Current definitions of advanced multimorbidity: a protocol for a scoping review.

INTRODUCTION: People living with and dying from multimorbidity are increasing in number, and ensuring quality care for this population is one of the major challenges facing healthcare providers. People with multimorbidity often have a high burden of palliative and end-of-life care needs, though they do not always access specialist palliative care services. A key reason for this is that they are often not identified as being in the last stages of their life by current healthcare providers and systems.This scoping review aims to identify and present the available evidence on how people with multimorbidity are currently included in research, policy and clinical practice. METHODS AND ANALYSIS: Scoping review methodology, based on Arksey and O'Malley's framework, will be undertaken and presented using the Preferred Reporting Items for Systematic Review and Meta-Analyses extension for Scoping Reviews. Search terms have been generated using the key themes of 'multimorbidity', 'end of life' and 'palliative care'. Peer-reviewed research will be obtained through systematic searching of Medline, EMBASE, CINAHL, Scopus and PsycINFO. Grey literature will be searched in a systematic manner. Literature containing a definition for adults with multimorbidity in a terminal phase of their illness experience will be included. After screening studies for eligibility, included studies will be described in terms of setting and characteristics as well as using inductive content analysis to highlight the commonalities in definitions. ETHICS AND DISSEMINATION: Ethical approval is not required for this scoping review. The findings of the scoping review will be used internally as part of SPB's PhD thesis at the University of St Andrews through the Multimorbidity Doctoral Training Programme for Health Professionals, which is supported by the Wellcome Trust (223499/Z/21/Z) and published in an open access, peer-reviewed journal for wider dissemination.

The research interest, capacity and culture of NHS staff in South East Scotland and changes in attitude to research following the pandemic: a cross-sectional survey.

BACKGROUND: The UK National Health Service (NHS) is ideally placed to undertake research. The UK Government recently launched its vision of research within the NHS to improve research culture and activity amongst its staff. Currently, little is known about the research interest, capacity and culture of staff in one Health Board in South East Scotland and how their attitudes to research may have changed as a result of the SARS-CoV-2 pandemic. METHODS: We used the validated Research Capacity and Culture tool in an online survey of staff working in one Health Board in South East Scotland to explore attitudes to research at the organisation, team and individual level together with involvement in, barriers to and motivators to engage in research. Questions included changes in attitude to research as a result of the pandemic. Staff were identified by professional group: nurses/midwives, medical/dental, allied health professionals (AHP), other therapeutic and administrative roles. Median scores and interquartile ranges were reported and differences between groups assessed using the Chi-square and Kruskal-Wallis tests with P < 0.05 accepted as statistical significance. Free-text entries were analysed using content analysis. RESULTS: Replies were received from 503/9145 potential respondents (5.5% response), of these 278 (3.0% response) completed all sections of the questionnaire. Differences between groups were noted in the proportions of those with research as part of their role (P = 0.012) and in being research-active (P < 0.001). Respondents reported high scores for promoting evidence-based practice and for finding and critically reviewing literature. Low scores were returned for preparing reports and securing grants. Overall, medical and other therapeutic staff reported higher levels of practical skills compared with other groups. Principal barriers to research were pressure of clinical work and lack of time, backfill and funds. 171/503 (34%) had changed their attitude to research as a result of the pandemic with 92% of 205 respondents more likely to volunteer for a study themselves. CONCLUSION: We found a positive change in attitude to research arising from the SARS-CoV-2 pandemic. Research engagement may increase after addressing the barriers cited. The present results provide a baseline against which future initiatives introduced to increase research capability and capacity may be assessed.

General practitioners' perspectives on the management of refugee health: a qualitative study.

OBJECTIVE: To explore general practitioners' (GPs) perceptions of the challenges and facilitators to managing refugee healthcare needs in regional Australia. SETTING: A regional community in Australia involved in the resettlement of refugees. PARTICIPANTS: Nine GPs from five practices in the region. DESIGN: A qualitative study based on semistructured interviews conducted between September and November 2020. RESULTS: The main challenges identified surrounded language and communication difficulties, cultural differences and health literacy and regional workforce shortages. The main facilitators were clinical and community supports, including refugee health nurses and trauma counselling services. Personal benefits experienced by GPs such as positive relationships, satisfaction and broadening scope of practice further facilitated ongoing healthcare provision. CONCLUSIONS: Overall, GPs were generally positive about providing care to refugees. However, significant challenges were expressed, particularly surrounding language, culture and resources. These barriers were compounded by the regional location. This highlights the need for preplanning and consultation with healthcare providers in the community both prior to and during the settlement of refugees as well as ongoing support proportional to the increase in settlement numbers.

Assessment of Potentially Inappropriate Prescribing for People With Type 2 Diabetes Mellitus Using IMPACT2DM, a New Explicit Tool.

BACKGROUND: People with type 2 diabetes mellitus (T2DM) are at greater risk of potentially inappropriate prescribing (PIP) due to multiple comorbidities and polypharmacy. IMPACT2DM (Inappropriate Medication Prescribing Assessment Criteria for Type 2 Diabetes Mellitus) is a tool designed to identify PIP for adults with T2DM. OBJECTIVES: To assess PIP for adults with T2DM in Ethiopia using the IMPACT2DM and to test the face validity and clinical validity of the tool. METHODS: A cross-sectional study was undertaken using data extracted retrospectively from the medical records of adults being managed for T2DM at Debretabore Hospital. PIP was assessed using IMPACT2DM. Some items/item components of IMPACT2DM were modified to increase the tool's applicability for the outpatient setting, to clarify content or to use the terms most common in this particular setting. Multivariant logistic regression analyses were conducted to identify factors associated with PIP. RESULTS: More than 90% of medical records had at least 1 PIP. Prescribing omission (80.9%) was the most commonly identified type of PIP. Adults with prescribing omissions are more likely to be ≥40 years old or to be prescribed with <5 medications. Adults with dosing problems were more likely ≥50 years old, or have had a fasting blood sugar (FBS) level out of the target range (80-130 mg/dL). CONCLUSIONS: IMPACT2DM is a clinically valid PIP identification tool for application in an Ethiopian outpatient setting. Health professionals should be alert to check for potential prescribing omissions for adults ≥40 years old and dosing problems for adults with an FBS level out of the target range or >50 years.

Potentially inappropriate prescribing for adults living with diabetes mellitus: a scoping review.

BACKGROUND: People living with diabetes often experience multiple morbidity and polypharmacy, increasing their risk of potentially inappropriate prescribing. Inappropriate prescribing is associated with poorer health outcomes. AIM: The aim of this scoping review was to explore and map studies conducted on potentially inappropriate prescribing among adults living with diabetes and to identify gaps regarding identification and assessment of potentially inappropriate prescribing in this group. METHOD: Studies that reported any type of potentially inappropriate prescribing were included. Studies conducted on people aged < 18 years or with a diagnosis of gestational diabetes or prediabetes were excluded. No restrictions to language, study design, publication status, geographic area, or clinical setting were applied in selecting the studies. Articles were systematically searched from 11 databases. RESULTS: Of the 190 included studies, the majority (63.7%) were conducted in high-income countries. None of the studies used an explicit tool specifically designed to identify potentially inappropriate prescribing among people with diabetes. The most frequently studied potentially inappropriate prescribing in high-income countries was contraindication while in low- and middle-income countries prescribing omission was the most common. Software and websites were mostly used for identifying drug-drug interactions. The specific events and conditions that were considered as inappropriate were inconsistent across studies. CONCLUSION: Contraindications, prescribing omissions and dosing problems were the most commonly studied types of potentially inappropriate prescribing. Prescribers should carefully consider the individual prescribing recommendations of medications. Future studies focusing on the development of explicit tools to identify potentially inappropriate prescribing for adults living with diabetes are needed.

Q Fever awareness and risk profiles among agricultural show attendees.

OBJECTIVE: To assess awareness and risk of Q fever among agricultural show attendees. SETTING: University of New England's Farm of the Future Pavilion, 2019, Sydney Royal Agricultural Show. PARTICIPANTS: Participants were ≥18 years, fluent in English, Australian residents, and gave their informed consent. MAIN OUTCOME MEASURES: Participants reported whether they had ever heard of Q fever and then completed the 'Q Tool' (www.qfevertool.com), which was used to assess participants' demographics and risk profiles. Cross-tabulations and logistic regression analyses were used to examine the relationship between these factors. RESULTS: A total of 344 participants were recruited who, in general, lived in major NSW cities and were aged 40-59 years. 62% were aware of Q fever. Living in regional/remote areas and regular contact with livestock, farms, abattoirs and/or feedlots increased the likelihood of Q fever awareness. Direct or indirect contact with feral animals was not associated with Q fever awareness after controlling for the latter risk factors. 40% of participants had a high, 21% a medium, and 30% a low risk of exposure. Slightly less than 10% reported a likely existing immunity or vaccination against Q fever. Among those who were not immune, living in a regional or remote area and Q fever awareness were independently associated with increased likelihood of exposure. CONCLUSIONS: Awareness of Q fever was relatively high. Although 61% of participants had a moderate to high risk of exposure to Q fever, they had not been vaccinated. This highlights the need to explore barriers to vaccination including accessibility of providers and associated cost.

Development and validation of explicit criteria to identify potentially inappropriate prescribing for adults with type 2 diabetes mellitus.

BACKGROUND: Early detection and timely resolution of potentially inappropriate prescribing (PIP) prevents adverse outcomes and improves patient care. An explicit tool specifically designed to detect PIP among people with Type 2 Diabetes Mellitus (T2DM) has not been published. OBJECTIVES: This study aims to develop and validate the Inappropriate Medication Prescribing Assessment Criteria for Type 2 Diabetes Mellitus (IMPACT2DM); an explicit tool that can be used to identify PIP for adults with T2DM. METHODS: Current national and international guidelines for the management of T2DM and drug information software programs were used to generate potential items. The content of the IMPACT2DM was validated by 2 consecutive rounds of Delphi method. Physicians and clinical pharmacists experienced in providing care for people with diabetes and authors of selected diabetes guidelines were invited to participate in the Delphi panel. Consensus was assumed if 90% (first round) and 85% (second round) of expert panelists showed agreement to include or exclude an item. RESULTS: A total of 95 potential items were generated from selected diabetes guidelines and drug information software programs. After the first Delphi round 27 items had ≥90% agreement and were included in the tool; 19 items were considered not PIP and were excluded from the tool. The second round contained 49 items; of these 43 were included and 6 were excluded from the tool. The final IMPACT2DM contains 70 items categorized by type of PIP and arranged in terms of medical conditions and medication classes. IMPACT2DM can be applied using information on medical charts and requires minimal or no clinical knowledge to assess quality of diabetes care and improve medication selection. CONCLUSIONS: IMPACT2DM has been developed from current quality evidence and undergone content validation. It is the first explicit tool specifically designed to identify PIP for adults with T2DM.

Within-treatment changes in a novel addiction treatment program using traditional Amazonian medicine.

AIMS: The therapeutic use of psychedelics is regaining scientific momentum, but similarly psychoactive ethnobotanical substances have a long history of medical (and other) uses in indigenous contexts. Here we aimed to evaluate patient outcomes in a residential addiction treatment center that employs a novel combination of Western and traditional Amazonian methods. METHODS: The study was observational, with repeated measures applied throughout treatment. All tests were administered in the center, which is located in Tarapoto, Peru. Data were collected between 2014 and 2015, and the study sample consisted of 36 male inpatients who were motivated to seek treatment and who entered into treatment voluntarily. Around 58% of the sample was from South America, 28% from Europe, and the remaining 14% from North America. We primarily employed repeated measures on a psychological test battery administered throughout treatment, measuring perceived stress, craving frequency, mental illness symptoms, spiritual well-being, and physical and emotional health. Addiction severity was measured on intake, and neuropsychological performance was assessed in a subsample from intake to at least 2 months into treatment. RESULTS: Statistically significant and clinically positive changes were found across all repeated measures. These changes appeared early in the treatment and were maintained over time. Significant improvements were also found for neuropsychological functioning. CONCLUSION: These results provide evidence for treatment safety in a highly novel addiction treatment setting, while also suggesting positive therapeutic effects.

Potentially inappropriate prescribing for adults with diabetes mellitus: a scoping review protocol.

OBJECTIVE: This scoping review aims to explore and map studies investigating potentially inappropriate prescribing (PIP) for adults with diabetes mellitus. INTRODUCTION: Inappropriate prescribing for people with diabetes mellitus has been reported by various authors focusing on different aspects of inappropriateness. A preliminary search revealed no published reviews on PIP for adults with diabetes mellitus. As a result, it is difficult to obtain a comprehensive map of PIP in this patient group. INCLUSION CRITERIA: This scoping review will consider all studies on PIP for adults with the diagnosis of type 1 or type 2 diabetes mellitus from any clinical setting. Studies conducted in pediatric populations or in adults with pre-diabetes or gestational diabetes will be excluded. METHODS: A three-step search strategy (i.e. an initial limited search in PubMed and ProQuest Central databases, a main search of eight databases and gray literature, and manual searches of reference lists of included articles) will be utilized. No language restrictions will be applied. All retrieved articles will be screened against the inclusion/exclusion criteria at title, abstract, and full-text stages. Data to be extracted from each study will include, but not be limited to, country, objective, study population, study methodology, type of PIP studied, examples of PIP events, medications involved, and criteria used for PIP identification. Data will be extracted by study team members using an online application for conducting systematic synthesis of evidence.

Evaluation of HealthPathways: an appraisal of usage, experiences and opinions of healthcare professionals in Australia and New Zealand.

Objectives HealthPathways, pioneered in Canterbury, New Zealand, in 2008, is a web-based tool designed to promote health care integration and patient management in primary care and to reduce fragmentation in the delivery of health services. This cross-sectional study evaluated the utilisation and perceptions of this tool among health professionals in Australia and New Zealand. Methods A cross-sectional survey was administered online through Research Electronic Data Capture (REDCap) to general practitioners (GPs), practice nurses and managers, nurse practitioners, specialist and community nurses, hospital clinicians, nurses, managers, and allied health professionals between April and September 2018. The frequency of HealthPathways use in the previous month was modelled as an ordered response using an ordered logistic regression model after adjusting for the possible effects of sex, age, years in clinical practice, location and time spent in practice. Results Health professionals perceived HealthPathways to be useful in primary care management and referral, as well as in the prereferral treatment of patients. GPs in New Zealand, New South Wales and Victoria were 73%, 47% and 27% more likely to have used HealthPathways ≥10 times in the previous month respectively. Conclusion The results suggest that HealthPathways is having a positive effect on healthcare systems in New Zealand and Australia. However, differences in uptake suggests the need for focused implementation, integration into eReferral software and expanding the tool to medical students, registrars, allied health professionals and potentially patients to encourage behavioural change. What is known about the topic? Early evaluations suggest that HealthPathways is a useful tool for health professionals, although uptake and utilisation may be limited. However, there is no comparative evidence regarding uptake and implementation of the tool. What does the paper add? This study is among the first to provide a comparative narrative of the literature assessing the implementation and uptake of HealthPathways across Australia and New Zealand. It is also among the first to compare the perceptions of allied health professionals in the use of HealthPathways across Australia and New Zealand. What are the implications for practitioners? The results of this study suggest the need for focused implementation, integration into eReferral software and expanding the tool to medical students, registrars, allied health professionals and potentially patients to encourage behavioural change.

Assessing research capacity in Victoria's south-west health service providers.

OBJECTIVE: To investigate the research interest, capacity and culture in individuals, teams and health organisations across south-western Victoria. DESIGN: Cross-sectional survey. SETTING: Eight public health services in the south-western region of Victoria. PARTICIPANTS: All staff were invited to participate. INTERVENTION: Hospital staff survey. MAIN OUTCOME MEASURE: The Research Capacity and Culture tool. RESULTS: The survey was completed by 776 staff including nurses, allied health staff and doctors. Half of the respondents were currently involved in research, while most wanted to be more involved. Respondents reported having moderate research skills and success at individual, team and organisation levels. Women and nurses reported having lower skills than comparable groups. Motivators for undertaking research were skill development (increased job satisfaction and brain stimulation) while the most commonly selected barriers were lack of time, other work taking priority and lack of funding. CONCLUSION: Health organisations in regional and rural Victoria could harness opportunities to enable staff participation in research by supporting identified strengths, addressing barriers and providing "permission" for staff to get involved in research. Efforts to improve research capacity among women and nurses could lead to the greatest overall improvement in organisations' research capacity and output-and translation of evidence into practice.

HealthPathways improving access to care.

Objective HealthPathways (HPW) is an international web-based information portal that provides health practitioners with guidelines and referral pathways to specialists and services. The present study explored usage of HPW by general practitioners (GPs) in the Barwon region, south-west Victoria, and any benefits and barriers to its use. Methods Approximately 421 GPs provide services in 86 clinics across the Barwon region, south-west Victoria and Barwon Health is the public health service providing acute, subacute, residential aged care and community health services to approximately 350000 people. The present study was a mixed-methods analysis of all GPs in the region, who were invited to complete a survey in two waves (2014 and 2016) and participate in focus groups. Data were survey/questionnaire (fixed response and free text options, analysed with descriptive statistics and content analysis), and focus groups (interview and facilitated group discussion, analysed using the principles of thematic analysis). Results Most GPs surveyed used HPW and usage increased over time from 2014 to 2016 (67% vs 77% respectively). Junior GPs used HPW more often than the more experienced practitioners. GPs reported that HPW was easy to access and navigate, improved their knowledge of local services, improved their confidence, changed their clinical management and saved them time. Main barriers to use of HPW were: GPs did not think to look at HPW, or simply did not know about it. Conclusions HPW has the potential to improve patient management and health outcomes, and use of HPW is increasing over time. What is known about the topic? Initiatives such as HPW are viewed positively by clinicians and have the potential to address challenges at the primary-secondary care interface, specifically, referral to secondary specialists. What does this paper add? Proof of concept that the ongoing availability of localised HPW for common clinical conditions improves GP usage of HPW and has increased access to HPW as the first source of clinical information. Benefits and barriers to use have been identified. What are the implications for practitioners? HPW improves knowledge of local services and provides GPs with easy access to referral pathways.

Locating advance care planning facilitators in general practice increases consumer participation.

BACKGROUND: Advance care planning (ACP) can positively affect end-of-life care experiences. However, uptake of ACP completion is low. The aim of this study was to investigate whether co-locating ACP facilitators in general practice increased participation METHODS: Barwon Health commenced promoting its ACP program in 2008. Trained ACP facilitators assisted consumers, which usually occurred in the program's community-based consulting rooms. From 2012 onwards, ACP facilitators were co-located with 18 general practices, where they assisted consumers at the point of care. RESULTS: Referrals to the program increased from 2008-11 (n = 2520) to 2012-15 (n = 6847). Between 2012 and 2015, 48% of referrals to the program were from the 18 general practices with co-located ACP facilitators, and 93% of these referrals resulted in ACPs completed, compared with 74% from practices without co-located facilitators and 55% from all other sources (P DISCUSSION: Co-locating ACP facilitators in general practice increased the number of referrals to the program and produced higher plan completion rates.

Grounded theory - a lens to understanding clinical reasoning.

This article was migrated. The article was marked as recommended. Clinical reasoning is fundamental to medical education and clinical practice ( Schmidt & Mamede, 2015). Despite its centrality, clinical reasoning is often regarded as difficult to conceptualise and teach ( Charlin, 2012; Pinnock & Welch, 2014). The pivotal role of clinical reasoning constitutes a compelling case for better understanding, more efficient teaching and practice that is more systematic and evidence-based. Clinical reasoning has been regarded as an art rather than a science ( Braude, 2012) and has attracted less research effort than befits its important function. The authors examined the suitability of grounded theory methodology to provide a more complete understanding of the clinical reasoning process. Grounded theory and clinical reasoning are processes which both qualitatively evaluate and analyse information from an interview subject as well as additional sources and arrive at a robust, defensible theory to explain their findings. Grounded theory offers considerable utility for (i) understanding and modelling clinical reasoning, (ii) researching clinical reasoning and (iii) as a heuristic for teaching clinical reasoning skills. This paper explores the parallels between grounded theory methodology and clinical reasoning, as well as the suitability of grounded theory as a framework for informing and transforming our understanding of clinical reasoning.

On the right path? Exploring the experiences and opinions of clinicians involved in developing and implementing HealthPathways Barwon.

The aims of this paper are to present the findings of a process evaluation exploring the experiences and opinions of clinicians who have been involved in the HealthPathways Barwon clinical workgroups and discuss implications for further development of the program, as well as regional health service initiatives more broadly. HealthPathways Barwon is a web-based program comprising locally agreed-upon evidence-based clinical pathways that assist with assessment, management and region-specific referral for various clinical conditions. Clinical workgroup members participated in focus groups. Coding and thematic analysis were performed and findings were compared with similar evaluations of HealthPathways in other jurisdictions. Five broad themes emerged from the focus group, each with several subthemes: (1) purpose of HealthPathways; (2) workgroup process; (3) barriers and facilitators to HealthPathways use; (4) impact of HealthPathways on clinical practice; and (5) measuring performance. Findings of particular interest were that the perceived drivers for implementation of HealthPathways Barwon are broad, HealthPathways Barwon is viewed positively by clinicians, the workgroup process itself has a positive impact on relationships between primary and secondary care clinicians, existing habits of clinicians are a major barrier to adoption of HealthPathways Barwon, the sustainability of HealthPathways Barwon is a concern and it is difficult to measure the outcomes of HealthPathways. Although HealthPathways Barwon is viewed positively by clinicians and is seen to have the potential to address many issues at the primary-secondary care interface, successful implementation and uptake will depend on buy-in from clinicians, as well as continuous evaluation to inform improved development and implementation. More broadly, health service initiatives like HealthPathways Barwon require longer-term certainty of funding and administration to become established and produce meaningful outcomes.

Development and validation of a work stressor scale for Australian farming families.

OBJECTIVE: The aim of this research was to gain insight into the key stressors for Australian farming families. It is well established that the farming work environment consists of a number of unique stressors which arise from dependency on factors beyond an individual's control (e.g. climate conditions) as well as the overlap between work and family environments. Despite this, limited research has included family factors in the assessment of stress felt by farmers and their families. This research sought to develop a scale of stressors for farming families in an Australian sample. DESIGN: A survey design was used for validity and reliability studies. The validity study involved assessment of factor structure, concurrent validity and discriminant validity. The reliability study used a test-retest reliability design. PARTICIPANTS: Participants were recruited from across Australia (38% Queensland; 30% New South Wales) and multiple industries (43% beef; 27% broadacre cropping; 26% horticulture). The validity study involved 278 participants and the reliability study involved 53 participants. MAIN OUTCOME MEASURE: Development of a Farming Family Stressor scale. RESULTS: The generated Farming Family Stressor scale presented satisfactory levels of concurrent validity (e.g. r = .73 against the Farm Stress Survey total score), discriminant validity (e.g. r = -.42 to r = .53 against the Satisfaction with Life and Kessler-10 total scores, respectively), internal consistency (Cronbach's alpha >.90) and test-retest reliability (rho > .66). CONCLUSION: This research lends insight into the complexity of stressors for farming families and has implications for occupational health and mental health programs that seek to reduce stress and improve health outcomes for that group.

Perceived discrimination and favourable regard toward underweight, normal weight and obese eating disorder sufferers: implications for obesity and eating disorder population health campaigns.

BACKGROUND: Obesity stigma has been shown to increase binge eating, whilst positive regard for eating disorders (EDs) may increase dietary restriction which can also lead to binge eating and weight gain. In the context of increasing prevalence of both obesity and EDs exploring community attitudes towards these illnesses may uncover new variables worthy of consideration in population health campaigns. The aim of the study was to explore community perceived stigma and conversely favourable regard toward eating disorder (ED) sufferers of varying weight status, and understand how the attitudes of obese individuals may differ from those of non-obese individuals. Data for this purpose were derived from interviews with individuals participating in a general population health survey. Vignettes of an underweight female with Anorexia Nervosa (AN), a normal weight male with an atypical eating disorder (NWED) and an obese female with Binge Eating Disorder (BED) were presented to three randomly selected sub-samples of n = 983, 1033 and 1030 respectively. Questions followed that assessed participants' attitudes towards and beliefs about the person described in the vignette and their eating behaviours. RESULTS: Sixty-six per cent of participants who responded to the obese BED vignette believed that there would be discrimination against the person described (primarily because of her weight). Corresponding figures were for the AN and NWED vignettes were 48% and 35%, respectively. A positive regard for weight-loss or body-image-enhancing ED behaviours was reported 'occasionally' or more often by 8.8% of respondents to the AN vignette and by 27.5% of respondents to the NWED vignette. Positive regard for ED behaviours was significantly more likely in obese participants (AN: 15%; NWED: 43%). CONCLUSION: The findings support integrated ED and obesity prevention programs that address weight stigma and the social desirability of ED behaviours in vulnerable individuals.

Nocebo effects in the treatment of major depression: results from an individual study participant-level meta-analysis of the placebo arm of duloxetine clinical trials.

BACKGROUND: The nocebo effect, when a harmless substance creates harmful effects in a person who takes it, is a clinically salient yet seldom studied phenomenon that may be associated with poorer treatment outcomes, perceived adverse events, and treatment discontinuation. The covert presence of nocebo responders in clinical trials may contribute to outcome variance in both placebo and active treatment arms for important primary and secondary endpoints. Nocebo effects are thought to be driven by expectancy and conditioning. METHOD: This study analyzed pooled clinical trial data in the placebo arms of controlled trials of antidepressant medications to investigate variables associated with the emergence of adverse outcomes in placebo-treated participants (N = 2,457). Specifically, we examined treatment-emergent adverse events (TEAEs) and discontinuation in placebo-treated individuals. Trials were commenced between 1993 and 2010 as studies of duloxetine versus active comparator and/or placebo. RESULTS: TEAEs were reported by 1,569 placebo-treated participants (63.9%), with 115 (4.7%) discontinuing from the studies due to TEAEs and 274 (11.2%) showing worsening of Hamilton Depression Rating Scale total score during placebo treatment. There was specifically no evidence to support the expectancy hypothesis, that reported TEAEs were influenced by adverse effects described in the clinical trials participant information and consent forms, or the conditioning hypothesis, that reported TEAEs would be influenced by adverse effect profiles of previous antidepressant medications used by these study participants. There was some evidence to suggest that people who had previously used complementary medications were more likely to report TEAEs. Variables specific to individual studies were the strongest predictors of TEAEs. DISCUSSION: In this study, TEAEs were very common among placebo-treated clinical trial participants. Unexpectedly, there was no evidence to associate TEAEs with adverse clinical outcomes, nor were the conditioning or expectancy hypotheses supported by these data. CONCLUSIONS: The nocebo effect is a common, covert, and poorly understood driver of clinical outcomes that requires further investigation.

HealthPathways: creating a pathway for health systems reform.

Inefficiencies in the co-ordination and integration of primary and secondary care services in Australia, have led to increases in waiting times, unnecessary presentations to emergency departments and issues around poor discharge of patients. HealthPathways is a program developed in Canterbury, New Zealand, that builds relationships between General Practitioners and Specialists and uses information technology so that efficiency is maximised and the right patient is given the right care at the right time. Healthpathways is being implemented by a number of Medicare Locals across Australia however, little is known about the impact HealthPathways may have in Australia. This article provides a short description of HealthPathways and considers what it may offer in the Australian context and some of the barriers and facilitators to implementation.

Within the boundary fence: an investigation into the perceptions of men's experience of depression in rural and remote areas of Australia.

This is a study exploring perceptions of men's experience of depression in rural and remote areas of Australia. The purpose of this investigation was to generate 'new' information that can inform models of diagnosis and primary care for the treatment of depression in men in rural and remote areas. Men and women were recruited from two North Queensland sites to participate in semistructured interviews in both an individual and focus group format and completing a series of questionnaires. A combination of grounded theory and content analysis was adopted to analyse the qualitative data, and develop theory around men's experience of depression in rural and remote areas. The findings of this study suggest that men's experience of depression within a rural context is defined by a process of 'internal compound' whereupon emotional distress can represent itself in avoidant and dulling behaviours along with self-reliant attempts to 'fix' the situation. From this study a language has been provided to give explanation to the experience of depression in men in rural and remote areas. The findings of this study have implications for, and provide opportunity for reform in, how we approach the recognition, diagnosis and treatment of depression for men in rural and remote areas.