Patients’ experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data

Figures & data

Table 1. Functional impairment and select satisfaction follow-up survey items.

Concept	Timepoint	Question	Likert scale response options
Degree of pain interference (functional impairment) in the past seven days	Baseline Week 4 Week 12	During the past 7 days, how much did pain interfere with your daily activities? (This includes activities like eating, dressing, activities related to personal hygiene, and sleep). During the past 7 days, how much did pain interfere with your ability to perform errands and chores around and outside your home? (This includes activities like preparing meals, gardening, driving, and cleaning). During the past 7 days, how much did pain interfere with physical activities? (This includes activities like going to the gym, running, jogging, and swimming). During the past 7 days, how much did pain interfere with your social activities? (This includes activities like parties, going to the theater, concerts, dining out, and activities with family and friends).	Not at all Somewhat Moderately Quite a bit Extremely
Degree of functional improvement compared to baseline	Week 4 Week 12	Mark the one response that best describes your ability to participate in your daily activities now, compared with how it was before using Voltaren Schmerzgel (this includes activities like eating, dressing, activities related to personal hygiene, and sleep). Mark the one response that best describes your ability to perform errands and chores around and outside your home now, compared with how it was before using Voltaren Schmerzgel (this includes activities like preparing meals, gardening, driving, and cleaning). Mark the one response that best describes your ability to participate in physical activities now, compared with how it was before using Voltaren Schmerzgel (this includes activities like going to the gym, running, jogging, and swimming). Mark the one response that best describes your ability to participate in your social activities now, compared with how it was before using Voltaren Schmerzgel (this includes things like parties, going to the theater, concerts, dining out, and activities with family and friends).	Very much better Much better A little better No change Much worse Very much worse
Satisfaction with treatment results	Week 4 Week 12	How satisfied are you with the result you experienced with the Voltaren Schmerzgel you bought 4 weeks/12 weeks ago?	Extremely satisfied Somewhat satisfied Neither satisfied nor dissatisfied Somewhat dissatisfied Extremely dissatisfied

Abbreviations. HrQoL, Health-related quality of life.

This represents the exact wording of the survey questions, however VGD is used throughout the manuscript for diclofenac gel and Voltaren Schmerzgel.

Figure 1. Participant baseline, Week 4 and Week 12 survey completion profile.

Figure 2. Percentage of Survey participants reporting pain on NRS pain Scale.

Scores are based on the pain NRS, with 0 = no pain and 10 = worst possible pain.

Figure 3. Percentage of Survey participants that changed to a better pain category from baseline.

Scores are based on the pain NRS, with 0 = no pain and 10 = worst possible pain.

Abbreviation. NRS, Numeric Rating Scale.

Figure 4. Percentage of Survey participants with improvement in ability to participate in functional activities from baseline to weeks 4 and 12.

Improvement defined as selecting ‘A little better’, ‘Much better’, or ‘Very much better’ when asked to describe ability to participate in functional activities compared to baseline.

Figure 5. Percentage of Survey participants reporting at least moderate pain interference with functional activities at baseline, Week 4 and Week 12.

Figure 6. Participant satisfaction with treatment results at Week 4 and 12 (survey).

Table 2. Reasons for satisfaction with VGD treatment results among survey participants.

	Reason for satisfaction with treatment results
	Maintaining social independence	Easy to use	Carrying out normal daily activities	Participating in recreational activities	Avoiding going to doctor to get treatment	Ability to care for self without needing to ask for help
Week 4 n = 326, n (%)	301 (92.3)	266 (81.6)	250 (76.7)	171 (52.5)	160 (49.1)	118 (36.2)
Week 12 n = 295, n (%)	273 (92.5)	229 (77.6)	225 (76.3)	170 (57.6)	148 (50.2)	133 (45.1)

Table 3. Satisfaction with VGD treatment results for survey participants with "quite a bit” or “extreme” interference with functional activities at baseline.

	Functional activity
	Daily activities	Errands and chores	Physical activities	Social activities
Week 4 n = 428, n (%)	131 (76.6)	108 (71.5)	161 (74.2)	64 (74.4)
Week 12 n = 382, n (%)	110 (73.3)	101 (74.3)	143 (73.3)	58 (55.6)

Table 4. VGD Use, pain, and treatment satisfaction results between older and younger survey population.

	Study population
	Overall participants N = 467	Participants 18 to 64 years old N = 264	Participants ≥65 years old N = 203
Total in study sample, n (%)^a	467 (100)	264 (56.5)	203 (43.5)
Comorbidities reported:
CV disease, n (%)^b	220 (47.1)	87 (33.0)	133 (65.5)
GI disorders, n (%)^c	15 (3.2)	9 (3.4)	6 (3.0)
Purchased VGD:
2.32% strength, n (%)	331 (70.9)	177 (67.0)	154 (75.9)
1.16% strength, n (%)	136 (29.1)	87 (33.0)	49 (24.1)
Repeat users of VGD, n (%)	362 (77.5)	185 (70.1)	177 (87.2)
Purchased VGD to:
Treatment of pain from sprains, strains or bruising following sport or accidental injuries	112 (24.0)	84 (31.8)	28 (13.8)
Treatment of pain because of arthritis	58 (12.4)	34 (12.9)	24 (11.8)
Treatment of pain in the back	111 (23.8)	63 (23.9)	48 (23.7)
Treatment of body pain not specific to arthritis	186 (39.8)	83 (31.4)	103 (50.7)
Worst pain^d in the seven days prior to:
Baseline, Mean (SD)	6.0 (1.9)	5.9 (1.9)	6.1 (1.9)
Week 4, Mean (SD)	5.1 (2.2)	5.00 (2.2)	5.2 (2.2)
Week 12, Mean (SD)	4.7 (2.4)	4.6 (2.3)	4.8 (2.5)
Participants reporting at least ‘quite a bit’ of pain interference with daily activities at:
Baseline, n (%)	190 (40.7)	94 (35.6)	96 (47.3)
Week 4, n (%)^e	123 (28.7)	61 (24.8)	62 (34.1)
Week 12, n (%)^e	104 (27.2)	53 (23.5)	51 (32.7)
Participants reporting at least ‘quite a bit’ of pain interference with errands and chores around/outside the home at:
Baseline, n (%)	169 (36.2)	85 (32.2)	84 (41.4)
Week 4, n (%)^e	102 (23.8)	45 (18.3)	57 (37.3)
Week 12, n (%)^e	80 (20.9)	42 (18.6)	38 (24.4)
Participants reporting at least ‘quite a bit’ of pain interference with physical activities:
Baseline, n (%)	238 (51.0)	136 (51.5)	102 (50.2)
Week 4, n (%)^e	148 (34.6)	79 (32.1)	69 (37.9)
Week 12, n (%)^e	118 (30.9)	68 (30.1)	50 (32.1)
Participants reporting at least ‘quite a bit’ of pain interference with social activities at:
Baseline, n (%)	99 (21.2)	45 (17.0)	54 (26.6)
Week 4, n (%)^e	67 (15.7)	30 (12.1)	37 (20.3)
Week 12, n (%)^e	50 (13.1)	26 (11.5)	24 (15.4)
Participants reporting at least ‘moderate’ pain interference with daily activities at:
Baseline, n (%)	366 (78.4)	190 (72.0)	176 (86.7)
Week 4, n (%)^e	268 (62.6)	148 (60.2)	120 (65.9)
Week 12, n (%)^e	213 (55.8)	118 (52.2)	95 (60.9)
Participants reporting at least ‘moderate’ pain interference with errands and chores around/outside the home at:
Baseline, n (%)	326 (69.8)	172 (65.2)	154 (75.9)
Week 4, n (%)^e	243 (56.8)	128 (52.0)	115 (63.2)
Week 12, n (%)^e	195 (51.0)	111 (49.1)	84 (53.8)
Participants reporting at least ‘moderate’ pain interference with physical activities:
Baseline, n (%)	371 (79.4)	210 (79.5)	161 (79.3)
Week 4, n (%)^e	279 (65.2)	156 (63.4)	123 (67.6)
Week 12, n (%)^e	208 (54.5)	119 (52.7)	89 (57.1)
Participants reporting at least ‘moderate’ pain interference with social activities at:
Baseline, n (%)	224 (48.0)	110 (41.7)	114 (56.2)
Week 4, n (%)^e	161 (37.6)	77 (31.3)	84 (46.2)
Week 12, n (%)^e	130 (34.0)	73 (32.3)	57 (36.5)
Improvement from baseline in the ability to participate in daily activities at:
Week 4, n (%)^e	385 (90.0)	225 (91.5)	160 (87.9)
Week 12, n (%)^e	351 (91.9)	206 (91.2)	145 (92.9)
Improvement from baseline in the ability to perform errands and chores around/outside the home at:
Week 4, n (%)^e	375 (87.6)	219 (89.0)	156 (85.7)
Week 12, n (%)^e	343 (89.8)	204 (90.3)	139 (89.1)
Improvement from baseline in the ability to participate in physical activities at:
Week 4, n (%)^e	347 (81.1)	209 (85.0)	138 (75.8)
Week 12, n (%)^e	328 (85.9)	195 (86.3)	133 (85.3)
Improvement from baseline in the ability to participate in social activities at:
Week 4, n (%), n (%)^e	293 (68.5)	164 (66.7)	129 (70.9)
Week 12, n (%)^e	305 (79.8)	176 (77.9)	129 (82.7)

^aDenominator for all rows, unless otherwise stated.

^bIncludes heart problems (such as a previous heart attack) and/or high blood pressure.

^cIncludes stomach or intestinal ulcers, bleeding from the stomach, or blood in the stools.

^dAssessed by pain NRS, with 0 = no pain and 10 = worst possible pain.

^eWeek 4 (N = 428 for Overall; 246 for 18 to 64 years; 182 for ≥65 years); Week 12 (N = 382 for Overall; 226 for 18 to 64 years; 156 for ≥65 years).

Abbreviations. CV, cardiovascular; GI, gastrointestinal; NRS, Numeric Rating Scale; SD, standard deviation.

Figure 7. Patient selection data flow from pharmacy dispensing software.

Negative dispensing could occur if a patient returned previously collected drug. Patients with dispensing <0 returned all dispensed packs within the study period.

The sum of patients who were dispensed 2.32% and 1.16% strength is greater than the total patients eligible for analysis because some patients had both strengths dispensed during the 12-month period.

Abbreviations. VGD, Voltaren gel diclofenac.