| Literature DB >> 32110758 |
Andrew J Dawson1, Arash Akaberi2, Jean-Philippe Galanaud3, David R Morrison2, Susan R Kahn2,4.
Abstract
INTRODUCTION: Elastic compression stockings (ECSs) are used to treat symptoms of venous insufficiency. However, lack of patient compliance can limit their effectiveness. In a secondary analysis of the SOX Trial, a randomized trial of active vs. placebo ECSs worn for 2 years to prevent postthrombotic syndrome after deep vein thrombosis, we aimed to describe patient-reported reasons for nondaily use of ECS and to identify predictors of noncompliance during follow-up.Entities:
Keywords: adherence; compliance; compression stockings; deep vein thrombosis; postthrombotic syndrome
Year: 2019 PMID: 32110758 PMCID: PMC7040536 DOI: 10.1002/rth2.12296
Source DB: PubMed Journal: Res Pract Thromb Haemost ISSN: 2475-0379
Baseline characteristics of study population
| Whole population | Active ECSs | Placebo ECSs | |
|---|---|---|---|
| N | 776 | 394 | 382 |
| Age, y | |||
| Mean ± SD | 55.1 ± 15.6 | 55.3 ± 15.3 | 54.8 ± 15.9 |
| <40 | 130 (16.8) | 64 (16.2) | 66 (17.3) |
| 40‐65 | 426 (54.9) | 215 (54.6) | 211 (55.2) |
| >65 | 220 (28.4) | 115 (29.2) | 105 (27.5) |
| Male sex | 470 (60.6) | 248 (62.9) | 222 (58.1) |
| Body mass index, kg/m2 | |||
| Mean ± SD | 29.0 ± 6.1 | 29.0 ± 6.1 | 28.9 ± 6.1 |
| <25 | 203 (26.2) | 102 (25.9) | 101 (26.4) |
| 25‐30 | 297 (38.3) | 148 (37.6) | 149 (39.0) |
| ≥30 | 276 (35.6) | 144 (36.5) | 132 (34.6) |
| Education | |||
| No school or primary only | 70 (9.0) | 34 (8.6) | 36 (9.4) |
| High school only | 242 (31.2) | 119 (30.2) | 123 (32.2) |
| Some college/university | 235 (30.3) | 122 (31.0) | 113 (29.6) |
| University graduate | 229 (29.5) | 119 (30.2) | 110 (28.8) |
| Smoking status | |||
| Nonsmoker | 630 (81.2) | 321 (81.5) | 309 (80.9) |
| Smoker | 146 (18.8) | 73 (18.5) | 73 (19.1) |
| Anatomical extent of DVT | |||
| Femoral or popliteal vein | 478 (61.6) | 246 (62.4) | 232 (60.7) |
| Common femoral or iliac vein | 298 (38.4) | 148 (37.6) | 150 (39.3) |
| Villalta score at baseline | |||
| Mean ± SD | 8.4 ± 4.6 | 8.3 ± 4.4 | 8.6 ± 4.8 |
| None (score < 5) | 164 (21.1) | 83 (21.1) | 81 (21.2) |
| Mild (5‐9) | 308 (39.7) | 167 (42.4) | 141 (36.9) |
| Moderate (10‐14) | 221 (28.5) | 110 (27.9) | 111 (29.1) |
| Severe (>14 or ulcer) | 83 (10.7) | 34 (8.6) | 49 (12.8) |
Data shown in table are n (%) unless indicated otherwise.
DVT, deep vein thrombosis; ECSs, elastic compression stockings; SD, standard deviation.
Reasons provided by patients for not wearing study stockings daily
| Whole population | Active ECSs | Placebo ECSs |
| |
|---|---|---|---|---|
| 1‐month visit | ||||
| Wear stockings every day | 564 (76.8) | 273 (73.0) | 291 (80.8) | .01 |
| Do not wear stockings every day | 170 (23.2) | 101 (27.0) | 69 (19.2) | |
| Reasons | ||||
| Difficult to put on | 45 (26.5) | 37 (36.6) | 8 (11.6) | .0003 |
| Difficult to remove | 13 (7.6) | 9 (8.9) | 4 (5.8) | .45 |
| Not helpful | 6 (3.5) | 2 (2.0) | 4 (5.8) | .22 |
| Makes symptoms worse | 11 (6.5) | 8 (7.9) | 3 (4.3) | .53 |
| Alternative reason | 119 (70.0) | 61 (60.4) | 58 (84.1) | .0009 |
| 6‐month visit | ||||
| Wear stockings every day | 376 (64.7) | 192 (64.0) | 184 (65.5) | .71 |
| Do not wear stockings every day | 205 (35.3) | 108 (36.0) | 97 (34.5) | |
| Reasons not worn daily: | ||||
| Difficult to put on | 28 (13.7) | 20 (18.5) | 8 (8.2) | .03 |
| Difficult to remove | 11 (5.4) | 8 (7.4) | 3 (3.1) | .17 |
| Not helpful | 6 (2.9) | 1 (0.9) | 5 (5.2) | .10 |
| Makes symptoms worse | 9 (4.4) | 4 (3.7) | 5 (5.2) | .74 |
| Alternative reason | 168 (82.0) | 84 (77.8) | 84 (86.6) | .10 |
| 12‐month visit | ||||
| Wear stockings every day | 293 (59.4) | 136 (55.5) | 157 (63.3) | .08 |
| Do not wear stockings every day | 200 (40.6) | 109 (44.5) | 91 (36.7) | |
| Reasons not worn daily | ||||
| Difficult to put on | 24 (12.0) | 18 (16.5) | 6 (6.6) | .03 |
| Difficult to remove | 8 (4.0) | 7 (6.4) | 1 (1.1) | .07 |
| Not helpful | 17 (8.5) | 11 (10.1) | 6 (6.6) | .38 |
| Makes symptoms worse | 8 (4.0) | 2 (1.8) | 6 (6.6) | .14 |
| Alternative reason | 159 (79.5) | 83 (76.1) | 76 (83.5) | .20 |
| 18‐month visit | ||||
| Wear stockings every day | 236 (56.3) | 113 (55.1) | 123 (57.5) | .63 |
| Do not wear stockings every day | 183 (43.7) | 92 (44.9) | 91 (42.5) | |
| Reasons not worn daily: | ||||
| Difficult to put on | 26 (14.2) | 19 (20.7) | 7 (7.7) | .01 |
| Difficult to remove | 5 (2.7) | 4 (4.3) | 1 (1.1) | .37 |
| Not helpful | 17 (9.3) | 7 (7.6) | 10 (11.0) | .43 |
| Makes symptoms worse | 6 (3.3) | 3 (3.3) | 3 (3.3) | >.99 |
| Alternative reason | 144 (78.7) | 73 (79.3) | 71 (78.0) | .83 |
| 24‐month visit | ||||
| Wear stockings every day | 205 (54.2) | 102 (53.1) | 103 (55.4) | .66 |
| Do not wear stockings every day | 173 (45.8) | 90 (46.9) | 83 (44.6) | |
| Reasons not worn daily: | ||||
| Difficult to put on | 27 (15.6) | 17 (18.9) | 10 (12.0) | .22 |
| Difficult to remove | 8 (4.6) | 7 (7.8) | 1 (1.2) | .07 |
| Not helpful | 26 (15.0) | 12 (13.3) | 14 (16.9) | .52 |
| Makes symptoms worse | 4 (2.3) | 3 (3.3) | 1 (1.2) | .62 |
| Alternative reason | 127 (73.4) | 64 (71.1) | 63 (75.9) | .48 |
Data shown in table are n (%) unless indicated otherwise.
ECSs, elastic compression stockings.
Reasons may add up to more than 100%, as patients were asked to tick all that apply.
Principal reason for nondaily use of ECSs at each study visit, in the whole study population and by intervention group
| Principal reason for nondaily use | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall | Active ECSs | Placebo ECSs | |||||||||||||
| M1 | M6 | M12 | M18 | M24 | M1 | M6 | M12 | M18 | M24 | M1 | M6 | M12 | M18 | M24 | |
| Total N | 170 | 205 | 197 | 180 | 172 | 102 | 108 | 108 | 90 | 90 | 68 | 97 | 89 | 90 | 82 |
| Aversive aspects of ECSs (%) | |||||||||||||||
| Uncomfortable, irritating, worsen symptoms | 27.1 | 21.0 | 13.2 | 10.6 | 11.0 | 29.4 | 19.4 | 11.1 | 13.3 | 12.2 | 23.5 | 22.7 | 15.7 | 7.8 | 9.8 |
| Stocking too hot | 5.3 | 15.6 | 15.2 | 17.2 | 15.7 | 5.9 | 13.9 | 13.9 | 12.2 | 18.9 | 4.4 | 17.5 | 16.9 | 22.2 | 12.2 |
| Causes itching or rash | 4.1 | 2.4 | 1.5 | 2.2 | 1.7 | 2.9 | 0.9 | 1.9 | 2.2 | 1.1 | 5.9 | 4.1 | 1.1 | 2.2 | 2.4 |
| Take too much time to put on | 3.5 | 3.9 | 5.1 | 3.9 | 3.5 | 2.9 | 4.6 | 4.6 | 1.1 | 1.1 | 4.4 | 3.1 | 5.6 | 6.7 | 6.1 |
| Too difficult to apply | 28.2 | 16.1 | 12.7 | 15.6 | 16.3 | 39.2 | 22.2 | 17.6 | 21.1 | 20.0 | 11.8 | 9.3 | 6.7 | 10.0 | 12.2 |
| Unaesthetic | 2.4 | 7.8 | 4.6 | 6.1 | 5.2 | 2.9 | 7.4 | 5.6 | 7.8 | 4.4 | 1.5 | 8.2 | 3.4 | 4.4 | 6.1 |
| They don’t help | 4.7 | 5.9 | 10.7 | 12.2 | 18.6 | 2.0 | 2.8 | 11.1 | 11.1 | 15.6 | 8.8 | 9.3 | 10.1 | 13.3 | 22.0 |
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| Patient behavior related (%) | |||||||||||||||
| Too lazy to put on, can’t be bothered | 4.1 | 2.4 | 3.0 | 2.8 | 5.2 | 1.0 | 2.8 | 2.8 | 3.3 | 2.2 | 8.8 | 2.1 | 3.4 | 2.2 | 8.5 |
| Forgets | 5.3 | 7.3 | 12.2 | 12.8 | 8.1 | 2.9 | 6.5 | 11.1 | 8.9 | 8.9 | 8.8 | 8.2 | 13.5 | 16.7 | 7.3 |
| Need a break | 7.1 | 5.4 | 9.6 | 4.4 | 3.5 | 5.9 | 7.4 | 10.2 | 6.7 | 5.6 | 8.8 | 3.1 | 9.0 | 2.2 | 1.2 |
| Only wears at certain times, eg, physical activity, working, standing | 1.8 | 4.4 | 2.5 | 5.6 | 2.3 | 1.0 | 3.7 | 2.8 | 4.4 | 3.3 | 2.9 | 5.2 | 2.2 | 6.7 | 1.2 |
| Patient preference not to wear them (not stated, or has other health issues) | 2.9 | 6.8 | 8.6 | 5.0 | 8.1 | 2.0 | 6.5 | 6.5 | 5.6 | 5.6 | 4.4 | 7.2 | 11.2 | 4.4 | 11.0 |
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| Other | |||||||||||||||
| Delay in receiving study stockings | 2.9 | 0 | 0 | 0.6 | 0 | 2.0 | 0 | 0 | 0 | 0 | 4.4 | 0 | 0 | 1.1 | 0 |
| Temporary prescription of nonstudy stockings by treating physician | 0.6 | 1.0 | 1.0 | 1.1 | 0.6 | 0 | 1.9 | 0.9 | 2.2 | 1.1 | 1.5 | 0 | 1.1 | 0 | 0 |
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M, month of follow‐up.
ECSs, elastic compression stockings.
Figure 1Category of principal reason for nondaily use of ECSs at each study visit, in whole study population and by intervention group (Y axis represents %). ECSs, elastic compression stockings
Figure 2Multiple logistic regression analysis of predictors of being an ECS noncomplier.# Note: The model was adjusted for all variables shown. #Being an “ECS complier” during the SOX Trial was defined a priori as patients who reported any stocking use on 3 or more out of 5 visits (ie, 1, 6, 12, 18, 24 months) and at these visits reported using stockings ≥3 days per week, for patients who attended all 5 study follow‐up visits, and patients who reported any stocking use on ≥2 visits and at these visits reported using stockings ≥3 days per week, for patients who attended <5 follow‐up visits. All other patients, as well as patients with 0 or 1 attended follow‐up visit, were considered ECS noncompliers. *Reference category: No school or primary school only. **We categorized the reasons provided for not wearing stockings daily at the 1‐month follow‐up visit (ie, information from Tables 2 and 3) into 1 of 4 categories: aversive aspects of ECS (n = 128), behavior related (n = 36), other reason (n = 6), or no reason provided (n = 594) (reference category). BMI, body mass index; ECSs, elastic compression stockings