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Treatment Characteristics (treatment + characteristic)
Selected AbstractsLaryngeal Cancer Cost Analysis: Association of Case-Mix and Treatment Characteristics With Medical Charges,THE LARYNGOSCOPE, Issue 1 2000David J. Arnold MD Abstract Objectives: To examine the relationship of various pretreatment case-mix characteristics and treatment modalities with medical charges incurred during diagnosis, treatment, and 2-year follow-up for patients with laryngeal cancer. Design: Retrospective chart review and billing record analysis. Methods: The charts and billing records of patients diagnosed with laryngeal cancer at the University of Iowa Hospitals and Clinics (UIHC) between January 1, 1991 and December 31, 1994 were reviewed. The independent variables included various pretreatment patient-mix and tumor characteristics (age, AJCC TNM clinical stage, smoking history, ASA class, and comorbidity as defined by Kaplan-Feinstein grade) as well as type of treatment. The dependent variables included total physician, office, and university hospital-based charges incurred during the pretreatment evaluation and 0- to 3-, 3- to 12-, and 12- to 24-month billing periods after the initiation of cancer-directed therapy. Total 1-year and 2-year charges were also evaluated. Univariate and multivariate analyses were used to investigate the relationships between dependent and independent variables and to develop models predictive of management charges during the individual and total billing periods. Results: Pretreatment charges showed no significant associations (P < .05) with any of the independent variables. Multiple regression analyses indicated that comorbidity, stage, and initial treatment modality were significant variables in one or more of the models predicting charges incurred during the 0- to 3-month, 3- to 12-month, total 1-year, and total 2-year billing periods. The models yielded R2 values for the total 1- and 2-year billing periods of 0.5246 and 0.5055, respectively. Conclusions: This work supports continued study of measures that may result in earlier detection of laryngeal cancer as a potential means of reducing management charges. These results also indicate that a more accurate method of stratifying the disease severity of laryngeal cancer patients for reimbursement purposes would include measurements of the severity of the index disease as well as comorbid diseases. [source] Re-Formulating Non-inferiority Trials as Superiority Trials: The Case of Binary OutcomesBIOMETRICAL JOURNAL, Issue 1 2009Valerie L. Durkalski Abstract Non-inferiority trials are conducted for a variety of reasons including to show that a new treatment has a negligible reduction in efficacy or safety when compared to the current standard treatment, or a more complex setting of showing that a new treatment has a negligible reduction in efficacy when compared to the current standard yet is superior in terms of other treatment characteristics. The latter reason for conducting a non-inferiority trial presents the challenge of deciding on a balance between a suitable reduction in efficacy, known as the non-inferiority margin, in return for a gain in other important treatment characteristics/findings. It would be ideal to alleviate the dilemma on the choice of margin in this setting by reverting to a traditional superiority trial design where a single p -value for superiority of both the most important endpoint (efficacy) and the most important finding (treatment characteristic) is provided. We discuss how this can be done using the information-preserving composite endpoint (IPCE) approach and consider binary outcome cases in which the combination of efficacy and treatment characteristics, but not one itself, paints a clear picture that the novel treatment is superior to the active control (© 2009 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Mohs Micrographic Surgery in the Treatment of Rare Aggressive Cutaneous Tumors: The Geisinger ExperienceDERMATOLOGIC SURGERY, Issue 3 2007CHADWICK JOHN THOMAS MD BACKGROUND Mohs micrographic surgery (MMS) offers high cure rates and maximum tissue preservation in the treatment of more common cutaneous malignancies, but its effectiveness in rare aggressive tumors is poorly defined. OBJECTIVE Evaluate the effectiveness of MMS in the treatment of six rare aggressive cutaneous malignancies as seen by Mohs surgeons working at a referral center. METHODS Retrospective chart review of 26,000 cases treated with MMS at the Geisinger Medical Center Department of Dermatology during a 16-year period with the following diagnoses: poorly differentiated squamous cell carcinoma (PDSCC), dermatofibrosarcoma protuberans (DFSP), microcystic adnexal carcinoma (MAC), extramammary Paget's disease (EMPD), Merkel cell carcinoma (MCC), and sebaceous carcinoma (SEB CA). Patient demographic data, tumor measurements, treatment characteristics, and marginal recurrence rates were compiled and evaluated. RESULTS The mean numbers of cases identified per year for each tumor type were as follows: PDSCC, 6.19; DFSP, 2.44; MAC, 1.63; and EMPD, 0.63. For PDSCC, 85 cases were available for follow-up with a local recurrence rate of 6% at a mean follow-up time of 45 months. For DFSP, there were 35 cases with no local recurrence at a mean follow-up of 39 months. For MAC, there were 25 cases with a local recurrence rate of 12% at a mean follow-up of 39 months. For EMPD, there were 10 cases with no local recurrences at a mean follow-up of 34 months. CONCLUSIONS Collectively, our data on PDSCC, DFSP, MAC, and EMPD, combined with other studies in the literature, show that MMS is the most effective therapy for these rare aggressive cutaneous malignancies. [source] Resource consumption and costs in Dutch patients with Type 2 diabetes mellitus.DIABETIC MEDICINE, Issue 3 2002Results from 29 general practices Abstract Aims The aims of this study were to estimate the costs incurred by Dutch patients with Type 2 diabetes, examine which patient and/or treatment characteristics are associated with costs, and estimate the medical and non-medical costs of patients with Type 2 diabetes in The Netherlands. Methods Twenty-nine Dutch general practitioners provided information on all Type 2 diabetes patients in their practice (n = 1371), information on demography, clinical characteristics, treatment type, the presence of complications and the type and amount of medical consumption during the previous 6 months. Medical costs were analysed using multivariate linear regression. Estimates of costs seen in The Netherlands were based on these results plus information from other sources regarding costs of end-stage renal disease, appliances, travel and productivity loss. Results Although only 9% of patients were hospitalized within the previous 6 months, hospitalization costs represented one-third of the medical costs, drug costs 40% and ambulatory costs 26%. Patients using insulin, patients with macrovascular complications only or in combination with microvascular complications incurred higher medical costs than other patients. Age and hyperlipidaemia were also positively related to medical costs. When these results were combined with other data sources, we estimated that patients with Type 2 diabetes are responsible for £365 500 000 (1 271 000 000 guilders) or 3.4% of the relevant parts of health care costs in 1998. The non-medical costs (travel costs, productivity costs) are limited: 52 500 000 (183 000 000 guilders). Conclusions Independent determinants of the medical costs of Type 2 diabetes in The Netherlands include age, complications, insulin use and hyperlipidaemia. Diabet. Med. 19, 246,253 (2002) [source] BDNF variability in opioid addicts and response to methadone treatment: preliminary findingsGENES, BRAIN AND BEHAVIOR, Issue 5 2008R. De Cid Brain-derived neurotrophic factor (BDNF) signaling pathways have been shown to be essential for opioid-induced plasticity. We conducted an exploratory study to evaluate BDNF variability in opioid addict responders and nonresponders to methadone maintenance treatment (MMT). We analyzed 21 single nucleotide polymorphisms (SNPs) across the BDNF genomic region. Responders and nonresponders were classified by means of illicit opioid consumption detected in random urinalysis. Patients were assessed by a structured interview (Psychiatric Research Interview for Substance and Mental Disorders (PRISM)-DSM-IV) and personality was evaluated by the Cloninger's Temperament and Character Inventory. No clinical, environmental and treatment characteristics were different between the groups, except for the Cooperativeness dimension (P < 0.001). Haplotype block analysis showed a low-frequency (2.7%) haplotype (13 SNPs) in block 1, which was more frequent in the nonresponder group than in the responder group (4/42 vs. 1/135; Pcorrected = 0.023). Fine mapping in block 1 allows us to identify a haplotype subset formed by only six SNPs (rs7127507, rs1967554, rs11030118, rs988748, rs2030324 and rs11030119) associated with differential response to MMT (global P sim = 0.011). Carriers of the CCGCCG haplotype had an increased risk of poorer response, even after adjusting for Cooperativeness score (OR = 20.25 95% CI 1.46,280.50, P = 0.025). These preliminary results might suggest the involvement of BDNF as a factor to be taken into account in the response to MMT independently of personality traits, environmental cues, methadone dosage and psychiatric comorbidity. [source] Enhancing the outcome of free latissimus dorsi muscle flap reconstruction of scalp defectsHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 1 2004FRCS(C), Joan E. Lipa MD Abstract Background. Reconstruction of scalp and calvarial defects after tumor ablation frequently requires prosthetic cranioplasty and cutaneous coverage. Furthermore, patients often have advanced disease and receive perioperative radiotherapy. We evaluated the complications of scalp reconstruction with a free latissimus dorsi muscle flap in this setting. Methods. The complications and the oncologic and aesthetic outcomes of six consecutive scalp reconstructions with a free latissimus dorsi muscle flap and skin graft in five patients with advanced cancer were retrospectively evaluated. Patient, tumor, defect, reconstructive, and other treatment characteristics were reviewed. Reconstructive and perioperative techniques intended to improve flap survival and aesthetic outcome and reduce complications in these patients. Results. All patients (52,76 years old) had recurrent tumors (sarcoma, melanoma, or squamous cell carcinoma) and received postoperative radiotherapy. The mean scalp defect size was 367 cm2, and partial-thickness or full-thickness calvarial resection was required in all six cases. No vein grafts were needed. The mean follow-up period and disease-free survival time were 18 and 13 months, respectively. Three patients died of their disease, and two survived disease free. There were no flap failures or dehiscences. Complications consisted of donor site seroma in two patients; partial skin graft loss in one patient; and radiation burns to the flap, face, and ears in one patient. Scalp contour and aesthetic outcome were very good in all cases except for the one case with radiation burns. Conclusions. Good outcomes were achieved using a free latissimus dorsi muscle flap with a skin graft for flap reconstruction in elderly patients with advanced recurrent cancers who received perioperative radiotherapy. Several technical aspects of the reconstruction technique intended to enhance the functional and aesthetic outcome and/or reduce complications were believed to have contributed to the good results. © 2004 Wiley Periodicals, Inc. Head Neck26: 46,53, 2004 [source] What Do Patients With Migraine Want From Acute Migraine Treatment?HEADACHE, Issue 2002Richard B. Lipton MD Migraine is a common chronic condition with an ever-expanding therapeutic armamentarium. As therapeutic options multiply, it is increasingly important to understand patients' attitudes and preferences regarding various treatment characteristics. Several strategies have evolved to establish treatment priorities in migraine and rationalize and prioritize end points and outcomes to meet the needs of patients. A survey of a population-based sample of migraineurs indicated that an overwhelming majority of patients consider complete relief of head pain, no recurrence, and rapid onset of action as important or very important attributes of acute migraine therapy. An analysis of the relationship between clinical end points and satisfaction found that more than 90% of patients who were pain-free at 2 hours were at least somewhat satisfied with treatment, but satisfaction was dependent on relatively rapid relief. Using a "willingness-to-pay" approach, results indicated that while patients will pay more for migraine treatment that produces rapid, consistent relief without adverse effects or recurrence, speed of complete relief is the most valued attribute. By assessing physician preferences and practices, degree of pain relief and rapid onset were identified as the most important attributes of acute therapy. Based on results from preference studies of triptans, 50% of patients cited more rapid pain relief as the most important determinant of treatment preference. Based on these various approaches, the consensus view is that both clinicians and patients desire a broad range of positive migraine treatment attributes, but rapid onset of complete pain relief is a particularly important priority. [source] Development and Validation of the Headache Needs Assessment (HANA) SurveyHEADACHE, Issue 4 2001Joyce A. Cramer BS Objective.,To develop and validate a brief survey of migraine-related quality-of-life issues. The Headache Needs Assessment (HANA) questionnaire was designed to assess two dimensions of the chronic impact of migraine (frequency and bothersomeness). Methods.,Seven issues related to living with migraine were posed as ratings of frequency and bothersomeness. Validation studies were performed in a Web-based survey, a clinical trial responsiveness population, and a retest reliability population. Headache characteristics (eg, frequency, severity, and treatment), demographic information, and the Headache Disability Inventory were used for external validation. Results.,The HANA was completed in full by 994 adults in the Web survey, with a mean total score of 77.98 ± 40.49 (range, 7 to 175). There were no floor or ceiling effects. The HANA met the standards for validity with internal consistency reliability (Cronbach , = .92, eigenvalue for the single factor = 4.8, and test-retest reliability = 0.77). External validity showed a high correlation between HANA and Headache Disability Inventory total scores (0.73, P<.0001), and high correlations with disease and treatment characteristics. Conclusions.,These data demonstrate the psychometric properties of the HANA. The brief questionnaire may be a useful screening tool to evaluate the impact of migraine on individuals. The two-dimensional approach to patient-reported quality of life allows individuals to weight the impact of both frequency and bothersomeness of chronic migraines on multiple aspects of daily life. [source] The International Quotidian Dialysis Registry: Annual report 2006HEMODIALYSIS INTERNATIONAL, Issue 3 2006Gihad E. NESRALLAH Abstract Interest in short daily and nocturnal hemodialysis (HD) regimens continues to grow worldwide. Despite growing optimism that these therapies will afford better patient outcomes over conventional HD, the current literature has not been viewed as sufficiently compelling to affect widespread implementation in most jurisdictions. Before these therapies can gain wider acceptance, larger and more rigorous studies will likely be needed. In June 2004, the Quotidian Dialysis Registry, based at the Lawson Health Research Institute at the University of Western Ontario, Canada, began recruiting patients across North America. By using an Internet-based data entry platform, patients from various centers worldwide will eventually be recruited, and studied prospectively. This paper constitutes the second annual update on patient and center recruitment, patient and treatment characteristics, and future directions for the registry. [source] Survival after recurrence of osteosarcoma: A 20-year experience at a single institutionPEDIATRIC BLOOD & CANCER, Issue 3 2006Brian D. Crompton MD Abstract Background Approximately one-third of patients with osteosarcoma who have a complete response to their initial treatment can be expected to relapse. It is important to define what host, tumor, or treatment characteristics determine outcome after relapse. We present findings in 59 patients treated at our institution from 1974 to 1996 who have relapsed one or more times after their initial response. Methods Host and tumor characteristics at diagnosis and relapse, therapeutic interventions and survival outcomes were determined from examination of medical records and a follow-up questionnaire. Results Of the 59 patients, 37 initially presented with localized disease of the extremity, 11 with localized non-extremity disease, and 11 with metastatic disease. This report focuses on those with localized disease of the extremity. For these patients, median time from original diagnosis to first recurrence was 14 months. Median survival after first recurrence was 31 months. The median post initial relapse survival was the same for patients whose first relapse occurred before or after 14 months from original diagnosis. Seventeen of 29 patients with systemic metastasis at first recurrence had complete removal of their disease and had a median post-op survival of 2.5 years, while the remaining 12 patients with no surgery, had a median survival of 2 years. Of the 37 patients who presented with primary disease only in the extremities and relapsed: 31 died (2 more than 6 years from first recurrence) and 6 are alive from 6 to 24 years from first recurrence (5 without disease and 1 with disease). Three of the five disease-free survivors had three or more relapses. Conclusion With a long follow-up time, we found 15% of patients with relapsed osteosarcoma who originally presented with localized disease in the extremity are alive with no evidence of disease at 10 years from first recurrence (Kaplan,Meier estimate). Even patients with multiple relapses may have long-term disease-free survival after salvage therapy. Chemotherapy and time to first recurrence were unrelated to survival after relapse in this study. Complete surgical removal of metastatic disease may be important for long-term survival. Pediatr Blood Cancer 2006;47:255,259. © 2005 Wiley-Liss, Inc. [source] Using medical records to supplement a claims-based comparative effectiveness analysis of antidepressants,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2010Thomas W. Croghan Abstract Purpose Because health insurance claims lack clinical information, comparative effectiveness research studies that rely on these data may be challenging to interpret and may result in biased inference. We conducted an exploratory study to determine if medical information contained in patient charts could offer clinical details that would assist in interpreting the results of a claims-based comparative effectiveness study of selective serotonin reuptake inhibitors (SSRIs). Methods Retrospective review of 457 charts of patients initiating SSRI treatment. Descriptive data elements included patient diagnosis, symptoms of depressive and anxiety disorders, provider's assessment, and medication treatment and side effects. Results Most subjects were excluded from the study because their charts were not accessible (58.7%), they did not have a follow-up visit (55.6%), providers could not be contacted (58.0%), or providers refused participation in the study (36.5%). Among those included in the study, most patients were noted to have depression, but most charts lacked information on the majority of depression symptoms at baseline and follow-up. Few concomitant symptoms, side effects, and other important clinical and treatment characteristics were recorded. Conclusions Inability to obtain charts due to plan or provider refusal, lack of available information in charts at key times in the course of illness, and missing data elements posed considerable challenges and prevented firm conclusions beyond those drawn from the parent, claims-based study. Copyright © 2010 John Wiley & Sons, Ltd. [source] Re-Formulating Non-inferiority Trials as Superiority Trials: The Case of Binary OutcomesBIOMETRICAL JOURNAL, Issue 1 2009Valerie L. Durkalski Abstract Non-inferiority trials are conducted for a variety of reasons including to show that a new treatment has a negligible reduction in efficacy or safety when compared to the current standard treatment, or a more complex setting of showing that a new treatment has a negligible reduction in efficacy when compared to the current standard yet is superior in terms of other treatment characteristics. The latter reason for conducting a non-inferiority trial presents the challenge of deciding on a balance between a suitable reduction in efficacy, known as the non-inferiority margin, in return for a gain in other important treatment characteristics/findings. It would be ideal to alleviate the dilemma on the choice of margin in this setting by reverting to a traditional superiority trial design where a single p -value for superiority of both the most important endpoint (efficacy) and the most important finding (treatment characteristic) is provided. We discuss how this can be done using the information-preserving composite endpoint (IPCE) approach and consider binary outcome cases in which the combination of efficacy and treatment characteristics, but not one itself, paints a clear picture that the novel treatment is superior to the active control (© 2009 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Three-year registry data on biological treatment for psoriasis: the influence of patient characteristics on treatment outcomeBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2009R.J.B. Driessen Summary Background, The course of biological treatment in clinical practice may be highly different from treatment schedules in clinical trials. Treatment modifications and patient characteristics may influence treatment safety and efficacy. So far, long-term results from the use of biological treatment in clinical practice are lacking. Objectives, To report short- and long-term efficacy and safety data on biologics, especially etanercept, used in daily clinical practice. Special attention has been paid to patient characteristics that may have influenced the response to therapy. Methods, Prospectively collected registry data of all patients with psoriasis treated with biologics in the Radboud University Nijmegen Medical Centre outpatient clinic were used for analysis. Patient and treatment characteristics were surveyed. Efficacy and safety of etanercept for up to 3 years were analysed. Moreover, the influence of patient characteristics on etanercept treatment response was studied. Results, The analysed cohort, consisting of 118 patients, went through 142 treatment episodes in total. Patients treated with biologics had an extensive medical history. Optimization of biological treatment was established in various ways, including treatment switches and introduction of concomitant therapies. Short-term etanercept efficacy analysis showed a mean Psoriasis Area and Severity Index (PASI) improvement at week 24 of 59·7%. No significant influence of gender, age, baseline PASI, body mass index, number of previous systemic therapies or duration of psoriasis was found on week 24 efficacy results, although trends were discernible. The efficacy of etanercept remained stable for up to 156 weeks. Long-term daily practice treatment with etanercept was only occasionally accompanied by major safety concerns. Conclusions, The current study demonstrates that etanercept is able to improve psoriasis symptoms for a considerable time, and that serious side-effects are infrequent. The influence of patient characteristics on treatment response is limited. [source] Adjuvant irradiation for cervical lymph node metastases from melanomaCANCER, Issue 7 2003Matthew T. Ballo M.D. Abstract BACKGROUND The risk of regional disease recurrence after surgery alone for lymph node metastases from melanoma is well documented. The role of adjuvant irradiation remains controversial. METHODS The medical records of 160 patients with cervical lymph node metastases from melanoma were reviewed retrospectively. Of these, 148 (93%) presented with clinically palpable lymph node metastases. All patients underwent surgery and radiation to a median dose of 30 grays (Gy) at 6 Gy per fraction delivered twice weekly. Surgical resection was either a selective neck dissection in 90 patients or local excision of the lymph node metastasis in 35 patients. Only 35 patients underwent a radical, modified radical, or functional neck dissection. RESULTS At a median follow-up of 78 months, the actuarial local, regional, and locoregional control rates at 10 years were 94%, 94%, and 91%, respectively. Univariate analysis of patient, tumor, and treatment characteristics failed to reveal any association with the subsequent rate of local or regional control. The actuarial disease-specific (DSS), disease-free, and distant metastasis-free survival (DMFS) rates at 10 years were 48%, 42%, and 43%, respectively. Univariate and multivariate analyses revealed that patients with four or more involved lymph nodes had a significantly worse DSS and DMFS. Nine patients developed a treatment-related complication requiring medical management, resulting in a 5-year actuarial complication-free survival rate of 90%. CONCLUSIONS Adjuvant radiotherapy resulted in a 10-year regional control rate of 94%. Complications for all patients were rare and manageable when they did occur. The authors recommend adjuvant irradiation for patients with extracapsular extension, lymph nodes measuring 3 cm in size or larger, the involvement of multiple lymph nodes, recurrent disease, or any patient having undergone a selective therapeutic neck dissection. Cancer 2003;97:1789,96. © 2003 American Cancer Society. DOI 10.1002/cncr.11243 [source] |