CKM Primary
Eligibility by Year
| N = 1,4851 | |
|---|---|
| Year of Eligibility | |
| 2012 | 81 (5.5%) |
| 2013 | 186 (13%) |
| 2014 | 118 (7.9%) |
| 2015 | 145 (9.8%) |
| 2016 | 166 (11%) |
| 2017 | 315 (21%) |
| 2018 | 274 (18%) |
| 2019 | 200 (13%) |
| 1 n (%) | |
Patient Characteristics at Eligibility
| Baseline Characteristics | Overall N = 1,4851 |
Eligibility Timing
|
|
|---|---|---|---|
| Pre-implementation N = 6411 |
Post-implementation N = 8441 |
||
| Age (years) | 76 (69, 82) | 76 (70, 82) | 75 (69, 82) |
| Age 75+ | 776 (52%) | 352 (55%) | 424 (50%) |
| Male | 894 (60%) | 370 (58%) | 524 (62%) |
| Race | |||
| Aboriginal | 45 (3.0%) | 18 (2.8%) | 27 (3.2%) |
| Asian | 92 (6.2%) | 51 (8.0%) | 41 (4.9%) |
| Black | 22 (1.5%) | 9 (1.4%) | 13 (1.5%) |
| Caucasian | 746 (50%) | 354 (55%) | 392 (46%) |
| Indian subcontinent | 52 (3.5%) | 23 (3.6%) | 29 (3.4%) |
| Latin American | 11 (0.7%) | 7 (1.1%) | 4 (0.5%) |
| Mid-East/Arabian | 10 (0.7%) | 6 (0.9%) | 4 (0.5%) |
| Other/multiracial | 14 (0.9%) | 5 (0.8%) | 9 (1.1%) |
| Pacific islander | 21 (1.4%) | 7 (1.1%) | 14 (1.7%) |
| Unknown | 472 (32%) | 161 (25%) | 311 (37%) |
| Weight (kg) | 80 (68, 93) | 78 (65, 91) | 81 (70, 95) |
| (Missing) | 372 | 189 | 183 |
| Height (in) | 170 (160, 175) | 170 (160, 175) | 167 (159, 176) |
| (Missing) | 1,284 | 444 | 840 |
| Smoker | 24 (12%) | 22 (11%) | 2 (50%) |
| (Missing) | 1,285 | 445 | 840 |
| Charlson Score | 4 (2, 5) | 4 (2, 5) | 4 (2, 5) |
| (Missing) | 522 | 308 | 214 |
| Modified Renal Charlson Score | 1 (0, 2) | 1 (0, 2) | 1 (0, 2) |
| (Missing) | 522 | 308 | 214 |
| eGFR | 13 (11, 15) | 13 (10, 15) | 14 (11, 15) |
| Creatinine | 302 (253, 367) | 299 (250, 386) | 303 (257, 356) |
| (Missing) | 49 | 47 | 2 |
| Hemoglobin | 107 (97, 119) | 107 (97, 118) | 108 (97, 120) |
| (Missing) | 48 | 46 | 2 |
| Albumin | 38 (34, 41) | 39 (35, 41) | 38 (34, 41) |
| (Missing) | 58 | 52 | 6 |
| C-Reactive Protein | 14 (7, 39) | 24 (9, 48) | 13 (6, 38) |
| (Missing) | 1,330 | 617 | 713 |
| Calcium | 2 (2, 2) | 2 (2, 2) | 2 (2, 2) |
| (Missing) | 48 | 46 | 2 |
| Ferratin | 149 (76, 279) | 155 (84, 299) | 144 (71, 271) |
| (Missing) | 71 | 57 | 14 |
| Phosphate | 1 (1, 2) | - | 1 (1, 2) |
| (Missing) | 909 | 641 | 268 |
| Parathyroid Hormone | 18 (12, 28) | - | 18 (12, 28) |
| (Missing) | 955 | 641 | 314 |
| 1 Median (Q1, Q3); n (%) | |||
Clinical Evaluations at Eligibility
| Baseline Clinical Evaluation | Overall N = 1,4851 |
Eligibility Timing
|
|
|---|---|---|---|
| Pre-implementation N = 6411 |
Post-implementation N = 8441 |
||
| Full or Partial Evaluation at Baseline | 995 (67%) | 331 (52%) | 664 (79%) |
| Pain Assessment Complete | 2 (0.8%) | 1 (0.9%) | 1 (0.6%) |
| (Missing) | 1,219 | 535 | 684 |
| Spiritual Concerns | 5 (0.5%) | 3 (0.9%) | 2 (0.3%) |
| (Missing) | 490 | 310 | 180 |
| Surprise Question (1 year) | 781 (78%) | 254 (77%) | 527 (79%) |
| (Missing) | 490 | 310 | 180 |
| Dementia | 20 (2.0%) | 8 (2.4%) | 12 (1.8%) |
| (Missing) | 490 | 310 | 180 |
| Vascular Disease | 76 (7.6%) | 29 (8.8%) | 47 (7.1%) |
| (Missing) | 490 | 310 | 180 |
| Karnofsky | 95 (90, 100) | 95 (90, 100) | 95 (90, 100) |
| (Missing) | 490 | 310 | 180 |
| Shower | |||
| 1 | 68 (7.0%) | 22 (6.7%) | 46 (7.1%) |
| 2 | 37 (3.8%) | 9 (2.7%) | 28 (4.3%) |
| 3 | 39 (4.0%) | 11 (3.3%) | 28 (4.3%) |
| 4 | 832 (85%) | 288 (87%) | 544 (84%) |
| (Missing) | 509 | 311 | 198 |
| Dress | |||
| 1 | 37 (3.8%) | 10 (3.0%) | 27 (4.2%) |
| 2 | 32 (3.3%) | 10 (3.0%) | 22 (3.4%) |
| 3 | 32 (3.3%) | 9 (2.7%) | 23 (3.6%) |
| 4 | 875 (90%) | 301 (91%) | 574 (89%) |
| (Missing) | 509 | 311 | 198 |
| Walk | |||
| 1 | 31 (3.2%) | 8 (2.4%) | 23 (3.6%) |
| 2 | 14 (1.4%) | 4 (1.2%) | 10 (1.5%) |
| 3 | 29 (3.0%) | 13 (3.9%) | 16 (2.5%) |
| 4 | 902 (92%) | 305 (92%) | 597 (92%) |
| (Missing) | 509 | 311 | 198 |
| Bed | |||
| 1 | 29 (3.0%) | 6 (1.8%) | 23 (3.6%) |
| 2 | 12 (1.2%) | 6 (1.8%) | 6 (0.9%) |
| 3 | 22 (2.3%) | 8 (2.4%) | 14 (2.2%) |
| 4 | 913 (94%) | 310 (94%) | 603 (93%) |
| (Missing) | 509 | 311 | 198 |
| Pain | 1 (0, 4) | 2 (0, 4) | 1 (0, 3) |
| (Missing) | 509 | 311 | 198 |
| Tired | 4 (1, 5) | 4 (2, 6) | 3 (1, 5) |
| (Missing) | 509 | 311 | 198 |
| Nausea | 0 (0, 0) | 0 (0, 0) | 0 (0, 0) |
| (Missing) | 509 | 311 | 198 |
| Depression | 0 (0, 2) | 0 (0, 2) | 0 (0, 2) |
| (Missing) | 509 | 311 | 198 |
| Anxiety | 0 (0, 2) | 0 (0, 2) | 0 (0, 2) |
| (Missing) | 509 | 311 | 198 |
| Drowsy | 1 (0, 4) | 1 (0, 4) | 1 (0, 4) |
| (Missing) | 509 | 311 | 198 |
| Appetite | 1 (0, 4) | 3 (0, 5) | 0 (0, 3) |
| (Missing) | 509 | 311 | 198 |
| Well Being | 3 (1, 5) | 3 (1, 5) | 3 (1, 5) |
| (Missing) | 509 | 311 | 198 |
| Shortness Of Breath | 1 (0, 3) | 1 (0, 4) | 1 (0, 3) |
| (Missing) | 509 | 311 | 198 |
| Sleep | 2 (0, 5) | 3 (1, 5) | 2 (0, 4) |
| (Missing) | 509 | 311 | 198 |
| Itch | 1 (0, 3) | 3 (1, 5) | 1 (0, 3) |
| (Missing) | 755 | 550 | 205 |
| RLS | 0 (0, 1) | - | 0 (0, 1) |
| (Missing) | 1,242 | 641 | 601 |
| Quality of Health VAS | 70 (50, 80) | 60 (50, 70) | 70 (50, 80) |
| (Missing) | 719 | 517 | 202 |
| 1 n (%); Median (Q1, Q3) | |||
Follow-up and Outcomes
| Outcomes | Overall N = 1,4851 |
Eligibility Timing
|
|
|---|---|---|---|
| Pre-implementation N = 6411 |
Post-implementation N = 8441 |
||
| Follow-up Time (months) | 32.8 (16.9, 58.3) | 63.8 (49.4, 76.7) | 19.2 (9.9, 29.3) |
| Crossover Status | |||
| All pre-implementation | 456 (31%) | 456 (71%) | 0 (0%) |
| Pre- and post-implementation | 185 (12%) | 185 (29%) | 0 (0%) |
| All post-implementation | 844 (57%) | 0 (0%) | 844 (100%) |
| Transplanted | 18 (1.2%) | 15 (2.3%) | 3 (0.4%) |
| Initiated Dialysis | 494 (33%) | 306 (48%) | 188 (22%) |
| Time to Dialysis (months) | 9.4 (3.1, 18.9) | 9.6 (3.0, 23.1) | 9.0 (3.2, 14.6) |
| Died | 641 (43%) | 396 (62%) | 245 (29%) |
| Any CKM Decision | 403 (27%) | 189 (29%) | 214 (25%) |
| Time to CKM (months) | 0.0 (0.0, 4.1) | 0.0 (0.0, 9.1) | 0.0 (0.0, 2.4) |
| New CKM (post-eligibility) Decision | 182 (12%) | 82 (13%) | 100 (12%) |
| New CKM Post-implementation | 136 (9.2%) | 36 (5.6%) | 100 (12%) |
| Death or eGFR <= 5 on CKM | 273 (18%) | 160 (25%) | 113 (13%) |
| CKM to Dialysis | 29 (2.0%) | 16 (2.5%) | 13 (1.5%) |
| Time from CKM to Dialysis (months) | 8.3 (3.8, 16.0) | 12.4 (6.8, 24.1) | 6.6 (3.4, 9.4) |
| 1 Median (Q1, Q3); n (%) | |||
Follow-up and Outcomes by Event Timing
| Outcomes | Overall N = 1,4851 |
Event Timing
|
|
|---|---|---|---|
| Pre-Implementation N = 4561 |
Post-Implementation N = 1,0291 |
||
| Eligibility Timing | |||
| Pre-implementation | 641 (43%) | 456 (100%) | 185 (18%) |
| Post-implementation | 844 (57%) | 0 (0%) | 844 (82%) |
| Year of Eligibility | |||
| 2012 | 81 (5.5%) | 74 (16%) | 7 (0.7%) |
| 2013 | 186 (13%) | 151 (33%) | 35 (3.4%) |
| 2014 | 118 (7.9%) | 90 (20%) | 28 (2.7%) |
| 2015 | 145 (9.8%) | 101 (22%) | 44 (4.3%) |
| 2016 | 166 (11%) | 40 (8.8%) | 126 (12%) |
| 2017 | 315 (21%) | 0 (0%) | 315 (31%) |
| 2018 | 274 (18%) | 0 (0%) | 274 (27%) |
| 2019 | 200 (13%) | 0 (0%) | 200 (19%) |
| Follow-up Time (months) | 32.8 (16.9, 58.3) | 68.8 (54.6, 77.2) | 23.6 (11.9, 33.2) |
| Transplanted | 18 (1.2%) | 14 (3.1%) | 4 (0.4%) |
| Initiated Dialysis | 494 (33%) | 234 (51%) | 260 (25%) |
| Time to Dialysis (months) | 9.4 (3.1, 18.9) | 7.4 (1.8, 14.5) | 11.6 (4.3, 21.1) |
| Died | 641 (43%) | 325 (71%) | 316 (31%) |
| Any CKM Decision | 403 (27%) | 153 (34%) | 250 (24%) |
| Time to CKM (months) | 0.0 (0.0, 4.1) | 0.0 (0.0, 0.2) | 0.2 (0.0, 6.8) |
| New CKM (post-eligibility) Decision | 182 (12%) | 46 (10%) | 136 (13%) |
| 1 n (%); Median (Q1, Q3) | |||
CKM Decisions by Year
Follow-up and Outcomes in Patients with New CKM Decisions
| New CKM Starts |
Eligibility Timing
|
|
|---|---|---|
| Pre-implementation N = 821 |
Post-implementation N = 1001 |
|
| Year of Eligibility | ||
| 2012 | 9 (11%) | 0 (0%) |
| 2013 | 18 (22%) | 0 (0%) |
| 2014 | 11 (13%) | 0 (0%) |
| 2015 | 24 (29%) | 0 (0%) |
| 2016 | 20 (24%) | 10 (10%) |
| 2017 | 0 (0%) | 47 (47%) |
| 2018 | 0 (0%) | 39 (39%) |
| 2019 | 0 (0%) | 4 (4.0%) |
| Age (years) | 80.4 (74.8, 85.3) | 80.6 (73.9, 84.2) |
| Age 75+ | 61 (74%) | 72 (72%) |
| Follow-up Time (months) | 54.3 (45.7, 73.5) | 23.2 (17.4, 30.8) |
| Time to New CKM Desicion (months) | 12.2 (3.1, 27.9) | 2.9 (0.5, 8.0) |
| CKM to Dialysis | 9 (11%) | 10 (10%) |
| Time from CKM to Dialysis (months) | 12.2 (7.5, 16.0) | 5.0 (2.8, 11.4) |
| 1 n (%); Median (Q1, Q3) | ||
Follow-up and Outcomes in Patients with New CKM Decisions by Event Timing
| New CKM Starts |
CKM Decision Timing
|
|
|---|---|---|
| Pre-Implementation N = 461 |
Post-Implementation N = 1361 |
|
| Eligibility Timing | ||
| Pre-implementation | 46 (100%) | 36 (26%) |
| Post-implementation | 0 (0%) | 100 (74%) |
| Year of Eligibility | ||
| 2012 | 5 (11%) | 4 (2.9%) |
| 2013 | 14 (30%) | 4 (2.9%) |
| 2014 | 8 (17%) | 3 (2.2%) |
| 2015 | 12 (26%) | 12 (8.8%) |
| 2016 | 7 (15%) | 23 (17%) |
| 2017 | 0 (0%) | 47 (35%) |
| 2018 | 0 (0%) | 39 (29%) |
| 2019 | 0 (0%) | 4 (2.9%) |
| Age (years) | 80.4 (75.5, 86.0) | 80.5 (73.9, 84.5) |
| Age 75+ | 35 (76%) | 98 (72%) |
| Follow-up Time (months) | 62.4 (47.4, 75.6) | 28.8 (19.2, 39.5) |
| Time to New CKM Desicion (months) | 4.9 (1.0, 14.6) | 5.5 (1.2, 15.8) |
| CKM to Dialysis | 7 (15%) | 12 (8.8%) |
| Time from CKM to Dialysis (months) | 8.3 (6.1, 16.0) | 6.9 (3.1, 14.2) |
| 1 n (%); Median (Q1, Q3) | ||
Time to CKM Decision in Patients with New CKM Decisions
Cumulative Incidence of New CKM - Competing Risks Models
Note: patients who crossed over prior to decision still included in pre-implementation cohort
Cumulative Incidence Plot (Competing Risks = Death/Dialysis)
Cumulative Incidence Table (Competing Risks = Death/Dialysis)
| 12 Months | 24 Months | 36 Months | 48 Months | 60 Months | 72 Months | 84 Months | p-value1 | |
|---|---|---|---|---|---|---|---|---|
| Eligibility Timing | 0.008 | |||||||
| Pre-implementation | 7.7% (5.6%, 10%) | 11% (8.2%, 13%) | 13% (10%, 16%) | 14% (11%, 17%) | 15% (12%, 18%) | 16% (13%, 19%) | 19% (13%, 25%) | |
| Post-implementation | 13% (11%, 16%) | 16% (13%, 19%) | 17% (14%, 21%) | 17% (14%, 21%) | 17% (14%, 21%) | 17% (14%, 21%) | 17% (14%, 21%) | |
| 1 Gray’s Test | ||||||||
Cause-Specific Hazard of New CKM - Timy Varying Models
Note: patients who crossed over prior to decision are included in the post-implementation cohort at the time of crossover. Competing risk events are considered censored.
Cumulative Incidence Plot (Time Varying)
Cause Specific Hazard Table (Time Varying CoxPH Model)
| Event N | HR | 95% CI | p-value | |
|---|---|---|---|---|
| Eligibility Timing | ||||
| Pre-implementation | 46 | — | — | |
| Post-implementation | 136 | 1.84 | 1.31, 2.57 | <0.001 |
| Abbreviations: CI = Confidence Interval, HR = Hazard Ratio | ||||
Cause Specific Hazard Table (Time Varying CoxPH Model - Adjusted)
Confounder summary score using: ckm ~ male + white + Karnofsky + Shower + Dress + Walk + Bed + Pain + Tired + Nausea + Depression + Anxiety + Drowsy + Appetite + WellBeing + ShortnessOfBreath + Sleep + Itch + HealthQOL + Dementia + albumin + hgb + GFR + calcium + ferritin + age + weight + ESKD_Ch
| Event N | HR | 95% CI | p-value | |
|---|---|---|---|---|
| Eligibility Timing | ||||
| Pre-implementation | 46 | — | — | |
| Post-implementation | 136 | 1.94 | 1.37, 2.74 | <0.001 |
| Confounder Summary Score | 182 | 1.04 | 1.03, 1.05 | <0.001 |
| Abbreviations: CI = Confidence Interval, HR = Hazard Ratio | ||||