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The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.
QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.
QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.
To justify the use of focus group interviews with patients and healthcare professionals within a phenomenological-hermeneutic approach inspired by the theory of the French philosopher Paul Gustave Ricoeur.
Methodological guidance and discussion grounded in Ricoeur's theory on narrative, dialogue, threefold mimesis and interpretation.
This phenomenological-hermeneutical approach to focus group interviews yields significant, in-depth understandings of lived experiences from both patients and healthcare professionals.
Ricoeur-inspired phenomenological-hermeneutical focus group interviews with patients and healthcare professionals offer a promising approach for exploring and generating new, valuable insights into the complexities of clinical nursing practice. Thus, this paper argues for an integration of focus group interviews and a phenomenological-hermeneutical approach within nursing science.
The approach has significant implications for nursing practice. By incorporating Ricoeur-inspired dialogue-based collective voices of patients and healthcare professionals in focus group interviews, nursing practices can be refined, leading to improved patient care and more effective clinical interventions. Thus, this approach advocates for a broader adoption of Ricoeur-inspired focus group interviews in nursing research and in health research in general to enhance the understanding and development of clinical models.
No available EQUATOR guidelines were applicable to this methodological paper, as no new data were created or analysed.
As this is a methodological paper, no new patient or public contributions are included.
Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).
This study aimed to explore what intervention specificities or attributes newly diagnosed individuals with multiple sclerosis (MS) find important and to explore possible reasons behind their evaluations.
A stepwise approach began with a systematic literature review to identify significant attributes. Patients with MS then assessed these attributes through an online survey, which included a ranking exercise and open-ended questions. Finally, the results were evaluated by the clinical team to select the most relevant factors for personalised care.
From June 2023 to December 2023, all consecutive patients referred to the MS Center of Careggi University Hospital were screened for inclusion. Following recruitment, cognitive and physical assessments were administered at the Don Gnocchi Centre. All participants were interviewed by an experienced neuropsychologist.
Participants were enrolled in the RELIABLE clinical trial, which included a ranking exercise and open-ended question. In the ranking exercise, patients prioritised levels of treatment attributes: treatment effects, methods of intervention, type of monitoring, monitoring, mode and mental support. The open-ended questions addressed the reasons behind the level rankings.
Participants’ rankings revealed the most important levels of each attribute. The highest-ranked method of intervention was disease-modifying treatment, which received 164 points. For mental support, individual psychotherapy was deemed most important with 149 points. Preservation of cognitive function, a key treatment effect, received 144 points. Clinical check-ups were the top type of monitoring with 129 points. Lastly, the hybrid mode of monitoring (half remote/half in-person) was ranked with 77 points. Open-ended responses provided insights into the reasons behind these preferences, emphasising the importance of maintaining mobility, cognitive function and emotional well-being. The clinical team evaluated these findings, confirming that the selected attributes were both clinically relevant and aligned with patient priorities. This evaluation process ensured that the treatment specificities chosen for individualised care were comprehensive and reflective of patient needs.
By identifying and prioritising key treatment attributes, this research highlights the multifaceted nature of MS management and emphasises the importance of aligning treatment options with patient preferences. Addressing these factors through further quantitative preference assessments is essential for preventative MS care, improving patient outcomes and promoting a more patient-centred approach to treatment.
by Anja Arner, Andreas Ettinger, Bradley Wayne Blaser, Bettina Schmid, Irmela Jeremias, Nadia Rostam, Vera Binder-Blaser
Acute lymphoblastic leukemia (ALL) is the most common type of malignancy in children. ALL prognosis after initial diagnosis is generally good; however, patients suffering from relapse have a poor outcome. The tumor microenvironment is recognized as an important contributor to relapse, yet the cell-cell interactions involved are complex and difficult to study in traditional experimental models. In the present study, we established an innovative larval zebrafish xenotransplantation model, that allows the analysis of leukemic cells (LCs) within an orthotopic niche using time-lapse microscopic and flow cytometric approaches. LCs homed, engrafted and proliferated within the hematopoietic niche at the time of transplant, the caudal hematopoietic tissue (CHT). A specific dissemination pattern of LCs within the CHT was recorded, as they extravasated over time and formed clusters close to the dorsal aorta. Interactions of LCs with macrophages and endothelial cells could be quantitatively characterized. This zebrafish model will allow the quantitative analysis of LCs in a functional and complex microenvironment, to study mechanisms of niche mediated leukemogenesis, leukemia maintenance and relapse development.
by Junning Chen, Marta Aido, Andreas Roschger, Alexander van Tol, Sara Checa, Bettina M. Willie, Richard Weinkamer
Osteocyte lacuno-canalicular network (LCN) is comprised of micrometre-sized pores and submicrometric wide channels in bone. Accumulating evidence suggests multiple functions of this network in material transportation, mechanobiological signalling, mineral homeostasis and bone remodelling. Combining rhodamine staining and confocal laser scanning microscopy, the longitudinal cross-sections of six mouse tibiae were imaged, and the connectome of the network was quantified with a focus on the spatial heterogeneities of network density, connectivity and length of canaliculi. In-vivo loading and double calcein labelling on these tibiae allowed differentiating the newly formed bone from the pre-existing regions. The canalicular density of the murine cortical bone varied between 0.174 and 0.243 μm/μm3, and therefore is three times larger than the corresponding value for human femoral midshaft osteons. The spatial heterogeneity of the network was found distinctly more pronounced across the cortex than along the cortex. We found that in regions with a dense network, the LCN conserves its largely tree-like character, but increases the density by including shorter canaliculi. The current study on healthy mice should serve as a motivating starting point to study the connectome of genetically modified mice, including models of bone diseases and of reduced mechanoresponse.
Hospital-acquired pressure injuries (HAPIs) are a global high-stakes patient safety issue. Key stakeholder perspectives regarding their role and experiences with pressure injuries is critical as part of the solution to minimizing HAPI occurrence and attain sustainability.
A qualitative, descriptive approach provided multiple perspectives of key stakeholders to support the complexity of HAPI care. The qualitative data are a part of a mixed method convergent research study examining pressure injury prevention and management practices.
Nursing system theory, mixed method convergent design, and participatory action research methodologies were chosen to address both the gap analysis development and results, achieve collaborative comprehensiveness, and enable key stakeholder involvement throughout this HAPI prevention and management initiative. Participants were recruited and enrolled from a large Level I trauma hospital and the key stakeholders. Demographic information were collected prior to the individual interview. Focused interviews were conducted virtually using zoom technology. Qualitative data were analyzed using NVivo software and thematic analysis was confirmed across the co-investigators for congruence and applicability to the research questions.
Qualitative interviews with 26 key stakeholders provided data to support and integrate a link with gap analysis results on the complex health issue of HAPIs. Specific barrier and recommendation themes identified interventions that could be prioritized. The 52 barrier and 52 recommendation themes/sub-theme(s) respectively were organized by Donabedian (structure, process, and outcome) with structure elements the majority. The top three structure barrier themes involved equipment and standards for use, staff prevention education, and specialized health professionals. The top three structure recommendation themes involved specialized health professionals, equipment and standards for use, and an educational plan for those at risk or with HAPIs.
The article provides findings from the qualitative portion of a mixed method study related to HAPIs. The qualitative findings associated with the gap analysis quantitative results, achieved the goal of the participatory action research key stakeholders' input into HAPI care and can be replicated internationally.
The benefit of key stakeholder's involvement in solving a clinical problem is sustainability. A quantitative approach and integrating qualitative stakeholders' perspectives provide an in-depth solution that will advance nursing capacity toward health care delivery and HAPI nursing science and policy development on a global level.
To develop an advance care planning intervention based on the needs of patients with chronic kidney disease, families and healthcare professionals.
Patients with chronic kidney disease and their families request early advance care planning that continues throughout their illness trajectory. Healthcare professionals experience barriers to initiating advance care planning. Involvement of stakeholders in development of health interventions is important, to identify priorities, understand the problem and find solutions.
The development was inspired by the Medical Research Council's framework, and codesign was applied. One future workshop and one design workshop were conducted with the consumers. The process was iterative, and data were analysed using the action research spiral. The Guidance for reporting intervention development studies in healthcare (GUIDED) was used.
Five areas were considered significant to an advance care planning intervention; a biopsychosocial approach, early palliative care, a family-focused approach, early and continuous advance care planning and a consumer-centred approach. Based on these, a conversation process with healthcare professionals was designed to give patients and families the opportunity to share values, preferences and wishes for treatment and their family and everyday life.
Codesign facilitated a collaborative process that allowed the consumers to have a significant impact on the design of an advance care planning intervention. A conversation process concerning everyday life, illness and treatment was designed for patients and families. The intervention included an advance care planning tool to guide the healthcare professionals.
The intervention has the intention to improve the communication between healthcare professionals, patients and families. The study provides important knowledge about the significance of giving the patients and their families support in sharing their values, preferences and wishes for treatment and everyday life, thus, to improve care and treatment in their illness trajectory.
What problem did the study address Patients with chronic kidney disease and their families strongly request early initiation of advance care planning that continues throughout the illness trajectory. Healthcare professionals experience barriers to the initiation of the advance care planning and request a more systematic approach. What were the main findings Development of a conversation process about everyday life, illness and treatment for patients diagnosed with chronic kidney disease and families, including an advance care planning tool to guide the healthcare professionals. Where and on whom will the research have an impact The study contributes an advance care planning intervention to patients in the early stages of chronic kidney disease and their families. We believe that the intervention could be included during consultations with healthcare professionals in other stages of chronic kidney disease as well as other chronic disease.
To strengthen the reporting of the development of the advance care planning intervention, we used the Guidance for reporting intervention development studies in healthcare (GUIDED).
The development of the intervention in this study was a collaborative process between patients, families, healthcare professionals and representatives from the Danish Kidney Association, the department's user council and the research team.
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