The epidemiology and functional outcomes after a major lower limb amputation (LLA) in Johannesburg
Date
2016
Authors
Godlwana, Lonwabo L
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Abstract
Background:
The incidence and prevalence of disease related lower limb amputation (LLA) operation at the Johannesburg metropolitan hospitals is unknown.
Lower limb amputation (LLA) results in a marked decline in functional independence. In Johannesburg South Africa, the LLA population is generally underprivileged, and Chris Hani Baragwanath Hospital and Charlotte Maxeke Johannesburg Academic hospital are not in a position to offer long-term rehabilitation to them on an inpatient basis. Patients often get discharged early as these tertiary hospitals have a high turnover and the demand for hospital beds is high.
Aims:
To establish the cumulative incidence and prevalence of disease related LLA at Johannesburg Metropolitan Hospitals.
To establish whether a self-administered postoperative exercise programme (home programme) will improve function and other selected outcomes. Measures were taken at three months and six months after the LLA.
Methods:
A population sample of all theatre register records was used to review theatre registers for the epidemiological study. All records of general surgery and vascular operations were reviewed to count the number of LLA operations performed over a two year period from June 2011-June 2013.
A randomised controlled trial (RCT) (n=154, n=77 per group) was conducted on participants who met the inclusion criteria. Allocation into groups was concealed and the assessor was blinded. The Barthel index to measure function (BI), Modified Amputee Body Image Scale (MABIS), Participation Scale (P-Scale), Euroqol EQ-5D quality of life (EQ-5D), Modified Locomotor Capabilities Index (MLCI) and the Timed Up and Go test (TUG) were used to gather data from the participants. The control group received the standard rehabilitation from Chris Hani Baragwanath or Charlotte Maxeke Johannesburg Academic hospitals and the intervention group received an additional exercise programme and an exercise diary (ED) to keep a record of compliance. The intervention was a home exercise programme which was administered from discharge until three month post amputation. A research assistant (a physiotherapist) administered the intervention and did weekly reminding of the participants about the exercises and the researcher did all the testing (interviews and physical tests).
Data were analyzed using IBM SPSS version 22. Descriptive and ratio analysis was used for the prevalence study. All continuous data are presented as means, standard deviations and
medians and percentiles. The two groups were compared using Fisher’s exact test for categorical data and the Mann Whitney U-test for continuous data. Bonferroni correction method was used when testing the tools item by item. Survival was established using the Kaplan-Meier test and the Log Rank (Mantel-Cox) test for comparison. Generalised Linear models (GLM) Generalised Estimating Equations (GEE), Repeated Measures Analysis of Covariance (RM-ANCOVA and Analysis of Variance (ANOVA) were used to exclude confounders. A multiple linear regression was used to establish associations between baseline characteristics and functional outcomes. An intention to treat analysis was used.
Results:
A total population of N=23617 people underwent general and vascular surgical procedures at the Johannesburg Metropolitan Hospitals during the study period. The majority of the amputations were BKA followed by AKA. The total number of amputations performed was 879. The cumulative prevalence of LLA operations is 0.037 (95% CI) (or 3722.0 per 100 000 persons seen at the Johannesburg Metropolitan hospitals).Total amputation number of new LLA performed was 743. The cumulative incidence of LLA is 0.031(95% CI) (or 3146 per 100 000 persons -2-years of study). The cumulative incidence of LLA in males is 0.038(95% CI) (or 3849.14 per 100 000 persons -2-years of study). The cumulative incidence of LLA in females is 0.023(95% CI) (or 2300 per 100 000 persons -2-years of study).
In the RCT, the median age was 58 per group (p=0.505), the control group had 66.2% males and the intervention group had 63.6% males (p=0.433). There were no significant (p˃0.05) differences in demographic characteristics between the two groups at baseline but the intervention group had a significantly (p=0.005) more participants with a BKA than the control group.
The groups were comparable at baseline on all the outcome measures except participation with the intervention group demonstrating significantly more participation restriction (P-Scale) (p=0.038) (25th percentile 0;0, median 0;0, 75th percentile 0;5 for group 1 and 2 respectively). However, the intervetion group demonstrated significantly less (p=0.004) participation restriction at three months postoperatively compared to the control group (25th percentile 10;6, median 28;18, 75th percentile 41;27 for group 1 and 2 respectively).
The intervention group demonstrated significantly lower (p=0.039) activity limitation levels (BI) at three months postoperatively compared to the control group (25th percentile 16;18, median 18;18, 75th percentile 19;20 for the control group and the intervention group respectively) and significantly lower (p=0.005) activity limitation levels (MLCI) (25th percentile 13;20, median 21;24, 75th percentile 30;38 for the control and the intervention group respectively) at three months postoperatively compared to control group. The intervention group demonstrated significantly lower (p=0.040) activity limitation levels at three months postoperatively compared to control group in the MLCI Basic Subscale score(25th percentile
7;9, median 9;11, 75th percentile 17;21 for the control and the intervention group respectively). Group 2 demonstrated significantly lower (p=0.001) activity limitation levels at three months postoperatively compared to the control group in the MLCI Advanced score (25th percentile 6;10, median 11;15, 75th percentile 14;19 for the control and the intervention group respectively). Body image perception (MABIS) showed no significant (p=0.201) difference between the groups (25th percentile 20;25, median 28;35, 75th percentile 40;43 for the control and the intervention group respectively) at three months.
The intervention group demonstrated a significantly (p=0.001) better QOL VAS (25th percentile 30;50, median 60;80, 75th percentile 80;80 for the control and the intervention group respectively) and a significant (p=0.033) index scores(25th percentile 0.264;0.689, median 0.725;0.796, 75th percentile 0.796;0.796 for the control and the intervention group respectively) of QOL at three months postoperatively compared to control group. The intervention group demonstrated significantly less risk of falling (better ability to balance) (TUG) at three months(25th percentile 25;19, median 34;24, 75th percentile 45;36 for the control and the intervention group respectively) (p=0.036) and six months (25th percentile 19;13, median 25.5;21, 75th percentile 36;32 for the control and the intervention group respectively) (p=0.046) postoperatively compared to the control group. Only balance remained different at six months, the other outcomes were similar between the groups. Being in the intervention group was associated with higher functional outcomes (activity levels, higher participatation levels, higher QOL and lower risk of falling) postoperatively. Being old was associated with lower functional outcomes (lower activity levels and high risk of falling) postoperatively. Being female was associated with lower functional outcomes (lower activity levels), absence of diabetes was associated with high QOL and absence of other comorbidities was associated with lower risk of falling.
Thirty-three participants died during the study period. There were significantly more smokers (p=0.016) and drinkers (p=0.022) among the group that died compared to the survivors. In the regression analysis, death was predicted by cigarette smoking, alcohol drinking and reduced preoperative participation.
Conclusion:
The intervention ensured early functional independence of the intervention group compared to the control group. This study suggests that the intervention could be adopted as standard care for lower limb amputation patients especially those from situations with limited resources as they tend to be discharged early from the hospitals in order to accommodate other admissions.
Description
This thesis is being submitted in fulfilment of the requirements for the degree of Doctor of Philosophy at the University of the Witwatersrand, Johannesburg.