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Chronic wounds have been a great burden to patients and the health care system. The popularity of the internet and smart devices, such as mobile phones and tablets, has made it possible to adopt telemedicine (TM) to improve the management of chronic wounds. However, studies conducted by different researchers have reported contradictory results on the effect of TM on chronic wound management.
The aim of this work was to evaluate the efficacy and safety of TM in chronic wound management.
We systematically searched multiple electronic databases (MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials [CENTRAL]) to identify eligible studies published from inception to June 12, 2019. Inclusion criteria were randomized controlled trials (RCTs) and interventional cohort studies that investigated the use of TM in chronic wound management. RCT and observational data were analyzed separately. A meta-analysis and qualitative analysis were conducted to estimate endpoints.
A total of 6 RCTs and 6 cohort studies including 3913 patients were included. Of these, 4 studies used tablets or mobile phones programmed with apps, such as Skype and specialized interactive systems, whereas the remaining 8 studies used email, telephone, and videoconferencing to facilitate the implementation of TM using a specialized system. Efficacy outcomes in RCTs showed no significant differences in wound healing (hazard ratio [HR] 1.16, 95% CI 0.96-1.39;
Currently available evidence suggests that TM seems to have similar efficacy and safety, and met noninferiority criteria with conventional standard care of chronic wounds. Large-scale, well-designed RCTs are warranted.
A chronic wound is defined as a break in the skin that failed to progress through a normal sequence of repair in 4-8 weeks [
Telemedicine (TM) is the use of telecommunication technologies to provide remote clinical services to patients to improve the quality of individual treatments. The concept of TM dates back to the 19th century. It was practiced via telegraph, telephone, and radio before the internet existed [
Within wound care, TM could support access to expertise in remote areas to improve management of chronic wounds in geographically challenging environments [
Findings from qualitative studies show positive results with several systematic reviews in recent years being published [
Our objective was to conduct a systematic review and meta-analysis of randomized and interventional cohort studies. We sought to investigate whether TM follow-up in community care in collaboration with specialists in wound center is noninferior to the conventional standard care of chronic wounds.
The systematic review and meta-analysis were conducted in accordance with recommendations by the Cochrane Collaboration [
A systematic search of databases (PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials [CENTRAL]) was conducted to identify eligible studies published from inception to June 12, 2019. The reference lists of all identified articles and reviews were searched for potentially eligible studies. Only published articles were included. The search strategy is available in
The bias of RCTs included in the systematic review was assessed using the Cochrane’s tool for assessing risk of bias [
Data extraction was performed independently by two reviewers (LC1 and LC2). Any discrepancies were resolved by discussion or by a third investigator (XR). All studies included in the meta-analysis had to be either RCTs or cohort studies. The prespecified primary outcomes were wound healing; the secondary outcomes were all-cause mortality, amputation, number of consultations, and patient experience.
A meta-analysis was performed using Stata 12.0 (Stata Corp) and RevMan 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration). Hazard ratio (HR) and associated statistics were either extracted directly from articles or estimated from Kaplan–Meier curves [
In addition, we tested the hypothesis of noninferiority of TM follow-up for the primary efficacy outcomes. We adopted a Δ=–0.15 as margin of minimum clinically important differences [
A total of 12,007 potential studies were identified by the systematic search. Of these, 58 studies were selected for full review. Ultimately, 12 trials met the inclusion criteria, comprising a total of 3913 patients. Of these 5 were cluster RCTs [
The selected studies [
The result of assessment of risk of bias is presented in
Characteristics of the clinical trials included
Study | Country | Wound etiology | No. of patients | Treatment strategyc | Control arm treatment location | Follow-up (months) | ||
|
|
|
TM | Control | TM | Control |
|
|
Smith-Strøm et al [ |
Norway | Diabetic foot ulcer | 94 | 88 | Via a web-based ulcer record and phone at least weekly; and outpatient consultation every 6 weeks | Outpatient consultation every second week | University hospital outpatient clinic | 12 |
Stern et al [ |
Canada | Pressure ulcer | 93 | 131 | MDT consultation by email, telephone, or video | Usual care | Community | 12 |
Vowden and Vowden [ |
UK | Any etiology | 17 | 9 | Consultation by wound-assessment form and images weekly | Home nursing | Nursing home | 6 |
Terry et al [ |
USA | Various etiologyd | 62 | 98 | Consultation by images weekly | Usual care | Home | 16 |
Santamaria et al [ |
Australia | Any etiology | 50 | 43 | Consultation by images and measurements every 2 weeks | Care from local wound care clinician | Local clinic | 12 |
Rasmussen et al [ |
Denmark | Diabetic foot ulcer | 193 | 181 | Two consultations by telephone or online written consultations and one outpatient consultation cycle | Three outpatient consultation cycle | Wound center | 12 |
Le Goff-Pronost et al [ |
France | Any etiology | 77 | 39 | Via videoconference and photos once a week | Primary care | Home | 9 |
Gamus et al [ |
Israel | Any etiology | 277 | 373 | Via videoconference | Outpatient clinic | Central clinic | 35 |
Wickström et al [ |
Sweden | Any etiology | 100 | 1888 | Video consultation | Primary care | Home | 24 |
Bergersen et al [ |
Norway | Any etiology | 32 | 21 | Via wound support network every 4 weeks | Primary home care | Home | 3 |
Zarchi et al [ |
Denmark | Any etiologye | 50 | 40 | Via a web-based program at a minimum of every second week | Home-care nursing | Home | 12 |
Wilbright et al [ |
USA | Diabetic foot ulcer | 20 | 120 | Via real-time interactive video weekly | Face-to-face consultation | Wound center | 3 |
aThe TM arm received primary care in collaboration with specialists in wound center; patients in the control arm received follow-up by community nurses; in addition, patients in the wound center-based model received treatment at wound center.
bTM: telemedicine.
cMDT: multidisciplinary teams (comprising 2 enterostomal nurses and 1 certified wound-care nurse, or hospital-based wound-expert team)
dNonhealing surgical wound, stasis ulcer, pressure ulcer.
eSurgical wounds, pressure ulcers, and cancer wounds excluded.
Five studies [
Eight studies [
Two studies [
The effect of telemedicine on wound healing. HR: hazard ratio.
The effect of telemedicine on wound healing around 1 year. RR: risk ratio.
The effect of telemedicine on wound healing around 3 months. RR: risk ratio.
One study [
Another study [
In the trial with uneven distribution of severity and type of wounds among groups [
Eight studies [
The effect of telemedicine on all-cause mortality. RR: risk ratio.
Three RCTs [
The effect of telemedicine on amputation. RR: risk ratio.
Three studies reported on the number of consultations. One RCT [
One study [
A total of 4 studies [
The sensitivity analysis is presented in
In this review, we included 6 RCTs and 6 cohort studies comprising 3913 patients to evaluate the effect of TM in chronic wound management. We adopted both HR and RR to evaluate the effect of TM. In RCTs, we observed no significant differences in the primary clinical outcome efficacies HR and RR around 1 year, and noninferiority criteria were met. In cohort studies, the outcome efficacy HR was in favor of TM, whereas the efficacy RR around 1 year was not significantly different between TM and conventional standard of care of chronic wounds. Overall, these results showed that TM was noninferior to conventional standard of care. In terms of mortality, TM was not significantly different from control in both RCTs and cohort studies. A decreased risk of amputation was observed in patients receiving TM. A few studies performed qualitative analysis on the number of consultations, patient satisfaction, and economic evaluation with the results showing that TM was not worse than conventional standard of care of chronic wounds. Therefore, TM seems to be a safe and effective method in the management of chronic wounds.
We carefully observed the difference of primary outcome between RCTs and cohort studies and found that the enrolled studies in RCTs were mainly wound center-based models, whereas those in cohort studies were all community-based models. Therefore, we speculate that the organization model may have a great influence on the effect of TM on wound healing; in particular, the community-based model may benefit from the implementation of TM. A possible explanation may be that in the community-based model, TM allowed patients in remote and rural settings easier access to multidisciplinary management which has been demonstrated to be an effective and efficient way of chronic wound management [
Subgroup analysis of RCTs suggested that in a community-based model, patients in the TM group have a decreased risk of mortality. Both the positive primary outcome in cohort studies and the decreased mortality are in favor of TM in the community-based model. This demonstrates that it is promising to take advantage of TM in community or remote rural areas.
To our knowledge, this review included the largest number of patients with different types of wounds. The results of this review coincide with the systematic review by Tchero et al [
Although similar mortality rates were revealed between TM and conventional care of chronic wound, the result of a well-designed RCT [
For the first time, we learned that the difference between the community- and wound center–based wound management models might seriously influence the effect of TM. A subgroup analysis was conducted to clarify the difference. Differing results between these two models indicate that it is prudent to understand the management model before interpreting the studies on TM in chronic wound management.
This study has several limitations. First, we only searched 3 databases and did not include non-English literature. Although we tried to identify articles from reference lists of other reviews, it is possible that some studies in other databases or published in other language were overlooked. Second, we included RCTs and interventional cohort studies in the analysis, and thus, a potential source of bias might be introduced. Third, several studies [
First, for RCTs, although blinding of outcome measurement would not seriously influence the results, nonblinding of participants might bias the effect. In future studies, more importance should be assigned to the blinding of participants and health care providers. For example, all participants can receive treatment/suggestions via TM, but the information would not be sent to wound center specialists. In this way, performance bias could be reduced to a minimum.
Second, subgroup analysis indicates that TM in the community-based model is superior to standard primary care of chronic wounds by presenting with better outcomes and less mortality. Therefore, it is promising to take advantage of TM in community or remote rural areas. However, the number of studies in this aspect is limited and most studies are cohort studies. Thus, in future studies, well-designed, large-scale RCTs should be performed to verify the effect of TM in the community-based model.
Third, subgroup analysis indicates that TM in the wound center-based model is similar to standard of care of chronic wounds. Therefore, it is necessary to investigate whether TM can have better performance in other aspects. Only a few studies showed that TM was not worse than conventional standard of care regarding number of consultations, patient satisfaction, and economic evaluation. Thus, in future studies, these aspects can be included in the design of trials to investigate the effect of TM.
Finally, results in this systematic review and meta-analysis also shed some light on clinical practices. If health care practitioners would like to use TM to improve wound healing, they do not have to worry about delayed wound healing. For those patients who lived far away from wound center, TM can provide appropriate wound management.
TM is noninferior to conventional standard care of chronic wounds. TM might be a prosperous method for improving outcomes of patients living in remote or rural areas. However, owing to the relatively low quality of evidence, well-designed and adequately powered RCTs are further needed to confirm the role of TM.
Search strategy.
Flow chart for study selection.
Risk of bias graph of RCTs.
Risk of bias summary of RCTs.
Risk of bias of cohort studies by the use of ROBINS-I.
Subgroup analysis of telemedicine on wound healing.
Subgroup analysis of telemedicine on all-cause mortality.
Results of sensitivity analysis.
hazard ratio
randomized controlled trials
risk ratio
telemedicine
This study was supported by the Health Medical Big Data Application and Innovation Project in Sichuan (Grant No. 2018gfgw001), National Science and Technology Major Project (Grant No. 2017ZX09304023), National Key R&D Program of China (Grant No. 2017YFC1309605), Science and Technology Bureau of Sichuan Province (Grant Nos 2018SZ0239 and 2018JY0608), and Science and Technology Bureau of Chengdu city (Grant No. 2017-CY02-00028-GX). We thank Dr Aristidis Veves and Mr Navin Jayaswal for their help in language modification.
None declared.