Retrospective online survey to investigate user experiences with herbal medicines (phytopharmaceuticals)/PhytoVIS

Study type

• Study topic:
  Herbal medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes
• If ‘other’, further details on the scope of the study:
  Health service research
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective online survey

Population studied

• Short description of the study population:
  The study population is not limited in this survey. Every natural person is to be surveyed, regardless of indication, product use, age, gender or ethnic origin. However, data on paediatric patients should be collected preferentially, e.g. by choosing an appropriate location for the survey, such as a paediatric doctor's office.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Children, adolescents
• Estimated number of subjects:
  20000

Study design details

• Study design:
  The retrospective one-off survey regarding the use of phytopharmaceuticals within the last 8 weeks, is conducted at doctors' offices, pharmacies, etc. by students of medicine, pharmacy, or related fields which interview any patient. The students will survey about 100 patients (100 product data sets.
• Main study objective:
  The new productive phase of PhytoVIS is intended to supplement the results obtained in the data analyses of the previous productive phase.; The productive phase II is intended to gain further experience with the application of the PhytoVIS tool under real-life study conditions. It covers all natural persons who have used a phytopharmaceutical in the last eight weeks at the time of the survey. The purpose of PhytoVIS is not to collect data on the specific efficacy of phytopharmaceuticals – this is not possible within the framework of observational studies. Rather, the aim is to record how patients assess the effect within the overall therapeutic intervention. This is done in the knowledge that, in addition to the therapeutic interventions, many other influencing factors, such as the spontaneous course of the diseases being treated, play a role. ; The focus should be shifted towards collecting data from children and adolescents, preferably through surveys conducted by paediatricians.; These special groups in particular show some significant results in the Clinical Global Impression Scale – Efficacy (CGI-E), which, however, need to be investigated further by increasing the number of cases..; With regard to adverse drug reactions, it is not possible to establish a causal link, e.g. with the use of certain products or with other therapeutic interventions. Furthermore, the statutory reporting system should not and cannot be duplicated. However, it will be ensured that adverse drug reactions that have led to a visit to a doctor can be reported via the questionnaire.; Due to the high number of data sets expected – a further 20,000 are targeted – statistically sound, differentiated subgroup analyses are also possible and planned.
• Setting:
  The study will take place all over Germany. The following universities are involved: Goethe University (Frankfurt), Ludwig-Maximilians University (Munich), University Greifswald (Greifswald), University of Cologne (Cologne).; Medical and pharmaceutical students of these universities will conduct the survey at any pharmacy (or any other point of sale for phytopharmaceuticals), doctor's practice, hospital, etc. The students have 4 weeks to collect at least 100 data sets.; The only inclusion criterion is that herbal medicinal products must have been used within the last eight weeks.; There are no exclusion criteria for this study.
• Outcomes:
  Efficacy and tolerability of the products (user assessment); The validated Clinical Global Impression Scale – Efficacy (CGI-E) is used to record the primary and secondary endpoints. The CGI-E scale is a 16-field matrix that shows the relationship between tolerability and therapeutic effect. Each field is assigned a score between 0.25 and 4.00. If the efficacy index is above 1.00, the therapeutic effect outweighs the adverse drug reactions in the respective dimension strength (1–2=marginal efficacy advantage vs. side effects; 3=moderate efficacy in the absence of side effects; 4=marked efficacy in the absence of side effects). With an index of 1.00, the effects cancel each other out. With a score of <1.00, the adverse drug effects outweigh the therapeutic effect.; Other outcomes:; Location of survey (Federal state, Place of administration); Complaints/illness (Questionnaire on indication and symptoms, Type of treatment (acute, chronic, preventive), Question about perceived severity (based on the Numeric Pain Intensity Scale); Information on the use of phytopharmaceuticals (Name of the product(s), Dosage, Time of application after onset of symptoms, Frequency, duration and dose of use, Time of onset of effect, Description of possible side effects for which a doctor was consulted, Source of recommendation for the product, Source of the product); Accompanying factors/comorbidities (Other diseases in addition to the indication already mentioned, Use of other medicines); Basic patient data (Age, Gender, Use during pregnancy or while breastfeeding); General survey data (Comment on the case by the interviewer);
• Data analysis plan:
  All questionnaires with the available data will be evaluated using IBM's SPSS statistical software or comparable programmes in the version available at the time of evaluation. In addition to the general target parameters, subgroup analyses (e.g. age groups, product groups, indication groups, etc.) will also be carried out as part of the evaluation.; Since the survey is not controlled and only takes place once, the data obtained is evaluated purely descriptively. Categorical data is presented using absolute and percentage frequencies. Numerical data is presented using the mean, median, standard deviation, 25/75 percentile, and minimum and maximum values.; After completion of the survey, the evaluation strategy is adapted to the given situation in an evaluation meeting. It is determined whether additional analyses appear useful and should be carried out in sub-collectives. If necessary, a statistical comparison between the subgroups can also be determined.;