Using the integrated theory of health behavior change to assess factors affecting diabetes medication adherence among black adults during COVID-19: an explanatory sequential mixed methods design.

OBJECTIVES: (1) Evaluate changes in medication adherence and the role of psychosocial and interpersonal factors on adherence. (2) Explain the changes in medication adherence based on patient perceptions of adherence behaviors. DESIGN: We used an explanatory sequential mixed methods design for surveys at baseline and 1-year follow-up, followed by interviews. The Integrated Theory of Health Behavior Change guided the design of a questionnaire including self-reported measures of medication adherence, psychosocial factors such as illness and medication beliefs, self-efficacy, and depressive symptoms, interpersonal factors including social support and patient-provider communication, and socio-demographic and clinical factors. A convenience sample (n = 228) of adult patients with type 2 diabetes who self-identified as Black/African American completed the mail/telephone surveys. Nine semi-structured interviews were conducted with respondents of both surveys who had changes in medication adherence. Descriptive, mean differential, bivariate correlational analyses, and content analysis was conducted. Data integration merged quantitative and qualitative results as a joint display. RESULTS: Response rates for the baseline and follow-up survey were 28% and 47% respectively. Medication adherence scores were significantly correlated with illness perceptions (r = .30) and depression (r = .25) at baseline, and self-efficacy (r = -.51) and depression (r = .37) at follow-up. Qualitative themes included patient perceptions of adherence behaviors, impact of the COVID-19 pandemic, health literacy and self-efficacy. Mixed methods integration showed contrasting perceptions of the same themes including adherence behaviors, medication beliefs, social support, and patient-provider communication among participants whose medication adherence increased and decreased overtime. CONCLUSION: Self-efficacy, diabetes beliefs, and depressive symptoms were key psychosocial factors that affected medication adherence among Blacks/African Americans. Contrasting perceptions of beliefs in medicines, social support, provider relationships and communication among increased and decreased adherence participant groups explained the changes in adherence, which can be used to adapt existing interventions.

Clinical and Radiographic Evaluation of Calcium Phosphate-Poly(lactide-co-glycolide) Graft in Regeneration of Intrabony Defects: Randomized Control Trial.

AIM: This study aims to evaluate the efficacy of calcium phosphate-poly(lactide-co-glycolide) composite graft in the regeneration of intrabony defects in chronic periodontitis patients over a period of 12 months. MATERIALS AND METHODS: A total of 11 systemically healthy chronic periodontitis patients with 22 graftable sites were treated with calcium phosphate cement (CPC) bone graft (control group) and CPC-poly(lactic-co-glycolic acid)(PLGA) composite (test group) after flap reflection and debridement. Clinical parameters such as probing pocket depth (PPD) and clinical attachment level (CAL) were recorded at baseline and 3, 6, 9, and 12 months. Bone probing depth (BPD) and radiographic parameters such as defect depth (DD), changes in alveolar crest level (ALR), defect depth reduction (DDR), and percentage in defect depth reduction (PDDR) were calculated at baseline, and 6 and 12 months. The data were recorded and statistically analyzed. RESULTS: On intragroup comparison, there was a significant improvement in all the parameters over a period of 1 year (clinically and radiographically). However, there was no statistically significant difference between the two groups in any of the parameters though there was a slightly higher bone fill noted in the test group. CONCLUSION: Even though the CPC-PLGA composite bone graft showed a slight improvement in clinical and radiographic parameters as compared to the CPC graft, it was not statistically significant. CLINICAL SIGNIFICANCE: A major drawback of Calcium Phosphate cements as bone grafts is their poor degradability. The PLGA microspheres degrade to expose macropores and interconnected pores in the graft substrate which in turn would promote the ingrowth of osteoblasts. Also, this composite graft is mouldable, and resorbable and has been shown to snugly fit into the defects making them a suitable scaffold material. How to cite this article: Ojha M, Pawar Chandrashekara Rao D, Gowda V. Clinical and Radiographic Evaluation of Calcium Phosphate-Poly(lactide-co-glycolide) Graft in Regeneration of Intrabony Defects: Randomized Control Trial. J Contemp Dent Pract 2023;24(12):921-927.

Psychometric evaluation of a culturally adapted illness perception questionnaire for African Americans with type 2 diabetes.

BACKGROUND: Diabetes is burdensome to African Americans, who are twice as likely to be diagnosed, more likely to develop complications and are at a greater risk for death and disability than non-Hispanic whites. Medication adherence interventions are sometimes ineffective for African Americans because their unique illness perceptions are not adequately addressed. The Illness Perception Questionnaire-Revised (IPQ-R) that assesses illness perceptions has shown reliability and validity problems when used with African Americans. Thus, the study objective was to adapt the IPQ-R for African Americans and assess the validity and reliability of the culturally adapted questionnaire. METHODS: The parent study used an exploratory sequential mixed methods design, to explore African Americans' illness perceptions qualitatively, used the results to adapt the IPQ-R, and tested the culturally adapted IPQ-R items quantitatively. In this paper, a preliminary culturally adapted IPQ-R refined based on the qualitative study, was administered to 170 middle-aged United States-based African Americans with type 2 diabetes in a face-to-face survey. Content, construct, convergent, and predictive validity, including reliability was examined. Pearson and item-total correlations, item analysis, exploratory factor analysis, multiple linear regression analysis, and test-retest were conducted. RESULTS: A revised culturally adapted IPQ-R was identified with a 9-factor structure and was distinct from the old factor structure of the original IPQ-R. The 'consequences' domain from the IPQ-R occurred as two factors (external and internal consequences) while the 'emotional representations' domain in the IPQ-R emerged as separate 'present' and 'future' emotional representation factors. Illness coherence' was differently conceptualized as 'illness interpretations' to capture additional culturally adapted items within this domain. Most items had factor loadings greater than 0.4, with moderate factor score correlations. Necessity and concern beliefs in medicines significantly correlated with domains of the culturally adapted IPQ-R. Pearson's correlation values were not greater than 0.7, indicating good convergent validity. The culturally adapted IPQ-R significantly predicted medication adherence. None of the correlation values were higher than 0.7 for the test-retest, indicating moderate reliability. Most domains of the culturally adapted IPQ-R had Cronbach's alpha values higher than 0.7, indicating good internal consistency. CONCLUSIONS: The results provide preliminary support for the validity of the culturally adapted IPQ-R in African Americans with diabetes, showing good construct, convergent and predictive validity, as well as reliability.

Wait No Longer: Reducing Medication Wait-Times for Individuals with Co-Occurring Disorders.

Objective: Community addiction treatment agencies have utilized Network for the Improvement of Addiction Treatment (NIATx), a proven implementation strategy, to reduce appointment wait-times. However, its effectiveness at reducing medication access wait-times has not been explored. Thus, we conducted an exploratory analysis to evaluate the impact of the NIATx implementation strategies on reduced wait-times to addiction, psychotropic or both medications for individuals with co-occurring disorders (COD). Methods: In a cluster-randomized waitlist control group design, community addiction treatment agencies (n = 49) were randomized to receive the NIATx strategy (Cohort 1, n = 25) or to a Waitlist control (Cohort 2, n = 24). All agencies had a 12-month active intervention period. The primary outcome was the medication encounter wait-time. A univariate general linear model analysis utilizing a logarithmic (log10) transformation examined medication wait-times improvements. Results: The intent-to-treat analysis for psychotropic medications and both medications (reflecting integrated treatment) showed significant main effects for intervention and time, especially comparing Baseline and Year 1 to Year 2. Conversely, only the main effect for time was significant for addiction medications. Wait-time reductions in Cohort 1 agencies was delayed and occurred in the sustainment phase. Wait-times to a psychotropic, addiction, or both medications encounter declined by 3 days, 4.9 days, and 6.8 days, respectively. For Cohort 2 agencies, reduced wait-times were seen for psychotropic (3.4 days), addiction (6 days), and both medications (4.9 days) during their active implementation period. Same- or next-day medication access also improved. Conclusions: NIATx implementation strategies reduced medication encounter wait-times but timing of agency improvements varied. Despite a significant improvement, a three-week wait-time to receive integrated pharmacological interventions is clinically suboptimal for individuals with a COD in need of immediate intervention. Community addiction treatment agencies should identify barriers and implement changes to improve medication access so that their patients "wait no longer" to receive integrated treatment and medications for their COD.

Pharmacist Views Regarding the Prescription Opioid Epidemic.

Community pharmacists have significant opportunity to contribute to prevention and treatment of opioid use disorders, but barriers to implementation still exist. Understanding their viewpoints is critical to designing future interventions.To qualitatively explore experiences and beliefs of community pharmacists regarding the misuse of prescription opioids in the United States.The study was part of a larger project that utilized a survey questionnaire to evaluate the relationships between knowledge, attitudes, and practices of community pharmacists in substance use disorders. The survey included an open-ended item on pharmacist views regarding the prescription opioid epidemic. The responses were used for inductive content analysis. Axial coding of themes was conducted to analyze underlying relationships: associations, consequences, intervening relationships, and action strategies regarding a central phenomenon. A model describing pharmacist experiences in the opioid epidemic was conceptualized.The open-ended question resulted in 50 (37.3%) usable responses. Final abstraction resulted in six themes including (1) overprescribing opioids: inappropriate prescribing as a contributor to the epidemic, (2) policy and practice recommendations: potential action strategies against the epidemic, (3) poor prescriber-pharmacist relationship: barrier to addressing the epidemic, (4) negative attitudes: intervening condition affecting roles of the pharmacist, (5) personal experience: facilitator to improve pharmacist roles and (6) decreased access to opioids: consequence of strict prescribing laws.The study identified themes that described pharmacist views, attitudes, barriers, and experiences related to their perceived role in prevention and treatment of opioid use disorders. Future research should consider the implications of the barriers and facilitators identified.

The relationship between knowledge, attitudes, and practices of community pharmacists regarding persons with substance use disorders.

Background: Community pharmacists can play a meaningful role in identification and treatment of substance use disorders (SUD). However, inadequate disease knowledge and negative attitudes are known barriers. The relationship between knowledge, attitudes, and practice of pharmacists regarding persons with SUD has not been evaluated comprehensively in the United States. The objective of the study was to assess knowledge of community pharmacists regarding medications for SUD and evaluate their attitudes, levels of stigma, and clinical practices in SUD. Methods: A questionnaire was developed to assess practices, knowledge, screening services, and attitudes toward harm reduction strategies and treatment. A standardized measure of stigma was included along with demographics. A cross-sectional electronic survey was conducted in Pennsylvania, Ohio, and West Virginia among a non-probability sample of community pharmacists working for a retail pharmacy chain (n = 910) and a local alumni network (n = 50). Scores were calculated for each factor and descriptive analyses, mean differences (t-tests and ANOVA), correlations with demographics and practice characteristics were performed. Linear and ordinal regressions were utilized to predict knowledge, practice, screening, and stigma scores. Results: A total of 134 responses (response rate 13.9%) were collected. On average, the pharmacists were 38 years old, had worked for 15 years, primarily full-time with practice locations in suburban settings. Only 53% reported they received SUD education in pharmacy school. Pharmacists received a mean score of 5.5 and 3.5 out of eight and seven on knowledge and practice scales, respectively. Pharmacists overall had slightly stigmatizing and negative attitudes, with higher stigma significantly related to performing lesser services and considering screenings as important. Number of years worked significantly predicted knowledge and screening. Conclusion: Relationships between knowledge, attitudes, and practices indicate a need for experiential education that includes psychosocial aspects of care with increased opportunities for practice.

Barriers and facilitators to shared decision-making in oncology: a systematic review of the literature.

PURPOSE: Shared decision-making (SDM) is a strategy to facilitate patient-centered care and is increasingly important in oncology, where patients are faced with complicated treatment decisions that require them to weigh efficacy and safety, quality of life, and cost. Understanding the contributors to the use of SDM may provide insight to its further implementation. Therefore, the objective of the study was to examine the patient-related barriers/facilitators to SDM in oncology care. METHODS: A systematic literature review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was executed. A search strategy composed of cancer, decision-making, and patient-centered terms was conducted utilizing PubMed, EBSCO MEDLINE, Scopus, CINAHL, and the Cochrane Library databases between January 2007 and November 2017. Full-text, US-based, English language articles describing the patient perspective of SDM in oncology care were included. Relevant data from articles were reviewed in a qualitative synthesis. RESULTS: From 3435 potential citations, a total of 35 articles were included. The most common cancers studied were breast (n = 22; 62.9%) and prostate (n = 9; 25.7%). The identified themes for barriers to SDM were uncertainty in the treatment decision, concern regarding adverse effects, and poor physician communication. Themes for facilitators for SDM included physician consideration of patient preferences, positive physician actions and behaviors, and use or encouragement of support systems. CONCLUSION: As SDM gains use within oncology practice, understanding key influences will allow for more effective implementation of strategies to increase patient engagement and improve care and value in the treatment process.

Hemisection: A Treatment Option for an Endodontically treated Molar with Vertical Root Fracture.

Vertical root fractures (VRF) in endodontically treated teeth have long been reported and pose diagnostic difficulties. A hemisection/root resection procedures removes the fractured fragments completely, and retains a portion of the compromized tooth offers a predictable treatment option. The key to this rests in ideal case selection involving balancing all indications and contraindications. The success of the treatment depends on careful case selection based on a firm set of guidelines. This article presents a case with VRF in an endodontic treated molar. This article describes the case of a 65-year-old man with a VRF on the mesial root and a healthy periodontium supporting the distal root making it ideal for retention as well as restoration and support of the final prosthesis. Also, the patient was motivated to try and save as much of the tooth as possible. Postoperatively no untoward complication was reported making it an alternative treatment option in patients with VRF in a molar, willing to retain the remaining tooth portion. With all other factors balanced, it allows for retaining the remaining intact portion of the tooth structure.

Patient and pharmacist perspectives on opioid misuse screening and brief interventions in community pharmacies.

BACKGROUND: Pharmacy-based screening and brief interventions (SBI) offer opportunities to identify opioid misuse and opioid safety risks and provide brief interventions that do not overly burden pharmacists. Currently, such interventions are being developed without patient input and in-depth contextual data and insufficient translation into practice. The purpose of this study is to qualitatively explore and compare patient and pharmacist perceptions and needs regarding a pharmacy-based opioid misuse SBI and to identify relevant SBI features and future implementation strategies. METHODS: Using the Consolidated Framework for Implementation Research, we conducted semi-structured interviews with 8 patients and 11 pharmacists, to explore needs and barriers to participating in a pharmacy-based SBI. We recruited a purposive sample of English-speaking patients prescribed opioids for chronic or acute pain and pharmacists practicing in varied pharmacies (small independent, large-chain, specialty retail) settings. We used an inductive content analysis approach to analyze patient interview data. Then through a template analysis approach involving comparison of pharmacist and patient themes, we developed strategies for SBI implementation. RESULTS: Most patient participants were white, older, described living in suburban areas, and were long-term opioid users. We identified template themes related to individual, interpersonal, intervention, and implementation factors and inferred applications for SBI design or potential SBI implementation strategies. We found that patients needed education on opioid safety and general opioid use, regardless of opioid use behaviors. Pharmacists described needing patient-centered training, protocols, and scripts to provide SBI. A short-self-reported screening and brief interventions including counseling, naloxone, and involving prescribers were discussed by both groups. CONCLUSIONS: Through this implementation-focused qualitative study, we identified patient needs such as opioid safety education delivered in a private and convenient format and pharmacist needs including training, workflow integration, protocols, and a time-efficient intervention for effective pharmacy-based SBI. Alternate formats of SBI using digital health technologies may be needed for effective implementation. Our findings can be used to develop patient-centered pharmacy-based SBI that can be implemented within actual pharmacy practice.

An Implementation-Focused Qualitative Exploration of Pharmacist Needs Regarding an Opioid Use Disorder Screening and Brief Intervention.

BACKGROUND: Screening and brief interventions (SBI) can help identify opioid safety risks and healthcare professionals can accordingly intervene without a significant increase in workload. Pharmacists, one of the most accessible healthcare professionals, are uniquely positioned to offer SBI. To design an effective intervention with high potential for implementation, we explored pharmacist needs and barriers regarding SBI for opioid use disorders. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted 11 semi-structured 60-minute interviews with community pharmacists. We used a purposeful sample of English-speaking pharmacists practicing in varied pharmacies (small independent, large-chain, specialty-retail) and positions (managers, owners, full-time/part-time pharmacists). Transcriptions were analyzed using deductive content analysis based on CFIR constructs, followed by inductive open coding. Utilizing a theoretical framework for data collection and analysis, a diverse sample of pharmacist roles, peer debriefing, and 2 independent coders for each transcript, altogether increased the credibility and transferability of our research. Data collection and analysis continued until data saturation was achieved. RESULTS: Pharmacists described good working relationships with colleagues, organization cultures that were open to new initiatives, and believed the SBI to be compatible with their organization goals and pharmacy structure, which are facilitators for future SBI implementation. Pharmacists were motivated by improved patient outcomes, more patient interaction and clinical roles, representing facilitators at the individual level. They also described stigma toward patients, mixed need for change, and lack of knowledge regarding SBI, which are potential barriers to be addressed. Pharmacists believed that the SBI model was adaptable, not complicated, and benefits outweighed implementation costs. CONCLUSIONS: We addressed current SBI literature gaps-mainly lack of focus on implementation and contextual data, through rigorous implementation-focused qualitative research. Our exploratory findings have direct implications on future pharmacy-based SBI implementation.

Implementing a pharmacist-integrated collaborative model of medication treatment for opioid use disorder in primary care: study design and methodological considerations.

BACKGROUND: Pharmacists remain an underutilized resource in the treatment of opioid use disorder (OUD). Although studies have engaged pharmacists in dispensing medications for OUD (MOUD), few studies have evaluated collaborative care models in which pharmacists are an active, integrated part of a primary care team offering OUD care. METHODS: This study seeks to implement a pharmacist integrated MOUD clinical model (called PrIMO) and evaluate its feasibility, acceptability, and impact across four diverse primary care sites. The Consolidated Framework for Implementation Research is used as an organizing framework for study development and interpretation of findings. Implementation Facilitation is used to support PrIMO adoption. We assess the primary outcome, the feasibility of implementing PrIMO, using the Stages of Implementation Completion (SIC). We evaluate the acceptability and impact of the PrIMO model at the sites using mixed-methods and combine survey and interview data from providers, pharmacists, pharmacy technicians, administrators, and patients receiving MOUD at the primary care sites with patient electronic health record data. We hypothesize that it is feasible to launch delivery of the PrIMO model (reach SIC Stage 6), and that it is acceptable, will positively impact patient outcomes 1 year post model launch (e.g., increased MOUD treatment retention, medication regimen adherence, service utilization for co-morbid conditions, and decreased substance use), and will increase each site's capacity to care for patients with MOUD (e.g., increased number of patients, number of prescribers, and rate of patients per prescriber). DISCUSSION: This study will provide data on a pharmacist-integrated collaborative model of care for the treatment of OUD that may be feasible, acceptable to both site staff and patients and may favorably impact patients' access to MOUD and treatment outcomes. TRIAL REGISTRATION: The study was registered on Clinicaltrials.gov (NCT05310786) on April 5, 2022, https://www. CLINICALTRIALS: gov/study/NCT05310786?id=NCT05310786&rank=1.

A scoping literature review of pharmacy-based opioid misuse screening and brief interventions.

BACKGROUND: Although prescription opioid dispensing rates have continued to decrease, overdose deaths involving prescription opioids have increased during the COVID-19 pandemic. Screening and brief interventions (SBI) are an effective prevention strategy to identify and address opioid misuse and safety risks. Emerging literature on pharmacy-based SBI needs to be systematically appraised to develop robust interventions. OBJECTIVE: Our objective was to conduct a scoping review of the literature regarding pharmacy-based opioid misuse SBI to identify relevant literature that explore the topic, evaluate the patient-centeredness of included studies, and explore the use of dissemination and implementation science in the literature. METHODS: The review was conducted according to Preferred Reporting of Systematic Reviews and Meta-analyses -Scoping reviews (PRISMA-Sc) guidelines. We searched PubMed, CINHAL, PsychInfo, and Scopus for studies regarding pharmacy-based SBI, published in the last 20 years. We also conducted a separate grey literature search. Two of three total reviewers screened each abstract individually and identified eligible full-texts for inclusion. We critically appraised quality of included studies and qualitatively synthesized the relevant information. RESULTS: The search resulted in 21 studies (categorized as intervention, descriptive, and observational research) and 3 grey literature reports. Of the recently published 21 studies, 11 were observational research, with six interventions in the pilot stages. Screening tools varied but naloxone was the brief intervention in 15 of the 24 results. Only eight studies had high validity, reliability, and applicability and only five were patient-centered. Implementation science principles were addressed in eight studies (mainly interventions). Overall, the findings suggest high potential for evidence-based SBI to be successful. CONCLUSIONS: Overall, the review suggested a strong lack of a patient-centered and implementation science-focused approach to designing pharmacy-based opioid misuse SBI. Findings suggest that a patient-centered, implementation focused approach is needed for effective and sustained pharmacy-based opioid misuse SBI.

Best practices for conducting and writing mixed methods research in social pharmacy.

Mixed method approaches are increasingly being used in social pharmacy research due to its potential to uncover insights that are not possible with separate quantitative and qualitative studies. Despite their increasing use, there are some limitations in these publications. Typically, specific mixed method designs are not chosen, quantitative and qualitative data are not systematically integrated, and the credibility or validity of the approach is not addressed. In this paper, we discuss mixed method designs and their applications in social pharmacy. Different integration techniques and legitimation types are detailed. We describe new methodological developments and provide examples from recent mixed method studies in social pharmacy. Finally, we also provide recommendations for planning, conducting, reporting, and evaluating mixed method studies. We suggest that researchers interested in conducting mixed method studies follow recommended guidelines and obtain training in mixed methods to ensure that rigorous mixed method studies are conducted in social and administrative pharmacy.

Erratum to "Perceptions of psychosocial and interpersonal factors affecting self-management behaviors among African Americans with diabetes" [Exploratory Research in Clinical and Social Pharmacy 3C (2021) 100057].

[This corrects the article DOI: 10.1016/j.rcsop.2021.100057.].

An Explorative Study of Common Themes of Patient Experiences With Migraine.

Objective: To explore important themes in patient experiences with migraine and to understand the relationship of these themes with external factors such as the health care system and societal influences.Methods: This qualitative study was part of a larger online survey (conducted for a period of 2 months from March 1, 2013, to April 30, 2013) that recruited participants with migraine through nonprobability-based sampling techniques. Respondents were asked an open-ended question to describe their experience with migraine. A codebook was developed based on existing literature and new categories that emerged from the responses. Deductive and inductive content analysis was conducted followed by axial coding of the themes based on the codebook.Results: The open-ended question resulted in 154 eligible responses. The final codebook contained 28 categories. The categories were combined into 6 distinct themes. The 6 themes included quality of life and health status, disease condition, societal response to disease, health care and medications, support, and patient response to disease. The most frequently occurring categories were pain and quality of life (QoL) (work functioning). The least frequent themes were cognitive symptoms, QoL economic functioning, and caregiver burden. Axial coding of the themes showed that QoL was the central theme. Aspects of the disease condition and negative societal responses were found to substantially affect QoL, leading to caregiver burden and absence/presence of social support.Conclusions: The findings demonstrate that pain and QoL are central to patient experience with migraine. Attention should be paid to improve the treatment and social support provided to patients and reduce stigma and invalidation.

Local delivery of hyaluronic acid as an adjunct to scaling and root planing in the treatment of chronic periodontitis in smokers and non-smokers: A clinical and microbiological study.

Objective: The objective of the study is to assess the effects of adjunctive use of hyaluronic acid (HA), clinically and microbiologically in smokers and nonsmokers, in the management of chronic periodontitis. Material and Methods: 48 sites from 24 chronic periodontitis patients, including smokers and nonsmokers with probing depth >5 mm, were selected for the study. A split-mouth design was followed. Scaling and root planing (SRP) was performed for all the patients. The test sites received 0.8% HA gel whereas the control site received placebo gel. The clinical parameters plaque, gingival and bleeding indices, Pocket Probing Depth (PPD), and clinical attachment level (CAL) were evaluated at baseline, 1 and 3 months. Microbiological parameters were evaluated at baseline and 1 month. Results: The results showed reduction in PPD and gain in CAL in both smokers and nonsmokers at the end of 3rd month. The improvements in the test sites were statistically significant when compared with that of control sites. The microbiological analysis showed a significant reduction in Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis at the test sites when compared to the controls in both the groups. Conclusion: The findings in both groups suggest that the use of locally delivered 0.8% HA gel may be valuable as an adjunct to SRP in the treatment of chronic periodontitis.

Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices.

BACKGROUND: A 2019 public workshop convened by the National Academies of Sciences, Engineering and Medicine (NASEM) Roundtable on Health Literacy identified a need to develop evidence-based guidance for best practices for health literacy and patient activation in clinical trials. PURPOSE: To identify studies of health literacy interventions within medical care or clinical trial settings that were associated with improved measures of health literacy or patient activation, to help inform best practices in the clinical trial process. DATA SOURCES: Literature searches were conducted in PubMed, the Cumulative Index to Nursing and Allied Health Literature, SCOPUS, Cochrane, and Web of Science from January 2009 to June 2021. STUDY SELECTION: Of 3592 records screened, 22 records investigating 27 unique health literacy interventions in randomized controlled studies were included for qualitative synthesis. DATA EXTRACTION: Data screening and abstraction were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. DATA SYNTHESIS: Types of health literacy interventions were multimedia or technology-based (11 studies), simplification of written material (six studies) and in-person sessions (five studies). These interventions were applied at various stages in the healthcare and clinical trial process. All studies used unique outcome measures, including patient comprehension, quality of informed consent, and patient activation and engagement. CONCLUSIONS: The findings of our study suggest that best practice guidelines recommend health literacy interventions during the clinical trial process, presentation of information in multiple forms, involvement of patients in information optimization, and improved standardization in health literacy outcome measures.

Clinicoradiographic evaluation of hyaluronan-nano hydroxyapatite composite graft in the management of periodontal infrabony defects.

BACKGROUND: Hyaluronan is a naturally occurring polysaccharide in the extracellular matrix of the connective tissue. It imparts antibacterial and osteogenic properties to the nano hydroxyapatite bone graft (NHA). AIM: This study aims to evaluate the efficacy of hyaluronan-NHA (H-NHA) composite in the treatment of infrabony defects in chronic periodontitis patients. MATERIALS AND METHODS: Eight systemically healthy chronic periodontitis patients with 32 graftable sites were included in the study. After flap reflection and debridement, the defect sites in the test quadrant were filled with H-NHA graft and those in the control quadrant were filled with NHA graft alone. Clinical parameters such as probing pocket depth (PPD) and clinical attachment level (CAL) were assessed at baseline and 3, 6, 9, and 12 months; bone probing depth (BPD) and radiographic parameters such as amount and percentage of defect depth reduction (DDR, PDDR) and change in alveolar crest level (ALR) were assessed at baseline and 6 and 12 months. STATISTICAL ANALYSIS USED: Descriptive statistics, one-way analysis of variance, and Student's t-test were used for statistical analysis. RESULTS: At the end of 12 months, H-NHA group showed a greater reduction in PPD (5.06 ± 0.582 mm), BPD (4.22 ± 0.371 mm), and gain in CAL (4.00 ± 0.421 mm) as compared to the NHA group (3.21 ± 0.648 mm, 3.21 ± 0.047 mm, and 2.86 ± 0.127 mm, respectively). In addition, DDR, PDDR, and ALR were better in H-NHA group (1.92 ± 0.647 mm 48.22 ± 31.561 mm, and 1.22 ± 0.808 mm, respectively) as compared to the NHA group (1.14 ± 0.602 mm, 20.14 ± 25.349 mm, and 0.89 ± 0.626 mm, respectively). Statistically significant improvements in all the parameters were seen in the test sites when compared to control sites at 12 months. CONCLUSION: H-NHA composite graft can be considered a promising periodontal regenerative material.

Perceptions of psychosocial and interpersonal factors affecting self-management behaviors among African Americans with diabetes.

Background: African Americans are more likely to be diagnosed with diabetes and have diabetes complications as compared to non-Hispanic Whites, but have lesser medication adherence and poorer self-management behaviors. Interventions to improve self-management behaviors may not be successful if psychosocial and interpersonal factors of African Americans are not addressed. Objective: The study objective was to qualitatively explore perceptions of African Americans with type 2 diabetes (T2DM) regarding self-management behaviors and understand the effect of psychosocial and interpersonal factors on behavior change. Methods: Adults with T2DM who self-identified as African American/Black were selected from a cohort participating in a mixed-methods study in a midwestern state. The data collection and analysis were guided by the Integrated Theory of Behavior Change. Ten semi-structured, 60-min, theory-based interviews were conducted and content analysis was utilized to identify themes. Themes were then categorized based on theoretical domains. Results: The sample was mostly female, an average of 52 years old, and had a high school education or more. Four themes were identified. Two themes were categorized as psychosocial factors: 1) attitude and beliefs regarding diabetes and 2) sociocultural influences on self-management, while two were interpersonal factors: 3) role of family and social support and 4) relationships with healthcare professionals. Themes connected back to the theory and directly affected self-management behaviors. Conclusion: Future research should focus on incorporating these themes when designing interventions that improve T2DM self-management behaviors and outcomes in African Americans. Health care professionals should emphasize individualized and culturally appropriate T2DM education and counseling.

Using an exploratory sequential mixed methods design to adapt an Illness Perception Questionnaire for African Americans with diabetes: the mixed data integration process.

BACKGROUND: Although qualitative methods have been used to develop quantitative behavioral health measurements, studies rarely report on the exact development process of these questionnaires. In this methodological paper, we highlight the procedure of a mixed data integration process in using qualitative data to create quantitative questionnaire items. METHODS: We used an exploratory sequential mixed methods study design to culturally adapt the Illness Perception Questionnaire-Revised (IPQ-R) and address the sociocultural contexts of African Americans with type 2 diabetes. Forty African Americans with type 2 diabetes taking oral diabetes medication completed the qualitative focus groups and 170 participants completed the quantitative phase (surveys). Using the 'building approach' to integration, qualitative themes from the focus groups were matched to survey domains based on the self-regulatory model. Qualitative themes assessing perceptions of diabetes among African Americans were used to develop new survey items for a culturally adapted IPQ-R, as well as adapt original survey items. RESULTS: Important themes included the effect on friend/family relationships, lifestyle changes, food experiences (consequences domain), importance of medications (treatment control), comparisons with family members (illness coherence), fear, future worries, and anger (emotional representations). A new domain, 'sociocultural influences' was added to the adapted questionnaire based on qualitative themes of race and racism on provider roles, personal control, and community influences. Merging and integration of the qualitative and quantitative phases, (reported via a joint display) showed evidence of congruence between the illness perceptions from the qualitative focus groups and scores on the survey items. CONCLUSION: The use of mixed methods allowed for the development of a robust and patient-centered questionnaire. Future research should consider psychometric testing of the adapted IPQ-R, so that it may be used in addressing illness perceptions among African Americans.