Real world management of pain: Do patient-specific factors influence treatment decisions and its outcomes? (RELIEF)

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is observational, prospective, non-interventional, international, multicentre, epidemiological study. In this epidemiological study were included only patients, who would also otherwise be treated in usual clinical practice with NSAIDs and/or tramadol/paracetamol combination and who agreed with the informed consent form and consent in collection, analysis and processing of personal data, which were collected during the epidemiological study. This protocol did not influence the decision of attending physician regarding patient management. Any diagnostic method or therapeutic decision made by a physician were independent from the inclusion of a patient in the study in accordance with its epidemiological design.

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DICLOFENAC

  ETORICOXIB

  IBUPROFEN
• Anatomical Therapeutic Chemical (ATC) code:
  (M01AB05) diclofenac

  diclofenac

  (M01AE01) ibuprofen

  ibuprofen

  (M01AH05) etoricoxib

  etoricoxib

  (M02AA12) naproxen

  naproxen

  (N02AJ13) tramadol and paracetamol

  tramadol and paracetamol

  (N02AX02) tramadol

  tramadol

  (N02BE01) paracetamol

  paracetamol
• Medical condition to be studied:
  Back pain

  Headache
• Additional medical condition(s):
  Neuropathic pain, other musculo-skeletal pain, trauma/injury pain (including postoperative pain), rheumatic pain and other types of pain

Population studied

• Short description of the study population:
  Patient with pain (regardless of the type, level of intensity and duration) who need treatment with NSAIDs and/or tramadol/paracetamol combination, alone or in combination with other analgesics and who agreed with informed consent form and consent for statistical evaluation of personal data were included in the study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  4496

Study design details

• Study design:
  Observational, prospective, non-interventional, international, multicentre, epidemiological study.
• Main study objective:
  The main study objective is to find out if and how patient-specific risk, intensity, type and duration of pain determine the choice of analgesic treatment (NSAIDs and/or tramadol/paracetamol combination), and evaluate the influence of pain and corresponding treatment choices on quality of life.
• Outcomes:
  Primary outcome: To evaluate how average intensity of pain in last 24 hours on VAS scale influences the prescription of analgesics (NSAIDs and/or tramadol/paracetamol combination) and to compare these influences among physicians in participating countries. To evaluate how patient’s risk factors influence the prescription of analgesics and to compare these variations among participating countries.; The secondary endpoints encompass 11 items realted with: demographic, risk factors, concomitant diseases, duration of pain, type of pain, quality of life, pain intensity, adherence, patient’s and investigator’s satisfaction with the treatment, investigator’s specialties, safety evaluation.
• Data analysis plan:
  The study characteristics of the protocol were entered into electronic data capture system - the eCRF application. All data and clinical information were collected in accordance with the country specific privacy laws, Helsinki declaration, protocol and regular clinical practice. Corrections made in eCRF by the were captured in audit trail log along with the date, person credentials and reason of correction. In case of missing, misleading or incomplete data during the study conductance, the monitor produced queries. Queries were forwarded to investigator’s clarification. Only investigator or authorized study personnel could provide data change or data correction. The locked database was used for the final statistical analysis and final study report. The statistical report includes standard descriptive statistics. For numerical variables and each group in question, the largest and the smallest value in the associated sample, the sample mean and the sample standard deviation, were recorded. For categorical variables and each group in question, the numeri and percentages of the categories present are listed. All patients included in the study are also included in the safety analysis. Two-sided confidence intervals are computed individually at level of confidence 95 % (by inversion, this corresponds to hypothesis tests with simple null hypothesis, possibly with nuisance parameters, and two-sided alternatives at level of significance 5 %). In this study, only the full analysis set is considered.