TR-06003; No of Pages 4 Thrombosis Research xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Thrombosis Research journal homepage: www.elsevier.com/locate/thromres
Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis Samantha Craigie a,b, Johnson F. Tsui c,d, Arnav Agarwal a,e, Per Morten Sandset f,g, Gordon H. Guyatt a,h, Kari A.O. Tikkinen i,j,⁎ a
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada Michael G. DeGroote National Pain Centre, McMaster University, Hamilton, ON, Canada Department of Urology, North Shore-LIJ Lenox Hill Hospital, New York, NY, USA d Institute for Prostate and Bladder Research, New York, NY, USA e Faculty of Medicine, University of Toronto, Toronto, ON, Canada f Department of Hematology, Oslo University Hospital, Oslo, Norway g Institute of Clinical Medicine, University of Oslo, Oslo, Norway h Department of Medicine, McMaster University, Hamilton, ON, Canada i Department of Urology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland j Department of Public Health, University of Helsinki, Helsinki, Finland b c
a r t i c l e
i n f o
Article history: Received 23 April 2015 Received in revised form 15 June 2015 Accepted 17 June 2015 Available online xxxx Keywords: adherence compliance compression devices foot pumps intermittent pneumatic compression devices stockings, compression surgery thromboprophylaxis thrombosis
a b s t r a c t Background: Many clinical practice guidelines, while recommending mechanical thromboprophylaxis after surgery, have raised concerns that discomfort may result in nonadherence. We therefore addressed adherence to mechanical thromboprophylaxis after surgery. Methods: We searched MEDLINE from January 1, 2000 to May 21, 2015 for English-language observational studies that assessed patient adherence to mechanical thromboprophylaxis after surgery. We conducted a meta-analysis to estimate average adherence rates. Results: We identified 8 studies (7 for compression devices, 1 for stockings) with median follow up time of 3 days. The pooled estimate of adherence for compression devices was 75% (median 78%, range 40%-89%). Studies with shorter follow-up (≤ 3 days, n = 4, pooled adherence 75%) and longer follow-up (N3 days, n = 3, pooled adherence 75%) reported similar adherence (p = 0.99). The studies varied in definitions of adherence, frequency of assessment, length of follow-up and completeness of reporting. No study followed patients after discharge. Conclusions: Up to one fourth of patients are nonadherent to mechanical thromboprophylaxis while hospitalized. Clinicians considering the relative merits of mechanical versus pharmacologic prophylaxis should address the issue of adherence. Strategies to improve adherence merit investigation. © 2015 Elsevier Ltd. All rights reserved.
1. Introduction Venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism, represents a serious, and on occasion fatal, complication of surgery [1,2]. Because randomized trials suggest that mechanical thromboprophylaxis may prevent postoperative VTE, and because they do not incur the bleeding risk associated with pharmacologic prophylaxis, clinical practice guidelines often recommend use of mechanical thromboprophylaxis after surgery [1,3]. In part as a result, these devices, which include elastic stockings and intermittent compression devices, are in wide use [1,2]. (See Table)
⁎ Corresponding author at: Department of Urology, Helsinki University Hospital, Haartmaninkatu 4, 00029 Helsinki, Finland. E-mail address: [email protected] (K.A.O. Tikkinen).
Effectiveness of mechanical prophylaxis requires, however, consistent use of the compression devices. Because the compression devices may sometimes be uncomfortable, guidelines have also raised concerns about nonadherence [1]. The extent to which patients comply with post-operative mechanical thromboprophylaxis is unclear, and no earlier systematic reviews of patient adherence exist. We therefore performed a systematic review of original studies that measured patient adherence to mechanical thromboprophylaxis after surgery in contemporary, real-life settings. 2. Material and methods We searched MEDLINE from Jan 1, 2000 to May 21, 2015 for Englishlanguage articles reporting on patient adherence to mechanical thromboprophylaxis (including stockings and compression devices) after surgery (see search strategy in Appendix). We included full-text
http://dx.doi.org/10.1016/j.thromres.2015.06.023 0049-3848/© 2015 Elsevier Ltd. All rights reserved.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
articles of observational studies that objectively assessed patient adherence to mechanical thromboprophylaxis after surgery. Eligible studies included patients recruited in or after the year 2000 undergoing surgery of any kind. We excluded intervention studies trying to directly impact adherence to mechanical thromboprophylaxis, randomized controlled trials (because adherence rates tend to be higher in randomized trials than in everyday clinical practice [4–6]), and studies that assessed adherence with more than one device. We accepted the definition of “adherence” used in each study, recognizing that there was heterogeneity in the definitions between studies. After extracting data on adherence from articles (independently and in duplicate using standardized forms), we pooled estimates of overall adherence. We pooled estimates in log-scale units across studies using DerSimonian and Laird’s random effects model weighted by the inverse of the variance and then back transformed to the rate in natural units. A component of variance due to inter-study variation, D, was incorporated in the confidence interval calculation for the estimate. We employed pre-specified hypothesis to examine heterogeneity using meta-regression analysis weighted by the inverse of variance in random effects model. We addressed the possibility that heterogeneity in median adherence might be explained by lower adherence in studies with longer follow-up.
Not reported Not reported Authors reported study was unfunded Not reportede
3. Results
a: Trauma, joint replacement, cardiothoracic, orthopedic, vascular, spinal cord injury, head injury b: “16 different mixed surgical specialty wards” c: Compression devices include sequential compression devices, venous foot pumps, pneumatic compression devices d: Calculated based on Fig. 1 of Ritsema et al. e: Lead author serves as a consultant to and receives research support from the company that produces the devices in the article
1 5 2.8d 3 218 846 100 100 Multib Orthopedic Urology Orthopedic Parnaby 2004 [10] Pitto 2008 [11] Ritsema 2013 [12] Westrich 2003 [13]
Not reported 66 59 Not reported
Not reported 52 24 Not reported
Stockings Compression devices Compression devices Compression devices
1 Continuous 2 32
Not reported Authors reported study was unfunded 7 5.2 3 Continuous 30 1577 Orthopedic Orthopedic Chan 2007 [8] Froimson 2009 [9]
72 66
Not reported Not reported
Compression devices Compression devices
2 2.4 2 2 150 59 Multia Obstetrics and gynecology Bockheim 2009 [7] Brady 2015 [14]
62 38
49 100
Compression devices Compression devices
Correctly in place, turned on, functioning In bed, device applied, turned on, OR ambulating OR sitting Correctly in place, turned on Total minutes used divided by total minutes enrolled Correctly in place Total number of hours device was activated Correctly in place, turned on Correctly in place, turned on, functioning
Mean days No. of times/ day patients assessed Definition of adherence Type of mechanical thromboprophylaxisc Female (%) Mean age # of patients Surgical population Reference
Table Characteristics of included studies.
Not reported Not reported
S. Craigie et al. / Thrombosis Research xxx (2015) xxx–xxx
Funding statement
2
Our search identified 221 reports (Fig. 1). Screening titles and abstracts and full texts yielded 8 eligible studies (Table). All studies were of surgical inpatients (median follow up time of 3 days); none included patients after discharge. Of the 8 studies, 4 (50%) enrolled only orthopedic surgery patients. The studies varied in their definitions of adherence, frequency of assessment, length of follow-up and completeness of reporting (Table). In 6 studies, investigators assessed adherence by periodic scheduled visits to the patients in which observers would note whether the patients were correctly using the devices [7,8,10,12–14]. In 2 studies, adherence was measured using a built-in meter that recorded the amount of time the device was in use [9,11]. We found 7 studies measuring adherence to compression devices and 1 study to compression stockings. (See Fig. 2.) The pooled estimate of adherence for compression devices was 75% (median 78%, range 40%-89%). Across all reports on compression devices, there was no difference in adherence between studies with shorter follow-up (≤3 days, n = 4, pooled adherence 75%) and longer follow-up (N 3 days, n = 3, pooled adherence 75%) (p = 0.99). The only study with elastic stockings reported adherence of 40%.
Fig. 1. Study flow chart.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
S. Craigie et al. / Thrombosis Research xxx (2015) xxx–xxx
3
5. Conclusions
Pitto 2008 Westrich 2003 Ritsema 2013 Froimson 2009 Bockheim 2009 Brady 2015 Chan 2007
0
25
50
75
100
Although experience with other therapies in other contexts might lead some to conclude that adherence in the order of 75% - the level demonstrated in our review - is satisfactory, the best standard of comparison here might be pharmacologic prophylaxis with heparins which, in hospitalized patients, should achieve close to 100% adherence. Furthermore, no information is available addressing adherence with mechanical devices after discharge. Clinicians considering the relative merits of mechanical versus pharmacologic prophylaxis should consider the issue of adherence. Practical strategies to improve adherence merit investigation.
Percentage of patients adherent to compression devices Authorship statement Fig. 2. Adherence to compression devices. We accepted the definition of “adherence” and the length of follow up used in each study, recognizing that there was heterogeneity in the definitions and follow up times between studies. See Table for details.
In half of the studies (n = 4), patients were asked why they were not adherent to prophylaxis [8,11,12,14]. Commonly reported reasons included sleep disturbance, discomfort, the device not being replaced or turned on by nurses, or the device being too hot or noisy.
SC, GHG, and KAOT conceived and designed the study. KAOT obtained funding and designed the search strategy. SC, JFT, AA, KAOT screened articles and collected data. All authors analyzed and interpreted the data. SC and KAOT wrote the first draft of the manuscript. All authors contributed to the revision, and approved the final version of the manuscript. Conflicts of interest statement
4. Discussion We performed a systematic review addressing patients’ adherence to mechanical thromboprophylaxis after surgery. We found eight studies, 7 for compression devices and 1 for stockings, all of which assessed adherence with prophylaxis while patients were in the hospital. No studies provided information on adherence to prophylaxis after discharge. Overall, pooled adherence for compression devices was 75% (median adherence 78%) with median follow up over 3 days (ranging from 1–7 days). One study addressed adherence over time and found reductions as post-operative time increased, from about 90% on the third day after surgery to less than 20% at 7 days after surgery [8]. Studies varied in the methods and credibility with which they measured adherence: 2 used systems built into the devices, while 6 relied on periodic visual checks of device use. Another issue is how studies defined patients who were not wearing the device while performing an activity such as bathing or walking. Some authors counted this as adherent [12–14]; some as a non-observation [7]; others authors did not specify how they handled this situation [8–11]. The strengths of this review include a thorough search of contemporary studies, application of explicit criteria to potentially eligible studies and employing standardized, piloted data forms guided by written instructions for data collection. We followed a pre-specified data analysis plan. This review also has limitations. We identified a small number of studies (8) that directly assessed adherence of surgical patients to mechanical thromboprophylaxis. These studies were variable in their results, reducing confidence in estimates of typical adherence. We were unable to examine the relationship between adherence and VTE incidence, as only two studies [9,11] reported VTE incidence. No studies measured adherence to mechanical thromboprophylaxis after patients were discharged from the hospital, and methods of measuring adherence in hospital varied from study to study. Lastly, the reporting in these studies was often suboptimal, particularly regarding funding and conflict of interest statements. We excluded randomized trials because the adherence found there is likely to be unrepresentative. We identified three randomized trials of compression devices that measured adherence [4–6]. The reported adherence in these three trials was 97% [4], 67% [5], and 93% [6]. Results suggest that differences in the patients enrolled, or the level of scrutiny and motivation, in randomized trials may sometimes (though not always) indeed influence adherence [4–6].
Authors have no financial conflicts of interest. Sandset and Guyatt are guideline panelists and Tikkinen is chairman of the European Association of Urology ad hoc guideline panel on Thromboprophylaxis. Sandset is chairman of the Norwegian working group on Antithrombotic Therapy and editor-in-chief of Thrombosis Research. Funding/Support and role of the sponsor This research was supported by the Academy of Finland (#276046), Hospital District of Helsinki and Uusimaa, Jane and Aatos Erkko Foundation, and Sigrid Jusélius Foundation. The sponsors had no role in the analysis and interpretation of the data or the manuscript preparation, review, or approval. Acknowledgments We are grateful for Qi Zhou for her help and advice on the statistical analysis. Appendix A. Supplementary data Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.thromres.2015.06.023. References [1] M.K. Gould, D.A. Garcia, S.M. Wren, P.J. Karanicolas, J.I. Arcelus, J.A. Heit, C.M. Samama, American College of Chest Physicians, Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, Chest 141 (2012) e227S. [2] J.A. Heit, Estimating the incidence of symptomatic postoperative venous thromboembolism: the importance of perspective, JAMA 307 (2012) 306. [3] K.A. Tikkinen, A. Agarwal, S. Craigie, R. Cartwright, M.K. Gould, J. Haukka, R. Naspro, G. Novara, P.M. Sandset, R.A. Siemieniuk, P.D. Violette, G.H. Guyatt, Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology, Syst. Rev. 3 (2014) 150. [4] G.L. Maxwell, I. Synan, R.P. Hayes, D.L. Clarke-Pearson, Preference and compliance in postoperative thromboembolism prophylaxis among gynecological oncology patients, Obstet. Gynecol. 100 (2002) 451. [5] A.T. Obi, R. Alvarez, B.N. Reames, M.J. Moote, M.A. Thompson, T.W. Wakefield, P.K. Henke, A prospective evaluation of standard versus batter-powered sequential compression devices in postsurgical patients, Am. J. Surg. 209 (2015) 675. [6] R.P. Pitto, H. Hamer, W. Heiss-Dunlop, J. Kuehle, Mechanical prophylaxis of deepvein thrombosis after total hip replacement, J. Bone Joint Surg. 86-B (5) (2004) 639.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
4
S. Craigie et al. / Thrombosis Research xxx (2015) xxx–xxx
[7] H.M. Bockheim, K.J. McAllen, R. Baker, J.F. Barletta, Mechanical prophylaxis to prevent venous thromboembolism in surgical patients: a prospective trial evaluating compliance, J. Crit. Care 24 (2009) 192. [8] J.C. Chan, S.J. Roche, B. Lenehan, M. O'Sullivan, K. Kaar, Compliance and satisfaction with foot compression devices: an orthopaedic perspective, Arch. Orthop. Trauma Surg. 127 (2007) 567. [9] M.I. Froimson, T.G. Murray, A.F. Fazekas, Venous thromboembolic disease reduction with a portable pneumatic compression device, J. Arthroplasty 24 (2009) 310. [10] C. Parnaby, A new anti-embolism stocking. Use of below-knee products and compliance, Br. J. Perioper. Nurs. 14 (2004) 302. [11] R.P. Pitto, S. Young, Foot pumps without graduated compression stockings for prevention of deep-vein thrombosis in total joint replacement: efficacy, safety and
patient compliance. A comparative, prospective clinical trial, Int. Orthop. 32 (2008) 331. [12] D.F. Ritsema, J.M. Watson, A.P. Stiteler, M.M. Nguyen, Sequential compression devices in postoperative urologic patients: an observational trial and survey study on the influence of patient and hospital factors on compliance, BMC Urol. 13 (2013) 20. [13] G.H. Westrich, P.H. Jhon, P.M. Sanchez, Compliance in using a pneumatic compression device after total knee arthroplasty, Am. J. Orthop. 32 (2003) 135. [14] M.A. Brady, A.W. Carroll, K.I. Cheang, C. Straight, D. Chelmow, Sequential compression device compliance in postoperative obstetrics and gynecology patients, Obstet. Gynecol. 125 (2015) 19–25.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
Contents lists available at ScienceDirect
Thrombosis Research journal homepage: www.elsevier.com/locate/thromres
Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis Samantha Craigie a,b, Johnson F. Tsui c,d, Arnav Agarwal a,e, Per Morten Sandset f,g, Gordon H. Guyatt a,h, Kari A.O. Tikkinen i,j,⁎ a
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada Michael G. DeGroote National Pain Centre, McMaster University, Hamilton, ON, Canada Department of Urology, North Shore-LIJ Lenox Hill Hospital, New York, NY, USA d Institute for Prostate and Bladder Research, New York, NY, USA e Faculty of Medicine, University of Toronto, Toronto, ON, Canada f Department of Hematology, Oslo University Hospital, Oslo, Norway g Institute of Clinical Medicine, University of Oslo, Oslo, Norway h Department of Medicine, McMaster University, Hamilton, ON, Canada i Department of Urology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland j Department of Public Health, University of Helsinki, Helsinki, Finland b c
a r t i c l e
i n f o
Article history: Received 23 April 2015 Received in revised form 15 June 2015 Accepted 17 June 2015 Available online xxxx Keywords: adherence compliance compression devices foot pumps intermittent pneumatic compression devices stockings, compression surgery thromboprophylaxis thrombosis
a b s t r a c t Background: Many clinical practice guidelines, while recommending mechanical thromboprophylaxis after surgery, have raised concerns that discomfort may result in nonadherence. We therefore addressed adherence to mechanical thromboprophylaxis after surgery. Methods: We searched MEDLINE from January 1, 2000 to May 21, 2015 for English-language observational studies that assessed patient adherence to mechanical thromboprophylaxis after surgery. We conducted a meta-analysis to estimate average adherence rates. Results: We identified 8 studies (7 for compression devices, 1 for stockings) with median follow up time of 3 days. The pooled estimate of adherence for compression devices was 75% (median 78%, range 40%-89%). Studies with shorter follow-up (≤ 3 days, n = 4, pooled adherence 75%) and longer follow-up (N3 days, n = 3, pooled adherence 75%) reported similar adherence (p = 0.99). The studies varied in definitions of adherence, frequency of assessment, length of follow-up and completeness of reporting. No study followed patients after discharge. Conclusions: Up to one fourth of patients are nonadherent to mechanical thromboprophylaxis while hospitalized. Clinicians considering the relative merits of mechanical versus pharmacologic prophylaxis should address the issue of adherence. Strategies to improve adherence merit investigation. © 2015 Elsevier Ltd. All rights reserved.
1. Introduction Venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism, represents a serious, and on occasion fatal, complication of surgery [1,2]. Because randomized trials suggest that mechanical thromboprophylaxis may prevent postoperative VTE, and because they do not incur the bleeding risk associated with pharmacologic prophylaxis, clinical practice guidelines often recommend use of mechanical thromboprophylaxis after surgery [1,3]. In part as a result, these devices, which include elastic stockings and intermittent compression devices, are in wide use [1,2]. (See Table)
⁎ Corresponding author at: Department of Urology, Helsinki University Hospital, Haartmaninkatu 4, 00029 Helsinki, Finland. E-mail address: [email protected] (K.A.O. Tikkinen).
Effectiveness of mechanical prophylaxis requires, however, consistent use of the compression devices. Because the compression devices may sometimes be uncomfortable, guidelines have also raised concerns about nonadherence [1]. The extent to which patients comply with post-operative mechanical thromboprophylaxis is unclear, and no earlier systematic reviews of patient adherence exist. We therefore performed a systematic review of original studies that measured patient adherence to mechanical thromboprophylaxis after surgery in contemporary, real-life settings. 2. Material and methods We searched MEDLINE from Jan 1, 2000 to May 21, 2015 for Englishlanguage articles reporting on patient adherence to mechanical thromboprophylaxis (including stockings and compression devices) after surgery (see search strategy in Appendix). We included full-text
http://dx.doi.org/10.1016/j.thromres.2015.06.023 0049-3848/© 2015 Elsevier Ltd. All rights reserved.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
articles of observational studies that objectively assessed patient adherence to mechanical thromboprophylaxis after surgery. Eligible studies included patients recruited in or after the year 2000 undergoing surgery of any kind. We excluded intervention studies trying to directly impact adherence to mechanical thromboprophylaxis, randomized controlled trials (because adherence rates tend to be higher in randomized trials than in everyday clinical practice [4–6]), and studies that assessed adherence with more than one device. We accepted the definition of “adherence” used in each study, recognizing that there was heterogeneity in the definitions between studies. After extracting data on adherence from articles (independently and in duplicate using standardized forms), we pooled estimates of overall adherence. We pooled estimates in log-scale units across studies using DerSimonian and Laird’s random effects model weighted by the inverse of the variance and then back transformed to the rate in natural units. A component of variance due to inter-study variation, D, was incorporated in the confidence interval calculation for the estimate. We employed pre-specified hypothesis to examine heterogeneity using meta-regression analysis weighted by the inverse of variance in random effects model. We addressed the possibility that heterogeneity in median adherence might be explained by lower adherence in studies with longer follow-up.
Not reported Not reported Authors reported study was unfunded Not reportede
3. Results
a: Trauma, joint replacement, cardiothoracic, orthopedic, vascular, spinal cord injury, head injury b: “16 different mixed surgical specialty wards” c: Compression devices include sequential compression devices, venous foot pumps, pneumatic compression devices d: Calculated based on Fig. 1 of Ritsema et al. e: Lead author serves as a consultant to and receives research support from the company that produces the devices in the article
1 5 2.8d 3 218 846 100 100 Multib Orthopedic Urology Orthopedic Parnaby 2004 [10] Pitto 2008 [11] Ritsema 2013 [12] Westrich 2003 [13]
Not reported 66 59 Not reported
Not reported 52 24 Not reported
Stockings Compression devices Compression devices Compression devices
1 Continuous 2 32
Not reported Authors reported study was unfunded 7 5.2 3 Continuous 30 1577 Orthopedic Orthopedic Chan 2007 [8] Froimson 2009 [9]
72 66
Not reported Not reported
Compression devices Compression devices
2 2.4 2 2 150 59 Multia Obstetrics and gynecology Bockheim 2009 [7] Brady 2015 [14]
62 38
49 100
Compression devices Compression devices
Correctly in place, turned on, functioning In bed, device applied, turned on, OR ambulating OR sitting Correctly in place, turned on Total minutes used divided by total minutes enrolled Correctly in place Total number of hours device was activated Correctly in place, turned on Correctly in place, turned on, functioning
Mean days No. of times/ day patients assessed Definition of adherence Type of mechanical thromboprophylaxisc Female (%) Mean age # of patients Surgical population Reference
Table Characteristics of included studies.
Not reported Not reported
S. Craigie et al. / Thrombosis Research xxx (2015) xxx–xxx
Funding statement
2
Our search identified 221 reports (Fig. 1). Screening titles and abstracts and full texts yielded 8 eligible studies (Table). All studies were of surgical inpatients (median follow up time of 3 days); none included patients after discharge. Of the 8 studies, 4 (50%) enrolled only orthopedic surgery patients. The studies varied in their definitions of adherence, frequency of assessment, length of follow-up and completeness of reporting (Table). In 6 studies, investigators assessed adherence by periodic scheduled visits to the patients in which observers would note whether the patients were correctly using the devices [7,8,10,12–14]. In 2 studies, adherence was measured using a built-in meter that recorded the amount of time the device was in use [9,11]. We found 7 studies measuring adherence to compression devices and 1 study to compression stockings. (See Fig. 2.) The pooled estimate of adherence for compression devices was 75% (median 78%, range 40%-89%). Across all reports on compression devices, there was no difference in adherence between studies with shorter follow-up (≤3 days, n = 4, pooled adherence 75%) and longer follow-up (N 3 days, n = 3, pooled adherence 75%) (p = 0.99). The only study with elastic stockings reported adherence of 40%.
Fig. 1. Study flow chart.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
S. Craigie et al. / Thrombosis Research xxx (2015) xxx–xxx
3
5. Conclusions
Pitto 2008 Westrich 2003 Ritsema 2013 Froimson 2009 Bockheim 2009 Brady 2015 Chan 2007
0
25
50
75
100
Although experience with other therapies in other contexts might lead some to conclude that adherence in the order of 75% - the level demonstrated in our review - is satisfactory, the best standard of comparison here might be pharmacologic prophylaxis with heparins which, in hospitalized patients, should achieve close to 100% adherence. Furthermore, no information is available addressing adherence with mechanical devices after discharge. Clinicians considering the relative merits of mechanical versus pharmacologic prophylaxis should consider the issue of adherence. Practical strategies to improve adherence merit investigation.
Percentage of patients adherent to compression devices Authorship statement Fig. 2. Adherence to compression devices. We accepted the definition of “adherence” and the length of follow up used in each study, recognizing that there was heterogeneity in the definitions and follow up times between studies. See Table for details.
In half of the studies (n = 4), patients were asked why they were not adherent to prophylaxis [8,11,12,14]. Commonly reported reasons included sleep disturbance, discomfort, the device not being replaced or turned on by nurses, or the device being too hot or noisy.
SC, GHG, and KAOT conceived and designed the study. KAOT obtained funding and designed the search strategy. SC, JFT, AA, KAOT screened articles and collected data. All authors analyzed and interpreted the data. SC and KAOT wrote the first draft of the manuscript. All authors contributed to the revision, and approved the final version of the manuscript. Conflicts of interest statement
4. Discussion We performed a systematic review addressing patients’ adherence to mechanical thromboprophylaxis after surgery. We found eight studies, 7 for compression devices and 1 for stockings, all of which assessed adherence with prophylaxis while patients were in the hospital. No studies provided information on adherence to prophylaxis after discharge. Overall, pooled adherence for compression devices was 75% (median adherence 78%) with median follow up over 3 days (ranging from 1–7 days). One study addressed adherence over time and found reductions as post-operative time increased, from about 90% on the third day after surgery to less than 20% at 7 days after surgery [8]. Studies varied in the methods and credibility with which they measured adherence: 2 used systems built into the devices, while 6 relied on periodic visual checks of device use. Another issue is how studies defined patients who were not wearing the device while performing an activity such as bathing or walking. Some authors counted this as adherent [12–14]; some as a non-observation [7]; others authors did not specify how they handled this situation [8–11]. The strengths of this review include a thorough search of contemporary studies, application of explicit criteria to potentially eligible studies and employing standardized, piloted data forms guided by written instructions for data collection. We followed a pre-specified data analysis plan. This review also has limitations. We identified a small number of studies (8) that directly assessed adherence of surgical patients to mechanical thromboprophylaxis. These studies were variable in their results, reducing confidence in estimates of typical adherence. We were unable to examine the relationship between adherence and VTE incidence, as only two studies [9,11] reported VTE incidence. No studies measured adherence to mechanical thromboprophylaxis after patients were discharged from the hospital, and methods of measuring adherence in hospital varied from study to study. Lastly, the reporting in these studies was often suboptimal, particularly regarding funding and conflict of interest statements. We excluded randomized trials because the adherence found there is likely to be unrepresentative. We identified three randomized trials of compression devices that measured adherence [4–6]. The reported adherence in these three trials was 97% [4], 67% [5], and 93% [6]. Results suggest that differences in the patients enrolled, or the level of scrutiny and motivation, in randomized trials may sometimes (though not always) indeed influence adherence [4–6].
Authors have no financial conflicts of interest. Sandset and Guyatt are guideline panelists and Tikkinen is chairman of the European Association of Urology ad hoc guideline panel on Thromboprophylaxis. Sandset is chairman of the Norwegian working group on Antithrombotic Therapy and editor-in-chief of Thrombosis Research. Funding/Support and role of the sponsor This research was supported by the Academy of Finland (#276046), Hospital District of Helsinki and Uusimaa, Jane and Aatos Erkko Foundation, and Sigrid Jusélius Foundation. The sponsors had no role in the analysis and interpretation of the data or the manuscript preparation, review, or approval. Acknowledgments We are grateful for Qi Zhou for her help and advice on the statistical analysis. Appendix A. Supplementary data Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.thromres.2015.06.023. References [1] M.K. Gould, D.A. Garcia, S.M. Wren, P.J. Karanicolas, J.I. Arcelus, J.A. Heit, C.M. Samama, American College of Chest Physicians, Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, Chest 141 (2012) e227S. [2] J.A. Heit, Estimating the incidence of symptomatic postoperative venous thromboembolism: the importance of perspective, JAMA 307 (2012) 306. [3] K.A. Tikkinen, A. Agarwal, S. Craigie, R. Cartwright, M.K. Gould, J. Haukka, R. Naspro, G. Novara, P.M. Sandset, R.A. Siemieniuk, P.D. Violette, G.H. Guyatt, Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology, Syst. Rev. 3 (2014) 150. [4] G.L. Maxwell, I. Synan, R.P. Hayes, D.L. Clarke-Pearson, Preference and compliance in postoperative thromboembolism prophylaxis among gynecological oncology patients, Obstet. Gynecol. 100 (2002) 451. [5] A.T. Obi, R. Alvarez, B.N. Reames, M.J. Moote, M.A. Thompson, T.W. Wakefield, P.K. Henke, A prospective evaluation of standard versus batter-powered sequential compression devices in postsurgical patients, Am. J. Surg. 209 (2015) 675. [6] R.P. Pitto, H. Hamer, W. Heiss-Dunlop, J. Kuehle, Mechanical prophylaxis of deepvein thrombosis after total hip replacement, J. Bone Joint Surg. 86-B (5) (2004) 639.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
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[7] H.M. Bockheim, K.J. McAllen, R. Baker, J.F. Barletta, Mechanical prophylaxis to prevent venous thromboembolism in surgical patients: a prospective trial evaluating compliance, J. Crit. Care 24 (2009) 192. [8] J.C. Chan, S.J. Roche, B. Lenehan, M. O'Sullivan, K. Kaar, Compliance and satisfaction with foot compression devices: an orthopaedic perspective, Arch. Orthop. Trauma Surg. 127 (2007) 567. [9] M.I. Froimson, T.G. Murray, A.F. Fazekas, Venous thromboembolic disease reduction with a portable pneumatic compression device, J. Arthroplasty 24 (2009) 310. [10] C. Parnaby, A new anti-embolism stocking. Use of below-knee products and compliance, Br. J. Perioper. Nurs. 14 (2004) 302. [11] R.P. Pitto, S. Young, Foot pumps without graduated compression stockings for prevention of deep-vein thrombosis in total joint replacement: efficacy, safety and
patient compliance. A comparative, prospective clinical trial, Int. Orthop. 32 (2008) 331. [12] D.F. Ritsema, J.M. Watson, A.P. Stiteler, M.M. Nguyen, Sequential compression devices in postoperative urologic patients: an observational trial and survey study on the influence of patient and hospital factors on compliance, BMC Urol. 13 (2013) 20. [13] G.H. Westrich, P.H. Jhon, P.M. Sanchez, Compliance in using a pneumatic compression device after total knee arthroplasty, Am. J. Orthop. 32 (2003) 135. [14] M.A. Brady, A.W. Carroll, K.I. Cheang, C. Straight, D. Chelmow, Sequential compression device compliance in postoperative obstetrics and gynecology patients, Obstet. Gynecol. 125 (2015) 19–25.
Please cite this article as: S. Craigie, et al., Adherence to mechanical thromboprophylaxis after surgery: A systematic review and meta-analysis, Thromb Res (2015), http://dx.doi.org/10.1016/j.thromres.2015.06.023
