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Journal of Vascular Surgery Aug 2018The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily decisions are often made using anecdotal or low-quality evidence.
METHODS
We searched multiple databases through May 7, 2017, for prospective studies with at least 1-year follow-up that evaluated patient-relevant outcomes of infrainguinal revascularization procedures in adults with CLTI. Independent pairs of reviewers selected articles and extracted data. Random-effects meta-analysis was used to pool outcomes across studies.
RESULTS
We included 44 studies that enrolled 8602 patients. Periprocedural outcomes (mortality, amputation, major adverse cardiac events) were similar across treatment modalities. Overall, patients with infrapopliteal disease had higher patency rates of great saphenous vein graft at 1 and 2 years (primary: 87%, 78%; secondary: 94%, 87%, respectively) compared with all other interventions. Prosthetic bypass outcomes were notably inferior to vein bypass in terms of amputation and patency outcomes, especially for below knee targets at 2 years and beyond. Drug-eluting stents demonstrated improved patency over bare-metal stents in infrapopliteal arteries (primary patency: 73% vs 50% at 1 year), and was at least comparable to balloon angioplasty (66% primary patency). Survival, major amputation, and amputation-free survival at 2 years were broadly similar between endovascular interventions and vein bypass, with prosthetic bypass having higher rates of limb loss. Overall, the included studies were at moderate to high risk of bias and the quality of evidence was low.
CONCLUSIONS
There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal disease, although no studies included long segment tibial lesions. Heterogeneity in patient risk, severity of limb threat, and anatomy treated renders direct comparison of outcomes from the current literature challenging. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision making in CLTI.
Topics: Amputation, Surgical; Blood Vessel Prosthesis Implantation; Chronic Disease; Clinical Decision-Making; Drug-Eluting Stents; Endovascular Procedures; Evidence-Based Medicine; Graft Occlusion, Vascular; Humans; Ischemia; Limb Salvage; Patient Selection; Peripheral Arterial Disease; Risk Factors; Saphenous Vein; Time Factors; Treatment Outcome
PubMed: 29804736
DOI: 10.1016/j.jvs.2018.01.066 -
The Cochrane Database of Systematic... Dec 2021Diabetes and vascular disease are the leading causes of lower limb amputation. Currently, 463 million adults are living with diabetes, and 202 million with peripheral... (Review)
Review
BACKGROUND
Diabetes and vascular disease are the leading causes of lower limb amputation. Currently, 463 million adults are living with diabetes, and 202 million with peripheral vascular disease, worldwide. When a lower limb amputation is considered, preservation of the knee in a below-knee amputation allows for superior functional recovery when compared with amputation at a higher level. When a below-knee amputation is not feasible, the most common alternative performed is an above-knee amputation. Another possible option, which is less commonly performed, is a through-knee amputation which may offer some potential functional benefits over an above-knee amputation.
OBJECTIVES
To assess the effects of through-knee amputation compared to above-knee amputation on clinical and rehabilitation outcomes and complication rates for all patients undergoing vascular and non-vascular major lower limb amputation.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials register to 17 February 2021. We undertook reference checking, citation searching, and contact with study authors to identify additional studies.
SELECTION CRITERIA
Published and unpublished randomised controlled trials (RCTs) comparing through-knee amputation and above-knee amputation were eligible for inclusion in this study. Primary outcomes were uncomplicated primary wound healing and prosthetic limb fitting. Secondary outcomes included time taken to achieve independent mobility with a prosthesis, health-related quality of life, walking speed, pain, and 30-day survival.
DATA COLLECTION AND ANALYSIS
Two review authors independently reviewed all records identified by the search. Data collection and extraction were planned in line with recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using the GRADE approach.
MAIN RESULTS
We did not identify RCTs that met the inclusion criteria for this review.
AUTHORS' CONCLUSIONS
No RCTs have been conducted to determine comparative clinical or rehabilitation outcomes of through-knee amputation and above-knee amputation, or complication rates. It is unknown whether either of these approaches offers improved outcomes for patients. RCTs are needed to guide practice and to ensure the best outcomes for this patient group.
Topics: Adult; Amputation, Surgical; Humans; Lower Extremity; Peripheral Vascular Diseases; Randomized Controlled Trials as Topic; Systematic Reviews as Topic; Walking
PubMed: 34904714
DOI: 10.1002/14651858.CD013839.pub2 -
The Cochrane Database of Systematic... Jun 2015Chronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.
OBJECTIVES
To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb.
SEARCH METHODS
For this second update we searched the Cochrane Wounds Group Specialised Register (searched 18 February 2015); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 1); Ovid MEDLINE (1946 to 17 February 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 17 February 2015); Ovid EMBASE (1974 to 17 February 2015); and EBSCO CINAHL (1982 to 17 February 2015).
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).
DATA COLLECTION AND ANALYSIS
Three review authors independently evaluated the risk of bias of the relevant trials using the Cochrane methodology and extracted the data from the included trials. We resolved any disagreement by discussion.
MAIN RESULTS
We included twelve trials (577 participants). Ten trials (531 participants) enrolled people with a diabetic foot ulcer: pooled data of five trials with 205 participants showed an increase in the rate of ulcer healing (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.19 to 4.62; P = 0.01) with HBOT at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of five trials with 312 participants, RR 0.36, 95% CI 0.11 to 1.18). One trial (16 participants) considered venous ulcers and reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and number of ulcers healed) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at six weeks (mean difference (MD) 33.00%, 95% CI 18.97 to 47.03, P < 0.00001). We identified one trial (30 participants) which enrolled patients with non-healing diabetic ulcers as well as venous ulcers ("mixed ulcers types") and patients were treated for 30 days. For this "mixed ulcers" there was a significant benefit of HBOT in terms of reduction in ulcer area at the end of treatment (30 days) (MD 61.88%, 95% CI 41.91 to 81.85, P < 0.00001). We did not identify any trials that considered arterial and pressure ulcers.
AUTHORS' CONCLUSIONS
In people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. More trials are needed to properly evaluate HBOT in people with chronic wounds; these trials must be adequately powered and designed to minimise all kinds of bias.
Topics: Amputation, Surgical; Chronic Disease; Diabetic Foot; Humans; Hyperbaric Oxygenation; Randomized Controlled Trials as Topic; Varicose Ulcer; Wound Healing
PubMed: 26106870
DOI: 10.1002/14651858.CD004123.pub4 -
Archives of Physical Medicine and... Jan 2021To present recent evidence on the prevalence, incidence, costs, activity limitations, and work limitations of common conditions requiring rehabilitation.
A Systematic Review of the Incidence, Prevalence, Costs, and Activity and Work Limitations of Amputation, Osteoarthritis, Rheumatoid Arthritis, Back Pain, Multiple Sclerosis, Spinal Cord Injury, Stroke, and Traumatic Brain Injury in the United States: A 2019 Update.
OBJECTIVES
To present recent evidence on the prevalence, incidence, costs, activity limitations, and work limitations of common conditions requiring rehabilitation.
DATA SOURCES
Medline (PubMed), SCOPUS, Web of Science, and the gray literature were searched for relevant articles about amputation, osteoarthritis, rheumatoid arthritis, back pain, multiple sclerosis, spinal cord injury, stroke, and traumatic brain injury.
STUDY SELECTION
Relevant articles (N=106) were included.
DATA EXTRACTION
Two investigators independently reviewed articles and selected relevant articles for inclusion. Quality grading was performed using the Methodological Evaluation of Observational Research Checklist and Newcastle-Ottawa Quality Assessment Form.
DATA SYNTHESIS
The prevalence of back pain in the past 3 months was 33.9% among community-dwelling adults, and patients with back pain contribute $365 billion in all-cause medical costs. Osteoarthritis is the next most prevalent condition (approximately 10.4%), and patients with this condition contribute $460 billion in all-cause medical costs. These 2 conditions are the most prevalent and costly (medically) of the illnesses explored in this study. Stroke follows these conditions in both prevalence (2.5%-3.7%) and medical costs ($28 billion). Other conditions may have a lower prevalence but are associated with relatively higher per capita effects.
CONCLUSIONS
Consistent with previous findings, back pain and osteoarthritis are the most prevalent conditions with high aggregate medical costs. By contrast, other conditions have a lower prevalence or cost but relatively higher per capita costs and effects on activity and work. The data are extremely heterogeneous, which makes anything beyond broad comparisons challenging. Additional information is needed to determine the relative impact of each condition.
Topics: Absenteeism; Amputation, Surgical; Arthritis, Rheumatoid; Back Pain; Brain Injuries, Traumatic; Health Expenditures; Humans; Incidence; Multiple Sclerosis; Osteoarthritis; Physical Functional Performance; Prevalence; Spinal Cord Injuries; United States
PubMed: 32339483
DOI: 10.1016/j.apmr.2020.04.001 -
Journal of Rehabilitation Research and... 2015The choice of a myoelectric or body-powered upper-limb prosthesis can be determined using factors including control, function, feedback, cosmesis, and rejection.... (Review)
Review
The choice of a myoelectric or body-powered upper-limb prosthesis can be determined using factors including control, function, feedback, cosmesis, and rejection. Although body-powered and myoelectric control strategies offer unique functions, many prosthesis users must choose one. A systematic review was conducted to determine differences between myoelectric and body-powered prostheses to inform evidence-based clinical practice regarding prescription of these devices and training of users. A search of 9 databases identified 462 unique publications. Ultimately, 31 of them were included and 11 empirical evidence statements were developed. Conflicting evidence has been found in terms of the relative functional performance of body-powered and myoelectric prostheses. Body-powered prostheses have been shown to have advantages in durability, training time, frequency of adjustment, maintenance, and feedback; however, they could still benefit from improvements of control. Myoelectric prostheses have been shown to improve cosmesis and phantom-limb pain and are more accepted for light=intensity work. Currently, evidence is insufficient to conclude that either system provides a significant general advantage. Prosthetic selection should be based on a patient's individual needs and include personal preferences, prosthetic experience, and functional needs. This work demonstrates that there is a lack of empirical evidence regarding functional differences in upper-limb prostheses.
Topics: Amputees; Arm; Artificial Limbs; Biomedical Engineering; Electromyography; Humans; Prosthesis Design
PubMed: 26230500
DOI: 10.1682/JRRD.2014.08.0192 -
Disability and Rehabilitation Dec 2016Most veterans live for many years after their war-related traumatic lower-limb amputation, which is why understanding which factors influence health-related quality of... (Review)
Review
PURPOSE
Most veterans live for many years after their war-related traumatic lower-limb amputation, which is why understanding which factors influence health-related quality of life (HRQoL) remains important to their long-term management. The objective of this study was to perform a review of the literature to summarize any evidence on the physical and social determinants for HRQoL in veterans with uni- or bilateral lower-limb amputation(s).
METHOD
MEDLINE, EMBASE, PEDro, CINAHL, Scopus and Cochrane databases were searched systematically for eligible studies. Inclusion criteria were: traumatic lower-limb amputation(s), HRQoL outcome and veterans. Physical and social factors that influence HRQoL were extracted.
RESULTS
The literature search identified 2073 citations, leading to the inclusion of 10 studies in the systematic review. Physical activity level, sport participation, level of amputation, back pain, years of education, as well as duration and severity of phantom pain were found to be determining factors for HRQoL among veterans with lower-limb amputation.
CONCLUSIONS
The identified physical and social determinants were similar to those found in civilian traumatic amputees. More high quality research designs, interventions and complex statistical analyses are warranted to identify the physical and social factors that influence the HRQoL of veteran amputees. Implications for Rehabilitation Rehabilitation staff should promote physical activity and participation in sport among veterans with lower-limb amputation(s). Level of amputation, back pain severity, years of education, duration of phantom pain and severity of phantom pain have been found to be determining factors for HRQoL and should be taken into consideration when planning rehabilitation programs for veterans with lower-limb amputations.
Topics: Amputation, Traumatic; Amputees; Exercise; Humans; Leg Injuries; Lower Extremity; Phantom Limb; Quality of Life; Sociological Factors; Surveys and Questionnaires; Veterans
PubMed: 26985705
DOI: 10.3109/09638288.2015.1129446 -
Wound Repair and Regeneration :... Jan 2019Chronic wounds are a health problem that have devastating consequences for patients and contribute major costs to healthcare systems and societies. To understand the...
Chronic wounds are a health problem that have devastating consequences for patients and contribute major costs to healthcare systems and societies. To understand the magnitude of this health issue, a systematic review was undertaken. Searches were conducted in MEDLINE, EMBASE, EBM Reviews and Cochrane library, CINAHL, EBSCO, PsycINFO, and Global Health databases for articles published between 2000 and 2015. Included publications had to target adults (≥18 years of age), state wound chronicity (≥3 weeks) and/or label the wounds as chronic, complex, hard-to-heal, or having led to an amputation. The review excluded studies that did not present data on generic health-related quality of life and/or cost data, case studies, randomized controlled trials, economic modeling studies, abstracts, and editorials. Extracted data were summarized into a narrative synthesis, and for a few articles using the same health-related quality of life instrument, average estimates with 95% confidence intervals were calculated. Thirty articles met the inclusion criteria. Findings revealed that health-related quality of life was lowest for physical pathologies, and based on average estimates were scores most inferior in the domain physical role for both patients with chronic wounds and for those with wound-related amputations. The cost burden was mainly attributed to amputations for patients also comorbid with diabetes, where the cost for hospitalization ranged from US$12,851 to US$16,267 (median) for this patient group. Patients with chronic wounds have poor health-related quality of life in general and wound-related costs are substantial. Development and implementation of wound management strategies that focus on increasing health-related quality of life and effectively reduce costs for this patient group are urgently needed.
Topics: Chronic Disease; Cost of Illness; Health Care Costs; Humans; Quality of Life; Wound Healing; Wounds and Injuries
PubMed: 30362646
DOI: 10.1111/wrr.12683 -
European Journal of Pain (London,... Jan 2023Phantom limb pain (PLP) concerns >50% of amputees and has a negative impact on their rehabilitation, mental health and quality of life. Mirror therapy (MT) is a... (Review)
Review
Effect of mirror therapy in the treatment of phantom limb pain in amputees: A systematic review of randomized placebo-controlled trials does not find any evidence of efficacy.
BACKGROUND AND OBJECTIVE
Phantom limb pain (PLP) concerns >50% of amputees and has a negative impact on their rehabilitation, mental health and quality of life. Mirror therapy (MT) is a promising strategy, but its effectiveness remains controversial. We performed a systematic review to: (i) evaluate the effectiveness of MT versus placebo in reducing PLP, and (ii) determine MT effect on disability and quality of life.
DATABASES AND DATA TREATMENT
We selected randomized-controlled trials in five databases (Medline, Cochrane Library, CINAHL, PEDro and Embase) that included patients with unilateral lower or upper limb amputation and PLP and that compared the effects on PLP of MT versus a placebo technique. The primary outcome was PLP intensity changes and the secondary outcomes were PLP duration, frequency, patients' disability and quality of life.
RESULTS
Among the five studies included, only one reported a significant difference between the MT group and control group, with a positive MT effect at week 4. Only one study assessed MT effect on disability and found a significant improvement in the MT group at week 10 and month 6.
CONCLUSIONS
Our systematic review did not allow concluding that MT reduces PLP and disability in amputees. This lack of strong evidence is probably due to (i) the low methodological quality of the included studies, and (ii) the lack of statistical power. Future trials should include a higher number of patients, increase the number and frequency of MT sessions, have a long-term follow-up and improve the methodological quality.
SIGNIFICANCE
Recent meta-analyses concluded that MT is effective for reducing phantom limb pain. Conversely, the present systematic review that included only studies with the best level of evidence did not find any evidence about its effectiveness for this condition. We identified many ways to improve future randomized-controlled trials on this topic: increasing the number of participants, reducing the intra-group heterogeneity, using a suitable placebo and intensifying the MT sessions and frequency.
Topics: Humans; Phantom Limb; Quality of Life; Mirror Movement Therapy; Amputees; Pain Management; Randomized Controlled Trials as Topic
PubMed: 36094758
DOI: 10.1002/ejp.2035 -
Asian Journal of Surgery Jan 2022The present systematic review and meta-analysis was performed to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic foot ulcers... (Meta-Analysis)
Meta-Analysis Review
The present systematic review and meta-analysis was performed to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic foot ulcers (DFUs). Relevant articles were retrieved from PubMed, the Cochrane Library, EMBASE and other databases through November 2020. A total of 20 randomized clinical trials and 1263 trials were included in the meta-analysis. For each trial, the average difference, odds ratio and 95% confidence interval were calculated to evaluate the efficacy. Hyperbaric oxygen therapy increased the healing rate of diabetic foot ulcers (relative risk, 1.901; 95% CI = 1.484-2.435, p < 0.0001), shortened the healing time (MD = -19.360; 95% CI = -28.753~-9.966, p < 0.001), and reduced the incidence of major amputation (relative risk, 0.518, 95% CI = 0.323-0.830, P < 0.01). In summary, our meta-analysis confirmed that hyperbaric oxygen therapy offers great benefits in the treatment of DFU and the reduction of amputation. In addition, larger and well-designed randomized controlled trials need to be planned and conducted to verify this conclusion.
Topics: Amputation, Surgical; Diabetes Mellitus; Diabetic Foot; Humans; Hyperbaric Oxygenation; Risk; Wound Healing
PubMed: 34376365
DOI: 10.1016/j.asjsur.2021.07.047 -
Annals of Physical and Rehabilitation... Sep 2016Phantom limb pain (PLP) is a major problem after limb amputation. Mirror therapy (MT) is a non-pharmacological treatment using representations of movement, the efficacy... (Review)
Review
BACKGROUND AND OBJECTIVE
Phantom limb pain (PLP) is a major problem after limb amputation. Mirror therapy (MT) is a non-pharmacological treatment using representations of movement, the efficacy of which in reducing PLP remains to be clarified. Here, we present the first systematic review on MT efficacy in PLP and phantom limb movement (PLM) in amputees (lower or upper limb).
METHODS
A search on Medline, Cochrane Database and Embase, crossing the keywords "Phantom Limb" and "Mirror Therapy" found studies which were read and analyzed according the PRISMA statement.
RESULTS
Twenty studies were selected, 12 on the subject of MT and PLP, 3 on MT and PLM, 5 on MT and both (PLP and PLM). Among these 20 studies, 5 were randomized controlled trials (163 patients), 6 prospective studies (55 patients), 9 case studies (40 patients) and methodologies were heterogeneous. Seventeen of the 18 studies reported the efficacy of MT on PLP, but with low levels of evidence. One randomized controlled trial did not show any significant effect of MT. As to the effect of MT on PLM, the 8 studies concerned reported effectiveness of MT: 4 with a low level of evidence and 4 with a high level of evidence. An alternative to visual illusion seems to be tactile or auditory stimulation.
CONCLUSION
We cannot recommend MT as a first intention treatment in PLP. The level of evidence is insufficient. Further research is needed to assess the effect of MT on pain, prosthesis use, and body representation, and to standardize protocols.
Topics: Adult; Amputees; Female; Humans; Imagery, Psychotherapy; Male; Middle Aged; Pain Management; Phantom Limb; Physical Therapy Modalities; Psychomotor Performance
PubMed: 27256539
DOI: 10.1016/j.rehab.2016.04.001