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.

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.

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.

Should vitamin D deficiency be corrected before parathyroidectomy?

BACKGROUND: Vitamin D deficiency is common in patients with hyperparathyroidism, but the importance of replacement before surgery is controversial. We aimed to evaluate the impact of vitamin D deficiency on the extent of resection and risk of postoperative hypocalcemia for patients undergoing parathyroidectomy for primary hyperparathyroidism. METHODS: We identified patients with primary hyperparathyroidism undergoing parathyroid surgery between 2000 and 2015 using a prospectively maintained database. Patients with normal (≥30 ng/mL) vitamin D were compared to those with levels less than 30 ng/mL. RESULTS: There were 1015 (54%) patients with normal vitamin D and 872 (46%) patients with vitamin D deficiency undergoing parathyroidectomy for primary hyperparathyroidism. Vitamin D deficiency was associated with higher preoperative parathyroid hormone (median 90 versus 77 pg/mL, P < 0.001) and calcium (median 10.5 versus 10.4 mg/dL, P < 0.001) compared with normal vitamin D. To achieve similar cure rates, patients with vitamin D deficiency were less likely to require removal of more than one gland (20% versus 30%, P < 0.001) than patients with normal vitamin D. Patients with vitamin D deficiency had similar rates of persistent (1.5% versus 2.0%, P = 0.43) and recurrent (1.7% versus 2.6%, P = 0.21) hyperparathyroidism. Postoperatively, both groups had equivalent rates of transient (2.3% versus 2.3%, P = 0.97) and permanent (0.2% versus 0.4%, P = 0.52) hypocalcemia. CONCLUSIONS: Restoring vitamin D in deficient patients should not delay the appropriate surgical treatment of primary hyperparathyroidism. Deficient patients are more likely to be cured with the excision of a single adenoma and no more likely to suffer persistence, recurrence, or hypocalcemia than patients with normal vitamin D.

Morphological fractal analysis of shape in cancer cells treated with combinations of microtubule-polymerizing and -depolymerizing agents.

The current prognostic parameters, including tumor volume, biochemistry, or immunohistochemistry, are not sufficient to reflect the properties of cancer cells that distinguish them from normal cells. Our focus is to evaluate the effects of a combination of microtubule-polymerizing Taxol and -depolymerizing colchicine on IAR20 PC1 liver cells by measuring the surface fractal dimension as a descriptor of two-dimensional vascular geometrical complexity. The fractal dimension offers a rapid means of assessing cell shape. Furthermore, we show correlations of fractal dimensions of cell contours with the latent factors from our previously employed cell shape analysis.