Description

Study Objective To establish the SLE patient registry in Pakistan.

The objectives of our lupus registry include:

1. Characterization of SLE phenotype: Our aim is to collect detailed data on the clinical characteristics, disease severity, and patterns of organ involvement among lupus patients in our local community.
2. Assessment of treatment patterns and outcomes: We intend to evaluate the treatment modalities and their effectiveness in controlling disease activity and preventing complications. Through longitudinal follow-up assessments, we will monitor treatment adherence, disease progression, and patient-reported outcomes, thereby offering valuable insights into real-world lupus management.
3. Identification of factors influencing disease course and treatment response.
4. Contribution to scientific knowledge and clinical practice: By disseminating our findings to the broader medical community, we aspire to advance lupus research and enhance clinical practice guidelines for managing lupus patients, both within Pakistan and internationally at the level of APLAR.

Study population This will be a longitudinal prospective cohort study. It will include adult patients diagnosed with SLE by a rheumatologist. Initially, patients with newly diagnosed and established SLE presenting to Fauji Foundation Hospital Rawalpindi will be included. Subsequently, data collection will be expanded to other centers across the country. At our center, we maintain medical records of lupus patients, ensuring access to accurate laboratory data essential for achieving the study's objectives. This setting will facilitate the systematic documentation and analysis of lupus cases at our center.

Sample size Our initial target will be to include at least 150-200 patients during the first year of the registry. We will employ consecutive non-probability sampling techniques to recruit patients from the outpatient clinics and inpatient department of the rheumatology department at Fauji Foundation Hospital, Rawalpindi. Subsequently, data collection will continue and expand into subsequent years to include more patients from our center as well as from other rheumatology centers across the country.

Methodology We will include adults diagnosed with systemic lupus erythematosus (SLE) by rheumatologists, based on established diagnostic criteria, regardless of gender or ethnicity, who have sought care at our facility. Individuals with diagnosis other than SLE and those who do not consent to participate will be excluded. Eligible individuals meeting the inclusion criteria will be approached during routine clinic visits or contacted via telephone to obtain informed consent for participation in the study. Since the study is observational, no interventions will be administered as part of the study protocol. Management decisions for each patient will be at the discretion of the treating physicians.

Data will be collected using a structured patient record form specifically designed for this study, adhering to established guidelines and recommendations for documenting clinical information in lupus registries. The domains and elements to be included in the study will be determined by the committee composed of the Principal Investigator (PI) and co-PIs after conducting a thorough literature search. The proposed domains to be included are as follows:

• Demographic information
• Disease characteristics (diagnostic criteria, disease duration, clinical manifestations, and disease activity)
• Laboratory results including serology, histopathology, and imaging
• Treatment history (medications, dosage, and duration)
• Outcomes (response to treatment, disease progression, damage, and complications)
• Patient-reported outcomes (Short Form-36 and PROMIS-57). Instruments used for data collection, especially Patient-Reported Outcomes (PROs), will be validated in the local language to ensure the capture of standardized and comprehensive data.

Laboratory and clinical data will be extracted from electronic medical records as necessary. Patients will be followed up longitudinally, with follow-up data recorded during three-monthly visits.

Ethical Issues This study will be conducted in accordance with the Declaration of Helsinki. Ethical approval has been obtained from the institutional ethical review committee (letter No. 808/RC/FFH/RWP, dated 13-03-24). Written informed consent will be obtained from each patient, and those who do not consent will be excluded from the study. Each patient retains the right to withdraw their consent at any time after enrollment, leading to exclusion from the registry.

To safeguard patient confidentiality, access to data will be restricted to authorized individuals, who will ensure the proper use of the data.

Expected results This will be the country's inaugural registry for SLE, poised to establish a comprehensive source of disease-related data. It is anticipated to pinpoint gaps in the current practices of SLE diagnosis and treatment, serving as a cornerstone for shaping health policies, guiding future research endeavors, and fostering collaborations. At least one research article is projected to be produced by the conclusion of this grant period. Moreover, the ongoing registry will continue to contribute to the generation of high-quality research literature in the future.