Gynecologic Survivorship Tool: Development, Implementation, and Symptom Outcomes.

PURPOSE: To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically treated for gynecologic cancer; to assess its feasibility; and to conduct a retrospective review of the data. MATERIALS AND METHODS: The GST was developed on the basis of a comprehensive review of the literature, multidisciplinary expert opinion, and feedback from women with a history of gynecologic cancer. It is composed of 17 questions addressing six main categories-gynecologic health (abnormal bleeding/pain), lymphedema, vaginal/vulvar dryness, sexual health, menopause (hot flushes/sleep difficulties), and bowel/urinary issues. An electronic version using the Memorial Sloan Kettering Cancer Center Engage platform was piloted in two clinics for patients with endometrial or cervical cancer. Health information was generated into clinical summaries and identified concerns for actionable response. Associations of symptom and survey time point were assessed by longitudinal models using generalized estimating equations. RESULTS: From January 1, 2019, to February 29, 2020, 3,357 GST assessments were assigned to 1,405 patients, with a 71% completion rate (90% within 5 minutes). Sixty-eight percent were performed at home via a patient portal, 32% at follow-ups using a clinic iPad. The most common symptoms were bowel problems, swelling/fluid, pain during examination, vaginal or vulvar dryness, and vaginal bleeding. Implementation challenges included improving patient compliance and ensuring that reports were reviewed by all clinical teams. We developed screening e-mails detailing patients whose assessments were due, planned training sessions for multidisciplinary teams, and incorporated feedback on methods for reviewing symptoms reports. CONCLUSION: The GST demonstrated feasibility, a high completion rate, and minimal time commitment. It was an effective electronic reporting mechanism for patients, enabling the medical team to develop specific strategies for alleviating bothersome symptoms during follow-up.

Electronic patient-reported symptom monitoring in patients recovering from ambulatory minimally invasive gynecologic surgery: A prospective pilot study.

OBJECTIVE: To evaluate the feasibility of an electronic symptom-tracking platform for patients recovering from ambulatory surgery. METHOD: We assessed user response to an electronic system designed to self-report symptoms. Endpoints included compliance, postoperative symptoms, patient satisfaction. An 8-item symptom inventory (pain, nausea, vomiting, shortness of breath, fever, swelling, discharge, redness) was developed and made available on postoperative days (POD) 2-6. Responses exceeding defined thresholds of severity triggered alerts to healthcare providers. Symptoms, alerts, actions taken, urgent care center (UCC) visits, hospital admissions were tracked until POD 30. Patient satisfaction was evaluated on POD 7. A patient was defined as "responder" if at least 5/8 items on at least 3 PODs were completed. The assessment method was deemed successful if 64/100 patients responded. RESULTS: 97/102 patients were evaluable; 65 met "responder" criteria (67% responder rate; 95% CI 57-76%). 321 surveys were completed (median 4/patient), 248 (77%) in ≤2 min. Involving caregivers and allowing additional symptom-reporting improved the responder rate to 72% (95% CI 58-84%). Most commonly-reported moderate, severe, very severe symptoms were pain, nausea, swelling; 71% reported moderate to very severe pain on POD 2. Phone calls and adjustment of medications adequately addressed most symptoms. Two patients (2%) presented at UCC before, 6 (6%) after, POD 6; 1 (1%) was admitted. Most agreed or strongly agreed that electronic symptom-tracking was helpful, easy to use, and would recommend it to others. CONCLUSION: Electronic symptom-tracking is feasible for patients undergoing ambulatory gynecologic cancer surgery. Symptom burden is high in the early postoperative period. Addressing patient-reported symptoms in a timely, automated manner may prevent severe downstream adverse events, reduce UCC visits and admission rates, and improve outcomes.

Interfaces for collecting data from patients: 10 golden rules.

Memorial Sloan Kettering Cancer Center has more than a decade's experience creating online interfaces for obtaining data from patients as part of routine clinical care. We have developed a set of "golden rules" for design of these interfaces. Many relate to the knowledge imbalance between professional staff (whether medical or informatics) and patients, who are often old and sick and have limited knowledge of technology. Others relate to the clinical nature of the encounter: data cannot be taken from patients as part of clinical care unless there is a plan to act on whatever information is prepared. We also note that the plethora of marketing questionnaires makes patients suspicious of surveys: patient trust is hard to gain and easy to lose. Addition of these golden rules to standard approaches to interface design will maximize our ability to obtain data from patients and thus improve communication between patients and clinicians.

Informing, Reassuring, or Alarming? Balancing Patient Needs in the Development of a Postsurgical Symptom Reporting System in Cancer.

After ambulatory surgeries, patients who recover at home have multiple questions about wound healing, symptoms and medication side effects, and recovery expectations. We conducted user testing and rapid application development of a newly developed symptom reporting system that supports home-based recovery by inviting patients to self-report symptoms in the days after surgery and then receive an immediate feedback report giving context for their reported symptoms. Findings showed that some participants primarily valued reassurance, whereas others prioritized receiving alerts about potential problems. Results also showed that most patients wanted feedback framed as comparing their progress to their expected progress, not to that of other patients. The final feedback report provided patients with actionable recommendations, small graphs showing their progress, and with short "gist" text interpretations. The system has been implemented, and recruitment is ongoing for a large clinical trial of its effectiveness for reducing adverse events and unnecessary emergency or urgent care visits.

Manifesto: towards a clinically-oriented psychometrics.

BACKGROUND: New technologies to collect patient - reported outcomes have substantially solved the challenge of integrating a questionnaire in a busy clinical practice. At Memorial Sloan Kettering, we have been collecting patient reported outcomes electronically for many years. Our experience confirms the predicted benefits of obtaining patient reported outcomes but has also raised serious concerns about whether instruments developed for the research setting are appropriate for routine clinical use. DISCUSSION: We summarize four principles for a clinically - relevant psychometrics. First, minimize patient burden: the use of a large number of items for a single domain may be of interest for research but additional items have little clinical utility. Secondly, use simplified language: patients who do not have good language skills are typically excluded from research studies but will nonetheless present in clinical practice. Third, avoid dumb questions: many questionnaire items are inappropriate when applied to a more general population. Fourth, what works for the group may not work for the individual: group level statistics used to validate survey instruments can obscure problems when applied to a subgroup of patients. CONCLUSION: There is a need for a clinically-oriented psychometrics to help design, test, and evaluate questionnaires that would be used in routine practice. Developing statistical methods to optimize questionnaires will be highly challenging but needed to bring the potential of patient reported outcomes into widespread clinical use.

Non-neoplastic parenchymal changes in kidney cancer and post-partial nephrectomy recovery of renal function.

OBJECTIVE: To explore the association of non-neoplastic parenchymal changes (nNPC) with patients' health and renal function recovery after partial nephrectomy (PN). MATERIALS AND METHODS: This retrospective review identified 800 pT1a patients who underwent PN at Memorial Sloan Kettering Cancer Center from 2007 to 2012. Pathology reports were reviewed for nNPC graded as mild or severe: vascular sclerosis (VS), glomerulosclerosis (GS), and fibrosis/scarring. Correlations between nNPC and known preoperative predictors of renal function [age, sex, African-American race, estimated glomerular filtration rate (eGFR), American Society of Anesthesiologists (ASA) score, body mass index, coronary artery disease, and hypertension (HTN)] were assessed using Spearman's rank correlation (ρ). Multivariable linear regression, adjusted for the described known preoperative risk predictors, was performed to evaluate whether the parenchymal features were able to predict 6-month postoperative eGFR. RESULTS: In this study, 46 % of tumors had benign surrounding parenchyma. We noted statistically significant yet weak associations of VS with age (ρ = 0.19; p < 0.001), ASA (ρ = 0.09; p < 0.001), preoperative eGFR (ρ = -0.14; p < 0.001), and HTN (ρ = 0.14; p < 0.001). GS also significantly correlated with HTN, but the correlation was again small (ρ = 0.12; p < 0.001). After adjusting for known risk predictors, only GS was a significant predictor of 6-month postoperative eGFR. When compared with no GS, mild and severe GS were negatively associated with a decrease of 4.9 and 10.8 mL/min/1.73 m(2) in 6-month postoperative eGFR, respectively. CONCLUSIONS: Presence of VS and GS correlated with patients' baseline health, and presence of GS predicted postoperative renal function recovery.

Black and White men younger than 50 years of age demonstrate similar outcomes after radical prostatectomy.

BACKGROUND: Black men with prostate cancer are diagnosed at a younger age, present with more aggressive disease, and experience higher mortality. We sought to assess pathological features and biochemical recurrence (BCR) in young men undergoing radical prostatectomy (RP) to determine if there is a difference between black and white men closer to the time of disease initiation. METHODS: We identified 551 white and 99 black men at a tertiary cancer center who underwent RP at ≤50 years of age. Baseline and pathological features were compared between the two groups. Cox proportional hazards models were utilized to examine the association of race and BCR, and Kaplan-Meier curves were generated to determine biochemical recurrence-free survival (bRFS). RESULTS: There were no differences in median age at surgery, biopsy Gleason score, or comorbidity. Black men had higher preoperative PSA (6.1 ng/ml vs 4.7 ng/ml, p = 0.004), but a greater percentage were cT1c (78% vs 63%), compared to white men. On multivariate analysis, black men demonstrated significantly lower odds of non-organ confined disease (OR 0.39; 95% CI: 0.18, 0.81; p = 0.01) and extracapsular extension (ECE) (OR 0.38; 95% CI: 0.18, 0.81, p = 0.01), and had no difference in Gleason score upgrading and seminal vesicle invasion compared to white men. There was no significant difference in bRFS in men with organ-confined disease; however, among men with locally advanced disease black men trended towards greater BCR (p = 0.052). Black men had 2-year bRFS of 56% vs 75% in white men. CONCLUSIONS: In this single institution study, there does not appear to be a racial disparity in outcomes among younger men who receive RP for prostate cancer. Black and white men in our cohort demonstrate similar bRFS with pathologically confirmed organ-confined disease. There may be greater risk of BCR among black men locally advanced disease compared to white men, suggesting that locally advanced disease is biologically more aggressive in black men.

The association between statin medication and progression after surgery for localized renal cell carcinoma.

PURPOSE: Evidence suggests that statins may influence pathways of renal cell carcinoma proliferation, although to our knowledge no study has examined the influence of statin medications on the progression of renal cell carcinoma in humans. MATERIALS AND METHODS: We identified 2,608 patients with localized renal cell carcinoma who were treated surgically between 1995 and 2010 at our tertiary referral center. Competing risks Cox proportional hazards models were used to evaluate the relationship between statin use and time to local recurrence or progression (metastases or death from renal cell carcinoma) and overall survival. Statin use was modeled as a time dependent covariate as a sensitivity analysis. Models were adjusted for clinical and demographic features. RESULTS: Of 2,608 patients 699 (27%) were statin users at surgery. Statin users had similar pathological characteristics compared to nonusers. At a median followup of 36 months there were 247 progression events. Statin use was associated with a 33% reduction in the risk of progression after surgery (HR 0.67, 95% CI 0.47-0.96, p = 0.028) and an 11% reduction in overall mortality that was not significant (HR 0.89, 95% CI 0.71-1.13, p = 0.3). Modeling statin use as a time dependent covariate attenuated the risk reduction in progression to 23% (HR 0.77, p = 0.12) and augmented the risk reduction in overall survival (HR 0.71, p = 0.002). CONCLUSIONS: In our cohort statin use was associated with a reduced risk of progression and overall mortality, although this effect was sensitive to the method of analysis. If validated in other cohorts, this finding warrants consideration of prospective research on statins in the adjuvant setting.

Preoperative serum albumin is associated with mortality and complications after radical cystectomy.

OBJECTIVE: To determine the association between preoperative serum albumin and mortality and postoperative complications after radical cystectomy (RC) and urinary diversion. PATIENTS AND METHODS: We conducted a retrospective review of 1097 RCs performed for the treatment of bladder cancer between 1992 and 2005. All data were entered prospectively into a hospital-based complications database. We used multivariable logistic regression to assess the association between preoperative serum albumin and complications and mortality ≤90 days of RC, while controlling for preoperative patient and disease characteristics. RESULTS: Low preoperative serum albumin was identified in 14% of the cohort. Preoperative serum albumin was a predictor of postoperative complications (adjusted odds ratio [OR] per unit increase in albumin: 0.61, 95% confidence interval [CI] 0.42-0.90) and 90-day mortality (OR 0.33, 95% CI 0.14-0.75) when controlling for sex, race, age-adjusted Charlson score, body mass index, prior history of abdominal surgery, clinical stage, and neoadjuvant chemotherapy. As serum albumin decreased, the risk of complications and mortality increased. CONCLUSIONS: In addition to age-adjusted Charlson score, low preoperative serum albumin is a significant predictor of complications and mortality after RC. Serum albumin testing can be used to identify individuals at high-risk of morbidity and mortality.

A randomized controlled trial of a cardiopulmonary resuscitation video in advance care planning for progressive pancreas and hepatobiliary cancer patients.

BACKGROUND: Cardiopulmonary resuscitation (CPR) is an important advance directive (AD) topic in patients with progressive cancer; however such discussions are challenging. OBJECTIVE: This study investigates whether video educational information about CPR engenders broader advance care planning (ACP) discourse. METHODS: Patients with progressive pancreas or hepatobiliary cancer were randomized to an educational CPR video or a similar CPR narrative. The primary end-point was the difference in ACP documentation one month posttest between arms. Secondary end-points included study impressions; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation; and longitudinal patient outcomes. RESULTS: Fifty-six subjects were consented and analyzed. Rates of ACP documentation (either formal ADs or documented discussions) were 40% in the video arm (12/30) compared to 15% in the narrative arm (4/26), OR=3.6 [95% CI: 0.9-18.0], p=0.07. Post-intervention knowledge was higher in both arms. Posttest, preferences for CPR had changed in the video arm but not in the narrative arm. Preferences regarding mechanical ventilation did not change in either arm. The majority of subjects in both arms reported the information as helpful and comfortable to discuss, and they recommended it to others. More deaths occurred in the video arm compared to the narrative arm, and more subjects died in hospice settings in the video arm. CONCLUSIONS: This pilot randomized trial addressing downstream ACP effects of video versus narrative decision tools demonstrated a trend towards more ACP documentation in video subjects. This trend, as well as other video effects, is the subject of ongoing study.

Intravesical gemcitabine for high risk, nonmuscle invasive bladder cancer after bacillus Calmette-Guérin treatment failure.

PURPOSE: We report our experience with intravesical gemcitabine for bladder cancer after failed bacillus Calmette-Guérin treatment. MATERIALS AND METHODS: We retrospectively reviewed the records of patients at our cancer center treated with intravesical gemcitabine after bacillus Calmette-Guérin failure. We estimated progression-free, recurrence-free and cancer specific survival using the cumulative incidence function, considering death from another cause as a competing risk. Comparisons were made using the Gray test. Overall survival was estimated using the Kaplan-Meier method and differences were compared with the log rank test. RESULTS: Of 69 patients treated with intravesical gemcitabine 37 had bacillus Calmette-Guérin refractory disease. Median followup in progression-free patients was 3.3 years. Progression-free and cancer specific survival were similar in patients with refractory disease and those with other types of bacillus Calmette-Guérin failure. Overall survival was lower in patients with refractory disease (58% vs 71%) but this was not statistically significant (p=0.096). Of the patients 27 patients experienced a complete response. Progression-free, cancer specific and overall survival did not differ significantly between patients with and without a complete response. Cystectomy was subsequently performed in 20 patients. Those with a complete response had a delayed time to cystectomy and no muscle invasive bladder cancer at cystectomy. There were no serious adverse events and only a minority of patients discontinued treatment due to adverse events. CONCLUSIONS: In our experience intravesical gemcitabine should be considered after bacillus Calmette-Guérin failure in patients with bladder cancer who refuse radical cystectomy or who are not candidates for major surgery.

Upper tract imaging surveillance is not effective in diagnosing upper tract recurrence in patients followed for nonmuscle invasive bladder cancer.

PURPOSE: We evaluated the usefulness of routine upper tract imaging in patients followed for nonmuscle invasive bladder cancer. MATERIALS AND METHODS: A retrospective review of patients treated for nonmuscle invasive bladder cancer between 2000 and 2006 was conducted. Kaplan-Meier curves were calculated to determine upper tract urothelial carcinoma-free probability for stage Ta and T1 disease. Bladder cancer stage was included as a time dependent covariate. Descriptive statistics were used to report rates of imaging studies used and the efficacy in diagnosing upper tract urothelial carcinoma. RESULTS: Of 935 patients treated and followed for nonmuscle invasive bladder cancer 51 were diagnosed with upper tract urothelial carcinoma. Median followup was 5.5 years. The 5-year upper tract urothelial carcinoma-free probability among patients with Ta and T1 disease was 98% and 93%, respectively. The 10-year upper tract urothelial carcinoma-free probability among patients with Ta and T1 disease was 94% and 88%, respectively. Only 15 (29%) patients were diagnosed on routine imaging while the others were diagnosed after symptoms developed. Overall 3,074 routine imaging scans were conducted for an overall efficacy of 0.49%. CONCLUSIONS: Upper tract recurrence is a lifelong risk in patients with bladder cancer, but most cases will be missed on routine upper tract imaging. The majority of upper tract urothelial carcinoma can be diagnosed using a combination of thorough history taking, physical examination, urine cytology and sonography, indicating that routine surveillance imaging may not be the most efficient way to detect upper tract recurrence.

Trends in partial and radical nephrectomy: an analysis of case logs from certifying urologists.

PURPOSE: Surgical treatment options for renal masses include radical vs partial nephrectomy and the open vs laparoscopic approach. Using American Board of Urology (ABU) case log data, we investigated contemporary trends in these treatment options, and how surgeon and practice characteristics may influence these trends. MATERIALS AND METHODS: Annualized case log data for nephrectomy were obtained from the ABU for all urologists certifying or recertifying from 2002 to 2010. We evaluated trends in nephrectomy use. Logistic regression was used to evaluate surgeon and practice characteristics as predictors of partial and laparoscopic procedures. RESULTS: From the 3,852 case logs submitted by nonpediatric urologists we analyzed a total of 48,384 nephrectomies. From 2002 to 2010 the proportion of annual nephrectomies performed as open radical nephrectomy gradually decreased from 54% to 29%. During the same period, there was a moderate gradual increase in laparoscopic radical nephrectomies (from 30% to 39%). The proportion of open partial nephrectomies remained stable at 15%, while laparoscopic partial nephrectomy increased from 2% to 17%. On multivariable analysis the use of partial nephrectomy and laparoscopy was predicted by urologist annual nephrectomy volume, initial or recertification status, subspecialty, practice area size and geographic region. CONCLUSIONS: Since 2002, the use of laparoscopic nephrectomy and partial nephrectomy has increased. However, the diffusion of these techniques is not uniform. Initial certification, higher surgical volume, and practicing in areas with more than 1,000,000 population and in the Northeast region were associated with greater use of laparoscopy and partial nephrectomy. Factors that affect the adoption of these techniques require further research.

Role of immediate radical cystectomy in the treatment of patients with residual T1 bladder cancer on restaging transurethral resection.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Bladder cancer patients with lamina propria invasion (T1 disease) and residual T1 disease on restaging transurethral resection of bladder tumour (re-TURBT) are at a very high risk for recurrence and progression. Despite this risk, most patients are treated with a bladder preserving approach and not immediate radical cystectomy (RC). In this study we have shown that a quarter of patients with T1 bladder cancer and residual T1 on re-TURBT who are treated with immediate RC are found to have carcinoma invading bladder muscle at RC and 5% have lymph node metastases. We have also found that >30% of patients treated with deferred RC after initial bladder-preserving therapy harbour carcinoma invading bladder muscle and almost 20% of these patients have lymph node metastases. Thus, immediate RC should be considered in all patients with T1 bladder cancer and residual T1 on re-TURBT. OBJECTIVE: To report the overall survival (OS) and cancer-specific survival (CSS) of patients with residual T1 bladder cancer on restaging transurethral resection of the bladder tumour (re-TURBT). MATERIALS AND METHODS: We performed a retrospective review of 150 evaluable patients treated for T1 bladder cancer with residual T1 disease found on re-TURBT between 1990 and 2007. Patients were treated with immediate radical cystectomy (RC) or a bladder-preserving approach (deferred or no RC). A univariate Cox proportional hazards regression model was used to test the association between treatment approach and survival. RESULTS: Residual T1 bladder cancer was found in 150 evaluable patients, of whom 57 received immediate RC and 93 were treated with a bladder-preserving approach. Fourteen out of 57 patients receiving immediate RC and 8/26 patients receiving deferred RC had carcinoma invading bladder muscle in the RC specimen. Three out of 57 and 5/26 patients had lymph node metastases in the RC specimen. Median follow-up was 3.74 years. Thirty-nine patients died during follow-up, 16 from bladder cancer. There was no significant association between immediate RC and CSS (hazard ratio [HR] 1.15, 95% confidence interval [CI] 0.43-3.09, P = 0.8) or OS (HR 0.79, 95% CI 0.4-1.53, P = 0.5). CONCLUSIONS: Because of the low number of events we cannot conclude whether RC offers a survival advantage in patients with residual T1 bladder cancer on re-TURBT. Since a quarter of patients had carcinoma invading bladder muscle, RC should be considered in these patients. A larger, preferably randomized, study with longer follow-up is needed.