Robert Yood

Background: Effective primary care necessitates follow-up actions by the patient beyond the visit. Prior research suggests room for improvement in patient adherence. Objective: This study sought to understand patients’ views on their primary care visits, the plans generated therein, and their self-reported adherence after 3 months. Methods: As part of a large multisite cluster randomized pragmatic trial in 3 health care organizations, patients completed 2 surveys—the first within 7 days after the index primary care visit and another 3 months later. For this analysis of secondary outcomes, we combined the results across all study participants to understand patient adherence to care plans. We recorded patient characteristics and survey responses. Cross-tabulation and chi-square statistics were used to examine bivariate associations, adjusting for multiple comparisons when appropriate. We used multivariable logistic regression to assess how patients’ intention to follow, agreement, and understanding of their plans impacted their plan adherence, allowing for differences in individual characteristics. Qualitative content analysis was conducted to characterize the patient’s self-reported plans and reasons for adhering (or not) to the plan 3 months later. Results: Of 2555 patients, most selected the top box option (9=definitely agree) that they felt they had a clear plan (n=2011, 78%), agreed with the plan (n=2049, 80%), and intended to follow the plan (n=2108, 83%) discussed with their provider at the primary care visit. The most common elements of the plans reported included reference to exercise (n=359, 14.1%), testing (laboratory, imaging, etc; n=328, 12.8%), diet (n=296, 11.6%), and initiation or adjustment of medications; (n=284, 11.1%). Patients who strongly agreed that they had a clear plan, agreed with the plan, and intended to follow the plan were all more likely to report plan completion 3 months later (P<.001) than those providing less positive ratings. Patients who reported plans related to following up with the primary care provider (P=.008) to initiate or adjust medications (P≤.001) and to have a specialist visit were more likely to report that they had completely followed the plan (P=.003). Adjusting for demographic variables, patients who indicated intent to follow their plan were more likely to follow-through 3 months later (P<.001). Patients’ reasons for completely following the plan were mainly that the plan was clear (n=1114, 69.5%), consistent with what mattered (n=1060, 66.1%), and they were determined to carry through with the plan (n=887, 53.3%). The most common reasons for not following the plan were lack of time (n=217, 22.8%), having decided to try a different approach (n=105, 11%), and the COVID-19 pandemic impacted the plan (n=105, 11%). Conclusions: Patients’ initial assessment of their plan as clear, their agreement with the plan, and their initial willingness to follow the plan were all strongly related to their self-reported completion of the plan 3 months later. Patients whose plans involved lifestyle changes were less likely to report that they had “completely” followed their plan. Trial Registration: ClinicalTrials.gov NCT03385512; https://clinicaltrials.gov/study/NCT03385512 International Registered Report Identifier (IRRID): RR2-10.2196/30431

BACKGROUND Effective primary care necessitates follow-up actions by the patient beyond the visit. Prior research suggests room for improvement in patient adherence. OBJECTIVE This study sought to understand patients’ views on their primary care visits, the plans generated therein, and their self-reported adherence after 3 months. METHODS As part of a large multisite cluster randomized pragmatic trial in 3 health care organizations, patients completed 2 surveys—the first within 7 days after the index primary care visit and another 3 months later. For this analysis of secondary outcomes, we combined the results across all study participants to understand patient adherence to care plans. We recorded patient characteristics and survey responses. Cross-tabulation and chi-square statistics were used to examine bivariate associations, adjusting for multiple comparisons when appropriate. We used multivariable logistic regression to assess how patients’ intention to follow, agreement, and understanding of their plans impacted their plan adherence, allowing for differences in individual characteristics. Qualitative content analysis was conducted to characterize the patient’s self-reported plans and reasons for adhering (or not) to the plan 3 months later. RESULTS Of 2555 patients, most selected the top box option (9=definitely agree) that they felt they had a clear plan (n=2011, 78%), agreed with the plan (n=2049, 80%), and intended to follow the plan (n=2108, 83%) discussed with their provider at the primary care visit. The most common elements of the plans reported included reference to exercise (n=359, 14.1%), testing (laboratory, imaging, etc; n=328, 12.8%), diet (n=296, 11.6%), and initiation or adjustment of medications; (n=284, 11.1%). Patients who strongly agreed that they had a clear plan, agreed with the plan, and intended to follow the plan were all more likely to report plan completion 3 months later (P<.001) than those providing less positive ratings. Patients who reported plans related to following up with the primary care provider (P=.008) to initiate or adjust medications (P≤.001) and to have a specialist visit were more likely to report that they had completely followed the plan (P=.003). Adjusting for demographic variables, patients who indicated intent to follow their plan were more likely to follow-through 3 months later (P<.001). Patients’ reasons for completely following the plan were mainly that the plan was clear (n=1114, 69.5%), consistent with what mattered (n=1060, 66.1%), and they were determined to carry through with the plan (n=887, 53.3%). The most common reasons for not following the plan were lack of time (n=217, 22.8%), having decided to try a different approach (n=105, 11%), and the COVID-19 pandemic impacted the plan (n=105, 11%). CONCLUSIONS Patients’ initial assessment of their plan as clear, their agreement with the plan, and their initial willingness to follow the plan were all strongly related to their self-reported completion of the plan 3 months later. Patients whose plans involved lifestyle changes were less likely to report that they had “completely” followed their plan. CLINICALTRIAL ClinicalTrials.gov NCT03385512; https://clinicaltrials.gov/study/NCT03385512 INTERNATIONAL REGISTERED REPORT RR2-10.2196/30431

Objective: The objective of this study is to investigate the clinical characteristics and treatment of patients with early‐onset gout.Methods: We retrospectively reviewed 327 adult patients with a first diagnosis of gout from 2008 to 2016 using the database of a multispecialty group practice in New England. Patients were classified into the following groups: age 30 years or younger at first diagnosis (group 1), age 31‐40 years (group 2), and age over 40 years (group 3). The clinical characteristics and treatment of gout were compared among the three groups.Results: We identified 87 patients in group 1 and 140 patients in group 2. Group 3 included 100 patients randomly chosen from the 7216 patients with a first diagnosis at age over 40 years. Patients within group 1 had significantly higher serum uric acid (sUA) levels at the time of diagnosis and a more prominent family history of gout. Younger patients (groups 1 and 2) had a significantly higher body mass index than patients over 40 years of age (group 3). A substantial number of younger patients also had hypertension or hyperlipidemia. The majority of younger patients met the 2012 American College of Rheumatology (ACR) guidelines for initiating urate‐lowering therapy (ULT) on the basis of frequency of gout attacks, whereas the majority of patients over 40 years of age met the guidelines for ULT on the basis of chronic kidney disease. Patients over 40 years of age were more likely to achieve an sUA level less than 6.0 mg/dl.Conclusion: Patients with a first diagnosis of gout at age 40 years or younger frequently had cardiovascular risk factors and were less likely to achieve an sUA level less than 6.0 mg/dl compared with patients over 40 years of age who were treated in routine clinical practice. Clinicians should be aware that patients with early‐onset gout may be an undertreated population with poor adherence to ULT and increased risk of recurrent gout and cardiovascular diseases.

The optimal form of outreach to promote repeated, on time screening mammograms in primary care has not been established. The purpose of this study is

To assess the prevalence of menopausal symptoms among women prescribed hormone therapy (HT) using electronic medical record data from a regional healthcare organization. Retrospective data from the Reliant Medical Group from 1/1/2006-12/31/2011 were assessed for 102 randomly-selected patients. Study eligibility criteria included: females aged 45 to 65; prescribed oral or transdermal HT; no history of breast cancer, venous thromboembolism, stroke, gynecological cancer, or hysterectomy; continuously enrolled in the health plan for 1 year before and after the first observed HT prescription. Prevalence of menopause-related symptoms was analyzed descriptively at both the patient and visit levels. Mean age of patients was 54 years. The most common menopausal symptoms were: hot flushes (40 %), night sweats (17 %), insomnia (16 %), vaginal dryness (13 %), mood disorders (12 %), and weight gain (12 %). Among the 102 patients, 163 individual visits listing menopausal symptoms were identified, of which hot flushes (71 visits) were the most common symptom identified. Our findings provide recent data on the types of menopausal symptoms experienced by mid-life women prescribed HT. Electronic medical records may be a rich source of data for future studies of menopausal symptoms in this population.

Pegloticase is approved in the US for treatment of refractory chronic gout. Since chronic kidney disease (CKD) is common in these patients, we conducted a post-hoc analysis of 2 replicate phase 3 trials and the subsequent open-label extension study to determine the effects of pegloticase on renal function in patients with CKD stages 3 and 4, as well as the effects of renal dysfunction on pegloticase efficacy and safety.

Introduction: Two replicate randomized, placebo-controlled six-month trials (RCTs) and an open-label treatment extension (OLE) comprised the pegloticase development program in patients with gout refractory to conventional therapy. In the RCTs, approximately 40% of patients treated with the approved dose saw complete response (CR) of at least one tophus. Here we describe the temporal course of tophus resolution, total tophus burden in patients with multiple tophi, tophus size at baseline, and the relationship between tophus response and urate-lowering efficacy. Methods: Baseline subcutaneous tophi were analyzed quantitatively using computer-assisted digital images in patients receiving pegloticase (8 mg biweekly or monthly) or placebo in the RCTs, and pegloticase in the OLE. Tophus response, a secondary endpoint in the trials, was evaluated two ways. Overall tophus CR was the proportion of patients achieving a best response of CR (without any new/enlarging tophi) and target tophus complete response (TT-CR) was the proportion of all tophi with CR. Results: Among 212 patients randomized in the RCTs, 155 (73%) had ≥1 tophus and 547 visible tophi were recorded at baseline. Overall tophus CR was recorded in 45% of patients in the biweekly group (P = 0.002 versus placebo), 26% in the monthly group, and 8% in the placebo group after six months of RCT therapy. TT-CR rates at six months were 28%, 19%, and 2% of tophi, respectively. Patients meeting the primary endpoint of sustained urate-lowering response to therapy (responders) were more likely than nonresponders to have an overall tophus CR at six months (54% vs 20%, respectively and 8% with placebo). Both overall tophus CR and TT-CRs increased with treatment duration in the OLE, reaching 70% (39/56) of patients and 55% (132/238) of target tophi after one year of treatment in patients receiving pegloticase during both the RCTs and OLE. At that time point, more tophi had resolved in responders (102/145 or 70% of tophi) than nonresponders (30/93; 32%). Conclusions: Pegloticase reduced tophus burden in patients with refractory tophaceous gout, especially those achieving sustained urate-lowering. Complete resolution of tophi occurred in some patients by 13 weeks and in others with longer-term therapy. Trial registrations: NCT00325195, NCT01356498

Despite the demonstrated need to increase screening mammography utilization and strong evidence that mail and telephone outreach to women can increase screening, most managed care organizations have not adopted comprehensive outreach programs. The uncertainty about optimum strategies and cost effectiveness have retarded widespread acceptance. While 70% of women report getting a mammogram within the prior 2 years, repeat mammography rates are less than 50%. This 5-year study is conducted though a Central Massachusetts healthcare plan and affiliated clinic. All womenhave adequate health insurance to cover the test.

We developed a clinical prediction rule score to predict medication non-adherence for women prescribed osteoporosis treatment. When combined into a summative score, 62% with seven or more points on the score demonstrated very low adherence. This compares with 17% subjects with fewer than seven points (c-statistic = 0.74).

Objective: There are many effective osteoporosis (OP) medications with a variety of dosing intervals and delivery options, but even when diagnosed, OP is often undertreated. We sought to determine the bone density consequences of the decision to initiate and comply with therapy for OP.Methods: We identified 243 women who received a dual x‐ray absorptiometry (DXA) evaluation and fulfilled the World Health Organization criteria for OP. One year later, the patients were asked to return for a followup DXA. Administrative electronic health records were used to identify prescription drug use.Results: A total of 142 women (58%) initiated pharmacologic therapy for OP during the year after the initial DXA; 144 returned for a followup DXA after 1 year. For those women with ≥66% of days receiving therapy, the mean annual change in spine bone mineral density (BMD) was 4.5% compared with 2.0% for those with P < 0.001). For those women with ≥66% of days receiving therapy, the mean change in hip BMD was 2.3% compared with 0.3% for those with P < 0.001).Conclusion: We found significant bone density consequences of the decision to initiate and comply with therapy in the first year after diagnosis of OP. Improvement in both initiation rates of treatment as well as compliance are needed in order to reduce the frequency of osteoporotic fractures.