To translate and culturally adapt six self-report measures for depression, anxiety, post-traumatic stress disorder (PTSD) and somatic symptom disorder into Hindi and determine their diagnostic accuracy against a diagnostic clinical interview.
Cross-sectional validation study.
Rural Kangra, Himachal Pradesh, northern India.
480 perinatal (pregnant or within 12 months postpartum) and non-perinatal (not currently pregnant and not given birth within 12 months) women at one tertiary hospital and district-level Anganwadi (community health) centres.
Symptom endorsement; and discriminant validity, sensitivity, specificity, positive and negative predictive values and area under the receiver operating characteristic curve (AUROC) of the Kessler Scale of Psychological Distress (K10), Patient Health Questionnaire (PHQ9), Edinburgh Postnatal Depression Scale (EPDS), Generalised Anxiety Disorder Scale (GAD7), Perinatal Anxiety Screening Scale (PASS), PTSD Checklist (PCL-5) and Scale for the Assessment of Somatic Symptoms (SASS).
Complete data were available for 443 participants. Tiredness and body weakness were the most commonly endorsed symptoms among participants with common mental disorders. Among perinatal participants, the AUROC was highest for the GAD7 (0.88, 95% CI 0.79 to 0.96) and SASS (0.84, 95% CI 0.71 to 0.96). Among non-perinatal participants, the AUROC was highest for the SASS (0.92, 95% CI 0.88 to 0.97) and PHQ9 (0.91, 95% CI 0.86 to 0.96).
Measures which assess for fatigue, tiredness and somatic symptoms may help to identify women experiencing common mental disorders in this setting. Small numbers of participants with clinically diagnosed mental disorders in our sample mean results must be interpreted cautiously.
To measure patients' views of nurses' communication and interpersonal skills during acute hospitalisation.
This was a descriptive cross-sectional study.
From January to June 2024, a convenience sampling approach was used to recruit patients hospitalised in acute care wards across two healthcare organisations in regional Victoria, Australia. A self-report survey, the Communication Assessment Tool for Nurses, included 15 items that measured patients' opinions about the quality of nurses' communication using a 5-point scale. Data were analysed by descriptive and univariate statistics and logistic regression.
The sample included 204 participants. Higher ratings were found for respectful care: ‘Treated me with respect’ and ‘Showed care and concern’. Lower ratings largely related to shared decision-making: ‘Encouraged me to ask questions’, ‘Informed me about my plan of care’, ‘Involved me in decisions as much as I wanted’ and ‘Showed interest in my ideas about my health’. Logistic regression revealed lower ratings for the quality of nurses' communication based on longer hospital stay for items related to greetings and shared decision-making.
Whilst this study found that patients perceive a high quality of respectful nursing care, the findings underscore the need for communication skills training to enhance shared decision-making by nurses. Consideration is needed regarding how nurses are prepared to engage in shared decision-making with patients during acute hospitalisation, particularly for longer hospital stays.
This study addresses a gap in evidence regarding patients' perceptions about the quality of nurses' communication during acute hospitalisation in the Australian context. Whilst they perceive that nurses communicate in a respectful and caring manner, opportunities for shared decision-making may not be capitalised on. Hospital managers and nurse academics should develop interventions to address essential communication skills.
This study did not include patient or public involvement in its design, conduct or reporting.
Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.
The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.
The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.
Meperidine, once viewed as relatively safe, is now discouraged in clinical settings due to its associated risks. Previous studies have identified a significant decrease in meperidine distribution across the USA from 2000 to 2021. Regional disparities accompanied this decline. The goal of this study was to investigate if the decrease in meperidine distribution has continued in recent years, 2019–2023, and if regional variations persist. This investigation also aimed to identify correlates of meperidine distribution, including adult obesity prevalence and annual income, to provide insight into the regional variation.
Retrospective observational study using data from the Automation of Reports and Consolidated Orders System Drug Retail Summary Reports by the Drug Enforcement Administration (DEA), the Centers for Disease Control and Prevention (CDC) and the US Census Bureau.
USA, including Puerto Rico.
US population.
The primary outcome was the meperidine distribution across the US between 2019 and 2023. Secondary outcomes included associations between meperidine distribution and adult obesity prevalence and median household income.
Total meperidine distribution across the USA dropped by 57.8% from 2019 to 2023. A substantial geographic variation was found with southern states accounting for the second, third and fourth highest in meperidine use per capita in 2023, only behind Puerto Rico. In contrast, northeastern states accounted for four of the five lowest states. A significant relationship was found between annual income and meperidine distribution in 2022 (r(49) = –0.38, p
Our study revealed a continued decrease in meperidine distribution and sustained presence of geographical variation from 2019 to 2023. Furthermore, novel relationships were identified between meperidine distribution, annual income and adult obesity prevalence.
Long-term brain health profiles following exposure to repetitive head impacts and/or concussions in contact sports are a public health focus and the subject of a national debate. The true prevalence rates of mild cognitive impairment (MCI) or neurobehavioural dysregulation are unknown in the nearly 20 000 current/living former professional football players. Here, we describe the procedures and methodology of the prevalence study of cognitive function in former professional football players from the Brain Health Initiative at the University of Pittsburgh. The objective is to define the prevalence of normal cognitive function versus neurodegeneration in former professional football players through clinical, neuroimaging and biomarker assessments.
Participants include former professional football players aged 29–59 years at study onset who played a minimum of three professional football games in three professional seasons and non-exposed controls. Participants are recruited by two mechanisms, a random and non-random sample. The full study protocol includes a 3–4-day, multidomain assessment (eg, neurological, neurocognitive, psychiatric, sleep, vestibular, orthopaedic and cardiovascular) for neurodegenerative disease and overall health and function, including MRI, positron emission tomography scans, analysis of blood plasma and cerebrospinal fluid, neurocognitive assessments, applanation tonometry, overnight sleep study and informant interview. A multidisciplinary clinical panel conducts a blinded diagnostic consensus conference to adjudicate the presence of MCI and/or traumatic encephalopathy syndrome, which serve as the study’s primary and secondary outcomes, respectively. Point prevalence of these for both the exposed and unexposed cohorts will be calculated as the primary statistical analysis.
The University of Pittsburgh Institutional Review Board approved the study prior to recruiting human subjects (protocol numbers STUDY19010008: sIRB - Brain Health Initiative (Part 1) and STUDY19030211: sIRB - Brain Health Initiative (Part 2)). The results will be disseminated in peer-reviewed journals and as presentations at national and international scientific conferences.
To develop and validate a polycystic ovary syndrome (PCOS) case definition using administrative health data sources.
A validation study.
Secondary care centre outpatient gynaecology clinic in Calgary, Alberta, Canada.
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.
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 68 case definitions for PCOS were estimated. Case definition performance was graded.
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%).
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.
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.
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.
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.
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.
For this phase (POPPY-Q), we used qualitative methods: semi-structured interviews with a grounded theory approach to analysis.
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.
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.
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.
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.
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.
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.
This article on realist reviews is the second in a four-part series on realist research.
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...
To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.
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.
An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.
Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.
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).
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.
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.
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.
The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).
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.
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.
Systematic review.
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.
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.
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.
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.
This study adheres to the PRISMA reporting guidelines.
A bespoke Research Advisory Group, consisting of people with young onset dementia, young family carers, clinicians and academics, guided the review.
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.
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 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
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.
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.