| Literature DB >> 30662286 |
Pierre Zitoun1, Jaya Parikh2, Martine Nijs3, Wenjie Zhang4, Rachel Levy-Toledano5, Boxiong Tang6.
Abstract
PURPOSE: The purpose of this study was to assess product-specific features for a variety of self-administered injection devices and identify key factors that patients and nurses in select European markets find most important when selecting injection devices for self-administration of recombinant human follicle-stimulating hormone and urinary human follicle-stimulating hormone for fertility/reproductive therapy. PATIENTS AND METHODS: Patients (N=402) in France, Italy, Spain, Germany, the UK, the Netherlands, and Belgium, as well as reproductive/fertility nurses (N=40) in Germany, Italy, France, Spain, and the Czech Republic were surveyed. All patients were previously prescribed a follicle-stimulating hormone (FSH) treatment for either in vitro fertilization or ovulation induction. Patient and nurse preferences for attributes across all injection devices in the market were obtained via an online questionnaire and evaluated using the maximum differential scaling (MaxDiff) and conjoint analyses, which captured the relative importance of the selected FSH injection device attributes to determine specific qualities in overall product preference.Entities:
Keywords: infertility; preference; prefilled pen device; recombinant human follicle-stimulating hormone; urinary follicle-stimulating hormone
Year: 2019 PMID: 30662286 PMCID: PMC6327888 DOI: 10.2147/IJWH.S175775
Source DB: PubMed Journal: Int J Womens Health ISSN: 1179-1411
The list of tested attributes and levels associated with each attribute
| ID | Attributes | Levels | Description |
|---|---|---|---|
| 1 | Injection device | • Single-use pen | Type of injector used for administering the drug |
| 2 | With “Steady Grip” | • Yes | Grip that helps the user to stably hold the pen injector |
| 3 | Visibility of remaining | • Yes | User can see the level of leftover drug in the loaded cartridge |
| 4 | Number of needles in | Range from 5 to 14 | The number of replacement needles in the package |
| 5 | With large display | • Yes | A large display window for the amount of drug to be injected |
| 6 | Dosing accuracy | Percentage of errors | Variation per day measured as percentage of the total daily |
| 7 | Minimum dosing | Range from 8.33 IU to 150 IU | Smallest amount of drug that can be injected using the device |
| 8 | Unit display | • Dash | This attribute describes how the injection amount can be read |
| 9 | Dial back function | • Yes | Dose correction can be made by turning the dial backwards to |
| 10 | Daily injection volume | • 0.01, 0.1, 0.3 mL for pens | Total volume of liquid being injected |
| 11 | Operation | • Side button (semi-automatic) | The mechanism by which the injection is being performed |
| 12 | Has overfilled cartridge | • Yes | Overfilled cartridge provides additional medicine for injector |
| 13 | Able to use multiple | • Yes | Multiple cartridges can be combined in pen to supply sufficient |
| 14 | Dosing increment | 12.5–25 IU for pens | Smallest incremental value for which the injection can be adjusted |
| 15 | Treatment diary | • Yes | Allows the user to track their injection activities |
| 16 | Product wastage | • High | Medicine wasted due to dosing change. |
| 17 | Easy for nurse to teach | • Yes | This is a general assessment about how easy it is to teach a |
| 18 | Time to remove from | • 10 minutes | Time required between the medicine being removed from the |
| 19 | Needle size | Range from 27 to 30 gage | Size of needle, where larger number indicates a smaller needle |
| 20 | Carrying pouch size | • Standard | Size of the container for the injection product bundle: |
The list of tested attributes and levels associated with each attribute
| ID | Attributes | Levels | Description |
|---|---|---|---|
| 1 | Injection device | • Pen | Type of injector used for administering the drug |
| 2 | Pen type | • Single-use pen | Type of pen used for administration |
| 3 | Visibility of remaining product in | • Yes | User can see the level of leftover drug in the loaded cartridge |
| 4 | Daily injection volume | • 0.01, 0.1, 0.3 mL for pens | Total volume of liquid being injected |
| 5 | Product wastage | • High | Medicine wasted due to dosing change: |
| 6 | Easy for nurse to teach | • Yes | General assessment of how easy it is to teach a patient to use |
Example of conjoint analysis question
| Hypothetical product A | Hypothetical product B |
|---|---|
| It is provided in an injection pen | It is provided in either a prefilled syringe or a syringe that needs to be filled prior to injection |
| The pen can be used for multiple injections as long as the reservoir is not depleted. The pen is also disposable | The pen can be used for a single injection only and is non-reusable |
| The remaining drug in a loaded cartridge cannot be seen through a window on the pen | The remaining drug in a loaded cartridge cannot be seen through a window on the pen |
| On average, this product will have an injection error within 1.5% of the patient’s prescribed daily dosage | On average, this product will have an injection error within 3.0% of the patient’s prescribed daily dosage |
| The daily injection volume using product A is 0.3 mL | The daily injection volume using product B is 0.01 mL |
| The product wastage is more than 100 IU | The product wastage is less than 50 IU |
Baseline characteristics of female patients participating in the survey
| UK | Germany | France | Italy | Spain | The Netherlands | Belgium | |
|---|---|---|---|---|---|---|---|
| Patients, n | 76 | 94 | 76 | 69 | 55 | 20 | 12 |
| Mean age, years | 33.30 | 35.51 | 33.64 | 35.42 | 33.56 | 31.58 | 31.5 |
| Previously on IVF treatments, n (%) | 75 (98.68) | 89 (94.68) | 74 (93.37) | 63 (91.30) | 50 (90.90) | 18 (90.00) | 10 (83.33) |
| Previously on non-IVF treatments, n (%) | 1 (1.32) | 5 (5.32) | 2 (2.63) | 6 (1.50) | 5 (9.10) | 2 (10.00) | 2 (16.67) |
| Pregnancy with IVF (%) | 57.33 | 56.18 | 60.81 | 44.44 | 58.00 | 44.44 | 40.00 |
| Live birth with IVF (%) | 57.33 | 49.44 | 56.76 | 42.86 | 52.00 | 44.44 | 40.00 |
Abbreviation: IVF, in vitro fertilization.
Baseline characteristics of nurses participating in survey
| Total number of nurses who have completed the surveys | 40 |
| Total number of nurses who work in reproductive endocrinologist practice | 11 |
| Total number of nurses who work in infertility clinics | 37 |
| Average number of physicians at the practice where the nurse works | 5 |
| Average number of nurses at the practice where the nurse works | 6 |
| Average number of patients that the nurse sees monthly | 299 |
| Percentage of patients that these nurses see who are using self-administered injectable ovarian stimulation treatments | 69 |
| Percentage of patients who are using self-administered ovarian stimulation treatments via injection pens | 67 |
| The average number of years of infertility treatment experience | 9 |
Figure 1Patient preference ranking of the tested attributes from the MaxDiff analysis.
Abbreviation: MaxDiff, maximum differential scaling.
Figure 2Nurse preference ranking of the tested attributes from the MaxDiff analysis.
Abbreviation: MaxDiff, maximum differential scaling.
Figure 3Patient preference ranking of selected attributes from the conjoint analysis.
Figure 4Nurse preference ranking for the selected attributes from the conjoint analysis.
The attribute characteristics of two hypothetical products in scenario analysis 1
| Product A | Product B | ||
|---|---|---|---|
| 1 | Injection device | Pen | Syringe and vial (1–2 mL) |
| 2 | Pen type | Single-use pen | |
| 3 | Visibility of leftover product | No | |
| 4 | Dosing accuracy | 3% error | 3% error |
| 5 | Pen daily injection volume | 0.3 mL | |
| 6 | Product wastage | High | High |
The attribute characteristics of two hypothetical products in scenario analysis 2
| Product A | Product B | ||
|---|---|---|---|
| 1 | Injection device | Pen | Pen |
| 2 | Pen type | Multiple-use reusable pen | Single-use pen |
| 3 | Visibility of leftover in cartridge | No | No |
| 4 | Dosing accuracy | 3% error | 3% error |
| 5 | Pen daily injection volume | 0.3 mL | 0.3 mL |
| 6 | Product wastage | High | High |
Figure 5The country-wise comparison of the relative importance score of attributes among patients.
Abbreviations: BE, Belgium; NL, the Netherlands; IT, Italy; FR, France.
Figure 6The country-wise comparison of the relative importance score of attributes among nurses.
Abbreviations: CZ, Czech Republic; IT, Italy; FR, France.
Selected preferred product attributes of currently available FSH injection devices
| Attributes | Gonal-f® | Puregon® | Bemfola® | Ovaleap® | Bravelle® | Menopur® | |
|---|---|---|---|---|---|---|---|
| 1 | Daily injection volume (150 IU) | 0.25 mL | 0.18 mL | 0.25 mL | 0.25 mL | 1–2 mL | 1–2 mL |
| 2 | Injection device | Single-use, multidose, pen | Multi-use, multidose, pen | Single-use, single-dose, pen | Multi-use, multidose, pen | Syringe and vials | Syringe and vials |
| 3 | Dial-back function | Yes | No | Yes | Yes | – | – |
| 4 | Dosing increments | 12.5 IU | 25 IU | 12.5 IU | 12.5 IU | – | – |
| 5 | Perform injection | Push knob | Push knob | Plunger | Release button | ||
| 6 | Visibility of leftover in cartridge | Yes | No | NA | Yes |