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While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer screening by fecal immunochemical test (FIT) reduces the burden of colorectal cancer. However, effectiveness relies on annual adherence, which presents challenges for clinic staff and patients.Objective: Describe FIT return rates and identify factors associated with FIT adherence over 2 years in a mailed FIT outreach program in federally qualified health centers.Design: Observational study nested in the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) trial. Five thousand one hundred ninety-five patients had an initial FIT order and were followed for ≥ 2 years (3574 also had a FIT order in the second year).Main Measures: FIT return percent in each year and patient- and neighborhood-level characteristics associated with FIT adherence.Key Results: Overall, the proportion of FIT orders that were completed was 46% in the patients' first year and 41% in the patients' second year. Of the 5195 patients with a FIT order in year 1, 3574 (69%) also had a FIT order in year 2 (71% of year 1 adherers and 67% of year 1 non-adherers, p = 0.009). Among those with a FIT order in the second year, the FIT return rate was about twice as high among those who were adherent in the first year (952/1674, or 57%) as among those who were not (531/1900, or 28%, p < 0.0001). Patient-level characteristics associated with higher odds of FIT return were a history of FIT screening at baseline, age over 65 (vs 50-65), no current tobacco use, recent receipt of a mammogram or flu vaccine, Asian ancestry (compared to non-Hispanic white), and non-English preference. The only neighborhood factor associated with lower FIT return rate was patient's larger residential city size.Conclusion: Our findings can inform the customization of programs to promote FIT return among patients who receive care at federally qualified health centers.Trial Registration: http://www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

The article recommends ways of protecting the security of health care system data used in embedded research from potential harm that may be caused by data sharing. Topics discussed include the ways in which health facilities or health care systems may be harmed by careless data sharing practices, the potential structures for data sharing in embedded research and the questions that should be asked before deciding on what technical and governance model will be used for data sharing.

Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity. [ABSTRACT FROM AUTHOR]

Background: Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening. Methods: In partnership with STOP CRC’s advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with Oregon Community Health Information Network, a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation. Results: From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow-up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements. Conclusion: Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research. [ABSTRACT FROM AUTHOR]

Background: The national mandate for health systems to transition from ICD-9-CM to ICD-10-CM in October 2015 has an impact on research activities. Clinical phenotypes defined by ICD-9-CM codes need to be converted to ICD-10-CM, which has nearly four times more codes and a very different structure than ICD-9-CM. Methods: We used the Centers for Medicare & Medicaid Services (CMS) General Equivalent Maps (GEMs) to translate, using four different methods, condition-specific ICD-9-CM code sets used for pragmatic trials (n=32) into ICD-10-CM. We calculated the recall, precision, and F score of each method. We also used the ICD-9-CM and ICD-10-CM value sets defined for electronic quality measure as an additional evaluation of the mapping methods. Results: The forward-backward mapping (FBM) method had higher precision, recall and F score metrics than simple forward mapping (SFM). The more aggressive secondary (SM) and tertiary mapping (TM) methods resulted in higher recall but lower precision. For clinical phenotype definition, FBM was the best (F=0.67), but was close to SM (F=0.62) and TM (F=0.60), judging on the F scores alone. The overall difference between the four methods was statistically significant (one-way ANOVA, F=5.749, p=0.001). However, pairwise comparisons between FBM, SM, and TM did not reach statistical significance. A similar trend was found for the quality measure value sets. Discussion: The optimal method for using the GEMs depends on the relative importance of recall versus precision for a given use case. It appears that for clinically distinct and homogenous conditions, the recall of FBM is sufficient. The performance of all mapping methods was lower for heterogeneous conditions. Since code sets used for phenotype definition and quality measurement can be very similar, there is a possibility of cross-fertilization between the two activities. Conclusion: Different mapping approaches yield different collections of ICD-10-CM codes. All methods require some level of human validation. [ABSTRACT FROM AUTHOR]

The article focuses on the Systems of Support to Increase Colorectal Cancer Screening (SOS) study conducted between 2008 and 2011 at medical centers in Western Washington. It mentions the effect of interventions of completion of colorectal cancer screening. It adds the recommendation of the U.S. Preventive Services Task Force screening guidelines including fecal occult blood testing (FOBT) and flexible sigmoidoscopy with interval FOBT or colonoscopy.

J Clin Hypertens (Greenwich). Team-based care is one of the key components of the patient-centered medical home. Studies have consistently demonstrated that teams involving pharmacists or nurses in patient management can significantly improve blood pressure control. These findings have been demonstrated in several meta-analyses and systematic reviews. These reviews have generally found that team-based care can reduce systolic blood pressure by 4-10 mm Hg over usual care. However, these reviews have also concluded that many of the studies had various limitations and that additional research should be conducted. The present state of the art review paper will highlight newer studies, many of which were funded by the National Institutes of Health. Newer strategies involve telephone and/or web-based management which is an evolving area to improve blood pressure control in large populations. Social media and other technology is currently being investigated to assist pharmacists or nurses in communicating with patients to improve hypertension management. Few cost-effectiveness analyses have been performed but generally have found favorable costs for team-based care when considering the potential to reduce morbidity and mortality. The authors will suggest additional research that needs to be conducted to help evaluate strategies to best implement team-based care to improve blood pressure management. [ABSTRACT FROM AUTHOR]

Background: Physician counseling of patients to increase physical activity has had limited success in changing behavior. Providing organizational support to primary care providers and their patients may increase effectiveness.Objective: This study evaluates the effectiveness of a telephone-based intervention to increase physical activity among patients who exercised <15 minutes daily and wanted to increase their physical activity over a 6-month period.Design: This was a randomized controlled trial, conducted from 1997 to 1998, of 316 patients aged 18 to 65 who were recruited from a mailed health risk assessment. Baseline and 6-month post-intervention telephone assessments were conducted by telephone.Setting: One family physician's patients in a suburban community.Intervention: Three sessions of telephone-delivered motivational counseling.Main Outcome Measures: Physical activity score (11-item Physician-Based Assessment and Counseling for Exercise [PACE]) 6 months after the intervention.Results: After adjusting for baseline exercise, there was a significantly higher level of self-reported exercise among individuals randomized to the intervention at the 6-month follow-up. The mean level of activity at follow-up for the intervention group was a PACE score of 5.37, compared to 4.98 in the control group (p<0.05). In the secondary analysis, which was limited to individuals who received the intervention, the effect was stronger (PACE score of 5.58 compared to 4.94, p<0.013).Conclusions: Patients can be recruited using a health-screening questionnaire to receive a telephone-delivered behavioral intervention to successfully increase their physical activity levels. [ABSTRACT FROM AUTHOR]

Abstract: To examine the relation of regular vigorous exercise to ovulatory infertility, we interviewed 346 infertile women, in whom there was evidence of ovulatory failure, regarding their exercise patterns during the year preceding their unsuccessful effort to conceive. Their responses were compared with similar exercise histories m women who had successfully conceived at the time the infertile women started trying to become pregnant. Vigorous exercise for an hour or more per day was reported more commonly in nulligravid cases (n = 187) than by their primiparous controls. The difference was particularly great in the subgroup of cases without additional evidence of tubal dysfunction (relative risk = 6.2, 90% confidence interval = 1.0 - 39.8). This association was not seen among infertile women who had previously been pregnant. Vigorous exercise for an average of < one hour per day was not associated with either primary or secondary infertility. [ABSTRACT FROM AUTHOR]

Background: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support.Methods: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions.Results: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3.Conclusion: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP.Trial Registration: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]