Understanding the barriers in compliance to elastic compression garments in the treatment of pediatric post-thrombotic syndrome: A qualitative study

Understanding the barriers in compliance to elastic compression garments in the treatment of pediatric post-thrombotic syndrome: A qualitative study

Thrombosis Research 144 (2016) 113–115 Contents lists available at ScienceDirect Thrombosis Research journal homepage: www.elsevier.com/locate/throm...

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Thrombosis Research 144 (2016) 113–115

Contents lists available at ScienceDirect

Thrombosis Research journal homepage: www.elsevier.com/locate/thromres

Correspondence Understanding the barriers in compliance to elastic compression garments in the treatment of pediatric post-thrombotic syndrome: A qualitative study Keywords: Compression stockings Compliance Treatment Post-thrombotic syndrome Children

1. Background Post-thrombotic syndrome (PTS) is a chronic complication of deepvein thrombosis (DVT) that can develop in a quarter of children [1]. The role of graduated elastic compression stockings/sleeves (ECS) in PTS has been studied in adults more than in pediatric patients. In adults, ECS have been indicated for both the treatment and, until recently, prevention of PTS [2]. The efficacy of ECS for PTS prevention in adults has been the recent focus of attention. While an earlier meta-analysis of randomized controlled trials (RCT) concluded that ECS reduced the incidence of PTS [3], a more recent RCT, the SOX trial [4], showed no effect. Poor patient compliance has surfaced as an underlying factor that could explain these conflicting results, since patient-reported compliance at 2 years was slightly above 50% in the SOX trial [5]. The low compliance reported in trials studying ECS to prevent PTS (i.e., for a future benefit), is not surprising. Research focused on ECS compliance in symptomatic adult patients diagnosed with chronic venous disease, who might be more inclined to use ECS for an immediate benefit, reported compliance rates as low as 47% [6]. The frequency of PTS is expected to increase in children, accompanying the rising incidence of pediatric venous thrombotic events in hospitalized patients. Hence, unraveling the role of ECS in the treatment of pediatric PTS seems timely and relevant. Indeed, despite limited literature on ECS for PTS management, compression therapy remains the only treatment used in pediatric PTS. Given that compliance to ECS may mask the understanding of the role of this treatment for PTS, as shown in adults, the main goal of our study was to explore barriers in compliance to ECS use. This is a first step that will likely facilitate future research, while also impacting clinical practice. A qualitative approach was thought to best address the research question as to why patients do or do not adhere to ECS treatment in the context of their daily lives.

2. Patients and methods Patients 19 years old and younger diagnosed with upper or lower limb PTS who were prescribed ECS were enrolled in the present study.

http://dx.doi.org/10.1016/j.thromres.2016.06.011 0049-3848/© 2016 Published by Elsevier Ltd.

Patients participated in a 20-minute semi-structured interview that explored their experience with ECS. The dyad approach was used with younger patients as this method has been shown to improve the accuracy of responses compared to proxy report alone [7]. Interviews were conducted at the local clinic or by phone, according to patient preference. Interviews were either audio recorded and transcribed, or detailed interview notes were taken by one interviewer while another conducted the interview. Qualitative data was analyzed using a phenomenological approach. Two authors reviewed the material to gain an overall sense of the data, while being mindful of preconceptions. Themes related to ECS adherence were identified and then examined for links and differences in order to generate distinct categories that captured the patient's experience with ECS adherence. Disagreements were resolved by discussion with a third investigator. Sample size was determined by interviewing patients until no new information was gathered, indicating data saturation [8]. A basic interview guide was used to cover the following themes: understanding of the reason for ECS prescription, adherence to ECS use (compliance), and experience wearing ECS. Patient/parent understanding of the reason for the ECS prescription was determined by matching their responses with the indication expressed by the health care provider in clinic records. Adherence to ECS was defined using three levels: Full compliance was ECS use as prescribed by the clinician, partial compliance was ECS use not as prescribed, and non-compliance was no ECS use. In addition to the interview, patients completed two questionnaires, which evaluated the number of PTS symptoms and functional impact of PTS. For the latter, the Pediatric Outcome Data Collection Instrument (PODCI) [9] was used. PODCI measures a child's ability to perform and participate in daily life activities; it produces a global score on a 0–100 scale (with 100 representing the best functioning). This tool has been validated for the assessment of functioning in children with a wide variety of clinical conditions affecting the upper and lower limbs [10]. For each participant, either a self-reported or proxy-reported version of the PODCI was completed based on age, those 11 years-old and older completed the self-reported version. Lastly, PTS severity and date of initial ECS prescription were extracted from clinical charts. PTS severity was evaluated using the Modified Villalta Scale (MVS) from the patients' most recent PTS assessment [11], in agreement with current recommendations for pediatric PTS evaluation. The MVS assesses signs (increased limb circumference, change in skin color, pitting edema, venous collaterals on skin, pigmentation of the skin, tenderness on palpation, varicosities, head swelling, and ulceration), and symptoms (pain or abnormal use and swelling), which are scored separately to generate a final score that is categorized as mild, moderate, or severe PTS. Descriptive variables were summarized using percentages, median and ranges. In addition to the qualitative analysis, we quantitatively explored the potential association between the most influential factors and compliance groups using a Fisher's exact test. The number of symptoms among compliance groups was examined using a Mann-Whitney U test. Significance was set at a 0.05 alpha level.

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The present study was approved by the local Research Ethics Board and informed consent was obtained. 3. Results and discussion Twenty patients were enrolled in the study; 4/20 patients were prescribed compression sleeves. The median age (range) was 13.5 years (8–19); 60% (12/20) of the participants were female. The distribution of patients across compliance groups was: Full compliance 40% (8/20), partial compliance 30% (6/20), and non-compliance 30% (6/20). These results are consistent with a review done by the World Health Organization on compliance to longterm therapies in adult and pediatric patients with chronic conditions, which reported 50% adherence to treatment [12]. Seven barriers to the use of ECS were identified (Fig. 1). Of these barriers, ECS discomfort, no perceived benefit, high cost, and difficulty applying ECS, have been previously documented in adult literature [6]. Interestingly, the theme lack of patient/parent understanding of their condition was documented in 45% (9/20) of the interviews. These patients/parents either could not recall the reason for the ECS prescription, or their responses substantially differed from the clinician's notes at the time of instruction. In addition, concerns regarding ECS appearance was cited by 35% (7/ 20, 3 males, 4 females) of patients/parents, with many of them stating that they would not wear ECS with shorts or dresses. The barrier of cultural factor arose from one patient/parent who reported that their culture had a method of relieving pain that was preferred over the ECS. Patient responses also suggested that most barriers were modifiable, except for high cost and cultural factors. Two facilitators to ECS use were also identified, and are also shown in Fig. 1. One was established as clinical knowledge transfer, which was conceptualized as effective clinician-patient communication that led to the patient's clear understanding of the reason for ECS prescription. This communication could have been initiated by the patient/parent or by the clinician during follow-ups. The second facilitator was access to specialized ECS care, such as a medical garment fitter. Patients that purchased their ECS from a specialized store tended to report less issues with applying the ECS or discomfort when wearing them. According to patient responses, medical garment fitters were more likely to provide patients with demonstrations on how to apply the ECS with ease, along with being knowledgeable in the types of brands and materials that addressed patient comfort. Exploratory analysis showed effective clinical knowledge transfer was associated with compliance groups (Full compliance 100%; partial

compliance 40%; non-compliance 0%; p = 0.001), but no association was found for specialized ECS care (Full compliance 88%; partial compliance 83%; non-compliance 33%; p = 0.10). Additional characteristics of the patients per compliance group are listed in Table 1. The median (range) number of reported PTS symptoms was 4.5 (1–9), and the median (range) global PODCI score was 87 (46– 100) points. As a reference, the mean global PODCI scores in healthy children ranges between 93 and 95 with a standard deviation of 7–8, based on the version used. All twenty patients completed their corresponding PODCI version. The median (range) MVS score closest to the time of the interview was 3 (1–4) points, measured at a median of 1.8 months (range 0–8) prior to the interview. The distribution of PTS severity per compliance group (Table 1) shows that non-compliant patients were cases of mild PTS, as per the MVS. Hence, one of the reasons for non-compliance could be a less severe condition. However, despite low MVS scores, non-compliant patients reported a median of 3.5 symptoms at the time of the interview. Moreover, the number of symptoms did not significantly differ to than those of fully compliant patients (p = 0.30). Thus, when assessing PTS, clinicians may take into account more PTS symptoms than the two symptoms included in the MVS, or may value them differently [13]. It is important to note that time between ECS prescription and interview across compliance groups was not significant (Kruskal-Wallis test, p = 0.37). The current study found that in this symptomatic group of pediatric patients with PTS, less than half of the children wore their ECS as instructed by their clinician, and about a third of them were not wearing the garments at all, much like compliance-focused studies with adults. This finding emphasizes the value of addressing ECS adherence both in clinical practice and research trials. One limitation in the current study could have been it's setting, which was a tertiary medical center in a developed country where many families had insurance. Therefore, in this context, the barrier of ECS cost may have been reduced. Furthermore, it is possible that some data may not have been accurately captured in interviews that were not audio recorded. Of note, patients' median PODCI scores were within 2 standard deviations below the known mean scores of healthy children. Future studies designed to investigate the functional impact of PTS in children and the impact of ECS on symptom improvement are warranted. In conclusion, the described barriers and facilitators to ECS compliance provide clinicians with a framework to better understand ECS adherence in children, and ultimately influence clinical practice so that facilitators are maximized in order to improve compliance in the treatment of PTS.

Fig. 1. Barriers and facilitators to the use of ECS identified in patient interviews. N = 20, or N = 18 (two patients did not purchase ECS).

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Table 1 Characteristics of patients per compliance level.

Variables Number of PTS Symptoms, median (range) PODCI score, median (range) Time between initial ECS prescription and interview, median (range) PTS severity on last assessment (MVS) Mild n (%) Moderate Time between last PTS assessment and interview, median (range)

Full compliance n=8

Partial compliance n=6

7 (1–9)

6 (1–8)

90.5 (46–100) 7.8 mo (1–92.2) 3 (38%) 5 (62%) 1.5 mo (0–5.1)

Non compliance n=6 3.5 (1–9)

83 (65–96) 32.9 mo (9–80.1) 3 (50%) 3 (50%) 4.5 mo (0–8.2)

84.5 (64–97) 17.6 mo (2–24) 6 (100%) 0 2.7 mo (0–5.7)

Legend: PTS refers to post-thrombotic syndrome; MVS, to Modified Villalta Scale; PODCI to pediatric outcome data collection instrument; ECS, to elastic compression stocking.

References [1] N.A. Goldenberg, et al., Post-thrombotic syndrome in children: a systematic review of frequency of occurrence, validity of outcome measures, and prognostic factors, Haematologica 95 (11) (2010) 1952–1959. [2] C. Kearon, et al., Antithrombotic therapy for VTE: chest guideline, Chest (2016) (Online First). [3] M.H. Musani, et al., Venous compression for prevention of postthrombotic syndrome: a meta-analysis, Am. J. Med. 123 (8) (2010) 735–740. [4] S.R. Kahn, et al., Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial, Lancet 383 (9920) (2014) 880–888. [5] N. Labropoulos, et al., Compression stockings to prevent post-thrombotic syndrome, Lancet 384 (9938) (2014) 129–130. [6] S. Raju, K. Hollis, P. Neglen, Use of compression stockings in chronic venous disease: patient compliance and efficacy, Ann. Vasc. Surg. 21 (6) (2007) 790–795. [7] W.J. Ungar, et al., A parent-child dyad approach to the assessment of health status and health-related quality of life in children with asthma, PharmacoEconomics 30 (8) (2012) 697–712. [8] J.W. Creswell, Qualitative inquiry and research design: choosing among five traditions, Thousand OAKS, Sage Publications. xv, Calif., 1998 (403 p). [9] L.H. Daltroy, et al., The POSNA pediatric musculoskeletal functional health questionnaire: report on reliability, validity, and sensitivity to change. Pediatric outcomes instrument development group, J. Pediatr. Orthop. 18 (5) (1998) 561–571. [10] S.E. Klepper, Measures of pediatric function: Child Health Assessment Questionnaire (C-HAQ), Juvenile Arthritis Functional Assessment Scale (JAFAS), Pediatric Outcomes Data Collection Instrument (PODCI), and Activities Scale for Kids (ASK), Arthritis Care Res (Hoboken) 63 (Suppl. 11) (2011) S371–S382. [11] S. Kuhle, et al., A cross-sectional study evaluating post-thrombotic syndrome in children, Thromb. Res. 111 (4–5) (2003) 227–233. [12] E. Sabaté, World Health Organization, Adherence to long-term therapies: evidence for action, Geneva: World Health Organization. (2003) xv (198 p). [13] T.T. Biss, et al., The use of elastic compression stockings for post-thrombotic syndrome in a child, Pediatr. Blood Cancer 53 (3) (2009) 462–463.

Madeline I. Montoya Maria Laura Avila Department of Pediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada Jennifer Vincelli Department of Nursing, The Hospital for Sick Children, Toronto, Ontario, Canada Suzan Williams Leonardo R. Brandão⁎ Department of Pediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada ⁎Corresponding author at: Department of Pediatrics, The Hospital for Sick Children, Toronto, Ontario M5G-1X8, Canada. E-mail address: [email protected] (L.R. Brandão). 22 April 2016 Available online 14 June 2016