Health literacy among fathers and fathers-to-be: a multi-country, cross-sectional survey.

During pregnancy and early fatherhood, men are at higher risk of poor health, exacerbated by low engagement by healthcare services. Yet the transition to fatherhood presents an opportunity for men to improve their health and health behaviours. Health literacy refers to individuals' competence in accessing and applying health information. Poor health literacy is associated with poor health and low help-seeking. The aim of this study was to identify health literacy strengths, needs and profiles among fathers. Men who were expecting a baby ('antenatal') or had become fathers in the past 18 months ('postnatal') were recruited through an international, online paid survey platform. The survey included the nine-scale Health Literacy Questionnaire (HLQ). Of 889 survey respondents (n = 416, 46.5% antenatal; n = 473, 53.5% postnatal), 274 (31.0%) were residing in the USA and 239 (27.0%) in the UK. Relatively higher scores were reported for HLQ scales relating to having sufficient information and finding and understanding this information, as well as social support for health. Relatively lower scores were obtained for scales relating to actively managing one's own health and navigating the health care system. Three scale scores were significantly lower among nulliparous than multiparous men. Seven health literacy profiles were identified. In conclusion, while fathers have some health literacy strengths, they also experience some barriers, particularly first-time fathers. Awareness of diverse health literacy profiles among fathers may assist in developing strategies to strengthen health services' capacity to meet fathers' needs and reduce risks to their health at this critical juncture in families' lives.

Soft infrastructure: the critical community-level resources reportedly needed for program success.

BACKGROUND: The mechanisms typically used to fund health promotion in communities, either as part of an effort to scale-up programs or to support the design of local activities, often pay insufficient attention to the foundational means of enhancing well-being. Only recently have researchers begun to critically 'unpack' how funding processes connect with and activate local community capacities. METHODS: We conducted a thematic analysis of 33 interviews with policy and program administrators in public health and local community workers and volunteers. We invited them to expound on their understandings of resources - specifically, what needs to be in place to make funded programs successful and/or what do communities draw on to make funded programs effective. RESULTS: Policy and program administrators reflected mostly on the importance of traditional resources, such as adequate funding and staffing. Community-based participants often went further to describe psychological and sociological resources - the "soft infrastructure" which included trust and hope. Both groups emphasised the importance of building networks and relationships at multiple levels. Community workers also provided examples of how resources grow and improve in value in combination with other processes or through pathways of resource use or resource distribution. So, resources like information/knowledge are made more valuable when relayed locally. Physical amenities (e.g., meeting spaces, kitchens) have an instrumental role, but also act powerfully as a symbolic resource for identity. Participants reported that funding processes can damage the resources required for community health improvement. Funding instability undermines capacity. The ongoing threat of funding removal was described by one administrator as community "bullying". CONCLUSIONS: Processes of health promotion funding, and even standard processes of program scale-up and readiness assessment, risk underestimating the range of resources that are fundamental for community health improvement, particularly among disadvantaged communities. Funders should design ways to resource communities so that there is constant attention to and coaching of critically important diverse processes of resource growth, independent of program-specific funds.

Icing or cake? Grant competitions as a model for funding chronic disease prevention in Tasmania, Australia.

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.

P043 Resource Utilization and Productivity Loss among Patients with Inflammatory Bowel Disease in Sweden: A Longitudinal Nationwide Population-based Study.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are the two most prevalent forms of inflammatory bowel disease (IBD) causing frequent diarrhea, rectal bleeding, fatigue, and abdominal pain. IBD may result in complications requiring hospitalizations and surgical procedure, hence IBD can negatively impact patients' quality of life, work productivity, and increase societal economic burden. Limited data exists assessing epidemiologic trends and population-level health outcomes among patients with IBD in Sweden. This study assessed the trends in annual incidence and prevalence of CD, annual inpatient and outpatient visits, employment status and sickness absence among adults with IBD in Sweden from 2001 to 2017. METHODS: Data were acquired from four nationwide registers provided by the National Board of Health and Welfare in Sweden and linked through the unique personal identity number. Individuals aged ≥18 years with ≥2 primary diagnoses of CD (ICD-10 K50) or ≥2 primary diagnoses of UC (ICD-10 K51) from 01/01/2001 to 12/30/2017 were selected. Date of the first CD or UC diagnosis was designated as index date. All individuals were followed until death, lost to follow up or end of study. RESULTS: A total of 30,895 patients with CD and 50,415 with UC were included in the analysis, respectively. The mean follow-up for patients was 10.1 (±5.33) and 10.4 (±5.21) years for CD and UC. The mean (±SD) age among CD patients was 40.4 (±18.4) years and 42.6 (±18.2) years for UC. The most frequently observed comorbid condition was noninfective enteritis and colitis for patients with CD (24.2%) and UC (15.7%). The annual incidence of CD was 10 per 100,000 person-years in 2017, while the incidence of UC was 3 per 100,000 in 2017. 40.6% of CD patients and 30.8% of UC patients had ≥ 1 inpatient admission during 1-year post-index period, of which 53.5% and 51.2% had inpatient care lasting more than 1 week. Among patients with ≥ 1 outpatient services (CD: n = 30,675; UC: n = 50,183), 41.7% and 29.2% of patients had more than 5 visits during 1-year post-index period. Among patients who were eligible for employment and disability benefit analyses who had at least 1-year follow-up (CD: n = 23,731; UC: n = 39,391), 27.9% of CD patients and 23.1% of UC patients were not in employment; among those who were in employment (CD: n = 17,039; UC: n=30,302), 30% and 24.6% reported sickness absence within the calendar year after the index date, respectively. CONCLUSION: Findings from this study of a large national cohort of patients followed for many years demonstrates the significant epidemiological, clinical, and socioeconomic impact of patients with CD and UC. Further research is needed to understand underlying factors driving inpatient admissions among patients with IBD. With an increasing annual prevalence, IBD continues to impose a substantial public health burden to patients, their families and health care services.

Pelvic pain: What are the symptoms and predictors for surgery, endometriosis and endometriosis severity.

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.

Factors that predict good Active Support in services for people with intellectual disabilities: A multilevel model.

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.

Human health benefit and burden of the schizophrenia health care pathway in Belgium: paliperidone palmitate long-acting injections.

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.

Human health benefits and burdens of a pharmaceutical treatment: Discussion of a conceptual integrated approach.

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.

Gender-sensitive community weight-loss programmes to address overweight and obesity in men: a scoping review.

OBJECTIVES: To examine how gender-sensitive community weight-loss programmes have been used to address overweight and obesity in men and to identify what can be learnt from this rapidly evolving field. DESIGN: Scoping review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review checklist for reporting. DATA SOURCES: A database search was conducted using EBSCOhost (Academic Search Complete, CINAHL Complete, Global Health, Health Source: Consumer Edition, Health Source: Nursing/Academic Edition and Medline Complete), Google, Google Scholar, Open Access Theses and Dissertations platform and Scopus. ELIGIBILITY CRITERIA: All weight-loss programmes using a gender-sensitive approach to address men's overweight and obesity in community settings. DATA EXTRACTION AND SYNTHESIS: Narrative synthesis was conducted based on the research questions and objectives. Primary outcomes include operationalisation, context and concept of the gender-sensitive approach. Information was reviewed and extracted to Microsoft Excel by two reviewers. RESULTS: A total of 40 studies (28 quantitative, eight mixed methods and four qualitative) were identified from 4617 records. Gender-sensitive approaches were undertaken in a range of settings and contexts including professional sports clubs (n=21), non-professional sporting clubs (n=16), workplace-based (n=2) and commercial organisation-based (n=1). The most common analysis approaches were evaluating the effect of the programmes (n=31) where positive impact was predominantly shown (eg, up to 3.9 kg weight reduction at 3-month follow-up). Programmes (ie, Football Fans in Training) were short-term cost-effective (eg, the cost was £862-£2228 per 5% weight reduction at 12-month follow-up). Qualitative evidence highlights factors that influenced men's participation (eg, camaraderie) and identifies areas for improvement. CONCLUSION: The findings demonstrate that gender-sensitive programmes for men's weight loss have been effectively applied using a range of different approaches and in a range of different contexts. Further evidence is needed to confirm the effectiveness of the programmes across diverse groups of men.

How do we fund Public Health in Australia? How should we?

OBJECTIVE: To map how public health is funded in Australia. To assess whether changes to funding methods might improve system performance. METHODS: Review of publicly accessible documents and discussions with public health key informants. RESULTS: Australia spent $140 per person on public health in 2019-20, (1.8% of total health spending). But there is considerable state and territory variation. This money flows through multiple channels and payment mechanisms. Responsibility for what is funded is largely delegated to authorities close to the problems. This makes it easier to choose the best mechanism for funding an activity. Much information is hidden from view, however. This makes it impossible to assess whether the potential for population benefit is fully realised. CONCLUSIONS: Australia avoids some of the difficulties experienced elsewhere because funding is largely devolved to states in block grants; they shape their own investments. The US, by contrast, prefers categorical funds for specific purposes. Three suggestions for making the funding system here more visible, useful and accountable are canvassed, including 'satellite accounts'. IMPLICATIONS FOR PUBLIC HEALTH: Funding needs to be more transparent before it is possible to assess whether public health system performance could be improved through changes to the way public health is funded.

"I always felt like I wasn't supposed to be there". An international qualitative study of fathers' engagement in family healthcare during transition to fatherhood.

OBJECTIVE: Engagement of fathers in family health services confers benefits for the health and wellbeing of the whole family. The childbirth continuum is traditionally considered a feminine event, however, commensurate with the changing paradigm of gender equity in family healthcare worldwide, the role of fathers is in transformation. The aim of the study is to explore father's perceptions and experiences of healthcare engagement during pregnancy and early infant care. DESIGN: Qualitative free-text questions were embedded in a large multi-country, cross-sectional survey, to explored fathers' attendance, participation, and experience of health care during appointments with their pregnant partner and/or baby. SETTING AND PARTICIPANTS: Expectant and new fathers were recruited through Prolific®, an international paid online survey platform. FINDINGS: Qualitative responses (n=889) were provided by fathers from 28 countries, with experiences of a range of contexts and models of care; 46.8% of whose partners were pregnant and 53.2% had given birth since 2020. The findings suggest that although most fathers wanted to attend and participate in maternity and early parenting-related healthcare, multiple barriers were identified at the individual father, organisational context, and societal levels. Fathers reported negative social factors such as gender bias and restrictive gender norms as barriers to their healthcare engagement. In contrast, factors that enabled fathers to overcome barriers included the fathers' feelings of confidence in their partner's autonomy and decision-making skills, trusted professional relationships with clinicians, and clinicians with good interpersonal skills. KEY CONCLUSIONS: Multiple barriers restrict the participation of fathers in healthcare for childbearing and early parenting. Knowledge of these barriers can inform healthcare redesign to include more successful engagement strategies for fathers, to benefit fathers, mothers, and infants alike. IMPLICATIONS FOR PRACTICE: Health professionals consulting with the mother, father and infant triad are ideally placed to address the healthcare needs of both parents. Early engagement of fathers in family health care by use of inclusive interpersonal skills and the development of a trusted relationship has potential to improve paternal mental health, and may be associated with benefits for the health, wellbeing and safety of the whole family.

Individual and community experiences of posttraumatic growth after disaster: 10 years after the Australian Black Saturday bushfires.

OBJECTIVE: To understand longer-term posttraumatic growth (PTG) and how this is associated with individual and community bushfire experiences. METHOD: Survey data (n = 391) from the Beyond Bushfires and the 10-year Beyond Bushfires studies were analyzed. Multilevel modeling examined relationships between basic individual demographics, bushfire exposure, and community-level variables at 3-4 years after the fires, and PTG at 10 years using the short form of the PTG Inventory. RESULTS: Ten years after these Australian bushfires, being female, experiencing higher degrees of property loss, and stronger individual sense of community were the factors associated with PTG. Approximately 12% of the variance observed in PTG scores was attributable to differences in PTG across communities. Individuals from medium and high bushfire-affected communities reported significantly higher PTG relative to those in low bushfire-affected communities. While there was evidence of community differences in PTG, and individuals' own sense of community was positively and significantly associated with increased PTG, community-level cohesion scores were not found to be significantly related to PTG (although the trend was in the expected direction). CONCLUSIONS: PTG is evident in longer-term disaster recovery. While PTG appears to vary across communities, the findings suggest that it is an individual's own sense of community (rather than community-level cohesion) that is most closely related to this longer-term growth following a bushfire event. While PTG is currently understood as an outcome of individual-level perceptions, community-level experiences shape the potential for positive transformations to occur after disasters and warrant further investigation. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Pain relief and tolerability balance of immediate release tapentadol or oxycodone treatment for patients with moderate to severe osteoarthritis or low back pain.

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.

Costs of gastrointestinal events after outpatient opioid treatment for non-cancer pain.

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.

Evidence suggests a need to rethink social capital and social capital interventions.

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.

Correction: Quantifying the handprint-Footprint balance into a single score: The example of pharmaceuticals.

[This corrects the article DOI: 10.1371/journal.pone.0229235.].

Quantifying the handprint-Footprint balance into a single score: The example of pharmaceuticals.

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.

Optimal dosing of galantamine in patients with mild or moderate Alzheimer's disease: post Hoc analysis of a randomized, double-blind, placebo-controlled trial.

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 [>or=0-point improvement], improvement >or=4 points and improvement >or=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.

Treatment with galantamine and time to nursing home placement in Alzheimer's disease patients with and without cerebrovascular disease.

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 < 0.05). For each year of treatment with galantamine or other AChEI, the risk of being admitted to a nursing home within a given period was reduced by 31% (galantamine) and 29% (other AChEI). CONCLUSIONS: Long-term treatment with galantamine or other AChEIs appears to be associated with a significant delay in the time to NHP in patients with AD and AD with CVD. Further prospective studies are needed to confirm these findings.