Chemotherapy Consent Research Articles

Quality improvement outcomes in an academic practice participating in ASCO’s Quality Oncology Practice Initiative (QOPI).

206 Background: The ASCO QOPI is an instrument for community and academic practices to assess quality and adherence to guidelines in areas of treatment planning and goals, chemotherapy consent documentation, smoking cessation, symptom control, palliative care, and disease specific measures. Following data submission QOPI summary reports for the submitting practice and QOPI aggregate are available for review and comparison. Methods: The academic practice of Rhode Island Hospital Comprehensive Cancer Center has participated in QOPI since the fall of 2008. QOPI measure summary reports for our practice and comparison to the Academic Aggregate are reviewed by our physicians after each round of chart abstraction, measures are identified for improvement. Interventions include education on practice improvement and development of policy and procedures for implementation by our Quality Control Officer in compliance with hospital policies. Results: Presented is a summary of quality improvement interventions implemented. Additional areas of quality improvement have been identified based on QOPI data, and improvement plans are ongoing including treatment summaries for patient and primary care physicians, tools to assess patient emotional well being, documentation of family history and referral for genetic assessment. Conclusions: QOPI provides a platform for collection, analysis and comparison of quality measures. For the measures of formulating a pain plan the intervention was a reminder to document the plan. For the measure hospice enrollment, a reflection on our hospice enrollment has lead to an increase in referral to palliative care. The ASCO QOPI program is a tool for quality improvement, our Quality Control Officer was essential in implementation of our improvement projects. [Table: see text]

Driving performance improvement using ASCO’s Quality Oncology Practice Initiative (QOPI).

203 Background: Defining and quantifying quality care is a challenge for cancer care providers. Since 2007 St. Luke’s Mountain States Tumor Institute (MSTI) has been participating in QOPI and was one of 23 practices that received the inaugural QOPI Certification in June 2010. The goal of participation is to benchmark MSTI’s performance with oncology practices across the nation and identify areas for improvement that are recognized as national quality standards. Methods: After each round of QOPI data abstraction, physician and administrative leadership selected measures with the greatest opportunity for improvement. Monthly chart audits for each measure were completed and the results were shared with individual staff to increase education and accountability. In Spring 2010, the education assessment in MSTI’s Electronic Medical Record (EMR) was redesigned to facilitate efficient documentation and data collection of smoking cessation counseling. In July 2011, the performance improvement (PI) team created “Quality Checklists (QCL)” in MSTI’s EMR for three different QOPI measures: i) signed chemotherapy consent, ii) smoking cessation counseling, and iii) assessment of emotional well-being. To ensure signed chemotherapy consent, one QCL included a reminder sent by the primary nurse or secretary to the chemotherapy infusion nurses. To ensure smoking cessation counseling and assessment of emotional well-being by social work, the other QCL included an alert sent by the new patient representative to the primary nurse and social worker. Results: Signed chemotherapy consent improved from 10% (n=229) in 2007 to 100% (n=117) in 2012. Smoking cessation counseling improved from 13% (n=40) in 2007 to 93% (n=272) in 2012. Assessment of emotional well-being improved from 78% (n=302) in 2007 to 95% (n=120) in 2012. Of the patients that had problems with emotional well-being, 73% (n=55) in 2007 had their problems addressed and 95% (n=41) in 2012. Conclusions: QOPI has provided MSTI with the initiatives and benchmarks to quantify quality cancer care. By combining participation in QOPI and ongoing PI data collection, analysis, and action plan implementation MSTI has enjoyed marked improvements in quality.

Predictors of newly diagnosed cancer patients' understanding of the goals of their care at initiation of chemotherapy.

The American Society of Clinical Oncology Quality Oncology Practice Initiative endorses in their core measures that providers should discuss the goals of care (GOC) at the time of chemotherapy consent. GOC refers to chemotherapy treatment intent: cure versus noncure. In this study, the authors sought to determine whether attributes of patients and initial patient-physician encounters were associated with patients' understanding of their GOC. In total, the authors surveyed 125 consecutive, newly diagnosed patients who were receiving chemotherapy for solid malignancies at a single academic cancer center and performed a medical record review for additional data. Patient understanding of their oncologist's GOC and oncologist's reported GOC were compared. The primary outcome was concordance of patient-physician dyads regarding the GOC (cure vs noncure). One hundred twenty-five of 137 of eligible patients (91%) completed the survey. Only 95 of 125 patient-physician pairs (75%) patient-physician pairs were concordant regarding the GOC. In a multivariable logistic regression, both older patients (odds ratio, 0.21; 95% confidence interval, 0.08-0.57) and non-native English speakers had an almost 80% lower odds (odds ratio, 0.23; 95% confidence interval, 0.05-0.93) of GOC concordance compared with younger patients and native English speakers. Patients who received printed chemotherapy information during the patient-physician consent process had almost 3 times greater odds (odds ratio, 2.88; 95% confidence interval, 1.24-6.68) of GOC concordance with their physician compared with those who did not receive materials. Patient misunderstanding of GOC was substantial, with 25% of cancer patients misunderstanding the goal of their chemotherapy treatment. Key predictors of GOC misunderstanding included factors that potentially were amenable to interventions at the time of chemotherapy consent.

An overview of breast medical oncology documentation through the Florida Initiative on Quality Cancer Care (FIQCC): The Phase II 2009 results.

73 Background: Following feedback provided to each site of their 2006 compliance results and enactment of improvement plans, the FIQCC re-evaluated the quality of documentation of specific quality indicators for breast cancer in the medical records of 11 participating FIQCC sites in 2009. Quality indicators were based upon ASCO, ACOS, NCCN, and expert-consensus panel recommendations. The findings were compared with 2006 results. Methods: Chart reviews from the same 2006 FIQCC sites for pre-specified Breast Medical Oncology quality indicators were performed by trained abstractors on patients first seen in 2009. The indicators included: clinical trial decisions, consent for treatment, definitive surgery after neo-adjuvant chemotherapy, published regimen dose plan, and chemotherapy selected from a published list. Statistical comparisons of 2006 and 2009 data were performed using the Pearson chi-square exact test based on Monte Carlo estimation. Results: 636 pts (99% female) [average age of 60.7 years (range 24-94)] were evaluated, with the 2009 number of cases per site ranging from 59 to 97. Significant improvements in treatment planning and administration were seen over time when comparing 2006 (n=602) to 2009 charts. This included signed chemotherapy consent (2006: 74%; 2009: 81% p=0.047), definitive surgery after neo-adjuvant chemotherapy (2006: 88%; 2009:100% p=0.017), and the planned dose being from a published list (2006: 74%;200: 84% p=0.020). Strides were also made in documenting that patients were evaluated for clinical trial enrollment (2006:13%; 2009: 21% p=0.001). Declines were seen in chemotherapy selections from an approved list (2006:94%; 2009: 82% p<0.001). Further investigations into this finding are underway and will be presented at the meeting. Conclusions: With the adoption of specific quality indicators, evaluation of a specified number of cases across multiple practices, and then providing feedback on documentation to providers and medical teams, here we demonstrate that significant improvements in medical charting and thus quality cancer care can be made.

Intensive Treatment in Elderly AML Patients Induce Prolonged Survival and Disease Remission If Early Mortality Is Prevented: The Case Record of the San Raffaele Scientific Institute

Abstract 4583 Background:the outcome of pts older than 65 with AML is dismal because of the unfavourable characteristics of the disease and the frequent co-morbidities. Intensive chemotherapeutic programs, with or without haematopoietic stem cells transplantation (HSCT), are not usually offered to these pts since they are considered too toxic. If treated with intensive therapeutic programs these pts show initial complete remission (CR) rates around 45% to 55% and 2 years survival of 10–20%. Since 2001 in our institution we have systematically screened AML elderly patients older than 65 yrs for comorbidites and offered to “fit” AML elderly pts an intensive approach aimed at curing the disease. In this single-center retrospective study we describe the outcome of this court of pts. Aim:to evaluate toxicity and survival after intensive treatments in an homogeneous court of AML pts older than 65. Methods:from 10/2001 to 3/2011 we treated 60 pts older than 65, median age 70 (66–77), 30 pts ≤70 yrs (median 68, 66–70), and 30 pts >70 (median 73, 71–77). Among AML pts older than 65 years old we considered eligible for intensive chemotherapy those with PS (ECOG) ≤ 2, renal, hepatic and cardiac function parameters within normal ranges. All pts signed informed consent for intensive chemotherapy. Diagnosis (WHO): 33 AML with MDS related changes, 4 AML with minimal differentiation, 6 AML w/o maturation, 8 AML with maturation, 5 AMML, 1 erythrolaeukemia, 1 AML with mutated NPM1, 2 t-AML. Cytogenetics: 43 intermediate risk (33 with normal karytotype), 10 high risk (7 complex, 3 with Monosomal Karyotype), 2 good risk, 5 not evaluable. Induction with one or two of the following chemo cycles was administered to each patient: FLAG-IDA (fludarabine + cytarabine + idarubicin) or 3–7 (cytarabine + daunorubicin, idarubicin or mitoxantrone), high-dose cytarabine (HiDAC). Post-remission treatment: chemotherapy (CHT) 1 patient, HiDAC 12 pts, autologous transplantation (AUTO) 14 pts, allogeneic transplantation (ALLO) 2 pts. Results:overall induction related mortality was 18.3%, 7% in pts ≤70 yrs, 30% in 30 pts >70 p=0.041, CR rate was 57% (34 pts), 73% in pts ≤70 yrs, 40% in pts >70 p=0.018. Relapse rate was 73.5% (25 pts), 68% pts ≤70 yrs, 83% in pts >70. Median OS was 386 days, 2 and 5 yrs OS was 38 and 19%, respectively, median DFS was 397 days and 2 yrs DFS was 22%. In pts ≤70 and >70 yrs, median OS and DFS were 574 and 313, 397 and 425 days, respectively, p=ns, 2 and 5 yrs OS was 41% and 27%, 30% and 8%, 2 yrs DFS 27% and 17%, respectively, p=ns. OS of pts who obtained the CR after induction: median 1155 and 790 days for pts ≤70 and >70 yrs, respectively, p=ns, 2 yrs OS 51% and 58%, respectively, p=ns. Conclusions:our data suggest that prolonged survival can be achieved in elderly AML who are fit to receive intensive chemotherapy. Data on mortality and remission induction are very promising in pts 66–70 yrs old, whereas early death is an important cause of treatment failure in older pts (>70), together with disease relapse. However, also older pts, with a median age of 73, who obtain the CR can reach a survival plateau at 2 yrs. Overall, these results i) indicate that selection of elderly AML pts for treatment assignment should be refined by the development of new tools for oncologic-geriatric assessment rather than by PS and vital organ function evaluation ii) prompt to design of prospective trials addressing the role of intensive regimens and transplantation programs in “fit” elderly AML pts. Disclosures:No relevant conflicts of interest to declare.

Predictors of patient misunderstanding of the goals of care at initiation of chemotherapy.

9038 Background: All patients should be apprised of the risks of treatment before starting chemotherapy. According to the ASCO QOPI core measures, providers should also discuss the associated goals of care (GOC) at the time of consent discussion. We sought to determine if attributes of patients and initial patient-MD encounters were associated with subsequent patient-MD concordance regarding GOC. Methods: At a single academic medical center, we surveyed 137 consecutive patients within 30 days of their consent for first chemotherapy to assess their understanding of the GOC (i.e., curative vs. non-curative). The patients had solid tumors and represented all stages of disease. The survey was designed to assess patient understanding of the GOC and to measure several areas that are plausibly relevant to this understanding. We compared this to the GOC documented by their treating oncologists in the institution's chemotherapy order entry system (required). Results: The survey response rate was 91% (125/137). Using the MD GOC as the gold- standard, we found that only 76% (95/125) of patient-MD pairs were concordant regarding the GOC; 16% (20/125) of patients erroneously believed their GOC was curative; and 8% (10/125) erroneously believed their GOC was not curative. In a multivariable logistic regression that controlled for patient demographics and other patient factors, we found that patients greater than 65 years of age had an almost 80% lower odds (OR 0.21, 95% CI: 0.08-0.55) of concordance compared to younger patients; that patients for whom English was not their native language also had an almost 80% lower odds (OR 0.22, 95% CI: 0.05-0.93) of concordance compared to native English speakers; and that patients who received printed materials during the patient-MD consent process had almost three times higher odds (OR 2.97, 95% CI: 1.13-7.79) of concordance compared to those not receiving such materials. Conclusions: Patient misunderstanding of MD's GOC was substantial. Key predictors of discordance included factors potentially amenable to interventions at the time of patient chemotherapy consent including provision of printed material and use of communication aids targeted at elderly and non-native English speaking patients. No significant financial relationships to disclose.

Void for Vagueness

“What would happen if the informed consent process were truly seen as an opportunity for optimizing decision making?” This excellent question appeared recently in this journal in an editorial by Rao and Kim,1 commenting on an article in which Arnold et al2 described a web-based tool for improving such decision making. Although there is certainly substantial room for improvement in obtaining informed consent in the face of complicated clinical decisions, those problems can be simple compared with the dilemma of doing a similarly good job in obtaining consent to participate in a clinical trial. Unlike a patient, who at least is under legal and ethical protections requiring the doctor to keep their well-being as the first priority, no such protection exists for the research subject. To the contrary, a research subject is under a watered-down set of protections. In research, to further the goal of answering a research question, the doctor is authorized to do a variety of things that may not advance the subject’s well-being and may in fact be substantially antithetical to that well-being. Article see p 151 It is for this reason that consent in the research setting bears such a great weight on its shoulders. Perhaps we should refer to it, in comparison to clinical consent, as a beefed-up consent, or consent on steroids. It is largely the fact that the subject has agreed to this weakened set of protections that makes research ethical. This key concept was recognized even in the early days of research ethics. In the landmark Nuremberg Code,3 more than half a century old, only 1 of its 10 paragraphs is more than a couple of sentences long. That single much longer paragraph, the very first, highlights the huge importance of informed consent in research. The very first words …

Medical Oncology Breast Cancer Quality Indicators: Adherence by the Florida Initiative for Quality Cancer Care (FIQCC) Consortium.

Abstract Background: The Florida Initiative for Quality Cancer Care (FIQCC) is comprised of 11 practice sites across the state that participate in a comprehensive review of quality of care specific to cancer patients across many disease sites. Quality indicators were scripted based on accepted QOPI, NCCN, ACOS, and site-specific PI panel consensus indicators for breast cancer (BRCA) patients. An evaluation was performed to assess adherence to the performance indicators across sites within the FIQCC.Methods: Comprehensive chart reviews were conducted for all patients with BRCA first seen in 2006 by a medical oncologist at one of the 11 FIQCC sites (3 academic/8 community). Quality measures included: 1) documentation of menopausal status; 2) documentation of receptor status in the chart and evidence that it guided treatment recommendations accordingly; 3) documentation that consent for chemotherapy was obtained; 4) documentation of the planned chemotherapy regimen; and 5) documentation that chemotherapy started within 8 weeks of surgery. A pilot measure included: 6) documentation of fertility preservation being addressed in pre-menopausal women. Pearson's Chi-square test was used to test variability on the quality measurements across practice sites.Results: Charts of 622 patients (99% female), median age of 60 years (range 22-95) were reviewed. Menopausal status was documented in 49% (307/622). Documentation of the receptor status (ER/PR/ Her2Neu) was excellent, 99% (532/537). For those with ER/PR positive, non-metastatic disease measuring at least 1cm, 98% (432/441) were considered for an aromatase inhibitor or tamoxifen within one year of diagnosis. For patients with Stage II-III BRCA with over-expression of Her2Neu (H2N), consideration or administration of trastuzumab was documented in 82% (95/116). With respect to chemotherapy, there was documentation of consent in 75% (247/330), planned chemotherapy regimen in 75% (226/302), and initiation of chemotherapy with 8 weeks of surgery in 84% (233/279). Fertility preservation was only addressed in 11% (10/88) of patients who were documented as pre-menopausal. A statistically significant difference (p< 0.05) across the sites was found for all quality indicators above, except two: documentation of consideration or administration of trastuzumab and discussions of fertility preservation.Discussion: The FIQCC allows for the identification of the need for quality improvements in multiple aspects of breast cancer care. Findings based on 2006 cases identified need for improvements in documentation and consenting for chemotherapy, reporting of menopausal status, consideration and administration of trastuzumab, and consideration of fertility counseling. These findings are now being used at the participating institutions to guide quality improvement efforts. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1078.

Informed Consent for Chemotherapy: ASCO Member Resources.

Consent to treatment is an important part of the delivery of quality cancer care. Physician practices that participate in ASCO’s Quality Oncology Practice Initiative (QOPI) and others expressed interest in having ASCO provide informed consent resources, and indicated that they would be more likely to use a consent form for chemotherapy if ASCO provided a template. Recent Journal of Oncology Practice articles outlining unique factors in consent for chemotherapy, documentation issues, and malpractice concerns also raised member interest. In response, members of ASCO’s Ethics and Quality of Care Committees formed a joint working group to design a consent form template and other resources that provide a framework for consent conversations between oncologists and patients receiving chemotherapy.

Documenting Informed Consent for Chemotherapy.

Documenting Informed Consent for Chemotherapy.

Using an interactive CD-ROM to gain informed consent for chemotherapy: Attempting to improve patient anxiety and depression during treatment

17071 Background: In a previous study, we found that an interactive CD-ROM did not adequately improve patients’ recall of chemotherapy treatment information compared to standard written information enough to warrant changes to the consent procedure. However, we further investigated whether this alternative mode of information delivery helped improve patients’ anxiety and depression over the treatment phase. Methods: Ninety-eight new patients about to commence chemotherapy were randomized to receive written information or an interactive CD-ROM containing treatment information before giving informed consent. Patients’ anxiety and depression were assessed pre- treatment using the Hospital Anxiety and Depression Scale (HADS) and once again at their second chemotherapy session along with their recall of treatment related information. Seventy patients completed all assessments. Results: Results indicated that anxiety and depression levels of the current sample were greater than those of normative groups including general population and cancer samples. Between/within subjects ANOVAs revealed that anxiety did decrease over the first phase of patients’ treatment (p = .001), but that written and CD-ROM groups did not differ in that increase (p = .99). Alternatively, depression scores increased during treatment but not significantly (p = .58) and once again, scores did not differ between the two information groups (p = .64). Conclusions: Given the results of some additional correlational analyses it appears that anxiety and depression scores are negatively associated with patients’ ability to recall and essentially understand aspects of treatment information given to them prior to chemotherapy. However, changing the mode of treatment information delivery does not appear to affect these psychological problems, and in turn, how they affect informed consent. No significant financial relationships to disclose.

Measuring Quality of Care in the Treatment of Colorectal Cancer: The Moffitt Quality Practice Initiative

The Moffitt Quality Practice Initiative (MQPI) is a practice-based system of quality self-assessment, the ultimate goal of which is to improve the quality of cancer care at a statewide level. The initial phase of this project focused on developing procedures, determining feasibility, and evaluating utility for assessing quality of care for colorectal cancer within an existing affiliate network. Representatives from four oncology groups selected quality measures consistent with evidence-, consensus-, and safety-based guidelines that could be abstracted from medical records. Trained abstractors then reviewed records of all eligible colorectal patients seen by each practice in 2004. Frequencies of responses for each indicator were tabulated for overall and practice-specific level of adherence and were compared among practices. Adherence was uniformly high for several indicators, including confirmatory pathology report, staging information, and chemotherapy discussion or recommendation. Lower adherence was evident across practices for performance of carcinoembryonic tests and complete colonoscopic evaluations. Significant variation among practices was evident only for consent for chemotherapy. The initial phase of MQPI demonstrated the feasibility and utility of assessing quality indicators for colorectal cancer among members of an existing affiliate network. Findings identified areas where adherence to care was uniformly high, but also identified areas where both overall and practice-specific adherence were less than optimal. These efforts lay the groundwork for expanding MQPI in several directions that have in common the potential to improve the quality of cancer care on a statewide basis.

Obtaining consent for chemotherapy

Purpose of the guideline Consent is a complex issue, which has received much attention of late, from both its medical and legal standpoints. This document sets out guidelines specifically addressing the issues which surround obtaining consent for the administration of chemotherapy in the haemato-oncology setting, although most of the points considered are of relevance in all the other areas involving patient treatment where consent must be sought.

A Process for Measuring the Quality of Cancer Care: The Quality Oncology Practice Initiative

The Quality Oncology Practice Initiative (QOPI) is a practice-based system of quality self-assessment sponsored by the participants and the American Society of Clinical Oncology (ASCO). The process of quality evaluation, development of the pilot questionnaire, and preliminary results are reported. Physicians from seven oncology groups developed medical record abstraction measures based on practice guidelines and consensus-supported indicators of quality care. Each practice completed two rounds of records review and received practice and aggregate results. Mean frequencies of responses for each indicator were compared among practices. Participants universally, if informally, find QOPI helpful, and results show statistically significant variation among practices for several indicators, including assessing pain in patients close to death, documentation of informed consent for chemotherapy, and concordance with granulocytic and erythroid growth factor administration guidelines. Measures with universally high concordance include the use of serotonin antagonist antiemetics according to the ASCO guideline; the presence of a pathology report in the record; the use of chemotherapy flow sheets; and adherence to standard chemotherapy recommendations for patients with certain stages of breast, colon, and rectal cancer. Concordance with quality indicators significantly changed between survey rounds for several measures. Pilot results indicate that the QOPI process provides a rapid and objective measurement of practice quality that allows comparisons among practices and over time. It also provides a mechanism for measuring concordance with published guidelines. Most importantly, it provides a tool for practice self-examination that can promote excellence in cancer care.

The Quality Oncology Practice Initiative (QOPI): Understanding and improving “Best Practices” by a community of oncologists

6023 Background: One goal of the QOPI project is to provide tools for practitioners to implement “best practices.” In an effort to provide comparative data regarding best practices, QOPI has developed a set of evidence and consensus-based measures. Concordance is assessed through a structured chart review that allows numeric scoring and generation of practice reports. Results can be compared over time and among practices. Methods: 23 practices of various sizes from across the U.S. were invited to participate. Measures relate to ASCO practice guidelines, national standards, or expert consensus. 2,410 charts have been abstracted to date. Observations and comparisons among groups are analyzed by construction of 95% confidence intervals (CI). Conclusions: We observed a clinically meaningful and statistically significant variation in achieving quality measures in oncology practices. The QOPI process provides a mechanism for documenting concordance with quality measures, testing interventions and documenting improvement. Measure N Mean %Yes 95% CI Lowest Ob- served Value Highest Ob- served Value Was pain addressed on the visit prior to death? 394 65.0% 55–75% 15.0% 92.9% Were granulocytic growth factors given per guideline? 203 30.6% 34–50% 0% 100% Were serotonin antagonist antiemetics given per guideline? 1160 97.0% 96–98% 84.1% 100% Were corticosteroids added per guideline? 1102 97.9% 97–99% 90.3% 100% Were erythroid growth factors given per guideline? 824 72.7% 68–77% 36.7% 94.7% Was a pathology report available in the chart? 2410 97.1% 96–98% 88.2 % 100% Was staging completed prior to definitive therapy? 2159 96.1% 94–98% 70.2% 100% Were flow sheets used when chemotherapy was given? 1997 99.8% 99–100% 97.3% 100% Was a signed consent for non-protocol chemotherapy in the chart? 1997 39.5% 28–51% 0% 100% Was verbal consent for chemotherapy documented? 692 88.7% 80–96% 73.6% 100% Was adjuvant chemotherapy given to breast cancer patients per NICCQ specifications? 131 100% N/A N/A N/A Was adjuvant chemotherapy given to colorectal cancer patients per NICCQ specifications? 270 99.2% 99–100% 91.7% 100% No significant financial relationships to disclose.

Informed consent for investigational chemotherapy: patients' and physicians' perceptions.

One hundred forty-four patients and 68 physicians at three cancer centers were studied for their perceptions of the consent procedure, in which they participated one to three weeks earlier, for chemotherapy by one of 65 investigational protocols. Patients recalled the procedure positively and relied heavily on physician's advice. They felt most physicians wanted them to accept; 29% felt their participation in the decision was not encouraged. Primary reasons for accepting were trust in the physician, belief the treatment would help, and fear the disease (viewed as highly serious) would get worse without it. Nearly a fourth did not recall the information given that treatment was investigational. The consent form played no role in decision-making for 69%. Physicians believed therapeutic benefits would exceed potential problems for most patients; they viewed 41% of the patients as less than eager for details of treatment, a third as avoiding the seriousness of the discussion, and a third as passive in decision-making. The perceptual set of both parties places inadvertent constraint on patients' autonomy in decision making.