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Correlating patient-reported outcomes and ambulation success following microsurgical lower extremity reconstruction in comorbid patients
Article first published online: 11 JUL 2013
Copyright © 2013 Wiley Periodicals, Inc.
Volume 34, Issue 1, pages 1–4, January 2014
How to Cite
Patel, K. M., Economides, J. M., Franklin, B., Sosin, M., Attinger, C. and Ducic, I. (2014), Correlating patient-reported outcomes and ambulation success following microsurgical lower extremity reconstruction in comorbid patients. Microsurgery, 34: 1–4. doi: 10.1002/micr.22126
- Issue published online: 26 DEC 2013
- Article first published online: 11 JUL 2013
- Manuscript Accepted: 25 MAR 2013
- Manuscript Revised: 14 MAR 2013
- Manuscript Received: 28 JAN 2013
Introduction: Microsurgical lower extremity flap reconstruction provides a valuable option for soft tissue reconstruction in comorbid patients. Limb salvage with flap reconstruction can result in limb length preservation. Despite this, few studies have examined the impact of salvage on patient-centered metrics in this cohort of patients. Therefore, we investigated quality of life and patient satisfaction following microsurgical lower extremity reconstruction in this high-risk patient population. Factors that resulted in improved patient-centered outcomes were also identified. Methods: A retrospective review was conducted of all patients who had lower extremity free flap reconstruction (FFR) following lower extremity wounds. High-risk patients were identified as having multiple comorbidities and chronic wounds. Patients with traumatic wounds were excluded from analysis. Quality of life was evaluated with the Short Form-12 (SF-12) validated survey. Phone interviews were conducted for survey evaluations. Results: From 2005 to 2010, 57 patients had lower extremity flap reconstruction that met the inclusion criteria. Average follow-up was 236.6 weeks (range, 111–461). Comorbidities included diabetes (36%), PVD (24.6%), and ESRD (7%). Limb length preservation and ambulation occurred in 82.5% (47/57). Revisional surgery occurred in 33.3% (19/57). Survey response rate was 63%. Average SF-12 PCS and MCS scores were 44.9 and 59.8 for patients able to achieve ambulation and 27.6 and 61.2 for nonambulatory patients. Conclusions: Microsurgical flap reconstruction is a valuable reconstructive option in high-risk patients. Quality of life is comparable with a normalized population if limb salvage is successful. Quality of life is decreased significantly when failure to ambulate occurs in this patient cohort. © 2013 Wiley Periodicals, Inc. Microsurgery 34:1–4, 2014.
Lower extremity reconstruction with the aim toward limb salvage in the co-morbid patient population is a difficult undertaking for the reconstructive surgeon. Co-morbidities such as diabetes mellitus, peripheral vascular disease, and renal failure add complexity to microsurgical reconstruction. Systemic vascular changes such as recipient vessel disease, recipient site scarring, and donor vessel disease may pose a technical challenge. However, successful outcomes in lower extremity reconstruction are well demonstrated in this patient population and provide patients with the option of limb salvage.[1, 2]
Early successful outcomes are predicated by overcoming compromised vascular inflow and by controlling infection. Following the early postoperative period, achieving successful long-term outcomes becomes more challenging. Traditionally flap survival was the marker for defining a successful outcome. However, the focus on long-term outcomes in this patient population has shifted toward achieving improved functionality and ambulation, patient satisfaction, and an overall better health related quality of life (HRQoL). Markers of successful outcomes may be associated with the ability to ambulate and lack of late wound formation or eventual amputation. However, there continues to be a paucity of literature investigating functional outcomes and patient satisfaction with regard to lower extremity reconstruction in patients with nontraumatic wounds associated with the aforementioned systemic diseases.
Patient reported outcomes measures assessing health related quality of life (HRQoL), functionality, and patient satisfaction are frequently studied via validated questionnaires such as the Short Form-36 (SF-36) and Short Form-12 (SF-12). The SF-12 is a generic 12-part questionnaire adapted from the lengthier SF-36. Assessment of function is separated into two general areas: Physical Health (PCS) and Mental Health (MCS). Analysis of scores compared to the general United States population provides a quantitative and qualitative understanding of postoperative physical function and patient satisfaction with limb salvage. This study examines long-term functional outcomes and patient satisfaction in patients undergoing lower extremity reconstruction.
PATIENTS AND METHODS
A retrospective review was conducted of all patients who underwent lower extremity free flap reconstruction (FFR) for lower extremity nontraumatic wounds by the senior author (I.D) between 2005 and 2010. Patients included in this study were identified as having multiple medical comorbidities with chronic wounds that were treated in the wound center. Patients with acute/traumatic wounds were excluded from analysis. Quality of life was evaluated using the Short Form-12 (SF-12) validated survey used widely in research of patient-reported outcomes. Surveys were completed via phone interview at a minimum of one year follow-up. In addition to HRQoL, data related to patient age, length of follow up, development of complications, ability to ambulate post-operatively, and wound formation was collected (Tables 1 and 2).
|Total No. of Patients||57|
|Range in years||19–86|
|Average Follow Up (weeks)||236.6|
|Range in weeks||111–461|
|Ambulatory Patients||Non-Ambulatory Patients|
|Total no. patients||47 (82.5)||10 (17.5)|
|Early complicationsa||3 (6.3)||1 (10)|
|Late complications||3 (6.3)||3 (30)|
|Ambulation successful||47 (100)||0 (0)|
|Time to ambulation, mean (weeks)||12.36||N/A|
|Range in weeks||4–38||N/A|
|Revisional Surgery||28 (59.5)||8 (80)|
|Eventual Same Side Amputation||5 (10.6)||8 (80)|
Physical (PCS) and mental (MCS) component scale scores were calculated from each completed SF-12 survey according to algorithms published by QualityMetric (Lincoln, Rhode Island). Scoring was norm-based to achieve a mean of 50 and standard deviation of 10, with lesser values indicating a greater degree of disability. Scores above 50 indicated no disability. PCS and MCS scores were analyzed using VassarStats (Poughkeepsie, NY). Means and confidence intervals were calculated for each subgroup. To assess for statistical significance between subgroups, scores were compared using t-tests. An a priori value of P < 0.05 was considered statistically significant.
A total of 57 patients (Table 1) who underwent free flap reconstruction (FFR) were included in this study with an average age of 58.2 years (range, 19–86) and an average follow up period of 235.6 weeks (range, 115–461). Comorbidities included diabetes (36%), peripheral arterial disease (PAD, 24.6%), and end-stage renal disease (ESRD, 7%) in this FFR cohort. Successful flap reconstruction was achieved in 100% of patients. Post-operative ambulation (Table 2) was achieved by 82.5% (47/57) of patients with an average time to ambulation of 12.36 weeks (range, 4–38). Additional surgeries were required in 35 patients (61%) after the initial reconstructive procedure, with the most common being debridement (25/35) and skin grafting (17/35). Late wound formation occurred in 16 patients at an average time of 14.75 weeks post-operatively (range, 3–86). Patient satisfaction was high with 95% of patients (18/19) willing to undergo their reconstructive procedure again, while 1 patient (5%) would opt for a below knee amputation instead. Average patient satisfaction as rated on a scale of 1 (least satisfied) to 5 (most satisfied) was 4.89.
SF-12 survey response rate was 63% (36/57) overall, 64% in the ambulating cohort, and 60% in the nonambulating cohort. Of those patients who were able to successfully ambulate following flap reconstruction of their lower extremity, average PCS and MCS scores were 44.9 and 59.8, respectively. For patients unable to ambulate following lower extremity reconstruction, these scores were 27.6 and 61.2. The difference in PCS values was found to be statistically significant with a P < 0.001. For all patients not requiring an amputation the mean PCS and MCS scores were 43.61 and 59.8 compared with 35.57 and 61.2 for all patients requiring an amputation. The PCS and MCS scores for nonambulatory patients not requiring an amputation were 23.2 and 60.9. These values were statistically different from the PCS and MCS scores of nonambulatory patients requiring amputation (29.92, 61.43, P = 0.03). Differences between other patient groupings were not found to be statistically significant (Tables 3 and 4).
|N||Mean||CI (0.95) +/−||p-value|
|All ambulatory patients||30||44.92||2.99||<0.0001|
|All nonambulatory patients||6||27.68||4.67|
|Ambulatory patients with immediate complications||33||42.16||3.37||0.89|
|Nonambulatory patients with immediate complications||3||40.73||40.5|
|Ambulatory patients with late complications||34||42.3||3.48||0.61|
|Nonambulatory patients with late complications||2||37.6||83.88|
|All patients without amputation||29||43.61||3.66||0.06|
|All patients with amputation||7||35.57||8.29|
|Ambulatory patients without amputation||27||45.12||3.2||0.73|
|Ambulatory patients with amputation||3||43.1||21.11|
|Nonambulatory patients without amputation||2||23.2||0||0.03|
|Nonambulatory patients with amputation||4||29.92||5.74|
|N||Mean||CI (0.95) +/−||P-value|
|All ambulatory patients||30||59.84||1.63||0.27|
|All nonambulatory patients||6||61.25||2.43|
|Ambulatory patients with immediate Complications||33||60.14||1.51||0.52|
|Nonambulatory patients with immediate complications||3||59.36||3.84|
|Ambulatory patients with late complications||34||59.98||1.45||0.41|
|Nonambulatory patients with late complications||2||61.7||19.06|
|All patients without amputation||29||59.8||1.67||0.27|
|All patients with amputation||7||61.2||2.27|
|Ambulatory patients without amputation||27||59.73||1.8||0.48|
|Ambulatory patients with amputation||3||60.9||5.3|
|Nonambulatory patients without amputation||2||60.9||0||0.74|
|Nonambulatory patients with amputation||4||61.43||4.74|
Commonly, successful outcomes of limb salvage procedures have been measured by the ability to reduce rates of complications and eliminate the need for further surgeries. Patient-centered outcomes such as HRQoL and patient satisfaction have not readily been addressed in the comorbid patient population as they have been in lower extremity wounds resulting from trauma. However, as free flap reconstruction (FFR) of lower extremity wounds in the comorbid patient population become more commonly used and as the medical mindset becomes driven toward patient-reported outcome measures (PROM), the need to address these outcomes in lower extremity reconstruction is becoming more apparent.
Quality of life assessments such as the SF-12 and SF-36 provide reliable and valid data on PROMs of various medical or surgical interventions. These assessments can also provide a picture of the overall health status of the patient compared with that of the general population. The SF-12 measures functional outcomes in two general areas, Physical Health (PCS), and Mental Health (MCS). Normalized scores related to the general US population allow for comparative analyses to determine the impact of surgical events on patient-related outcomes. Scores above 50 in either category indicate the patient has no disability. Scores under 50 indicate increasing levels of disability compared to the general population (40–50 = mild disability, 30–40 = moderate disability, <30 = severe disability).
FFR is a valuable reconstructive option in high-risk patients with success rates as high as 80%. Beyond successful limb salvage, we showed that the ability to ambulate significantly increased one's physical HRQoL and that ambulatory patients could achieve a HRQoL comparable to that of the general population. Factors such as the development of either immediate or late complications did not influence HRQoL.
The physical HRQoL scores as measured by the SF-12 in our patient cohort showed only mild disability compared with the general population when ambulation was achieved (82% of patients). This was in contrast to decreased physical HRQoL for nonambulatory patients post-operatively. Mental HRQoL was comparable with the general population for both ambulatory and nonambulatory patients.
Another important factor influencing HRQoL was amputation. We showed that patients had a higher physical HRQoL (comparable with that of the general population) when they did not undergo an amputation. However, this value continued to be influenced by the ambulatory status of the patient. Ambulatory patients showed only mild disability regardless of amputation status, and there was no difference between the physical HRQoL of ambulatory amputees and nonamputees. However, the HRQoL decreased dramatically for both amputees and nonamputees when these patients were not ambulatory. Interestingly, although both groups showed severe disability, the HRQoL was significantly higher for ambulatory amputees than nonambulatory nonamputees, further suggesting that the ability to ambulate was the main factor influencing HRQoL.
This cohort of patients required a high rate of revisional surgeries (61% of patients) to achieve a successful outcome. Although the great majority of these additional surgical procedures were minor, subjecting patients to multiple surgeries could conceivably reduce their satisfaction with the initial procedure. Despite this concern, we found that 95% of patients would choose to undergo FFR again if given the choice, with average patient satisfaction of 4.89 on a 5-point scale.
The high level of HRQoL in ambulatory patients is a desirable result after FFR of the lower extremity. Although various other studies have previously reported evidence of patient satisfaction or HRQoL outcomes following FFR, none has so far employed the use of a validated questionnaire in this patient cohort.[10, 11] The evidence has thus far been sporadic and largely anecdotal. Of course, there are limitations to this study as well, such as the potential for self-selection bias. However, the near-equal response rate between ambulatory and non-ambulatory populations is reassuring. As patient-reported outcome measures continue to play a larger role in managing patient care, validated studies, such as the SF-12, will provide a reliable way to analyze PROMs.
In conclusion, patient-centered and quality of life outcome measures are an important part of evaluating the usefulness of FFR of lower extremity wounds. Without procedure-specific assessments currently available, these outcomes can be easily measured using standardized questionnaires such as the SF-12 or SF-36. We have shown that microsurgical flap reconstruction is a valuable reconstructive option in high-risk patients and offers a HRQoL comparable with that of the general population. In addition, successful ambulation in patients who have undergone FFR improves HRQoL, whereas quality of life is decreased significantly when failure to ambulate occurs.
- 5Adult measures of general health and health-related quality of life: Medical Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of Well-Being Scale (QWB), and Assessment of Quality of Life (AQoL). Arthritis Care Res 2011;63:S383-S412., , , , , .
- 6User's Manual for the SF-12v2 Health Survey, 2nd ed. Lincoln: QualityMetric, 2009..
- 7VassarStats: Statistical Computation Website. Vassar College..
- 10SF-12: How to score the SF-12 Physical and Mental Health Summary Scales, 3rd ed. Lincoln, RI: QualityMetric Incorporated, 1998., , .
- 13Digital artery flaps for closure of soft tissue defects of the forefoot. J Foot Ankle Surg 2003;42:208–214., , .