To evaluate the cost-effectiveness of implementing a penicillin allergy assessment pathway (PAAP) versus usual care within the NHS.
A decision tree analysis over a 5-year time-period, informed by a randomised controlled trial (RCT) of PAAP and systematic review. Value of information analysis was also conducted to estimate the value of conducting a new trial.
Model inputs were informed by the ALABAMA RCT participants included in the primary analysis, 811 adults with penicillin allergy labels and recent antibiotic prescriptions, and data from published literature.
Participants in the ALABAMA trial included in the primary analysis: PAAP (n=401) and usual care (n=410).
Costs are presented in GBP (£) at 2022–2023 prices, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio, incremental net monetary benefit (INMB), the probability of cost-effectiveness at the £20,000 and £30,000 per QALY threshold, and the cost effectiveness of a new follow-on trial.
PAAP had incremental costs of £–83 (probability of cost saving 47.5%) and incremental QALYs of 0.036 (probability of positive benefits 47.5%). The INMBs (probability of cost-effectiveness) were £806 (48%) and £1167 (48%) under the decision thresholds of £20,000 and £30,000 per QALY, respectively. PAAP was more cost-effective among females, people aged >65 years, and more frequent antibiotic users. A new follow-on trial involving 1267 participants was estimated to cost £2.4 million and, by reducing uncertainty in the evidence, would avoid £19.6 million in costs of incorrect management decisions for eligible patients over the next 10 years.
The PAAP was considered cost-effective, but significant uncertainty remained. Future trials with adequate power and longer follow-up are needed to determine the most cost-effective models for penicillin allergy testing.
Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.
Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.
This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).
by Kennedy M. Peter-Marske, Annie Green Howard, Kelly R. Evenson, Sara Jones Berkeley, Joanna Maselko, Mario Sims, Stuart D. Russell, Anna Kucharska-Newton, Kevin J. Sullivan, Wayne D. Rosamond
We assessed whether social isolation (SI), social support (SS), and subtypes of SS were associated with self-rated health trajectories and clinical heart failure (HF) outcomes among participants with incident HF hospitalizations. We included 2967 Atherosclerosis Risk in Communities study participants with incident HF hospitalization after Visit 2 (1990–1992). SI, SS, and subtypes of SS were measured at Visit 2. We identified incident HF hospitalization as ICD-9 code 428 and physician adjudicated events; on average HF occurred 17 (SD 8) years after Visit 2. We assessed associations with trajectories of annually measured self-rated health in the 4 years prior to and after incident HF hospitalization (excellent/good self-rated health on a 0–100 scale), using linear mixed effects models. We calculated hazard ratios (HR) and 95% confidence intervals (CIs) for associations with time to first all-cause rehospitalization and all-cause mortality using Cox proportional hazard models. Low overall SS had a 5.8 point (95% CI 7.8, 3.8) lower self-rated health value over time than high SS; associations of subtypes of SS with this outcome were similar. Low belonging SS was associated with greater days to first rehospitalization (HR 0.85; 95% CI 0.79, 0.96) compared to the highest tertile; however, belonging SS was not associated with mortality (HR 1.05; 95% CI 0.95, 1.17). Being socially isolated/high risk for SI was associated with greater hazard of all-cause mortality among females (HR 1.57; 95% CI 1.20, 2.06) but not males (HR 0.95; 95% CI 0.75, 1.19), compared to low SI. SI and SS were not associated with number of hospitalizations in the first year or percent of first year spent at home.Studying issues related to stroke medication non-adherence is essential for secondary prevention of stroke. This study aimed to identify the prevalence of medication non-adherence and risk factors among stroke survivors. The reasons behind this are that some patients may not follow stroke medication plans, and potential ways to help patients adhere better to medication plans.
This study employed a cross-sectional patient survey.
The study was conducted in 20 public and private healthcare facilities in a resource-constrained setting, in Punjab, the largest province of Pakistan.
We included 6538 stroke survivors aged 21–75 years with at least a 6 month history of stroke who were prescribed one or more anti-stroke medications and met the inclusion criteria.
The main outcome was medication non-adherence, measured by the Self-Efficacy for Appropriate Medication Scale (SEAMS) and self-reported pill count. Descriptive statistics were used to summarise study variables. chi-square (²)/Fisher’s exact test and independent t-test/ANOVA were employed. A generalised linear model (logit model using multivariable logistic regression shows that several factors are associated with medication non-adherence and adherence. Odds ratio (OR) plots were generated using Seaborn and Matplotlib.
Non-adherence based on pill counts was 49.7%, while the mean SEAMS score (31.3±7.7) showed moderate self-reported adherence. After adjusting for age, gender, marital status, education, income, health insurance, smoking status, comorbidities, stroke type, disease duration, blood pressure control, number of medications, dosing frequency, physiotherapy continuation, perceived side effects and doctor-patient satisfaction, we found that female gender (vs male: AOR 0.31, 95% CI 0.27 to 0.35), lower income (10k–25k PKR vs >100k PKR: AOR 0.31, 95% CI 0.23 to 0.41; 26k–50k PKR vs >100k PKR: AOR 0.57, 95% CI 0.47 to 0.68), primary/secondary education (vs postgraduate: AOR 0.74, 95% CI 0.64 to 0.87), controlled BP (vs uncontrolled: AOR 0.66, 95% CI 0.59 to 0.73), longer disease duration (≥5 years vs
This study addresses the significant issue of medication non-adherence in stroke patients in Pakistan, reflecting global patterns yet remaining under-explored locally. It emphasises the critical role of adherence in managing chronic conditions such as stroke, where consistent use of preventive therapies is vital for reducing recurrence and improving outcomes. While the non-adherence rates are consistent with global trends, there is a notable lack of observational studies and epidemiological data in the Pakistani context. Our findings support a comprehensive approach to enhance medication adherence, taking into account the complex connections among social, behavioural and clinical factors. It also highlights the importance of maintaining detailed records to monitor adherence trends, identify high-risk groups and inform targeted public health interventions.
Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.
Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).
Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
The purpose of this study was to explore the experiences of informal caregivers receiving nurse telephone support for an older person discharged from hospital and how the nursing support influenced their experiences of caring.
A descriptive qualitative study.
Purposive sampling was used to recruit participants who cared for older adults from two states in Australia between April 2022 and March 2023 for one-on-one interviews 6 months (n = 28) and 12 months (n = 24) after patient discharge from hospital. Inductive directional content analysis was used to analyse the qualitative data.
Three themes were identified: (1) Caregiving elicited a complex mix of emotions; (2) nursing support improved caregivers' preparedness to care over time and (3) caregivers welcomed emotional and practical support as they took on new responsibilities. They reflected that nurse telephone support offered emotional and practical support, helping caregivers feel more confident and less stressed in the caregiving role.
The study highlighted the value of proactive nurse-led programs to support informal caregivers after patient discharge from hospital, improving their experience. Providing ongoing support after discharge via telephone communication can play a critical role in caregiver wellbeing and facilitate the sustainability of their caregiving responsibilities in the home.
Study design and conduct are reported in line with the consolidated criteria for reporting qualitative studies (COREQ) guidelines.
The research team includes a consumer investigator (H.L.) who has provided feedback and input at all stages of the research, including grant application, project design, data analysis and manuscript review.
Australian New Zealand Clinical Trials Registry identifier (ANZCTR): 12620000060943
To examine whether manpower and expertise understaffing are distinct, and whether they relate similarly to nursing stressors, burnout, job satisfaction and intentions to turnover.
A cross-sectional survey of hospital nurses nested within units was used.
The sample included 402 nurses. Nurses provided ratings of the study's variables using validated self-report measures. The data were analysed both as multilevel and single-level data.
Manpower and expertise understaffing contributed unique explained variance to all of the examined outcomes. Nurses within the same units experience different understaffing levels. Expertise understaffing emerged as a significantly stronger predictor than manpower understaffing for three of the six of the outcome variables (illegitimate tasks, job satisfaction and turnover intentions).
Manpower and expertise understaffing are distinct, and both are associated with nurse outcomes.
We have adhered to the STROBE guideline for cross-sectional studies.
Considering both manpower and expertise understaffing to maintain proper staffing levels in nursing units is crucial.
A Director of Patient Care Services from the hospital where the study was conducted is a member of the research team. This member contributed to designing and conducting the study as well as interpreting the results.
To explore oncology nursing advance care planning practices and understand how to better support nurses in conducting advance care planning with patients and their families.
Qualitative interpretive descriptive methodology.
Semi-structured, individual telephone or Zoom interviews with 19 oncology nurses in a Western province of Canada between May and August 2022. Interviews were audio-recorded, transcribed, de-identified, and analysed using inductive, thematic, and constant comparative techniques.
Oncology nurses highlighted several factors affecting their ability to engage in advance care planning, including (1) uncertainties related to the nursing role in advance care planning, such as how and when a nurse ought to engage; (2) the educational, experiential, and training environment; and (3) structural barriers, such as a lack of time, space, and privacy; models of care that inhibit nurses from developing longitudinal relationships with their patients; and team dynamics that affect advance care planning interdisciplinary collaboration.
To create environments that support oncology nurses to conduct advance care planning, the findings suggest uncertainties be addressed through a clear and cohesive organisational approach to advance care planning and ongoing, integrated educational opportunities. Further, service delivery models may need to be restructured such that nurses have dedicated time and space for nurse-led advance care planning and opportunities to develop trusting relationships with both patients and their interdisciplinary colleagues.
Oncology nurses recognised the value of advance care planning in supporting patient-centred care and shared decision making, yet they reported limited engagement in advance care planning in their practice. To support oncology nurses in conducting advance care planning, healthcare leaders may address (1) advance care planning-related uncertainties and (2) structural barriers that prevent nurses from engaging in advance care planning with patients and their families. Findings may guide modifications to care models, enhancing support for oncology nurses in conducting advance care planning.
We selected and adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ) as the most applicable guideline.
No patient or public contribution.
To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.
Triangulation to integrate quantitative and qualitative data.
Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.
A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.
To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.
Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.
There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.
To develop and validate a screening tool to identify patients with cardiovascular disease at risk of poor oral health and requiring referrals.
This study was part of a larger pilot study involving a cross-sectional survey and an oral health assessment conducted with patients with cardiovascular disease.
A four-item screening tool was developed by an expert panel and validated through a cross-sectional survey of patients with cardiovascular disease. The survey contained the tool and the oral health impact profile (OHIP-14) (first gold standard). Additionally, all survey participants were provided a clinical oral health assessment (second gold standard). Sensitivity and specificity analysis was undertaken comparing the tool to the two gold standards to assess patients with cardiovascular disease at risk of poor oral health.
Three hundred and twenty-one participants completed the cross-sectional survey and eighty nine undertook the oral health assessment. Results from both approaches showed that the tool had high sensitivities (OHIP-14 = 89%, Oral assessment = 88%) and low specificities (OHIP-14 = 33% and Oral assessment = 24%).
The four-item screening tool is a simple and valid tool to identify patients with cardiovascular disease at risk of poor oral health and requiring a dental referral. The tool could be incorporated into routine practice of nurses across various cardiac settings.