Degrees of Inflammation in the Treatment of Subglottic Stenosis in a Rabbit Model: Histopathological Assessment of a Novel Bioabsorbable Ultra-high Ductility Magnesium Alloy Stent.

OBJECTIVE: Utilizing a novel histopathological scoring system and subglottic stenosis (SGS) rabbit model, we aimed to compare degrees of inflammation and severity of narrowing in the subglottis between two minimally invasive therapeutic modalities: endoscopic balloon dilation (EBD) alone versus EBD with placement of a bioabsorbable ultra-high ductility magnesium (UHD-Mg) alloy stent. METHODS: SGS was induced endoscopically via microsuspension laryngoscopy in 23 New Zealand white rabbits. The control group (n = 11) underwent EBD alone, the study arm (n = 12) underwent EBD with implantation of bioabsorbable UHD-Mg alloy stents. Rabbits were euthanized at 2-, 3-, and 6-weeks after SGS induction, coinciding with wound healing stages. Using Optical Coherence Tomography (OCT), cross-sectional areas of airways were compared to calculate the mean percentage of intraluminal area at sequential time points. A novel histopathological scoring system was used to analyze frozen sections of laryngotracheal complexes. The degree of inflammation was quantified by scoring changes in inflammatory cell infiltration, epithelial ulceration/metaplasia, subepithelial edema/fibrosis, and capillary number/dilation. Univariate analysis was utilized to analyze these markers. RESULTS: We found rabbits implanted with the bioabsorbable UHD-Mg alloy stent had statistically significantly higher scores in categories of hyperplastic change (stents vs controls: 1.48 vs 0.46 p < 0.001), squamous metaplasia (22 vs 5 p < 0.001), and neutrophils/fibrin in lumen (31 vs 8, p < 0.001). Rabbits who received EBD alone had higher scores of subepithelial edema and fibrosis (2.70 vs 3.49, p < 0.0256). The stented rabbits demonstrated significantly increased mean percent stenosis by intraluminal mean area compared to controls at 2 weeks (88.56 vs 58.98, p = 0.032), however at all other time points there was no significant difference between intraluminal subglottic stenosis by mean percent stenosis area. DISCUSSION: Rabbits with SGS treated with UHD-Mg alloy stents demonstrated histopathologic findings suggestive of lower levels of tracheal fibrosis. This could indicate a reduced tendency towards the development of stenosis when compared to EBD alone. There was not a difference in luminal size between stent and non-stented rabbits at the six-week end point. Histologically, however, overall the use of bioabsorbable UHD-Mg alloy stenting elicited a greater tissue response at the level of the superficial mucosa rather than fibrosis of the lamina propria seen in the stented rabbits. This suggests more favorable healing and less of a tendency towards fibrosis and stenosis even though there may not be a benefit from a luminal size standpoint during this early healing period. Compared to known complications of currently available non-bioabsorbable metal or silicone-based stents, this proof-of-concept investigation highlights the potential use of a novel biodegradable UHD-Mg stent as a therapeutic modality for pediatric SGS.

Screening for Financial Toxicity Among Patients With Cancer: A Systematic Review.

OBJECTIVE: Despite the pervasiveness and adverse impacts of financial toxicity (FT) in cancer care, there are no definitive measures for FT screening that have been widely integrated into clinical practice. The aim of this review is to evaluate current methods of assessing FT among patients with cancer and confirm factors associated with higher risk of FT. METHODS: A systematic review was performed according to PRISMA guidelines. We included peer-reviewed studies that cross-sectionally, longitudinally, or prospectively measured the self-reported financial impact of patients undergoing cancer care in the United States. RESULTS: Out of 1,085 identified studies, 51 met final inclusion criteria. Outcomes evaluated included FT measures or tools, time and setting of screening, FT prevalence, and sociodemographic or clinical patient-level associated factors. Our findings demonstrate that there is wide variability in FT screening practices including in the timing (diagnosis versus treatment versus survivorship), setting (clinic-based, online, telephone or mail), tools used (21 unique tools, 7 previously validated), and interpretations of screening results (varying FT score cutoffs defining high versus low FT). Younger age, lower income, lower education, non-White race, employment status change, advanced cancer stage, and systemic or radiation therapy were among factors associated with worse FT across the studies. DISCUSSION: FT screening remains heterogenous within the United States. With the ever-escalating cost of cancer care, and the strong association between FT and poor patient outcomes, universal and routine FT screening is imperative in cancer care. Further research and multifaceted interventions identifying best practices for FT screening are needed.

Addressing Financial Toxicity in Head and Neck Cancer-A Crucial Imperative.

This Viewpoint calls for consideration of the financial costs of head and neck cancer care when choosing treatment strategies for patients who may face severe financial stress or insolvency due to cancer treatment.

Feasibility and Cost of Telehealth Head and Neck Cancer Survivorship Care: A Systematic Review.

OBJECTIVE: Evaluate the feasibility and cost-effectiveness of telehealth head and neck cancer (HNC) survivorship care. DATA SOURCES: Ovid MEDLINE, Embase, Scopus, CINAHL. REVIEW METHODS: A systematic search for peer-reviewed feasibility studies on telehealth models for HNC survivorship care published between 2005 and 2021 was conducted using the terms "head and neck cancer" and "telehealth" and their synonyms. Inclusion criteria were studies on telehealth survivorship program interventions for HNC patients with quantitative feasibility outcome measures (eg, enrollment, retention, attrition/dropout rate, adherence/task completion rate, patient satisfaction, cost). RESULTS: Thirty-eight studies out of 1557 identified met inclusion criteria and were included for analysis. Feasibility outcomes evaluated were enrollment and attrition rates, adherence/task completion rates, patient satisfaction, and user feedback surveys in different survivorship domains. Patient enrollment ranged from 20.8% to 85.7%, while attrition ranged from 7% to 47.7%. Overall, adherence was 30.2% higher in the intervention group than in the control group (46.8% vs 16.6%). Studies with cost analysis found telehealth models of care to be statistically significantly less expensive and more cost-efficient than the standard model of care, with a $642.30 saving per patient (n = 3). Telehealth models also substantially reduced work time saving per visit (on average, 7 days per visit). CONCLUSION: While telehealth survivorship programs are feasible and cost-effective and are associated with improved patient outcomes, they might not be ideal for every patient. Further investigations are needed to understand the role of telehealth in survivorship care, given the variability in study design, reporting, measures, and methodological quality.

Impact of Race and Insurance Status on Primary Treatment for HPV-Associated Oropharyngeal Squamous Cell Carcinoma.

OBJECTIVE: To assess the impact of sociodemographic factors on primary treatment choice (surgery vs radiotherapy) in patients with human papillomavirus-associated (HPV+) oropharyngeal squamous cell carcinoma (OPSCC). STUDY DESIGN: Retrospective analysis of the National Cancer Database. SETTING: Data from >1500 Commission on Cancer institutions (academic and community) via the National Cancer Database. METHODS: Our sample consists of patients diagnosed with HPV+ OPSCC from 2010 to 2015. The primary outcome of interest was initial treatment modality: surgery vs radiation. We performed multivariable logistic models to assess the relationship between treatment choice and sociodemographic factors, including sex, race, treatment facility, and insurance status. RESULTS: Of the 16,043 patients identified, 5894 (36.7%) underwent primary surgery while 10,149 (63.3%) received primary radiotherapy. Black patients were less likely than White patients to receive primary surgery (odds ratio [OR], 0.80; 95% CI, 0.66-0.96). When compared with privately insured patients, those who were uninsured or on Medicaid or Medicare were also less likely to receive primary surgery (OR, 0.70 [95% CI, 0.56-0.86]; OR, 0.77 [95% CI, 0.65-0.91]; OR, 0.85 [95% CI, 0.75-0.96], respectively). Patients receiving treatment at an academic/research cancer program were more likely to undergo primary surgery than those treated at comprehensive community cancer programs (OR, 1.33; 95% CI, 1.14-1.56). CONCLUSION: In this large sample of patients with HPV+ OPSCC, race and insurance status affect primary treatment choice. Specifically, Black and nonprivately insured patients are less likely to receive primary surgery as compared with White or privately insured patients. Our findings illuminate potential disparities in HPV+ OPSCC treatment.

The cost of cure: Examining objective and subjective financial toxicity in head and neck cancer survivors.

BACKGROUND: Little is documented regarding objective financial metrics and their impact on subjective financial toxicity in head and neck cancer (HNC) survivors. METHODS: In a cross-sectional analysis, 71 survivors with available claims data for HNC-specific out-of-pocket expenses (OOPE) completed a survey including patient-reported, subjective financial toxicity outcome tools: the Comprehensive Score for financial Toxicity (COST) and the Financial Distress Questionnaire (FDQ). RESULTS: Worse COST scores were significantly associated with lower earnings at survey administration (coefficient = 3.79; 95% CI 2.63-4.95; p < 0.001); loss of earnings after diagnosis (coefficient = 6.03; 95% CI 0.53-11.52; p = 0.032); and greater annual OOPE as a proportion of earnings [log10(Annual OOPE:Earnings at survey): coefficient = -5.66; 95% CI -10.28 to -1.04; p = 0.017]. Similar results were found with FDQ. CONCLUSION: Financial toxicity is associated with particular socioeconomic characteristics which, if understood, would assist the development of pre-treatment screening tools to detect at-risk individuals and intervene early in the HNC cancer survivorship trajectory.

Exploring caregiver burden and financial toxicity in caregivers of tracheostomy-dependent children.

OBJECTIVE: Measure the prevalence of and factors associated with financial toxicity (FT) and caregiver burden in families of tracheostomy-dependent children. FT is defined as the objective and subjective patient-level impact of the costs of medical care and has been associated with lower quality of life, decreased compliance with treatment, and increased mortality. METHODS: A medical record review was performed on all children with a tracheostomy tube placed from 2009 to 2018 at a tertiary children's hospital to identify and include children younger than 18 years old, not deceased, and not decannulated at the time of review. Eligible children's caregivers were contacted to fill out a 36-item questionnaire and three validated instruments: The Comprehensive Score for Financial Toxicity (COST) and the Financial Distress Questionnaire (FDQ), both addressed to the parent/primary caregiver, and the Burden Scale for Family Caregivers - short version (BSFC-s). RESULTS: Of the 140 eligible tracheostomy patients identified, 45 caregivers (32.1%) returned the survey. The average COST score was 18 ± 1.7 with 73.3% of caregivers reporting high toxicity based on FDQ, and 75.6% having severe-to-very severe caregiver burden. Significant increase in FT was seen in households where an adult had to leave a paid position (p = 0.047) or work less (p = 0.002) because of their child's condition; or needed to omit some of the child's medical services or medications due to cost-prohibitive reasons (p<0.001). Financial toxicity was associated with caregiver burden (by BSFC-s) [r = -596; beta coefficient = -0.95, t(43) = -4.87, p<0.001] and financial distress (by FDQ; p<0.001). CONCLUSION: Caregivers of children with medically complex, tracheostomy-dependent conditions suffer from FT and caregiver burden. As a result, harmful financial coping mechanisms such as missing necessary care components or forgoing prescribed treatments, may be adopted for cost-prohibitive reasons.

Quality and Readability Assessment of Websites on Human Papillomavirus and Oropharyngeal Cancer.

OBJECTIVES/HYPOTHESIS: The incidence of human papillomavirus-positive (HPV+) oropharyngeal cancer is rising, but public knowledge about this diagnosis remains low. This study aimed to investigate the quality and readability of online information about HPV+ oropharyngeal cancer. STUDY DESIGN: Cross-sectional website analysis. METHODS: This study conducted a total of 12 web searches across Google, Yahoo, and Bing to identify websites related to HPV+ oropharyngeal cancer. The QUality Evaluation Scoring Tool (QUEST) was used to measure quality based on seven website criteria. The Flesch Reading Ease Score (FRES) and Flesch-Kincaid Grade Level (FKGL) were used to measure readability, with scores estimating the education level a reader would require to understand a piece of text. Readability improves as FRES increases and FKGL decreases. RESULTS: Twenty-seven unique web pages were evaluated. The mean USA reading grade level as measured by FKGL was 10.42 (standard deviation = 1.54). There was an inverse relationship between quality and readability, with a significant positive correlation between QUEST score and FKGL (r = 0.343, P = .040) and a significant negative correlation between QUEST score and FRES (r = -0.537, P = .002). CONCLUSIONS: With a mean USA reading grade level more than four grades above the American Medical Association's recommendation and results indicating that readability suffers as quality improves, these findings suggest that the currently available online information about HPV+ oropharyngeal cancer is insufficient. Improved patient education practices and resources about this diagnosis are needed. LEVEL OF EVIDENCE: NA Laryngoscope, 131:87-94, 2021.

Potential impact of the COVID-19 pandemic on financial toxicity in cancer survivors.

BACKGROUND: In the context of COVID-19, cancer survivors represent a particularly vulnerable population that may be "doubly hit" by both costs of cancer treatment and financial strain imposed by the pandemic. METHODS: We performed a review of the literature pertaining to cancer, financial toxicity, and economic challenges. RESULTS: Multiple societies have put forth recommendations to modify delivery of cancer care in order to minimize patient exposure to the virus. Cancer survivors, especially patients with head and neck cancer, have been disproportionately affected by rising unemployment levels and economic recessions in the past, both of which are linked to higher cancer mortality. Patients who rely on employer-provided insurance and do not qualify for Medicaid may lose access to life-saving treatments. CONCLUSIONS: It is essential to implement interventions and policy changes in order to mitigate the effects of this pandemic but also to ensure this becomes a nonissue during the next one.

Understanding financial toxicity in head and neck cancer survivors.

OBJECTIVES: (1) Describe financial toxicity (FT) in head and neck cancer (HNC) survivors and assess its association with personal/health characteristics and health-related quality of life (HRQOL); (2) examine financial coping mechanisms (savings/loans); (3) assess relationship between COmprehensive Score for financial Toxicity (COST) and Financial Distress Questionnaire (FDQ). PATIENTS AND METHODS: Cross-sectional survey from January - April 2018 of insured patients at a tertiary multidisciplinary HNC survivorship clinic who completed primary treatment for squamous cell carcinoma of the oral cavity, oropharynx, or larynx/hypopharynx. RESULTS: Of 104 survivors, 30 (40.5%) demonstrated high FT. Patients with worse FT were more likely (1) not married (COST, 25.33 ±â€¯1.87 vs. 30.61 ±â€¯1.34, p = 0.008); (2) of lower education levels (COST, 26.12 ±â€¯1.47 vs. 34.14 ±â€¯1.47, p < 0.001); and (3) with larynx/hypopharynx primaries (COST, 22.86 ±â€¯2.28 vs. 30.27 ±â€¯1.50 vs. 32.72 ±â€¯1.98, p = 0.005). Younger age (4.23, 95%CI 2.20 to 6.26, p < 0.001), lower earnings at diagnosis (1.17, 95%CI 0.76 to 1.58, p < 0.001), and loss in earnings (-1.80, 95%CI -2.43 to -1.16, p < 0.001) were associated with worse FT. COST was associated with HRQOL (0.08, p = 0.03). Most survivors (63/102, 60%) reported using savings and/or loans. Worse FT was associated with increased likelihood of using more mechanisms (COST, OR1.06, 95%CI 1.02 to 1.10, p = 0.004). Similar results were found with FDQ. CONCLUSIONS: We found differences in FT by primary site, with worst FT in larynx/hypopharynx patients. This finding illuminates potential site-specific factors, e.g. workplace discrimination or inability to return to work, that may contribute to increased risk. FDQ correlates strongly with COST, encouraging further exploration as a clinically-meaningful screening tool.

Comparative effectiveness of allergy testing method in driving immunotherapy outcomes.

BACKGROUND: Skin-prick testing (SPT), in vitro testing (IVT), and intradermal-dilutional testing (IDT) are methods to detect patient sensitivities to specific allergens and direct immunotherapy dosing. We used objective and subjective measures of improvement to compare outcomes based on test method. METHODS: Patients underwent 1 of 3 protocols: SPT, screening SPT followed by IDT, or IVT. We used institution billing data to do a cost analysis of these tests. The time to maintenance (TTM) therapy was analyzed and patients were stratified into high and low reactors. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used to quantify symptoms pre-maintenance and post-maintenance. RESULTS: Of 177 patients (SPT, n = 40; IVT, n = 91; IDT, n = 46), 115 (SPT, n = 35; IVT, n = 39; IDT, n = 41) were high reactors. Out of 90 patients (SPT, n = 17; IVT, n = 37; IDT, n = 36) reaching maintenance, 58 were high reactors (SPT, n = 15; IVT, n = 12; IDT, n = 31). Overall, SPT, IVT, and IDT median TTM were 542, 329, and 578.5 days, respectively. IDT TTM was shorter compared to IVT overall and in high reactors (hazard ratio [HR] = 1.91, p = 0.02; HR = 2.12, p = 0.03), but was not significant compared to SPT high reactors (p = 0.33). The IDT cost was $62.66, translating to an incremental cost-effectiveness ratio of $0.23 per day of shortened TTM. Median RQLQ change for the SPT, IVT, and IDT groups was 6.5, 1, and 1.5, respectively, but was not significant (p = 0.60). CONCLUSION: IDT reached maintenance immunotherapy quicker than IVT but there was no difference compared to SPT. TTM did not correlate with improvements in patient symptoms between testing methods. This study represents a novel comparison of outcomes based on initial allergy testing method.

Research productivity and gender disparities: a look at academic plastic surgery.

OBJECTIVES: The h-index has utility in examining the contributions of faculty members by quantifying both the amount and the quality of research output and as such is a metric in approximating academic productivity. The objectives of this study were (1) to evaluate the relationship between h-index and academic rank in plastic surgery and (2) to describe the current gender representation in academic plastic surgery to assess whether there are any gender disparities in academic productivity. DESIGN: The h-index was used to evaluate the research contributions of plastic surgeons from academic departments in the United States. RESULTS: There were 426 (84%) men and 79 (16%) women in our sample. Those in higher academic ranks had higher h-index scores (p < 0.0005). There was a significant difference in overall mean h-index by gender, where the mean scores were 9.0 and 6.0 for men and women, respectively (p = 0.0005). When analyzed by academic rank, there was a significant difference in academic productivity between men and women in assistant and associate professor positions (6.4 vs 5.1, respectively; p = 0.04). CONCLUSIONS: The h-index is able to objectively and reliably quantify academic productivity in plastic surgery. We found that h-indices increased with higher academic rank, and men had overall higher scores than their female colleagues. Adoption of this metric as an adjunct to other objective and subjective measures by promotions committees may provide a more reliable measure of research relevance and academic productivity in academic plastic surgery.

A look inside the courtroom: an analysis of 292 cosmetic breast surgery medical malpractice cases.

BACKGROUND: Malpractice claims affect the cost and quality of health care. OBJECTIVE: The authors examine litigation in cosmetic breast surgery and identify factors influencing malpractice litigation outcomes. METHODS: The Westlaw database was searched for jury verdict and settlement reports related to medical malpractice and cosmetic breast surgeries. Cases included for analysis were examined for year, geographic location, patient demographics, procedure performed, alleged injury, causes of action, verdict, and indemnity payments. RESULTS: Of 292 cases, the most common injury sustained was disfigurement (53.1%). Negligent misrepresentation had a 98% greater chance of resolution in favor of the plaintiff (relative risk [RR], 1.98; 95% confidence interval [CI], 1.41-2.79), and fraud had a 92% greater chance of disposition in favor of the plaintiff (RR, 1.92; 95% CI, 1.32-2.80). The most common causes of action cited were negligence (88.7%) and lack of informed consent (43.8%). One hundred sixty-nine (58.3%) cases resulted in favor of the defendant and 121 (41.7%) cases were disposed in favor of the plaintiff; 97 (33.4%) cases resulted in damages awarded and 24 (8.3%) cases resulted in settlement. No significant difference was found between the medians of indemnity payments awarded to plaintiffs ($245 000) and settlements ($300 000). CONCLUSIONS: Based on this study, negligent or intentional misrepresentation strongly favors plaintiffs in either awarded damages or settlements in cases of cosmetic breast surgery litigation. This study emphasizes that transparency and adequate communication are at the crux of the physician-patient relationship and are tools by which plastic surgeons may reduce the frequency of litigations, thereby containing health care costs at a minimum.

Beyond the operating room: a look at legal liability in body contouring procedures.

BACKGROUND: Malpractice claims affect the cost and quality of health care. OBJECTIVE: In this study, the authors examine legal litigation following body contouring surgery and identify factors influencing malpractice litigation outcomes. METHODS: The Westlaw legal database was searched for jury verdict and settlement reports related to body contouring procedures and medical malpractice. Cases included for analysis were examined for year of report, geographic location, patient demographics, procedure performed, alleged injury, causes of action, verdict, and indemnity payments. RESULTS: Of 113 cases, the most common injuries sustained were disfigurement (33.6%) and the necessitation of a revision procedure (33.6%). The most common cause of action cited was negligence (84.1%). Median plaintiff ages differed significantly (P = .003) between cases favoring the defendant (44.5 years) and those favoring the plaintiff (36 years). Of the alleged injuries, those cases citing an iatrogenic injury were 2.5 times more likely to result in either damages awarded or settlement (relative risk [RR], 2.5; 95% confidence interval [CI], 1.66-3.80). Cases that cited disfigurement were 87% more likely to result in damages awarded to the plaintiff (RR, 1.87; 95% CI, 1.08-3.26). CONCLUSIONS: Based on this study of body contouring litigation, younger plaintiff age and iatrogenic injury strongly favored plaintiffs in either awarded damages or a settlement. Disfigurement favored plaintiffs only in awarded damages. Our study emphasizes the need for adequate communication with the patient explaining realistic aesthetic results and risks of the procedure. In addition, iatrogenic organ injury must be handled expeditiously. Incorporating these recommendations into clinical practice may promote an improved physician-patient relationship while reducing litigatious health care costs.

Geographic differences in academic promotion practices, fellowship training, and scholarly impact.

PURPOSE: Previous literature described how clinical fellowship training impacts scholarly production among academic otolaryngologists, finding that fellowship-trained practitioners had higher research productivity than their non-fellowship-trained peers, and head and neck (H&N) surgeons and otologists had the highest scholarly impact. In this analysis we investigate whether geographic differences in academic promotion and scholarly impact exist, and whether such differences are associated with emphasis on regional fellowship training patterns. METHODS: The Scopus database was used to determine scholarly impact (as measured by the h-index) of 1109 academic otolaryngologists from 97 departments. Online faculty listings were organized by fellowship training, academic rank, and location. RESULTS: Fellowship-trained practitioners had greater research productivity than non-fellowship-trained otolaryngologists (H=9.5 ± 0.26 SEM vs. 6.5 ± 0.43, p<0.001), a finding that persisted throughout except in the Mountain and East South Central Regions. H&N surgeons and otologists had the highest h-indices. Practitioners in the West had the highest h-index, with differences persisting upon examination of junior faculty. The West (62.1%) and Midwest (60.5%) had the highest proportions of senior faculty. Regional differences in scholarly impact and academic promotion were further noted upon organizing faculty by subspecialty fellowship training. CONCLUSIONS: Geographic differences in academic promotion and scholarly impact exist, most markedly among junior faculty. Practitioners in the West had high impact and were more represented at senior ranks. Upon examination by fellowship training status, fellowship-trained otolaryngologists had higher impact in most, but not all, geographic regions. Regional variations in promotion were noted upon organizing faculty by subspecialty, although association with scholarly impact differs by region.

Physician accountability in iatrogenic cerebrospinal fluid leak litigation.

BACKGROUND: The potentially severe complications resulting from cerebrospinal fluid (CSF) leak makes iatrogenic injury a medicolegal area of concern for otolaryngologists and neurosurgeons. The objectives of this analysis were to study legal outcomes as well as medical and nonmedical elements affecting malpractice litigation. METHODS: Public court records available in the Westlaw legal database (Thomson Reuters, New York, NY) were searched for medical malpractice litigation related to iatrogenic CSF leak. Of the 18 jury verdicts and settlements included, outcomes and awards, patient demographic data, and other factors instrumental in determining legal responsibility were recorded for comparison. RESULTS: Ten (55.6%) cases were resolved in the defendant's favor, 2 (11.1%) resulted in damages awarded by a jury, and 6 (33.3%) were settled out of court before resolution of trial. Mean damages awarded were $1.1 million, while out of court settlements averaged $966,887. Malpractice stemming from patients who underwent endoscopic sinus surgery comprised 77.8% of cases analyzed. The most frequent alleged factors cited for litigation included having to undergo additional surgery (88.9%), developing meningitis (50.0%), and failing to recognize complications in a timely manner (44.4%). Perceived deficits in informed consent were alleged in one-third of cases. CONCLUSION: Although a slight majority of cases were resolved in the defendant's favor, payments made were considerable, averaging approximately $1 million. Strategies to decrease liability and allow patients to make more informed decisions should include clear communication with patients that explicitly states potential risks, such as meningitis, and possible need to undergo additional reparative surgery.