Abstract Background Low levels of health literacy (HL) are associated with worse health outcomes and increased mortality. Surgery is among the top three risks of dying in a hospital worldwide. An improvement in health literacy is known to be associated with better healthcare outcomes. To date, there is no data available, on whether a learning instrument can improve health literacy in surgical oncologic patients or if it influences short-term surgical outcomes. Methods The APERIO trial is a multicenter prospective randomized controlled trial comparing a digital app-based preparation platform with the hospitals’ standard care. The trial seeks to enroll 382 patients in three different countries who will be randomized in either the intervention or the control group. The primary objective is to evaluate the efficacy of the Ready4OP app in improving health literacy in surgical oncologic patients. The secondary endpoints are investigating 90-day mortality rates, compliance, and adherence to Ready4OP as a digital learning platform, to increase equality of cancer patients’ health literacy in three different European countries and to evaluate the influence of an app-based educational platform on surgical oncologic short-term outcomes and morbidity. Discussion We form the hypothesis that providing a digital app-based preparation platform for patients before major surgical oncologic procedures will reduce the number of badly informed patients from 60 to 45% as measured by standardized questionnaires. Therefore, the APERIO trial aims to evaluate the efficacy of the Ready4OP app in improving health literacy in surgical oncologic patients. Trial registration Trial registered in the German Clinical Trial Registry (DRKS00031507, Registered on May 22 2023), Goethe University Ethics approval 09.05.2023 (2023-1173).
Family members are the primary source of support for older care recipients. Promoting cooperative strategies between family members may foster shared solutions to care-related challenges. Based on our previous research we developed a dyadic problem-solving intervention that equally addresses the needs of both caregivers and care recipients. This pragmatic randomized controlled clinical trial evaluates the implementation and effectiveness of the intervention under routine conditions within a national care counselling service setting. Due to recruitment obstacles and low participant enrolment the randomized design was modified to a non-randomized study. Main inclusion criterion for caregivers was a positive screening of desire to change the care situation, frequent caregiving challenges, or difficulty managing care. Participants are assigned to either the CoPlan intervention or control group with routine care counselling. Self-reported questionnaires are administered at baseline (t0) and 3 months post-intervention (t2) to collect endpoint data, with an intermediate non-endpoint assessment following the initial counselling (t1). Primary and secondary endpoint comparisons are based on data collected at t2 controlled for baseline values. Primary outcome is the quality of informal care (QiC), main secondary outcomes include caregiver self-efficacy, depressive symptoms, and positive aspects of caregiving. A process evaluation assesses intervention dose, fidelity, and experiences of interventionists, care counsellors of a German long-term care insurance, and participants. This study represents one of the few translational studies in care counselling research. By promoting shared appraisals and open communication in a dyadic approach, the novel counselling method addresses a largely underexplored area. The difficulty in recruiting participants through care counsellors, along with the resulting study design modification, highlights the difficulties of conducting studies within real-world practice settings. Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00032492 . Registered on 5 September 2023 (current status: recruitment completed).
Cognitive impairment caused by white matter injury in cerebral small vessel disease (CSVD) is common among the elderly but currently lacks effective treatment. Pentoxifylline (PTX) is a nonselective phosphodiesterase inhibitor that exhibits protective effects in a variety of vascular diseases. Previous animal studies have revealed that PTX can alleviate cognitive impairment mediated by chronic ischemic white matter injury (white matter hyperintensity, WMH) and mitigate WMH progression. However, there is still a lack of clinical studies on whether pentoxifylline can improve cognitive dysfunction caused by cerebral small vessel disease. This trial was designed to evaluate the safety and efficacy of pentoxifylline in improving cognitive impairment caused by WMH in cerebral small vessel disease. A prospective, randomized controlled, open-label, multicenter clinical study will be conducted at 13 medical centers in China. Approximately 240 eligible patients will be randomly assigned in a 1:1 ratio to receive or without pentoxifylline (400 mg tablets twice daily) for 6 months, with a follow-up of 1–2 years. Both groups will receive basic treatments (controlling blood pressure, blood sugar, etc.). Randomization sequences will be computer-generated by a professional clinical statistician and stratified by participating centers. The primary outcome is the change in white matter hyperintensity (WMH) volume from baseline to 6 months. The secondary outcomes include changes in white matter hyperintensity (WMH) volume from baseline to 1 year and 2 years, changes in cognitive performance from baseline to follow-up assessments (6 months, 1 year and 2 years after baseline), as well as changes in neurocognitive, behavioral, and physiological parameters (including blood and neuroimaging biomarkers), assessed at baseline and post-intervention. Safety outcomes are adverse events, adverse drug reactions, severe or life-threatening hemorrhage and the occurrence of complex cardiovascular and cerebrovascular events. ChiCTR, ChiCTR2300069867. Registered on 28 March 2023, (https://www.chictr.org.cn/showproj.html?proj=192462ChiCTR-2300069867). Date: 14/12/2022
Equity, diversity and inclusion in randomised trials is widely acknowledged as a scientific and ethical imperative, yet persistent barriers remain relating to cultural, linguistic, geographical and other social and structural determinants of health. Such determinants become pervasive systemic barriers that compromise the real-world relevance of randomised trials and perpetuate health inequities. International and national Australian regulatory bodies promote equity, diversity and inclusion in randomised trials, but implementation is inconsistent. This commentary describes the methodological process to design and conduct a think tank event as a strategy to raise awareness and promote the consideration of equity, diversity and inclusion in randomised trials in Australia. Through outreach via university and clinical research networks, we identified and invited 27 attendees to a think tank event that explored strategies for advancing equity, diversity and inclusion in Australian randomised trials. Held in Brisbane, Queensland, attendees included academics, clinician researchers, social impact and cultural diversity professionals, research ethics and governance professionals, consumer and community representatives, and other research-adjacent service providers. The event drew upon two participatory discussion methodologies, World Café and Yarning Circle, to facilitate in-depth conversation amongst the diverse attendees. Discussions flowed from three guiding questions regarding randomised trials in Australia: “What does health equity mean?”, “what factors influence health equity?”, and “what are the next steps?” Combining World Café’s structured, idea-generating format with Yarning Circle’s culturally grounded, relational approach enabled both breadth and depth of insights. Insights generated from the think tank event were graphically recorded by a professional artist, which will be combined with other collected data (online and table notes) to inform future actions. Addressing equity, diversity and inclusion in randomised trials requires moving beyond policy statements to practical, collaborative action. Participatory methods such as World Café and Yarning Circle are favourable approaches for fostering inclusive dialogue and co-designing ideas that can inform future action.
Informed consent is a cornerstone of ethical clinical research. However, the increasing length and complexity of information and consent forms (ICFs) raise concerns about their effectiveness in ensuring truly informed participation. This study examined the role of written ICFs in cancer patients’ decision-making and their practical use during clinical trial participation. We conducted an exploratory qualitative study. Semi-structured interviews were conducted with 29 cancer patients recently enrolled in clinical trials, 18 physicians involved in patient inclusion, and 15 clinical research nurses. Interview transcripts underwent textual (IRaMuTeQ and JAMOVI software) and thematic analysis. Patients’ decisions to participate were driven almost entirely by oral discussions with their physicians rather than by written information. Sixty-five percent of patients reported not reading, or only skimming, the ICF before signing. Trust in the physician was the main determinant of consent (mentioned by 86
