Pleural Disease: Phenotypes, Diagnostic Yield and Outcomes
Condition: Pleural Diseases
MeSH terms: Pleural Diseases
Study type: Observational [Patient Registry]

Summary: 
      Pleural disease i.e. with effusions or pneumothorax have a high disease burden to patients.
      This is because most patients require diagnostic and therapeutic interventions in the form of
      drainage and biopsies. With increasing age, the incidence of pleural disease is likely to
      rise with concomitant rise in pulmonary malignancy and infection.

      The impact of pleural disease, especially ambulatory drainage depends not only on patient
      factors such as effusion size, cardiopulmonary co-morbidities and underlying aetiology. It
      also depends on socioeconomic factors such as ability to afford ambulatory equipment (which
      is not covered by Medisave), availability of care-givers and coping mechanisms.

      To phenotype patients presenting to Singapore General Hospital with pleural disease and
      evaluate impact on outcomes of pleural interventions

      This study will collect existing or prospective data that is part of standard clinical care

        -  Source of the data: electronic medical record of patients (ambulatory and inpatient)

        -  Data will be collected prospectively.
    

Detailed description: 
      1. BACKGROUND AND RATIONALE

           Pleural disease i.e. with effusions or pneumothorax have a high disease burden to
           patients. This is because most patients require diagnostic and therapeutic interventions
           in the form of drainage and biopsies. With increasing age, the incidence of pleural
           disease is likely to rise with concomitant rise in pulmonary malignancy and infection.

           The impact of pleural disease, especially ambulatory drainage depends not only on
           patient factors such as effusion size, cardiopulmonary co-morbidities and underlying
           aetiology. It also depends on socioeconomic factors such as ability to afford ambulatory
           equipment (which is not covered by Medisave), availability of care-givers and coping
           mechanisms.

           Therefore, translating internationally accepted pleural interventions into an Asian
           context, moreover a Singaporean one, is challenging.

        2. HYPOTHESIS AND OBJECTIVES

           Asian patients with pleural disease have unique phenotypes and outcomes from pleural
           interventions

           To phenotype patients presenting to Singapore General Hospital with pleural disease and
           evaluate impact on outcomes of pleural interventions

        3. EXPECTED RISKS AND BENEFITS

           There are likely to be no benefits to subjects. They will not be subject to any novel
           therapy and their clinical data will only be collected.

           Risks are minimal because patients are subject to only standard therapy and existing
           clinical data collected. There will be no new additional interventions, consultations or
           hospital visits. They will be asked to complete validated quality of life surveys that
           will be included into the clinical record.

        4. STUDY POPULATION

           4.1. List the number and nature of subjects to be enrolled.

           Patients will only be enrolled from those who present to Singapore General Hospital
           (either in an ambulatory or inpatient setting). There is no exclusion of women, children
           or minorities, although clinical catchment includes mostly adult patients.

           4.2. Criteria for Recruitment and Recruitment Process

           Subjects will be recruited if they already have radiographic evidence of pleural
           disease.

           4.3. Inclusion Criteria

           The subject must meet all of the following inclusion criteria to participate in this
           study.

             1. Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed
                Tomography regardless of underlying aetiology

             2. No age or gender restrictions

             3. Ability to provide informed consent

           4.4. Exclusion Criteria Subjects who no radiographic evidence of pleural disease or who
           are unwilling/unable to provide informed consent

        5. STUDY DESIGN AND PROCEDURES/METHODOLOGY

           This study will collect existing or prospective data that is part of standard clinical
           care

             -  Source of the data: electronic medical record of patients (ambulatory and
                inpatient)

             -  Data will be collected prospectively.

             -  Time period: March 2018-2023

             -  When subject collection is complete, the data will be de-identified and kept in an
                electronic database

             -  Only principal investigator and co-investigators will have access to collected
                information.

             -  Data be kept for 5 years after completion of study for data analysis and manuscript
                preparation

             -  All electronic copies of data will be destroyed at the end of the study. All manual
                records if any will be shredded.

           Data that will be collected

             -  Demographic data such as age, gender, ethnicity

             -  Clinical data such as co-morbidities, medication history, American Society of
                Anaesthesiologists (ASA) status, smoking history, functional status (eg, ECOG)

             -  Radiographic data including effusion size, septations, nodularity, underlying
                emphysema/fibrosis/consolidation/malignancy

             -  Laboratory data: Serum and pleural LDH, glucose, albumin, total protein; Full blood
                counts, Renal panel, Liver Panel, Coagulation studies

             -  Histopathology and microbiology results

             -  Procedure (Pleural tap/catheter insertion/biopsy) details: designation of operator,
                procedure duration, anaesthesia used, complications, volume of effusion drained,
                number of biopsies taken, location of procedure, anti-microbials, pleurodesis.

             -  Outcome measures such as radiographic improvement, duration of pleural catheter,
                quality of life using standardized measures (eg. St George's Respiratory
                Questionnaire), survival, hospital re-admission, further procedures needed (eg
                interventional radiology or thoracic surgery)

           Subjects may withdraw voluntarily from participation in the study at any time. They will
           have standard care as indicated by the managing physician

        6. SAFETY MEASUREMENTS 6.1. Definitions

           An adverse event (AE) is any untoward medical occurrence that occurs as a result of the
           study. This will reported to CRIB.

           6.2. Collecting, Recording and Reporting of Adverse Events and Serious Adverse Events to
           CIRB

           PI will be responsible for submitting to the approving CIRB the completed serious AE
           Reporting Form within 7 calendar days after the investigator is aware of the event,
           followed by a complete report within 8 additional calendar days. AE that are related
           events should be reported at least annually (together with Study Status Report for
           annual review).

           6.3. Safety Monitoring Plan

           Not applicable. Current standard investigations and treatment to be provided to all
           subjects.

           6.4. Complaint Handling

           Complaints about the study will be escalated to the clinical Head of Department and
           included in reports to the CIRB.

        7. DATA ANALYSIS

           7.1. Data Quality Assurance

           Data collection will be done by the investigators through the clinical team managing the
           patient to ensure completion and accuracy.

           7.2. Data Entry and Storage

             -  Data will be entered and stored in a secure web application (REDCap)/password
                controlled hospital computer. When subject data collection is complete, the data
                will be de-identified and kept in an electronic database (password secured) for
                analysis. Only investigators will have access to the data.

             -  There are no plans to keep any documentation of patients beyond the informed
                consent forms. These will be stored in the locked department office of the
                investigators.

        8. SAMPLE SIZE AND STATISTICAL METHODS

           8.1. Determination of Sample Size

           The sample size is determined by the number of patients accrued into the database during
           the study period. As this is a non-comparative study, study size calculation not
           applicable.

           8.2. Statistical and Analytical Plans

             -  Continuous safety analyses tracking for AE

             -  Interim Analyses of data on an annual basis

        9. DIRECT ACCESS TO SOURCE DATA/DOCUMENTS

           The CRIB will be permitted to audit the database as needed. Source documents are from
           electronic medical records.

       10. QUALITY CONTROL AND QUALITY ASSURANCE

           Data collection will be done by the investigators through the clinical team managing the
           patient to ensure completion and accuracy.

       11. ETHICAL CONSIDERATIONS

      11.1. Informed Consent

      Informed consent will be sought from the patient or legal guardian (in the case of minors) by
      the study investigators before any data collection is done.

      11.2. Confidentiality of Data and Patient Records

        -  Data will be entered and stored in a secure web application (REDCap)/password controlled
           hospital computer. When subject data collection is complete, the data will be
           de-identified and kept in an electronic database (password secured) for analysis. Only
           investigators will have access to the data.

        -  There are no plans to keep any documentation of patients beyond the informed consent
           forms. These will be stored in the locked department office of the investigators.
    

Intervention name(s): Pleural disease management
Intervention type(s): Other
Intervention description(s): History, physical examination, pleural drainage, lab/radiographic investigations
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited if they already have radiographic evidence of pleural disease.