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Competitive grant funding is a well-established mechanism for generating activity and interventions in the field of chronic disease prevention. Yet grant competitions may be burdensome for organizations, and money may not be enough to bring about lasting change in communities. In this study, we explore the dynamics of awarding and receiving money in the context of a state-level government grant competition to support community organizations and promote community-driven action for health and well-being in Tasmania, Australia. Drawing on reflections of successful grant recipients and real-time observation of grant decision-making, we consider the role and value of grant competitions both for individual organizations and for generating broader change processes. We found that grant competitions operated according to an 'icing-on-the-cake' approach to funding, whereby money was provided for extra activities and new initiatives. In this way, the grant competition was valuable not only for stimulating new programme activities but also to effect broader organizational change, such as developing planning capacity, igniting new directions and pushing organizations towards 'health'-focused activities. But for smaller organizations, grant funding was often stretched to support core work (i.e. cake rather than icing). Grants targeting specific focus areas could be a drain on resources if they diverted staff time away from core activities. We suggest an alternative approach to funding in which grants are able to be more responsive to the needs of community organizations and the support they require, as well as to desired outcomes. We describe the policy response to the results to date.When a person attends a class on buying, storing and cooking fresh vegetables, or enrols in a walking group, or joins others to learn first aid, this ‘community-based health promotion’ is often the product of ideas and actions taken by staff employed in health services, local government and the community sector (e.g. neighbourhood houses). Grant competitions are intended to foster new ideas by providing money for new services, equipment or expertise. We investigated what happens behind the scenes when state government grants are awarded. We found that large organizations fare well as they can use new funds to innovate or gather evidence about the value of new ventures. But many smaller organizations suffer as they do not have the person power to write grants, hire extra staff or support new activities. Restrictions on what can and can’t be done with grant money can make receiving grants a burden, that is, grants fund ‘icing’ when what is needed is ‘cake’. An inadequate mix of funding types at the community level can mean that grant schemes are pressured to fill gaps for which they were not designed. Our policy partners have responded with more community-centred grant making, better tailored to various levels of community organizational need.

The COVID-I9 pandemic represents a massive challenge to the ordinary work of community-based organisations. We present results from a study of the actions and experiences of community-based organisations and funding agencies in the context of a grants program for chronic disease prevention in Tasmania, Australia during 2020. Community-based organisations had just received funding to implement programs targeting smoking, obesity, nutrition and physical activity when the first lockdowns were put in place. Though the rapid changes triggered by the pandemic placed strain on organisations in certain ways, we record the adaptive practices that took place as the pandemic unfolded. We observed two levels of adaptation: 1) program-level adaptation, as new ways of reaching people and delivering planned services were devised; and 2) system-level adaptation, as funding agreements were revised and the range of organisational procedures were altered, new partnerships were formed and the span of operations were rewritten. The suspension of usual rules and activities gave permission to experiment with new roles and ‘blue sky’ ideas. Organisations who provided compelling accounts of adaptation had leaders and past history that enabled them to tap into wide networks to access resources and coordinate action. We suggest that these insights from ‘extraordinary’ times are helpful for priming or building greater adaptability and transformability in community-based prevention programs, their host organisations and their funders in ‘ordinary’ times. Drawing on the theoretical foundations of liminality theory, complexity, and viable systems theory, we consider how (better) system-level capability for chronic disease prevention is built.

ObjectiveTo assess annual healthcare resource utilization including inpatient admission and outpatient visits, employment status, and sickness absence associated with myasthenia gravis (MG).BackgroundMG is a rare, chronic and debilitating autoimmune neuromuscular disease characterized by muscle weakness and fatigue that leads to hallmark symptoms including ptosis, dysphagia, dyspnea and limb weakness. Nearly 10% of patients are estimated to have treatment-refractory MG.Design/MethodsData were linked from four longitudinal nationwide population-based registries in Sweden. Patients with = 1 diagnosis of MG (ICD-10 G70.0) from 01/01/2001 to 12/30/2017 were selected. Date of 1st MG diagnosis in the national patient register was designated as index date. The healthcare resource use, employment status, and sickness absence for all cause and associated with MG within 1-year post-index period were evaluated.ResultsA total of 4,339 patients with newly diagnosed MG were identified from 2001 and 2017. Mean (±SD) age at index date was 59.8 (±19.5) years; 54% were female. During the first year post-MG diagnosis, 50.6% of patients) had = 1 MG-related inpatient admission and 23.6% spent >1 month as an inpatient. Most patients (89.3%, n = 3,875) had = 1 specialist visits for MG and 16.1% had >5 visits during 1-year post-index period. 58.9% of patients had = 1 all-cause inpatient admission and 97.5% of patients used = 1 outpatient specialist services in the same period. Among patients of working age with =1-year follow-up (n = 2,006), 37.3% of them were not employed; among those in employment (n = 1,250), 44.6% reported = 1 sickness absences within 1-year post-index period.ConclusionsPatients with MG require considerable care both for MG and comorbidities over a period of years. An important sub-population of patients (e.g., those with MG crisis) may be the intensive users of both inpatient and outpatient care. Future research needs to detail treatment pattern and outcomes in this population.

© 2019 The Authors. Journal of Applied Research in Intellectual Disabilities published by John Wiley & Sons Ltd Background: Active Support, now widely adopted by disability support organizations, is difficult to implement. The study aim was to identify the factors associated with good Active Support. Methods: Data on service user and staff characteristics, quality of Active Support and practice leadership were collected from a sample of services from 14 organizations annually for between 2 and 7 years, using questionnaires, structured observations and interviews. Data were analysed using multilevel modelling (MLM). Results: Predictors of good Active Support were adaptive behaviour, practice leadership, Active Support training, and time since its implementation. Heterogeneity, having more than six people in a service and larger organizations were associated with lower quality of Active Support. Conclusions: In order to ensure that Active Support is consistently implemented, and thus, quality of life outcomes improved, organizations need to pay attention to both service design and support for staff through training and practice leadership.

Background Chronic pelvic pain (CPP) is a common condition which significantly impacts the quality of life and wellbeing of many women. Laparoscopy with histopathology is recommended for investigation of pelvic pain and identification of endometriosis with concurrent removal. Never-the-less, the association between endometriosis and pelvic pain is challenging, with endometriosis identified in only 30-50% of women with pain. Aims To explore the predictors for undergoing surgery, for identifying endometriosis and endometriosis severity in a cohort of women with CPP. Materials and methods This study forms part of the Persistent Pelvic Pain project, a prospective observational cohort study (ANZCTR:ACTRN12616000150448). Women referred to a public gynaecology clinic with pain were randomised to one of two gynaecology units for routine care and followed for 36 months with 6-monthly surveys assessing demographics, medical history, quality of life, and pain symptoms measured on a Likert scale. Operative notes were reviewed and endometriosis staged. Results Of 471 women recruited, 102 women underwent laparoscopy or laparotomy, of whom 52 had endometriosis (n = 37 stage I-II; n = 15 Stage III-IV). Gynaecology unit, pelvic pain intensity and lower parity were all predictors of surgery (odds ratio (OR) 0.342; 95% CI 0.209-0.561; OR 1.303; 95% CI: 1.079-1.573; OR 0.767; 95% CI: 0.620-0.949, respectively). There were no predictors identified for endometriosis diagnosis and the only predictor of severity was increasing age (OR 1.155; 95% CI: 1.047-1.310). Conclusions Gynaecology unit and pain intensity were key predictors of undergoing laparoscopy; however, pain severity did not predict endometriosis diagnosis or staging. These findings indicate the need to review current frameworks guiding practice toward surgery for pelvic pain.

BackgroundChronic pelvic pain (CPP) is a common condition which significantly impacts the quality of life and wellbeing of many women.Laparoscopy with histopathology is recommended for investigation of pelvic pain and identification of endometriosis with concurrent removal. Never-the-less, the association between endometriosis and pelvic pain is challenging, with endometriosis identified in only 30-50% of women with pain.AimsTo explore the predictors for undergoing surgery, for identifying endometriosis and endometriosis severity in a cohort of women with CPP.Materials and MethodsThis study forms part of the Persistent Pelvic Pain project, a prospective observational cohort study (ANZCTR:ACTRN12616000150448). Women referred to a public gynaecology clinic with pain were randomised to one of 2 gynaecology units for routine care and followed for 36-months with 6-monthly surveys assessing demographics, medical history, quality of life, and pain symptoms measured on a Likert scale. Operative notes were reviewed, and endometriosis staged.ResultsOf 471 women recruited, 102 women underwent laparoscopy or laparotomy, of whom 52 had endometriosis (n=37 stage I-II; n=15 stage III-IV). Gynaecology unit, pelvic pain intensity and lower parity were all predictors of surgery (Odds ratio (OR) 0.342; 95%CI 0.209-0.561; OR 1.303; 95%CI: 1.079-1.573; OR 0.767; 95%CI: 0.620-0.949 respectively). There were no predictors identified for endometriosis diagnosis and the only predictor of severity was increasing age (OR 1.155; 95%CI: 1.047-1.310).ConclusionsPain intensity and gynaecology unit were key predictors of undergoing laparoscopy, however, pain severity did not predict endometriosis diagnosis or staging. These findings indicate the need to review current frameworks guiding practice towards surgery for pelvic pain.

Life Cycle Assessment typically focuses on the footprint of products and services, expressed on three Areas of Protection (AoP): Human Health, Ecosystems and Resources. While the handprint is often expressed qualitatively, quantified handprints have recently been compared directly to the footprint concerning one AoP: Human Health. We propose to take this one step further by simultaneously comparing the quantified handprint and footprint on all AoPs through normalization and weighting of the results towards a single score. We discuss two example cases of a pharmaceutical treatment: mebendazole to treat soil-transmitted helminthiases and paliperidone palmitate to treat schizophrenia. Each time, treatment is compared to 'no treatment'. The footprint of health care is compared to the handprint of improved patient health. The handprint and footprint were normalized separately. To include sensitivity in the normalization step we applied four sets of external normalization factors for both handprint (Global Burden of Disease) and footprint (ReCiPe and PROSUITE). At the weighting step we applied 26 sets of panel weighting factors from three sources. We propose the Relative Sustainability Benefit Rate (RSBR) as a new metric to quantify the relative difference in combined handprint and footprint single score between two alternatives. When only considering the footprint, the first case study is associated with an increased single score burden of treatment compared to 'no treatment', while in the second case study treatment reduces the single score burden by 41.1% compared to 'no treatment'. Also including the handprint provided new insights for the first case study, now showing a decrease of 56.4% in single score burden for treatment compared to 'no treatment'. For the second case study the reduction of single score burden was confirmed as the handprint burden was also decreased because of treatment by 9.9%, reinforcing the findings.

Opioid analgesia is the mainstay of treatment for moderate to severe acute and chronic pain and is highly effective in relieving pain but can be limited by side effects, the most common of which affect the gastrointestinal (GI) and central nervous systems. A growing body of evidence demonstrates that opioid-associated GI side effects constitute an important health problem with significant humanistic and economic consequences that warrant consideration by healthcare professionals and administrators in optimizing patients’ pain management. This article documents the frequency of opioid-associated GI side effects and describes its clinical and economic burdens based on a systematic review of the medical literature between 1966 and 2008.

A number of theoretical approaches suggest that gender inequity may give rise to health risks for men. This study undertook a multilevel analysis to ascertain if state-level measures of gender inequity are predictors of men's mortality in the United States. Data for the analysis were taken primarily from the National Longitudinal Mortality Study, which is based on a random sample of the non-institutionalised population. The full data set included 174,703 individuals nested within 50 states and had a six-year follow-up for mortality. Gender inequity was measured by nine variables: higher education, reproductive rights, abortion provider access, elected office, management, business ownership, labour force participation, earnings and relative poverty. Covariates at the individual level were age, income, education, race/ethnicity, marital status and employment status. Covariates at the state level were income inequality and per capita gross domestic product. The results of logistic multilevel modelling showed a number of measures of state-level gender inequity were significantly associated with men's mortality. In all of these cases greater gender inequity was associated with an increased mortality risk. In fully adjusted models for all-age adult men the elected office (OR 1.05 95% CI 1.01–1.09), business ownership (OR 1.04 95% CI 1.01–1.08), earnings (OR 1.04 95% CI 1.01–1.08) and relative poverty (OR 1.07 95% CI 1.03–1.10) measures all showed statistically significant effects for each 1 standard deviation increase in the gender inequity z-score. Similar effects were seen for working-age men. In older men (65+ years) only the earnings and relative poverty measures were statistically significant. This study provides evidence that gender inequity may increase men's health risks. The effect sizes while small are large enough across the range of gender inequity identified to have important population health implications., Highlights • Theoretical approaches link gender inequity to increased health risks for men. • Multilevel analysis allows investigation of a contextual effect of gender inequity. • The study modelled the effect of state-level gender inequity on men's mortality. • Aspects of gender inequity predicted an increased mortality risk for men.

Empirical studies suggest gender inequity increases men’s health risks. Multiple pathways may explain this relationship. These pathways however have not been explored concurrently. This paper is based on an extensive review of the theoretical literature linking gender inequity to men’s health. It identifies a range of theoretical approaches and examines links between them. In particular, it discusses masculinities and health theory, which argues gender inequity is linked to gender norms that lead to poor health-related beliefs and behaviours; the impact of gender inequity on men’s psychosocial and emotional experiences through limiting social roles, setting unattainable and restrictive expectations, and reducing access to social and emotional support; reproductive pathways, wherein gender inequity compromises optimal reproductive and early life outcomes leading to lifelong health impacts for males; and political, economic and social processes influenced by women’s social position that shape the social and economic resources, such as welfare and support, available to men. There are important interdependencies between these pathways. For example, masculine gender norms appear to not only increase poor health-related beliefs and behaviours, but also limit men’s opportunities to satisfy psychosocial and emotional needs. The findings suggest the extent of gender inequity can accentuate or buffer the negative health effects of other social inequalities. Further, while gender inequity provides men with many benefits, it limits access to the rich array of re-sources required to meet a diversity of lifelong health-related challenges. The paper provides the basis for richer theoretical approaches to men’s health.

The effects of a pharmaceutical treatment have until now been evaluated by the field of Health Economics on the patient health benefits, expressed in Quality-Adjusted Life Years (QALYs) versus the monetary costs. However, there is also a Human Health burden associated with this process, resulting from emissions that originate from the pharmaceutical production processes, Use Phase and End of Life (EoL) disposal of the medicine. This Human Health burden is evaluated by the research field of Life Cycle Assessment (LCA) and expressed in Disability-Adjusted Life Years (DALYs), a metric similar to the QALY. The need for a new framework presents itself in which both the positive and negative health effects of a pharmaceutical treatment are integrated into a net Human Health effect. To do so, this article reviews the methodologies of both Health Economics and the area of protection Human Health of the LCA methodology and proposes a conceptual framework on which to base an integration of both health effects. Methodological issues such as the inclusion of future costs and benefits, discounting and age weighting are discussed. It is suggested to use the structure of an LCA as a backbone to cover all methodological challenges involved in the integration. The possibility of monetizing both Human Health benefits and burdens is explored. The suggested approach covers the main methodological aspects that should be considered in an integrated assessment of the health effects of a pharmaceutical treatment.

In the 21 years since social capital first appeared in the public health literature, the evidence base has grown enormously, now reaching 28 systematic reviews encompassing more than 850 individual studies. We summarise this evidence and explain why conclusions relating to both the relationship between social capital and health, and the effectiveness of interventions to promote population health remain elusive and contradictory. A critical factor is the inadequate way that context is treated in the research, and especially how context interacts with efforts to promote health in a dynamic fashion. Of all the different types of interventions one could employ to improve the health of the public, ‘social capital’ interventions are likely to be the most context specific and especially affected by the boundaries placed around the context. A way forward is offered that requires a combination of insights from systems thinking, community-based participatory research, and intervention and improvement sciences. This requires renewed focus on the specific components of social capital, an understanding of how context interacts dynamically with efforts to improve health, a greater role for practice in the design, implementation, adaptation and evaluation of interventions, and the support of researchers to develop better methods for recognising and classifying the knowledge generated by complex interventions.

Objective: To assess the uptake of Medicare Benefit payments for non-directive pregnancy support counselling which commenced in November 2006. Methods: Counts of services for pregnancy counselling from 1 July 2007 to 30 June 2012, where a Medicare rebate was paid, were used to calculate age-, state- and provider-specific rates per 100,000 women aged 15–44 years, and rates per 100,000 births for each study year. Results: Rates of Medicare rebates for pregnancy counselling were low, with a mean of 90.6 services per 100,000 women recorded over the study period. GP services were accessed most frequently, while services provided by allied health professionals averaged less than 5% of those for GPs. The overall rate of services fell in all jurisdictions except Victoria/Tasmania, although services provided by allied health professionals remained steady or rose in all jurisdictions over the study period. Conclusions: There has been a low uptake of pregnancy counselling covered by the Medicare Benefits Item numbers introduced in 2006, especially for services provided by allied health professionals. Due to a lack of available data, the impact on abortion rates is unknown. Implications: Provision of Medicare rebates for pregnancy counselling does not appear to be an effective way of assisting women with unintended pregnancies.

Background Environmental impact assessments of pharmaceuticals typically consider only a part of the pharmaceutical supply chain, e.g. tablet formulation. While the environmental impact can be expressed in environmental Human Health burden due to resource use and emissions, the Human Health benefit of the pharmaceutical treatment of patients is currently not simultaneously taken into account. The study aims include a cradle-to-grave assessment of all Human Health impacts of the production, administration and disposal of two antipsychotics for the treatment of schizophrenia. This is complemented with the environmental impact of health care providers such as hospitals. The aim is to holistically quantify to what extent the environmental Human Health burden compares to the Human Health benefit associated with the treatment. Methods We applied an overall framework which included Life Cycle Assessment to model the environmental Human Health impacts of the pharmaceutical supply chain, administration and disposal of the drug and health care providers. To model the patient benefit, this was complemented with a Markov model with a 1-year time horizon. Three patient groups were modeled: medicine coverage of paliperidone palmitate for either one month (PP1M) or three months (PP3M) at a time, and compared to Treatment Interruption (TI) as a control group. Outcomes were quantified using Years of Life Lost (YLL), Years Lived with Disability (YLD) and Disability-Adjusted Life Years (DALY). Results The main environmental impacts were visits to the psychiatrist and psychiatric hospitals. The pharmaceutical supply chain had a limited impact. For 1000 patients for 1 year, PP1M and PP3M respectively avoided 0.38 and 0.49 environmental DALYs compared to TI. PP1M and PP3M further avoided 45.60 and 57.87 YLL and 23.31 and 29.91 YLD compared to TI. The main outcome was the sum of environmental DALYs, YLL and YLD, in which PP1M and PP3M respectively avoided 69.29 and 88.26 DALYs. Alternative analysis of Quality-Adjusted Life Years confirmed the results. Conclusions The overall environmental burden was lower for PP1M and PP3M treatment than Treatment Interruption because patients are kept more stable, which reduces the environmental burden due to hospitals. Moreover, the Human Health burden was outweighed by the Human Health benefit. Electronic supplementary material The online version of this article (10.1186/s12913-019-4247-2) contains supplementary material, which is available to authorized users.

Objectives: Constipation is a common side effect of opioid therapy. Tapentadol immediate release (IR) was better tolerated than oxycodone IR in 2 clinical trials involving patients with low back or osteoarthritis pain. The objective of this study was to examine patient-reported bowel function during those trials. Methods: Bowel function was assessed during secondary post hoc analyses using: the bowel movement questionnaire (BMQ; 10-d trial); the Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM; 90-day trial); and laxative use (both trials). Random effects maximum likelihood regressions were run to examine PAC-SYM data. BMQ data were analyzed using 1-way analyses of variance and a multinomial logistic regression. Rates of laxative use were compared using χ(2) statistics. Results: The 10- and 90-day trials consistently showed that tapentadol IR caused less impairment of bowel function than oxycodone IR. BMQ data were comparable between patients receiving tapentadol IR and placebo, and better versus oxycodone IR including: lower proportion of days where bowel movement was absent (P

In Alzheimer's disease (AD), it is important to consider long-term effects, not only in patients receiving treatment, but also in subjects in whom therapy has been discontinued. The present analysis evaluates the long-term effects of galantamine on cognitive function in AD in terms of Mini-Mental State Examination (MMSE) scores for up to 7 years, using both clinical data and epidemiological modeling. Consideration is given not only to patients continuing to receive galantamine therapy, but also to those who stop this treatment. In a retrospective review of medical notes, re-contacted study investigators obtained data from 258 patients originally recruited into three previously described randomized clinical trials involving galantamine: two placebo-controlled trials in mild-to-moderate AD (of 3 and 6 months' duration, followed by open-label extensions) and the galantamine-treatment arm of a 12-month comparative study with donepezil in moderate AD. Information relating to disease progression was collated (up to five MMSE scores, separated by at least 3 months, for each patient). Changes in MMSE scores over time were evaluated using observed data. In the absence of long-term placebo, the rate of cognitive decline without treatment was projected using a previously described epidemiological model. A new, exploratory statistical model was also developed. Results showed that patients with mild-to-moderate AD who received long-term galantamine treatment exhibited attenuated decline in cognitive function, as assessed by MMSE, compared with decline predicted in the absence of treatment. Furthermore, patients who stopped treatment experienced subsequent cognitive decline at a rate similar to that predicted for untreated patients.

Kavanagh S, Gaudig M, Van Baelen B, Adami M, Delgado A, Guzman C, Jedenius E, Schauble B. Galantamine and behavior in Alzheimer disease: analysis of four trials. Acta Neurol Scand: 2011: 124: 302–308. © 2011 John Wiley & Sons A/S. Objectives – Many individuals with Alzheimer’s disease (AD) experience behavioral and neuropsychiatric symptoms, which may cause caregiver distress and lead to the institutionalization of the patient. This analysis characterized behavioral symptoms and caregiver distress in trials of galantamine and their response to treatment. Materials and methods – Data were pooled from four randomized, placebo-controlled clinical trials of galantamine in patients with mild to moderate AD (three studies) or AD plus cerebrovascular disease (one study) (n = 2177). Behavior and associated caregiver distress were assessed in each study using the Neuropsychiatric Inventory (NPI) and NPI distress (NPI-D), respectively. Results – After 5/6 months, but not after 3 months, NPI score was significantly improved with galantamine vs placebo (P = 0.013). The benefit was particularly pronounced in patients categorized as having advanced moderate AD. At 5/6 months, there was a numerical benefit of galantamine over placebo in terms of caregiver distress; the difference was statistically significant in patients with moderate or advanced moderate AD. Conclusions – Galantamine reduces behavioral symptoms in patients with mild to moderate AD, leading to reduced caregiver burden. The reductions were greatest in patients with moderate or advanced moderate disease.

This study examined the relative impact of pain relief and opioid side effects on patients' and physicians' preferences for medication. An Internet survey was completed by 618 patients (302 acute pain, 316 chronic pain) and 325 physicians (83 primary care, 80 pain specialists, 41 oncologists, 40 general surgeons, 40 orthopedic surgeons, 20 rheumatologists, 21 neurologists). Respondents completed an Adaptive Conjoint Analysis (ACA) exercise in which they indicated their relative preference for 20 pairs of hypothetical opioid pain medications described by varying levels of pain relief and side-effect incidence. Almost all patients (96% of chronic, 92% of acute) reported experiencing at least 1 side effect while on opioid medication, but physician-estimated incidence rates of most opioid side effects were much lower than those reported by patients. Opioid side effects, rather than pain relief, explained the majority of variance for medication preference for both patients (74% for chronic, 73% for acute) and treating physicians (73% for chronic, 74% for acute) in this exercise. Nausea and vomiting were major determinants of opioid medication preference, with each explaining as much of the variance in preference as did pain relief (21% to 25%). Nausea and vomiting were the most important side effects based on the amount of pain relief that respondents were willing to give up for reducing the incidence of side effects. The importance of side effects was confirmed in an open-ended question where 51% of patients and 58% of physicians identified side-effect reduction as an unmet need for pain medications. Perspective This study provided insights into patient and physician preferences of the risk and benefit balance of opioid therapy. This information could improve understanding of patient needs and facilitate the incorporation of patient preference into therapy choice.

Background: Tapentadol immediate-release (IR) tablets are indicated for the treatment of moderate to severe acute pain. In clinical trials, tapentadol IR effectively reduced moderate to severe pain with improved tolerability compared with oxycodone IR at doses providing comparable analgesia. Objective: This analysis compared the cost-effectiveness of tapentadol IR with doses of oxycodone IR providing comparable analgesia in the outpatient treatment of acute postsurgical and nonsurgical pain. The perspective was that of a US managed care health plan as third-party payer. Methods: A Markov model was developed to simulate clinical-economic outcomes for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute postsurgical pain (3 days) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain (10 days). The model simulated changes in pain relief; occurrence of opioid-related adverse events (AEs); opioid switching, discontinuation, and dose change; and number of quality-adjusted life-days (QALDs). Data inputs for the model were obtained from clinical trials, claims databases, surveys, Medicare fee schedules, and other published sources. Only direct costs were included. Drug costs were based on the wholesale acquisition cost. Prescription copayments were set at $5 for oxycodone IR and $25 for tapentadol IR. All costs were in 2008 US dollars. Sensitivity analyses were conducted on key model parameters. Results: The cost of pain medication per patient was higher for tapentadol IR than for oxycodone IR in both the surgical pain setting ($15.23 vs $9.57, respectively) and the nonsurgical pain setting ($57.17 vs $21.31). However, this cost difference was offset by reductions in pharmacy and medical costs associated with the treatment of AEs and opioid switching/discontinuation, resulting in a lower mean treatment cost per patient for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute surgical pain ($52.90 vs $55.99) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain ($139.48 vs $144.79). Tapentadol IR also was associated with a greater mean number of treatment days with ≥30% improvement in pain intensity without opioid-related AEs compared with oxycodone IR and a greater mean number of QALDs (surgical pain: 1.73 vs 1.68; nonsurgical pain: 6.03 vs 4.92). Because both doses of tapentadol IR were dominant (ie, lower treatment costs and greater effectiveness) relative to the corresponding doses of oxycodone IR providing com- parable analgesia, incremental cost-effectiveness ratios were not calculated. Conclusion: The results of this model suggest that at doses providing comparable analgesia, tapentadol IR is a cost-effective alternative to oxycodone IR for the treatment of acute surgical and nonsurgical pain.

Theoretical approaches suggest that gender inequity increases men’s health risks. Previous findings from the United States support this contention, however only a small number of health outcomes have been explored. This study extends the range of health outcomes examined by using a cross-sectional, multilevel analysis to investigate whether measures of state-level gender inequity are predictors of men’s self-rated health. Data were derived primarily from the Behavioral Risk Factor Surveillance System and the full-case data set included 116,594 individuals nested within 50 states. Gender inequity was measured with nine variables: higher education, women’s reproductive rights, abortion provider access, elected office, management, business ownership, labour force participation, earnings and relative poverty. Covariates at the individual level were age, income, education, race/ethnicity, marital status and employment status. Covariates at the state level were income inequality and gross domestic product per capita. In fully adjusted models for all-age men the reproductive rights (OR 1.06 95% CI 1.01–1.11), abortion provider access (OR 1.11 95% CI 1.05–1.16) and earnings (OR 1.06 95% CI 1.02–1.12) measures all predicted an increased risk of men reporting poorer self-rated health for each 1 standard deviation increase in the gender inequity z-score. The most consistent effect was seen for the 65+ age group where the reproductive rights (OR 1.09 95% CI 1.03–1.16), abortion provider access (OR 1.15 95% CI 1.09–1.21), elected office (OR 1.06 95% CI 1.01–1.11) and earnings (OR 1.10 95% CI 1.04–1.16) measures all showed a significant effect. These findings provide evidence that some aspects of gender inequity increase the risk of poorer self-rated health in men. The study contributes to a growing body of literature implicating gender inequity in men’s health patterns.

Objective This study evaluated patient and treatment (galantamine and other acetylcholinesterase inhibitors (AChEIs)) factors associated with the time until nursing home placement (NHP) in patients with Alzheimer's disease (AD) with and without cerebrovascular disease (CVD). Methods Re-contact follow-up study conducted in 2004 of 548 patients who had previously participated in RCTs with galantamine. Time to NHP was analyzed using Kaplan-Meier estimates and Cox regression analysed factors associated with NHP. Results There were 57% of female subjects and the mean age (SE) was 73.6 (±0.33) years. Within this cohort 78% of patients had AD, and 22% had AD with CVD. Overall, 59% of subjects had a NHP (median 42.4 months 95%CI: 38.0–48.0). The Cox regression model identified higher baseline Disability Assessment in Dementia (DAD) and Mini Mental State Examination (MMSE) scores, diagnosis (AD with CVD vs AD), living with caregiver, country, and treatment duration with galantamine or other AChEIs as factors associated with a reduced risk of institutionalization (p

Background: Galantamine (hydrobromide), a reversible acetylcholinesterase inhibitor and allosteric nicotinic receptor modulator, slows cognitive and functional decline in mild to moderate dementia of the Alzheimer’s type. Although several drugs are indicated for mild to moderate Alzheimer’s disease (AD), no published study has separately analysed mild and moderate AD subgroups to assess the effect of dosage. Objective: To compare the efficacy and safety of galantamine 16 and 24 mg/day in patient subgroups with mild or moderate AD. Methods: This post hoc analysis (n = 838) of a 5-month, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of galantamine 16 and 24 mg/day in a subgroup of patients with mild AD (Mini-Mental State Examination [MMSE] >18) and a subgroup with moderate AD (MMSE 10–18). Efficacy outcomes included the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) score and treatment response (ADAS-cog maintenance [≥0-point improvement], improvement ≥4 points and improvement ≥7 points). Results: Mean ADAS-cog scores of patients with mild AD demonstrated significant improvement from baseline with galantamine 16 and 24 mg/day (p < 0.001 for both), whereas cognitive function did not change significantly for placebo recipients (p = 0.559). Patients with moderate AD improved with galantamine 24 mg/day (p = 0.009) but not with 16 mg/day (p = 0.768); a decline occurred with placebo (p < 0.001). A greater proportion of patients treated with galantamine 16 mg/day (76% and 52% for mild and moderate AD, respectively) or 24 mg/day (69% and 61%, respectively) demonstrated a treatment response (i.e. ADAS-cog was maintained or improved) relative to placebo (55% and 28%, respectively; p < 0.05). Patients with moderate AD trended toward greater response with the 24 mg/day dosage than with the 16 mg/day dosage. Galantamine was well tolerated. Adverse events were comparable for all study groups with mild or moderate AD. Conclusion: This post hoc analysis suggests that galantamine 16 mg/day is the optimal dosage for patients with mild AD, as similar efficacy is observed with the 24 mg/day dose. However, patients with moderate AD appear to gain additional benefit from galantamine 24 mg/day.

Chronic osteoarthritis (OA) pain impacts health-related quality of life (HR-QOL).The primary aim of this study was to evaluate and compare HR-QOL outcomes following treatment with once-daily push-pull Osmotic controlled-Release Oral delivery System (OROS) hydromorphone versus twice-daily extended-release (ER) oxycodone for moderate to severe chronic knee or hip OA pain.This was a 6-week, randomized, open-label, parallel-group, multicenter study of 124 patients with OA whose pre-trial treatment included NSAIDs or other non-steroidal, non-opioid analgesics. The HR-QOL of patients was assessed using the Medical Outcomes Study (MOS) Sleep Scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™). Within- and between-group changes from baseline to 6 weeks were evaluated using ANOVA.At baseline, trial patients had significantly worse MOS Sleep Scale (multivariate ANOVA [MANOVA] F = 11.0, p 0.001) and WOMAC™ scores (MANOVA F = 55.7, p 0.001) than chronic disease benchmarks. Both treatment groups showed significant improvements on the sleep disturbance scale (p 0.01), with additional improvements observed with OROS hydromorphone on the sleep quantity (p = 0.046), sleep snoring (p = 0.044), awaken short of breath or with a headache (p = 0.024), 6-item sleep problems index I (p 0.001), and 9-item sleep problems index II (p 0.001) scales. Significant treatment differences in favor of OROS hydromorphone over ER oxycodone were also observed on the awaken short of breath or with a headache (p = 0.014) scale and sleep problems index I (p = 0.045). Both treatment groups showed comparable large effect size (0.8 SD unit) improvements on the WOMAC™ scale (measuring functionality outcomes such as pain, stiffness, physical function etc).Both OROS hydromorphone and ER oxycodone improved sleep and function, with greater sleep benefits being observed in patients treated with OROS hydromorphone.

The objective of this paper is to investigate the service needs and support costs of elderly people with cognitive impairment on hospital and community health services, primary health care, social services, and informal carers in England. It examines the resource consequences of major changes in the provision of care, exploring the implications for both cost and effectiveness. The study was designed to provide a secondary analysis of the OPCS disability surveys in order to estimate the balance of care, and current provision of services. It also estimates of costs of present provision and potential policy options. Results show large scale improvements in the provision of care for people living in private households and local authority homes require significant increases in funding, but reductions in the provision of long-stay hospital beds can significantly reduce the cost burden to the public purse. Given the increasing demand pressure on health and social care expenditure, it seems unlikely that large scale improvements in the care supplied to elderly people with cognitive impairment can be achieved without some change in the balance of care. The cost of implementing improvements in care for the 200000 people living in private households and the 45000 people in local authority homes could be offset by reducing the provision of costly long stay hospital provision with alternative institutional care such as NHS nursing homes.

Placebo data were pooled from two 1-year, randomized, double-blind, placebo-controlled trials of sabeluzole in patients with mild-to-moderate Alzheimer disease (AD). Cognition was assessed using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and activities of daily living (ADL) with the Disability Assessment in Dementia (DAD). Time spent assisting with ADL was estimated according to the caregiver for each DAD domain in the 2 weeks before assessment. Progressive annual decline was seen on ADAS-cog (5.6 +/- 7.3 [mean +/- SD]) and DAD (-12.4 +/- 17.8), with greater decline in moderate patients (Mini-Mental State Examination [MMSE]or =18) than mild patients (MMSE18). An MMSE score of 16 appeared to be a key transition point at which most instrumental ADL were lost and major losses of basic ADL began to occur over the next 12 months. Caregivers spent, on average, 14 hours more assisting with ADL over 2 weeks at the end of 1 year. The proportion of care provided by paid caregivers increased relative to the time spent by informal caregivers. Patients with mild-to-moderate AD experience predictable annual decline in cognition and daily functioning, with measurably increased caregiver time. Small changes in ADAS-cog are nevertheless associated with a substantial measurable effect on the daily lives of both patients and caregivers.

BackgroundThe high support needs of elderly people with cognitive disability raise questions about the cost-effectiveness of different treatments. Associations between costs and cognitive disability could be influenced by other factors, particularly comorbidities.AimsTo examine the links between costs and cognitive disability in the context of covariates.MethodSecondary analyses of data from the UK Office of Population Censuses and Surveys disability surveys for over 4500 elderly people living in households were used to examine associations between cost and cognitive disability.ResultsCosts varied considerably, and were associated with severity of disability along a number of dimensions. The cost-raising effects of cognitive disability were smaller when the analyses controlled for levels of disability in other domains.ConclusionsCognitive disability is significantly associated with higher costs, but these analyses highlight the need to examine a range of disabilities.

Government policy continues to emphasise the commissioning and needs-assessment role of health authorities, local authorities and - to a greater extent - general practitioners. To date, much available information for this purpose has been based on service utilisation data or from registers based on case finding from service contacts. As an alternative, we conducted secondary analyses of the national Surveys of Disability of Children and Adults by the Office of Population Censuses and Surveys. The prevalence of intellectual disability for people who had 'mental handicap' reported as an underlying health problem was 3.5 per 1000 in the overall population. Rates rose from 1.7 per 1000 among those aged 4 and under, reaching a peak of 63 per 1000 among 16-19 year olds and falling to 2.8 per 1000 among people aged 75 or more. Residence in a communal establishment increased markedly with age. People in households had high levels of disability and consequently problems with personal care. Furthermore, behaviour problems were commonplace. Consequently, carers spent long hours caring and often reported adverse effects on their health.

The effects of the routine use of early amniotomy to speed up labour have been analysed in a systematic review of randomized controlled trials. In this paper the authors used this data from the systematic review and a survey of costs to analyse the cost consequences of early amniotomy.

Deinstitutionalisation coupled with reforms to the organisation and financing of services are having a profound impact on mental healthcare. This paper outlines common difficulties facing healthcare systems and some of the evolving structures. Despite historical differences between the US and UK systems, certain common themes are emerging.

There has been considerable debate concerning the cost-effectiveness of selective serotonin re-uptake inhibitors (SSRIs) versus tricyclic antidepressants (TCAs) thus far using crude prescription price comparisons or reductionist decision-analytic models. This paper employs a retrospective quasi-experimental design where data on service utilisation, use of medication and informal care were collected for two groups of patients in general practice settings. The mean cost of treatment was marginally greater for those people receiving TCA medication due to greater use of psychiatric services. Factors such as age, previous depression and concomitant physical illness are all associated with greater treatment costs. Further analysis using a prospective design is recommended.

This study assesses the effects of relocation from hospital on the level of functioning, morale and satisfaction of 188 long-stay patients discharged from the six major psychiatric hospitals in Northern Ireland during 1990-1992. There was little change in clients' skills (eg. domestic and social skills) one and two years after discharge. The behaviour of former patients was not adversely affected by life in the community. They were less depressed than in hospital and were also more satisfied with their living environments. Overall, the findings, which are broadly in line with those reported elsewhere, indicate that the policy of relocating people outside hospital has been a limited success.

The replacement of long-stay hospital services with community-based care can have considerable resource consequences. How much community care costs and whether it is more expensive than hospital care are questions high on the policy and planning agenda. Decision-makers should also be interested in whether levels of expenditure are associated with clients' needs and with changes in their wellbeing. These questions were addressed in a wide-ranging evaluation of community care in N. Ireland. In examining the costs of accommodation and other services used by former residents of nine hospitals (n=133) the study found community care to be cheaper than hospital care. Broadly speaking, the new service was a cost-effective alternative as little change in clients' welfare was found. However, analysis of the variations in community care costs found only weak associations with clients' personal characteristics and needs, and found no link between differential spending and differential outcomes.

The reforms introduced by the 1990 National Health Service and Community Care Act are bringing about the most far-reaching changes to the provision and financing of health and social care in the United Kingdom in the past fifty years. Market forces are receiving an enormous boost; responsibilities are being shifted between public-sector agencies; private-sector bodies are increasingly active; primary care physicians in the public sector can control their own budgets; secondary care provision, such as hospital and specialist community services, has been partly moved into a quasi-market; crossservice coordination of care is emphasized; and both users and family caregivers are more likely to be involved in decision making. Although there is much lively discussion of alternative forms offinancing, health and social care in the United Kingdom will be dominated by public funding for the foreseeable future. The government’s broad objectives in relation to mental health are to decrease both morbidity and mortality, with specific quantitative targets limited to reducing the suicide rate. Health and social care services obviously should help to meet these objectives, but other influential factors and inputs from agencies such as housing and social security also play important roles. Our examination of mental health care reform is therefore conducted in recognition of the limited role of health and social care agencies.

Purpose. Opioid treatment effectiveness may be best compared using definitions of treatment response, which combine measures assessing pain reduction and the occurrence of adverse events (AEs). This analysis of data from two phase III clinical trials was conducted to examine the pain relief and tolerability (PRT) balance of immediate release (IR) tapentadol and oxycodone in patients with moderate to severe osteoarthritis (OA) or low back pain. Methods. This was a post hoc analysis of two multicenter, randomized, double-blind studies (10-day and 90-day) that evaluated the efficacy and safety of tapentadol IR in patients with moderate–severe OA pain. PRT was defined as adequate pain reduction (30% or 50% pain intensity improvement from baseline) and no gastrointestinal AE or other type of treatment-emergent AE. The percentage of patients and mean number of days per patient meeting the PRT criteria were summarized. Results. In the 10-day trial, the percentages of patients meeting PRT criteria (30% reduction) for both tapentadol groups were consistently above that for oxycodone 10 mg, although only significantly different for the 50 mg formulation. The mean number of days per patient meeting the PRT criteria was 3.7, 3.2, and 2.3 days for tapentadol 50 mg, 75 mg and oxycodone 10 mg, respectively. No significant difference between the groups was observed using the 50% pain reduction criterion. For the 90-day trial, using multiple definitions, tapentadol IR showed a significantly higher proportion of days meeting PRT criteria. Conclusion. Pain reduction and tolerability are both important attributes of an effective analgesic treatment. Based on data from two trials, tapentadol IR produced an improved PRT balance compared with oxycodone IR.

This paper describes where elderly people with moderate to severe (‘advanced’) cognitive impairment are living, what resources they use and the costs of these services to different funding agencies. It operationally defines dementia in terms of cognitive impairment and uses the OPCS disability surveys to estimate the prevalence of moderate to severe cognitive impairment in England. The paper goes on to describe services received by this client group on the basis of the same surveys, and costs these by supplementing the data with information from related studies by the PSSRU. Since accommodation is a major cost, the population of elderly people with cognitive impairment is classified according to their place of residence. Thus we are able to estimate the ‘baseline’ global cost of provision for this client group at current prices. We make cost projections at 1991/92 price levels to the national level, and discuss the implications in terms of burdens to different agencies.

Background: This analysis aimed to identify an operational, clinically relevant definition of response achieved in short-term clinical trials to support the identification of patients with Alzheimer’s disease (AD) who would benefit most from long-term galantamine therapy. Methods: Data were analyzed from 6 randomized placebo-controlled trials of up to 6 months’ duration, which included patients with mild to moderate AD receiving maintenance doses of galantamine 16-24 mg/day, and from 12 open-label extensions (galantamine 24 mg/day maintenance therapy). Assessments included changes from baseline in the 11-item AD Assessment Scale-Cognitive subscale (ADAS-Cog 11). Results: Pooled analysis of the 5-6 month trial data showed that at the trial endpoint (2-5 months after reaching maintenance doses), the proportions of galantamine- (n=1,173) versus placebo-treated patients (n=801) with probable AD categorized according to “improved”, “stable” or “non-rapid decline” criteria, were 45.8% versus 27.2%, 59.5% versus 37.1%, and 87.6% versus 69.7%, respectively (observed cases analysis), whilst changes in ADAS-Cog 11 scores versus baseline were -4.9, -4.7 and -2.9 points, respectively, for “improved”, “stable” and “non-rapid decline” galantamine-treated patients (-1.5 points for galantamine recipients overall). “Improved” or “stable” galantamine-treated patients displayed mean improvement in ADAS-Cog 11 scores over baseline until 18 months after starting treatment, and attenuated deterioration thereafter; for galantamine-treated patients exhibiting “non-rapid decline”, mean ADAS-Cog 11 score returned to baseline after approximately 12 months. Conclusions: Patients who demonstrate improvement, stability, or limited cognitive decline 2-5 months after reaching maintenance doses of galantamine are more likely to experience continued benefit from long-term galantamine therapy.

Background Gastrointestinal (GI) adverse effects are common with oral opioid treatment. Objective To estimate the costs associated with GI events after oral short-acting opioid treatment, from the payer perspective. Methods Medical and pharmacy claims from the PharMetrics’ Patient-Centric Database were used to identify opioid-naïve patients who received a new prescription for oxycodone- or hydrocodone-containing immediate-release oral products between 2002 and 2006. Health-care resource use and costs were determined for patients with claims associated with ICD-9 CM (International Classification of Diseases—9th Clinical Modification) codes for nausea/vomiting (787.0x), constipation (564.0x), bowel obstruction (560, 560.1, 560.3, 560.39, 564.81), or antiemetic and laxative prescriptions during the 3 months after opioid index prescription and compared with patients without these GI event medical or prescription claims. Resource use data were compared using negative binomial regression and cost data were compared using ordinary least squares confirmed by generalized gamma regression analysis while controlling for demographics, treatment duration, and comorbidities. Results Data from 237,447 patients were analyzed. Patients with GI event claims had significantly more hospitalizations (adjusted mean 0.20 to 0.97 vs 0.17, respectively, p < 0.001), days in the hospital (1.12 to 12.05 vs 1.00 days, p < 0.001), emergency department visits (0,36 to 1.44 vs 0.25 visits, p < 0.001), outpatient office visits (5.68 to 11.81 vs 4.11 visits, p < 0.001), and prescription claims (7.46 to 8.21 vs 6.06 claims, p < 0.001) than did patients without any GI event claims in the 3 months after index opioid prescription. Compared with patients without any GI event claims, incremental adjusted mean total health-care costs for patients with any of the GI event claims ranged from $4,880 to $36,152 and were significant (p < 0.001). Conclusions The economic burden of GI events coincident with opioid treatment is significant for patients with a GI event recorded in claims. Reducing GI adverse effects has potential cost savings for the health-care system.