Informed Consent and Informed Decision-Making in High-Risk Surgery: A Quantitative Analysis.

BACKGROUND: Informed consent is an ethical and legal requirement that differs from informed decision-making-a collaborative process that fosters participation and provides information to help patients reach treatment decisions. The objective of this study was to measure informed consent and informed decision-making before major surgery. STUDY DESIGN: We audio-recorded 90 preoperative patient-surgeon conversations before major cardiothoracic, vascular, oncologic, and neurosurgical procedures at 3 centers in the US and Canada. Transcripts were scored for 11 elements of informed consent based on the American College of Surgeons' definition and 9 elements of informed decision-making using Braddock's validated scale. Uni- and bivariate analyses tested associations between decision outcomes as well as patient, consultation, and surgeon characteristics. RESULTS: Overall, surgeons discussed more elements of informed consent than informed decision-making. They most frequently described the nature of the illness, the operation, and potential complications, but were less likely to assess patient understanding. When a final treatment decision was deferred, surgeons were more likely to discuss elements of informed decision-making focusing on uncertainty (50% vs 15%, p = 0.006) and treatment alternatives (63% vs 27%, p = 0.02). Conversely, when surgery was scheduled, surgeons completed more elements of informed consent. These results were not associated with the presence of family, history of previous surgery, location, or surgeon specialty. CONCLUSIONS: Surgeons routinely discuss components of informed consent with patients before high-risk surgery. However, surgeons often fail to review elements unique to informed decision-making, such as the patients' role in the decision, their daily life, uncertainty, understanding, or patient preference.

Patients' Reaction to Diagnosis with Thyroid Cancer or an Indeterminate Thyroid Nodule.

Introduction: Little is known about the experiences and concerns of patients recently diagnosed with thyroid cancer or an indeterminate thyroid nodule. This study sought to explore patients' reactions to diagnosis with papillary thyroid cancer (PTC) or indeterminate cytology on fine needle aspiration. Methods: We conducted semistructured interviews with 85 patients with recently diagnosed PTC or an indeterminate thyroid nodule before undergoing thyroidectomy. We included adults with nodules ≥1 cm and Bethesda III, IV, V, and VI cytology. The analysis utilized grounded theory methodology to create a conceptual model of patient reactions. Results: After diagnosis, participants experienced shock, anxiety, fear, and a strong need to "get it out" because "it's cancer!" This response was frequently followed by a sense of urgency to "get it done," which made waiting for surgery difficult. These reactions occurred regardless of whether participants had confirmed PTC or indeterminate cytology. Participants described the wait between diagnosis and surgery as difficult, because the cancer or nodule was "still sitting there" and "could be spreading." Participants often viewed surgery and getting the cancer out as a "fix" that would resolve their fears and worries, returning them to normalcy. The need to "get it out" also led some participants to minimize the risk of complications or adverse outcomes. Education about the slow-growing nature of PTC reassured some, but not all patients. Conclusions: After diagnosis with PTC or an indeterminate thyroid nodule, many patients have strong emotional reactions and an impulse to "get it out" elicited by the word "cancer." This reaction can persist even after receiving education about the excellent prognosis. Understanding patients' response to diagnosis is critical, because their emotional reactions likely pose a barrier to implementing guidelines recommending less extensive management for PTC.

Perceived Professional and Institutional Factors Influencing Clinical Adoption of Pharyngeal High-Resolution Manometry.

Purpose We assessed experienced clinicians' perceptions of benefits and drawbacks to the clinical adoption of pharyngeal high-resolution manometry (HRM). This article focuses on the professional and institutional factors that influence the clinical adoption of pharyngeal HRM by speech-language pathologists (SLPs). Method Two surveys (closed- and open-ended questions) and a series of focus groups were completed with SLP members of both the American Speech-Language-Hearing Association and the Dysphagia Research Society (DRS). Transcripts were inductively coded for emergent themes. Results Thirteen SLPs were recruited to attend focus group sessions at the American Speech-Language-Hearing Association. Eighty-seven SLPs responded to the DRS open-set response survey. Two additional focus groups of 11 SLPs were convened at the DRS meeting. Conventional content analysis revealed overall SLP enthusiasm for the clinical use of HRM, with some concerns about the technology adoption process. The following themes related to the professional and institutional factors influencing clinical adoption were identified: (a) scope of practice, (b) access, (c) clinical workflow, and (d) reimbursement. Conclusion These data serve to elucidate the most salient factors relating to the clinical adoption of pharyngeal HRM into routine speech-language pathology clinical practice. While enthusiasm exists, a variety of systems-level issues must be addressed to support this process.

A Novel Surgical Patient Engagement Model: A Qualitative Study of Postoperative Patients.

BACKGROUND: Strong patient engagement is often associated with better postoperative outcomes and reduced risk of dangerous and expensive complications for the patient. Our goal with this project is to define a new model specifically for surgical patient engagement to guide future work to improve patient outcomes. METHODS: Open-ended qualitative interviews were conducted with 38 postoperative patients, analyzed using the conventional content analysis method, and coded with NVivo 11. Patients from either a safety net or private hospital in the Houston area between the ages of 18 and 70 y were recruited after surgery for either thyroid, parathyroid, colon, or rectal cancer, inflammatory bowel disease, and diverticulitis. Pregnant and incarcerated patients in addition to those with postoperative complications or interview time frames greater than 4 wk postoperatively were excluded. RESULTS: Of patients completing the Patient Activation Measure, 98% obtained a score of 3 or 4, indicating optimal levels of activation despite differences in socio-economic status. Upon analysis of coded transcripts, four main themes of "self-efficacy," "resilience," "transitional agency," and "enabling agency," in addition to a fifth emergency rescue activator, "family and social support," were discovered as "drivers" of patient engagement. CONCLUSIONS: A novel model of patient engagement specific to surgical patients is necessary because of the unique recovery track they endure. Our new model can be used to develop interventions for these patients to improve their engagement and thereby their outcomes.

"Like a Normal Person Again": A Qualitative Analysis of the Impact of Headache Surgery.

BACKGROUND: Outcomes after migraine surgery have been previously assessed using quantitative measurements, including the migraine headache index. Qualitative methodologies offer the ability to analyze patients' perceptions and pain experience, and may point to changes in domains not captured by quantitative instruments. The purpose of this study was to characterize individual patients' experiences with migraines and to analyze how patients' experience of headaches changes in relation to surgery. METHODS: Patients who previously underwent migraine surgery performed by a single surgeon participated in semistructured interviews at least 1 year after surgery. Purposive sampling was used to recruit patients [n = 15 (73 percent female)]. Interviews were transcribed verbatim. A multidisciplinary team with backgrounds in surgery, pain management, medicine, and health services research coded and analyzed transcripts. RESULTS: Participants reported improvements in one or more domains of pain following surgery, and changes in medication use and effectiveness. Even in individuals with persistent pain postoperatively, surgery appeared to facilitate an improvement in headache self-efficacy, including an ability to participate in daily activities. Migraineurs frequently described a new degree of control over at least one aspect of their pain. CONCLUSIONS: Migraine surgery appears to positively impact patients' lives in ways that support and expand on previously published outcomes. Patients report benefiting from surgery in ways that are not currently captured in commonly used metrics. This study's findings support the need for more specific patient-reported outcome measures to help clinicians and patients understand the impact of surgery and which outcomes matter most to patients.

A Qualitative Analysis of the Preoperative Needs of Patients With Papillary Thyroid Cancer.

BACKGROUND: Thyroid cancer patients report unmet needs after diagnosis. However, little is known about their specific needs. Therefore, we sought to characterize the needs of patients with thyroid cancer before undergoing surgery. MATERIAL AND METHODS: We conducted semistructured interviews with 32 patients with papillary thyroid cancer after their preoperative surgical consultation. Data were analyzed using thematic content analysis. RESULTS: The central need of patients with thyroid cancer was a strong patient-surgeon relationship characterized by informational and emotional support, and respect for the patient as a person. Patients preferred disease- and treatment-related information to be individualized and to take into account aspects of their daily life. They wanted adequate time for asking questions with thoughtful answers tailored to their case. Patients additionally desired emotional support from the surgeon characterized by empathy and validation of their cancer experience. They particularly wanted surgeons to address their fears and anxiety. Patients also highly valued the surgeons' ability to see beyond their disease and acknowledge them as a unique person with respect to their occupation, psychosocial state, and other individual characteristics. When surgeons met patients' needs, they felt reassured, comfortable with their cancer diagnosis, and prepared for treatment. Suboptimal support increased patients' anxiety particularly when they felt the surgeon minimized their concerns. CONCLUSIONS: Preoperatively, patients with thyroid cancer desire a strong patient-surgeon relationship. They rely on the surgeon to provide adequate informational and emotional support and respect them as individuals. In turn, patients feel reassured and prepared for treatment.

Correlates of Early Pharyngeal High-Resolution Manometry Adoption in Expert Speech-Language Pathologists.

Pharyngeal high-resolution manometry (HRM) is at a point of entry into speech-language pathologist (SLP) clinical practice. However, the demographic characteristics of SLPs who are early adopters of HRM are unclear; perspectives of early adopters may shape how the technology is received by the field at large. We hypothesized that younger SLPs, those working in outpatient settings, those with a strong knowledge base in HRM, and those with experience in other types of instrumentation are more likely to have interest in adopting HRM. We surveyed the population of board-certified SLPs (BCS-S; n = 262) with a 33% response rate (n = 78). Firth logistic regression was used to determine differences in those expressing interest in adopting HRM into future practice (n = 28) and those who did not (n = 45) from the analytic sample of 73 respondents. The best fitting model predicted that SLPs: (1) with training in more types of instrumentation; and (2) believing they could explain the HRM procedure to a patient were more likely to plan to adopt pharyngeal HRM into regular clinical practice. Experience with a variety of instrumentation techniques may encourage SLPs to use new forms of technology. Knowledge of early adopter demographics will allow for development of targeted trainings and determination of HRM implementation barriers. Identification of a clinician sub-group more likely to adopt other new technologies in the future may also be possible.

SLP-Perceived Technical and Patient-Centered Factors Associated with Pharyngeal High-Resolution Manometry.

High-resolution manometry (HRM) objectively measures swallowing-related pressures in the pharynx and esophagus. It has been used in many research applications, but it is unclear how HRM is perceived amongst speech-language pathologists (SLP) as it enters into clinical practice. The purpose of this study was to explore SLP perceptions of clinical HRM use. Based on qualitative data collected at four focus groups held at two national conferences and a survey based on open-ended questions, we found broad consensus among those queried regarding how HRM's objective and targeted data could enhance diagnosis and drive treatments. However, we found less consensus among SLPs regarding which patients may and may not benefit, as well as when in the clinical process HRM would best supplement existing technologies, showing a need for further research. These findings highlight how SLPs can be motivated to adopt new clinical technologies if they see a patient-centered benefit and underscore the need for continued SLP education on pharyngeal HRM.

Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Voice changes after thyroidectomy are typically attributed to recurrent laryngeal nerve injury. However, most postoperative voice changes occur in the absence of clinically evident vocal fold paralysis. To date, no study has compared the prevalence, duration, and consequences of voice-related disability from the patient perspective with use of quantitative vocal measures. Objectives: To assess the quality-of-life consequences of postthyroidectomy voice change from the perspective of patients with thyroid cancer and to compare patient-perceived voice changes with changes in quantitative vocal variables at 5 time points in the first postoperative year. Design, Setting, and Participants: This prospective mixed methods observational study within a randomized clinical trial occurred at the University of Wisconsin Hospital and Clinics. Participants were 42 patients with clinically node-negative papillary thyroid cancer without a preexisting vocal cord paralysis who were recruited and enrolled from outpatient clinics between June 6, 2014, and March 6, 2017, as part of the ongoing randomized clinical trial. Intervention: Total thyroidectomy. Main Outcomes and Measures: Semistructured interviews, symptom prevalence, and instrumental voice evaluations (laryngoscopy, phonation threshold pressure, Dysphonia Severity Index, and Voice Handicap Index) occurred at baseline (n = 42) and 2-week (n = 42), 6-week (n = 39), 6-month (n = 35), and 1-year (n = 30) postoperative time points. Results: Participants had a mean age of 48 years (interquartile range, 38-58 years; age range, 22-70 years) and were mostly female (74% [31 of 42]) and of white race/ethnicity (98% [41 of 42]). Impaired communication was the primary theme derived from patient interviews from before thyroidectomy to after thyroidectomy. Voice changes were perceived by 24 participants at 2 weeks after thyroidectomy. After surgery, voice symptoms were prevalent and persisted for 50% (21 of 42) of participants out to at least 1 year of follow-up. Quantitative vocal perturbations were detected in the Dysphonia Severity Index and Voice Handicap Index at the 2-week follow-up but returned to baseline levels by the 6-week follow-up visit. Conclusions and Relevance: Voice changes are common after surgery for papillary thyroid cancer and affect quality of life for many patients out to 1 year of follow-up. Directly querying patients about postoperative voice changes and questioning whether commonly used aerodynamic and acoustic variables detect meaningful voice changes are important in identifying patients whose quality of life has been affected by postthyroidectomy dysphonia. Trial Registration: ClinicalTrials.gov Identifier: NCT02138214.

Patient-Reported Dysphagia After Thyroidectomy: A Qualitative Study.

Importance: It is important that clinicians understand consequences of thyoridectomy on swallowing from the patient perspective to better care for this population. Objective: Using rigorous qualitative methodology, this study set out to characterize the effect of swallowing-related symptoms after thyroidectomy on patient quality of life and swallowing-related outcomes. Design, Setting, and Participants: Prospective, grounded theory analysis of interviews with 26 patients at 3 time points after thyroidectomy (2 weeks, 6 weeks, and 6 months). Data were collected from an ongoing clinical trial (NCT02138214), and outpatient interviews were conducted at the University of Wisconsin Hospital and Clinics. All participants were age 21 to 73 years with a diagnosis of papillary thyroid cancer without cervical or distant metastases and had undergone total thyroidectomy. Exclusion criteria were preexisting vocal fold abnormalities (eg, polyps, nodules), neurological conditions affecting the voice or swallowing ability, and/or development of new-onset vocal fold paresis or paralysis (lasting longer than 6 months) after total thyroidectomy. Interventions: Total thyroidectomy. Main Outcomes and Measures: Symptoms of dysphagia and related effects on quality of life elicited through grounded theory analysis of semistructured interviews with patients after thyroidectomy designed to foster an open-ended, patient-driven discussion. Results: Of the 26 patients included, 69% were women (n = 18); mean (SD) age, 46.4 (14.1) years; mean (SD) tumor diameter 2.2 (1.4) cm. Two weeks after thyroidectomy, 80% of participants (n = 20) reported at least 1 swallowing-related symptom when prompted by the interview cards; during the open interview, 53% of participants (n = 14) volunteered discussion of swallowing-related symptoms unprompted. However, only 8% of participants in this study (n = 2) qualified for a follow-up dysphagia evaluation, indicating that the majority of reported symptoms were subjective in nature. Six weeks and 6 months after thyroidectomy, 42% (n = 11) and 17% (n = 4) of participants, respectively, reported continued swallowing symptoms using the prompts; 12% (n = 3) discussed symptoms without prompting cards at both time points. Conclusions and Relevance: Swallowing symptoms after thyroidectomy are underreported in the literature. This study revealed that as many as 80% of patients who have thyroidectomy may experience swallowing-related symptoms after surgery, and many develop compensatory strategies to manage or reduce the burden of these symptoms. Considering the large number of individuals who may experience subjective dysphagia, preoperative counseling should include education and management of such symptoms.

Papillary Thyroid Cancer: The Good and Bad of the "Good Cancer".

BACKGROUND: Papillary thyroid cancer is often described as the "good cancer" because of its treatability and relatively favorable survival rates. This study sought to characterize the thoughts of papillary thyroid cancer patients as they relate to having the "good cancer." METHODS: This qualitative study included 31 papillary thyroid cancer patients enrolled in an ongoing randomized trial. Semi-structured interviews were conducted with participants at the preoperative visit and two weeks, six weeks, six months, and one year after thyroidectomy. Grounded theory was used, inductively coding the first 113 interview transcripts with NVivo 11. RESULTS: The concept of thyroid cancer as "good cancer" emerged unprompted from 94% (n = 29) of participants, mostly concentrated around the time of diagnosis. Patients encountered this perception from healthcare providers, Internet research, friends, and preconceived ideas about other cancers. While patients generally appreciated optimism, this perspective also generated negative feelings. It eased the diagnosis of cancer but created confusion when individual experiences varied from expectations. Despite initially feeling reassured, participants described feeling the "good cancer" characterization invalidated their fears of having cancer. Thyroid cancer patients expressed that they did not want to hear that it's "only thyroid cancer" and that it's "no big deal," because "cancer is cancer," and it is significant. CONCLUSIONS: Patients with papillary thyroid cancer commonly confront the perception that their malignancy is "good," but the favorable prognosis and treatability of the disease do not comprehensively represent their cancer fight. The "good cancer" perception is at the root of many mixed and confusing emotions. Clinicians emphasize optimistic outcomes, hoping to comfort, but they might inadvertently invalidate the impact thyroid cancer has on patients' lives.

Using Public-Private Partnerships to Mitigate Disparities in Access to Genetic Services: Lessons from Wisconsin.

PURPOSE: This mixed-methods study reports on an outreach clinics program designed to deliver genetic services to medically underserved communities in Wisconsin. METHODOLOGY: We show the geographic distribution, funding patterns, and utilization trends for outreach clinics over a 20-year period. Interviews with program planners and outreach clinic staff show how external and internal constraints limited the program's capacity. We compare clinic operations to the conceptual models guiding program design. FINDINGS: Our findings show that state health officials had to scale back financial support for outreach clinic activities while healthcare providers faced increasing pressure from administrators to reduce investments in charity care. These external and internal constraints led to a decline in the overall number of patients served. We also find that redistribution of clinics to the Milwaukee area increased utilization among Hispanics but not among African-Americans. Our interviews suggest that these patterns may be a function of shortcomings embedded in the planning models. IMPLICATIONS: Planning models have three shortcomings. First, they do not identify the mitigation of health disparities as a specific goal. Second, they fail to acknowledge that partners face escalating profit-seeking mandates that may limit their capacity to provide charity services. Finally, they underemphasize the importance of seeking trusted partners, especially in working with communities that have been historically marginalized. CONTRIBUTION: There has been little discussion about equitably leveraging genetic advances that improve healthcare quality and efficacy. The role of State Health Agencies in mitigating disparities in access to genetic services has been largely ignored in the sociological literature.

Stimulated recall methodology for assessing work system barriers and facilitators in family-centered rounds in a pediatric hospital.

Human factors and ergonomics methods are needed to redesign healthcare processes and support patient-centered care, in particular for vulnerable patients such as hospitalized children. We implemented and evaluated a stimulated recall methodology for collective confrontation in the context of family-centered rounds. Five parents and five healthcare team members reviewed video records of their bedside rounds, and were then interviewed using the stimulated recall methodology to identify work system barriers and facilitators in family-centered rounds. The evaluation of the methodology was based on a survey of the participants, and a qualitative analysis of interview data in light of the work system model of Smith and Carayon (1989, 2001). Positive survey feedback from the participants was received. The stimulated recall methodology identified barriers and facilitators in all work system elements. Participatory ergonomics methods such as the stimulated recall methodology allow a range of participants, including parents and children, to participate in healthcare process improvement.