Graduated compression stockings for the initial treatment of varicose veins in people without venous ulceration.

BACKGROUND: Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. This is the second update of a review first published in 2011. OBJECTIVES: To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in people without healed or active venous ulceration. SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 May 2020. We also checked references of studies identified from the literature searches. SELECTION CRITERIA: We included randomised controlled trials (RCTs) involving people diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment or placebo stockings, or compression stockings plus drug intervention versus drug intervention alone. We also included trials comparing different lengths and pressures of stockings. We excluded trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. Two review authors independently assessed trials for inclusion, extracted data, assessed risk of bias and assessed the certainty of the evidence using GRADE. Outcomes of interest were change in symptoms; physiological measures; complications; compliance; comfort, tolerance and acceptability of wearing stockings; and quality of life. MAIN RESULTS: We included 13 studies with 1021 participants with varicose veins without healed or active venous ulceration. One study included pregnant women while other studies included participants who had sought medical intervention for their varicose veins by being on surgical waiting lists, or attending vascular surgery or dermatology clinics or outpatient departments. The stockings used in the studies exerted different levels of pressure, ranging from 10 mmHg to 50 mmHg. Five studies assessed compression stockings versus no compression stockings or placebo stockings. Three of these studies used knee-length stockings, one used full-length stockings and one used full tights. Eight studies compared different types or pressures of knee-length stockings. The risk of bias of many included trials was unclear, mainly because of inadequate reporting. We were unable to pool studies as they did not report the same outcomes or used different ways to assess them. Many studies were small and there were differences in the populations studied. The certainty of the evidence was therefore low to very low. Compression stockings compared with no treatment or placebo stockings All four studies that reported change in symptoms found a subjective improvement by the end of the study. However, change in symptoms was not always analysed by comparing the randomised arms of the studies and was therefore subject to bias. Two studies assessed physiological measures using either ankle circumference or duplex sonography to measure oedema. Ankle circumference showed no clear difference between baseline and follow-up while oedema was reduced in the stocking group compared with the placebo stocking group. Three studies reported complications or side effects with itching and irritation the main side effects reported. None of the trials reported severe side effects. Reports of compliance varied between studies. One study reported a high dropout rate with low levels of compliance due to discomfort, application and appearance; two studies reported generally good levels of compliance in the stocking group compared to placebo/no treatment. Two studies reported comfort, tolerance and acceptability with outcomes affected by the study population. Compression tights were increasingly rejected by pregnant women as their pregnancy progressed, while in one study of non-pregnant women, the stockings group showed no more hindrance of normal activities and daytime discomfort when compared with placebo stockings. One study reported quality of life showing no clear differences between the stocking and placebo stocking groups. Compression stockings compared with different compression stockings All five studies that reported change in symptoms found a subjective improvement in symptoms by the end of the study. Change in symptoms was not always analysed comparing the randomised arms of the trials and was therefore subject to bias. Five studies reported a variety of physiological measures such as foot volumetry, volume reduction and change in diameter. Generally, there were no clear differences between study arms. Four studies reported complications or side effects, including sweating, itching, skin dryness, and constriction and tightness. None of the trials reported severe side effects. Two studies reported compliance showing no difference in compliance rates between stockings groups, although one study reported high initial levels of dropout due to discomfort, appearance, non-effectiveness and irritation. Four studies reported comfort, tolerance and acceptability. Two studies reported similar levels of tolerance and discomfort between groups. Discomfort was the main reason for indicating a preference for one type of stocking over another. None of the studies assessed quality of life. No conclusions regarding the optimum length or pressure of compression stockings could be made as there were no conclusive results from the included studies. AUTHORS' CONCLUSIONS: There is insufficient high-certainty evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of large RCTs of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place.

Health utilities in relation to treatment response and adverse events in relapsed/refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma.

New therapies for relapsing/refractory Hodgkin lymphoma (R/R HL) and R/R systemic anaplastic large-cell lymphoma (sALCL) have emerged. This study captured utility values for R/R HL and sALCL to support economic evaluation. Health state "vignettes" were developed describing states associated with R/R HL and sALCL: treatment response (complete or partial response), stable and progressive disease and treatment-related adverse events (B-symptoms, acute/chronic graft-versus-host disease [GVHD] and peripheral neuropathy). Vignettes were evaluated by members of the public in the UK, Australia, Taiwan, Thailand, South Korea, Brazil and Mexico using the time trade-off method. Mean utilities varied substantially. Complete response utility scores were UK: 0.906, Australia: 0.889, Taiwan: 0.597, Thailand: 0.728, South Korea: 0.827, Brazil: 0.764, Mexico: 0.728. Adverse events were associated with disutility: acute GVHD, lowest mean utility value: Thailand 0.124; highest value: Mexico 0.467. Societal evaluation of health states for R/R HL and sALCL revealed a marked perceived benefit of a treatment response.

Health state utilities for chronic lymphocytic leukemia: importance of prolonging progression-free survival.

Chronic lymphocytic leukemia (CLL) is a largely incurable disease which affects patients' health related quality of life (HRQL). Treatment is often initiated when symptoms affect HRQL, and patients can experience many rounds of treatment throughout their life. Therefore, the economic burden of CLL can be high. Utility or preference weights for health states reflect the value of HRQL of a given health state and range from 1 (full health) to 0 (dead) and below (negative values possible). Nine health states were developed representing different CLL treatment lines or disease stages. One hundred members of the UK general public valued each health state using the time trade-off methodology. Progression-free survival (PFS) without therapy (mean utility = 0.82) was the least burdensome, with relapsed lines of treatment (mean utility = 0.42) representing the greatest burden. The results underline the value in maintaining a state of PFS for as long as possible.

Treatment preference, adherence and outcomes in patients with cancer: literature review and development of a theoretical model.

OBJECTIVE: A patient's preference may guide their behavior and influence their willingness to take medication or undergo treatment affecting outcomes, such as health-related quality of life, or survival. The importance of understanding patient preferences within oncology is unclear and few adherence studies exist compared with other therapeutic areas. RESEARCH DESIGN AND METHODS: This study was designed to review the literature regarding patient preferences, adherence and their link to outcomes specifically in the oncology setting and to propose a theoretical model. An in-depth review was conducted, using Embase, MEDLINE and Cochrane Library databases to search for published data examining patient preference, adherence and oncology-specific outcomes, from 1982-2012. Articles were reviewed independently by two authors and rated for relevance and quality. Information from high-quality articles and discussion with oncology and patient preference experts were used to identify associations between important individual concepts as a basis for a theoretical model. RESULTS: In total, 1362 abstracts were identified. After removal of duplicates and initial review, 1269 were excluded and 93 reviewed in detail. Of these publications, 18 were deemed 'high-quality' and used to develop the final model. Variables associated with patient preference, adherence and outcome were identified. External variables included communication, treatment and mode of administration; patient beliefs and values were identified as cognitive variables; and adherence was attributed as a behavioral variable. Relationships between patient preference, adherence and clinical outcomes were established. Adverse events had a strong relationship with adherence; patient beliefs and values were identified as having a moderating effect on adherence. Adherence behavior had a direct relationship to outcomes. CONCLUSIONS: Improving our understanding of patient preference may improve clinical outcomes in oncology patients. Although the proposed theoretical model is limited, it provides a basis to develop testable hypotheses for the relationships between patient preference, adherence and outcomes specific to oncology.

Compression stockings for the initial treatment of varicose veins in patients without venous ulceration.

BACKGROUND: Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. This is an update of a review first published in 2011. OBJECTIVES: To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in patients without healed or active venous ulceration. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched August 2013) and CENTRAL (2013, Issue 5). SELECTION CRITERIA: Randomised controlled trials (RCTs) were included if they involved participants diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment, compression versus placebo stockings, or compression stockings plus drug intervention versus drug intervention alone. Trials comparing different lengths and pressures of stockings were also included. Trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery, were excluded. DATA COLLECTION AND ANALYSIS: Two authors assessed the trials for inclusion and quality (SS and LR). SS extracted the data, which were checked by LR. Attempts were made to contact trial authors where missing or unclear data were present. MAIN RESULTS: Seven studies involving 356 participants with varicose veins without healed or active venous ulceration were included. Different levels of pressure were exerted by the stockings in the studies, ranging from 10 to 50 mmHg. One study assessed compression hosiery versus no compression hosiery. The other six compared different types or pressures of stockings. The methodological quality of all included trials was unclear, mainly because of inadequate reporting.The symptoms subjectively improved with the wearing of stockings across trials that assessed this outcome, but these assessments were not made by comparing one randomised arm of a trial with a control arm and are therefore subject to bias.Meta-analyses were not undertaken due to inadequate reporting and actual or suspected high levels of heterogeneity. AUTHORS' CONCLUSIONS: There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of a large RCT of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place.

Elicitation of health state utilities in soft tissue sarcoma.

PURPOSE: Soft tissue sarcomas (STS) are uncommon tumours with varying histological subtypes. There is a paucity of available data concerning the quality-of-life (QoL) impact of STS which could be used to support economic evaluation of future treatments. This study aimed to elicit societal utility values for health states that depict the impact of STS and its treatment. METHODS: Following the development of eight health state vignettes, a sample of 100 members of the UK general public participated in a valuation exercise to elicit utility values using the time trade-off procedure. RESULTS: The treatment response state was valued as the least burdensome by participants followed by the prospect of stable disease (mean utility value: 0.736 SD 0.21). Serious adverse events were associated with a range of disutilities from -0.236 for grade III/IV pain to -0.357 for grade III/IV nausea/vomiting. Progressive disease was deemed the least desirable outcome and was associated with a substantial decline in utility (-0.473). CONCLUSIONS: Findings suggest advanced STS are associated with significant burden for individuals. Treatment-related adverse events were seen as debilitating, however, progression represents an enormous challenge to QoL. This illustrates the significant value to individuals of extending the progression free survival period.

Compression stockings for the initial treatment of varicose veins in patients without venous ulceration.

BACKGROUND: Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. OBJECTIVES: To assess the effectiveness of compression stockings for the initial treatment of varicose veins in patients without healed or active venous ulceration. SEARCH METHODS: The Cochrane Peripheral Vascular Disease Group searched their Specialised Register (last searched 31 May 2011) and CENTRAL (2011, Issue 2). In addition, the reference lists of relevant articles were searched. Authors of ongoing and current trials were contacted. There were no language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) were included if they involved participants diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment, compression versus placebo stockings, or compression stockings + drug intervention versus drug intervention alone. Trials comparing different lengths and pressures of stockings were also included. Trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery, were excluded. DATA COLLECTION AND ANALYSIS: Two authors assessed the trials for inclusion and quality (SS and LR). SS extracted the data, which were checked by LR. Attempts were made to contact trial authors where missing or unclear data were present. MAIN RESULTS: Seven studies involving 356 participants with varicose veins without healed or active venous ulceration were included. Different levels of pressure were exerted by the stockings in the studies, ranging from 10 to 50 mmHg. One study assessed compression hosiery versus no compression hosiery. The other six compared different types or pressures of stockings. The methodological quality of all included trials was unclear, mainly because of inadequate reporting.The symptoms subjectively improved with the wearing of stockings across trials that assessed this outcome, but these assessments were not made by comparing one randomised arm of a trial with a control arm and are therefore subject to bias.Meta-analyses were not undertaken due to inadequate reporting and actual or suspected high levels of heterogeneity. AUTHORS' CONCLUSIONS: There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of a large RCT of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place.