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238 L. C. Burgess et al outcomes from many individual NMES and oedema stu- dies remain inconclusive. Thus, the current systematic review assessed studies that evaluated NMES devices for patients presenting with oedema. The results of this review could help the development of rehabilitation programmes focused on helping patients with oedema. METHODS Data sources A systematic review was conducted to examine current publis- hed evidence regarding the use of NMES for treatment of oede- ma. The methodology of this review was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement (www.prismastatement. org/PRISMAStatement) (6). A computer-based search was completed in July 2018, and the electronic database sourced was PubMed (https://www.ncbi.nlm.nih.gov/pubmed/). The search reviewed all fields of the available literature, published in the English language (or those for which a translation was available) to the earliest record on file. A secondary search was also conducted, whereby the reference lists of articles, review papers and textbooks were scanned for additional papers. There are 2 categories of this type of stimulation, one type of device (named NMES) is used to treat muscle atrophy when the muscle is in a resting state, and the other, named functional electrical stimulation (FES), used to enhance functionality of neurologi- cally impaired individuals. Therefore, FES search terms were also included. Other devices delivering electrical stimulation were excluded. Studies were considered eligible for inclusion within the synthesis if they met the specified inclusion and exclusion criteria listed in Table I. Quality assessment The Downs and Black checklist (8) was used to assess the risk of bias within the studies sourced. The 27-item methodological quality checklist has been shown to have good intra-rater (r. 0.88) and inter-rater (r. 0.75) reliability (8) It has been used previously in systematic reviews with various study designs, and has also been amended to suit the structure of the review in which it was utilized (9, 10). Similarly, a modified version of the Downs and Black checklist was employed with the items that were not suitable to the review removed (items 5, 8, 14, 15, 21–27). The adapted version of the tool consisted of 16 items (Appendix 1), including items 1–4, 6, 7, 9–13 and 16–20 from the original list, with a maximum possible score of 16. The higher scores indicated superior quality. The first 8 items on the scale relate to reporting and include aims, outcome measures and results. Items 11–13 relate to external validity and consider whether results from the study can be generalized to a wider population. Items 16–20 relate to internal validity. Risk of bias was assessed by 2 independent assessors (LB and TI) and any discrepancies were resolved through discussion. Study selection Statistical analysis In order to capture studies published across all rehabilitation disciplines; a broad search strategy was adopted (Table II). All of the studies within this review compared pre- and post- intervention values for oedema size. The majority of the data were not normally distributed and, therefore, non-parametric testing was used to compare means and variation. Six studies also compared between-group changes when electrical stimula- tion was compared with the following factors: no stimulation, placebo stimulation, compression stockings, limb elevation, and a whirlpool bath. Table I. Inclusion and exclusion criteria Inclusion criteria Exclusion criteria Population Any patient population in a rehabilitation setting where oedema was treated. Intervention Neuromuscular electrical stimulation Functional electrical stimulation Outcome measure Oedema size, or swelling of limb Methodology Randomized clinical trials Non-randomized clinical trials of good methodological quality Studies on animals Functional electrical stimulation cycling Electromyographic biofeedback Transcutaneous electrical nerve stimulation Calf muscle pump stimulation Implanted peripheral nerve electrodes Neuromuscular monitoring High-voltage pulsed current Publication Published in English Access to full text www.medicaljournals.se/jrm Table II. Search strategy Search strategy Search terms 1 2 Review articles Case studies Historical studies All titles and abstracts were initially checked for relevance and duplicates by 2 independent reviewers (LB and TW). The remaining results then underwent a full-text appraisal to ensure that the studies were of good methodological quality, that their findings were significant, that they were evaluating a NMES device, and that they were examining the effectiveness of the device to treat oedema. Study design was assessed using the PICO (Patient, Intervention, Comparison and Outcome) fram- ework to ensure the study was relevant (7). Secondary searching was also undertaken, whereby reference lists of the selected articles were reviewed for additional studies not identified in the primary search. Unpublished studies Study protocols Cross-sectional studies Historical studies 3 4 ((neuromuscular[All Fields] AND (”electric stimulation”[MeSH Terms] OR (”electric”[All Fields] AND ”stimulation”[All Fields]) OR ”electric stimulation”[All Fields] OR (”electrical”[All Fields] AND ”stimulation”[All Fields]) OR ”electrical stimulation”[All Fields])) AND (”oedema”[All Fields] OR ”edema”[MeSH Terms] OR ”edema”[All Fields])) OR (electrostimulation[All Fields] AND (”oedema”[All Fields] OR ”edema”[MeSH Terms] OR ”edema”[All Fields])) (neuromuscular[All Fields] AND stimulation[All Fields] AND (”oedema”[All Fields] OR ”edema”[MeSH Terms] OR ”edema”[All Fields])) (electrostimulation[All Fields] AND (”oedema”[All Fields] OR ”edema”[MeSH Terms] OR ”edema”[All Fields])) (functional[All Fields] AND (”electric stimulation”[MeSH Terms] OR (”electric”[All Fields] AND ”stimulation”[All Fields]) OR ”electric stimulation”[All Fields] OR (”electrical”[All Fields] AND ”stimulation”[All Fields]) OR ”electrical stimulation”[All Fields]) AND (”oedema”[All Fields] OR ”edema”[MeSH Terms] OR ”edema”[All Fields]))