Screw Thread Configuration Has No Effect on Outcomes of In Situ Fixation for Stable Slipped Capital Femoral Epiphysis.

BACKGROUND: No consensus exists regarding the optimal surgical management of slipped capital femoral epiphysis (SCFE). Treatment goals include avoiding slip progression and sequelae such as avascular necrosis (AVN). Factors associated with surgical implants merit further research. This study investigates the effect of screw thread configuration and the number of screws on surgical outcomes. METHODS: A total of 152 patients undergoing cannulated, stainless steel, in situ screw fixation of SCFE between January 2005 and April 2018 were included. Procedure laterality, screw number and thread configuration (partially threaded/fully threaded), bilateral diagnosis, Loder classification, final follow-up, patient demographics, and endocrinopathy history were analyzed. Primary outcomes were return to the operating room (ROR), AVN, hardware failure/removal, and femoroacetabular impingement (FAI). RESULTS: Most patients received a single (86.2%), partially threaded (81.6%) screw; most were unilateral (67.8%) and stable (79.6%). Mean follow-up was 2.0±2.7 years, with a 15.8% rate of ROR, 5.3% exhibiting AVN, 6.6% exhibiting FAI, and 9.2% experiencing hardware failure/removal. Number of screws was the sole predictor of ROR [odds ratio (OR)=3.35, 95% confidence interval (CI): 1.18-9.49]. Unstable SCFE increased the odds of AVN (OR=38.44; 95% CI: 4.35-339.50) as did older age (OR=1.43, 95% CI: 1.01-2.03). Female sex increased risk for FAI (OR=4.87, 95% CI: 1.20-19.70), and bilateral SCFE elevated risk for hardware failure/removal versus unilateral SCFE (OR=4.41, 95% CI: 1.39-14.00). Screw thread configuration had no significant effect on any outcome (for each, P ≥0.159). CONCLUSIONS: Rates of ROR, AVN, FAI, and hardware failure/removal did not differ between patients treated with partially threaded or fully threaded screws. The use of 2 screws was associated with an increased likelihood of ROR. These findings suggest that screw thread configuration has no impact on complication rates, whereas screw number may be an important consideration in SCFE fixation. LEVEL OF EVIDENCE: Level III-retrospective cohort study.

Implementing an EMR-Based Referral for Smoking Quitline Services with Additional Provider Education, a Cluster-Randomized Trial.

BACKGROUND: Despite evidence of their effectiveness, free smoking quitlines are underused. The best way to educate providers about and encourage use of quitlines is not established. We examined if electronic medical record (EMR)-integrated best practices alerts (BPAs) with or without additional provider education resulted in increased quitline referrals. METHODS: Waitlist-controlled, cluster-randomized trial of primary care practices assigned to three arms. Providers in participating sites received a new EMR-based BPA for quitline referral and additional education outreach visits, the BPA alone, or usual care. The study was conducted in 2 phases: phase 1 from April 17 to October 16, 2017, and phase 2 from November 9, 2017, to May 8, 2018. In phase 2, the usual-care sites were randomized to either of the two intervention arms. The unit of randomization was primary care practice site. All in-office, primary care provider visits with smokers were included. The primary outcome was referral to the quitline. Secondary outcomes included patient acceptance and enrollment in quitline services. RESULTS: Twenty-two practice sites were enrolled. Smoking prevalence at sites ranged from 4.4 to 23%. In phase 1, the BPA-plus-education arm had 5636 eligible encounters and 405 referrals (referral rate 7.2%) while the BPA-only arm had 6857 eligible encounters and 623 referrals (referral rate 9.1%). The usual-care arm had 7434 encounters but no referrals. Comparing the BPA-plus arm to the BPA-only arm, the odds ratio of referral was 0.76 (CI 0.3-1.8). In phase 2, the combined BPA-plus-education sites had 8516 eligible encounters and 475 referrals (rate 5.6%). The BPA-only sites had 9134 eligible encounters and 470 referrals (rate 5.2%). The odds ratio comparing the 2 groups in phase 2 was 1.06 (0.5-2.2). CONCLUSIONS: An EMR-based BPA can improve the number of referrals to quitline services, though more work is needed to improve providers' use of quitlines and low patient acceptance of services. Trial Registration NIH Clinicaltrials.gov identifier: NCT03229356.

Hypoglycemia Communication in Primary Care Visits for Patients with Diabetes.

BACKGROUND: Hypoglycemia is a common and serious adverse effect of diabetes treatment, especially for patients using insulin or insulin secretagogues. Guidelines recommend that these patients be assessed for interval hypoglycemic events at each clinical encounter and be provided anticipatory guidance for hypoglycemia prevention. OBJECTIVE: To determine the frequency and content of hypoglycemia communication in primary care visits. DESIGN: Qualitative study PARTICIPANTS: We examined 83 primary care visits from one urban health practice representing 8 clinicians and 33 patients using insulin or insulin secretagogues. APPROACH: Using a directed content analysis approach, we analyzed audio-recorded primary care visits collected as part of the Achieving Blood Pressure Control Together study, a randomized trial of behavioral interventions for hypertension. The coding framework included communication about interval hypoglycemia, defined as discussion of hypoglycemic events or symptoms; the components of hypoglycemia anticipatory guidance in diabetes guidelines; and hypoglycemia unawareness. Hypoglycemia documentation in visit notes was compared to visit transcripts. KEY RESULTS: Communication about interval hypoglycemia occurred in 24% of visits, and hypoglycemic events were reported in 16%. Despite patients voicing fear of hypoglycemia, clinicians rarely assessed hypoglycemia frequency, severity, or its impact on quality of life. Hypoglycemia anticipatory guidance was provided in 21% of visits which focused on diet and behavior change; clinicians rarely counseled on hypoglycemia treatment or avoidance of driving. Limited discussions of hypoglycemia unawareness occurred in 8% of visits. Documentation in visit notes had low sensitivity but high specificity for ascertaining interval hypoglycemia communication or hypoglycemic events, compared to visit transcripts. CONCLUSIONS: In this high hypoglycemia risk population, communication about interval hypoglycemia and counseling for hypoglycemia prevention occurred in a minority of visits. There is a need to support clinicians to more regularly assess their patients' hypoglycemia burden and enhance counseling practices in order to optimize hypoglycemia prevention in primary care.

Awareness and Discussions About Chronic Kidney Disease Among African-Americans with Chronic Kidney Disease and Hypertension: a Mixed Methods Study.

BACKGROUND: Routine primary care visits provide an educational opportunity for African-Americans with chronic kidney disease (CKD) and CKD risk factors such as hypertension. The nature of patient-physician discussions about CKD and their impact on CKD awareness in this population have not been well explored. OBJECTIVE: To characterize patient CKD awareness and discussions about CKD between patients and primary care physicians (PCPs). DESIGN: Mixed methods study. PATIENTS: African-American patients with uncontrolled hypertension (≥ 140/90 mmHg) and CKD (albuminuria or eGFR < 60 ml/min/1.73 m2) recruited from an urban primary care clinic. MAIN MEASURES: We assessed patient CKD awareness with questionnaires and audio-recorded patients-PCP discussions during a routine visit. We characterized discussions and used multivariate regression analysis to identify independent patient and visit predictors of CKD awareness or CKD discussions. RESULTS: Among 48 African-American patients with uncontrolled hypertension and CKD, 29% were aware of their CKD. After adjustment, CKD awareness was associated with moderate-severe CKD (stages 3-4) (vs. mild CKD [stages 1-2]) (prevalence ratio [PR] 2.82; 95% CI 1.18-6.78) and inversely associated with diabetes (vs. without diabetes) (PR 0.28; 95% CI 0.10-0.75). CKD discussions occurred in 30 (63%) visits; most focused on laboratory assessment (n = 23, 77%) or risk factor management to delay CKD progression (n = 19, 63%). CKD discussions were associated with moderate-severe CKD (vs. mild CKD) (PR 1.57; 95% CI 1.04-2.36) and diabetes (vs. without diabetes) (PR 1.42; 95% CI 1.09-1.85), and inversely associated with uncontrolled hypertension (vs. controlled) (PR 0.58; 95% CI 0.92-0.89). In subgroup analysis, follow-up CKD awareness did not change by presence or absence of CKD discussion (10.5% vs. 7.7%, p = 0.8). CONCLUSIONS: In patients at risk of CKD progression, few were aware of CKD, and CKD discussions were not associated with CKD awareness. More resources may be needed to enhance the clarity of clinical messages regarding CKD and its significance for patients' health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01902719.

Hypertension Self-management in Socially Disadvantaged African Americans: the Achieving Blood Pressure Control Together (ACT) Randomized Comparative Effectiveness Trial.

BACKGROUND: Effective hypertension self-management interventions are needed for socially disadvantaged African Americans, who have poorer blood pressure (BP) control compared to others. OBJECTIVE: We studied the incremental effectiveness of contextually adapted hypertension self-management interventions among socially disadvantaged African Americans. DESIGN: Randomized comparative effectiveness trial. PARTICIPANTS: One hundred fifty-nine African Americans at an urban primary care clinic. INTERVENTIONS: Participants were randomly assigned to receive (1) a community health worker ("CHW") intervention, including the provision of a home BP monitor; (2) the CHW plus additional training in shared decision-making skills ("DoMyPART"); or (3) the CHW plus additional training in self-management problem-solving ("Problem Solving"). MAIN MEASURES: We assessed group differences in BP control (systolic BP (SBP) < 140 mm Hg and diastolic BP (DBP) < 90 mmHg), over 12 months using generalized linear mixed models. We also assessed changes in SBP and DBP and participants' BP self-monitoring frequency, clinic visit patient-centeredness (i.e., extent of patient-physician discussions focused on patient emotional and psychosocial concerns), hypertension self-management behaviors, and self-efficacy. KEY RESULTS: BP control improved in all groups from baseline (36%) to 12 months (52%) with significant declines in SBP (estimated mean [95% CI] - 9.1 [- 15.1, - 3.1], - 7.4 [- 13.4, - 1.4], and - 11.3 [- 17.2, - 5.3] mmHg) and DBP (- 4.8 [- 8.3, - 1.3], - 4.0 [- 7.5, - 0.5], and - 5.4 [- 8.8, - 1.9] mmHg) for CHW, DoMyPART, and Problem Solving, respectively). There were no group differences in BP outcomes, BP self-monitor use, or clinic visit patient-centeredness. The Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 18.7 [4.0, 87.3]) and self-efficacy scores (OR [95% CI] 4.7 [1.5, 14.9]) at 12 months compared to baseline, while other groups did not. Compared to DoMyPART, the Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 5.7 [1.3, 25.5]) at 12 months. CONCLUSION: A context-adapted CHW intervention was correlated with improvements in BP control among socially disadvantaged African Americans. However, it is not clear whether improvements were the result of this intervention. Neither the addition of shared decision-making nor problem-solving self-management training to the CHW intervention further improved BP control. TRIAL REGISTRY: ClinicalTrials.gov Identifier: NCT01902719.

Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial).

BACKGROUND: Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP. METHODS AND STUDY DESIGN: The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently. DISCUSSION: The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT. TRIAL REGISTRATION: ClinicalTrials.govNCT02647658 Registered Jan. 6, 2016.

Cost implications of PSA screening differ by age.

BACKGROUND: Multiple guidelines seek to alter rates of prostate-specific antigen (PSA)-based prostate cancer screening. The costs borne by payers associated with PSA-based screening for men of different age groups-including the costs of screening and subsequent diagnosis, treatment, and adverse events-remain uncertain. We sought to develop a model of PSA costs that could be used by payers and health care systems to inform cost considerations under a range of different scenarios. METHODS: We determined the prevalence of PSA screening among men aged 50 and higher using 2013-2014 data from a large, multispecialty group, obtained reimbursed costs associated with screening, diagnosis, and treatment from a commercial health plan, and identified transition probabilities for biopsy, diagnosis, treatment, and complications from the literature to generate a cost model. We estimated annual total costs for groups of men ages 50-54, 55-69, and 70+ years, and varied annual prostate cancer screening prevalence in each group from 5 to 50% and tested hypothetical examples of different test characteristics (e.g., true/false positive rate). RESULTS: Under the baseline screening patterns, costs of the PSA screening represented 10.1% of the total costs; costs of biopsies and associated complications were 23.3% of total costs; and, although only 0.3% of all screen eligible patients were treated, they accounted for 66.7% of total costs. For each 5-percentage point decrease in PSA screening among men aged 70 and older for a single calendar year, total costs associated with prostate cancer screening decreased by 13.8%. For each 5-percentage point decrease in PSA screening among men 50-54 and 55-69 years old, costs were 2.3% and 7.3% lower respectively. CONCLUSIONS: With constrained financial resources and with national pressure to decrease use of clinically unnecessary PSA-based prostate cancer screening, there is an opportunity for cost savings, especially by focusing on the downstream costs disproportionately associated with screening men 70 and older.

A Dietary Intervention in Urban African Americans: Results of the "Five Plus Nuts and Beans" Randomized Trial.

INTRODUCTION: Unhealthy diets, often low in potassium, likely contribute to racial disparities in blood pressure. We tested the effectiveness of providing weekly dietary advice, assistance with selection of higher potassium grocery items, and a $30 per week food allowance on blood pressure and other outcomes in African American adults with hypertension. DESIGN: We conducted an 8-week RCT with two parallel arms between May 2012 and November 2013. SETTING/PARTICIPANTS: We randomized 123 African Americans with controlled hypertension from an urban primary care clinic in Baltimore, Maryland, and implemented the trial in partnership with a community supermarket and the Baltimore City Health Department. Mean (SD) age was 58.6 (9.5) years; 71% were female; blood pressure was 131.3 (14.7)/77.2 (10.5) mmHg; BMI was 34.5 (8.2); and 28% had diabetes. INTERVENTION: Participants randomized to the active intervention group (Dietary Approaches to Stop Hypertension [DASH]-Plus) received coach-directed dietary advice and assistance with weekly online ordering and purchasing of high-potassium foods ($30/week) delivered by a community supermarket to a neighborhood library. Participants in the control group received a printed DASH diet brochure along with a debit account of equivalent value to that of the DASH-Plus group. MAIN OUTCOME MEASURES: The primary outcome was blood pressure change. Analyses were conducted in January to October 2014. RESULTS: Compared with the control group, the DASH-Plus group increased self-reported consumption of fruits and vegetables (mean=1.4, 95% CI=0.7, 2.1 servings/day); estimated intake of potassium (mean=0.4, 95% CI=0.1, 0.7 grams/day); and urine potassium excretion (mean=19%, 95% CI=1%, 38%). There was no significant effect on blood pressure. CONCLUSIONS: A program providing dietary advice, assistance with grocery ordering, and $30/week of high-potassium foods in African American patients with controlled hypertension in a community-based clinic did not reduce BP. However, the intervention increased consumption of fruits, vegetables, and urinary excretion of potassium.

Hybrid fixation with sublaminar polyester bands in the treatment of neuromuscular scoliosis: a comparative analysis.

BACKGROUND: Segmental spinal instrumentation with Luque wire fixation has been the standard treatment of neuromuscular scoliosis for >30 years. More recently, pedicle screw constructs have become the most widely utilized method of posterior spinal fixation; however, they are associated with complications such as implant malposition. We report the use of polyester bands and clamps utilized with pedicle screws in a hybrid fixation construct in the treatment of neuromuscular scoliosis. METHODS: A retrospective review was conducted of 115 pediatric spinal deformity cases between 2008 and 2010 at a single center performed by a single surgeon. Intraoperative and postoperative complications were recorded. Radiographs were reviewed preoperatively and at the latest follow-up. A systematic review of the literature was conducted. Data from case series reporting outcomes of sublaminar wires and all-pedicle screw constructs in the treatment of neuromuscular scoliosis were compared with outcomes of the present study. RESULTS: Twenty-nine patients with neuromuscular scoliosis who underwent segmental spinal instrumentation with a hybrid construct including sublaminar bands and pedicle screws were included. There was an average follow-up of 29 months (range, 12 to 40 mo). The average postoperative correction of coronal balance was 69% (range, 24 to 71 degrees). Sagittal balance was corrected to within 2 cm of the C7 plumbline in 97% of patients. The loss of coronal and sagittal correction at latest follow-up was 0% and 2%, respectively. There were 2 intraoperative clamp failures of the 398 implants (0.5%). There were 2 major (6.9%) and 7 minor (24%) complications in 7 patients (24% overall). These results compared favorably to previous case series of sublaminar wire and all-pedicle screw fixation techniques. CONCLUSIONS: The polyester band technique is an excellent adjunct in the correction of spinal deformity in patients with neuromuscular scoliosis. Sublaminar bands utilized in a hybrid construct appear to be safe, can achieve corrections equivalent to all-pedicle screw constructs, and may decrease the potential complications associated with every level transpedicular fixation in the patient with a highly dysmorphic and osteoporotic spine. LEVEL OF EVIDENCE: Level IV: cohort study.

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

BACKGROUND: Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. METHODS/DESIGN: We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. DISCUSSION: Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control.

Adapting hypertension self-management interventions to enhance their sustained effectiveness among urban African Americans.

African Americans suffer disproportionately poor hypertension control despite the availability of efficacious interventions. Using principles of community-based participatory research and implementation science, we adapted established hypertension self-management interventions to enhance interventions' cultural relevance and potential for sustained effectiveness among urban African Americans. We obtained input from patients and their family members, their health care providers, and community members. The process required substantial time and resources, and the adapted interventions will be tested in a randomized controlled trial.

Facilitators and barriers to hypertension self-management in urban African Americans: perspectives of patients and family members.

INTRODUCTION: We aimed to inform the design of behavioral interventions by identifying patients' and their family members' perceived facilitators and barriers to hypertension self-management. MATERIALS AND METHODS: We conducted focus groups of African American patients with hypertension and their family members to elicit their views about factors influencing patients' hypertension self-management. We recruited African American patients with hypertension (n = 18) and their family members (n = 12) from an urban, community-based clinical practice in Baltimore, Maryland. We conducted four separate 90-minute focus groups among patients with controlled (one group) and uncontrolled (one group) hypertension, as well as their family members (two groups). Trained moderators used open-ended questions to assess participants' perceptions regarding patient, family, clinic, and community-level factors influencing patients' effective hypertension self-management. RESULTS: Patient participants identified several facilitators (including family members' support and positive relationships with doctors) and barriers (including competing health priorities, lack of knowledge about hypertension, and poor access to community resources) that influence their hypertension self-management. Family members also identified several facilitators (including their participation in patients' doctor's visits and discussions with patients' doctors outside of visits) and barriers (including their own limited health knowledge and patients' lack of motivation to sustain hypertension self-management behaviors) that affect their efforts to support patients' hypertension self-management. CONCLUSION: African American patients with hypertension and their family members reported numerous patient, family, clinic, and community-level facilitators and barriers to patients' hypertension self-management. Patients' and their family members' views may help guide efforts to tailor behavioral interventions designed to improve hypertension self-management behaviors and hypertension control in minority populations.