bluuebunny/crossref_metadata_2025_split huggingface dataset:
Measuring quality with the Quality Oncology Practice Initiative (QOPI) at a university comprehensive cancer center
Authors: Blayney D. W. , Miela G. , Markstrom D. , Hanauer D. , McNiff K. , Neuss M. 
Published: March 2020

6535 Background: QOPI is a tool which measures adherence to both guidelines and to process for use in quality improvement. QOPI was designed and pilot tested predominately in physician office practices [Neuss et al, JCO 23:6233]. We tested QOPI at UMCCC, a large, hospital-based, academic cancer center, where medical documents are stored in a free-text electronic record, in a paper-based hospital record, and in clinic charts. In 2006, 136 physicians and 58 mid-level practitioners provided 66,699 clinic visits and oversaw 37,500 infusion visits. Methods: The tumor registry selected consecutive cases of breast (BrCa), lung, and colorectal cancer (CRC), and lymphoma (L), diagnosed between minus 6 and minus 30 months from day 0 of each QOPI round. Forty charts with each tumor type and 40 deceased patient records were identified for each round. A clinical pharmacist accessed the pharmacy database to obtain drug data, and the tumor registrar abstracted the three other chart formats, using an electronic text search tool [Hanauer et al Proc ASCO 2006 abs 6080] for the electronic record. De-identified data were submitted to a secure, ASCO-hosted server, for analysis. Results: In the Spring 2006 round, 163 charts yielding 1641 measures required 148 hours of abstractor effort, for an average of 54 minutes (mins) per chart and 5.4 mins per measure. In the Fall, 2006 round, 236 charts yielding 2334 measures required 256.5 hours of effort for 65 mins per chart and 6.6 mins per measure. For comparison, a survey of QOPI practices for the Fall round yielded 29 mins per chart. UMCCC treatment (Rx) and process measures are shown in the table . Conclusions: Abstracting for QOPI measures, using abstractors not involved in patient care, is labor intensive but feasible at a large cancer center. QOPI has allowed UMCCC to assess concordance with guidelines and other quality measures, provides comparison data to other practices, and identifies processes for improvement. The evolution of QOPI will include data transfer from electronic records. [Table: see text] [Table: see text]
Paradoxical benefit of increased distance of residence from cancer treatment hospitals (CTH) in the United Kingdom (UK)
Authors: Crawford S. M. , Sauerzapf V. , Jones A. P. , Haynes R. , Zhao H. , Forman D. 
Published: March 2020

6536 Background: UK residents have, through the National Health Service, access via primary care referral to diagnostic and treatment services free of charge. However there is evidence of uneven uptake by cancer patients. Methods: We have undertaken a cancer registry based study relating socioeconomic characteristics of the patient's place of residence and travel to CTH to uptake and outcome. We report here these relationships according to whether patients underwent any surgery, radiotherapy or chemotherapy. Results: The Table shows the number of patients by site and the percentage receiving any of the specified treatments. Against each deprivation quartile defined by the index of multiple deprivation (DQ1 is least deprived) is given the odds ratio (95% confidence interval) by logistic regression analysis of receiving treatment as it increases with each minute of travel time between home and hospital after allowing for age, sex, and whether or not the CTH was a specialised cancer centre plus site in bowel and lung cancer type. The tendency for odds ratios to be greater with increasing deprivation is significant (Kendall concordance = 0.6417, p=0.022). Conclusions: We observed an increase in treatment activity with increasing travel time to the CTH when a ‘distance decay’ effect was expected. We hypothesise that this relates to the difficulties of providing primary care in the deprived urban areas in which most CTH are situated. Higher odds ratios for more deprived people suggest that the distance advantage compensates for the effect of deprivation. No significant financial relationships to disclose. [Table: see text]
Quality and consistency of phase III clinical trial abstracts presented at an Annual Meeting of the American Society of Clinical Oncology compared with their subsequent full-text publications
Authors: Tam V. C. , Hotte S. J. 
Published: March 2020

6537 Background: Practice guidelines and evidence summaries in oncology are developed by experts to assist providers in making appropriate decisions regarding management. These documents result from a systematic review of literature from medical journals and meeting proceedings. Because there is often less rigorous peer reviewing of abstracts published in these proceedings compared to journal publications, the quality of evidence provided by these abstracts is uncertain. Methods: We identified abstracts describing phase III clinical trials of chemotherapy, chemoradiotherapy, immune therapy and hormone therapy presented at the 36th ASCO Annual Meeting in May 2000. We searched Medline and Pubmed for all corresponding publications. Data was extracted from the abstracts and publications meeting our inclusion criteria. Results: A total of 192 abstracts were identified. Seventy-four abstracts met our inclusion criteria. Six years after the 2000 ASCO Annual Meeting, 74% of these abstracts had corresponding publications. 39% of the abstracts explicitly indicated that they were reporting interim results. The primary endpoint was stated in 34% of the abstracts and 100% of the published papers. The primary outcome result differed by greater than five percent between the abstract and publication in 25% of the abstracts. The statistical significance of the primary outcome changed in 7% of the abstracts with publications. The final conclusion was consistent between the abstract and publication for 92% of the abstracts with reported conclusions. Conclusions: ASCO annual meeting abstracts of phase III trials appear to consistently reflect final published results and can likely be used in practice guidelines. However, occasional discrepancies underline the need for caution in completely adopting these results prior to full publication. No significant financial relationships to disclose.
Trends in the quality of abstracts of articles describing randomized controlled cancer trials (RCTs) from 1975–2004
Authors: Cescon D. W. , Booth C. M. , Wang L. , Tannock I. F. , Krzyzanowska M. K. 
Published: March 2020

6541 Background: Busy oncologists may rely on abstracts to obtain most of their information from published reports. Here we evaluate the quality of abstracts in articles reporting RCTs, and whether quality of reporting has changed over time. Methods: Reports of RCTs evaluating systemic therapy for breast, colorectal and non-small cell lung cancer published 1975–2004 in 6 major journals were identified. The quality of abstracts was evaluated using a scale which awards 1 point for full and 1/2 point for partial reporting of each of 6 items: study rationale, statement of primary endpoint, description of intervention, treatment effect size, P-values or confidence intervals (CI), and toxicity. The scale was a modification of one previously developed to assess quality of reporting of conference abstracts. Trends in the reporting of individual items and composite scores were evaluated over three 10-year periods (1975–84, 1985–94, 1995–2004) using descriptive statistics. Results: Of 326 eligible articles, 319 had an abstract. Unstructured abstracts were common before 1994 ( Table ). The minimum and maximum quality scores assigned were 0.5 and 6/6. Median quality scores improved significantly with time (from 2.5 to 4.5/6, P < .001), as did inclusion of each of the individual items (P < .001). In the most recent 10-year period, three variables were adequately reported in less than half of abstracts (primary endpoint 38.0%, rationale 38.6%, toxicity 40.4%). Since the publication of the revised CONSORT statement in 2001, reporting of these items has improved (58.2%, 47.8%, 44.8% for 2002–2004). Conclusions: Quality of abstracts for published RCTs has improved over time, but deficiencies still exist. Items requiring improved reporting include identification of the primary endpoint, description of rationale, and a summary of toxicity. No significant financial relationships to disclose. [Table: see text]
Understanding patient expectations in early-phase clinical trials
Authors: Weinfurt K. P. , Seils D. M. , Tzeng J. P. , Compton K. L. , Sulmasy D. P. , Astrow A. B. , Schulman K. A. , Meropol N. J. 
Published: March 2020

6543 Background: Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented. Such concerns are based on assumptions about what patients mean when they respond to questions about likelihood of benefit. In this study, we explored some of these assumptions. Methods: Participants were 27 women and 18 men in phase 1 or 2 oncology trials and randomized to 1 of 3 interview protocols corresponding to 3 target questions about likelihood of benefit: frequency-type (‘Out of 100 patients who participate in this study, how many do you expect will have their cancer controlled as a result of the experimental therapy?‘); belief-type (‘How confident are you that the experimental therapy will control your cancer?‘); and vague (‘What is the chance that the experimental therapy will control cancer?‘). In semistructured interviews, we queried participants about how they understood and answered the target question. Each participant then answered and discussed one of the other target questions. Results: Participants tended to provide higher expectations in response to the belief-type question (median, 80) than in response to the frequency-type or vague questions (medians, 50) (P=.02). Only 7 (16%) participants said their answers were based on what they were told during the consent process. The most common justifications for responses involved positive attitude (n=27 [60%]) and references to physical health (n=23 [51%]). References to positive attitude were most common among participants with high (>70%) expectations of benefit (n=11 [85%]) and least common among those with low (<50%) expectations of benefit (n=3 [27%]) (P=.04). Conclusions: We identified two factors that should be considered when determining whether high expectations of benefit are signs of misunderstanding. First, participants report different expectations of benefit depending on how the question is asked. Second, the justifications participants give for their answers suggest that many participants use their responses to express hope rather than to describe their understanding of the clinical trial. These findings should inform methods for evaluating the quality of informed consent in early-phase trials. No significant financial relationships to disclose.
Beware of the isolated intermediate quality measure: A lesson in choosing an ovarian cancer surgeon
Authors: Silber J. H. , Rosenbaum P. R. , Polsky D. , Millman A. M. , Ross R. N. , Even-Shoshan O. , Schwartz J. S. , Armstrong K. , Randall T. 
Published: March 2020

6546 Background: Measuring surgical quality has recently focused on isolated processes (such as P4P measures) and intermediate outcomes (such as infection rates). Some have argued that such isolated measures are inherently flawed since they may have only minor influence on more important primary outcomes such as survival. Hence, referral decisions based on such isolated processes or intermediate outcomes may lead to less than optimal care. We asked whether surgeon type influenced isolated process measures (longer operative time, thought to be a function of increased node sampling), intermediate outcomes (deep wound infection, often found to be a function of operative time) and the primary outcome of survival. Methods: We obtained SEER-Medicare claims for the years 1991–2001 for ovarian cancer. We identified the first definitive cancer surgery and the surgical provider type for that procedure: General Surgeon (GS) N=545 and GYN Oncologist (GO) N=1,554. We determined operative time from the anesthesia claims, number of nodes sampled from the SEER record, deep wound infection from the ICD9CM secondary diagnoses and survival from Medicare vital status files. Models were adjusted for 30 patient characteristics and comorbidities. To account for potential reclassification bias due to variations in the pattern of node dissection across GO and GS surgical types, which can potentially influence stage identification, we report survival results both with and without stage adjustments. Results: Definitive surgery by GOs was associated with more extensive node dissection and longer operative time. GO patients also displayed a trend for increased deep wound infection as compared to cases operated on by GS. However, 5-year survival was significantly longer in the GO group, with or without stage adjustment. Conclusions: GO cases took longer, tended to have higher infection rates, yet had better overall 5-year survival. Isolated intermediate outcome measures, such as deep wound infection, may not be good quality indicators. No significant financial relationships to disclose. [Table: see text]
Factors associated with reductions in chemotherapy dose intensity: Impact of clinical, sociodemographic and practice setting
Authors: Lyman G. H. , Kuderer N. M. , Poniewierski M. S. , Crawford J. , Wolff D. A. , Culakova E. , Dale D. C. 
Published: March 2020

6550 Background: A nationwide, prospective cohort study of patients receiving cancer chemotherapy was undertaken to better define treatment-associated toxicities and delivered dose intensity. Methods: Following informed consent, 3,670 patients initiating a new chemotherapy regimen with lymphoma (n=547) or carcinomas of the colon (n=521), breast (n=1,473), lung (n=907) or ovary (n=312) were prospectively registered at 117 randomly selected US oncology practices between March 2002 and December 2005. Pretreatment characteristics including clinical and sociodemographic factors and practice setting associated with reductions in chemotherapy dose intensity over 4 cycles were evaluated. Results: Chemotherapy regimen standards and intended dose and schedule were defined in 97% and 93% of patients, respectively. Average initial (planned) relative dose intensity (RDI) was 90% while the mean RDI actually delivered over 4 cycles was 83%. Reductions in RDI =15% of standard were planned in 23% of patients and actually occurred over 4 cycles in 38%. Body surface area (BSA) calculated by the method of Mosteller exceeded the BSA utilized by the oncology practices in two-thirds of patients most often due to capping at 2 m2. Obese patients with a body mass index (BMI) =30 were more likely to receive planned RDI reductions =15% (30%) than patients with BMI <30 (21%) (P<.0001). Other factors associated with planned reductions in RDI in multivariate analysis included: older age, male gender, lower education, absence of myeloid growth factor prophylaxis and cancers of the lung or ovary as well as the practice setting, size and geographic location. Factors associated with unplanned (subsequent) reductions in RDI included: older age, male gender, poorer Charlson comorbidity index, prior chemotherapy, lung cancer, low baseline hematocrit, white blood or platelet count, poor renal or hepatic function and low serum albumin as well as smaller practice and rural setting. Conclusions: A substantial proportion of patients receiving cancer chemotherapy experience both planned and unplanned reductions in RDI. Further understanding of factors associated with such reductions may provide opportunities for improving the quality of cancer care and clinical outcomes. No significant financial relationships to disclose.
Comorbidity, age and stage at diagnosis in colorectal cancer (CRC)
Authors: Zafar Y. , Abernethy A. P. , Abbott D. H. , Herndon J. E. , Rowe K. , Kolimaga J. , Conner L. , Patwardhan M. , Grambow S. , Provenzale D. 
Published: March 2020

6554 Background: Stage at diagnosis is a crucial predictor of outcome in CRC. The purpose of this study is to determine if comorbidity and age affect the stage at which CRC is diagnosed. Identifying variables that influence stage might improve outcomes in CRC. Due to frequent contact with the health care system, we hypothesize that patients with greater comorbidity and older age are more likely to be diagnosed with early-stage disease. Methods: We present data from two distinct patient populations: using the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) database, we identified CRC patients treated at 15 Veterans Administration (VA) hospitals from 2003-present. We also identified CRC patients treated from 2003-present at 10 non-VA, fee-for-service (FFS) practices in North and South Carolina. Data were abstracted by retrospective chart review. Comorbidity was calculated by the Charlson comorbidity index (CCI) with high comorbidity defined as CCI =3. Older age was defined as age =70 years. Data were analyzed using logistic regression where the odds of late stage at diagnosis were modeled as influenced by older age, high CCI, and race. The analysis included estimation of adjusted and unadjusted odds ratios. Results: 347 VA and 282 FFS patients were included. 98% VA vs 50% FFS were male; 43% VA vs 27% FFS were aged =70; 56% VA vs 70% FFS were white; 26% VA vs 44% FFS presented with metastatic CRC; and 21% VA vs 6% FFS had a CCI =3. In both patient populations, regression analysis showed that older age, high CCI and white race were not significant predictors of stage at diagnosis. VA 95% confidence intervals (CI's) were 0.52–1.41 (age =70), 0.50–1.75 (CCI =3), and 0.42–1.11 (white race). FFS 95% CI's were 0.52–1.53 (age =70), 0.36–2.78 (CCI =3), and 0.74–2.11 (white race). Broader 95% CI's in the FFS analysis were due to smaller sample size. Conclusions: In CRC patients, age and comorbidity were not related to stage at diagnosis. The findings are similar whether the patients were treated in a fee-for-service or VA health system. While older age and greater illness might provide more contact with the health care system, this exposure did not result in earlier diagnosis of CRC. Future studies will examine the impact of comorbidity on CRC treatment and survival. No significant financial relationships to disclose.
Patient-reported outcome (PRO)-assessed clinical benefit with panitumumab (Pmab) in metastatic colorectal cancer (mCRC) patients (pts)
Authors: Hendlisz A. , Van Cutsem E. , Peeters M. , Humblet Y. , Neyns B. , Sobrero A. , Devercelli G. , Wolf M. , Amado R. G. , Siena S. 
Published: March 2020

6560 Background: In a phase III study of mCRC pts, Pmab monotherapy significantly improved partial response (PR) rates and progression-free survival (PFS) compared with best supportive care (BSC). This analysis characterizes the clinical benefit of PR/stable disease (SD) and PFS in mCRC pts with respect to health-related quality of life (HRQoL) and CRC symptoms. Methods: Pts had documented disease progression (DP) after treatment (tx) with fluoropyrimidine-, irinotecan-, and oxaliplatin- containing chemotherapy regimens. Pts were randomized 1:1 to receive BSC + Pmab 6mg/kg Q2W. HRQoL (EQ-5D and EORTC QLQ-C30 Global QoL subscale) and CRC symptoms (NCCN/FACT CRC symptom index, FCSI) were assessed at baseline, at least Q4W during tx, and at the 30 day safety follow-up visit. Only pts with PFS ≥ 56 days were included in the analysis to minimize potential lead-time bias associated with response evaluation. T-tests and least square estimates were calculated for differences in PRO measures at 4, 8, 12, 16, and 20 weeks controlling for baseline score by best response (PR or SD vs. other) and by tx arm. Imputation of missing data incorporated each pt's rate of change to assign missing values. Results: In the Pmab arm (n=231), 36% of pts had PR or SD; in the BSC arm (n=232) 10% of pts had SD (no PRs). 109 Pmab pts and 63 BSC pts had at least 1 post-baseline PRO assessment and a PFS time ≥ 56 days. In the Pmab arm, pts with a best response of PR or SD (n=73) had significantly higher mean HRQoL scores at all 5 time points (indicating better HRQoL) compared to those with a best response of < SD (n=36, p=0.03). Consistent results were observed between pts with a best response of PR/SD and CRC symptom scores (p=0.002), indicating less CRC symptomatology. However, in the BSC arm, pts with SD (n=20) had no significant differences in HRQoL or CRC symptoms at any time point compared to pts with < SD (n=43, p=0.12). Results were consistent across all instruments and imputation methods used. Conclusions: These findings show that among Pmab pts with PFS ≥ 56 days, those who had a best response of PR or SD experience significantly higher HRQoL and less CRC symptomatology than Pmab pts without a response. These data suggest that delaying DP may result in clinical benefit. [Table: see text]
Screening and genetic counseling practices for hereditary non-polyposis colorectal cancer (HNPCC)
Authors: Karri S. , Govindarajan S. R. , Bendure W. B. , Jackson S. A. , McKelvey K. D. , Govindarajan R. 
Published: March 2020

6564 Background: HNPCC, the most common cause of hereditary colorectal cancer (CRC), is inherited in an autosomal dominant fashion and caused by micro satellite instability and mutations in mismatch repair genes. Affected patients (pts) and first degree relatives tend to develop colonic and extra colonic tumors that need to be tested for the mutations. Genetic consultation (GC) should be routinely offered to the affected pts and relatives. To assess the utilization of GC, we assessed the frequency of referral for GC for the presence of HNPCC syndrome at our medical center. Methods: Patients with CRC were identified from the tumor registry at the University of Arkansas for Medical Sciences (UAMS) and the Central Arkansas Veterans Healthcare System (CAVHS) from January 1st 2000 to September, 2006. Pts’ charts were reviewed for synchronous or metachronous HNPCC tumors and family history (FH). FH was categorized as positive according to the Bethesda criteria (BC, 2000–2002), revised Bethesda criteria (RBC, 2003–2006), negative (documented FH but no h/o cancer) or inadequate documentation. Percentage of pts with positive FH for HNPCC syndrome and those with CRC less than 50 years of age (for pts diagnosed 2003–2006) who were referred for GC was calculated. The list of these pts was cross referenced to the list in genetics clinic at UAMS and CAVHS. Results: 858 patient charts were reviewed. Table 1 shows the number of pts meeting criteria for genetic counseling. 138 (16%) pts had inadequate /no documented FH. Of the 720 pts with documented FH, 67 (9.3%) had positive FH and 126(17%) met BC / RBC. Only 13 (10.3%) of 126 pts were referred for genetic counseling. The number of pts eligible for GC increased with inclusion of RBC. However, the percentage of eligible pts referred for GC was extremely low. Conclusions: FH is not adequately documented in many pts presenting with CRC. Only a small percentage of pts who qualify for GC are referred. Education of health care providers for referral to genetics counseling is warranted. No significant financial relationships to disclose. [Table: see text]