Development and Psychometric Analysis of a Patient-Reported Measure of Diagnostic Excellence for Emergency and Urgent Care Settings.

BACKGROUND: Emergency and urgent care settings face challenges with routinely obtaining performance feedback related to diagnostic care. Patients and their care partners provide an important perspective on the diagnostic process and outcome of care in these settings. We sought to develop and test psychometric properties of Patient-Report to IMprove Diagnostic Excellence in Emergency Department settings (PRIME-ED), a measure of patient-reported diagnostic excellence in these care settings. METHODS: We developed PRIME-ED based on literature review, expert feedback, and cognitive testing. To assess psychometric properties, we surveyed AmeriSpeak, a probability-based panel that provides sample coverage of approximately 97% of the U.S. household population, in February 2022 to adult patients, or their care partners, who had presented to an emergency department or urgent care facility within the last 30 days. Respondents rated their agreement on a 5-point Likert scale with each of 17 statements across multiple domains of patient-reported diagnostic excellence. Demographics, visit characteristics, and a subset of the Emergency Department Consumer Assessment of Healthcare Providers & Systems were also collected. We conducted psychometric testing for reliability and validity. RESULTS: Over a thousand (n = 1116) national panelists completed the PRIME-ED survey, of which 58.7% were patients and 40.9% were care partners; 49.6% received care at an emergency department and 49.9% at an urgent care facility. Responses had high internal consistency within 3 patient-reported diagnostic excellence domain groupings: diagnostic process (Cronbach's alpha 0.94), accuracy of diagnosis (0.93), and communication of diagnosis (0.94). Domain groupings were significantly correlated with concurrent Emergency Department Consumer Assessment of Healthcare Providers & Systems items. Factor analyses substantiated 3 domain groupings. CONCLUSIONS: PRIME-ED has potential as a tool for capturing patient-reported diagnostic excellence in emergency and urgent care.

Freestream velocity-profile measurement in a large-scale, high-enthalpy reflected-shock tunnel.

ABSTRACT: We apply Krypton Tagging Velocimetry (KTV) to measure velocity profiles in the freestream of a large, national-scale high-enthalpy facility, the T5 Reflected-Shock Tunnel at Caltech. The KTV scheme utilizes two-photon excitation at 216.67 nm with a pulsed dye laser, followed by re-excitation at 769.45 nm with a continuous laser diode. Results from a nine-shot experimental campaign are presented where N 2 and air gas mixtures are doped with krypton, denoted as 99% N 2 /1% Kr, and 75% N 2 /20% O 2 /5% Kr, respectively. Flow conditions were varied through much of the T5 parameter space (reservoir enthalpy h R ≈ 5 - 16  MJ/kg). We compare our experimental freestream velocity-profile measurements to reacting, Navier-Stokes nozzle calculations with success, to within the uncertainty of the experiment. Then, we discuss some of the limitations of the present measurement technique, including quenching effects and flow luminosity; and, we present an uncertainty estimate in the freestream velocity computations that arise from the experimentally derived inputs to the code.

Trends in invasive disease due to Candida species following heart and lung transplantation.

Although invasive candidiasis (IC) causes significant morbidity and mortality in patients who undergo heart, lung, or heart-lung transplantation, a systematic study in a large cohort of thoracic organ transplant recipients has not been reported to date. Clinical and microbiological data were reviewed for 1305 patients who underwent thoracic organ transplantation at Stanford University Medical Center between 1980 and 2004. We identified and analyzed 76 episodes of IC in 68 patients (overall incidence 5.2% per patient).The incidence of IC was higher in lung (LTx) and heart-lung transplant (HLTx) recipients as compared with heart transplant (HTx) recipients (risk ratio [RR] 1.7, 95% confidence interval [CI] 1.1-2.7).The incidence of IC decreased over time in all thoracic organ transplant recipients, decreasing from 6.1% in the 1980-1986 time period to 2.1% in the 2001-2004 era in the HTx recipients, and from 20% in the 1980-1986 period to 1.8% in the 2001-2004 period in the LTx and HLTx recipients.The most common site of infection differed between the HTx and LTx cohorts, with bloodstream or disseminated disease in the former and tracheobronchitis in the latter. IC in the first year after transplant was significantly associated with death in both HTx (RR 2.9, 95% CI 1.8-4.6, P=0.001) and LTx and HLTx patients (RR 3.0, 95% CI 1.9-4.6, P<0.001). The attributable mortality from IC decreased during the 25-year period of observation, from 36% to 20% in the HTx recipients and from 39% to 15% in the LTx and HLTx recipients. There were a significant number of cases caused by non-albicans Candida species in all patients, with a trend toward higher mortality in the HTx group. In conclusion, the incidence and attributable mortality of IC in thoracic organ transplant recipients has significantly declined over the past 25 years.The use of newer antifungal agents for prophylaxis and treatment, the decrease in the incidence of cytomegalovirus disease, and the use of more selective immunosuppression, among other factors, may have been responsible for this change.

Endometrial cancer, obesity, and body fat distribution.

A case-control study was undertaken to evaluate the roles of obesity and body fat distribution in the etiology of endometrial cancer. The study also included an evaluation of the associations of serum estrone, estradiol, and androstenedione with obesity, body fat distribution, and endometrial cancer risk. The study included 168 cases and 334 control subjects identified at an optometry clinic. A strong, positive relationship between overall obesity and endometrial cancer was found. The relative rate of endometrial cancer for women in the upper 90th percentile of a body mass index compared to those below the median was estimated as 5.5 with 95% confidence limits of 3.2-9.6. There was no association between endometrial cancer and the waist to hip ratio, an index of upper versus lower body fat distribution. A statistical test of trend across the four quartiles of the waist to hip ratio yielded a P value of 0.45 after adjustment for confounding by the body mass index. On the other hand, there was a statistically significant, independent positive effect of a high subscapular to tricep skinfold ratio, a measure of central versus peripheral obesity, on endometrial cancer risk. The relative rates of endometrial cancer for the second, third, or fourth quartile compared to the first quartile of this index were 1.5, 1.9, and 2.7, respectively (P = 0.007), after adjustment for the body mass index. Serum estrone and estradiol, but not androstenedione, were statistically significantly correlated with the body mass index among control subjects (r = 0.37 and 0.40 for estrone and estradiol, respectively). On the other hand, each of the sex hormones was uncorrelated with the waist to hip ratio after adjustment for body mass. The correlations between each of the three hormones and the subscapular to tricep skinfold ratio among controls were weak and were not statistically significant (0.10, 0.10, and 0.14 for estrone, estradiol and androstenedione, respectively). Cases had statistically significantly higher mean serum estrogen and androstenedione levels than did controls and these elevations did not simply reflect a higher prevalence of obesity among them. The findings are equivocal with respect to fat patterns and endometrial cancer. We suggest that future epidemiological studies of cancer and body fat distribution more carefully distinguish among the various types of fat patterns.

Technetium-99m-sulfur colloid SPECT imaging in infants with suspected heterotaxy syndrome.

UNLABELLED: For the evaluation of a variety of hepatosplenic disorders, SPECT complements planar 99mTc-sulfur colloid liver/spleen imaging. By isolating small, ectopic or poorly functioning spleen(s) from overlying or adjacent liver, SPECT imaging should facilitate identification of splenic tissue in infants with suspected heterotaxy syndrome. METHODS: During a 10-yr period, 10 planar-only and 9 planar-plus-SPECT liver/spleen scans were obtained from 15 infants, 13 of whom were less than 1 mo of age at first examination. Four of the planar-only group had follow-up planar-plus-SPECT imaging. Scintigraphic diagnosis regarding presence of splenic tissue was correlated with clinical diagnosis. RESULTS: Thirteen infants had splenic tissue; two were asplenic. Planar-only imaging provided correct diagnoses in six [four with, two without spleen(s)] but was negative or equivocal in four infants. Planar-plus-SPECT imaging was positive in all in whom it was performed; moreover, in 4/13 infants (31%), splenic tissue was documented only by SPECT imaging. CONCLUSION: Particularly when planar views are inconclusive, SPECT imaging is invaluable for identification and localization of functioning splenic tissue in infants with suspected heterotaxy syndrome.

Endometrial adenocarcinoma after in utero diethylstilbesterol exposure.

The association of cervicovaginal adenocarcinoma and in utero diethylstilbesterol exposure is well known. There is concern that offspring exposed in utero may be predisposed to develop other malignancies as well. Presented is a case of endometrial adenocarcinoma occurring in this clinical setting. To the best of the authors' knowledge this association has not been reported previously.

Treatment of the small unruptured ectopic pregnancy: a cost analysis of methotrexate versus laparoscopy.

OBJECTIVE: To compare the economic costs between two strategies for management of the small unruptured ectopic pregnancy: initial treatment with methotrexate versus initial treatment with laparoscopic salpingostomy. METHODS: We assumed that both treatment strategies would result in identical clinical outcomes: resolution of the ectopic pregnancy without maternal mortality or long-term morbidity. Based on a literature review, estimates were derived for the likely clinical outcomes of a single injection of methotrexate (50 mg/m2) and for the likely clinical outcomes of the laparoscopy strategy. A range of values was evaluated for the initial success rate of each strategy and varying assumptions made about the type of treatment modality used for initial treatment failures. Direct medical costs of each strategy were estimated based on actual reimbursement rates of a third-party payer for the components of each strategy. The treatment strategies were compared in best-case/worst-case scenarios to determine the potential range of differences in costs between the two strategies. RESULTS: The cost of the methotrexate strategy ranged from $438 to $1390, and the cost of laparoscopic salpingostomy ranged from $2506 to $2974; therefore, the methotrexate strategy was less costly than laparoscopy, with a cost difference ranging from $1124 (best-case laparoscopy-worst-case methotrexate scenario) to $2536 (worst-case laparoscopy-best-case methotrexate scenario). Sensitivity analyses demonstrated that initial therapy with methotrexate was less costly over a wide range of probability and cost estimates. CONCLUSION: Initial methotrexate is a cost-effective alternative to laparoscopic salpingostomy in the treatment of the small unruptured ectopic pregnancy.

The significance of age in the colposcopic evaluation of women with atypical apanicolaou smears.

As women age, atypical Papanicolaou smears are associated with more advanced cervical neoplasia. The woman under age 30 had less than one chance in a hundred of having invasive carcinoma if she has an atypical Papanicolaou smear, while the woman over age 60 has one chance in six of this finding. An atypical Papanicolaou smear does not necessarily mean neoplasia is present; 23% of the women evaluated for atypical smears had a negative evaluation, and this included women over age 60. Endocervical currettings containing neoplastic tissue frequently are seen after age 30 and may contribute significant information to the final diagnosis; stenosis of the endocervix, however, may prevent curettage in postmenopausal women. Diagnostic conizations of the cervix rarely are necessary prior to age 30 if colposcopic technics are used. The need for conizations increases by decade of age and is required in at least one-third of postmenopausal women evaluated initially by colposcopy.

Cryosurgery of cervical intraepithelial neoplasia.

Nine hundred sixty-eight patients with cervical intraepithelial neoplasia (CIN) were evaluated with colposcopy and treated with cryosurgery; 722 had a pretreatment diagnosis of CIN I or II and 246 had CIN III. Of those patients available for 2 follow-up smears, histologically proved persistence of CIN was found in 10% of patients with CIN I and II and 20% of patients with CIN III. Recurrent disease was detected in 3.2 and 3.8%, respectively. No patients had a recurrence after 5 negative Papanicolaou smears. One patient had invasive carcinoma 30 months after treatment. Failure of patients to return for follow-up was a significant problem. When the present results were compared to those published in the literature, cryosurgery was found to be less effective than conization in treating CIN III.

The Swan-Ganz catheter and management of patients undergoing pelvic exenteration.

A Swan-Ganz catheter has been used in 10 consecutive patients undergoing pelvic exenteration and has made the intraoperative and postoperative management of these patients a much easier task. Use of this catheter eliminates the guesswork involved in managing fluid and volume status by providing an accurate assessment of left ventricular end diastolic pressure. The complication rate is reported as 5% and consists mostly of ruptured balloons, infection, coiling of the catheter, and cardiac irritability. There have been no complications in the 10 patients in whom we have used the catheter. We believe that the use of the Swan-Ganz catheter in these difficult-to-manage patients is justified because of its low complication rate, easy use, and the accurate valuable information obtained.

Clinical and histopathologic factors predicting recurrence and survival after pelvic exenteration for cancer of the cervix.

Between September 1969 and January 1, 1986, 143 pelvic exenterations for recurrent cervical cancer were performed by the gynecologic oncologists at the University of Alabama at Birmingham. Of this group, 78 patients underwent total pelvic exenteration, 63 patients had anterior exenteration, and two had posterior exenteration. The overall operative mortality rate was 6.3%, mostly associated with total pelvic exenteration. The 5-year survival rates were 50% overall, 63% with anterior exenteration and 42% with total exenteration. Univariate and multivariate analyses were performed to identify clinical and histopathologic factors predictive of prolonged survival. Using three clinical factors (duration from initial radiation therapy to exenteration, size of the central mass, and presence of preoperative sidewall fixation), low-, intermediate-, and high-risk groups were constructed; the 5-year survival rates for these groups were 82, 46, and 0%, respectively. Inclusion of one histopathologic factor (margin status of the surgical specimen) added to the ability to predict 2- and 5-year survival rates. The best candidates for cure by pelvic exenteration were those with recurrent small (less than 3 cm), mobile central masses who were a year or longer from the time of their previous radiation therapy. Attempts to resect bulky pelvic recurrences that impinge on the pelvic sidewall, especially in the case of persistent or early recurrent disease (within 6 months), or continuation of exenterative procedures in women known to have nodal metastases or extrapelvic spread, are generally futile. For those women falling between the two extremes, sound clinical and operative judgment is imperative in regard to selecting the treatment offering the best quality of life.

Cervical intraepithelial neoplasia associated with exposure to diethylstilbestrol in utero: a clinical and pathologic study.

The anatomic, colposcopic, cytologic, and histologic findings of the cervix in 300 women exposed to diethylstilbestrol (DES) in utero are reported. Structural cervical abnormalities were found in 51.7% of these patients and an abnormal colposcopic examination was present in 50.6%. The initial interpretation of the pathologic specimens revealed that 26.6% of patients had cytologic or histologic evidence of cervical dysplasia. A uniform pathologic review demonstrated that 10.8% of the cytologic specimens and 37.5% of the histologic specimens had been overread by the initial pathologist. A correlation of the review cytology and histology revealed that the Papanicolaou smear sensitivity for the prediction of abnormal histology was 83.9% and specificity was 86.3%. The probability of an atypical cytologic finding predicting an abnormal histologic pattern was highly significant (P less than .00001). Colposcopic and structural cervical abnormalities were not predictive of an abnormal histologic diagnosis. Of the 18 patients (6%) with histologic evidence of mild-moderate dysplasia, 12 have been followed with no treatment, and cytologic and colposcopic examination has been normal. Marked dysplasia-carcinoma in situ was found in 14 patients (4.7%). Their therapy is summarized. These data strongly suggest that women exposed to DES may be followed safely with Papanicolaou smears and colposcopic examinations provided that both cytopathologists and colposcopists are cognizant of the metaplastic changes in the DES progeny that distinguish them from patients with cervical intraepithelial neoplasia (CIN) who were not exposed to DES. Biopsy should be performed only if indicated by cytologic atypia, colposcopic evidence of advanced CIN, or the presence of an invasive lesion.

Correlation of perioperative morbidity and conization to radical hysterectomy interval.

Between October 1969 and December 1980, radical hysterectomies were performed on 311 patients at the University of Alabama Medical Center in Birmingham. The hospital records of these patients were reviewed for perioperative morbidity. One hundred twenty-two patients (39.2%) had had previous cold knife conization. The conization to radical hysterectomy interval varied between 48 hours and 8 weeks. An analysis of the perioperative morbidity was performed comparing patients with to those without prior conization. Previous cervical conization, regardless of the interval, was not associated with increased hospital stay, operative time, blood loss, or febrile morbidity in patients undergoing radical hysterectomy. These findings suggest that a radical hysterectomy may be safely performed after cervical conization, regardless of the intervening interval.

Surgical treatment of women found to have invasive cervix cancer at the time of total hysterectomy.

Twenty-three patients were referred after the unexpected finding of invasive cervix cancer at the time of total hysterectomy. Each was deemed a candidate for additional therapy and was treated surgically with a radical reoperation consisting of a lymphadenectomy, radical parametrectomy, and upper vaginectomy. When compared with patients undergoing radical hysterectomy at this institution, this reoperation was not technically more difficult as judged by the objective measures of operative time and blood loss. The risk of perioperative morbidity was not greater than radical hysterectomy. The surgical findings obviated the need for additional radiation therapy in more than 73% of patients. While therapy for all patients must be individualized, a radical reoperation should be considered a safe and efficacious alternative to pelvic radiation for patients who are deemed to require additional therapy in this clinical situation.

Tumor recurrence and survival in stage IB cancer of the cervix.

Clinical records of 371 women with carcinoma of the cervix, Stage IB, treated in the decade 1969-1979 were reviewed. Cancer recurred in 67 women (18.1%). A group of 171 patients treated by radiation, including 25 who were surgically staged prior to treatment, was compared to 200 patients treated by radical abdominal hysterectomy and pelvic node dissection, including 35 who had postoperative whole pelvis radiation. A multifactorial analysis included time to recurrence, site of recurrence, treatment for recurrence, and survival after recurrence. Pathology review and clinicopathological correlation included tumor configuration, histologic type, size of tumor in greatest dimension, and rate of node metastases in patients undergoing either radical hysterectomy or surgical staging procedures. Lesion size was found to be the most accurate predictor of disease-free survival; this was true whether the patient was treated by surgery or radiation and was not significantly affected by the tumor histology. Nodal metastases were associated with increasing size of lesions and predicted high recurrence rates. Node metastasis rates were not affected by the histology of the tumor.

Intraperitoneal radioimmunochemotherapy of ovarian cancer: a phase I study.

A phase I trial was designed to examine the feasibility of combining interferon and Taxol with intraperitoneal radioimmunotherapy (177Lu-CC49). Patients with recurrent or persistent ovarian cancer confined to the abdominal cavity after first line therapy, Karnofsky performance status > 60, adequate liver, renal and hematologic function, and tumor that reacted with CC49 antibody were enrolled. Human recombinant alpha interferon (IFN) was administered as 4 subcutaneous injections of 3 x 10(6) U on alternate days beginning 5 days before RIT to increase the expression of the tumor-associated antigen, TAG-72. The addition of IFN increased hematologic toxicity such that the maximum tolerated dose (MTD) of the combination was 40 mCi/m2 compared to 177Lu-CC49 alone (45 mCi/m2). Taxol, which has radiosensitizing effects as well as antitumor activity against ovarian cancer, was given intraperitoneally (i.p.) 48 hrs before RIT. It was initiated at 25 mg/m2 and escalated at 25 mg/m2 increments to 100 mg/m2. Subsequent groups of patients were treated with IFN + 100 mg/m2 Taxol + escalating doses of 177Lu-CC49. Three or more patients were treated in each dose group and 34 patients were treated with the 3-agent combination. Therapy was well tolerated with the expected reversible hematologic toxicity. The MTD for 177Lu-CC49 was 40 mCi/m2 when given with IFN + 100 mg/m2 Taxol. Interferon increased the effective whole body half-time of radioactivity and the whole body radiation dose. Taxol did not have a significant effect on pharmacokinetic or dosimetry parameters. Four of 17 patients with CT measurable disease had a partial response (PR) and 4 of 27 patients with non-measurable disease have progression-free intervals of 18+, 21+, 21+, and 37+ months. The combination of intraperitoneal Taxol chemotherapy (100 mg/m2) with RIT using 177Lu-CC49 and interferon was well tolerated, with bone marrow suppression as the dose-limiting toxicity.

The contribution of endocervical smears to cervical cancer detection.

Data from a Colposcopy Clinic have been presented in which endocervical and cervical smears were evaluated in singly and in combination for accuracy and effectiveness. In patients with marked dysplasia, carcinoma in situ and early invasive cancer, false negative results rarely occurred using either cervical or endocervical smears; more false negatives were encountered in the minimal to moderate dysplasia group of lesions. Endocervical smears were found to be unreliable in determining the distribution of cervical neoplasia when correlated with endocervical curettage specimens. These smears contributed little as supplemental screening procedures for early cervical neoplasia since less procedures for early cervical neoplasia since less than three per cent of lesions would have been missed had only a cervical scrape smear been performed. It should be pointed out, however, that this was a young population in which cervical eversion with exposure of endocervical tissue and the neoplastic lesions was the rule. The accuracy of endocervical aspiration and endocervical swab techniques was similar although there was a much higher proportion of unsatisfactory specimens with the dry cotton swab technique.

Cervical choriocarcinoma associated with an intrauterine contraceptive device: a case report.

PIP: Choriocarcinoma most commonly occurs within the uterine corpus. Just as placental implantation rarely occurs in the cervix, choriocarcinoma of the cervix is unusual. A case is presented of a 35-year old white woman, para 1-0-0-1 who had an uneventful term pregnancy 1 year prior to admission. She used an IUD and reported regular menses until 3 months prior to admission when she noted irregular bleeding. At initial examination a serum pregnancy test was positive, indicating a mass thought to be a cervical leiomyoma and bilateral cystic ovaries. Pathologic interpretation of an endocervical curettage was choriocarcinoma. At that point a hysterectomy was performed; there were no further complications and the patient subsequently received 3 additional courses of methotrexate. Cervical choriocarcionoma may develop from cervical metastases from a primary tumor in the corpus which later spontaneously regresses, malignant transformation of a cervical pregnancy, or transport of chorionic cells from a preceding pregnancy that undergo malignant transformations after a dormant period. In the nulliparous patient the conservation of reproductive function should be considered if possible.^ieng

Outpatient evaluation of patients with atypical Papanicolaou smears: contribution of endocervical curettage.

A series of 603 patients referred with atypical Papanicolaou smears was evaluated by repeat smears, colposcopically directed cervical biopsies, and endocervical curettage. These techniques as a unit can establish an accurate outpatient diagnosis superior to any of these modalities used alone and comparable with findings in conization and hysterectomy specimens. Endocervical curettage has made a unique contribution to the evaluation of such patients; these curettings have allowed examination of tissue fragments and are more reliable in diagnosing neoplasia than are endocervical smears. Invasive carcinoma and its precursors confined to the anatomic endocervical canal can be recognized by this technique, and conversely the absence of neoplastic epithelium in adequate endocervical curettings rules out occult carcinoma. Indications for conization of the cervix are discussed in reference to the other biopsy and cytologic findings, and guidelines are presented for patient management, stressing clinicopathologic correlation and cooperation.