Dataset Information

The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study.

ABSTRACT:

Background

Accurate prediction of outcomes following surgery with high morbidity and mortality rates is essential for informed shared decision-making between patients and clinicians. It is unknown how accurately healthcare professionals predict outcomes following major lower-limb amputation (MLLA). Several MLLA outcome-prediction tools have been developed. These could be valuable in clinical practice, but most require validation in independent cohorts before routine clinical use can be recommended. The primary aim of this study is to evaluate the accuracy of healthcare professionals' predictions of outcomes in adult patients undergoing MLLA for complications of chronic limb-threatening ischaemia (CLTI) or diabetes. Secondary aims include the validation of existing outcome-prediction tools.

Method

This study is an international, multicentre prospective observational study including adult patients undergoing a primary MLLA for CLTI or diabetes. Healthcare professionals' accuracy in predicting outcomes at 30-days (death, morbidity and MLLA revision) and 1-year (death, MLLA revision and ambulation) will be evaluated. Sixteen existing outcome-prediction tools specific to MLLA will be examined for validity. Data collection began on 1 October 2020; the end of follow-up will be 1 May 2022. The C-statistic, Hosmer-Lemeshow test, reclassification tables and Brier score will be used to evaluate the predictive performance of healthcare professionals and prediction tools, respectively.

Study registration and dissemination

This study will be registered locally at each centre in accordance with local policies before commencing data collection, overseen by local clinician leads. Results will be disseminated to all centres, and any subsequent presentation(s) and/or publication(s) will follow a collaborative co-authorship model.

SUBMITTER: Gwilym BL

PROVIDER: S-EPMC8634116 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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: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.

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Project description:AbstractLower limb amputation (LLA) is still a health issue requiring rehabilitation and long-term care even in industrial societies. Several studies on subjects with LLA have been focused on the efficacy of rehabilitation and factors influencing the use of prosthesis. However, literature data on the recovery of ability to walk outdoors, and thus to participate in social life in this population is limited.To investigate potential correlations between socio-demographic and clinical factors, and the use of the prosthesis for indoor and/or outdoor walking referred to as community ambulation (CA) in subjects with LLA.An observational cohort study on 687 LLA subjects was conducted. Socio-demographic and clinical characteristics of 302 subjects who received similar rehabilitative treatment with respect to the standard protocol were collected by a telephone survey with a structured questionnaire. The CA recovery, in terms of patient's autonomy and participation, assessed by Walking Handicap Scale, was considered as the main outcome.The univariate analysis demonstrated statistical significant positive correlation between CA and gender (χ2 = 3.901, P = .048); amputation level (χ2 = 24.657, P < .001); pre-LLA (χ2 = 6.338, P = .012) and current work activity (χ2 = 25.192, P < .001); prosthesis use (χ2 = 187.037, P < .01); and time from LLA (r = 0.183, P < .001); increasing age was negatively correlated with the outcome (r = -0.329, P < .001), while pain intensity was not significant. Being male (75.4%); trans-tibial (TT) amputation level (9.79%); working before (3.81%) and after LLA (7.68%); and the prosthesis use (24.63%) increased the probability of CA recovery. Multivariate binary logistic regression analysis confirmed that the prosthesis use (P < .001) and TT amputation level (P = .042) are predictors of a positive outcome (Walking Handicap Scale 4-6).These findings highlight the importance of the use of prosthesis in people with LLA for the restoration of a good capacity of participation (CA), especially in subjects with TT amputation level. The identification of predictive factors may help tailor-made rehabilitation approaches addressing an earlier reintegration to social life.

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