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Epidemiology of major lower limb amputation using routinely collected electronic health data in the UK: a systematic review protocol.

ABSTRACT: INTRODUCTION:It is estimated that peripheral arterial disease occurs in one in five people aged over 60 years in the UK. Major lower limb amputation is a debilitating and life-changing potential outcome of peripheral arterial disease. A number of risk factors are involved in the development of the disease including smoking and diabetes. There is debate over the prevalence of major lower limb amputation in the UK with regional variations unexplained. The choice of data source can affect the epidemiological calculations and sources can also differ in the ability to explain variation. This study will aim to estimate the prevalence/incidence/number of major lower limb amputation in the UK. It will also identify sources of routinely collected electronic health data which report the epidemiology of major lower limb amputation in the UK. METHODS AND ANALYSIS:A systematic search of peer-reviewed journals will be conducted in Medline, Excerpta Medica database, Cumulative Index of Nursing and Allied Health Literature, Allied and Complementary Medicine Database, The Cochrane Library and Scopus. A grey literature search for government and parliament publications, conference abstracts, theses and unpublished articles will be performed. Articles will be screened against the inclusion/exclusion criteria and data extracted using a pretested extraction form by two independent reviewers. Prevalence, incidence or number of cases (depending on data reported) will be extracted. Disagreements will be resolved by discussion. Data synthesis will be performed either as a narrative summary or by meta-analysis. Heterogeneity will be assessed using the I2 statistic. If heterogeneity is low-moderate, pooled estimates will be calculated using random-effects models. If possible, meta-regression for time trends in the incidence of major lower limb amputation will be performed along with subgroup analysis, primarily in regional variation. ETHICS AND DISSEMINATION:Ethics approval is not required for this study as study data are anonymised and available in the public domain. Dissemination will be by publication in a peer reviewed journal and by appropriate conference presentation.PROSPERO registration numberCRD42020165592.

SUBMITTER: Meffen A

PROVIDER: S-EPMC7295407 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Epidemiology of major lower limb amputation using routinely collected electronic health data in the UK: a systematic review protocol.

Meffen Anna A Pepper Coral J CJ Sayers Robert D RD Gray Laura J LJ

BMJ open 20200611 6

<h4>Introduction</h4>It is estimated that peripheral arterial disease occurs in one in five people aged over 60 years in the UK. Major lower limb amputation is a debilitating and life-changing potential outcome of peripheral arterial disease. A number of risk factors are involved in the development of the disease including smoking and diabetes. There is debate over the prevalence of major lower limb amputation in the UK with regional variations unexplained. The choice of data source can affect t ...[more]

PMID: 32532778

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Project description:ObjectiveThe aim of this observational cross-sectional study was to analyse the spatial distribution of major lower limb amputation (MLLA) rates and associate them to socioeconomic, demographic and public healthcare access-related variables in the State of Paraná, Brazil, from 2012 to 2017.MethodData on MLLA, revascularisation surgeries, diagnostic exams and healthcare coverage were obtained from the Brazilian Public Hospital Information System. Socioeconomic data were obtained from the Brazilian Institute of Geography and Statistics. Spatial autocorrelation of the MLLA rates was tested using Moran's I method. Multivariate spatial regression models using ordinary least squares regression (OLS) and geographically weighted regression (GWR) were used to identify the variables significantly correlated with MLLA.ResultsA total of 5270 MLLA were included in the analysis. Mean MLLA rates were 24.32 (±18.22)/100 000 inhabitants, showing a positive global spatial autocorrelation (Moran's I=0.66; p<0.001). Queen contiguity matrix demonstrates that MLLA rates ranged from 7.6 to 46.6/100 000 with five large clusters of high MLLA rates. OLS showed that four of the nine studied variables presented significant spatial correlation with MLLA rates. Colour Doppler ultrasound showed a negative association (p<0.001), while revascularisation surgeries and illiteracy showed a positive correlation (p<0.01). GWR presented the best model (adjusted R2=0.77) showing that the predictors differentially affect the MLLA rates geographically.ConclusionThe high MLLA rates in some regions of the state are influenced by the high rate of illiteracy and low utilisation rate of colour Doppler, indicating a social problem and difficulty in accessing health. On the other hand, the high rates of revascularisation surgeries are related to higher MLLA rates, possibly due to delayed access to specialised hospitals. This indicates that attention must be given to population access to public healthcare in the State of Paraná in order to ensure proper and timely medical attention.

Project description:BACKGROUND:Pain after major lower limb amputation for peripheral arterial disease (PAD) is a significant problem. A perineural catheter (PNC) can be placed adjacent to the major nerve at the time of amputation with a continuous local anaesthetic infusion given postoperatively to try and reduce pain. Although low-quality observational data suggest that PNC usage reduces postoperative opioid requirements, there are limited data regarding its effect on pain. The aim of PLACEMENT is to explore the feasibility of running an effectiveness trial to assess the impact of a PNC with continuous local anaesthetic infusion, inserted at the time of amputation, on short and medium-term postoperative outcomes. METHODS/DESIGN:Fifty patients undergoing a major lower limb amputation (below or above the knee) for PAD will be recruited from two centres. Patients will be randomised in a 1:1 ratio to receive standard postoperative analgesia, with or without insertion of a PNC and local anaesthetic infusion for the first 5 postoperative days. Outcome data will be captured for the first 5 days, including pain scores (primary outcome, captured three times a day), opioid use, nausea or vomiting, itching, dizziness and complications. Patients will be contacted 2 and 6 months after surgery to assess quality of life, phantom limb pain, chronic stump pain and total healthcare costs. Semi-structured interviews will be conducted with at least 10 patients (dependent on saturation of analytic themes on preliminary coding) purposefully sampled to achieve variation in site and study arm. Interviews will explore patients' perception of post-amputation pain and its treatment, and experience of study processes. Semi-structured interviews with 5-10 health professionals will explore feasibility, fidelity, and acceptability of the study. Data from this pilot will be used to assess feasibility of, and estimate parameters to calculate the sample size for an effectiveness trial. Full ethical approval has been granted (Wales Research Ethics Committee 3 reference number 16/WA/0353). DISCUSSION:PLACEMENT will be the first study to explore the feasibility of running an effectiveness trial on PNC usage for postoperative pain in amputees, and provide parameters to calculate the appropriate sample size for this study. TRIAL REGISTRATION:ISRCTN.com, ISRCTN85710690 . Registered on 21 October 2016. European Clinical Trials Database (EudraCT), 2016-003544-37. Registered on 24 August 2016.

Project description:ObjectivesTo explore patient experiences, understanding and perceptions of analgesia following major lower limb amputation.DesignQualitative interview study, conducted as part of a randomised controlled feasibility trial.SettingParticipants were recruited from two general hospitals in South Wales.ParticipantsInterview participants were patients enrolled in PLACEMENT (Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial): a randomised controlled feasibility trial comparing the use of perineural catheter (PNC) versus standard care for postoperative pain relief following major lower limb amputation. PLACEMENT participants who completed 5-day postoperative follow-up, were able and willing to participate in a face-to-face interview, and had consented to be contacted, were eligible to take part in the qualitative study. A total of 20 interviews were conducted with 14 participants: 10 male and 4 female.MethodsSemi-structured, face-to-face interviews were conducted with participants over two time points: (1) up to 1 month and (2) at least 6 months following amputation. Interviews were audio-recorded, transcribed verbatim and analysed using a framework approach.ResultsInterviews revealed unanticipated benefits of PNC usage for postoperative pain relief. Participants valued the localised and continuous nature of this mode of analgesia in comparison to opioids. Concerns about opioid dependence and side effects of pain relief medication were raised by participants in both treatment groups, with some reporting trying to limit their intake of analgesics.ConclusionsFindings suggest routine placement of a PNC following major lower limb amputation could reduce postoperative pain, particularly for patient groups at risk of postoperative delirium. This method of analgesic delivery also has the potential to reduce preoperative anxiety, alleviate the burden of pain management and minimise opioid use. Future research could further examine the comparison between patient-controlled analgesia and continuous analgesia in relation to patient anxiety and satisfaction with pain management.Trial registration numberISRCTN: 85710690; EudraCT: 2016-003544-37.

Project description:BackgroundTo evaluate cycling participation and identify barriers and facilitators related to cycling participation in people with a lower limb amputation (LLA) in the Netherlands.MethodsA questionnaire was sent to adults with a LLA between March and August 2019 to obtain information regarding prosthesis, individual's characteristics, amputation, cycling barriers and facilitators, and prosthetic satisfaction. The questionnaires were distributed via 8 orthopedic workshops, post and were given directly. To find cycling predictors, variables associated with cycling (p < 0.1) were entered into a logistic regression analysis. Non-significant variables were removed manually.ResultsParticipants (n = 207, 71% males) had a mean age of 62.0 ± 13.0 years. The most frequent level of amputation was transtibial (42%), and trauma was the most frequent cause of amputation (43%). After the LLA, 141 participants (68%) cycled for recreation (80%), physical fitness (74%), and transport (50%). In the past six months, cyclists cycled for recreation (79%) and transport (66%). Most cycled less than once a day. Recreational cyclists cycled alone (75%) for a median duration of 45 min or 14 km per ride. Cyclists with a transportation purpose usually cycled to go shopping (80%) or to visit friends (68%), with a median duration of 20 min or five kilometers per ride. Cyclists reported more facilitators (median (IQR) = 5 (3, 7) than non-cyclists 0 (0, 3). The majority of cyclists reported a positive attitude toward cycling (89%) and cycled because of health benefits (81%). A dynamic foot (odds ratio: 5.2, 95% CI 2.0, 13.3) and a higher number of facilitators (odds ratio: 1.3, 95% CI 1.2, 1.5) positively predicted cycling, whereas the presence of other underlying diseases (odds ratio: 0.4, 95% CI 0.2, 0.9) negatively predicted cycling (R2: 40.2%).ConclusionIn the Netherlands, the majority of adults cycled after a LLA, mainly for recreational purposes. A dynamic foot, a higher number of facilitators, and no other underlying diseases increases the likelihood of cycling after a LLA. The results suggest that personal motivation and a higher mobility level could be the key to increasing cycling participation. Future research should determine the association between motivation, mobility levels, and cycling with a LLA.

Project description:Lower extremity amputation is often performed in patients where both lower extremities are at risk due to peripheral arterial disease or diabetes, yet the proportion of patients who progress to amputation of their contralateral limb is not well defined. We sought to determine the rate of subsequent amputation on both the ipsilateral and contralateral lower extremities following initial amputation.We conducted a retrospective review of all patients undergoing lower extremity amputation (exclusive of trauma or tumor) at our institution from 1998 to 2010. We used International Classification of Diseases-Ninth Revision codes to identify patients and procedures as well as comorbidities. Outcomes included the proportion of patients at 1 and 5 years undergoing contralateral and ipsilateral major and minor amputation stratified by initial major vs minor amputation. Cox proportional hazards regression analysis was performed to determine predictors of major contralateral amputation.We identified 1715 patients. Mean age was 67.2 years, 63% were male, 77% were diabetic, and 34% underwent an initial major amputation. After major amputation, 5.7% and 11.5% have a contralateral major amputation at 1 and 5 years, respectively. After minor amputation, 3.2% and 8.4% have a contralateral major amputation at 1 and 5 years while 10.5% and 14.2% have an ipsilateral major amputation at 1 and 5 years, respectively. Cox proportional hazards regression analysis revealed end-stage renal disease (hazard ratio [HR], 3.9; 95% confidence interval [CI], 2.3-6.5), chronic renal insufficiency (HR, 2.2; 95% CI, 1.5-3.3), atherosclerosis without diabetic neuropathy (HR, 2.9; 95% CI, 1.5-5.7), atherosclerosis with diabetic neuropathy (HR, 9.1; 95% CI, 3.7-22.5), and initial major amputation (HR, 1.8; 95% CI, 1.3-2.6) were independently predictive of subsequent contralateral major amputation.Rates of contralateral limb amputation are high and predicted by renal disease, atherosclerosis, and atherosclerosis with diabetic neuropathy. Physicians and patients should be alert to the high risk of subsequent amputation in the contralateral leg. All patients, but particularly those at increased risk, should undergo close surveillance and counseling to help prevent subsequent amputations in their contralateral lower extremity.

Project description:OBJECTIVES:To determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome. DESIGN:Randomised controlled feasibility trial. SETTING:Two vascular Centres in South Wales, UK. PARTICIPANTS:50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease. INTERVENTIONS:The treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6?month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain. RESULTS:Seventy-six of 103 screened patients were deemed eligible over a 10?month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6?month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable. CONCLUSIONS:Recruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult. TRIAL REGISTRATION NUMBER:ISRCTN: 85?710?690. EudraCT: 2016-003544-37.

Dataset Information

Epidemiology of major lower limb amputation using routinely collected electronic health data in the UK: a systematic review protocol.

Publications

Epidemiology of major lower limb amputation using routinely collected electronic health data in the UK: a systematic review protocol.

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