Development and validation of a claims-based measure as an indicator for disease status in patients with multiple sclerosis treated with disease-modifying drugs.

BACKGROUND: Administrative healthcare claims data provide a mechanism for assessing and monitoring multiple sclerosis (MS) disease status across large, clinically representative "real-world" populations. The estimation of MS disease status using administrative claims can be a challenge, however, due to a lack of detailed clinical information. Retrospective claims analyses in MS have traditionally used rates of MS relapses to approximate disease status. Healthcare costs may be alternate, broader claims-based indicators of disease activity because costs reflect multiple facets of care of patients with MS, and there is a strong correlation between quality of life of patients with MS and costs of the disease. This study developed, tested, and validated a healthcare cost-based measure to serve as an indicator of overall disease status in patients with MS treated with disease-modifying drugs (DMDs) utilizing administrative claims. METHODS: Using IMS Health Real World Data Adjudicated Claims - US data (January 2006-June 2013), a negative binomial regression predicted annual all-cause medical costs. Coefficients reaching statistical significance (p < 0.05) and increasing costs by ≥5% were selected for inclusion into an MS-specific severity score (scale of 0 to 100). Components of the score included rehabilitation services, altered mental state, pain, disability, stiffness, balance disorder, urinary incontinence, numbness, malaise/fatigue, and infections. Coefficient weights represented each predictor's contribution. The predictive model was derived using 50% of a random sample and tested/validated using the remaining 50%. RESULTS: Average overall predicted annual total medical cost was $11,134 (development sample, n = 11,384, vs. $10,528 actual) and $11,303 (validation sample, n = 11,385, vs. $10,620 actual). The model had consistent bias (approximately +$600 or +6% of actual costs) for both samples. In the validation sample, mean MS disease status scores were 0.24, 8.95, and 21.77 for low, medium, and high tertiles, respectively. Mean costs were most accurately predicted among less severe patients ($5243 predicted vs. $5233 actual cost for lowest tertile). CONCLUSION: The algorithm developed in this study provides an initial step to helping understand and potentially predict cost changes for a commercially insured MS population.

Burden of illness and healthcare resource use in United States patients with sporadic inclusion body myositis.

INTRODUCTION: We analyzed the burden of illness of sporadic inclusion body myositis (sIBM) patients and the costs to the healthcare system. METHODS: A retrospective cohort analysis of 333 sIBM patients aged ≥ 50 years was performed using United States (U.S.) claims data. sIBM patients were matched in a 1:5 ratio to randomly selected individuals with ≥1 healthcare encounter within the year of index date. RESULTS: sIBM patients presented with higher rates of disease- and muscle-related conditions, such as myalgia, myositis, muscle weakness, dysphagia, pneumonia, and falls. Use of healthcare resources, including physical therapy, office visits, emergency room (ER) visits, and hospitalizations, was greater in sIBM patients. This was also reflected in significantly higher overall healthcare costs in the sIBM population driven mainly by more all-cause office visits, all-cause ER visits and hospitalizations. CONCLUSIONS: sIBM imposes a substantial burden on U.S. patients in terms of additional healthcare usage and associated costs. Muscle Nerve 56: 861-867, 2017.

An analysis of dental patient safety incidents in a patient complaint and healthcare supervisory database in Finland.

OBJECTIVE: Few studies of patient harm and harm-prevention methods in dentistry exist. This study aimed to identify and characterize dental patient safety incidents (PSIs) in a national sample of closed dental cases reported to the Regional State Administrative Agencies (AVIs) and the National Supervisory Authority for Welfare and Health (Valvira) in Finland. MATERIALS AND METHODS: The sample included all available fully resolved dental cases (n = 948) during 2000-2012 (initiated by the end of 2011). Cases included both patient and next of kin complaints and notifications from other authorities, employers, pharmacies, etc. The cases analyzed concerned both public and private dentistry and included incident reports lodged against dentists and other dental-care professionals. Data also include the most severe cases since these are reported to Valvira. PSIs were categorized according to common incident types and preventability and severity assessments were based on expert opinions in the decisions from closed cases. RESULTS: Most alleged PSIs were proven valid and evaluated as potentially preventable. PSIs were most often related to different dental treatment procedures or diagnostics. More than half of all PSIs were assessed as severe, posing severe risk or as causing permanent or long-lasting harm to patients. The risk for PSI was highest among male general dental practitioners with recurring complaints and notifications. CONCLUSIONS: Despite some limitations, this register-based study identifies new perspectives on improving safety in dental care. Many PSIs could be prevented through the proper and more systematic use of already available error-prevention methods.

Making sense of the Medicare physician payment data release: uses, limitations, and potential.

In April 2014, the Centers for Medicare and Medicaid Services released a data file containing information on Medicare payments made to physicians and other providers. Though an important achievement in promoting greater health system transparency, limitations in the data have hindered key users, including consumers, payers, and providers, from discerning meaningful information from the file. This brief outlines the significance of the data release, the limitations of the dataset, the current uses of the information, and proposals for rendering the file more meaningful for public use.

Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory?

The need to align investments in health research and development (R&D) with public health demands is one of the most pressing global public health challenges. We aim to provide a comprehensive description of available data sources, propose a set of indicators for monitoring the global landscape of health R&D, and present a sample of country indicators on research inputs (investments), processes (clinical trials), and outputs (publications), based on data from international databases. Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion. Of the US$214 billion invested in high-income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non-profit organisations). Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries. This report confirms that substantial gaps in the global landscape of health R&D remain, especially for and in low-income and middle-income countries. Too few investments are targeted towards the health needs of these countries. Better data are needed to improve priority setting and coordination for health R&D, ultimately to ensure that resources are allocated to diseases and regions where they are needed the most. The establishment of a global observatory on health R&D, which is being discussed at WHO, could address the absence of a comprehensive and sustainable mechanism for regular global monitoring of health R&D.

Evaluating tools to support a new practical classification of diabetes: excellent control may represent misdiagnosis and omission from disease registers is associated with worse control.

AIMS: To conduct a service evaluation of usability and utility on-line clinical audit tools developed as part of a UK Classification of Diabetes project to improve the categorisation and ultimately management of diabetes. METHOD: We conducted the evaluation in eight volunteer computerised practices all achieving maximum pay-for-performance (P4P) indicators for diabetes; two allowed direct observation and videotaping of the process of running the on-line audit. We also reported the utility of the searches and the national levels of uptake. RESULTS: Once launched 4235 unique visitors accessed the download pages in the first 3 months. We had feedback about problems from 10 practices, 7 were human error. Clinical audit naive staff ran the audits satisfactorily. However, they would prefer more explanation and more user-familiar tools built into their practice computerised medical record system. They wanted the people misdiagnosed and misclassified flagged and to be convinced miscoding mattered. People with T2DM misclassified as T1DM tended to be older (mean 62 vs. 47 years old). People misdiagnosed as having T2DM have apparently 'excellent' glycaemic control mean HbA1c 5.3% (34 mmol/mol) vs. 7.2% (55 mmol/mol) (p<0.001). People with vague codes not included in the P4P register (miscoded) have worse glycaemic control [HbA1c 8.1% (65 mmol/mol) SEM=0.42 vs.7.0% (53mmol/mol) SEM=0.11, p=0.006]. CONCLUSIONS: There was scope to improve diabetes management in practice achieving quality targets. Apparently 'excellent' glycaemic control may imply misdiagnosis, while miscoding is associated with worse control. On-line clinical audit toolkits provide a rapid method of dissemination and should be added to the armamentarium of quality improvement interventions.

Burden of osteoporosis in adults in Korea: a national health insurance database study.

We evaluated the number of osteoporosis patients under treatment and secular trends in 2005-2008 in South Korea. We investigated nationwide data regarding the number of osteoporosis patients under treatment in South Korea using data from the Health Insurance Review and Assesment Service (HIRA), which includes nationwide information [corrected]. Reimbursement records from the HIRA database between 1 January 2004 and 31 December 2008 were investigated. Patients aged ≥30 years old with osteoporosis were identified based on a study-defined algorithm using prescription data and diagnostic codes. During the study periods, the number of patients receiving medical treatment related to osteoporosis increased from 1,034,399 to 1,392,189 for women and from 120,496 to 171,902 for men. The calculated proportion of osteoporosis patients under treatment in the general population over 50 years of age was 6.1% for men and 33.3% for women, and in the general population over 30 years of age was 2.7% for men and 16.6% for woman. More than 40% of patients (59.1% for women; 41.2% for men) were treated with medication indicated only for osteoporosis. About 4-7% of osteoporosis patients had a past medical history suggesting a secondary cause of osteoporosis. More than 80% of all osteoporosis patients were women older than 50 years, reflecting the pronounced burden of osteoporosis among postmenopausal women. This study demonstrated a substantial increasing trend in medical claims related to osteoporosis in 2005-2008 among adults in Korea and a pronounced burden of osteoporosis among postmenopausal women.

The cumulative needs for care monitor: a unique monitoring system in the south of the Netherlands.

INTRODUCTION: Patients diagnosed with severe mental illness (SMI) have a complex combination of psychiatric, somatic and social needs for care, requiring an integrated, multidisciplinary health care approach. The present paper describes the methods of the cumulative needs for care monitor (CNCM), a monitoring system in operation in a geographically defined area. METHODS: The CNCM provides information on need for care, functioning and other outcomes in SMI patients in the area. This information can be used not only to plan treatment at the individual level, but also to conduct health services research at the group level.

Health benefit costs and absenteeism due to insomnia from the employer's perspective: a retrospective, case-control, database study.

OBJECTIVE: To objectively assess the economic impact of insomnia on direct medical and prescription costs and indirect absence-related salary replacement costs and on absences and to compare the prevalence and costs of comorbidities in employees with and without insomnia. METHOD: A retrospective analysis was performed on employee data from the Human Capital Management Services Research Reference Database (January 2001-September 2007). Employees were identified as having insomnia (ICD-9 criteria) based on history of receiving medications used to treat insomnia or physician's diagnosis of insomnia. Control employees had no history of medications used to treat insomnia and no insomnia diagnosis. Annual costs and number of absences were compared using 2-part regression models, controlling for demographics, job information, geographic region, comorbid disorders, and the Charlson Comorbidity Index score. Comorbidity prevalence, costs, and services were compared. RESULTS: Data were collected for 299,188 employees (17,230 employees with insomnia and 281,958 control employees). Annual mean incremental costs were $2,053 greater (in total) for employees with insomnia compared with controls (specific increments: medical $751, drug $735, sick leave $208, short-term disability $179, long-term disability $10, and workers' compensation $170). Employees with insomnia missed a mean of 3.10 more workdays annually than those without insomnia. Nearly all comorbid conditions were more prevalent, were more costly, and resulted in a greater utilization of services in employees with insomnia compared to those without. All of the above comparisons were significant (P < .05). CONCLUSION: Insomnia was associated with increased costs, greater absenteeism, and an increased number of comorbid conditions in an employed population. Consistent with other analyses based on these data, the study estimated the annual cost of insomnia in the US civilian labor force to be approximately $15.0-17.7 billion (US dollars).

Comparison of commission on cancer-approved and -nonapproved hospitals in the United States: implications for studies that use the National Cancer Data Base.

BACKGROUND: The Commission on Cancer (CoC) designates cancer programs on the basis of the ability to provide a wide range of oncologic services and specialists. All CoC-approved hospitals are required to report their cancer diagnoses to the National Cancer Data Base (NCDB), and the cancer diagnoses at these hospitals account for approximately 70% of all new cancers diagnosed in the United States annually. However, it is unknown how CoC-approved programs compare with non-CoC-approved hospitals. METHODS: By using the American Hospital Association Annual Survey Database (2006), CoC-approved and non-CoC-approved hospitals were compared with respect to structural characteristics (ie, accreditations, geography, and oncologic services provided). RESULTS: Of the 4,850 hospitals identified, 1,412 (29%) were CoC-approved hospitals, and 3,438 (71%) were not CoC-approved hospitals. The proportion of CoC-approved hospitals varied at the state level from 0% in Wyoming to 100% in Delaware. Compared with non-CoC-approved hospitals, CoC-approved programs were more frequently accredited by the Joint Commission, designated as a Comprehensive Cancer Center by the National Cancer Institute, and affiliated with a medical school or residency program (P < .001). CoC-approved hospitals were less likely to be critical access hospitals or located in rural areas (P < .001). CoC-approved hospitals had more total beds and performed more operations per year (P < .001). CoC-approved programs more frequently offered oncology-related services, including screening programs, chemotherapy and radiation therapy services, and hospice/palliative care (P < .001). CONCLUSION: Compared with non-CoC-approved hospitals, CoC-approved hospitals were larger, were more frequently located in urban locations, and had more cancer-related services available to patients. Studies that use the NCDB should acknowledge this limitation when relevant.

Monitoramento da doença renal crônica terminal pelo subsistema de Autorização de Procedimentos de Alta Complexidade: Apac: Brasil, 2000 a 2006 / Monitoring End Stage Renal Disease through the High Complexity Procedures Authorization Subsystem: Apac: in Brazil, 2000-2006

Este estudo descreve dados gerados pelo Subsistema de Autorização de Procedimento de Alta Complexidade de Terapia Renal Substitutiva (Apac-TRS) 2000-2006 e avalia seu potencial para monitoramento da doença renal crônica terminal no Brasil. Após concatenar 2.192 arquivos da Apac-TRS e excluir pacientes repetidos, analisou-se o perfil epidemiológico dos ingressos em TRSsegundo idade, sexo, região, tratamento e causa da doença renal. Identificaram-se 148.284 pacientes em tratamento dialítico no período, sendo a incidência estimada em 119,8/1.000.000 habitantes/ano no Brasil, variando de 143,6/1.000.000/ano na Região Sul a 66,3/1.000.000/ano na Região Norte. Hipertensão foi a causa em 32.571 (22,0%), diabetes mellitus em 20.412 (13,8%), glomerulonefrites em 10.654 (7,2%) e causa indeterminada em 66.439 (44.8 %) dos casos. A incidência foi estável no período, exceto para as faixas etárias acima de 65 anos, em que se observou aumento. Apesar das limitações inerentes aos bancos de dados administrativos, a base Apac-TRS tem potencial para ser utilizada no monitoramento da doença renal crônica terminal.

This study describes data available at the High Complexity Procedures Authorization Subsystem on Renal Replacement Therapy (Apac/TRS) from 2000 to 2006 and evaluates its potential use for monitoring end stage chronic renal disease patients in Brazil. After gathering 2,192 Apac files and excluding repeated records, we have analyzed the epidemiological profile of patients initiating Renal Replacement Therapy according to age, sex, region, treatment and cause of renal disease. We have identified 148,284 patients in dialysis during the period of the study. The incidence rate was estimated as 119,8/1,000,000 inhabitants/year, varying from 143,6/1,000,000/year in the South of Brazil to 66,3/1,000,000/year in the North of the country. Hypertension was the listed cause of renal disease in 32,571 cases (22%), followed by diabetes mellitus in 20,414 cases (13.8%) and glomerulonephritis in 10,654 cases (7.2%). Undetermined cause accountedfor 66,439 of all cases (44.8%). Incidence was stable, except for those patients over 65, among whom incidence has increased. The data available at Apac/TRS demonstrate that, despite limitations due to its administrative nature, the system is potentially useful for monitoring end stage chronic renal disease patients.

Different methodological approaches to the assessment of in vivo efficacy of three artemisinin-based combination antimalarial treatments for the treatment of uncomplicated falciparum malaria in African children.

BACKGROUND: Use of different methods for assessing the efficacy of artemisinin-based combination antimalarial treatments (ACTs) will result in different estimates being reported, with implications for changes in treatment policy. METHODS: Data from different in vivo studies of ACT treatment of uncomplicated falciparum malaria were combined in a single database. Efficacy at day 28 corrected by PCR genotyping was estimated using four methods. In the first two methods, failure rates were calculated as proportions with either (1a) reinfections excluded from the analysis (standard WHO per-protocol analysis) or (1b) reinfections considered as treatment successes. In the second two methods, failure rates were estimated using the Kaplan-Meier product limit formula using either (2a) WHO (2001) definitions of failure, or (2b) failure defined using parasitological criteria only. RESULTS: Data analysed represented 2926 patients from 17 studies in nine African countries. Three ACTs were studied: artesunate-amodiaquine (AS+AQ, N = 1702), artesunate-sulphadoxine-pyrimethamine (AS+SP, N = 706) and artemether-lumefantrine (AL, N = 518).Using method (1a), the day 28 failure rates ranged from 0% to 39.3% for AS+AQ treatment, from 1.0% to 33.3% for AS+SP treatment and from 0% to 3.3% for AL treatment. The median [range] difference in point estimates between method 1a (reference) and the others were: (i) method 1b = 1.3% [0 to 24.8], (ii) method 2a = 1.1% [0 to 21.5], and (iii) method 2b = 0% [-38 to 19.3].The standard per-protocol method (1a) tended to overestimate the risk of failure when compared to alternative methods using the same endpoint definitions (methods 1b and 2a). It either overestimated or underestimated the risk when endpoints based on parasitological rather than clinical criteria were applied. The standard method was also associated with a 34% reduction in the number of patients evaluated compared to the number of patients enrolled. Only 2% of the sample size was lost when failures were classified on the first day of parasite recurrence and survival analytical methods were used. CONCLUSION: The primary purpose of an in vivo study should be to provide a precise estimate of the risk of antimalarial treatment failure due to drug resistance. Use of survival analysis is the most appropriate way to estimate failure rates with parasitological recurrence classified as treatment failure on the day it occurs.

Multiple episodes in children and adolescents with bipolar disorder: comorbidity, hospitalization, and treatment (data from a cohort of 8,129 patients of a national managed care database).

OBJECTIVE: The purpose of this study was to delineate the prevalence, demographic characteristics, comorbidity, hospitalization, and medication use of a large cohort of patients with and without multiple episodes per year. We hypothesized that children and adolescents with multiple episodes per year would have a higher comorbidity and require more hospitalizations and pharmacological treatment than their counterparts without multiple episodes. METHODS: Analysis was conducted on a cohort of 8,129 children and adolescents patients (< or = 18 y.o.) with bipolar disorders (BD), from the Integrated Healthcare Information Services (IHCIS) identified from June 30, 2000 to July 1, 2003. Demographics variables, type of hospitalization, and psychotropic medication used in the year of follow-up were compared between children and adolescents with multiple and those without multiple episodes per year. RESULTS: Included were 58 patients with multiple episodes (defined as: > or = 4 or more reports of inpatient treatment for any affective disorders per year) and 8,071 without multiple episodes. Children and adolescents with multiple episodes versus those without multiple episodes were differentiated as follows: more comorbid attention deficit disorder (ADD) (80.9% versus 29.4%) (chi2 = 70.61, df = 1, p < 0.0001); higher rate of hospital admission for depression (12.1% vs. 1.8%, chi2 = 27.86, df = 1, p < 0.0001); for other psychiatric conditions (48.3% vs. 11.2, chi2 = 74.47, df = 1, p < 0.0001) and for medical conditions (22.4% vs. 3.9%, chi2 = 46.26, df = 1, p < 0.0001). Patients with multiple episodes per year were more likely than those without multiple episodes to be given mood stabilizers (91.4% vs. 60.3%, chi2 = 22.02, df = 1, p < 0.0001), antidepressants (79.3% vs. 59.2%, chi2 = 8.82, df = 1, p = .0003), and antipsychotics (89.7% vs. 45.8%, chi2 = 42.91, df = 1, p < 0.0001). The use of stimulants did not differ between the two groups (24.1% vs. 23.0%), chi2 = 0.02, df = 1, p = 0.96). CONCLUSIONS: Our findings support previous studies demonstrating that children and adolescents with multiple episodes per year present a higher comorbidity and require more hospitalizations and pharmacological treatment than those without multiple episodes. The diagnosis and treatment of children and adolescents with BD will have to take into account the high comorbidity of ADD mainly in children and adolescents with multiple episodes. Future prospective studies will help to better characterize the impact of multiple episodes in the course of pediatric BD and facilitate appropriate treatment strategies.

What can we learn about patient safety from information sources within an acute hospital: a step on the ladder of integrated risk management?

OBJECTIVE: To assess the utility of data already existing within hospitals for monitoring patient safety. SETTING: An acute hospital in southern England. DESIGN: Mapping of data sources proposed by staff as potentially able to identify patient safety issues followed by an in-depth analysis of the content of seven key sources. Data source analysis: For each data source: scope and depth of content in relation to patient safety, number and type of patient safety incidents identified, degree of overlap with incidents identified by different sources, levels of patient harm associated with incidents. RESULTS: A wide range of data sources existing within the hospital setting have the potential to provide information about patient safety incidents. Poor quality of coding, delays in reports reaching databases, the narrow focus of some data sources, limited data-collection periods and lack of central collation of findings were some of the barriers to making the best use of routine data sources for monitoring patient safety. An in-depth analysis of seven key data sources (Clinical Incident database, Health and Safety Incident database, Complaints database, Claims database and Inquest database, the Patient Administration System and case notes) indicated that case notes have the potential to identify the largest number of incidents and provide the richest source of information on such incidents. The seven data sources identified different types of incidents with differing levels of patient harm. There was little overlap between the incidents identified by different sources. CONCLUSION: Despite issues related to the quality of coding, depth of information available and accessibility, triangulating information from more than one source can identify a broader range of incidents and provide additional information related to professional groups involved, types of patients affected and important contributory factors. Such an approach can provide a focus for further work and ultimately contributes to the identification of appropriate interventions that improve patient safety.

High-frequency users of detoxification: who are they?

Utilizing a longitudinal database (1996-2002) with all intake information from entries to all licensed drug treatment programs in Massachusetts (N = 27,801), this study examined factors associated with multiple detoxification admissions by injection drug users (IDUs). Four logistic regression models were developed. Although our hypothesis was that the highest frequency treatment users (in the 95th percentile) would be those in the detoxification-only group, this was incorrect: the highest frequency detoxification users were those most likely to use detoxification along with methadone maintenance, outpatient counseling, and/or residential treatment. Health insurance was a key factor. Study implications, limitations, and future research directions are noted.

Results of an assessment of information needs among speech-language pathologists and audiologists in Idaho.

OBJECTIVES: The research assesses the information needs of speech-language pathologists (SLPs) and audiologists in Idaho and identifies specific needs for training in evidence-based practice (EBP) principles and searching EBP resources. METHODS: A survey was developed to assess knowledge and skills in accessing information. Questionnaires were distributed to 217 members of the Idaho Speech-Language-Hearing Association, who were given multiple options to return the assessment survey (web, email, mail). Data were analyzed descriptively and statistically. RESULTS: The total response rate was 38.7% (84/217). Of the respondents, 87.0% (73/84) indicated insufficient knowledge and skills to search PubMed. Further, 47.6% (40/84) indicated limited knowledge of EBP. Of professionals responding, 52.4% (44/84) reported interest in learning more about EBP and 47.6% (40/84) reported interest in learning to search PubMed. SLPs and audiologists who graduated within the last 10 years were more likely to respond online, while those graduating prior to that time preferred to respond via hard copy. DISCUSSIONS/CONCLUSION: More effort should be made to ensure that SLPs and audiologists develop skills in locating information to support their practice. Results from this information needs assessment were used to design a training and outreach program on EBP and EBP database searching for SLPs and audiologists in Idaho.

Methods for causality assessment of adverse drug reactions: a systematic review.

Numerous methods for causality assessment of adverse drug reactions (ADRs) have been published. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. We conducted electronic searches in MEDLINE (via PubMed), EMBASE and the Cochrane databases to find all assessment methods. Thirty-four different methods were found, falling into three broad categories: expert judgement/global introspection, algorithms and probabilistic methods (Bayesian approaches). Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. As a result of problems of reproducibility and validity, no single method is universally accepted. Different causality categories are adopted in each method, and the categories are assessed using different criteria. Because assessment methods are also not entirely devoid of individual judgements, inter-rater reliability can be low. In conclusion, there is still no method universally accepted for causality assessment of ADRs.

The effectiveness of group cognitive behaviour therapy for unipolar depressive disorders.

This paper evaluates the effectiveness of group cognitive behaviour therapy (GCBT) as an intervention for unipolar depressive disorders. PsychINFO and PubMed databases were selected to generate the 34 papers used for this review. Our results showed that effect sizes for GCBT over the control conditions range from small (0.1) to large (2.87) with the mean effect size of 1.10. The pre-post treatment effect sizes for GCBT range from 0.30 to 3.72 with a mean of 1.30. Convergent evidence was demonstrated across different outcome measures of GCBT. Our findings indicated that GCBT yielded outcomes better than no-treatment controls and was comparable with other treatments (including both bona fide and non-bona fide comparison treatments). It was concluded that GCBT was effective for the treatment of Unipolar depression and thus can be used with confidence. There is now an urgent need to develop and evaluate a coherent GCBT theory, in particular the roles of group processes in GCBT, before further major advancement in this area can be made.

Impact of outcomes research on the management of vascular surgery patients.

Vascular surgery has traditionally relied on prospective, randomized clinical trials, case-control series from single institutions of excellence, and case studies to guide clinical decision-making. However, the use of a number of new clinical research tools has allowed the vascular surgeon to more critically assess the indications for particular operations, the costs of various procedures from both a monetary and quality-of-life standpoint, and the "real world" outcomes that can be expected from practitioners across the United States, not just from centers of excellence. Decision analysis with modeling of cohorts with desired characteristics and vascular disease has allowed for the objective determination of procedural cost-effectiveness and evaluation of patient quality-of-life issues surrounding vascular procedures. The use of large national administrative databases has yielded important information concerning factors associated with improved outcomes after several vascular procedures across the entire United States, especially after relatively uncommon operations, such as thoracoabdominal aortic aneurysm repair. Administrative data have also enabled us to learn that access to various new endovascular procedures is somewhat limited, especially for the uninsured or poor. Hospital and surgeon volume, as a surrogate marker for quality, has been directly correlated with lower morbidity and mortality as well as differences in perioperative complications after multiple vascular procedures. A certificate of added qualification in General Vascular Surgery has also been shown to improve outcomes in patients undergoing vascular procedures. Finally, pioneered by the Veteran's Affairs administration and championed by the American College of Surgeons, prospectively collected data (National Surgery Quality Improvement Program) from the Veteran's Affairs and private sector hospitals is providing high-quality, risk-adjusted feedback about multiple vascular procedures to the hospital and the individual practitioner. Importantly, the body of literature generated using these new clinical research tools is being monitored by insurers and patients, as well as by the surgeons providing the care. This ultimately will have a direct impact on practice and referral patterns. It is therefore mandatory that vascular surgeons understand these new tools so that we can police our own practices before others, such as insurance companies and hospital administrators, do it for us.

Role of radiologic imaging at the time of initial diagnosis of stage T1b-T3b melanoma.

BACKGROUND: In patients with T1b-T3b cutaneous melanoma the utility of radiologic imaging at the time of diagnosis is unclear. Whether initial imaging led to a change in stage or treatment plan was investigated. METHODS: The melanoma database was searched for patients with T1b-T3b primary lesions, clinically N0, and asymptomatic for metastatic disease. Radiologic studies conducted before wide local excision +/- sentinel lymph node biopsy as well as all further imaging and investigations were analyzed. Outcome measures included upstaging, change in initial surgical management, true-positive, false-positive, true-negative, and false-negative rates of each imaging modality. RESULTS: In all, 344 preoperative imaging studies (chest x-ray [CXR], computed tomography [CT], positron emission tomography [PET]/CT) were performed on 158 patients, resulting in 49 findings suspicious for metastatic melanoma and 134 findings suggestive of nonmelanoma pathology. Only 1 of 344 (0.3%) studies, a PET/CT, correlated with confirmed metastatic melanoma. The false-positive rates were CXR 5 of 7 (71.4%), chest CT 21 of 24 (87.5%), abdomen/pelvis CT 10 of 11 (90.9%), head CT 2 of 2 (100.0%), PET/CT 3 of 5 (60.0%). No patient was upstaged or had a change in initial surgical management based on preoperative imaging. The cost of all initial imaging and imaging to follow-up abnormal findings was estimated as $555,308 for the 158 patients studied. CONCLUSIONS: Imaging at the time of initial diagnosis of T1b-T3b, clinically N0, M0 melanoma was of low yield with a high false-positive rate, and did not lead to upstaging or change in initial surgical management. These findings suggest that imaging of asymptomatic patients at the time of diagnosis may not be warranted.