Daniel M. Frendl

Lack of Impact of Paramedic Training and Use of the Cincinnati Prehospital Stroke Scale on Stroke Patient Identification and On-Scene Time

Background and Purpose— The Cincinnati Prehospital Stroke Scale (CPSS) is recommended for emergency medical services use in identifying patients with stroke. Data evaluating its performance in the field are limited. We assessed the impact of training and use of the CPSS on the accuracy of paramedics’ stroke patient identification and on-scene time. Methods— A 1-hour interactive educational presentation on the use of the CPSS was conducted for paramedics transporting patients to an academic medical center. Patients with stroke/transient ischemic attack (TIA) were identified retrospectively from paramedic records and were compared with the hospital’s prospective stroke registry for the year before and after the training. Results— There were 154 patients with suspected stroke/transient ischemic attack identified (56% women, 53% white, 44% black, mean age 67±16 years). There was no difference in paramedics’ use of the CPSS (37.5% versus 23.8%, P=0.123) or accuracy of stroke/TIA patient identification (40.5% versus 38.9%, P=0.859) before and after training. Of responsive patients identified by paramedics as having a stroke/TIA, 57% had an abnormality in at least one CPSS item with no effect on on-scene time (17±6 minutes with a normal versus 18±6 minutes with an abnormal CPSS, P=0.492). Those with a final diagnosis of stroke/TIA (n=61, 40%) more frequently had at least one abnormal CPSS item (70% versus 30%, P=0.008, sensitivity 0.71, specificity 0.52) with 49% of patients with an abnormality having a discharge diagnosis of stroke/TIA. Conclusions— Paramedic training in the CPSS, or its use, had no impact on the accuracy of their identification of patients with stroke/TIA or on-scene time.

Patient-reported functional health and well-being outcomes with drug therapy: a systematic review of randomized trials using the SF-36 health survey.

Objectives:To evaluate the responsiveness of the SF-36 Health Survey in drug trials and to determine how often clinically efficacious treatments produce meaningful functional health changes across medical conditions. Research Design:We conducted a systematic review of randomized, double-blind, placebo-controlled drug trials published from 1995 to 2011 that documented results for primary clinical endpoints and SF-36 outcomes. PubMed and a database of SF-36 publications were searched. We evaluated responsiveness as concordance (both statistically significant or both nonsignificant) between primary clinical and SF-36 outcomes. To determine how often SF-36 physical and mental component summary (PCS, MCS) score changes were of meaningful magnitude, mean net of placebo changes with treatment were compared against the developer’s recommended 3-point threshold for a minimal important difference (MID) across groups of medical conditions. Results:Of 805 screened trials, 185 met eligibility criteria. Primary clinical and SF-36 outcomes were concordant in 151 trials (82%). Among clinically efficacious trials, 58% reported net mean SF-36 improvements ≥MID threshold; however, SF-36 changes were often modest (PCS IQR, 1.6–4.1; MCS IQR, 0.8–3.5). Variations in treatment impact were apparent across conditions. Clinically efficacious therapies for rheumatoid arthritis, psoriatic arthritis, and psoriasis consistently achieved the largest SF-36 improvements, with 87% exceeding MID, whereas no efficacious therapies for peripheral arterial disease or chronic obstructive pulmonary disease achieved MID threshold. Conclusions:The SF-36 responds to treatment impact, distinguishing drug therapies that, on average, produce meaningful functional health benefits. Overall, just over half of clinically efficacious trials report meaningful functional health improvements, and results vary widely by medical condition.

Assessing health-related quality of life in patients with benign non-toxic goitre

Health-related quality of life (HRQoL) assessments are increasingly used to evaluate treatment effects and to shape the delivery of value based care. Valid generic and disease specific tools are available for quantifying HRQoL in patients with non-toxic goitre. However, few studies have applied these validated instruments to assess HRQoL in patients with benign non-toxic goitre. Limited evidence suggests that patients with non-toxic goitre have HRQoL impairments in multiple HRQoL domains. While the HRQoL-impact of non-toxic goitre may be small relative to other severely disabling medical conditions, treatment is almost exclusively elected for HRQoL indications. Thus better quantification of HRQoL, particularly at better (or more favorable) levels where many patients score, is essential. Web and mobile technologies have eased the ability to deliver surveys to patients. Routine consideration of HRQoL provides the opportunity to monitor the impact of treatment on the outcomes most meaningful for patients and the opportunity to help shape the delivery of value based health care.

Impact of 2012 USPSTF Screening PSA Guideline Statement: Changes in Primary Care Provider Practice Patterns and Attitudes

Introduction: Prostate specific antigen use in prostate cancer screening has undergone significant changes since the 2012 release of the USPSTF (United States Preventive Services Task Force) guideline statement. The effect on specific primary care provider practice patterns and attitudes is not well characterized. We describe the impact of the USPSTF statement on prostate cancer screening practices, attitudes and knowledge among primary care providers. Methods: A survey composed of 25 questions was mailed electronically to approximately 350 primary care providers within a single academic health care system. Responses were recorded and could not be traced to the respondent. Results: A total of 73 primary care providers (21%) responded to the survey. Of the respondents 75% reported a change in prostate specific antigen screening practices resulting from the USPSTF recommendations and 35% reported a decrease in digital rectal examination use, although the latter test is not explicitly addressed in the guideline statement. A third of respondents believe that prostate specific antigen screening has “likely had no role” in the 2‐decade decline in prostate cancer mortality and 70% agree that prostate specific antigen screening may “impart more harm than good” to the patient. Despite these opinions, there was markedly greater concern for medicolegal consequences of a missed diagnosis compared to over diagnosis. Conclusions: The results of the survey, while limited to a single large academic center, show the impact of the USPSTF 2012 statement on physician attitudes and practice patterns. The results define the need for more educational opportunities for primary care providers regarding the USPSTF statement, American Urological Association guidelines and identification of patients appropriate for prostate specific antigen screening.

Clinical and policy perspectives on the adoption of active surveillance for low-risk prostate cancer

The past several decades have yielded many advances in the treatment of prostate cancer. The United States has witnessed a decline in the absolute number of deaths from prostate cancer during a period of increased screening for prostate-specific antigen (PSA) and improving treatment options. However, widespread PSA testing has also resulted in a shift in the type of tumor identified. Today, most newly diagnosed prostate cancers are low risk: low grade, nonpalpable, and confined to the prostate. An estimated 100,000 such low-risk cases are diagnosed annually. Particularly in older men, these tumors have a low probability of resulting in death, even in the absence of definitive treatment (surgery or radiation). For many patients with low-risk prostate cancer, primary definitive treatment may not maximize value in terms of promoting longevity or improving quality of life. To justify broad screening, and reduce overtreatment, it is essential to have value-based strategies for managing these cancers. Active surveillance has emerged as a management strategy for patients diagnosed with low-risk prostate cancer. It relies on routine monitoring of PSA levels, prostate biopsies, and physical examination, and reserves definitive treatment for individuals who demonstrate rapidly increasing PSA or tumor volume. Evidence is amassing, demonstrating that active surveillance with delayed intervention is noninferior and often preferable to primary definitive therapy for patients with low-risk tumors. Despite this evidence, and despite guidelines recommending the use of active surveillance, up to 90% of patients eligible for active surveillance still undergo primary definitive therapy. Growing concern regarding the overtreatment of large numbers of patients diagnosed with low-risk prostate cancer has led to recommendations for abandoning broad prostate cancer screening. In 2012, the US Preventive Services Task Force (USPSTF) officially recommended against PSA screening for the detection of prostate cancer, citing substantial rates of overdiagnosis, risk of harm from biopsy, and overtreatment of cancers that may never become symptomatic. However, simulation studies indicate that PSA screening may have contributed heavily to the gains in prostate cancer survival to date. The USPSTF’s controversial policy shift, in the long term, may lead to many men not receiving this sensitive screening test and may lead to missed opportunities for identifying and treating higher risk tumors that benefit from definitive treatment. The USPSTF’s emphasis on the overtreatment of prostate cancer highlights the need to adopt value-based management strategies, such as active surveillance, for the large number of patients who are diagnosed with low-risk prostate cancer. In this issue of Medical Care, Dr Kim and colleagues provide insight into prostate cancer specialists’ perceptions of active surveillance and potential explanations for why the majority of patients eligible for active surveillance still undergo primary definitive therapy. Dr Kim and colleagues report that although the vast majority of urologists and radiation oncologists believe that active surveillance is effective and underutilized, only a

Understanding temporal trends in medical costs associated with progression to metastatic prostate cancer

In an era when the controversy over prostate cancer screening and overtreatment of localized disease continues to unfold, it is easy to overlook the burden associated with advanced-stage prostate cancer. In 2016, there were still an estimated 26,120 deaths due to prostate cancer, which remains the sixth leading cause of cancer-related death in the United States. Clinical progression to metastatic disease poses a significant burden for the patients whom it affects. The vast majority of prostate cancer metastases are to the bone, and roughly half of the patients with bony metastases experience a fracture or spinal cord compression or require radiation or surgery for palliation. Quality of life significantly deteriorates for patients with metastases because of both the disease process itself and the morbidity associated with additional treatments. Metastasis also results in increased utilization of health care resources as patients undergo diagnostic workups and subsequent medical care. Although the duration of survival with metastatic disease has improved, patients with metastatic disease often require multiple therapies to delay prostate-specific death and to manage the morbidity of metastasis; this results in lasting increases in medical resource use. Recent randomized controlled trial data provide quality evidence showing that early definitive treatment of localized prostate cancer reduces the rate of metastatic disease by more than 50%. This demonstrates the effectiveness of early definitive interventions for combatting progression to metastatic disease. However, there is a concern that rates of advanced-stage and metastatic disease may rise in coming years. Prostate cancer screening rates have declined broadly since the US Preventive Services Task Force issued recommendations against prostate-specific antigen screening in 2012. Although the rates of advanced-stage prostate cancer have remained constant over the decade preceding 2013, data suggest that there may already be an evolving shift toward tumors being identified at later stages. The US Preventive Services Task Force recommendation against prostate cancer screening was heavily influenced by an emphasis on mortality as an outcome; the impact of reducing the morbidity and cost burden associated with metastatic disease was minimally addressed. This was partly due to a lack of quality data available at the time of guideline development on the epidemiology of metastasis and the benefit of treatment for reducing metastatic development. Two key data elements required for the equitable evaluation of the benefit of avoiding or delaying metastatic prostate cancer are the epidemiology of metastasis and the modern health care cost and resource utilization patterns associated with the development of metastasis. In this issue of Cancer, Li et al present a study of longitudinal medical cost and resource utilization patterns in the year before and after the development of metastatic prostate cancer in men initially diagnosed with localized disease between 2000 and 2011. The authors compare data from matched controls who did not develop metastases with the National Cancer Institute’s Surveillance, Epidemiology, and End Results cancer registry data linked to medical insurance claims from Medicare. Li et al report that overall, 7.1% of men initially diagnosed with localized prostate cancer in the Surveillance, Epidemiology, and End Results registry developed subsequent metastases over the 12-year follow-up period. On average, during the month of the diagnosis of metastatic disease, medical costs increased 5-fold over the premetastatic baseline cost and remained roughly twice the cost of prediagnosis care through 1 and 2 years of followup. Although medical resource use was equivalent in the 2 groups before the diagnosis of metastasis, during the month of the diagnosis of metastatic disease, there was a significant rise in medical resource utilization, with nearly half (48.6%) requiring inpatient admission, and the metastatic group remained twice as likely to be hospitalized as the controls for the duration of follow-up. For the group diagnosed with metastatic disease, the utilization of outpatient resources, including home health aides, skilled nursing facilities, and hospice, increased from roughly 19% of patients using 1 of these services

Predicting Other Cause Mortality Risk for Older Men with Localized Prostate Cancer: A Dissertation

Background: Overtreatment of localized prostate cancer (PCa) is a concern as many men die of other causes prior to experiencing a treatment benefit. This dissertation characterizes the need for assessing other cause mortality (OCM) risk in older men with PCa and informs efforts to identify patients most likely to benefit from definitive PCa treatment. Methods: Using the linked Surveillance Epidemiology and End Results-Medicare Health Outcomes Survey database, 2,931 men (mean age=75) newly diagnosed with clinical stage T1a-T3a PCa from 1998-2009 were identified. Survival analysis methods were used to compare observed 10-year OCM by primary treatment type. Age and health factors predictive of primary treatment type were assessed with multinomial logistic regression. Predicted mortality estimates from Social Security life tables (recommended for life expectancy evaluation) and two OCM risk estimation tools were compared to observed rates. An improved OCM prediction model was developed fitting Fine and Gray competing risks models for 10-year OCM with age, sociodemographic, comorbidity, activities of daily living, and patient-reported health data as predictors. The tools’ ability to discriminate between patients who died and those who did not was evaluated with Harrell’s c-index (range 0.5-1), which also guided new model selection. Results: Fifty-four percent of older men with localized PCa underwent radiotherapy while 13% underwent prostatectomy. Twenty-three percent of those treated with radiotherapy and 12% of those undergoing prostatectomy experienced OCM within 10 years of treatment and thus were considered overtreated. Health factors indicative of a shorter life expectancy (increased comorbidity, worse physical health, smoking) had little to no association with radiotherapy assignment but were significantly related to reductions in the likelihood of undergoing prostatectomy. Social Security life tables overestimated mortality risk and discriminated poorly between men who died and those who did not over 10 years (c-index=0.59). Existing OCM risk estimation tools were less likely to overestimate OCM rates and had limited but improved discrimination (c-index=0.64). A risk model developed with self-reported age, Charlson comorbidity index score, overall health (excellent-good/fair/poor), smoking, and marital status predictors had improved discrimination (c-index=0.70). Conclusions: Overtreatment of older men with PCa is primarily attributable to radiotherapy and may be reduced by pretreatment assessment of mortality-related health factors. This dissertation provides a prognostic model which utilizes a set of five self-reported characteristics that better identify patients likely to die of OCM within 10 years of diagnosis than age and comorbidity-based assessments alone.