How do Mental Health Services Foster Hope? Experience of People Accessing Services.

Hope is essential to mental health recovery, yet little is known about how mental health services can foster hope. This paper addresses the question: How can mental health services influence the sense of hope experienced by people who access their services? Sixty-one people who accessed a new mental health service were interviewed about their experiences, including about how the service had influenced their sense of hope. Interviews were analysed using constant comparative analysis. The data revealed that hope increased when people perceived positive changes in themselves and their circumstances: developing new understandings and perspectives; having effective strategies to manage challenges; seeing progress or having plans; and having support. Changes were attributed to three major features of the service: accessibility; staff competence and wisdom; and caring interactions. The findings highlight that, while individual clinicians are important, other interactions with services and the wider service context are also critical for facilitating hope.

Clinician by day, filmmaker by night: The development of a consumer inspired educational electroconvulsive therapy video.

OBJECTIVE: Electroconvulsive therapy (ECT) is a highly effective form of treatment used for major psychiatric disorders. However, significant stigma surrounds ECT and mental health consumers and they often report lack of knowledge prior to receiving ECT. They complain of inadequacies in information being provided by health professionals and difficulty finding reliable, balanced information that incorporates the experience of consumers who have received ECT. To address these limitations, a collaborative team of ECT consumers and health professionals created a new ECT video to provide consumers and their relatives with up-to-date, easy to understand information about ECT. The educational video includes evidence-based information from health professionals and genuine consumer perspectives. CONCLUSION: A gap in clinical care and service provision was identified and a collaborative project was undertaken to address these limitations. In the process of creating an ECT video, many lessons were learned and a range of recommendations were implemented, including a memory rehabilitation program and new and improved access to ECT information resources.

Co-design and evaluation of a multidisciplinary teaching resource on mental health recovery involving people with lived experience.

BACKGROUND: Students from a range of health disciplines need to learn from people with lived experience of mental distress and recovery to develop recovery capabilities for mental health practice. AIMS: The aims of this study are to describe the co-design of a teaching resource, to explore the experience of people with lived experience during the resource development, and to evaluate the outcome of the resource on student recovery capabilities. METHOD: Using a sequential mixed method, a project group consisting of six people with lived experience and 10 academics from five health disciplines was convened to co-develop teaching resources. People with lived experience met independently without researchers on several occasions to decide on the key topics and met with the research team monthly. The teaching resource was used in mental health subjects for two health professional programmes, and the Capabilities for Recovery-Oriented Practice Questionnaire (CROP-Q) was used before and after to measure any change in student recovery capabilities. Scores were compared using the Wilcoxon signed rank test. The people with lived experience were also interviewed about their experience of being involved in constructing the teaching resources. Interviews were audiotaped, transcribed, and analysed thematically. RESULTS: The finished resource consisted of 28 short videos and suggested teaching plans. Occupational therapy and nursing student scores on the CROP-Q prior to using the educational resource (n = 33) were 68 (median) and post scores (n = 28) were 74 (median), indicating a statistically significant improvement in recovery capability (P = 0.04). Lived experience interview themes were (i) the importance of lived experience in education; (ii) personal benefits of participating; (iii) co-design experience; and (iv) creating the resource. CONCLUSION: Co-design of teaching resources with people with lived experience was pivotal to the success and quality of the final product, and people with lived experience described personal benefits of participating in resource development. More evidence to demonstrate the use of the CROP-Q in teaching and practice is needed.

Effect of an Educational Video and Information Pamphlet on Knowledge and Attitudes About Electroconvulsive Therapy: A Randomized, Blind, Controlled Study.

OBJECTIVE: Electroconvulsive therapy (ECT) is considered an effective, yet underused and stigmatized form of psychiatric treatment. Public misconception can impact informed decision making, and therefore, it is important to educate the community with accurate and realistic representations of modern ECT. The aim of this study was to determine whether exposure to brief information packages developed in Australia leads to changes in attitudes and knowledge about ECT. METHODS: A sample of 100 undergraduate psychology students and 88 volunteers from the general public were randomly allocated to view 1 of 3 resource packages (each containing an information pamphlet and videos totaling ~15 minutes): Concord Centre for Mental Health-Revised, Concord Centre for Mental Health-Original, and a generic information package on depression. Participants' attitudes and knowledge of ECT were assessed before and after psychoeducation using the Questionnaire on Attitudes and Knowledge of ECT (QuAKE). RESULTS: Participants in the student and general population exposed to either ECT resource package showed significantly improved attitudes and knowledge of ECT compared with participants exposed to generic information about depression and its treatment. A fine-grained analysis of the QuAKE revealed that, although many aspects of knowledge and attitudes improved after exposure to ECT information packages, some remained unchanged. CONCLUSIONS: Brief education through information resources in video and written format can markedly improve attitudes and knowledge toward ECT. Further research is recommended to determine whether the resources contribute to informed decision making of consumers with mental illness, especially those who are candidates for ECT.

How Do People Perceive and Adapt to Any Consequences of Electro Convulsive Therapy on Their Daily Lives?

Great controversy surrounds the use of electroconvulsive therapy or ECT. However, it continues to be used internationally. While research on short term effects of ECT abound, there is limited knowledge about long term impacts of ECT on individuals, especially from the lived experience perspective. The aim of this qualitative study was to gain an in-depth understanding of longer-term lived experiences of ECT and how people navigate any impacts on their daily lives. Twenty-three people participated in semi-structured interviews. Data collection and analysis involved an iterative process. Data were coded into four categories: (1) My ECT experience included physical mechanics, decision making, clinic experiences, post ECT support and attitudes and support of others); (2) Direct impacts of ECT on me encompassed both cognitive and emotional impacts; (3) Impacts on my life comprised daily activities, relationships, ongoing health care; and My strategies incorporated fixing or working around the problem, reframing, using support networks, protecting myself and taking control. Insights gleaned through lived experiences have important implications for other service users, direct service providers and those striving for system reforms that embrace more recovery orientated and trauma informed practices.

Learning from lived experience: Outcomes associated with students' involvement in co-designed and co-delivered recovery-oriented practice workshops.

INTRODUCTION: Learning from individuals with lived experience is considered an important element of developing recovery-oriented practice capabilities in mental health contexts. Additionally, service user involvement in the education of occupational therapy students is a requirement in accreditation standards. Despite this, many barriers to meaningful inclusion of Lived Experience Educators have previously been identified. METHOD: This study evaluated the outcomes achieved by students who were involved in a unit of study that incorporated four recovery-oriented practice workshops that were co-designed and co-delivered by Lived Experience Educators and an occupational therapy academic. Change over time was measured using the Recovery Knowledge Inventory (RKI) and the Capabilities for Recovery Oriented Practice Questionnaire (CROP-Q). Change over time was evaluated using paired t-tests. Students also provided qualitative feedback at the conclusion of the workshops. These comments were analysed using interpretive content analysis. RESULTS: Students' scores on the RKI and CROP-Q both demonstrated statistically significant improvements from the beginning of the semester to the end of semester (RKI: 53.6-57.7, t = 6.3, P < 0.001; CROP-Q: 75.6-77.0, t = 2.4, P = 0.019). The most common categories included in the qualitative comments were: "Learning from real experiences"; "Learning about how to be a better clinician"; "See the strength and resilience of the educators, reduce stigma"; "Learning about the negative aspects of the mental health system"; and "More effective than other types of learning". CONCLUSION: This study has demonstrated that students who engaged with the co-designed and co-delivered workshops improved their recovery knowledge and recovery-oriented capabilities over the course of the semester. Qualitative feedback also suggests that students' attitudes and skills for future practice were also influenced in positive ways by engaging with Lived Experience Educators.

Testing Robustness of Child STEPs Effects with Children and Adolescents: A Randomized Controlled Effectiveness Trial.

A critical task in psychotherapy research is identifying the conditions within which treatment benefits can be replicated and outside of which those benefits are reduced. We tested the robustness of beneficial effects found in two previous trials of the modular Child STEPs treatment program for youth anxiety, depression, trauma, and conduct problems. We conducted a randomized trial, with two significant methodological changes from previous trials: (a) shifting from cluster- to person-level randomization, and (b) shifting from individual to more clinically feasible group-based consultation with STEPs therapists. Fifty community clinicians from multiple outpatient clinics were randomly assigned to receive training and consultation in STEPs (n= 25) or to provide usual care (UC; n= 25). There were 156 referred youths-ages 6-16 (M= 10.52, SD = 2.53); 48.1% male; 79.5% Caucasian, 12.8% multiracial, 4.5% Black, 1.9% Latino, 1.3% Other-who were randomized to STEPs (n= 77) or UC (n= 79). Following previous STEPs trials, outcome measures included parent- and youth-reported internalizing, externalizing, total, and idiographic top problems, with repeated measures collected weekly during treatment and longer term over 2 years. Participants in both groups showed statistically significant improvement on all measures, leading to clinically meaningful problem reductions. However, in contrast to previous trials, STEPs was not superior to UC on any measure. As with virtually all treatments, the benefits of STEPs may depend on the conditions-for example, of study design and implementation support-in which it is tested. Identifying those conditions may help guide appropriate use of STEPs, and other treatments, in the future.

Igniting and Maintaining Hope: The Voices of People Living with Mental Illness.

The study objective was to identify the types of experiences that consumers identify as igniting and maintaining hope, and those most frequently reported. Data were collected through an anonymous online survey. Two open-ended questions elicited reflective personal accounts regarding hope-promoting experiences. Using an interpretive content analysis design, data were coded inductively using constant comparative analysis. Numbers of participants reporting each type of experience were calculated to identify patterns of hopeful experiences. Findings from 72 participants highlighted a diversity of hope-promoting experiences and sources. Fifteen experiences were identified, forming two broad categories: interactions and experiences involving others, and personal or internal experiences, insights and actions. Findings suggest that consumers play an active role in igniting and maintaining their own hope. Peer workers and health workers can support this by being cognizant of the quality of their interactions with consumers and by facilitating connections with others, particularly families, friends and peers.

Validating an algorithm for multiple myeloma based on administrative data using a SEER tumor registry and medical record review.

PURPOSE: Large numbers of multiple myeloma patients can be studied in real-world clinical settings using administrative databases. The validity of these studies is contingent upon accurate case identification. Our objective was to develop and evaluate algorithms to use with administrative data to identify multiple myeloma cases. METHODS: Patients aged ≥18 years with ≥1 International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for multiple myeloma (203.0x) were identified at two study sites. At site 1, several algorithms were developed and validated by comparing results to tumor registry cases. An algorithm with a reasonable positive predictive value (PPV) (0.81) and sensitivity (0.73) was selected and then validated at site 2 where results were compared with medical chart data. The algorithm required that ICD-9-CM codes 203.0x occur before and after the diagnostic procedure codes for multiple myeloma. RESULTS: At site 1, we identified 1432 patients. The PPVs of algorithms tested ranged from 0.54 to 0.88. Sensitivities ranged from 0.30 to 0.88. At site 2, a random sample (n = 400) was selected from 3866 patients, and medical charts were reviewed by a clinician for 105 patients. Algorithm PPV was 0.86 (95% CI, 0.79-0.92). CONCLUSIONS: We identified cases of multiple myeloma with adequate validity for claims database analyses. At least two ICD-9-CM diagnosis codes 203.0x preceding diagnostic procedure codes for multiple myeloma followed by ICD-9-CM codes within a specific time window after diagnostic procedure codes were required to achieve reasonable algorithm performance.

Serum cholesterol trajectories in the 10 years prior to lymphoma diagnosis.

PURPOSE: Many studies suggest a role for cholesterol in cancer development. Serum cholesterol levels have been observed to be low in newly diagnosed lymphoma cases. The objective of these analyses was to examine the time-varying relationship of cholesterol with lymphomagenesis in the 10 years prior to diagnosis by lymphoma subtype. METHODS: Participants were selected from the combined membership of six National Cancer Institute-funded Cancer Research Network health plans from 1998 to 2008, excluding members with human immunodeficiency virus, cancer (except lymphoma), or organ transplants. Incident lymphoma cases within this population were ascertained and matched with up to five controls. Total serum cholesterol, high-density lipoprotein, and low-density lipoprotein were collected from plan databases. Multilevel, multivariable longitudinal models were fit after choosing the best polynomial order by deviance statistics for selected lymphoma histotypes to examine pre-diagnosis cholesterol trajectories: Hodgkin lymphoma (n = 519) and all non-Hodgkin lymphomas combined (n = 12,635) as well as six subtypes of the latter. RESULTS: For all categories, lymphoma cases had statistically significantly lower estimated total serum cholesterol, high-density lipoprotein, and low-density lipoprotein levels than controls in the years prior to diagnosis/index date. Between-group differences were most pronounced 3-4 years prior to diagnosis, when cases' cholesterol levels declined steeply. CONCLUSIONS: This analysis is the first to examine changes in serum cholesterol for a decade prior to lymphoma diagnosis. A drop in cholesterol levels was evident several years before diagnosis. Our results suggest that cholesterol-related pathways have an important relationship with lymphomagenesis and low cholesterol could be a preclinical lymphoma marker.

Decision making and support available to individuals considering and undertaking electroconvulsive therapy (ECT): a qualitative, consumer-led study.

BACKGROUND: Electroconvulsive therapy (ECT) is one of the most controversial treatments in psychiatry. This controversy and diverse and often strongly held opinions can make decision making processes around ECT more complex. METHOD: This consumer-led project explored the experiences of individuals who had received ECT in terms of the information they received, their experience of ECT and suggestions for ways that decision making processes and experiences of ECT can be improved. Interviews were conducted by consumer researchers who had also received ECT and transcripts were analysed using constant comparative techniques. RESULTS: Seventeen individuals participated. Four overarching categories were identified from participant interviews: Information matters; Preparation and decisions before ECT; Experience of ECT; and Suggestions for improvement. Most participants suggested that more information was required and that this information should be made available more regularly to support decision making. Additional suggestions included greater involvement of family and friends (including having a family member or friend present during the ECT procedure), opportunities to gain information from individuals who had received ECT and more support for managing memory and cognitive side effects. CONCLUSION: This study provides valuable consumer-provided insights and recommendations for psychiatrists and mental health clinicians working within ECT clinics and with consumers considering or preparing for ECT.

Statin use and risk of multiple myeloma: An analysis from the cancer research network.

Animal and human data suggest statins may be protective against developing multiple myeloma; however, findings may be biased by the interrelationship with lipid levels. We investigated the association between statin use and risk of multiple myeloma in a large US population, with an emphasis on accounting for this potential bias. We conducted a case-control study nested within 6 US integrated healthcare systems participating in the National Cancer Institute-funded Cancer Research Network. Adults aged ≥40 years who were diagnosed with multiple myeloma from 1998-2008 were identified through cancer registries (N = 2,532). For each case, five controls were matched on age, sex, health plan, and membership duration prior to diagnosis/index date. Statin prescriptions were ascertained from electronic pharmacy records. To address potential biases related to lipid levels and medication prescribing practices, multivariable marginal structural models were used to model statin use (≥6 cumulative months) and risk of multiple myeloma, with examination of multiple latency periods. Statin use 48-72 months prior to diagnosis/index date was associated with a suggestive 20-28% reduced risk of developing multiple myeloma, compared to non-users. Recent initiation of statins was not associated with myeloma risk (risk ratio range 0.90-0.99 with 0-36 months latency). Older patients had more consistent protective associations across all latency periods (risk ratio range 0.67-0.87). Our results suggest that the association between statin use and multiple myeloma risk may vary by exposure window and age. Future research is warranted to investigate the timing of statin use in relation to myeloma diagnosis.

Assessing differences in inhaled corticosteroid response by self-reported race-ethnicity and genetic ancestry among asthmatic subjects.

BACKGROUND: Inhaled corticosteroids (ICSs) are the preferred treatment for achieving asthma control. However, little is known regarding the factors contributing to treatment response and whether treatment response differs by population group. OBJECTIVE: We sought to assess behavioral, sociodemographic, and genetic factors related to ICS response among African American and European American subjects with asthma. METHODS: Study participants were part of the Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-ethnicity (SAPPHIRE). The analytic sample included asthmatic subjects aged 12 to 56 years with greater than 12% bronchodilator reversibility and percent predicted FEV1 of between 40% and 90%. Participants received 6 weeks of inhaled beclomethasone dipropionate. The primary measure of ICS response was a change in Asthma Control Test (ACT) score; the secondary measure was a change in prebronchodilator FEV1. Adherence was measured with electronic monitors. Genetic ancestry was estimated for African American participants by using genome-wide genotype data. RESULTS: There were 339 study participants; 242 self-identified as African American and 97 as European American. Baseline ACT score, percent predicted FEV1, degree of bronchodilator response, and ICS adherence were significantly associated with ICS response. A baseline ACT score of 19 or less was useful in identifying those who would respond, as evidenced by the significant dose-response relationship with ICS adherence. Neither self-reported race-ethnicity among all participants nor proportion of African ancestry among African American participants was associated with ICS responsiveness. CONCLUSIONS: Our findings suggest that baseline lung function measures and self-reported asthma control predict ICS response, whereas self-reported race-ethnicity and genetic ancestry do not.

Association of antidiabetic medications targeting the glucagon-like peptide 1 pathway and heart failure events in patients with diabetes.

BACKGROUND: Glucagon-like peptide-1 (GLP-1) agonists and dipeptidyl peptidase 4 (DPP-4) inhibitors (GLP-1 agents) may be protective in heart failure (HF). We set out to determine whether GLP-1 agent use is associated with HF risk in diabetics. METHODS AND RESULTS: In this retrospective cohort study of members of a large health system, we identified >19,000 adult diabetics from January 1, 2000, to July 1, 2012. GLP-1 agent users were matched 1:2 to control subjects with the use of propensity matching based on age, race, sex, coronary disease, HF, diabetes duration, and number of antidiabetic medications. The association of GLP-1 agents with time to HF hospitalization was tested with multivariable Cox regression. All-cause hospitalization and mortality were secondary end points. We identified 1,426 users of GLP-1 agents and 2,798 control subjects. Both were similar except for angiotensin-converting enzyme inhibitors/angiotensin receptor blocker use, number of antidiabetic medications, and age. There were 199 hospitalizations, of which 128 were for HF, and 114 deaths. GLP-1 agents were associated with reduced risk of HF hospitalization (adjusted hazard ratio [aHR] 0.51, 95% confidence interval [CI] 0.34-0.77; P = .002), all-cause hospitalization (aHR 0.54, 95% CI 0.38-0.74; P = .001), and death (aHR 0.31, 95% CI 0.18-0.53; P = .001). CONCLUSIONS: GLP-1 agents may reduce the risk of HF events in diabetics.

Incidence of liver injury among cancer patients receiving chemotherapy in an integrated health system.

PURPOSE: Using liver laboratory tests (LLTs), Hy's law is a method used to identify drug-induced liver injury (DILI), after excluding other causes. Elevated LLTs in chemotherapy-exposed patients may result from tumor effects or comorbidities. This study evaluated incidence of Hy's law in chemotherapy-treated cancer patients. METHODS: We identified breast, colorectal, and lung cancer patients diagnosed in 1 January 2000 to 31 December 2007 at a Midwestern health system. Using automated data, potential Hy's law (PHL) cases were defined by patterns of elevated LLTs suggestive of DILI. Among those treated with chemotherapy, we excluded PHL patients with pre-existing conditions that could cause liver injury, producing a cohort meeting Hy's law criteria, according to automated data. Medical record review, conducted among these automated data-derived Hy's law patients, further excluded those with causes of liver injury other than chemotherapy. RESULTS: Using automated data, among chemotherapy-exposed patients (N = 2788), 91 (3.3%) met PHL criteria using LLTs and 64 (2.3%) met Hy's law after excluding underlying liver injury using the International Classification of Diseases, 9th Revision codes. After a medical record review, 62 of 64 patients qualifying as Hy's law through automated data had other potential causes, leaving two patients (0.07%; 95%CI: 0.01-0.24%) with chemotherapy as a likely alternative cause of liver injury. CONCLUSIONS: Abnormal LLTs are common in chemotherapy-treated patients. Medical record review showed that the incidence of Hy's law events is rare. These data provide context for evaluating DILI in clinical trials and postmarketing surveillance of anticancer therapies, understanding that automated data alone may substantially overestimate the number of Hy's law cases.

Nocturnal asthma and the importance of race/ethnicity and genetic ancestry.

RATIONALE: Nocturnal asthma is a common presentation and is associated with a more severe form of the disease. However, there are few epidemiologic studies of nocturnal asthma, particularly in minority populations. OBJECTIVES: To identify factors associated with nocturnal asthma, including the contribution of self-identified race/ethnicity and genetic ancestry. METHODS: The analysis included individuals from the Study for Asthma Phenotypes and Pharmacogenomic Interactions by Race-ethnicity (SAPPHIRE) cohort. Nocturnal asthma symptoms were assessed by questionnaire. Genome-wide genotype data were used to estimate genetic ancestry in a subset of African American participants. Logistic regression was used evaluate the association of various factors with nocturnal asthma, such as self-identified race/ethnicity and genetic ancestry. MEASUREMENT AND MAIN RESULTS: The study comprised 3,380 African American and 1,818 European Americans individuals with asthma. After adjusting for other potential explanatory variables, including controller medication use, African Americans were more than twice as likely (odds ratio, 2.56; 95% confidence interval, 2.24-2.93) to report nocturnal asthma when compared with European American individuals. Among the subset of African American participants with genome-wide genotype data (n = 1,040), estimated proportion of African ancestry was also associated with an increased risk of nocturnal asthma (P = 0.007). Differences in lung function explained a small, but statistically significant (P = 0.02), proportion of the relationship between genetic ancestry and nocturnal asthma symptoms. CONCLUSIONS: Both self-identified race/ethnicity and African ancestry appear to be independent predictors of nocturnal asthma. The mechanism by which genetic ancestry contributes to population-level differences in nocturnal asthma appears to be largely independent of lung function.

Counselor-Level Predictors of Sustained Use of an Indicated Preventive Intervention for Aggressive Children.

Despite widespread concern about the frequent failure of trained prevention staff to continue to use evidence-based programs following periods of intensive training, little research has addressed the characteristics and experiences of counselors that might predict their sustained use of a program. The current study follows a sample of school counselors who were trained to use an indicated preventive intervention, the Coping Power program, in an earlier dissemination study, and determines their levels of continued use of the program's child and parent components in the 2 years following the counselors' intensive training in the program. Counselor characteristics and experiences were also examined as predictors of their sustained use of the program components. The Coping Power program addresses children's emotional regulation, social cognitive processes, and increases in positive interpersonal behaviors with at-risk children who have been screened to have moderate to high levels of aggressive behavior. The results indicated that counselors' perceptions of interpersonal support from teachers within their schools, their perceptions of the effectiveness of the program, and their expectations for using the program were all predictive of program use over the following 2 years. In addition, certain counselor personality characteristics (i.e., conscientiousness) and the level of actual teacher-rated behavior change experienced by the children they worked with during training were predictors of counselors' use of the program during the second year after training. These results indicate the central importance of teacher support and of child progress during training in the prediction of counselors' sustained use of a prevention program.

A school-based post-Katrina therapeutic intervention.

The current study presents the implementation of a set of school based interventions in a greater New Orleans school district one year following Hurricane Katrina. The interventions included adaptation and implementation of evidence based treatments in a crisis situation with at-risk youth which involved training and clinical challenges. 386 students found to have significant depressive and/or disruptive disorder symptoms received treatment from the School Therapeutic Enhancement Program (STEP). Further, a district-wide mental health needs assessment of middle and high school students (N = 11,861) screened for behavioral and emotional difficulties at the beginning and end of the school year provided a benchmark for community youth's emotional and behavioral distress. High-need intervention students demonstrated clinically significant lower levels of emotional and behavioral problems, depression and inattention in comparison to pre-treatment levels as indicated by multiple informants (i.e., self, parent, teacher). Self-reported distress levels were also lower than screening group students at post-test. These findings support the efficacy of a school-based intervention for youth struggling with the aftereffects of a highly disruptive natural disaster. Implications for utilizing a flexible adaptation of an evidence-based training model involving coaching and consultation are discussed.

Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach.

In May 2013, GlaxoSmithKline (980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) established a new online system to enable scientific researchers to request access to anonymised patient level clinical trial data. Providing access to individual patient data collected in clinical trials enables conduct of further research that may help advance medical science or improve patient care. In turn, this helps ensure that the data provided by research participants are used to maximum effect in the creation of new knowledge and understanding. However, when providing access to individual patient data, maintaining the privacy and confidentiality of research participants is critical. This article describes the approach we have taken to prepare data for sharing with other researchers in a way that minimises risk with respect to the privacy and confidentiality of research participants, ensures compliance with current data privacy legal requirements and yet retains utility of the anonymised datasets for research purposes. We recognise that there are different possible approaches and that broad consensus is needed.

Comparison of ß-blocker effectiveness in heart failure patients with preserved ejection fraction versus those with reduced ejection fraction.

BACKGROUND: The aim of this study was to compare the benefit of beta-blockers (BB) in heart failure (HF) with preserved versus reduced ejection fraction (EF). METHODS AND RESULTS: This was a retrospective study of insured patients who were hospitalized for HF from January 2000 to June 2008. Pharmacy claims were used to estimate BB exposure over 6-month rolling windows. The association between BB exposure and all-cause hospitalization or death was tested with the use of time-updated proportional hazards regression, with adjustment for baseline covariates and other HF medication exposure. The groups were compared by stratification (EF <50% vs ≥50%) and with the use of an EF-group × BB exposure interaction term. A total of 1,835 patients met the inclusion criteria, 741 (40%) with a preserved EF. Median follow-up was 2.1 years. In a fully adjusted multivariable model, BB exposure was associated with a decreased risk of death or hospitalization in both groups (EF <50%: hazard ratio [HR] 0.53 [P < .0001]; EF ≥50%: HR 0.68 [P = .009]). There was no significant difference in this protective association between groups (interaction: P = .32). CONCLUSIONS: BB exposure was associated with a similar protective effect regarding time to death or hospitalization in HF patients regardless of whether EF was preserved or reduced. An adequately powered randomized trial of BB in HF with preserved EF is warranted.