https://orcid.org/0000-0002-2412-9541
Abstract
Background
In the study on triglyceride-induced pancreatitis (TG-IAP), a core clinical dataset using the Jandhyala method was developed to collect the minimum amount of information for each patient presenting with TG-IAP globally. This approach offered a unified framework for observing multiple populations of TG-IAP patients using the same set of indicators, resulting in a considerably larger and uniform real-world population. It was understood that when this core dataset is implemented in a patient registry it could address the issue of missing data in observational studies and produce higher-quality research. In this paper, the protocol used to design and implement a patient registry for this core dataset to generate real-world evidence from multiple sites is described.
Method
The study is designed as an international, multicenter, non-interventional, observational registry that will enroll adult patients with hypertriglyceridemia to collect natural history data on the treatment, progression, and long-term outcomes of hypertriglyceridemia-induced acute pancreatitis. Patients with both hypertriglyceridemia and pancreatitis will be invited to participate in the registry at participating hospitals and centers worldwide.
Discussion
Data from this registry, and others like it, is intended for healthcare providers to optimize clinical decision-making through an enhanced understanding of the variability, progression, and natural history of hypertriglyceridemia as well as the burden of disease.
Conclusion
Global epidemiological data on hypertriglyceridemia and its role in acute pancreatitis is limited. Using real-world evidence, this registry, along with others like it, may help healthcare providers understand the variability, progression, natural history, and burden of the disease, and improve the diagnosis and management of HTG and TG-IAP.
PLAIN LANGUAGE SUMMARY
In a 2022 study, information was collected from literature, patients, and doctors who care for patients to create a record with the most important information needed to understand patients with a disease called triglyceride-induced acute pancreatitis (TG-IAP). This type of record may help people find patients with the disease and the type of care or treatment they require. The study was started and completed because the doctors used methods to guide and help them understand what needed to be done. This paper describes the method used for this study, including information on:
Data collection: how the relevant information about TG-IAP patients was collected;
Permissions: how permission was gained to do the study;
Patient information: how the information collected about TG-IAP patients will be used; and
Patient protection: how the patients who takes part in the study will be protected.
Introduction
Hypertriglyceridemia (HTG) is a condition characterized by elevated fasting serum triglyceride levels, with a threshold of 150 mg/dL (1.7 mmol/L)Citation1. It is a significant, yet often overlooked, contributor to acute pancreatitis (AP), accounting for up to 10% of cases, ranking third behind gallstones (up to 60%) and alcohol (up to 30%)Citation2. The risk of AP increases with higher triglyceride (TG) levels, but no definitive threshold for inducing AP has been established. HTG has two main categories of etiology: primary and secondary, with primary factors causing more severe HTG. However, it is the interaction between primary and secondary factors that ultimately leads to severe HTGCitation3.
Acute pancreatitis (AP) is an inflammatory condition of the pancreas that presents with severe abdominal pain and elevated pancreatic enzyme levelsCitation4. The global incidence of AP is estimated at 36 cases per 100,000 population per yearCitation2.
Although there is no absolute threshold for the induction of AP by hypertriglyceridemia (HTG), the risk increases with higher triglyceride (TG) levels. Retrospective studies in patients with severe HTG and adult cohort studies have suggested that TG levels greater than 1,000 mg/dL are a primary cause of pancreatitisCitation5. The clinical course of TG-induced pancreatitis (TG-IAP) varies widely, from mild self-limiting incidents to severe disease with pancreatic necrosis, organ failure, and deathCitation5. Retrospective studies have found that TG-IAP patients are more likely to be male, have higher dietary fat intake, higher body mass indices (BMI), and a higher prevalence of multiple organ dysfunction syndromeCitation6.
Various studies have found that patients with TG-IAP often have one or more secondary factors. Such factors may include obesity, alcohol abuse, uncontrolled diabetes mellitus, hypothyroidism, chronic renal failure, and medications such as estrogen, corticosteroids, and retinoidsCitation3,Citation7. A thorough patient history should be conducted to identify underlying factors in those with TG-IAP, and genetic screening should be considered if appropriate based on the patient’s family historyCitation3.
In this manuscript, the protocol used to implement and validate the newly developed TG-IAP core datasetCitation8 in a patient registry will be described, following established patient registry methodologyCitation9.
Methods
Study population
Inclusion criteria
Patients meeting the following criteria at the baseline (enrolment) visit will be considered eligible for inclusion into the registry:
Patients who are 18 years or older at baseline.
Patients with confirmed HTG diagnosis based on biochemical analysis and/or fasting serum triglyceride level above 500 md/dL.
Patients with a confirmed AP diagnosis, characterized by typical clinical symptoms such as epigastric pain, associated with elevated lipase serum levels above three times the normal range. Additionally, the patient must not be currently participating in an interventional clinical trial and must provide informed consent.
Exclusion criteria
Patients meeting any of the following criteria at the baseline (enrolment) visit will be excluded from the registry:
Patients or their legally designated representatives who lack the cognitive capacity to provide informed consent.
Patients who are currently participating in an interventional clinical trial. These patients may be approached for inclusion into the registry after their involvement in the trial ends, including the completion of all follow-up assessments.
Patients with other etiologies of acute pancreatitis, including but not limited to the presence of gallstones or biliary sludge on imaging, suspicion of drug-induced AP, presence of pancreatic cancer or cystic tumors, hypercalcemia, HISORT probable or definitive criteria for autoimmune pancreatitis, chronic pancreatitis (Wirsungs duct‚ ≥4 mm or pancreatic calcifications), mutations in PRSS-1, SPINK-1, or mutations in CFTR associated with pancreatitis, and post-ERCP pancreatitis.
Therapy schedule
The treating physician may administer any drug therapy deemed necessary for the patient’s well-being. Throughout the patient’s participation in the registry, all treatments and any modifications should be recorded in the database.
Study design
This is a 10-year international, multicenter, prospective, non-interventional, observational registry aimed at gathering natural history data on hypertriglyceridemia and characterizing the treatment, progression, and long-term outcomes of hypertriglyceridemia-induced acute pancreatitis in adult patients.
The registry will include patients diagnosed with hypertriglyceridemia, regardless of their treatment regimen, at the time of identification unless they are participating in an interventional clinical trial. Patients participating in an interventional clinical trial will be invited to join the registry once their involvement in the trial has concluded. The primary objective of the registry is to gather data on the natural course of hypertriglyceridemia, as well as the outcomes of hypertriglyceridemia-induced acute pancreatitis, in adult patients.
Registry objectives
The registry has two primary objectives. Firstly, it aims to gather natural history data on hypertriglyceridemia as a risk factor for acute pancreatitis in patients with TG-IAP, characterizing its treatment, progression, and long-term outcomes. Secondly, it seeks to describe the effectiveness and safety of treatments used to manage the symptoms and signs of hypertriglyceridemia.
Sample size calculation
This is a prospective observational registry of patients diagnosed with hypertriglyceridemia. The sample size is not based on statistical considerations, and all eligible patients will be included in the registry.
Ethics
Ethical review
Before patient enrollment in the registry, all necessary ethical approvals will be obtained. The study sponsor is responsible, as per local regulations, for keeping the Institutional Review Boards (IRBs) and Local Ethics Committee (LEC) informed of any significant protocol amendments during the study period. Written approval from the IRB/LEC, including the registry identification and review date, will be filed with the study sponsor and at participating sites, along with a list of the IRB/LEC members, their job titles or occupations, and institutional affiliations. All communication with the IRB/IEC will be documented and kept with the study sponsor and at the participating registry sites. The study sponsor (to be named here) will complete annual and final registry reports for the Institutional Review Board (IRB)/Local Ethics Committee (IEC).
Ethical conduct of the study
The study activities will be conducted in accordance with the Declaration of HelsinkiCitation10. The UK Policy Framework for Health and Social Care Research imposes responsibilities on the study sponsor, which they must fulfill. Additionally, the study sponsor will adhere to the requirements of the General Data Protection Regulations (GDPR) and follow the Health Research Authority (HRA) guidelines in the application of GDPR to health and care research. The study sponsor will include information related to their role as the data controller, as well as participants’ rights to access, modify or transfer their data, in the participant information sheets and on their website, as recommended by the HRA for commercial organizations.
Data collection and management
Determination of data and variables to collect
The observational cohort clinical study aimed to minimize or eliminate missing data. To achieve this objective, a core data set that conforms to standard diagnostic and monitoring practices was developed. This core data set was established in a pioneering studyCitation8. The Jandhyala methodCitation11 was used to create a clinical questionnaire comprising 46 broader categorical items and indicators. To ensure the questionnaire’s comprehensiveness, the input of 10 international experts from the US and Europe was sought. The broader categorical items contain more granular items that represent highly specific results from larger laboratory tests, and they also contain many granular items for complete laboratory tests.
Data to be collected
Eligible patients with pancreatitis and hypertriglyceridemia at participating centers or hospitals will be invited to participate in the registry. Patients who provide informed consent will be enrolled in the registry using their demographic information, and an electronic data capture (EDC) platform, such as REDCap, Caster EDC, Medidata, or OpenClinica, will automatically generate a patient identification number. Patient data will be link-anonymized, and physicians will keep a site enrollment log containing patient identification numbers and identifiable information at the participating centers or hospitals without transferring it outside of the centers or hospitals.
Although no pre-determined follow-up requirements exist, physicians or their designated staff will receive monthly email correspondence reminding them to update the registry with patient data related to visits over the 10-year study period. After entering information for a patient’s previous visit, they will be prompted to update the registry at regular intervals. All patient visits to participating centers or hospitals will be recorded to enable a sub-study of hypertriglyceridemia’s public health cost.
Patients’ informed consent will be obtained to include hospitalization and general medical history details to enhance the understanding of hypertriglyceridemia’s natural history.
Physicians will be encouraged to enter all available information into the Schedule of Assessments for Data Recordings (), but patient care and management will ultimately be at the physician’s discretion.
Table 1. Schedule of assessments for data recordings.
The clinical questionnaire (Appendix 1) was used to collect the following data:
Informed consent, including the date and type of consent, was obtained from participants. Personally identifiable information, such as name, age, sex, ethnicity, and location (limited to country and city/town), was collected for research and, when necessary, monitoring purposes.
Patient demographics, including age, sex, ethnicity, and location (limited to country and city/town), as well as any other relevant demographic information as determined by the patient’s physician.
Past medical history was recorded.
Family history was noted.
Social history was documented.
Admission examination findings were recorded.
Laboratory investigations that were performed upon admission were recorded.
Follow-up visit parameters were documented.
Complete drug history was recorded from the medical record when available.
Prospective/routine clinic visit
To ensure comprehensive data collection and disease progression monitoring, relevant information will be gathered using the same questionnaire as the baseline visit, as well as a follow-up data capture questionnaire (Appendix 2) during all subsequent hospital visits. All data will be recorded in the registry.
To prompt regular updates to the registry, the database will issue monthly reminders based on the previous visit date. Additionally, if there is no contact reported for a registered patient after 12 months, the system will issue a reminder requesting a status report for that patient.
Data extraction
In the future, it may be possible to extract aggregated data sets from the registry to create a global resource for studying the natural history of hypertriglyceridemia. All stakeholders involved in this study are committed to maintaining patient confidentiality, ensuring data security, and enabling access to data for the characterization of treatment, progression, and long-term outcomes of hypertriglyceridemia.
Data protection statement
To protect patient privacy, all data in the registry will be anonymized, and the study sponsor will not have access to identifiable patient data. Personally identifiable data will be processed at each participating site in accordance with regulatory approvals and standard operating procedures. The confidentiality of all information received from participating sites will be strictly maintained.
Patients enrolled in the registry retain control over their data in accordance with the General Data Protection Regulation (GDPR). Patients have the right to access, correct, erase, object, and transfer their data. Questions or requests regarding data in the Patient Registry should be directed to the sponsor’s Ethics and Data Protection Officer. If participants wish to file a complaint with the Information Commissioner’s Office, they can by visiting www.ico.org.uk.
Statistical methods
Analysis of the data set
The data analysis set will include all relevant patient data collected using the Core Dataset Clinical Questionnaire.
Analysis of registry data
The registry will employ ICD-10 and ICD-11 coding to classify medical conditions. Patient reports will be updated with the latest registry information. Standard statistical measures, including the number of observations, mean, standard deviation, median, and range (minimum and maximum values), will be used to describe continuous variables in regular registry reports. Frequency tables will be used to summarize categorical variables. Patient disposition, demographics, and baseline characteristics will be handled as previously described. Clinical data, including laboratory measurements, will be tabulated. Medical history and medication information will be coded using the World Health Organization Drug Dictionary and presented in summary tables. Patient outcomes and quality-of-life questionnaires will be listed and summarized.
Data quality assurance
Monitoring and auditing procedure
Physicians and institutions involved will allow registry-related monitoring of the data. Medialis Ltd will remotely monitor the registry site, requesting essential registry and site documents from the Lead Investigator or designated staff for quality checks and storage in the registry master file. MS Teams meetings will be held periodically, no more than every 6 months, to assist with registry activities and address queries. On-site monitoring may occur if deemed necessary by Medialis Ltd, with the Monitor given access to relevant clinical records without compromising patient confidentiality. In addition to monitoring calls, any data inconsistencies or lack of follow-up assessments will be reviewed and resolved with the sites. If needed, participating centers/hospitals may undergo quality assurance audits by Medialis Ltd.
Electronic case report forms (eCRFs)
The registry’s electronic case report form (eCRF) will be completed and signed electronically for each patient included in the registry. Only qualified and trained individuals are permitted to complete and verify the eCRFs, with confirmation of their qualifications available for inspection. Authorized personnel will receive a username and password for data entry. Any missing data will be highlighted in the eCRF, and the missing value must be entered or declared not done/not known before the section can be signed off.
The Research Manager EDC contractor will maintain the Patient Registry eCRF, with secure servers located in Hengelo (OV), The Netherlands, and backups located in another geographical location in Enschede, The Netherlands. This is in compliance with the EU Data Protection Directive. Access to the servers is controlled by 24-h physical and digital surveillance. The servers holding the data have been certified according to the international information security norm ISO/IEC 27001:2013 by Dekra Quality Assurance.
Management and reporting of adverse events/adverse reactions
The registry is designed to gather unsolicited reports of adverse events related to the treatment of hypertriglyceridemia. These reports will include details of adverse events associated with any treatment submitted for individual patients, forming part of their drug history in the Registry. The cumulative adverse event information collected will be evaluated and reported in both the interim and final analyses of the registry.
Source data
It is essential that the data entered in the electronic case report form (eCRF) match the data recorded in the source documents, as appropriate. In order to maintain patient confidentiality, all data reported in the eCRF will be identified solely by patient identification numbers.
Participant information and consent
Physicians or clinical designates are responsible for providing potential patients with comprehensive verbal and written information about the objectives and procedures of the registry, and addressing any questions they may have during their participation. They must also share any relevant new information with the patient in a timely manner. Patients must be informed of their right to withdraw from the registry at any time without affecting their future treatment options. The physician or clinical designate should allow sufficient time for the patient to consider participation, as determined by the physician.
Physicians or clinical designates must obtain signed informed consent (or witnessed verbal consent, as per local regulations) from all patients before they are included in the registry. The informed consent form must be signed and dated before any data can be registered, and filed by the physician for future audits or inspections. A copy of the completed informed consent form must be given to the patient. Physicians will indicate receipt of the signed informed consent form by marking the appropriate field of the patient’s electronic case report form (eCRF).
The final version of the patient information sheet and informed consent form has received approval from the IRB/LEC(s) and cannot be altered without permission from the study sponsor and local IRB/LEC.
Processing of personalized data
The physician or their designee must maintain a patient enrollment log that includes sufficient information to link records, such as the electronic case report form (eCRF) and clinical records. This log should be preserved for potential future audits and inspections but should not be made available to the study sponsor, except for monitoring or auditing purposes if required.
All patient data will be stored in a regulatory-compliant database and processed in accordance with the European Directive on the processing of personal data and the protection of privacy in the electronic communication sector (2002/58/EC) and the UK General Data Protection Regulation (GDPR). National data protection standards will be followed when handling patient information, and individual patient data will only be identifiable to the site physician.
Potential registry patients must be informed that, by signing the informed consent form, they authorize the processing of their data, and that authorized representatives from the study sponsor, IRB/LEC, and regulatory authorities have direct access to their medical records. Patients have the right to withdraw their permission for data entry into the registry at any time, but informed consent will be requested to retain all data recorded up until the date of withdrawal.
Each center will only have access to the patients under their direct care. Demographic information is necessary for patient registration and contextualizing clinical data collected in the registry. A unique username and password will be generated for each individual entering data. Once a patient is enrolled in the system, they will be assigned a unique number, which will serve as their identification within the registry system.
Removal of patients from the registry
To withdraw from the registry, a patient may make a request which will be recorded in the registry along with the reason for withdrawal, if provided. In the event that a patient in the registry decides to participate in an interventional clinical trial, their data collection and participation in the registry will be temporarily halted. Once the patient’s participation in the trial has ended, data entry for the registry will resume. This is defined by the completion of all trial-associated follow-up assessments.
Patient confidentiality
In order to maintain confidentiality, patients enrolled in the registry will be assigned a patient identification number upon registration, and no personally identifiable information will be entered into the electronic data capture forms. Throughout the study, this identification number will be used in place of identifying information. Patient names and identifying information will be kept confidential and will not be shared with the study sponsor or any external organizations outside of the participating center/hospital. It is important to note that identifiable information may be accessed during clinical site audits in accordance with regulatory guidelines.
Disclosure and confidentiality
Third-party disclosure of registry data will be restricted to legitimate peer reviewers and participants, including those receiving treatments, to ensure customary medical care and informed consent. The hypertriglyceridemia Registry Access Agreement outlines the terms of data access. Participant information will be handled in compliance with applicable health research regulations, as well as GDPR guidelines.
Scientific steering committee
The registry is overseen by a scientific committee comprising clinical experts on hypertriglyceridemia-induced pancreatitis, including physicians from the EU, the USA, and China. The committee’s governance principles will outline their responsibilities and obligations and the scientific oversight of the registry’s publication policy (Hypertriglyceridemia Registry Access Agreement). In the future, patient representatives and other stakeholders, such as medical experts from the pharmaceutical industry, may be added to the committee. Physicians who input data into the registry will own their center’s aggregated data set and they or the patient may withdraw consent for their data to be used in analyses at any time. Medialis Ltd. will own the evidence generated from the aggregated data set, which will be freely published by researchers with recognition given to the Sponsor and contributing investigator sites.
Discussion
To address the issue of poor standardization in severity reporting for hypertriglyceridemia and acute pancreatitis, the most current consensus definition of AP suggests severity classification at three different levels (mild, moderately severe, and severe AP) based on the presence and persistence of organ failure, and local and systemic complicationsCitation12. However, optimal management strategies for TG-IAP remain underdefined due to limited studies and sparse case reports. Incomplete or missing data is a direct consequence of the divide in clinical data-capture standards, as structured data capture varies vastly by disease and protocol. Therefore, cohort clinical studies cannot rely solely on protocol-specific data collectionCitation13.
Patient registries can provide valuable information on the natural history, epidemiology, and clinical characteristics of rare diseases that may be difficult to obtain through traditional meansCitation14. Recruiting a sufficient number of patients for statistical analysis in single-center or even single-country studies of hypertriglyceridemia (HTG) is unlikelyCitation15. The utilization of a published core dataset in a large, international registry-based study can address the limitations of smaller studies relying solely on cohort clinical dataCitation16.
In addition to the registry protocol, there are plans to initiate several sub-studies from the established registry. One such sub-study will focus on quality-of-life (QoL) given the impact of disease progression on patients. All patients enrolled in the registry will be invited to participate in the QoL sub-study. The information collected will be organized into relevant domains to develop a weighting tool. Participants will rate the relevant importance of the different areas to be included in the QoL questionnaire. Once the QoL questionnaire is developed, all eligible patients will be invited to complete it monthly, running concurrently with the HTG Patient Registry. The confounding factors that could affect the data gathered from such a study have also been acknowledged. Factors such as socioeconomic statusCitation17, self-efficacyCitation18, health literacyCitation19, and the adherence to medicationCitation20 can impact the QoL and, as such, affect the type of data collected. Further context on factors that can influence QoL can be seen in the paper written by Braveman and GottliebCitation17, where evidence of the impact of socioeconomics on health outcomes is described. Here it is acknowledged that factors such as income, wealth, and education may have a significant effect on health outcomes.
In order to account for the variation between patients, statistical weighting may be conducted to measure the impact of each confounding variable on the overall QoL.
A second sub-study will focus on health economics modeling, aiming to generate an extensive list of cost categories associated with hypertriglyceridemia burden from various perspectives, including wider societal, payor, and patient perspectives. The study will be informed by systematic literature reviews and supplemented by data from the steering committee members. Its goal is to assess the magnitudes of costs rather than providing precise estimates.
Limitations
The FAIR (findability, accessibility, interoperability, and reuse of digital assets) principlesCitation21 may have limited applicability to a clinical study on HTG due to data protection and confidentiality restrictions that prohibit the utilization and sharing of patient-level data. While patient-level data won’t be publicly accessible, evidence generated from the aggregated data will be made available in peer-reviewed journals. Moreover, the HTG Registry will be registered on ClinicalTrials.gov, making full information publicly accessible and allowing suitably qualified individuals to request access for research purposes. Although this approach does not meet all components of the FAIR principles, it satisfies the interoperability and reuse aspectsCitation21.
Conclusion
The lack of reliable and valid global epidemiological data on hypertriglyceridemia (HTG) and its role in acute pancreatitis is a major challenge. The data collected through this registry, and similar ones, can help healthcare providers optimize clinical decision-making by enhancing their understanding of the variability, progression, and natural history of HTG, as well as the burden of disease. The ultimate goal of this registry is to synthesize, publish, and disseminate real-world evidence from the collected data, with the aim of improving the diagnosis and clinical management of HTG and, by extension, TG-IAP.
Transparency
Declaration of funding
No funding was received for this work.
Declaration of financial/other relationships
Dr Ravi Jandhyala is a visiting senior lecturer at the Centre for Pharmaceutical Medicine Research at King’s College London and developer of “The Jandhyala method”. He is responsible for researching real-world evidence approaches and is also the founder and CEO of Medialis Ltd, a medical affairs consultancy and contract research organization. Medialis Ltd specializes in the design and delivery of real-world evidence in the pharmaceutical industry. The Jandhyala method is free of commercial licensing restrictions, and, although used as part of proprietary methodology, the author does not profit from this method directly. Co-authors and reviewers named in this manuscript have no relevant relationships to disclose.
Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.
Author contributions
RJ conducted the study and prepared, authored, and approved the manuscript. SF, RS, VR, EM, VS, ML, EB, and RJ prepared, authored, and approved the manuscript. The authors affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Acknowledgements
The authors would like to acknowledge the contributions to the development of the core dataset made by the non-author advisors Robert Sutton, Vikesh K. Singh, Michael Davidson, Andres Gelrud, and Chris Forsmark. They would also like to acknowledge the contribution of Medialis personnel (Omolade Femi-Ajao, Radek Wojcik, Brendon Pearce, Mohammed Kabiri, Ziyaad Rahman, and Obuchinezia Anyanwu) to the development of the core dataset and this manuscript. All persons mentioned here have consented to be named.
Data availability statement
The data that support the findings of this study are available from the corresponding author, R. Jandhyala, upon reasonable request.
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Appendix 1
Past medical history (mark with an X)
Nature of previous discharge: Home □ Rehabilitation unit □
Diagnosis of any of the following:
Cardiovascular disease Yes □ No □
Diabetes and/or pancreatitis Yes □ No □
Acute Pancreatitis Yes □ No □
Organ failure (single or multiple) Yes □ No □ Single □ Multiple □
Gallstones Yes □ No □
Fatty liver disease Yes □ No □
Splenic vein thrombosis Yes □ No □
Chronic Kidney Disease Yes □ No □
Acute kidney injury Yes □ No □
Hypertriglyceridemia Yes □ No □ Primary □ Secondary □
HIV Yes □ No □
Autoimmune disorder Yes □ No □
Have you ever experienced any venous thromboembolic events? Yes □ No □
Have you previously had an eruptive xanthoma? Yes □ No □
Has your physician prescribed any dietary modifications? Yes □ No □
Family history (mark with an X)
(1) Has any family member, to your knowledge, been diagnosed with:
Pancreatitis Yes □ No □
Diabetes Yes □ No □
Hypertriglyceridemia Yes □ No □
Social history (mark with an X)
In the past 30 days have you:
Indulged in cigarette smoking Yes □ No □
Consumed alcohol Yes □ No □ Habitual □
Used any illicit drugs Yes □ No □
Admission Examination
Abdominal pain severity on a scale from 1–10: ____________
Abdominal tenderness or distension present Yes □ No □
In the past few days/weeks, have you experienced disturbances in your mental state?
Yes □ No □
Do you consent to have a blood sample drawn for laboratory testing for Triglyceride-induced Acute Pancreatitis? Yes □ No □
Laboratory investigation performed upon admission
Complete drug history (only if available from the medical record)
All previous and current medications used in the management of pancreatitis and hypertriglyceridemia (including dose, compliance, duration of treatment, and reason for discontinuation if applicable)
Appendix 2.
Follow-up data capture sheet
Captured at each follow-up visit
Change from baseline in non-HDL-Cholesterol level ____%
Change from baseline in Triglyceride level ____%
Management of organ dysfunction:
Enteral nutrition during the last admission Yes □ No □
Interventional radiology at last admission Yes □ No □
Intravenous fluids at last admission Yes □ No □ with Heparin □
Insulin infusion at last admission Yes □ No □
Pancreatic enzyme replacement therapy Yes □ No □
The % change in fasting triglycerides (in response to intervention) ____________
Severity/QoL score available from the medical record:___________________________________