Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease.

BACKGROUND: Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear. METHODS: In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years. RESULTS: The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P=0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P=0.02 and P=0.009, respectively, for trend in the two outcomes). CONCLUSIONS: Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; ClinicalTrials.gov number, NCT00468923.).

Two placebo-controlled crossover studies in healthy subjects to evaluate gastric acid neutralization by an alginate-antacid formulation (Gaviscon Double Action).

OBJECTIVE: To investigate the intragastric acid neutralization activity of a combined alginate-antacid formulation. SIGNIFICANCE: Published studies have investigated the reflux-suppressing alginate component of Gaviscon Double Action (Gaviscon DA; RB, UK) but intragastric acid neutralization activity of the antacid component has not been evaluated in vivo. METHODS: Intragastric pH monitoring, using a custom-made 10-electrode catheter, was evaluated in a two-part exploratory study in healthy subjects; Part I (n = 6) tested suitability of the catheter using antacid tablets (Rennie; Bayer, Germany); Part II (n = 12) evaluated gastric acid neutralization activity of Gaviscon DA liquid (20 ml) versus placebo in fasted subjects using a randomized, open-label, crossover design. The primary endpoint was the percentage of time that intragastric pH ≥4 was measured during 30 min post-treatment. A confirmatory study of identical design was subsequently conducted (n = 20). RESULTS: Monitoring pH using the multielectrode catheter was a viable approach, directly detecting changes in intragastric pH following a single dose of antacid tablets. In the exploratory study, the percentage of time that pH ≥4 during 30 minutes post-treatment was 46.8% with Gaviscon DA liquid versus 4.7% with placebo (p = 0.0004). These findings were supported by the confirmatory study, where pH ≥4 was recorded 50.8% of the time with Gaviscon DA versus 3.5% with placebo (p = 0.0051). In this study, Gaviscon DA was safe and well tolerated. CONCLUSIONS: These studies demonstrate the effective acid neutralizing capacity of Gaviscon DA versus placebo in healthy, fasted subjects. This adds to the evidence base for the combination of alginates and antacids.

Psychometric evaluation of a daily gastro-oesophageal reflux disease symptom measure.

OBJECTIVE: The objective of this study was to evaluate the validity of the Heartburn Reflux Dyspepsia Questionnaire (HRDQ), a newly developed measure of gastro-oesophageal reflux disease (GORD) symptoms. Specifically, the HRDQ was developed for patients, who still experience symptoms with proton pump inhibitor (PPI) treatment. MATERIAL AND METHODS: The psychometric properties of HRDQ were evaluated based on data from two clinical trials of patients with GORD with a partial response to PPIs, one from the UK and one from Denmark and Germany. RESULTS: The HRDQ had good internal consistency (Cronbach's alpha range .83-.88) and test-retest reliability (intraclass correlation coefficient range .71-.90). Convergent and discriminant validity were supported by high correlations with ReQuest™ and ability to differentiate between groups based on ReQuest™ cut-off values. Responsiveness of HRDQ was demonstrated by moderate to high correlations with ReQuest™ change scores and time with symptoms. An HRDQ cut-off value of 0.70 for definition of 'bad day' was also evaluated. CONCLUSIONS: Based on existing evidence, the HRDQ is a valid and reliable measure of GORD symptoms that can be used as a study outcome in clinical trials.

Measuring preparedness for mammography in women with intellectual disabilities: a validation study of the Mammography Preparedness Measure.

BACKGROUND: Women with intellectual disabilities have similar breast cancer rates as the general population, but lower rates of regular mammography and higher breast cancer mortality rates. Although prior qualitative work demonstrates that women with intellectual disabilities face unique, disability-specific barriers to mammography, the present authors lack standardized, validated instruments for measuring knowledge of breast cancer screening in this population. In addition, much research related to adults with intellectual disabilities focuses on family or carer perspectives, rather than involving women with intellectual disabilities, themselves. METHODS: The present authors first pilot tested a general population instrument measuring breast cancer knowledge, and found that it did not perform adequately in women with intellectual disabilities. In response, the present authors developed the Mammography Preparedness Measure (MPM), a direct short interview tool to measure knowledge and preparedness in women with intellectual disabilities, themselves, rather than relying on caregiver or other reports, and using inclusive methodology. The present authors validated the MPM by assessing test-retest reliability. RESULTS: Average test-retest per cent agreement of 84%, ranging from 74 to 91% agreement per item, with an overall kappa of 0.59. CONCLUSION: The MPM appears to be a valid instrument appropriate for measuring mammography preparedness in women with intellectual disabilities. The success of this innovative tool suggests that direct, rather than informant-directed tools can be developed to measure health knowledge and cancer screening readiness in adults with intellectual disabilities, an important measure in studying and reducing disparities.

The perceived effects of faculty presence vs. absence on small-group learning and group dynamics: a quasi-experimental study.

BACKGROUND: Medical education increasingly relies on small-group learning. Small group learning provides more active learning, better retention, higher satisfaction, and facilitates development of problem-solving and team-working abilities. However, less is known about student experience and preference for different small groups teaching models. We evaluated group educational dynamics and group learning process in medical school clerkship small group case-based settings, with a faculty member present versus absent. METHODS: Students completed surveys after cases when the faculty was present ("in") or absent ("out") for the bulk of the discussion. 228 paired surveys (114 pairs) were available for paired analysis, assessing group dynamics, group learning process, student preference, and participation through self-report and self-rating of group behaviors tied to learning and discussion quality. RESULTS: Ratings of group dynamics and group learning process were significantly higher with the faculty absent vs. present (p range <0.001 to 0.015). Students also reported higher levels of participation when the faculty member was absent (p = 0.03). Students were more likely to express a preference for having the faculty member present after "in" case vs. "out" case discussions. (p < 0.001). There was no difference in reported success of the case discussion after "in" vs. "out" cases (p = 0.67). CONCLUSIONS: Student groups without faculty present reported better group dynamics, group learning processes, and participation with faculty absent. Students reported that they feel somewhat dependent on faculty, especially when the faculty is present, though there was no significant difference in students reporting that they obtained the most they could from the discussion of the case after both "in" and "out" cases.

Testing the feasibility of a DVD-based intervention to promote preparedness for mammography in women with intellectual disabilities.

Women with intellectual disabilities (ID, formerly mental retardation) have a similar breast cancer incidence as the general population, but they have higher breast cancer mortality and lower rates of regular screening mammography. We conducted a feasibility study evaluating acceptability, demand, and limited efficacy of a health education DVD about mammography for women with ID. The DVD was developed in order to address disability-specific barriers to mammography identified in prior studies, such as anxiety related to navigating the logistics of obtaining a mammogram. The DVD was found to be acceptable and feasible, and led to a moderate increase in mammography preparedness in this population. Study results suggest that this DVD-based intervention is an appropriate candidate for further study measuring efficacy and effectiveness in increasing regular mammography in women with ID, a disparity population.

Actual vs Documented Advance Care Planning in a Primary Care Clinic.

Introduction: Advance care planning (ACP) is a complex and multifaceted entity that has significant impact on patient care. ACP takes many forms, may be underbilled, and can have significant ramifications on quality care metrics. We performed a retrospective chart review for patients over 70 years in age in our family medicine resident clinic to evaluate the ways in which ACP is charted and the gap between billed and nonbilled ACP. Methods: The first 50 patients over 70 years in age seen between August 25, 2020 and September 25, 2020 were selected for standardized chart review. Billing for ACP was defined as Current Procedural Terminology codes=-10 codes 99497 or 99498. Primary outcomes were the percentage of patients with ACP and incidence of ACP documents. Secondary outcome was the proportion of documented ACP conversations in office visits which had billing for ACP. Results: Forty-eight patients over 70 years in age were identified with an average age of 80.9 years old. Forty-one of 48 patients (85.4%) had some form of ACP and 12 (25%) had formal ACP documents. Of 25 patients with documented ACP conversations in office visits, eleven patients (44%) had ACP which had been formally billed. Conclusion: The majority of our patients had some form of ACP ranging from inpatient discussions of code status to outpatient visits regarding end-of-life care. However, ACP was underbilled in our practice. Physicians are often evaluated based on quality care metrics such as billed ACP which may not accurately reflect the work physicians are doing.

'It's easier said than done': perspectives on mammography from women with intellectual disabilities.

PURPOSE: Women with intellectual disabilities (or mental retardation) are living longer, receiving primary care in the community, and have equal rates of breast cancer compared with women in the general population, but they have lower rates of mammography. Although several public campaigns have successfully raised the mammography rate for racial and ethnic minority women, they have not penetrated the community of women with intellectual disabilities. No research to date has explored potential barriers to mammography for these women by involving the women themselves as participants. METHODS: We undertook a qualitative study to explore the perceptions and understanding of mammography for women with intellectual disabilities and some of the potential reasons they would or would not have the test. Twenty-seven intellectually disabled women were recruited through a variety of community groups and interviewed using a semistructured interview guide. Data were analyzed using qualitative techniques from grounded theory. RESULTS: Participants in this study described being poorly prepared for mammography: they did not understand its purpose and were not prepared for the logistics of the experience. The latter was more upsetting to participants and contributed to their negative perceptions of mammography. Participants reported feeling unprepared and singled out for being unprepared, despite their desire to have at least 1 mammogram, as do other women their age. CONCLUSIONS: Women with intellectual disabilities perceive mammography differently than do women who do not have intellectual disabilities, and their perception is informed by inadequate knowledge, anxiety, and inadequate preparation. These themes should be considered when planning cancer prevention interventions with this population and when counseling individual women in the clinical setting.

Associations between colorectal cancer screening and glycemic control in people with diabetes, Boston, Massachusetts, 2005-2010.

INTRODUCTION: Recent studies indicate an increased risk of colorectal cancer in people with diabetes. However, people with diabetes may have lower colorectal cancer screening rates than people without diabetes. Few data are available regarding factors associated with lack of screening for people with diabetes. Our objective was to describe factors associated with lack of timely colorectal cancer screening in people with diabetes. METHODS: We examined an electronic medical record database with more than 6,000 patients aged 50 years or older who had diabetes and were seen in a large hospital system in Boston, Massachusetts. We compared patients who had received timely colorectal cancer screening with those who had not on several variables, including glycemic control, expressed as average hemoglobin A1c (HbA1c). Bivariate analyses were performed using χ(2) and t tests for means when applicable. Logistic regression was used to determine the independent association of variables with lack of screening. RESULTS: Patients with poor glycemic control (average HbA1c >8.5%) were more likely not to have been screened for colorectal cancer than those with good glycemic control, even after adjusting for the number of primary care visits. Patients with fewer than 20 primary care visits in 5 years were more likely not to have been screened than those with more visits. CONCLUSION: Glycemic control appears to be independently associated with the likelihood of colorectal cancer screening. People with poorly controlled diabetes should be targeted in future research and individual patient care.

A Student Telephone Intervention for Primary Care Patient Safety During the COVID-19 Pandemic.

BACKGROUND AND OBJECTIVES: During the COVID-19 pandemic, medical students were unable to participate in clinical learning for several weeks. Many primary care patients no-showed to appointments and did not receive care. We implemented a telephone outreach program using medical students to call primary care patients who no-showed to appointments and did not receive care. METHODS: A brief plan-do-study-act cycle was used to establish protocols and supervision for the phone calls. RESULTS: In the first 5 weeks, of 3,274 scheduled patients there were 426 no-shows; 309 received outreach from students. We developed protocols for supervision, routing, and triage. CONCLUSION: It is feasible and educationally valuable to collaborate with students to reach patients who are at home due to the pandemic. Other practices could adapt this tool in similar situations.

Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial.

BACKGROUND/AIMS: To examine how measuring adherence at 3 weeks by self-report and pill counts compares to measurements at 7 weeks in a pre-randomization run-in period. METHODS: Study within a trial of an international parallel group randomized controlled trial (RCT) that compares spironolactone to placebo. Adults receiving dialysis enter an 8-week active run-in period with spironolactone. Adherence was assessed by both self-report and pill counts in a subgroup of participants at both 3 weeks and 7 weeks. RESULTS: 332 participants entered the run-in period of which 166 had complete data. By self-report, 146/166 (94.0%) and 153/166 (92.2%) had at least 80% adherence at 3 and 7 weeks respectively (kappa = 0.27 (95% C.I. 0.16 to 0.38). By pill counts, the mean (SD) adherence was 96.5% (16.1%) and 92.4% (18.2%) at 3 and 7 weeks respectively (r = 0.32) with a mean (SD) difference of 3.1% (17.8%) and a 95% limit of agreement from -31.7% to +37.9%. The proportion of adherent participants by self-report and pill counts at 3 weeks agreed in 87.4% of participants (McNemar's p-value 0.58, kappa 0.11, p = 0.02) and at 7 weeks agreed in 92.2% (McNemar's p-value 0.82, kappa 0.47, p < 0.001). CONCLUSIONS: Three and seven-week run-in periods and both self-reported and pill count assessments performed similarly. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03020303.

Effect of Patients' Life Stories in Bringing Meaning to Nursing Home Care.

INTRODUCTION: Although there is an increasing need for geriatricians, fewer physicians are entering the field. Family medicine residents find geriatrics, especially nursing home care, unsatisfying. Life stories of older adult patients may help providers cope with the challenges of nursing home care and increase provider satisfaction by offering a way to connect with patients. METHODS: We conducted a qualitative study on life stories' effects on attitudes towards nursing home care. Fourteen patient stories were created. Seven Boston University family medicine residents and one nurse practitioner participated in a semistructured interview both before and at least 2 months after learning about their patients' stories. Data were analyzed using qualitative techniques from grounded theory. RESULTS: Participants found nursing home care challenging, particularly for patients who were nonverbal due to advanced dementia, because they had difficulties forming meaningful relationships or discussing medical decisions with their patients. Life stories increased empathy, deepened relationships with patients, and led participants to feel more satisfied in their role as providers. The stories were considered useful for end-of-life discussions. CONCLUSION: Life stories incorporated into physician practice may help health care providers feel more connected to their patients and ultimately more satisfied in the care of nursing home patients.

Randomized clinical trial: a double-blind, placebo-controlled study to assess the clinical efficacy and safety of alginate-antacid (Gaviscon Double Action) chewable tablets in patients with gastro-oesophageal reflux disease.

BACKGROUND: The alginate-antacid Gaviscon Double Action (Gaviscon DA) has a combined acid-neutralizing and reflux-suppressing action. Response to treatment in a symptomatic gastro-oesophageal reflux disease (GERD) population has not yet been tested in a large-scale clinical study. AIM: The aim of this study was to assess the efficacy and safety of Gaviscon DA compared with matched placebo tablets in the reduction of upper gastrointestinal symptoms in patients with GERD. PARTICIPANTS AND METHODS: In this multicentre, randomized, double-blind, placebo-controlled study, adults with GERD symptoms (N=424) received Gaviscon DA or placebo tablets for 7 days. The primary endpoint was a clinically important reduction of at least 1.5 points in the Reflux Disease Questionnaire (RDQ) GERD dimension (combined heartburn/regurgitation) between baseline and the end of the treatment. Secondary endpoints included the change in RDQ score from baseline for individual RDQ dimensions and Overall Treatment Evaluation. RESULTS: A significantly greater proportion of patients treated with Gaviscon DA met the primary endpoint compared with placebo (47.8 vs. 33.2%, respectively, P=0.0031; odds ratio: 1.85, 95% confidence interval: 1.23-2.78). A significant treatment effect was also observed for heartburn, regurgitation and dyspepsia individually. Patients in the Gaviscon DA group rated their overall treatment response greater than patients in the placebo group [mean Overall Treatment Evaluation (SD): 3.2 (3.08) vs. 2.2 (3.34); P<0.001]. No notable differences in the incidence of adverse events were observed between treatments. CONCLUSION: The alginate-antacid combination, Gaviscon DA, is an effective and well-tolerated treatment to reduce reflux symptoms and associated dyspepsia in symptomatic GERD patients.

Family medicine obstetrics fellowship graduates: training and post-fellowship experience.

BACKGROUND AND OBJECTIVES: Family medicine obstetrics and maternal-child health fellowships offer family physicians additional training in pregnancy care. Our objectives were to assess the content of these fellowship programs, the clinical practices of fellowship graduates, and factors associated with inclusion of cesarean delivery in practice after fellowship training. METHODS: A survey was sent to graduates of obstetrics or maternal-child fellowships around the country regarding their fellowship experience and current practice characteristics. RESULTS: A total of 165 graduates responded, for a response rate of 64%. Cesarean delivery, postpartum tubal ligation, and dilation and curettage are taught in most fellowships. Involvement in residency education and caring for outpatient family medicine patients are also included in most fellowships. Forty-four percent of fellowship graduates practice in rural areas, 88% are based in community hospitals, and 49% are faculty in family medicine residency programs. Most fellowship graduates are comfortable caring for high-risk pregnancy patients and performing related operative procedures. Sixty-six percent of graduates reported obtaining cesarean delivery privileges. Practicing in the Northeastern part of the United States decreased the likelihood of graduates having cesarean delivery privileges while practicing in a rural community increased it. CONCLUSIONS: A majority of family physicians care for high-risk pregnancy patients and perform operative procedures related to pregnancy after completing an obstetrics fellowship.

Prayer for health and primary care: results from the 2002 National Health Interview Survey.

BACKGROUND AND OBJECTIVES: Prayer for health (PFH) is common; in 2002, 35% of US adults prayed for their health. We examined the relationship of PFH and primary care visits, with a special focus on African American women, using data from the 2002 National Health Interview Survey (NHIS). METHODS: We used chi-square analyses to compare the demographic (age group, gender, race, region, marital status, educational level, ethnicity) and health-related covariates (alcohol use, smoking status, and selected medical conditions) between individuals who did and did not pray for their health in the past year. Univariate associations between PFH and visit to primary care provider (PCP), with Mantel-Haenszel adjustment for confounding, were determined. Multivariate regression was used to determine independent factors associated with PFH and PCP visit, with SUDAAN to adjust for the clustered survey design. RESULTS: Subjects who prayed were more likely to be female, older than 58, Black, Southern, separated, divorced or widowed, and nondrinkers. Subjects who prayed were also more likely to have seen a PCP within the past year. Black women who prayed were also more likely to see a PCP. CONCLUSIONS: These findings suggest that people who pray for their health do so in addition to, not instead of, seeking primary care. This finding is maintained but with a smaller effect size, in Black women.

Physicians' Experiences with Male Patients Who Perpetrate Intimate Partner Violence.

INTRODUCTION: Despite the prevalence of intimate partner violence (IPV), there is a paucity of research exploring the role that physicians might play in intervening with IPV perpetrators. METHODS: A qualitative study explored interactions between family medicine physicians and male perpetrators of IPV. Fifteen physicians were purposefully sampled from 1 hospital system. The physicians were individually interviewed using a semistructured interview guide, and interview transcripts were analyzed using techniques from grounded theory. RESULTS: Three main themes relating to physicians' experiences were identified: (1) how physicians learned of or identified IPV perpetration by men (usually disclosure by the victim, but perpetrators also disclosed it); (2) how physicians assessed for comorbidities or responded to IPV perpetration by men; and (3) facilitators of and barriers to physician identification of and response to IPV perpetration by men. Facilitators identified include having a trusting relationship with the perpetrator and support services, whereas barriers consisted of strong negative emotions and a lack of training. CONCLUSIONS: Family medicine physicians in this sample reported feeling underprepared to serve patients whom they know are perpetrators of IPV, particularly if they are also providing care to the victim. Additional research is needed to develop interventions and effective trainings.

Alginate antacid (Gaviscon DA) chewable tablets reduce esophageal acid exposure in Chinese patients with gastroesophageal reflux disease and heartburn symptoms.

OBJECTIVE: To assess the efficacy of Gaviscon Double Action (DA) alginate antacid chewable tablets for reducing esophageal acid exposure in Chinese patients with gastroesophageal reflux disease (GERD). METHODS: Altogether 44 patients reporting moderate to severe heartburn symptoms underwent two pH monitoring visits. The treatment sequence was randomized to patients received DA alginate antacid or placebo at one visit and the alternate treatment 7 days later. After a standardized reflux-provoking meal, patients took four tablets of DA alginate antacid or placebo. Esophageal pH was measured for 4 h post-dosing using an electrode positioned 5 cm above the lower esophageal sphincter. The primary end-point was the percentage of 4-h post-dosing period with pH <4. Secondary end-points were number of acid reflux episodes (pH <4), longest reflux time and DeMeester scores. RESULTS: All 44 patients completed the study and provided data for analysis. With DA alginate antacid, the mean percentage time with pH <4 was 5.1%, significantly less (P = 0.0003) than with placebo (14.8%). DA alginate antacid was statistically significantly superior (P = 0.0290) to placebo (from at least twofold to threefold better) for all other end-points. Two patients reported two mild adverse events (AEs) that resolved within a month of completing the study. No patients had serious and/or severe AEs and none withdrew due to AEs. CONCLUSIONS: DA alginate antacid was statistically significantly superior to placebo in reducing post-prandial acid exposure without serious clinically relevant health risks. These findings suggest DA alginate antacid tablets are appropriate for treating acid reflux in Chinese GERD patients with heartburn symptoms.