Incorporating Stakeholder Perspectives on Scarce Resource Allocation: Lessons Learned from Policymaking in a Time of Crisis.

The coronavirus disease (COVID-19) crisis provoked an organizational ethics dilemma: how to develop ethical pandemic policy while upholding our organizational mission to deliver relationship- and patient-centered care. Tasked with producing a recommendation about whether healthcare workers and essential personnel should receive priority access to limited medical resources during the pandemic, the bioethics department and survey and interview methodologists at our institution implemented a deliberative approach that included the perspectives of healthcare professionals and patient stakeholders in the policy development process. Involving the community more, not less, during a crisis required balancing the need to act quickly to garner stakeholder perspectives, uncertainty about the extent and duration of the pandemic, and disagreement among ethicists about the most ethically supportable way to allocate scarce resources. This article explains the process undertaken to garner stakeholder input as it relates to organizational ethics, recounts the stakeholder perspectives shared and how they informed the triage policy developed, and offers suggestions for how other organizations may integrate stakeholder involvement in ethical decision-making as well as directions for future research and public health work.

A survey of risk tolerance to multiple sclerosis therapies.

OBJECTIVE: To determine tolerance to various risk scenarios associated with current multiple sclerosis (MS) therapies. METHODS: People with MS from the North American Research Committee on Multiple Sclerosis Registry's online cohort and the National Multiple Sclerosis Society were invited to complete a questionnaire on tolerance to real-world risks associated with a hypothetical therapy. Multiple risks levels were presented, including skin rash, infection, kidney injury, thyroid injury, liver injury, and progressive multifocal leukoencephalopathy (PML). RESULTS: Both PML and kidney injury had the lowest risk tolerance (RT) at 1:1,000,000, and thyroid and infection risks had the highest tolerance at 1:1,000. Men, younger individuals, and participants with greater disability reported a higher tolerance to all risk scenarios. Those who were currently taking an MS therapy reported higher tolerance than those not taking any therapy. Participants taking infusion therapies reported high tolerance to all risks, and those taking injectables reported a lower tolerance. CONCLUSION: People with MS displayed a wide range of RT for MS therapies. Our study identified sex, age, disability, and current disease-modifying therapy use to be associated with RT.

Balancing Needs and Autonomy: The Involvement of Pregnant Women's Partners in Decisions About cfDNA.

Cell-free fetal DNA (cfDNA) screening is used to identify the presence of fetal genetic variants early in pregnancy. Patients' informed decision-making is central to the success of this new screen in clinical practice. Although research has focused on pregnant women's decision-making, little is known about partners' role and preferences as a member of the decision-making dyad. Using a grounded theory approach, this study analyzed 23 in-depth interviews to examine partners' perspectives about cfDNA screening and preferences with respect to their role in the decision-making process. Participants wished to be actively involved in testing decisions. They articulated a distinct set of needs and preferences in the decision-making process. Such involvement was hindered by several biological and logistical barriers. This study demonstrates the need to develop mechanisms that foster informed decision-making for cfDNA screening and related new reproductive genetic technologies that focus on not just the pregnant woman but also the decision-making dyad that includes her partner as well.

Cardiovascular care guideline implementation in community health centers in Oregon: a mixed-methods analysis of real-world barriers and challenges.

BACKGROUND: Spreading effective, guideline-based cardioprotective care quality improvement strategies between healthcare settings could yield great benefits, particularly in under-resourced contexts. Understanding the diverse factors facilitating or impeding such guideline implementation could improve cardiovascular care quality and outcomes for vulnerable patients. METHODS: We sought to identify multi-level factors affecting uptake of cardioprotective care guidelines in community health centers (CHCs), within a successful trial of cross-setting implementation of an effective intervention. Quantitative analyses used multivariable logistic regression to examine in-person patient encounters at 10 CHCs from June 2011-May 2014. At these encounters, a point-of-care alert flagged adults with diabetes who were clinically indicated for, but not currently prescribed, cardioprotective medications. The main outcome measure was the rate of relevant prescriptions issued within two days of encounters. Qualitative analyses focused on CHC providers and staff, and, guided by the constant comparative method, were used to enhance understanding of the factors that influenced this prescribing. RESULTS: Recommended prescribing occurred at 13-16% of encounters with patients who were indicated for such prescribing. The odds of this prescribing were higher when the patient was male, had HbA1c ≥7, was previously prescribed a similar medication, gave diabetes as the chief complaint, saw a mid-level practitioner, or saw their primary care provider. The odds were lower when the patient was insured, had ≥1 clinic visits in the past year, had kidney disease, or was prescribed certain other medications. Additional factors were associated with prescribing of each medication class. Qualitative results both supported and challenged the quantitative findings, illustrating important tensions involved in guideline-based prescribing. Clinic staff stressed the importance of the provider-patient relationship in guiding prescribing decisions in the face of competing priorities and care needs, and the impact of rapidly changing guidelines. CONCLUSIONS: Diverse factors associated with guideline-concordant prescribing illuminate the complexity of delivering evidence-based care in CHCs. We present possible strategies for addressing barriers to guideline-based prescribing. CLINICAL TRIALS REGISTRATION: This trial was registered retrospectively. Currently Controlled Trials NCT02299791 . Retrospectively registered 10 November 2014.

"Salt in the Wound": Safety Net Clinician Perspectives on Performance Feedback Derived From EHR Data.

Electronic health record (EHR) data can be extracted for calculating performance feedback, but users' perceptions of such feedback impact its effectiveness. Through qualitative analyses, we identified perspectives on barriers and facilitators to the perceived legitimacy of EHR-based performance feedback, in 11 community health centers (CHCs). Providers said such measures rarely accounted for CHC patients' complex lives or for providers' decisions as informed by this complexity, which diminished the measures' perceived validity. Suggestions for improving the perceived validity of performance feedback in CHCs are presented. Our findings add to the literature on EHR-based performance feedback by exploring provider perceptions in CHCs.

Feasibility and impact of implementing a private care system's diabetes quality improvement intervention in the safety net: a cluster-randomized trial.

BACKGROUND: Integrated health care delivery systems devote considerable resources to developing quality improvement (QI) interventions. Clinics serving vulnerable populations rarely have the resources for such development but might benefit greatly from implementing approaches shown to be effective in other settings. Little trial-based research has assessed the feasibility and impact of such cross-setting translation and implementation in community health centers (CHCs). We hypothesized that it would be feasible to implement successful QI interventions from integrated care settings in CHCs and would positively impact the CHCs. METHODS: We adapted Kaiser Permanente's successful intervention, which targets guideline-based cardioprotective prescribing for patients with diabetes mellitus (DM), through an iterative, stakeholder-driven process. We then conducted a cluster-randomized pragmatic trial in 11 CHCs in a staggered process with six "early" CHCs implementing the intervention one year before five "'late" CHCs. We measured monthly rates of patients with DM currently prescribed angiotensin converting enzyme (ACE)-inhibitors/statins, if clinically indicated. Through segmented regression analysis, we evaluated the intervention's effects in June 2011-May 2013. Participants included ~6500 adult CHC patients with DM who were indicated for statins/ACE-inhibitors per national guidelines. RESULTS: Implementation of the intervention in the CHCs was feasible, with setting-specific adaptations. One year post-implementation, in the early clinics, there were estimated relative increases in guideline-concordant prescribing of 37.6 % (95 % confidence interval (CI); 29.0-46.2 %) among patients indicated for both ACE-inhibitors and statins and 38.7 % (95 % CI; 23.2-54.2 %) among patients indicated for statins. No such increases were seen in the late (control) clinics in that period. CONCLUSIONS: To our knowledge, this was the first clinical trial testing the translation and implementation of a successful QI initiative from a private, integrated care setting into CHCs. This proved feasible and had significant impact but required considerable adaptation and implementation support. These results suggest the feasibility of adapting diverse strategies developed in integrated care settings for implementation in under-resourced clinics, with important implications for efficiently improving care quality in such settings. CLINICALTRIALS.gov: NCT02299791 .

Communicating with biobank participants: preferences for receiving and providing updates to researchers.

BACKGROUND: Research biobanks collect biologic samples and health information. Previous work shows that biobank participants desire general study updates, but preferences about the method or frequency of these communications have not been explored. Thus, we surveyed participants in a long-standing research biobank. METHODS: Eligible participants were drawn from a study of patients with personal/family history suggestive of Cowden syndrome, a poorly recognized inherited cancer syndrome. Participants gave blood samples and access to medical records and received individual results but had no other study interactions. The biobank had 3,618 participants at sampling. Survey eligibility included age ≥18 years, enrollment within the biobank's first 5 years, normal PTEN analysis, and contiguous U.S. address. Multivariate logistic regression analyses identified predictors of participant interest in Internet-based versus offline methods and methods allowing participant-researcher interaction versus one-way communication. Independent variables were narrowed by independent Pearson correlations by cutoff P < 0.2, with P < 0.02 considered significant. RESULTS: Surveys were returned from 840 of 1,267 (66%) eligible subjects. Most (97%) wanted study updates, with 92% wanting updates at least once a year. Participants preferred paper (66%) or emailed (62%) newsletter methods, with 95% selecting one of these. Older, less-educated, and lower-income respondents strongly preferred offline approaches (P < 0.001). Most (93%) had no concerns about receiving updates and 97% were willing to provide health updates to researchers. CONCLUSION: Most participants were comfortable receiving and providing updated information. Demographic factors predicted communication preferences. IMPACT: Researchers should make plans for ongoing communication early in study development and funders should support the necessary infrastructure for these efforts.

Online direct-to-consumer messages about non-invasive prenatal genetic testing.

Non-invasive prenatal testing (NIPT) has been integrated into clinical care at a time when patients and healthcare providers increasingly utilize the internet to access health information. This study evaluated online direct-to-consumer information about NIPT produced by commercial laboratories accessible to both patients and healthcare providers. A coding checklist captured areas to describe content and assess concordance with clinical guidelines. We found that the information presented about NIPT is highly variable, both within a single website and broadly across all websites. Variability was noted in how NIPT is characterized, including test characteristics and indications. All laboratories offer NIPT to test for common sex chromosome aneuploidies, although there is a lack of consistency regarding the conditions offered and information provided about each. Although indicated for a subset of women at increased risk of aneuploidy, some laboratories describe the use of NIPT for all pregnant women. A subset of laboratories offers screening for microdeletions, although clinical practice guidelines do not yet recommend for general use for this indication. None of the online materials addressed the ethical issues associated with NIPT. This study highlights the need for clear, consistent, and evidence-based materials to educate patients and healthcare providers about the current and emerging applications of NIPT.

'Someone should oversee it': patient perspectives on the ethical issues arising with the regulation of probiotics.

BACKGROUND: Although many probiotic products are currently available in yogurt or pill form in the United States (US), there is uncertainty surrounding the structure of regulation of these products. As more therapeutic probiotics are developed, changes to existing regulatory process in the United States may be required to meet the needs of patients and users in the population. OBJECTIVE: This study examined how patients with chronic gastrointestinal (GI) diseases view the regulation of probiotics. DESIGN: We conducted a multi-site qualitative study consisting of focus groups of patients with chronic gastrointestinal diseases at three tertiary hospitals: at [institutions removed for blinded review]. RESULTS: We conducted 22 focus groups with 136 patients with major gastrointestinal (GI) diseases between March and August 2009. Participants were not familiar with the existing regulation of probiotic products but wanted assurances of accurate labelling of strain as well as safety. Participants raised concerns that regulation of probiotics might be accompanied by greater costs, reduced access and increased involvement of pharmaceutical companies. Although participants voiced significant doubt of government regulators, they felt that products containing genetically modified probiotic strains should have oversight comparable to that of pharmaceutical drugs. DISCUSSION AND CONCLUSION: If GI patient perspectives are indicative of public perceptions of therapeutic probiotics in the United States, consumers may expect more rigorous regulation in the future while simultaneously wanting low costs, easy access and low involvement of pharmaceutical companies. Manufacturers, translational scientists, clinicians and regulators should be sensitive to consumer attitudes when designing, testing and regulating new therapeutic probiotics.

Ethnographic process evaluation in primary care: explaining the complexity of implementation.

BACKGROUND: The recent growth of implementation research in care delivery systems has led to a renewed interest in methodological approaches that deliver not only intervention outcome data but also deep understanding of the complex dynamics underlying the implementation process. We suggest that an ethnographic approach to process evaluation, when informed by and integrated with quantitative data, can provide this nuanced insight into intervention outcomes. The specific methods used in such ethnographic process evaluations are rarely presented in detail; our objective is to stimulate a conversation around the successes and challenges of specific data collection methods in health care settings. We use the example of a translational clinical trial among 11 community clinics in Portland, OR that are implementing an evidence-based, health-information technology (HIT)-based intervention focused on patients with diabetes. DISCUSSION: Our ethnographic process evaluation employed weekly diaries by clinic-based study employees, observation, informal and formal interviews, document review, surveys, and group discussions to identify barriers and facilitators to implementation success, provide insight into the quantitative study outcomes, and uncover lessons potentially transferable to other implementation projects. These methods captured the depth and breadth of factors contributing to intervention uptake, while minimizing disruption to clinic work and supporting mid-stream shifts in implementation strategies. A major challenge is the amount of dedicated researcher time required. The deep understanding of the 'how' and 'why' behind intervention outcomes that can be gained through an ethnographic approach improves the credibility and transferability of study findings. We encourage others to share their own experiences with ethnography in implementation evaluation and health services research, and to consider adapting the methods and tools described here for their own research.

Ethical Discourse about the Modification of Food for Therapeutic Purposes: How Patients with Gastrointestinal Diseases View the Good, the Bad, and the Healthy.

BACKGROUND: Researchers have the potential to utilize genetic modification (GM) technologies to create a hybrid of "food" and "medicine" that may challenge traditional understandings of what is "natural". Moral and ethical concerns are likely to arise in any discussion of these therapeutic foods and will affect the integration of products into clinical care and daily life. This study examined how patients with chronic gastrointestinal (GI) diseases view probiotics as future bioengineered therapeutic foods. METHODS: A multi-site qualitative study consisting of focus groups with chronic GI diseases was conducted at Cleveland Clinic, Mayo Clinic, and Johns Hopkins University RESULTS: We conducted twenty-two focus groups with 136 patients with major GI diseases between March and August 2009. GI patients associated the term "natural" with concepts of diminished risk and morally "good"; conversely, patients associated the term "unnatural" with things that are "risky," "foreign", and morally "bad". Readily available unmodified probiotics were more commonly described as "natural" while genetically modified probiotics were more commonly labeled as "unnatural" and "risky". However, patients acknowledged that not all natural products are safe, nor are unnatural products always harmful. CONCLUSIONS: If GI patient perspectives are indicative of public perceptions of therapeutic foods, our findings suggest that the potential benefits and risks of clinical and public health initiatives employing therapeutic foods will be understood in moralistic terms. Bioethicists and others should be sensitive to the implicit normative appeals that are often embedded in the language of what is "natural" and "unnatural".

How patients view probiotics: findings from a multicenter study of patients with inflammatory bowel disease and irritable bowel syndrome.

BACKGROUND: Patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) have access to a growing number of probiotic products marketed to improve digestive health. It is unclear how patients make decisions about probiotics and what role they expect their gastroenterologists to play as they consider using probiotics. Understanding patients' knowledge, attitudes and expectations of probiotics may help gastroenterologists engage patients in collaborative discussions about probiotics. STUDY: Focus groups were conducted with patients with IBD and IBS at the Cleveland Clinic, Mayo Clinic, and Johns Hopkins University. Inductive analytic methods were used to identify common themes and draw interpretations from focus group narratives. RESULTS: One hundred thirty-six patients participated in 22 focus groups between March and August 2009. Patients viewed probiotics as an appealing alternative to pharmaceutical drugs and understood probiotics as a more "natural," low-risk therapeutic option. Many patients were hesitant to use them without consulting their gastroenterologists. Patients would weigh the risks and benefits of probiotics, their disease severity and satisfaction with current treatments when considering probiotic use. CONCLUSIONS: Patients are interested in probiotics but have many unanswered questions about their use. Our findings suggest that patients with IBD and IBS will look to gastroenterologists and other clinicians as trustworthy advisors regarding the utility of probiotics as an alternative or supplement to pharmaceutical drugs. Gastroenterologists and other clinicians who care for patients with these diseases should be prepared to discuss the potential benefits and risks of probiotics and assist patients in making informed decisions about their use.

Will mothers discuss parenting stress and depressive symptoms with their child's pediatrician?

BACKGROUND: Parenting stress and maternal depressive symptoms are ubiquitous and have negative consequences for children. Pediatricians may be an underused resource to mothers regarding these issues. OBJECTIVE: To explore maternal beliefs and perceptions about discussing the stress of parenting and depressive symptoms with their child's pediatrician. DESIGN/METHODS: Mothers were recruited from 5 community-based pediatric practices and 1 hospital-based practice to ensure a diverse sample. An experienced, trained facilitator conducted focus groups by using open-ended questions and administered a standard questionnaire. Audiotapes and transcripts of the groups were reviewed for major themes by 3 independent researchers using grounded theory and immersion/crystallization technique. RESULTS: Seven focus groups (N = 44) were convened. Participants were 70% black and 30% white with a mean age of 27 years; 61% were single; 50% were educated beyond high school; and 43% received public assistance as their main source of income. The mean score on the Psychiatric Symptom Index was 26.3 (high > or =20). Within 2 overarching domains (maternal and interaction between mother and pediatrician), several themes emerged. Within the maternal domain, dominant themes included 1) emotional health: all respondents indicated that a mother's emotional health greatly affects her child's well being; 2) self-efficacy: mothers believed in the importance of accepting responsibility for monitoring their own well being and that of their child; and 3) support systems: all mothers expressed the need to share parenting experiences, stressors, and depressive symptoms with someone (most preferred to speak with family or friends rather than with their child's pediatrician). Within the interaction domain, 2 themes emerged: 1) communication: open communication with a pediatrician who listens well was perceived by mothers in all groups as very important, and 2) trust: mothers trust pediatricians with their child's health, but many were hesitant to discuss their own stress or depressive symptoms. Mothers in all socioeconomic groups expressed fear of judgment and possible referral to child protection if they talked about such issues. Both of these were mediated by the presence of an ongoing relationship between the pediatrician and mother. Mothers were more likely to discuss their own emotional health if they felt their child's pediatrician "knew them well." CONCLUSIONS: Mothers are aware that their own emotional health has consequences for their children. Although many mothers experienced lacks in their social support systems, many are reluctant to discuss parenting stress and depressive symptoms with their child's pediatrician because of mistrust and fear of judgment. Mothers are, however, generally receptive to the idea of open communication with their pediatricians and are interested in receiving supportive written communication about parenting stress and depressive symptoms from pediatricians. These qualitative data are valuable in developing an intervention to help pediatricians assist mothers at risk.