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1.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
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.
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
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
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
PMCID: PMC3742442  PMID: 23966839
2.  Is Content of Medical Journals Related to Advertisements? Case-control Study 
Croatian medical journal  2007;48(6):786-790.
To assess the relatedness of journal content to paid advertisements published in the journal.
The case-control study was performed on a convenience sample of 7 journals subscribed by Central Medical Library in Moscow – 4 international (American Journal of Hypertension, British Journal of General Practice, The Lancet, and New England Journal of Medicine) and 3 Russian peer reviewed journals (Terapevticheskii Arkhiv, Khirurgiia, and Voeno-Meditsinskii Zhurnal). In each issue containing a paid advertisement, classifieds excluded, we searched for articles related to the advertised product and compared this issue with a control issue – the next or a later issue without this advertisement.
In American Journal of Hypertension (33 issues from 2002-2004) 94 placements of advertisements were found, 7 of which were closely related to the article topic in the same issue (7/94) vs 2/66 in the control issue. The odds ratio (OR) and 95% confidence interval (CI) for advertisements to be accompanied by related articles was OR, 2.6; 95%CI, 0.5-13). In British Journal of General Practice (27 issues from 2003-2005) there were 7/63 advertisements related to the article topic vs 0/28 in the control issue (OR, 7.2; 95% CI, 1.3 to 44). In The Lancet (49 issues from 2004) there were 8/162 advertisements related to the article topic vs 8/104 in the control issue (OR, 0.6; 95% CI, 0.3-1.5). In New England Journal of Medicine (37 issues from 2004) there were 12/81 advertisements related to the article topic vs 8/75 in the control issue (OR, 1.5; 95% CI, 0.56-3.79). In Terapevticheskii Arkhiv (10 issues from 2004) there were 38/93 advertisements related to the article topic vs 1/83 in the control issue (OR, 56.66; 95% CI, 4.4-253). In Khirurgiia (25 issues from 2003-2005) there were 3/83 advertisements related to the article topic vs 0/70 in the control issue (OR, 2.7; 95% CI, 0.3-26). In Voeno-Meditsinskii Zhurnal (33 issues from 2003-2005) there were 17/31 advertisements related to the article topic vs 2/31 in the control issue (OR,17.6; 95% CI, 3.6-87).
The strong relatedness between the content of the articles and advertisements placed in 3 of 7 journals and explicit placement of the advertisements face to face or overleaf the related research articles support the hypothesis that journal content is manipulated to place more emphasis on the advertisements.
PMCID: PMC2213802  PMID: 18074412
3.  Nurse managers' experience with ethical issues in six government hospitals in Malaysia: A cross-sectional study 
BMC Medical Ethics  2011;12:23.
Nurse managers have the burden of experiencing frequent ethical issues related to both their managerial and nursing care duties, according to previous international studies. However, no such study was published in Malaysia. The purpose of this study was to explore nurse managers' experience with ethical issues in six government hospitals in Malaysia including learning about the way they dealt with the issues.
A cross-sectional study was conducted in August-September, 2010 involving 417 (69.2%) of total 603 nurse managers in the six Malaysian government hospitals. Data were collected using three-part self-administered questionnaire. Part I was regarding participants' demographics. Part II was about the frequency and areas of management where ethical issues were experienced, and scoring of the importance of 11 pre-identified ethical issues. Part III asked how they dealt with ethical issues in general; ways to deal with the 11 pre-identified ethical issues, and perceived stress level. Data were analyzed using descriptive statistics, cross-tabulations and Pearson's Chi-square.
A total of 397 (95.2%) participants experienced ethical issues and 47.2% experienced them on weekly to daily basis. Experiencing ethical issues were not associated with areas of practice. Top area of management where ethical issues were encountered was "staff management", but "patient care" related ethical issues were rated as most important. Majority would "discuss with other nurses" in dealing generally with the issues. For pre-identified ethical issues regarding "patient care", "discuss with doctors" was preferred. Only 18.1% referred issues to "ethics committees" and 53.0% to the code of ethics.
Nurse managers, regardless of their areas of practice, frequently experienced ethical issues. For dealing with these, team-approach needs to be emphasized. Proper understanding of the code of ethics is needed to provide basis for reasoning.
PMCID: PMC3228789  PMID: 22085735
4.  Everyday ethics in internal medicine resident clinic: an opportunity to teach 
Medical Education  2011;45(7):712-721.
Being a good doctor requires competency in ethics. Accordingly, ethics education during residency training is important. We studied the everyday ethics-related issues (i.e. ordinary ethics issues commonly faced) that internal medical residents encounter in their out-patient clinic and determined whether teaching about these issues occurred during faculty preceptor–resident interactions.
This study involved a multi-method qualitative research design combining observation of preceptor-resident discussions with preceptor interviews. The study was conducted in two different internal medicine training programme clinics over a 2-week period in June 2007. Fifty-three residents and 19 preceptors were observed, and 10 preceptors were interviewed. Transcripts of observer field notes and faculty interviews were carefully analysed. The analysis identified several themes of everyday ethics issues and determined whether preceptors identified and taught about these issues.
Everyday ethics content was considered present in 109 (81%) of the 135 observed case presentations. Three major thematic domains and associated sub-themes related to everyday ethics issues were identified, concerning: (i) the Doctor–Patient Interaction (relationships; communication; shared decision making); (ii) the Resident as Learner (developmental issues; challenges and conflicts associated with training; relationships with colleagues and mentors; interactions with the preceptor), and; (iii) the Doctor–System Interaction (financial issues; doctor–system issues; external influences; doctor frustration related to system issues). Everyday ethics issues were explicitly identified by preceptors (without teaching) in 18 of 109 cases (17%); explicit identification and teaching occurred in only 13 cases (12%).
In this study a variety of everyday ethics issues were frequently encountered as residents cared for patients. Yet, faculty preceptors infrequently explicitly identified or taught these issues during their interactions with residents. Ethics education is important and residents may regard teaching about the ethics-related issues they actually encounter to be highly relevant. A better understanding of the barriers to teaching is needed in order to promote education about everyday ethics in the out-patient setting.
PMCID: PMC3233355  PMID: 21649704
5.  Association between Participant-Identified Problems and Depression Severity in Problem-Solving Therapy for Low-Income Homebound Older Adults 
The purpose of this study was to examine the relationship between the severity of baseline depressive symptoms and the problems that low-income homebound older adults (n = 66) identified in their problem-solving therapy (PST) sessions.
Depressive symptoms were measured with the 24-item Hamilton Rating Scale for Depression (HAMD). Participant-identified problems recorded in the therapists’ worksheets were coded into seven categories: living arrangement/housing issues; financial/healthcare expenses issues; family or other relationship issues; hygiene/task issues; social isolation issues; physical/functional health issues; and mental/emotional health issues. T-tests and ordinary least squares (OLS) regression analysis were used to examine differences in HAMD scores between those who identified any problem in each category and those who did not.
Participants who had living arrangement/housing and family or other relationship issues had higher baseline HAMD scores than the rest of the participants. At 2-week posttest, those with living arrangement/housing issues continued to have higher HAMD scores than the others, while those with family or other relationship issues did not.
The study findings provide insights into the problems that low-income, depressed homebound individuals bring to their PST sessions. It was not clear if family conflict or other relationship issues contributed to their depression or vice versa, but it appears that PST may have contributed to alleviating depressive symptoms associated with these issues. Precarious living/housing situations appeared to have had a serious depressogenic effect and could not be easily resolved within a short time frame of the PST process, as these issues required formal support.
PMCID: PMC3196815  PMID: 21638330
Homebound older adults; problem-solving therapy; family relationship
6.  Clinical management issues vary by specialty in the Victorian Audit of Surgical Mortality: a retrospective observational study 
BMJ Open  2014;4(6):e005554.
Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved.
This study used retrospectively analysed observational data from VASM. Clinical management issues between eight specialties were assessed using χ2 analysis.
Data sources
VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria.
A total of 2946 specific clinical issues as deficiencies of care were reported. 15% of cases had significant issues of care. The most common clinical management issue was the delay in delivery of treatment. Other clinical issues included the quality of communication and documentation, preoperative and postoperative care, adverse events and protocol issues. There were significant differences in issues between specialties.
The clinical management issues presented across surgical specialties were similar; however, five issues of clinical care differed significantly in frequency across surgical specialties. The three main issues varying among specialties were complications after operation, communication and postoperative care. Addressing these clinical management issues via the peer-review process may impact positively on patient care.
PMCID: PMC4078770  PMID: 24980043
7.  The identification of the general practice registrar needing assistance 
The Australasian Medical Journal  2011;4(6):308-314.
Doctors undertaking vocational training in general practice in Australia may require assistance, in addition to the normal training offered as part of their training programme. Issues requiring assistance may go undetected for a period of time. Delay in the identification of issues leads to delay in the provision of the assistance. The aim of this study is to determine the most common reasons registrars require extra assistance, and how these issues are identified. The findings of this study will provide direction for 21 regionally based training providers (RTPs) to develop improved tools to ensure earlier detection of registrars requiring assistance.
This study is based on qualitative research methods, using semi-structured interviews with senior medical education staff of four regional general practice training providers in Victoria, Australia.
Issues identified included language and cultural issues, applied knowledge and skills, attitude and professionalism, and health and family issues.
The principal method that training providers identified issues was via the GP supervisor. This was predominantly by informal communication, rather than formal evaluation sheets. Other methods included the external clinical teaching visit and other training formative assessments. These more formalised procedures were more likely to identify issues later than desired. They were also used as a way of clarifying suspected problems. The selection process was not felt to be helpful, and the examinations provided information too late.
An increased awareness of the potential issues leading to a registrar to require assistance enables identification and subsequent action to occur in a more timely and more useful fashion. Informal communication between practices and training programme staff should be encouraged to enable these issues to be dealt with early in training.
PMCID: PMC3562948  PMID: 23386893
General practice; remediation; vocational training
8.  Family issues and family functioning of Japanese outpatients with type 2 diabetes: a cross-sectional study 
Previous studies confirmed that the control of diabetes is related to family functioning, but the validity of the tools used to assess family functioning in these studies is questionable. Few studies have focused on family issues. In this study, we used a new assessment tool to evaluate family functioning and family issues of patients with type 2 diabetes.
A cross-sectional questionnaire was given to outpatients with type 2 diabetes at a community hospital in Aichi, Japan, between August 2001 and March 2002. First, the patients were asked to answer FACESKGIV-16, which measures cohesion and adaptability, questions regarding family issues, daily lifestyle, and HAD. Physical and serological data were measured. Family functioning, family issues, and relationships between each parameter and family functioning or family issues were analyzed.
Of the 133 participants, 121 (33.3%) had some sort of family issue. Family issues included “Health problems of family members” (40.9%), “Family life cycle issues” (22.7%), and others.
The best fit multiple regression model (Adjusted R2: 0.494, p = 0.020) included Plasma Glucose as an independent variable, and the squared value of cohesion score, depression score of HAD, Total calorie intake, Exercise time, Housekeeping time, and BMI were dependent variables. The results show that extremes of family cohesion with either too many or too few issues related to family functioning are correlated with the plasma glucose level.
Family issues were common among patients with type 2 diabetes, and the extremes of family cohesion were associated with the glucose level, in contrast to the common wisdom that a well balanced family leads to good control of diabetes.
PMCID: PMC3700776  PMID: 23799927
Family; Family Research; Diabetes Mellitus; Family Relations; Family Characteristics; Family Members
9.  Evaluating a Web-Based Health Risk Assessment With Tailored Feedback: What Does an Expert Focus Group Yield Compared to a Web-Based End-User Survey? 
Increasingly, Web-based health applications are developed for the prevention and management of chronic diseases. However, their reach and utilization is often disappointing. Qualitative evaluations post-implementation can be used to inform the optimization process and ultimately enhance their adoption. In current practice, such evaluations are mainly performed with end-user surveys. However, a review approach by experts in a focus group may be easier to administer and might provide similar results.
The aim of this study was to assess whether industrial design engineers in a focus group would address the same issues as end users in a Web-based survey when evaluating a commercial Web-based health risk assessment (HRA) with tailored feedback.
Seven Dutch companies used the HRA as part of their corporate health management strategy. Employees using the HRA (N=2289) and 10 independent industrial designers were invited to participate in the study. The HRA consisted of four components: (1) an electronic health questionnaire, (2) biometric measurements, (3) laboratory evaluation, and (4) individually tailored feedback generated by decision support software. After participating in the HRA as end users, both end users and designers evaluated the program. End users completed an evaluation questionnaire that included a free-text field. Designers participated in a focus group discussion. Constructs from user satisfaction and technology acceptance theories were used to categorize and compare the remarks from both evaluations.
We assessed and qualitatively analyzed 294 remarks of 189 end users and 337 remarks of 6 industrial designers, pertaining to 295 issues in total. Of those, 137 issues were addressed in the end-user survey and 148 issues in the designer focus group. Only 7.3% (10/137) of the issues addressed in the survey were also addressed in the focus group. End users made more remarks about the usefulness of the HRA and prior expectations that were not met. Designers made more remarks about how the information was presented to end users, quality of the feedback provided by the HRA, recommendations on the marketing and on how to create more unity in the design of the HRA, and on how to improve the HRA based on these issues.
End-user surveys should not be substituted for expert focus groups. Issues identified by end users in the survey and designers in the focus group differed considerably, and the focus group produced a lot of new issues. The issues addressed in the focus group often focused on different aspects of user satisfaction and technology acceptance than those addressed by the survey participants; when they did focus on the same aspects, then the nature of issues differed considerably in content.
PMCID: PMC3906664  PMID: 24384408
health risk assessment; health information systems; qualitative research; evaluation; end users; professional review; designers; optimization
10.  Informal hospice caregiver pain management concerns: A qualitative study 
Palliative medicine  2013;27(7):673-682.
Informal, unpaid, family caregivers provide much hospice care in the United States. These caregivers suffer physically, psychologically, emotionally, and socially from the burden of caring. The most often identified area of caregiver burden is the management of end-of-life pain. However, little empirical evidence exists of effective interventions to help caregivers manage end-of-life pain, and issues surrounding caregiver pain management remain vague and undefined. Understanding these concerns will inform the design of effective caregiver interventions.
The purpose of this study was to describe and organize caregiver pain management challenges faced by home hospice caregivers of cancer patients.
A content analysis of secondary data, namely, recordings of caregiver interviews, was conducted to describe pain management issues. These interviews were part of a larger clinical trial.
Multiple sessions with 29 informal caregivers, of patients dying of cancer, were audio-recorded. Subjects were purposively selected from two hospice programs in the Northwestern United States. Caregivers of noncancer patients were excluded from the study sample.
A framework of six major themes with subordinate subthemes was developed through a literature review and peer review. The framework was used to organize the content of 87 caregiver interviews. The six major themes identified in the analysis included Caregiver-Centric Issues, Caregiver Medication Skills and Knowledge Issues, End-of-Life Symptom Knowledge Issues, Communication and Teamwork Issues, Organizational Skill Issues, and Patient-Centric Issues.
This analysis clearly articulated and classified caregiver issues surrounding pain management. Future hospice research may benefit from the use of this analysis and framework in the development of tools to alleviate this major cause of caregiver burden.
PMCID: PMC3950803  PMID: 23612959
Caregivers; hospice care; pain; pain management; palliative care; end-of-life
11.  Participation in EHR based simulation improves recognition of patient safety issues 
BMC Medical Education  2014;14(1):224.
Electronic health records (EHR) are becoming increasingly integrated into the clinical environment. With the rapid proliferation of EHRs, a number of studies document an increase in adverse patient safety issues due to the EHR-user interface. Because of these issues, greater attention has been placed on novel educational activities which incorporate use of the EHR. The ICU environment presents many challenges to integrating an EHR given the vast amounts of data recorded each day, which must be interpreted to deliver safe and effective care. We have used a novel EHR based simulation exercise to demonstrate that everyday users fail to recognize a majority of patient safety issues in the ICU. We now sought to determine whether participation in the simulation improves recognition of said issues.
Two ICU cases were created in our EHR simulation environment. Each case contained 14 safety issues, which differed in content but shared common themes. Residents were given 10 minutes to review a case followed by a presentation of management changes. Participants were given an immediate debriefing regarding missed issues and strategies for data gathering in the EHR. Repeated testing was performed in a cohort of subjects with the other case at least 1 week later.
116 subjects have been enrolled with 25 subjects undergoing repeat testing. There was no difference between cases in recognition of patient safety issues (39.5% vs. 39.4%). Baseline performance for subjects who participated in repeat testing was no different than the cohort as a whole. For both cases, recognition of safety issues was significantly higher among repeat participants compared to first time participants. Further, individual performance improved from 39.9% to 63.6% (p = 0.0002), a result independent of the order in which the cases were employed. The degree of improvement was inversely related to baseline performance. Further, repeat participants demonstrated a higher rate of recognition of changes in vitals, misdosing of antibiotics and oversedation compared to first time participants.
Participation in EHR simulation improves EHR use and identification of patient safety issues.
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6920-14-224) contains supplementary material, which is available to authorized users.
PMCID: PMC4287422  PMID: 25336294
12.  Postpartum anxiety, depression and social health: findings from a population-based survey of Australian women 
BMC Public Health  2010;10:771.
Whilst the prevalence and correlates of postpartum depression are well established, far less is known about postpartum anxiety. Studies have described the association between socio-demographic factors and postpartum depression, yet few have explored the association between stressors in women's lives around the time of having a baby and maternal psychological morbidity. This study aimed to describe the population prevalence of postpartum depression, anxiety, co-morbid anxiety and depression and social health issues; and to examine the association between postpartum psychological and social health issues experienced in the six months following birth.
Population-based survey of all women who gave birth in Victoria and South Australia in September/October 2007. Women were mailed the survey questionnaire six months following birth. Anxiety and depression were measured using the Depression Anxiety Stress Scales (DASS-21).
Questionnaires were completed by 4,366 women. At six months postpartum the proportion of women scoring above the 'normal' range on the DASS-21 was 12.7% for anxiety,17.4% for depression, and 8.1% for co-morbid depression and anxiety. Nearly half the sample reported experiencing stressful life events or social health issues in the six months following birth, with 38.3% reporting one to two and 8.8% reporting three or more social health issues. Women reporting three or more social health issues were significantly more likely to experience postnatal anxiety (Adj OR = 4.12, 95% CI 3.0-5.5) or depression (Adj OR = 5.11, 95% CI = 3.9-6.7) and co-morbid anxiety and depression (Adj OR = 5.41, 95% CI 3.8-7.6) than women who did not report social health issues.
Health care providers including midwives, nurses, medical practitioners and community health workers need to be alert to women's social circumstances and life events experienced in the perinatal period and the interplay between social and emotional health. Usual management for postpartum mental health issues including Cognitive Behavioural Therapy and pharmacological approaches may not be effective if social health issues are not addressed. Coordinated and integrated perinatal care that is responsive to women's social health may lead to improvements in women's emotional wellbeing following birth.
PMCID: PMC3022850  PMID: 21167078
13.  Clinical Audit on “Evaluation of Special Issues in Adolescents with Cancer Treated in an Adult Cancer Setting”: An Indian Experience 
Indian Journal of Palliative Care  2012;18(3):196-201.
Adolescents with cancer form a distinct group with special care needs. These patients are often cared in an adult supportive care setting where the special needs of adolescents are not met.
To identify special issues in adolescents with cancer and to determine whether special needs of adolescents are met in an adult cancer setting
Materials and Methods:
10 adolescents with cancer were randomly chosen and retrospectively studied for physical, psychoscocial and emotional issues using an internally validated tool.
Pain was the most common physical symptom seen in all 10 patients. 3 out of 10 patients were involved in decision making, 3 out of 10 patients had identity issues and 4 out of 10 patients had peer group isolation issues. Only 3 were aware of diagnosis and none were aware of treatment outcomes and mortality. 4 out of 10 had anxiety and depression and 3 out of 10 had body image issues. Sexuality, spiritual and existential issues were not explored in any of the patients studied.
The outcomes of the study were in an adult oncology setting there was a poor recognition of key adolescent issues such as sexuality, body image, identity and peer group isolation. The psychosocial supports to these adolescents were minimal and spiritual and existential issues were not explored. The inferences drawn from this study suggested a need for multidisciplinary team approach oriented in handling adolescent care needs and preferably to have a dedicated space that will help the peer group to interact, bond and cope better with the illness.
PMCID: PMC3573474  PMID: 23439995
Adolescents; Cancer; Supportive care
14.  A Review of the Evidence to Support Influenza Vaccine Introduction in Countries and Areas of WHO's Western Pacific Region 
PLoS ONE  2013;8(7):e70003.
Immunization against influenza is considered an essential public health intervention to control both seasonal epidemics and pandemic influenza. According to the World Health Organization (WHO), there are five key policy and three key programmatic issues that decision-makers should consider before introducing a vaccine. These are (a) public health priority, (b) disease burden, (c) efficacy, quality and safety of the vaccine, (d) other inventions, (e) economic and financial issues, (f) vaccine presentation, (g) supply availability and (h) programmatic strength. We analyzed the body of evidence currently available on these eight issues in the WHO Western Pacific Region.
Methodology/Principal Findings
Studies indexed in PubMed and published in English between 1 January 2000 and 31 December 2010 from the 37 countries and areas of the Western Pacific Region were screened for keywords pertaining to the five policy and three programmatic issues. Studies were grouped according to country income level and vaccine target group. There were 133 articles that met the selection criteria, with most (90%) coming from high-income countries. Disease burden (n = 34), vaccine efficacy, quality and safety (n = 27) and public health priority (n = 27) were most frequently addressed by studies conducted in the Region. Many studies assessed influenza vaccine policy and programmatic issues in the general population (42%), in the elderly (24%) and in children (17%). Few studies (2%) addressed the eight issues relating to pregnant women.
The evidence for vaccine introduction in countries and areas in this Region remains limited, particularly in low- and middle-income countries that do not currently have influenza vaccination programmes. Surveillance activities and specialized studies can be used to assess the eight issues including disease burden among vaccine target groups and the cost-effectiveness of influenza vaccine. Multi-country studies should be considered to maximize resource utilization for cross-cutting issues such as vaccine presentation and other inventions.
PMCID: PMC3713047  PMID: 23875015
15.  Analysis of US Food and Drug Administration Warning Letters 
Pharmaceutical medicine  2008;22(2):10.1007/BF03256691.
Recent studies have suggested that there has been an increase in the number of ‘warning letters’ issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion.
All warning letters published by the FDA between 5 May 1995 and 11 June 2007 were reviewed. Warning letters related to promotional issues were included and analysed. Information related to the identification number, date of the warning letter, FDA division that issued the letter, drug name, manufacturer, specific warning problem, type of promotional material and requested action was extracted. Two independent investigators reviewed and classified each PDF file, any differences were discussed until a consensus was reached.
Between May 1995 and June 2007 a total of 8692 warning letters were issued, of which 25% were related to drugs. Of these, 206 warning letters focused on drug promotion and were included in this study: 23% were issued in 2005, 15% in 2004 and 14% in 1998. In total, 47% of the warning letters were issued because of false or misleading unapproved doses and uses, 27% failed to disclose risks, 15% cited misleading promotion, 8% related to misleading labelling and 3% promoted false effectiveness claims.
There is an important variation in the number of warning letters issued in the last decade, probably because of the increasing number of drugs approved by the FDA, drug withdrawal scandals, and the publication of the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines.
We found that benefit-related claims, such as unapproved uses or doses of drugs, and failure to disclose risks, are the main causes of FDA issued warning letters for promotional claims related to medications.
PMCID: PMC3864040  PMID: 24353430
16.  An Online Forum As a Qualitative Research Method: Practical Issues 
Nursing research  2006;55(4):267-273.
Despite positive aspects of online forums as a qualitative research method, very little is known about practical issues involved in using online forums for data collection, especially for a qualitative research project.
The purpose of this paper is to describe the practical issues that the researchers encountered in implementing an online forum as a qualitative component of a larger study on cancer pain experience.
Throughout the study process, the research staff recorded issues ranged from minor technical problems to serious ethical dilemmas as they arose and wrote memos about them. The memos and written records of discussions were reviewed and analyzed using the content analysis suggested by Weber.
Two practical issues related to credibility were identified: a high response and retention rate and automatic transcripts. An issue related to dependability was the participants’ easy forgetfulness. The issues related to confirmability were difficulties in theoretical saturation and unstandardized computer and Internet jargon. A security issue related to hacking attempts was noted as well.
The analysis of these issues suggests several implications for future researchers who want to use online forums as a qualitative data collection method.
PMCID: PMC2491331  PMID: 16849979
Issues; Online Forums; Cancer Patients; Qualitative Research
17.  Caregiver awareness of reproductive health issues for women with intellectual disabilities 
BMC Public Health  2011;11:59.
Limited attention has been paid to the issue of reproductive health as it affects women with intellectual disabilities, despite reproductive health being a vital issue in public health policy for women in the general population. This paper describes caregiver awareness of reproductive health issues relative to women with intellectual disabilities who are being cared for in welfare institutions in Taiwan.
The study employed a cross-sectional, questionnaire-based study which recruited 1,152 caregivers (response rate = 71.87%) from 32 registered disability welfare institutions in Taiwan. We classified their understanding/awareness of reproductive health issues into four domains: menstrual (1) and menopause (2) issues, sex education (3), and reproductive health services (4). Each domain had five associated yes/no questions and the total score for the four domains was out of a maximum of 20. Data were analyzed using SPSS 15.0 software.
We found that most of the caregivers were familiar with matters concerning sex education, menopause, and reproductive health services, but they lacked adequate understanding of issues associated with menstruation in women with ID. Many aspects of reproductive health such as "menstrual pain", "age at menarche", "masturbation", "diet during perimenopause", and "publicly available reproductive health services" were issues in which caregivers lacked adequate knowledge and required further instruction. Logistic regression analysis revealed that female caregivers with a university degree, and those who had experience assisting with reproductive health care were more inclined to have higher reproductive health awareness scores than their counterparts.
This study highlights that service providers should offer appropriate reproductive health education to institutional caregivers, and that more attention be focused on the personal experiences and concerns of intellectually disabled women in future research.
PMCID: PMC3042389  PMID: 21272374
18.  Negotiation From a Near and Distant Time Perspective 
Across 3 experiments, the authors examined the effects of temporal distance on negotiation behavior. They found that greater temporal distance from negotiation decreased preference for piecemeal, single-issue consideration over integrative, multi-issue consideration (Experiment 1). They also found that greater temporal distance from an event being negotiated increased interest in conceding on the lowest priority issue and decreased interest in conceding on the highest priority issue (Experiment 2). Lastly, they found increased temporal distance from an event being negotiated produced a greater proportion of multi-issue offers, a greater likelihood of conceding on the lowest priority issue in exchange for a concession on the highest priority issue, and greater individual and joint outcomes (Experiment 3). Implications for conflict resolution and construal level theory are discussed.
PMCID: PMC3153434  PMID: 17014295
construal; time; psychological distance; negotiation; integrative
19.  Health care issues in Croatian elections 2005-2009: series of public opinion surveys 
Croatian Medical Journal  2011;52(5):585-592.
To compare the results of a series of public opinion surveys on experiences with the health care sector in Croatia conducted in the time of elections and to analyze whether political party affiliation had any influence on issues of priority ranking.
The surveys were conducted during 2005, 2007, and 2009. They were administered through a Computer Assisted Telephone Interviewing method to representative samples of Croatian population and were statistically weighted according to sex, age, level of education, and political party affiliation. The random sampling of the person within the household was done using the table of random numbers.
Health and health care system was the most important issue (58%) during the 2007 parliamentary election and the second most important issue during the 2005 and 2009 elections (46% and 28%). In the 2007 election, health care was viewed as most important by women, respondents with lower education levels, and respondents with lower income. In 2005, the most important health care issues were corruption and lack of funding (45% and 43%, respectively), in 2007 poor organization and lack of funding (43% and 42%, respectively), and in 2009 lack of funding and corruption (51% and 45%, respectively).
Health and health care system were consistently among the top two issues in all elections from 2005 to 2009. The top three most important health care sector issues were corruption, poor organization, and lack of funding. This indicates that political parties should include solutions to these issues in their health care policymaking.
PMCID: PMC3195967  PMID: 21990075
20.  Influence of medical journal press releases on the quality of associated newspaper coverage: retrospective cohort study 
Objective To determine whether the quality of press releases issued by medical journals can influence the quality of associated newspaper stories.
Design Retrospective cohort study of medical journal press releases and associated news stories.
Setting We reviewed consecutive issues (going backwards from January 2009) of five major medical journals (Annals of Internal Medicine, BMJ, Journal of the National Cancer Institute, JAMA, and New England Journal of Medicine) to identify the first 100 original research articles with quantifiable outcomes and that had generated any newspaper coverage (unique stories ≥100 words long). We identified 759 associated newspaper stories using Lexis Nexis and Factiva searches, and 68 journal press releases using Eurekalert and journal website searches. Two independent research assistants assessed the quality of journal articles, press releases, and a stratified random sample of associated newspaper stories (n=343) by using a structured coding scheme for the presence of specific quality measures: basic study facts, quantification of the main result, harms, and limitations.
Main outcome Proportion of newspaper stories with specific quality measures (adjusted for whether the quality measure was present in the journal article’s abstract or editor note).
Results We recorded a median of three newspaper stories per journal article (range 1-72). Of 343 stories analysed, 71% reported on articles for which medical journals had issued press releases. 9% of stories quantified the main result with absolute risks when this information was not in the press release, 53% did so when it was in the press release (relative risk 6.0, 95% confidence interval 2.3 to 15.4), and 20% when no press release was issued (2.2, 0.83 to 6.1). 133 (39%) stories reported on research describing beneficial interventions. 24% mentioned harms (or specifically declared no harms) when harms were not mentioned in the press release, 68% when mentioned in the press release (2.8, 1.1 to 7.4), and 36% when no press release was issued (1.5, 0.49 to 4.4). 256 (75%) stories reported on research with important limitations. 16% reported any limitations when limitations were not mentioned in the press release, 48% when mentioned in the press release (3.0, 1.5 to 6.2), and 21% if no press release was issued (1.3, 0.50 to 3.6).
Conclusion High quality press releases issued by medical journals seem to make the quality of associated newspaper stories better, whereas low quality press releases might make them worse.
PMCID: PMC3267473  PMID: 22286507
21.  Age-Related Patterns in Clinical Presentations and Gluten-Related Issues Among Children and Adolescents With Celiac Disease 
Celiac disease (CD) is common and often cited as an “iceberg” phenomenon (i.e., an assumed large number of undiagnosed cases). Recently, atypical or asymptomatic manifestations are becoming more commonly described in older children and adolescents. Moreover, CD diagnosis in children can be complicated by several factors, including its diverse clinical presentations, delay in recognizing CD signs and symptoms, and premature dietary gluten avoidance before the formal diagnosis of CD. To date, few studies have directly examined age-related differences in clinical characteristics and gluten-related issues among children with CD. The aim of this study was to determine age-related patterns in clinical characteristics and gluten-related issues among children with confirmed CD.
We performed a structured medical record review of biopsy-proven CD patients, aged 0–19 years, between 2000 and 2010 at a large Boston teaching hospital. Data collection included demographics, medical history, gluten-related issues, and diagnostic investigations (CD-specific serology, upper gastrointestinal endoscopy, and small intestinal biopsy). The first positive duodenal biopsy with Marsh III classification defined age of diagnosis. Patients were divided into three age groups for comparisons of the aforementioned characteristics: infant-preschool group (0–5 years), school-aged group (6–11 years), and adolescence group (12–19 years).
Among 411 children with biopsy-proven CD, the mean age was 9.5 (s.d. 5.1) years. Most were female (63%) and white (96%). All children had positive CD-specific serology. Most children presented with either abdominal complaints or bowel movement changes. Overall, boys were more common among infant-preschool group compared with the other age groups. More distinct clinical manifestations (vomiting, bowel movement changes, and weight issues) were apparent in the youngest group, whereas school-aged children had more subjective abdominal complaints at the initial presentation. Conversely, the adolescents were most likely to present without any gastrointestinal (GI) symptoms, but not when this was combined with absence of weight issues. Age of diagnosis was not associated with atypical extraintestinal CD presentations. Regarding the gluten-related issues, 10% of school-aged children avoided dietary gluten before the formal CD diagnosis, and 27% of the adolescents reported dietary gluten transgression within the first 12 months of diagnosis, significantly higher than the other age groups. Age differences in histopathology were also found. Whereas the infant-preschool group had a higher proportion of total villous atrophy, the older children were more likely to have gross duodenal abnormalities and chronic duodenitis suggestive of CD at the time of diagnosis.
Children and adolescents with CD have age-related patterns in both the clinical presentations and gluten-related issues. More pronounced clinical and histological features were determined in younger children, whereas older children more commonly presented with solely subjective abdominal complaints or even without any GI symptoms. However, silent and atypical extraintestinal CD presentations were comparable between age groups. In addition to the aforementioned presentations, the higher rates of dietary gluten avoidance and transgression in older children make CD diagnosis and management particularly challenging. These age-related patterns may further increase awareness, facilitate early diagnosis, and improve patient care of pediatric CD.
PMCID: PMC3365672  PMID: 23238134
22.  Multiple Intravenous Infusions Phase 1b 
Minimal research has been conducted into the potential patient safety issues related to administering multiple intravenous (IV) infusions to a single patient. Previous research has highlighted that there are a number of related safety risks. In Phase 1a of this study, an analysis of 2 national incident-reporting databases (Institute for Safe Medical Practices Canada and United States Food and Drug Administration MAUDE) found that a high percentage of incidents associated with the administration of multiple IV infusions resulted in patient harm.
The primary objectives of Phase 1b of this study were to identify safety issues with the potential to cause patient harm stemming from the administration of multiple IV infusions; and to identify how nurses are being educated on key principles required to safely administer multiple IV infusions.
Data Sources and Review Methods
A field study was conducted at 12 hospital clinical units (sites) across Ontario, and telephone interviews were conducted with program coordinators or instructors from both the Ontario baccalaureate nursing degree programs and the Ontario postgraduate Critical Care Nursing Certificate programs. Data were analyzed using Rasmussen’s 1997 Risk Management Framework and a Health Care Failure Modes and Effects Analysis.
Twenty-two primary patient safety issues were identified with the potential to directly cause patient harm. Seventeen of these (critical issues) were categorized into 6 themes. A cause-consequence tree was established to outline all possible contributing factors for each critical issue. Clinical recommendations were identified for immediate distribution to, and implementation by, Ontario hospitals. Future investigation efforts were planned for Phase 2 of the study.
This exploratory field study identifies the potential for errors, but does not describe the direct observation of such errors, except in a few cases where errors were observed. Not all issues are known in advance, and the frequency of errors is too low to be observed in the time allotted and with the limited sample of observations.
The administration of multiple IV infusions to a single patient is a complex task with many potential associated patient safety risks. Improvements to infusion and infusion-related technology, education standards, clinical best practice guidelines, hospital policies, and unit work practices are required to reduce the risk potential. This report makes several recommendations to Ontario hospitals so that they can develop an awareness of the issues highlighted in this report and minimize some of the risks. Further investigation of mitigating strategies is required and will be undertaken in Phase 2 of this research.
Plain Language Summary
Patients, particularly in critical care environments, often require multiple intravenous (IV) medications via large volumetric or syringe infusion pumps. The infusion of multiple IV medications is not without risk; unintended errors during these complex procedures have resulted in patient harm. However, the range of associated risks and the factors contributing to these risks are not well understood.
Health Quality Ontario’s Ontario Health Technology Advisory Committee commissioned the Health Technology Safety Research Team at the University Health Network to conduct a multi-phase study to identify and mitigate the risks associated with multiple IV infusions. Some of the questions addressed by the team were as follows: What is needed to reduce the risk of errors for individuals who are receiving a lot of medications? What strategies work best?
The initial report, Multiple Intravenous Infusions Phase 1a: Situation Scan Summary Report, summarizes the interim findings based on a literature review, an incident database review, and a technology scan.
The Health Technology Safety Research Team worked in close collaboration with the Institute for Safe Medication Practices Canada on an exploratory study to understand the risks associated with multiple IV infusions and the degree to which nurses are educated to help mitigate them. The current report, Multiple Intravenous Infusions Phase 1b: Practice and Training Scan, presents the findings of a field study of 12 hospital clinical units across Ontario, as well as 13 interviews with educators from baccalaureate-level nursing degree programs and postgraduate Critical Care Nursing Certificate programs. It makes 9 recommendations that emphasize best practices for the administration of multiple IV infusions and pertain to secondary infusions, line identification, line set-up and removal, and administering IV bolus medications.
The Health Technology Safety Research Team has also produced an associated report for hospitals entitled Mitigating the Risks Associated With Multiple IV Infusions: Recommendations Based on a Field Study of Twelve Ontario Hospitals, which highlights the 9 interim recommendations and provides a brief rationale for each one.
PMCID: PMC3377572  PMID: 23074426
23.  Political priority in the global fight against non–communicable diseases 
Journal of Global Health  2012;2(2):020403.
The prevalence of non–communicable diseases (NCDs) – such as cancer, diabetes, cardiovascular disease, and chronic respiratory diseases – is surging globally. Yet despite the availability of cost–effective interventions, NCDs receive less than 3% of annual development assistance for health to low and middle income countries. The top donors in global health – including the Bill and Melinda Gates Foundation, the US Government, and the World Bank – together commit less than 2% of their budgets to the prevention and control of NCDs. Why is there such meagre funding on the table for the prevention and control of NCDs? Why has a global plan of action aimed at halting the spread of NCDs been so difficult to achieve?
This paper aims to tackle these two interrelated questions by analysing NCDs through the lens of Jeremy Shiffman’s 2009 political priority framework. We define global political priority as ‘the degree to which international and national political leaders actively give attention to an issue, and back up that attention with the provision of financial, technical, and human resources that are commensurate with the severity of the issue’. Grounded in social constructionism, this framework critically examines the relationship between agenda setting and ‘objective’ factors in global health, such as the existence of cost–effective interventions and a high mortality burden. From a methodological perspective, this paper fits within the category of discipline configurative case study.
We support Shiffman’s claim that strategic communication – or ideas in the form of issue portrayals – ought to be a core activity of global health policy communities. But issue portrayals must be the products of a robust and inclusive debate. To this end, we also consider it essential to recognise that issue portrayals reach political leaders through a vast array of channels. Raising the political priority of NCDs means engaging with the diverse ways in which actors express concern for the global proliferation of these diseases.
Ultimately, our political interactions amount to struggles for influence, and determining which issues to champion in the midst of these struggles – and which to disregard – is informed by subjectively held notions of the right, the good, and the just. Indeed, the very act of choosing which issues to prioritise in our daily lives forces us to evaluate our values and aspirations as individual agents against the shared values that structure the societies in which we live.
PMCID: PMC3529321  PMID: 23289078
24.  Governance Around Quality of Care at Hospitals that Disproportionately Care for Black Patients 
Hospital boards of directors can play a pivotal role in improving care, yet we know little about how the boards of hospitals that disproportionately serve minority patients engage in this issue.
To examine how boards of directors at black-serving hospitals are engaged in quality of care issues and compare priorities and practices of black-serving and non-black-serving hospital boards.
We identified all nonprofit U.S. hospitals in the top decile of proportion of elderly black patients (“black-serving”) and surveyed their board chairpersons and a national sample of chairpersons from other nonprofit U.S. hospitals (“non-black-serving”).
Board chairpersons of black-serving and non-black-serving U.S. hospitals.
Board chairpersons’ familiarity and expertise with quality of care issues, level of engagement with quality management, prioritization of quality issues, and efforts to improve quality or to reduce racial disparities in the quality of care.
We received responses from 79% of black-serving hospitals and 78% of non-black-serving hospitals. We found that board chairpersons from black-serving hospitals less often reported having at least moderate expertise in quality of care (68% versus 79%, P = 0.04) or rating it as one of the top two priorities for board oversight (48% versus 57%, P = 0.09) or for CEO performance evaluation (40% versus 50%, P = 0.05). Only 14.2% of board chairpersons from black-serving hospitals (and 7.7% of non-black-serving hospitals) agreed with the statement that disparities exist among my hospital patients, although less than 10% of all board chairpersons reported examining quality or patient satisfaction data stratified by race.
Board chairpersons of black-serving hospitals report less expertise with quality of care issues and are less likely to give high priority to these issues than board chairpersons of non-black-serving hospitals. Interventions to engage and educate board members in issues of quality and racial disparities may be needed to improve quality and reduce disparities in care.
PMCID: PMC3286564  PMID: 21948204
quality of care; disparities; quality improvement
25.  A specialist’s audit of aggregated occurrence records: An ‘aggregator’s’ perspective 
ZooKeys  2013;67-76.
A recent ZooKeys’ paper (Mesibov, 2013: has highlighted data quality issues in aggregated data sets, but did not provide a realistic way to address these issues. This paper provides an aggregator’s perspective including ways that the whole community can help to address data quality issues. The establishment of GBIF and national nodes (national aggregators) such as the Atlas of Living Australia (ALA) have integrated and exposed a huge diversity of biological observations along with many associated issues. Much of the admirable work by Mesibov (2013) was enabled by having the data exposed.
Data quality, one of the highest priorities for GBIF, the national nodes and other aggregators, depends on both automatic methods and community experts to detect and correct data issues. Not all issues can however be automatically detected or corrected, so community assistance is needed to help improve the quality of exposed biological data. We do need to improve the infrastructure and associated processes to more easily identify data issues and document all changes to ensure a full record is permanently and publicly available.
PMCID: PMC3689094  PMID: 23794914
Australia; occurrence records; data quality; data cleaning; ALA; GBIF; millipede; fitness for use

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