Development of the AMPDECIDE Decision Aid to Facilitate Shared Decision Making in Patients Facing Amputation Secondary to Chronic Limb Threatening Ischemia.

INTRODUCTION: We developed a patient decision aid to enhance patient participation in amputation level decision making when there is a choice between a transmetatarsal or transtibial amputation. METHODS: In accordance with International Patient Decision Aid Standards, we developed an amputation level patient decision aid for patients who are being considered for either a transmetatarsal or transtibial amputation, incorporating qualitative literature data, quantitative literature data, qualitative provider and patient interviews, expert panel input and iterative patient feedback. RESULTS: The rapid qualitative literature review and qualitative interviews identified five domains outcome priority domains important to patients facing amputation secondary to chronic limb threatening ischemia: 1) the ability to walk, 2) healing and risk for reamputation, 3) rehabilitation program intensity, 4) ease of prosthetic use, and 5) limb length after amputation. The rapid quantitative review identified only two domains with adequate evidence comparing differences in outcomes between the two amputation levels: mobility and reamputation. Patient, surgeon, rehabilitation and decision aid expert feedback allowed us to integrate critical facets of the decision including addressing the emotional context of loss of limb, fear and anxiety as an obstacle to decision making, shaping the decision in the context of remaining life years, and how to facilitate patient knowledge of value tradeoffs. CONCLUSIONS: Amputation level choice is associated with significant outcome trade-offs. The AMPDECIDE patient decision aid can facilitate acknowledgment of patient fears, enhance knowledge of amputation level outcomes, assist patients in determining their personal outcome priorities, and facilitate shared amputation level decision making.

The Effect of Prosthetic Limb Sophistication and Amputation Level on Self-reported Mobility and Satisfaction With Mobility.

OBJECTIVE: To determine if lower limb prosthesis (LLP) sophistication is associated with patient-reported mobility and/or mobility satisfaction, and if these associations differ by amputation level. DESIGN: Cohort study that identified participants through a large national database and prospectively collected self-reported patient outcomes. SETTING: The Veterans Administration (VA) Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls. PARTICIPANTS: 347 Veterans who underwent an incident transtibial (TT) or transfemoral (TF) amputation due to diabetes and/or peripheral artery disease and received a qualifying LLP between March 1, 2018, and November 30, 2020. INTERVENTIONS: Basic, intermediate, and advanced prosthesis sophistication was measured by the accurate and reliable PROClass system. MAIN OUTCOME MEASURE: Patient-reported mobility using the advanced mobility subscale of the Locomotor Capabilities Index-5; mobility satisfaction using a 0-10-point Likert scale. RESULTS: Lower limb amputees who received intermediate or advanced prostheses were more likely to achieve advanced mobility than those who received basic prostheses, with intermediate nearing statistical significance at nearly twice the odds (adjusted odds ratio (aOR)=1.8, 95% confidence interval (CI), .98-3.3; P=.06). The association was strongest in TF amputees with over 10 times the odds (aOR=10.2, 95% CI, 1.1-96.8; P=.04). The use of an intermediate sophistication prosthesis relative to a basic prosthesis was significantly associated with mobility satisfaction (adjusted ß coefficient (aß)=.77, 95% CI, .11-1.4; P=.02). A statistically significant association was only observed in those who underwent a TT amputation (aß=.79, 95% CI, .09-1.5; P=.03). CONCLUSIONS: Prosthesis sophistication was not associated with achieving advanced mobility in TT amputees but was associated with greater mobility satisfaction. In contrast, prosthesis sophistication was associated with achieving advanced mobility in TF amputees but was not associated with an increase in mobility satisfaction.

Differences in Prosthetic Prescription Between Men and Women Veterans After Transtibial or Transfemoral Lower-Extremity Amputation: A Longitudinal Cohort Study (2005-2018).

OBJECTIVE: To evaluate whether prosthetic prescription differed by gender and the extent to which differences were mediated by measured factors. DESIGN: Retrospective longitudinal cohort study using data from Veterans Health Administration (VHA) administrative databases. SETTING: VHA patients throughout the United States. PARTICIPANTS: The sample included 20,889 men and 324 women who had an incident transtibial or transfemoral amputation between 2005 and 2018. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Time to prosthetic prescription (up to 1 year). We used parametric survival analysis (an accelerated failure time model) to assess gender differences. We estimated mediation effects of amputation level, pain comorbidity burden, medical comorbidities, depression, and marital status on time to prescription. RESULTS: In the 1 year after amputation, the proportion of women (54.3%) and men (55.7%) prescribed a prosthesis was similar. However, after we controlled for age, race, ethnicity, enrollment priority, VHA region, and service-connected disability, the time to prosthetic prescription was significantly faster among men compared with women (acceleration factor=0.73; 95% confidence interval, 0.61-0.87). The difference in time to prosthetic prescription between men and women was significantly mediated by amputation level (23%), pain comorbidity burden (-14%), and marital status (5%) but not medical comorbidities or depression. CONCLUSIONS: Although the proportion of patients with prosthetic prescription at 1-year postamputation was similar between men and women, women received prosthetic prescriptions more slowly than men, suggesting that more work is needed to understand barriers to timely prosthetic prescriptions among women, and how to intervene to reduce those barriers.

AMPREDICT PROsthetics-Predicting Prosthesis Mobility to Aid in Prosthetic Prescription and Rehabilitation Planning.

OBJECTIVE: To develop and validate a patient-specific multivariable prediction model that uses variables readily available in the electronic medical record to predict 12-month mobility at the time of initial post-amputation prosthetic prescription. The prediction model is designed for patients who have undergone their initial transtibial (TT) or transfemoral (TF) amputation because of complications of diabetes and/or peripheral artery disease. DESIGN: Multi-methodology cohort study that identified patients retrospectively through a large Veteran's Affairs (VA) dataset then prospectively collected their patient-reported mobility. SETTING: The VA Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls. PARTICIPANTS: Three-hundred fifty-seven veterans who underwent an incident dysvascular TT or TF amputation and received a qualifying lower limb prosthesis between March 1, 2018, and November 30, 2020 (N=357). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The Amputee Single Item Mobility Measure (AMPSIMM) was divided into a 4-category outcome to predict wheelchair mobility (0-2), and household (3), basic community (4), or advanced community ambulation (5-6). RESULTS: Multinomial logistic lasso regression, a machine learning methodology designed to select variables that most contribute to prediction while controlling for overfitting, led to a final model including 23 predictors of the 4-category AMPSIMM outcome that effectively discriminates household ambulation from basic community ambulation and from advanced community ambulation-levels of key clinical importance when estimating future prosthetic demands. The overall model performance was modest as it did not discriminate wheelchair from household mobility as effectively. CONCLUSIONS: The AMPREDICT PROsthetics model can assist providers in estimating individual patients' future mobility at the time of prosthetic prescription, thereby aiding in the formulation of appropriate mobility goals, as well as facilitating the prescription of a prosthetic device that is most appropriate for anticipated functional goals.

Comparing Patient and Provider Priorities Around Amputation Level Outcomes Using Multiple Criteria Decision Analysis.

BACKGROUND: Patients with chronic limb threatening ischemia may require a transmetatarsal amputation (TMA) or a transtibial amputation. When making an amputation-level decision, these patients face a tradeoff-a TMA preserves more limb and may provide better mobility but has a lower probability of primary wound healing and may therefore result in additional same or higher level amputation surgeries with an associated negative impact on function. Understanding differences in how patients and providers prioritize these tradeoffs and other outcomes may enhance shared decision-making. OBJECTIVES: Compare patient priorities with provider perceptions of patient priorities using Multiple Criteria Decision Analysis (MCDA). METHODS: The MCDA Analytic Hierarchy Process was chosen due to its low cognitive burden and ease of implementation. We included 5 criteria (outcomes): ability to walk, healing after amputation surgery, rehabilitation program intensity, limb length, and ease of use of prosthetic/orthotic device. A national sample of dysvascular lower-limb amputees and providers were recruited from the Veterans Health Administration with the MCDA administered online to providers and telephonically to patients. RESULTS: Twenty-six dysvascular amputees and 38 providers participated. Fifty percent of patients had undergone a TMA; 50%, a transtibial amputation. When compared to providers, patients placed higher value on TMA (72% vs. 63%). Patient versus provider priorities were ability to walk (47% vs. 42%), healing (18% vs. 28%), ease of prosthesis use (17% vs. 13%), limb length (11% vs. 13%), and then rehabilitation intensity (7% vs. 6%). LIMITATIONS: Our sample may not generalize to other populations. CONCLUSIONS: Provider perceptions aligned with patient values on amputation level but varied around the importance of each outcome. IMPLICATIONS: These findings illuminate some differences between patients' values and provider perceptions of patient values, suggesting a role for shared decision-making. Embedding this MCDA framework into a future decision aid may facilitate these discussions.

Mortality Conversations Between Male Veterans and Their Providers Prior to Dysvascular Lower Extremity Amputation.

BACKGROUND: Among patients facing lower extremity amputation due to dysvascular disease, the mortality risk is very high. Given this, as well as the importance of a patient-centered approach to medical care, informing patients about their possible risk of dying may be important during preoperative shared decision-making. The goal of this investigation was to gain an understanding of patient and provider experiences discussing mortality within the context of amputation within the Veterans Health Administration. METHODS: Semistructured interviews were performed with Veterans with peripheral arterial disease and/or diabetes, vascular and podiatric surgeons, and physical medicine and rehabilitation physicians. Interviews were analyzed using team-based content analysis to identify themes related to amputation-level decisions. RESULTS: We interviewed 22 patients and 21 surgeons and physicians and identified 3 themes related to conversations around mortality: (1) both patients and providers report that mortality conversations are not common prior to amputation; (2) while most providers find value in mortality conversations, some express concerns around engaging in these discussions with patients; and (3) some patients perceive mortality conversations as unnecessary, but many are open to engaging in the conversation. CONCLUSIONS: Providers may benefit from introducing the topic with patients, including providing the context for why mortality conversations may be valuable, with the understanding that patients can always decline to participate should they not be interested or comfortable discussing this issue.

Voices of Women Veterans with Lower Limb Prostheses: a Qualitative Study.

BACKGROUND: Women Veterans with amputation are a group with unique needs whose numbers have grown over the last 5 years, accounting for nearly 3% of all Veterans with amputation in 2019. Although identified as a national priority by the Veterans Health Administration, the needs of this population have remained largely underrepresented in amputation research. OBJECTIVE: To describe the experiences of women Veterans with lower extremity amputation (LEA) related to prosthetic care provision and devices. DESIGN: National qualitative study using semi-structured individual interviews. PARTICIPANTS: Thirty women Veterans with LEA who had been prescribed a prosthesis at least 12 months prior. APPROACH: Inductive content analysis. KEY RESULTS: Four key themes emerged: (1) a sense of "feeling invisible" and lacking a connection with other women Veterans with amputation; (2) the desire for prosthetic devices that meet their biological and social needs; (3) the need for individualized assessment and a prosthetic limb prescription process that is tailored to women Veterans; the current process was often perceived as biased and either dismissive of women's concerns or failing to adequately solicit them; and (4) the desire for prosthetists who listen to and understand women's needs. CONCLUSIONS: Women Veterans with LEA articulated themes reminiscent of those previously reported by male Veterans with LEA, such as the importance of prostheses and the central role of the provider-patient relationship. However, they also articulated unique needs that could translate into specific strategies to improve prosthetic care, such as integrating formal opportunities for social support and peer interaction for women Veterans with LEA, advocating for administrative changes and research efforts to expand available prosthetic component options, and ensuring that clinical interactions are gender-sensitive and free of bias.

Risks and Risk Factors for Contralateral Amputation in Patients who have Undergone Amputation for Chronic Limb Threatening Ischaemia.

OBJECTIVE: The aim of this study was to determine the cumulative incidence of, and the risk factors associated with, contralateral amputation in patients with chronic limb threatening ischaemia (CLTI). METHODS: This was a retrospective cohort study of patients with incident unilateral transmetatarsal (TM), transtibial (TT), or transfemoral (TF) amputation secondary to CLTI, identified from the National Veterans Affairs Surgical Quality Improvement Program database (2004 - 2014). Thirteen potential pre-operative risk factors for contralateral amputation were considered. A competing risk analysis to estimate the cumulative incidence of contralateral amputation was performed using a Fine-Gray subdistribution hazard model. The effect of risk factors on contralateral amputation was estimated by computing subdistribution hazard ratios (sub-HR) with 95% confidence intervals (CI). RESULTS: From the database, 7 360 patients met the inclusion criteria. The contralateral amputation risk was 7.7% and was greatest in those who underwent a TF amputation (9.7%), followed by TT (7.4%) and TM amputation (6.6%) (p < .001). Among the 588 contralateral amputations, 50% were at the TF level, 34% at the TT level, and 16% at the TM level. The adjusted risk of contralateral amputation was greater in those who underwent an incident TF amputation or were Black or Hispanic. The factor that contributed to risk of contralateral amputation to the greatest extent was dialysis (sub-HR, 2.3; 95% CI 1.7 - 3.0; p < .001) while those who were obese (compared with underweight) were at lowest risk (0.67; 95% CI 0.46 - 0.97; p = .030). CONCLUSION: The one year risk of contralateral amputation in patients with CLTI is related to incident amputation level, medical comorbidities, correlates with race/ethnicity, and body mass index at the time of the incident amputation. The identified risk factors are largely not modifiable; however, they can be used to help identify populations at elevated risk.

The Development and Usability of the AMPREDICT Decision Support Tool: A Mixed Methods Study.

OBJECTIVE: Amputation level decision making in patients with chronic limb threatening ischaemia is challenging. Currently, evidence relies on published average population risks rather than individual patient risks. The result is significant variation in the distribution of amputation levels across health systems, geographical regions, and time. Clinical decision support has been shown to enhance decision making, especially complex decision making. The goal of this study was to translate the previously validated AMPREDICT prediction models by developing and testing the usability of the AMPREDICT Decision Support Tool (DST), a novel, web based, clinical DST that calculates individual one year post-operative risk of death, re-amputation, and probability of achieving independent mobility by amputation level. METHODS: A mixed methods approach was used. Previously validated prediction models were translated into a web based DST with additional content and format developed by an expert panel. Tool usability was assessed using the Post-Study System Usability Questionnaire (PSSUQ; a 16 item scale with scores ranging from 1 to 7, where lower scores indicate greater usability) by 10 clinician end users from diverse specialties, sex, geography, and clinical experience. Think aloud, semi-structured, qualitative interviews evaluated the AMPREDICT DST's look and feel, user friendliness, readability, functionality, and potential implementation challenges. RESULTS: The PSSUQ overall and subscale scores were favourable, with a mean overall total score of 1.57 (standard deviation [SD] 0.69) and a range from 1.00 to 3.21. The potential clinical utility of the DST included (1) assistance in counselling patients on amputation level decisions, (2) setting outcome expectations, and (3) use as a tool in the academic environment to facilitate understanding of factors that contribute to various outcome risks. CONCLUSION: After extensive iterative development and testing, the AMPREDICT DST was found to demonstrate strong usability characteristics and clinical relevance. Further evaluation will benefit from integration into an electronic health record with assessment of its impact on physician and patient shared amputation level decision making.

A Systematic Review and Narrative Synthesis of Risk Prediction Tools Used to Estimate Mortality, Morbidity, and Other Outcomes Following Major Lower Limb Amputation.

OBJECTIVE: The decision to undertake a major lower limb amputation can be complex. This review evaluates the performance of risk prediction tools in estimating mortality, morbidity, and other outcomes following amputation. METHODS: A systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The MEDLINE, Embase, and Cochrane databases were searched to identify studies reporting on risk prediction tools that predict outcomes following amputation. Outcome measures included the accuracy of the risk tool in predicting a range of post-operative complications, including mortality (both short and long term), peri-operative morbidity, need for re-amputation, and ambulation success. A narrative synthesis was performed in accordance with the Guidance on the Conduct of Narrative Synthesis In Systematic Reviews. RESULTS: The search identified 518 database records. Twelve observational studies, evaluating 13 risk prediction tools in a total cohort of 61 099 amputations, were included. One study performed external validation of an existing risk prediction tool, while all other studies developed novel tools or modified pre-existing generic calculators. Two studies conducted external validation of the novel/modified tools. Nine tools provided risk estimations for mortality, two tools provided predictions for post-operative morbidity, two for likelihood of ambulation, and one for re-amputation to the same or higher level. Most mortality prediction tools demonstrated acceptable discrimination performance with C statistic values ranging from 0.65 to 0.81. Tools estimating the risk of post-operative complications (0.65 - 0.74) and necessity for re-amputation (0.72) also performed acceptably. The Blatchford Allman Russell tool demonstrated outstanding discrimination for predicting functional mobility outcomes post-amputation (0.94). Overall, most studies were at high risk of bias with poor external validity. CONCLUSION: This review identified several risk prediction tools that demonstrate acceptable to outstanding discrimination for objectively predicting an array of important post-operative outcomes. However, the methodological quality of some studies was poor, external validation studies are generally lacking, and there are no tools predicting other important outcomes, especially quality of life.

Self-Management to Improve Function After Amputation: A Randomized Controlled Trial of the VETPALS Intervention.

OBJECTIVE: To (1) evaluate the effects of a group-based self-management treatment intervention (VETPALS) on physical and psychosocial functioning (primary outcomes) and quality of life (secondary outcome) in individuals with amputation and (2) examine the feasibility and acceptability of the intervention in a large national health care system. DESIGN: Randomized controlled trial with masked outcome assessment. SETTING: Five Veterans Affairs medical centers geographically dispersed across the United States. PARTICIPANTS: 147 individuals with amputation during the past 2 years due to chronic limb threatening ischemia (N=147). INTERVENTIONS: Participants were randomized into VETPALS (N =71) or education control (N=76). VETPALS consisted of a 4-hour workshop and 4 additional 2-hour sessions addressing self-management skills, health and activity, managing emotions, communication and social support, and maintaining goals and gains. Education control consisted of the provision of amputation-related educational materials and provider follow-up if requested. MAIN OUTCOME MEASURES: Primary outcomes were physical functioning (Short Musculoskeletal Functional Assessment) and psychosocial functioning (Patient Health Questionnaire-9). Secondary outcomes were quality of life (global) and quality of life (satisfaction with health) from the World Health Organization Quality of Life Scale (brief). Assessment was conducted at baseline, 6 weeks (treatment completion), and 6 months (follow-up). RESULTS: Participants randomized to VETPALS reported significantly improved psychosocial functioning and quality of life (satisfaction with health) relative to controls at 6 months (B=1.84; 95% confidence interval, 0.37,3.31 and B=-0.61; 95% confidence interval, -1.11,-0.12, respectively). There were no differences in physical functioning over time between VETPALS and education control at either time point. Follow-up multiple imputation sensitivity analyses produced an identical pattern of results. Among VETPALS participants, treatment initiation was low (56%), but treatment retention (93% attended 4 of 5 classes) and overall satisfaction (100% reported very helpful or better and would recommend to a friend) were high. CONCLUSIONS: Group-based self-management improves psychosocial functioning for individuals with amputation due to chronic limb threatening ischemia. In-person participation is challenging for this population, but individuals who successfully initiate treatment typically persist and are highly satisfied.

Rates of early complications and mortality in patients older than 80 years of age after surgical treatment of acute traumatic spinal fractures: ankylosing spondylitis versus osteoporosis.

OBJECTIVE: The purpose of this retrospective cohort study was to analyze the early complications and mortality associated with multilevel spine surgery for unstable fractures in patients older than 80 years of age with ankylosing spondylitis and to compare the results with an age- and sex-matched cohort of patients with unstable osteoporotic fractures. METHODS: A retrospective review of the electronic medical records at a single institution was conducted between January 2014 and December 2019. Patient demographics, surgical characteristics, complications, hospital course, and 90-day mortality were collected. Comorbidities were stratified using the age-adjusted Charlson Comorbidity Index (CCI). RESULTS: Among 11,361 surgically treated patients, 22 patients with ankylosing spondylitis (AS group) and 24 patients with osteoporosis (OS group) were identified. The mean ages were 83.1 ± 3.1 years and 83.2 ± 2.6 years, respectively. A significant difference in the mean CCI score was found (7.6 vs 5.6; p < 0.001). Multilevel posterior fusion procedures were conducted in all patients, with 6.7 ± 1.4 fused levels in the AS group and 7.1 ± 1.1 levels fused in the OS group (p > 0.05). Major complications developed in 10 patients (45%) in the AS group compared with 4 patients (17%) in the OS group (p < 0.05). The 90-day mortality was 36% in the AS group compared with 0% in the OS group (p < 0.001). CONCLUSIONS: Patients older than 80 years of age with AS bear a high risk of adverse events after multilevel spinal fusion procedures. The high morbidity and 90-day mortality should be clearly discussed and carefully weighed against surgical treatment.

Risks and Risk Factors for Ipsilateral Re-Amputation in the First Year Following First Major Unilateral Dysvascular Amputation.

OBJECTIVE: To identify timing, incidence, and risk factors for ipsilateral re-amputation within 12 months of first dysvascular amputation and to determine specific subgroups of patients at each amputation level that are at increased risk. METHODS: A retrospective cohort study evaluating 7187 patients with first unilateral transmetatarsal (TM), transtibial (TT), or transfemoral (TF) amputation secondary to diabetes and/or peripheral artery disease (PAD) were identified in the VA Surgical Quality Improvement Program database between 2004 and 2014. Re-amputation was defined as any subsequent ipsilateral soft tissue/bony revision or amputation to a higher level. Twenty-three potential pre-operative risk factors (and nine potential interactions) were identified. A backward stepwise Cox regression was used to identify risk factors. Incidence rates and hazard ratios (HR) with 95% confidence intervals (CI) were computed. RESULTS: The median time to highest level of re-amputation in the first year was 33 (interquartile range, 13-73) days. Risk of requiring at least one re-amputation was 41% (TM), 25% (TT), and 9% (TF). Risk factors associated with requiring re-amputation included chronic obstructive pulmonary disease, elevated white blood cell count, abnormal ankle brachial index (ABI), history of revascularisation, and alcohol misuse. TM patients who had diabetes only (HR 1.9; 95% CI 1.4-2.5), diabetes with an abnormal ankle brachial index (ABI) score (HR 2.4; 95% CI 1.8-3.2), and kidney failure (HR 1.7; 95% CI 1.3-2.1) were at the greatest risk of re-amputation. TT amputees who were smokers were also at an increased risk (HR 1.4; 95% CI 1.2-1.6). CONCLUSION: This research identified important risk factors for failure of primary healing and need for re-amputation at the TM and TT level. If considering a TM amputation, caution should be exercised in patients with diabetes, in particular those with an abnormal ABI and/or renal failure. At the TT level, caution should be exercised in those who smoke.

Randomized trial of acupuncture with antiemetics for reducing postoperative nausea in children.

BACKGROUND: Postoperative nausea and vomiting (PONV) is common after tonsillectomy in children. There is evidence that perioperative acupuncture at the pericardium 6 (P6) point is effective for preventing PONV in adults. Our goal was to determine if intraoperative acupuncture at the P6 point, in addition to usual antiemetics, is more effective than antiemetics alone in preventing PONV in children. METHODS: In a randomized double-blind trial, 161 children age 3 through 9 years undergoing tonsillectomy with or without adenoidectomy were randomized to either bilateral acupuncture at P6 plus antiemetics (n = 86) or antiemetics only (n = 75). All participants received ondansetron 0.15 mg/kg and dexamethasone 0.25 mg/kg, up to 10 mg. The presence of nausea, retching, emesis and administration of additional antiemetics were recorded during phases I and II of PACU recovery. Follow-up calls occurred on postoperative day 1 (POD 1). RESULT: During phase I and II recovery, the incidence of PONV was significantly less with acupuncture than without (7.0% vs 34.7%, RR: 0.2, 95% CI: 0.09-0.46; P < 0.001). The difference in PONV was driven by less nausea in the acupuncture group (5.0% vs 24.0%), with no difference in vomiting between the two groups. In the first 24 hours, PONV occurred in 36.1% with acupuncture and 49.3% without; these values did not differ significantly (P = 0.09). CONCLUSIONS: Children receiving acupuncture plus antiemetic therapy had less risk of developing nausea during phase I and II recovery, but there was no difference in PONV on POD 1. Acupuncture may reduce nausea in the PACU, even when combined with antiemetics.

A Prospective Longitudinal Study of Trajectories of Depressive Symptoms After Dysvascular Amputation.

OBJECTIVES: Characterize the course of depressive symptoms during the first year after dysvascular amputation and identify factors that predict symptom trajectories. DESIGN: Prospective cohort study of individuals undergoing lower extremity amputation (LEA), surveyed at 4 time points (perioperative period, 6 weeks, 4 months, and 12 months postamputation). Multilevel modeling was used to describe and predict trajectories. SETTING: Four Veterans Affairs medical centers, a university hospital, and a level I trauma center. PARTICIPANTS: Participants (N=141; 74% retention) were a consecutive sample, eligible if they were undergoing their first unilateral LEA secondary to dysvascular disease. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Patient Health Questionnaire-9. RESULTS: Approximately 40% of participants endorsed at least moderate depressive symptoms at perioperative baseline. Individuals with greater depressive symptoms in the perioperative period concurrently reported greater pain, poorer self-rated health, and prior mental health treatment. In the first 6 weeks after amputation there was a substantial improvement in depressive symptoms, especially among individuals with greater symptoms at baseline. Depressive symptoms were generally stable after 6 weeks. None of the covariates assessed significantly predicted trajectories of depressive symptom improvement. CONCLUSIONS: Watchful waiting may be the most appropriate course of action for many patients in the first 6 weeks after amputation. After 6 weeks, however, symptom levels tend to stabilize, suggesting that active intervention is called for if patients remain depressed at this point. Some patients may benefit from more proactive intervention, such as those with prior mental health treatment histories.

Risk factors associated with non-union after triple pelvic osteotomy (Toennis and Kalchschmidt technique): a case-control study and review of the literature.

INTRODUCTION: Dysplasia of the hip is a well known cause of secondary osteoarthritis of the hip. The triple pelvic osteotomy (TPO), according to the technique described by Toennis and Kalchschmidt, is a well established procedure to address dysplasia of the hip joint. Non-unions after triple pelvic osteotomies are rare and can occur at each of these osteotomies. The literature is lacking in studies investigating larger group of patients with non-unions after triple pelvic osteotomy. The aim of this study is to evaluate risk factors leading to a non-union after triple pelvic osteotomy. METHODS: A total of 53 patients with a non-union after triple pelvic osteotomy were included in this retrospective case-control. In addition, we identified a cohort of randomly selected patients undergoing hardware removal after triple pelvic osteotomy ("union" group) but had not developed non-union as the control group. This control group underwent the same procedure by the same group of surgeons in the same time period. The variables obtained from the review of the two groups were analyzed using appropriate statistical methods including Bivariable Analysis (p < 0.005) and Multivariable logistic regression analysis (p < 0.015). RESULTS: We identified a total of 53 patients out of the 3269 who had undergone TPO and had developed a non-union. The control group consisted of 117 patients who did not experience a non-union. Bivariable analysis of basic demographic characteristics demonstrated that gender, BMI, smoking, preoperative CE angle and degree of surgical correction did not differ significantly between the groups. There was a statistically significant (p < 0.05) difference between age (31.5 ± 9.4 vs. 27.5 ± 9.0 in the non-union and union groups, respectively; p = < 0.001) and postoperative CE angle (34.4 ± 5.0 vs. 32.8 ± 3.5 in the non-union and union groups, respectively; p = 0.02). Multivariable analysis demonstrated that an age over 30 was significantly associated with non-union (p = 0.01, OR 2.6, 95% CI 1.3-5.3). CONCLUSION: Non-unions after TPO are rare. A higher age and higher degree of surgical correction might be associated risk factors for developing a non-union. Furthermore, smoking, obesity and previous hip surgeries might also contribute to developing a non-union after triple pelvic osteotomy.

Quality of Relationships With Caregivers, Depression, and Life Satisfaction After Dysvascular Lower Extremity Amputation.

OBJECTIVE: To describe the relationship between caregiver-specific support and conflict, and psychosocial outcomes among individuals experiencing their first dysvascular lower extremity amputation (LEA). DESIGN: Cross-sectional cohort study using self-report surveys. SETTING: Department of Veterans Affairs, academic medical center, and level I trauma center. PARTICIPANTS: Individuals undergoing their first major LEA because of complications of peripheral arterial disease (PAD) or diabetes who have a caregiver and completed measures of caregiver support and conflict (N=137; 94.9% men). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The Patient Health Questionnaire-9 to assess depression and the Satisfaction With Life Scale to assess life satisfaction. RESULTS: In multiple regression analyses, controlling for global levels of perceived support, self-rated health, age, and mobility, caregiver-specific support was found to be associated with higher levels of life satisfaction and caregiver-specific conflict was found to be associated with lower levels of life satisfaction and higher levels of depressive symptoms. CONCLUSIONS: The specific relationship between individuals with limb loss and their caregivers may be an important determinant of well-being. Conflict with caregivers, which has received little attention thus far in the limb loss literature, appears to play a particularly important role. Individuals with limb loss may benefit from interventions with their caregivers that both enhance support and reduce conflict.

The development and validation of the AMPREDICT model for predicting mobility outcome after dysvascular lower extremity amputation.

OBJECTIVE: The objective of this study was the development of AMPREDICT-Mobility, a tool to predict the probability of independence in either basic or advanced (iBASIC or iADVANCED) mobility 1 year after dysvascular major lower extremity amputation. METHODS: Two prospective cohort studies during consecutive 4-year periods (2005-2009 and 2010-2014) were conducted at seven medical centers. Multiple demographic and biopsychosocial predictors were collected in the periamputation period among individuals undergoing their first major amputation because of complications of peripheral arterial disease or diabetes. The primary outcomes were iBASIC and iADVANCED mobility, as measured by the Locomotor Capabilities Index. Combined data from both studies were used for model development and internal validation. Backwards stepwise logistic regression was used to develop the final prediction models. The discrimination and calibration of each model were assessed. Internal validity of each model was assessed with bootstrap sampling. RESULTS: Twelve-month follow-up was reached by 157 of 200 (79%) participants. Among these, 54 (34%) did not achieve iBASIC mobility, 103 (66%) achieved at least iBASIC mobility, and 51 (32%) also achieved iADVANCED mobility. Predictive factors associated with reduced odds of achieving iBASIC mobility were increasing age, chronic obstructive pulmonary disease, dialysis, diabetes, prior history of treatment for depression or anxiety, and very poor to fair self-rated health. Those who were white, were married, and had at least a high-school degree had a higher probability of achieving iBASIC mobility. The odds of achieving iBASIC mobility increased with increasing body mass index up to 30 kg/m2 and decreased with increasing body mass index thereafter. The prediction model of iADVANCED mobility included the same predictors with the exception of diabetes, chronic obstructive pulmonary disease, and education level. Both models showed strong discrimination with C statistics of 0.85 and 0.82, respectively. The mean difference in predicted probabilities for those who did and did not achieve iBASIC and iADVANCED mobility was 33% and 29%, respectively. Tests for calibration and observed vs predicted plots suggested good fit for both models; however, the precision of the estimates of the predicted probabilities was modest. Internal validation through bootstrapping demonstrated some overoptimism of the original model development, with the optimism-adjusted C statistic for iBASIC and iADVANCED mobility being 0.74 and 0.71, respectively, and the discrimination slope 19% and 16%, respectively. CONCLUSIONS: AMPREDICT-Mobility is a user-friendly prediction tool that can inform the patient undergoing a dysvascular amputation and the patient's provider about the probability of independence in either basic or advanced mobility at each major lower extremity amputation level.

The development and validation of a novel outcome measure to quantify mobility in the dysvascular lower extremity amputee: the amputee single item mobility measure.

OBJECTIVE: This study describes the development and psychometric evaluation of a novel patient-reported single-item mobility measure. DESIGN: Prospective cohort study. SETTING: Four Veteran's Administration Medical Centers. SUBJECTS: Individuals undergoing their first major unilateral lower extremity amputation; 198 met inclusion criteria; of these, 113 (57%) enrolled. INTERVENTIONS: None. MAIN MEASURES: The Amputee Single Item Mobility Measure, a single item measure with scores ranging from 0 to 6, was developed by an expert panel, and concurrently administered with the Locomotor Capabilities Index-5 (LCI-5) and other outcome measures at six weeks, four months, and 12 months post-amputation. Criterion and construct validity, responsiveness, and floor/ceiling effects were evaluated. Responsiveness was assessed using the standardized response mean. RESULTS: The overall mean 12-month Amputee Single Item Mobility Measure score was 3.39 ±1.4. Scores for transmetatarsal, transtibial, and transfemoral amputees were 4.2 (±1.3), 3.2 (±1.5), and 2.9 (±1.1), respectively. Amputee Single Item Mobility Measure scores demonstrated "large" and statistically significant correlations with the LCI-5 scores at six weeks (r = 0.72), four months (r = 0.81), and 12 months (r = 0.86). At four months and 12 months, the correlation between Amputee Single Item Mobility Measure scores and hours of prosthetic use were r = 0.69 and r = 0.66, respectively, and between Amputee Single Item Mobility Measure scores and Trinity Amputation and Prosthesis Experience Scales functional restriction scores were r = 0.45 and r = 0.67, respectively. Amputee Single Item Mobility Measure scores increased significantly from six weeks to 12 months post-amputation. Minimal floor/ceiling effects were demonstrated. CONCLUSIONS: In the unilateral dysvascular amputee, the Amputee Single Item Mobility Measure has strong criterion and construct validity, excellent responsiveness, and does not exhibit floor/ceiling effects.