Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.
Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.
Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.
Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p
In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.
The hormone replacement drug levothyroxine is the most common therapy for people with reduced function of the thyroid gland. The optimal dosage varies considerably between individuals, and reaching the correct dosage is often a time-consuming task. To reduce the time needed for dose adjustments, we have developed a model for calculating each patient’s optimal dosage and an associated decision support tool (DST). We present the study protocol for a randomised controlled trial using the DST in initiation and adjustment of levothyroxine therapy for thyroidectomised patients. The aim of the study is to assess the tool’s efficacy on therapeutic target achievement and to investigate whether faster dose adjustments lead to better patient-reported outcomes on symptoms and health-related quality of life (HRQoL).
We will conduct a randomised, controlled, multicentre, non-blinded, parallel arm trial with three intervention groups and one control group. We will include 240 patients undergoing total or completion thyroidectomy in three Norwegian hospitals. Patients allocated to the three intervention groups will have the option to use the DST in dose adjustments after the operation. Each intervention group will test a different version of the DST. The control group will follow standard care practice. The randomisation ratio will be 1:1:1:1. Our primary outcome is proportion of patients within biochemical target at 8 weeks postoperatively. Secondary outcomes are distance from biochemical target at 8 weeks, mean time to achieve biochemical target, change in HRQoL, adverse events and number of days absence from work.
The study has been approved by the Norwegian Medical Products Agency (CIV-23-02-042436), The Norwegian Ethics Committee for Clinical Trials on Medicinal Products and Medical Devices (547311), and the patient protection officer at the University Hospital of North Norway. All participants will give written informed consent prior to inclusion. Results will be published open access in international peer-reviewed journals and communicated to the public through appropriate channels.
This study aimed to analyse patient-initiated compliment letters from a single institution, identify the key elements that patients value and offer actionable insights to enhance patient-centred care.
A retrospective, single-institution study using the Healthcare Complaints Analysis Tool (HCAT), text network analysis and latent Dirichlet allocation (LDA) topic modelling on patient compliment letters to pinpoint key valued care elements.
A newly established general hospital in Gwangmyeong, South Korea, opened on 22 March 2022.
A total of 1213 compliment letters were collected through the hospital’s feedback system, which accepted both online and on-site submissions between 25 March 2022 and 28 June 2024. Letters lacking substantive descriptive content and those containing purely administrative requests were excluded.
The HCAT was adapted to categorise positive statements into clinical, management and relationship domains, along with six stages of care. Inter-rater reliability was evaluated using Gwet’s AC1 statistic. A text network analysis, applying a term frequency–inverse document frequency approach, was conducted to identify prominent keywords. Subsequently, LDA was performed to extract thematic topics.
Most compliments concerned the ‘relationship’ domain (62%), particularly during the care in the ward stage (56%). Keyword analysis indicated that the most frequently mentioned terms were ‘gratitude’, ‘kindness’, ‘nurse’, ‘doctor’ and ‘heart/mind’, underscoring patients’ high valuation of positive interactions, professional competence and compassionate communication with medical staff. Topic modelling identified three primary topics, namely, ‘appreciation of nursing care’ (39%), ‘professionalism in surgery and treatment’ (35%) and ‘effective communication during consultations’ (26%).
Positive relationships with medical staff, particularly kindness, professionalism and effective communication, influence patient satisfaction. Patient compliment letters serve as important indicators of exceptional care and can inform quality improvement initiatives. Healthcare institutions should leverage these insights to enhance patient-centred services by strengthening patient–provider relationships and promoting a culture of excellence.
Despite anatomical correction, people born with oesophageal atresia±tracheoesophageal fistula (OA-TOF) experience lifelong morbidity. Core outcome sets (COSs) are recognised as a means of improving research quality and, as a consequence, improving patient outcomes; one was not available for this population.
The scope of the study was to develop a COS for people born with OA-TOF that would be applicable regardless of age or geographic location.
Patient input was paramount to this study. For long-list generation, in addition to the systematic review (SR), patients and representatives were invited to participate in focus groups, interviews or complete activity packs to ascertain outcomes that matter most to them. International consensus was then sought using a two-step Delphi survey followed by an online consensus meeting.
Eight outcomes were identified through patient events that had not been picked up from SR. 175 people completed the Delphi survey from 26 countries and health care professionals from 13 different disciplines. 24 outcomes met predefined criteria for inclusion and following discussion and voting in the consensus meeting, and 14/24 outcomes were agreed for inclusion in the COS.
14 outcomes have been agreed on to form the COS. 12 of these outcomes are relevant to people of all ages, 1 to paediatric population and 1 to adult cohorts. The COS is, therefore, truly applicable lifelong, which was the scope of the project. This COS will help reduce research heterogeneity, enabling better quality research outcomes and more comparable data.
Overmedication of off-label use of psychotropic medicines to address behaviours of concern in people with intellectual and developmental disabilities is a major public health concern. Disability support workers (DSWs) play a pivotal role in supporting adults with intellectual and developmental disabilities who are prescribed psychotropic medicines. Therefore, there is an urgent need to train DSWs to help understand the appropriate use of these medicines. This paper describes the protocol of a project that aims to develop such a programme.
A participatory action framework will underscore the programme and follow a Universal Design for Learning approach. It will be a co-production involving all stakeholders, including people with intellectual and developmental disabilities, their families, members of the disability workforce, healthcare professionals and educational designers. The programme will be developed using the following steps: (a) development of a consumer advisory committee and expert panel groups, (b) an online survey of learning needs analysis, (c) a rapid umbrella review of the relevant literature, (d) focus groups involving participants from different parts of Australia, (e) co-design events in four Australian cities, (f) field testing on 6–12 DSWs to determine any practical difficulties of implementing the programme, (g) a feasibility trial involving at least 1200 DSWs using a train-the-trainer model and online resources and (h) a mixed-method process evaluation using interviews of a purposive sample of trainees and online questionnaire survey.
Ethics approval will be sought at each stage of the co-design process. Each step of the project will include an academic language paper and Easy Read report developed. The training programme will be shared across Australia, with DSWs able to complete the project for free. We expect the training will help improve DSWs’ knowledge of appropriate psychotropic medicine prescribing in people with intellectual and developmental disabilities, confidence in effectively communicating with health professionals and using non-pharmacological approaches to support behaviours of concern, promote shared decision-making with clients, advocate for psychotropic medicine reviews by healthcare professionals, encourage positive interactions with people with intellectual and developmental disabilities and their families and self-reflection on their own behaviour and attitude can influence their client and behaviours of concern.
Knee osteoarthritis (OA) causes pain, reduced function and disability and may require total knee replacement (TKR). Although TKR is effective, up to 20% of patients remain dissatisfied, partly due to poor preoperative function and unrealistic expectations. Long waiting times for surgery may worsen patients’ function, yet preoperative physiotherapy is rarely offered. Prehabilitation—exercise and education before surgery—could improve postoperative recovery, but current evidence is limited. This trial investigates whether adding prehabilitation to standard care before TKR improves postoperative patient-reported joint awareness, enablement and knee function.
This multicentre, randomised controlled parallel-group trial is planned to be conducted within two specialised orthopaedic outpatient rehabilitation units in the southeast healthcare region of Sweden. Eligible patients (40–85 years, awaiting unilateral TKR) are randomised 1:1, stratified by age (≤67, >67 years), to either 8 weeks of prehabilitation—comprising two times per week supervised exercise therapy (strength, range of motion and balance) and education—in addition to standard care, or to standard care alone. Standard care consists of self-care, a single standardised preoperative education session and standardised postoperative rehabilitation. Assessments are conducted at baseline, post-intervention, 1 week pre-surgery and 6, 12 and 52 weeks post-surgery. A total of 110 patients will be recruited to the trial. Primary outcomes are joint awareness (Forgotten Joint Score-12) and patient enablement (modified Patient Enablement Instrument-2). Secondary outcomes are patient satisfaction (5-category Likert scale), the Knee injury and Osteoarthritis Outcome Score, the EuroQol 5 Dimension 3 Level questionnaire, the International Physical Activity Questionnaire—short form, objective function and accelerometer-based physical activity. Analyses will follow intention-to-treat and per-protocol principles. Between-group and within-group differences will be tested using t-tests or non-parametric equivalents, and linear mixed models or generalised linear models. Multiple linear regression and logistic regression will be used to analyse predictor variables for the primary outcomes. Sensitivity analyses will be performed to quantify the magnitude of missing data from patients lost to follow-up.
The trial has received ethical approval from the Swedish Ethical Review Authority (reg. no.2023-05120-01) and complies with the Declaration of Helsinki. Signed informed consent is collected for all patients before entering the trial. Results will be submitted for publication in a peer-reviewed journal and presented at international/national conferences. The findings may improve future clinical guidelines and care pathways for patients undergoing TKR.
Endometriosis is a chronic, oestrogen-dependent condition with a wide range of symptoms and comorbidities that significantly affect physical, emotional and psychological well-being, as well as quality of life. Women with endometriosis often face complex treatment decisions with no universally accepted gold-standard therapy. Shared decision-making, supported by patient decision aids (PtDAs), can enhance patient knowledge and promote informed preferences and decisions. Digital PtDAs, in particular, offer potential for personalised, interactive and accessible decision support. Their characteristics, development process and evaluation in endometriosis care remain underexplored. The objective of this scoping review is to map the existing literature on digital PtDAs developed for women of reproductive age (18–49) with endometriosis, across a range of healthcare and digital health contexts.
This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews. A comprehensive three-step search, developed with an information specialist, will be conducted across MEDLINE (PubMed), CINAHL, Embase, Web of Science, Cochrane databases and grey literature sources. Citations will be imported into Rayyan for screening. Two independent reviewers will conduct study selection, data extraction and analysis. Data will be summarised using tables and descriptive content analysis to identify key features, development processes and evaluation methods of digital PtDAs. The review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
This review started off in July 2025, and the anticipated end date is November 2025. We plan to disseminate this research through publications, presentations at relevant national and international conferences and meetings with relevant stakeholders. This scoping review protocol has been registered at Open Science Framework (osf.io/fp86m). As this scoping review will use data from published and publicly available sources, research ethics approval is not required.
Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.
The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.
The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.
The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.
The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.
ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.
The diversity of treatment options for diabetic retinopathy (DR) and the high uncertainty about the benefits and risks of different treatment modalities necessitate shared decision-making between patients and healthcare professionals. However, little is known about the involvement of individuals with DR in treatment decision-making in China. This study aims to gain insight into the current status and factors associated with involvement in treatment decision-making in patients with DR. Furthermore, we will explore the experiences and perceptions of patients with DR regarding their involvement in treatment decision-making.
We will conduct a mixed-method study using an explanatory sequential design. In the quantitative research (n=350), participants’ actual decision-making roles, sociodemographic data, disease-related data, health literacy, need for involvement in decision-making, decision-making self-efficacy, social support and ophthalmologist facilitation of patient involvement will be investigated to analyse the current state of patient involvement in treatment decision-making and the factors influencing it. Descriptive statistics, one-way analysis of variance and multinomial logistic regression will be performed. During this period, individual semistructured interviews will be conducted with a subset of these participants to understand the perceptions and experiences of people with DR regarding their involvement in treatment decision-making, and thematic analysis will be used to analyse the interview data. Finally, the joint display will be used to integrate quantitative and qualitative data.
Ethical approval for this study has been obtained from the Ethical Review Committee for Human Trials of Shanghai General Hospital, China (number: 2024–098). Written informed consent will be obtained from all participants after they have been fully informed about the study, prior to any data collection. The study’s findings will be disseminated through peer-reviewed publications and conference reports.
ChiCTR2400087906.
To date, few studies have investigated the factors associated with musculoskeletal patients’ willingness to donate biological samples and their knowledge regarding the use of such samples. We investigated the associations between these distinct knowledge factors, patients’ willingness to donate and socio-demographic factors.
Cross-sectional survey.
Musculoskeletal outpatient clinics across four sites in England, representing varied demographic populations.
A total of 469 adult patients attending musculoskeletal appointments were recruited through convenience sampling.
Ordinal regression models were employed to identify socio-demographic and clinical predictors of patients’ willingness to donate biological samples. Other outcome measures specifically in two areas of patient knowledge include: (1) knowledge of sample use and (2) knowledge of surgical waste tissue value and management.
Only 37% of participants were aware of the term ‘biobank’. Despite this, participants showed a high level of knowledge regarding both biological sample use and surgical waste tissue management, although their understanding varied considerably by ethnicity and education. Participants with no formal education exhibited a lower level of knowledge in both areas related to sample use and surgical waste tissue management for biomedical research ((OR 0.30, 95% CI 0.14 to 0.61; p=0.001); (OR=0.29, 95% CI 0.16 to 0.52, p
Despite low awareness, musculoskeletal patients showed a high willingness to participate in biobanking. However, significant disparities by ethnicity and education persist. Targeted, inclusive engagement strategies are needed to address under-representation and foster informed, equitable participation of musculoskeletal patients in biomedical research.
Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.
A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.
Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.
A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.
A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.
Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.
Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.
To describe the prevalence and characteristics of traditional, complementary and integrative medicine (TCIM) practice and product use by the population of the UK providing up-to-date data on the landscape of TCIM use in the UK.
A cross-sectional online survey, administered using the Qualtrics platform, among adults (aged 18 years and over) residing in the UK (England, Wales, Scotland or Northern Ireland). Data were collected between May and October 2024. The 40-item instrument covered four domains: demographics, health status, use of health products and practices, and use of health services. Descriptive statistics were used to summarise survey responses, and ² tests were applied to assess associations between participant characteristics and TCIM use. Backwards stepwise logistic regression was conducted to identify predictors of TCIM use across four outcome categories (p≤0.05).
The sample (n=1559) was broadly representative of the UK population. Prevalence of any TCIM use over a 12-month period was 65.9% with 19.1% consulting a TCIM practitioner and 63.3% using any TCIM product or practice. Bodywork therapists (massage therapists 9.4%, chiropractors 7.9%, yoga teachers 5.0%) and homeopaths (4.1%) were the most commonly consulted TCIM practitioners and Anthroposophic doctors were the least commonly consulted (2.1%). Among TCIM products, vitamin and mineral supplements were the most commonly used (37.3%) and relaxation or meditation practices were reported by 19.4% of respondents. TCIM users were more likely to be female, identify as Asian or Black, have a chronic disease diagnosis, report good health, possess private health insurance, have a higher education level, be employed (or seeking employment) and sometimes experience financial management difficulties.
There is substantial use of TCIM across the UK adult population and there is a need for more research on integrating TCIM into mainstream healthcare and the National Health Service. Clear strategies are necessary to enhance communication between TCIM and conventional healthcare providers, ensure patient safety and promote person-centred, coordinated models of care.
Healthcare professionals are increasingly burdened by clerical tasks, contributing to reduced job satisfaction, heightened burnout and potential risk for patient safety. Despite ongoing efforts to promote patient-centred care, direct interaction time with patients remains limited, affecting both professional fulfillment and the quality of patient experience. In response, hospitals have begun implementing structured programmes to enhance protected patient time, though their effectiveness remains uncertain. The Geneva University Hospitals (HUG) developed the ‘More Time at Patients’ Side’ (MTP) programme, integrating Lean management and Design Thinking principles to optimise clinical interactions. This study aims to evaluate an MTP booster intervention, designed to reinforce selected programme elements, using a cluster-randomised controlled trial focusing on patient pain management and healthcare professional job satisfaction.
The MTP Booster will be implemented in selected units at HUG across internal medicine, surgery, rehabilitation, palliative care and paediatrics units. Originally launched in 2017, the MTP programme introduced structured medical rounds, delegated clerical tasks and communication tools such as patient whiteboards. The booster intervention follows a stepped-wedge cluster-randomised design, with immediate reactivation in intervention units and delayed implementation in control units. The intervention consists of two key components: (A) a collaborative selection of MTP elements to reinforce, based on their feasibility and perceived usefulness and (B) structured integration of audit and feedback into daily routines, including on-site observations and staff training. The primary outcome is the quality of pain management, measured by the timely administration of analgesia. Secondary outcomes include pain documentation, patient satisfaction, healthcare professional work satisfaction, burnout levels, turnover risk and absenteeism. Other MTP-related audits are suspended during the study to preserve methodological integrity, and concurrent institutional initiatives will be documented as potential confounders.
The trial has a declaration of no objection by Swissethics (2024-00169). All final results will be reported in accordance with the Consolidated Standards of Reporting Trials extended for cluster-randomised trials. We intend to publish the results of this trial in an international peer-reviewed journal, irrespective of the results.
The trial is currently in the pre-results stage and is registered at ClinicalTrials.gov, ID: NCT06491797, 9 July 2024.
Medication-related issues are prevalent among older adults with chronic diseases, especially in community outpatient settings where medication regimens are complex and largely self-managed. These issues, such as inappropriate prescribing, non-adherence and drug interactions, can result in avoidable harm and increased healthcare burden. Although patient engagement is crucial for medication safety, few interventions are based on behavioural theory or tailored for older adults in low-resource settings. Digital health tools present promising opportunities to provide personalised, accessible medication safety support. This study aims to develop, implement and evaluate a theory-informed digital intervention to enhance medication safety engagement among older adults with chronic conditions in community settings.
This quasi-experimental study will take place in two community health service centres in Beijing, China. Participants will be older adults aged 60–80 years with type 2 diabetes and at least one additional chronic condition. They must be prescribed at least one antidiabetic medication, capable of using a smartphone, cognitively intact and permanent residents of Beijing. The study plans to recruit 388 participants (194 per arm) to achieve 80% power with a two-sided α=0.05. Participants will be assigned to either an intervention group receiving a digital medication safety programme or a control group receiving routine care and printed educational materials. The intervention is a structured, theory-informed programme delivered via a WeChat-based platform, aimed at enhancing medication safety engagement among older adults. The study follow-up will last 3 months. The primary outcome is the change in medication safety engagement, measured using a validated scale. Secondary outcomes include perceived efficacy in patient-physician interactions, medication knowledge and fasting glucose levels. The acceptability of the intervention will be evaluated in the intervention group using the System Usability Scale and qualitative interviews. Data collection will occur at baseline, 1 month and 2 months post-intervention.
Ethical approval was obtained from the Medical Ethics Committee of Capital Medical University, Beijing, China (initial approval Z2023SY066 on May 2023; amendment Z2025SY020 on April 2025). All participants will provide written informed consent prior to enrolment. The study findings will be disseminated through peer-reviewed publications and conference presentations. A model participant information sheet and informed consent form has been developed for this trial.
Chinese Clinical Trial Registry (ChiCTR2300072716).
Binge drinking in the previous month was reported in 23.5% of US adults, and 28.1 million adults met criteria for Alcohol Use Disorder (AUD) in 2023. Individuals with AUD face increased risks of oral health problems, including caries, periodontal disease and mucosal lesions. Poor oral hygiene, nutrition and dental care all contribute to these conditions, but individuals with AUD are often under-represented in oral health surveys. Understanding relationships between oral health behaviours, attitudes and general health is crucial for designing future interventions. This pilot aims to explore the relationship between oral and systemic health in subjects with AUD, focusing on oral health behaviours, salivary biomarkers and clinical phenotype, including systemic biomarkers of inflammation, to inform future research on oral–systemic interactions in AUD.
This protocol has two parts. Part 1 involves cognitive interviews to assess the content validity and interpretability of the Oral Health Behaviours Assessment (OHBA) questionnaire. Part 2 will collect biological and behavioural data from treatment-seeking patients with AUD and matched controls (age, sex and smoking status), including saliva, blood, dental exams, and health behaviour and symptom measures. Inpatients with AUD will provide biospecimens and answer symptom severity questionnaires at admission and again at the dental exam visit (7–12 days later), while controls will provide a single set of measures at their dental exam visit. Oral health will be assessed through structured dental and periodontal examinations, radiographs and validated questionnaires (including the OHBA). Additional data will include alcohol use history, psychiatric and medical history assessments, dietary recall, and measures of stress, sleep and mood to capture potential moderators of oral–systemic relationships. Biomarkers of inflammation and stress will be quantified from saliva and blood using immunoassays. Primary outcomes will compare oral health, salivary biomarkers and clinical measures between AUD and controls, while secondary outcomes will evaluate within-subject changes in patients with AUD during inpatient treatment and early abstinence.
This clinical protocol was approved by the National Institutes of Health Institutional Review Board (IRB #002005). Prior to enrolling, participants will be informed of the study purpose, risks and benefits, and study procedures, and evaluated for understanding prior to signing consent. Part 1 of the protocol is currently active and recruiting participants for cognitive interviews. The study findings will be disseminated through journals and conferences related to addiction medicine, psychology, immunology, neuroscience and dentistry. We expect the results of the pilot study will inform future research on oral health and salivary bioscience while also providing treatment-seeking patients with AUD targeted information on the importance of oral health behaviours for maintaining oral and systemic health.
NCT06684483; preresults.
Infection prevention and control (IPC) interventions are multifactorial and are used to prevent healthcare-associated infections in healthcare facilities. However, patient views and enabling patient and public involvement (PPI) in their development has been minimal.
This systematic review aims to identify peer-reviewed publications reporting patient satisfaction outcomes in the context of IPC interventions, to document the methods used to assess patient satisfaction and to conduct a meta-analysis on reported satisfaction outcomes.
Systematic review and meta-analysis following the Joanna Briggs Institute (JBI) methodology and the PRISMA statement, with oversight from a steering group including PPI partners. Studies in peer-reviewed journals were included based on eligibility criteria.
MEDLINE, Scopus, Web of Science, EMBASE, Cochrane Library, CINAHL and PsycINFO were searched in June 2024.
Included studies investigated satisfaction among hospitalised patients in acute care settings following IPC measures, including isolation, cohorting, screening, hand hygiene, antimicrobial stewardship, patient flagging, education, personal protective equipment use, visiting restrictions and treatment delays
Titles and abstracts were screened independently by two reviewers; disagreements were resolved by a third. Study quality was assessed using the JBI manual for evidence synthesis. A meta-analysis was conducted where four or more studies used comparable designs and methods within the same areas of IPC, with heterogeneity evaluated using Cochran’s Q statistic and I2 and pooled estimates calculated with 95% CIs using the Wilson (score) method.
Twenty-nine studies were identified. Among IPC measures, isolation precautions were the most commonly reported intervention (11 studies, 38%). The Likert scale was the predominant assessment method (13 studies, 45%). Patient satisfaction with IPC interventions ranged from 58.3% to 97.2%. Meta-analysis of four studies using the Hospital Consumer Assessment of Healthcare Providers and Systems survey showed substantial heterogeneity (I2, 55%, p=0.08) and a pooled patient satisfaction level of 69% (95% CI 63.6% to 74.4%) for isolation precautions.
Sixty-nine percent of isolated patients reported satisfaction with their care. Patient satisfaction with IPC interventions varies widely, highlighting limitations in current measurement approaches. Strengthening PPI in the design and evaluation of satisfaction measures is essential to capture meaningful data and improvements in IPC programmes.
IS 2024 CRD42024558385.
Post-COVID syndrome manifests with a diverse array of symptoms for which no standard care plan currently exists. Many questions were raised by patients, which underscored the need for a validated patient-reported outcome measure (PROM). Therefore, a post-COVID module was developed to be included in the Assessment of Burden of Chronic Conditions (ABCC-) tool. The ABCC-tool evaluates and visualises the perceived physical, emotional and social burden of one or multiple chronic disease(s) using a balloon diagram and aims to facilitate person-centred care and structured discussions between patients and healthcare professionals. This study explores the patients’ perspective on the content of the ABCC-tool for post-COVID and the tool’s usability in a home-based setting.
All patients who completed the ABCC-tool for post-COVID were invited for an online semi-structured interview. We selected post-COVID patients who had used the tool in the past three months. Interviews were audio recorded and analysed using a thematic approach with Atlas.ti version 23.
Nineteen post-COVID patients (10 males, mean age 56) were interviewed between May and August 2024. The tool was regarded as user-friendly, and patients indicated they would use the tool again in the future. Patients valued the tool’s broad range of topics, some of which are often overlooked in standard healthcare consultations. The tool was comprehensible and relevant according to all patients. The balloon diagram was easy to understand, but a legend explaining the colours of the balloons was preferred. Other suggestions for improvement included adding open-text fields and periodic reminders to increase usability and adding long-term data.
The ABCC-tool is a promising instrument for post-COVID patients, offering a structured way to monitor and communicate experienced burden in addition to standard healthcare consultations. Refinements addressing usability and comprehensiveness are recommended to facilitate its integration into clinical practices.
To investigate the attitudes of physicians towards addressing environmental sustainability in patient conversations, and to identify barriers and facilitators to doing so.
A qualitative, nation-wide study was conducted using semi-structured online focus groups and interviews. Reflexive thematic analysis was used to analyse transcripts, guided by the Theoretical Domains Framework.
Secondary and tertiary healthcare institutions in the Netherlands.
Participants were medical specialists and residents in obstetrics and gynaecology (OB-GYN physicians) in the Netherlands. Participants were purposefully identified to capture diverse demographics and practice settings.
Physicians’ attitudes towards discussing the environmental impact of healthcare and the health effects of environmental pollution with patients. Themes were identified and categorised using the Theoretical Domains Framework.
The study included 28 OB-GYN physicians working across 23 healthcare institutions in the Netherlands. Six themes were developed: (1) strong sense of urgency to reduce healthcare's environmental impact, (2) knowledge gaps impair communication about environmental impact to patients, (3) prioritisation of individual patient health over environmental concerns in decision-making, (4) perceived lack of patient interest in environmental outcomes, (5) system-level support facilitates discussions about environmental sustainability with patients and (6) limited perceived value in discussing the health effects of environmental pollution and climate change with patients.
OB-GYN physicians are supportive of discussing the environmental impact of healthcare services when clinically appropriate. Addressing knowledge gaps, providing evidence-based guidance and embedding sustainability into clinical guidelines and decision aids may facilitate the integration of environmental sustainability into patient-provider interactions.
This study aims to develop a robust, targeted measure of patient experiences of person-centred care (PCC), informed by the lived experiences of patients with chronic illness using the psychometric theory of Rasch measurement.
The Rasch measurement model was used to analyse the psychometric functioning of 57 candidate items and select appropriate items for a targeted measure.
Participants were recruited from Prolific.com, having experience of both chronic or long-term illness and first-hand experience of primary or secondary care in the UK healthcare setting and completed a survey containing PCC items and descriptors of healthcare experience.
Data from 501 adult persons (49.5% men and 49.7% women) with different types of long-term conditions recruited from the prolific web panel.
For an initial analysis of all 57 candidate items, there were several indicators of misfit, such as signs of local dependence and multidimensionality. The response options worked as intended according to threshold ordering. After removal of misfitting items and refinement for the best spread of locations, a 14-item solution showed good fit to the Rasch model in this UK sample.
The results support a unidimensional measurement of patients’ experiences of PCC, once the local dependency was accommodated. The present work thus offers a 14-item measure of PCC experience. The present work also contains a robust item bank for the further development of dynamic computerised adaptive testing.
Many people with long-term conditions such as pain and arthritis struggle with their health and well-being. To support better self-management, a new peer-delivered coaching intervention (Health Connect Coaching) was set up at a National Health Service integrated care organisation in Southwest England. Based on principles of personalised care and supported goal setting, the one-to-one coaching programme, targeting patients with low activation, delivered coaching sessions in a step-down approach over 6 months. A randomised controlled feasibility trial (fRCT) of Health Connect Coaching was conducted to inform the design of a definitive randomised controlled trial. This article reports the embedded qualitative component of the fRCT, describing the experiences of coaches, peers and staff of implementing and participating in the intervention and trial that ultimately struggled to recruit sufficient peers.
Semi-structured online interviews were conducted with coaches (n=16) and peers (n=6), and informal discussions held with staff (n=7). Interviews were recorded and transcribed verbatim, and summaries of informal discussions were made. Data were analysed using thematic framework analysis.
Four themes were identified from the interview and discussion data: (1) motivation for participation, (2) balance, (3) flexibility and (4) connection and building relationships.
One-to-one peer coaching demonstrates potential as an intervention to enable people to better manage their chronic health condition. However, in people with low activation, programmes and effectiveness studies need to pay close attention in their design to the motivation of peers, flexible delivery models that enable connection but can accommodate fluctuating needs and facilitating links between coaching services and clinical teams.