Education Team Time Out in Oncologic Visceral Surgery Optimizes Surgical Resident Training and Team Communication-Results of a Prospective Trial.

BACKGROUND: Surgical education is highly dependent on intraoperative communication. Trainers must know the trainee's training level to ensure high-quality surgical training. A systematic preoperative dialogue (Educational Team Time Out, ETO) was established to discuss the steps of each surgical procedure. METHODS: Over 6 months, ETO was performed within a time limit of 3 minutes. Digital surveys on the utility of ETO and its impact on performance were conducted immediately after surgery and at the end of the study period among the staff of the participating disciplines (trainer, trainee, surgical nursing staff, anaesthesiologists, and medical students). The number of surgical substeps performed was recorded and compared with the equivalent period one year earlier. RESULTS: ETO was performed in 64 of the 103 eligible operations (62%). Liver resection (n = 37) was the most frequent procedure, followed by left-sided colorectal surgery (n = 12), partial pancreaticoduodenectomy (n = 6), right-sided hemicolectomies (n = 5), and thyroidectomies (n = 4). Anaesthesiologists most frequently reported that ETO had a direct impact on their work during surgery (90.9%). The influence scores were 46.8% for trainees, 8.8% for trainers, 53.3% for surgical nursing staff and 66.6% for medical students. During the implementation of ETO, a trend towards more assisted substeps in oncologic visceral surgery was seen compared to the corresponding period one year earlier (51% vs.40%; p = 0.11). CONCLUSION: ETO leads to improved intraoperative communication and more performed substeps during complex procedures, which increases motivation and practical training. This concept can easily be implemented in all surgical specialties to improve surgical education.

Guiding the rational design of patient-centred drug trials in Cystic Fibrosis: A Delphi study.

BACKGROUND: Making trials more patient-centred improves recruitment and retention, patient satisfaction and makes research accessible to a more representative population. We aimed to understand the factors that influence participation and engagement in clinical trials in cystic fibrosis (CF) trials to guide the rational design and delivery of patient-centred trials. METHODS: We used a Delphi process, supported by extensive literature review and 3 workshops, to determine which factors stakeholders think exert significant influence in participation and engagement in CF trials. Panellists were recruited from across the UK and the study was administered online. RESULTS: We had representation from 19 CF centres; 28 people with CF (pwCF), 26 parents and 30 healthcare professionals (HCPs). Panels were presented with a shortlist of 104 factors and asked which they thought influence participation and engagement in CF trials. After 3 iterations, 43 statements met consensus for pwCF, 48 for the parents and 69 for the HCPs. CONCLUSIONS: We identified many targets to make trials more patient-centred. Whilst some require an overhaul of trial delivery, many are relatively easy to implement. We outline a list of 'dos and don'ts' for sponsors and research teams including: focus on good communication; recognise that lack of time is the greatest barrier to trial participation so minimise the frequency and length of visits; help participants fit trials around busy lives; remember trial participation can be a major life-event and support participants accordingly; and don't underestimate the impact of simple strategies e.g. on-site access to Wifi and cups of tea.

The outcome of pregnancies in women with cystic fibrosis--single centre experience 1998-2011.

OBJECTIVE: To describe the maternal and fetal outcomes of pregnancies in women with cystic fibrosis. DESIGN: Retrospective study. SETTING: Single obstetric hospital and adult cystic fibrosis centre. METHODS: Retrospective case-note review of pregnant women with cystic fibrosis referred for antenatal care and delivery. MAIN OUTCOME MEASURES: Maternal and fetal outcomes, mode of delivery, lung function and pregnancy complications. RESULTS: Forty-eight pregnancies were studied in 41 women. There were two miscarriages, 44 singleton pregnancies and two sets of twins. All babies were liveborn and survived. The mean gestational age at delivery was 35.9 ± 3.3 weeks. There were no fetal abnormalities or terminations of pregnancy. The median birthweight centile was 31.9 (interquartile range 14.9-55.6). Twenty-five (52.1%) of the women had pancreatic insufficiency and 17 (35.4%) required insulin. There was a positive correlation between booking predicted forced expiratory volume in 1 second (FEV(1) ) and gestational age at delivery (P < 0.01). Women with FEV(1) ≤60% were more likely to deliver earlier and by caesarean section compared with women with FEV(1) >60% (35.0 ± 3.2 weeks versus 37.1 ± 3.0 weeks; P = 0.02 and 75.0% versus 25.0%; P = 0.01). Three of the seven women with an FEV(1) <40% died within 18 months of delivery. Four of the eight women with FEV(1) 40-50% died between 2 and 8 years after delivery. CONCLUSION: Pregnancy for women with cystic fibrosis is possible and results in favourable maternal and fetal outcomes, but the incidence of preterm delivery and caesarean section is increased. Women with pre-existing poor lung function should be counselled antenatally to ensure that they understand the implications of their shortened life-expectancy and parenthood.

Development of a social inclusion index to capture subjective and objective life domains (Phase II): psychometric development study.

OBJECTIVES: To produce a robust measure of social inclusion [Social and Community Opportunities Profile (SCOPE)] that is multidimensional and captures multiple life domains; incorporates objective and subjective indicators of inclusion; has sound psychometric properties including responsiveness; facilitates benchmark comparisons with normative general population and mental health samples [including common mental disorder (CMD) and severe mental illness groups]; can be used with people with mental health problems receiving support from mental health services or not; and can be used across a range of community service settings. DESIGN: Phase I: conceptual framework developed from a review of the literature and concept mapping. Phase II: questionnaire developed including UK national population surveys and other normative data. Pre-testing using cognitive appraisal and evaluation then pilot testing in a small convenience sample. Preliminary testing (following modification) in community (n = 252) and mental health service users (MHSUs) samples (n = 43). Data reduction including factor analysis and Mokken scaling for polytomous item response analysis then psychometric evaluation, including internal consistency and discriminant and construct validity. Test-retest reliability assessed in a convenience sample of students (n = 119). Final testing in clinical services including psychometric evaluation and responsiveness testing. SETTING: The community sample was set in participants' households across the UK. The MHSU sample was set in a south Wales resource centre. The student sample was set in a university. PARTICIPANTS: The community sample was randomly selected from the postal address file in five areas in England and Wales. Forty people in this sample were subgrouped as having a CMD based on their responses to the Mental Health Index five items. Two MHSU samples were obtained from existing services. RESULTS: Psychometric testing on the field data from the SCOPE long version demonstrated good internal consistency of all scales (alpha ≥ 0.7), good construct validity, with SCOPE scales correlating highly with each other sharing between 40% and 61% of variance and a close but lesser association with community participation and social capital. Chi-squared tests on objective items and analysis of variance between groups on SCOPE scales demonstrated good discriminant validity between different mental health groups (and better than the Mokken scaling results). Acceptability was good, with 77% of the service user sample finding the SCOPE domains relevant. The number of items in SCOPE decreased from 121 to 48 following data reduction. Scales in the short version of SCOPE retained reasonable internal consistency (alpha between 0.60 and 0.75). Test-retest reliability demonstrated reliability over time, with strong associations between all items over a 2-week period. Repeating the discriminant validity tests on the short version demonstrates good discriminant validity between the mental health groups. Acceptability improved, with 90% of the sample describing questions as relevant to them. CONCLUSIONS: The main aim of producing an instrument with good psychometric properties for use in research and clinical settings, namely the SCOPE short version, was achieved. Ongoing data collection will enable responsiveness testing in the future. Further research is needed including larger samples of minority and disadvantaged groups, including those with physical illnesses and disabilities, and specific mental health diagnostic groups. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Patterns of HIV testing at a London teaching hospital between 2004 and 2007.

The aims of this study were to observe trends in testing for HIV between 2004 and 2007 in one London, UK, hospital and to observe the seroprevalence of HIV within subgroups. Tests were grouped according to source and reason for testing. A total of 58,720 tests were considered (HIV-1 seroprevalence 0.9%). The majority (75.4%) of tests were performed as part of routine and opt-out protocols including antenatal and genitourinary (GU) screening. Among people specifically seeking HIV testing, the HIV seroprevalence was 3.5%. Medical specialties performed fewer tests but a high HIV seroprevalence was observed, including infectious disease (seroprevalence 4.4%) and other medical specialties (seroprevalence 3.4%). A small number of specialties performed few HIV tests. HIV testing was cost-effective in virtually all settings. This study suggests that more HIV tests could be performed, for example, in acute medicine, and training might increase the number of tests offered in some settings. The most effective way of increasing testing appears to be opt-out testing.

Patterns of HIV testing at a London teaching hospital between 2004 and 2007.

To observe trends in testing for HIV between 2004 and 2007 in a London hospital and to observe the seroprevalence of HIV within subgroups. Tests were grouped according to source and reason for testing; 58,720 tests were considered (HIV-1 seroprevalence = 0.9%). The majority (75.4%) of tests were performed as part of routine and opt-out protocols including antenatal and genitourinary screening. Among people specifically seeking HIV testing, the HIV seroprevalence was 3.5%. Medical specialties performed fewer tests but a high HIV seroprevalence was observed, including infectious disease (seroprevalence 4.4%) and other medical specialties (seroprevalence 3.4%). A small number of specialties performed few HIV tests. HIV testing was cost-effective in virtually all settings. This study suggests that more HIV tests could be performed, for example, in acute medicine, and training might increase the number of tests offered in some settings. The most effective way of increasing testing appears to be opt-out testing.

Ocular adnexal diffuse large B-cell lymphoma: local disease correlates with better outcomes.

PURPOSE: To describe the clinical, immunohistochemical and prognostic features, as well as outcomes of a large series of patients with orbital and periorbital diffuse large B-cell lymphoma (DLBCL). DESIGN: This study is a multicentre, retrospective non-comparative consecutive case series. METHODS: The setting for this study was institutional. A total of 37 consecutive patients identified from the institutions' databases with periorbital and orbital DLBCL were enrolled in the study. A retrospective chart review was used for observation. The main outcome measures were patient demographics, clinical features, imaging, immunohistochemical and histopathological data, treatments administered, and survival. RESULTS: A total of 20 out of 37 cases (54.1%) represented localised periorbital disease (group L), 11 of 37 (29.7%) had systemic disease at presentation with periorbital disease (group S1), and 6 of 37 (16.2%) had previous history of systemic lymphoma (group S2). In all, 28 out of 30 (93.3%) patients were CD20+, 5 of 25 (20%) were CD3+, and 11 of 11 (100%) were CD79a+ (varying denominators reflect the different numbers of patients tested). A total of 25 out of 32 patients (78.1%) received chemotherapy, 14 (43.8%) received rituxmab plus chemotherapy, and 19 (59.3%) received radiotherapy. Nine deaths occurred, one in group L (not lymphoma related), six in group S1, and two in group S2. Five-year Kaplan-Meier survival estimates were 55.9% for all cases, 90.9% for group L, 36.0% for group S1, and 0% for group S2. One-year progression-free survival estimates in groups S1 and S2 combined were 58.3% for patients treated with rituximab and 28.6% for those who were not. CONCLUSIONS: To our knowledge, this report represents the largest series of patients with periorbital and orbital DLBCL in the literature. The difference in survival between groups L, S1 and S2 was striking, reflecting the grave prognosis of systemic DLBCL, but conversely the relatively optimistic outlook for patients with localised disease. Rituximab plus chemotherapy may be associated with increased survival.

Tenofovir-associated renal and bone toxicity.

OBJECTIVES: The aims of the study were to describe the clinical presentation and renal and bone abnormalities in a case series of HIV-infected patients receiving treatment with tenofovir (TDF), and to recommend appropriate screening for toxicity related to TDF. METHODS: Patients were identified from referrals to a specialist HIV renal clinic. Patients were included if treatment with TDF was assessed as the primary cause of the renal function impairment and clinical data were available prior to and following discontinuation of TDF treatment. Data were collected from case note review and clinic databases. RESULTS: Twenty-two patients (1.6% of all those who received TDF) were identified with TDF-associated renal toxicity. All had normal serum creatinine prior to TDF therapy. All presented with proteinuria. On stopping TDF, renal function improved. Eight patients had confirmed Fanconi syndrome. Twelve patients presented with bone pain and osteomalacia was confirmed on an isotope bone scan in seven of these patients. The findings (in those patients tested) of tubular proteinuria, reduced tubular transport maximum of phosphate (TmP), and glycosuria were all consistent with the proximal tubule being the site of toxicity. CONCLUSION: Renal toxicity remains a concern in patients treated with TDF. Clinical presentation may be with renal dysfunction, Fanconi syndrome or osteomalacia. Our investigations suggest proximal tubular toxicity as a common pathogenic mechanism.

Prevalence of incontinence and incontinence-specific quality of life impairment in women with cystic fibrosis.

AIMS: Cystic fibrosis (CF) is the commonest autosomal recessive disorder in Caucasians. With advancing medical technology, the life expectancy has more than double in the last twenty years. This has led to new unforeseen health problems like urinary incontinence. The aim was to establish the prevalence, symptomatic typology, and quality of life impact of incontinence in a population of women with CF. METHODS: Women were recruited from two London tertiary referral centres for CF. They were asked to fill in a self- completed anonymous King's Health Questionnaire (KHQ) for assessment of symptoms and quality of life Impairment. Their age was also noted. Descriptive statistics are reported. Correlation was assessed using Pearson's Product Moment Correlation Coefficient (r). RESULTS: One hundred and forty six women were approached for enrolment. 98(67%) consented to take part in study. Their mean age was 28. Seventy three (74%) reported symptoms of urinary incontinence, which in all cases was perceived as stress urinary incontinence. Of these 44(60%) reported mild stress incontinence, 16(22%) moderate stress incontinence and 13(18%) severe stress incontinence. Continent and incontinent women perceived their general health to be similarly poor (mean score 40 vs 44 points). Strong positive correiations were found between age and stress urinary incontinence severity (r=0.742; P <0.001) and between age and total King's Health Questionnaire score (r=0.828; P <0.001). CONCLUSIONS: Women with CF have a higher prevalence of stress urinary incontinence than the general population, with both the prevalence and associated quality of life impairment increasing with age.

Craniofacial fibrous dysplasia: clinical characteristics and long-term outcomes.

AIM: To present the clinical features and management outcomes in a large longitudinal series of patients with craniofacial fibrous dysplasia (CFD). METHODS: Retrospective interventional consecutive case series. Main outcome measures included signs and symptoms, radiographic findings, long-term outcomes, and postoperative complications. RESULTS: A total of 42 patients with CFD were identified. The mean age at presentation was 16.7 years; mean follow-up was 12.6 years. Out of these 42 patients, 37 (88.1%) had unilateral involvement and 5 (11.9%) had bilateral involvement, of which 3 (7.1%) had McCune-Albright syndrome. The commonest presenting symptom was facial asymmetry (36 cases, 86%). The frontal bone was the most commonly involved (27 cases, 64.3%), zfollowed by the sphenoid (24 cases, 57.1%). The most common pattern of bone involvement was monostotic (32 cases, 76.2%). Radiological optic canal involvement occurred in 18 eyes of 15 (37.5%) patients, with optic atrophy in 9 eyes (18.8%) of 7 patients (16.7%). Surgical intervention was performed in 30 (71.4%) cases for both functional and reconstructive reasons. Optic canal decompression was performed in three cases, in all of which stabilization of vision was achieved; no patient lost vision as a result of surgery. CONCLUSIONS: In this large longitudinal series of CFD, visual loss was not uncommon and occurred insidiously. The presenting clinical and radiological features, surgical interventions, and outcomes are discussed.

An audit of viral load in one clinical population to describe features of viraemic patients on antiretroviral therapy.

OBJECTIVES: To assess the prevalence of an undetectable viral load (VL) (<50 HIV-1 RNA copies/mL) in a clinical population and to identify those viraemic and at risk of failing antiretroviral therapy (ART). METHODS: An audit of a complete clinical population on 1 January 2005 via a clinical database and clinical note review. RESULTS: On 1 January 2005, 1910 patients were under care; 1229/1332 (92%) of those exposed to ART for >16 weeks had a VL of <50 copies/mL. We examined 49/56 case notes of viraemic patients to identify explanations for viraemia. Common reasons included previous initial mono- or dual therapy, adherence problems, more advanced HIV disease, concomitant medications, physical and mental health issues and being less well linked into the service. A review of these patients' current status on 1 April 2007 showed that six of the 49 had since died. However, of those still alive, 20 (47%) had a VL <500 copies/mL. CONCLUSIONS: The proportion of patients on ART with detectable viraemia is low in current clinical practice. New drugs may help those who are failing because of resistance. However, there is a small minority of patients who, for various reasons, appear unable to maintain sufficient adherence to ART.

Guidelines for the management of pregnancy in women with cystic fibrosis.

Women with cystic fibrosis (CF) now regularly survive into their reproductive years in good health and wish to have a baby. Many pregnancies have been reported in the literature and it is clear that whilst the outcome for the baby is generally good and some mothers do very well, others find either their CF complicates the pregnancy or is adversely affected by the pregnancy. For some, pregnancy may only become possible after transplantation. Optimal treatment of all aspects of CF needs to be maintained from the preconceptual period until after the baby is born. Clinicians must be prepared to modify their treatment to accommodate the changing physiology during pregnancy and to be aware of changing prescribing before conception, during pregnancy, after birth and during breast feeding. This supplement offers consensus guidelines based on review of the literature and experience of paediatricians, adult and transplant physicians, and nurses, physiotherapists, dietitians, pharmacists and psychologists experienced in CF and anaesthetist and obstetricians with experience of CF pregnancy. It is hoped they will provide practical guidelines helpful to the multidisciplinary CF teams caring for pregnant women with CF.

No association between HIV disease and its treatment and thyroid function.

OBJECTIVES: The aims of the study were (i) to investigate the prevalence of overt and subclinical thyroid disease in HIV-positive patients in a London teaching hospital; (ii) to determine risk factors associated with the development of thyroid dysfunction, including highly active antiretroviral therapy (HAART) and individual antivirals, and (iii) to determine the occurrence of thyroid dysfunction longitudinally over 3 years. METHODS: The study consisted of retrospective analyses of thyroid function tests (TFT) in HIV-positive patients. The period prevalence of and factors associated with clinical and subclinical thyroid dysfunction were investigated. Patients with normal TFT but previous thyroid disease were identified from pharmacy records and included in the overt category. RESULTS: A total of 1565 patients (73% of the clinic population) had at least one TFT taken since 2001. Overall, 3584 samples were analysed. Of the patients included in the study, 1233 (79%) were male, 1043 (66%) were white and 365 (23%) were black African, and in 969 (62%) the main risk for HIV was homosexual sex. Median age at baseline was 37 years. Nine hundred patients (58%) were on HAART at the start of the study. Thirty-nine (2.5%) were found to have overt hypothyroidism, and eight (<1%) had overt hyperthyroidism. Sixty-one (4%) had subclinical hypothyroidism, five (<1%) had subclinical hyperthyroidism and 263 (17%) had a nonthyroidal illness. A normal TFT was obtained for 1118 patients (75.5%). Multivariate analysis suggested that no independent variables were significantly associated with overt hypothyroidism, including HAART and stavudine use specifically. Repeated measurements over 3 years were available for 825 patients and only eight new cases (1%) of overt thyroid disease occurred. CONCLUSIONS: The prevalence of overt thyroid disease was low in this cohort, suggesting that screening is not warranted.

A comparison of the prevalence of urinary incontinence in girls with cystic fibrosis, asthma, and healthy controls.

Urinary incontinence (UI) is recognized as a significant problem in adult females with cystic fibrosis and can often have a marked impact on day-to-day activities. The prevalence and severity of UI in the pediatric cystic fibrosis (CF) female population is less clear and there are no comparative data with healthy children or children with other respiratory disorders. An anonymous self-completed semi-structured questionnaire was used to study the prevalence rates of UI in girls with CF aged between 11 and 17 and compared it to age-matched asthmatic and healthy girls. The prevalence of UI in girls with CF was significantly higher (17/51, 33%) than the asthmatic (4/25, 16%) and healthy girls (2/27, 7%) (P = 0.02). It may manifest as early as 11 years of age and is associated with increasing lung disease. Surprisingly it is perceived as a relatively minor problem in terms of the distress it causes. Pediatric CF clinics should be routinely addressing UI as a potential problem in all girls from the age of 11 years.

Cervical screening in HIV-positive women: characteristics of those who default and attitudes towards screening.

OBJECTIVES: To determine the characteristics of HIV-positive women who undergo cervical screening and to identify negative attitudes and experiences of these women to screening and the factors associated with these. METHODS: We compared the Royal Free Cohort data from 59 newly diagnosed HIV-infected women, 31 of whom did and 28 of whom did not attend for cervical screening in 2001, and from 227 women under active cervical screening follow-up (at least one cervical screen since June 2001) and 88 HIV-infected women lost to follow-up (not screened since January 2001). Attitudes to screening were investigated with the aid of a questionnaire given to all women attending clinic who had had a previous colposcopy. RESULTS: Of the 59 newly HIV diagnosed women, 31 (53%) underwent cervical screening. These 31 women were more likely to be heterosexual (100 vs 89%, P=0.05), to have lower median viral loads (< 50 vs 3210 HIV-1 RNA copies/mL) and to be receiving antiretrovirals (ARVs) (74 vs 54%, P=0.1) than those not screened. Of the 315 women who had at least one screen, 72% returned for further follow-up. There were no differences in age or ethnicity between these groups. Those under active follow-up had a higher CD4 count (P=0.04) and lower viral load (P=0.0001) at their last visit. They were also more likely to be on highly active antiretroviral therapy (HAART) (68 vs 52%, P=0.006). A total of 78 of 104 questionnaires (75%) were returned. Women participating in the questionnaire study were mainly of back ethnicity (68%), did not speak English as their first language (59%) and were taking ARVs (76%). Most agreed that regular smears and colposcopy were valuable. Women of white ethnicity, and those speaking English as a first language, were more likely to dislike colposcopy compared with those of nonwhite ethnicity (87 vs 25%, respectively, P=0.0007) and not speaking English as a first language (74 vs 26%, respectively, P=0.002). Those of white ethnicity were more likely to find smears and colposcopy painful (60 and 73%) compared with those of black ethnicity (46 and 51%, P=0.47 and 0.28, respectively). CONCLUSIONS: Our results suggest that women on HAART with better disease control, older women, and those of black African ethnicity are more likely to take up cervical screening. Cervical screening experience varies by ethnicity and language.

Are we training junior doctors to respond to major incidents? A survey of doctors in the Wessex region.

OBJECTIVE: To assess the current status of awareness and training of junior medical staff in the Wessex region in the event of a "conventional" major incident. METHODS: A telephone questionnaire of specialist registrars (SpRs) (or equivalent, for example, staff grade) in six core specialties was performed in all the 11 acute hospitals in the Wessex region on the same evening. This group was selected to represent a sample of the most senior medical staff "on site" at each hospital. RESULTS: 56 of 64 (87.5%) SpRs participated. Nine of the 56 (16%) SpRs questioned had previously been involved in a major incident, and 18 (32%) had experienced some form of major incident training exercise. Subgroup analysis of the specialties showed that although there were no significant differences in numbers of training experiences between specialties, only one of nine (11%) orthopaedic SpRs had ever been involved in a training exercise. Twenty five of the 56 (45%) SpRs felt that they were confident of their role in the event of an incident. CONCLUSION: Most middle grade staff in Wessex were not confident of their role in the event of a major incident. Most SpRs questioned had never attended a major incident training exercise.

An audit of antiretroviral treatment use in HIV-infected patients in a London clinic: the limitations of observational databases when auditing antiretroviral treatment use.

OBJECTIVE: To audit the use of antiretroviral (ARV) treatment in a large treatment clinic in the UK against the British HIV Association (BHIVA) ARV treatment guidelines. METHODS: All patients under follow-up between 1st January 2000 and 1st January 2001 were included. The most recent CD4 count and HIV RNA level prior to 1st January 2001, and the nadir CD4 count and peak HIV RNA level over follow-up, were used to identify which patients should be receiving HAART according to the guidelines. RESULTS: One thousand two hundred and sixty-four patients were included in the analysis (63.8% homosexual, 29.0% heterosexual risk; 72.9% white; 79.2% male). Almost half of patients had ever had a CD4 count below 200 cells/ micro L and over 80% had previously had a viral load above 4 log10 HIV-1 RNA copies/mL. Under 2000 BHIVA guidelines, treatment would be recommended in 77.4% patients. Overall, 819 patients were receiving ARV therapy. Two hundred and eighty-five patients were not receiving treatment when guidelines suggest they should (including 33 patients who were receiving regimens not recommended in the guidelines). These patients were younger, less likely to be homosexual and had higher CD4 nadirs than those who were receiving ARV treatment. Almost half of these patients had previously received ARV therapy but were not currently receiving it. CONCLUSION: Only a small proportion of patients at our centre were not receiving ARV treatment in line with national guidelines. While genuine reasons may exist for these departures from optimal care, this may simply reflect the limitations of using observational databases when auditing treatment use in a clinic setting.