Incidence of skeletal-related events (SREs) among prostate cancer patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Marianne Ulcickas Yood ◽  
Teresa Maria Zyczynski ◽  
Karen Wells ◽  
Deborah Casso ◽  
Benjamin Gutierrez ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Spinal Cord ◽  
Cancer Patients ◽  
Stage Iv ◽  
Cord Compression ◽  
Population Based ◽  
Tumor Registry ◽  
Ajcc Stage ◽  
Skeletal Related Events

e16035 Background: Skeletal related events (SREs) occur in men with prostate cancer and may result from both bone metastases and exposure to androgen deprivation therapy (ADT). The objective of this study was to quantify the incidence of SREs in patients with prostate cancer treated with ADT or orchiectomy in clinical practice. Methods: Prostate cancer patients served by Henry Ford Health System (HFHS) were identified via the HFHS tumor registry. Eligible patients were newly diagnosed with prostate cancer between 2004 and 2010 and treated with ADT or orchiectomy. Comprehensive population-based data were compiled using tumor registry with linkages to pharmacy, laboratory results, and healthcare encounter databases. SREs included spinal cord compression, surgery to bone, pathologic fracture and radiation to bone. Disease progression and metastases were identified by medical record review. Results: We identified 702 patients with prostate cancer and receipt of ADT or orchiectomy; 57.6% were >70 years of age and 43.7% were African American. 56.3% of patients were initially diagnosed at AJCC stage II, 9.8% at stage III, 22.1% at stage IV, and 11.8% had missing or unknown stage. A total of 93 patients (13.2%) had one or more SREs: radiation to bone (8.5%) and spinal cord compression (3.1%) were the most common SREs. We then limited the cohort to patients initially diagnosed with or progressing to AJCC stage IV prostate cancer (N=207). Among this group, 47.8% were >70 years of age. The mean time from stage IV diagnosis to end of follow-up was 35.6 months. In this subgroup, 16.4% of patients were initially diagnosed at AJCC stage II, 8.2% at stage III, 69.6% at stage IV, and 5.8% had missing or unknown stage. 57 patients (27.5%) had one or more SREs. Conclusions: Some clinical trials have found 36-41% of high-risk metastatic prostate cancer patients developed SREs during 3 years of follow-up. In this population-based cohort of patients with prostate cancer receiving ADT or orchiectomy and treated in real-world clinical practice, we found the incidence of SREs to be lower than what has been reported in clinical trials. Additional analyses exploring the incidence of SREs in patients diagnosed with metastatic castrate resistant prostate cancer will be presented.

Prostate cancer burden at the Uganda Cancer Institute (UCI).

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 246-246
Author(s):  
Fred Machyo Okuku ◽  
Jackson Orem ◽  
George Holoya ◽  
Christopher J De Boer ◽  
Matthew M. Cooney
Keyword(s):  
Prostate Cancer ◽  
Spinal Cord ◽  
Gleason Score ◽  
Spinal Cord Compression ◽  
Stage Iv ◽  
Cord Compression ◽  
Screening Programs ◽  
Stage Iv Disease ◽  
Lost To Follow Up

246 Background: In Uganda prostate cancer is the most common cancer and the incidence is increasing 5.2% annually. This burden is seen without screening programs in a country with limited access to cancer care. Data describing patient presentation and outcomes are lacking. Methods: Retrospective chart review for men with histologically-confirmed prostate cancer at the UCI from January 1 to December 17, 2012. Patient characteristics, treatments, and survival data were obtained. Results: There were 181 men with confirmed prostate cancer [C1] . Mean age was 69.5 (SD 9.0) with a median age of 70 (IQR: 64-75). Men presented with symptoms of lower urinary tract symptoms 73% (n=131), bone pain in 18% (n=32), elevated PSA 3% (n=5) and other causes 6% (n=11). Median baseline PSA was 91.3 ng/ml (IQR: 19.5-311.3 ng/ml) and upon presentation 51.1% (n=92) had a PSA value over 100 ng/ml. Gleason Score was 9 or 10 in 66.7% (n=120), Gleason Score 7 to 8 in 23.4% (n=44), and Gleason six or lower in 10% (n=18). Ninety percent (n=136) of patients had stage IV disease, 6.5% (n=11) were stage III, 11.9% were (n= 20) stage II, and 1 individual (0.6%) had stage I. Common sites of metastases included bone 73% (n=102), visceral metastases 21% (n=29), and lymph node involvement 4% (n=5). Spinal cord compression occurred in 30.9% (n=55) and 5.6% (n=10) experienced a fracture. A total of 14.9% (n=27) patients underwent radical prostatectomy and 17.7% (n=32) received radiotherapy. GNRH agonist was given to 45.3% (n=82) of patients, 29.2% (n=53) of men received diethylstilbestrol, and 26% (n=47) underwent bilateral orchiectomy. Chemotherapy was administered to 21.6% (n=39) and 52.5% (n=95) received bisphosphonates. During the 12 months of study 23.8% (n=43) of men experienced death and 54.4% (n=98) were lost to follow up. Conclusions: UCI patients present with significant symptoms, high PSA, and aggressive Gleason Scores. 90% present with stage IV disease and almost 33% develop spinal cord compression. Prostatectomy and radiotherapy are infrequently given and the primary treatments are hormonal manipulation and chemotherapy. Almost 25% of patients succumb within a year of presentation and there is a high rate of patients lost to follow up.

Skeletal-Related Events In Myeloma: A Population-Based Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3158-3158 ◽  
Author(s):  
John Ashcroft ◽  
Bagguley Timothy ◽  
Alexandra Smith ◽  
Han-I Wang ◽  
Debra Howell ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Vertebral Fractures ◽  
Research Funding ◽  
Cord Compression ◽  
Population Based ◽  
Newly Diagnosed ◽  
Population Based Study ◽  
Skeletal Related Events ◽  
Bed Days

Abstract Introduction New therapies have resulted in improvements in myeloma survival, with increasing numbers of patients receiving treatment over several years. Despite this progress, the remitting and relapsing course of the disease continues to be associated with increases in patient morbidity and mortality due to skeletal related events (SREs), including fractures and spinal cord compression. Contemporary information on SRE frequency in myeloma patients at a population-based level is, however, sparse. The aim of this study was to evaluate the incidence of SREs and associated inpatient (I/P) reimbursement costs for myeloma patients. Methods Myeloma patients newly diagnosed between 2004-9 were identified from a UK specialist population-based study (the Haematological Malignancy Research Network – www.hmrn.org) and followed-up until April, 2011. Information on diagnosis, treatment (first and subsequent lines) and response was abstracted from medical records and all subjects were linked to Hospital Episodes Statistics (HES), a national database containing details of all hospital admissions in England. In our analyses, SREs within HES were identified by diagnosis and procedure codes using International Classification of Diseases (ICD-10) and Operating Procedure Code Set (OPCS-4), respectively. Associated reimbursements were estimated using Healthcare Resource Group (HRG codes); this was done for both SRE related events and the total inpatient treatment pathway. Results Of the 1,112 patients newly diagnosed (median age 72.6 years, 57% males, incidence rate - 6.7 per 100,000), 72% received induction chemotherapy; the remainder received supportive care or radiotherapy only, or were asymptomatic and actively monitored. Overall, 32% of patients had an I/P episode related to an SRE; with 15% having non-vertebral fractures, 6% vertebral fractures, 6% spinal cord compression and 17% undergoing surgery to bone (Table 1). The Figure, which presents data by vital status, clearly shows that SREs occurred throughout the pathway. Median follow-up time was 3.8 years and each individual patient's pathway is illustrated by a single grey line, spanning 90 days pre-diagnosis through to death/end of follow-up. SRE I/P episodes are shown in blue and other I/Ps in green. Overall, the average number of bed days for each patient, for any reason, was 43.6, with a total reimbursement cost (excluding drug costs for myeloma) of pounds sterling (GBP) 13,930, equating to GBP 656/month. For myeloma patients with an SRE, the total number of SRE related bed days was 27.3, and total SRE related reimbursement costs were GBP 4,488. Conclusions In our contemporary UK population-based dataset, around a third of myeloma patients experienced at least one SRE associated I/P episode at some point in their pathway, with such events being at least as common after diagnosis and first/subsequent treatment(s) as before. Clearly, in the era of novel myeloma therapies, SREs remain an important cause of morbidity, attracting significant inpatient health care costs. Disclosures: Ashcroft: Celgene: Research Funding. Jack:Roche /Genentech: Research Funding. Roman:Celgene: Research Funding.

Skeletal related events (SREs) in metastatic androgen independent prostate cancer (AIPC) treated with docetaxel-based chemotherapy: Results from ASCENT

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4614-4614 ◽  
Author(s):  
J. S. Chan ◽  
C. W. Ryan ◽  
P. M. Venner ◽  
D. P. Petrylak ◽  
G. S. Chatta ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Cord Compression ◽  
Entire Group ◽  
Large Prospective Study ◽  
Free Survival ◽  
Skeletal Related Events ◽  
The Impact ◽  
Androgen Independent

4614 Background: Docetaxel prolongs survival in AIPC patients and zoledronic acid (ZA) reduces the incidence of SREs. The SRE incidence of patients treated with docetaxel-based chemotherapy has not previously been reported. Methods: ASCENT was a randomized clinical trial that compared weekly DN-101 (calcitriol, 45 μg p.o. on day 1) plus docetaxel (36 mg/m2 iv on day 2 for 3 weeks of a 4-week cycle) to placebo plus docetaxel in patients with chemotherapy-naïve metastatic AIPC. ZA use was not restricted. SRE-free survival was described for the entire group and then compared for patients randomly assigned to DN-101 or placebo and stratified by ZA use. Statistical comparisons were conducted using Cochran-Mantel-Haenszel for incidence and log-rank for SRE-free survival. Results: With a median follow-up of 18.3 months, 33% of subjects experienced at least one SRE and the overall median SRE-free survival was 13 (95% CI 10.5–14.3) months. The incidence of SRE by type was: radiation to bone (18.8%), fracture (10%), spinal cord compression (4%), surgery to bone (0.4%). Eighty-five (34%) patients received ZA. The study was not adequately powered to measure the impact of DN-101 or ZA on SRE endpoints. Exploratory analyses showed a trend for an increase in SRE-free survival (HR 0.78, p = 0.13) of DN-101-treated patients. SRE-free survival and incidence for subgroups were examined ( Table ). Conclusions: This is the first report of SRE incidence in a large, prospective study of docetaxel-based therapy. Improved therapies for reducing SREs in AIPC are needed because the risk of SREs remains high despite the use of modern chemotherapy and ZA. [Table: see text] [Table: see text]

The prognostic significance of bone metastases and skeletal-related events (SREs) in prostate cancer survival: A population-based historical cohort study in Denmark (1999–2007)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5160-5160 ◽  
Author(s):  
J. P. Fryzek ◽  
K. Cetin ◽  
M. Nørgaard ◽  
A. Ø. Jensen ◽  
J. Jacobsen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Cancer Progression ◽  
Large Population ◽  
Prognostic Significance ◽  
Population Based ◽  
Short Term ◽  
Historical Cohort

5160 Background: Common among advanced prostate cancer patients, bone metastases indicate cancer progression and poor prognosis but few studies have quantified their influence on patient survival, particularly in the presence of subsequent skeletal-related complications. We therefore sought to examine this in a large population-based cohort of prostate cancer patients. Methods: Using data from the Danish National Patient Registry (covering all Danish hospitals), we studied 23,087 patients diagnosed with prostate cancer between 1999 and 2007, with follow-up through April 2008 (median follow-up: 2.2 years). We estimated the incidence of bone metastases following cancer diagnosis and the subsequent occurrence of SREs (radiation and surgery to the bone, fracture, spinal cord compression). We then computed and compared survival for three prostate cancer subgroups - no bone metastases, bone metastases, and bone metastases with SREs - using Kaplan-Meier and multivariate Cox proportional hazards models. Results: Across the study period, 14% (n = 3,261) of the prostate cancer patients developed bone metastases: 6.8% (n = 1,570) had bone metastases and no SRE and 7.3% (n = 1,691) had both bone metastases and at least one SRE (radiation to the bone was most frequent). One-year survival was lowest for prostate cancer patients with bone metastases and SREs (40%) compared to the groups with no bone metastases (87%) and with bone metastases but no SREs (47%). Similarly, after adjusting for age and the presence of comorbidities, short-term prognosis was poorest in patients with both bone metastases and SREs: compared to prostate cancer patients with no bone metastases, the 1-year mortality rate was 6.7 times greater for those with bone metastases and SREs (95% confidence interval (CI): 6.0–7.6) versus just 4.7 times higher in those with only bone metastases (95% CI: 4.3–5.2). Less than 1% of prostate cancer patients who developed bone metastases and suffered any SRE survived beyond five years. Conclusions: Although the presence of bone metastases confers a short-term prognosis in prostate cancer patients, survival is even poorer for patients who also experience skeletal-related complications. [Table: see text]

Impact of skeletal-related events on survival in patients with prostate cancer metastatic to bones.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 223-223
Author(s):  
Jean A. McDougall ◽  
Bernardo Haddock Lobo Goulart ◽  
Sean D Sullivan ◽  
Jeannine S. McCune ◽  
Aasthaa Bansal ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Spinal Cord ◽  
Spinal Cord Compression ◽  
Metastatic Prostate Cancer ◽  
Pathological Fracture ◽  
Cord Compression ◽  
Time Dependent ◽  
Risk Of Death ◽  
Skeletal Related Events ◽  
The Impact

223 Background: Skeletal related events (SREs), defined as pathological fracture, spinal cord compression, surgery or radiotherapy to the bone, occur in nearly half of men diagnosed with metastatic prostate cancer. Accurate assessment of the risk of death associated with SREs is important to making decisions about the use of recently approved treatments, which have been shown to decrease the frequency of skeletal events, yet estimating the impact of SREs on survival presents several methodological challenges given the recurrent time-dependent nature of exposure. Methods: A cohort of men >65years of age, diagnosed with prostate cancer and bone metastasis between January 1, 2004 and December 31, 2009 was identified from the Surveillance Epidemiology and End Results (SEER) registries were linked to Medicare Parts A and B claims. The outcome of interest, death from any cause, was ascertained from SEER and survival time was calculated from the date of metastatic prostate cancer diagnosis. Multivariable Cox proportional hazards models treating the occurrence of an SRE as a time-dependent exposure were used to estimate the hazard ratios (HR) and corresponding 95% confidence intervals (CI) for the association between SRE occurrence, number, and type, and death. Results: Among 3,297 men with metastatic prostate cancer, 40% experienced ≥1 SRE during the observational follow-up period (median 19 months). Compared to men who remained SRE-free, cohort members who had ≥1 SREs had a two-fold higher risk of death (HR 2.2, 95% CI 2.0-2.4). Those whose first SRE was a pathological fracture had a 2.7-fold higher risk of death (HR 2.7, 95% CI 2.3-3.1), followed by spinal cord compression (HR 2.1, 95% CI 1.8-2.5), surgery (HR 1.8, 95% CI 1.5-2.2) and radiotherapy (HR 2.2, 95% CI 1.9-2.4). Compared to those experiencing only one SRE, men who experienced a second SRE of any type had double the risk of death (HR 2.2, 95% CI 1.9-2.6). Conclusions: SREs were associated with ≥50% reduction in overall survival. This finding is consistent across different types of SREs and supports using therapies to prevent or treat SREs in patients with prostate cancer metastatic to the bones.

scholarly journals Prostate Cancer Burden at the Uganda Cancer Institute

2016 ◽  
Vol 2 (4) ◽  
pp. 181-185 ◽  
Author(s):  
Fred Okuku ◽  
Jackson Orem ◽  
George Holoya ◽  
Chris De Boer ◽  
Cheryl L. Thompson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Stage Iv ◽  
Cord Compression ◽  
Hormonal Manipulation ◽  
Number Of Patients ◽  
Stage Iv Disease ◽  
Metastatic Sites ◽  
Lost To Follow Up

Purpose In Uganda, the incidence of prostate cancer is increasing at a rate of 5.2% annually. Data describing presentation and outcomes for patients with prostate cancer are lacking. Methods A retrospective review of medical records for men with histologically confirmed prostate cancer at the Uganda Cancer Institute (UCI) from January 1 to December 17, 2012, was performed. Results Our sample included 182 men whose mean age was 69.5 years (standard deviation, 9.0 years). Patients who presented to the UCI had lower urinary tract symptoms (73%; n = 131), bone pain (18%; n = 32), increased prostate-specific antigen (PSA; 3%; n = 5), and other symptoms (6%; n = 11). Median baseline PSA was 91.3 ng/mL (interquartile range, 19.5-311.3 ng/mL), and 51.1% of the patients (n = 92) had a PSA value above 100 ng/mL. Gleason score was 9 or 10 in 66.7% of the patients (n = 120). Ninety percent (n = 136) had stage IV disease, and metastatic sites included bone (73%; n = 102), viscera (21%; n = 29), and lymph nodes (4%; n = 5). Spinal cord compression occurred in 30.9% (n = 55), and 5.6% (n = 10) experienced a fracture. A total of 14.9% (n = 27) underwent prostatectomy, and 17.7% (n = 32) received radiotherapy. Gonadotropin-releasing hormone agonist was given to 45.3% (n = 82), 29.2% (n = 53) received diethylstilbestrol, and 26% (n = 47) underwent orchiectomy. Chemotherapy was administered to 21.6% (n = 39), and 52.5% (n = 95) received bisphosphonates. During the 12 months of study, 23.8% of the men (n = 43) died, and 54.4% (n = 98) were lost to follow-up. Conclusion UCI patients commonly present with high PSA, aggressive Gleason scores, and stage IV disease. The primary treatments are hormonal manipulation and chemotherapy. Almost 25% of patients succumb within a year of presentation, and a large number of patients are lost to follow-up.

Denosumab for the prevention of symptomatic skeletal events in patients with castration-resistant advanced prostate cancer: A comparison with skeletal-related events.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 35-35 ◽  
Author(s):  
Matthew R. Smith ◽  
Robert E. Coleman ◽  
Laurence Klotz ◽  
Kenneth B. Pittman ◽  
Piotr Milecki ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Compression ◽  
Controlled Trial ◽  
Cord Compression ◽  
Castration Resistant ◽  
Pathologic Fractures ◽  
Skeletal Related Events ◽  
Fracture Surgery

35 Background: In a randomized controlled trial of men with castration-resistant prostate cancer (CRPC) and bone metastases, denosumab was superior to zoledronic acid (ZA) for reducing skeletal-related events (SRE, defined as pathological fracture, surgery or radiation to bone [including the use of radioisotopes], or spinal cord compression) (Fizazi, et al. Lancet 2011;377:813-822.). Recently, the composite endpoint of symptomatic skeletal event (SSE, defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression) was introduced as an alternative term/clinical trial endpoint to describe skeletal morbidity. Methods: Men with CRPC, ≥ 1 bone metastasis, and no prior IV bisphosphonate use received either SC denosumab 120 mg or IV ZA 4 mg (adjusted for creatinine clearance) in a blinded fashion every 4 weeks. Oral calcium and vitamin D supplements were recommended. SSEs included pathologic fractures considered symptomatic by the investigator, spinal cord compression and surgery and radiation to bone. Results: As previously reported, fewer men who received denosumab than ZA had confirmed first SREs, and experienced multiple SREs (Table). Similarly, fewer patients in the denosumab group than the ZA group had confirmed first SSE and multiple SSEs. The median (95% CI) estimate of time to first SSE (superiority analysis) for denosumab was not reached (28.8 mo, not estimable), and for ZA it was 24.2 (20.7, 30.2) mo (HR = 0.78 (0.66, 0.93) P = 0.01). Conclusions: Denosumab reduced the risk of skeletal events in men with CRPC regardless of endpoint definition as SRE or SSE. The risk of developing SSEs was reduced by up to 22% when comparing denosumab with ZA. Clinical trial information: NCT00321620. [Table: see text]

The natural history of bone metastases in castrate-resistant prostate cancer.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 239-239
Author(s):  
Robert James Pell ◽  
Stephen John Harland
Keyword(s):  
Prostate Cancer ◽  
Spinal Cord ◽  
Bone Metastases ◽  
Cancer Diagnosis ◽  
Pathological Fracture ◽  
Cord Compression ◽  
Castrate Resistant Prostate Cancer ◽  
Skeletal Related Events ◽  
Castrate Resistant ◽  
Resistant State

239 Background: Previous authorities have commented on the lack of data regarding overall prevalence of Skeletal-Related Events (SREs) in Castrate Resistant Prostate Cancer (CRPC) in patients who have not received therapy for SRE prevention. We describe a cohort of 129 patients followed to death. Methods: 129 patients treated with palliative chemotherapy for CRPC at University College Hospital London between 01/01/2006 and 31/12/2010 had retrospective collection of data concerning date of prostate cancer diagnosis, date of CRPC, date of death, date of bone metastasis development, radiotherapy treatment, pathological fracture, bone surgery, and spinal cord compression up until 01/06/2013. Results: Median age at castrate resistant prostate cancer development was 70 years. Overall median time from prostate cancer diagnosis to establishment of castrate-resistant state was 33 months (range 5-223). Median time from castrate-resistant state to death was 23 months (0-99). Only 9/129 patients failed to develop bone metastases. A total of 162 palliative radiotherapy treatments were given to 74 patients. Only 10 radiotherapy treatments occurred prior to the development of castrate-resistant disease, the remaining 152 all occurred after castrate-resistance occurred. Symptomatic pathological fracture occurred 28 times in 22 (17%) patients. One or more surgical interventions for bone disease were carried out in 23 (18%) patients. 27 (21%) patients were treated for spinal cord compression. In total, 352 skeletal-related events occurred in 89 patients. Conclusions: Important skeletal-related events occurred in 69% of patients with mCRPC. It is possible that incomplete follow-up in clinical trials of agents such as bisphosphonates considerably under estimate the effect of the investigational agent. The frequency of pathological long bone fracture suggests current measures to detect prefracture and intervene are inadequate. [Table: see text]

scholarly journals Quality of care indicators and their related outcomes: A population-based study in prostate cancer patients treated with radical prostatectomy

2014 ◽  
Vol 8 (7-8) ◽  
pp. 572 ◽  
Author(s):  
Colleen Webber ◽  
David Robert Siemens ◽  
Michael Brundage ◽  
Patti A Groome
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Quality Indicators ◽  
Hospital Volume ◽  
A Priori ◽  
Population Based ◽  
Follow Up Care ◽  
Cause Specific Survival

Introduction: We evaluated the validity of 8 quality of care indicators for prostate cancer patients treated curatively with radical prostatectomy (RP) by examining their association with indicator relevant outcomes.Methods: We conducted a population-based retrospective cohort study of 646 prostate cancer patients diagnosed between 1990 and 1998 who received RP within 6 months of diagnosis. Data were collected from treating charts and linked to registry and administrative data. Quality indicators included: hospital volume, pre-treatment risk assessment, consultation with a radiation oncologist, appropriate follow-up care, nerve-sparing surgery, units of blood transfused, surgical margin status, and pelvic lymph node dissection during RP. Indicator-relevant outcomes were selected a priori by clinical members of the research team. The associations between indicators and their relevant outcomes were analyzed using regression techniques, to control for potential confounders.Results: Of the quality indicators evaluated, only hospital volume was statistically significantly associated with the gradient in the expected direction. Patients treated in the lowest-volume hospitals (<1 RP/month) had lower cause-specific survival rates compared to patients treated in the highest-volume hospitals (≥7 RP/month) (HR=4.71 95%; CI 1.06-20.82). Completeness of follow-up care was associated with cause-specific survival but in the opposite direction to our hypothesis.Conclusion: The structural indicator of hospital volume was associated with cause-specific survival in accordance with our a priori hypothesis. Our negative findings for completeness of follow-up care call its validity into question. Issues of statistical power and measurement accuracy may have affected our validation of the remaining indicators underscoring the challenges in assessing the impact of accepted quality indicators.

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