Creating an Extraordinary Experience for Women Undergoing Cystoscopy: A Patient-Centered Approach to Process Improvement.

OBJECTIVE: To re-examine and improve the cystoscopy process for women based on patient input. While cystoscopy is a common urological procedure, women perceive it as invasive, personal, and fear-inducing. Patients want to be treated as individuals and not just another "procedure." METHODS: Women's perspectives on cystoscopy were collected using experience-based design. Observations and timings, emotion word lists, debrief forms, patient surveys, simulation, and interviews were used. A structured 2-day quality improvement event included both in-person and virtual patient participation to gain a deeper understanding of patients' perspectives. Ideas for process improvements were generated using brainstorming, creativity exercises, and prioritization. These changes were implemented and refined using an iterative process based on feedback. RESULTS: Patients who reported feeling grateful for the positive impact of their care tended to minimize procedure-associated wait times, inconvenience, and discomfort. Women in the evaluation phase of their treatment and those who were unhappy with their symptoms tended to magnify the negative emotions associated with their procedure. Patient feedback and areas for improvement specific to women's needs were identified. Actionable changes were implemented including engaging clinic staff, updating the cystoscopy workflow, and physical changes to enhance patient privacy. CONCLUSION: Identifying and addressing the needs of women undergoing cystoscopy improves satisfaction as their emotional, physical, and knowledge-based needs are addressed. Active participation in the health care process empowers patients to have a voice in their care. An extraordinary experience with cystoscopy may decrease anxiety of the unknown and help patients have control over the experience.

Coupling Lean and Experience-Based Design for Measuring and Incorporating Patient Emotional Experience Into the Redesign of Health Care.

BACKGROUND AND OBJECTIVES: Incorporation of Lean into health care requires consideration of the patient and other customer experience of care as well as final health outcomes. We incorporate experience-based design (EBD) into our Lean management method to assess the experience of care, guide redesign of care processes, and assess the effectiveness of quality improvement on the care experience. Foundational to EBD is identification of "touch points," moments in the health care delivery process where a patient has a strong positive or negative emotional response that has the potential to alter the way patients feel about their overall care experience. METHODS: EBD proceeds sequentially from qualitative assessment of customer experience and touch points (through observations and interviews); semiquantitatively assessing the experience across many patients (through EBD questionnaires); engaging in codesign with patients (through improvement teams and events); and reassessing the care experience after improvement (through follow-up EBD questionnaires). The use of project-specific (EBD) emotion word questionnaires enables assessment of change over time. These EBD questionnaires are developed ad hoc for each care improvement effort, to reflect the specific high emotion touch points patients identify for that care process, and therefore pose unique validity and reliability challenges. We have previously validated a set of emotion words that form the library from which questionnaire designers select the relevant emotion word choices. In addition, to assess consistency of measurement in the absence of any improvement, we performed a repeated-measures study deploying the same EBD questionnaire to different groups of patients, separated by a 60-day interval in the absence of any quality improvement work. RESULTS: We apply EBD across the health care enterprise, including patients and family caregivers, as well as staff members. Examples where EBD has been incorporated into care redesign have included; outpatient care for pancreatic cancer patients; clinic visits in rheumatology; delirium care for hospital inpatients; and the orientation process for newly hired advanced practice providers. Our reliability data demonstrate that moderate differences in scores on the EBD questionnaire (up to 19 percentage points) may reflect random variability, but differences of greater magnitude reflect actual changes in the patient experience. CONCLUSIONS: In summary, experience-based design has promise as a methodology to incorporate patient experience within a Lean management structure. EBD can aid with health care redesign, defining the emotional touch points that are foundational to the experience of care, enabling targeting of quality improvement efforts, and assessing change.

Sensitivity and specificity of urinary neutrophil gelatinase-associated lipocalin and kidney injury molecule-1 for the diagnosis of renal cell carcinoma.

BACKGROUND/AIMS: Neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) are urinary biomarkers of diagnostic relevance in a wide variety of acute and chronic kidney diseases. Their diagnostic sensitivity and specificity for kidney cancer are largely unknown and therefore the subject of this investigation. METHODS: A prospective cohort study was performed to evaluate urine biomarkers for clear-cell and papillary subtypes of renal cancer (67 patients undergoing nephrectomy) and 55 control patients undergoing non-kidney surgery. Urinary KIM-1 and NGAL concentrations were determined by sensitive and specific ELISAs. RESULTS: In renal cancer patients, median NGAL excretion was 0.52 (1st to 3rd quartiles: 0.28-0.82) ng/mg urinary creatinine (U(Cr)) before nephrectomy compared to 0.15 (0.04-0.31) ng/mg U(Cr) in controls (p < 0.001), and there was a modest decrease of 30% after nephrectomy (p < 0.008). NGAL was not correlated to tumor size (r = 0.19, p = 0.27) or stage. Before nephrectomy, KIM-1 excretion was 0.68 (0.40-1.12) ng/mg U(Cr) compared to 0.03 (0.01-0.06) in controls (p < 0.001). There was a linear correlation between KIM-1 excretion before nephrectomy and tumor size (Spearman's r = 0.66, p < 0.001), tumor stage, and a 50% decrease in median KIM-1 concentration 1 month following tumor excision (p < 0.01). Biomarker concentration ranges for renal cancer patients and controls overlapped substantially for NGAL but not KIM-1. CONCLUSION: NGAL is not a sensitive or specific urinary biomarker of kidney cancer. Although KIM-1 had diagnostic sensitivity for kidney cancer, it is well known to reflect many types of kidney injuries, thus limiting its specificity as a diagnostic biomarker for renal cancer.

Perioperative pharmacokinetics of methadone in adolescents.

BACKGROUND: Methadone is frequently administered to adults experiencing anesthesia and receiving pain treatment. Methadone pharmacokinetics in adults are well characterized, including the perioperative period. Methadone is also used in children. There is, however, no information on methadone pharmacokinetics in children of any age. The purpose of this investigation was to determine the pharmacokinetics of intravenous methadone in children undergoing surgery. Perioperative opioid-sparing effects were also assessed. METHODS: Eligible subjects were children 5-18 yr undergoing general anesthesia and surgery, with an anticipated postoperative inpatient stay exceeding 3 days. Three groups of 10 to 11 patients each received intravenous methadone hydrochloride after anesthetic induction in ascending dose groups of 0.1, 0.2, and 0.3 mg/kg (up to 20 mg). Anesthetic care was not otherwise changed. Venous blood was obtained for 4 days, for stereoselective determination of methadone and metabolites. Pain assessments were made each morning. Daily and total opioid consumption was determined. Perioperative opioid consumption and pain was determined in a second cohort, which was matched to age, sex, race, ethnicity, surgical procedure, and length of stay, but not receiving methadone. RESULTS: The final methadone study cohort was 31 adolescents (14 ± 2 yr, range 10-18) undergoing major spine surgery for a diagnosis of scoliosis. Methadone pharmacokinetics were linear over the dose range 0.1-0.3 mg/kg. Disposition was stereoselective. Methadone administration did not dose-dependently affect postoperative pain scores, and did not dose-dependently decrease daily or total postoperative opioid consumption in spinal fusion patients. CONCLUSIONS: Methadone enantiomer disposition in adolescents undergoing surgery was similar to that in healthy adults.

Pharmacokinetics and tissue penetration of cefoxitin in obesity: implications for risk of surgical site infection.

BACKGROUND: Obesity is a significant risk factor for surgical site infections (SSIs), for poorly understood reasons. SSIs are a major cause of morbidity, prolonged hospitalization, and increased health care cost. Drug disposition in general is frequently altered in the obese. Preoperative antibiotic administration, achieving adequate tissue concentrations at the time of incision, is an essential strategy to prevent SSIs. Nonetheless, there is little information regarding antibiotic concentrations in obese surgical patients. This investigation tested the hypothesis that the prophylactic antibiotic cefoxitin may have delayed and/or diminished tissue penetration in the obese. METHODS: Plasma and tissue concentrations of cefoxitin were determined in obese patients undergoing abdominal and pelvic surgery (body mass index 43 ± 10 kg/m(2), n = 14, 2 g cefoxitin) and in normal-weight patients and healthy volunteers (body mass index 20 ± 2 kg/m(2), n = 13, 1 g cefoxitin). Tissue concentrations were measured using a microdialysis probe in the subcutaneous layer of the abdomen, and in adipose tissue excised at the time of incision and wound closure. RESULTS: Plasma concentrations and area under the concentration-time curve (AUC) were approximately 2-fold higher in the obese patients because of the 2-fold-higher dose. Dose-normalized concentrations were higher, although AUCs were not significantly different. Measured and dose-normalized subcutaneous cefoxitin concentrations and AUCs in the obese patients were significantly lower than in the normal-weight subjects. There was an inverse relationship between cefoxitin tissue penetration (AUC(tissue)/AUC(plasma) ratio) and body mass index. Tissue penetration was substantially lower in the obese patients (0.08 ± 0.07 vs 0.37 ± 0.26, P < 0.05). Adipose tissue cefoxitin concentrations in obese patients were only 7.8 ± 7.3 and 2.7 ± 1.4 µg/g, respectively, at incision and closure, below the minimum inhibitory concentration of 8 and 16 µg/mL, respectively, for aerobic and anaerobic microorganisms. CONCLUSION: Obese surgical patients have impaired tissue penetration of the prophylactic antibiotic cefoxitin, and inadequate tissue concentrations despite increased clinical dose (2 g). Inadequate tissue antibiotic concentrations may be a factor in the increased risk of SSIs in obese surgical patients. Additional studies are needed to define doses achieving adequate tissue concentrations.

Using Experience-Based Design to Improve the Care Experience for Patients With Pancreatic Cancer.

PURPOSE: Despite the importance of the patient care experience to quality and outcome, the literature detailing the care experience in patients with pancreatic cancer is limited. METHODS: To elicit the experience of patients with pancreatic cancer for care redesign, we deployed experience-based design, an emerging methodology based on identification of events of high emotional content, known as touch points, to delineate qualitatively what matters most to patients and families. We defined touch points through direct observations, interviews, and a focus group. We then used experience questionnaires to measure emotional content and develop an experience map to graphically display the fluctuating emotional journey through the care processes. Study subjects were patients with pancreatic cancer who were cared for at Virginia Mason Medical Center, family caregivers, and staff. Redesign was initiated through an all-day improvement event in September 2013. RESULTS: During 2013 and 2014, we cared for 485 new patients with pancreatic cancer, the majority of whom had local disease at diagnosis. The response rate for the experience questionnaire was 23% (117 of 500 questionnaires distributed). The experience-based design results were often contrary to staff preconceptions of the care experience for patients with pancreatic cancer, and contributed to redesign in three key areas: understanding and documenting patient goals and values, providing better resources for caregivers/families, and improving care coordination and support services. CONCLUSION: Experience-based design enabled us to understand the care experience and associated emotional content for patients with pancreatic cancer and their caregivers. This knowledge then supported care redesign targeted at areas of high negative emotional content.

Simultaneous determination of alfentanil and midazolam in human plasma using liquid chromatography and tandem mass spectrometry.

A fast, sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of alfentanil and midazolam in human plasma has been developed and validated. Alfentanil and midazolam were extracted from plasma using a mixed-mode cation exchange solid phase extraction method, with recoveries of both compounds greater than 80% at 3 different concentrations (1, 10 and 100ng/ml). Compounds were analyzed on a C(18) column with a water and methanol mobile phase gradient with acetic acid as an additive, at a flow rate of 0.3ml/min. The working assay range was linear from 0.25 to 100ng/ml for each compound. The signal to noise ratio was 80 and 40 for alfentanil and midazolam, respectively, at the lowest concentration calibration standard, with less than 10% matrix suppression by human plasma at this concentration. Alfentanil and midazolam were stable in human plasma during storage at -80°C, processing, and analysis. The procedure was validated and applied to the analysis of plasma samples from healthy human subjects administered oral and intravenous alfentanil and midazolam.

Urinary biomarkers for the early diagnosis of kidney cancer.

OBJECTIVE: To test the hypothesis that increased tumor expression of proteins such as aquaporin-1 (AQP1) and adipophilin (ADFP) in patients with renal cancer would result in increased urine AQP1 and ADFP excretion. PATIENTS AND METHODS: Prenephrectomy and postnephrectomy (pseudocontrol) urine samples were collected from 42 patients with an incidental radiographically discovered renal mass and presurgical presumptive diagnosis of kidney cancer from July 8, 2008, through March 10, 2009. Also enrolled were 15 control patients who underwent nonrenal surgery and 19 healthy volunteers. Urine AQP1 and ADFP concentrations normalized to urine creatinine were determined by sensitive and specific Western blot assays. RESULTS: Mean +/- SD preexcision urine AQP1 and ADFP concentrations (76+/-29 and 117+/-74 arbitrary units, respectively) in patients with a pathologic diagnosis of clear cell (n=22) or papillary (n=10) cancer were significantly greater than in patients with renal cancer of nonproximal tubule origin, control surgical patients, and healthy volunteers (combined values of 0.1+/-0.1 and 1.0+/-1.6 arbitrary units, respectively; n=44; P<.001). The AQP1 and ADFP concentrations decreased 88% to 97% in the 25 patients with clear cell or papillary cancer who provided postnephrectomy follow-up urine samples. In patients with clear cell and papillary carcinoma, a linear correlation (Spearman) was found between tumor size and preexcision urine AQP1 or ADFP concentration (r=0.82 and 0.76, respectively; P<.001 for each). CONCLUSION: Urine AQP1 and ADFP concentrations appear to be sensitive and specific biomarkers of kidney cancers of proximal tubule origin. These biomarkers may be useful to diagnose an imaged renal mass and screen for kidney cancer at an early stage. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00851994.