Registry-derived stage (RD-Stage) for capturing cancer stage at diagnosis for endometrial cancer.

BACKGROUND: Capture of cancer stage at diagnosis is important yet poorly reported by health services to population-based cancer registries. In this paper we describe current completeness of stage information for endometrial cancer available in Australian cancer registries; and develop and validate a set of rules to enable cancer registry medical coders to calculate stage using data available to them (registry-derived stage or 'RD-Stage'). METHODOLOGY: Rules for deriving RD-stage (Endometrial carcinoma) were developed using the American Joint Commission on Cancer (AJCC) TNM (tumour, nodes, metastasis) Staging System (8th Edition). An expert working group comprising cancer specialists responsible for delivering cancer care, epidemiologists and medical coders reviewed and endorsed the rules. Baseline completeness of data fields required to calculate RD-Stage, and calculation of the proportion of cases for whom an RD stage could be assigned, was assessed across each Australian jurisdiction. RD-Stage (Endometrial cancer) was calculated by Victorian Cancer Registry (VCR) medical coders and compared with clinical stage recorded by the patient's treating clinician and captured in the National Gynae-Oncology Registry (NGOR). RESULTS: The necessary data completeness level for calculating RD-Stage (Endometrial carcinoma) across various Australian jurisdictions varied from 0 to 89%. Three jurisdictions captured degree of spread of cancer, rendering RD-Stage unable to be calculated. RD-Stage (Endometrial carcinoma) could not be derived for 64/485 (13%) cases and was not captured for 44/485 (9%) cases in NGOR. At stage category level (I, II, III, IV), there was concordance between RD-Stage and NGOR captured stage in 393/410 (96%) of cases (95.8%, Kendall's coefficient = 0.95). CONCLUSION: A lack of consistency in data captured by, and data sources reporting to, population-based cancer registries meant that it was not possible to provide national endometrial carcinoma stage data at diagnosis. In a sample of Victorian cases, where surgical pathology was available, there was very good concordance between RD-Stage (Endometrial carcinoma) and clinician-recorded stage data available from NGOR. RD-Stage offers promise in capturing endometrial cancer stage at diagnosis for population epidemiological purposes when it is not provided by health services, but requires more extensive validation.

Impulsivity and Treatment Outcomes in Individuals with Cocaine Use Disorder: Examining the Gap between Interest and Adherence.

Background: Impulsivity is implicated in the development and maintenance of Cocaine Use Disorder (CUD). Less work has examined impulsivity's role on interest in initiating treatment, treatment adherence, or treatment response. No pharmacotherapies are approved for CUD, so efforts to understand and bolster the effects of psychotherapy are important in guiding and refining treatment. The present study examined the impact of impulsivity on interest in treatment, treatment initiation, treatment adherence, and treatment outcomes in individuals with CUD. Methods: Following the completion of a larger study on impulsivity and CUD participants were offered 14 sessions of (12 weeks) Cognitive Behavioral Relapse Prevention (CBT-RP). Before starting treatment, participants completed seven self-report and four behavioral measures of impulsivity. Sixty-eight healthy adults (36% female) with CUD (aged 49.4 ± 7.9) expressed an interest in treatment. Results: Greater scores on several self-report measures of impulsivity, and fewer difficulties with delayed gratification were associated with increased interest in treatment in both males and females. 55 participants attended at least 1 treatment session, while 13 participants did attend a single session. Individuals who attended at least one treatment session scored lower on measures of lack of perseverance and procrastination. Still, measures of impulsivity did not reliably predict session attendance nor the frequency of cocaine-positive urine samples throughout treatment. Males attended nearly twice as many treatment sessions as females despite nonsignificant associations between impulsivity in males and the number of sessions attended. Conclusions: Greater impulsivity in individuals with CUD was associated with expressing an interest in treatment, but not treatment adherence or response.

Gabapentin increases the abuse liability of alcohol alone and in combination with oxycodone in participants with co-occurring opioid and alcohol use disorder.

BACKGROUND: People who have co-occurring Alcohol Use Disorder (AUD) and Opioid Use Disorder (OUD) carry a higher risk of adverse outcomes, including drug overdose. Early clinical and preclinical studies suggested that gabapentin may be effective in treating both disorders. The present study was designed to assess the effects of gabapentin on the subjective and physiological effects of oxycodone (OXY) and alcohol (ALC), alone and in combination. METHODS: During an 8-week, inpatient, within-subject, randomized, double-blind, placebo-controlled crossover study, non-treatment seeking participants (N = 13; 12 M/1F; 44.1 ± 3 years of age) with OUD and AUD were maintained on oral morphine (120 mg daily). Under gabapentin (1800 mg/day) and placebo (0 mg/day) maintenance, participants completed nine separate test sessions (three sessions per week) during which they received an oral solution containing 0, 15, or 30 mg/70 kg OXY in combination with 0, 0.5, or 0.75 g/kg ALC. During test sessions, subjective effects and physiological responses were assessed repeatedly on 100-mm visual analog scales (VAS). The primary outcome variable was the VAS rating of drug liking after receiving the drug challenge. RESULTS: Alcohol alone (but not oxycodone alone) produced dose-related increases in several positive subjective responses, including drug liking. Gabapentin significantly increased drug liking when given in combination with ALC and OXY + ALC (p < 0.05). Gabapentin did not clinically compromise respiration or other vital functions. CONCLUSIONS: Gabapentin may increase the abuse liability of ALC and OXY + ALC in those with co-occurring OUD and AUD.

(Dis)concordance of comorbidity data and cancer status across administrative datasets, medical charts, and self-reports.

BACKGROUND: Benchmarking outcomes across settings commonly requires risk-adjustment for co-morbidities that must be derived from extant sources that were designed for other purposes. A question arises as to the extent to which differing available sources for health data will be concordant when inferring the type and severity of co-morbidities, how close are these to the "truth". We studied the level of concordance for same-patient comorbidity data extracted from administrative data (coded from International Classification of Diseases, Australian modification,10th edition [ICD-10 AM]), from the medical chart audit, and data self-reported by men with prostate cancer who had undergone a radical prostatectomy. METHODS: We included six hospitals (5 public and 1 private) contributing to the Prostate Cancer Outcomes Registry-Victoria (PCOR-Vic) in the study. Eligible patients from the PCOR-Vic underwent a radical prostatectomy between January 2017 and April 2018.Health Information Manager's in each hospital, provided each patient's associated administrative ICD-10 AM comorbidity codes. Medical charts were reviewed to extract comorbidity data. The self-reported comorbidity questionnaire (SCQ) was distributed through PCOR-Vic to eligible men. RESULTS: The percentage agreement between the administrative data, medical charts and self-reports ranged from 92 to 99% in the 122 patients from the 217 eligible participants who responded to the questionnaire. The presence of comorbidities showed a poor level of agreement between data sources. CONCLUSION: Relying on a single data source to generate comorbidity indices for risk-modelling purposes may fail to capture the reality of a patient's disease profile. There does not appear to be a 'gold-standard' data source for the collection of data on comorbidities.

"Prostate cancer is far more hidden ": Perceptions of stigma, social isolation and help-seeking among men with prostate cancer.

The purpose of this study was to provide in-depth insight into men's experiences of prostate cancer, specifically: perceived stigma and self-blame, social isolation, unmet need and help-seeking. A qualitative descriptive approach was used. Semi-structured interviews were undertaken with 20 men diagnosed with prostate cancer, and thematic analysis was undertaken. Some participants perceived a stigma associated with prostate cancer and cancer in general, which sometimes acted as a barrier to disclosure. Self-blame and internalisation of cause was not a prominent issue. Participants' descriptions of emotional distress, social isolation and anxiety demonstrated the impact of prostate cancer. Social isolation was most commonly reported as a physical consequence of treatment and/or side effects. Participants felt both support and ongoing care were limited at post-treatment. Most did not seek or receive help for emotional or psychosocial problems from a formal source due to anticipated awkwardness, autonomous coping, not burdening others, unwanted sympathy and retaining privacy. Prostate cancer can cause considerable emotional and social burden for some men, and many are unlikely to seek or receive help. Men, and their support networks, require active encouragement throughout diagnosis, treatment and follow-up to overcome barriers and access additional support, particularly for sexual, emotional and psychosocial issues.

Oncological outcomes in an Australian cohort according to the new prostate cancer grading groupings.

BACKGROUND: A new 5-tiered grading grouping system has recently been endorsed for reporting of prostate cancer (PCa) grade to better reflect escalating risk of progression and cancer death. While several validations of the new grade groupings have been undertaken, most have involved centralised pathological review by specialist urological pathologists. METHODS: Participants included 4268 men with non-metastatic PCa diagnosed between 2006 and 2013 from the multi-institutional South Australia Prostate Cancer Clinical Outcomes Collaborative registry. PCa-specific survival and biochemical recurrence-free survival were compared across the five grade groups using multivariable competing risk regression. RESULTS: For the entire cohort, risk of PCa death increased with increasing grade groups (at biopsy) Adjusted subdistribution-hazard ratios [sHR] and 95% confidence intervals [95%CI] were: 2.2 (1.5-3.6); 2.5 (1.6-4.2); 4.1 (2.6-6.7) and 8.7 (4.5-14.0) for grade groups II (pattern 3 + 4), III (pattern 4 + 3), IV (total score 8) and V (total score 9-10) respectively, relative to grade group I (total score < =6). Clear gradients in risk of PCa death were observed for radical prostatectomy (RP), but were less clear for those who had radiotherapy (RT) with curative intent and those who were managed conservatively. Likewise, risk of biochemical recurrence increased across grade groups, with a strong and clear gradient for men undergoing RP [sHR (95%CI): 2.0 (1.4-2.8); 3.8 (2.9-5.9); 5.3 (3.5-8.0); 11.2 (6.5-19.2) for grade groups II, III, IV and V respectively, relative to grade group I], and a less clear gradient for men undergoing RT. CONCLUSION: In general, the new five-tiered grade groupings distinguished PCa survival and recurrence outcomes for men with PCa. The absence of a clear gradient for RT may be due to heterogeneity in this patient group.

Need for a roadmap for development of a coordinated national registry programme.

Clinical quality registries are an overlooked and under-funded arm of clinical research in Australia. Registries are databases for patients with a particular disease, or who undergo a procedure, or use a health resource. Registries, where properly funded and universally adopted, have provided substantial benefits to the quality of healthcare and, in some cases, have had demonstrable effect in reducing costs. There is a lack of a coordinated programme for both funding and development of registries in Australia. A coordinated effort is required to address key gaps in registry coverage and ensure registries comply with appropriate technical and operating principles, and target areas where registries can add value to the health system. This will ensure that Australia is competitive with its international peers in this dynamic environment.

The Victorian Lung Cancer Registry pilot: improving the quality of lung cancer care through the use of a disease quality registry.

BACKGROUND: Lung cancer remains a major disease burden in Victoria (Australia) and requires a complex and multidisciplinary approach to ensure optimal care and outcomes. To date, no uniform mechanism is available to capture standardized population-based outcomes and thereby provide benchmarking. The establishment of such a data platform is, therefore, a primary requisite to enable description of process and outcome in lung cancer care and to drive improvement in the quality of care provided to individuals with lung cancer. MATERIALS AND METHODS: A disease quality registry pilot has been established to capture prospective data on all adult patients with clinical or tissue diagnoses of small cell and non-small cell lung cancer. Steering and management committees provide clinical governance and supervise quality indicator selection. Quality indicators were selected following extensive literature review and evaluation of established clinical practice guidelines. A minimum dataset has been established and training and data capture by data collectors is facilitated using a web-based portal. Case ascertainment is established by regular institutional reporting of ICD-10 discharge coding. Recruitment is optimized by provision of opt-out consent. RESULTS: The collection of a standardized minimum data set optimizes capacity for harmonized population-based data capture. Data collection has commenced in a variety of settings reflecting metropolitan and rural, and public, and private health care institutions. The data set provides scope for the construction of a risk-adjusted model for outcomes. A data access policy and a mechanism for escalation policy for outcome outliers has been established. CONCLUSIONS: The Victorian Lung Cancer Registry provides a unique capacity to provide and confirm quality assessment in lung cancer and to drive improvement in quality of care across multidisciplinary stakeholders.

A survey of Australian clinical registries: can quality of care be measured?

BACKGROUND: Clinical quality registries gather and analyse information to monitor and enhance the quality of care received by patients. The aim of the present study was to determine the attributes of Australian clinical registries to identify their capacity to accurately assess quality of care. METHODS: A survey was distributed to registry custodians managing multi-site clinical outcome registries. They were asked to self-report on general aspects of registries, including coverage, length of operation, data collection process, data management, quality of data and registry governance structures. RESULTS: A total of 28 registries were identified and all provided responses to the survey. The majority of the registries require modifications to their procedures in order to provide useful and reliable information for quality improvement purposes. Thirteen registries (46%) did not assess or recruited fewer than 80% of the eligible population and 23 (82%) did not formally audit reliability of coding at the clinical level. Five (18%) did not collect the information required for basic risk adjustment of outcome measures. While most registries produced reports for providers and interested parties, the approach to disseminating this information was highly variable. CONCLUSION: Clinical registries provide the most credible information about quality of care. However, most key registries in Australia require some adaptation of procedures in order to accomplish this task. Funding should be provided to enable registries to make the necessary changes.

Improving measurement in clinical handover.

BACKGROUND: Poor clinical handover creates discontinuities in care leading to patient harm. However, the field of handover research continues to lack standardised definitions and reliable measurement tools to identify factors that would lead to harm reduction and improved safety strategies. OBJECTIVE: This paper introduces a conceptual framework to underpin a research agenda around the important patient safety topic of clinical handover. METHODS: Five frameworks with potential application to clinical handover were identified in a consultation process with clinicians, researchers and policy makers. RESULTS: The framework consists of three key handover elements-information, responsibility and/or accountability and system-in relation to three key measurement elements-policy, practice and evaluation. Using this framework an analysis of current "gaps" in the measurement of handover was completed. CONCLUSION: The paper argues that measurement will identify gaps in knowledge about handover practice and promote rigor in the design and evaluation of interventions to reduce patient harm.

Prioritizing quality indicator development across the healthcare system: identifying what to measure.

Measuring healthcare quality has become an increasingly important task for regulating bodies and healthcare institutions. Strategically chosen quality indicators provide a means of understanding the quality and safety of the healthcare system. Current frameworks developed to determine aspects of care to be measured do not provide the level of precision required to ensure that indicators are best selected to enable focused action to improve health. We propose a clearly structured process for selecting indicators at a national and local level based on six steps: (i) identify the problem for which measurement is needed, (ii) identify the perspective from which to measure, (iii) focus measurement on transition points through the health system, (iv) identify the type of probe required, (v) apply evaluation criteria to prioritize indicator selection and action and (vi) test the indicator in the clinical setting to which it will be applied. These steps should form the basis of a framework to drive quality indicator development.

Measuring the quality of hospital care: an inventory of indicators.

BACKGROUND: Development of indicators to measure health-care quality has progressed rapidly. This development has, however, rarely occurred in a systematic fashion, and some aspects of care have received more attention than others. The aim of this study is to identify and classify indicators currently in use to measure the quality of care provided by hospitals, and to identify gaps in current measurement. METHODS: A literature search was undertaken to identify indicator sets. Indicators were included if they related to hospital care and were clearly being collected and reported to an external body. A two-person independent review was undertaken to classify indicators according to aspects of care provision (structure, process or outcome), dimensions of quality (safety, effectiveness, efficiency, timeliness, patient-centredness and equity), and domain of application (hospital-wide, surgical and non-surgical clinical specialities). RESULTS: 383 discrete indicators were identified from 22 source organizations or projects. Of these, 27.2% were relevant hospital-wide, 26.1% to surgical patients and 46.7% to non-surgical specialities, departments or diseases. Cardiothoracic surgery, cardiology and mental health were the specialities with greatest coverage, while nine clinical specialities had fewer than three specific indicators. Processes of care were measured by 54.0% of indicators and outcomes by 38.9%. Safety and effectiveness were the domains most frequently represented, with relatively few indicators measuring the other dimensions. CONCLUSION: Despite the large number of available indicators, significant gaps in measurement still exist. Development of indicators to address these gaps should be a priority. Work is also required to evaluate whether existing indicators measure what they purport to measure.

Biology of Isl1+ cardiac progenitor cells in development and disease.

The LIM-homeodomain transcription factor Islet-1 (Isl1) marks a cell population which makes a substantial contribution to the embryonic heart. Isl1 expression is downregulated as soon as the cells adopt a differentiated phenotype, suggesting that this transcription factor delineates a cardiogenic progenitor cell population. Taking advantage of this developmental lineage marker, we have identified in the postnatal heart a novel cardiac cell type, which is capable of self-renewal and readily differentiates into mature cardiomyocytes. Utilization of embryonic stem (ES) cells that harbour knock-ins of reporter genes into the endogenous Isl1 locus will enable us to isolate Isl1+ cardiac progenitors from mouse and human ES cell systems during in vitro cardiogenesis. These genetic cell-based systems should allow the direct identification of signalling pathways which guide formation, renewal and diversification of Isl1+ cardiogenic progenitors into distinct heart cell lineages, and would complement in vitro studies in the mouse embryo during cardiac development.

Attitudes and barriers to incident reporting: a collaborative hospital study.

OBJECTIVES: To assess awareness and use of the current incident reporting system and to identify factors inhibiting reporting of incidents in hospitals. DESIGN, SETTING AND PARTICIPANTS: Anonymous survey of 186 doctors and 587 nurses from diverse clinical settings in six South Australian hospitals (response rate = 70.7% and 73.6%, respectively). MAIN OUTCOME MEASURES: Knowledge and use of the current reporting system; barriers to incident reporting. RESULTS: Most doctors and nurses (98.3%) were aware that their hospital had an incident reporting system. Nurses were more likely than doctors to know how to access a report (88.3% v 43.0%; relative risk (RR) 2.05, 95% CI 1.61 to 2.63), to have ever completed a report (89.2% v 64.4%; RR 1.38, 95% CI 1.19 to 1.61), and to know what to do with the completed report (81.9% v 49.7%; RR 1.65, 95% CI 1.27 to 2.13). Staff were more likely to report incidents which are habitually reported, often witnessed, and usually associated with immediate outcomes such as patient falls and medication errors requiring corrective treatment. Near misses and incidents which occur over time such as pressure ulcers and DVT due to inadequate prophylaxis were least likely to be reported. The most frequently stated barrier to reporting for doctors and nurses was lack of feedback (57.7% and 61.8% agreeing, respectively). CONCLUSIONS: Both doctors and nurses believe they should report most incidents, but nurses do so more frequently than doctors. To improve incident reporting, especially among doctors, clarification is needed of which incidents should be reported, the process needs to be simplified, and feedback given to reporters.

Osteoporosis screening in people with airways disease.

We tested associations between risk factors and bone mineral density in airways disease subjects, and developed a clinical screening tool to identify people who could benefit from bone mineral density testing. Subjects were recruited through hospital outpatients and pharmacies (Newcastle, n = 172). With survey refinement, we then tested a revised tool in a second sample (Adelaide, n = 317). Study factors included oral/inhaled corticosteroid use, asthma severity, respiratory admissions, physical activity, percent predicted forced expiratory volume in one second (FEV1), body mass index, and smoking history. Outcomes were bone mineral density of lumbar vertebra (L2-4) and total (or neck of) femur. Analysis was logistic regression with generation of a simple screening algorithm based upon coefficients. Scoring algorithm risk factors for T-score of < - 2.0: age > or = 68 = 10 points, bone mineral density < 20 = 25, weight < 60 kg = 20, 60-69 kg = 10, > or = 80 cigarette pack years = 15, low-level leisure activity = 5, area under receiver operator curve 0.83. For a cut-off score of 10, sensitivity was 91.2%, specificity 53.9%, positive and negative predictive values 52.3 and 91.7%, and 67.2% were correctly classified. In conclusions, our model has acceptable sensitivity, although limited specificity. Use of this tool may reduce unnecessary referrals for bone mineral density measurement.

Measurements of hypoxia ([(18)F]-FMISO, [(18)F]-EF5) with positron emission tomography (PET) and perfusion using PET ([(15)O]-H(2)O) and power Doppler ultrasonography in feline fibrosarcomas*.

Abstract The aim of this study was to evaluate if hypoxia in feline fibrosarcomas can be detected. This was done using positron emission tomography (PET), two hypoxia tracers and polarographic pO(2) measurements. Of the seven cats included, five received [(18)F]-fluoromisonidazole and two 2-(2-nitro-1H-imidazol-1-yl)-N-(2,2,3,3,3-pentafluoropropyl) acetamide. Perfusion was evaluated with [(15)O]-H(2)O (n = 4) and with contrast-enhanced power Doppler ultrasonography (n = 5). Hypoxia was detected in three cats. Polarographic pO(2) measurements did not confirm PET results. In the ultrasonographic evaluation, low vascularity and low perfusion were seen with a peripheral vascular pattern and no perfusion in the centre of the tumour. This was in contrast to the [(15)O]-H(2)O scans, where central perfusion of the tumour was also found. In conclusion, it appears that hypoxia exists in this tumour type. The presence of tumour necrosis and heterogeneous hypoxia patterns in these tumours may explain the found discrepancies between the applied techniques.

Fluid for thought: availability of drinks in primary and secondary schools in Cardiff, UK.

OBJECTIVE: While adequate hydration is undoubtedly essential for health, well-being, performance and learning, it is important to recognize that drinks may also have significant detrimental effects on both general and dental health. Since, on weekdays, at least half of a child's recommended daily fluid intake must be imbibed at school, this study sought to examine the provision of drinks in that setting. SUBJECTS AND METHODS: A self-administered postal questionnaire study was sent to the head teachers of all 107 state primary and all 20 state secondary schools in Cardiff, South Wales, UK. RESULTS: A response rate of 81.9% was achieved. Children had access to fresh drinking water from at least one drinking fountain in 69 (66.4%) of the 104 schools who responded to the questionnaire. Milk was available in 69 (80.2%) of the 86 responding primary schools. Sixteen (88.9%) of the 18 responding secondary schools had drink vending machines selling a variety of drinks. CONCLUSIONS: While primary schools appear largely to restrict the availability of drinks to those conducive to the maintenance of good general and dental health, secondary schools appear to foster the use of vending machines. Guidelines should be developed on the use and content of vending machines in schools in order to both meet school objectives and promote healthy choices.

Differential response to alcohol in light and moderate female social drinkers.

Individuals who are moderate drinkers are at increased risk to abuse alcohol. Moreover, women are more vulnerable than men to the adverse consequences of alcohol consumption and recent data indicate that the drinking pattern in women is becoming more similar to that of men. However, few studies have determined whether female moderate drinkers (MD) show a differential response to the subjective and performance effects of alcohol, compared to female light drinkers (LD). Fifteen female MD who consumed an average of 34.7 drinks/month were compared to 15 female LD who consumed an average of 6.7 drinks/month. None of the participants had a first-degree family history of alcoholism or substance abuse. The acute effects of alcohol (0, 0.25, 0.50, 0.75 mg/kg) were evaluated using a double-blind, placebo-controlled outpatient design. Drug effects were assessed using a full range of performance measures, subjective-effects questionnaires and observer ratings. Alcohol impaired performance in a dose-related manner on all performance tasks for both groups of females. However, MD were less impaired than LD on balance and Digit Symbol Substitution Test (DSST). This reduced response was also evident from the observer ratings, with MD being viewed as less impaired by alcohol than LD. While ratings of Drug Liking increased in both groups of women on the ascending limb of the breath alcohol curve, alcohol was disliked by LD on the descending limb and LD reported increased ratings of Bad Drug Effects following the high dose of alcohol. The reduced performance impairment, coupled with the positive subjective effects and relative absence of adverse subjective effects, suggestive of behavioral tolerance, could result in a progression towards increased alcohol consumption among moderate female social drinkers.

Randomized controlled trial of alendronate in airways disease and low bone mineral density.

BACKGROUND: Patients with airways disease have been demonstrated to be at risk of osteoporosis, and this is likely to be multifactorial. Our aim was to identify patients with low bone mineral density (BMD) using a screening program, and then evaluate the benefit of daily alendronate. METHOD: Subjects with hip or lumbar spine baseline T-scores < - 2.5, or Z-score < - 1.0 commenced on alendronate/calcium (10 mg/600 mg day) or placebo/calcium, in a double blind randomized controlled trial. BMD by dual emission X-ray absorptiometry (lumbar vertebrae 2-4, neck of femur, total femur) was repeated after 12 months, with adverse events recorded. RESULTS: 145 subjects (74 male, 71 female, mean age 67, median FEV1 1.0 litres = 43% of predicted) were enrolled; 66 alendronate/calcium, 79 placebo/calcium with 24 and 26 withdrawals, respectively. Per protocol but not intention to treat analysis of covariance demonstrated statistically significant improvements in T and Z scores for lumbar spine bone mineral density (P = 0.035, P = 0.040), with no improvement demonstrated at the hip. CONCLUSIONS: Improvement in bone mineral density has been demonstrated at the lumbar spine, but not hip, by per protocol analysis, with daily alendronate, at 12 months.