Phase 1 dose-escalation study of a novel oral PI3K/mTOR dual inhibitor, LY3023414, in patients with cancer.

LY3023414 is an oral, selective adenosine triphosphate-competitive inhibitor of class I phosphatidylinositol 3-kinase isoforms, mammalian target of rapamycin, and DNA-protein kinase in clinical development. We report results of a 3 + 3 dose-escalation Phase 1 study for twice-daily (BID) dosing of LY3023414 monotherapy in Japanese patients with advanced malignancies. The primary objective was to evaluate tolerability and safety of LY3023414. Secondary objectives were to evaluate pharmacokinetics and to explore antitumor activity. A total of 12 patients were enrolled and received 150 mg (n = 3) or 200 mg (n = 9) LY3023414 BID. Dose-limiting toxicities were only reported at 200 mg LY3023414 for 2 patients with Grade 3 stomatitis. Common treatment-related adverse events (AEs) across both the dose levels included stomatitis (75.0%), nausea (66.7%), decreased appetite (58.3%), diarrhea, and decreased platelet count (41.7%), and they were mostly mild or moderate in severity. Related AEs Grade ≥ 3 reported for ≥1 patient included anemia, stomatitis, hypophosphatemia, and hyperglycemia (n = 2, 16.7%). Two patients discontinued due to AEs (interstitial lung disease and stomatitis). No fatal events were reported. The pharmacokinetic profile of LY3023414 was characterized by rapid absorption and elimination. Five patients had a best overall response of stable disease (150 mg, n = 3; 200 mg, n = 2) for a 55.6% disease control rate. LY3023414 up to 200 mg BID is tolerable and safe in Japanese patients with advanced malignancies.

Correction to: Phase 1 dose-escalation study of a novel oral PI3K/mTOR dual inhibitor, LY3023414, in patients with cancer.

The article Phase 1 dose-escalation study of a novel oral PI3K/mTOR dual inhibitor, LY3023414, in patients with cancer, written by Shunsuke Kondo, Masaomi Tajimi, Tomohiko Funai, Koichi Inoue, Hiroya Asou, Vinay Kumar Ranka, Volker Wacheck, Toshihiko Doi, was originally published electronically on the publisher's internet portal on 23 June 2020 without open access.

Incident Reporting to Improve Patient Safety: The Effects of Process Variance on Pediatric Patient Safety in the Emergency Department.

OBJECTIVE: Medical errors threaten patient safety, especially in the pediatric emergency department (ED) where overcrowding, multiple handoffs, and workflow interruptions are common. Errors related to process variance involve situations that are not consistent with standard ED operations or routine patient care. SETTING/PARTICIPANTS: We performed a planned subanalysis of the Pediatric Emergency Care Applied Research Network incident reporting data classified as process variance events. Confidential deidentified incident reports (IRs) were collected and classified by 2 independent investigators. Events categorized as process variance were then subtyped for severity and contributing factors. Data were analyzed using descriptive statistics. OUTCOME MEASURES: The study intention was to describe and measure reported medical errors related to process variance in 17 EDs in the Pediatric Emergency Care Applied Research Network from 2007 to 2008. RESULTS: Between July 2007 and June 2008, 2906 eligible reports were reviewed. Process variance events were identified in 15.4% (447/2906). The majority were related to patient flow (35.4%), handoff communication (17.2%), and patient identification errors (15.9%). Most staff involved included nurses (47.9%) and physicians (28%); trainees were infrequently reported. The majority of events did not result in harm (65.7%); 17.9% (80/447) of cases were classified as unsafe conditions but did not reach the patient. Temporary harm requiring further treatment or hospitalization was reported in 5.6% (25/447). No events resulted in permanent harm, near death, or death. Contributing factors included human factors (92.1%), in particular handoff communication, interpersonal skills, and compliance with established procedures, and system-level errors (18.1%), including unclear or unavailable policies and inadequate staffing levels. CONCLUSIONS: Although process variance events accounted for approximately 1 in 6 reported safety events, very few led to patient harm. Because human and system-level factors contributed to most of these events, our data provide an insight into potential areas for further investigation and improvements to mitigate errors in the ED setting.

Radiologic Safety Events Within a Pediatric Emergency Medicine Network.

OBJECTIVES: The aim of this study was to describe the epidemiology of radiologic safety events using an analysis of deidentified incident reports (IRs) collected within a large multicenter pediatric emergency medicine network. METHODS: This study is a report of a planned subanalysis of IRs that were classified as radiologic events. The parent study was performed in the PECARN (Pediatric Emergency Care Applied Research Network). Incident reports involving radiology were classified into subtypes: delay in test, delay in results, misread or changed reading, wrong patient, wrong site, or other. The severity of radiology-related incidents was characterized. Contributing factors were identified and classified as environmental, equipment, human (employee), information technology systems, parent or guardian, or systems based. RESULTS: Two hundred three (7.0%) of the 2906 IRs submitted during the study period involved radiology. Eighteen of the hospitals submitted at least 1 IR and 15 of these hospitals reported at least 1 radiologic event. The most common type of radiologic event was misread/changed reading, which accounted for over half of all IRs (50.3%). Human factors were the most frequent contributing factor identified and accounted for 67.6% of all factors. The severity of events ranged from unsafe conditions to events with temporary harm that required hospitalization. CONCLUSIONS: We described the epidemiology of radiology-related IRs from a large multicenter pediatric emergency research network. The study identified specific themes regarding types of radiologic errors, including the systems issues and the contributing factors associated with those errors. Results from this analysis may help identify effective intervention strategies to ameliorate the frequency of radiology-related safety events in the emergency department setting.

The Pediatric Risk of Mortality Score: Update 2015.

OBJECTIVES: Severity of illness measures have long been used in pediatric critical care. The Pediatric Risk of Mortality is a physiologically based score used to quantify physiologic status, and when combined with other independent variables, it can compute expected mortality risk and expected morbidity risk. Although the physiologic ranges for the Pediatric Risk of Mortality variables have not changed, recent Pediatric Risk of Mortality data collection improvements have been made to adapt to new practice patterns, minimize bias, and reduce potential sources of error. These include changing the outcome to hospital survival/death for the first PICU admission only, shortening the data collection period and altering the Pediatric Risk of Mortality data collection period for patients admitted for "optimizing" care before cardiac surgery or interventional catheterization. This analysis incorporates those changes, assesses the potential for Pediatric Risk of Mortality physiologic variable subcategories to improve score performance, and recalibrates the Pediatric Risk of Mortality score, placing the algorithms (Pediatric Risk of Mortality IV) in the public domain. DESIGN: Prospective cohort study from December 4, 2011, to April 7, 2013. MEASUREMENTS AND MAIN RESULTS: Among 10,078 admissions, the unadjusted mortality rate was 2.7% (site range, 1.3-5.0%). Data were divided into derivation (75%) and validation (25%) sets. The new Pediatric Risk of Mortality prediction algorithm (Pediatric Risk of Mortality IV) includes the same Pediatric Risk of Mortality physiologic variable ranges with the subcategories of neurologic and nonneurologic Pediatric Risk of Mortality scores, age, admission source, cardiopulmonary arrest within 24 hours before admission, cancer, and low-risk systems of primary dysfunction. The area under the receiver operating characteristic curve for the development and validation sets was 0.88 ± 0.013 and 0.90 ± 0.018, respectively. The Hosmer-Lemeshow goodness of fit statistics indicated adequate model fit for both the development (p = 0.39) and validation (p = 0.50) sets. CONCLUSIONS: The new Pediatric Risk of Mortality data collection methods include significant improvements that minimize the potential for bias and errors, and the new Pediatric Risk of Mortality IV algorithm for survival and death has excellent prediction performance.

Limiting and Withdrawing Life Support in the PICU: For Whom Are These Options Discussed?

OBJECTIVES: Most deaths in U.S. PICUs occur after a decision has been made to limitation or withdrawal of life support. The objective of this study was to describe the clinical characteristics and outcomes of children whose families discussed limitation or withdrawal of life support with clinicians during their child's PICU stay and to determine the factors associated with limitation or withdrawal of life support discussions. DESIGN: Secondary analysis of data prospectively collected from a random sample of children admitted to PICUs affiliated with the Collaborative Pediatric Critical Care Research Network between December 4, 2011, and April 7, 2013. SETTING: Seven clinical sites affiliated with the Collaborative Pediatric Critical Care Research Network. PATIENTS: Ten thousand seventy-eight children less than 18 years old, admitted to a PICU, and not moribund at admission. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Families of 248 children (2.5%) discussed limitation or withdrawal of life support with clinicians. By using a multivariate logistic model, we found that PICU admission age less than 14 days, reduced functional status prior to hospital admission, primary diagnosis of cancer, recent catastrophic event, emergent PICU admission, greater physiologic instability, and government insurance were independently associated with higher likelihood of discussing limitation or withdrawal of life support. Black race, primary diagnosis of neurologic illness, and postoperative status were independently associated with lower likelihood of discussing limitation or withdrawal of life support. Clinical site was also independently associated with likelihood of limitation or withdrawal of life support discussions. One hundred seventy-three children (69.8%) whose families discussed limitation or withdrawal of life support died during their hospitalization; of these, 166 (96.0%) died in the PICU and 149 (86.1%) after limitation or withdrawal of life support was performed. Of those who survived, 40 children (53.4%) were discharged with severe or very severe functional abnormalities, and 15 (20%) with coma/vegetative state. CONCLUSIONS: Clinical factors reflecting type and severity of illness, sociodemographics, and institutional practices may influence whether limitation or withdrawal of life support is discussed with families of PICU patients. Most children whose families discuss limitation or withdrawal of life support die during their PICU stay; survivors often have substantial disabilities.

Laboratory Errors in a Pediatric Emergency Department Network: An Analysis of Incident Reports.

OBJECTIVES: To describe the types and severity of reported laboratory errors in pediatric emergency departments. METHODS: Retrospective review of incident reports classified as laboratory errors from July 2007 to June 2008 within the Pediatric Emergency Care Applied Research Network. Laboratory testing errors recorded included: delayed results or lost specimen, unlabeled specimens, wrong patient, failure to label specimen correctly, and other. The severity of laboratory-related incidents was characterized using the National Coordinating Council for Medication Error Reporting and Prevention severity classification system. Contributing factors were classified as environmental, equipment, human (employee), information technology systems, parent or guardian, or systems-based. RESULTS: A total of 335 (42.2%) laboratory reports were related to events in the preanalytic phase. Involved staff personnel were identified in 345 of the reports (43.5%). Nurses were identified in 179 (22.6%) and physicians in 38 (4.8%). The majority of laboratory errors [408 (51.5%)] were not associated with harm; 138 (17.4%) patients were harmed by the error; 136 (98.6%) patients were temporarily harmed and required treatment, and 1 (0.7%) patient was hospitalized or had their hospitalization prolonged with the event. Human factors 657 (82.8%) were the most common contributing factor. CONCLUSIONS: Laboratory errors are a common cause of safety events in the pediatric ED. Most events are preanalytic and involve problems with specimens that are improperly collected, mislabeled, or lost. Although most events were not associated with harm, there is potential for significant injury.

Simultaneous Prediction of New Morbidity, Mortality, and Survival Without New Morbidity From Pediatric Intensive Care: A New Paradigm for Outcomes Assessment.

OBJECTIVES: Assessments of care including quality assessments adjusted for physiological status should include the development of new morbidities as well as mortalities. We hypothesized that morbidity, like mortality, is associated with physiological dysfunction and could be predicted simultaneously with mortality. DESIGN: Prospective cohort study from December 4, 2011, to April 7, 2013. SETTING: General and cardiac/cardiovascular PICUs at seven sites. PATIENTS: Randomly selected PICU patients from their first PICU admission. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 10,078 admissions, the unadjusted morbidity rates (measured with the Functional Status Scale and defined as an increase of ≥ 3 from preillness to hospital discharge) were 4.6% (site range, 2.6-7.7%) and unadjusted mortality rates were 2.7% (site range, 1.3-5.0%). Morbidity and mortality were significantly (p < 0.001) associated with physiological instability (measured with the Pediatric Risk of Mortality III score) in dichotomous (survival and death) and trichotomous (survival without new morbidity, survival with new morbidity, and death) models without covariate adjustments. Morbidity risk increased with increasing Pediatric Risk of Mortality III scores and then decreased at the highest Pediatric Risk of Mortality III values as potential morbidities became mortalities. The trichotomous model with covariate adjustments included age, admission source, diagnostic factors, baseline Functional Status Scale, and the Pediatric Risk of Mortality III score. The three-level goodness-of-fit test indicated satisfactory performance for the derivation and validation sets (p > 0.20). Predictive ability assessed with the volume under the surface was 0.50 ± 0.019 (derivation) and 0.50 ± 0.034 (validation) (vs chance performance = 0.17). Site-level standardized morbidity ratios were more variable than standardized mortality ratios. CONCLUSIONS: New morbidities were associated with physiological status and can be modeled simultaneously with mortality. Trichotomous outcome models including both morbidity and mortality based on physiological status are suitable for research studies and quality and other outcome assessments. This approach may be applicable to other assessments presently based only on mortality.

Patient- and Community-Level Sociodemographic Characteristics Associated with Emergency Department Visits for Childhood Injury.

OBJECTIVE: To examine pediatric emergency department (ED) visits over 5 years, trends in injury severity, and associations between injury-related ED visit outcome and patient and community-level sociodemographic characteristics. STUDY DESIGN: Retrospective analysis of administrative data provided to the Pediatric Emergency Care Applied Research Network Core Data Project, 2004-2008. Home addresses were geocoded to determine census block group and associated sociodemographic characteristics. Maximum Abbreviated Injury Scale severity and Severity Classification System scores were calculated. Generalized estimating equations were used to test for associations between sociodemographic characteristics and admission or transfer among injury-related ED visits. RESULTS: Overall ED visits and injury-related visits increased from 2004 to 2008 at study sites. Of 2,833676 successfully geocoded visits, 700,821 (24.7%) were injury-related. The proportion of higher severity injury-related visits remained consistent. Nearly 10% of injury-related visits resulted in admission or transfer each year. After adjusting for age, sex, payer, and injury severity, odds of admission or transfer were lower among minority children and children from areas with moderate and high prevalence of poverty. CONCLUSIONS: Pediatric injury-related ED visits to included sites increased over the study period while injury severity, anticipated resource utilization, and visit outcomes remained stable, with low rates of admission or transfer. Sociodemographic differences in injury-related visits and ED disposition were apparent. ED-based injury surveillance is essential to understand disparities, inform targets for prevention programs, and reduce the overall burden of childhood injuries.

Pediatric intensive care outcomes: development of new morbidities during pediatric critical care.

OBJECTIVE: To investigate significant new morbidities associated with pediatric critical care. DESIGN: Randomly selected, prospective cohort. SETTING: PICU patients from eight medical and cardiac PICUs. PATIENTS: This was a randomly selected, prospective cohort of PICU patients from eight medical and cardiac PICUs. MEASUREMENTS AND MAIN RESULTS: The main outcomes measures were hospital discharge functional status measured by Functional Status Scale scores and new morbidity defined as an increase in the Functional Status Scale of more than or equal to 3. Of the 5,017 patients, there were 242 new morbidities (4.8%), 99 PICU deaths (2.0%), and 120 hospital deaths (2.4%). Both morbidity and mortality rates differed (p < 0.001) among the sites. The worst functional status profile was on PICU discharge and improved on hospital discharge. On hospital discharge, the good category decreased from a baseline of 72% to 63%, mild abnormality increased from 10% to 15%, moderate abnormality status increased from 13% to 14%, severe status increased from 4% to 5%, and very severe was unchanged at 1%. The highest new morbidity rates were in the neurological diagnoses (7.3%), acquired cardiovascular disease (5.9%), cancer (5.3%), and congenital cardiovascular disease (4.9%). New morbidities occurred in all ages with more in those under 12 months. New morbidities involved all Functional Status Scale domains with the highest proportions involving respiratory, motor, and feeding dysfunction. CONCLUSIONS: The prevalence of new morbidity was 4.8%, twice the mortality rate, and occurred in essentially all types of patients, in relatively equal proportions, and involved all aspects of function. Compared with historical data, it is possible that pediatric critical care has exchanged improved mortality rates for increased morbidity rates.

Characteristics of the pediatric patients treated by the Pediatric Emergency Care Applied Research Network's affiliated EMS agencies.

OBJECTIVE: To describe pediatric patients transported by the Pediatric Emergency Care Applied Research Network's (PECARN's) affiliated emergency medical service (EMS) agencies and the process of submitting and aggregating data from diverse agencies. METHODS: We conducted a retrospective analysis of electronic patient care data from PECARN's partner EMS agencies. Data were collected on all EMS runs for patients less than 19 years old treated between 2004 and 2006. We conducted analyses only for variables with usable data submitted by a majority of participating agencies. The investigators aggregated data between study sites by recoding it into categories and then summarized it using descriptive statistics. RESULTS: Sixteen EMS agencies agreed to participate. Fourteen agencies (88%) across 11 states were able to submit patient data. Two of these agencies were helicopter agencies (HEMS). Mean time to data submission was 378 days (SD 175). For the 12 ground EMS agencies that submitted data, there were 514,880 transports, with a mean patient age of 9.6 years (SD 6.4); 53% were male, and 48% were treated by advanced life support (ALS) providers. Twenty-two variables were aggregated and analyzed, but not all agencies were able to submit all analyzed variables and for most variables there were missing data. Based on the available data, median response time was 6 minutes (IQR: 4-9), scene time 15 minutes (IQR: 11-21), and transport time 9 minutes (IQR: 6-13). The most common chief complaints were traumatic injury (28%), general illness (10%), and respiratory distress (9%). Vascular access was obtained for 14% of patients, 3% received asthma medication, <1% pain medication, <1% assisted ventilation, <1% seizure medication, <1% an advanced airway, and <1% CPR. Respiratory rate, pulse, systolic blood pressure, and GCS were categorized by age and the majority of children were in the normal range except for systolic blood pressure in those under one year old. CONCLUSIONS: Despite advances in data definitions and increased use of electronic databases nationally, data aggregation across EMS agencies was challenging, in part due to variable data collection methods and missing data. In our sample, only a small proportion of pediatric EMS patients required prehospital medications or interventions.

High Reliability Pediatric Septic Shock Quality Improvement Initiative and Decreasing Mortality.

BACKGROUND AND OBJECTIVE: Septic shock impacts mortality, morbidity, and health care costs. A quality improvement (QI) initiative was launched to improve early recognition and timely treatment of patients with septic shock in a pediatric emergency department (PED). Our primary aim was to describe the longitudinal effectiveness of the program, iterative changes in clinical practice, and associated outcomes. METHODS: We implemented multiple interventions during our QI initiative (February 2007 to December 2014). Analysis of compliance and outcomes focused on a bundle consisting of: (1) timely antibiotics, (2) intravenous fluids (IVF) for rapid reversal of perfusion abnormalities and/or hypotension. Logistic regression was used to obtain adjusted odds ratios (ORs) for death and pediatric ICU (PICU) admission. RESULTS: A total of 1380 patients were treated for septic shock; 93% met screening criteria at triage. Implementation of the various processes improved timely interventions. One example included implementation of a sepsis order set, after which the mean proportion of patients receiving timely antibiotics increased to its highest rate. The odds of death were 5 times as high for children who did not receive bundle-compliant care (OR, 5.0 [95% Confidence Interval 1.9, 14.3]) compared with those who did (OR, 0.20 [95% Confidence Interval 0.07, 0.53]). Among PICU admitted patients, the odds of mortality were greater for children who presented with abnormal mental status and a higher pediatric index of mortality 2 score. CONCLUSIONS: QI methodology improved septic shock program goal adherence and decreased mortality without increasing PICU admissions or PED length of stay over the 8-year period, supporting continued emphasis on early recognition, timely IVF resuscitation, and antibiotic administration.

Anticipated resource utilization for injury versus non-injury pediatric visits to emergency departments.

BACKGROUND: Childhood injuries are increasingly treated in emergency departments (EDs) but the relationship between injury severity and ED resource utilization has not been evaluated. The objective of this study was to compare resource utilization for pediatric injury-related ED visits across injury-severity levels and with non-injury visits, using standardized, validated scales. METHODS: A retrospective analysis of 2004-2008 ED visits from the Pediatric Emergency Care Applied Research Network Core Data Project. Maximum Abbreviated Injury Scale severity (MAIS) and Severity Classification System (SCS) scores were calculated and compared. MAIS and SCS are ordinal scales from 1 (minor injury) to 6, and 1 (low anticipated resource utilization) to 5, respectively. ED length of stay (LOS) and admission percentages were calculated as comparative proxy measures of resource utilization. RESULTS: There were 763,733 injury visits and 2,328,916 non-injury visits, most with SCS of 2 or 3. Of the injured patients, 59.2 % had an MAIS of 1. ED LOS and admission percentage increased with increasing MAIS from 1-5. LOS and admission percentage increased with increasing SCS in both samples. Median LOS was shorter for injured versus non-injured patients with SCS 3-5. Non-injured patients with SCS 2-5 were more likely admitted than injured patients. Most injured patients had an SCS 3 with an MAIS 1-2, or an SCS 2 with an MAIS 1, with no correlation between the two scales. CONCLUSION: While admission rates and LOS increase with increasing AIS and SCS severity, these two classification schemas do not reliably correlate. Similarly, ED visit metrics differ between injured and non-injured patients in similar SCS categories. Although AIS and SCS both have value, these differences should be considered when using these schemas in research and quality improvement.

Near misses and unsafe conditions reported in a Pediatric Emergency Research Network.

OBJECTIVE: Patient safety may be enhanced by using reports from front-line staff of near misses and unsafe conditions to identify latent safety events. We describe paediatric emergency department (ED) near-miss events and unsafe conditions from hospital reporting systems in a 1-year observational study from hospitals participating in the Pediatric Emergency Care Applied Research Network (PECARN). DESIGN: This is a secondary analysis of 1 year of incident reports (IRs) from 18 EDs in 2007-2008. Using a prior taxonomy and established method, this analysis is of all reports classified as near-miss (events not reaching the patient) or unsafe condition. Classification included type, severity, contributing factors and personnel involved. In-depth review of 20% of IRs was performed. RESULTS: 487 reports (16.8% of eligible IRs) are included. Most common were medication-related, followed by laboratory-related, radiology-related and process-related IRs. Human factors issues were related to 87% and equipment issues to 11%. Human factor issues related to non-compliance with procedures accounted for 66.4%, including 5.95% with no or incorrect ID. Handoff issues were important in 11.5%. CONCLUSIONS: Medication and process-related issues are important causes of near miss and unsafe conditions in the network. Human factors issues were highly reported and non-compliance with established procedures was very common, and calculation issues, communications (ie, handoffs) and clinical judgment were also important. This work should enable us to help improve systems within the environment of the ED to enhance patient safety in the future.

Relationship between the functional status scale and the pediatric overall performance category and pediatric cerebral performance category scales.

IMPORTANCE: Functional status assessment methods are important as outcome measures for pediatric critical care studies. OBJECTIVE: To investigate the relationships between the 2 functional status assessment methods appropriate for large-sample studies, the Functional Status Scale (FSS) and the Pediatric Overall Performance Category and Pediatric Cerebral Performance Category (POPC/PCPC) scales. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study with random patient selection at 7 sites and 8 children's hospitals with general/medical and cardiac/cardiovascular pediatric intensive care units (PICUs) in the Collaborative Pediatric Critical Care Research Network. Participants included all PICU patients younger than 18 years. MAIN OUTCOMES AND MEASURES: Functional Status Scale and POPC/PCPC scores determined at PICU admission (baseline) and PICU discharge. We investigated the association between the baseline and PICU discharge POPC/PCPC scores and the baseline and PICU discharge FSS scores, the dispersion of FSS scores within each of the POPC/PCPC ratings, and the relationship between the FSS neurologic components (FSS-CNS) and the PCPC. RESULTS: We included 5017 patients. We found a significant (P < .001) difference between FSS scores in each POPC or PCPC interval, with an FSS score increase with each worsening POPC/PCPC rating. The FSS scores for the good and mild disability POPC/PCPC ratings were similar and increased by 2 to 3 points for the POPC/PCPC change from mild to moderate disability, 5 to 6 points for moderate to severe disability, and 8 to 9 points for severe disability to vegetative state or coma. The dispersion of FSS scores within each POPC and PCPC rating was substantial and increased with worsening POPC and PCPC scores. We also found a significant (P < .001) difference between the FSS-CNS scores between each of the PCPC ratings with increases in the FSS-CNS score for each higher PCPC rating. CONCLUSIONS AND RELEVANCE: The FSS and POPC/PCPC system are closely associated. Increases in FSS scores occur with each higher POPC and PCPC rating and with greater magnitudes of change as the dysfunction severity increases. However, the dispersion of the FSS scores indicated a lack of precision in the POPC/PCPC system when compared with the more objective and granular FSS. The relationship between the PCPC and the FSS-CNS paralleled the relationship between the FSS and POPC/PCPC system.