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Back to Journal »Patient Preferences and Compliance» Volume 15

Improving compliance with compression stockings in patients with chronic venous insufficiency and venous ulcers of the lower extremities: scope review

Author: Bar L, Brandis S, Marks D 

Published on September 17, 2021, the 2021 volume: 15 pages 2085-2102

DOI https://doi.org/10.2147/PPA.S323766

Single anonymous peer review

Editor who approved for publication: Dr. Johnny Chen

Laila Bar, 1 Susan Brandis, 1 Darryn Marks 2 1 Department of Occupational Therapy, School of Health Sciences and Medicine, Bond University, Queensland, Australia; 2 Department of Physiotherapy, Bond University, School of Health Sciences and Medicine, Queensland, Australia) Low. Poor compliance with compression stockings can lead to VLU recurrence and impaired healing. Therefore, the purpose of this review is to report the scientific evidence related to compliance and to explore the variable factors that affect the compliance of compression stockings. Method: A system search was conducted from the beginning to October 31, 2019. Follow the PRISMA-ScR checklist and use search terms to explore PubMed, Medline, CINAHL, Cochrane, Embase, OT Seeker, and Web of Science: compression/compression stockings/compression clothing/compression socks/stockings/clothing and compliance/compliance Sex/consistency. Results: We identified 2613 papers, of which 125 full-text papers were assessed as qualified and 69 papers met the inclusion criteria. The thesis is grouped and diagrammed according to the concepts related to the research question, and narrative synthesis is carried out. Several main themes emerged and a conceptual framework was developed that included modifiable variables, compliance itself, and compliance-related results. With special consideration of interventions to improve compliance, only 5 out of 14 randomized controlled trials were able to prove that compliance was improved through a one-dimensional approach. All nine case studies/series show a positive impact on compliance, and eight of them describe a multidimensional approach to personalization. The lack of consensus on defining, measuring, and quantifying the compliance of compression stockings has led to large differences in reported compliance rates. Conclusion: The inconsistency in the definition and measurement of compliance limits the meaningful interpretation of the literature. No individual intervention has consistently shown improved compliance. Multidimensional interventions show promise, but high-quality trials are needed for further investigation. Improving compliance seems to improve the health outcomes of the VLU/CVI population, but there is a lack of information directly linking improved compliance to cost outcomes. Trial registration: Open Science Framework: ACTRN12620000544976p. Keywords: scope review, compression stockings, compliance, leg ulcers, chronic venous insufficiency

Venous leg ulcers are open ulcers on the skin of the lower legs. They are usually painful, slow to heal, and expensive to treat. Wearing elastic stockings is the best treatment to cure and prevent ulcers, but some patients do not wear elastic stockings as much as possible. In other words, compliance with recommended treatment is very low. The literature was reviewed to find out what is known about the subject and what is missing. We found that researchers try to improve compliance by wearing compression stockings, but are still exploring ways to improve compliance, because everyone does not wear them for different reasons (obstacles). Where the author identified individual barriers and then developed personalized and multi-dimensional interventions, higher compliance rates were found. However, this can be difficult when dealing with large numbers of people. Interventions that can be applied to a large number of people are needed, and the patient’s barriers are first identified before developing a personalized treatment plan. There is almost no consistency in the way of scoring or measuring compliance. In order to enable future researchers to compare studies, it would be beneficial to use a consistent way to score and measure compliance.

Venous leg ulcers (VLU) are open skin wounds caused by high blood pressure in the legs. 1-3 are most common in the elderly with chronic venous insufficiency (CVI), they follow long-term healing and relapse 2-4 and may become chronic for many years. 4 VLU can cause pain, loss of function and pain. 4-6 International prevalence studies estimate that 1.5 to 3.0 people per 1,000 people have active leg ulcers. 4 Medically prescribed compression stockings are the gold standard for long-term management of CVI, which can cure and prevent VLU. 1,7-9 compression can reduce vein dilation, help calf muscle tissue to pump blood against gravity and reduce edema. 10 VLU is more likely to relapse in the following cases. Patients who do not comply with compression therapy. 11 Adherence rates of 12% to 52%12 indicate that many patients do not receive health benefits from compression therapy. Poor compliance also has a big financial impact. 13 In Australia, if compression stockings are used as prescribed, it is estimated that the cost of curing VLU can be reduced from 10743 Australian dollars per patient to 3883 US dollars. 14 In addition, if compression stockings were provided to all affected people, it would cost an additional A$270 million for individuals nationwide, but would save A$1.4 billion in five years. 15

It is widely documented in the literature that there are many unalterable barriers to the wearing of compression stockings, including human-related factors such as age, educational background and cognition, and environmental factors such as climate and income. 4,16 Acknowledge that although these variables may change, such as moving to a cooler climate, these variables are basically fixed during any patient intervention. On the other hand, other variables are easier to modify during intervention and can be resolved by clinicians and researchers, such as stocking type, stocking education, and use of auxiliary equipment. Many variables have been described, but to date, the literature related to these factors has not been extensively synthesized.

Improving compliance with compression therapy provides an opportunity to reduce the personal health burden that VLU brings to patients and benefit the wider society economically. However, it is not clear how to do this. The 2016 Cochrane review of interventions to improve compliance with compression therapy in patients with VLU resulted in only three randomized controlled trials (RCTs). They concluded that there is a lack of high-quality trials and they are not sure whether any interventions will help. Other comments on this topic provide some potential insights, although they encompass a wider patient population than VLU and/or a wider area of ​​compliance than compression therapy. A comment17 focused on the impact of compression levels on the post-thrombosis and VLU population, and found that the lower the compression level, the higher the compliance. Another18 takes a more multi-dimensional perspective by investigating the reasons why patients do not adhere to compression therapy, lifestyle advice, and exercise. They concluded that both the patient’s perceived pain and professional advice affect compliance and indicated the need for a multidimensional approach. These authors11, 18 do not have comprehensive data on the efficacy of interventions aimed at compliance. An earlier literature review as of 2005 synthesized various research designs on compliance interventions, and revealed some support for multidimensional approaches to improve compliance, but again includes compression, leg exercises, and elevations. Compliance standards. 11 Therefore, to ensure that clinical practice is up-to-date and research gaps are targeted, extensive and current literature is required, especially regarding compliance with compression therapy in VLU.

There are also ambiguities in the definition and measurement of compliance. 11 The literature refers to compliance differently as "compliance" or "consistency". In the medical context, these terms indicate the degree to which the patient follows the treatment instructions. 19 In the context of pressure wear, the term "compliance" is preferred because it means non-judgment; "statement of fact attributable to the patient, prescriber, or compression therapy rather than blame." 17 Some people suggest that compliance should be “defined specifically for specific situations, and acceptable compliance parameters should be carefully described”20, but the literature suggests that there is a lack of standardization of healthy behaviors. 20

Sock compliance can be used as a two-variable measure, that is, the number of days to wear elastic stockings per week and the number of hours per day, but the way researchers measure it lacks consistency. 21 The lack of clarity and consensus definitions and scoring methods may confuse the interpretation and generality of clinical research results. 22 This highlights the need to extensively review the compliance literature of the VLU and CVI patient groups to describe and synthesize the definition of compliance and its measurement to inform the methodological quality of future research.

Therefore, the purpose of this scope review is to report on the scope and breadth of the literature specifically related to VLU and CVI, which involves persistent use of compression stockings, especially in relation to interventions, and how to measure and define this phenomenon. This will be the first scoping review specifically aimed at improving compliance with compression therapy in the VLU and CVI population.

What factors and interventions have been reported in the literature to try to improve the compliance of compression stockings? How is compliance defined in the literature, and how is compliance reported and measured in the VLU and CVI population? How does compliance affect the prognosis of patients? What knowledge gaps currently exist?

In order to make the research library cohesive and understand the breadth of the areas that affect compliance with compression therapy, a scoping literature review was selected. 23 Due to the exploratory nature of the subject, this approach will allow collation of information from multidisciplinary knowledge systems and allow mapping of key concepts and knowledge gaps.

PRISMA Scope Review Extension (PRISMA-ScR): Checklists and explanations 24 are used. A health librarian and a second reviewer support this process.

An a priori agreement was developed and released on the open science framework:

https://mfr.osf.io/render?url=https://osf.io/egn53/?direct%26mode=render%26action=download%26mode=render

The design consists of two phases. First, the search strategy adopted the methodological framework of Arksey and O'Malley25, using an iterative approach to allow a comprehensive review, aimed at identifying all relevant literature, regardless of the research design. After analyzing the literature, a conceptual framework was subsequently developed, using Jabareens' method26 to link multidisciplinary knowledge systems.

Using the PCC (Population/Concept/Background) framework, 27 eligibility criteria are defined as: population (including the target population with VLU or CVI), concepts (including any research that investigates modifiable variables related to the use of compression stockings as the research Direct results, accidental discoveries or expert comments, and background (including any research with any research design and publication date). Including articles and meeting minutes published in English.

The exclusion criteria are a) studies that pay special attention to short-term/limited time wearing compression stockings, such as during pregnancy, for the treatment of deep vein thrombosis, "flying stockings", TED (thromboembolic device), burns and vein surgery, b) only Focus on the treatment of lymphedema, c) focus only on unchangeable variables (such as climate, cognitive ability, access to stockings, religious or ethnic variables, etc.), d) use languages ​​other than English, e) are books, patents or web pages , F) The compression described is only provided by other means, such as bandages, wrapping systems or intermittent pneumatic pumps, and f) no full text. Those papers that did not meet the criteria were deleted. Subsequently, the full text of the remaining studies was obtained and screened to determine eligibility.

The following e-book databases were searched: Medline, PubMed, CINAHL, Embase, Cochrane, Web of Science, Google Scholar and OT Seeker. The search strategy was peer reviewed by expert health librarians. The date of the search is from the beginning of the database to the final date of the search (October 25, 2019). Download references from electronic search engines, enter them into Excel spreadsheets, and then transfer them to the electronic bibliography system (ENDNOTE). The terms used in the search are as follows: compression/compression stockings/compression clothing/compression stockings/stockings/clothing and compliance/compliance/consistency. Although we were particularly interested in VLU, we began to look for a wider range of lower extremity vascular conditions. The initial search using the MESH term venous leg ulcer and chronic venous insufficiency ruled out many related articles. When included as an "or" MESH term, the number of meaningless articles is determined, so each article needs to be manually evaluated based on the parameters of this review. This allows us to include papers that may have research results transferable to a wider population. Then narrow the scope to include only those with CVI or VLU. The two stages of snowballing are to complement our search strategy.

Since the scope and nature of the available evidence are not known in advance, as data is extracted and tabulated, the development of categories and groups for mapping purposes is iteratively developed. See Appendix 1 for the data extraction template. Consistent with Jabareen's method, 26 data is narratively synthesized according to the categories defined in the mapping process to allow flexibility in theme development, so that the data remains consistent. A conceptual framework is reasonably constructed around the subject of compliance. 26,28 Using bibliographic analysis, papers are grouped by year of publication and further classified using a pyramid of evidence levels. 29 Because we are particularly interested in finding out whether any interventions can affect compliance, and further analyzing RCTs and case reports/series to solve research questions. Use frequency for analysis, supplemented by narrative comments. To maintain consistency, data on compliance rates were converted from raw scores to percentages for comparison between studies.

Of the 2613 articles that were initially identified through the application of search terms, 69 references were finally included for analysis. Figure 1 illustrates the flow chart of the constructed PRISMA-ScR. 24 Appendix 2 provides an overview of the included studies. The initial use of the MESH term venous ulcers and chronic venous insufficiency of the lower extremities was too narrow to search out many related articles. When included as an "or" MESH term, the number of meaningless articles is determined, so each article needs to be manually evaluated based on the parameters of this review. After preliminary screening of titles and abstracts, the original number was reduced to 282. Then came the two separate stages of snowballing. Manually filtering the reference list from the full-text articles, resulting in 54 more articles. After the first stage of Snowball, 48 duplicate articles were deleted, and after the second stage, 107 articles that did not meet the inclusion criteria were deleted. In the end, 126 full-text articles were printed and evaluated for eligibility. A total of 57 articles were excluded (see Figure 1 for reasons). This left 69 articles that met the eligibility criteria. Figure 1 Research flow chart (PRISMA-ScR flow chart 24). Adapted from Tricco AC, Lillie E, Zarin W, and others. PRISMA Scope Review Extension (PRISMA-ScR): Checklist and explanation. An intern doctor. 2018;169(7):467–473.

Figure 1 Research flow chart (PRISMA-ScR flow chart 24). Adapted from Tricco AC, Lillie E, Zarin W, and others. PRISMA Scope Review Extension (PRISMA-ScR): Checklist and explanation. An intern doctor. 2018;169(7):467–473.

Since 1991, the number of publications has steadily increased (Figure 2). From 2011 to October 2019, a total of 38 articles that met the inclusion criteria were published. No papers before 1991 were found. Figure 2 The number of publications in the year from the beginning to the end of the search.

Figure 2 The number of publications in the year from the beginning to the end of the search.

The 69 included papers were grouped using the evidence hierarchy 29 (Figure 3). Four systematic reviews, three rigorously evaluated topics, 14 randomized controlled trials, 17 prospective cohort designs, 5 retrospective cohort designs, nine case studies/reports, 13 background papers, and four based on interviews were identified The qualitative design. Figure 3 Count of publications organized by level of evidence.

Figure 3 Count of publications organized by level of evidence.

The themes that appear logically by defining the multidisciplinary knowledge system are visually represented in the conceptual framework (Figure 4). These topics are shown below, consistent with research questions 1-3. Research question 4 (knowledge gap) runs through. Figure 4 Conceptual framework for compliance.

Figure 4 Conceptual framework for compliance.

Question 1: What factors and interventions are reported in the literature to try to improve the compliance of compression stockings?

Various interventions have been studied, but the reported compliance results did not show a consistent or clear preference for any intervention. Therefore, the current evidence does not support any intervention in other people. The factors reported to improve patient compliance are divided into three main themes: a) the way healthcare professionals (HCP) interact with patients, b) the design of education delivery, and c) changes in the application and removal of stockings. Most studies with larger cohorts tried to improve stocking compliance through one-dimensional methods, but the reported impact was limited. In contrast, some smaller studies (N=1-4) generally report the positive impact of personalized, multidimensional approaches on compliance. Table 1 summarizes the results of interventions on compliance. Table 1 The impact of intervention on compliance

Table 1 The impact of intervention on compliance

a) 14 articles 6, 21, 30-41 discuss how HCP affects compliance. Mainly discussion articles (N=12), only two (case studies)30,32 attempt to directly influence compliance. A comment38 investigated the compliance of socks after VLU healing, suggesting that HCPs should ensure that their communication enhances the perceived value of compression stockings to improve compliance. A case study 30 describes how a patient’s cure rate can increase when a patient has more control over her care through a partnership with the nursing team. Another study32 emphasized the contribution of encouraging patient health ownership, which promotes autonomy, compliance and better outcomes. In four articles, the establishment of partnerships between HCP and patients is particularly recommended. 30,38,40,41 This is a situation where a care plan is negotiated. The HCP will consider the patient's knowledge, experience, beliefs, and practical needs. Mentioning emotional terms such as empathy, 33 honesty, 34 and mutual respect 32, several papers 21, 34, and 36 argue that patient-centered care is the gold standard to be achieved. The concept of developing non-judgmental relationships has also been recognized. 6,18,31

b) Among the educational themes, four studies 41-43,60 used various methods aimed at improving compliance. A quasi-RCT43 showed the benefits of using pamphlets to improve patient knowledge, which reported that this resulted in higher compliance. A prospective cohort study60 reported that the results will vary depending on the source of the information provided. The study reported that compared with general practitioners (67%), patients treated by vascular specialists (93% compliance) had higher compliance. An RCT42 concluded that after repeating HCP recommendations and mobile phone text messages reminders, the compliance of the control group increased from 33% to 48%, and increased to 71% in the intervention group. A prospective cohort intervention led by nurses41 used education as the main tool to improve the conservative management of VLU. The report stated that education provided a way to positively influence participants’ general compliance with lifestyle recommendations, but did not increase the time to wear elastic stockings.

c) 14 articles 45-58 reported that participants’ ability to manage the task of applying or removing stockings was used as an influencing factor for compliance. The difficulty of putting on and taking off compression stockings is a known compliance disorder. 54 It is clinically recognized that some socks are easier to wear than others (eg lighter pressure). 57,58 In addition, certain physical properties increase the difficulty of application, (for example, a lower body mass index). 55 Twelve studies reported interventions that tried to improve compliance by changing the specific characteristics of the stockings themselves. Three studies 49, 51, and 56 compared mild (level 1) and moderate (level 2) compression. The Rees49 case study documented that lighter compression improved compliance, while the other two studies did not report statistically significant results. (Suehiro56 did not disclose the results. Clarke-Moloney51 reported P=0.760). Three further studies 45, 57, and 58 compared moderate (level 2) and high (level 3) compressions and supported the widely held hypothesis that higher compressions are less tolerant and more difficult to apply , Although Milic’s study 45 did not report statistical significance P=0.188. Nelson57 recommends that patients wear the highest level of pressure that is comfortable for them. Two studies comparing different brands of stockings52,53 show that there is no difference in adherence rates, and neither is easier to use than the other. An RCT50 compares decreasing stockings (tighter calves and looser ankles) with progressive stockings (standard classification-tight ankles and looser calves). It is found that decreasing stockings are easier to apply, but Does not significantly improve compliance. Other papers 46-48 discuss alternative methods of applying compression stockings, such as changing the sock design or adjustable pressure wrap, and suggest that these may help improve the compliance of some patients who have difficulty using standard graded compression stockings. The remaining papers include a qualitative analysis using structured interviews55 and a literature review, in which the author54 recommends that all patients should be educated in the application of compression stockings and provide them with application equipment when needed.

Real-world studies (such as case studies) may provide evidence of the effectiveness of interventions in clinical practice,59 although RCTs are considered the gold standard for evaluating the effectiveness of interventions. Taken together, these different research types can provide a deeper understanding of interventions. 59 Further analysis of 69 articles identified 23 studies that attempted to directly affect compliance by modifying one or more variables, including 14 RCTs42,43,45,50–53,57,58,60–64 and nine Case study (or case series). 30, 32, 46–49, 65–67 These are classified according to the research design and the number and type of modified variables. The variables investigated are shown in Figure 5. Figure 5 Variables investigated in RCT and case studies/series.

Figure 5 Variables investigated in RCT and case studies/series.

All RCTs have modified a variable in their research design, that is, they are one-dimensional. Five of the 14 RCTs described the increase in compliance after the intervention. One42 is related to educational variables, and Three45,57,58 provides evidence that reducing compression strength may increase compliance but increase the risk of VLU recurrence. In a study comparing stress levels to compliance64, the level 3 group showed better compliance than the two types of bandages, although no significant data were provided. Nine case studies/series describe successful attempts to influence compliance. Six of the studies 46-49, 66, 67 used personalized and novel clothing prescription methods (velcro wraps, grip tops, zippers, and compression bags), while 330, 32, and 65 advocated personalized collaboration methods to make medical Professionals and important other people of the patient participate in the care. Eight of the nine case studies/series 30,32,46–49,65,66 reported personalized multidimensional interventions that modified at least two variables in the treatment plan.

Question 2: How to define compliance in the literature, and how to report and measure compliance in VLU and CVI populations?

The included studies provided variable and sometimes conflicting descriptions of compliance, which depended on related concepts of definition, measurement, and ratios. Fourteen studies9,38,41,42,44,61,63,68-74 considered compliance as the primary outcome indicator, while the remaining studies discussed compliance as a secondary outcome indicator or discussion point. There are 30 studies that report the rate of compliance with numbers as a result of the study. The eight studies that provided compliance rates7,9,42,60,68,72,75,76 did not give a clear definition of compliance. Research uses measurement scales (dichotomies or intervals) and/or prescribed thresholds to define compliance through various fields (compliance or broader grouping with other factors). Table 2 summarizes a meaningful sample of this information. Definition of compliance: The way in which compliance is defined varies greatly. Only 28 of the 69 studies described their determination of compliance, and three of them 31, 56, 58 did not describe how they measured it. Domain: Most studies only report compliance with stress wear, while some studies have broader definitions, including, for example, attending appointments, wound care, exercise, and leg elevation. 41,60,61 Scale: Those who provide compliance rate (N=30), most (N=18) 12,16,44,45,56–58,60,62,63,68,73,74, 77–81 recorded whether their participants complied or disobeyed the dichotomy. In other words, participants must either follow the prescribed wearing protocol or not. 11 studies described an interval scale 9, 38, 42, 51, 52, 61, 69, 71, 72, 82, 83, ranging from three to eight levels, but only two of them 38,51 explained their Which levels are then classified as compliance or non-compliance. For example, Ayala69 uses a 4-level interval scale to classify stocking wear, but does not describe which level is classified as compliance and non-compliance. Threshold: Considering changes in behavioral standards for compliance or non-compliance classification. A study that assesses compliance with doctors’ instructions81 requires 100% compliance, while other studies12,51 have broad categories, but the threshold score is not clearly defined. For example, a study considering buying stockings is compliance. hypothesis of. 71 Assume that the stricter the parameters that define compliance, the lower the reported compliance rate. For example, in Hanley's study, 77 participants were classified as compliance if they wore stockings 4-7 days a week. Similarly, Kapp's 58 RCT classifies compliance as wearing stockings for more than 50% of the study days. However, the Franks52 study investigated the VLU recurrence rate of patients who wore any of two different brands of stockings. If they “wore their stockings all day every day”,52 it indicated that their study participants needed to wear harder. The system can be classified as a "adherent." Measurement: Eight studies 9, 30, 44, 45, 60, 72, 78, 81 are completely dependent on the observation of clinicians (nurses or doctors), while 15 studies 12, 16, 38, 41, 51, 52, 61 , 62, 69, 70, 73, 74, 79, 80, 82 Rely on patient self-reports provided verbally or through questionnaires or diaries. Three studies 57, 71, and 77 combined observation and self-reporting. Heat tracking devices and patient self-reports were used in three studies. 42,63,68 Six studies did not disclose how their information was recorded or collected. 7,56,58,64,75,76 Table 2 Compliance: measurement, scale, requirements and ratios to achieve compliance

Table 2 Compliance: measurement, scale, requirements and ratios to achieve compliance

The compliance rate ranges from 20.3% to 95%. Due to the variability of definitions and measurements, the reliability of the reported compliance rate (reported in Table 2) is limited.

Question 3: How does compliance affect patient outcomes?

Different compliance with doctor's orders for elastic stockings can affect a person's physical, social and psychological conditions in various ways. 58 The findings are divided into three key themes that often appear in the literature, linking compliance with 1) VLU healing time/relapse, 2) patient’s quality of life, and 3) cost.

Table 3 includes and summarizes studies considering the link between persistent stockings and VLU healing and recurrence. 15 items meet these criteria, 8 of which are RCTs, 45,51,52,57,58,60,61,64 1 is a systematic review, 84 one 85 provides background information, and the other is a case series report 66, The remaining four are observational studies. 9,77,78,81 All reported that low compliance with stockings was associated with delayed VLU healing and increased recurrence. Hanley77 reported that 25% of those who followed at the 2-year follow-up had poor continuity After-effects, the proportion of non-compliant people is 53%. In Mayberry's study, 78 VLU healing occurred in 97% of adherents and 55% of non-adherents, and all non-adherent patients had recurrence of ulcers at 36 months. Moffat's 2009 review85 determined that 6 of the 10 included studies reported that the time to complete healing was twice as long when patients did not comply. In addition, if non-adherent heals, the recurrence rate will be 2-20 times higher. Evidence clearly shows that adherence to compression therapy is essential for the healing and prevention of VLU, and the tighter the compression, the better. 45,51,84 Table 3 Persistence and reference healing time and recurrence

Table 3 Persistent and reference healing time and recurrence

Seven papers 6, 41, 42, 55, 63, 75, 80 discussed patient quality of life (QoL) as a measure of clinical outcome for wearing compression stockings, but only three of them 42, 63, 75 used validated assessments Tools, as well as compliance and QoL are not well explored. A paper reported that patients felt that compressions were “inconvenient and have doubts about improving the quality of life”. 55 However, this is an exception because other included studies have positively confirmed QoL. Motykie75 reported that when they started wearing compression stockings, patients became less frustrated with the appearance of their legs, began to sleep more regularly, and began to increase their daily activity levels. Uhl42 used a thermal sensor to verify the patient’s self-report and found that there was a significant correlation between the wearing time and the two parameters of the QoL questionnaire: psychological and social parameters (both P<0.001), but it was not found to be related to physical or pain parameters. Include Only four of the papers made meaningful comments on costs. 7,9,16,32 Murdoch32 reports that the prevention of VLU is usually more cost-effective than the management of the resulting disease.

This is the first scoping review on the breadth of the literature on the persistence of compression stockings by the VLU and CVI population. The themes that emerged from the literature and presented in the conceptual framework (Figure 4) revealed several key findings.

First, with regard to variables that increase compliance, large-scale research reports investigating single-dimensional methods have hardly been successful. In contrast, although there is less research on multidimensional methods, it has a greater impact on improving compliance. Since most patients with low compliance usually have multiple barriers when wearing compression stockings, 86 studies that modify only a single variable may not affect the proportion of study participants not related to that single variable. Multiple factors may also affect compliance, so interventions for a single variable may be doomed to failure. By acknowledging the complexity of the individual and his environment, this view is echoed in recommendations for the management of other chronic diseases, including diabetes87 and chronic kidney disease88. The literature that studies single-dimensional methods lacks relevance to clinical doctors who collect information from multiple areas in the evaluation. Van Hecke's 2009 literature review18 provided early support, suggesting that future attempts to solve the complex problem of low stocking compliance should focus on considering comprehensive multi-dimensional packaging and personalizing it according to individual needs. In addition, neither single-dimensional or multi-dimensional studies that attempt to improve compliance can show a clear preference for any intervention. Clinicians need to have a greater evidence-based basis for improving the compliance of compression stockings, so further in-depth research on patient-centered multi-dimensional methods is needed.

Second, the lack of a consistent definition of compliance and measurement parameters supports the wide range of compliance rates reported in the literature, and it also creates obstacles to clinical practice and research. For example, when stricter parameters must be adhered to in order to meet compliance standards, lower compliance will be reported, and the opposite relationship will also exist. Moffatt 85's 2009 literature review came to similar conclusions, attributing the wide differences in reported compliance rates to background differences between trials. The dichotomy report of compliance may reduce the sensitivity of its measurement, but the interval scale used so far lacks justification or explanation for defining the threshold of compliance. Patient self-report is the main method to measure compliance, although there are concerns about the effectiveness of this method due to the risk of memory bias and the susceptibility to social needs. 89 There is indeed a superior Thermotrackers method, but it cannot be used in all climates. 42,68 and its use may cause unacceptable costs to researchers. Van Hecke's 2009 literature review reported a study on the reasons for low-stocking compliance, which is consistent with the results of this review, in which the study showed poor compliance in the definition and operation of compliance. 11 Defining the clarity and consistency of compliance behavior may undermine the reliability and validity of research results.

Finally, a survey of compliance results showed that increased compliance is associated with improved health outcomes, which is consistent with previous authors. 41,42 Although cost is important, only 4 of the 69 studies included in this review reported this relationship. Some authors4,14 have reported a link between increased stocking compliance and reduced health costs, but health economics evidence on this link is still scarce. There is evidence that due to the negative correlation between VLU and QoL, the quality of life of people who insist on using compression stockings may improve, 90 and because of better compliance, the cure rate will increase and the relapse rate will decrease. 9 ,58,77 However, the information contained in this review is very limited. Therefore, future research needs more information on the economic impact of quality of life and increased compliance to better provide information for policies and funding in this area.

Several key gaps in the literature have been identified. It is clear from this review that there is a lack of consistency in defining the compliance of compression stockings, as well as inconsistent methods of measuring compliance. Changes in the behavioral standards determined by compliance or non-compliance between studies limit our confidence in making comparisons. The literature also shows that in a population where each participant is unique to stress therapy and often has multiple barriers, there has been limited success in improving compliance with compression stockings. Individualized multi-dimensional treatment methods have shown promise in small studies, but have not yet been implemented in large populations. The health economic outcomes associated with different levels of compliance have not been fully explored. The link between quality of life and compliance has also not been clarified.

A consistent definition of compliance and scoring system will allow for improved comparisons between studies, such as standardized tools for measuring medication compliance. 91 A more sensitive tool with an interval scale is needed. A personalized, multi-dimensional approach may be more likely to improve compliance. Future attempts to solve this complex problem should focus on considering multi-dimensional packages that are personalized according to individual needs. Considerations include education, negotiation, and tailor-made socks selection based on the patient's tolerance to pressure and their ability to put on and take off socks. In addition, it is recommended to conduct high-quality trials to investigate the cost-effectiveness of such interventions to improve our understanding of the financial impact and take into account any perceived patient and social benefits.

One of the strengths of this review is its breadth and overview of the topic, as well as the synthesis of new information to help understand the adherence to compression in this patient group.

This review also has some limitations. First, some factors that may affect compliance are unchangeable during the intervention, such as climate, cognitive abilities, and religious beliefs. These factors are excluded. This is a deliberate decision to focus the review results and conclusions on modifiable factors that can better be positioned for follow-up clinical research. Finally, the search is limited to English, because language translation is beyond the scope of this work. The other three studies 92,93,94 that met the inclusion criteria appeared in Appendix 2, but were not cited in other tables or key topics in this review.

The often opaque and inconsistent ways of measuring and defining compression stocking compliance currently limit meaningful comparisons between studies and reduce the potential impact of clinical trials trying to improve compliance. Various interventions have been studied, but none of them have shown clear or consistent advantages over other interventions. RCT has generally studied single-dimensional interventions, but it has failed to improve compliance. Multidimensional interventions have proven to have a more positive impact on compliance, but so far have only been investigated in smaller cohorts, case series, or case studies. Improving compliance seems to improve the health outcomes of patients with VLU/CVI, but there is a lack of information directly linking improved compliance with cost outcomes. Therefore, the current evidence base provides little support for clinicians seeking to improve patient compression compliance. High-quality multi-dimensional intervention trials are required for compliance, with clear definitions and simultaneous cost assessments.

CEAP, Chronic Venous Disease Classification System; CS, Compression Stockings; CVI, Chronic Venous Insufficiency; HCP, Healthcare Professionals; N, Quantity; OTS, Ready-made; QoL, Quality of Life; RCT, Randomized Controlled Trial; V, Yes ; VAS, visual analog scale; VCSS, venous clinical severity score; VLU, lower extremity venous ulcer.

Bronwyn Linthwaite. The Director of Health Sciences and Medicine at Bond University Library assisted in document retrieval.

The authors report no conflicts of interest in this work.

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