A retrospective observational study on characteristics, treatment patterns, and healthcare resource use of patients with xerostomia in primary care settings using Optimum Patient Care Research Database in United Kingdom.

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective observational study

Study drug and medical condition

• Medical condition to be studied:
  Dry mouth

Population studied

• Short description of the study population:
  Patients with xerostomia aged 18 years or older identified from the Optimum Patient Care Research Database (OPCRD).; Inclusion criteria:; 1. Patients with a first record of a diagnosis of xerostomia or dry mouth during the study eligibility period (see Table 1 for code list); ; Exclusion criteria:; 1. Patients with <12 months baseline data prior to index date; 2. Patients with <12 months follow-up data post index date; 3. Patients <16 years old
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with xerostomia
• Estimated number of subjects:
  12625

Study design details

• Main study objective:
  The general aim of the study is to gain a better understanding of the xerostomia patients, in terms of their characteristics, treatment patterns, and burden in primary care including primary healthcare resource use and associated costs.
• Outcomes:
  To describe patients newly diagnosed with xerostomia in terms of their socio-demographic characteristics, comorbidities, and treatments susceptible to cause xerostomia prior to index date. To describe treatment for xerostomia and associated costs, post-index date. To describe primary healthcare resource use and associated costs, pre- and post-index date in patients with xerostomia.
• Data analysis plan:
  All statistical analyses will be documented in a formal statistical analysis plan (SAP) that will be finalised prior to database lock. All analyses will be descriptive. Distributions and descriptive statistics of central tendency (medians and arithmetic means) and dispersion (standard deviation, interquartile range, and range) will be presented for quantitative variables wherever possible. Categorical variables will be described with frequencies and percentages. No statistical comparisons will be performed between groups. As patients’ follow-up will likely differ between patients, healthcare resource use and cost will be expressed per person-years, using all person-years at risk for each patient. Costs for primary care activity and delivery of treatment will be derived from the BNF Drug Costs for cost treatment, and National Health Service (NHS) reference costs in Personal Social Services Research Unit (PSSRU) for activity (23–25).