Health Services Research Studies Research Articles

Social networks in health care teams: evidence from the United States

Purpose The purpose of this paper is to synthesize existing evidence regarding health care team networks, including their formation and association with outcomes in various health care settings. Design/methodology/approach Network theory informed this review. A literature search was conducted in major databases for studies that used social network analysis methods to study health care teams in the USA between 2000 and 2014. Retrieved studies were reviewed against inclusion and exclusion criteria. Findings Overall, 25 studies were included in this review. Results demonstrated that health care team members form professional (e.g. consultation) and personal (e.g. friendship) networks. Network formation can be influenced by team member characteristics (i.e. demographics and professional affiliations) as well as by contextual factors (i.e. providers sharing patient populations and physical proximity to colleagues). These networks can affect team member practice such as adoption of a new medication. Network structures can also impact patient and organizational outcomes, including occurrence of adverse events and deficiencies in health care delivery. Practical implications Administrators and policy makers can use knowledge of health care networks to leverage relational structures in teams and tailor interventions that facilitate information exchange, promote collaboration, increase diffusion of evidence-based practices, and potentially improve individual and team performance as well as patient care and outcomes. Originality/value Most health services research studies have investigated health care team composition and functioning using traditional social science methodologies, which fail to capture relational structures within teams. Thus, this review is original in terms of focusing on dynamic relationships among team members.

Modeling zero-modified count and semicontinuous data in health services research Part 1: background and overview.

Health services data often contain a high proportion of zeros. In studies examining patient hospitalization rates, for instance, many patients will have no hospitalizations, resulting in a count of zero. When the number of zeros is greater or less than expected under a standard count model, the data are said to be zero modified relative to the standard model. A similar phenomenon arises with semicontinuous data, which are characterized by a spike at zero followed by a continuous distribution with positive support. When analyzing zero-modified count and semicontinuous data, flexible mixture distributions are often needed to accommodate both the excess zeros and the typically skewed distribution of nonzero values. Various models have been introduced over the past three decades to accommodate such data, including hurdle models, zero-inflated models, and two-part semicontinuous models. This tutorial describes recent modeling strategies for zero-modified count and semicontinuous data and highlights their role in health services research studies. Part 1 of the tutorial, presented here, provides a general overview of the topic. Part 2, appearing as a companion piece in this issue of Statistics in Medicine, discusses three case studies illustrating applications of the methods to health services research. Copyright © 2016 John Wiley & Sons, Ltd.

Reflexivity and the "Acting Subject": Conceptualizing the Unit of Analysis in Qualitative Health Research.

The ways in which social scientists conceptualize the "reflexive" human subject have important consequences for how we go about our research. Whether and how we understand human subjects to be the authors of our own actions helps to structure what we say about health, health care, and the many other topics addressed in qualitative health research. In this article, I critically discuss assumptions of human reflexivity that are built into qualitative social science of health and medicine. I describe three alternative ways of understanding reflexive thought and human action derived from the theoretical works of Pierre Bourdieu, Bruno Latour, and George Lakoff and Mark Johnson, respectively. I then apply these three different ways of thinking about reflexivity and the acting subject to the analysis of an excerpt of participant observation data from a health services research study of transitions from hospital to home, illuminating the different kinds of analyses that arise from each perspective. I conclude with a call for social scientists to commit to the search for better ways of understanding the human subject, resisting the temptation to "settle" on theoretical statements that close down the path to more sophisticated conceptualizations of human thought and action.

Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project.

BackgroundColorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients.MethodsDesign: a prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention.Statistical analysis: In relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models.DiscussionThe identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this large cohort of patients may provide useful information to answer different health services research questions.Trial registrationClinicalTrials.gov Identifier: NCT02488161. Registration date: June 16, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-016-2475-y) contains supplementary material, which is available to authorized users.

The Kaiser Permanente Northern California Adult Member Health Survey.

The Kaiser Permanente Northern California (KPNC) Member Health Survey (MHS) is used to describe sociodemographic and health-related characteristics of the adult membership of this large, integrated health care delivery system to monitor trends over time, identify health disparities, and conduct research. To provide an overview of the KPNC MHS and share findings that illustrate how survey statistics and data have been and can be used for research and programmatic purposes. The MHS is a large-scale, institutional review board-approved survey of English-speaking KPNC adult members. The confidential survey has been conducted by mail triennially starting in 1993 with independent age-sex and geographically stratified random samples, with an option for online completion starting in 2005. The full survey sample and survey data are linkable at the individual level to Health Plan and geocoded data. Respondents are assigned weighting factors for their survey year and additional weighting factors for analysis of pooled survey data. Statistics from the 1999, 2002, 2005, 2008, and 2011 surveys show trends in sociodemographic and health-related characteristics and access to the Internet and e-mail for the adult membership aged 25 to 79 years and for 6 age-sex subgroups. Pooled data from the 2008 and 2011 surveys show many significant differences in these characteristics across the 5 largest race/ethnic groups in KPNC (non-Hispanic whites, blacks, Latinos, Filipinos, and Chinese). The KPNC MHS has yielded unique insights and provides an opportunity for researchers and public health organizations outside of KPNC to leverage our survey-generated statistics and collaborate on epidemiologic and health services research studies.

Qualitative Research in Health Services Research - Discussion Paper, Part 3: Quality of Qualitative Research

The third and final discussion paper of the German Network of Health Services Research's (DNVF) "Qualitative Methods Working Group" demonstrates methods for the evaluation and quality of qualitative research in health services research. In this paper we discuss approaches described in evaluating qualitative studies, including: an orientation to the general principles of empirical research, an approach-specific course of action, as well as procedures based on the research-process and criteria-oriented approaches. Divided into general and specific aspects to be considered in a qualitative study quality evaluation, the central focus of the discussion paper undertakes an extensive examination of the process and criteria-oriented approaches. The general aspects include the participation of relevant groups in the research process as well as ethical aspects of the research and data protection issues. The more specific aspects in evaluating the quality of qualitative research include considerations about the research interest, research questions, and the selection of data collection methods and types of analyses. The formulated questions are intended to guide reviewers and researchers to evaluate and to develop qualitative research projects appropriately. The intention of this discussion paper is to ensure a transparent research culture, and to reflect on and discuss the methodological and research approach of qualitative studies in health services research. With this paper we aim to initiate a discussion on high quality evaluation of qualitative health services research.

Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study

Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed.

Patient and public involvement in data collection for health services research: a descriptive study.

Plain English summaryThere is a consensus that patients and the public should be involved in research in a meaningful way. To date, lay people have been mostly involved in developing research ideas and commenting on patient information but not as much in actual data collection.We have had firsthand experience with lay people helping to conduct a study on how patients in hospital are involved with their medicines. In the first part of this study, we observed doctors’ ward rounds, pharmacists’ ward visits and nurses’ drug administration rounds, to find out if and how healthcare professionals interacted with patients about their medicines. Lay people conducted some of these observations. We wanted to explore the benefits and challenges of having lay people conduct these observations, to tell us more about how lay people can be involved in conducting such research.We interviewed the lay members and researchers involved in this research to find out their views. We also looked at the observation notes to identify what the lay people had noticed that the researchers had not.The lay members and researchers reported that lay members added value to the study by bringing new perspectives. Lay people had noticed some different things to the researchers. We experienced some challenges which need to be addressed. These weregetting the lay observers registered with the hospitals to allow them to be on the wards in this capacitylay observers and researchers having different understanding of research procedures such as patient consenttrying to find lay observers of different backgrounds and ethnic groupsBackground: It is recognised that involving lay people with research in a meaningful rather than tokenistic way is both important and challenging. In a recent health services research study addressing inpatient involvement in medication safety, we sought to overcome this challenge by including lay people in collecting observational data in the hospital setting. The aim of this study was to evaluate lay and researcher perspectives on lay involvement in data collection in order to inform and enhance the future role of lay people in carrying out health services research.Methods: We conducted semi-structured interviews with the lay members who collected observational data in our wider study and the researchers who provided support and/or were involved in their recruitment and training. The interviews were transcribed verbatim and coded using open thematic analysis. In addition, we conducted secondary analysis of the observational data to identify the specific contributions of lay observers.Results: We interviewed the three lay members and the four researchers involved. Both these interviews and the secondary data analysis demonstrated that the lay members added value to the study by bringing additional general perspectives on communication with hospital inpatients.Combined with researchers’ perspectives on interactions more specifically related to medication, this provided a broader answer to our research question of how healthcare professionals facilitate inpatient understanding of their medication and involvement in medication safety. This contrasted to the involvement lay observers reported having in previous research where their role had been more consultative. The lay members all reported that carrying out the observations had been an interesting and informative experience.Some challenges arose including the infrastructure not having been in place to support this specialist lay research role, differing paradigms of research governance held by the public and researchers in relation to consent procedures and difficulties in recruiting a diverse range of members of the public to carry out the role.Conclusions: Lay members can add value to research by being involved in data collection within health services research. There is a need to build infrastructure to better support this involvement.

Journalists, district attorneys and researchers: why IRBs should get in the middle.

BackgroundFederal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public.DiscussionUsing two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public’s interest in transparency, the researcher’s interest in their science, and the research participants’ interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis.SummaryFor health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.

Project INTEGRATE - a common methodological approach to understand integrated health care in Europe.

The use of case studies in health services research has proven to be an excellent methodology for gaining in-depth understanding of the organisation and delivery of health care. This is particularly relevant when looking at the complexity of integrated healthcare programmes, where multifaceted interactions occur at the different levels of care and often without a clear link between the interventions (new and/or existing) and their impact on outcomes (in terms of patients health, both patient and professional satisfaction and cost-effectiveness). Still, integrated care is seen as a core strategy in the sustainability of health and care provision in most societies in Europe and beyond. More specifically, at present, there is neither clear evidence on transferable factors of integrated care success nor a method for determining how to establish these specific success factors. The drawback of case methodology in this case, however, is that the in-depth results or lessons generated are usually highly context-specific and thus brings the challenge of transferability of findings to other settings, as different health care systems and different indications are often not comparable. Project INTEGRATE, a European Commission-funded project, has been designed to overcome these problems; it looks into four chronic conditions in different European settings, under a common methodology framework (taking a mixed-methods approach) to try to overcome the issue of context specificity and limited transferability. The common methodological framework described in this paper seeks to bring together the different case study findings in a way that key lessons may be derived and transferred between countries, contexts and patient-groups, where integrated care is delivered in order to provide insight into generalisability and build on existing evidence in this field. To compare the different integrated care experiences, a mixed-methods approach has been adopted with the creation of a common methodological framework (including data collection tools and case study template report) to be used by the case studies for their analyses. The four case studies attempt to compare health care services before and after the 'integration' of care, while triangulating the findings using quantitative and qualitative data, and provide an in-depth description of the organisation and delivery of care, and the impact on outcomes. The common framework aims to allow for the extraction of key transferable learning from the cases, taking into account context-dependency. The application and evaluation of the common methodological approach aim to distill and identify important elements for successful integrated care, in order to strengthen the evidence base for integrated care (by facilitating cross-context comparisons), increase the transferability of findings from highly context-specific to other settings and lead to concrete and practical policy and operational recommendations.

A primer on marginal effects-part II: health services research applications.

Marginal analysis evaluates changes in a regression function associated with a unit change in a relevant variable. The primary statistic of marginal analysis is the marginal effect (ME). The ME facilitates the examination of outcomes for defined patient profiles or individuals while measuring the change in original units (e.g., costs, probabilities). The ME has a long history in economics; however, it is not widely used in health services research despite its flexibility and ability to provide unique insights. This article, the second in a two-part series, discusses practical issues that arise in the estimation and interpretation of the ME for a variety of regression models often used in health services research. Part one provided an overview of prior studies discussing ME followed by derivation of ME formulas for various regression models relevant for health services research studies examining costs and utilization. The current article illustrates the calculation and interpretation of ME in practice and discusses practical issues that arise during the implementation, including: understanding differences between software packages in terms of functionality available for calculating the ME and its confidence interval, interpretation of average marginal effect versus marginal effect at the mean, and the difference between ME and relative effects (e.g., odds ratio). Programming code to calculate ME using SAS, STATA, LIMDEP, and MATLAB are also provided. The illustration, discussion, and application of ME in this two-part series support the conduct of future studies applying the concept of marginal analysis.

A primer on marginal effects--Part I: Theory and formulae.

Marginal analysis evaluates changes in an objective function associated with a unit change in a relevant variable. The primary statistic of marginal analysis is the marginal effect (ME). The ME facilitates the examination of outcomes for defined patient profiles while measuring the change in original units (e.g., costs, probabilities). The ME has a long history in economics; however, it is not widely used in health services research despite its flexibility and ability to provide unique insights. This paper, the first in a two-part series, introduces and illustrates the calculation of the ME for a variety of regression models often used in health services research. Part One includes a review of prior studies discussing MEs, followed by derivation of ME formulas for various regression models including linear, logistic, multinomial logit model (MLM), generalized linear model (GLM) for continuous data, GLM for count data, two-part model, sample selection (two-stage) model, and parametric survival model. Prior theoretical papers in health services research reported the derivation and interpretation of ME primarily for the linear and logistic models, with less emphasis on count models, survival models, MLM, two-part models, and sample selection models. These additional models are relevant for health services research studies examining costs and utilization. Part Two of the series will focus on the methods for estimating and interpreting the ME in applied research. The illustration, discussion, and application of ME in this two-part series support the conduct of future studies applying the marginal concept.

Contribution of focus group discussions to Aboriginal Australian health service research

Focus Group Discussions (FGDs) are a common way of gathering qualitative data in Aboriginal health services research; however there have been no studies on the question of whether they are appropriate research tools in such contexts, nor are there are specific guidelines available to ensure that FGDs are delivered to collect data in ways that are consistent with Aboriginal approaches to consultation, ownership and ways of knowing. Furthermore, there is a lack of clarity concerning the theoretical and methodological perspectives that could be operationalised by FGDs to gather data, guide analysis and interpretation in ways that are culturally appropriate, ethically sound and rigorous. We undertook a content analysis of Aboriginal health services research studies using FGDs to determine their use and elements that may provide insight into good practice. A framework is proposed to help guide future FGD research with Aboriginal people.

Mental Health Services Research Training for the Next Generation of Leaders in the Public Health Sector: A Case Study of the UCSF/SFGH Public Psychiatry Fellowship

Community mental health centers serve over 3.5 million adults with severe mental illness annually.1 However, a chronic shortage of well-trained community psychiatrists perpetuates difficulties in providing effective, evidence-based services in community mental health settings.2 To increase the number of community psychiatrists able to implement high quality care, a sustainable clinical leadership training program with a health services research emphasis was created in San Francisco County. The University of California, San Francisco/San Francisco General Hospital (UCSF/SFGH) Public Psychiatry Fellowship is a public-academic partnership between UCSF and San Francisco's Community Behavioral Health Services (CBHS). The UCSF/SFGH Department of Psychiatry has had a long and close relationship with CBHS. The fellowship was initially funded by Mental Health Services Act (MHSA) dollars allocated to San Francisco County. The MHSA, commonly referred to as “the Millionaires Tax,” was passed by statewide referendum in 2004 and places a 1% state surcharge tax on annual incomes of over $1 million.3 Revenue is earmarked by to provide mental health services and new workforce education and development programs to “remedy shortage of qualified individuals to address severe mental illnesses.”3 Being aware of these funds, we developed a business plan estimating that the clinical revenue generated by fellows would generate sufficient dollars to cover the costs. In addition, the fellowship would train psychiatrists interested in working in CBHS clinics, which was important because CBHS frequently had difficulty filling openings. In 2011, CBHS agreed to use a portion of their allocated MHSA money to fund the UCSF/SFGH Public Psychiatry Fellowship for a two year trial period. Funding covers salaries and benefits for two fellows, a portion of two faculty salaries, some research assistant time and administrative costs. In return, fellows work as psychiatrists in CBHS clinics four days a week. The primary fellowship goals include: 1) recruitment of well-trained psychiatrists dedicated to working in community mental health settings; 2) generation of Medicaid revenue sufficient to cover the costs of the program, 3) completion of mental health services research projects addressing CBHS priorities, and 4) placement of fellows in leadership roles in public mental health settings. After the program showed initial success, we have secured continued funding through CBHS and created additional funding arrangements with local community based organizations to support additional fellows. Of the 15 Public Psychiatry Fellowships in the country, our program is unique in having fellows implement and complete a mental health services research study during the fellowship year.4 This research component both improves the capacity to evaluate services provided in community settings, and also addresses many of the goals outlined in the 2006 NIMH report on the future of mental health services research.5 For example, the fellowship focuses on the importance of true public-academic partnerships to bridge science and service, and emphasizes the importance of research that incorporates public health significance, practical utility, and acceptability to participants.5

Abstract W MP108: Accuracy of Diagnoses in Contemporary Medicare Data: REGARDS Study Linked With Medicare Claims

Background: Administrative data such as Medicare data are commonly used for health services research and comparative effectiveness studies. These databases are readily available and a good source of long-term data on healthcare utilization and health outcomes in real-world settings. Outcomes are captured using diagnostic codes, but the evidence on the validity of these codes is scarce in contemporary Medicare data. Methods: We linked the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study data using SSN, date of birth and sex to 2003-2009 Medicare claims. In addition to the events captured by REGARDS phone interviews, medical charts were pursued for Medicare-identified strokes not previously identified in REGRADS. Events were adjudicated by stroke specialists using the retrieved medical charts. Using all the adjudicated strokes as gold standard, we calculated the sensitivity, specificity, PPV and NPV of inpatient stroke algorithms with ICD-9-CM codes [430, 431, 433.x1, 434.x1, 436] in the primary discharge diagnosis. Results: We successfully linked 15,089 REGARDS participants with mean age of 69.3, 52% female and 37% Black. We adjudicated 457 strokes, of which 48 were identified by claims only and not by interviews. The tested algorithms had high specificity (99.8-100%), PPV (88.6-90.5%) and NPV (98.9-99.9%), but low sensitivity (58.6-67.4%) (Table). Conclusions: High specificity and PPV of our algorithms to identify strokes in contemporary Medicare populations support their use in etiological and comparative effectiveness studies. While our inpatient Medicare algorithms identified 12% extra cases of strokes, their usefulness for estimating stroke incidence or related healthcare utilizations is limited by their low sensitivity. Linking cohorts to Medicare data is feasible and should be considered to increase the completeness of follow-up. Further studies are needed to evaluate more sensitive Medicare algorithms.

Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research

BackgroundTo assess healthcare processes during treatment of neovascular age-related macular degeneration (AMD) in patients under real-life conditions and evaluate efficacy of monthly visual acuity (VA) assessment in a pro re nata treatment regime.MethodsA multicentre, prospective, non-interventional study based in Germany included neovascular AMD patients treated with intravitreal ranibizumab. Patients completed a 3-month loading phase with monthly intravitreal injections of 0.5 mg ranibizumab, followed by a 12-month maintenance phase during which investigators documented VA, additional injections, metamorphopsias, routine ophthalmological examinations and adverse events at monthly follow-up visits. Efficacy analysis included change from baseline in best-corrected VA (BCVA) based on descriptive statistics.ResultsA total of 2,232 patients were enrolled throughout Germany and 1,729 patients (mean age 77.8 years, 63.2 % women) comprised the efficacy population with a complete set of data. In the clinical setting recorded in our study, only a minority of patients underwent optical coherence tomography during the maintenance phase (71 of 1,729 patients). Patients received a mean total of 4.5 injections; three injections during upload phase and 1.5 additional injections during maintenance phase. Over half of the patients (51.4 %) did not receive additional injections. Mean decimal BCVA increased during the upload phase, (from LogMAR mean of 0.201 at baseline to 0.219 at Month 4) but displayed a decline over time (0.192 at Month 15).ConclusionRanibizumab treatment in a real-life setting demonstrated efficacy in neovascular AMD patients, as shown by initial gains in BCVA. However, maintenance and improvement of these gains during the maintenance phase in a clinical routine setting remained below those expected compared with MARINA, ANCHOR and CATT trials, most likely due to a low number of retreatments, and the high number of patients with a poor response in regard to improvements of VA who were not investigated in these studies.Trial registration numberThis phase IV non-interventional health services research study was conducted under the Novartis internal registration code, CRFB002ADE10.

The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

Well-designed trials are of paramount importance in improving the delivery of care to patients with kidney disease. However, it remains unknown whether contemporary clinical trials within nephrology are of sufficient quality and quantity to meet this need. Systematic review. Studies registered with ClinicalTrials.gov. Interventional (ie, nonobservational) studies (both randomized and nonrandomized) registered between October 2007 and September 2010 were included for analysis. Studies were reviewed independently by physicians and classified by clinical specialty. Nephrology versus cardiology versus other trials. Select clinical trial characteristics. Of 40,970 trials overall, 1,054 (2.6%) were classified as nephrology. Most nephrology trials were for treatment (75.4%) or prevention (15.7%), with very few diagnostic, screening, or health services research studies. Most nephrology trials were randomized (72.3%). Study designs included 24.9% with a single study group, 64.0% that included parallel groups, and 9.4% that were crossover trials. Nephrology trials, compared with2,264 cardiology trials (5.5% overall), were more likely to be smaller (64.5% vs 48.0% enrolling≤100 patients), phases 1-2 (29.0% vs 19.7%), and unblinded (66.2% vs 53.3%; P<0.05 for all). Nephrology trials also were more likely than cardiology trials to include a drug intervention (72.4% vs 41.9%) and less likely to report having a data monitoring committee (40.3% vs 48.5%; P<0.05 for all). Finally, there were few trials funded by the National Institutes of Health (NIH; 3.3%, nephrology; 4.2%, cardiology). Does not include all trials performed worldwide, and frequent categorization of funding source as university may underestimate NIH support. Critical differences remain between clinical trials in nephrology and other specialties. Improving care for patients with kidney disease will require a concerted effort to increase the scope, quality, and quantity of clinical trials within nephrology.

PC-FACS

PC-FACS

Choroidale Neovaskularisation (CNV) bei pathologischer Myopie (PM): epidemiologische Daten aus einer Versorgungsforschungsstudie bei Ophthalmologen in Deutschland

Pathological myopia (PM) or high myopia is defined as excessive short-sightedness (more than -6 dioptres) caused by a strong dilation of the bulbus oculi, that can induce the development of new and unstable vessel structures [choroidal neovascularisation (CNV)]. Since there are only limited epidemiological data available on PM, this health services research study was conducted. A health services survey with ophthalmologists throughout Germany was undertaken. Physicians were asked to complete a 51-item questionnaire on CNV in PM as well as on its early stages in their daily practice, diagnosis, control and treatment, patient numbers and evaluation of health care situation. Statistical analyses were entirely descriptive. Of 7,500 ophthalmologists, a representative sample of 800 was randomly selected; 340 physicians took part. The mean prevalence rates/year/practice were 1,765.5 ± 1,218.1 with myopia, 230.7 ± 278.6 patients with high myopia, subdivided into 129.3 ± 242.8 patients with PM without macular degeneration (MD), 39.6 ± 64.8 patients with PM and MD, and 13.3 ± 30.3 patients with PM and CNV. Data on diagnosis and control show a lack of clearly defined standardisation. With regard to treatment of CNV in PM the data show the current discrepancy of guideline recommendations and approved treatment options. The prevalence and incidence data collected in this study vary considerably between physicians. This may be explained by the various grades of specialisation as well as to possibly existing uncertainties regarding the definition and nomenclature of PM/high myopia and their different stages of the disease that should be harmonised. A generally accepted definition of severity grades, recommendations on diagnosis as well as detailed information and continuous training programmes on this disease is necessary.

Willingness-to-pay and patient-defined benefits in the treatment of hyperhidrosis: results from the first German health services research study in hyperhidrosis

Willingness-to-pay and patient-defined benefits in the treatment of hyperhidrosis: results from the first German health services research study in hyperhidrosis