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1.  Clinical and Ethical Aspects of Financial Capacity in Dementia: A Commentary 
In contrast to issues like treatment and research consent capacity, financial capacity has received relatively little clinical and ethical attention in the dementia literature. Yet issues of financial capacity emerge frequently in patients with Alzheimer's disease (AD), Parkinson's disease (PD) and related dementias, and commonly present ethical and clinical challenges for clinicians treating these patients. These issues include whether a patient with possible dementia has sufficient capacity independently to manage their financial affairs, needs referral for financial capacity assessment, and/or is being financially exploited or abused by others. The accurate identification, assessment and successful handling of such financial capacity issues can have a substantial impact on the financial and psychological well-being of patients and their family members. The present commentary presents an overview of financial capacity and associated clinical and ethical issues in dementia, and describes a set of possible clinician roles regarding these issues as they arise in clinical practice. The commentary concludes with a section describing educational resources available to clinicians and bioethicists seeking additional guidance in handling financial capacity issues. The ultimate goal of the paper is to focus clinical and ethical attention on a neglected capacity that is of fundamental importance for patients, families, and health care and legal professionals.
doi:10.1097/JGP.0b013e31826682f4
PMCID: PMC3784311  PMID: 24078779
2.  Subjective Experiences of Clients in a Voluntary Money Management Program 
A large proportion of people diagnosed with mental illnesses have difficulty managing their money, and therefore many psychiatric treatments involve providing money management assistance. However, little is known about the subjective experience of having a money manager, and extant literature is restricted to people forced to work with a representative payee or conservator. In this study, fifteen people were interviewed about their experience receiving a voluntary money management intervention designed to minimize substance use. Clients emphasized the importance of trusting the money manager, financial mindfulness (an enhanced awareness of the financial transactions in clients’ day-to-day lives), agency over their own affairs, and addiction. In contrast to evaluations of people assigned representative payees and/or conservators, there was little mention of feeling coerced. These findings suggest that money management programs can address client concerns by building trust, relating budgeting to clients’ day-to-day lives, and encouraging clients’ control over their own affairs.
doi:10.1080/15487768.2013.789699
PMCID: PMC3942091  PMID: 24605071
3.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
4.  The Check Effect Reconsidered 
Addiction (Abingdon, England)  2011;106(6):1071-1077.
Aims
The “check effect” refers to the use of disability payments to purchase illegal drugs or alcohol. This article describes subsequent research concerning three interrelated issues: the check effect, whether receipt of disability payments is associated with more overall substance use, and potential policy responses to misuse of disability payments for substances.
Methods
Review and synthesis of published articles.
Results
Increased substance use at the beginning of the month has been described in a variety of settings. The tendency to purchase substances at the beginning of the month is impacted by household wealth, the tendency to discount future rewards, and cyclical economic activity. However, in naturalistic observational cohort studies, beneficiaries who receive disability payments had no greater substance use than those without disability payments. Potential policy responses to misspending of disability checks include financial counseling that discourages spending on drugs, and the assignment of a representative payee to prevent misuse of benefits for substances. Assignment of a representative payee per se has not been associated with reduced substance use but payeeship administered by agencies that integrate payee practice into treatment has been.
Conclusion
Disability payments impact the timing of substance use, but receipt of disability payments is not associated with more overall substance use than unalleviated poverty. Money management-based clinical interventions, which may involve assignment of a representative payee, can minimize the purchase of substances with disability payments.
doi:10.1111/j.1360-0443.2011.03409.x
PMCID: PMC3094507  PMID: 21338431
5.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Background
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Conclusions
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001498.
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
doi:10.1371/journal.pmed.1001498
PMCID: PMC3742442  PMID: 23966839
6.  Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States 
PLoS Medicine  2013;10(8):e1001500.
Background
Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members' industry ties.
Methods and Findings
We undertook a cross-sectional study of the most recent publication between 2000 and 2013 from national and international guideline panels making decisions about definitions or diagnostic criteria for common conditions in the United States. We assessed whether proposed changes widened or narrowed disease definitions, rationales offered, mention of potential harms of those changes, and the nature and extent of disclosed ties between members and pharmaceutical or device companies.
Of 16 publications on 14 common conditions, ten proposed changes widening and one narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating “pre-disease”; lowering diagnostic thresholds; and proposing earlier or different diagnostic methods. Rationales included standardising diagnostic criteria and new evidence about risks for people previously considered to not have the disease. No publication included rigorous assessment of potential harms of proposed changes.
Among 14 panels with disclosures, the average proportion of members with industry ties was 75%. Twelve were chaired by people with ties. For members with ties, the median number of companies to which they had ties was seven. Companies with ties to the highest proportions of members were active in the relevant therapeutic area. Limitations arise from reliance on only disclosed ties, and exclusion of conditions too broad to enable analysis of single panel publications.
Conclusions
For the common conditions studied, a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, and most had a majority of members disclosing financial ties to pharmaceutical companies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Health professionals generally base their diagnosis of physical and mental disorders among their patients on disease definitions and diagnostic thresholds that are drawn up by expert panels and published as statements or as part of clinical practice guidelines. These disease definitions and diagnostic thresholds are reviewed and updated in response to changes in disease detection methods, treatments, medical knowledge, and, in the case of mental illness, changes in cultural norms. Sometimes, the review process widens disease definitions and lowers diagnostic thresholds. Such changes can be beneficial. For example, they might ensure that life-threatening conditions are diagnosed early when they are still treatable. But the widening of disease definitions can also lead to over-diagnosis—the diagnosis of a condition in a healthy individual that will never cause any symptoms and won't lead to an early death. Over-diagnosis can unnecessarily label people as ill, harm healthy individuals by exposing them to treatments they do not need, and waste resources that could be used to treat or prevent “genuine” illness.
Why Was This Study Done?
In recent years, evidence for widespread financial and non-financial ties between pharmaceutical companies and the health professionals involved in writing clinical practice guidelines has increased, and concern that these links may influence professional judgments has grown. As a result, a 2011 report from the US Institute of Medicine (IOM) recommended that, whenever possible, guideline developers should not have conflicts of interest, that a minority of the panel members involved in guideline development should have conflicts of interest, and that the chairs of these panels should be free of conflicts. Much less is known, however, about the ties between industry and the health professionals involved in reviewing disease definitions and whether these ties might in some way contribute to over-diagnosis. In this cross-sectional study (an investigation that takes a snapshot of a situation at a single time point), the researchers identify panels that have recently made decisions about definitions or diagnostic thresholds for conditions that are common in the US and describe the industry ties among the panel members and the changes in disease definitions proposed by the panels.
What Did the Researchers Do and Find?
The researchers identified 16 publications in which expert panels proposed changes to the disease definitions and diagnostic criteria for 14 conditions that are common in the US such as hypertension (high blood pressure) and Alzheimer disease. The proposed changes widened the disease definition for ten diseases, narrowed it for one disease, and had an unclear impact for five diseases. Reasons included in the publications for changing disease definitions included new evidence of risk for people previously considered normal (pre-hypertension) and the emergence of new biomarkers, tests, or treatments (Alzheimer disease). Only six of the panels mentioned possible harms of the proposed changes and none appeared to rigorously assess the downsides of expanding definitions. Of the 15 panels involved in the publications (one panel produced two publications), 12 included members who disclosed financial ties to multiple companies. Notably, the commonest industrial ties among these panels were to companies marketing drugs for the disease being considered by that panel. On average, 75% of panel members disclosed industry ties (range 0% to 100%) to a median of seven companies each. Moreover, similar proportions of panel members disclosed industry ties in publications released before and after the 2011 IOM report.
What Do These Findings Mean?
These findings show that, for the conditions studied, most panels considering disease definitions and diagnostic criteria proposed changes that widened disease definitions and that financial ties with pharmaceutical companies with direct interests in the therapeutic area covered by the panel were common among panel members. Because this study does not include a comparison group, these findings do not establish a causal link between industry ties and proposals to change disease definitions. Moreover, because the study concentrates on a subset of common diseases in the US setting, the generalizability of these findings is limited. Despite these and other study limitations, these findings provide new information about the ties between industry and influential medical professionals and raise questions about the current processes of disease definition. Future research, the researchers suggest, should investigate how disease definitions change over time, how much money panel members receive from industry, and how panel proposals affect the potential market of sponsors. Finally it should aim to design new processes for reviewing disease definitions that are free from potential conflicts of interest.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001500.
A PLOS Medicine Research Article by Knüppel et al. assesses the representation of ethical issues in general clinical practice guidelines on dementia care
Wikipedia has a page on medical diagnosis (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
An article on over-diagnosis by two of the study authors is available; an international conference on preventing over-diagnosis will take place this September
The 2011 US Institute of Medicine report Clinical Practice Guidelines We Can Trust is available
A PLOS Medicine Essay by Lisa Cosgrove and Sheldon Krimsky discusses the financial ties with industry of panel members involved in the preparation of the latest revision of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM), which provides standard criteria for the classification of mental disorders
doi:10.1371/journal.pmed.1001500
PMCID: PMC3742441  PMID: 23966841
7.  Health-Related Quality of Life and Overall Life Satisfaction in People with Serious Mental Illness 
Quality of life (QoL) in people with schizophrenia and other serious mental illnesses (SMI) is an important outcome goal, yet there is no consistent definition of the construct. We examined three aspects of QoL in persons with SMI: overall life satisfaction, physical health-related QoL (HRQoL), and mental HRQoL. This study had two primary aims: first, to examine whether there are differences in physical and mental HRQoL in persons with SMI, and, second, to investigate the cognitive, clinical, and functional correlates of the three QoL indicators. Participants were 48 persons with SMI who completed assessments of QoL, cognition, functional capacity, psychiatric symptomatology, and medical comorbidity. Results indicate that participants experience similar levels of physical and mental HRQoL, and these two constructs are not related to one another. Physical HRQoL is associated with less medical comorbidity, while mental HRQoL is associated with negative and depressive symptoms. Overall life satisfaction was associated with fewer psychiatric symptoms and less medical comorbidity. This study adds to the important literature defining distinct domains of QoL and supports the necessity of addressing both physical and mental health factors as they relate to recovery and well-being among persons with SMI.
doi:10.1155/2012/245103
PMCID: PMC3507053  PMID: 23213525
8.  Acceptability of Contingency Management among Clinicians and Clients within a Co-occurring Mental Health and Substance Use Treatment Program 
Background
Emerging evidence supports the effectiveness of contingency management (CM) for addictions treatment among individuals with co-occurring serious mental illness (SMI). Addiction treatment for people with SMI generally occurs within community mental health centers (CMHCs) and it is not known whether CM is acceptable within this context. Client views regarding CM are also unknown.
Objectives
This study is the first to describe CM acceptability among CMHC clinicians, and the first to explore client views. Clinician-level predictors of CM acceptability are also examined.
Methods
This study examined views about CM among 80 clinicians and 29 clients within a CMHC within the context of a concurrent CM study.
Results
Three-quarters of clinicians reported they would use CM if funding were available. Clinicians and clients affirmed that incentives enhance abstinence motivation. Clinician CM acceptability was related to greater years of experience, and identifying as an addictions or co-occurring disorders counselor, more than a mental health clinician.
Conclusions
The findings provide preliminary evidence that CMHC clinicians, serving clients with addictions and complicating SMI, and client participants in CM, view CM as motivating and a positive tool to facilitate recovery.
Scientific Significance
As an evidence-based intervention, CM warrants further efforts toward funding and dissemination in CMHCs.
doi:10.1111/j.1521-0391.2013.00333.x
PMCID: PMC4249672  PMID: 23952887
9.  Client Participation in Moral Case Deliberation: A Precarious Relational Balance 
Hec Forum  2011;23(3):207-224.
Moral case deliberation (MCD) is a form of clinical ethics support in which the ethicist as facilitator aims at supporting professionals with a structured moral inquiry into their moral issues from practice. Cases often affect clients, however, their inclusion in MCD is not common. Client participation often raises questions concerning conditions for equal collaboration and good dialogue. Despite these questions, there is little empirical research regarding client participation in clinical ethics support in general and in MCD in particular. This article aims at describing the experiences and processes of two MCD groups with client participation in a mental healthcare institution. A responsive evaluation was conducted examining stakeholders’ issues concerning client participation. Findings demonstrate that participation initially creates uneasiness. As routine builds up and client participants meet certain criteria, both clients and professionals start thinking beyond ‘us-them’ distinctions, and become more equal partners in dialogue. Still, sentiments of distrust and feelings of not being safe may reoccur. Client participation in MCD thus requires continuous reflection and alertness on relational dynamics and the quality of and conditions for dialogue. Participation puts the essentials of MCD (i.e., dialogue) to the test. Yet, the methodology and features of MCD offer an appropriate platform to introduce client participation in healthcare institutions.
doi:10.1007/s10730-011-9157-6
PMCID: PMC3178761  PMID: 21792683
Moral case deliberation; Client participation; Dialogue; Inclusion; Organization
10.  Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach 
Background
Clinical practice guidelines (CPGs), a core tool to foster medical professionalism, differ widely in whether and how they address disease-specific ethical issues (DSEIs), and current manuals for CPG development are silent on this issue. The implementation of an explicit method faces two core challenges: first, it adds further complexity to CPG development and requires human and financial resources. Second, in contrast to the in-depth treatment of ethical issues that is standard in bioethics, the inclusion of DSEIs in CPGs need to be more pragmatic, reductive, and simplistic, but without rendering the resulting recommendations useless or insufficiently justified. This paper outlines a six-step approach, EthicsGuide, for the systematic and transparent inclusion of ethical issues and recommendations in CPGs.
Methods
The development of EthicsGuide is based on (a) methodological standards in evidence-based CPG development, (b) principles of bioethics, (c) research findings on how DSEIs are currently addressed in CPGs, and (d) findings from two proof-of-concept analyses of the EthicsGuide approach.
Results
The six steps are 1) determine the DSEI spectrum and the need for ethical recommendations; 2) develop statements on which to base ethical recommendations; 3) categorize, classify, condense, and paraphrase the statements; 4) write recommendations in a standard form; 5) validate and justify recommendations, making any necessary modifications; and 6) address consent. All six steps necessarily come into play when including DSEIs in CPGs.
Conclusions
If DSEIs are not explicitly addressed, they are unavoidably dealt with implicitly. We believe that as ethicists gain greater involvement in decision-making about health, personal rights, or economic issues, they should make their methods transparent and replicable by other researchers; and as ethical issues become more widely reflected in CPGs, CPG developers have to learn how to address them in a methodologically adequate way. The approach proposed should serve as a basis for further discussion on how to reach these goals. It breaks open the black box of what ethicists implicitly do when they develop recommendations. Further, interdisciplinary discussion and pilot tests are needed to explore the minimal requirements that guarantee a simplified procedure which is still acceptable and does not become mere window dressing.
doi:10.1186/s13012-014-0184-y
PMCID: PMC4265426  PMID: 25472446
Clinical practice guideline; Guideline development; Ethical recommendation; Clinical ethics; Medical professionalism
11.  Recovery and Money Management 
Objective
Social recovery and external money management are important approaches in contemporary mental health care, but little research has been done on the relationship between the two or on application of recovery principles to money management for people at risk of being assigned a representative payee or conservator.
Methods
Twenty-five transcripts out of forty-nine total qualitative interviews with persons receiving SSI or SSDI who were at risk of being assigned a money manager were analyzed to assess the presence of recognized recovery themes.
Results
The recovery principles of self-direction and responsibility were strong themes in participant comments related to money management.
Conclusions and Implications for Practice
Money management interventions should incorporate peoples’ recovery-related motivations to acquire financial management skills as a means to direct and assume responsibility for one’s finances. Staff involved in money management should receive training to support client’s recovery-related goals.
doi:10.1037/h0094982
PMCID: PMC3992283  PMID: 23750764
12.  Measuring Money Mismanagement Among Dually Diagnosed Clients 
Clients dually diagnosed with psychiatric and substance abuse disorders may be adversely affected if they mismanage their Social Security or public support benefits. Assistance managing funds, including assignment of a representative payee, is available but there are no objective assessments of money mismanagement. In this study, a Structured Clinical Interview for Money Mismanagement was administered twice at one-week intervals to 46 clients receiving disability payments and was compared to clinician’s judgment that the client was incapable of managing funds, the frequent basis for payee assignment by the Social Security Administration and Veterans Affairs. Clinician’s judgment and structured interview were concordant on 71% of capability judgments. The interview had high test-retest reliability and was correlated with self-reported money mismanagement and GAF scores, but clinician judgment was not associated with these measures. Results suggest that the interview is sensitive in detecting money mismanagement and raises questions concerning the validity of clinicians’ judgments.
doi:10.1097/NMD.0b013e31817d0535
PMCID: PMC2804268  PMID: 18626300
Psychiatric Dual Diagnosis; Substance Abuse; Financial Management; Disability
13.  Neglect of Medical Evidence of Torture in Guantánamo Bay: A Case Series 
PLoS Medicine  2011;8(4):e1001027.
Vincent Iacopino and Stephen Xenakis review case records of nine individuals imprisoned at Guantánamo Bay which indicate that medical personnel assigned to the US Department of Defense neglected and/or concealed medical evidence of torture.
Background
In the wake of the September 11, 2001 attacks on the US, the government authorized the use of “enhanced interrogation” techniques that were previously recognized as torture. While the complicity of US health professionals in the design and implementation of US torture practices has been documented, little is known about the role of health providers, assigned to the US Department of Defense (DoD) at the US Naval Station Guantánamo Bay, Cuba (GTMO), who should have been in a position to observe and document physical and psychological evidence of torture and ill treatment.
Methods and Findings
We reviewed GTMO medical records and relevant case files (client affidavits, attorney–client notes and summaries, and legal affidavits of medical experts) of nine individuals for evidence of torture and ill treatment and documentation by medical personnel. In each of the nine cases, GTMO detainees alleged abusive interrogation methods that are consistent with torture as defined by the UN Convention Against Torture as well as the more restrictive US definition of torture that was operational at the time. The medical affidavits in each of the nine cases indicate that the specific allegations of torture and ill treatment are highly consistent with physical and psychological evidence documented in the medical records and evaluations by non-governmental medical experts. However, the medical personnel who treated the detainees at GTMO failed to inquire and/or document causes of the physical injuries and psychological symptoms they observed. Psychological symptoms were commonly attributed to “personality disorders” and “routine stressors of confinement.” Temporary psychotic symptoms and hallucinations did not prompt consideration of abusive treatment. Psychological assessments conducted by non-governmental medical experts revealed diagnostic criteria for current major depression and/or PTSD in all nine cases.
Conclusion
The findings in these nine cases from GTMO indicate that medical doctors and mental health personnel assigned to the DoD neglected and/or concealed medical evidence of intentional harm.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Torture has been used throughout history for interrogation, coercion, and punishment. Ingenious methods have been devised to inflict severe physical or mental pain or suffering intentionally on an individual to obtain a confession or information, or to punish, intimidate, or coerce. Nowadays, torture is prohibited under international law and under the domestic law of most countries, and is considered to be a violation of human rights. Article 5 of the United Nations (UN) Universal Declaration of Human Rights, which was adopted in December 1948, states: “No one should be subjected to torture or to cruel, inhuman or degrading treatment or punishment.” Similarly, signatories of the Geneva Conventions, which provide protection for people who fall into enemy hands during conflicts, have agreed not to torture prisoners. Torture is also prohibited by the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, which came into force in June 1987. Implementation of this Convention by participating states is monitored the UN Committee against Torture.
Why Was This Study Done?
After the September 11, 2001 attacks on the United States, the US government redefined acts such as waterboarding (simulated drowning), sleep deprivation, and prolonged isolation as “safe, legal, ethical, and effective” “enhanced interrogation” techniques (EITs). These EITs were previously recognized as torture by the UN Committee against Torture. US health professionals are known to have been complicit in the design and implementation of EITs. For example, the US Central Intelligence Agency (CIA) and Department of Defense (DoD) designated “non-clinical” health professionals to monitor the use of EITs at the US detainee facility at the US Navy Base at Guantánamo Bay, Cuba (GTMO), and the active role of these individuals during interrogations has been documented. Much less is known, however, about the role of health professionals assigned to the DoD to provide medical and mental health care to the GTMO detainees. Specifically, it is not known whether these health professionals accurately documented physical and psychological evidence of torture and ill treatment among the detainees. In this case series, the researchers review GTMO medical records and case files of nine detainees for evidence of documentation of ill treatment and torture by medical personnel.
What Did the Researchers Do and Find?
The researchers—non-governmental medical experts retained by legal representatives of GTMO detainees alleging torture and ill treatment—reviewed the medical records, client affidavits, attorney–client notes, and legal declarations of medical experts of nine GTMO detainees. In each case, the detainee alleged abusive interrogation methods consistent with torture as defined by the UN Convention against Torture. The researchers report that the medical affidavits for all the cases indicate that the allegations of torture and ill treatment were consistent with physical and psychological evidence of torture and ill treatment documented in the medical records and in evaluations by non-governmental experts. However, the medical personnel responsible for the detainees' routine medical and mental health care failed to inquire about and/or document the causes of the physical injuries and psychological symptoms that they observed. Instead, they attributed psychological symptoms to “personality disorders” and “routine stressors of confinement”. Moreover, psychotic symptoms such as hallucinations did not prompt consideration of abusive treatment. Importantly, psychological assessments conducted by non-governmental experts revealed diagnostic criteria for current major depression and/or post-traumatic stress disorder (PTSD, a common outcome of torture or ill treatment) in all the cases.
What Do These Findings Mean?
These findings indicate that health professionals assigned to the DoD to provide medical and mental health care to GTMO detainees neglected and/or concealed evidence of intentional harm. Because only nine cases are included in this case series, these findings may not be generalizable to other GTMO detainees. The findings are also limited by their reliance on medical records and case files that were sometimes heavily edited and on psychological assessments based on questionnaires rather than on direct examination. Nevertheless, these findings reveal new information about the potential extent of medical complicity in US torture practices, and they highlight the need for a thorough and impartial investigation of all the available information, including relevant classified information.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.pmed.1001027.
This study is further discussed in the April 2011 PLoS Medicine Editorial
Wikipedia has pages on torture, and on the Guantánamo Bay detention camp note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Office of the UN High Commissioner for Human Rights provides information about the UN Convention against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment and the UN Committee against Torture (in several languages)
Physicians for Human Rights is a non-profit organization that mobilizes health professionals to advance health, dignity and justice, and promotes the right to health for all. Its Campaign against Torture seeks to restore the US commitment against torture
Amnesty International provides information about the Guantánamo Bay detention camp
doi:10.1371/journal.pmed.1001027
PMCID: PMC3084605  PMID: 21559073
14.  Advisor-Teller Money Manager (ATM) Therapy for Substance Use Disorders 
Objective
Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management–based therapy, advisor-teller money manager (ATM), on substance abuse or dependence.
Methods
Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization.
Results
Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived.
Conclusions
ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety.
doi:10.1176/appi.ps.61.7.707
PMCID: PMC3064073  PMID: 20592006
15.  Changes in capacity to consent over time in patients involved in psychiatric research 
The British Journal of Psychiatry  2013;202(6):454-458.
Background
Informed consent is a key element of ethical clinical research. Patients with serious mental illness may be at risk for impaired consent capacity. Corrective feedback improves within-session comprehension of consent-relevant information, but little is known about the trajectory of patients’ comprehension after the initial enrolment session.
Aims
To examine whether within-session gains in understanding after feedback were maintained between study visits and to examine stability of decisional capacity over time.
Method
This was a longitudinal, within-participants comparison of decisional capacity assessed at baseline, 1 week, 3 months, 12 months and 24 months in 161 people with schizophrenia or bipolar disorder.
Results
Within-session gains from corrective feedback generally dissipated over each follow-up interval. Decisional capacity showed a general pattern of stability, but there was significant between-participant heterogeneity. Better neuropsychological performance was associated with better decisional capacity across time points. Positive symptoms of schizophrenia did not predict any aspects of decisional capacity, but general psychopathology, negative symptoms and depression evidenced some modest associations with certain subdomains of decisional capacity.
Conclusions
Informed consent may be most effectively construed as an ongoing dialogue with participants at each study visit.
doi:10.1192/bjp.bp.112.121160
PMCID: PMC3669878  PMID: 23661766
16.  Financial Conflicts of Interest and Reporting Bias Regarding the Association between Sugar-Sweetened Beverages and Weight Gain: A Systematic Review of Systematic Reviews 
PLoS Medicine  2013;10(12):e1001578.
Maira Bes-Rastrollo and colleagues examine whether financial conflicts of interest are likely to bias conclusions from systematic reviews that investigate the relationship between sugar-sweetened beverages and weight gain or obesity.
Please see later in the article for the Editors' Summary
Background
Industry sponsors' financial interests might bias the conclusions of scientific research. We examined whether financial industry funding or the disclosure of potential conflicts of interest influenced the results of published systematic reviews (SRs) conducted in the field of sugar-sweetened beverages (SSBs) and weight gain or obesity.
Methods and Findings
We conducted a search of the PubMed, Cochrane Library, and Scopus databases to identify published SRs from the inception of the databases to August 31, 2013, on the association between SSB consumption and weight gain or obesity. SR conclusions were independently classified by two researchers into two groups: those that found a positive association and those that did not. These two reviewers were blinded with respect to the stated source of funding and the disclosure of conflicts of interest.
We identified 17 SRs (with 18 conclusions). In six of the SRs a financial conflict of interest with some food industry was disclosed. Among those reviews without any reported conflict of interest, 83.3% of the conclusions (10/12) were that SSB consumption could be a potential risk factor for weight gain. In contrast, the same percentage of conclusions, 83.3% (5/6), of those SRs disclosing some financial conflict of interest with the food industry were that the scientific evidence was insufficient to support a positive association between SSB consumption and weight gain or obesity. Those reviews with conflicts of interest were five times more likely to present a conclusion of no positive association than those without them (relative risk: 5.0, 95% CI: 1.3–19.3).
An important limitation of this study is the impossibility of ruling out the existence of publication bias among those studies not declaring any conflict of interest. However, the best large randomized trials also support a direct association between SSB consumption and weight gain or obesity.
Conclusions
Financial conflicts of interest may bias conclusions from SRs on SSB consumption and weight gain or obesity.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In our daily lives, we frequently rely on the results of scientific research to make decisions about our health. If we are healthy, we may seek out scientific advice about how much exercise to do to reduce our risk of a heart attack, and we may follow dietary advice issued by public health bodies to help us maintain a healthy weight. If we are ill, we expect our treatment to be based on the results of clinical trials and other studies. We assume that the scientific research that underlies our decisions about health-related issues is unbiased and accurate. However, there is increasing evidence that the conclusions of industry-sponsored scientific research are sometimes biased. So, for example, reports of drug trials sponsored by pharmaceutical companies sometimes emphasize the positive results of trials and “hide” unwanted side effects deep within the report or omit them altogether.
Why Was This Study Done?
Although the effects of company sponsors on the conclusions of pharmaceutical research have been extensively examined, little is known about the effects of industry sponsorship on nutrition research, even though large commercial entities are increasingly involved in global food and drink production. It is important to know whether the scientific evidence about nutrition is free of bias because biased information might negatively affect the health of entire populations. Moreover, scientific evidence from nutrition research underlies the formulation of governmental dietary guidelines and food-related public health interventions. In this systematic review, the researchers investigate whether the disclosure of potential financial conflicts of interest (for example, research funding by a beverage company) has influenced the results of systematic reviews undertaken to examine the association between the consumption of highly lucrative sugar-sweetened beverages (SSBs) and weight gain or obesity. Systematic reviews identify all the research on a given topic using predefined criteria. In an ideal world, systematic reviews provide access to all the available evidence on specific exposure–disease associations, but publication bias related to authors' conflicts of interest may affect the reliability of the conclusions of such studies.
What Did the Researchers Do and Find?
The researchers identified 18 conclusions from 17 systematic reviews that had investigated the association between SSB consumption and weight gain or obesity. In six of these reviews, a financial conflict of interest with a food industry was disclosed. Among the reviews that reported having no conflict of interest, 83.3% of the conclusions were that SSB consumption could be a potential risk factor for weight gain. By contrast, the same percentage of reviews in which a potential financial conflict of interest was disclosed concluded that the scientific evidence was insufficient to support a positive association between SSB consumption and weight gain, or reported contradictory results and did not state any definitive conclusion about the association between SSB consumption and weight gain. Reviews in which a potential conflict of interest was disclosed were five times more likely to present a conclusion of no positive association between SSB consumption and weight gain than reviews that reported having no financial conflict of interest.
What Do These Findings Mean?
These findings indicate that systematic reviews that reported financial conflicts of interest or sponsorship from food or drink companies were more likely to reach a conclusion of no positive association between SSB consumption and weight gain than reviews that reported having no conflicts of interest. A major limitation of this study is that it cannot assess which interpretation of the available evidence is truly accurate. For example, the scientists involved in the systematic reviews that reported having no conflict of interest may have had preexisting prejudices that affected their interpretation of their findings. However, the interests of the food industry (increased sales of their products) are very different from those of most researchers (the honest pursuit of knowledge), and recent randomized trials support a positive association between SSB consumption and overweight/obesity. Thus, these findings draw attention to possible inaccuracies in scientific evidence from research funded by the food and drink industry. They do not imply that industry sponsorship of nutrition research should be avoided entirely. Rather, as in other research areas, clear guidelines and principles (for example, sponsors should sign contracts that state that they will not be involved in the interpretation of results) need to be established to avoid dangerous conflicts of interest.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001578.
The Research Ethics Program at the University of California, San Diego provides an overview of conflicts of interest for researchers and details of US regulations and guidelines
The PLOS Medicine series on Big Food examines the activities and influence of the food industry in global health
A PLOS Medicine Research Article by Basu et al. uses mathematical modeling to investigate whether SSB taxation would avert obesity and diabetes in India
A 2012 policy brief from the Yale Rudd Center for Food Policy and Obesity discusses current evidence regarding SSB taxes
The US National Institutes of Health has regulations on financial conflicts of interest for institutions applying to receive funding
Wikipedia has pages on conflict of interest, reporting bias, systematic review, and SSBs (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
doi:10.1371/journal.pmed.1001578
PMCID: PMC3876974  PMID: 24391479
17.  Non-clinicians’ judgments about asylum seekers’ mental health: how do legal representatives of asylum seekers decide when to request medico-legal reports? 
European Journal of Psychotraumatology  2012;3:10.3402/ejpt.v3i0.18406.
Background
Procedures for determining refugee status across Europe are being speeded up, despite the high prevalence of mental health difficulties among asylum seekers. An assurance given is that ‘‘vulnerable applicants’’ will be identified and excluded from accelerated procedures. Although experts have recommended assessments to be undertaken by experienced clinicians, this is unlikely to happen for political and financial reasons. Understanding how non-clinically qualified personnel perform assessments of mental health issues is timely and crucial. Misrecognition of refugees due to the inappropriate use of accelerated procedures involves the risk of returning the very people who have the right to protection from further persecution.
Objective
To examine the decision making of immigration lawyers, who are an example of a group of nonclinicians who decide when and whether to refer asylum-seekers for psychiatric assessment.
Method
Semi-structured interviews were conducted with 12 legal representatives working with people seeking refugee or human rights protection in the United Kingdom. The resultant material was analysed using Framework Analysis.
Results
Themes clustered around the legal case, the client, the representative and the systems, all with sub-themes. A mapping exercise integrated these themes to show how representatives brought together questions of (1) evidential reasons for a report, influenced by their legal, psychological and case law knowledge, and (2) perceived evidence of mental distress, influenced by professional and personal experiences and expectations.
Conclusions
The legal representatives interviewed were well-informed and trained in psychological issues as well as clearly dedicated to their clients. This helped them to attempt quasi-diagnoses of common mental health problems. They nonetheless demonstrated stereotypical understanding of post-traumatic stress disorder and other possible diagnoses and the role of subjectivity. The study has implications for other groups – particularly those less trained and compassionate – who are required to make clinical judgments without the necessary expertise.
doi:10.3402/ejpt.v3i0.18406
PMCID: PMC3475000  PMID: 23082238
Refugees; asylum; decision-making; psychological assessment; vulnerability assessment
18.  Comparison of ethical judgments exhibited by clients and ethics consultants in Japan 
BMC Medical Ethics  2014;15:19.
Background
Healthcare professionals must make decisions for patients based on ethical considerations. However, they rely on clinical ethics consultations (CEC) to review ethical justifications of their decisions. CEC consultants support the cases reviewed and guide medical care. When both healthcare professionals and CEC consultants face ethical problems in medical care, how is their judgment derived? How do medical judgments differ from the ethical considerations of CECs? This study examines CECs in Japan to identify differences in the ethical judgment of clients and CEC consultants.
Methods
The CEC request and response documents of all 60 cases reviewed across Japan between October 2006 and the end of October 2011 were classified in terms of the presence of decisional capacity in the patient. We conducted a qualitative content analysis of the differences in reasoning between client and CEC consultants. Reasoned judgments were verified in individual cases to classify the similarities or differences of opinion between CEC clients and teams.
Results
As the result of classification of the decisional capacity and the difference of opinion regarding medical care, the most frequent category was 25 cases (41.7%) of “uncertain decisional capacity,” and 23 cases (38.3%) of “withholding of decision-making.” A chi-square analysis was performed on presence of decisional capacity and agreement in decision-making, yielding a statistically significant difference (p < 0.05). The CEC consultants’ reasoning was based on “patient’s preference was ambiguous,” “validity of family as a surrogate,” “estimation of patient preference,” and “patient’s best interest,” whereas the CEC client’s reasoning was based on “consistent family preference was shown/not shown” and “appropriate therapeutic methods to manage patient safety.”
Conclusion
Differences in opinions were found in cases classified according to decisional capacity. Furthermore, the reasoning behind judgments differed between CEC clients and CEC consultants. The reasoning of CEC consultants was critical and reflective, while for clients it was situational and pragmatic.
doi:10.1186/1472-6939-15-19
PMCID: PMC3975850  PMID: 24592932
Clinical ethics consultation; Ethical judgment; Ethical reasoning; Clinical ethics; Quality of healthcare
19.  Evaluation of a remote monitoring system in people with mental illness and medical co-morbidity 
Introduction
High medical co-morbidity, poor health behaviors, medication side effects, and inadequate health care contribute to a 25–30 year disparity in life expectancy between people with serious mental illness (SMI) and people without mental illness. There is an urgent need to enable providers to monitor health status and risk daily to improve health outcomes for this high-risk, high cost group. Telehealth interventions hold promise for monitoring patients remotely, with the hope of reducing costs and increasing accessibility of interventions; however, they have rarely been used or evaluated in people with SMI.
Aims and objectives
Primary aim: Determine the feasibility and acceptability of an in-home remote monitoring system programmed with daily dialogues specific to the user’s medical and psychiatric condition in outpatients diagnosed with SMI and either diabetes, hypertension, cardiac disease, COPD, or chronic pain.
Secondary aim: Evaluate the potential effectiveness of remote monitoring with respect to management of psychiatric and medical illness symptoms.
Methods
Seventy community mental health center (CMHC) clients were randomly assigned to either immediately receive the remote monitoring system (n=37) for 6 months or to receive it after a 6-month wait (n=33). Service use, illness management and recovery, subjective and objective health, medical co-morbidity, disease management self-efficacy, and psychiatric symptoms were assessed at baseline and at 6 and 12 months. Satisfaction with the device was assessed after 6 months. Responses to daily dialogue questions were reviewed by a CMHC nurse care manager.
Results
The telehealth device was highly acceptable and valued. Adherence with daily sessions was extremely high. Mean adherence across all participants for 6 months was 71%. Over half completed 89% or more of their sessions. Participants who immediately received the device demonstrated greater improvement in overall psychiatric symptom severity compared to the waitlist group. Use of the device resulted in significant reduction of diastolic blood pressure and a significant increase in depression self-management. Among individuals with diabetes, remote monitoring resulted in lower fasting glucose and lower use of urgent care visits. Sixty-six percent of diabetic participants had glucose >140 at baseline. After using the device for 3 months, 38% had a >20% reduction in glucose, and 14% reduced their glucose by >100. At 6 months, 50% had achieved a >20% reduction. Mean glucose dropped from 209 at baseline to 128 at 6 months. Satisfaction with the device at 6 months was extremely high; 81% reported that they would be very willing to continue using it.
Conclusions
In the USA, 1300 community mental health centers annually serve 6 million adults, children, and families. Facilitating patient/clinician communication is particularly important in SMI treatment due to common barriers, specifically problem behaviors and poor adherence. If use of remote monitoring with psychiatric patients can improve symptom management, support people’s ability to live more independently, and reduce emergency room visits, this has great potential to improve outcomes and quality of life. The findings here that remote monitoring led to improved management of psychiatric symptoms and health outcomes, especially in patients with SMI and diabetes, therefore have international implications.
PMCID: PMC3571159
mental illness; telehealth; medical comorbidity; remote monitoring
20.  Legal rights of client councils and their role in policy of long-term care organisations in the Netherlands 
Background
Legislation demands the establishment of client councils in Dutch nursing homes and residential care facilities. The members of those councils are residents or their representatives. Client councils have the right to participate in the strategic management of long-term care facilities. More specifically, they need to be consulted regarding organisational issues and a right to consent on issues regarding daily living of residents, including CQ-index research. CQ-index research concerns a method that measures, analyses and report clients' experiences about the quality of care. Research questions were: 'Do client councils exercise their rights to be consulted and to give their consent?' and 'What is the role of client councils in the process of measuring clients' experiences with the CQ-index and what is their opinion about the CQ-index?'
Methods
Postal questionnaires were sent to members of 1,540 client councils of Dutch nursing homes and residential care facilities. The questionnaire focussed on background information and client councils' involvement in decision-making and strategic management.
Results
The response rate was 34% (n = 524). Most councils consisted of seven members (range: 5 to 12 members). One out of four members participating in the client councils were clients themselves. Although councils have a legal right to be consulted for organisational issues like finance, vision, annual report, and accommodation, less than half the councils (31-46%) reported that they exercised this right. The legal right to consent was perceived by 18 to 36% of the councils regarding client care issues like food and drink, complaints registration, respectful treatment, and activities. For CQ-index research, only 18% of the client councils perceived a right to consent. Their rights to choose an approved contractor -who performs CQ-index research- and indicating improvement priorities, were hardly used.
Conclusions
Client councils play a rather passive role in determining the policy on quality of long-term care. Therefore, specific attention and actions are needed to create a more proactive attitude in councils towards exercising their rights, which are already supported by legislation.
doi:10.1186/1472-6963-11-215
PMCID: PMC3181203  PMID: 21910899
Consumer participation; empowerment; patients' rights; long-term care
21.  Navigating the mental health and addictions maze: a community-based pilot project of a new role in primary mental health care 
Problem being addressed In a medically under-served rural Canadian community where overburdened family physicians provide most of the cae for patients with mental illness and substance use problems, providing access to timely and effective help for all citizens is a challenge. The care burden of unmet mental health needs is experienced throughout the larger community by diverse community service providers.
Supporting a shared understanding of the needs and challenges, and ensuring effective connection and clear communication between diverse disciplines in primary care, community services and the formal mental health system requires models of service organisation and delivery that go beyond traditional clinical roles.
In cancer care a navigator model has previously been used to address information and service gaps and improve patient experience. We wished to evaluate whether a community-supported navigator model could help solve some of the challenges for clients and service providers in our community, while at the same time allowing data collection that offers a clearer understanding of actual service needs.
Pre-programme activities Community members formed an interdisciplinary community steering committee which met monthly for two years to develop and adapt a service and collaborative research model, generate support, secure ethical approval and raise funds.
Programme description The navigator service was embedded in a local family service organisation, the steering committee met monthly, and along with the researchers met regularly with programme staff and provided support, oversight and development of ethical data collection.
Navigators provided low barrier access, comprehensive assessment, collaborative service planning, and linkage and referral facilitation for any individual or family who requested assistance with a mental health or substance use concern. Navigators also serve as an information resource for any community service provider or family physician needing to assist a client, and collected data on local service needs.
Conclusions Analysis of quantitative administrative data, consented research data, and qualitative interview and survey data demonstrated that this community supported navigator service model was effective in improving service access, assessment and linkage for citizens with mental health and addictions concerns, and connecting a range of community services into a more effective network of care. Connecting unattached clients with a primary care provider and supporting needs assessment and service planning for patients of local family physicians were key navigator functions.
PMCID: PMC2777588  PMID: 22477883
community based participator research; mental health navigation; navigator model; primary mental health care
22.  Supported housing programs for persons with serious mental illness in rural northern communities: A mixed method evaluation 
Background
During the past two decades, consumers, providers and policy makers have recognized the role of supported housing intervention for persons diagnosed with serious mental illness (SMI) to be able to live independently in the community. Much of supported housing research to date, however, has been conducted in large urban centers rather than northern and rural communities. Northern conditional and contextual issues such as rural poverty, lack of accessible mental health services, small or non-existing housing markets, lack of a continuum of support or housing services, and in some communities, a poor quality of housing challenge the viability of effective supported housing services. The current research proposal aims to describe and evaluate the processes and outcomes of supported housing programs for persons living with SMI in northern and rural communities from the perspective of clients, their families, and community providers.
Methods
This research will use a mixed method design guided by participatory action research. The study will be conducted over two years, in four stages. Stage I will involve setting up the research in each of the four northern sites. In Stage II a descriptive cross-sectional survey will be used to obtain information about the three client outcomes: housing history, quality of life and housing preference. In Stage III two participatory action strategies, focus groups and photo-voice, will be used to explore perceptions of supported housing services. In the last stage findings from the study will be re-presented to the participants, as well as other key community individuals in order to translate them into policy.
Conclusion
Supported housing intervention is a core feature of mental health care, and it requires evaluation. The lack of research in northern and rural SMI populations heightens the relevance of research findings for health service planning. The inclusion of multiple stakeholder groups, using a variety of data collection approaches, contributes to a comprehensive, systems-level examination of supported housing in smaller communities. It is anticipated that the study's findings will not only have utility across Ontario, but also Canada.
doi:10.1186/1472-6963-8-156
PMCID: PMC2527314  PMID: 18652689
23.  Efficacy and cost-effectiveness of minimal guided and unguided internet-based mobile supported stress-management in employees with occupational stress: a three-armed randomised controlled trial 
BMC Public Health  2014;14(1):807.
Background
Internet- and mobile based stress-management interventions (iSMI) may be an effective means to address the negative consequences of occupational stress. However, available results from randomised controlled trials are conflicting. Moreover, it is yet not clear whether guided or unguided self-help iSMI provide better value for money. Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional. However, direct comparisons in randomised controlled trials are scarce and, to the best of our knowledge, the comparative (cost)-effectiveness of guided vs. unguided iSMI has not yet been studied. Hence, this study investigates the acceptability and (cost-) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress.
Methods
A three-armed randomised controlled trial (RCT) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition (WLC). Both active conditions are based on the same iSMI, i.e. GET.ON Stress, and differ only with regard to the guidance format. Employees with heightened levels of perceived stress (PSS ≥ 22) will be randomised to one of three conditions. Primary outcome will be comparative changes in perceived stress (PSS). Secondary outcomes include changes in self-reported depression, work-engagement, presenteeism and absenteeism. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective, including both direct medical costs and costs related to productivity losses. In addition, a cost-benefit analysis will be conducted from the employer’s perspective. Incremental net-benefit regression analyses will address the question if there are any baseline factors (i.e. subgroups of employees) associated with particularly favorable cost-effectiveness when the experimental intervention is offered. Assessments take place at baseline, 7 weeks post-treatment and 6 months after randomisation.
Discussion
Online-based (guided) self-help interventions could be an acceptable, effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress. This study evaluates the (cost-) effectiveness of two versions of an iSMI, minimal guided and unguided iSMI. Thus, the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs.
Trial registration
German Clinical Trial Registration (DRKS): DRKS00005687.
doi:10.1186/1471-2458-14-807
PMCID: PMC4153891  PMID: 25099533
Guided self-help; Unguided self-help; Occupational health; Stress management; Internet-based; Randomised controlled trial; Cost-effectiveness
24.  How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review 
BMC Medical Ethics  2008;9:6.
Background
Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.
Discussion
Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.
The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.
Conclusion
Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?
doi:10.1186/1472-6939-9-6
PMCID: PMC2324094  PMID: 18373857
25.  HIV Testing among Individuals with a Severe Mental Illness: Review, Suggestions for Research, and Clinical Implications 
Psychological medicine  2008;39(3):355-363.
Background
The prevalence of HIV is elevated among individuals with a severe mental illness (SMI). Because of the benefits of HIV testing, it is important for individuals with SMI to have routine access to testing.
Objectives
The goals of this review are to summarize knowledge about HIV testing prevalence, correlates, and interventions among individuals with a SMI; to identify research needs; and to discuss clinical implications of the studies reviewed.
Methods
Literature searches were conducted using PsycINFO, PubMed, and MEDLINE. Additional articles were obtained from reference lists of relevant articles.
Results
Fewer than one-half of individuals with a SMI have been tested for HIV in the past year. Engaging in sex or drug risk behavior was the only consistent correlate of HIV testing. Interventions for promoting HIV testing among individuals with a SMI have not been well-developed or evaluated.
Conclusions
Research on HIV testing among individuals with a SMI is needed. Mental health settings may be opportune venues for HIV testing, even though providers face ethical challenges when implementing testing programs in these settings.
doi:10.1017/S0033291708003930
PMCID: PMC2640447  PMID: 18606051

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