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1.  Family-Focused Treatment for Adolescents and Young Adults at High Risk for Psychosis: Results of a Randomized Trial 
Longitudinal studies have begun to clarify the phenotypic characteristics of adolescents and young adults at clinical high risk for psychosis. This 8-site randomized trial examined whether a 6-month program of family psychoeducation was effective in reducing the severity of attenuated positive and negative psychotic symptoms and enhancing functioning among individuals at high risk.
Adolescents and young adults (mean 17.4±4.1 years) with attenuated positive psychotic symptoms, brief and intermittent psychosis, or genetic risk with functional deterioration were randomly assigned to 18 sessions of family-focused therapy for individuals at clinical high risk (FFT-CHR) in 6 months or 3 sessions of family psychoeducation (enhanced care, or EC). FFT-CHR included psychoeducation about early signs of psychosis, stress management, communication training, and problem-solving skills training, whereas EC focused on symptom prevention. Independent evaluators assessed participants at baseline and 6 months on positive and negative symptoms and social-role functioning.
Of 129 participants, 102 (79.1%) were followed at 6 months. Participants in FFT-CHR showed greater improvements in attenuated positive symptoms over 6 months than participants in EC (F[1,97]=5.49, P=.02). Negative symptoms improved independently of psychosocial treatments. Changes in psychosocial functioning depended on age: participants over 19 years showed more role improvement in FFT-CHR, whereas participants between 16 and 19 years showed more role improvement in EC. The results were independent of concurrent pharmacotherapy.
Interventions that focus on improving family relationships may have prophylactic efficacy in individuals at high risk for psychosis. Future studies should examine the specificity of effects of family intervention compared to individual therapy of the same duration and frequency.
PMCID: PMC4112074  PMID: 25062592
attenuated psychotic symptoms; schizophrenia; early warning signs; psychoeducation; family therapy
2.  The development of the Content of Attenuated Positive Symptoms Codebook for those at clinical high risk of psychosis 
Psychosis  2011;4(3):191-202.
Examining the content of psychotic symptoms may be relevant for understanding symptom development particularly in those in the very early stages of psychosis. The Content of Attenuated Positive Symptoms codebook was developed as a means to overcome methodological issues in the current literature. Three separate samples at clinical high risk of psychosis were used to develop, modify and finalize the codebook. The inter-rater reliability was moderate to excellent. Specific content items were consistently endorsed across samples. This codebook offers a reliable way to assess content in the clinical high-risk population.
PMCID: PMC4493420  PMID: 26161138
psychosis; positive symptoms; clinical high risk; prodrome
3.  Intravenous Therapy Duration and Outcomes in Melioidosis: A New Treatment Paradigm 
PLoS Neglected Tropical Diseases  2015;9(3):e0003586.
International melioidosis treatment guidelines recommend a minimum 10 to 14 days’ intravenous antibiotic therapy (intensive phase), followed by 3 to 6 months’ oral therapy (eradication phase). This approach is associated with rates of relapse, defined as recurrence following the eradication phase, that can exceed 5%. Rates of recrudescence, defined as recurrence during the eradication phase, have not previously been reported. In response to low eradication phase completion rates in Australia, a local guideline has evolved over the last ten years recommending a longer minimum intensive phase duration for many cases of melioidosis.
Methodology/ Principal Findings
This retrospective cohort study reviews antibiotic duration for the first episode of care for all patients diagnosed with melioidosis and surviving the intensive phase during a recent three year period in the tropical north of Australia’s Northern Territory; we also review adherence to the current local guideline and treatment outcomes. Of 215 first episodes of melioidosis surviving the intensive phase, the median (interquartile range) intensive phase duration was 26 (14-34) days. One hundred and eight (50.2%) patients completed eradication therapy; 58 (27.0%) patients took no eradication therapy. At 28 months’ follow-up, one (0.5%) relapse and eleven (5.1%) recrudescences had occurred. On exact logistic regression analysis, the only independent risk factors for recrudescence were self-discharge during the intensive phase (odds ratio 6.2 [95% confidence interval 1.2-30.0]) and septic shock (odds ratio 5.3 [95% confidence interval 1.1-25.7]).
Conclusions/ Significance
Relapsed melioidosis is rare in patients who receive a minimum intensive phase duration specified by our guideline and extended according to clinical progress. Recrudescence rates may improve with reductions in rates of self-discharge. Given the low relapse rate despite a high rate of eradication therapy non-adherence, the duration and necessity of eradication therapy for different patients after guideline-concordant intensive therapy should be evaluated further.
Author Summary
Melioidosis is an infection caused by the soil bacterium Burkholderia pseudomallei; patients usually present with pneumonia, blood-stream infection and/or skin or internal organ abscesses. Melioidosis occurs most commonly in northern Australia and parts of Southeast Asia. It has a high mortality rate and, with standard treatment, a relapse rate greater than 5%; patients who relapse often represent severely unwell. Treatment comprises an intensive (intravenous antibiotic) phase, followed by a prolonged eradication (oral antibiotic) phase. Previous studies have found that the intensive phase is important to prevent mortality, and the eradication phase is important to prevent relapse. However, these studies have not been designed to detect an effect of intensive therapy on relapse rate. We know that adherence to eradication therapy is poor, and many of our patients live remotely making follow-up difficult. In order to address this, we have developed a new treatment guideline which stipulates a longer intensive phase for most patients. We show that adherence to this guideline is associated with very low relapse rates despite poor adherence to eradication therapy. It is possible that for many patients the eradication phase could be shortened or avoided when this intensive phase guideline is followed; this requires further research.
PMCID: PMC4374799  PMID: 25811783
4.  Cognitive Behavioral Therapy in Prodromal Psychosis 
Current pharmaceutical design  2012;18(4):558-565.
There is a strong impetus in the psychosis research field to develop interventions that aim to prevent the onset of psychotic disorders. Over the past 15 years there has been a tremendous development in the work aimed at understanding the pre-psychotic period. More recently there has been a focus on developing and testing treatments both pharmacological and psychological that could potentially prevent or delay the onset of psychosis. One of the psychological treatments that has received the most attention is cognitive behavioral therapy (CBT). Relatively few trials have been completed and this paper reviews the existing trials. Implications of these trials for the treatment of this early phase as well as for designing future studies are discussed.
PMCID: PMC4356485  PMID: 22239588
Cognitive behavioral therapy; prodromal psychosis
5.  Developing a checklist for guideline implementation planning: review and synthesis of guideline development and implementation advice 
Developers, users and others have requested or advocated for guidance on how to plan for, and implement guidelines concurrent to their development given that existing resources are lacking such information. The purpose of this research was to develop a guideline implementation planning checklist.
Documents that described or evaluated the processes of planning or undertaking implementation were identified in several publications that had systematically identified such resources, and by searching medical literature databases (MEDLINE, EMBASE). Data that described implementation planning; how to develop guideline versions or tools that would support user implementation; and options and mechanisms for disseminating or implementing guidelines were independently extracted from eligible documents by the principal investigator and a trained research assistant. Data were integrated to create a unique list of guideline implementation planning processes and considerations.
Thirty-five documents were eligible. Of these, 16 (45.7%) provided sparse information on implementation planning, 25 (71.4%) mentioned different versions or tools for implementation, and 30 (85.7%) listed options for dissemination or implementation. None provided instructions for operationalizing implementation strategies. Data were integrated into a multi-item Guideline Implementation Planning Checklist including considerations for implementation planning (12), development of implementation tools (8), types of implementation tools (12), and options for dissemination (11) and implementation (12).
Developers or users can apply the Guideline Implementation Planning Checklist to prepare for and/or undertake guideline implementation. Further development of the checklist is warranted to elaborate on all components. In ongoing research, we will consult with the international guideline community to do so. At the same time, guideline implementation is complex, so developers and users would benefit from training, and by including knowledge translation experts and brokers on implementation planning committees.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0205-5) contains supplementary material, which is available to authorized users.
PMCID: PMC4329197  PMID: 25884601
Guidelines; Implementation
6.  A Randomized Trial of Family Focused Therapy With Populations at Clinical High Risk for Psychosis: Effects on Interactional Behavior 
This study investigated whether family focused therapy (FFT-CHR), an 18-session intervention that consisted of psychoeducation and training in communication and problem solving, brought about greater improvements in family communication than enhanced care (EC), a 3-session psychoeducational intervention, among individuals at clinical high risk for developing psychosis.
This study was conducted within a randomized controlled trial across 8 sites. We examined 10-min problem-solving discussions at baseline and 6-month reassessment among 66 adolescents and young adults and their parents. Trained coders who were blind to treatment and time of assessment achieved high levels of interrater reliability when evaluating family discussions on categories of calm–constructive and critical– conflictual behavior.
Individuals at high risk and their family members who participated in FFT-CHR demonstrated greater improvement from baseline to 6-month reassessment in constructive communication and decreases in conflictual behaviors during family interactions than those in EC. Participants in FFT-CHR showed greater increases from baseline to 6 months in active listening and calm communication and greater decreases in irritability and anger, complaints and criticism, and off-task comments compared to participants in EC. These changes occurred equally in high-risk participants and their family members.
A 6-month family skills training treatment can bring about significant improvement in family communication among individuals at high risk for psychosis and their parents. Future studies should examine the association between enhancements in family communication and reduced risk for the onset of psychosis among individuals at high risk.
PMCID: PMC3909734  PMID: 24188511
randomized clinical trial; expressed emotion; family problem solving; schizophrenia
7.  Brief Report: Un Abrazo Para la Familia: Providing Low-Income Hispanics with Education and Skills in Coping with Breast Cancer and Caregiving 
Psycho-oncology  2011;22(2):470-474.
Un Abrazo Para La Familia [A Hug for the Family] is an intervention designed to increase the accessibility of cancer information to low-income and medically underserved co-survivors of cancer. Co-survivors are family members or friends of an individual diagnosed with cancer. Our goal was to increase socio-emotional support for co-survivors, and improve skills in coping with cancer. The purpose of our pilot study was to explore the effectiveness of the intervention in increasing cancer knowledge and self-efficacy among co-survivors.
Un Abrazo consisted of three one-hour sessions, in either Spanish or English. Sessions were delivered by a trained promotora [community health worker], in partnership with a counselor. Sixty participants completed measures of cancer knowledge and self-efficacy preceding (pre-test) and following the intervention (post-test).
From pre- to post-test, the percentage of questions answered correctly about cancer knowledge increased (p < .001), as did ratings of self-efficacy (p < .001). Decreases were seen in “Do not know” responses for cancer knowledge (p < .01), with a negative correlation between number of “Do not knows” on cancer knowledge at pre-test and ratings of self-efficacy at pre-test (r = −.47, p < .01).
When provided an accessible format, co-survivors of cancer from underserved populations increase their cancer knowledge and self-efficacy. This is notable because research indicates that family members and friends with increased cancer knowledge assume more active involvement in the cancer care of their loved ones.
PMCID: PMC3563927  PMID: 22140003
low-income; Hispanic; cancer knowledge; oncology; co-survivors; self-efficacy
8.  Impact of Hiv-Associated Conditions on Mortality in People Commencing Anti-Retroviral Therapy in Resource Limited Settings 
PLoS ONE  2013;8(7):e68445.
To identify associations between specific WHO stage 3 and 4 conditions diagnosed after ART initiation and all cause mortality for patients in resource-limited settings (RLS).
Design, Setting
Analysis of routine program data collected prospectively from 25 programs in eight countries between 2002 and 2010.
Subjects, Participants
36,664 study participants with median ART follow-up of 1.26 years (IQR 0.55–2.27).
Outcome Measures
Using a proportional hazards model we identified factors associated with mortality, including the occurrence of specific WHO clinical stage 3 and 4 conditions during the 6-months following ART initiation.
There were 2922 deaths during follow-up (8.0%). The crude mortality rate was 5.41 deaths per 100 person-years (95% CI: 5.21–5.61). The diagnosis of any WHO stage 3 or 4 condition during the first 6 months of ART was associated with increased mortality (HR: 2.21; 95% CI: 1.97–2.47). After adjustment for age, sex, region and pre-ART CD4 count, a diagnosis of extrapulmonary cryptococcosis (aHR: 3.54; 95% CI: 2.74–4.56), HIV wasting syndrome (aHR: 2.92; 95%CI: 2.21 -3.85), non-tuberculous mycobacterial infection (aHR: 2.43; 95% CI: 1.80–3.28) and Pneumocystis pneumonia (aHR: 2.17; 95% CI 1.80–3.28) were associated with the greatest increased mortality. Cerebral toxoplasmosis, pulmonary and extra-pulmonary tuberculosis, Kaposi’s sarcoma and oral and oesophageal candidiasis were associated with increased mortality, though at lower rates.
A diagnosis of certain WHO stage 3 and 4 conditions is associated with an increased risk of mortality in those initiating ART in RLS. This information will assist initiatives to reduce excess mortality, including prioritization of resources for diagnostics, therapeutic interventions and research.
PMCID: PMC3720807  PMID: 23935870
9.  Incidence of WHO Stage 3 and 4 Conditions following Initiation of Anti-Retroviral Therapy in Resource Limited Settings 
PLoS ONE  2012;7(12):e52019.
To determine the incidence of WHO clinical stage 3 and 4 conditions during early anti-retroviral therapy (ART) in resource limited settings (RLS).
A descriptive analysis of routine program data collected prospectively from 25 Médecins Sans Frontières supported HIV treatment programs in eight countries between 2002 and 2010.
35,349 study participants with median follow-up on ART of 1.33 years (IQR 0.51–2.41).
Outcome Measures
Incidence in 100 person-years of WHO stage 3 or 4 conditions during 5 periods after ART initiation. Diagnoses of conditions were made according to WHO criteria and relied upon clinical assessments supported by basic laboratory investigations.
The incidence of any WHO clinical stage 3 or 4 condition over 3 years was 40.02 per 100 person-years (31.77 for stage 3 and 8.25 for stage 4). The incidence of stage 3 and 4 conditions fell by over 97% between months 0–3 and months 25–36 (77.81 to 2.40 for stage 3 and 28.70 to 0.64 for stage 4). During months 0–3 pulmonary tuberculosis was the most common condition diagnosed in adults (incidence 22.24 per 100 person-years) and children aged 5–14 years (25.76) and oral candidiasis was the most common in children <5 years (25.79). Overall incidences were higher in Africa compared with Asia (43.98 versus 12.97 for stage 3 and 8.98 versus 7.05 for stage 4 conditions, p<0.001). Pulmonary tuberculosis, weight loss, oral and oesophageal candidiasis, chronic diarrhoea, HIV wasting syndrome and severe bacterial infections were more common in Africa. Extra-pulmonary tuberculosis, non-tuberculous mycobacterial infection, cryptococcosis, penicilliosis and toxoplasmosis were more common in Asia.
The incidence of WHO stage 3 and 4 conditions during the early period after ART initiation in RLS is high, but greatly reduces over time. This is likely due to both the benefits of ART and deaths of the sickest patients occurring shortly after ART initiation. Access to appropriate disease prevention tools prior to ART, and early initiation of ART, are important for their prevention.
PMCID: PMC3527377  PMID: 23284857
10.  Considerations of Culture and Social Class for Families Facing Cancer: The Need for a New Model for Health Promotion and Psychosocial Intervention 
Cancer is a family experience, and family members often have as much, or more, difficulty in coping with cancer as does the person diagnosed with cancer. Using both family systems and sociocultural frameworks, we call for a new model of health promotion and psychosocial intervention that builds on the current understanding that family members, as well as the individuals diagnosed with cancer, are themselves survivors of cancer. We argue that considering culture, or the values, beliefs, and customs of the family, including their choice of language, is necessary to understand fully a family’s response to cancer. Likewise, acknowledging social class is necessary to understand how access to, and understanding of, otherwise available interventions for families facing cancer can be limited. Components of the model as conceptualized are discussed and provide guidance for psychosocial cancer health disparities research and the development of family-focused, strength-based, interventions.
PMCID: PMC3521537  PMID: 21688902
low-income; cancer; family; culture; psychosocial
11.  Acute Post-Streptococcal Glomerulonephritis in the Northern Territory of Australia: A Review of 16 Years Data and Comparison with the Literature 
Data relating to acute post-streptococcal glomerulonephritis (APSGN) from the notifiable diseases surveillance system in the Northern Territory of Australia was extracted and analyzed. Isolates of Streptococcus pyogenes from confirmed cases were emm sequence typed. From 1991 to July 2008, there were 415 confirmed cases and 23 probable cases of APSGN notified. Four hundred fifteen (94.7%) of these were Indigenous Australians and 428 (97.7%) were people living in remote or very remote locations. The median age of cases was 7 years (range 0–54). The incidence of confirmed cases was 12.5/100,000 person-years, with an incidence in Indigenous Australian children younger than 15 years of age of 94.3 cases/100,000 person-years. The overall rate ratio of confirmed cases in Indigenous Australians to non-Indigenous Australians was 53.6 (95% confidence interval 32.6–94.8). Outbreaks of disease across multiple communities occurred in 1995 (N = 68), 2000 (N = 55), and 2005 (N = 87 [confirmed cases]). Various emm types of S. pyogenes were isolated from cases of APSGN including some types not previously recognized to be nephritogenic. The widespread outbreak in 2005 was caused by emm55.0 S. pyogenes. Acute post-streptococcal glomerulonephritis continues to occur in remote Indigenous communities in Australia at rates comparable to or higher than those estimated in developing countries. Improvements in preventative and outbreak control strategies are needed.
PMCID: PMC3183781  PMID: 21976576
12.  The European Society of Human Reproduction and Embryology guideline for the diagnosis and treatment of endometriosis: an electronic guideline implementability appraisal 
Clinical guidelines are intended to improve healthcare. However, even if guidelines are excellent, their implementation is not assured. In subfertility care, the European Society of Human Reproduction and Embryology (ESHRE) guidelines have been inventoried, and their methodological quality has been assessed. To improve the impact of the ESHRE guidelines and to improve European subfertility care, it is important to optimise the implementability of guidelines. We therefore investigated the implementation barriers of the ESHRE guideline with the best methodological quality and evaluated the used instrument for usability and feasibility.
We reviewed the ESHRE guideline for the diagnosis and treatment of endometriosis to assess its implementability. We used an electronic version of the guideline implementability appraisal (eGLIA) instrument. This eGLIA tool consists of 31 questions grouped into 10 dimensions. Seven items address the guideline as a whole, and 24 items assess the individual recommendations in the guideline. The eGLIA instrument identifies factors that influence the implementability of the guideline recommendations. These factors can be divided into facilitators that promote implementation and barriers that oppose implementation. A panel of 10 experts from three European countries appraised all 36 recommendations of the guideline. They discussed discrepancies in a teleconference and completed a questionnaire to evaluate the ease of use and overall utility of the eGLIA instrument.
Two of the 36 guideline recommendations were straightforward to implement. Five recommendations were considered simply statements because they contained no actions. The remaining 29 recommendations were implementable with some adjustments. We found facilitators of the guideline implementability in the quality of decidability, presentation and formatting, apparent validity, and novelty or innovation of the recommendations. Vaguely defined actions, lack of facilities, immeasurable outcomes, and inflexibility within the recommendations formed barriers to implementation. The eGLIA instrument was generally useful and easy to use. However, assessment with the eGLIA instrument is very time-consuming.
The ESHRE guideline for the diagnosis and treatment of endometriosis could be improved to facilitate its implementation in daily practice. The eGLIA instrument is a helpful tool for identifying obstacles to implementation of a guideline. However, we recommend a concise version of this instrument.
PMCID: PMC3034686  PMID: 21247418
13.  Survival of elderly patients with stage 5 CKD: comparison of conservative management and renal replacement therapy 
Nephrology Dialysis Transplantation  2010;26(5):1608-1614.
Background. Elderly patients with end-stage renal disease and severe extra-renal comorbidity have a poor prognosis on renal replacement therapy (RRT) and may opt to be managed conservatively (CM). Information on the survival of patients on this mode of therapy is limited.
Methods. We studied survival in a large cohort of CM patients in comparison to patients who received RRT.
Results. Over an 18-year period, we studied 844 patients, 689 (82%) of whom had been treated by RRT and 155 (18%) were CM. CM patients were older and a greater proportion had high comorbidity. Median survival from entry into stage 5 chronic kidney disease was less in CM than in RRT (21.2 vs 67.1 months: P < 0.001). However, in patients aged > 75 years when corrected for age, high comorbidity and diabetes, the survival advantage from RRT was ~ 4 months, which was not statistically significant. Increasing age, the presence of high comorbidity and the presence of diabetes were independent determinants of poorer survival in RRT patients. In CM patients, however, age > 75 years and female gender independently predicted better survival.
Conclusions. In patients aged > 75 years with high extra-renal comorbidity, the survival advantage conferred by RRT over CM is likely to be small. Age > 75 years and female gender predicted better survival in CM patients. The reasons for this are unclear.
PMCID: PMC3084441  PMID: 21098012
Chronic kidney disease; Comorbidity; Conservative management; Elderly; Survival

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