Prevalence of drug-induced constipation and severity of associated biopsychosocial effects in patients with nonmalignant pain. A cross-sectional review of depersonalized data from the German Pain e-Registry (DRIP)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Tolerability
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

  Other
• Non-interventional study design, other:
  Retrospective registry analysis

Study drug and medical condition

• Medical condition to be studied:
  Pain
• Additional medical condition(s):
  Chronic nonmalignant pain

Population studied

• Short description of the study population:
  Patients with chronic nonmalignant pain (NMP), who frequently receive a polymedication with or without opioid analgesics.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Estimated number of subjects:
  150000

Study design details

• Main study objective:
  To assess the influence of drug-induced constipation on pain, pain-related disabilities in daily life, and further biopsychosocial factors such as quality-of-life, depression, anxiety, mood, and overall wellbeing
• Outcomes:
  The primary end point was the proportion of patients with five or more serious findings within the nine properties evaluated (based on the following cut-off ranges: a) pain intensity, b) daily functioning, c/d) physical/mental quality-of-life, e) depression, f) anxiety, g) stress, h) wellbeing, and i) quality-of-life impairment by pain.
• Data analysis plan:
  Biometric analyses will beperformed using the descriptive procedures suitable for the respective data format. Mean data will be presented with standard deviation or 95% confidence intervals (CI), proportions expressed in percent (%) and if necessary, adjusted for the number of patients with available data (a%). For statistical between cohort comparisons Pearson’s chi-square test and Wilcoxon’s signed rank test will be performed using a two-sided significance level of 0.05. All comparisons will be exploratory, therefore neither significance levels will be adjusted for multiplicity nor confirmatory analyses performed. All analyses will be conducted with PASW Statistics version 18.