Cognitive and Psychological Impact of BRCA Genetic Counseling in Before and After Definitive Surgery Breast Cancer Patients

Purpose

To examine changes in cancer-related knowledge, distress, and decisional conflict from pre- to post-genetic counseling (GC) in before (BDS) and after (ADS) definitive surgery breast cancer (BC) patients.

Methods

Sociodemographic and clinical characteristics were collected at baseline; primary outcome data were collected before (T1) and after (T2) pretest GC. Within group changes for cancer-related knowledge, distress, and decisional conflict over genetic testing were compared by Wilcoxon signed-rank tests.

Results

Of 103 BC patients, 87 were ADS and 16 were BDS. Analyses revealed that both groups reported significant increases in knowledge between T1 and T2 (median change 4.2, p?=?0.004, and 2.7, p?<?0.001, for BDS and ADS patients, respectively). Overall cancer-related distress showed a downward trend between T1 and T2 for both groups and was significant for BDS patients (p?=?0.041). Reports of BDS patients trended toward overall and subscale-specific increases in decisional conflict, with the exception of the uncertainty which trended downward, but did not reach significance. Overall decisional conflict decreased in ADS patients, approaching marginal significance (p?=?0.056), with significant improvements in informed decision making (median change ?12.6, p?<?0.001; i.e., pretest GC yielded improved knowledge of benefits, risks, and side effects of available options).

Conclusions

These pilot data suggest that pretest GC increases cancer-related knowledge for both BDS and ADS patients, decreases distress in BDS patients, and improves informed decision making in ADS patients. Future studies with larger sample sizes are needed to replicate these results.     

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.     

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.     

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.     

Decisional conflict between treatment options among end‐stage renal disease patients evaluated for kidney transplantation

Although kidney transplantation provides a significant benefit over dialysis, many patients with end‐stage renal disease (ESRD) are conflicted about their decision to undergo kidney transplant. We aimed to identify the prevalence and characteristics associated with decisional conflict between treatment options in ESRD patients presenting for transplant evaluation. Among a cross‐sectional sample of patients with ESRD (n=464) surveyed in 2014 and 2015, we assessed decisional conflict through a validated 10‐item questionnaire. Decisional conflict was dichotomized into no decisional conflict (score=0) and any decisional conflict (score>0). We investigated potential characteristics of patients with decisional conflict using bivariate and multivariable logistic regression. The overall mean age was 50.6 years, with 62% male patients and 48% African American patients. Nearly half (48.5%) of patients had decisional conflict regarding treatment options. Characteristics significantly associated with decisional conflict in multivariable analysis included male sex, lower educational attainment, and less transplant knowledge. Understanding characteristics associated with decisional conflict in patients with ESRD could help identify patients who may benefit from targeted interventions to help patients make informed, value‐based, and supported decisions when deciding how to best treat their kidney disease.     

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.     

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.     

A systematic review of decision aids for patients making a decision about treatment for early breast cancer

Several complex treatment decisions may be offered to women with early stage breast cancer, about a range of treatments from different modalities including surgery, radiotherapy, and endocrine and chemotherapy. Decision aids can facilitate shared decision-making and improve decision-related outcomes. We aimed to systematically identify, describe and appraise the literature on treatment decision aids for women with early breast cancer, synthesise the data and identify breast cancer decisions that lack a decision aid.A prospectively developed search strategy was applied to MEDLINE, the Cochrane databases, EMBASE, PsycINFO, Web of Science and abstract databases from major conferences. Data were extracted into a pre-piloted form. Quality and risk of bias were measured using Qualsyst criteria. Results were synthesised into narrative format.Thirty-three eligible articles were identified, evaluating 23 individual treatment decision aids, comprising 13 randomised controlled trial reports, seven non-randomised comparative studies, eight single-arm pre-post studies and five cross-sectional studies. The decisions addressed by these decision aids were: breast conserving surgery versus mastectomy (+/− reconstruction); use of chemotherapy and/or endocrine therapy; radiotherapy; and fertility preservation. Outcome measures were heterogeneous, precluding meta-analysis. Decisional conflict decreased, and knowledge and satisfaction increased, without any change in anxiety or depression, in most studies. No studies were identified that evaluated decision aids for neoadjuvant systemic therapy, or contralateral prophylactic mastectomy.Decision aids are available and improved decision-related outcomes for many breast cancer treatment decisions including surgery, radiotherapy, and endocrine and chemotherapy. Decision aids for neoadjuvant systemic therapy and contralateral prophylactic mastectomy could not be found, and may be warranted.     

What do patients and health care professionals view as important attributes in radiotherapy decisions? Input for a breast cancer patient decision aid

Background and aimThere is increased attention for shared decision making (SDM) when deciding on radiotherapy for selected patients with Stage 0–2 breast cancer. This study aimed to explore patients' and health care professionals’ experiences, decisional attributes and needs as input for the development of a patient decision aid to facilitate SDM.MethodsQualitative semi-structured interviews were held with fifteen breast cancer patients, being confronted with a radiotherapy decision one month to eight years earlier. Another fifteen interviews were held with professionals specialized in breast cancer care. Interviews were transcribed verbatim and independently coded by two researchers, who agreed upon relevant issues.ResultsMost patients made their decision by weighing the advantages of radiotherapy, i.e. comparing the decrease in recurrence risk with and without radiotherapy, and disadvantages, i.e. possible side effects. Patients and professionals agreed that recurrence risks should be communicated, but not on how to deal with uncertainty. There was wide variation in which, and how, side effects were explained by professionals. The most common side effects mentioned by both patients and professionals were skin toxicity, fatigue and breast deformity.ConclusionPatients and professionals appeared to agree on what type of attributes should be communicated during SDM on radiotherapy, but how this should be done is up for discussion. To ensure the patient's voice these attributes and needs need to be incorporated in the risk communication and value elicitation part of the patient decision aid. The format in which the attributes are communicated should be critically evaluated.     

Evaluation of a Patient Decision Aid for Unicompartmental or Total Knee Arthroplasty for Medial Knee Osteoarthritis

Background

Many patients with isolated medial compartment osteoarthritis are candidates for either unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA). A novel patient decision aid (PDA) was developed to educate patients on both interventions and prepare them for making the decision with their surgeon. The study objective was to evaluate the acceptability and usefulness of a PDA for informing and helping patients reach a surgical preference without increasing decisional conflict.

Role of decision aids in orthopaedic surgery

Medical treatment of patients inherently entails the risk of undesired complication or side effects. It is essential to inform the patient about the expected outcomes, but also the possible undesired outcomes. The patients preference and values regarding the potential outcomes should be involved in the decision making process. Even though many orthopaedic surgeons are positive towards shared decision-making, it is minimally introduced in the orthopaedic daily practice and decision-making is still mostly physician based. Decision aids are designed to support the physician and patient in the shared- decision-making process. By using decision aids, patients can learn more about their condition and treatment options in advance to the decision-making. This will reduce decisional conflict and improve participation and satisfaction.     

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     

The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: A multi-center randomized trial

ObjectiveThe purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice.MethodsA randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored.ResultsA total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate ?3.61; (confidence interval, ?7.01, 0.22), and values clarity (estimate ?3.57; confidence interval (?5.85,?1.30). Borderline effect was seen for the total decisional conflict score (estimate ?1.75; confidence interval (?3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated.ConclusionThe Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.     

Shared decision making in the management of midshaft clavicular fractures: Nonoperative treatment or plate fixation

IntroductionMost patients with a displaced midshaft clavicular fracture can be treated either operatively or nonoperatively, with similar long-term outcomes. The treatment choice depends on individual preferences, and is therefore suited for a shared decision making (SDM) approach. However, little is known about SDM in fracture treatment. The purpose of this study was to evaluate the current daily practice of shared decisional behaviour in clavicular fracture treatment, in order to assess the need for improvement and set a baseline level for future research.Patients and methodsAll consecutive adult patients treated in two hospitals for a displaced, midshaft clavicular fracture in 2015 filled out a questionnaire shortly after the decision making moment, that consisted of questions concerning their knowledge and preferences regarding the treatment options; the SDM-Q-9-NL to measure the perceived degree of SDM, and the Control Preferences Scale to measure patients’ preferred and actual roles in decision making.ResultsFifty patients were included. Eighteen percent of the patients were unaware of the treatment options before the consultation, 48% had no preference for either treatment option. The mean score for perceived degree of SDM was 74 out of 100 (SD 23, range 12.5–100). In 68% of patients, the preferred role matched the actual role in making the decision. Sixteen patients (32%) would have preferred either a less (n = 8) or a more (n = 8) active role.ConclusionThe patient-reported level of SDM in treatment decisions for clavicular fractures was high, but not all patients had the role in this process that they preferred. To improve patients’ involvement in the treatment decision making process for clavicular fractures, it is important to create general awareness about SDM, and increase knowledge of orthopaedic trauma surgeons about SDM behaviour.     

Canadian Association of General Surgeons and American College of Surgeons Evidence-Based Reviews in Surgery. 27.: Quality-of-life outcomes with sentinel node biopsy versus standard axillary treatment in patients with operable breast cancer

Objective: To compare quality of life and arm morbidity outcomes among patients with clinically node-negative invasive breast cancer who received either sentinel lymph node biopsy (SNB) or standard axillary treatment. Methods: A total of 1031 patients were randomly assigned to either SNB (n = 515) or standard axillary surgery (n = 516). Sentinel node biopsy was performed before the breast tumour was removed, according to a standardized protocol that used a radiopharmaceutical compound and a blue dye with routine preoperative lymphoscintigraphy. Standard axillary treatment was defined as either an axillary lymph node dissection or 4-node axillary sampling. Outcomes were evaluated by patients' self-assessments of arm morbidity and quality of life. The patients completed the assessments using the Functional Assessment of Cancer Therapy — Breast scale, version 4 (FACT-B) at follow-up visits 1, 3, 6, 12 and 18 months after the procedure. Results: The relative risks of any lymphedema and sensory loss for the SNB group compared with the standard axillary surgery group at 12 months were 0.37 (95% confidence interval [CI] 0.23–0.60, absolute rates 5% v. 13%) and 0.37 (95% CI 0.27–0.50, absolute rates 11% v. 31%), respectively. Drain usage, length of stay in hospital and time to resumption of normal day-to-day activities after surgery were significantly lower in the SNB group (p < 0.001), and axillary operative time was reduced (p = 0.06). Overall patient-recorded scores for quality of life and arm functioning were significantly better in the SNB group throughout the follow-up period (p ≤ 0.003). These benefits were observed with no increase in anxiety levels in the SNB group (p ≥ 0.05). Conclusion: Sentinel node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment, and it should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.     

Shared Decision Making in Breast Cancer: National Practice Patterns of Surgeons

Background

The purpose of this study was to assess national practices of surgeons who treat breast cancer in order to identify opportunities to improve patient education.

Methods

In June 2012, the membership of the American Society of Breast Surgeons (ASBrS) (n = 2,818) was surveyed via email questionnaire to evaluate their current practice of shared decision making and informed consent for breast cancer patients.

Results

A total of 737 members (26 %) responded, including 384 breast surgeons and 306 general surgeons, 13 midlevel providers, and 25 other specialists. It was found that 90 % of surgeons spent more than 30 min meeting with a new cancer patient, and of these, 30 % spent more than an hour. Surgeons who spent more than 1 h face-to-face with a new cancer patient reported higher levels of overall patient knowledge compared with those who spent less (mean = 3.80 vs. 3.64 of 5; p = 0.001). Also, 89 % of respondents reported using educational tools, of whom more than 90 % used written tools. In addition, 65 % of members stated an interest in a free online educational tool if available and indicated a preference for a flexible tool that could be used by the patient alone or with a nurse.

Conclusions

While practice patterns may vary, our results reveal that one-third of surgeons spend at least 1 h in consultation with a new breast cancer patient. More time spent translated to a higher perceived patient understanding of their disease and treatment options. Although the majority of surgeons currently use written materials, there was clear support for a free online educational tool.     

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。