Decision Regret Following the Choice of Surgery or Active Surveillance for Small, Low-Risk Papillary Thyroid Cancer: A Prospective Cohort Study.

Background: It is important to understand cancer survivors' perceptions about their treatment decisions and quality of life. Methods: We performed a prospective observational cohort study of Canadian patients with small (<2 cm) low-risk papillary thyroid cancer (PTC) who were offered the choice of active surveillance (AS) or surgery (Clinicaltrials.gov NCT03271892). Participants completed a questionnaire one year after their treatment decision. The primary intention-to-treat analysis compared the mean decision regret scale total score between patients who chose AS or surgery. A secondary analysis examined one-year decision regret score according to treatment status. Secondary outcomes included quality of life, mood, fear of disease progression, and body image perception. We adjusted for age, sex, and follow-up duration in linear regression analyses. Results: The overall questionnaire response rate was 95.5% (191/200). The initial treatment choices of respondents were AS 79.1% (151/191) and surgery 20.9% (40/191). The mean age was 53 years (standard deviation [SD] 15 years) and 77% (147/191) were females. In the AS group, 7.3% (11/151) of patients crossed over to definitive treatment (two for disease progression) before the time of questionnaire completion. The mean level of decision regret did not differ significantly between patients who chose AS (mean 22.4, SD 13.9) or surgery (mean 20.9, SD 12.2) in crude (p = 0.730) or adjusted (p = 0.29) analyses. However, the adjusted level of decision regret was significantly higher in patients who initially chose AS and crossed over to surgery (beta coefficient 10.1 [confidence interval; CI 1.3-18.9], p = 0.02), compared with those remaining under AS. In secondary adjusted analyses, respondents who chose surgery reported that symptoms related to their cancer or its treatment interfered with life to a greater extent than those who chose AS (p = 0.02), but there were no significant group differences in the levels of depression, anxiety, fear of disease progression, or overall body image perception. Conclusions: In this study of patients with small, low-risk PTC, the mean level of decision regret pertaining to the initial disease management choice was relatively low after one year and it did not differ significantly for respondents who chose AS or surgery.

Gender Differences in Fears Related to Low-Risk Papillary Thyroid Cancer and Its Treatment.

Importance: Fear is commonly experienced by individuals newly diagnosed with papillary thyroid cancer (PTC). Objective: To explore the association between gender and fears of low-risk PTC disease progression, as well as its potential surgical treatment. Design, Setting, and Participants: This single-center prospective cohort study was conducted at a tertiary care referral hospital in Toronto, Canada, and enrolled patients with untreated small low risk PTC (<2 cm in maximal diameter) that was confined to the thyroid. All patients had a surgical consultation. Study participants were enrolled between May 2016 and February 2021. Data analysis was performed from December 16, 2022, to May 8, 2023. Exposures: Gender was self-reported by patients with low-risk PTC who were offered the choice of thyroidectomy or active surveillance. Baseline data were collected prior to the patient deciding on disease management. Main Outcomes and Measures: Baseline patient questionnaires included the Fear of Progression-Short Form and Surgical Fear (referring to thyroidectomy) questionnaires. The fears of women and men were compared after adjustment for age. Decision-related variables, including Decision Self-Efficacy, and the ultimate treatment decisions were also compared between genders. Results: The study included 153 women (mean [SD] age, 50.7 [15.0] years) and 47 men (mean [SD] age, 56.3 [13.8] years). There were no significant differences in primary tumor size, marital status, education, parental status, or employment status between the women and men. After adjustment for age, there was no significant difference observed in the level of fear of disease progression between men and women. However, women reported greater surgical fear compared with men. There was no meaningful difference observed between women and men with respect to decision self-efficacy or the ultimate treatment choice. Conclusions and Relevance: In this cohort study of patients with low-risk PTC, women reported a higher level of surgical fear but not fear of the disease compared with men (after adjustment for age). Women and men were similarly confident and satisfied with their disease management choice. Furthermore, the decisions of women and men were generally not significantly different. The context of gender may contribute to the emotional experience of being diagnosed with thyroid cancer and its treatment perception.

Informing decision makers about public preferences for different modalities of cancer treatment in the Rhône-Alps region in France.

BACKGROUND: Alternative options to hospital care like home care or local health centers (LHCs) are being advocated. However, no study has measured citizens' preferences (who will finance these services via taxation) for these options. OBJECTIVES: We measured (i) citizens' preferences for these services, that is, respondents stated where they would like to get the treatment; (ii) the strength of their preference. METHODS: A computerized survey composed of (i) a decision aid to inform respondents about the three options; (ii) three scenarios, from light-to-heavy care, that respondents should rank from the most to the least preferred option of care. (iii) a contingent valuation survey (CVS) to assess how much respondents were willing to pay for their preferred option (except for hospital care if chosen, because it is the default option and free). (iv) a socio-demographic questionnaire. RESULTS: Data were collected from a representative sample of citizens living in the Rhône-Alps Region (n = 800). The heavier the care was, the more respondents preferred hospital care. Willingness to pay for additional taxation per household/month varied from €13.9 for light care in LHC to €19.1 for heavy home care. The small number of protesting respondents and outliers, and the close correlation between preferences, income, and WTP supports the validity of the CVS. CONCLUSION: In France, for cancer, not all citizens would prefer to be treated at home rather than in a hospital. Only less than a quarter would prefer LHC. These results show the mismatch between public health policies and the citizens' preferences.

A Quantitative Analysis Examining Patients' Choice of Active Surveillance or Surgery for Managing Low-Risk Papillary Thyroid Cancer.

Background: It is important to understand patient preferences on managing low-risk papillary thyroid cancer (PTC). Methods: We prospectively followed patients with low-risk PTC <2 cm in maximal diameter, who were offered the choice of thyroidectomy or active surveillance (AS) at the University Health Network (UHN), in Toronto, Canada. The primary outcome was the frequency of AS choice (percentage with confidence interval [CI]). Univariate and multivariable analyses were performed to identify predictors of the choice of AS. Results: We enrolled 200 patients of median age 51 years (interquartile range 42-62). The primary tumor measured >1 cm in 55.5% (111/200) of participants. The AS was chosen by 77.5% [71.2-82.7%, 155/200] of participants. In a backwards conditional regression model, the clinical and demographic factors independently associated with choosing AS included: older age (compared with referent group <40 years)-age 40-64 years-odds ratio (OR) 2.78 [CI, 1.23-6.30, p = 0.014], age ≥65 years-OR 8.43 [2.13-33.37, p = 0.002], and education level of high school or lower-OR 4.41 [1.25-15.53, p = 0.021]; AS was inversely associated with the patient's surgeon of record being affiliated with the study hospital-OR 0.29 [0.11-0.76, p = 0.012]. In a separate backwards conditional logistic regression model examining associations with psychological characteristics, AS choice was independently associated with a fear of needing to take thyroid hormones after thyroidectomy-OR 1.24 [1.11-1.39, p < 0.001], but inversely associated with fear of PTC progression-OR 0.94 [0.90-0.98, p = 0.006] and an active coping mechanism ("doing something")-OR 0.43 [0.28-0.66, p < 0.001]. Conclusions: Approximately three-quarters of our participants chose AS over surgery. The factors associated with choosing AS included older age, lower education level, and having a surgeon outside the study institution. Patients' fears about either their PTC progressing or taking thyroid hormone replacement as well as the level of active coping style were associated with the decision. Our results inform the understanding of patients' decisions on managing low-risk PTC. Registration: Clinicaltrials.gov NCT03271892.

A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer.

Background: The traditional management of papillary thyroid cancer (PTC) is thyroidectomy (total or partial removal of the thyroid). Active surveillance (AS) may be considered as an alternative option for small, low risk PTC. AS involves close follow-up (including regularly scheduled clinical and radiological assessments), with the intention of intervening with surgery for disease progression or patient preference. Methods: This is a protocol for a prospective, observational, long-term follow-up multi-centre Canadian cohort study. Consenting eligible adults with small, low risk PTC (< 2cm in maximal diameter, confined to the thyroid, and not immediately adjacent to critical structures in the neck) are offered the choice of AS or surgery for management of PTC. Patient participants are free to choose either option (AS or surgery) and the disease management course is thus not assigned by the investigators. Surgery is provided as usual care by a surgeon in an institution of the patient's choice. Our primary objective is to determine the rate of 'failure' of disease management in respective AS and surgical arms as defined by: i) AS arm - surgery for progression of PTC, and ii) surgical arm - surgery or other treatment for disease persistence or progression after completing initial treatment. Secondary outcomes include long-term thyroid oncologic and treatment outcomes, as well as patient-reported outcomes. Discussion: The results from this study will provide long-term clinical and patient reported outcome evidence regarding active surveillance or immediate surgery for management of small, low risk PTC. This will inform future clinical trials in disease management of small, low risk papillary thyroid cancer. Registration details: This prospective observational cohort study is registered on clinicaltrials.gov (NCT04624477), but it should not be considered a clinical trial as there is no assigned intervention and patients are free to choose either AS or surgery.

Proceedings of the Canadian Thyroid Cancer Active Surveillance Study Group 2019 national investigator meeting.

Active surveillance (AS) in the management of small, low risk papillary thyroid cancer (PTC) as an alternative option to thyroidectomy, is an area of active research. A national Canadian study is proposed to evaluate the long-term outcomes of patients with small, low risk PTC who choose AS or surgery. This letter describes the proceedings of a national investigator meeting to plan the study.

Posthospital discharge venous thromboembolism prophylaxis among colorectal and hepatobiliary surgeons: A practice survey.

BACKGROUND: Recent practice guidelines recommend venous thromboembolism prophylaxis for 28 days after cancer surgery. We sought to characterize and compare awareness, agreement, adoption, and adherence to these guidelines among surgeons. METHODS: We electronically surveyed Canadian hepatobiliary surgeons registered with the Canadian Hepatopancreatobiliary Association, general and colorectal surgeons registered with the College of Physicians and Surgeons of Ontario and the Canadian Society of Colorectal Surgeons who provide colorectal cancer care with a pilot-tested questionnaire. Attitudes to relevant guideline recommendations and perceived barriers to postdischarge venous thromboembolism prophylaxis were assessed on a 5-point Likert scale. RESULTS: There were 128 responses (response rate 60%, 128 of 213), including 60 general/colorectal and 68 hepatobiliary surgeons. Most surgeons were aware (122 of 128, 95%), agreed (101 of 122, 83%), adopted (78 of 101, 77%), and adhered (74 of 78, 95%) with guidelines. Preexisting venous thromboembolism-prophylaxis hospital programs, hepatobiliary surgeons, and geographical region were associated with increased likelihood of adherence. Among respondents that did not agree, insufficient evidence (median Likert: 4, interquartile range 3-5) and low incidence of venous thromboembolism (median Likert: 4, interquartile range 3-4) were cited as the strongest barriers. Surgeons who agreed but did not adopt these programs reported that the most significant barriers were "drug cost" (median Likert: 4, interquartile range 3-4) and "subcutaneous injections" (median Likert: 4, interquartile range 3-4). Surgeons that adhered additionally reported "logistical challenges of prescribing" as the greatest implementation barrier. CONCLUSION: Surgeons who remain apprehensive about postdischarge venous thromboembolism prophylaxis cite poor evidence and cost of the medication as the major barriers. Adherence was higher among hepatobiliary surgeons and at hospitals with existing venous thromboembolism-prophylaxis programs.

Decision-making in Surgery or Active Surveillance for Low Risk Papillary Thyroid Cancer During the COVID-19 Pandemic.

We describe our experience conducting a prospective observational cohort study on the management of small, low risk papillary thyroid cancer during the COVID-19 pandemic. Our study participants are given the choice of active surveillance (AS) or surgery, and those in the AS arm are followed at the study center, whereas surgical patients undergo usual care. During the pandemic we have transitioned from in-person research patient visits to largely virtual care of patients under AS. As of 30 October 2020, we had enrolled 181 patients enrolled in our study (including 25 during the pandemic), of which 92.3% (167/181) consented to telephone communication and 79.0% (143/181) consented to secure videoconferencing communication. Prior to the pandemic, 74.5% (117/157) of our patients chose AS over surgery, whereas during the pandemic, 96.0% (24/25) chose AS. Of the 133 study patients who were under AS within the timeframe from 12 March 2020, to 30 October 2020, the percentage of patients who missed appointments was 8.3% (11/133, for neck ultrasound and physician visits, respectively) and delayed appointments was 23.3% (31/133). This preliminary data suggests that prospective observational research on AS of thyroid cancer can safely continue during the pandemic.

Cancer care at home or in local health centres versus in hospital: Public policy goals and patients' preferences in the Rhône-Alps region in France.

In France, cancer treatments are mainly provided in hospitals, which are expensive and crowded. Health decision-makers therefore want to develop alternative structures such as home care and local health centres. OBJECTIVES: To elicit cancer patients' preferences for home, local health centre, or hospital, and analyze factors affecting these choices: patients' characteristics, experiences of care, expectations and perceptions of cancer management. METHODS: We developed a decision aid composed of 1) information on the 3 options 2) a questionnaire to measure preferences; 3) a questionnaire on sociodemographics and experiences of care, 386 patients participated in the survey. RESULTS: hospital was the preferred option for 71 % of the participants, especially for complicated care, followed by home care (24 %) and local health centres (5%). Main reasons for preferring hospital were the wish to separate home life and place of care, wanting to avoid being a burden on their relatives. Reasons influencing a preference for home care were wanting to avoid trips, maintain their lifestyle, and finding hospitals frightening. Neither socio-demographics nor even experience of care seemed to explain preferences. CONCLUSION: A quarter of patients preferred home care, which is highly disproportionate to the home care currently available. This suggests that hindrances to developing alternatives to hospital do not come from patients' reluctance to make use of them, but rather from healthcare providers' objections.

Nurse home visiting and prenatal substance use in a socioeconomically disadvantaged population in British Columbia: analysis of prenatal secondary outcomes in an ongoing randomized controlled trial.

BACKGROUND: Nurse-Family Partnership (NFP) involves public health nurses providing frequent home visits from early pregnancy until children reach age 2 years, focusing on first-time parents experiencing socioeconomic disadvantage. Our aim was to evaluate NFP's effectiveness in improving child and maternal health. METHODS: We conducted an analysis of prenatal secondary outcomes in an ongoing randomized controlled trial in British Columbia; the data used in this analysis were collected from January 2014 to May 2017. Participants were pregnant girls and women aged 14-24 years who were preparing to parent for the first time and experiencing socioeconomic disadvantage. They were randomly allocated 1:1 to the intervention (NFP plus existing services) or control group (existing services). Prespecified prenatal secondary outcome indicators were changes in use of nicotine cigarettes and alcohol use by 34-36-weeks' gestation. We also report on prespecified exploratory cannabis and street drug use measures. We used mixed-effect models for longitudinal and clustered data to estimate intervention effects. Analyses were by intention to treat. RESULTS: The median gestational age at baseline for the 739 participants (368 participants in the intervention group, 371 in the comparison group) was 20 weeks, 6 days. By 34-36 weeks' gestation, NFP significantly reduced cigarette counts (over the past 2 d) (difference in changes [DIC] of count -1.6, 95% confidence interval [CI] -6.4 to -1.3) in those who smoked. NFP also significantly reduced rates of prenatal cannabis use (DIC -6.4, 95% CI -17.0 to -1.7), but not rates of street drug or "any" substance use. While we observed decreased rates of cigarette and alcohol use in both groups (DIC of proportions -2.8, 95% CI -15.3 to 0.6; DIC -0.5, 95% CI -8.7 to 1.8, respectively), these changes were not statistically significant. INTERPRETATION: We found no evidence that NFP was effective in reducing rates of prenatal cigarette and alcohol use; however, it led to reduced prenatal cannabis use, and in smokers it led to modest reductions in cigarette use. NFP may therefore hold promise for reducing some types of prenatal substance use in disadvantaged populations. Trial registration: ClinicalTrials.gov, no. NCT01672060.

Laparoscopic hepatectomy is safe and effective for the management of patients with colorectal cancer liver metastases in a population-based analysis in Ontario, Canada. A retrospective cohort study.

BACKGROUND: Laparoscopic hepatectomy (LH) has been deemed safe, and, in the case of minor hepatectomy, the standard of care. Short-, long-term outcomes and costs of LH compared with open hepatectomy (OH) in patients with colorectal cancer liver metastases have not been well described at the population level. MATERIALS AND METHODS: Patients diagnosed with colorectal cancer undergoing hepatectomy were included in this population-based retrospective cohort study from 2006- to 2014. Postoperative complications (per Clavien-Dindo) and survival were analyzed using a linear mixed model and Cox-Proportional hazards model respectively. Costs of surgery and the 90-day postoperative period were considered in 2018 Canadian dollars and compared from the perspective of a third-party payer. RESULTS: Over a median follow-up of 56 months, 95% confidence interval (CI): 51 to 68), there were 2991 hepatectomies (OH: 2551 (85%) and LH: 440 (15%)). LH compared to OH was more common for patients >70 years-old (30% vs. 22%, p = 0.004) and for minor hepatectomy (52% vs. 32%, p < 0.001) respectively. By multivariable analyses, OH was associated with similar 90-day mortality (Odds Ratio (OR) 1.05, 95% CI: 0.56-1.97), and overall survival (Hazard Ratio (HR) 1.08, 95% CI: 0.90-1.29), but higher rates of major postoperative complications (OR 1.34, 95% CI: 1.03-1.76), higher cost (median difference $6,163, 95% CI: $3229 to $9096), and longer length of hospital stay (LOS) (mean difference 3.04 days, 95% CI: 2.7 to 3.91). CONCLUSION: LH was associated with lower postoperative complications, shorter LOS, which translated into lower costs to the healthcare system, without differences in postoperative mortality and survival.

Comparison of Heart Team vs Interventional Cardiologist Recommendations for the Treatment of Patients With Multivessel Coronary Artery Disease.

Importance: Although the heart team approach is recommended in revascularization guidelines, the frequency with which heart team decisions differ from those of the original treating interventional cardiologist is unknown. Objective: To examine the difference in decisions between the heart team and the original treating interventional cardiologist for the treatment of patients with multivessel coronary artery disease. Design, Setting, and Participants: In this cross-sectional study, 245 consecutive patients with multivessel coronary artery disease were recruited from 1 high-volume tertiary care referral center (185 patients were enrolled through a screening process, and 60 patients were retrospectively enrolled from the center's database). A total of 237 patients were included in the final virtual heart team analysis. Treatment decisions (which comprised coronary artery bypass grafting, percutaneous coronary intervention, and medication therapy) were made by the original treating interventional cardiologists between March 15, 2012, and October 20, 2014. These decisions were then compared with pooled-majority treatment decisions made by 8 blinded heart teams using structured online case presentations between October 1, 2017, and October 15, 2018. The randomized members of the heart teams comprised experts from 3 domains, with each team containing 1 noninvasive cardiologist, 1 interventional cardiologist, and 1 cardiovascular surgeon. Cases in which all 3 of the heart team members disagreed and cases in which procedural discordance occurred (eg, 2 members chose coronary artery bypass grafting and 1 member chose percutaneous coronary intervention) were discussed in a face-to-face heart team review in October 2018 to obtain pooled-majority decisions. Data were analyzed from May 6, 2019, to April 22, 2020. Main Outcomes and Measures: The Cohen κ coefficient between the treatment recommendation from the heart team and the treatment recommendation from the original treating interventional cardiologist. Results: Among 234 of 237 patients (98.7%) in the analysis for whom complete data were available, the mean (SD) age was 67.8 (10.9) years; 176 patients (75.2%) were male, and 191 patients (81.4%) had stenosis in 3 epicardial coronary vessels. A total of 71 differences (30.3%; 95% CI, 24.5%-36.7%) in treatment decisions between the heart team and the original treating interventional cardiologist occurred, with a Cohen κ of 0.478 (95% CI, 0.336-0.540; P = .006). The heart team decision was more frequently unanimous when it was concordant with the decision of the original treating interventional cardiologist (109 of 163 cases [66.9%]) compared with when it was discordant (28 of 71 cases [39.4%]; P < .001). When the heart team agreed with the original treatment decision, there was more agreement between the heart team interventional cardiologist and the original treating interventional cardiologist (138 of 163 cases [84.7%]) compared with when the heart team disagreed with the original treatment decision (14 of 71 cases [19.7%]); P < .001). Those with an original treatment of coronary artery bypass grafting, percutaneous coronary intervention, and medication therapy, 32 of 148 patients [22.3%], 32 of 71 patients [45.1%], and 6 of 15 patients [40.0%], respectively, received a different treatment recommendation from the heart team than the original treating interventional cardiologist; the difference across the 3 groups was statistically significant (P = .002). Conclusions and Relevance: The heart team's recommended treatment for patients with multivessel coronary artery disease differed from that of the original treating interventional cardiologist in up to 30% of cases. This subset of cases was associated with a lower frequency of unanimous decisions within the heart team and less concordance between the interventional cardiologists; discordance was more frequent when percutaneous coronary intervention or medication therapy were considered. Further research is needed to evaluate whether heart team decisions are associated with improvements in outcomes and, if so, how to identify patients for whom the heart team approach would be beneficial.

Simultaneous versus staged resection for synchronous colorectal liver metastases: A population-based cost analysis in Ontario, Canada - Health economic evaluation.

BACKGROUND: Simultaneous compared to staged resection of synchronous colorectal cancer liver metastases is considered safe. We aimed to determine their cost implications. STUDY DESIGN: Population-based cohort was generated by linking administrative healthcare datasets in Ontario, Canada (2006-2014). Resection of colorectal cancer and liver metastases within six months was considered synchronous. Cost analysis was performed from the perspective of a third-party payer. Median costs with range were estimated using the log-normal distribution of cost using t-test with a one-year time horizon. RESULTS: Among patients undergoing staged resection (n = 678), the estimated median cost was $54,321 CAD (IQR 45,472 to 68,475) and $41,286 CAD (IQR 31,633 to 58,958) for those undergoing simultaneous resection (n = 390), median difference: $13,035 CAD (p < 0.001). Primary cost driver were all costs related to hospitalization for liver and colon resection, which was higher for the staged approach, median difference: $16,346 CAD (p < 0.001). This was mainly due to a longer median length of hospital stay in the staged vs. simultaneous group (11 vs. 8 days, p < 0.001 respectively), which was not attributable to differences in major postoperative complication rates (23% vs. 28%, p = 0.067 respectively). Other costs, including cost of chemotherapy within six months of surgery ($11,681 CAD vs. $8644 CAD, p = 0.074 respectively) and 90-day re-hospitalization cost ($2155 CAD vs. $2931 CAD, p = 0.454 respectively) were similar between groups. CONCLUSION: Cost of staged resection of synchronous colorectal cancer liver metastases is significantly higher compared to the simultaneous approach, mostly driven by a longer length of hospital stay despite similar postoperative complication rates.

A Prospective Mixed-Methods Study of Decision-Making on Surgery or Active Surveillance for Low-Risk Papillary Thyroid Cancer.

Background: Active surveillance (AS) of small, low-risk papillary thyroid cancers (PTCs) is increasingly being considered. There is limited understanding of why individuals with low-risk PTC may choose AS over traditional surgical management. Methods: We present a mixed-methods analysis of a prospective observational real-life decision-making study regarding the choice of thyroidectomy or AS for management of localized, low-risk PTCs <2 cm in maximum diameter (NCT03271892). Patients were provided standardized medical information and were interviewed after making their decision (which dictated disease management). We evaluated patients' levels of decision-self efficacy (confidence in medical decision-making ability) at the time information was presented and their level of decision satisfaction after finalizing their decision (using standardized questionnaires). We asked patients to explain the reason for their choice and qualitatively analyzed the results. Results: We enrolled 74 women and 26 men of mean age 52.4 years, with a mean PTC size of 11.0 mm (interquartile range 9.0, 14.0 mm). Seventy-one patients (71.0% [95% confidence interval 60.9-79.4%]) chose AS over surgery. Ninety-four percent (94/100) of participants independently made their own disease management choice; the rest shared the decision with their physician. Participants had a high baseline level of decision self-efficacy (mean 94.3, standard deviation 9.6 on a 100-point scale). Almost all (98%, 98/100) participants reported high decision satisfaction. Factors reported by patients as influencing their decision included the following: perceived risk of thyroidectomy or the cancer, family considerations, treatment timing in the context of life circumstances, and trust in health care providers. Conclusions: In this Canadian study, ∼7 out of 10 patients with small, low-risk PTC, who were offered the choice of AS or surgery, chose AS. Personal perceptions about cancer or thyroidectomy, contextual factors, family considerations, and trust in health care providers strongly influenced patients' disease management choices.

Postoperative complications in elderly patients following pancreaticoduodenectomy lead to increased postoperative mortality and costs. A retrospective cohort study.

BACKGROUND: Complications frequently occur after pancreaticoduodenectomy. Patients undergoing pancreaticoduodenectomy tend to be older; age and postoperative complication may be associated. To clarify this association, we compared postoperative outcomes in patients undergoing pancreaticoduodenectomy based on age group. We aimed to determine whether we could identify an age cutoff where the incidence and cost of postoperative complications starts increasing and potentially outweigh the potential benefits of pancreaticoduodenectomy. MATERIALS AND METHODS: We built a retrospective cohort of consecutive patients undergoing pancreaticoduodenectomy at one institution from 2011 to 2017. Demographics, operative data and costs were obtained from hospital and administrative databases. A restricted cubic spline regression analysis was performed to graphically identify the age in which the comprehensive complication index (CCI) substantially increased. Cost analysis was undertaken from the perspective of a third-party payer. Differences in costs between age groups were tested using t-test. RESULTS: Among 440 patients, the CCI became significantly higher at the age cutoff of 72 (median 21 in the older vs. 12 in the younger group, P = 0.014). Postoperative complications (74% vs. 64%, P = 0.038), and mortality (8% vs. 3%, P = 0.016) were also significantly higher in the older age group; mostly driven by pneumonia (11% vs. 6%, P = 0.097), myocardial infarction (12% vs. 4%, P < 0.002) and urinary tract infection (18% vs. 5%, P = 0.003). Median length of hospital stay was also longer for the older age group (10 vs. 8 days, P = 0.002). Total mean cost was significantly higher in the older age group ($38,225 CAD vs. $29,771 CAD). CONCLUSIONS: In our cohort of patients, after age 72, pancreaticoduodenectomy is associated with significantly more postoperative complications and deaths which translated in longer hospital stay and higher costs. This information may help patients and surgeons make informed decisions.

A protocol for a Canadian prospective observational study of decision-making on active surveillance or surgery for low-risk papillary thyroid cancer.

INTRODUCTION: Low-risk papillary thyroid cancer (PTC) is increasingly being diagnosed throughout the world; yet the mortality risk is low compared with other malignancies. Traditional management includes thyroid surgery, sometimes followed by radioactive iodine and thyroid hormone treatment. Active surveillance (AS) has been proposed as a means to reduce overtreatment of PTC. AS involves close disease follow-up, with the intention to intervene if the disease progresses, or on patient request. METHODS AND ANALYSIS: This is a multiphase prospective observational study. In the first phase of this study, consenting eligible adults with low-risk PTC, that is, <2 cm in maximal diameter, confined to the thyroid and not immediately adjacent to critical structures in the neck, are provided verbal and written information about PTC disease prognosis following surgery or AS. Questionnaires are administered at baseline and after the disease management decision on AS or surgery is finalised. Patients may choose either option (surgery or AS), and the primary outcome is the frequency with which either disease management option is chosen. Secondary outcomes include: rationale for the decision, role of the patient in decision-making and decision satisfaction. In the second phase of the study, consenting eligible adult patients who completed the first study phase may enrol in respective AS or surgery group follow-up studies. The following outcomes are examined 1 year after enrolment in the follow-up phase: decision regret about disease management choice (primary outcome), psychological distress, disease-specific quality of life, fear of disease progression, body image satisfaction, disease progression, crossover to surgery in the AS group, new chronic thyroid hormone use and healthcare resource utilisation. ETHICS AND DISSEMINATION: The University Health Network Research Ethics Board approved this study (ID 15-8942). The results will be published in an open access journal. TRIAL REGISTRATION NUMBER: NCT03271892; Pre-results.

Simultaneous resection of colorectal cancer with synchronous liver metastases (RESECT), a pilot study.

INTRODUCTION: The "traditional approach" to resect synchronous colorectal cancer with liver metastases (CRLM) is to perform staged resections. Many institutions perform simultaneous resection. Disadvantages to the simultaneous approach include longer operating room times, which may increase major postoperative complication rates. Data supporting simultaneous resection are limited to retrospective studies that are subject to selection bias. Therefore, we have proposed a single-arm prospective cohort pilot study to evaluate the postoperative complications following simultaneous resection of synchronous CRLM. METHODS AND ANALYSIS: This single-arm study will be performed in five high-volume hepatobiliary centres to prospectively evaluate the following objectives: (1) To determine the 90-day postoperative complication rate of patients diagnosed with synchronous CRLM undergoing a simultaneous colorectal and liver resection, including major liver resections; (2) To determine the postoperative mortality rate at 90 days following index surgery; (3) To determine change in global health-related Quality of Life (QoL) following simultaneous resection at three months compared to baseline; and (4) To build a costing model for simultaneous resection, We will also evaluate the feasibility of performing combined resection in these patients by evaluating the number of eligible patients enrolled in the study and determining the reasons eligible patients were not enrolled. This protocol has been registered with ClinicalTrials.gov (NCT02954913). ETHICS AND DISSEMINATION: This study has been provincially approved by the central research ethics board. Study results will inform the design a randomized controlled trial by providing information about the comprehensive complication index in this patient population used to calculate the sample size for the trial.

The TRIO Framework: Conceptual insights into family caregiver involvement and influence throughout cancer treatment decision-making.

OBJECTIVE: Family caregivers are regularly involved in cancer consultations and treatment decision-making (DM). Yet there is limited conceptual description of caregiver influence/involvement in DM. To address this, an empirically-grounded conceptual framework of triadic DM (TRIO Framework) and corresponding graphical aid (TRIO Triangle) were developed. METHODS: Jabareen's model for conceptual framework development informed multiple phases of development/validation, incorporation of empirical research and theory, and iterative revisions by an expert advisory group. RESULTS: Findings coalesced into six empirically-grounded conceptual insights: i) Caregiver influence over a decision is variable amongst different groups; ii) Caregiver influence is variable within the one triad over time; iii) Caregivers are involved in various ways in the wider DM process; iv) DM is not only amongst three, but can occur among wider social networks; v) Many factors may affect the form and extent of caregiver involvement in DM; vi) Caregiver influence over, and involvement in, DM is linked to their everyday involvement in illness care/management. CONCLUSION: The TRIO Framework/Triangle may serve as a useful guide for future empirical, ethical and/or theoretical work. PRACTICE IMPLICATIONS: This Framework can deepen clinicians's and researcher's understanding of the diverse and varying scope of caregiver involvement and influence in DM.

Attributing a monetary value to patients' time: A contingent valuation approach.

It is hard to ignore the importance of patient time investment in the production of health since the influential paper by Grossman (1972). Patients' time includes time to admission, travel time, waiting time, and treatment time and can be substantial. Patients' time is, however, often ignored in economic analyses. This may lead to biased results and inappropriate policy recommendations, which may eventually influence patients' health, wellbeing and welfare. How to value patient time is not straightforward. Although there is some emerging literature on the monetary valuation of patient time, an important challenge remains to develop an approach that can be used to monetarily value time of patients not participating in the labour market. We aim to contribute to the health economics literature by describing and empirically illustrating how to monetarily value the time of patients not participating in the labour market comprehensively, using the contingent valuation method. It is worth noting that our method can also be applied to people participating in the labour market. This paper describes the development of the contingent valuation survey. We apply our survey approach to a sample of 238 Dutch patients not participating in the labour market: n = 107 Radiotherapy department (data collected between November 2011 and January 2013); n = 44 Rehabilitation department (March 2012-May 2012); n = 87 Orthopaedics department (January to June 2013). Results show that those patients value waiting time the highest (€30.10 per hour) and value travel and treatment time equally with respectively €13.20 and €13.32 per hour. This paper encourages future empirical research refining and applying the developed survey methodology to create more data on how other subgroups of individuals value their patients' time.