Routinely anonymised electronic healthcare data, including general practice data and hospital data, are used to support medicines safety assessments. However, such data have been rarely used for medical device safety monitoring largely due to recognised limitations particularly with respect to capturing information on the use of specific devices. While hospital data on patients cannot be used to determine the specific brand type of medical device, information on patients undergoing surgical procedures is collected, offering some potential for devices monitoring. The overall aim of this study is to explore the value of using CPRD data from general practice to support medical device safety monitoring. For this feasibility study, data relating to women undergoing a procedure to treat stress urinary incontinence (SUI), which leads to involuntary leakage of urine when laughing, sneezing, coughing or through physical activity and pelvic organ prolapse (POP), where organs bulge from their natural position into or outside of the vagina and potential adverse outcomes, will be analysed as a case study. Due to the uncertainties of the utility of CPRD data with regards to medical devices safety monitoring and whether it can be used meaningfully for decision-making, this study will take a step-wise approach, with an assessment of data conducted at each stage to inform a decision on further continuation of the study.
The aim of this study is to assess the value of linked CPRD data to support the MHRA's medical devices vigilance by exploring adverse events in women who had surgery for a mesh or non-mesh procedure to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP) as a case study. This descriptive exploratory retrospective cohort study will be conducted in the HES admitted patient care data for England utilising the linkage to primary care data. Two cohorts of women aged 18 years and above who had a first surgery for SUI or POP, with a mesh or non-mesh procedure, between April 2002-March 2016 will be derived. Adverse event incidence rates will be estimated, stratified by procedure type (mesh vs. non-mesh), and the pattern of potential symptoms emerging prior to mesh removal explored. Patient characteristics will be described according to age-group, BMI, recent childbirth (within 1 year of the index date - the first SUI or POP procedure), year and surgical speciality of the consultant performing the procedure. A decision on the continuation of the study will be made using an iterative approach, the first step determining whether our data are consistent with the respect to the study aims and the trends observed published recently using NHS Digital English national HES data.
Primary:
- Immediate postoperative complications within the index admission record (measured in HES)
- Late postoperative complications within a subsequent admission to the index admission (measured in HES)
- Further surgical procedures related to incontinence or prolapse subsequent to the index admission (measured in HES)
Secondary
- Incidence of uterine, vaginal bleeding and discharge symptoms recorded in primary care (measured in CPRD)
- Incidence of urinary tract infections recorded in primary care (measured in CPRD)
- Incidence of blood in urine recorded in primary care (measured in CPRD)
- Incidence of pain (abdominal, pelvic, leg, buttock, lower back, chronic pain) recorded in primary care (measured in CPRD)
Katherine Donegan - Chief Investigator - MHRA
Craig Allen - Corresponding Applicant - MHRA
HES Admitted Patient Care;Pregnancy Register