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Development of a case definition for polycystic ovary syndrome using administrative health data: a validation study

Por: Salem · J. N. · Vettese · R. · Yamamoto · J. M. · Koshy · S. · Harrison · T. · Stephenson · N. · Ronksley · P. E. · Metcalfe · A. · Brennand · E. A. · Benham · J. L.
Objectives

To develop and validate a polycystic ovary syndrome (PCOS) case definition using administrative health data sources.

Design

A validation study.

Setting

Secondary care centre outpatient gynaecology clinic in Calgary, Alberta, Canada.

Participants

3951 electronic health records of women aged 18–45 years who presented to a gynaecology clinic in Calgary, Canada, between January 2014 and December 2019 were reviewed. We identified 180 patients with PCOS using the Rotterdam criteria. Participants were excluded if they were biologically male, pregnant at the time of the consultation, did not meet the date criteria or if their consultation note was missing. The chart data were connected to the Practitioner Claims and the Discharge Abstract Database by personal health number.

Primary and secondary outcome measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 68 case definitions for PCOS were estimated. Case definition performance was graded.

Results

Of the 68 case definitions tested, none had high validity. The best performing case definitions were: (1) ≥3 instances of International Classification of Diseases-9 code 256.4 (polycystic ovaries) with exclusion codes (sensitivity 23.89%, specificity 99.59%, PPV 74.14%, NPV 96.35%) and (2) 626.X (irregular menstruation), 704.1 (hirsutism) and ≥3 instances of code 256.4 with exclusion codes (sensitivity 2.78%, specificity 99.97%, PPV 83.33%, NPV 95.40%).

Conclusions

We identified several case definitions for PCOS of moderate validity with high PPV (>70%) for case ascertainment in PCOS research in jurisdictions with similar administrative health data. These case definitions are limited by low sensitivity, which should be considered when interpreting research findings.

Personalising anal cancer radiotherapy dose (PLATO): protocol for a multicentre integrated platform trial

Por: Frood · R. · Gilbert · A. · Gilbert · D. · Abbott · N. L. · Richman · S. D. · Goh · V. · Rao · S. · Webster · J. · Smith · A. · Copeland · J. · Ruddock · S. P. · Berkman · L. · Muirhead · R. · Renehan · A. G. · Harrison · M. · Adams · R. · Hawkins · M. · Brown · S. · Sebag-Montefiore · D.
Introduction

The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.

PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.

Methods and analysis

The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.

Ethics and dissemination

This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.

Trial registration number

ISRCTN88455282.

Qualitative investigation of the experiences of older people living with persistent pain and frailty and their decision to seek support: findings from the POPPY-Q study

Por: Harrison · N. · Mossabir · R. · Forster · A. · Kime · N. · Williams · A. C. d. C. · Brown · L.
Objectives

Persistent pain is common among older people living with frailty and can impact on their daily living, mobility, social interactions and sleep. However, healthcare support to mitigate impact is lacking in this population. The Pain in Older People with Frailty (POPPY) study is a multiphase, mixed-methods study that addresses how pain management services for older people with frailty should be organised and delivered.

Design

For this phase (POPPY-Q), we used qualitative methods: semi-structured interviews with a grounded theory approach to analysis.

Setting and participants

Community-dwelling older people (≥75 years) with persistent pain and frailty were invited to participate in two qualitative interviews (in-person/remotely) 10 weeks apart. Interviews took place in varied geographical locations across England between July 2022 and August 2023 and explored experiences of living with pain and access to and engagement with services and healthcare professionals (HCPs) and support and treatments received for pain.

Results

Twenty-six people (77–91 years) with pain and frailty (from mild to severe) consented and were interviewed; 24 completed a second interview. Three interviews included a spouse/family member. Themes were general health and well-being; pain and its impact; acceptance of living with pain; support-seeking decisions; experience of accessing support; and perception/experience of pain support and treatment. This paper focuses on pain acceptance and support-seeking; other themes are used contextually, and accessing support was rare. Many participants were stoical about pain; some prioritised other health conditions; some preferred self-management; some were resigned and had lost hope of effective treatment; some expressed concern about burdening healthcare resources.

Conclusions

HCPs should be aware of the stances of older people with frailty about seeking support for pain and should be proactive, asking about pain. Longer appointments for complex cases may allow general practitioners to address pain, offer reassurance, provide information or referral or arrange a follow-up consultation focused on pain management.

Non-invasive respiratory support in paediatric critical care: protocol for a cohort study emulating the FIRST-line support for Assistance in Breathing in Children (FIRST-ABC) step-up randomised clinical trial using routinely collected data from the Paedia

Por: Giallongo · E. · Carroll · O. · Ramnarayan · P. · Mitting · R. · Seaton · S. E. · Shortt · D. · Mason · A. J. · Harrison · D. A. · Grieve · R.
Introduction

The development of the target trial emulation (TTE) methodology has enhanced the conduct of non-randomised studies. By leveraging readily available routinely collected data, TTEs offer opportunities for complementing randomised controlled trials (RCTs), providing more precise estimates and improving the external validity of RCTs. To explore this potential, we selected a successfully completed RCT as a case study. In the FIRST-line support for Assistance in Breathing in Children (FIRST-ABC) step-up RCT, high flow nasal cannula (HFNC) was found to be non-inferior to continuous positive airway pressure (CPAP) in terms of time to liberation from respiratory support in the paediatric critical care setting. We will emulate the FIRST-ABC step-up trial using routinely collected data from the Paediatric Intensive Care Audit Network (PICANet) database.

Methods and analysis

This is a protocol for a TTE that will use longitudinally collected data from the PICANet database. The study aims to emulate the FIRST-ABC step-up RCT using an observational study design in a frequentist framework. We will benchmark the results against the published trial. The study will apply a new-user design by selecting children admitted to paediatric intensive care units that started HFNC or non-invasive ventilatory support (as a surrogate for CPAP). The eligibility criteria and selected outcomes will reflect those of FIRST-ABC within the constraints of the available routinely collected data. We will use advanced quantitative doubly robust methods to minimise the impact of confounding by indication and allow for heterogeneity according to child characteristics. The analysis will be repeated using a Bayesian approach for follow-up research.

Ethics and dissemination

The research received ethics approval from the London School of Hygiene & Tropical Medicine Research Ethics Committee. This study will expand the findings from the FIRST-ABC step-up RCT, providing additional insight from a large representative sample using real-world data. The frequentist and Bayesian approaches will enable a discussion about the advantages and drawbacks of the two strategies. The results will be disseminated to the research and clinical community and made accessible to the public. In addition, the study results will be used in future research, which aims to supplement RCTs with additional evidence from a TTE.

Realist reviews: making sense of evidence for complex nursing interventions

Por: Fitzgerald · I. · Harrison · M. · Clibbens · N. · Howe · J.
Introduction

This article on realist reviews is the second in a four-part series on realist research.1–3 Evidence synthesis involves collating published research to address specific research questions,4 commonly centred around identifying what works for an average person within a population of interest.5 Systematic reviews are thought of as the universal gold standard in conducting evidence synthesis.5 6 However, when it comes to understanding intervention effectiveness, complementary knowledge is needed addressing why some interventions work and others do not, among whom they work best and in what contexts.3 In answering such questions, a different approach to systematic review methodology is required.

Realist reviews (or realist evidence syntheses) are a theory-building, interpretative approach to evidence synthesis. Realist reviews aim to go beyond seeking whether interventions work (ie, are effective), to generating explanations as to...

Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E.
Objectives

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

Design

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

Setting

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Participants

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Interventions

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

Primary and secondary outcomes

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

Results

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

Conclusions

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

Trial registration number

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

A Systematic Review of the Needs of Children and Young People of a Parent Diagnosed With Young‐Onset‐Dementia: Informing a Nursing Intervention

ABSTRACT

Aim

The aim of this study was to understand the needs of children and young people of a parent with young-onset dementia, to inform the development of a nursing model.

Background

Children and young people of a parent diagnosed with young onset dementia have a range of needs that are subject to change and aligned to their stage of development and growth.

Design

Systematic review.

Data Sources

Searches were conducted in PsycInfo (1806–Jan 2025), Medline (1996–Jan 2025) and CINAHL (1961–Jan 2025); search terms were developed in consultation with an academic librarian.

Review Methods

The Preferred Reporting Items for Systematic reviews and Meta-Analyses was used to assess the trustworthiness and applicability of the findings and the Mixed Methods Assessment Tool to assess quality. The review protocol was registered on PROSPERO (CRD42024534104). Needs identified from the literature were matched with the activities and interventions of a specialist nursing model.

Results

Searches yielded 223 records of which 17 met the inclusion/exclusion criteria, the majority of which used qualitative methods (N = 16). A thematic synthesis approach was used to analyse data to reveal four emergent themes: (1) finding a way, (2) social connection and peer support, (3) preserving childhood and adolescence and (4) practical support, including the needs relating to education. Identified needs: knowledge and information, emotional support, consistency in education and development, maintaining social connections, physical and psychological well-being, and grief and loss were mapped against a specialist nurse role.

Conclusion

Children and young people with a parent diagnosed with young-onset dementia face unique challenges compared to older carers. Despite growing awareness of their needs, this population is often overlooked in national dementia strategies. Developing a specialist nurse role is a positive step, but broader systemic support is essential to safeguard their well-being and future opportunities.

Reporting Method

This study adheres to the PRISMA reporting guidelines.

Patient or Public Contribution

A bespoke Research Advisory Group, consisting of people with young onset dementia, young family carers, clinicians and academics, guided the review.

Patient and physical therapist perspectives on spinal manipulative therapy for low back pain and associated clinical outcomes: protocol for a prospective, single-arm intervention study

Por: Beneciuk · J. M. · Bialosky · J. · Hayes · J. R. · Buzzanca-Fried · K. E. · Rowe · R. · Cristello · S. · Harrison · T. · Vickers · R. · Shan · G.
Introduction

Spinal manipulative therapy (SMT) is a common manual therapy intervention provided by healthcare providers for patients with low back pain (LBP). Responses to SMT are influenced by interactions between the patient and provider. Contextual factors may be specific to the patient, provider, patient-provider relationship or environment in which treatment is provided, with all capable of influencing clinical outcomes. The overall goal of this study is to gain a deeper understanding of contextual factors associated with manual therapy utilisation, perception and outcomes, from both patient and provider perspectives. A better understanding of modifiable contextual factors will inform future studies testing the impact on how SMT is delivered to patients influences clinical outcomes that could potentially advance the clinical science of manual therapy.

Methods and analysis

A prospective, single-arm study design with follow-up measures assessed up to 26 weeks after initiation of physical therapy for LBP will be used to assess relationships between physical therapy clinical outcomes and contextual factors related to the patient (preference, expectation, pain beliefs, pain associated distress and prior manual therapy experiences), the provider (equipoise, expectation, pain beliefs and clinical experience) and the interaction between the two (therapeutic alliance). Multimodal treatment approach of SMT (required during initial three treatment sessions within a 2week period), exercise and education supported by recent clinical practice guidelines will be encouraged for this study.

Ethics and dissemination

Ethics approval for the study was obtained from the University of Florida Institutional Review Board. Informed consent is required for physical therapist and patient participant enrolment in this project. The results of this study will be disseminated at professional scientific conferences and submitted for publication in peer-reviewed journals. Reference or approval number: IRB#: IRB202301700

Trial registration number

NCT06590116.

Realist research in nursing: an introduction to seeing beyond 'what works

Por: Howe · J. · Harrison · M. · Fitzgerald · I. · Clibbens · N.
Introduction

This article is the first in a series exploring realist research, a methodological approach well suited to the complexity of nursing practice. Unlike traditional approaches such as randomised controlled trials (RCTs) and systematic reviews, which focus on whether interventions work, realist research examines how and why interventions work when implemented in specific groups; reflecting the individualised care nurses provide. By introducing the key concepts of realist research, this article highlights its relevance to nursing and lays the groundwork for using realist research to drive meaningful improvements in healthcare.

The importance of realist research within nursing

Realist research offers a unique lens to examine the complexity of healthcare delivery. While traditional research methods often seek to determine if interventions work or not in controlled environments, realist research seeks to explain how, why, for whom and under what circumstances interventions succeed—or fail—in real-world settings.1 This makes...

Factors Affecting Research Participation Among Specialist Dementia Nurses

imageBackground Research involvement and engagement is a vital aspect of nursing practice. However, research in dementia care remains limited compared to research focused on finding a cure, presenting a significant gap that specialist dementia nurses (Admiral Nurses) can help bridge by participating in research themselves and facilitating recruitment to research. Objectives This study aimed to assess the research involvement and support needs of Admiral Nurses and identify factors affecting their participation in research. This research is particularly timely as Dementia UK has launched its first research strategy, which necessitates strengthening research capacity within Admiral Nursing. Methods We used a mixed methods convergent parallel synthesis design, simultaneously collecting quantitative and qualitative data. An online survey was conducted in January 2023, targeting current Admiral Nurses across the United Kingdom. The survey included questions addressing demographics, research experience, goals, barriers, facilitators, and support needs. Data analysis involved descriptive statistics, frequencies, univariate analyses, and thematic analysis. Results A positive relationship was found between the highest level of academic achievement and current or previous research involvement, as well as interest in becoming involved in research in the future. Although most nurses recognized the importance of research, only half reported current or past research involvement, indicating a need for increased support. A lack of access and opportunities for peer discussion hindered engagement with research findings. Time constraints, lack of support, and low confidence were major barriers to research involvement. Support needs varied but included mentorship, coaching, and the potential for a community of practice for research. Discussion This survey of Admiral Nurses sheds light on their research involvement, support needs, and barriers to participation. Recognizing the significance of research while identifying challenges and support requirements is crucial for enhancing research capacity among these specialized nurses. This study contributes valuable insights into the world of specialist dementia nursing and lays the foundation for future strategies to increase research engagement in this field.

Critical care nursing workforce in crisis: A discussion paper examining contributing factors, the impact of the COVID‐19 pandemic and potential solutions

Abstract

Aims and Objectives

The critical care nursing workforce is in crisis, with one-third of critical care nurses worldwide intending to leave their roles. This paper aimed to examine the problem from a wellbeing perspective, offering implications for research, and potential solutions for organisations.

Design

Discursive/Position paper.

Method

The discussion is based on the nursing and wellbeing literature. It is guided by the authors' collaborative expertise as both clinicians and researchers. Data were drawn from nursing and wellbeing peer-reviewed literature, such as reviews and empirical studies, national surveys and government and thinktank publications/reports.

Results

Critical care nurses have been disproportionately affected by the COVID-19 pandemic with studies consistently showing critical care nurses to have the worst psychological outcomes on wellbeing measures, including depression, burnout and post-traumatic stress disorder (PTSD). These findings are not only concerning for the mental wellbeing of critical care nurses, they also raise significant issues for healthcare systems/organisations: poor wellbeing, increased burnout and PTSD are directly linked with critical care nurses intending to leave the profession. Thus, the wellbeing of critical care nurses must urgently be supported. Resilience has been identified as a protective mechanism against the development of PTSD and burnout, thus offering evidence-based interventions that address resilience and turnover have much to offer in tackling the workforce crisis. However, turnover data must be collected by studies evaluating resilience interventions, to further support their evidence base. Organisations cannot solely rely on the efficacy of these interventions to address their workforce crisis but must concomitantly engage in organisational change.

Conclusions

We conclude that critical care nurses are in urgent need of preventative, evidence-based wellbeing interventions, and make suggestions for research and practice.

Longitudinal Effects of Sex, Aging, and Multiple Sclerosis Diagnosis on Function

imageBackground A gap in research about the trajectories of function among men and women aging with functional limitations because of multiple sclerosis (MS) hinders ability to plan for future needs. Objectives Using a biopsychosocial model, we characterize how men and women with MS report changes over time in their function and test how person-level differences in age, diagnosis duration, and sex influence perceived function. Methods A longitudinal study with multiple waves of surveys was used to collect data on participant perceptions of function, as well as demographic and contextual variables. Self-reported functional limitation was measured over a decade. The study participants were community residing with physician-diagnosed MS. Results The people with MS had a diagnosis duration of about 13 years and were around 51 years of age, on average, at the start of the study. They were primarily women and non-Hispanic White. We analyzed the data using mixed-effects models. Subject-specific, functional limitation trajectories were described best with a quadratic growth model. Relative to men, women reported lower functional limitation and greater between-person variation and rates of acceleration in functional limitation scores. Discussion Results suggest function progressed through two pathways for over a decade, particularly closer to diagnoses. Variability in trajectories between individuals based on sex and years since diagnosis of disease indicates that men and women with MS may experience perceptions of their function with age differently. This has implications for clinician advice to men and women with MS.
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