Health care workers, such as nurses, nursing aides, orderlies, and attendants, who manually move patients, are consistently listed in the top professions for musculoskeletal injuries (MSIs) by the Bureau of Labor Statistics. These MSIs are typically caused by high-risk patient caregiving activities. In 2008, a safe patient handling (SPH) program was implemented in all 153 Veterans Administration Medical Centers (VAMCs) throughout the United States to reduce patient handling injuries.The goal of the present study is to evaluate the effects associated with the national implementation of a comprehensive SPH program. The primary objectives of the research were to determine the effectiveness of the SPH program in improving direct care nursing outcomes and to provide a context for understanding variations in program results across sites over time. Secondary objectives of the present research were to evaluate the effectiveness of the program in reducing direct and indirect costs associated with patient handling, to explore the potential mediating and moderating mechanisms, and to identify unintended consequences of implementing the program.This 3-year longitudinal study used mixed methods of data collection at 6- to 9-month intervals. The analyses will include data from surveys, administrative databases, individual and focus group interviews, and nonparticipant observations. For this study, a 3-tiered measurement plan was used. For Tier 1, the unit of analysis was the facility, the data source was the facility coordinator or administrative data, and all 153 VAMCs participated. For Tier 2, frontline caregivers and program peer leaders at 17 facilities each completed different surveys. For Tier 3, six facilities completed qualitative site visits, which included individual interviews, focus groups, and nonparticipant observations. Multiple regression models were proposed to test the effects of SPH components on nursing outcomes related to patient handling. Content analysis and constant comparative analysis were proposed for qualitative data analysis to understand the context of implementation and to triangulate quantitative data.All three tiers of data for this study have been collected. We are now in the analyses and writing phase of the project, with the possibility for extraction of additional administrative data. The focus of this paper is to describe the SPH program, its evaluation study design, and its data collection procedures. This study evaluates the effects associated with the national implementation of a comprehensive SPH program that was implemented in all 153 VAMCs throughout the United States to reduce patient handling injuries.To our knowledge, this is the largest evaluation of an SPH program in the United States. A major strength of this observational study design is that all VAMCs implemented the program and were included in Tier 1 of the study; therefore, population sampling bias is not a concern. Although the design lacks a comparison group for testing program effects, this longitudinal field study design allows for capturing program dose-response effects within a naturalistic context. Implementation of the VA-wide SPH program afforded the opportunity for rigorous evaluation in a naturalistic context. Findings will guide VA operations for policy and decision making about resources, and will be useful for health care, in general, outside of the VA, in implementation and impact of an SPH program. Health care workers, such as nurses, nursing aides, orderlies, and attendants, who manually move patients, are listed in the top professions for musculoskeletal injuries (MSIs) by the Bureau of Labor Statistics . MSIs arSafe patient handling (SPH) programs consist of the following components: equipment, ergonomic assessment protocols, no-lift policies, and staff training. Recent studies have shown that SPH programs have a positive effect on MSIs -11. In oGiven that the Veterans Health Administration (VHA) employs approximately 77,000 nurses, nursing assistants, health aids and technicians, and trainees , the effThe goal of the research was to assess the processes and outcomes associated with the implementation of a comprehensive SPH program across all 153 VAMCs. The primary objectives of the research were to: (1) determine the effectiveness of the SPH program in improving direct care nursing outcomes  and patient outcomes (injuries associated with patient handling), and (2) provide a context for understanding variations in program results across multiple facilities over time including barriers and facilitators to implementation, local customization of the program, and organizational and individual factors that influenced implementation and program effects. Secondary objectives of the research were to: (1) evaluate the effectiveness of the program in reducing direct and indirect costs associated with patient handling, (2) explore the potential mediating and moderating mechanisms  by which SPH program exerts its effects on outcomes, and (3) identify unintended consequences of implementing the program. All data for this study have been collected. We are now in the analyses and writing phase of the project, with the possibility for extraction of additional administrative data. The intention of this paper is to describe the SPH program, its evaluation study design, and its data collection procedures.Implementation of evidence-based practices is a function of multiple factors including the nature of the evidence, the transmission of knowledge to users, and context of implementation including the health system and organizational factors . TheoretThe SPH program was primarily conceptualized as an evidence-based health care safety program based on ergonomic principles and designed to improve both caregiver and patient outcomes. The key elements of SPH program include: (1) ergonomic risk assessment of each unit or area to evaluate and address conditions that may present injury risks related to patient handling, (2) selection and purchase of safe handling equipment, (3) training and continuing staff SPH competency evaluations, (4) ongoing evaluation and reporting of program outcomes, (5) peer leadership to implement at the unit level, (6) a multidisciplinary facility-level Safe Patient Handling Committee, representing all stakeholders of the program, (7) local policy mandating minimal patient lifting and moving, and (8) a part-time facility coordinator to assume leadership of the program implementation and serve as a bridge among administrators, managers, and caregivers.The selection of indicators for measuring context, knowledge transmission, program, and outcomes was guided by theoretical underpinnings of implementation, and all of these variables were grouped into relational categories in a quantitative conceptual model see . HoweverThis 3-year longitudinal study used mixed methods of data collection at 6- to 9-month intervals: analysis of data from surveys, administrative databases, individual and focus group interviews, and nonparticipant observations. All measures of indicators and data sources are given in For the present study, a 3-tiered evaluation plan was used. For Tier 1, the data sources were facility coordinators and administrative data, and all 153 VAMCs participated. The coordinators at 12 facilities were responsible for 2 VAMCs. Therefore, the maximum number of surveys that could be collected was 141 (92.1%). Ethnography was used as the qualitative methodology of Tier 3. Ethnography is a qualitative research method that is used to engage with others and their practices to better understand their culture . It doesThe Milestone Questionnaire was developed to track each facility’s progress in meeting predetermined quarterly activities of the program. The milestones were developed by the VHA Occupational Health Program Office and covered patient care ergonomics, patient handling equipment, SPH policy, patient assessment forms, algorithms, and peer leader development. For each of 36 milestone items, the respondent could answer any of the following: did not start this task, started this task but did not complete it, or have completed this task. Furthermore, facility coordinators were asked if they had updated a list of 10 key stakeholders groups. They were also asked if they had made progress in developing their facility’s SPH policy which should have included seven core program components.The Program Dose Survey measured the degree of deployment of SPH program elements. The survey was developed by the research team and was composed of the following three sections: (1) percent of program elements deployed, (2) percent handling equipment installed, and (3) adequacy and usage of equipment. Section 1 contained 10 elements including ceiling lifts, policy, competency evaluations, peer leader program, staff involvement in equipment selection, after actions reviews, assessments forms, routine orientation of new clinical staff, marketing program, and bariatric program. For each element, patient care areas  received percent implementation scores. In section 2, percent equipment coverage was recorded for each nursing unit . Finally, for section 3, the facility coordinator was asked to rate the adequacy and usage of the equipment, number of patient handling devices, number of slings, use of devices by caregivers over manual handling, and how the facility was situated to implement the program from completely disagree to completely agree (5 points).The Program Status Report was developed by the investigators to examine human factors associated with implementing the program, and was organized into five sections: (1) facility coordinator demographics, (2) caregiver training, (3) peer leader program, (4) marketing, and (5) program support. Each section contained at least one open-ended question generally related to effectiveness. The last portion of the survey contained open-ended questions about facilitators, barriers, and customization of program implementation.In section 1 of the Program Status Report, the survey collected data on the demographic patterns and turnover of the facility coordinator. All coordinators were asked about the implementation of their position as the facility coordinators . The position development questionnaire included questions about the status of the job description, maintenance of position, role expectations, succession planning, and role orientation. The coordinators were also asked to rate their own effectiveness in implementing the program from extremely effective to extremely ineffective . In section 2, they rated the caregiver training for the five patient areas  with 0, 25, 50, 75, or 100% implemented as anchors. In section 3, the coordinators completed a grid based on the number of peer leaders needed, trained, vacant positions, and the number who had received annual training for each of five patient care areas. Similar to their self-rating, the coordinators also rated peer leaders for two areas: (1) position development and maintenance such as job description, role expectations, succession planning, role orientation, and whether they have selected persons to cover each shift in all care clinical, and (2) overall effectiveness of peer leaders in implementing the program. The marketing section contained two questions about the development of a marketing plan and the implementation of the plan, with 0, 25, 50, 75, or 100% implemented as anchors. In the last section, the coordinators rated the support received from 12 individual persons or groups regarding the program, for example, facility senior leadership and peer leaders, using a 5-point Likert scale from extremely supportive to extremely unsupportive.Injury data and staff demographics were collected from VA Nursing Outcomes database, Nurse Staff Injury database, along with reports on incident records from the Automated Safety Incident Surveillance Tracking . The AutNurses have the highest number of injuries in the VA and make up the greatest percentage (31% as of 2011) of workers in the VA. MSI data extraction was restricted to direct care nursing occupations and the anatomical sites of back, abdomen, and trunk. MSI incidence rate, defined as the number of injuries and/or illnesses per 10,000 full-time nursing occupation employees, is calculated as follows: Incidence rate=(N/EH)×20,000,000. In this formula, N is the number of back, abdomen, or trunk injuries; EH is the total hours worked by nursing employees  during the fiscal year; and 20,000,000 resulted from 10,000 equivalent full-time nursing occupation employees .Bed days of care data was extracted from the National Bed Control System file, which is available from the VHA Support Service Center . This daThe VHA’s 2011 Facility Complexity Model classification is based on seven standardized criteria : (1) volThe Peer Leader Survey was developed by the investigators and distributed to all peer leaders at each of the 17 regions included in Tier 2. The survey contained 28 items organized into following four sections: (1) demographics, (2) perceived support for the program, (3) peer leader job activities, and (4) effectiveness ratings by peer leaders . The nine demographic questions concerned their work, such as employment duration at this hospital, area of specialty, and length of time as a peer leader. The peer leaders rated the support received from individual persons or groups  regarding the program. They were asked to indicate the number of times they had done a specific job activity during the past week, for example, demonstrating the use of patient handling equipment or dealing with a problem that arose while operating the lifting device.The staff survey was developed by the investigators to capture information on: (1) demographics, (2) culture of safety, (3) job satisfaction, and (4) personal injury severity. The same demographic questions used in the Peer Leader Survey were repeated in the staff survey also. Two of the eight components of the Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture  were useThe Stamps and Piedmont Index of Work Satisfaction Instrument was used to measure job satisfaction for nurses . With peTo capture information on staff injury incident related to patient handling in the past 6 months, 12 questions were asked. Follow-up questions included: where they received treatment for the injury, what type of treatment they received, how many treatment visits were needed, how the treatment was paid for, how many days in total were taken off, and how many days the staff person worked on a restricted or modified duty basis. These questions were previously created for a prior study on the VA SPH program .Data was collected through site visits, which included individual interviews, focus groups, observations, and taking photographs. Data collection tools for this tier included: (1) previsit clinical coordinator phone call script, (2) interview guide , and (3) unit observation walk-around checklist.The previsit clinical coordinator phone call script was used to (1) collect data on the SPH policy of the facility, (2) identify key informants and others for interviews during the site visit, and (3) identify a unit that was doing well with implementing SPH and a unit that was struggling to implement SPH. During the call, coordinators were told to recruit key informants for the site visits, from the safety committee chair, industrial hygienist, occupational medicine physician, engineering service chief, peer leaders, the nurse executive, and nurse mangers. Altogether, they were asked to recruit 27-34 individuals for each site visit. A list of potential candidates was emailed to the facility coordinator. The interview guide for individuals and focus groups contained a general overview of procedures, ground rules, and confidentiality. Interview questions asked about roles in the program, what was working well and not, barriers and facilitators to program implementation, strategies to overcome barriers or customize the program, and surprises in implementation, sustainability, and support. Peer leaders, facility coordinators, managers, and administrators were further prompted to explain their roles and reasons for choosing those roles. Prompts and storytelling techniques were used to stimulate the discussion. For example, staff members were asked to describe a recent interaction with another staff member regarding the program.The unit walk-around checklist included general questions for staff about their perceptions of the SPH program and targeted questions on the number of beds, number of ceiling lifts, method of equipment handling, training received, sling storage, equipment maintenance, and comfort in using equipment. Open-ended questions addressed the availability of equipment, supervisory support, protocols on the unit, and who would they go to for help regarding SPH and when.Data collection for Tier 1 included extractions from several VA extant databases including Veterans Affairs Nursing Outcomes database, Automated Safety Incident Surveillance and Tracking System, Bed Cube, and the Human Resources Employee Cube. Data were extracted using ProClarity Microsoft software  and expoThe survey instructions to the facility coordinators explained that the hospital or regional director might want to see responses to the Milestone Questionnaire, but responses to the Program Status and Program Dose questionnaires should not be shared.In Tier 2, the local site investigators sent emails to invite the peer leaders of their facilities asking them to participate in the survey. A separate email invitation was sent to the frontline staff to participate in the staff survey. All recruitment materials and survey instructions stated that the surveys were completely voluntary, that no rewards would be given for participation, and that the surveys would remain anonymous. Participants in both Peer Leader and Staff surveys were offered the options to fill out the survey either online or using paper-and-pencil version of the survey. The same security procedures were followed for either option as described in Tier 1.For Tier 3, we collected data during previsit phone calls with facility coordinators, 1- to 2-day visits to facilities and during post-site visit activities. Using a scripted guide, during previsit phone calls, investigators planned site visits with the facility coordinator, requested SPH policies, and finalized logistics of the site visit. During the site visits, experienced investigators conducted 1-hour-long semistructured interviews with key informants  using the interview guide. During the unit walk-arounds, the facility coordinator or other staff escorted investigators to selected units where they made observations, conducted informal interviews with caregivers, and photographed places and persons to capture activities illustrative of key concepts and local innovations. After the site visit, investigators conducted debriefings to note significant observations, identify preliminary conclusions and gaps in data, and determine if changes in approaches to data collection or in the use of data collection instruments were warranted. Post-site visit activity also included document review of the facility SPH policy.Missing data can be a potential problem in any large-scale longitudinal study, particularly those that rely, in part, on administrative data systems. To minimize missing data in Tier 1, the project manager maintained a database to track incoming data and followed up by phone calls and emails to increase response rates. The milestone survey was an administrative requirement associated with program funding; therefore, high response rate was expected.All survey data were scanned into a database using Teleform . EffortsTo ensure data quality of interviews, experienced focus group facilitators and individual interviewers conducted all interviews. Data collection and analysis ran concurrently in the interviews, that is, feedback was obtained as conclusions were drawn; an assistant recorded notes of discussions during the focus groups; audio tape recordings of interviews were used to ensure no material was missed during analysis; and analysis was conducted by two investigators. The data record of Tier 3 included notes from the pre-site visit interviews and unit walk-around observations, field notes written by site visitors, transcripts of the interviews and focus groups, and photographs taken during the unit observations for all site visits.The study used a prospective cohort of facilities, in observation design with up to five waves of data collection points over time. Because the SPH program was already implemented by all VAMC facilities before the evaluation study was established, there will be no intervention-control groups for testing comparative effects of the SPH program. Therefore, we propose a standard approach to investigating causal effects in designs without a control group. That is, our design can yield strong causal inferences mainly by reducing the plausibility of alternative explanations for the program effects . Given tSummary scores for each program component will be produced as a continuous measure for each facility at each data wave, and dose-response approach to analysis will be used. Where appropriate, the scores from Tier 1 survey data will be calculated as average over time to obtain a single score per facility before they are used as predictors in a model. To investigate our primary outcome , a more specific H2 is: after accounting for contextual factors , higher scores on SPH implementation, strength, and SPH uptake measures will be significantly associated with (1) lower 2011 MSI incidence rates and (2) greater decline of MSI incidence rates over the study period. The more specific H3 can be explained as follows: the effects of contextual factors on MSI incidence rates will be moderated by SPH implementation and SPH uptake. A multiple regression model of 2011 MSI incidence rates with contextual factors as predictors will test H1. For H2a, H2b, and H3, SPH components and contextual factors will be included as predictors, respectively, in (1) a multiple regression model of 2011 MSI incidence rates, (2) a growth curve model of repeated observations of MSI incidence rates over time, and (3) additional testing of two-way interactions between SPH components and contextual factors in the regression models. The models will evaluate the direct effects of the SPH program components on MSI rates, as well as moderation of the effects of contextual factors by program components. The growth model will facilitate a greater understanding of the individual facility differences in change in MSI incidence rates over time. Parallel hypotheses will be similarly tested for handling-related patients’ injuries and costs outcomes.mgcv [R2) in the outcome in the most parsimonious way, that is, variation explained in addition to the proportion already explained by a base model containing only non-SPH program variables.To accommodate both linear and nonlinear relationships in the data, the Generalized Additive Model method available in the R package mgcv  will be mgcv -34. The A two-level latent growth curve model will be specified . The time trends of MSI incidence rates (level 1) will be characterized by estimated growth parameters for individual facilities. Simultaneously, the growth parameters will be modeled as dependent variables that are predicted by facility-level variables (level 2), for example, by contextual factors and SPH component scores. The estimated growth parameters including intercept, linear slope, and quadratic slope will, respectively, approximate initial MSI incidence rate, rate of decline of MSI incidence rate, and acceleration of decline of MSI incidence rate. Only the first two parameters need to be estimated and modeled if prior graphical examination reveals linear trends, or if the estimated quadratic parameter is not statistically significant. Within the structural equation model framework, the contextual factors will be added first to the model as plausible alternative explanatory variables for the growth factors, followed by SPH program components . This will allow SPH components to explain systematic patterns of MSI incidence rates over time across facilities while accounting for alternative sources of variation in these patterns. We will explore two options to incorporate SPH program scores in the growth model. The first option will use each program component score averaged over time per facility as a static (time-invariant) predictor variable. The second option will apply the repeated assessment scores of each component as a dynamic (time-varying) predictor variable having different values at different time points. To investigate the meditational process of SPH program effects, we will test a number of specific H4: for example, higher levels of Peer Leader effectiveness (predictor) will lead to increased use of equipment (mediator), which will cause reduction in MSI incidence rate (outcome); and the proportion of the total effects of predictor on outcome that is mediated can also be determined using a single mediator model . The groSince individual facilities but not persons can be linked across the four assessment occasions at Tier 2, two approaches can be adopted to analyze both Staff and Peer Leader surveys: (1) choosing a single time point , and (2) analyzing change over time using data aggregated at the facility level (N=17 facilities). Consistent with our global H2, here we hypothesize that after accounting for contextual factors, higher scores on SPH implementation strength and/or SPH uptake measures will be significantly associated with (1) higher staff job satisfaction and (2) steeper positive trend in staff job satisfaction over the study period. In keeping with H3, we also hypothesize that contextual factors  will be significantly associated with SPH program implementation strength .In the first approach, a multilevel analysis will be appropriate given the nested structure of the data . Therefore, to test a variable-specific H2(a), a two-level regression model will be used to examine Feb 2011 staff job satisfaction  as a function of predictors both at the individual level  and at the facility level . For another specific H2(b), a growth model will test the predictive effects of the scores of SPH program implementation (averaged over time) on the trajectory of staff job satisfaction as described by growth parameters including intercept  and linear slope (rate of change), while adjusting for other covariates. To test hypothesis H3, a regression model of program implementation strength  will be fitted to include contextual factor (culture of safety) aggregated at facility level as a predictor. All modeling will be performed in Mplus .In the qualitative tier, all electronic interview and focus group files, field notes, documents, and photographs were transcribed verbatim or scanned and stored on a secure VA server with access only by the research team. All files were loaded into the qualitative computer analysis software program ATLAS.ti to systematically develop a code book that catalogued and organized defined codes. Qualitative data were analyzed using a content analysis approach that used memos, process mapping, and diagramming to describe, categorize, and connect the data to determine common themes. For this purpose, analysts (1) assigned first level codes to units of meaning, (2) synthesized codes into complex categories, (3) compared and contrasted the categories to identify relationships across categories, (4) grouped categories into a taxonomic structure that described the data set, and (5) linked representative sections of text to the categories to identify salient quotes that illustrated the codes and constructs and that supported the coding decisions. Multiple sites, interviews, focus groups, and observations allowed for methodological triangulation, thereby increasing likelihood of credible findings.Logistically, Drs. Besterman-Dahan and Elnitsky led the qualitative data analysis and Dr. Powell-Cope provided consultation as needed. In later stages of the project, additional analysts joined the qualitative team. Initially, the team members compared and contrasted perceptions of key findings following interviews, focus groups and observations at individual sites. The analysis strategy of the project was as follows: (1) data analysts reviewed the first few transcripts and developed codes independently, (2) they reviewed their work together and through consensus agreed on codes and definitions, (3) they continued to double code transcripts making memos and including field notes where relevant, and (4) after 90% agreement was attained, they coded transcripts independently using the common codebook. Every fifth coded transcript they met to review randomly selected portions for agreement, and discrepancies were discussed and decisions were made jointly to determine whether new codes were needed. Data analysts met regularly to review ongoing coding results and resolve coding issues.Approval for the study was obtained by the VA Research and Development Committees and the associated Institutional Review Boards at the evaluation center facility and all facilities participating in Tiers 2 and 3. Approval for Tier 1 data collection, with a waiver of informed consent was sought and granted from the Department of Research and Development, James A Haley Veterans Hospital and from the Institutional Review Board, University of South Florida, in Tampa Florida. For Tiers 2 and 3 data collection, permission from each site respective VA Research and Development Department and Institutional Review Board were sought and obtained. To maintain anonymity, we received waivers of written informed consent for Tier 2 Peer Leader and Staff surveys. We obtained written informed consent for all interviews conducted and all photography of persons in Tier 3.All three tiers of data for this study have been collected. We are now in the analyses and writing phase of the project, with the possibility for extraction of additional administrative data. This study evaluates the effects associated with the national implementation of a comprehensive SPH program that was implemented nationally in all 153 VAMCs to reduce patient handling injuries.To our knowledge, this is the largest evaluation of an SPH program in the United States. The direct cost of treating an average back injury case is US $19,000, with serious cases involving surgery costing as much as US $85,000 . The larHowever, there are some potential limitations in this study. The lack of experimental groups for comparison is a limitation of the present design, particularly at Tiers 1 and 2. Another major concern is that the potential SPH program effects may be compounded with cohort effects (changes and variations occurring irrespective of intervention as the cohort of facilities moves through time). However, these limitations have been partially addressed by the adoption of dose-response approach and do not constitute a serious threat to the study design and inferences based on the results.A major strength of this observational study design is that all existing 153 VAMCs implemented the program and are included in Tier 1. Therefore, population sampling bias in relation to tests of program effects is not a concern. Moreover, unlike the typical experimental and controlled designs, our nonexperimental one-cohort design in which repeated data points capture differential program implementation rates across all VAMC facilities and over time better approximates a “real-world” situation. Although designs without control groups make it difficult to know what would have happened without an intervention, the differential program implementation or intervention exposure rates (across facilities and over time) allow us to tap into some information about what might have happened to facilities had the SPH program not been implemented in terms of degree and timeliness. Also, the longitudinal setting for this study establishes a temporality critical for establishing a cause-and-effect relationship among key variables, while also accounting for competing time effects . To enhance external validity of findings from Tier 2 data, some degree of control was instituted for the sample selection. In this part of the study, 17/21 (81%) regions were represented.In conclusion, VA-wide implementation of the SPH program afforded the opportunity for rigorous evaluation in a naturalistic context. In the process, we are posed to contribute to implementation science in health care by linking program dose and quality to outcomes. Outcomes will be useful for VA operations for policy and resourcing decision making, and to health care outside of the VA in decision making about SPH programming.


IKur) represents a promising therapeutic strategy in the therapy of atrial fibrillation. However, experimental and clinical data on the antiarrhythmic efficacy remain controversial. We tested the hypothesis that antiarrhythmic effects of IKur inhibitors are dependent on kinetic properties of channel blockade. A mathematical description of IKur blockade was introduced into Courtemanche-Ramirez-Nattel models of normal and remodeled atrial electrophysiology. Effects of five model compounds with different kinetic properties were analyzed. Although a reduction of dominant frequencies could be observed in two dimensional tissue simulations for all compounds, a reduction of spiral wave activity could be only be detected in two cases. We found that an increase of the percent area of refractory tissue due to a prolongation of the wavelength seems to be particularly important. By automatic tracking of spiral tip movement we find that increased refractoriness resulted in rotor extinction caused by an increased spiral-tip meandering. We show that antiarrhythmic effects of IKur inhibitors are dependent on kinetic properties of blockade. We find that an increase of the percent area of refractory tissue is the underlying mechanism for an increased spiral-tip meandering, resulting in the extinction of re-entrant circuits.Inhibition of the atrial ultra-rapid delayed rectifier potassium current ( Ikur) is virtually absent in human ventricles but highly expressed in the atria, it has been proposed to be a promising target for atrial-selective antiarrhythmic therapy IKur inhibition affects atrial action potential (AP) configuration and prolongs APD in trabeculae from AF atria IKur current.Atrial fibrillation (AF) is the most common sustained arrhythmia in the elderly and is associated with serious health consequences. In search for novel therapeutic strategies, much effort has been made to identify pharmacological targets for an atrial specific anti-arrhythmic drug therapy IKur inhibition theoretically represents an effective mechanism in AF therapy, clinical data are somewhat conflicting. Olson and co-workers reported a loss-of-function mutation within the Kv1.5 potassium channel, the molecular basis of human IKur, as the cause of a form of familial AF IKur has been associated with both anti- and pro-arrhythmic effects on human atrial cells IKur inhibitors, including time- and voltage-dependence of block as well as simultaneous inhibitory effects on other cardiac ion channels Although selective IKur inhibition on basic electrophysiological tissue properties. A simplified two-dimensional in silico model of cAF was then applied to test the hypothesis that functional reentry and termination of AF is influenced by the kinetic properties of inhibitory compounds. Our results show that antiarrhythmic properties of IKur inhibitors are strongly dependent on the ability to prolong the wavelength thereby reducing the percent area of non-refractory space.Using a mathematical model of chronic atrial fibrillation (cAF) we first analyzed the influence of time- and voltage-dependence of The Courtemanche, Ramirez, Nattel (CRN) model IK1 by 110%, and a decrease of ICa,L and Ito by each 65%. Additionally, the tissue conductivity was reduced by 30% in order to reflect gap junction remodeling.The occurrence and perpetuation of AF can be favored by changes in the electrical, structural and contractile function of the atria, a process termed “atrial remodeling”. Electrical remodeling is commonly promoted by AF itself and is thought to be due to the high rate of atrial activation IKur described by the CRN model is given byKur is the maximum conductance, ua is the activation gating variable, ui is the inactivation gating variable, Vm is the transmembrane voltage, and EK is the Nernst voltage. To simulate the human atrial AP with voltage- and time-dependent block of IKur, the equation was modified according to Tsujimae et al. IKur:Kur was calculated with the following differential equation∞,Kur is the steady state value of yKur and τyKur is the time constant. y∞,Kur describes the voltage dependence of the blockade and is expressed by a Boltzmann function with a half-maximum block voltage of −40 mV and a slope of 5 mVIKur is not inhibited at hyperpolarized voltages whereas at large depolarized voltages 90% of the channels can be blocked. The time dependence of the IKur blockade is described byonset is the time constant for the activation of channel inhibition and τrecovery the time constant for recovery from inhibition. Since different agents seemed to block the channel preferentially in the open state, τonset describes the time constant at large depolarized voltages. In contrast, channels recover from inhibition after repolarization. Therefore, τrecovery describes the time constant at large hyperpolarized voltages. A variation of both parameters results in a different time-dependence of the blockade.The formulation of In order to simulate excitation propagation, the monodomain model was used. It was implemented in the simulation framework acCELLErate APD, ERP, CV and WL restitution were calculated as described in The percentage of refractory tissue was determined by retrieving the value of the h-variable of the sodium current:e at a position P in an infinite homogeneous space can be approximated by:Im is the electrical source current and r the distance from the position P to the current source. This approximation assumes that the electrical conductivity of both the extracellular space, and the medium external to the tissue equals to σ.The extracellular electrical potential ΦThe pseudo-ECG was calculated as the difference between the signals at positions P1 and P2, both situated in the center of the 2D patch 10 mm apart from each other and with a distance of 5 mm from the tissue,IKur inhibition on functional reentry and AF termination using an in silico model of atrial tissue. To create a model of chronic AF, we first integrated the electrophysiological remodeling processes into the cellular model 30, APD70 and APD90) were reduced from 140 ms, 230 ms, and 300 ms in normal atrial cells to 40 ms, 100 ms, and 129 ms in cAF cells, respectively , compounds #1 and #3 additionally elevated the potential of the plateau phase . With decreasing diastolic intervals, the APD exhibited a decrease for cAF control tissue, as well as all of the inhibitory model compounds , the inhibitory model compounds were added one at a time. The effects on the number of spiral waves were again followed over a time period of 30 seconds. Under control conditions, the number of 5 spiral waves persisted over the complete time period . SimilarWavelength prolongation has been shown to reduce rotor frequency by enlarging the reentrant circle Besides being a powerful tool to easily assess the number of spiral waves, our automated detection algorithm also opens up the possibility to automatically track spiral-tip meandering. The spatial arrangement of the spiral waves under control conditions showed a rosette-like pattern with only minor movements of the rotor centers . In thesIKur inhibitors on basic electrophysiological properties as well as fibrillatory activity. Although inhibition of IKur failed to prolong the terminal phase of the AP in normal atrial cells, a marked prolongation could be observed in cAF cells. Similar results were obtained for the ERP in the one-dimensional simulations. As expected for pure potassium channel inhibitors, none of the model compounds resulted in a marked change of the CV. Using two-dimensional simulations of cAF tissue, the effects of the different kinetic properties on fibrillatory activity were analyzed. Under control conditions, a number of five stable spiral waves could be induced. Interestingly, a relevant reduction of the number of rotors could only be observed for two of the inhibitory compounds, both resulting in pronounced spiral-tip meandering. We further provide evidence that the observed anti-arrhythmic effect might be due to a limitation of the non-refractory space.Using a mathematical model of human atrial tissue, we analyzed the impact of time and voltage dependence of Ito and ICa,L to 65% and increasing the maximum conductance of IK1 by 110% 90 reduction from 300 ms to 129 which is concordant with experimental data derived from human atrial tissue Ito, ICa,L and IK1 were altered similarly in the CAF2 case of Pandit's model, they further included a reduction of IKur by 50% IKur in order to better visualize the differential impact of IKur blockade. However, in case of a 50% downregulation of IKur, the control situation would be expected to be identical to compound #5 (tonic blockade) in terms of wavelength prolongation and wavelet count. Any further inhibition of the downregulated current by the test compounds would result in a further wavelength prolongation similar to our observed effects. However, considering the smaller impact of the downregulated IKur on repolarization, differences between the kinetic properties of the test compounds would be less pronounced. A significant difference between the models, however, relates to gap junction remodeling. In order to include AF induced alterations in connexin Cx40 expression, we decided to reduce the conductance of the monodomain equation by 30% In our computational study, we used a modified Courtemanche-Ramirez-Nattel (CRN) model of atrial electrophysiology including electrophysiological remodeling. As reported previously by our group, electrical remodeling was introduced by reducing the maximum conductance of IKur and Ito but not IKr or IKs resulted in rotor termination IKur inhibition IKur inhibitors depend on kinetic properties of inhibition, we introduced the mathematical description of time- and voltage-dependence of block in our in silico model of cAF. Compound #1 represents the fictitious inhibitory profile recommended by Tsujimae et al. IKur inhibitors belonging to the group of diphenyl phosphine oxides (DPO) IKur and Ito blocker AVE0118 dose-dependently terminated persistent AF Data from computational studies provide interesting insights into antiarrhythmic mechanisms of different antiarrhythmic compounds. For example, Kneller and co-workers elegantly showed that pure sodium channel blockade results in AF termination by enlargement of the center of rotation, increased meandering of spiral tips and a reduction in the number of secondary wavelets IKur blockade in in silico models of AF The computational model used in this study represents a simplification of the human situation in terms of 3D tissue geometry, anisotropic fiber arrangement, as well as structural and electrical heterogeneities: The analysis of spiral wave activity was carried out in a small two-dimensional tissue sheet. As a consequence, the influence of myocardial thickness as well as gradients in myocardial thickness could not be addressed. However, it is well recognized that the electrical dissociation between the epicardial layer and the endocardial bundle network increases the stability of AF by enlarging the area available for reentry IKur inhibitors are strongly dependent on kinetic properties of blockade. Especially compounds with slow recovery kinetics result in an effective prolongation of the wavelength thereby increasing the area of refractory space. In these cases chaotic meandering of spiral-tips leads to a reduction of reentrant circuits.Taken together, we provide evidence that antiarrhythmic effects of


In 2008, the Sunshine Coast Division of General Practice (SCDGP) in Queensland, Australia initiated a highly successful Improved Diabetes Management (IDM) program with general practices in a regional area. The IDM program was evaluated against the 10 elements of a high functioning clinical microsystem framework as identified by Nelson et al. (2007) in order to determine key factors contributing to the successful adoption and uptake of the program in participating general practices.The evaluation focussed on in-depth key informant interviews with 10 SCDGP staff and general practitioners (GPs) involved in the IDM program. A thematic analysis was undertaken and common emergent themes were reviewed against the 10 elements of high performing clinical microsystem.While all aspects of the clinical microsystem approach appeared effective in the design, implementation and adoption of the IDM program, several characteristics were crucial. The identification of champions of change in both the division and participating practices, the celebration of positive achievements and the use ‘real data’ from practices to demonstrate improved health outcomes for patients from the practice were instrumental in motivating participating GPs to both implement and sustain changes in their diabetes care delivery.In designing and redesigning health care, the clinical microsystems approach offers a pathway for the effective uptake of innovation in Australian primary health care; a means of integrating structure, process and outcomes of a care framework for reviewing improvements in the health care delivery process and could lead to improvements in patient health outcomes. The Australian Divisions of General Practice aim to guide and support improvements to health care delivery in general practices within a defined geographic area. Currently general practitioners (GPs) screen for and manage the majority of diabetes complications and achieving best practice diabetes care is a goal of many of these organisations. In 2008, the Sunshine Coast Division of General Practice (SCDGP) on the east coast of Queensland, Australia initiated and led an Improved Diabetes Management (IDM) program with 12 general practices. The design and implementation of this innovative program was based on the clinical microsystem approach. This approach focuses on the microsystems in health care, defined as “the small, functional, front-line units that provide most health care to most people” and are “essential building blocks of larger organisations and of the health system” really appreciated the support. I know with one particular GP because of the inter-professional learning sessions that we provided and with me going into the practice not long after that session, she really engaged me as well as the practice nurse in consultation with the patient. She could then consolidate her knowledge around insulin initiation for example (Staff 3)It was also the level of support that they were given and the rapport that they’d built up with the IT people and with their diabetes educator (Staff 1)The education and training component of the program was perceived as an important characteristic, in particular the structure and delivery of the inter-professional training sessions. Two interviewees noted that making attendance at the workshops a mandatory part of program participation was the key to fostering team-based care amongst the participating health care professionals.They [the GPs and staff] had to attend the compulsory workshops as part of the contractual arrangement, and part of the agreement was that a GP had to attend, so what happened was they all came along and then the ideas started to flow… (Staff 2)The incentive was extra training and the course that was actually funded for me, so the incentive of actually getting some up-skilling and some recognised clinical skilling, at no cost to myself, was certainly an incentive. And having done that, the incentive now is just to keep that knowledge there and increase it further and use it. Just helps in my enjoyment of medicine as a whole (GP 1)Figure The interplay of these characteristics is complex and interrelated. For example, the incorporation of strong information technology approaches resulted in the ability for the division to foster improved management processes and provide direct feedback on the performance of each practice as the program continued. The IDM program had a strong patient focus which resulted from an identified community need. In addition, improved patient care and health outcomes, fed back to practices as part of the IDM program implementation, were strong motivators for GP participation. The identification of GP peer support, particularly the use of a GP to present the positive outcomes of improved diabetes management, was used during education and training sessions to underline the practical benefits of the program and evidence of its effectiveness in general practice settings. The division provided onsite diabetes educators to provide ongoing clinical support to GPs and nurses involved in the program. This resulted in the opportunity for onsite learning and the development of new clinical and management skills as part of normal practice. The use of the inter-professional learning framework to guide the practice workshop sessions promoted team-based care and facilitated the adoption of new roles and responsibilities by staff.The division developed a formal implementation program however much was learnt from the first stages of the program to the final stages. Program strategies were adapted and changed during the course of program delivery. This flexibility allowed the SCDGP to tailor their approaches to better meet the needs of each practice in the second phase of the program. Overall, the division employed and led a clear and simple approach to the implementation of the program in each practice and this was seen as a crucial trigger for change.Finally, the application of the audit tool and the improvements to patient data management enabled improvements to patient management and health outcomes  to be evidenced in each practice. Ongoing feedback of these improvements, as part of a formal evaluation process, was made to each general practice. This enabled the division to continually adjust the strategies to ensure that positive outcomes were achieved and practices to clearly see the benefits of the program to their own patients.While all aspects of the clinical microsystem approach appeared effective in the design, implementation and adoption of the IDM program, several characteristics were crucial. The identification of champions of change in both the division and participating practices, the celebration of positive achievements resulting from practice change and the use ‘real data’ from practices, to demonstrate improved health outcomes for patients from the practice were instrumental in motivating participating GPs to both implement and sustain changes in their diabetes care delivery. The education and training strategies employed by the division were simple and flexible. They encompassed both formal workshops and onsite education and training as part of practise. The opportunities for GPs to attend workshop sessions which were clinically relevant and not time-consuming was an important feature of the successful uptake of the program. Informal onsite education and training enabled GPs to continue to up-skill in diabetes care as part of everyday practise.This work aimed to explore the feasibility of the clinical microsystem approach as a valid process for informing the development and implementation of the program from the perspective of the staff involved.There are two limitations to this study, namely: (1) characteristics, such as the divisions of general practice, that are unique to the Australian primary health care context; and (2) the small numbers of staff interviewed. Following this, the findings from these interviews may not be directly transferable across other Australian or international settings.In designing and redesigning health care, the clinical microsystems approach offers a pathway for the effective uptake of innovation in primary health care delivery in Australia; it offers a way to integrate structure, process and outcomes of care. It alsoThe authors declare that they have no competing interests.All mentioned authors made substantial contribution to this research and manuscript: TJ was involved in research protocol development, submission of ethics application, and different phases of the data collection and analysis, and writing of manuscript. LC was involved in all phases of data collection and analysis, and writing of manuscript. CJ participated in the design of the study, provided important intellectual content and was involved in the drafting of the manuscript. JM was involved in recruiting of participants and data collection. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/15/32/prepub


Objective. Pregnant women are especially vulnerable to adverse outcomes related to HIV infection and gender-based violence (GBV). We aimed at developing a program for prevention and mitigation of the effects of GBV among pregnant women at an antenatal clinic in rural Kenya. Methods. Based on formative research with pregnant women, male partners, and service providers, we developed a GBV program including comprehensive clinic training, risk assessments in the clinic, referrals supported by community volunteers, and community mobilization. To evaluate the program, we analyzed data from risk assessment forms and conducted focus groups (n = 2 groups) and in-depth interviews (n = 25) with healthcare workers and community members. Results. A total of 134 pregnant women were assessed during a 5-month period: 49 (37%) reported violence and of those 53% accepted referrals to local support resources. Qualitative findings suggested that the program was acceptable and feasible, as it aided pregnant women in accessing GBV services and raised awareness of GBV. Community collaboration was crucial in this low-resource setting. Conclusion. Integrating GBV programs into rural antenatal clinics has potential to contribute to both primary and secondary GBV prevention. Following further evaluation, this model may be deemed applicable for rural communities in Kenya and elsewhere in East Africa. Gender-based violence (GBV) is a major source of preventable mortality and morbidity for women globally –3. In KeGBV is also a driver of the global HIV epidemic, particularly in sub-Saharan Africa where women are disproportionately at risk of both GBV and HIV infection. GBV increases risk of HIV acquisition , 14, andIn addition to direct effects of GBV on maternal and child health, GBV may indirectly worsen health by reducing pregnant women's uptake of essential maternity and HIV services. In Kenya, women who anticipated partner stigma or violence were more than two times more likely to refuse HIV testing during antenatal care . HIV-posDespite growing recognition of the urgent need for primary and secondary prevention of GBV, there are few best practices for integrating GBV services into primary healthcare settings in low- and middle-income countries . Of the There is an urgent need to integrate GBV programs into health services in rural areas and to link them with existing community structures and support services , 29. In Kenya is one of the sub-Saharan African countries greatly affected by HIV and AIDS . Nyanza We followed the six-step process recommended by the WHO for implementing intimate partner violence (IPV) and sexual violence prevention programs . As illuWe conducted a pilot of the program in one community in rural Nyanza Province, during the period November 2010–February 2011. The pilot program was carried out in four phases see  and inclIn Phase 1, we built the skills of local community partners  to respond to GBV. In a two-day workshop, local partners learned about GBV and effects on health, mapped out their neighborhood, discussed existing  services that could be supportive of GBV victims, and established a local referral tree.In Phase 2, we trained all clinic staff  through a 40-hour training program. Topics covered in the training included gender and human rights, GBV sensitization, links between GBV and HIV, HIV-related stigma, role of the health sector, privacy and confidentiality, IPV screening tools and techniques, sexual violence and postrape care, supported referral protocols, provider safety and self-care, and communication skills. Two new program tools were developed to facilitate links between the clinic and community. The first was a “risk assessment form,” based on formative research and existing GBV screening tools from South Africa and the United States –39. ThisIn Phase 3, the clinic staff began to screen all pregnant women visiting the antenatal care clinic, where women are also tested for HIV and received prevention of mother-to-child transmission (PMTCT) interventions. In lieu of providing all necessary GBV services in the clinic, community volunteers were trained to offer “supported referrals” to services that already existed in the province. Supported referrals are distinct from ordinary referrals because community volunteers offer concrete assistance for reaching referral services in the community or the nearest town, including provision of transport costs, personally escorting women to services, telephoning ahead and offering emotional support. Existing resource persons included medical professionals trained in GBV, community elders, chiefs, counselors, church leaders, police, and a probono lawyer. The community volunteers, called Community Referral Persons , assisted with phoning ahead, escorting women to services, and facilitating reimbursement for transport fare . Limited funds were available to support transport costs for clients and CRPs to reach referral agencies in the nearest town, cell phone costs for health workers, and CRPs to communicate with each other and referral agencies and for biweekly meetings of the CRPs led by FACES Coordinators. Throughout this phase, community mobilization events in different parts of the clinic catchment area were conducted by members of the FACES team and the CRPs. During Phase 4, we conducted an evaluation of the pilot program by examining risk assessment forms and conducting focus groups and in-depth interviews with community and clinic participants. Evaluation methods and findings are described in detail below.Due to limited resources and ethical considerations, we conducted a small-scale mixed methods evaluation using anonymous screening from data and qualitative research methods. Although we collected significant data from pregnant women at baseline to inform the design of the program , we wereQuantitative. GBV risk assessment questions routinely asked of antenatal clients during the pilot included the following. (1) If you told your partner that you came here for health services today, would s/he react angrily or negatively? (2) Has your partner or another person close to you: (a) Pushed, grabbed, slapped, choked hit or kicked you? (b) Threatened to hurt you, your children or someone close to you? (c) Taken away money/resources that you/your children need to survive? (d) Sent you back to your maternal home, (e) Forced you to have sex when you did not want to? (3) Has your partner tried to get you pregnant when you did not want to be? (4) If you wanted to use a condom or another family planning method, would you be afraid to ask your partner? (5) Are you worried your partner (or another person close to you) will be angry and/or hurt you if s/he finds out you were tested for HIV? (6) Do you feel unsafe returning to your home today? Clients answering “Yes” to any of these questions were considered to be at risk of or experiencing GBV. These anonymous risk assessment forms were completed by the health providers  during antenatal visits at the clinic. The healthcare providers read the questions to the women (in her preferred language) and women orally provided answers that were recorded on the form. Risk assessments took place in a private room in the antenatal clinic, and no other staff or patients were present. Data from these forms (n = 134) were examined and simple descriptive statistics were conducted to identify monthly numbers and trends in screening, cases identified, and referral after the initiation of the program activities. Qualitative. Focus groups with clinic staff and community members were conducted after the program had been active for two months. Participants  were purposively selected from those who participated in or were affected by the GBV program and included health workers from the clinic, the CRPs, FACES Coordinators, local administrators, church and community leaders, elders, and local nongovernmental organization representatives. Each focus group included a mixture of participants from these target groups. The groups were led by an experienced qualitative researcher in Dholuo or English language (both languages are widely spoken in the district) using a moderator's guide and were audio-recorded after obtaining permission from the participants. Topics included feedback on the overall GBV program approach, the training received, the process of supported referrals; the impact of the program on the clinic, clients, and community; and suggestions for improvement. n = 5); Ministry of Health, police, and other community, district, and service leaders (n = 10); CRPs (n = 5); and FACES staff (n = 5). These interviews were conducted in English by an experienced qualitative researcher using an in-depth interview guide developed by the research team and were audio-recorded after obtaining permission from the participants. Topics in the interview guide included the participant's role in the community and their overall impression of and role in the program; experiences with GBV risk assessment and the referral process; views on addressing GBV in the community; and facilitators and barriers to program success.In addition, 5-6 months after the program activities were initiated, we conducted a series of in-depth interviews with key informants (6 women and 19 men) who had been involved in the program. Types of informants included health workers at the clinic  and then translated to English if necessary by experienced translators based in Kenya. The English transcripts were coded by two researchers in QSR NVivo 9, using a thematic approach to data analysis . An initEthical Considerations. All participants were taken through an informed consent process and provided verbal informed consent to participate in the research. Ethical approval for this study was obtained from the Kenya Medical Research Institute (KEMRI), the University of California, San Francisco (UCSF), and the University of Alabama at Birmingham (UAB). A total of 134 women were screened in the ANC clinic during the months December 2010 from April 2011. Forty-nine women (37%) reported some type of violence or risk of violence . Of the 134 forms, 24 (18%) included a report of physical violence , 23 (17%) sexual violence (forcing sex), 26 (19%) psychological violence (threatening own safety or children/persons close to you), and 15 (11%) economic violence (forcing out of home or taking away money/resources you or your children need to survive). Of those reporting violence, 26 (53%) accepted referrals to support resources in the province . Support was provided for these women to access these support resources including referrals to community referral persons (23 women), police in the nearest town (4 women) , local government administrators (3 women) (to help with needs for shelter and food), nongovernmental organizations working on women's rights (2 women) (for counseling), a probono lawyer (1 woman) , and village elders (1 woman) (for help with communication with the husband and family). Examination of numbers of risk assessment forms, including the two months after the initial pilot period ended in February, indicated that the volume of screening in the ANC clinic declined over time, although the number of ANC visitors remained relatively stable . CharactThe major themes that emerged from the qualitative data analysis included: changes in community GBV awareness, the role of screening at the health facility in facilitating women's access to GBV services, the importance of community collaboration, social risks in the community for persons working to prevent and address GBV, and challenges to program success. At least they know there are people somewhere who are out for women. At least there is somewhere where women can file their cases when they are battered, so at least there is a change, they are getting to know that they should do the right thing at the right time, it is not like those days when they use to beat us.   The participants felt that the GBV program had begun to make a difference in the community. Victims of violence had become aware that there was a way to get help, and perpetrators of violence were learning that there were consequences of partner violence. Several interviews and focus group discussions highlighted the benefit of simply knowing where to receive GBV-related services:It's not the same, because now men fear beating women or doing such violence because they know they may be arrested or there may be steps taken for them if they do that. (In-Depth Interview participant #11)One participant explained that the program raised awareness of the consequences of perpetrating violence, creating a disincentive for men to use physical GBV towards their partners:This program can be so nice such that at every health facility, any woman walking there can be able to be screened and then any gender-based violence can be identified and then they can be helped… And that can only be generated from the screening and when the screening is not done at that [health] facility level, then you cannot get the other proceedings. Participants saw benefits to screening at the health facility in rural areas, as women commonly access health clinics but may be less familiar with other available services for GBV. In several focus group discussions, participants explained that GBV screening offered a crucial first step for assisting women with violence:We accommodated the lady I think for two to three days in the chief's home. He is a simple man, so that is where she stayed, she took a bath she was feeling good… The same lady came back to me and then I found for her shelter with a neighbor,… so I went and talked to that lady and she stayed with her for three days. The involvement of community partners in the GBV program resulted in the ability to find local solutions to help victims, even in this rural setting where there is no battered woman's shelter and limited formal resources for GBV. One participant in a focus group explained how they leveraged space in the chief's home as a way to provide a woman safety while she decided on her next move:So when somebody is saying that women are not supposed to be beaten, that… they should go to somebody and take some action, in the community it is like that person is acting against the will of the community. To the men it is like he is an outcast in the community, an outlaw who is not supposed to be there…. In social places you will hear them saying that he is not a good person because if he is preaching to our ladies and women to take action against us, then it is like he wants to bring a revolution, women are going to overpower us and then we are going to be voiceless. Although the health workers and CRPs felt empowered by the training and felt they were doing good in the community, some found the work challenging and were criticized by other community members  because of their new role:In order to carry out this work more effectively, most participants stressed the need for repeated refresher trainings and sensitization for service providers and local partners  as well as additional counseling skills for CRPs and health workers.Sometimes you get a woman has been beaten by her husband. And when she comes here to report, she reports the matter. Then you start to give her P3 [official violence reporting form]. When she goes home, she's threatened by the family of the husband: “If you go ahead with that case, you are not going to stay. You'll not be here. We will chase you away, if our brother is arrested. (In-Depth Interview participant #20)Despite their successes, the participants discussed many continuing challenges to addressing GBV in their community. They explained that socioeconomically disempowered women were reluctant to press charges against a violent husband for fear of “breaking the family” and subsequently being left without a home or resources. Some service providers mentioned that they, as well as the women, often preferred to “solve things at home” instead of seeking outside help. Extended family members and village elders  in some cases supported the violent man over the woman. Several participants explained that criminal and legal procedures for reporting GBV cases could not be completed locally but had to be carried out in the nearest town, resulting in difficulties in pressing charges and delays in action: The forms of resistance to this type of program underscore the need to include local partners and community-level education in order to facilitate acceptance of a clinic-based approach to GBV.The current study suggests that an integrated program in a rural primary healthcare setting in Kenya is acceptable and feasible to both healthcare providers and the surrounding community. Initial assessment suggests that the program has potential to contribute to both primary and secondary prevention of GBV. The program addressed many of the barriers that have been cited as inhibiting the health sector response to GBV, including lack of provider knowledge, insufficient staff training, few existing policies, poor management support for GBV response, and a lack of coordination between the health sector and other services , 45. We The program harnessed an important “window of opportunity” among pregnant women attending a rural antenatal clinic. Women in their reproductive years use medical services more frequently than at any other time . This plThe 40-hour training program for all clinic staff and the community volunteers seemed to provide the necessary skills for this type of GBV risk assessment and referral work, although periodic refresher trainings would be necessary to address gaps in skills and maintain these tasks over time. As has been found elsewhere , data frWe also found that community collaboration was crucial to the success of the program in this low-resource setting without any shelters or other formal resources for victims of violence. It is recognized that effective GBV referral services need to offer more support than simply handing women a sheet of paper with a list of potential resources . The necCertainly this program did not address all the challenges to primary and secondary prevention of GBV in this setting. A preference among both service providers and clients to “solve things at home” and use “family mediation” approaches to help the couple to live peacefully may be problematic, especially in severe situations when the woman's life is in danger . This fiImplementing this pilot GBV program using a six-step process as recommended by the WHO  has impoSASA! Program for preventing violence against women and HIV infection in Uganda [However, it should be noted that the pilot was conducted in only one community/clinic, and some special features of this setting may make the strategy less generalizable. Although we built in program evaluation, using anonymous risk assessment form data, focus groups, and in-depth interviews, we were not able to collect data directly from ANC clients on their experiences with the screening and the GBV program. Although we have clinic data on screening and referrals and a wealth of stories from the research participants on the outcome of the GBV cases identified, we were not able to follow women or collect any quantitative data on the outcomes of GBV referrals. Some of these limitations were due to resource constraints, while others had to do with the highly sensitive nature of this topic and the need to avoid putting women at any additional risk due to research procedures . In addin Uganda . AlthougWe integrated a GBV program into a rural antenatal clinic that also provides HIV testing and PMTCT services with the participation of the community and primary healthcare workers. This program was found to be acceptable and feasible and has potential to contribute to primary and secondary prevention of GBV. This model may be applicable to address GBV in the multitude of rural communities in Kenya and elsewhere in sub-Saharan Africa, where the majority of the African population live . If this


Reducing the portion size of food and beverages served at restaurants has emerged as a strategy for addressing the obesity epidemic; however, barriers and facilitators to achieving this goal are not well characterized.In fall 2012, the Los Angeles County Department of Public Health conducted semistructured interviews with restaurant owners to better understand contextual factors that may impede or facilitate participation in a voluntary program to recognize restaurants for offering reduced-size portions.Interviews were completed with 18 restaurant owners (representing nearly 350 restaurants). Analyses of qualitative data revealed 6 themes related to portion size: 1) perceived customer demand is central to menu planning; 2) multiple portion sizes are already being offered for at least some food items; 3) numerous logistical barriers exist for offering reduced-size portions; 4) restaurant owners have concerns about potential revenue losses from offering reduced-size portions; 5) healthful eating is the responsibility of the customer; and 6) a few owners want to be socially responsible industry leaders.A program to recognize restaurants for offering reduced-size portions may be a feasible approach in Los Angeles County. These findings may have applications for jurisdictions interested in engaging restaurants as partners in reducing the obesity epidemic. Child and adult obesity rates in the United States have increased dramatically in the past 20 years –3. RisinAs a strategy for addressing the obesity epidemic, numerous US jurisdictions and organizations have created voluntary public recognition programs for restaurants. Such programs typically offer restaurants publicity, technical assistance, or other incentives if they comply with program standards, which frequently focus on setting limits on nutrient content  for a small number of meals or items ,11 or inThe Los Angeles County (LAC) Department of Public Health (DPH) launched a formative research investigation in January 2012 to study the feasibility of establishing a countywide, voluntary public recognition program for restaurants. DPH sought to support broad participation from restaurants in the region by creating program standards that eliminated the need for nutrient analysis, a documented barrier to program participation . Guided Because little is known about restaurant owners’ interest in offering and ability to offer reduced-size portions, DPH selected a qualitative approach to study this issue. DPH conducted semistructured qualitative interviews with restaurant owners, operators, presidents, or directors who owned or operated restaurants in LAC (hereafter “restaurant owners”) to gather in-depth information on restaurants’ capacity to offer reduced-size portions. Purposeful recruitment, based on maximum variation sampling principles , was appRecruitment occurred in 2 stages. First, in July 2012, representatives from DPH gave a brief presentation on the proposed restaurant recognition program at a regularly scheduled meeting of the Los Angeles chapter of the California Restaurant Association. At the meeting, DPH recruited volunteers to participate in the interviews. All 7 attendees who were restaurant owners expressed interest in participating in the interview and provided their contact information. Second, desired target restaurant categories were shared with the DPH’s restaurant hygiene inspection program which, through a gradual recruitment process, identified additional participants to respond for restaurant categories we had not yet filled . All restaurants were recruited through e-mail or telephone. An interview was scheduled with each owner who agreed to participate.Semistructured interviews were conducted via telephone by DPH’s interview team during September through November 2012. Each interview used a 34-question scripted interview guide that contained both closed- and open-ended questions organized in 5 sections: restaurant background , restaurant customers , current healthful offerings and activities , ability to meet proposed DPH program standards , and potential facilitators to program participation . When a restaurant owner represented multiple different restaurants, he or she was asked to select 1 restaurant (based on his or her preference) to base answers on. Before field implementation, all study protocols and materials were reviewed and approved by the Los Angeles County Department of Public Health Institutional Review Board.Each interview lasted approximately 30 to 60 minutes. The interviews were not audiotaped because many prospective interviewees had indicated they would not participate if taping was involved. Each interview was attended by 2 members from the interview team (in addition to the primary interviewer), who took detailed notes to capture responses. At the completion of each interview, the primary interviewer and the 2 members summarized personal impressions and reactions as well as emerging themes about the telephone encounter; these documentations were completed independently and analyzed along with the interview notes.Interview data were analyzed by using a 3-stage process. First, the interviewer and 1 of the team members who attended the interview conducted an independent analysis of the interview notes and their personal and theoretical summaries to identify themes that reflected barriers or facilitators to program participation. Each team member then reviewed all of the documentation a second time to assign codes to specific excerpts of text using the constant comparison method . Second,Of the 38 restaurant owners initially contacted, 18 (47%) completed an interview. About half (56%) of the respondents were owners or operators of small chains or affiliated groups of restaurants . TogetheDuring the interviews, 17 restaurant owners mentioned the importance of customer demand in menu planning. As stated by 1 owner, “The restaurant owners will do whatever it takes to accommodate the customer.” The perceived type of demand differed depending on the type of customers the restaurant typically served. Half of the restaurant owners interviewed, whose restaurants tended to be more chef-driven or offered specialty healthy cuisine, mentioned that their customers were more health-conscious . Many of the restaurants already offered what they perceived as healthier options or in-house promotions of more healthful foods . Owners of these restaurants generally expressed interest in participating in the proposed voluntary program because they thought their customers would respond favorably to reduced-size portions.Ten restaurant owners mentioned they did not perceive a strong demand from their customers for healthy food or reduced-size portions. These owners tended to represent restaurants that were quick service, offered meals at lower cost, or served customers who were tourists. They stated that their customers “value large portions,” “don’t want to feel cheated,” and “expected large sizes for certain items.” One restaurant owner commented that customers came to his restaurant “to treat themselves.” Another stated that his customers would generally consider any item labeled as “healthy” as not flavorful. These owners tended to be most concerned about the program. However, most did not rule out participating. Instead, they emphasized the need to wait and see how their customers would react to reduced-size portions and advocated for more public education. One owner stated, “[Customers] are used to having dishes look a certain way. There would have to be educational efforts for our customers.”The 2 subthemes mentioned above (perceived customer demand versus no customer demand) were not mutually exclusive. For example, some restaurant owners who were more cautious about offering reduced-size portions commented on society’s recent “culture shift” toward healthier options. As stated by 1 owner “[The restaurant] is a place where people go to indulge. [Smaller portions] haven’t been a part of the culture, but with the advent of emphasis on healthy cuisine, [we] are opening ourselves up to it more.”Twelve restaurant owners reported that their establishment(s) already offered at least some menu items in multiple portion sizes. The most commonly cited items that were available in multiple sizes were soups, salad, sandwiches, pizzas, and side dishes; only 8 reported offering multiple sizes for entrées. The 3 most commonly mentioned reasons for offering multiple portion sizes were accepted industry practice , efforts to facilitate “customer choice” , and ability to have more competitive (lower) prices for reduced-size items. No restaurant owners mentioned offering reduced-size portions for health reasons.When asked about the possibility of offering reduced-size portions for additional menu items, 12 restaurant owners named logistical challenges. In general, they were particularly concerned about serving reduced-size entrée items, asking questions like “How do you cut a hot dog in half?” or citing presentation barriers . As stated by 1 owner, “Entrées are much harder to cut down as it relates to presentation and perceived customer value.”Some restaurant owners were resistant to changing their menus or making their menus more complicated . Some owners also raised preparation challenges, including the need for additional time, staff training, and management oversight to prepare and serve a larger variety of items. Some owners cited lack of knowledge about how to increase healthfulness of meals or reduce portion sizes or both  as barriers. Many raised concerns about the availability and costs of smaller product sizes from vendors ; this was especially true for restaurants that used mostly prepared items. Finally, many restaurant owners noted the potential increase in costs associated with nutrient analysis and calorie postings although such analyses would not be a part of the proposed program. Many owners cited these costs as particularly challenging for small restaurant businesses.Six restaurant owners were concerned about the potential negative economic impact of offering reduced-size portions. All owners agreed that reduced-size portions would need to be offered at a lower price (compared with standard sizes) and most believed that many customers would be motivated to choose the smaller portions to spend less money. Many noted that restaurants have fixed costs  not associated with portion sizes, so if they sell the same amount of reduced-size items, this would affect their bottom line. As stated by 1 owner, “Smaller portions increase operating costs and the profit margin is too small to offer smaller portions.” To participate, owners would need a way to offset the potential decrease in revenues . One restaurant owner proposed charging higher prices on beverages as a way to make up for possible revenue losses due to selling reduced-size portions.Five restaurant owners emphasized that people have the ultimate responsibility to make healthful food choices. Many owners felt that restaurants have been unfairly targeted as a cause of the obesity epidemic. Owners emphasized the need for further public education and cited the lack of customer demand to facilitate making substantive changes to their menus. As stated by 1 owner, “We need to educate the public about not overeating. We don’t want to babysit everyone. . . . I can pay attention to what I serve, but I have no control over what people are buying.” Similarly, many restaurant owners were resistant to government involvement  in determining what size portions they should serve.Three restaurant owners mentioned the desire to offer smaller portions for social or personal reasons, including the need to reduce plate waste, increase the health of their community, or because they have personally experienced the negative health effects of obesity or related disease . As described by 1 owner, “We also have to set an example. People look to [us to] be a leader because we’ve always been on the forefront of these types of issues.”Offering reduced-size portions appears to be a feasible approach among restaurants that participated in this study. Restaurant owners reported many potential barriers to offering reduced-size portions, including lack of perceived customer demand, operational barriers related to preparation and serving, unfavorable economics, and the need for customer responsibility in making food choices. However, despite the perceived barriers noted, some owners see demand from customers for more healthful menu items, many currently offer at least some menu items in reduced-size portions, and most indicated interest in learning more about or participating in the proposed restaurant recognition program.Similar to findings in prior research, our findings of the need to successfully meet perceived customer demand were cited by many restaurant owners as a central driver to menu planning ,20. PrevOur results suggest the need for targeted engagement and technical assistance with restaurant owners. A successful restaurant recognition program will need to address challenges with food preparation and presentation associated with portion size, found both in this study and previous work . ProvidiAlthough this formative work provides critical insights on restaurant owners’ perspectives, its methods are subject to limitations. LAC has a very large number of restaurants, distributed across a wide geographic area. Despite efforts to obtain a diversity of opinions, limited time and staffing constraints precluded comprehensive sampling of all combinations of restaurant categories. Furthermore, sampling methods were designed to gather information from chef-driven independent or small chain restaurants, which are not necessarily representative of all LAC restaurant owners. The opinions expressed by the owners in this study may be more favorable toward the program than the opinions of the general LAC restaurant owner population. Special consideration will need to be given to the potential barriers and facilitators for large chain restaurants, a substantial number of which are represented in the region. Factors that shaped our decision not to focus on them in this study, such as the lack of participation by franchisees in menu planning, indicate the need for further study of large chain–specific barriers and facilitators to participation in voluntary restaurant recognition programs.Much remains unknown about best practices for administering a successful voluntary recognition program focused on reduced-size portions. Although this qualitative study suggests that this approach for operating a voluntary program may be feasible, further assessment  of restaurant owners’ and customers’ knowledge, attitudes, and beliefs for program implementation may be warranted.The study findings serve as a useful starting point for engaging restaurant owners and suggest that a program to recognize restaurants for providing reduced-size portions may be a feasible approach. The lessons learned from this formative work may have applications in other jurisdictions, especially for those interested in establishing similar programs to address nutrition-related issues and obesity in their communities.