Translation, linguistic validation and reliability of FACT-H&N questionnaire in Oral Cancer patients in Sudan.

BACKGROUND: This study aimed to translate and validate an Arabic version of the Functional Assessment of Cancer Therapy Head and Neck Scale (FACT-H&N, v-4) for use among Sudanese oral cancer patients. METHODS: The instrument underwent translation and validation following the standard FACT translation methodology. The translated instrument was pre-tested for face validity and content validity using semi-structured, in-depth interviews with ten oral cancer patients to assess acceptability. The questionnaire was pilot tested with 60 patients; reliability was tested for internal consistency with Cronbach's alpha while construct validity was tested using 'known-group validity'. RESULTS: The pre-test study revealed no major issues, apart from a reluctance to answer questions on sexual satisfaction. The FACT-H&N demonstrated good internal consistency, it considered five particular constructs: PWB, SWB, EWB, FWB and FACT-H&N, their Cronbach's α values were positive and close to 1 with values of 0.85, 0.788, 0.86, 0.895 and 0.703 respectively, indicating that the questionnaire was valid and the responses consistent. Sixty patients were asked the global health-related quality of life item, 36.3% rated their QOL as very good or good (36.3%), while 41.7% rated it as average, and 21.7% as poor or very poor. Then FACT subscale mean scores were tabulated against three categories; patients with very poor/poor recorded significantly lower scores indicating construct validity. Some psychometric properties were consistent with other FACT-H&N translations such as the Chinese, French, Pakistani and Malaysian. CONCLUSIONS: This study validates the Arabic version of the FACT-H&N. It is a reliable tool and, will assist further QoL research in other Arabic-speaking countries.

While survival rates are routinely used to evaluate treatment outcomes in oral cancer, increased understanding of the human cost of this disease highlights the need to also consider the impact of the disease and therapy on patients' quality of life (QoL). Measurement of quality of life outcomes requires a validated QoL questionnaire with proven applicability in that specific context. Little research has been undertaken on the QoL of cancer patients in Sudan and no published research exists to date on the QoL of Sudanese oral cancer patients. While an Arabic version of the FACT-G general questionnaire exists, the FACT-H&N module was not previously available in Arabic. This paper describes the translation of the FACT-H&N from English into Arabic to suit Sudanese patients and other Arabic-speaking patients, with a detailed pre-test review by 10 patients, a pilot study with 60 patients and further validation with 130 patients. This study represents the first QoL research undertaken in oral cancer patients in Sudan and provides some insight into the impact of oral cancer on their lives. Findings from this study indicate that the Arabic version of the FACT-H&N questionnaire is a valid, reliable and acceptable method for assessing health related QoL in Arabic-speaking Sudanese oral cancer patients. This work will benefit future researchers working with Arabic-speaking oral cancer patients.

Headache Management in Community Pharmacies.

Many headache patients self-medicate and choose their preferred analgesic from a range of acute analgesics available on the high-street and from community pharmacies. Little is known about their presenting symptoms, headache diagnosis and their preferred treatments. A questionnaire was distributed to community pharmacies in the Munster region of Ireland and was administered to patients requesting treatment for headache. A total of 1023 completed questionnaires were received, 76.7% (n=765) were female and 51.8% were aged 18-39 years. 53.3% (n=542) were not previously diagnosed by a GP and 49.6% (n=502) had never sought advice from a pharmacist. According to the symptoms described, 32% (n=327) had episodic migraine and a further 15.2% (n=155) had probable episodic migraine. 30.3% (n=310) had tension type headache. 10.7% (n=105) had chronic daily headache. Codeine based products were the preferred treatment choice for 43.1% (n=441). Triptans were the most effective, 68.6% (n=166), in those for whom they were previously prescribed. 11.8% (n=121) had medication-overuse. The community pharmacist is an important resource in headache management. An expanded role incorporating best practice management guidelines has the potential to improve the outcomes for many headache sufferers.

Conceiving a national head and neck cancer screening programme.

BACKGROUND: This study was undertaken to determine the optimum approach to screening for head and neck cancer based on international experiences. OBJECTIVE: To determine whether or not head and neck cancer is suitable for screening, and, if so, what the ideal approach should be. METHODS: An electronic search of online databases up to and including May 2014 was conducted. Key search terms included 'head and neck', 'cancer', 'screening', 'larynx', 'oropharynx' and 'oral'. RESULTS: Subset analysis of high-risk cohorts showed statistically significant improvements in early detection of head and neck cancer via screening. CONCLUSION: Current levels of public awareness regarding head and neck cancers are suboptimal, despite increased incidence and mortality. Scheduled and opportunistic screening, coupled with efforts to enhance education and health behaviour modification, are highly recommended for pre-defined, high-risk, targeted populations. This can enable early detection and therefore improve morbidity and mortality.

'I'll continue as long as I can, and die when I can't help it': a qualitative exploration of the views of end-of-life care by those affected by head and neck cancer (HNC).

BACKGROUND: Evidence currently suggests that many people would prefer to die at home. However, optimal end-of-life homecare depends on the patient's ability to express their care preferences, prognostic awareness, complexity of care, concordance of patient/carer preferences and availability of appropriate services/support. This study explores Irish Head and Neck Cancer (HNC) patient and caregivers' views on end-of-life care (EoLC), an area hitherto little studied. METHODS: Qualitative data were collected using semistructured, one-to-one interviews with HNC patients with therapeutic experience and their nearest caregivers (n=10, 7 patients, 3 carers). Interview topic guide was developed from the PRISMA EoLC survey. Thematic content analysis was employed to interpret findings. RESULTS: Thematic analysis identified five broad EoLC themes: prognostication, decision making, preferred focus of care/advanced care planning (ACP), preferred place of care/death, perceived barriers/supports to home death. Participants were very willing to discuss most aspects of EoLC, exhibiting no signs of distress. Patients were reluctant to discuss preferred focus-of-care and ACP. This seemed linked to an overly optimistic view of aggressive medical intervention. While carers favoured full patient involvement in decision making, patients were divided between wanting autonomy and those preferring a more passive approach. All expressed a preference for homecare, and most felt they would ideally prefer to die at home. However, decision making was considered a complex process intertwined with risks, responsibilities and commitments to others. Carer burden and symptom control were major concerns. CONCLUSIONS: Normalising discussions on EoLC may benefit those affected by HNC. However, in HNC, this needs to be done alongside discussions regarding potentially life-extending treatment, symptom management and support.

Dental health of Irish alcohol/drug abuse treatment centre residents.

OBJECTIVES: This study examines the independent and combined impact of 'alcohol only' and 'alcohol plus drug' abuse on the dental health of Irish alcohol/drug abuse treatment centre residents, comparing their dental caries experience. METHODS: Four Irish treatment centres were visited periodically over a year. Data was collected on residents' alcohol, tobacco and drug habits. Participants underwent comprehensive oral examination. RESULTS: Of 210 participants (148 males and 62 females), 53% reported an 'alcohol plus drug' abuse; 44% had an 'alcohol-only' abuse. 'Drug-only' abusers (n = 7) were excluded. Ages ranged from 18-73 with 59% aged under 40. 'Alcohol-only' abusers were significantly older than "alcohol plus drugs" abusers (p < 0.001). Mean DMFT (14.4, sd 7.3) and MT scores (7.3, sd 6.8) were above the national averages. "Alcohol-only" abusers had higher DMFT scores (p < 0.001), more missing teeth (p < 0.001) and more filled teeth (p < 0.01) than "drugs plus alcohol" abusers. DT scores did not vary significantly between study groups. Multivariate analysis confirmed the significance of gender (males OR = 2.31, p = 0.009) on DT scores and highly significant influence of age (age < 36, OR = 0.08, p < 0.001) on MT status. However, study group was not a significant influence once age was taken into consideration. CONCLUSIONS: The study reveals a high level of dental disease among Irish alcohol/drug abusers. While some authors have suggested that 'alcohol-only' abusers may experience less decay than 'alcohol plus drug' abusers, this study found no significant difference in the caries experience of the two groups once age was taken into consideration.

Prevalence of oral mucosal abnormalities in addiction treatment centre residents in Southern Ireland.

This study examines the prevalence of oral mucosal lesions and conditions among Irish addiction treatment centre residents and explores the feasibility and acceptability of a targeted oral cancer screening programme for such individuals. Four alcohol addiction treatment centres were visited periodically over a 12-month period. Two hundred and twenty residents (78% of 283 targeted) were interviewed regarding their alcohol, tobacco and drug habits (type, quantity, duration), and attitudes to dental care. Comprehensive oral examinations were performed. All potentially sinister soft tissue lesions/symptoms were referred for further investigation. Data analysis utilised SPSS-18. Ten participants who denied a history of alcohol/drug addiction were excluded from the main study. Remaining 210 participants comprised 148 males (70%) and 62 females (30%), ranging from 18 to 73 years of age, (mean 37.65; S.D. 13.82); 60% were under 40. High rates of tobacco and alcohol usage were recorded, 53% reported dual addiction (drug+alcohol), 44% alcohol only, 3% drug only. The prevalence of mucosal abnormalities was 29% with 84 mucosal abnormalities/symptoms detected in 61 subjects, comprising 28 extra-oral lesions/symptoms and 56 intra-oral lesions. Residents with mucosal abnormalities were significantly older (mean 41.8 years; S.D. 14.3) than those without such lesions (mean 35.95; S.D. 13.3), (p<0.05). Highest prevalences were noted for candidiasis (3.8%), facial scaring/laceration (3.8%), intra-oral lumps/swellings (2.9%), lymphadenopathy (2.9%) and hoarseness (1.9%). Four red areas suggestive of erythroplasia and two leukoplakic lesions were detected. Study addresses the paucity of data on the prevalence of oral mucosal lesions in addicted persons in Southern Ireland. Thirteen extra-oral lesions/symptoms and 19 intra-oral lesions were potentially significant. Despite the relatively poor follow-up compliance rate (33%), two premalignant lesions were confirmed in the main study group, yielding a detection rate of 0.9%. Results suggest that an oral cancer screening programme targeted at individuals in addiction treatment centres may provide a feasible way to access persons with a history of tobacco and alcohol abuse. A high rate of untreated disease and emergency only attendance was seen in this study suggesting a lack of engagement with GDP services. Opportunistic screening in primary care is therefore unlikely to capture this cohort. Inclusion of oral cancer screening in the routine medical examination given to residents of addiction treatment centres may provide an efficient and effective way to detect potentially malignant lesions in these high-risk individuals.

Clinical effectiveness and safety of acupuncture in the treatment of irradiation-induced xerostomia in patients with head and neck cancer: a systematic review.

BACKGROUND: Irradiation-induced xerostomia seriously reduces quality of life for patients with head and neck cancer (HNC). Anecdotal evidence suggests that acupuncture may be beneficial. OBJECTIVE: To systematically review evidence on clinical effectiveness and safety of acupuncture in irradiation-induced xerostomia in patients with HNC. METHODS: A detailed search was performed to identify randomised controlled trials (RCTs) and systematic reviews of RCTs on acupuncture in irradiation-induced xerostomia, using AMED, BNIA, CINAHL, Cochrane, Embase, HPSI, PsycInfo and Medline. Grey literature was explored and 11 journals hand searched. Search terms included: acupuncture, xerostomia, salivary hypofunction, hyposalivation, dry mouth, radiotherapy, irradiation, brachytherapy, external beam. Two authors independently extracted data for analysis using predefined selection criteria and quality indicators. RESULTS: 43 of the 61 articles identified were excluded on title/abstract. 18 articles underwent full-text review; three were deemed eligible for inclusion. Two trials had moderate risk of bias; one had high risk. Two trials compared acupuncture with sham acupuncture; one control arm received 'usual care'. Outcome measurements included salivary flow rates (SFRs) in two trials and subjective questionnaires in three. All three trials reported significant reduction in xerostomia versus baseline SFR (p<0.05); one reported greater effect in the intervention group for stimulated SFR (p<0.01). Subjective assessment reported significant differences between real acupuncture and control in two trials (p<0.02-0.05). Insufficient evidence was presented to undertake risk/benefit assessment. CONCLUSIONS: Limited evidence suggests that acupuncture is beneficial for irradiation-induced xerostomia. Although current evidence is insufficient to recommend this intervention, it is sufficient to justify further studies. Highlighted methodological limitations must be dealt with.

A national study on the attitudes of Irish dental faculty members to faculty development.

INTRODUCTION: International studies suggest that dental faculty are resistant to the concept and practice of faculty development. This paper analyses the demographic and educational profile of Irish Dental Faculty, exploring their attitudes to educational initiatives. METHODS AND MATERIALS: Irish dental faculty were invited to participate in a national study on perceived educational needs. A custom-designed questionnaire was distributed using a 'mixed-method' approach, incorporating both quantitative and qualitative components. Overall response rate was 64.6%. RESULTS: Analysis of the demographic profile of Irish dental faculty reveals a male dominated regime (64%). Whilst faculty possess many professional qualifications and extensive clinical experience, most have little or no training in how to teach. Many had attended teacher training programmes; however, 92% merely attended infrequent, informal sessions. Less than a third (30%) of the part-time staff had attended teacher training (P

International variation in the incidence of oral and pharyngeal cancer.

OBJECTIVE: An accurate epidemiological profile is a crucial component of any cancer strategy. The ongoing development of population-based cancer registries provides an invaluable information resource in this regard. Examination of international incidence levels indicates substantial geographical variation. This study assesses the precise extent of such variation. BASIC RESEARCH DESIGN: The age-standardised rates (ASRs) for oral and pharyngeal cancer (OPC) were analysed for 183 registries in the IARC/WHO publication CIFC-Volume VII. RESULTS: The median annual age-standardised incidence rates were mouth (2.3 per 100,000), tongue (2.0), lip (1.2), and salivary gland (0.6); the corresponding female rates were mouth (0.8), tongue (0.7), salivary gland (0.4) and lip (0.2). A substantial level of heterogeneity existed between registries in most instances. In the case of males, the highest ASR and the inter-quartile range of ASRs were as follows--mouth (highest rate of 12.4 per 100,000; IQR 1.4 to 3.6), tongue (max. 8.0; IQR 1.1 to 2.9), lip (max. 13.5; IQR 0.3 to 2.4) and salivary gland (max. 4.2; IQR 0.4 to 0.8). Corresponding statistics for females were also recorded. Comb graphs are used to highlight the significance of specific geographical-based trends and putative aetiological factors explored. CONCLUSIONS: This study reveals substantial international variation in the incidence rates of OPC, with up to 20-fold variation between countries in annual incidence rates for individual sites. The novel presentational technique makes this information readily accessible to non-specialists and highlights the need for disaggregation in future OPC studies.

Oral and pharyngeal cancer in Ireland.

Early diagnosis and treatment of cancer are essential to achieving a good prognosis. This is particularly true for oral and pharyngeal cancer (OPC) which accounts for over half a million new cases and 200,000 deaths worldwide per annum. Despite the high mortality and high morbidity associated with OPC, it remains a relatively unknown disease. The lack of public awareness and the low profile of this disease, even among health care professionals, are considered among the main reasons for late presentation, with 60% of cases presenting at an advanced stage. Due to the age and general medical profile of the average oral cancer patient, many attend their general physician on a regular basis. An opportunity therefore exists to increase the rate of detection of early asymptomatic lesions by opportunistic screening particularly of "high risk individuals". Furthermore, prompt recognition of symptomatic lesions has the potential to greatly enhance the outcome for these patients. The aim of this paper is to increase awareness of OPC and to highlight the need for closer interdisciplinary links between medical and dental professionals.

Patterns of disease-modifying antirheumatic drug use, medical resource consumption, and cost among rheumatoid arthritis patients.

We compared medical resource use and costs among rheumatoid arthritis (RA) patients receiving alternative disease-modifying antirheumatic drugs (DMARDs). The cohort study used data from a managed care organization. Health plan members who were prescribed DMARD therapy for at least 2 consecutive months, were age 18 years or older, had at least 6 months of DMARD-free enrollment prior to the first DMARD, and had a diagnosis of RA before or during the first month of DMARD were eligible. Median duration of initial DMARD therapy was 10 months overall: 11 months for hydroxychloroquine (n = 252), 15 months for methotrexate (n = 185), 5 months for sulfasalazine (n = 49), and 5 months for other mono/combination therapy (n = 85) (p < 0.0001). The average monthly cost of care was $853, of which $294 (34%) was for RA-coded medical services. In multivariate analyses, monthly RA-coded costs varied significantly by initial DMARD. RA costs and duration of initial therapy varied significantly by initial DMARD.

One-year costs of second-line therapies for depression.

BACKGROUND: We compared patterns of medical resource utilization and costs among patients receiving a serotonin-norepinephrine reuptake inhibitor (venlafaxine), one of the selective serotonin reuptake inhibitors (SSRIs), one of the tricyclic agents (TCAs), or 1 of 3 other second-line therapies for depression. METHOD: Using claims data from a national managed care organization, we identified patients diagnosed with depression (ICD-9-CM criteria) who received second-line antidepressant therapy between 1993 and 1997. Second-line therapy was defined as a switch from the first class of antidepressant therapy observed in the data set within 1 year of a diagnosis of depression to a different class of antidepressant therapy. Patients with psychiatric comorbidities were excluded. RESULTS: Of 981 patients included in the study, 21% (N = 208) received venlafaxine, 34% (N = 332) received an SSRI, 19% (N = 191) received a TCA, and 25% (N = 250) received other second-line antidepressant therapy. Mean age was 43 years, and 72% of patients were women. Age, prescriber of second-line therapy, and prior 6-month expenditures all differed significantly among the 4 therapy groups. Total, depression-coded, and non-depression-coded 1-year expenditures were, respectively, $6945, $2064, and $4881 for venlafaxine; $7237, $1682, and $5555 for SSRIs; $7925, $1335, and $6590 for TCAs; and $7371, $2222, and $5149 for other antidepressants. In bivariate analyses, compared with TCA-treated patients, venlafaxine- and SSRI-treated patients had significantly higher depression-coded but significantly lower non-depression-coded expenditures. Venlafaxine was associated with significantly higher depression-coded expenditures than SSRIs. However, after adjustment for potential confounding covariables in multivariate analyses, only the difference in depression-coded expenditures between SSRI and TCA therapy remained significant. CONCLUSION: After adjustment for confounding patient characteristics, 1-year medical expenditures were generally similar among patients receiving venlafaxine, SSRIs, TCAs, and other second-line therapies for depression. Observed differences in patient characteristics and unadjusted expenditures raise questions as to how different types of patients are selected to receive alternative second-line therapies for depression.

Cost effectiveness of microwave thermotherapy in patients with benign prostatic hyperplasia: part I-methods.

OBJECTIVES: To present the method used to evaluate the cost effectiveness, from the societal perspective, of transurethral microwave thermotherapy relative to medical therapy (alpha-blocking agents) and transurethral resection of the prostate (TURP) for a hypothetical cohort of 65-year-old men with moderate-to-severe benign prostatic hyperplasia (BPH) symptoms. METHODS: We constructed a decision-analytic Markov model with 25 health states describing the 3 treatments, 5 short-term clinical events, and 17 possible long-term outcomes. Each health state had an associated cost and utility. Utility weights, reflecting an individual's preference for a specific health outcome, range from 0, indicating death, to 100, indicating perfect health. Utility estimates were obtained by interviewing 13 men with moderate-to-severe BPH symptoms using the standard gamble preference measurement technique. On the basis of their risk attitudes, the patients were classified as risk averse or non-risk averse. The rates of remission, temporary and permanent adverse events, retreatment, and mortality were obtained from the Targis System (Urologix) randomized clinical trial, published reports, and a consensus panel. The costs during the 5 years after treatment initiation were estimated using national Medicare reimbursement schedules. The costs are reported in 1999 U.S. dollars. RESULTS: Eliciting utility values from patients with BPH was feasible and generated internally consistent and externally valid measures. In the non-risk-averse group, the utility value for significant remission, moderate remission, no remission, and worsening BPH symptoms without an adverse event was 99.1, 97.1, 94.4, and 87.3, respectively. As expected, the risk-averse individuals (n = 6) exhibited higher utility values than those in the non-risk-averse group (n = 7). In the non-risk-averse group, thermotherapy was the preferred treatment, and in the risk-averse group, medical therapy was preferred. In both groups, TURP was the least preferred therapy. The initial thermotherapy procedure costs without complications were estimated at $2629, and the initial TURP procedure costs without complications were estimated at $4597. Time-dependent probabilities were developed to reflect treatment durability. CONCLUSIONS: The resulting model parameters appear to be suitable for evaluating the cost effectiveness of thermotherapy relative to medical therapy and TURP in 65-year-old men with moderate-to-severe BPH symptoms.

Cost effectiveness of microwave thermotherapy in patients with benign prostatic hyperplasia: part II--results.

OBJECTIVES: To evaluate the cost effectiveness of transurethral microwave thermotherapy relative to medical therapy (alpha-blocking agents) and transurethral resection of the prostate (TURP) for patients with moderate-to-severe benign prostatic hyperplasia (BPH) symptoms. METHODS: A cost-effectiveness analysis was performed from the societal perspective for a hypothetical cohort of 65-year-old men with moderate-to-severe BPH symptoms. We calculated the incremental cost effectiveness of thermotherapy relative to medical therapy and TURP during 5 years after treatment initiation. Event probabilities were obtained from published reports, a consensus panel, and the Targis System (Urologix) randomized clinical trial. Costs were estimated using the national Medicare reimbursement schedules. Costs are reported in 1999 U.S. dollars. Total thermotherapy procedure costs were estimated at $2629. Quality-of-life and utility estimates were obtained by interviewing 13 patients with moderate-to-severe BPH symptoms. On the basis of their risk attitudes, patients were classified into risk-averse or non-risk-averse groups. The costs and health effects were discounted at 3% annually. RESULTS: In a hypothetical cohort of 10,000 non-risk-averse patients who were candidates for all three modalities, the 5-year costs were highest for patients undergoing TURP and lowest for those receiving medical therapy ($7334 and $6294, respectively). The thermotherapy group exhibited the highest 5-year utility value (53.52 quality-adjusted life-months). Compared with medical therapy, thermotherapy resulted in an additional 0.23 quality-adjusted life-months, with an incremental cost of $741. This yielded an incremental cost per quality-adjusted life-year gained of $38,664 for thermotherapy compared with medical therapy. Thermotherapy had a higher utility (difference of 1.71 quality-adjusted life-months) and lower cost (difference of $299) compared with TURP and thus was dominant over TURP. The results were similar for a hypothetical cohort of 10,000 risk-averse patients. CONCLUSIONS: From a societal perspective, thermotherapy appears to be a reasonable and cost-effective alternative to both medical and surgical treatment. However, the actual treatment decision should be based on multiple factors, only one of which is cost effectiveness.

Medical resource use and costs among rheumatoid arthritis patients receiving disease-modifying antirheumatic drug therapy.

OBJECTIVE: To identify costs among rheumatoid arthritis (RA) patients receiving alternative disease-modifying antirheumatic drug (DMARD) therapies. METHODS: Using managed care organization data, we identified members who (a) were prescribed any DMARD therapy for two consecutive months between July 1993 and February 1998, (b) were aged > or = 18 years, (c) had > or = 6 months of DMARD-free enrollment prior to the first DMARD, and (d) had a diagnosis of RA. RESULTS: The average age of the cohort (n = 571) was 51 years, and 70% were women. Mean duration of enrollment following initiation of DMARD therapy (observation period) was 19.5 months; 28.8% of patients switched DMARD regimens. The average monthly cost of care was $853, of which $294 (34%) was for RA-coded medical services. Monthly RA-coded costs varied by DMARD: hydroxychloroquine $227 (n = 252), methotrexate $340 (n = 185); sulfasalazine $233 (n = 49), and other mono/combination therapy $425 (n = 85) (P = 0.001). CONCLUSION: Costs of RA-coded care in patients receiving DMARDs are low and vary by DMARD.

Medical resource use and cost of venlafaxine or tricyclic antidepressant therapy. Following selective serotonin reuptake inhibitor therapy for depression.

OBJECTIVE: An analysis of administrative and claims data was performed to compare the resource use and costs to a managed-care organisation of venlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), versus tricyclic antidepressant (TCA) therapy, after switching from a selective serotonin reuptake inhibitor (SSRI). DESIGN: One-year costs and frequencies of all medical services, and of services coded for depression, were compared between patients who received venlafaxine and TCA therapy as second-line therapy using bivariate and multivariate statistical analyses. SETTING: Data were obtained from 9 individual health plans with more than 1.1 million covered lives affiliated with a national managed-care organisation. PATIENTS AND PARTICIPANTS: Health plan members were included if they had a diagnosis of depression between July 1993 and February 1997. They also had to have at least 2 months of prescriptions for SSRI therapy followed by at least 2 months of venlafaxine or TCA therapy, and continuous enrollment in the plan from at least 6 months prior to 12 months following initiation of venlafaxine or TCA therapy. 188 patients who received venlafaxine and 172 patients who received TCAs met the inclusion criteria. MAIN OUTCOME MEASURES AND RESULTS: Patients who received TCAs were slightly but significantly older (43 vs 40 years) than venlafaxine recipients and, during 6 months prior to initiating therapy, had significantly higher mean costs coded for depression ($US451 vs $US311) and costs not coded for depression ($US4500 vs $US2090). Psychiatrists prescribed a significantly higher proportion of venlafaxine than TCA prescriptions (46.3 vs 25.0%). Prior to adjusting for confounding characteristics, during 12 months following initiation of therapy, mean depression-coded costs were significantly higher for venlafaxine than TCA recipients ($US1948 vs $US1396) and mean costs not coded for depression were significantly lower ($US4595 vs $US6677). Overall costs were not significantly different ($US6543 for venlafaxine vs $US8073 for TCA). Significant cost differences were observed with primary care physicians as initial prescribers of second-line therapy but not with psychiatrists. However, costs between the 2 groups were similar after adjusting for confounding variables, including prior 6-month costs and initial prescriber of second-line therapy. CONCLUSIONS: Payer costs are similar among patients receiving venlafaxine and TCA therapy following SSRI therapy. Higher costs of venlafaxine pharmacotherapy relative to TCA therapy may be offset by lower costs of other medical services. Differences in prescribing patterns and costs between primary care physicians and psychiatrists warrant further investigation.

The epidemiology of rubella and congenital rubella in Australia, 1992 to 1997.

Selective rubella vaccination of schoolgirls commenced in 1971 and was followed by a significant reduction in congenital rubella. Infant vaccination with MMR was introduced in 1989 to interrupt circulation of the virus in young children, and in 1994/95 the adolescent school based rubella vaccination program was changed to MMR for both boys and girls. This report reviews the epidemiology of rubella and congenital rubella between 1992 and 1997 using reports to the National Notifiable Diseases Surveillance System (NNDSS) and the Australian Paediatric Surveillance Unit (APSU). Notification rates for rubella exceeded 20 per 100,000 in 1992, 1993 and 1995 and declined to 7.2 per 100,000 in 1997. Sixty-one per cent of notifications occurred between September and December and 68% occurred in males. The incidence rate in males aged 15-22 years peaked at 152.6 per 100,000 in 1995 reflecting the lack of immunisation in this cohort. From 1993 to 1997, 19 children were reported with congenital rubella syndrome, representing 1 in 67,000 live births. Of these, 17 had multiple defects (4 died) and 2 had deafness only. There were also 5 infants with congenital rubella infection but no defects. Australia's rate of congenital rubella syndrome exceeded that of the United Kingdom and the United States of America but this may be partly attributable to differences in reporting practices. The impact of changing the second dose of MMR vaccine to 4 years of age in 1998 will require careful monitoring.

GBF1: A novel Golgi-associated BFA-resistant guanine nucleotide exchange factor that displays specificity for ADP-ribosylation factor 5.

Expression cloning from a cDNA library prepared from a mutant CHO cell line with Golgi-specific resistance to Brefeldin A (BFA) identified a novel 206-kD protein with a Sec7 domain termed GBF1 for Golgi BFA resistance factor 1. Overexpression of GBF1 allowed transfected cells to maintain normal Golgi morphology and grow in the presence of BFA. Golgi- enriched membrane fractions from such transfected cells displayed normal levels of ADP ribosylation factors (ARFs) activation and coat protein recruitment that were, however, BFA resistant. Hexahistidine-tagged-GBF1 exhibited BFA-resistant guanine nucleotide exchange activity that appears specific towards ARF5 at physiological Mg2+concentration. Characterization of cDNAs recovered from the mutant and wild-type parental lines established that transcripts in these cells had identical sequence and, therefore, that GBF1 was naturally BFA resistant. GBF1 was primarily cytosolic but a significant pool colocalized to a perinuclear structure with the beta-subunit of COPI. Immunogold labeling showed highest density of GBF1 over Golgi cisternae and significant labeling over pleiomorphic smooth vesiculotubular structures. The BFA-resistant nature of GBF1 suggests involvement in retrograde traffic.