Decision regret,adverse outcomes,and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial

IntroductionMen diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted the secondary outcome of post-treatment decision regret.MethodsParticipants were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care prior to a final treatment decision. Symptoms were measured just before randomization and 6 months later; decision regret was measured at 6 months along with records review to ascertain treatment choices. Regression modeling explored associations between baseline variables including race and D`Amico risk, study group, and 6-month variables regret, choice, and symptoms.ResultsAt 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered the regret scale. Regret was not significantly different between participants randomized to the P3P intervention compared to the control group (P = 0.360). In univariate analyses, we found that Black men, men with hormonal symptoms, and men with bowel symptoms reported significantly higher decision regret (all P < 0.01). Significant interactions were detected between race and study group (intervention vs. usual care) in the multivariable model; use of the Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (P = 0.037). Interactions between regret, symptoms and treatment revealed that (1) men choosing definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others; and (2) men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others.ConclusionThe Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer.Trial RegistrationNCT01844999     

Decision aids can decrease decisional conflict in patients with hip or knee osteoarthritis: Randomized controlled trial

BACKGROUNDThe interest in shared decision making has increased considerably over the last couple of decades. Decision aids (DAs) can help in shared decision making. Especially when there is more than one reasonable option and outcomes between treatments are comparable.AIMTo investigate if the use of DAs decreases decisional conflict in patients when choosing treatment for knee or hip osteoarthritis (OA).METHODSIn this multi-center unblinded randomized controlled trial of patients with knee or hip OA were included from four secondary and tertiary referral centers. One-hundred-thirty-one patients who consulted an orthopedic surgeon for the first time with knee or hip OA were included between December 2014 and January 2016. After the first consultation, patients were randomly assigned by a computer to the control group which was treated according to standard care, or to the intervention group which was treated with standard care and provided with a DA. After the first consultation, patients were asked to complete questionnaires about decisional conflict (DCS), satisfaction, anxiety (PASS-20), gained knowledge, stage of decision making and preferred treatment. Follow-up was carried out after 26 wk and evaluated decisional conflict, satisfaction, anxiety, health outcomes (HOOS/KOOS), quality of life (EQ5D) and chosen treatment. RESULTSAfter the first consultation, patients in the intervention group (mean DCS: 25 out of 100, SD: 13) had significantly (P value: 0.00) less decisional conflict compared to patients in the control group (mean DCS: 39 out of 100, SD 11). The mean satisfaction score for the given information (7.6 out of 10, SD: 1.8 vs 8.6 out of 10, SD: 1.1) (P value: 0.00), mean satisfaction score with the physician (8.3 out of 10, SD: 1.7 vs 8.9 out of 10, SD: 0.9) (P value: 0.01) and the mean knowledge score (3.3 out of 4, SD: 0.9 vs 3.7 out of, SD: 0.6) (P value: 0.01) were all significantly higher in the intervention group. At 26-wk follow-up, only 75 of 131 patients (57%) were available for analysis. This sample is too small for meaningful analysis. CONCLUSIONProviding patients with an additional DA may have a positive effect on decisional conflict after the first consultation. Due to loss to follow-up we are unsure if this effect remains over time.     

Evidence-based surgery. Canadian Association of General Surgeons and American College of Surgeons Evidence Based Reviews in Surgery. 19. The effect of a decision aid on knowledge and treatment decision making for breast cancer.

Question: What is the impact of a decision aid outlining the different surgical options for stage I or stage II breast cancer on patient decision making? Design: Cluster randomized controlled trial. Setting: Twenty surgeons from communities in central-west and eastern Ontario. Patients: A total of 201 of 208 patients (97%) with newly diagnosed clinical stage I or stage II breast cancer agreed to participate in the trial. Of these women, 94 were randomized to the decision aid group and 107 to usual standard of care. Intervention: Patients assigned to the decision aid group were shown a decision board that presented information, including acute and long-term adverse effects associated with treatment and the effects of treatment on a patient''s breast, long-term survival and quality of life, for the different treatment options. As well, patients were able to express a preference for treatment. Main outcome measures: (1) Patient knowledge about surgical treatment of breast cancer, (2) decisional conflict, (3) satisfaction with decision making and (4) treatment decision after the consultation. Results: Patients in the decision aid group had higher knowledge scores about their treatment options (66.9 v. 58.7; p < 0.001), had less decisional conflict (1.40 v. 1.62; p = 0.02) and were more satisfied with decision making (4.50 v. 4.32; p = 0.05). Patients who used the decision board were more likely to choose breast conservation therapy (BCT) (94% v. 76%, p = 0.03). Conclusions: The decision aid was helpful in improving communication and patient knowledge. The use of the decision aid resulted in less decisional conflict and better patient satisfaction with their treatment decision.     

Racial/ethnicity differences in endorsing influential factors for prostate cancer treatment choice: An analysis of data from the personal patient profile-prostate (P3P) I and II trials

ObjectiveRates and choice of treatment for localized prostate cancer vary according to race/ethnicity in American men. We hypothesized that there were group differences in influential values and preferences related to treatment decisions.MethodsWe analyzed samples from 2 multicenter, randomized trials of the Patient Profile-Prostate (P3P) I and II decision aid, first comparing the groups on other demographic and decisional variables using Chi-square tests. Stratified (P3P I vs. II) logistic regression was then used to assess the univariate association between race/ethnicity and endorsement of moderate-or-strong influence of 14 lifestyle factors, current or future symptoms, or important others on the decision. A multivariable stratified logistic regression with backward variable selection was used to further estimate the association between influential factors and race/ethnicity.ResultsThere were 494 and 392 participants in P3P I and P3P II, respectively, with 40 Hispanic, 168 non-Hispanic black, 637 non-Hispanic white, 19 others and 6 missing. Age (P = 0.0001), education (P < 0.0001), marital status (P < 0.0001), income (P < 0.0001), Internet use for information (P < 0.0001) and decisional control preference were significantly different across racial/ethnic groups. In adjusted analyses, we saw racial/ethnic differences in the decisional influence of age (Non-Hispanic Black (NHB) vs. Non-Hispanic White (NHW) OR: 0.56 95%CI 0.38–0.85 P = 0.002), religion/spirituality (NHB vs. NHW OR: 3.2095%CI1.95–5.26, P < 0.0001), future bladder function (NHB vs. NHW OR: 0.5795%CI 0.35–0.90, P = 0.04), future ability to engage in recreation (NHB vs. NHW OR: 0.5495%CI 0.34–0.86, P = 0.02), and a story of a famous person with prostate cancer (NHB vs. NHW OR: 2,11 95%CI 1.30–3.43, P = 0.007). No interactions were found.ConclusionOur results suggest racial/ethnic differences for influences underlying treatment choice. Better understanding these influences may help us present salient information about treatment options to patients and address disparities.     

The Effect of Providing Audiovisual Surgical Information on Decisional Conflict in Patients Undergoing Plate Fixation for Distal Radius Fractures

BackgroudPatients experiencing acute trauma have limited time for their involvement in shared decision making, which may lead to decisional conflict. The purpose of this study was to evaluate whether providing audiovisual surgical information can reduce decisional conflict when deciding between surgical and nonsurgical treatment in patients with distal radius fractures (DRFs) and to evaluate factors that may affect decisional conflict.MethodsWe prospectively enrolled 50 consecutive patients who presented with acute DRFs and chose to undergo surgery, for which volar plate fixation was recommended. We randomized these patients into 2 groups. The test group was given a video clip of audiovisual surgical information in addition to regular information while the control group was only given regular information. The video clip consisted of the purpose, procedure, and effect of the surgery, precautions and complications after the operation, and other treatment options that could be performed if operation was not performed. At 2 weeks after the surgery, we evaluated patients'' decisional conflict using a decisional conflict scale (DCS). In addition, we evaluated factors that might affect decisional conflict, such as age, dominant hand, comorbidities, history of previous operations, perceived disability, and provision of the video clip.ResultsThe test group showed significantly lower DCS scores than the control group (19.6 vs. 32.1, p = 0.001). In multivariate analysis, younger age and provision of the video clip were associated with lower DCS scores.ConclusionsThis study has demonstrated that providing information through audiovisual media such as video clips could reduce decisional conflict in patients who chose to undergo plate fixation for DRFs. This study also suggests that older patients may need more careful doctor-patient communication as they have more decisional conflict than younger patients.     

Feasibility,Acceptability, and Behavioral Outcomes from a Technology-enhanced Behavioral Change Intervention (Prostate 8): A Pilot Randomized Controlled Trial in Men with Prostate Cancer

BackgroundIncreasing evidence suggests that lifestyle factors may decrease the risk of prostate cancer progression. Lifestyle guidelines and tools may support lifestyle modification after diagnosis.ObjectiveTo determine the feasibility and acceptability of a digital lifestyle intervention among men with prostate cancer.Design, setting, and participantsA 12-wk pilot randomized controlled trial among 76 men with clinical stage T1–T3a prostate cancer. Eligibility included Internet access, no contraindications to aerobic exercise, and engaging in four or fewer of eight targeted behaviors at baseline.InterventionWebsite, Fitbit One, and text messaging to facilitate adoption of eight behaviors: vigorous activity, smoking cessation, and six diet improvements.Outcome measurements and statistical analysisOur primary outcomes were feasibility and acceptability based on recruitment and user data, and surveys, respectively. Secondarily, we evaluated the change in eight lifestyle behaviors, and also objective physical activity. Each factor was assigned one point, for an overall “P8 score” (range 0–8). Analysis of covariance (ANCOVA) was conducted. Exploratory outcomes included quality of life, anthropometrics, and circulating biomarkers after 12 wk, and behaviors after 1 yr.Results and limitationsAt baseline, men in both arms met a median of three targeted behaviors. Sixty-four men (n = 32 per arm) completed the study; 88% completed 12-wk assessments (intervention, 94%; control, 82%). Intervention participants wore their Fitbits a median of 82 d (interquartile range [IQR]: 72–83), replied to a median of 71% of text messages (IQR: 57–89%), and visited the website a median of 3 d (IQR: 2–5) over 12 wk. Median (IQR) absolute changes in the P8 score from baseline to 12 wk were 2 (1, 3) for the intervention and 0 (?1, 1) for the control arm. The estimated mean score of the intervention arm was 1.5 (95% confidence interval: 0.7, 2.3) higher than that of the control arm at 12 wk (ANCOVA p < 0.001). Changes were driven by diet rather than exercise. Limitations include self-reported diet and exercise data.ConclusionsOverall, in this novel pilot trial, the intervention was feasible and acceptable to men with prostate cancer. Next steps include improving the intervention to better meet individuals’ needs and focusing on increasing physical activity in men not meeting nationally recommended physical activity levels.Patient summaryTailored print materials combined with technology integration, including the use of a website, text messaging, and physical activity trackers, helped men with prostate cancer adopt healthy lifestyle habits, in particular recommended dietary changes, in the Prostate 8 pilot trial.     

Low conflict and high satisfaction: Decisional outcomes after attending a combined clinic to choose between robotic prostatectomy and radiotherapy for prostate cancer

BackgroundDecisional conflict and post-treatment decisional regret have been documented in men with localised prostate cancer (LPC). However, there is limited evidence regarding decisional outcomes associated with the choice between robotic-assisted radical prostatectomy (RARP) and radiotherapy, when both treatment options are available in the public health system. There is increasing support for multidisciplinary approaches to guide men with LPC in their decision-making process. This study assessed decisional outcomes in men deciding between RARP or radiotherapy treatment before and after attending a LPC combined clinic (CC).MethodsQuantitative longitudinal data were collected from 52 men who attended a LPC CC, where they saw both a urologist and radiation oncologist. Patients completed questionnaires assessing involvement in decision-making, decisional conflict, satisfaction and regret before and after the CC, three months, six months and 12 months post-treatment. Urologists and radiation oncologists also reported their perceptions regarding patients' suitability for, openness to, perceived preferences and appropriateness for each treatment. Data was analysed using paired/independent samples t-tests and McNemar's tests.ResultsMost participants (n = 37, 71%) opted for RARP over radiotherapy (n = 14, 27%); one participant deferred treatment (2%). Urologists and radiation oncologists reported low agreement (κ = 0.26) regarding the most appropriate treatment for each patient. Participants reported a desire for high levels of control over their decision-making process (77.5% patient-led, 22.5% shared) and high levels of decisional satisfaction (M = 4.4, SD = 0.47) after the CC. Decisional conflict levels were significantly reduced (baseline: M = 29.3, SD = 16.9, post-CC: M = 16.3, SD = 11.5; t = 5.37, P < 0.001) after the CC. Mean decisional regret scores were ‘mild’ at three-months (M = 16.0, SD = 17.5), six-months (M = 18.8, SD = 18.7) and 12-months (M = 18.2, SD = 15.1) post-treatment completion.ConclusionThis is the first Australian study to assess decisional outcomes when patients are offered the choice between RARP and radiotherapy in the public health system. A CC seems to support decision-making in men with LPC and positively impact some decisional outcomes. However, larger-scale controlled studies are needed to confirm these findings.     

Facilitating decision-making in women undergoing genetic testing for hereditary breast cancer: BRECONDA randomized controlled trial results

BackgroundDecision-making concerning risk-reducing mastectomy for women at hereditary risk of breast cancer entails complex personal choices. Deciding whether and how to restore breast shape after risk-reducing mastectomy is a key part of this process. We developed a web-based decision aid, BRECONDA (Breast Reconstruction Decision Aid), to assist women in decision-making regarding breast reconstruction.MethodThis study assessed the efficacy of BRECONDA to assist women at increased risk of breast cancer in making decisions regarding risk-reducing mastectomy in terms of decisional conflict, knowledge, and satisfaction with information. Women at hereditary risk of breast cancer (N = 64) were recruited into this randomized controlled trial from four Australian hereditary cancer clinics. Participants initially provided online consent and completed baseline questionnaires assessing decisional conflict, knowledge, and satisfaction with information. They were then randomly assigned to either: 1) Intervention – unlimited access to BRECONDA, with usual care; or, 2) Control – usual care. At 2-months follow-up (N = 60) the outcomes were re-assessed. Intervention participants also completed user acceptability ratings for the intervention overall and specific key modules.ResultsMANCOVA analyses indicated that Intervention participants reported lower decisional conflict (P = 0.027), and greater knowledge (P = 0.019) and satisfaction with information (P < 0.0005) at 2-months follow-up compared with Controls. Intervention participants reported high user acceptability and satisfaction with the intervention.ConclusionBRECONDA benefits women considering risk-reducing mastectomy by reducing decisional conflict, and improving knowledge and satisfaction with information. These benefits, coupled with high user acceptability, demonstrate the feasibility of implementing BRECONDA in the hereditary cancer risk context.     

Assessment of men’s risk thresholds to proceed with prostate biopsy for the early detection of prostate cancer

Purpose

To delineate the range of “risk thresholds” for prostate biopsy to determine how improved prostate cancer (CaP) risk prediction tools may impact shared decision-making (SDM).

Methods

We conducted a cross-sectional survey study involving men 45–75 years old attending a multispecialty urology clinic. Data included demographics, personal and family prostate cancer history, and prostate biopsy history. Respondents were presented with a summary of the details, risks, and benefits of prostate biopsy, then asked to indicate the specific risk threshold (% chance) of high-grade CaP at which they would proceed with prostate biopsy.

Results

Of a total of 103 respondents, 18 men (17%) had a personal history of CaP, and 31 (30%) had undergone prostate biopsy. The median risk threshold to proceed with prostate biopsy was 25% (interquartile range 10–50%). Risk thresholds did not vary by race, education, or employment. Personal history of CaP or prostate biopsy was significantly associated with lower mean risk thresholds (19% vs. 32% [P?=?0.02] and 23% vs. 33% [P?=?0.04], respectively). In the lowest versus highest risk threshold quartiles, there were significantly higher rates of CaP (36% vs. 1%, P?=?0.01) and prior prostate biopsy (46% vs. 17%, P?<?0.01).

Conclusions

Men have a wide range of risk thresholds for high-grade CaP to proceed with prostate biopsy. Men with a prior history of CaP or biopsy reported lower risk thresholds, which may reflect their greater concern for this disease. The extent to which refined risk prediction tools will improve SDM warrants further study.

     

Decisional conflict in breast cancer patients considering immediate breast reconstruction

BackgroundBreast cancer (BC) patients who are treated with mastectomy are frequently offered immediate breast reconstruction. This study aimed to assess decisional conflict in patients considering immediate breast reconstruction, and to identify factors associated with clinically significant decisional conflict (CSDC).MethodsBaseline data of a multicenter randomized controlled trial evaluating the impact of an online decision aid for BC patients considering immediate breast reconstruction after mastectomy were analyzed. Participants completed questionnaires assessing sociodemographic and clinical characteristics, decisional conflict and other patient-reported outcomes related to decision-making such as breast reconstruction preference, knowledge, information resources used, preferred involvement in decision-making, information coping style, and anxiety. Multivariable logistic regression analysis was performed to identify factors associated with CSDC (score > 37.5 on decisional conflict).ResultsOf the 250 participants, 68% experienced CSDC. Patients with a slight preference for breast reconstruction (odds ratio (OR) = 6.19, p < .01), with no preference for or against breast reconstruction (OR = 11.84, p < .01), and with a strong preference for no breast reconstruction (OR = 5.20, p < .05) were more likely to experience CSDC than patients with a strong preference for breast reconstruction. Furthermore, patients with more anxiety were more likely to experience CSDC (OR = 1.03, p = .01).ConclusionA majority of BC patients who consider immediate breast reconstruction after mastectomy experience clinically significant decisional conflict. The findings emphasize the need for decision support, especially for patients who do not have a strong preference for breast reconstruction.     

原发性开角型青光眼患者决策辅助方案的构建及应用

目的 探讨决策辅助方案在原发性开角型青光眼患者中的应用效果。方法 将100例原发性开角型青光眼患者按住院时间分为对照组与观察组各50例;对照组行常规护理,观察组在常规护理基础上实施决策辅助方案。分别于干预后（出院前）、出院后1、3个月评价干预效果。结果 干预后观察组决策困境得分显著低于对照组,决策准备得分显著高于对照组,出院后1、3个月药物依从性得分显著高于对照组,出院后3个月目标眼压达标率显著高于对照组（均P＜0.05）。结论 决策辅助方案的应用可有效降低原发性开角型青光眼患者决策困境水平,提高决策准备度,增强用药依从性,从而提高目标眼压达标率。     

Predictors of bariatric surgery among an interested population

BackgroundSeverely obese patients considering bariatric surgery face a difficult decision given the tradeoff between the benefits and risks of surgery. The objectives of this study was to study the forces driving this decision and improve our understanding of the decision-making process.MethodsA 64-item survey was developed to assess factors in the decision-making process for bariatric surgery. The survey included the decisional conflict scale, decision self-efficacy scale, EuroQol 5D, and the standard gamble. Patients were recruited from a regularly scheduled bariatric surgery interest group meeting associated with a large, university-based bariatric practice and administered a survey at the conclusion of the interest group. Logistic regression models were used to predict who pursued or still planned to pursue surgery at 12 months.Results200 patients were recruited over an 8-month period. Mean age was 45 years; mean BMI was 48 kg/m², and 77% were female. The 12-month follow-up rate was 95%. At 12 months, 33 patients (17.6%) had surgery and 30 (16.0%) still planned to have surgery. There was no association between age, gender, or obesity-associated conditions and surgery or plan to have surgery. Patients having surgery or still planning to have surgery had significantly worse scores for quality of life and better scores for decisional conflict (indicating readiness to make a decision).ConclusionThe decision to have bariatric surgery is strongly associated with patientsʼ perceptions of their current quality of life. In addition, lower decisional conflict and higher self-efficacy are predictive of surgery. Interestingly, factors that clinicians might consider important, such as gender, age, and the presence of obesity-associated co-morbidities did not influence patientsʼ decisions.     

Pilot trial of a computerized decision aid for breast cancer prevention

This study sought to evaluate a shared decision-making aid for breast cancer prevention care designed to help women make appropriate prevention decisions by presenting information about risk in context. The decision aid was implemented in a high-risk breast cancer prevention program and pilot-tested in a randomized clinical trial comparing standard consultations to use of the decision aid. Physicians completed training with the decision aid prior to enrollment. Thirty participants enrolled (15 per group) and completed measures of clinical feasibility and effectiveness prior to, immediately after, and at 9 months after their consultations. The decision aid was feasible to use during the consultations as measured by consultation duration, user satisfaction, patient knowledge, and decisional conflict. The mean consultation duration was not significantly different between groups (24 minutes for intervention group versus 21 minutes for control group, p = 0.42). The majority found the decision aid acceptable and useful and would recommend it to others. Both groups showed an improvement in breast cancer prevention knowledge postvisit, which was significant in the intervention group (p = 0.01) but not the control group (p = 0.13). However, the knowledge scores returned to baseline at follow-up in both groups. Decision preference for patients who chose chemoprevention post consultations remained constant at follow-up for the intervention group, but not for the control group. The decision framework provides access to key information during consultations and facilitates the integration of emerging biomarkers in this setting. Initial results suggest that the decision aid is feasible for use in the consultation room. The tendency for the decision choices and knowledge scores to return to baseline at follow-up suggests the need for initial and ongoing prevention decision support.     

Association between neighborhood food environments and bariatric surgery outcomes

BackgroundIndividual characteristics associated with weight loss after bariatric surgery are well established, but the neighborhood characteristics that influence outcomes are unknown.ObjectivesThe objective of this study was to determine if neighborhood characteristics, including social determinants and lifestyle characteristics, were associated with weight loss after bariatric surgery.SettingSingle university healthcare system, United States.MethodsIn this retrospective cohort study, all patients who underwent primary bariatric surgery from 2008 to 2017 and had at least 1 year of follow-up data were included. Patient-level demographics and neighborhood-level social determinants (area deprivation index, urbanicity, and walkability) and lifestyle factors (organic food use, fresh fruit/vegetable consumption, diet to maintain weight, soda consumption, and exercise) were analyzed. Median regression with percent total body weight (%TBW) loss as the outcome was applied to examine factors associated with weight loss after surgery.ResultsOf the 647 patients who met inclusion criteria, the average follow-up period was 3.1 years, and the mean %TBW loss at the follow-up was 22%. In adjusted median regression analyses, Roux-en-Y gastric bypass was associated with greater %TBW loss (11.22%, 95% confidence interval [8.96, 13.48]) compared to sleeve, while longer follow-up time (?2.42% TBW loss per year, 95% confidence interval [?4.63, ?0.20]) and a preoperative diagnosis of diabetes (?1.00% TBW loss, 95% confidence interval [?1.55, ?0.44]) were associated with less. None of the 8 neighborhood level characteristics was associated with weight loss.ConclusionsPatient characteristics rather than neighborhood-level social determinants and lifestyle factors were associated with weight loss after bariatric surgery in our cohort of bariatric surgery patients. Patients from socioeconomically deprived neighborhoods can achieve excellent weight loss after bariatric surgery.     

Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial

Background contextSystematic reviews of randomized controlled trials suggest that spinal manipulative therapy (SMT) is efficacious for care of cervicogenic headache (CGH). The effect of SMT dose on outcomes has not been studied.PurposeTo compare the efficacy of two doses of SMT and two doses of light massage (LM) for CGH.Patient sampleEighty patients with chronic CGH.Main outcome measuresModified Von Korff pain and disability scales for CGH and neck pain (minimum clinically important difference=10 on 100-point scale), number of headaches in the last 4 weeks, and medication use. Data were collected every 4 weeks for 24 weeks. The primary outcome was the CGH pain scale.MethodsParticipants were randomized to either 8 or 16 treatment sessions with either SMT or a minimal LM control. Patients were treated once or twice per week for 8 weeks. Adjusted mean differences (AMD) between groups were computed using generalized estimating equations for the longitudinal outcomes over all follow-up time points (profile) and using regression modeling for individual time points with baseline characteristics as covariates and with imputed missing data.ResultsFor the CGH pain scale, comparisons of 8 and 16 treatment sessions yielded small dose effects: |AMD|≤5.6. There was an advantage for SMT over the control: AMD=?8.1 (95% confidence interval=?13.3 to ?2.8) for the profile, ?10.3 (?18.5 to ?2.1) at 12 weeks, and ?9.8 (?18.7 to ?1.0) at 24 weeks. For the higher dose patients, the advantage was greater: AMD=?11.9 (?19.3 to ?4.6) for the profile, ?14.2 (?25.8 to ?2.6) at 12 weeks, and ?14.4 (?26.9 to ?2.0) at 24 weeks. Patients receiving SMT were also more likely to achieve a 50% improvement in pain scale: adjusted odds ratio=3.6 (1.6 to 8.1) for the profile, 3.1 (0.9 to 9.8) at 12 weeks, and 3.1 (0.9 to 10.3) at 24 weeks. Secondary outcomes showed similar trends favoring SMT. For SMT patients, the mean number of CGH was reduced by half.ConclusionsClinically important differences between SMT and a control intervention were observed favoring SMT. Dose effects tended to be small.     

卵巢癌患者医患共同决策现状及影响因素分析

目的 了解卵巢癌患者医患共同决策现状，分析影响因素，为针对性干预提供参考。方法 采用一般资料调查问卷、中文版患者参与治疗决策态度问卷和决策困境量表对205例卵巢癌患者进行调查。结果 卵巢癌患者参与治疗决策态度总均分为2.39±0.57,决策困境总分为34.23±5.79;logistic回归分析显示，年龄、首次治疗、决策困境是参与治疗决策态度的主要影响因素(均P<0.05)。结论 卵巢癌患者参与医患共同决策态度积极，决策困境呈中等偏上水平；医护人员应针对影响因素提供个体化指导，以降低患者决策困境，提高患者共同决策参与度。     

El índice de masa corporal y la dieta afectan el desarrollo del cáncer de próstata

IntroductionProstate cancer (CaP) is one of the most important causes of morbidity and mortality in the world. There is evidence that obesity and inadequate eating habits may promote CaP development.ObjectiveTo analyze and compare the body mass index (BMI) and the food intake, especially fats and antioxidants, among subjects with CaP and those free of disease as a control group.Material and MethodsA sample of 40 men between 50 and 80 years old were selected for the study: 20 with CaP and 20 healthy men as control group. All volunteers underwent a digital rectal examination, prostate specific antigen level, ultrasound and transrectal prostate biopsy, and a nutritional interview where a dietary history and different anthropometric measurements were made. Statistical analysis was performed using the Student T test for independent samples (p <0.05).ResultsBMI in the subjects with CaP was higher than in controls (29.8 kg/m2 vs. 27.96 kg/m2, p = 0.13) but not statistically significant. However, there was a direct correlation between BMI and tumor aggressiveness (r = 0.79, P <0.001). Total, saturated, monounsaturated and polyunsaturated fat intake was significantly higher in subjects with CaP; while ?3 fatty acids, vitamin C and lycopene intake was significantly lower than in controls (p <0.05).ConclusionsA healthy weight and a diet low in total fat, saturated, monounsaturated and polyunsaturated fat and rich in ?3 fatty acids, vitamin C and lycopene is associated with a lower risk of CaP.     

Application of machine learning to the prediction of postoperative sepsis after appendectomy

BackgroundWe applied various machine learning algorithms to a large national dataset to model the risk of postoperative sepsis after appendectomy to evaluate utility of such methods and identify factors associated with postoperative sepsis in these patients.MethodsThe National Surgery Quality Improvement Program database was used to identify patients undergoing appendectomy between 2005 and 2017. Logistic regression, support vector machines, random forest decision trees, and extreme gradient boosting machines were used to model the occurrence of postoperative sepsis.ResultsIn the study, 223,214 appendectomies were identified; 2,143 (0.96%) were indicated as having postoperative sepsis. Logistic regression (area under the curve 0.70; 95% confidence interval, 0.68?0.73), random forest decision trees (area under the curve 0.70; 95% confidence interval, 0.68?0.73), and extreme gradient boosting (area under the curve 0.70; 95% confidence interval, 0.68?0.73) afforded similar performance, while support vector machines (area under the curve 0.51; 95% confidence interval, 0.50?0.52) had worse performance. Variable importance analyses identified preoperative congestive heart failure, transfusion, and acute renal failure as predictors of postoperative sepsis.ConclusionMachine learning methods can be used to predict the development of sepsis after appendectomy with moderate accuracy. Such predictive modeling has potential to ultimately allow for preoperative recognition of patients at risk for developing postoperative sepsis after appendectomy thus facilitating early intervention and reducing morbidity.     

Prospective multicentre study using high intensity focused ultrasound (HIFU) for the focal treatment of prostate cancer: Safety outcomes and complications

PurposeTo investigate focal therapy using High Intensity Focused Ultrasound (HIFU) for the treatment of localized prostate cancer (CaP), we analyzed the safety and complications of this procedure.MethodsPatients (pts) eligible for this multicenter prospective cohort study suffered from low to intermediate risk localized CaP with no prior treatment. After tumor identification on multiparametric MRI and in prostate biopsy, the lesions were treated with HIFU observing a safety margin of 8 to 10 mm. Adverse events (AE) after 30 and 90 days, as well as the required interventions were assessed and stratified for treatment localizations.ResultsOf the 98 men included in the study in two European centers, 35 (35.7%) experienced AEs in the first 30 days after HIFU intervention with Clavien-Dindo grade ≤ II: 15 pts (15.3%) had a postoperative urinary tract infection and 26 pts (26.5%) a urinary retention. Four pts (4.1%) underwent subsequent intervention (Clavien-Dindo grade IIIa/b). The number of late postoperative complications occurring between 30 and 90 days after intervention was low (2.0%). The highest complication rate was associated with tumors located at the anterior base (50.0%). The inclusion of the urethra in the ablation zone led to AEs in 20 out of 41 cases (48.8%) and represented a significant risk factor for complications within 30 days (odds ratio = 2.53; 95% confidence interval: 1.08–5.96; P = 0.033).ConclusionsFocal therapy of CaP lesions with a robotic HIFU-probe is safe and renders an acceptable rate of minor early AEs. The inclusion of the urethra in the ablation zone leads to an increase in early complications and should be avoided whenever possible.     

Multiple primary cancers in men with sporadic or familial prostate cancer: Its clinical implications

ObjectiveTo evaluate the risk of concordant cancers in patients with prostate cancer (CaP) and examine whether this risk differed according to family history of CaP.Materials and methodsWe examined 1,102 patients with CaP , having prospectively acquired pedigrees, and analyzed information regarding multiple primary cancers. The prevalence of concordant cancers was assessed with respect to the family history of CaP . First-degree familial CaP was defined as a positive history of CaP in first-degree relatives (parents, siblings, and offspring). Odds ratios for each concordant cancer in men with first-degree familial CaP were estimated. Clinical characteristics were compared between men with and without concordant cancers.ResultsThe prevalence of multiple primary cancers in sporadic PCa was 12.0%, similar to that of first-degree familial CaP (13.5%, P = 0.698). Gastrointestinal cancer was the most common concordant cancer (3.6%), followed by colorectal (2.9%), lung (1.5%), urothelial (1.3%), kidney (1.1%), and other cancers. Colorectal cancer was more frequent in first-degree familial CaP than in sporadic disease (6.8 vs. 2.7%, P = 0.045). However, the rates of other concordant cancers were similar between the 2 groups (P range, 0.242–0.963). Compared with sporadic disease, the age-adjusted odds ratio for concordant colorectal cancer in first-degree familial CaP was 2.930 (95% confidence interval, 1.082–7.929). Patients with concordant colorectal cancer had fewer (2.8 vs. 3.9 cores, P = 0.041) and a lower percentage of (23.5 vs. 33.1%, P = 0.030) positive biopsy cores than CaP only patients.ConclusionsA family history of CaP was significantly associated with a risk of concordant colorectal cancer. These findings imply that some CaP shares a genetic pathogenesis with colorectal cancer.