Psychological safety is associated with better work environment and lower levels of clinician burnout.

Burnout is attributed to negative work environments and threatens patient and clinician safety. Psychological safety is the perception that the work environment is safe for interpersonal risk-taking and may offer insight into the relationship between the work environment and burnout. In this cross-sectional analysis of survey data from 621 nurse practitioners in California, we found that one-third (34%) experienced high burnout. Four factors in the work environment were negatively associated with burnout and positively associated with psychological safety. Significant mediation effects of psychological safety were observed on the relationships between each work environment factor and both emotional exhaustion and depersonalization. The largest mediation effects were observed on the total effects of Nurse Practitioner-Physician Relations and Practice Visibility on Emotional Exhaustion (37% and 32%, respectively) and Independent Practice and Support and NP-Administration Relations on Depersonalization (32% and 29%, respectively). We found, overall, that psychological safety decreased the strength of the negative relationship between work environment and burnout. We argue that research, practice, and policy efforts to mitigate burnout and improve the work environment should consider psychological safety as a metric for system-level well-being.

The Social Ecology of Burnout: A framework for research on nurse practitioner burnout.

BACKGROUND: The U.S. health system is burdened by rising costs, workforce shortages, and unremitting burnout. Well-being interventions have emerged in response, yet data suggest that the work environment is the problem. Nurse practitioner (NP) burnout is associated with structural and relational factors in the work environment, practice autonomy, and hierarchical leadership. PURPOSE: We explore the unique social, cultural, and political environment in which NPs work through the lens of social ecology and present the Social Ecology of Burnout (SEB) framework. METHODS: We review current burnout frameworks in the context of the NP practice environment and discuss the SEB, specifically exploring psychological safety and its influence on burnout. FINDINGS: Psychological safety, work environment, and policy are presented within the SEB and solutions which empower NPs are considered. DISCUSSION: Our framework can serve as a guide for future nursing research, practice, and policy.

Hospital Adaptions to Mitigate the COVID-19 Pandemic Effects on MARQUIS Toolkit Implementation and Sustainability.

OBJECTIVE: To explore the perceived effects of COVID-19 on MARQUIS toolkit implementation and sustainability, challenges faced by hospitals in sustaining medication reconciliation efforts, and the strategies used to mitigate the negative effects of the pandemic. DATA SOURCES AND STUDY SETTINGS: Primary qualitative data were extracted from a Web-based survey. Data were collected from hospitals that participated in MARQUIS2 ( n = 18) and the MARQUIS Collaborative ( n = 5). STUDY DESIGN: A qualitative, cross-sectional study was conducted. DATA COLLECTION/DATA EXTRACTION: Qualitative data were extracted from a Research Electronic Data Capture survey databased and uploaded into an Excel data analysis template. Two coders independently coded the data with a third coder resolving discrepancies. PRINCIPAL FINDINGS: Thirty-one team members participated, including pharmacists ( n = 20; 65%), physicians ( n = 9; 29%), or quality-improvement (QI) specialists ( n = 2; 6%) with expertise in medication reconciliation (MedRec) (14; 45%) or QI (10; 32%). Organizational resources were limited, including funding, staffing, and access to pharmacy students. To support program continuation, hospitals reallocated staff and used new MedRec order sets. Telemedicine, workflow adaptations, leadership support, QI team involvement, and ongoing audits and feedback promoted toolkit sustainability. CONCLUSIONS: COVID-19 affected the capacity of hospitals to sustain the MARQUIS toolkit. However, hospitals adapted various strategies to sustain the toolkit.

Effects of a medication adherence app among medically underserved adults with chronic illness: a randomized controlled trial.

For individuals living with a chronic illness who require use of long-term medications, adherence is a vital aspect of successful symptom management and outcomes. This study investigated the effect of a smartphone app on adherence, self-efficacy, knowledge, and medication social support in a medically underserved adult population with various chronic illnesses. Participants were randomized to a group who used the app for one month or a control group provided with a printed medication list. Compared to the control group, participants receiving the intervention had significantly greater medication adherence (Cohen's d = -0.52, p = .014) and medication self-efficacy (Cohen's d = 0.43, p = .035). No significant effects were observed related to knowledge or social support. The findings suggest use of the app could positively impact chronic disease management in a medically underserved population in the United States.

Effect of a Medication Adherence Mobile Phone App on Medically Underserved Patients with Chronic Illness: Preliminary Efficacy Study.

BACKGROUND: Medication adherence is vital in the treatment of patients with chronic illness who require long-term medication therapies to maintain optimal health. Medication adherence, a complex and widespread problem, has been difficult to solve. Additionally, lower-income, medically underserved communities have been found to have higher rates of inadequate adherence to oral medications. Even so, this population has been underrepresented in studies using mobile medication adherence app interventions. Federally qualified health centers provide care for medically underserved populations, defined as communities and populations where there is a demonstrable unmet need for health services. These centers have been reporting an increase in a more complex chronic disease population. Including medically underserved individuals in mobile health studies provides opportunities to support this disproportionately affected group, work toward reducing health disparities in access to health care, and understand barriers to mobile health uptake. OBJECTIVE: The aim of this preliminary efficacy study was to evaluate the effects and feasibility of a commercially available medication adherence app, Medisafe, in a medically underserved adult population with various chronic illnesses seeking care in a federally qualified health center. METHODS: Participants in this single-arm pre-post intervention preliminary efficacy study (N=10) completed a baseline survey, used the app for 2 weeks, and completed an end-of-study survey. The primary outcome measures were medication adherence and medication self-efficacy. Feedback on the use of the app was also gathered. RESULTS: A statistically significant median increase of 8 points on the self-efficacy for adherence to medications scale was observed (P=.03, Cohen d=0.69). Though not significant, the adherence to refills and medications scale demonstrated a median change of 2.5 points in the direction of increased medication adherence (P=.21, Cohen d=0.41). Feedback about the app was positive. CONCLUSIONS: Use of the Medisafe app is a viable option to improve medication self-efficacy and medication adherence in medically underserved patients in an outpatient setting with a variety of chronic illnesses.

Screening Health-Related Social Needs in Hospitals: A Systematic Review of Health Care Professional and Patient Perspectives.

Health outcomes are markedly influenced by health-related social needs (HRSN) such as food insecurity and housing instability. Under new Joint Commission requirements, hospitals have recently increased attention to HRSN to reduce health disparities. To evaluate prevailing attitudes and guide hospital efforts, the authors conducted a systematic review to describe patients' and health care providers' perceptions related to screening for and addressing patients' HRSN in US hospitals. Articles were identified through PubMed and by expert recommendations, and synthesized by relevance of findings and basic study characteristics. The review included 22 articles, which showed that most health care providers believed that unmet social needs impact health and that screening for HRSN should be a standard part of hospital care. Notable differences existed between perceived importance of HRSN and actual screening rates, however. Patients reported high receptiveness to screening in hospital encounters, but cautioned to avoid stigmatization and protect privacy when screening. Limited knowledge of resources available, lack of time, and lack of actual resources were the most frequently reported barriers to screening for HRSN. Hospital efforts to screen and address HRSN will likely be facilitated by stakeholders' positive perceptions, but common barriers to screening and referral will need to be addressed to effectively scale up efforts and impact health disparities.

Development and preliminary validation of a health-related family quality of life instrument.

The researchers' aims for this preliminary study was to develop an instrument, guided by the Theory of Health-related Family Quality of Life, to measure health-related family quality of life (HR-FQoL) as perceived by women with cancer. The researchers used a two phase design for instrument development: (1) establishing face validity of a 38-item instrument with an expert panel and patient review, and (2) focusing on the internal structure and construct validity of the instrument with responses from female patients (N = 236) with a cancer diagnosis (breast, gynecologic). The researchers identified a final 25-item HR-FQoL instrument with four sub-scales that each captured multiple concepts within the Theory of HR-FQoL. The resulting instrument maybe used by researchers and clinicians to assess various aspects of health-related family quality of life among female breast and gynecological cancer survivors.

What works in medication reconciliation: an on-treatment and site analysis of the MARQUIS2 study.

BACKGROUND: The second Multicenter Medication Reconciliation Quality Improvement Study demonstrated a marked reduction in medication discrepancies per patient. The aim of the current analysis was to determine the association of patient exposure to each system-level intervention and receipt of each patient-level intervention on these results. METHODS: This study was conducted at 17 North American Hospitals, the study period was 18 months per site, and sites typically adopted interventions after 2-5 months of preintervention data collection. We conducted an on-treatment analysis (ie, an evaluation of outcomes based on patient exposure) of system-level interventions, both at the category level and at the individual component level, based on monthly surveys of implementation site leads at each site (response rate 65%). We then conducted a similar analysis of patient-level interventions, as determined by study pharmacist review of documented activities in the medical record. We analysed the association of each intervention on the adjusted number of medication discrepancies per patient in admission and discharge orders, based on a random sample of up to 22 patients per month per site, using mixed-effects Poisson regression with hospital site as a random effect. We then used a generalised linear mixed-effects model (GLMM) decision tree to determine which patient-level interventions explained the most variance in discrepancy rates. RESULTS: Among 4947 patients, patient exposure to seven of the eight system-level component categories was associated with modest but significant reductions in discrepancy rates (adjusted rate ratios (ARR) 0.75-0.97), as were 15 of the 17 individual system-level intervention components, including hiring, reallocating and training personnel to take a best possible medication history (BPMH) and training personnel to perform discharge medication reconciliation and patient counselling. Receipt of five of seven patient-level interventions was independently associated with large reductions in discrepancy rates, including receipt of a BPMH in the emergency department (ED) by a trained clinician (ARR 0.40, 95% CI 0.37 to 0.43), admission medication reconciliation by a trained clinician (ARR 0.57, 95% CI 0.50 to 0.64) and discharge medication reconciliation by a trained clinician (ARR 0.64, 95% CI 0.57 to 0.73). In GLMM decision tree analyses, patients who received both a BPMH in the ED and discharge medication reconciliation by a trained clinician experienced the lowest discrepancy rates (0.08 per medication per patient). CONCLUSION AND RELEVANCE: Patient-level interventions most associated with reductions in discrepancies were receipt of a BPMH of admitted patients in the ED and admission and discharge medication reconciliation by a trained clinician. System-level interventions were associated with modest reduction in discrepancies for the average patient but are likely important to support patient-level interventions and may reach more patients. These findings can be used to help hospitals and health systems prioritise interventions to improve medication safety during care transitions.

Medication Discussions With Patients With Cardiovascular Disease in the Emergency Department: An Opportunity for Emergency Nurses to Engage Patients to Support Medication Reconciliation.

INTRODUCTION: This study aimed to investigate the level of patient involvement in medication reconciliation processes and factors associated with that involvement in patients with cardiovascular disease presenting to the emergency department. METHODS: An observational and cross-sectional design was used. Patients with cardiovascular disease presenting to the adult emergency department of an academic medical center completed a structured survey inclusive of patient demographics and measures related to the study concepts. Data abstracted from the electronic health record included the patient's medical history and emergency department visit data. Our multivariable model adjusted for age, gender, education, difficulty paying bills, health status, numeracy, health literacy, and medication knowledge and evaluated patient involvement in medication discussions as an outcome. RESULTS: Participants' (N = 93) median age was 59 years (interquartile range 51-67), 80.6% were white, 96.8% were not Hispanic, and 49.5% were married or living with a partner. Approximately 41% reported being employed and 36.9% reported an annual household income of <$25,000. Almost half (n = 44, 47.3%) reported difficulty paying monthly bills. Patients reported moderate medication knowledge (median 3.8, interquartile range 3.4-4.2) and perceived involvement in their care (41.8 [SD = 9.1]). After controlling for patient characteristics, only difficulty paying monthly bills (b = 0.36, P = .005) and medication knowledge (b = 0.30, P = .009) were associated with involvement in medication discussions. DISCUSSION: Some patients presenting to the emergency department demonstrated moderate medication knowledge and involvement in medication discussions, but more work is needed to engage patients.

Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes.

Background: Patients underwent a compression (sleeve and gauntlet) intervention for subclinical breast cancer-related lymphedema (S-BCRL). Physical, emotional, and quality-of-life (QoL) outcomes were examined. Associations of change in extracellular fluid alone through bioimpedance spectroscopy (BIS) or change in whole-arm volume through tape measure with the outcomes at time of S-BCRL were explored. Methods and Results: We enrolled newly diagnosed nonmetastatic breast cancer patients for surveillance up to 36 months postoperatively. Upon detection of S-BCRL, a 28-day compression intervention was initiated. Data were obtained through physical examination/measurement and self-report instruments: skin examination, Lymphedema Symptom Intensity and Distress Survey-Arm, and Functional Assessment of Cancer Therapy General (FACT-G), Breast (FACT-B), and FACT-B+4. Improvements with intervention were observed in the proportion of patients reporting symptom scores ≥3 in function (Cohen's d = -0.46, p < 0.01), in biobehavioral (Cohen's d = -0.30, p < 0.05), maximum number of skin conditions (Cohen's d = -0.34, p < 0.05. 3), FACT-B (Cohen's d = 0.52, p < 0.01), and FACT-B + four (Cohen's d = -0.42, p < 0.01). At the study endpoint, compared with those who did not progress, chronic breast cancer-related lymphedema (C-BCRL) progressing patients had higher overall symptom scores (p = 0.037), more skin conditions (p = 0.009), and lower total FACT-G and FACT-B scores (p < 0.05). At the time of S-BCRL, detection of greater BIS unit change correlated with higher symptom, skin condition, and QoL values. Greater whole-arm volume change correlated with higher FACT-B+4 scores (all p < 0.05). Conclusions: Prospective surveillance, symptom assessment, and compression intervention promote low progression rates from S-BCRL to C-BCRL and as such reduce symptom burden. This closed study is registered with ClinicalTrials.gov NCT02167659.

Risk factors for breast cancer-related lymphedema in patients undergoing 3 years of prospective surveillance with intervention.

BACKGROUND: To evaluate risk factors (treatment-related, comorbidities, and lifestyle) for breast cancer-related lymphedema (BCRL) within the context of a Prospective Surveillance and Early Intervention (PSEI) model of care for subclinical BCRL. METHODS: The parent randomized clinical trial assigned patients newly diagnosed with breast cancer to PSEI with either bioimpedance spectroscopy (BIS) or tape measurement (TM). Surgical, systemic and radiation treatments, comorbidities, and lifestyle factors were recorded. Detection of subclinical BCRL (change from baseline of either BIS L-Dex ≥6.5 or tape volume ≥ 5% and < 10%) triggered an intervention with compression therapy. Volume change from baseline ≥10% indicated progression to chronic lymphedema and need for complex decongestive physiotherapy. In this secondary analysis, multinomial logistic regressions including main and interaction effects of the study group and risk factors were used to test for factor associations with outcomes (no lymphedema, subclinical lymphedema, progression to chronic lymphedema after intervention, progression to chronic lymphedema without intervention). Post hoc tests of significant interaction effects were conducted using Bonferroni-corrected alphas of .008; otherwise, an alpha of .05 was used for statistical significance. RESULTS: The sample (n = 918; TM = 457; BIS = 461) was female with a median age of 58.4 years. Factors associated with BCRL risk included axillary lymph node dissection (ALND) (p < .001), taxane-based chemotherapy (p < .001), regional nodal irradiation (RNI) (p ≤ .001), body mass index >30 (p = .002), and rurality (p = .037). Mastectomy, age, hypertension, diabetes, seroma, smoking, and air travel were not associated with BCRL risk. CONCLUSIONS: Within the context of 3 years of PSEI for subclinical lymphedema, variables of ALND, taxane-based chemotherapy, RNI, body mass index >30, and rurality increased risk.

Assessing postgraduate outcomes of research-intensive nursing science PhD programs: Methods and metrics.

BACKGROUND: Across disciplines and within higher educational systems, assessing postgraduate outcomes is essential for evaluating doctoral programs, including research-intensive nursing science doctoral programs. However, there are limited reports regarding methods and metrics related to postgraduate longitudinal evaluation of research-focused nursing doctoral programs. PURPOSE: The purpose of this paper is to summarize studies in the area of postgraduate outcome assessment and provide recommendations regarding outcome methods and metrics for evaluating the effectiveness of research-focused nursing doctoral programs. METHODS: PubMed/Medline, CINHAL Complete, and Google Scholar databases were searched using key words including PhD program, doctoral program, longitudinal evaluation, evaluation, program evaluation, PhD alumni survey, education outcomes and PhD program outcomes. We excluded non-English and full-text articles that were not available for review. DISCUSSION: Based on a review of the literature, there are few reports on methods and questionnaires for postgraduate outcome assessment. There is a critical need to develop standardized core metrics/questions, longitudinal assessments, and a shared data repository. The latter will allow for comparisons across nursing doctoral programs. CONCLUSION: Robust standardized longitudinal assessment of nursing doctoral programs is a necessary step for comparison across programs and re-envisioning the nursing doctoral education of the future.

Seeking to Understand: Qualitative Research on Sustainability of Evidence-Based Practice in Acute Care.

OBJECTIVE: The aim of this study was to describe cultural characteristics, values, and beliefs that influence sustainability of an evidence-based practice (EBP) intervention in the acute care clinical setting. BACKGROUND: There is an urgent need to identify best practices to sustain EBP to gain efficiencies in nursing care delivery and improve patient outcomes. METHODS: A focused ethnographic qualitative study was conducted in a community hospital with nurses that used Screening, Brief Intervention, and Referral to Treatment (SBIRT). RESULTS: Customizing the intervention to the unit culture evolved and was crucial for sustainability. Overlap in responsibilities, time, clinician confidence, and impact to workflow were noted as negative influences. The intervention was primarily viewed as a task to be checked off a list instead of a tool that informs the patient's plan of care. CONCLUSIONS: Assessing clinician experiences, beliefs, and values of an EBP should be incorporated into a strategic sustainability plan. Clinician understanding of how an EBP can advance the patient plan of care could promote ownership of professional practice and sustainment.

Effects of a refined evidence-based toolkit and mentored implementation on medication reconciliation at 18 hospitals: results of the MARQUIS2 study.

BACKGROUND: The first Multicenter Medication Reconciliation Quality Improvement (QI) Study (MARQUIS1) demonstrated that mentored implementation of a medication reconciliation best practices toolkit decreased total unintentional medication discrepancies in five hospitals, but results varied by site. The objective of this study was to determine the effects of a refined toolkit on a larger group of hospitals. METHODS: We conducted a pragmatic quality improvement study (MARQUIS2) at 18 North American hospitals or hospital systems from 2016 to 2018. Incorporating lessons learnt from MARQUIS1, we implemented a refined toolkit, offering 17 system-level and 6 patient-level interventions. One of eight physician mentors coached each site via monthly calls and performed one to two site visits. The primary outcome was number of unintentional medication discrepancies in admission or discharge orders per patient. Time series analysis used multivariable Poisson regression. RESULTS: A total of 4947 patients were sampled, including 1229 patients preimplementation and 3718 patients postimplementation. Both the number of system-level interventions adopted per site and the proportion of patients receiving patient-level interventions increased over time. During the intervention, patients experienced a steady decline in their medication discrepancy rate from 2.85 discrepancies per patient to 0.98 discrepancies per patient. An interrupted time series analysis of the 17 sites with sufficient data for analysis showed the intervention was associated with a 5% relative decrease in discrepancies per month over baseline temporal trends (adjusted incidence rate ratio: 0.95, 95% CI 0.93 to 0.97, p<0.001). Receipt of patient-level interventions was associated with decreased discrepancy rates, and these associations increased over time as sites adopted more system-level interventions. CONCLUSION: A multicentre medication reconciliation QI initiative using mentored implementation of a refined best practices toolkit, including patient-level and system-level interventions, was associated with a substantial decrease in unintentional medication discrepancies over time. Future efforts should focus on sustainability and spread.

Implementation strategies in the context of medication reconciliation: a qualitative study.

BACKGROUND: Medication reconciliation (MedRec) is an important patient safety initiative that aims to prevent patient harm from medication errors. Yet, the implementation and sustainability of MedRec interventions have been challenging due to contextual barriers like the lack of interprofessional communication (among pharmacists, nurses, and providers) and limited organizational capacity. How to best implement MedRec interventions remains unclear. Guided by the Expert Recommendations for Implementing Change (ERIC) taxonomy, we report the differing strategies hospital implementation teams used to implement an evidence-based MedRec Toolkit (the MARQUIS Toolkit). METHODS: A qualitative study was conducted with implementation teams and executive leaders of hospitals participating in the federally funded "Implementation of a Medication Reconciliation Toolkit to Improve Patient Safety" (known as MARQUIS2) research study. Data consisted of transcripts from web-based focus groups and individual interviews, as well as meeting minutes. Interview data were transcribed and analyzed using content analysis and the constant comparison technique. RESULTS: Data were collected from 16 hospitals using 2 focus groups, 3 group interviews, and 11 individual interviews, 10 sites' meeting minutes, and an email interview of an executive. Major categories of implementation strategies predominantly mirrored the ERIC strategies of "Plan," "Educate," "Restructure," and "Quality Management." Participants rarely used the ERIC strategies of finance and attending to policy context. Two new non-ERIC categories of strategies emerged-"Integration" and "Professional roles and responsibilities." Of the 73 specific strategies in the ERIC taxonomy, 32 were used to implement the MARQUIS Toolkit and 11 new, and non-ERIC strategies were identified (e.g., aligning with existing initiatives and professional roles and responsibilities). CONCLUSIONS: Complex interventions like the MARQUIS MedRec Toolkit can benefit from the ERIC taxonomy, but adaptations and new strategies (and even categories) are necessary to fully capture the range of approaches to implementation.

Organizational Readiness for Lung Cancer Screening: A Cross-Sectional Evaluation at a Veterans Affairs Medical Center.

OBJECTIVES: Lung cancer has the highest cancer-related mortality in the United States and among Veterans. Screening of high-risk individuals with low-dose CT (LDCT) can improve survival through detection of early-stage lung cancer. Organizational factors that aid or impede implementation of this evidence-based practice in diverse populations are not well described. We evaluated organizational readiness for change and change valence (belief that change is beneficial and valuable) for implementation of LDCT screening. METHODS: We performed a cross-sectional survey of providers, staff, and administrators in radiology and primary care at a single Veterans Affairs Medical Center. Survey measures included Shea's validated Organizational Readiness for Implementing Change (ORIC) scale and Shea's 10 items to assess change valence. ORIC and change valence were scored on a scale from 1 to 7 (higher scores representing higher readiness for change or valence). Multivariable linear regressions were conducted to determine predictors of ORIC and change valence. RESULTS: Of 523 employees contacted, 282 completed survey items (53.9% overall response rate). Higher ORIC scores were associated with radiology versus primary care (mean 5.48, SD 1.42 versus 5.07, SD 1.22, ß = 0.37, P = .039). Self-identified leaders in lung cancer screening had both higher ORIC (5.56, SD 1.39 versus 5.11, SD 1.26, ß = 0.43, P = .050) and change valence scores (5.89, SD 1.21 versus 5.36, SD 1.19, ß = 0.51, P = .012). DISCUSSION: Radiology health professionals have higher levels of readiness for change for implementation of LDCT screening than those in primary care. Understanding health professionals' behavioral determinants for change can inform future lung cancer screening implementation strategies.

Implementing a prospective surveillance and early intervention model of care for breast cancer-related lymphedema into clinical practice: application of the RE-AIM framework.

PURPOSE: Chronic lymphedema following breast cancer (BC) affects individuals physically, functionally, psychologically, and financially. Despite national guidelines and evidence-based research supporting a prospective surveillance and early intervention model of care (PSM), bridging the gap between research and clinical practice has been difficult. METHOD: As part of an international randomized controlled trial (RCT), Australian women with BC from four hospitals were recruited, monitored for lymphedema at regular intervals over a 3-year period, and were provided a compression garment if intervention was triggered. The reach, effectiveness, adoption, implementation and maintenance (RE-AIM) evaluation framework was used retrospectively to assess a PSM at the individual and organizational level for those who had completed at least 2-year follow-up (N = 219) in the RCT. RESULTS: The application of the RE-AIM framework retrospectively demonstrated an extensive reach to patients across public and private settings; the effectiveness of prospective surveillance and early intervention was achieved through low progression rates to clinical lymphedema (1.8%), and all hospital sites initially approached adopted the research study. Key implementation strategies necessary for effectiveness of this model of care included education to health professionals and patients, staff acceptability, and development of a referral and care pathway. Maintenance dimensions were evaluated both at the individual level with 92-100% adherence rates for all nonoptional study appointments over the 2-year period, and at the organizational-level, PSM was sustained after recruitment ceased for the research study. CONCLUSION: The PSM for lymphedema in BC can be successfully implemented using the RE-AIM framework applied retrospectively. The implementation of the PSM used in the RCT has assisted in changing clinical practices and improving the quality and effectiveness of the health care system.