Objective Clinical Data Research Articles

Laparoscopic Utero-Sacral Plication Addressing Apical Vaginal Prolapse: Nothing New!

Study Objective: To describe and lend further support to a simple, effective, safe and minimally invasive surgical technique (laparoscopic uterosacral ligament plication), used to address apical vaginal prolapse. To report objective clinical data that demonstrate successful outcome. Design: Describe technique, report data on a case series from retrospective chart review and clinical interview. Setting: Antrim Area Hospital, Department of Gynaecology, Northern Ireland. Patients: 10 patients with apical vaginal prolapse underwent laparoscopic uterosacral ligament plication either as a primary procedure or as an adjunct to laparoscopic paravaginal repair or total laparoscopic hysterectomy. Intervention: The ureters are first identified and releasing incisions made medially on the uterosacral ligaments. Non-absorbable, monofilament, sutures 0 (Monosof™) are then run continuously from a posterior position, anteriorly onto the pubo-cervical fascia. Extra-corporeal sutures are then tied and tightened to shorten the uterosacral ligament, elevating the vaginal apex. Cystoscopy is performed using intravenous indigo carmine to ensure there is no ureteric injury, occlusion or kinking. Measurements and Main Results: Pelvic organ prolapse quantification (POP-Q) assessments were made pre and post operatively and at 3 months post surgery, providing an objective measurement of the surgical result. POP-Q demonstrated immediate improvement in prolapse staging of all patients. Three months to 1 year after initial operation 2 patients required further surgery to address middle compartment prolapse. These women had chosen to retain their uteri and went on to have a hysterectomy. Subjectively 8/10 (80%) patients reported a “satisfactory to excellent” result from the procedure. There were no major complications or ureteric injuries. Conclusion: This small case series demonstrates the safety and effectiveness of a laparoscopic equivalent to the vaginal apical support technique originally described by McCall in 1957.

Costs of inpatient and emergency department care for chronic obstructive pulmonary disease in an elderly Medicare population

Objective:Treatment in the hospital setting accounts for the largest portion of healthcare costs for COPD, but there is little information about components of hospital care that contribute most to these costs. The authors determined the costs and characteristics of COPD-related hospital-based healthcare in a Medicare population.MethodsUsing administrative data from 602 hospitals, 2008 costs of COPD-related care among Medicare beneficiaries age ≥65 years were calculated for emergency department (ED) visits, simple inpatient admissions and complex admissions (categorized as intubation/no intensive care, intensive care/no intubation, and intensive care/intubation) in a cross-sectional study. Rates of death at discharge and trends in costs, length of stay and readmission rates from 2005 to 2008 also were examined.Main results:There were 45,421 eligible healthcare encounters in 2008. Mean costs were $679 (SD, $399) for ED visits (n = 10,322), $7,544 ($8,049) for simple inpatient admissions (n = 25,560), and $21,098 ($46,160) for complex admissions (n = 2,441). Intensive care/intubation admissions (n = 460) had the highest costs ($45,607, SD $94,794) and greatest length of stay (16.3 days, SD 13.7); intubation/no ICU admissions had the highest inpatient mortality (42.1%). In 2008, 15.4% of patients with a COPD-related ED visit had a repeat ED visit and 15.5–16.5% of those with a COPD-related admission had a readmission within 60 days. From 2005 to 2008, costs of admissions involving intubation increased 10.4–23.5%. Study limitations include the absence of objective clinical data, including spirometry and smoking history, to validate administrative data and permit identification of disease severity.Conclusions:In this Medicare population, COPD exacerbations and related inpatient and emergency department care represented a substantial cost burden. Admissions involving intubation were associated with the highest costs, lengths of stay and inpatient mortality. This population needs to be managed and treated adequately in order to prevent these severe events.

경피적 내시경 수핵제거술 후 운동유형이 체간근력 및 요통지수에 미치는 영향

This study looked at the effects on the trunk muscle strength and the oswestry disability index(ODI) of modes of waist-hip exercise (static stability, dynamic stability, weight), after a patient was operated by percutaneous endoscopic discectomy. Furthermore, this study was implemented to provide necessary supporting data for designing a desirable future rehabilitation and exercise program for the patient with the percutaneous endoscopic discectomy, reaching the conclusions as below. 1. Trunk Muscle Strength As for the changes in trunk muscle strength by angle when measuring with the Centaur, the differences between periods per group have shown that all the three groups - static stability exercise, dynamic stability exercise and weight exercise - the trunk muscle strength on both sides increased more significantly (p.001) after exercise than before exercise, while no significant differences were present between groups per period. 2. The Oswestry Disability Index(ODI) In the differences between periods per group, all the three groups - static stability exercise, dynamic stability exercise and weight exercise - turned out to show reduction, 4, 8 and 12 weeks after exercise, more significantly (p.001) than before exercise. In the differences between groups per period, on the other hand, the weight exercise group released a significantly lower figure(p.05) 12 weeks after exercise than both groups of static and dynamic stability exercise. As examined above, different exercise programs were implemented separately, which consequently showed that, after the percutaneous endoscopic discectomy applied to a patient with extreme lateral lumbar disc herniation, those programs - the static, dynamic stability exercise and the weight exercise program - had positive effects on DITI-based trunk muscle strength the passage of time. However, this study failed to provide the most effective exercise mode among the programs by exercise mode. Therefore, we see it necessary to apply continuing, systematic and objective exercise programs, and to add the realization of data standardization to use as objective clinical data, by designing multiple methods of measurement for the patients related.

Defining higher-risk surgery

Defining the contemporary high-risk noncardiac surgical population using objective clinical outcomes data is paramount for the rational allocation of healthcare resources, truly informed patient consent and improving patient-centered outcomes. Data from independent healthcare systems have identified that the development, and consequences, of postoperative morbidity extend beyond the immediate postoperative hospital period and confer substantially increased risk of death. Cardiac insufficiency, rather than the relatively heavily explored paradigm of perioperative cardiac ischemia, is emerging as the dominant factor associated with excess risk of prolonged postoperative morbidity. The development of prospective, validated, time-sensitive morbidity data collection tools has also helped define patients at higher risk of noncardiac morbidities and short-term perioperative outcomes. Higher risk surgical patients present an increasingly major challenge for healthcare resource utilization. Detailed outcome studies using validated morbidity tools are urgently required to establish the extent to which postoperative morbidity may be predicted. Robust identification of patients at the highest risk of perioperative morbidity may permit further clinic-to-bench translational understanding of the pathophysiologic mechanisms underlying postoperative organ dysfunction. Defining the high-risk surgical patient population is as critically important for global public health planning as it is for the perioperative team.

Predicting Pregnancy after Surgery for Pelvic Endometriosis: A Multivariate Analysis Based on Objective Clinical Data

Background Endometriosis is a common disorder in women of reproductive age and is a major cause of pelvic pain and infertility. Counseling women with endometriosis about their reproductive future remains a difficult task. Because many women are diagnosed with endometriosis before any attempt to conceive, they still are not considered infertile and therefore a thorough investigation of fertility parameters is not advisable at that time. The aim of the present study was to evaluate clinical factors that are promptly available upon diagnosis, to see which of them might predict a subsequent pregnancy in women with endometriosis. Methods Surgical and clinical data were obtained from 71 women who underwent laparoscopy for endometriosis in two tertiary medical centers and responded to a follow-up interview after an average of 18 months. Data were analyzed with multivariate logistic regression. Results The only independent predictors of becoming pregnant during the follow-up period were age (adjusted odds ratio for age >30 y=0.063, 95% confidence interval [CI] 0.015–0.262, p Conclusions While women reporting acyclic pelvic pain are less likely to achieve pregnancy after endometriosis surgery, age remains the only independent, strong predictor of time to pregnancy and of becoming pregnant.

Estimating Lung Resection Risk: A Pilot Study of Trainee and Practicing Surgeons

Most surgeons believe that experience-based risk estimates for major lung resection are reliable. Elements that influence such estimates are poorly understood. Clinical vignettes were created for patients who underwent lung resection; 48 patients who had major complications were matched to 48 patients without complications. Ten senior surgical trainees and 9 practicing thoracic surgeons blinded to outcomes estimated the risk of complications using a seven-point scale (uninformed estimates). After review of a calculated risk score, risk was again estimated (informed estimates). Risk estimates did not differentiate between patient groups with and without complications (4.8 versus 4.9; p=0.94 for trainees; 4.5 versus 4.2; p=0.21 for practicing surgeons). The accuracy of predicting complications was only fair, but was better for practicing surgeons than for trainees (58% versus 51%; p=0.041). Risk estimates correlated moderately well with baseline pulmonary function and possibly with age, but not with performance status or extent of resection. Knowledge of a calculated risk score resulted in more frequent alterations of trainee risk scores, improved interobserver agreement in both groups, and aligned trainee and practicing surgeon estimates more closely. Surgeon estimates are not accurate in predicting lung resection complications using vignette-based, matched-pair methodology. Practicing surgeons and trainees base risk estimates on limited objective clinical data. Trainee estimates are more susceptible to modification by a standard risk score than are estimates of practicing surgeons. Prospective studies are necessary to further explore the etiology, accuracy, and utility of surgeon risk estimates.

Repair versus Reconstruction of the Fibular Collateral Ligament and Posterolateral Corner in the Multiligament-Injured Knee

Background Treatment of the multiligament-injured knee remains controversial. Purpose To compare clinical and functional outcomes of a consecutive series of multiligament-injured knees that underwent repair of the fibular collateral ligament (FCL) and posterolateral corner (PLC), followed by delayed cruciate ligament reconstructions, with those that had single-stage multiligament reconstruction. Study Design Cohort study; Level of evidence, 3. Methods Patients with multiligament knee injury treated by a single surgeon were identified in our prospective database. Between February 2004 and May 2005, patients underwent repair of medial- and lateral-sided injuries, followed by delayed cruciate ligament reconstructions. Between May 2005 and February 2007, patients underwent single-stage multiligament knee reconstruction. All patients followed a standard rehabilitation protocol. Inclusion criteria were minimum 2-year follow-up and multiligament knee injury including the FCL/PLC. International Knee Documentation Committee subjective and Lysholm scores and objective clinical data were documented. Results We identified 45 knees (42 patients); 17 knees (14 patients) were excluded, leaving 28 knees (28 patients) in the study. The repair/staged group (10 knees in 10 patients) had a mean follow-up of 34 months (range, 24-49 months). The reconstruction group (18 knees in 18 patients) had a mean follow-up of 28 months (range, 24-41 months). Four of the 10 FCL/PLC repairs (40%) and 1 of the 18 FCL/PLC reconstructions (6%) failed (P = .04). After revision reconstructions, there were no statistically significant differences between mean International Knee Documentation Committee subjective scores (79 vs. 77, P = .92) and mean Lysholm scores (85 vs 88, P = .92). Regression analysis showed no effect on failure based on age, sex, injury mechanism, time to surgery, interval between stages, total number of ligaments injured, or location of tear. Conclusion Our series demonstrated a statistically significant higher rate of failure for repair compared with reconstruction of the FCL/PLC. Reconstruction of the FCL/PLC structures is a more reliable option than repair alone in the setting of a multiligament knee injury.

Predicting pregnancy after surgery for pelvic endometriosis: A multivariate analysis based on objective clinical data

BackgroundEndometriosis is a common disorder in women of reproductive age and is a major cause of pelvic pain and infertility. Counseling women with endometriosis about their reproductive future re...

Evaluation of Quantitative IFN-γ Response for Risk Stratification of Active Tuberculosis Suspects

The contribution of interferon-gamma release assays (IGRAs) to appropriate risk stratification of active tuberculosis suspects has not been studied. To determine whether the addition of quantitative IGRA results to a prediction model incorporating clinical criteria improves risk stratification of smear-negative-tuberculosis suspects. Clinical data from tuberculosis suspects evaluated by the San Francisco Department of Public Health Tuberculosis Control Clinic from March 2005 to February 2008 were reviewed. We excluded tuberculosis suspects who were acid fast-bacilli smear-positive, HIV-infected, or under 10 years of age. We developed a clinical prediction model for culture-positive disease and examined the benefit of adding quantitative interferon (IFN)-gamma results measured by QuantiFERON-TB Gold (Cellestis, Carnegie, Australia). Of 660 patients meeting eligibility criteria, 65 (10%) had culture-proven tuberculosis. The odds of active tuberculosis increased by 7% (95% confidence interval [CI], 3-11%) for each doubling of IFN-gamma level. The addition of quantitative IFN-gamma results to objective clinical data significantly improved model performance (c-statistic 0.71 vs. 0.78; P < 0.001) and correctly reclassified 32% of tuberculosis suspects (95% CI,11-52%; P < 0.001) into higher-risk or lower-risk categories. However, quantitative IFN-gamma results did not significantly improve appropriate risk reclassification beyond that provided by clinician assessment of risk (4%; 95% CI, -7 to +22%; P = 0.14). Higher quantitative IFN-gamma results were associated with active tuberculosis, and added clinical value to a prediction model incorporating conventional risk factors. Although this benefit may be attenuated within highly experienced centers, the predictive accuracy of quantitative IFN-gamma levels should be evaluated in other settings.

The Case for Open Forehead Rejuvenation

To review the role of open forehead procedures in upper-face rejuvenation. The clinical records of consecutive patients undergoing a coronal or trichophytic brow-lift from July 1, 1993, to June 30, 2005, were reviewed. Patient demographics and complication rates were tabulated and compared with published rates for endoscopic brow-lifts. Patient questionnaires were sent to correlate subjective outcome measures with objective clinical record data. To obtain population-based perceptions, 200 women aged 30 to 70 years were surveyed at a local mall. A total of 628 coronal and 376 trichophytic forehead-lifts were performed for which there were clinical records. There were 6 revisions (0.57%), no hematomas, 12 cases of permanent numbness (1.20%), 7 cases of permanent alopecia (0.70%), and no cases of permanent frontal branch weakness. The adjusted response rate for the questionnaire was 64.0% (416 of 650). Open procedures in this series had a complication rate equal to or lower than published rates in endoscopic brow-lift series. Open brow-lift procedures are an effective means of upper-face rejuvenation and, when performed correctly, demonstrate high rates of patient satisfaction.

The Development of a VBHOM-based Outcome Model for Lower Limb Amputation Performed for Critical Ischaemia

Background: VBHOM (Vascular Biochemistry and Haematology Outcome Models) adopts the approach of using a minimum data set to model outcome and has been previously shown to be feasible after index arterial operations. This study attempts to model mortality following lower limb amputation for critical limb ischaemia using the VBHOM concept. Methods: A binary logistic regression model of risk of mortality was built using National Vascular Database items that contained the complete data required by the model from 269 admissions for lower limb amputation. The subset of NVD data items used were urea, creatinine, sodium, potassium, haemoglobin, white cell count, age on and mode of admission. This model was applied prospectively to a test set of data (n = 269), which were not part of the original training set to develop the predictor equation. Results: Outcome following lower limb amputation could be described accurately using the same model. The overall mean predicted risk of mortality was 32%, predicting 86 deaths. Actual number of deaths was 86 (χ2 = 8.05, 8 d.f., p = 0.429; no evidence of lack of fit). The model demonstrated adequate discrimination (c-index = 0.704). Conclusions: VBHOM provides a single unified model that allows good prediction of surgical mortality in this high risk group of individuals. It uses a small, simple and objective clinical data set that may also simplify comparative audit within vascular surgery.

The Development of a VBHOM-based Outcome Model for Lower Limb Amputation Performed for Critical Ischaemia

Background VBHOM (Vascular Biochemistry and Haematology Outcome Models) adopts the approach of using a minimum data set to model outcome and has been previously shown to be feasible after index arterial operations. This study attempts to model mortality following lower limb amputation for critical limb ischaemia using the VBHOM concept. Methods A binary logistic regression model of risk of mortality was built using National Vascular Database items that contained the complete data required by the model from 269 admissions for lower limb amputation. The subset of NVD data items used were urea, creatinine, sodium, potassium, haemoglobin, white cell count, age on and mode of admission. This model was applied prospectively to a test set of data ( n = 269), which were not part of the original training set to develop the predictor equation. Results Outcome following lower limb amputation could be described accurately using the same model. The overall mean predicted risk of mortality was 32%, predicting 86 deaths. Actual number of deaths was 86 ( χ 2 = 8.05, 8 d.f., p = 0.429; no evidence of lack of fit). The model demonstrated adequate discrimination ( c-index = 0.704). Conclusions VBHOM provides a single unified model that allows good prediction of surgical mortality in this high risk group of individuals. It uses a small, simple and objective clinical data set that may also simplify comparative audit within vascular surgery.

Painful varicocele in pediatric age: is there a correlation between pain, testicular damage and hormonal values to justify surgery?

Pain is one of the indications to treat varicocele at any age. The purpose of this study is to find a possible correlation between pain and objective testicular damage through the analysis of hormonal values. Between 1990 and 2001, varicocelectomy was performed on 44 adolescents with painful varicocele using two different techniques. Thirty-eight patients were eligible for the study. Pre- and post-operative hormonal values were analyzed retrospectively to find a possible correlation between pain and testicular damage or discomfort. The patients had to fill out a simple questionnaire about their type of pain following a two-grade rating scale. After treatment, relief of pain or persistence of symptoms were recorded. Six months after surgery 26 patients showed complete relief of pain. There was not a statistically significant correlation between grade of varicocele, type of surgery and relief of symptoms. Clinically there was not a statistically significant correlation between pain and hormonal values. Management of painful varicocele in pediatric patients should be studied through randomized trials comparing conservative and surgical treatments. While waiting for objective data supporting surgery, clinical evidence justifies varicocelectomy which, on the other hand, is not supported by objective clinical data (i.e., hormonal values).

SURGICAL MANAGEMENT OF ADULT HYDROCEPHALUS

The management of adult hydrocephalus spans a broad range of disorders and ages. Modern management strategies include endoscopic and adjustable cerebrospinal fluid shunt diversionary techniques. The assessment and management of the following clinical conditions are discussed: 1) the adult patient with congenital or childhood-onset hydrocephalus, 2) adult slit ventricle syndrome, 3) multicompartmental hydrocephalus, 4) noncommunicating hydrocephalus, 5) communicating hydrocephalus, 6) normal pressure hydrocephalus, and 7) the shunted patient with headaches. The hydrodynamics of cerebrospinal fluid shunt diversion are discussed in relation to mechanisms of under- and overdrainage conditions. A rationale for the routine implementation of adjustable valves for adult patients with hydrocephalus is provided based on objective clinical and experimental data. For the condition of normal pressure hydrocephalus, recommendations are offered regarding the evaluation, surgical treatment, and postoperative management of this disorder.

384: Are Laboratory and Objective Clinical Data Predictive of Complicated Acute Diverticulitis in Emergency Department Patients?

Acute diverticulitis has varying severity and potential for complications. If ED patients with complicated disease (perforation and/or abscess) could be identified by objective clinical and laboratory data prior to undergoing computed tomography (CT) imaging, prompt management and consultation could be initiated with the aim of minimizing morbidity.

VBHOM, a data economic model for predicting the outcome after open abdominal aortic aneurysm surgery

Vascular Biochemistry and Haematology Outcome Models (VBHOM) adopted the approach of using a minimum data set to model outcome. This study aimed to test such a model on a cohort of patients undergoing open elective and non-elective abdominal aortic aneurysm (AAA) repair. A binary logistic regression model of risk of in-hospital mortality was built from the 2002-2004 submission to the UK National Vascular Database (NVD) (2718 patients). The subset of NVD data items used comprised serum levels of urea, sodium and potassium, haemoglobin, white cell count, sex, age and mode of admission. The model was applied prospectively using Hosmer-Lemeshow methodology to a test data set from the Cambridge Vascular Unit. The validation set contained 327 patients, of whom 208 had elective AAA repair and 119 had emergency repair of a ruptured AAA. Outcome following elective and non-elective AAA repair could be described accurately using the same model. The overall mean predicted risk of death was 14.13 per cent, and 48 deaths were predicted. The actual number of deaths was 53 (chi(2) = 8.40, 10 d.f., P = 0.590; no evidence of lack of fit). The model also demonstrated good discrimination (c-index = 0.852). The VBHOM approach has the advantage of using simple, objective clinical data that are easy to collect routinely. The VBHOM data items potentially allow prediction of risk in an individual patient before aneurysm surgery.

Critical Evaluation of the Efficacy and Safety of Anticholinergics in Overactive Bladder

Antimuscarinic agents are the primary pharmacologic treatment of overactive bladder (OAB), and objective clinical data are available in a range of formats including head-to-head studies, systematic reviews and adjusted indirect comparisons. This paper reexamines the various data available on the safety and efficacy of the antimuscarinics. Clinical studies determine whether one treatment is better than another, rather than examining which treatment is best for the individual patient. Favourable treatment outcome may not be attained because of unrealistic expectations of the patient, who may also be dissatisfied with the complications of the treatment. Comparisons between clinical studies on drug therapy for OAB may be complicated by the high placebo response rates. Variations exist in the study populations in terms of symptom severity and tolerance of adverse events, and the diverse methods of assessment employed. Apart from head-to-head studies, meta-analyses can be employed to compare different classes of drugs (lumping method) or individual drugs (splitting method) by pooling of clinical data. The adjusted indirect comparison method has been developed as a method to allow the outcome of two different trials to be compared. Overall, data from clinical trials indicate that the commonly used antimuscarinics have different tolerability and safety profiles but broadly similar efficacy profiles. Consequently, therapy should be tailored to individual patient needs rather than one drug fits all.

Presbyopietherapie mit Femtosekundenlaser

Presbyopia is by far the most common refractive error worldwide, with no permanent therapeutic option available. All efforts to restore accommodation by the use of surgery have not led to a generally accepted therapy. However, there is evidence from an animal model that the use of a femtosecond (fs) laser might influence the modulus of elasticity in the lens. Fs-laser impulses can create intralenticular disruption in animal eyes as well as human cadaver lenses and improve elasticity. The concept of treating presbyopia with fs-laser requires a new, complex theory combining the optical and the mechanical aspects of accommodation in the eye. Diagnostic tools for measuring optical change in power and geometrical modification as the eye views from far to near are needed to obtain objective clinical data. A non-invasive treatment of presbyopia to restore accommodation might be possible in the future.

HEALTH-RELATED QUALITY OF LIFE (HRQL) AMONG PATIENTS WITH SARCOIDOSIS AND ITS RELATIONSHIP TO THE PATIENT FUNCTIONAL STATUS

PURPOSE: Sarcoidosis is a multisystem disorder, the range of symptoms and natural history varies tremendously. The relationship between quality of life, frequently reported symptoms and objective evaluations (PFT's, 6 min walk test) has not yet been studied.Purpose: To identify association(s) between Health Related Quality of Life scores with patients' objective clinical data. Using a cross sectional study to examine the correlation of frequently reported subjective symptoms (quality of life domains) with the 6 minute walk test and PFT's.

Renal Cell Carcinoma Recurrence After Nephrectomy for Localized Disease: Predicting Survival From Time of Recurrence

Prognostic factors for patients with metastatic renal cell carcinoma (RCC) are well established. However, the risk profile is unknown for patients with recurrent RCC after a nephrectomy for localized disease. From January 1989 to July 2005, we identified patients with localized RCC treated by nephrectomy who subsequently developed recurrent disease. We applied a validated prognostic scoring system previously developed for patients with metastatic RCC. Each patient was given a total risk score of 0 to 5, with one point for each of five prognostic variables (recurrence < 12 months after nephrectomy, serum calcium > 10 mg/dL, hemoglobin < lower limit of normal, lactate dehydrogenase > 1.5x upper limit of normal, and Karnofsky performance status < 80%). Patients were categorized into low- (score = 0), intermediate- (score = 1 to 2), and high-risk subgroups (score = 3 to 5). Our final cohort included 118 patients, with a median survival time of 21 months from the time of recurrence. Median follow-up time for survivors was 27 months. Overall survival was strongly associated with risk group category (P < .0001). Low-risk, intermediate-risk, and high-risk criteria were fulfilled in 34%, 50%, and 16% of patients, respectively. Median survival time for low-risk, intermediate-risk, and high-risk patients was 76, 25, and 6 months, respectively. Two-year overall survival rates for low-risk, intermediate-risk, and high-risk patients were 88% (95% CI, 77% to 99%), 51% (95% CI, 37% to 65%), and 11% (95% CI, 0% to 24%), respectively. At disease recurrence after nephrectomy for localized disease, a scoring system based on objective clinical and laboratory data provides meaningful risk stratification for both patient counseling and clinical trial entry.