Patient Information Sheets Research Articles

Comic-based consenting on patient-reported experience and outcome measures for transfemoral aortic valve implantation

Abstract Background The impact of an improved patient informed consent (IC) before transcatheter aortic valve implantation (TAVI) on patient-reported experience and outcome measures (PREMs and PROMs) as well as on clinical outcomes remains unclear. Purpose To investigate patient satisfaction, PREMs, PROMs and clinical outcomes in patients receiving additional illustrative graphic-based IC (comic group) compared to conventional IC (control group) for TAVI at two tertiary care centers as part of a randomised controlled trial ("TAVI-COMIC study"). Methods Adult patients undergoing elective TAVI were enrolled. Patient satisfaction and PREMs were assessed after providing IC, PROMs at 90 days after TAVI and clinical safety outcomes within 7 days after TAVI (Figure). Results Only 48 (32%) of all patients read the official usual patient information sheet. Of 299 patients undergoing TAVI, comic-based IC was performed in 152 (51%) patients. Patient satisfaction was significantly higher (29 [23-32] vs 25 [22-30] of a maximum of 32 points in the validated Client Satisfaction Questionnaire [CSQ], p<0.001) and anxiety was lower (34 [25-51] vs 39 [29-55], p<0.001 in the validated Spielberger State-Trait-Anxiety Inventory [STAI]) in the comic group. 92 (61%) patients in the comic group felt "relaxed" prior to the procedure compared to only 44 (30%) patients receiving conventional IC (p<0.001). 91 (60%) were "very satisfied" with the delivered patient IC compared to 28 (19%) patients in the control group (p<0.001). PROMs at 90 days were assessed in a subgroup of 198 (66% of total cohort) patients: The comic group had similar PROMs as the control group (e.g. general health condition, walking ability and rate of dizziness, syncope, helplessness, depression, dyspnea or angina). Clinical outcomes, such as bleeding, pneumonia, stroke, delirium, or TAVI unit and hospital length of stay, were similar in both groups. Conclusion Use of an alternative IC approach, such as medical graphic narratives, might significantly improve patient satisfaction and PREMs, while facilitating similar PROMs and procedural safety as conventional treatment strategies.

Suitability of ChatGPT as a Source of Patient Information for Screening Mammography.

ChatGPT3.5 and ChatGPT4 were released publicly in late November 2022 and March 2023, respectively, and have emerged as convenient sources of patient health education and information, including for screening mammography. ChatGPT4 offers enhanced capabilities; however, it is only available by paid subscription. The purported benefits of ChatGPT for health education need to be objectively evaluated. To assess performance differences, ChatGPT3.5 and GPT4 were used between 13 April and 29 May 2023 to generate breast screening patient information sheets, which were evaluated using the Patient Education Materials Assessment Tool for printed materials (PEMAT-P) and the CDC Clear Communication Index (CDC Index) Score Sheet; and benchmarked against gold standard content in BreastScreen NSW's patient information sheet. Mean scores were reported for comparison. GPT3.5 provided the appropriate tone and currency of information but lacked accuracy, omitting key insights: PEMAT-P understandability 68.0% (SD = 6.56) and actionability 36.7% (SD=20.4); CDC Index 58.8% (SD = 15.3). GPT4 was deemed superior to GPT3.5 but included several key omissions: PEMAT-P understandability 75.0% (SD = 17) and actionability 53.3% (SD = 11.54); CDC Index 66.0% (SD = 4.1). Both ChatGPT versions exhibited poor understandability and actionability and were unclear in their messaging. Those with poor health literacy will not benefit from accessing current versions of ChatGPT and may be further disadvantaged if they do not have access to a paid subscription. ChatGPT is evidenced to be an unreliable and inaccurate source of information concerning breast screening that may undermine participation and risk increased morbidity and mortality from breast cancer. ChatGPT may increase the demand on health care educators to rectify misinformation.

Exploring the User Acceptability and Feasibility of a Clinical Decision Support Tool Designed to Facilitate Timely Diagnosis of New-Onset Type 1 Diabetes in Children: Qualitative Interview Study Among General Practitioners.

Up to half of the children with new-onset type 1 diabetes present to the hospital with diabetic ketoacidosis, a life-threatening condition that can develop because of diagnostic delay. Three-quarters of Australian children visit their general practitioner (GP) the week before presenting to the hospital with diabetic ketoacidosis. Our prototype, DIRECT-T1DM (Decision-Support for Integrated, Real-Time Evaluation and Clinical Treatment of Type 1 Diabetes Mellitus), is an electronic clinical decision support tool that promotes immediate point-of-care testing in general practice to confirm the suspicion of diabetes. This avoids laboratory testing, which has been documented internationally as a cause of diagnostic delay. In this investigation, we aimed to pilot and assess the feasibility and acceptability of our prototype to GP end users. We also explored the challenges of diagnosing type 1 diabetes in the Australian general practice context. In total, 4 GPs, a pediatric endocrinologist, and a PhD candidate were involved in conceptualizing the DIRECT-T1DM prototype, which was developed at the Department of General Practice and Primary Care at the University of Melbourne. Furthermore, 6 GPs were recruited via convenience sampling to evaluate the tool. The study involved 3 phases: a presimulation interview, simulated clinical scenarios, and a postsimulation interview. The interview guide was developed using the Consolidated Framework for Implementation Research (CFIR) as a guide. All phases of the study were video, audio, and screen recorded. Audio recordings were transcribed by the investigating team. Analysis was carried out using CFIR as the underlying framework. Major themes were identified among three domains and 7 constructs of the CFIR: (1) outer setting-time pressure, difficulty in diagnosing pediatric type 1 diabetes, and secondary care considerations influenced GPs' needs regarding DIRECT-T1DM; (2) inner setting-DIRECT-T1DM fits within existing workflows, it has a high relative priority due to its importance in patient safety, and GPs exhibited high tension for change; and (3) innovation-design recommendations included altering coloring to reflect urgency, font style and bolding, specific language, information and guidelines, and inclusion of patient information sheets. End-user acceptability of DIRECT-T1DM was high. This was largely due to its implications for patient safety and its "real-time" nature. DIRECT-T1DM may assist in appropriate management of children with new-onset diabetes, which is an uncommon event in general practice, through safety netting.

A protocol for an open-label randomized parallel group clinical study on non-alcoholic fatty liver disease (NAFLD)

The primary objective of this study is to evaluate the efficacy of the combined effect of Agnideepan and Vyadhipratyaneek Chikitsa on the Fatty Liver Index (FLI) score in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Secondary objectives include assessing the impact of combined chikitsa on Agni, lipid profile, body weight, waist circumference, and BMI. The study also aims to evaluate the effects of Vyadhi Pratyaneekachikitsa on changes in the FLI, lipid profile, body weight, waist circumference, BMI, and Agni, as well as the impact of Agni Deepanchikitsa on these parameters. Additionally, the quality of life of NAFLD patients will be evaluated using the SF36 questionnaire. Patients diagnosed with NAFLD will be selected from the outpatient department of CARICD, now renamed the Central Ayurveda Research Institute in New Delhi. Patient information sheets and consent forms will be provided to all willing participants. Screening will be conducted, and suitable patients will be randomized using a computer-generated chart. Trial formulations will be prescribed according to a set schedule, and patients will be called for follow-up visits accordingly. It is expected that the combined treatment of Agnideepan and Vyadhipratyaneek Chikitsa will be more effective than Vyadhipratyaneek Chikitsa alone in managing NAFLD. This study aims to explore the effectiveness of Ayurveda interventions in managing NAFLD through a disease-specific approach to precisely correct RaktavahaSrotodushti with Yakrt involvement and a general approach aimed at correcting metabolism. This dual approach highlights the role of multiple therapeutic targets in disease management tailored to patient-specific factor.

Comparative Assessment of Postoperative Pain After Three Irrigation Techniques in Single-Rooted Teeth With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Controlled Trial.

Aim This study aimed to assess the impact of positive pressure, negative pressure (EndoVac), and sonic-activated irrigation (EndoActivator) on postoperative pain with symptomatic irreversible pulpitis and symptomatic apical periodontitis. The hypothesis tested the superiority of negative pressure irrigation in reducing pain and analgesic requirements. Methodology Forty-eight eligible patients meeting inclusion criteria were enrolled, ensuring comprehension through verbal and written patient information sheets. The sample size calculation, based on prior data, determined 14 teeth per group with consideration for potential dropouts, resulting in 16 teeth per group. Inclusion criteria included healthy individuals aged 16-65 years with single-rooted teeth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis, while exclusion criteria comprised recent analgesic intake, pregnancy, lactation, and specific dental conditions. Participants were allocated to three groups using computer-generated block randomization with allocation concealment via sequentially numbered opaque sealed envelopes. While blinding of the operator was not feasible, patient and assessor blinding was ensured. Preoperative data collection included patient demographics, tooth details, and pain intensity assessed on a Visual Analogue Scale (VAS). Root canal therapy procedures, conducted in two visits, included instrumentation and irrigation using 3% NaOCl across three groups: positive pressure irrigation, negative pressure irrigation, and sonic activation. Postoperative pain and analgesic intake were evaluated using VAS at specific intervals. One assessor tabulated and analyzed all the information. Results Postoperative pain assessments revealed that the EV group experienced the lowest pain levels, followed by the EA and SVN groups, with significant differences observed at six and 24 hours postoperatively (p < 0.05). Analgesic requirements correlated with pain levels, with the SVN group requiring the most analgesics and the EV group the least, highlighting the efficacy of the interventions. Conclusions Negative pressure irrigation (EndoVac) significantly reduced postoperative pain compared to conventional side-vented needle irrigation. These findings enhance understanding and guide evidence-based recommendations for optimizing endodontic procedures and prioritizing patient comfort and outcomes.

#2422 Iohexol plasma clearance measurement protocol standardization—a consensus of the European Kidney Function Consortium

Abstract Background and Aims International consensus supports the development of standardized protocols for measured glomerular filtration rate (mGFR) to facilitate the adoption of mGFR determination in both clinical and research settings. Method The European Kidney Function Consortium (EKFC) convened an international group of mGFR experts. The working group performed an extensive literature search to inform the development of recommendations for mGFR determination using one-compartment plasma clearance models and iohexol as the exogenous filtration marker. Iohexol was selected as it is non-radio labeled, inexpensive, widely available, and can be assayed at a central laboratory. Other commonly used non-radio labeled tracers have been (inulin) or are soon to be (iothalamate) discontinued. A plasma clearance model was selected as it requires no timed urine collections. A one-compartment model was preferred to a two compartment model as it requires fewer samples. The resulting recommendations were based on published evidence complemented by expert opinion. Results Recommendations include practical advice for patients and health professionals, preparation, administration and safety aspects of iohexol, laboratory analysis, blood sample collection and sample timing for both multiple and single sample protocols, description of the mGFR mathematical calculations as well as implementation strategies (Fig.). EKFC will provide materials such as patient information sheets, standard operating procedures, a study protocol template, and support for mGFR calculation. Conclusion Members of the EKFC have evaluated the evidence and formulated recommendations that include all aspects of iohexol plasma clearance measurement using a one compartment model. *Author list on behalf of the European Kidney Function Consortium (EKFC).

Driving quality in delirium care through a patient-centered monitoring system in palliative care: Protocol for the two-staged exploratory sequential mixed methods MODEL-PC study

Introduction Delirium is a serious acute neurocognitive condition that is common in palliative care units and yet under-addressed. To improve delirium care in this setting, we will develop and pilot a monitoring system that integrates the Delirium Clinical Care Standard, Palliative Care Outcomes Collaboration (PCOC) methods, and perspectives of patients, carers and staff. Methods This paper reports the protocol for a two-stage, exploratory, sequential mixed-methods implementation study. Stage 1 data collection includes Delirium Standard-aligned process mapping and clinical audits, and Critical Incident Technique interviews with patients, carers and staff with a recent experience of delirium. We will present integrated stage 1 findings to stakeholders then collaboratively develop a delirium monitoring system that aligns with the Delirium Standard and PCOC methods. In stage 2, we will pilot the new system and repeat stage 1 data collection and analyses, adding PCOC and adverse event measures. Implementation principles and strategies such as audit and feedback and education will be applied. We developed simplified participants information sheets and consent forms for interview and process mapping participants, who will provide written informed consent; and waiver of consent to collect clinical audit, PCOC and adverse event data from patients’ medical records is approved. At study end, we will report implementation, effectiveness and safety outcomes, including systemic utility of the delirium monitoring system for wider testing and use to meet the Delirium Standard in palliative care units. Quantitative data analyses will include descriptive and inferential statistics and qualitative analyses will incorporate thematic content analysis aligned to the Critical Incident Technique. Mixed methods data integration will be at the end of each stage. Discussion This protocol paper describes the mixed methods, systems integration, and innovative measures and study processes of the MODEL-PC study. We also share data collection tools and a simplified information sheet and consent form for patients.

An audit and analysis of electro convulsive therapy patient information sheets used in local health districts in New South Wales Australia.

Electroconvulsive Therapy (ECT) is a widely used psychiatric treatment; however, it remains contentious. It is therefore important that people are provided with accurate and balanced information before consenting to ECT. The aim of this study was to audit and analyse the content and language of ECT information sheets used in local health districts (LHDs) across the state of New South Wales Australia. Descriptive content analysis and evaluative linguistic analysis were used to investigate the information sheets, with findings then considered from a mad studies perspective. Thirteen ECT information sheets were obtained and reviewed, with the audit finding they lacked accuracy and balance. Linguistic tools were used to exaggerate positive outcomes and minimise negative effects. Despite commonalities, the structure and content of the sheets varied considerably. Findings indicate a need for co-design and co-production approaches to developing ECT information sheets. This should occur in genuine partnership with lived experience representatives based on current evidence, using neutral language, and with attention to their intent as part of processes of informed consent and decision making.

Lessons from studies of medication reduction in psychosis: giving participants accurate information about risk in psychiatric research trials.

All research needs ethical regulation, which is institutionalized in research ethics committees. The patient information sheet, approved by a research ethics committee, sets out what patients need to know to make an informed choice about research participation. However, guidance from research ethics committees is much less explicit about risk communication. In this commentary, the balance of risk in the patient information sheets from protocols of 2 randomized controlled trials (RCTs) of medication reduction in psychosis was compared with numbers needed to treat and harm from the literature. The patient information sheet omitted risk of excess death and incomplete recovery following relapse, and overestimated the anticipated benefits. All of these risks were demonstrated in the published results of 1 of the 2 RCTs. Quantifying and tabulating risk might improve patient information sheets.

ChatGPT: Is This Patient Education Tool for Urological Malignancies Readable for the General Population?

With widespread adoption of technological advancements in everyday life, patients are now increasingly able and willing to obtain information about their health conditions, treatment options, and indeed expected outcomes via the convenience of any device than can access the worldwide web. This introduces another aspect of patient care in the provision of healthcare for the modern doctor. ChatGPT is the first of an increasing number of self learning programs that have been released recently which may revolutionize and impact healthcare delivery. The aim of this study is to obtain an objective measure of the readability of information provided on ChatGPT when compared with current validated patient information sheets provided by government health institutions in Western Australia. The same structured questions were input into the program for three major urological malignancies (urothelial, renal, and prostate), with the response generated evaluated with a validated readability scoring system - Flesch-Kincaid reading ease score. The same scoring system was then applied to current patient information sheets in circulation from Cancer Council Australia and UpToDate. Findings in this study looking at ease of readability of information provided on ChatGPT as compared to other government bodies and healthcare institutions confirm that they are non-inferior and may be a useful tool or adjunct to the traditional clinic based consultations. Ease of use of the information generated from ChatGPT was increased further when the question was modified to target an audience of 16 years of age, the average level of education attained by an Australian. Future research can be done to look into incorporating the use of similar technologies to increase efficiency in the healthcare system and reduce healthcare costs.

Patient Involvement in the Design of an Innovative Clinical Study to Compare the Palatability of Anti-Hyperkalemia Medications.

The inclusion of patient representatives as study consultants brings diverse perspectives, insights, and experiences to clinical trial design and execution, and their role in the clinical trial development process is being increasingly recognized and valued. The APPETIZE study evaluated the palatability of, and preference for, three potassium binders for treating hyperkalemia in patients with chronic kidney disease. A core aspect of the development of this study was the inclusion of a patient representative during the design stage. Here, I describe the process of patient involvement in the APPETIZE study design (ClinicalTrials.gov Identifier: NCT04566653), the resultant positive impacts, and key learnings. A patient with chronic kidney disease was invited to be a member of the APPETIZE trial design team. This patient representative attended study team meetings and provided invaluable input into protocol development, questionnaire selection, design of patient information sheets and consent forms, and primary manuscript structure. These critical insights resulted in an enhanced trial design and generation of high-quality, patient-relevant data. APPETIZE provides an excellent example of a patient preference study that relied on input from multiple stakeholder groups, including, most notably, the patients themselves. This approach may serve as a model for early and deep patient engagement in the design and interpretation of clinical trials.

Abstract A080: Engagement and experience with clinical trial counseling in adult glioma patients: A single institution, mixed-methods study

Abstract Introduction: Participation in a clinical trial offers the promise for high-quality medical care for patients with cancer, particularly glioma; however, disparities exist in the accrual of underserved patient populations, including minority patients. A multi-pronged approach for increasing the accrual of underrepresented patients to meet NIH-defined benchmarks includes optimizing patient trial education and counseling. This study seeks to assess the perceptions of the trial counseling process and barriers to trial enrollment among a diverse population of patients with low-and high-grade glioma. Methods: Adult glioma patients who received care from the UCSF Brain Tumor Center from 2020 to 2022 participated in supervised interviews and completed a validated survey, Service Evaluation of Patient Experience of Clinical Trials and Factors Influencing Clinical Trial Entry (SPECIFIC). Thematic analysis, descriptive statistics, and Chi-square tests were used for analysis. Results: One hundred and thirty-six patients completed the SPECIFC questionnaire. There were 44 trial participants (TPs), and 92 non-trial participants (NTPs). Compared to NTPs, TPs were on average 49.8 years old (NTPs 54.6, p=.11) and white (86.3% v. 70%, p=.009). Four core themes emerged from patient perspectives, either as facilitators or barriers to clinical trial participation: 1) Cancer Awareness/Knowledge of Scientific Research 2) Flexible Lifestyle/Affordability 3) Consistency with Values/Faith/Belief System 4) Existing Family/Community Support. Both TPs and NTPs overwhelmingly agreed that clinical trials help improve treatments for cancer. However, compared to 100% of TPs, only 57% of NTPs believed trials offered the best treatment available (p=.001). TPs were more likely to be referred to our institution specifically to enroll in a trial (p=.003), have done prior research on specific experimental treatments (p=.002), have had more than two appointments with the neurosurgeon/neuro-oncologist, and report receiving the most counseling directly from an MD level provider (p=.01). When evaluating the trial counseling process, 93% of TPs reported willingness to consent the same day, but 5% endorsed feeling pressure to participate. TPs were satisfied with the quality of the patient information sheet, with 88% rating the information sheet as good or excellent and 88% reporting that the information sheet was easy to understand. While 14% of TPs believed the information sheet was too long, 27% and 41% desired more information about the trial therapeutic and participation requirements, respectively. Conclusion: Overwhelmingly, trial participants were confident in the information they received and were willing to begin clinical trial enrollment on the same day of receiving information. Interventions to improve the quality and equitable delivery of patient trial education must be paired with other validated multi-dimensional strategies to reach target accrual benchmarks of underserved patient populations to therapeutic clinical trials. Citation Format: Mulki Mehari, Sheantel Reihl, Ramin Morshed, Jasleen Kaur, Mikias Negussie, Ugomma Chukwueke, Alyx Porter, Valy Fontil, Shawn Hervey-Jumper. Engagement and experience with clinical trial counseling in adult glioma patients: A single institution, mixed-methods study [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A080.

Equality, diversity, and inclusion in oncology clinical trials: an audit of essential documents and data collection against INCLUDE under-served groups in a UK academic trial setting.

Clinical trials should be as inclusive as possible to facilitate equitable access to research and better reflect the population towards which any intervention is aimed. Informed by the UK's National Institute for Health and Care Research (NIHR) Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE) guidance, we audited oncology trials conducted by the Clinical Trials and Statistics Unit at The Institute of Cancer Research, London (ICR-CTSU) to identify whether essential documents were overtly excluding any groups and whether sufficient data were collected to assess diversity of trial participants from groups suggested by INCLUDE as under-served by research in the UK. Thirty cancer clinical trials managed by ICR-CTSU and approved between 2011-2021 were audited. The first ethics approved version of each trial's protocol, patient information sheet, and patient completed questionnaire, together with the first case report forms (CRFs) version were reviewed. A range of items aligned with the INCLUDE under-served groups were assessed, including age, sex and gender, socio-economic and health factors. The scope did not cover trial processes in participating hospitals. Data relating to participants' age, ethnic group and health status were well collected and no upper age limit was specified in any trials' eligibility criteria. 23/30 (77%) information sheets used at least one gendered term to address patients. Most CRFs did not specify whether they were collecting sex or gender and only included male or female categories. The median reading age for information sheets was 15-16 years (IQR: 14-15 - 16-17). Socio-economic factors were not routinely collected and not commonly mentioned in trial protocols. No systemic issues were identified in protocols which would explicitly prevent any under-served group from participating. Areas for improvement include reducing use of gendered words and improving readability of patient information. The challenge of fully assessing adequate inclusion of under-served populations remains, as socio-economic factors are not routinely collected because they fall beyond the data generally required for protocol-specified trial endpoint assessments. This audit has highlighted the need to agree and standardise demographic data collection to permit adequate monitoring of the under-served groups identified by the NIHR.

Putative Items for Oral Diagnostic and Surgical Department Information Sheet

Introduction: In oral surgery practice the student needs to implement wide scope of acquired theoretical knowledge. This knowledge includes theoretical understanding of intertwined biomechanics of teeth and jaw bone structures. In addition, student should have suitable relevant medical knowledge with direct and indirect influence of different medical conditions on oral surgical procedures. Through addressing students concerns and performances within two related previous studies within this research project it might be possible to utilize single patient information sheet for both diagnostic and surgical dental education. Aim of the study: To improve dental students' cognitive skills through unified diagnostic and technical training approach. Materials and Methods: One hundred and nineteen 5th year dental students from College of Dentistry, Almustansiriyah University, agreed to participate in the study. The students were asked to state their preference toward each question in oral medicine and oral surgery information sheets. Descriptive and analytic statistics were performed using SPSS Ver.23. Results: students prefer oral medicine items in different levels. The highest level of difference is shown in history of present illness (HPI) item. This has been statistically confirmed. Detailed types of question have shown to be the main reason for preference compared to other reasons. The second reason for preference was easiness of questions. This has been statistically confirmed (p&lt;0.05). Conclusion: Based on this study within the context of the research project, a standard patient information sheet items is suggested for a single department under the name of oral diagnostic and surgical department for undergraduate dental education.

Situational Analysis of Barriers to Continuity of End-of-Life Care in Urban Areas, Bangkok

This qualitative study was designed to describe the continuity of end-of-life care and identify barriers to continuity in urban Bangkok. Continuity of care is considered an essential part of palliative care to promote the quality of life of patients at the end of life. The majority of studies have been conducted exploring continuity of care in rural communities. However, few studies have focused on urban areas, particularly in big cities. Twelve healthcare providers were the participants, including nurses in inpatient units, and in the Health Community and Continuity of Care Unit, a palliative care physician, and social workers. The data collection consisted of individual interviews, field notes, and observations. Content analysis was used to analyze data and identify barriers. The continuity of end-of-life care in a selected setting was fragmented. Three main barriers to the continuity of end-of-life care consisted of misunderstandings about patients who required palliative care, staff workloads, and incomplete patient information. The development of a comprehensive patient information sheet for communication among a multidisciplinary team could promote continuity of end-of-life care from hospital to home. An interprofessional training course on continuity of end-of-life care is also recommended. Finally, the staff workload should be monitored and managed.

DPYD variant testing in candidates for fluoropyrimidine treatment: A study protocol

ObjectiveThe main purpose of this study is to evaluate the potential clinical impact of pharmacogenetic testing on the reduction of the toxicity in patients treated with fluoropyrimidines. This will be achieved by comparing the frequency of adverse events and the incidence of toxicity of two groups of patients that will differ from each other only in that one will receive pharmacogenetic counseling. The hypothesis is that availability of a pharmacogenetic report prior to treatment initiation has a positive effect. One of the main secondary goals is to analyze allele frequencies and the association of polymorphisms rs895819 (miR27A) and rs1801160 (DPYD*6) with toxicity by conducting an observational study to determine their clinical relevance and standardize a dose adjustment recommendation. MethodThe study has an single-center ambispective, quasi-experimental design and is based on a multidisciplinary protocol involving implementation and standardization of DPYD*2A; DPYD*13; c.2846A>T; and HapB3 measurements. Following these measurements, pharmacogenetic counseling will be carried out and its clinical impact will be evaluated. The primary endpoint of the study is severe toxicity and/or mortality. The toxicity observed in two groups with similar epidemiological characteristics will be compared: the intervention group (candidates for treatment with fluoropyrimidines who will be subjected to the protocol) and the control group (retrospective cohort). Additionally, rs895819 (MIR27A) and rs1801160 (DPYD*6) will be determined. Testing for these variants is not part of the hospital's daily practice, nor are they included in clinical guidelines. However, according to recently published studies, the activity of dihydropyrimidine dehydrogenase might be affected by these variants, as they may be associated with toxicity. The results of the measurements of these two variants will not be incorporated to pharmacogenetics counseling until their association with toxicity is determined by means of the observational study to be conducted. The project, as well as the patient information sheet and the informed consent form, were approved by the Ethics Committee of the participating center (code 20/006).

ChatGPT and Patient Information in Nuclear Medicine: GPT-3.5 Versus GPT-4.

The GPT-3.5-powered ChatGPT was released in late November 2022 powered by the generative pretrained transformer (GPT) version 3.5. It has emerged as a readily accessible source of patient information ahead of medical procedures. Although ChatGPT has purported benefits for supporting patient education and information, actual capability has not been evaluated. Moreover, the March 2023 emergence of paid subscription access to GPT-4 promises further enhanced capabilities requiring evaluation. Methods: ChatGPT was used to generate patient information sheets suitable for gaining informed consent for 7 common procedures in nuclear medicine. Responses were generated independently for both GPT-3.5 and GPT-4 architectures. Specific procedures were selected that had a long-standing history of use to avoid any bias associated with the September 2021 learning cutoff that constrains both GPT-3.5 and GPT-4 architectures. Each information sheet was independently evaluated by 3 expert assessors and ranked on the basis of accuracy, appropriateness, currency, and fitness for purpose. Results: ChatGPT powered by GPT-3.5 provided patient information that was appropriate in terms of being patient-facing but lacked accuracy and currency and omitted important information. GPT-3.5 produced patient information deemed not fit for the purpose. GPT-4 provided patient information enhanced across appropriateness, accuracy, and currency, despite some omission of information. GPT-4 produced patient information that was largely fit for the purpose. Conclusion: Although ChatGPT powered by GPT-3.5 is accessible and provides plausible patient information, inaccuracies and omissions present a risk to patients and informed consent. Conversely, GPT-4 is more accurate and fit for the purpose but, at the time of writing, was available only through a paid subscription.

Understanding the impact of radiotherapy related insufficiency fractures and exploring satisfaction with two existing patient reported outcome measures: A qualitative interview study.

Radiotherapy related insufficiency fractures (RRIFs) occur in approximately 10-15% of cancer survivors who underwent pelvic radiotherapy. Little research has been conducted to explore the impact of RRIFs on quality of life (QOL). Patient reported outcome measures (PROMs) are often used in oncology to measure side effects and QOL. The study aims to understand the influence of RRIF on QOL and to discover whether available PROMs address their needs. Twenty-five patients randomly selected from a Tertiary Oncology Centre bone health clinic database of patients referred with RRIFs were approached. Interested patients were sent two existing PROMs and a patient information sheet. Eleven patients agreed to take part in a semi-structured interview to explore their experiences and their opinion on the existing PROMs. Telephone interviews were conducted. Interviews were audio recorded, transcribed, and analysed using thematic analysis. Four themes were identified: 1) Route to diagnosis, 2) management of RRIFs and 3) resilience all had an impact on 4) QOL. Additionally, participants discussed PROMs and how they might be integrated into clinical practice. The data highlights the wide ranging QOL impacts experienced and highlights potential areas for improvement in terms of diagnosis and management pathways. The impact of RRIFs on QOL is considerable. Participants highlighted key areas for improvement including the provision of more information, more access to support and improved management pathways. Participants also highlighted the potential benefits of PROMs but suggested existing measures could be improved.

1080 A Quality Improvement Project Developing a 'Return to Scan' Failsafe Protocol for Barnsley Hospital Emergency Department Patients with Suspected Cauda Equina and Renal Colic

Abstract Aim A staff survey noted patients returning for scans for suspected cauda equina and renal colic were on occasion not returning or returning late. Overall, staff and patient experience were poor and posed risk to patients. To improve this, aims were to develop a standard process for recording ED patients due to return for scan and formalised information about this process to be provided to the patient. Method Three cycles were completed. Staff surveys identified areas of concern, supported by a fishbone diagram and process map. A proforma and patient information sheet were developed. Further staff surveys assessed satisfaction and effectiveness of the changes, leading to replacement of the proforma with a patient notes sticker. A booking system was created identifying patients to reception staff. Further cycles identified 64 patients in a 3-month period by suspected diagnosis using SNOMED codes. Records were accessed electronically using Mediviewer to review documentation and time returned for scan. Results 98% of patients returned for scan. Process followed: 36% of patients returned late, with an average of 22 minutes and maximum of 40 minutes late. Process not followed: 36% of patients returned late, with an average of 58 minutes and maximum of 219 minutes late. The process was followed correctly in 17% of cases. Conclusions Patients were late by a shorter on average time when the process was followed - with providing patient information having the greatest positive impact. Staff education may improve process compliance which is poor. Patient experience and barriers to returning on time must be explored.

Knowledge support for optimising antibiotic prescribing for common infections in general practices: evaluation of the effectiveness of periodic feedback, decision support during consultations and peer comparisons in a cluster randomised trial (BRIT2) – study protocol

IntroductionThis project applies a Learning Healthcare System (LHS) approach to antibiotic prescribing for common infections in primary care. The approach involves iterations of data analysis, feedback to clinicians and implementation...