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Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe

Por: Zhang · J. · Kelkar · S. S. · Prabhu · V. S. · Qiao · Y. · Grall · V. · Miles · N. · Marth · C.
Objective

To evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe.

Design

Endometrial Cancer Health Outcomes-Europe (ECHO-EU) is a retrospective patient chart review study.

Setting

ECHO-EU is a multicentre study conducted in the UK, Germany, Italy, France and Spain.

Participants

Patients with recurrent/advanced endometrial cancer who progressed between 1 July 2016 and 30 June 2019 following prior first-line systemic therapy were eligible and data were collected until last available follow-up through November 2021.

Primary and secondary outcome measures

Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed since initiation of second-line therapy to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS) and overall survival (OS).

Results

A total of 475 patients were included from EU5 countries. Median age was 69 years at advanced endometrial cancer diagnosis, 78.7% had stage IIIB–IV disease, 45.9% had Eastern Cooperative Oncology Group status ≥2 at second-line therapy initiation. In second line, a majority of patients initiated either non-platinum-based chemotherapy (55.6%) or endocrine therapy (16.2%). Physician-reported real-world overall response rate (classified as complete or partial response) to second-line therapy was 34.5%, median rwPFS was 7.4 months (95% CI 6.2 to 8.0) and median OS was 11.0 months (95% CI 9.9 to 12.3).

Conclusions

Patients had poor clinical outcomes with a median OS of

Pressure injury risk assessment and prescription of preventative interventions using a structured tool versus clinical judgement: An interrater agreement study

Abstract

Aim

To assess agreement of pressure injury risk level and differences in preventative intervention prescription between nurses using a structured risk assessment tool compared with clinical judgement.

Design

Interrater agreement study.

Methods

Data were collected from November 2019 to December 2022. Paired nurse-assessors were allocated randomly to independently assess pressure injury risk using a structured tool (incorporating the Waterlow Score), or clinical judgement; then prescribe preventative interventions. Assessments were conducted on 150 acute patient participants in a general tertiary hospital. Agreement of risk level was analysed using absolute agreement proportions, weighted kappa and prevalence-adjusted and bias-adjusted kappa.

Results

Ninety-four nurse assessors participated. Absolute agreement of not-at-risk versus at-risk-any-level was substantial, but absolute agreement of risk-level was only fair. Clinical judgement assessors tended to underestimate risk. Where risk level was agreed, prescribed intervention frequencies were similar, although structured tool assessors prescribed more interventions mandated by standard care, while clinical judgement assessors prescribed more additional/optional interventions. Structured tool assessors prescribed more interventions targeted at lower-risk patients, whereas assessors using clinical judgement prescribed more interventions targeted at higher-risk patients.

Conclusion

There were clear differences in pressure injury risk-level assessment between nurses using the two methods, with important differences in intervention prescription frequencies found. Further research is required into the use of both structured tools and clinical judgement to assess pressure injury risk, with emphasis on the impact of risk assessments on subsequent preventative intervention implementation.

Impact

The results of this study are important for clinical practice as they demonstrate the influence of using a structured pressure injury risk assessment tool compared to clinical judgement. Whilst further research is required into the use of both structured tools and clinical judgement to assess pressure injury risk and prescribe interventions, our findings do not support a change in practice that would exclude the use of a structured pressure injury risk assessment tool.

Reporting Method

This study adhered to the GRRAS reporting guideline.

Patient/Public Contribution

No patient or public involvement in this study.

Implications for the profession and/or patient care

Educators and researchers can use the findings to guide teaching about pressure injury risk assessment and preventative intervention and to direct future studies. For clinical nurses and patients, a change in clinical practice that would exclude the use of a structured risk assessment tool is not recommended and further work is needed to validate the role of clinical judgement to assess risk and its impact on preventative intervention.

Protocol of a 12-week eHealth programme designed to reduce concerns about falling in community-living older people: Own Your Balance randomised controlled trial

Por: Lim · M. L. · Perram · A. · Radford · K. · Close · J. · Draper · B. · Lord · S. R. · Anstey · K. J. · O'Dea · B. · Ambrens · M. · Hill · T.-Y. · Brown · A. · Miles · L. · Ngo · M. · Letton · M. · van Schooten · K. S. · Delbaere · K.
Introduction

Concerns about falling (CaF) are common in older people and have been associated with avoidance of activities of daily life. Exercise designed to prevent falls can reduce CaF, but the effects are usually short-lived. Cognitive behavioural therapy (CBT) can reduce CaF for longer but is not readily available in the community and unlikely to prevent falls. A multidomain intervention that combines CBT, motivational interviewing and exercise could be the long-term solution to treat CaF and reduce falls in older people with CaF. This paper describes the design of a randomised controlled trial to test the effectiveness of two different 12 week self-managed eHealth programmes to reduce CaF compared with an active control.

Methods

A total of 246 participants (82 per group) aged 65 and over, with substantial concerns about falls or balance will be recruited from the community. They will be randomised into: (1) myCompass-Own Your Balance (OYB) (online CBT programme) intervention or (2) myCompass-OYB plus StandingTall intervention (an eHealth balance exercise programme), both including motivational interviewing and online health education or (3) an active control group (online health education alone). The primary outcome is change in CaF over 12 months from baseline of both intervention groups compared with control. The secondary outcomes at 2, 6 and 12 months include balance confidence, physical activity, habitual daily activity, enjoyment of physical activity, social activity, exercise self-efficacy, rate of falls, falls health literacy, mood, psychological well-being, quality of life, exercise self-efficacy, programme adherence, healthcare use, user experience and attitudes towards the programme. An intention-to-treat analysis will be applied. The healthcare funder’s perspective will be adopted for the economic evaluation if appropriate.

Ethics and dissemination

Ethical approval was obtained from the South Eastern Sydney Local Health District Human Research Ethics Committee (2019/ETH12840). Results will be disseminated via peer-reviewed journals, local and international conferences, community events and media releases.

Trial registration number

ACTRN12621000440820.

ARCHERY: a prospective observational study of artificial intelligence-based radiotherapy treatment planning for cervical, head and neck and prostate cancer - study protocol

Por: Aggarwal · A. · Court · L. E. · Hoskin · P. · Jacques · I. · Kroiss · M. · Laskar · S. · Lievens · Y. · Mallick · I. · Abdul Malik · R. · Miles · E. · Mohamad · I. · Murphy · C. · Nankivell · M. · Parkes · J. · Parmar · M. · Roach · C. · Simonds · H. · Torode · J. · Vanderstraeten · B. · Lan
Introduction

Fifty per cent of patients with cancer require radiotherapy during their disease course, however, only 10%–40% of patients in low-income and middle-income countries (LMICs) have access to it. A shortfall in specialised workforce has been identified as the most significant barrier to expanding radiotherapy capacity. Artificial intelligence (AI)-based software has been developed to automate both the delineation of anatomical target structures and the definition of the position, size and shape of the radiation beams. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy.

Methods

ARCHERY is a non-randomised prospective study to evaluate the quality and economic impact of AI-based automated radiotherapy treatment planning for cervical, head and neck, and prostate cancers, which are endemic in LMICs, and for which radiotherapy is the primary curative treatment modality. The sample size of 990 patients (330 for each cancer type) has been calculated based on an estimated 95% treatment plan acceptability rate. Time and cost savings will be analysed as secondary outcome measures using the time-driven activity-based costing model. The 48-month study will take place in six public sector cancer hospitals in India (n=2), Jordan (n=1), Malaysia (n=1) and South Africa (n=2) to support implementation of the software in LMICs.

Ethics and dissemination

The study has received ethical approval from University College London (UCL) and each of the six study sites. If the study objectives are met, the AI-based software will be offered as a not-for-profit web service to public sector state hospitals in LMICs to support expansion of high quality radiotherapy capacity, improving access to and affordability of this key modality of cancer cure and control. Public and policy engagement plans will involve patients as key partners.

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