New England Journal of Medicine, Volume 392, Issue 14, Page 1428-1437, April 10, 2025.
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Designing and validating a patient education model for cardiovascular patients: protocol for a multilevel mixed-method study
Introduction
Patient education is an integral component of advanced nursing care. However, current educational practice approaches exhibit numerous deficiencies and have not yielded favourable outcomes. The models used for educating patients with cardiovascular conditions lack specificity for these patients, and each addresses only a particular aspect of patient education. Consequently, this study aims to describe the process of designing and validating a patient education model for the cardiovascular community.
Methods and analysis
This study will employ a multilevel mixed design, encompassing ‘evidence analysis and context explanation’ and ‘validity testing’. The linking phase, namely, model design, will connect the two phases by building a preliminary model based on findings from the first phase. The evidence analysis and context explanation phase will involve three key steps. First, a scoping review will identify existing patient education processes and frameworks through a comprehensive literature search that includes qualitative and quantitative studies, review articles, mixed-methods research and developmental studies. This review aims to map existing evidence and provide an overview of current constructs in patient education, such as models, theories, frameworks, protocols and methods. Second, stakeholder experience elucidation will use conventional content analysis to explore stakeholders’ experiences, including nurses, patient education managers, physicians, patients and their families regarding current patient education practices. Third, situational analysis will evaluate human resources by assessing the performance of nurses and physicians in delivering patient education while also analysing non-human resources by examining the physical space and materials for patient education, evaluating current educational content and assessing educational outcomes. In the linking phase (model design), data collected during Phase One will be integrated to create an initial construct derived from the scoping review. This construct will be refined through content analysis and clarified using situational analysis data. The third phase (model validation) will focus on internal and external validation. For internal validation, a Delphi study will achieve expert consensus on the proposed model, involving specialists engaged in patient education who will evaluate its elements. For external validation, the model will undergo pilot testing in clinical settings to assess its utility by measuring outcomes for cardiac patients, such as self-care, quality of life, patient education satisfaction and treatment adherence. After the validation process, the final patient education model will be reviewed and finalised based on insights gained during both study phases.
Ethics and dissemination
This study has been approved by the Regional Ethics Committee at Tabriz University of Medical Sciences (IR.TBZMED.REC.1402.670). Dissemination will be achieved by publishing findings and depositing data in a publicly accessible repository to ensure transparency and facilitate future research.
How Would You Manage This Patient With Decreased Bone Density? Grand Rounds Discussion From Beth Israel Deaconess Medical Center
Annals of Internal Medicine, Ahead of Print.
Patient and healthcare professionals perception of weekly prophylactic catheter washout in adults living with long-term catheters: qualitative study of the CATHETER II trial
Objectives
To explore trial participants’ experience of long-term catheters (LTC), the acceptability of washout policies, their experience of the CATHETER II trial (a randomised controlled trial comparing the clinical effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters) and their satisfaction with the outcomes. The objectives of the healthcare professionals (HCPs) focus group and interview were to explore their attitudes towards weekly prophylactic catheter washout, views on the provision of training and participants’ ability to enact washout behaviours.
Methodology
A longitudinal qualitative study embedded within the CATHETER II randomised controlled trial, which included semi-structured interviews and focus groups with participants from multiple trial sites. Data were analysed using the Theoretical Framework of Acceptability and Theoretical Domains Framework. This UK community-based study included 50 (24 female, 26 male) CATHETER II trial participants, aged between 23 and 100 years, with LTC and able to self-manage the washout and study documentation either independently or with the help of a carer. Seven HCPs (five female, two male) also participated.
Results
The participants had positive attitudes towards weekly prophylactic saline or acidic catheter washouts and other trial elements, such as washout training, catheter calendar and monthly phone calls. Participants and HCPs found the ‘ask’ of the CATHETER II trial and the weekly self-administered prophylactic washout policies to be feasible. The participants reported that the catheter washout training provided during the trial enhanced their self-efficacy, skills and self-reported capability to carry out the washouts. Participants reported having positive outcomes from the weekly washout. These included reduced blockage, pain or infection, reduced need for HCP support and greater psychological reassurance. HCPs attested to the participants’ understanding of and adherence to the weekly washouts and other elements of the trial.
Conclusions
This study shows acceptability, feasibility and self-reported fidelity of the CATHETER II trial on a behavioural level. Self-management for prophylactic catheter washouts is both feasible and, following training, achievable without any need for additional support.
Trial registration number
ISRCTN17116445.
Patient Information: Calcific Aortic Stenosis
This JAMA Patient Page describes the risk factors, symptoms, diagnosis, and management of calcific aortic stenosis.
Diagnostic dilemma: sudden onset of multiple skin lesions in a patient with intestinal disease
Clinical presentation The patient was a 36-year-old man, who had a 4-year history of ulcerative colitis (UC), for which he had received mesalazine, oral prednisolone and infliximab, neither of which had any long-lasting therapeutic benefit. This patient was admitted to our hospital with skin lesions, abdominal pain and diarrhoea. Two types of skin lesions were evident. First, one well-demarcated superficial ulcer, covered by yellow secretions and surrounded by a purple halo, was seen over the patient’s left knee region (figure 1A). Second, on the patient’s face (figure 1B) and trunk (figure 1C), there was a polymorphic rash consisting of open comedones, papules and some deeply set cysts, in association with numerous hyperpigmented scars. He was treated with minocycline 100 mg/day for 2 months, with no benefit. The lesions responded to treatment with prednisolone (40 mg/day), but recurred as soon as prednisolone was tapered below…
La Giornata della salute della donna compie 10 anni
Le iniziative di Atena che ha promosso la ricorrenza
Patient-reported factors associated with emergency department referrals from a co-located out-of-hours walk-in clinic in Germany: a cross-sectional observational study
Objectives
The aim of this study was to identify patient-reported factors associated with the likelihood of emergency department (ED) referral following treatment at a co-located out-of-hours (OOH) walk-in clinic.
Design
Monocentric cross-sectional observational study.
Setting
An OOH walk-in clinic co-located with the ED of the University Medical Center Hamburg-Eppendorf, Germany. The study period was from November 2019 to February 2020.
Participants
A total of 3708 patients attended the walk-in clinic during the study period, with 2574 patients (69.4%) participating in the study.
Main outcome measures
We used logistic regression analysis to calculate adjusted OR (aORs) for patient-reported factors influencing ED referral. The factors examined included reasons for encounter (RFEs), medical history and treatment urgency, categorised according to the International Classification of Primary Care, second edition. Secondary outcomes include descriptive measures of RFE distribution within the study cohort.
Results
The mean age of participants was 40 years (±15.8), and 54.5% were women. The ED referral rate was 15.2% (n=392). Patient-reported factors that increased the likelihood of ED referral included trauma (aOR 2.61; 95% CI: 1.24 to 5.50), eye symptoms (aOR 2.67; 95% CI: 1.48 to 4.83), abdominal pain (aOR 2.51; 95% CI: 1.74 to 3.64), history of type 2 diabetes (aOR 2.24; 95% CI: 1.18 to 4.25), neurological symptoms (aOR 2.18; 95% CI: 1.24 to 3.84) and higher self-perceived urgency (aOR 1.46; 95% CI: 1.12 to 1.89). Factors that decreased the likelihood of ED referral included respiratory symptoms (aOR 0.58; 95% CI: 0.36 to 0.93), neck/back symptoms (aOR 0.52; 95% CI: 0.31 to 0.88), urinary tract symptoms (aOR 0.18; 95% CI: 0.06 to 0.57) and a duration of the health problem >4 days (aOR 0.72; 95% CI: 0.55 to 0.95).
Conclusions
10 patient-reported factors of ED referrals were identified. Collecting this information during patient registration may enhance resource utilisation and streamline patient flow between walk-in clinic and adjacent ED. These findings could support the development of triage tools for patients in OOH care.
Lived experiences and insights of Chinese patients with symptomatic osteoporosis on a patient-reported outcome (PRO) programme: a qualitative phenomenological study in Southwest China
Objectives
To explore the lived experiences of patients with symptomatic osteoporosis on a patient-reported outcomes (PROs) programme for symptom management and quality of life (QoL) improvement.
Design
This is a qualitative phenomenological study.
Setting
Participants
14 active participants in the PROs programme were recruited and interviewed through semi-structured face-to-face interviews. Colaizzi’s seven-step method was employed for thematic analysis.
Results
Four overarching themes and two sub-themes emerged, including (1) varied perceptions of the PROs programme, where some participants found it beneficial for tracking symptoms while others cited challenges such as technological barriers and lack of actionable outcomes; (2) PROs as a tool for enhancing communication and facilitating appointments by enabling more efficient doctor–patient interactions and quicker scheduling; (3) emotional support provided by regular doctor–patient communication, with sub-themes of fostering a sense of belonging and offering psychological comfort; and (4) limitations of remote communication, highlighting challenges in addressing complex medical needs and providing immediate solutions for medication adjustments.
Conclusions
PROs programmes facilitate symptom tracking, enhance communication and provide emotional support for patients with osteoporosis. However, limitations such as technological barriers and reliance on remote communication must be addressed. Ethical considerations, including potential over-reporting of symptoms to expedite care, require careful management. Future research should include patients who discontinue participating in the PROs programme prematurely and the perspectives of healthcare providers to provide a more balanced, comprehensive understanding.
Qualitative study to inform the design and contents of a patient-reported symptom-based risk stratification system for patients referred from primary care on a suspected head and neck cancer diagnostic pathway
Objectives
This study aims to inform the development of a patient-reported symptom questionnaire for head and neck cancer and outline the requirements for a patient-reported symptom-based risk stratification system. The study objectives are to explore how clinicians ask questions and decide subsequent steps for patients referred with suspected head and neck cancer; the language patients and clinicians use to describe symptoms; how clinicians reassure and discharge low-risk patients; and identify clinician and patient experiences of the head and neck cancer diagnostic pathway and their views on a novel diagnostic pathway using patient-reported symptom-based risk stratification.
Design
The study employed qualitative methods including observation and recordings of clinic consultations and semistructured interviews with clinicians and patients. Analysis proceeded concurrently with data collection using a rapid qualitative analysis approach.
Setting
Three acute UK National Health Service Trusts with variation in service delivery models. Data collection took place between April and October 2023.
Participants
One hundred and fifty-six adults referred for suspected head and neck cancer, and 21 clinicians from different subspecialties were recruited. A subset of recruited patients (n=16) and clinicians (n=13) were interviewed. One observation of a general head and neck clinic was conducted.
Results
The findings highlight types of symptoms and the language used by patients and clinicians to describe these symptoms in clinic consultations. During interviews, patients described the need for in-person support and human clinical decision-making, an accessible system for reporting their symptoms and reassurance regarding the security of patient data. Clinicians discussed the need for risk scores to be sufficiently validated to be trusted, the potential clinical usefulness of a risk score-based system, for example, to support triage by discriminating symptoms, and accessibility for patients. The observation highlighted inconsistent and sometimes unclear referral information and the limited time clinicians have to read referral information.
Conclusion
The findings have implications for the development of a patient-reported symptom-based risk stratification system. As well as ensuring patients can understand the language used, it will be important to consider how their emotional needs can be met. The findings also have wider implications for understanding the impact of language on emotionally evocative healthcare interactions.
Patient decision aids for hip and knee arthroplasty decision-making: a scoping review protocol
Introduction
Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are effective methods carried out widely in patients with end-stage hip and knee osteoarthritis (OA). Despite the trend towards shared decision-making in surgical decisions, patients often struggle to fully participate due to a lack of informational support. Patient decision aids (PtDAs) which provide evidence-based sources of health information can address this issue and facilitate shared decision-making. However, most existing studies and systematic reviews focus on the effects of PtDAs in the decision-making process for THA and TKA, with little attention given to a comprehensive scoping review of the range and scope of research in this area. Therefore, this review aims to assess the state of the literature on PtDAs for THA and TKA, describe the features of PtDAs for patients with OA who are considering primary elective THA or TKA and identify the questions in the implementation of decision-making.
Methods and analysis
This scoping review will be conducted according to the framework recommended by Arksey and O’Malley. The search will be limited to articles written in English and Chinese, while the publication date restriction is from ‘inception’ to ‘February 2025’. Studies on PtDAs for patients with OA considering primary elective THA and TKA will be considered for inclusion. Five electronic databases will be searched (CINAHL, Pubmed, Embase, PsycINFO and Web of Science). Studies for inclusion will be selected independently by two review authors. Data will be extracted using a predefined data extraction form. Findings will be presented in tabular form. A narrative description of the evidence will complement the tabulated results.
Ethics and dissemination
This scoping review does not require ethical approval, as it will involve a secondary analysis of existing literature. Findings will be published in a peer-reviewed journal.
Registration details
Open Science Framework (https://doi.org/10.17605/OSF.IO/9JCG3).
Wise or wide (WoW) study protocol: a national, multicentre, prospective, randomised and controlled, parallel group, non-inferiority study to compare single-staged versus two-staged excisions of thin invasive (<=1.0 mm) melanoma
Background
Sweden has one of the highest incidence rates of cutaneous melanoma globally, and the incidence is rapidly increasing. Melanoma mortality is linked to the thickness of the primary tumour, with thicker melanomas having a poorer prognosis. Thin invasive melanomas (≤1.0 mm Breslow thickness) have excellent prognosis. Traditionally, the surgical approach for melanoma involves a two-step procedure of a diagnostic excision followed by a wide local excision (WLE) with 10 mm clinical margins. The WLE aims to remove potential microsatellites and residual melanoma, which in theory would prevent loco-regional recurrence and could improve survival. However, recent research questions the necessity of WLE for thin invasive melanomas, given their favourable prognosis, minimal risk of microsatellitosis and low rates of residual melanoma found in WLE tissue specimens.
Methods and analysis
This multicentre, non-inferiority, randomised controlled trial seeks to enrol 2486 patients with thin invasive melanomas that are completely excised with ≥1.5 mm histopathological margins following the diagnostic excision. Patients will be randomly assigned to either a control group that will undergo a WLE with 10 mm clinical margins according to current clinical routine or an experimental group without a WLE. The primary and secondary endpoints are recurrence-free survival at 5 and 10 years, respectively, with tertiary aims including postoperative complications, scar quality, patient satisfaction and quality of life, healthcare resource utilisation as well as differences in biomarkers of recurrent and non-recurrent melanomas. Patients will be assessed at clinical follow-up visits at 3 months as well as at 1, 2, 3, 5 and 10 years.
Ethics and dissemination
Approval of this study was obtained from the Swedish Ethical Review Authority (2024-03274-01). The findings of the study will be presented at international scientific meetings and published in peer-reviewed academic journals.
Trial registration number
NCT06363591.
In older adults with severe AS and complex CAD, PCI + TAVI vs. SAVR + CABG reduced patient-oriented outcomes at 1 y
Annals of Internal Medicine, Ahead of Print.
In acute respiratory failure, HFNO was noninferior to NIV for endotracheal intubation or death at 7 d in 4 of 5 patient subgroups
Annals of Internal Medicine, Ahead of Print.
Patient Navigation to Improve Colonoscopy Completion After an Abnormal Stool Test Result
Annals of Internal Medicine, Ahead of Print.
[Articles] Breaking through the mind-body divide: patient priorities for interoception research
Together, this broad scoping study establishes new, transdiagnostic, patient-led priorities for the developing field of interoception in psychiatry to ensure future research focusses on the areas of greatest impact for people with mental health conditions.