Effect of antenatal micronutrient or antidepressant exposure on Brazelton neonatal behavioral assessment scale (NBAS) performance within one-month of birth.

BACKGROUND: Antenatal depression is a risk factor for poor infant outcomes. Broad-spectrum-micronutrients (vitamins and minerals) have shown efficacy in treating psychiatric symptoms in non-pregnant populations and are associated with reduced incidence of adverse birth outcomes, and improvements in neonatal development. We investigated the effects of treatment of antenatal depression with micronutrients above the Recommended Dietary Allowance on infant development compared to treatment with antidepressant medications and controls. METHOD: One-hundred-and-three infants were assessed using the Brazelton Neonatal Behavioral Assessment Scale (NBAS) within 28 days of birth: 37 exposed to micronutrients in-utero (50-182 days exposure), 18 to antidepressants in-utero (exposure for full gestation), and 48 controls whose mothers received neither treatment nor experienced depressive symptoms. RESULTS: Controlling for gestational age and parity, there were significant group differences on habituation, orientation, motor, state regulation, autonomic stability and reflexes (p < .05). Micronutrient-exposed performed better than antidepressant-exposed and controls on habituation, motor and autonomic stability (p < .05), effect sizes ranged 1.0-1.7 and 0.5-1.0, respectively. Antidepressant-exposed performed significantly worse on orientation and reflexes compared to micronutrient-exposed and controls. Micronutrient-exposed had significantly better state regulation compared to antidepressant-exposed. There was an association between micronutrient exposure length and better habituation (r = 0.41, p = .028). Micronutrient exposure was generally identified as a stronger predictor of neonatal performance over maternal depression, social adversity, gestational age and infant sex. CONCLUSION: In-utero micronutrient exposure appears to mitigate risks of depression on infant outcomes showing positive effects on infant behavior, on par with or better than typical pregnancies and superior to antidepressants. Limitations include differential exposure to micronutrients/antidepressants and lack of group blinding.

Volume-outcome relationship in intra-abdominal robotic-assisted surgery: a systematic review.

As robotic-assisted surgery (RAS) expands to smaller centres, platforms are shared between specialities. Healthcare providers must consider case volume and mix required to maintain quality and cost-effectiveness. This can be informed, in-part, by the volume-outcome relationship. We perform a systematic review to describe the volume-outcome relationship in intra-abdominal robotic-assisted surgery to report on suggested minimum volumes standards. A literature search of Medline, NICE Evidence Search, Health Technology Assessment Database and Cochrane Library using the terms: "robot*", "surgery", "volume" and "outcome" was performed. The included procedures were gynecological: hysterectomy, urological: partial and radical nephrectomy, cystectomy, prostatectomy, and general surgical: colectomy, esophagectomy. Hospital and surgeon volume measures and all reported outcomes were analysed. 41 studies, including 983,149 procedures, met the inclusion criteria. Study quality was assessed using the Newcastle-Ottawa Quality Assessment Scale and the retrieved data was synthesised in a narrative review. Significant volume-outcome relationships were described in relation to key outcome measures, including operative time, complications, positive margins, lymph node yield and cost. Annual surgeon and hospital volume thresholds were described. We concluded that in centres with an annual volume of fewer than 10 cases of a given procedure, having multiple surgeons performing these procedures led to worse outcomes and, therefore, opportunities should be sought to perform other complimentary robotic procedures or undertake joint cases.

Improving systems of care during and after a pregnancy complicated by hyperglycaemia: A protocol for a complex health systems intervention.

BACKGROUND: Many women with hyperglycaemia in pregnancy do not receive care during and after pregnancy according to standards recommended in international guidelines. The burden of hyperglycaemia in pregnancy falls disproportionately upon Indigenous peoples worldwide, including Aboriginal and Torres Strait Islander women in Australia. The remote and regional Australian context poses additional barriers to delivering healthcare, including high staff turnover and a socially disadvantaged population with a high prevalence of diabetes. METHODS: A complex health systems intervention to improve care for women during and after a pregnancy complicated by hyperglycaemia will be implemented in remote and regional Australia (the Northern Territory and Far North Queensland). The Theoretical Domains Framework was used during formative work with stakeholders to identify intervention components: (1) increasing workforce capacity, skills and knowledge and improving health literacy of health professionals and women; (2) improving access to healthcare through culturally and clinically appropriate pathways; (3) improving information management and communication; (4) enhancing policies and guidelines; (5) embedding use of a clinical register as a quality improvement tool. The intervention will be evaluated utilising the RE-AIM framework at two timepoints: firstly, a qualitative interim evaluation involving interviews with stakeholders (health professionals, champions and project implementers); and subsequently a mixed-methods final evaluation of outcomes and processes: interviews with stakeholders; survey of health professionals; an audit of electronic health records and clinical register; and a review of operational documents. Outcome measures include changes between pre- and post-intervention in: proportion of high risk women receiving recommended glucose screening in early pregnancy; diabetes-related birth outcomes; proportion of women receiving recommended postpartum care including glucose testing; health practitioner confidence in providing care, knowledge and use of relevant guidelines and referral pathways, and perception of care coordination and communication systems; changes to health systems including referral pathways and clinical guidelines. DISCUSSION: This study will provide insights into the impact of health systems changes in improving care for women with hyperglycaemia during and after pregnancy in a challenging setting. It will also provide detailed information on process measures in the implementation of such health system changes.

A unified call to action from Australian nursing and midwifery leaders: ensuring that Black lives matter.

Nurses and midwives of Australia now is the time for change! As powerfully placed, Indigenous and non-Indigenous nursing and midwifery professionals, together we can ensure an effective and robust Indigenous curriculum in our nursing and midwifery schools of education. Today, Australia finds itself in a shifting tide of social change, where the voices for better and safer health care ring out loud. Voices for justice, equity and equality reverberate across our cities, our streets, homes, and institutions of learning. It is a call for new songlines of reform. The need to embed meaningful Indigenous health curricula is stronger now than it ever was for Australian nursing and midwifery. It is essential that nursing and midwifery leadership continue to build an authentic collaborative environment for Indigenous curriculum development. Bipartisan alliance is imperative for all academic staff to be confident in their teaching and learning experiences with Indigenous health syllabus. This paper is a call out. Now is the time for Indigenous and non-Indigenous nurses and midwives to make a stand together, for justice and equity in our teaching, learning, and practice. Together we will dismantle systems, policy, and practices in health that oppress. The Black Lives Matter movement provides us with a 'now window' of accepted dialogue to build a better, culturally safe Australian nursing and midwifery workforce, ensuring that Black Lives Matter in all aspects of health care.

Assertive outreach treatment versus care as usual for the treatment of high-need, high-cost alcohol related frequent attenders: study protocol for a randomised controlled trial.

BACKGROUND: Alcohol-related hospital admissions have doubled in the last ten years to > 1.2 m per year in England. High-need, high-cost (HNHC) alcohol-related frequent attenders (ARFA) are a relatively small subgroup of patients, having multiple admissions or attendances from alcohol during a short time period. This trial aims to test the effectiveness of an assertive outreach treatment (AOT) approach in improving clinical outcomes for ARFA, and reducing resource use in the acute setting. METHODS: One hundred and sixty ARFA patients will be recruited and following baseline assessment, randomly assigned to AOT plus care as usual (CAU) or CAU alone in equal numbers. Baseline assessment includes alcohol consumption and related problems, physical and mental health comorbidity and health and social care service use in the previous 6 months using standard validated tools, plus a measure of resource use. Follow-up assessments at 6 and 12 months after randomization includes the same tools as baseline plus standard measure of patient satisfaction. Outcomes for CAU + AOT and CAU at 6 and 12 months will be compared, controlling for pre-specified baseline measures. Primary outcome will be percentage of days abstinent at 12 months. Secondary outcomes include emergency department (ED) attendance, number and length of hospital admissions, alcohol consumption, alcohol-related problems, other health service use, mental and physical comorbidity 6 and 12 months post intervention. Health economic analysis will estimate the economic impact of AOT from health, social care and societal perspectives and explore cost-effectiveness in terms of quality adjusted life years and alcohol consumption at 12-month follow-up. DISCUSSION: AOT models piloted with alcohol dependent patients have demonstrated significant reductions in alcohol consumption and use of unplanned National Health Service (NHS) care, with increased engagement with alcohol treatment services, compared with patients receiving CAU. While AOT interventions are costlier per case than current standard care in the UK, the rationale for targeting HNHC ARFAs is because of their disproportionate contribution to overall alcohol burden on the NHS. No previous studies have evaluated the clinical and cost-effectiveness of AOT for HNHC ARFAs: this randomized controlled trial (RCT) targeting ARFAs across five South London NHS Trusts is the first. TRIAL REGISTRATION: International standard randomized controlled trial number (ISRCTN) registry: ISRCTN67000214, retrospectively registered 26/11/2016.

The effects of a multidisciplinary high-throughput skin clinic on healthcare costs of organ transplant recipients.

BACKGROUND: A long-term complication among organ transplant recipients (OTRs) is skin malignancies which are associated with level and duration of immunosuppressive treatment, sun exposure and age. Dermatological surveillance is recommended for OTRs at high risk of skin malignancies, but evidence is lacking on the benefits of such services. OBJECTIVE: To examine the economic impact on patients and on the hospital service of a multidisciplinary high-throughput skin cancer clinic in Brisbane, Australia, dedicated to dermatological and surgical care of high-risk OTRs. METHODS: In a pre/postdesign, hospital admission and cost data were obtained for 101 consecutively enrolled study participants from 12 months prior to the introduction of the clinic (to February 2016), the 3-month 'run-in' period (March to May 2016) and 12 months subsequent (to June 2017). Differences between pre- and post-clinic hospital costs were tested using non-parametric bootstrapping and interrupted time series analysis. A survey of patient out-of-pocket costs and perceived financial burden was also undertaken during the clinic. RESULTS: Overall hospital costs were higher after the clinic but 3-monthly hospital costs for skin procedures trended downwards. Despite 3-monthly mean, hospital visits increasing from 85 to 314, mean 3-monthly costs reduced by AU$1491 (P < 0.001) indicating greater cost efficiency. Total patient out-of-pocket costs were AU$18 377 over 3 months. CONCLUSION: Clinical costing data revealed higher, more rapid throughput and significantly lower per patient costs pre- and postestablishment of a multidisciplinary skin cancer clinic for OTRs.

De-simplifying single-tablet antiretroviral treatments: uptake, risks and cost savings.

OBJECTIVES: As more HIV-positive individuals receive antiretroviral therapy (ART), payers are seeking options for covering these increased and sustained drug costs. Strategic use of available generic antiretroviral (ARV) formulations may be feasible. De-simplifying a single-tablet co-formulation (STF) into two or more tablets using both brand and generic drugs has been proposed. We determine if voluntary de-simplification of one STF could be utilized as a cost-saving strategy. We report on the challenges, uptake, outcomes and cost savings of this initiative. METHODS: Patients stable on the most commonly used STF (Triumeq® ) were offered the option of remaining on Triumeq® or switching to generic abacavir/lamivudine and Tivicay® between 1 January 2015 and 1 January 2018; those starting ART consisting of abacavir/lamivudine/doulutegravir in the same period were offered the option of starting Triumeq® or generic abacavir/laminvudine and Tivicay® . No incentives were provided. We examined the acceptance/decline rates, patient satisfaction, health care outcomes and annual cost savings. RESULTS: Of 626 patients receiving Triumeq® , 321 were approached; 177 (55.1%) agreed to de-simplify. Of patients initiating ART, 62.7% chose the generic co-formulation. Patients switching to or starting on the generic co-formulation were more likely to be male, > 45 years old, Caucasian, men who have sex with men (MSM) and more HIV-experienced, and to have more comorbidities (all P < 0.05). Preference for STF was cited for declining de-simplification. No concern about generic ARVs was expressed. The rate of viral load > 500 HIV-1 RNA copies/mL after baseline was 2.7% in switched patients compared with 7.0% in those declining to switch. No de novo resistance occurred. A saving of Cdn$1 319 686 was achieved in the first year. CONCLUSIONS: Reliance on altruism, while respecting patient autonomy, achieved de-simplification in > 50% of patients approached, and generated immediate cost savings with no increased risk of adverse events, viral breakthrough or resistance.

Assessment of a Watch-and-Wait Strategy for Rectal Cancer in Patients With a Complete Response After Neoadjuvant Therapy.

IMPORTANCE: The watch-and-wait (WW) strategy aims to spare patients with rectal cancer unnecessary resection. OBJECTIVE: To analyze the outcomes of WW among patients with rectal cancer who had a clinical complete response to neoadjuvant therapy. DESIGN, SETTING, AND PARTICIPANTS: This retrospective case series analysis conducted at a comprehensive cancer center in New York included patients who received a diagnosis of rectal adenocarcinoma between January 1, 2006, and January 31, 2015. The median follow-up was 43 months. Data analyses were conducted from June 1, 2016, to October 1, 2018. EXPOSURES: Patients had a clinical complete response after completing neoadjuvant therapy and agreed to a WW strategy of active surveillance and possible salvage surgery (n = 113), or patients underwent total mesorectal excision and were found to have a pathologic complete response (pCR) at resection (n = 136). MAIN OUTCOMES AND MEASURES: Kaplan-Meier estimates were used for analyses of local regrowth and 5-year rates of overall survival, disease-free survival, and disease-specific survival. RESULTS: Compared with the 136 patients in the pCR group, the 113 patients in the WW group were older (median [range], 67.2 [32.1-90.9] vs 57.3 [25.0-87.9] years, P < .001) with cancers closer to the anal verge (median [range] height from anal verge, 5.5 [0.0-15.0] vs 7.0 [0.0-13.0] cm). All 22 local regrowths in the WW group were detected on routine surveillance and treated by salvage surgery (20 total mesorectal excisions plus 2 transanal excisions). Pelvic control after salvage surgery was maintained in 20 of 22 patients (91%). No pelvic recurrences occurred in the pCR group. Rectal preservation was achieved in 93 of 113 patients (82%) in the WW group (91 patients with no local regrowths plus 2 patients with local regrowths salvaged with transanal excision). At 5 years, overall survival was 73% (95% CI, 60%-89%) in the WW group and 94% (95% CI, 90%-99%) in the pCR group; disease-free survival was 75% (95% CI, 62%-90%) in the WW group and 92% (95% CI, 87%-98%) in the pCR group; and disease-specific survival was 90% (95% CI, 81%-99%) in the WW group and 98% (95% CI, 95%-100%) in the pCR group. A higher rate of distant metastasis was observed among patients in the WW group who had local regrowth vs those who did not have local regrowth (36% vs 1%, P < .001). CONCLUSIONS AND RELEVANCE: A WW strategy for select rectal cancer patients who had a clinical complete response after neoadjuvant therapy resulted in excellent rectal preservation and pelvic tumor control; however, in the WW group, worse survival was noted along with a higher incidence of distant progression in patients with local regrowth vs those without local regrowth.

Validity of World Health Organisation prescribing indicators in Namibia's primary healthcare: findings and implications.

OBJECTIVE: World Health Organization/International Network of Rational use of Drugs (WHO/INRUD) indicators are widely used to assess medicine use. However, there is limited evidence on their validity in Namibia's primary health care (PHC) to assess the quality of prescribing. Consequently, our aim was to address this. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: An analytical cross-sectional survey design was used to examine and validate WHO/INRUD indicators in out-patient units of two PHC facilities and one hospital in Namibia from 1 February 2015 to 31 July 2015. The validity of the indicators was determined using two-by-two tables against compliance to the Namibian standard treatment guidelines (NSTG). The receiver operator characteristics for the WHO/INRUD indicators were plotted to determine their accuracy as predictors of compliance to agreed standards. A multivariate logistic model was constructed to independently determine the prediction of each indicator. MAIN OUTCOMES AND RESULTS: Out of 1243 prescriptions; compliance to NSTG prescribing in ambulatory care was sub-optimal (target was >80%). Three of the four WHO/INRUD indicators did not meet Namibian or WHO targets: antibiotic prescribing, average number of medicines per prescription and generic prescribing. The majority of the indicators had low sensitivity and/or specificity. All WHO/INRUD indicators had poor accuracy in predicting rational prescribing. The antibiotic prescribing indicator was the only covariate that was a significant independent risk factor for compliance to NSTGs. CONCLUSION: WHO/INRUD indicators showed poor accuracy in assessing prescribing practices in ambulatory care in Namibia. There is need for appropriate models and/or criteria to optimize medicine use in ambulatory care in the future.

Patient perspectives on de-simplifying their single-tablet co-formulated antiretroviral therapy for societal cost savings.

OBJECTIVES: The incremental costs of expanding antiretroviral (ARV) drug treatment to all HIV-infected patients are substantial, so cost-saving initiatives are important. Our objectives were to determine the acceptability and financial impact of de-simplifying (i.e. switching) more expensive single-tablet formulations (STFs) to less expensive generic-based multi-tablet components. We determined physician and patient perceptions and acceptance of STF de-simplification within the context of a publicly funded ARV budget. METHODS: Programme costs were calculated for patients on ARVs followed at the Southern Alberta Clinic, Canada during 2016 (Cdn$). We focused on patients receiving Triumeq® and determined the savings if patients de-simplified to eligible generic co-formulations. We surveyed all prescribing physicians and a convenience sample of patients taking Triumeq® to see if, for budgetary purposes, they felt that de-simplification would be acceptable. RESULTS: Of 1780 patients receiving ARVs, 62% (n = 1038) were on STF; 58% (n = 607) of patients on STF were on Triumeq®. The total annual cost of ARVs was $26 222 760. The cost for Triumeq® was $8 292 600. If every patient on Triumeq® switched to generic abacavir/lamivudine and Tivicay® (dolutegravir), total costs would decrease by $4 325 040. All physicians (n = 13) felt that de-simplifying could be safely achieved. Forty-eight per cent of 221 patients surveyed were agreeable to de-simplifying for altruistic reasons, 27% said no, and 25% said maybe. CONCLUSIONS: De-simplifying Triumeq® generates large cost savings. Additional savings could be achieved by de-simplifying other STFs. Both physicians and patients agreed that selective de-simplification was acceptable; however, it may not be acceptable to every patient. Monitoring the medical and cost impacts of de-simplification strategies seems warranted.

What is quality primary dental care?

In the first paper of a series exploring quality in primary dental care a definition for quality in dentistry is sought. There is a little agreement in academic literature as to what quality really means in primary dental care and without a true understanding it is difficult to measure and improve quality in a systematic way. 'Quality' of healthcare in dentistry will mean different things to practitioners, policy makers and patients but a framework could be modelled on other definitions within different healthcare sectors, with focus on access, equity and overall healthcare experience.

A national study of the provision of oncology sperm banking services among Canadian fertility clinics.

The purpose of this study was to survey the current state of oncology sperm banking services provided by fertility clinics across Canada. A total of 78 Canadian fertility facilities were invited to complete a questionnaire related to the availability, accessibility, affordability and utilisation of sperm banking services for cancer patients. The total response rate was 59%, with 20 (69%) in vitro fertilisation clinics and 26 (53%) other fertility centres returning the survey. A total of 24 responding facilities accepted oncology sperm banking referrals. The time frame to book the first banking appointment for 19 (79%) facilities was within 2 days. Inconsistent practice was found regarding the consent process for cancer patients who are of minority age. Eight (33%) facilities did not provide any subsidy and charged a standard banking fee regardless of patients' financial situations. Overall, the utilisation of oncology sperm banking services was low despite its availability and established efficacy, suggesting that Canadian cancer patients are notably underserved. The study has highlighted some important issues for further consideration in improving access to sperm banking services for cancer patients, especially for adolescents. Better collaboration between oncology and reproductive medicine to target healthcare providers would help to improve sperm banking rates.

Are specific initiatives required to enhance prescribing of generic atypical antipsychotics in Scotland?: International implications.

BACKGROUND: National and regional authorities in Scotland have introduced multiple measures to appreciably enhance prescribing efficiency for the proton pump inhibitors (PPIs), statins and renin-angiotensin inhibitor drugs. Generic oral risperidone recently became available in Scotland; however, schizophrenia is a complex disease with advice from respected authorities suggesting that treatment should be individualised. AIMS: To assess (i) changes in atypical antipsychotic drug (AAP) utilisation and expenditure following the availability of oral generic risperidone in Scotland; (ii) to determine (a) current INN prescribing rates for risperidone following generic availability and (b) decrease in expenditure/DDD for generic risperidone; (iii) to suggest additional measures that could possibly be introduced in Scotland to further enhance prescribing of generic AAPs; and (iv) to provide guidance to NHS Scotland as well as other European authorities on the implications. METHODS: Retrospective observational study and an interrupted time series design. RESULTS: No appreciable change in the utilisation patterns of risperidone pre- and postgeneric availability. Appreciable INN prescribing averaged 93-98% of total oral risperidone. Generic risperidone was 84% below prepatent loss prices by study end, reducing annual expenditure for oral risperidone in 2010 by GB£3.19mn compared with prepatent loss situation. However, overall expenditure on AAPs increased by 42% from 2005 to 2010. DISCUSSION: As expected, there was no change in utilisation patterns for risperidone, although potential to influence prescribing patterns. Continued high INN prescribing suggests no problems with generic risperidone in practice. Costs will start to decrease as more AAPs lose their patents (olanzapine and quetiapine). There is the possibility to accelerate this reduction through educational activities. CONCLUSION: There is potential to realise some savings with generic AAPs. However, this is limited by the complexity of the disease area. Any measures introduced must aim at increasing the prescribing of generic AAPs first line in suitable patients.

Comparative assessment of a DNA and protein Leishmania donovani gamma glutamyl cysteine synthetase vaccine to cross-protect against murine cutaneous leishmaniasis caused by L. major or L. mexicana infection.

Leishmaniasis is a major health problem and it is estimated that 12 million people are currently infected. A vaccine which could cross-protect people against different Leishmania spp. would facilitate control of this disease as more than one species of Leishmania may be present. In this study the ability of a DNA vaccine, using the full gene sequence for L. donovani gamma glutamyl cysteine synthetase (γGCS) incorporated in the pVAX vector (pVAXγGCS), and a protein vaccine, using the corresponding recombinant L. donovani γGCS protein (LdγGCS), to protect against L. major or L. mexicana infection was evaluated. DNA vaccination gave transient protection against L. major and no protection against L. mexicana despite significantly enhancing specific antibody titres in vaccinated infected mice compared to infected controls. Vaccination with the LdγGCS protected against both species but only if the protein was incorporated into non-ionic surfactant vesicles for L. mexicana. The results of this study indicate that a L. donovani γGCS vaccine could be used to vaccinate against more than one Leishmania species but only if the recombinant protein is used.

Multiple strategies for quality improvement and patient safety--money alone is not the answer, nor is trust. Conclusions of the 6th EQuiP Invitational Conference April 2011.

On 7-9 April 2011 the 6th EQuiP Invitational Conference took place in Copenhagen. Key note lectures were delivered by Professor Frede Olesen (Denmark), Professor Andreas Christian Soennichsen (Austria), Professor Martin Roland (UK) and Professor Richard Roberts (US), and a key note panel discussion was held on the pros and cons of pay-for-performance led by Doctors Iona Heath (UK) and José Braspenning (The Netherlands). In addition, there were 9 workshops and 23 oral presentations. Videos of many presentations as well as PowerPoint and other materials can be found at EQuiP's website: http://www.equip.ch .

Health checks in primary care for adults with intellectual disabilities: how extensive should they be?

BACKGROUND: Routine health checks have gained prominence as a way of detecting unmet need in primary care for adults with intellectual disabilities (ID) and general practitioners are being incentivised in the UK to carry out health checks for many conditions through an incentivisation scheme known as the Quality and Outcomes Framework (QOF). However, little is known about the data being routinely recorded in such health checks in relation to people with ID as practices are currently only incentivised to keep a register of people with ID. The aim of this study was to explore the additional value of a health check for people with ID compared with standard care provided through the current QOF structure. METHODS: Representative practices were recruited using a stratified sampling approach in four primary care trusts to carry out health checks over a 6-month period. The extracted data were divided into two aggregated informational domains for the purpose of multilevel regression analysis: 'ID-specific' (containing data on visual assessment, hearing assessment, behaviour assessment, bladder function, bowel function and feeding assessment) and financially incentivised QOF targets (blood pressure, smoking status, ethnicity, body mass index, urine analysis and carer details) which are incentivised processes. RESULTS: A total of 651 patients with ID were identified in 27 practices. Only nine practices undertook a health check on 92 of their patients with ID. Significant differences were found in the recorded information, between those who underwent a health check and those who did not (P < 0.001, chi(2) = 56.3). In the group that had health check, recorded information was on average higher for the 'QOF targets' domain, compared with the 'ID-specific' domain, by 58.7% (95% CI: 54.1, 63.3, P < 0.001). CONCLUSIONS: If incentives are to be used as a method for improving care for people with ID through health checks a more targeted approach focused on ID-specific health issues might be more appropriate than an extensive health check.

Rationale and design of the ADDITION-Leicester study, a systematic screening programme and randomised controlled trial of multi-factorial cardiovascular risk intervention in people with type 2 diabetes mellitus detected by screening.

BACKGROUND: Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in type 2 diabetes mellitus (T2DM). Latent phase identification through screening requires structured, appropriately targeted population-based approaches. Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from randomised intervention trials in screen-detected T2DM cases. UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM. To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care. Here we describe the rationale and methods of a systematic community screening programme and randomised controlled trial of cardiovascular risk management within a UK multiethnic setting (ADDITION-Leicester). DESIGN: A single-blind cluster randomised, parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care. METHODS: ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practices coordinated from a single academic research centre. Screening adopts a universal diagnostic approach via repeated 75g-oral glucose tolerance tests within an eligible non-diabetic population of 66,320 individuals aged 40-75 years (25-75 years South Asian). Volunteers also provide detailed medical and family histories; complete health questionnaires, undergo anthropometric measures, lipid profiling and a proteinuria assessment. Primary outcome is reduction in modelled Coronary Heart Disease (UKPDS CHD) risk at five years. Seven thousand (30% of South Asian ethnic origin) volunteers over three years will be recruited to identify a screen-detected T2DM cohort (n = 285) powered to detected a 6% relative difference (80% power, alpha 0.05) between treatment groups at one year. Randomisation will occur at practice-level with newly diagnosed T2DM cases receiving either conventional (according to current national guidelines) or intensive (algorithmic target-driven multi-factorial cardiovascular risk intervention) treatments. DISCUSSION: ADDITION-Leicester is the largest multiethnic (targeting >30% South Asian recruitment) community T2DM and vascular risk screening programme in the UK. By assessing feasibility and efficacy of T2DM screening, it will inform national disease prevention policy and contribute significantly to our understanding of the health care needs of UK South Asians. TRIAL REGISTRATION: Clinicaltrial.gov (NCT00318032).

The Thai-Australian Health Alliance: developing health management capacity and sustainability for primary health care services.

CONTEXT: There have been recent calls for a renewed worldwide focus on primary health care. The Thai-Australian Health Alliance addresses this call by developing health care management capability in primary health care professionals in rural Thailand. OBJECTIVES: This paper describes the history and current activities of the Thai-Australian Health Alliance and its approaches to developing health care management capacity for primary care services through international collaborations in research, education and training over a sustained time period. METHODS: The Alliance's approach is described herein as a distributed network of practices with access to shared knowledge through collaboration. Its research and education approaches involve action research, multi-methods projects, and evaluative studies in the context of workshops and field studies. WHO principles underpin this approach, with countries sharing practical experiences and outcomes, encouraging leadership and management resource networks, creating clearing houses/knowledge centres, and harmonising and aligning partners with their country's health systems. FINDINGS: Various evaluations of the Alliance's activities have demonstrated that a capacity building approach that aligns researchers, educators and health practitioners in comparative and reflective activities can be effective in transferring knowledge and skills among a collaboration's partners. Project participants, including primary health care practitioners, health policy makers and academics embraced the need to acquire management skills to sustain primary care units. Participants believe that the approaches described herein were crucial to developing the management skills needed of health care professionals for rural and remote primary health care. The implementation of this initiative was challenged by pre-existing low opinions of the importance of the management role in health care, but with time the Alliance's activities highlighted for all the importance of health care management. Acceptance of its activities and goals are evidenced by the establishment of a Centre of Leadership Expertise in Health Management and the endorsement of the Phitsanulok Declaration by more than 470 primary health care practitioners, academics and policy makers. DISCUSSION AND CONCLUSION: Problems with the primary health care delivery system in rural Thailand continue, but the Alliance has successfully implemented a cross cultural strategic collaboration through a continuity of activities to augment practice management capacities in primary care practices.

Measuring case-mix and outcome for older people in acute hospital care across Europe: the development and potential of the ACMEplus instrument.

AIM: To identify case-mix variables measured shortly after admission to be included in a patient classification system (ACMEplus) that best explains hospital outcome for older people in different health care systems. DESIGN: Observational prospective cohort study collecting patient factors (sociodemographics, functional, mental, clinical, administrative and perceived health) at different time assessments. METHODS: Multicentre study involving eight hospitals in six European countries (United Kingdom, Spain, Italy, Finland, Greece and Poland). It included consecutive patients aged 65 years or older admitted to hospital for acute medical problems. MAIN OUTCOME MEASURES: discharge status, hospital readmission, mortality and length of stay. RESULTS: Of the 1667 included patients (mean age = 78.1 years; male gender = 43.5%) two-third had at least one 'Geriatric Giant' (immobility, confusion, incontinence or falls) on admission or shortly after. The most frequently affected system was cardiovascular (29.2%) and 31% of patients declared poor or very poor health. Mean length of stay was 17.9 days, 79% of patients were discharged to their usual residence; in-hospital and 1-month follow up mortality were 7.4% and 11.6%, respectively. Physical function explained the highest variation (between 8% and 21%), followed by cognitive status and number of Geriatric Giants, for almost all outcomes except readmission. CONCLUSION: Factors other than diagnosis (physical function, cognition and presenting problems) are important in predicting key outcomes of acute hospital care for older people and are consistent across countries. Their inclusion in a standardized system of measurement may be a way of improving quality and equity of medical care in older people.