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: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.

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