 1, participants wore the TicWatchS2 and ActiGraph simultaneously on the wrist for 3 days. In experiment 2, participants wore the TicWatch Pro 2 Ultra GPS on the wrist and ActiGraph on the thigh for 3 days. In both experiments participants also carried a Qstarz data logger for trips outside the home. The TicWatch Pro 3 Ultra GPS performed better than the S2 model and was similar to the Qstarz in all tested trip-related measures, and it was able to estimate both passive and active trip modes. Both models showed similar results to the gold standard Qstarz in life-space-related measures. The TicWatch S2 demonstrated good to excellent overall agreement with the ActiGraph algorithms for the time spent in sedentary and non-sedentary activities, with 84% and 87% agreement rates, respectively. Under controlled conditions, the TicWatch Pro 3 Ultra GPS consistently measured step count in line with the participants’ self-reported data, with a bias of 0.4 steps. The thigh-worn ActiGraph algorithm accurately classified sitting and lying postures (97%) and standing postures (90%). Our multi-sensor approach to monitoring mobility has the potential to capture both accelerometer-derived movement data and trip/life-space data only available through GPS. In this study, we found that the TicWatch models were valid devices for capturing GPS and raw accelerometer data, making them useful tools for assessing real-life mobility in older adults.This study aimed to explore the perceptions and experiences of barriers and facilitators to accessing Long COVID community rehabilitation.
We used a qualitative descriptive design over two rounds of data collection with three participant groups: (1) people with experience of rehabilitation for Long COVID (PwLC); (2) National Health Service (NHS) staff delivering and/or managing community rehabilitation services (allied health professionals (AHPs)) and (3) NHS staff involved in strategic planning around Long COVID in their health board (Long COVID leads).
Four NHS Scotland territorial health boards.
51 interviews: eight Long COVID leads (11 interviews); 15 AHPs (25 interviews) and 15 PwLC (15 interviews).
Three key themes were identified: (1) accessing care for PwLC, (2) understanding Long COVID and its management and (3) strengths and limitations of existing Long COVID rehabilitation services.
Organisational delivery of Long COVID community rehabilitation is complex and presents multiple challenges. In addition, access to Long COVID community rehabilitation can be challenging. When accessed, these services are valued by PwLC but require adequate planning, publicity and resource. The findings presented here can be used by those developing and delivering services for people with Long COVID.
Paramedic assessment data have not been used for research on avoidable calls. Paramedic impression codes are designated by paramedics on responding to a 911/999 medical emergency after an assessment of the presenting condition. Ambulatory care sensitive conditions (ACSCs) are non-acute health conditions not needing hospital admission when properly managed. This study aimed to map the paramedic impression codes to ACSCs and mental health conditions for use in future research on avoidable 911/999 calls.
Mapping paramedic impression codes to existing definitions of ACSCs and mental health conditions.
East Midlands Region, UK and Southern Ontario, Canada.
Expert panel from the UK-Canada Emergency Calls Data analysis and GEospatial mapping (EDGE) Consortium.
Mapping was iterative first identifying the common ACSCs shared between the two countries then identifying the respective clinical impression codes for each country that mapped to those shared ACSCs as well as to mental health conditions. Experts from the UK-Canada EDGE Consortium contributed to both phases and were able to independently match the codes and then compare results. Clinical impression codes for paramedics in the UK were more extensive than those in Ontario. The mapping revealed some interesting inconsistencies between paramedic impression codes but also demonstrated that it was possible.
This is an important first step in determining the number of ASCSs and mental health conditions that paramedics attend to, and in examining the clinical pathways of these individuals across the health system. This work lays the foundation for international comparative health services research on integrated pathways in primary care and emergency medical services.
Background
Chronic pain occurs in 30% of older adults. This prevalence rate is expected to increase, given the growth in the older adult population and the associated growth of chronic conditions contributing to pain. No population-based studies have provided detailed, longitudinal information on the experience of chronic pain in older adults; the pharmacological and nonpharmacological strategies that older adults use to manage their chronic pain; and the effect of chronic pain on patient-reported outcomes.
Objectives
This article aims to describe the protocol for a population-based, longitudinal study focused on understanding the experience of chronic pain in older adults. The objectives are to determine the prevalence and characteristics of chronic pain; identify the pharmacological and nonpharmacological pain treatments used; evaluate for longitudinal differences in biopsychosocial factors; and examine how pain types and pain trajectories affect important patient-reported outcomes. Also included are the results of a pilot study.
Methods
A population-based sample of approximately 1,888 older adults will be recruited from the National Opinion Research Center at the University of Chicago’s AmeriSpeak Panel to complete surveys at three waves: enrollment (Wave 1), 6 months (Wave 2), and 12 months (Wave 3). To determine the feasibility, a pilot test of the enrollment survey was conducted among 123 older adults.
Results
In the pilot study, older adults with chronic pain reported a range of pain conditions, with osteoarthritis being the most common. Participants reported an array of pharmacological and nonpharmacological pain strategies. Compared to participants without chronic pain, those with chronic pain reported lower physical and cognitive function and poorer quality of life. Data collection for the primary, longitudinal study is ongoing.
Discussion
This project will be the first longitudinal population-based study to examine the experience and overall effect of chronic pain in older adults. Pilot study results provide evidence of the feasibility of study methods. Ultimately, this work will inform the development of tailored interventions for older patients targeted to decrease pain and improve function and quality of life. Health and care resources are under increasing pressure, partly due to the ageing population. Physical activity supports healthy ageing, but motivating exercise is challenging. We aimed to explore staff perceptions towards a virtual reality (VR) omnidirectional treadmill (MOTUS), aimed at increasing physical activity for older adult care home residents.
Interactive workshops and qualitative evaluation.
Eight interactive workshops were held at six care homes and two university sites across Cornwall, England, from September to November 2021.
Forty-four staff participated, including care home, supported living, clinical care and compliance managers, carers, activity coordinators, occupational therapists and physiotherapists.
Participants tried the VR treadmill system, followed by focus groups exploring device design, potential usefulness or barriers for care home residents. Focus groups were audio-recorded, transcribed verbatim and thematically analysed. We subsequently conducted a follow-up interview with the technology developer (September 2022) to explore the feedback impact.
The analysis produced seven key themes: anticipated benefits, acceptability, concerns of use, concerns of negative effects, suitability/unsuitability, improvements and current design. Participants were generally positive towards VR to motivate care home residents’ physical activity and noted several potential benefits (increased exercise, stimulation, social interaction and rehabilitation). Despite the reported potential, staff had safety concerns for frail older residents due to their standing position. Participants suggested design improvements to enhance safety, usability and accessibility. Feedback to the designers resulted in the development of a new seated VR treadmill to address concerns about falls while maintaining motivation to exercise. The follow-up developer interview identified significant value in academia–industry collaboration.
The use of VR-motivated exercise holds the potential to increase exercise, encourage reminiscence and promote meaningful activity for care home residents. Staff concerns resulted in a redesigned seated treadmill for those too frail to use the standing version. This novel study demonstrates the importance of stakeholder feedback in product design.
To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness.
Parallel two-arm, cluster-level randomized controlled trial.
Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses.
We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570–572 (98.1%–98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the ‘other’ ethnicity subgroup.
We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care.
We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required.
Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care.
CONSORT and CONSERVE.
Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.
To evaluate the impact of a co-designed intervention to reduce time spent on clinical documentation and increase time for direct patient care.
A pre- and post-test interventional study with multi-method evaluation, reported according to the Transparent Reporting of Evaluations with Nonrandomised Evaluations Designs guidelines.
An intervention to decrease the burden of documentation was co-designed and implemented. Pre- and post-intervention data were collected via time and motion studies and the Burden of Documentation for Nurses and Midwives (BurDoNsaM) survey. Documentation audits were conducted to assess intervention fidelity.
Twenty-six shifts were observed (13 pre-intervention, 13 post-intervention). Although the coronavirus pandemic contributed to decreases in staffing levels by 38% (from 118 to 73 staff), the number of task episodes completed increased post-intervention, across all shift patterns. Documentation took less time to complete post-intervention when assessing time per episode. A mean increase of 201 episodes was observed on morning shifts, 78 on evening shifts and 309 on night shifts. There were small increases for time spent on direct patient care compared to pre-intervention but there was less time per episode. Results from the BurDoNsaM survey indicated that participants felt documentation took less time post-intervention. Documentation audits found completion improved as staff gained familiarity, but deteriorated when staffing levels were reduced.
The intervention was able to reduce time spent completing documentation, increasing the time available for direct patient care.
Completing clinical documentation is part of the daily work of nurses and midwives. Clinical documentation needs to accurately capture key information in a concise and streamlined manner to avoid unnecessary burdens and release time for direct patient care.
This study tested a co-designed intervention to address the burden of clinical documentation for nurses and midwives, The intervention reduced time spent on clinical documentation and increased time for direct patient care, This study could be replicated to reduce the burden of clinical documentation in other settings and benefit clinicians and patients by releasing more time for direct patient care.
The study is reported using the Transparent Reporting of Evaluations with Nonrandomised Evaluations Designs (TREND) guidelines.
The research project and intervention evaluated in this study were co-designed through a clinician-researcher collaboration. A research team that consisted of clinically based nurses and midwives and nurse scientists was formed to address the burden of clinical documentation. As the end-users of clinical documentation, the clinically based nurse and midwife co-investigators were involved in the design, conduct, interpretation of the data, and preparation of the manuscript.
It is common for community-based healthcare providers (CHPs)—many of whom have not received specialised training in wound care—to deliver initial and ongoing management for various wound types and diverse populations. Wounds in any setting can rapidly transition to a stalled, hard-to-heal wound (HTHW) that is not following a normal healing trajectory. Failure to recognise or address issues that cause delayed healing can lead to increased costs, healthcare utilisation and suffering. To encourage early intervention by CHPs, a panel of wound care experts developed actionable evidence-based recommendations for CHPs delineating characteristics and appropriate care in identifying and treating HTHWs. A HTHW is a wound that fails to progress towards healing with standard therapy in an orderly and timely manner and should be referred to a qualified wound care provider (QWCP) for advanced assessment and diagnosis if not healed or reduced in size by 40%–50% within 4 weeks. HTHWs occur in patients with multiple comorbidities, and display increases in exudate, infection, devitalised tissue, maceration or pain, or no change in wound size. CHPs can play an important initial role by seeing the individual's HTHW risk, addressing local infection and providing an optimal wound environment. An easy-to-follow one-page table was developed for the CHP to systematically identify, evaluate and treat HTHWs, incorporating a basic toolkit with items easily obtainable in common office/clinic practice settings. A flow chart using visual HTHW clinical cues is also presented to address CHPs with different learning styles. These tools encourage delivery of appropriate early interventions that can improve overall healthcare efficiency and cost.
Background
Up to 45% of patients report cancer-related cognitive impairment (CRCI). A variety of characteristics are associated with the occurrence and/or severity of CRCI. However, an important gap in knowledge of risk factors for CRCI is the relative contribution of each factor. The multifactorial model of cancer-related cognitive impairment (MMCRCI) is a conceptual model of CRCI that can be used to evaluate the strength of relationships between various factors and CRCI.
Objectives
The purpose of this study was to use structural regression methods to evaluate the MMCRCI using data from a large sample of outpatients receiving chemotherapy (n = 1,343). Specifically, the relationships between self-reported CRCI and four MMCRCI concepts (i.e., social determinants of health, patient-specific factors, treatment factors, and co-occurring symptoms) were examined. The goals were to determine how well the four concepts predicted CRCI and determine the relative contribution of each concept to deficits in perceived cognitive function.
Methods
This study is part of a larger, longitudinal study that evaluated the symptom experience of oncology outpatients receiving chemotherapy. Adult patients were diagnosed with breast, gastrointestinal, gynecological, or lung cancer; had received chemotherapy within the preceding 4 weeks; were scheduled to receive at least two additional cycles of chemotherapy; were able to read, write, and understand English; and gave written informed consent. Self-reported CRCI was assessed using the attentional function index. Available study data were used to define the latent variables.
Results
On average, patients were 57 years of age, college educated, and with a mean Karnofsky Performance Status score of 80. Of the four concepts evaluated, whereas co-occurring symptoms explained the largest amount of variance in CRCI, treatment factors explained the smallest amount of variance. A simultaneous structural regression model that estimated the joint effect of the four exogenous latent variables on the CRCI latent variable was not significant.
Discussion
These findings suggest that testing individual components of the MMCRCI may provide useful information on the relationships among various risk factors, as well as refinements of the model. In terms of risk factors for CRCI, co-occurring symptoms may be more significant than treatment factors, patient-specific factors, and/or social determinants of health in patients receiving chemotherapy. Background
Morning and evening fatigue are distinct and distressing symptoms experienced during chemotherapy that demonstrate a large amount of interindividual variability.
Objectives
The objectives of this study were to identify subgroups of patients with distinct morning and evening fatigue co-occurrence profiles and evaluate for differences among these subgroups in demographic, clinical, and symptom characteristics and quality of life.
Methods
Oncology patients (n = 1,334) completed the Lee Fatigue Scale to self-report morning and evening fatigue, six times over two cycles of chemotherapy. Latent profile analysis was used to identify subgroups of patients with distinct morning and evening physical fatigue profiles.
Results
Four distinct morning and evening fatigue profiles were identified (i.e., Both Low, Low Morning + Moderate Evening, Both Moderate, and Both High). Compared to the Both Low profile, the Both High profile was significantly younger, less likely to be married or partnered, more likely to live alone, had a higher comorbidity burden, and lower functional status. The Both High profile had higher levels of anxiety, depressive symptoms, sleep disturbance, and pain and lower levels of quality of life.
Discussion
The variability in the morning and evening severity scores among the four profiles supports the hypothesis that morning and evening fatigue are distinct but related symptoms. Clinically meaningful levels of both morning and evening fatigue were reported by 50.4% of our sample, which suggests that the co-occurrence of these two symptoms is relatively common. Patients in Both Moderate and Both High profiles experienced an extremely high symptom burden that warrants ongoing assessments and aggressive symptom management interventions. 
FreshRSS 