Rehabilitation and physical functioning after treatment for lower extremity musculoskeletal tumours

PhD ThesisPhysical deficits are common after treatment for musculoskeletal tumours. Good quality support services, and the use of valid and reliable physical assessments to guide rehabilitation could significantly reduce these deficits, but knowledge about this is lacking. This PhD thesis therefore, examines the national state of rehabilitation services and outcomes for patients who have an amputation for sarcoma (phase 1), systematically reviews the current state of objective clinical measurement of physical functioning (phase 2), and pilots the use of small accelerometer-based body worn monitors (BWMs) to assess physical functioning in patients treated for lower extremity musculoskeletal tumours (phase 3). Original contributions to knowledge are: - Phase 1: Patients have a variable experience of rehabilitation services in England, after amputation for sarcoma, with services falling short of recommended national standards. Patients also present with poor physical functioning, pain and quality of life. - Phase 2: Studies quantifying balance, gait and physical activity (PA) are lacking in patients with lower extremity sarcomas, with most not using valid and reliable instruments. - Phase 3: This study supports the feasibility, acceptability and general validity of using a low-cost accelerometer-based BWM for rapid physical assessments in the clinic and real world. BWM measures of ellipsis (area of postural sway), root mean square (magnitude of sway), jerk (smoothness of sway), step time, stance time, step length, step velocity, total time, instrumented timed up and go (iTUG) time, total steps/day and alpha (pattern of bouts) were most sensitive in characterising physical functioning. The major conclusions were that patient experience of rehabilitation services and outcomes are variable after amputation for sarcoma, with scope for improvements. There is a deficit of studies on balance, gait and PA assessments in patients with sarcoma and accelerometer-based BWMs, could be a solution as the thesis supports their feasibility, acceptability and validity.Quality Improvement Development and Innovation Scheme (QIDIS) Scheme, Children with cancer, Sarcoma UK charity, Shears foundation, and N.O.R.T.H. charitie

Free-living Monitoring of Ambulatory Activity after Treatments for Lower Extremity Musculoskeletal Cancers using an Accelerometer-based Wearable – A New Paradigm to Outcome Assessment in Musculoskeletal Oncology?

Purpose Ambulatory activity (walking) is affected after sarcoma surgery yet is not routinely assessed. Small inexpensive accelerometers could bridge the gap. Study objectives investigated, whether in patients with lower extremity musculoskeletal tumours: (A) it was feasible to conduct ambulatory activity assessments in patient’s homes using an accelerometer-based wearable (AX3, Axivity). (B) AX3 assessments produced clinically useful data, distinguished tumour sub-groups and related to existing measures. Methods In a prospective cross-sectional pilot, 34 patients with musculoskeletal tumours in the femur/thigh (19), pelvis/hip (3), tibia/leg (9), or ankle/foot (3) participated. Twenty-seven had limb-sparing surgery and seven amputation. Patients were assessed using a thigh-worn monitor. Summary measures of volume (total steps/day, total ambulatory bouts/day, mean bout length), pattern (alpha), and variability (S2) of ambulatory activity were derived. Results AX3 was well-tolerated and feasible to use. Outcomes compared to literature but did not distinguish tumour sub-groups. Alpha negatively correlated with disability (walking outside (r=–418, p = 0.042*), social life (r=–0.512, p = 0.010*)). Disability negatively predicted alpha (unstandardised co-efficient= −0.001, R2=0.186, p = 0.039*). Conclusions A wearable can assess novel attributes of walking; volume, pattern, and variability after sarcoma surgery. Such outcomes provide valuable information about people’s physical performance in their homes, which can guide rehabilitation. Implications for rehabilitation Routine capture of ambulatory activity by sarcoma services in peoples’ homes can provide important information about individuals “actual” physical activity levels and limitations after sarcoma surgery to inform personalised rehabilitation and care needs, including timely referral for support. Routine remote ambulatory monitoring about out of hospital activity can support personalised care for patients, including identifying high risk patients who need rapid intervention and care closer to home. Use of routine remote ambulatory monitoring could enhance delivery of evidence-based care closer to peoples’ homes without disrupting their daily routine and therefore reducing patient and carer burden. Collection of data close to home using questionnaires and objective community assessment could be more cost effective and comprehensive than in-hospital assessment and could reduce the need for hospital attendance, which is of importance to vulnerable patients, particularly during the Covid-19 pandemic

Are Accelerometer-based Functional Outcome Assessments Feasible and Valid After Treatment for Lower Extremity Sarcomas?

Background: Aspects of physical functioning, including balance and gait, are affected after surgery for lower limb musculoskeletal tumors. These are not routinely measured but likely are related to how well patients function after resection or amputation for a bone or soft tissue sarcoma. Small, inexpensive portable accelerometers are available that might be clinically useful to assess balance and gait in these patients, but they have not been well studied. Questions/purposes: In patients treated for lower extremity musculoskeletal tumors, we asked: (1) Are accelerometer-based body-worn monitor assessments of balance, gait, and timed up and go tests (TUG) feasible and acceptable? (2) Do these accelerometer-based body-worn monitor assessments produce clinically useful data (face validity), distinguish between patients and controls (discriminant validity), reflect findings obtained using existing clinical measures (convergent validity) and standard manual techniques in clinic (concurrent validity)? Methods: This was a prospective cross-sectional study. Out of 97 patients approached, 34 adult patients treated for tumors in the femur/thigh (19), pelvis/hip (3), tibia/leg (9), or ankle/foot (3) were included in this study. Twenty-seven had limb-sparing surgery and seven underwent amputation. Patients performed standard activities while wearing a body-worn monitor on the lower back, including standing, walking, and TUG tests. Summary measures of balance (area [ellipsis], magnitude [Root Mean Square (RMS)], jerkiness [jerk], frequency of postural sway below which 95% of power of acceleration power spectrum is observed [f95 of postural sway], gait [temporal outcomes, step length and velocity], and TUG time were derived. Body-worn monitor assessments were evaluated for feasibility by investigating data loss and patient-reported acceptability and comfort. In addition, outcomes in patients were compared with datasets of healthy controls collected in parallel studies using identical methods as in this study to assess discriminant validity. Body-worn monitor assessments were also investigated for their relationships with routine clinical scales [(Musculoskeletal Tumour Society Scoring system (MSTS), Toronto Extremity Salvage Score (TESS), Quality of life-Cancer survivors [QoL-CS)] to assess convergent validity and their agreement with standard manual techniques (video and stopwatch) to assess concurrent validity. Results: Although this was a small patient group, there were initial indications that body-worn monitor assessments were well-tolerated, feasible to perform, acceptable to patients who responded (19 of 20 [95%] found the body-worn monitor acceptable and comfortable and 17 of 20 [85%] found it user-friendly), and produced clinically useful data comparable to the evidence. Balance and gait measures distinguished patients and controls (discriminant validity), for instance balance outcome (ellipsis) in patients (0.0475; 95% confidence interval [CI] 0.0251–0.0810 m2/s4) was affected compared with controls (0.0007; 95% CI, 0.0003–0.0502 m2/s4; p = 0.001). Similarly gait outcome (step time) was affected in patients (0.483; 95% CI, 0.451–0.512 seconds (s)) compared with controls (0.541; 95% CI, 0.496–0.573 s; p < 0.001). Moreover, body-worn monitor assessments showed significant relationships with existing clinical scales (convergent validity), for instance ellipsis with MSTS (r = -0.393; p = 0.024). Similarly, manual techniques showed excellent agreement with body-worn monitor assessments (concurrent validity), for instance stopwatch time 22.28 +/- 6.93 s with iTUG time 21.18 +/- 6.23 s (ICC agreement = 0.933; p < 0.001). P < 0.05 was considered statistically significant. Conclusions: Although we had a small, heterogeneous study patient population, this pilot study suggests that body-worn monitors might be useful clinically to quantify physical functioning in patients treated for lower extremity tumors. Balance and gait relate to disability and quality of life. These measurements could provide clinicians with useful novel information on balance and gait, which in turn can guide rehabilitation strategies. Level of Evidence: Level III, diagnostic study

Initial invasive or conservative strategy for stable coronary disease

BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, 121.8 percentage points; 95% CI, 124.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used

Health-status outcomes with invasive or conservative care in coronary disease

BACKGROUND In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients. METHODS We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency. RESULTS At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina). CONCLUSIONS In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline