Specification, validation, and adherence of quality indicators to optimize the safe use of nonsteroidal anti-inflammatory drugs for knee osteoarthritis pain in the primary care setting.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) used for osteoarthritis (OA) in primary care may cause gastrointestinal or renal injury. This study estimated adherence to two quality indicators (QIs) to optimize NSAID safety: add proton pump inhibitors (PPI) to NSAIDs for patients with gastrointestinal (GI) risk (QI #1 NSAID-PPI) and avoid oral NSAIDs in chronic kidney disease (CKD) stage G4 or G5 (QI #2 NSAID-CKD). METHODS: This retrospective study included index primary care clinic visits for knee OA at our health system in 2019. The validation cohort consisted of a random sample of 60 patients. The remainder were included in the expanded cohort. Analysis of structured data extracts was validated against chart review of clinic visit notes (validation cohort) and estimated QI adherence (expanded cohort). RESULTS: Among 60 patients in the validation cohort, analysis of data extracts was validated against chart review for QI #1 NSAID-PPI (100% sensitivity and 91% specificity) and QI #2 NSAID-CKD (100% accuracy). Among 335 patients in the expanded cohort, 44% used NSAIDs, 27% used PPIs, 73% had elevated GI risk, and only 2% had CKD stage 4 or 5. Twenty-one percent used NSAIDs and had elevated GI risk but were not using PPIs. Therefore, adherence to QI #1 NSAID-PPI was 79% (95% CI, 74-83%). No patients with CKD stage 4 or 5 used NSAIDs. Therefore, adherence to QI #2 NSAID-CKD was 100%. CONCLUSION: A substantial proportion of knee OA patients with GI risk factors did not receive PPI with NSAID therapy during primary care visits.

Quality indicators for osteoarthritis pain management in the primary care setting.

BACKGROUND: Development of valid and feasible quality indicators (QIs) is needed to track quality initiatives for osteoarthritis pain management in primary care settings. METHODS: Literature search identified published guidelines that were reviewed for QI extraction. A panel of 14 experts was assembled, including primary care physicians, rheumatologists, orthopedic surgeons, pain specialists, and outcomes research pharmacists. A screening survey excluded QIs that cannot be reliably extracted from the electronic health record or that are irrelevant for osteoarthritis in primary care settings. A validity screening survey used a 9-point Likert scale to rate the validity of each QI based on predefined criteria. During expert panel discussions, stakeholders revised QI wording, added new QIs, and voted to include or exclude each QI. A priority survey used a 9-point Likert scale to prioritize the included QIs. RESULTS: Literature search identified 520 references published from January 2015 to March 2021 and 4 additional guidelines from professional/governmental websites. The study included 41 guidelines. Extraction of 741 recommendations yielded 115 candidate QIs. Feasibility screening excluded 28 QIs. Validity screening and expert panel discussion excluded 73 QIs and added 1 QI. The final set of 15 prioritized QIs focused on pain management safety, education, weight-management, psychological wellbeing, optimizing first-line medications, referral, and imaging. CONCLUSION: This multi-disciplinary expert panel established consensus on QIs for osteoarthritis pain management in primary care settings by combining scientific evidence with expert opinion. The resulting list of 15 prioritized, valid, and feasible QIs can be used to track quality initiatives for osteoarthritis pain management.

Using the 4 pillars™ practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial.

BACKGROUND: An evidence-based, step-by-step guide, the 4 Pillars™ Practice Transformation Program, was the foundation of an intervention to increase adult immunizations in primary care and was tested in a randomized controlled cluster trial. The purpose of this study is to report changes in influenza immunization rates and on factors related to receipt of influenza vaccine. METHODS: Twenty five primary care practices were recruited in 2013, stratified by city (Houston, Pittsburgh), location (rural, urban, suburban) and type (family medicine, internal medicine), and randomized to the intervention (n = 13) or control (n = 12) in Year 1 (2013-14). A follow-up intervention occurred in Year 2 (2014-15). Demographic and vaccination data were derived from de-identified electronic medical record extractions. RESULTS: A cohort of 70,549 adults seen in their respective practices (n = 24 with 1 drop out) at least once each year was followed. Baseline mean age was 55.1 years, 35 % were men, 21 % were non-white and 35 % were Hispanic. After one year, both intervention and control arms significantly (P < 0.001) increased influenza vaccination, with average increases of 2.7 to 6.5 percentage points. In regression analyses, likelihood of influenza vaccination was significantly higher in sites with lower percentages of patients with missed opportunities (P < 0.001) and, after adjusting for missed opportunities, the intervention further improved vaccination rates in Houston (lower baseline rates) but not Pittsburgh (higher baseline rates). In the follow-up intervention, the likelihood of vaccination increased for both intervention sites and those that reduced missed opportunities (P < 0.005). CONCLUSIONS: Reducing missed opportunities across the practice increases likelihood of influenza vaccination of adults. The 4 Pillars™ Practice Transformation Program provides strategies for reducing missed opportunities to vaccinate adults. TRIAL REGISTRATION: This study was registered as a clinical trial on 03/20/2013 at ClinicalTrials.gov, Clinical Trial Registry Number: NCT01868334 , with a date of enrollment of the first participant to the trial of April 1, 2013.

Cultivating a cycle of trust with diverse communities in practice-based research: a report from PRIME Net.

PURPOSE: Practice-based research networks (PBRNs) are increasingly seen as important vehicles to translate research into practice, although less is known about the process of engaging diverse communities in PBRN research. The objective of this study was to identify strategies for successfully recruiting and retaining diverse racial/ethnic communities into PBRN research studies. METHODS: This collaborative, multisite study engaged 5 of the 8 networks of the PRImary care MultiEthnic Network (PRIME Net) consortium that conducts research with traditionally underrepresented/underserved populations. We used a sequential, qualitative research design. We first conducted 1 key informant interview with each of 24 researchers experienced in recruiting research participants from 5 racial/ethnic communities (African American, Arab/Chaldean, Chinese, Hispanic, and Native American). Subsequently, we conducted 18 focus groups with 172 persons from these communities. RESULTS: Participants' comments indicated that successful recruitment and retention of underrepresented populations in PBRN studies is linked to the overall research process. This process, which we termed the cycle of trust, entailed developing and sustaining relationships of trust during 4 interrelated stages: before the study, during study recruitment, throughout study conduct, and after study completion. Participants identified a set of flexible strategies within each stage and called for close engagement with clinic and community partners. CONCLUSIONS: Our participants suggest that approaches to research that lay a foundation of trust, demonstrate respect for community members, and extend beyond the enrollment and data collection phases are essential to enhance the participation of diverse populations in PBRN research. These findings offer the PBRN community a guide toward achieving this important goal.

Spirituality and confidence to resist substance use among celebrate recovery participants.

Since self-efficacy is a positive predictor of substance use treatment outcome, we investigated whether it is associated with spirituality within a religious 12-step program. This was a cross-sectional survey (N = 91) of 10 different Celebrate Recovery sites held at community churches. The mean spirituality score for those with high confidence was significantly greater than those with low confidence. Spirituality associated with greater confidence to resist substance use (OR = 1.09, 95% CI 1.02-1.17, P < 0.05). So every unit increase of measured spirituality increased the odds of being above the median in self-efficacy by 9%. We conclude that spirituality may be an important explanatory variable in outcomes of a faith-based 12-step recovery program.

Using a Mixed Methods Approach to Examine Practice Characteristics Associated With Implementation of an Adult Immunization Intervention Using the 4 Pillars Practice Transformation Program.

Adult immunization rates are consistently suboptimal, exacting significant human and financial burden of preventable disease. Practice-level interventions to improve immunization rates have produced mixed results. The context of change critically affects implementation of evidence-based interventions. We conducted a randomized controlled cluster trial of the 4 Pillars Practice Transformation Program to increase adult vaccination rates in primary care practices and used qualitative methods to test intervention effects and understand practice characteristics associated with implementation success. We conducted qualitative interviews with staff from 14 practices to assess implementation experiences. Thematic analysis of data pointed to the importance of quality improvement history, communication and practice leadership, Immunization Champion leadership effectiveness, and organizational flexibility. Practices were scored on these characteristics and grouped into four types: Low Implementers, Medium Implementers, High Implementers, and Public/University Practices. Intervention uptake and immunization rate changes were compared, and a significant increase in influenza vaccination rates (3.9 percentage points [PPs]; p = .038) was observed for High Implementers only. Significant increases in Tdap vaccination rates were observed for High Implementers (9.3 PP; p = 0.006) and the Public/University groups (6.5 PP; p = 0.012), but not other groups. Practice characteristics may be critical factors in predicting intervention success.

Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Trial.

OBJECTIVES: To test the effectiveness of a step-by step, evidence-based guide, the 4 Pillars Practice Transformation Program, to increase adult pneumococcal vaccination. DESIGN: Randomized controlled cluster trial (RCCT) in Year 1 (June 1, 2013 to May 31, 2014) and pre-post study in Year 2 (June 1, 2014 to January 31, 2015) with data analyzed in 2016. Baseline year was June 1, 2012, to May 31, 2013. Demographic and vaccination data were derived from deidentified electronic medical record extractions. SETTING: Primary care practices (n = 25) stratified according to metropolitan area (Houston, Pittsburgh), location (rural, urban, suburban), and type (family medicine, internal medicine), randomized to receive the intervention in Year 1 (n = 13) or Year 2 (n = 12). PARTICIPANTS: Individuals aged 65 and older at baseline (N = 18,107; mean age 74.2; 60.7% female, 16.5% non-white, 15.7% Hispanic). INTERVENTION: The 4 Pillars Program, provider education, and one-on-one coaching of practice-based immunization champions. Outcome measures were 23-valent pneumococcal polysaccharide vaccine (PPSV) and pneumococcal conjugate vaccine (PCV) vaccination rates and percentage point (PP) changes in vaccination rates. RESULTS: In the Year 1 RCCT, PPSV vaccination rates increased significantly in all intervention and control groups, with average increases ranging from 6.5 to 8.7 PP (P < .001). The intervention was not related to greater likelihood of PPSV vaccination. In the Year 2 pre-post study, the likelihood of PPSV and PCV vaccination was significantly higher in the active intervention sites than the maintenance sites in Pittsburgh but not in Houston. CONCLUSION: In a RCCT, PPSV vaccination rates increased in the intervention and control groups in Year 1. In a pre-post study, private primary care practices actively participating in the 4 Pillars Practice Transformation Program improved PPSV and PCV uptake significantly more than practices that were in the maintenance phase of the study.

Toward silencing the burden of malaria: progress and prospects for RNAi-based approaches.

The discovery of RNA interference (RNAi) is one of the most significant of recent years, with potential for application beyond the laboratory to the clinic. As a tool for functional genomics, RNAi has permitted the characterization of genes in organisms that had previously remained recalcitrant to targeted gene manipulation. Efforts to understand its mode of action have revealed a central role in gene regulation and host defense. Finally, as a therapeutic tool, it has shown enormous promise in the control of a large array of diseases. Here we examine how RNAi is revolutionizing malaria research in an organism, the Anopheles mosquito, that until recently was essentially resistant to genetic study, and show how its application in both the mosquito vector and the Plasmodium parasite might ultimately lead to new ways of controlling and perhaps even eradicating this devastating disease.

Stable and heritable gene silencing in the malaria vector Anopheles stephensi.

Heritable RNA interference (RNAi), triggered from stably expressed transgenes with an inverted repeat (IR) configuration, is an important tool for reverse genetic studies. Here we report on the development of stable RNAi in Anopheles stephensi mosquitoes, the major vector of human malaria in Asia. Trans genic mosquitoes stably expressing a RNAi transgene, designed to produce intron-spliced double-stranded RNA (dsRNA) targeting the green fluorescent protein EGFP gene, were crossed to an EGFP-expressing target line. EGFP expression was dramatically reduced at both the protein and RNA levels. The levels of gene silencing depended upon the RNAi gene copy number and its site of integration. These results demonstrate that specific RNAi-mediated knockdown of gene function can be achieved with high efficiency in Anopheles . This will be invaluable to systematically unravel the function of Anopheles genes determining the vectorial capacity of the malaria parasite.

Using the 4 Pillars™ Practice Transformation Program to increase adult Tdap immunization in a randomized controlled cluster trial.

INTRODUCTION: National adult Tdap vaccination rates are low, reinforcing the need to increase vaccination efforts in primary care offices. The 4 Pillars™ Practice Transformation Program is an evidence-based, step-by-step guide to improving primary care adult vaccination with an online implementation tracking dashboard. This study tested the effectiveness of an intervention to increase adult Tdap vaccination that included the 4 Pillars™ Program, provider education, and one-on-one coaching of practice-based immunization champions. METHODS: 25 primary care practices participated in a randomized controlled cluster trial (RCCT) in Year 1 (6/1/2013-5/31/2014) and a pre-post study in Year 2 (6/1/2014-1/31/2015). Baseline year was 6/1/2012-5/31/2013, with data analyzed in 2016. Demographic and vaccination data were derived from de-identified electronic medical record (EMR) extractions. The primary outcomes were vaccination rates and percentage point (PP) changes/year. RESULTS: The cohort consisted of 70,549 patients ⩾18years who were seen in the practices ⩾1 time each year, with a baseline mean age=55years; 35% were men; 56% were non-white; 35% were Hispanic and 20% were on Medicare. Baseline vaccination rate averaged 35%. In the Year 1 RCCT, cumulative Tdap vaccination increased significantly in both intervention and control groups; in both cities, the percentage point increases in the intervention groups (7.7 PP in Pittsburgh and 9.9 PP in Houston) were significantly higher (P<0.001) than in the control groups (6.4 PP in Pittsburgh and 7.6 PP in Houston). In the Year 2 pre-post study, in both cities, active intervention groups increased rates significantly more (6.2 PP for both) than maintenance groups (2.2 PP in Pittsburgh and 4.1 PP in Houston; P<0.001). CONCLUSIONS: An intervention that includes the 4 Pillars™ Practice Transformation Program, staff education and coaching is effective for increasing adult Tdap immunization rates within primary care practices. Clinical Trial Registry Name/Number: NCT01868334.

Association of patient recall, satisfaction, and adherence to content of an electronic health record (EHR)-generated after visit summary: a randomized clinical trial.

OBJECTIVE: Most electronic health record (EHR) systems have the capability of generating a printed after-visit summary (AVS), but there has been little research on optimal content. We conducted a qualitative study and a randomized trial to understand the effect of AVS content on patient recall and satisfaction. METHODS: Adult primary care patients (n = 272) with at least 1 chronic condition were randomly assigned to 4 AVS content conditions: minimum, intermediate, maximum, or standard AVS. Demographics and health literacy were measured at an index clinic visit. Recall and satisfaction were measured by telephone 2 days and 2 to 3 weeks after the clinic visit. RESULTS: Average age was 52 years; 75% of patients were female, 61% were Hispanic, and 21% were African American, and 64% had adequate health literacy. Average medication recall accuracy was 53% at 2 days and 52% at 3 weeks, with no significant difference among groups at either time. Satisfaction with AVS content was high and did not differ among groups. Recall of specific content categories was low and unrelated to group assignment. Health literacy was unrelated to recall and satisfaction. CONCLUSION: Primary care patients like to receive an AVS, but the amount of information included does not affect content recall or satisfaction with the information.

Use of community engagement strategies to increase research participation in practice-based research networks (PBRNs).

PURPOSE: Practice-based research networks (PBRNs) are increasingly encouraged to use community engagement approaches. The extent to which PBRNs engage clinic and community partners in strategies to recruit and retain participants from their local communities (specifically racial/ethnic communities) is the focus of this study. METHODS: The design was a cross-sectional survey of PBRN directors in the United States. Survey respondents indicated whether their research network planned for, implemented, and has capacity for activities that engage clinic and community partners in 7 recommended strategies organized into study phases, called the cycle of trust. The objectives of the national survey were to (1) describe the extent to which PBRNs across the United States routinely implement the strategies recommended for recruiting diverse patient groups and (2) identify factors associated with implementing the recommended strategies. RESULTS: The survey response rate was 63%. Activities that build trust often are used more with clinic partners than with community partners. PBRNs that adopt engagement strategies when working with clinic and community partners have less difficulty in recruiting diverse populations. Multivariate analysis showed that the targeting racial/ethnic communities for study recruitment, Clinical and Translational Science Award affiliation, and planning to use community engagement strategies were independent correlates of PBRN implementation of the recommended strategies. CONCLUSION: PBRNs that successfully engage racial/ethnic communities as research partners use community engagement strategies. New commitments are needed to support PBRN researchers in developing relationships with the communities in which their patients live. Stable PBRN infrastructure funding that appreciates the value of maintaining community engagement between funded studies is critical to the research enterprise that values translating research findings into generalizable care models for patients in the community.

Chronic non-cancer pain: a siren for primary care--a report from the PRImary Care MultiEthnic Network (PRIME Net).

INTRODUCTION: Patients with chronic non-cancer pain (CNCP) are common and have a high degree of morbidity. Previous studies document clinician frustration and variability in CNCP management. We conducted this study to gather in-depth clinicians' views about factors that affect management of CNCP. METHODS: We conducted a survey in the Primary Care MultiEthnic Network, a consortium of PBRNs of primary care clinicians practicing in low-income, medically underserved communities, and in a network of private primary care offices. RESULTS: Of 792 clinicians surveyed, 497 (63%) participated. Responses and accompanying narrative comments clustered around 5 themes: (1) barriers to and uncertainties in optimal management; (2) the complex biopsychosocial nature of CNCP; (3) seriousness of prescription opioid abuse; (4) effort and burden required to properly manage CNCP; and (5) clinician commitment to provide care for CNCP patients and benefits of expanded care model for CNCP. One-third reported a severe outcome (death or life-threatening event) in a CNCP patient for whom they had prescribed opioids. Roughly one-third do not initiate prescribing of opioids. CONCLUSIONS: Guidelines and increased continuing medical education alone are unlikely to be the solutions to the challenges of CNCP management. Increased evidence for recommendations and resources for more comprehensive care management are needed.

Short-term starvation of immune deficient Drosophila improves survival to gram-negative bacterial infections.

BACKGROUND: Primary immunodeficiencies are inborn errors of immunity that lead to life threatening conditions. These predispositions describe human immunity in natura and highlight the important function of components of the Toll-IL-1- receptor-nuclear factor kappa B (TIR-NF-kappaB) pathway. Since the TIR-NF-kappaB circuit is a conserved component of the host defence in higher animals, genetically tractable models may contribute ideas for clinical interventions. METHODOLOGY/PRINCIPAL FINDINGS: We used immunodeficient fruit flies (Drosophila melanogaster) to address questions pertaining to survival following bacterial infection. We describe here that flies lacking the NF-kappaB protein Relish, indispensable for countering Gram-negative bacteria, had a greatly improved survival to such infections when subject to dietary short-term starvation (STS) prior to immune challenge. STS induced the release of Nitric Oxide (NO), a potent molecule against pathogens in flies, mice and humans. Administering the NO Synthase-inhibitory arginine analog N-Nitro-L-Arginine-Methyl-Ester (L-NAME) but not its inactive enantiomer D-NAME increased once again sensitivity to infection to levels expected for relish mutants. Surprisingly, NO signalling required the NF-kappaB protein Dif, usually needed for responses against Gram-positive bacteria. CONCLUSIONS/SIGNIFICANCE: Our results show that NO release through STS may reflect an evolutionary conserved process. Moreover, STS could be explored to address immune phenotypes related to infection and may offer ways to boost natural immunity.

A Drosophila ortholog of the human cylindromatosis tumor suppressor gene regulates triglyceride content and antibacterial defense.

The cylindromatosis (CYLD) gene is mutated in human tumors of skin appendages. It encodes a deubiquitylating enzyme (CYLD) that is a negative regulator of the NF-kappaB and JNK signaling pathways, in vitro. However, the tissue-specific function and regulation of CYLD in vivo are poorly understood. We established a genetically tractable animal model to initiate a systematic investigation of these issues by characterizing an ortholog of CYLD in Drosophila. Drosophila CYLD is broadly expressed during development and, in adult animals, is localized in the fat body, ovaries, testes, digestive tract and specific areas of the nervous system. We demonstrate that the protein product of Drosophila CYLD (CYLD), like its mammalian counterpart, is a deubiquitylating enzyme. Impairment of CYLD expression is associated with altered fat body morphology in adult flies, increased triglyceride levels and increased survival under starvation conditions. Furthermore, flies with compromised CYLD expression exhibited reduced resistance to bacterial infections. All mutant phenotypes described were reversible upon conditional expression of CYLD transgenes. Our results implicate CYLD in a broad range of functions associated with fat homeostasis and host defence in Drosophila.

Association of spirituality and sobriety during a behavioral spirituality intervention for Twelve Step (TS) recovery.

Twelve-Step (TS) recovery utilizes spirituality to promote sobriety, yet there are no proven programs designed to facilitate spiritual involvement. We developed a seven-week behavioral spirituality intervention titled "Knowing Your Higher Power" for implementation along with usual TS care. Twenty-six participants from a recovery center enrolled. We assessed behavior at baseline, 7-week, and 12-week follow-up. The sample showed significant increase in spiritual involvement and beliefs over the 12-week measurement period and a significantly greater spirituality score in those maintaining total sobriety compared to those that relapsed. These findings encourage a controlled trial to determine if this work has efficacy for practitioners in substance abuse treatment.

The physician's role in the assessment and treatment of spiritual distress at the end of life.

OBJECTIVE: Patients at the end of their life typically endure physical, emotional, interpersonal, and spiritual challenges. Although physicians assume a clearly defined role in approaching the physical aspects of terminal illness, the responsibility for helping their patients' spiritual adaptation is also important. METHODS: This article (1) describes the terms and definitions that have clinical utility in assessing the spiritual needs of dying patients, (2) reviews the justifications that support physicians assuming an active role in addressing the spiritual needs of their patients, and (3) reviews clinical tools that provide physicians with a structured approach to the assessment and treatment of spiritual distress. RESULTS: This review suggests that physicians can and should be equipped to play a key role in relieving suffering at the end of life. SIGNIFICANCE OF RESULTS: Physicians can help their patients achieve a sense of completed purpose and peace.

Alcohol recovery and spirituality: strangers, friends, or partners?

Alcoholics Anonymous, with its steady but nonspecific promotion of belief in a higher power and its emphasis on the group process, long held a near-monopoly in the outpatient alcohol recovery field, but its hegemony has now been challenged by two very different perspectives. The first is a nonspiritual approach that emphasizes the individual's capability to find a personal pathway to sobriety, exemplified by Rational Recovery. The second is a faith-based method, built on a religious understanding of alcoholism, of which Celebrate Recovery is a prominent example, based upon Christianity. Most communities offer a variety of approaches, so clinicians who are aware of these differences are in a good position to help patients make intelligent choices among the competing recovery philosophies.

Depressed mood and social support as predictors of quality of life in women receiving home health care.

We examined relationships among depressed mood, social support and quality of life in 58 medically ill low-income women 40 years and older receiving home health care. Analyses showed a negative relationship between depressed mood and quality of life (p's < or = 0.05). Positive relationships were found between number of people available for support and two of three quality of life domains as well as satisfaction with support and all three domains (p's < or = 0.05). Results also provided preliminary support that belonging to a church is related to emotional well-being (p = 0.039) and among those belonging to a church, recent increased activity was related to social/family well-being (p = 0.004). Mediational analyses revealed a cycle of depressed mood, dissatisfaction with social support, and loss of social support providers underlying the poor quality of life of many participants. This highlights the need to address the relationship between depression and social support when treating patients with chronic illness.