outcomes measurement in patients with head and neck cancer

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HEAD AND NECK CANCERS (E HANNA, SECTION EDITOR) Outcomes Measurement in Patients with Head and Neck Cancer Christine G. Gourin Published online: 2 February 2014 # Springer Science+Business Media New York 2014 Abstract Outcomes research is defined as clinical and population-based research that investigates the results of healthcare practices or interventions through the filter of the benefit to the patient and other stakeholders. Outcomes research is an increasingly important field or research, be- cause of the pressing need for evidence-based information that can be used to make better informed health and healthcare decisions, and define desired health care practices in the current era of healthcare reform. This article will review the head and neck cancer (HNCA) outcomes literature published in the past year, with a focus on studies evaluating treatment and survival, short-term and long-term complications, and quality of life (QOL). Keywords Head and neck . Head and neck cancer . HNCA . Oncology . Outcomes . Outcome measurements . Outcomes literature . Treatment and survival . Complications . Quality of life . QOL . Research . Volume . Survival . Function . Gastrostomy Introduction Outcomes research refers to research investigating the end results of a health care intervention or practice that has mean- ingful value to patients, their family members, and other stakeholders. The end results of health outcomes research include mortality, morbidity, functional measures, and patient experiences with care, and may also include issues such as cost, accessibility, and patient preferences [1]. Outcomes research includes comparative effectiveness research, which is the comparison of treatment interventions to determine which treatments work best and specifically for which pa- tients. However, outcomes research interventions are not lim- ited to treatment, but can include the provision of other ser- vices or health care policies. The key to differentiating out- comes research from other types of clinical research is that outcomes research should measure outcomes that matter to patients, and provide information that can be used to allow informed decision making, or to develop better ways to im- prove the quality and value of care [2]. As an example, a study that reports survival or functional outcomes from surgery for head and neck cancer (HNCA) is not outcomes research, while a study comparing outcomes for different types of treatment or treatment delivered at different locations would be outcomes research. When viewed through this filter, many studies that report outcomes do not in fact meet the definition of true outcomes research. While outcomes research is not a new field, it is critically important because of the pressing need for evidence-based information that can be used to make better informed health and healthcare decisions, and define desired health care prac- tices in the current era of healthcare reform. Volume and Outcome The effect of treating hospital location on outcomes has been the subject of several studies that seek to answer the question: does it matter where you get your care? An analysis of retrospective data from 78,478 larynx cancer surgical patients in the Nationwide Inpatient Sample (NIS) for the years 19932008 was performed, to evaluate the effect of surgeon and hospital volume on short-term outcomes for larynx cancer This article is part of the Topical Collection on Head and Neck Cancers C. G. Gourin (*) Department of OtolaryngologyHead and Neck Surgery, and the Armstrong Institute for Patient Safety and Quality, Johns Hopkins University, 601 N. Caroline Street Suite 6260, Baltimore, MD 21287, USA e-mail: [email protected] Curr Oncol Rep (2014) 16:376 DOI 10.1007/s11912-013-0376-7

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Page 1: Outcomes Measurement in Patients with Head and Neck Cancer

HEAD AND NECK CANCERS (E HANNA, SECTION EDITOR)

Outcomes Measurement in Patients with Headand Neck Cancer

Christine G. Gourin

Published online: 2 February 2014# Springer Science+Business Media New York 2014

Abstract Outcomes research is defined as clinical andpopulation-based research that investigates the results ofhealthcare practices or interventions through the filter of thebenefit to the patient and other stakeholders. Outcomesresearch is an increasingly important field or research, be-cause of the pressing need for evidence-based information thatcan be used to make better informed health and healthcaredecisions, and define desired health care practices in thecurrent era of healthcare reform. This article will review thehead and neck cancer (HNCA) outcomes literature publishedin the past year, with a focus on studies evaluating treatmentand survival, short-term and long-term complications, andquality of life (QOL).

Keywords Head and neck . Head and neck cancer . HNCA .

Oncology . Outcomes . Outcomemeasurements . Outcomesliterature .Treatment and survival .Complications .Qualityoflife . QOL . Research . Volume . Survival . Function .

Gastrostomy

Introduction

Outcomes research refers to research investigating the endresults of a health care intervention or practice that has mean-ingful value to patients, their family members, and otherstakeholders. The end results of health outcomes researchinclude mortality, morbidity, functional measures, and patient

experiences with care, and may also include issues such ascost, accessibility, and patient preferences [1]. Outcomesresearch includes comparative effectiveness research, whichis the comparison of treatment interventions to determinewhich treatments work best and specifically for which pa-tients. However, outcomes research interventions are not lim-ited to treatment, but can include the provision of other ser-vices or health care policies. The key to differentiating out-comes research from other types of clinical research is thatoutcomes research should measure outcomes that matter topatients, and provide information that can be used to allowinformed decision making, or to develop better ways to im-prove the quality and value of care [2]. As an example, a studythat reports survival or functional outcomes from surgery forhead and neck cancer (HNCA) is not outcomes research,while a study comparing outcomes for different types oftreatment or treatment delivered at different locations wouldbe outcomes research. When viewed through this filter, manystudies that report outcomes do not in fact meet the definitionof true outcomes research.

While outcomes research is not a new field, it is criticallyimportant because of the pressing need for evidence-basedinformation that can be used to make better informed healthand healthcare decisions, and define desired health care prac-tices in the current era of healthcare reform.

Volume and Outcome

The effect of treating hospital location on outcomes has beenthe subject of several studies that seek to answer the question:does it matter where you get your care? An analysis ofretrospective data from 78,478 larynx cancer surgical patientsin the Nationwide Inpatient Sample (NIS) for the years 1993–2008 was performed, to evaluate the effect of surgeon andhospital volume on short-term outcomes for larynx cancer

This article is part of the Topical Collection on Head and Neck Cancers

C. G. Gourin (*)Department of Otolaryngology–Head and Neck Surgery, and theArmstrong Institute for Patient Safety and Quality, Johns HopkinsUniversity, 601 N. Caroline Street Suite 6260, Baltimore,MD21287,USAe-mail: [email protected]

Curr Oncol Rep (2014) 16:376DOI 10.1007/s11912-013-0376-7

Page 2: Outcomes Measurement in Patients with Head and Neck Cancer

surgery [3•]. High-volume hospitals and surgeons were morelikely to perform partial laryngectomy and flap reconstruction,while high-volume surgeons were additionally more likely tooperate on patients with advanced comorbidity and with ahistory of prior irradiation. There was a significant temporaltrend of increased centralization of care at high-volume hos-pitals, and increased odds of prior radiation in recent years. In-hospital mortality was rare and was not associated with treat-ment volume, and no association was found between volumeand postoperative complications. However, high-volume hos-pitals and surgeons were significantly associated with reducedlength of hospitalization, and high-volume surgeons wereadditionally associated with lower costs of care.

A similar study was performed using the NIS to evaluateoutcomes in 75,828 oropharyngeal cancer surgical patients[4•]. High-volume surgeons were more likely to perform flapreconstruction and treat patients with prior irradiation. Asignificant temporal trend of centralization of oropharynxcancer surgery at high-volume hospitals and an increase inprior irradiation was seen. A statistically significant interac-tion was found between high-volume surgeons and high-volume hospitals, with reduced hospital-related costs ob-served for surgery performed at a high-volume hospital whenperformed by a high-volume surgeon. These data suggest thatthere are differences in the process measures used byhigh-volume surgeons that are associated with reducedcosts despite more extensive surgery and prior radiation, andprovide support for the observed trend of centralization ofHNCA cancer care.

More recently, the association between hospital volumeand short-term outcomes following HNCA surgery was eval-uated using the University HealthSystems Consortium (UHC)database [5]. The authors studied 11,573 HNCA surgicalpatients from the UHC database from 2006–2009, which isan alliance of academic centers and their affiliated hospitals.The authors found that high-volume hospitals were associatedwith a lower complication rate, after controlling for all othervariables, but were not associated with differences in morbid-ity, length of hospitalization, or costs. Comorbidity was asso-ciated with increased length of hospitalization and costs, whilepatients with private insurance had lower complication rates,length of hospitalization, and costs. Differences in the com-position of patients represented in this database may explainsome of the differences observed, because of the overrepre-sentation of academic medical centers in the UHC. However,this study provides further support for a favorable relationshipbetween volume and outcome in HNCA surgery.

Analysis of the association between volume and long-termsurvival has been reported in two recent studies. Lassig et al.[6] performed a retrospective review of 388 HNCA patientsevaluated at the University of Minnesota from 2002–2008who underwent primary or adjuvant radiation. Patients whoreceived radiation at an academic center had more advanced

disease, were more likely to receive chemotherapy, andwere more likely to have oropharyngeal cancer, com-pared to patients treated at a community hospital. Patientstreated at academic or community hospitals had similar ratesof treatment completion and treatment break rates; however,long-term survival rates were higher in patients treated in anacademic setting, after controlling for all other variables,including primary site and chemotherapy. These data suggestthat there are favorable differences in the quality of caredelivered in an academic center that are associated with im-proved survival, and suggest that identification of differencesin process measures between academic and community prac-tices warrant further investigation. However, no informationon other outcome measures that may be important to patients,such as long-term toxicity, is provided.

The relationship between treating hospital volume andlong-term survival of HNCA patients was investigated bySharma et al. [7] using the Surveillance, Epidemiology, andEnd Results (SEER)-Medicare database. The study popula-tion comprised 1,195 patients, was limited to patients withadvanced stage disease, and included both surgical and non-surgical treatment. There were no significant differences in thetype of care (surgical or nonsurgical) received by hospitalvolume status. Patients treated at a high-volume hospital wereno more likely to receive multimodality treatment as recom-mended by the National Comprehensive Cancer Network(NCCN) guidelines, but high-volume hospital care was asso-ciated with improved survival, which approached statisticalsignificance in a multivariate model. These data suggest thatthere may be differences in the process measures of carebetween high-volume and low-volume hospitals that are notreflected by NCCN guidelines. The lack of an associationbetween volume and survival may be due to treatment-related differences (which were not specifically evaluated),as well as the fact that analysis was restricted to the Medicarepopulation captured by SEER.

Location and Outcome

The question “does it matter where you get your care” is notlimited to volume, but extends to location, hospital type, andeven when you get your care. A retrospective study of 1,308Medicaid patients with HNCA treated in California andGeorgia was performed using Medicaid claims linked withcancer registry data from 2002 to 2006 [8•]. The authorsreported that black patients were less likely to receive surgeryand had poorer 1-year and 2-year survival. Geographicdifferences in the type of initial treatment were observed,with a reduced likelihood of receiving chemotherapy inGeorgia, and in increased likelihood of primary surgeryin California. Long-term survival at 2 years was signif-icantly better for patients treated in California. These

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data suggest that there are differences between states thatmay reflect disparities in access and quality of care,suggesting a target for healthcare reform efforts.

An analysis of retrospective data from the NationwideInpatient Sample (NIS) from 123,662 HNCA surgery patientsin 2001–2008 looked at short-term outcomes at safety-nethospitals that serve a high proportion of poor and minoritypatients [9]. This study found that safety-net hospitals weremore likely to be teaching hospitals and treat patients withadvanced comorbidity and who require more extensive pro-cedures, but found no association between safety-net statusand in-hospital mortality, complications, or costs. A separateanalysis of data from the NIS in 2005–2008 was performed tolook for associations between teaching hospital status andspecifically a July admission and short-term morbidity andmortality in 48,263 HNCA surgery patients [10]. Major sur-gical procedures and advanced comorbidity were found to beassociated with increased in-hospital mortality, postoperativemedical and surgical complications, length of hospitalization,and costs. However, no association was found between monthof admission or teaching hospital status and short-term mor-bidity and mortality. An association was found betweenteaching hospital status and increased length of hospital-ization and costs; however no interaction was foundbetween teaching hospital status and month of admission.These data provide important information in addressingpatient and other stakeholder concerns about where andwhen HNCA surgical care is provided.

Short-Term Complications

Hospital-acquired conditions (HACs) have been the focus ofmuch attention as preventable complications for which centersfor medicare & medicaid services (CMS) will not reimbursecare. An analysis of HACs in the HNCA surgical population(surgical site infection and deep venous thrombosis [DVT])were excluded, as these apply only to select cardiac and ortho-pedic surgical populations) was performed using data for123,662 patients from a retrospective review of the NIS from2001 to 2008 [11]. HACs evaluated included foreign objectafter surgery, air embolism, blood incompatibility, pressureulcers, falls/trauma, vascular catheter-associated infection,catheter- associated urinary tract infection (UTI), manifesta-tions of poor glycemic control, and central line-associatedbloodstream infection. The incidence of HACs in HNCA sur-gery patients was <1 %, with vascular catheter- associatedinfection representing >70% of HACs. Advanced comorbidityand more extensive procedures were associated with an in-creased risk of HACs, which were associated with increasedrisk of in-hospital death, length of hospitalization, and costs.There was no association between structural variables includinghospital size, location, ownership, HNCA surgical volumes,

teaching status, or hospital safety-net burden and the occur-rence of HACs, suggesting that HACs are universalevents that cross demographic, geographic, and structuralboundaries and require the universal adoption of a patientsafety culture not limited to location or size.

A more in-depth study of variables associated withcatheter-associated UTI, which is subject to financial penaltyfrom CMS as a preventable “never event”, evaluated 93,663HNCA surgery patients from the NIS in 2003–2008 [12]. Thisstudy showed that the incidence of catheter- associated UTI inHNCA surgery patients is low, but the risk is increased inpatients of advanced age (> 80 years), undergoing majorsurgical procedures, with advanced comorbidity, Medicaidpayor status, and with predisposing bladder and prostate con-ditions. The distinction between catheter-associated UTI andUTI can be difficult, and most HNCA patients undergo peri-operative urinary catheterization and are at increased risk. Thedevelopment of a UTI was associated with significantly in-creased length of hospitalization and costs. Catheter-associated UTI is also a target for healthcare reform andsubject to financial penalty from CMS as a “never event” thatCMS considers preventable. These data identify pre-dischargevariables that identify high-risk patients in whom targetedquality improvement interventions should be directed.

Readmission within 30 days of discharge is the latest“never event” proposed by CMS, and is now subject tofinancial penalties as a proposed indicator of poor quality.Graboyes et al. [13] performed a retrospective review of1,271 otolaryngology admissions at Washington Universityin 2011. They found that risk factors associated with a signif-icantly increased unplanned readmission rate included newtotal laryngectomy, postoperative complications, cardiacor pulmonary comorbidity, drug use, and discharge to askilled nursing facility. These data report important pre-discharge variables that are amenable to targeted qualityimprovement interventions, to reduce the incidence ofunplanned hospital readmission.

Ventilator-associated pneumonia has been proposed byCMS as a “never event” indicative of poor quality to beexempt from reimbursement in the future. An analysis of theNIS from 2003 to 2008 evaluated the incidence of ventilator-associated pneumonia in 93,663 HNCA surgery patients [14].Similar to catheter-associated UTI, the distinction betweenventilator-associated pneumonia and pneumonia from othercauses can be difficult, and the former is rarely coded. HNCAsurgery patients are at increased risk because all spend sometime on a ventilator, and many have an increased risk ofaspiration pneumonia from patient, tumor, and treatment var-iables. The development of pneumonia was associated withpulmonary disease, dysphagia, and weight loss, and was in-creased in patients undergoing major surgical procedures.Length of hospitalization, costs, and in-hospital mortalitywere all significantly increased in this population after

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controlling for all other variables. These data suggestthat preoperative identification of high-risk patients withunderlying pulmonary disease, dysphagia, malnutrition,or who are undergoing higher-risk procedures that canpredisposed to aspiration, can be targeted for qualityimprovement interventions.

Deep venous thrombosis (DVT) can lead to pulmonaryembolism (PE), is a potential “never event” that may besubject to CMS penalties in the HNCA surgery populationin the future, and is currently the focus of institutional qualityimprovement interventions. An analysis of NIS data from2003 to 2008 investigating the occurrence of DVT or PE in93,663 HNCA surgical patients found an overall incidence of2 %, but an increased risk in patients with advanced comor-bidity and undergoing major surgical procedures [15]. Noassociation was found between an increased risk of DVTand traditional variables associated with DVT, such as obesity,paralysis, smoking, weight loss or cardiac disease. DVT wasassociated with increased risk of in-hospital mortality, postop-erative complications, length of hospitalization, and costs.These data suggest that at-risk groups are not restricted totraditional risk factors for DVT, and support the use broadquality improvement interventions to reduce the risk of DVTin this population.

Long-Term Complications

Pain

An exploratory study of treatment-related differences in 1-month post-treatment outcomes, as measured by the EORTCquality of life (QOL) instrument, demonstrated significantdifferences in short-term QOL between patients treated withsurgery including postoperative radiation, and those treatednonoperatively [16]. A variety of differences between treat-ment groups were seen, with nonoperative patients reportingoverall greater impairment in the domains of pain, oral func-tion and nutritional intake. There are significant limitations toextrapolating the results of this study: the overall cohort wassmall (52 patients), treatment was not randomized, and tumorstage and multivariate testing was not performed; thus some ofthe observed differences may have been due to patient selec-tion, stage, and comorbidity.

A larger study evaluating predictors of pain 1 year aftertreatment for HNCA utilized the 36-Item Short-FormInstrument (SF-36) bodily pain score in 374 patients prospec-tively [17]. The majority of patients had advanced stagedisease (75 %), oropharyngeal cancer (53 %), radiation ther-apy (84 %) and chemotherapy (62 %); surgery was performedin 38 % and neck dissection in 43 %. Worse pain scores at 1year following treatment were significantly associated with alow pretreatment pain score, lower educational levels, neck

dissection, xerostomia, gastrostomy dependence, low physicalactivity levels, poor sleep quality, and depression. Thesefindings identify a cohort at increased risk for significantlong-term treatment-related pain who can be targetedbefore treatment through treatment of modifiable riskfactors, referred early for aggressive pain management,and counseled appropriately.

Depression

A recent study from the University of California-Davis eval-uated long-term depressive symptoms in 211 HNCA patientstreated with radiation using the University of Washington(UW) QOL instrument [18]. The authors reported a 17 %incidence of depression by the UW-QOL instrument, and nosignificant difference between mood scores at 1, 3, and 5 yearsafter treatment. Variables significantly associated with depres-sion were the presence of a tracheostomy or laryngectomystoma, gastrostomy dependence, and continued smoking.At 5 years, 0 % of patients were using antidepressants,psychotherapy, or counseling to manage depression. Thesedata suggest that despite a high incidence of depressivesymptomatology, the use of effective treatments were sig-nificantly underutilized.

Lydiatt et al. [19••] conducted a randomized, double blindplacebo-controlled clinical trial evaluating the prophylacticuse of the antidepressant escitalopram in 148 patients withHNCA at the University of Nebraska and NebraskaMethodistCancer Center. Success in treatment of depression was mea-sured by the number of patients who developed moderate orgreater depression severity as measured by the QuickInventory of Depressive Symptomatology. The majority ofpatients had oral cancer, advanced stage disease, andunderwent surgery as the primary treatment modality.Compared to controls, patients treated with escitalopram hada significantly reduced risk of developing depression of great-er than 50 % (hazard ratio [HR] 0.37 [0.14–0.96]).Nonoperative treatment was associated with an increased riskof developing depression compared to primary surgical treat-ment (HR 3.61[1.38–9.40]). Prevention of depression had along-term favorable impact on QOL, with better UW-QOLscores in those patients in the treatment group who did notdevelop depression that persisted for 3 consecutive monthsafter cessation of drug. This important study showed thatproactive treatment for depression can have a measurableimpact on QOL, regardless of primary treatment modality.

Swallowing Impairment

In a retrospective study of 88 patients with oropharyngealSCCA treated with IMRT, Amin et al. [20••] reported thatthe radiation dose delivered to the larynx and esophageal inletin patients with oropharyngeal SCCA was significantly

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associated with duration and likelihood of gastrostomy depen-dence. A dose reduction to the larynx and esophageal inlet of≤60 Gy was associated with a median gastrostomy depen-dence of 6 months, while a dose to the larynx and esophagealinlet of >60 Gy was associated with a median gastrostromydependence of 11 months. No QOL swallowing measureswere reported, but gastrostomy dependence was a surrogatefor swallowing impairment, with gastrostomy removal per-formed only when patients could maintain their weight withoral intake alone.

Late toxicity following nonoperative treatment was evalu-ated in a retrospective study of 204 patients with locallyadvanced oropharyngeal SCCA treated nonoperatively [21].Grade 3 mucositis was reported in 75 %, and gastrostomydependence in 65 % at the end of treatment. At 5-year follow-up, grade 2 or 3 toxicity was reported in 44 %, with chemo-radiation a risk factor for severe late toxicity. Dysphagia,defined as gastrostomy dependence and xerostomia. was themost common late toxicity reported and was present in 44 %of chemoradiation patients. Overall, the authors found thatchemoradiation was associated with improved survival, butwith significantly increased treatment-related toxicity.

Several studies have suggested that social support mayinfluence QOL and the likelihood of long-term feeding tubedependence. A retrospective review of 364 patients treated forHNCA at the University of Iowa found a significant associa-tion between pretreatment social support and 1-year post-treatment global and HNCA-specific QOL, as measured bythe SF-36 and the Head and Neck Cancer Inventory (HNCI)[22]. A retrospective review of 154 patients treated for HNCAat the University of Alabama found that rates of gastrostomydependence at 12 months were significantly higher for pa-tients who received radiation, who required a tracheostomyfor more than 30 days, and for those without a partner [23].The majority of patients underwent surgery, with most receiv-ing free flap reconstruction and a minority of surgical patientsreceiving postoperative radiation. While the use of aggressiveswallowing therapy and other interventions was not reported,these findings do support previous reports that demonstrate anassociation between social support and gastrostomy depen-dence, and suggest the need to identify social support statusand implement clinical interventions aimed at providing socialsupport resources in HNCA patients, in order to optimizefunctional outcomes.

A comparison of functional swallowing outcomes in pa-tients undergoing transoral robotic surgery compared to pri-mary chemoradiation was reported by researchers at theUniversity of Kansas [24•]. A total of 40 patients with ad-vanced stage disease of the oropharynx or supraglottic larynxwere evaluated, and were evenly divided between treatmentmodalities. Adjuvant radiation was used in all surgical pa-tients, with adjuvant chemoradiation required in 60 % basedon adverse histologic features. Swallowing was assessed with

the MDAnderson Dysphagia Inventory (MDADI) instrumentbefore treatment and at 3 months, 6 months, and 12 monthspost-treatment. The authors found no difference in pretreat-ment or 3-month swallowing scores; however, at 6 and12 months, patients treated with transoral surgery had signif-icantly better swallowing scores as measured by the MDADI.These data suggest that transoral robotic surgery has a func-tional advantage over primary nonoperative treatment, evenwhen adjuvant chemoradiation is required. Transoral surgeryallows treatment deintensification, even when postoperativechemoradiation is given, which appears to have meaningfullong-term impact on swallowing function and is valuable forinformed decision making.

The type of surgical approach in the setting of recurrentcancer was investigated in a multi-institutional study thatcompared 64 patients treated with salvage surgery usingtransoral robotic surgery, with 64 stage-matched patientssalvaged with open approaches [25]. Rates of gastrostomydependence were significantly lower in the robotic sur-gery salvage group compared to the open salvage group.The authors reported that 2-year disease-free survivalrates were higher with robotic approaches, although thismay reflect treatment selection. These data suggest thatwhen feasible, transoral robotic surgery may provide asimilar long-term swallowing advantage in the salvagesurgery setting, when such an approach is feasible.

Patient Preferences

These studies suggest that the choice of treatment may impactfunctional outcomes. What outcomes do patients value mostwhenmaking treatment decisions? A recent study investigatedthe effect of patient preferences in weighing the impact ofincreased treatment-related toxicity with chemotherapy,against the improved survival posited by the addition ofchemotherapy to radiation [26••]. Semi-structured interviewswere administered to 51 oropharyngeal cancer patients whohad completed chemoradiation that contrasted the toxicitiesassociated with radiation alone vs. chemoradiation. A toxicitytrade-off task was performed by presenting patients with risks,benefits, and outcomes associated with treatment optionsthrough a decision board. Patient preference was determinedby weighing toxicity against a survival rate to reveal themaximum amount of survival a patient would trade for re-duced toxicity, or the “cure sacrifice threshold” (the percent-age of cure sacrificed). Descriptive interviews were performedthat included a clinical scenario involving a hypotheticaldeintensification trial. The authors found that the majority ofpatients would not tolerate significant differences in survivaland would not trade the possibility of reduced survival, with69 % of participants choosing chemoradiation even when thedifference in survival rate between radiation alone and che-moradiation was <5 %. However, 80 % of patients stated they

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would choose to avoid chemotherapy based on their personalexperience, and the self-rating of treatment experience was theonly significant predictor of cure sacrifice thresholds (willing-ness to trade survival for reduced toxicity). Surprisingly,patients with more negative treatment experiences with che-moradiation had lower cure-sacrifice thresholds (less willingto risk survival). These data suggest that HNCA patientsultimately prioritize survival over QOL, and that patients inpoorer health may place less value on better health status thanthose patients who already perceive themselves to be in goodhealth. This data has important implications at a time whenhuman papillomavirus (HPV)-associated HNCA is increasingin epidemic proportions, affecting patients who are typicallyyounger and healthier and are more likely to live longer andexperience long-term sequelae of treatment.

Conclusions

Outcomes research in HNCA is still in its early stages com-pared to other disciplines, but offers numerous opportunitiesfor further exploration. Recent years have seen an increase inmore costly treatments and a greater recognition of the impactof treatment on long-term toxicities and QOL. There is a clearneed for evidence-based information that can be used toidentify quality indicators of HNCA care, implement targetedquality improvement interventions, and allow patients, clini-cians, and other stakeholders to make better informedhealthcare decisions. This is a fertile area for research thatcan be used to inform and define desired health care practicesin the current era of healthcare reform.

Compliance with Ethics Guidelines

Conflict of Interest Christine G. Gourin declares that she has noconflict of interest.

Human and Animal Rights and Informed Consent This article doesnot contain any studies with human or animal subjects performed by anyof the authors.

References

Papers of particular interest, published recently, have beenhighlighted as:• Of importance•• Of major importance

1. Clancy CM, Eisenberg JM. Outcomes Research: Measuring theEnd Results of Health Care. Science. 1998;282:245–6.

2. “What is outcomes research?” Available at: http://www.ahrq.gov/research/findings/factsheets/outcomes/outfact/index.html.Accessed November 4, 2013.

3.• Gourin CG, Frick KD. National trends in laryngeal cancer surgeryand the effect of surgeon and hospital volume on short-term out-comes and cost of care. Laryngoscope. 2012;122:88–94. This ret-rospective review of robust NIS data demonstrated a trend towardscentralization of larynx cancer surgical care at high-volume hospi-tals, greater case complexity in cases cared for by high-volumesurgeons, and a significant relationship between surgeon volumeand short-term outcomes, supporting a trend for centralization oflarynx cancer surgical care.

4.• Gourin CG, Frick KD. National trends in oropharyngeal cancersurgery and the effect of surgeon and hospital volume on short-term outcomes and cost of care. Laryngoscope. 2012;122:542–51.This retrospective review of robust NIS data demonstrated a trendtowards centralization of oropharynx cancer surgical care at high-volume hospitals, greater case complexity in cases cared for byhigh-volume surgeons, and a significant relationship between sur-geon and hospital volume and short-term outcome, supporting atrend for centralization of oropharynx cancer surgical care.

5. Jalisi S, Bearelly S, Abdillahi A, TruongMT. Outcomes in head andneck oncologic surgery at academic medical centers in the UnitedStates. Laryngoscope. 2013;123:689–98.

6. Lassig AA, Joseph AM, Lindgren BR, et al. The effect of treatinginstitution on outcomes in head and neck cancer. Otolaryngol HeadNeck Surg. 2012;147:1083–92.

7. Sharma A, Schwartz SM, Mendez E. Hospital volume is associatedwith survival but not multimodality therapy in Medicare patientswith advanced head and neck cancer. Cancer. 2013;119:1845–52.

8.• Subramanian S, Chen A. Treatment patterns and survival amonglow-income Medicaid patients with head and neck cancer. JAMAOtolaryngol Head Neck Surg. 2013;139:489–95. This retrospectivereview of Medicaid data for two states found racial disparities inaccess to treatment and survival, and geographic differences ininitial treatment and survival.

9. Genther DJ, Gourin CG. The effect of hospital safety-net burdenstatus on short-term outcomes and cost of care after head and neckcancer surgery. Archives Otolaryngol Head Neck Surg. 2012;138:1015–22.

10. Hennessey PT, Francis HW, Gourin CG. Is there a “July Effect” forhead and neck cancer surgery? Laryngoscope. 2013;123:1889–95.

11. Kochhar A, Pronovost PJ, Gourin CG. Hospital-acquired condi-tions in head and neck cancer surgery. Laryngoscope. 2013;123:1660–9.

12. Chan JY, Semenov YR, Gourin CG. Postoperative urinary tractinfection and short-term outcomes and costs in head and neckcancer surgery. Otolaryngol Head Neck Surg. 2013;148:602–10.

13.• Graboyes EM, Liou TN, Kallogjeri D, Nussenbaum B, Diaz JA.Risk factors for unplanned hospital readmission in otolaryngologypatients. Otolaryngol Head Neck Surg. 2013;149:562–71. Thisretrospective study evaluated all otolaryngology admissions to atertiary care hospital over one year, and found that patients with anew laryngectomy, postoperative complications, cardiac or pulmo-nary comorbidity, drug use, and discharge to a skilled nursingfacility had an increased rate of readmission. These data reportimportant pre-discharge variables that are amenable to targetedquality improvement interventions to reduce the incidence of un-planned hospital readmission.

14. Semenov YR, Starmer HM, Gourin CG. The effect of pneumoniaon short-term outcomes and cost of care after head and neck cancersurgery. Laryngoscope. 2012;122:1994–2004.

15. Hennessey P, Semenov YR, Gourin CG. The effect of deep venousthrombosis on short-term outcomes and cost of care after head andneck surgery. Laryngoscope. 2012;122:2199–204.

16. De Leeuw J, van den Berg MG, van Achterberg T, Merkx MA.Supportive care in early rehabilitation for advanced-stage radiatedhead and neck cancer patients. Otolaryngol Head Neck Surg.2013;148:625–32.

376, Page 6 of 7 Curr Oncol Rep (2014) 16:376

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17. Shuman AG, Terrel JE, Light E, et al. Predictors of pain amongpatients with head and neck cancer. Archives Otolaryngol HeadNeck Surg. 2012;138:1147–54.

18. Chen AM, Daly ME, Vazquez E, et al. Depression among long-term survivors of head and neck cancer treated with radiationtherapy. JAMA Otolaryngol Head Neck Surg. 2013;139:885–9.

19.•• Lydiatt WM, Bessette D, Schmid KK, Sayles H, Burke WJ.Prevention of depression with escitalopram in patients undergoingtreatment for head and neck cancer: randomized, double-blind,placebo-controlled clinical trial. JAMA Otolaryngol Head NeckSurg. 2013;139:678–86. This randomized double-blind placebocontrolled trial of the use of an antidepressant in HNCA patientsbefore treatment demonstrated a significant risk reduction in thedevelopment of depressive symptoms, which in turn was associatedwith improved QOL.

20.•• Amin N, Reddy K, Westerly D, et al. Sparing the larynx andesophageal inlet expedited feeding tube removal in patients withstage III-IV oropharyngeal squamous cell carcinoma treated withintensity-modulated radiotherapy. Laryngoscope. 2012;122:2736–42. This retrospective study demonstrated that the radiation dosedelivered to the larynx and esophageal inlet in patients with oro-pharyngeal SCCA was significantly associated with duration andlikelihood of gastrostomy dependence. A dose reduction to thelarynx and esophageal inlet of ≤60 Gy was associated with amedian gastrostomy dependence of 6 months, while a dose to thelarynx and esophageal inlet of >60 Gy was associated with amedian gastrostromy dependence of 11 months..

21. Al-Mamgani A, van Rooij P, Verduijn GM, et al. The impact oftreatment modality and radiation technique on outcomes and tox-icity of patients with locally advanced oropharyngeal cancer.Laryngoscope. 2013;123:386–93.

22. Howren MB, Christensen AJ, Karnell LH, Van Liew JR, Funk GF.Influence of pretreatment social support on health-related quality of

life in head and neck cancer survivors: results form a prospectivestudy. Head Neck. 2013;35:779–87.

23. Magnuson JS, Durst J, Rosenthal EL, et al. Increased likelihood oflong-term gastrostomy tube dependence in head and neck cancersurvivors without partners. Head Neck. 2013;35:420–5.

24.• More YI, Tsue TT, Girod DA, et al. Functional swallowing out-comes following transoral robotic surgery vs primary chemoradio-therapy in patients with advanced-stage oropharynx andsupraglottis cancer. JAMA Otolaryngol Head Neck Surg.2013;139:43–8. This small prospective study compared functionalswallowing as measured by the MDADI in patients with advancedstage HNCA undergoing transoral robotic surgery with adjuvantradiotherapy or chemoradiotherapy vs. patients treated with pri-mary chemoradiation alone. Significantly better swallowing scoreswere seen in the surgical group at 6 months and 12 months follow-ing treatment. These data suggest that transoral robotic surgery hasa functional advantage over primary nonoperative treatment, evenwhen adjuvant chemoradiation is required, which is useful forinformed decision making.

25. White H, Ford B, Bush B, et al. Salvage surgery for recurrencecancers of the oropharynx: comparing TORS with standard opensurgical approaches. JAMA Otolaryngol Head Neck Surg.2013;139:773–8.

26.•• Brotherston DC, Poon I, Le T, et al. Patient preferences for oropha-ryngeal cancer treatment de-escalation. Head Neck. 2013;35:151–9. This study evaluated patient preferences in weighing the impactof increased treatment-related toxicity against the improved surviv-al posited by the addition of chemotherapy to radiation. While 80%of patients stated they would choose to avoid chemotherapy basedon their personal experience, 69 % of participants chose chemora-diation if the difference in survival rate between radiation alone andchemoradiation was as small as <5 %. These data suggest thatHNCA patients ultimately prioritize survival over QOL.

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