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Title: Development, feasibility, and efficacy of decision aids to improve decision-making for post-mastectomy breast reconstruction: A systematic review and meta-analysis Open Access Deposited

http://creativecommons.org/licenses/by-nc/4.0/
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Methodology
  • Broad literature searches were run in several databases. Duplicate citations were removed in Endnote X6 (Clarivate Analytics). The remaining citations were imported into DistillerSR (Evidence Partners, Inc.) for study selection. Data was extracted from the final set of included studies. Statistical analyses were performed using RevMan5.
Description
  • This systematic review and meta-analysis assesses decision aids in the context of patients considering post-mastectomy breast reconstruction.

  • NOTE: An updated Read Me file was added to this data set on May 24, 2018 replacing the original.
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  • markmac@umich.edu
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Keyword
Citations to related material
  • Berlin NL, Tandon VJ, Hawley ST, et al. Feasibility and Efficacy of Decision Aids to Improve Decision Making for Postmastectomy Breast Reconstruction: A Systematic Review and Meta-analysis. Med Decis Making. 2019;39(1):5–20. https://doi.org/10.1177/0272989X18803879
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  • On January 31, 2020, Citation for related publication was added to record metadata.
Last modified
  • 02/03/2020
Published
  • 03/23/2018
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DOI
  • https://doi.org/10.7302/Z2XP734R
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To Cite this Work:
Berlin, N., MacEachern, M. (2018). Development, feasibility, and efficacy of decision aids to improve decision-making for post-mastectomy breast reconstruction: A systematic review and meta-analysis [Data set]. University of Michigan - Deep Blue. https://doi.org/10.7302/Z2XP734R

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Record #1 of 90
ID: CN-01112825
AU: Causarano N
AU: Platt J
AU: Baxter NN
AU: Bagher S
AU: Jones JM
AU: Metcalfe KA
AU: Hofer SO
AU: O'Neill AC
AU: Cheng T
AU: Starenkyj E
AU: Zhong T
TI: Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.
SO: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
YR: 2015
VL: 23
NO: 5
PG: 1365-75
PM: PUBMED 25351455
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [surgery];Decision Making;Decision Support Techniques;Health Knowledge, Attitudes, Practice;Informed Consent;Mammaplasty [education];Mastectomy;Patient Education as Topic;Physician-Patient Relations;Pilot Projects;Referral and Consultation;Self Efficacy;Surveys and Questionnaires;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1007/s00520-014-2479-6
AB: PURPOSE: Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction.METHODS: We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT.RESULTS: Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06.CONCLUSIONS: A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/825/CN-01112825/frame.html

Record #2 of 90
ID: CN-01368609
AU: Sherman KA
AU: Shaw LK
AU: Winch CJ
AU: Harcourt D
AU: Boyages J
AU: Cameron LD
AU: Brown P
AU: Lam T
AU: Elder E
AU: French J
AU: Spillane A
TI: Reducing Decisional Conflict and Enhancing Satisfaction with Information among Women Considering Breast Reconstruction following Mastectomy: results from the BRECONDA Randomized Controlled Trial
SO: Plastic and reconstructive surgery
YR: 2016
VL: 138
NO: 4
PG: 592e-602e
PM: PUBMED 27673530
PT: Journal Article; Multicenter Study; Randomized Controlled Trial
KY: Decision Making;Decision Support Techniques;Follow-Up Studies;Internet;Mammaplasty [psychology];Mastectomy;Outcome Assessment (Health Care);Patient Education as Topic;Patient Participation [methods] [psychology];Patient Satisfaction [statistics & numerical data];Single-Blind Method;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1097/PRS.0000000000002538
AB: METHODS: Women (n = 222) diagnosed with breast cancer or ductal carcinoma in situ, and eligible for reconstruction following mastectomy, completed an online baseline questionnaire. They were then assigned randomly to receive either standard online information about breast reconstruction (control) or standard information plus access to BRECONDA (intervention). Participants then completed questionnaires at 1 and 6 months after randomization. The primary outcome was participants' decisional conflict 1 month after exposure to the intervention. Secondary outcomes included decisional conflict at 6 months, satisfaction with information at 1 and 6 months, and 6-month decisional regret.RESULTS: Linear mixed-model analyses revealed that 1-month decisional conflict was significantly lower in the intervention group (27.18) compared with the control group (35.5). This difference was also sustained at the 6-month follow-up. Intervention participants reported greater satisfaction with information at 1- and 6-month follow-up, and there was a nonsignificant trend for lower decisional regret in the intervention group at 6-month follow-up. Intervention participants' ratings for BRECONDA demonstrated high user acceptability and overall satisfaction.CONCLUSIONS: Women who accessed BRECONDA benefited by experiencing significantly less decisional conflict and being more satisfied with information regarding the reconstruction decisional process than women receiving standard care alone. These findings support the efficacy of BRECONDA in helping women to arrive at their breast reconstruction decision.BACKGROUND: Deciding whether or not to have breast reconstruction following breast cancer diagnosis is a complex decision process. This randomized controlled trial assessed the impact of an online decision aid [Breast RECONstruction Decision Aid (BRECONDA)] on breast reconstruction decision-making.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/609/CN-01368609/frame.html

Record #3 of 90
ID: CN-00481444
AU: Roosmalen MS
AU: Stalmeier PF
AU: Verhoef LC
AU: Hoekstra-Weebers JE
AU: Oosterwijk JC
AU: Hoogerbrugge N
AU: Moog U
AU: Daal WA
TI: Randomized trial of a shared decision-making intervention consisting of trade-offs and individualized treatment information for BRCA1/2 mutation carriers
SO: Journal of clinical oncology
YR: 2004
VL: 22
NO: 16
PG: 3293-3301
PM: PUBMED 15310772
PT: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [genetics] [psychology] [surgery];DNA Mutational Analysis;Decision Making;Decision Support Techniques;Genes, BRCA1;Genes, BRCA2;Genetic Predisposition to Disease;Genetic Testing;Life Expectancy;Mastectomy;Ovarian Neoplasms [genetics] [surgery];Patient Education as Topic;Patient Participation;Patient Satisfaction;Quality of Life;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-GYNAECA
DOI: 10.1200/JCO.2004.05.066
AB: PATIENTS AND METHODSThe SDMI consisted of two value assessment sessions, using the time trade-off method, followed by individualized treatment information based on (quality-adjusted) life expectancy. After the baseline assessment (2 weeks after a positive DNA test result), women were randomly assigned to the SDMI group (n = 44), receiving the SDMI 2 months after the test result, or to the control group (n = 44). The short- and long-term effects, 3 and 9 months after the test result, were assessed using questionnaires. Data were collected on well-being, treatment choice, and decision-related outcomes.RESULTSIn the short term, the SDMI had no effect. In the long term, with respect to well-being, patients in the SDMI group had less intrusive thoughts (P =.05) and better general health (P =.01) and tended to be less depressed (P =.07). With respect to decision-related outcomes for the breasts, the SDMI group held stronger preferences (P =.02) and agreed more strongly to having weighed the pros and cons (P =.01). No effect was found on treatment choice. In the long term, interaction effects between the SDMI and cancer history were found. The SDMI showed an overall beneficial effect for unaffected women, whereas affected women tended to experience detrimental effects.CONCLUSIONWe conclude that the SDMI improved decision making in unaffected BRCA1/2 mutation carriers. Supporting decision making in a systematic way using trade-offs is beneficial for these women.PURPOSETo evaluate a shared decision-making intervention (SDMI) for BRCA1/2 mutation carriers who have to make a choice between screening and prophylactic surgery for breasts and/or ovaries.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/444/CN-00481444/frame.html

Record #4 of 90
ID: CN-00482845
AU: Whelan T
AU: Levine M
AU: Willan A
AU: Gafni A
AU: Sanders K
AU: Mirsky D
AU: Chambers S
AU: O'Brien MA
AU: Reid S
AU: Dubois S
TI: Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial
SO: JAMA
YR: 2004
VL: 292
NO: 4
PG: 435-441
PM: PUBMED 15280341
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [surgery];Decision Making;Decision Support Techniques;General Surgery;Health Knowledge, Attitudes, Practice;Mastectomy;Mastectomy, Segmental;Patient Education as Topic;Patient Participation;Patient Satisfaction;Physician-Patient Relations;Referral and Consultation;Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA
DOI: 10.1001/jama.292.4.435
AB: OBJECTIVETo evaluate the impact of a decision aid regarding the different surgical treatment options on patient decision making.DESIGN AND SETTINGA cluster randomized trial for which general surgeons in the communities of central-west, and eastern Ontario, Canada, were randomly assigned to use the decision aid or not in the surgical consultation. Patients received the decision aid or not based on the surgeon seen.PARTICIPANTSTwenty surgeons participated in the study. Of the 208 eligible women with newly diagnosed clinical stage I or II breast cancer seen by study surgeons, 201 agreed to be evaluated: 94 were assigned to the decision board and 107 to usual practice. Patients were recruited from November 1999 to April 2002.INTERVENTIONThe decision board is a decision aid designed to help physicians inform their patients about different treatment options and to enable patients to express a preference for treatment.MAIN OUTCOME MEASURESPatient knowledge about the surgical treatment of breast cancer; decisional conflict; satisfaction with decision making; and the treatment decision following the consultation.RESULTSPatients in the decision board group had higher knowledge scores about their treatment options (66.9 vs 58.7; Pdyad (Multifocal approach to the 'sharing' in shared decision-making: observer instrument dyad). Secondary endpoints include the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), informed choice, decisional conflict and the duration of encounters. It is expected that decision coaching and the provision of evidence-based patient decision aids will increase patients' involvement in decision-making with informed choices and reduce decisional conflicts and duration of physician encounters. Furthermore, an accompanying process evaluation will be conducted. Discussion: To our knowledge, this is the first study investigating the implementation of decision coaches in German breast care centers. Trial registration: Current Controlled Trials ISRCTN46305518 , date of registration: 5 June 2015.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/134/CN-01106134/frame.html

Record #43 of 90
ID: CN-00379899
AU: Rimer BK
AU: Halabi S
AU: Sugg Skinner C
AU: Lipkus IM
AU: Strigo TS
AU: Kaplan EB
AU: Samsa GP
TI: Effects of a mammography decision-making intervention at 12 and 24 months
SO: American journal of preventive medicine
YR: 2002
VL: 22
NO: 4
PG: 247-257
PM: PUBMED 11988381
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
KY: Breast Neoplasms [prevention & control];Counseling;Decision Making;Decision Support Techniques;Health Education [methods];Health Knowledge, Attitudes, Practice;Mammography [statistics & numerical data];North Carolina;Telephone;Time Factors;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-CANCER: SR-COMMUN
AB: METHODSWe conducted a randomized controlled trial, which ran from 1997 to 2000. Women aged 40 to 44 and 50 to 54, who were enrolled in Blue Cross Blue Shield of North Carolina, were randomly assigned to one of three groups: usual care (UC), tailored print (TP) materials, or TP plus tailored telephone counseling (TP+TC). We assessed the impact of tailored interventions on knowledge about breast cancer and mammography, accuracy of breast cancer risk perceptions, and use of mammography at two time points after intervention-12 and 24 months.RESULTSAt 12 and 24 months, women who received TP+TC had significantly greater knowledge and more accurate breast cancer risk perceptions. Compared to UC, they were 40% more likely to have had mammograms (odds ratio=0.9-2.1). The effect was primarily for women in their 50s. TP had significant effects for knowledge and accuracy, but women who received TP were less likely to have had mammography.CONCLUSIONSDecision-making interventions, comprised of two tailored print interventions (booklet and newsletter), delivered a year apart, with or without two tailored telephone calls, significantly increased knowledge and accuracy of perceived breast cancer risk at 12 and 24 months post-intervention. The effect on mammography use was significant in bivariate relationships but had a much more modest impact in multivariate analyses.BACKGROUNDMost women are not getting regular mammograms, and there is confusion about several mammography-related issues, including the age at which women should begin screening. Numerous groups have called for informed decision making about mammography, but few programs have resulted. Our research is intended to fill this gap.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/899/CN-00379899/frame.html

Record #44 of 90
ID: CN-00571237
AU: Tiller K
AU: Meiser B
AU: Gaff C
AU: Kirk J
AU: Dudding T
AU: Phillips KA
AU: Friedlander M
AU: Tucker K
TI: A randomized controlled trial of a decision aid for women at increased risk of ovarian cancer
SO: Medical decision making
YR: 2006
VL: 26
NO: 4
PG: 360-372
PM: PUBMED 16855125
XR: EMBASE 44050841
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Anxiety [etiology];Decision Making;Decision Support Techniques;Genetic Predisposition to Disease;Ovarian Neoplasms [genetics] [psychology] [therapy];Pamphlets;Patient Education as Topic;Patient Satisfaction;Female[checkword];Humans[checkword];Middle Aged[checkword];adult; article; breast cancer; cancer risk; clinical trial; colorectal cancer; controlled clinical trial; controlled study; decision aid; decision making; distress syndrome; family history; female; follow up; human; major clinical study; *ovary cancer; randomized controlled trial; risk management; scientific literature
CC: SR-GYNAECA: SR-HEALTHP
DOI: 10.1177/0272989X06290486
AB: METHODSThis randomized trial, conducted through 6 familial cancer centers, compared the efficacy of tailored decision aid to that of a general educational pamphlet in preparing women for decision making.PARTICIPANTS131 women with a family history of breast and/or ovarian cancer or of hereditary nonpolyposis colorectal cancer.OUTCOME MEASURESDecisional conflict, knowledge about ovarian cancer risk management options, and psychological adjustment were reassessed at 3 time points.RESULTSCompared to those who received the pamphlet (control), women who received the decision aid (intervention) were significantly more likely to report a high degree of acceptability of the educational material at both follow-up assessment time points. Findings indicate neither group experienced significant increases in psychological distress at either follow-up assessment time points relative to baseline. Two weeks postintervention, the intervention group demonstrated a significant decrease in decisional conflict compared to the control group (t = 2.4, P < 0.025) and a trend for a greater increase in knowledge about risk management options (t = 2.1, P = 0.037). No significant differences were found 6 months postintervention.CONCLUSIONThis form of educational material is successful in increasing knowledge about risk management options and in reducing decisional conflict in the shorter term. The decision aid is an effective and acceptable strategy for patient education to facilitate an inclusive and informed decision-making process about managing ovarian cancer risk.PURPOSETo carry out a randomized controlled trial of a decision aid for women at increased risk of developing ovarian cancer to facilitate decision making regarding risk management options.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/237/CN-00571237/frame.html

Record #45 of 90
ID: CN-01256200
AU: Klafke N
AU: Mahler C
AU: Hagens C
AU: Rochon J
AU: Schneeweiss A
AU: Müller A
AU: Salize HJ
AU: Joos S
TI: A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial
SO: Trials
YR: 2015
VL: 16
PG: 51
PM: PUBMED 25887713
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [psychology] [therapy];Complementary Therapies [nursing];Data Interpretation, Statistical;Genital Neoplasms, Female [psychology] [therapy];Outcome Assessment (Health Care);Quality Assurance, Health Care;Quality of Life;Sample Size;Social Support;Female[checkword];Humans[checkword]
DOI: 10.1186/s13063-014-0538-4
AB: METHODS/DESIGN: CONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM. Primary outcome data on participants' HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted. A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients.DISCUSSION: Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).BACKGROUND: Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/200/CN-01256200/frame.html

Record #46 of 90
ID: CN-01077267
AU: Shaffer VA
AU: Owens J
AU: Zikmund-Fisher BJ
TI: The effect of patient narratives on information search in a web-based breast cancer decision aid: an eye-tracking study.
SO: Journal of medical Internet research
YR: 2013
VL: 15
NO: 12
PG: e273
PM: PUBMED 24345424
XR: EMBASE 24345424
PT: Journal: Article
KY: adult; aged; article; breast cancer; *breast tumor/su [Surgery]; decision aids; decision making; *decision support system; eye movement; eye tracking; female; human; information seeking; *Internet; middle aged; patient participation; personal narratives; psychological aspect; *telemedicine; videorecording
AB: Previous research has examined the impact of patient narratives on treatment choices, but to our knowledge, no study has examined the effect of narratives on information search. Further, no research has considered the relative impact of their format (text vs video) on health care decisions in a single study. Our goal was to examine the impact of video and text-based narratives on information search in a Web-based patient decision aid for early stage breast cancer. Fifty-six women were asked to imagine that they had been diagnosed with early stage breast cancer and needed to choose between two surgical treatments (lumpectomy with radiation or mastectomy). Participants were randomly assigned to view one of four versions of a Web decision aid. Two versions of the decision aid included videos of interviews with patients and physicians or videos of interviews with physicians only. To distinguish between the effect of narratives and the effect of videos, we created two text versions of the Web decision aid by replacing the patient and physician interviews with text transcripts of the videos. Participants could freely browse the Web decision aid until they developed a treatment preference. We recorded participants' eye movements using the Tobii 1750 eye-tracking system equipped with Tobii Studio software. A priori, we defined 24 areas of interest (AOIs) in the Web decision aid. These AOIs were either separate pages of the Web decision aid or sections within a single page covering different content. We used multilevel modeling to examine the effect of narrative presence, narrative format, and their interaction on information search. There was a significant main effect of condition, P=.02; participants viewing decision aids with patient narratives spent more time searching for information than participants viewing the decision aids without narratives. The main effect of format was not significant, P=.10. However, there was a significant condition by format interaction on fixation duration, P75%) of INT participants indicated high to very high overall satisfaction with the intervention, reporting that it was easy to use, presented a balanced view and that the amount of information provided was "just right" (75%). CONCLUSIONS: These findings indicate that participants assigned to the intervention benefitted in terms of their overall decisional process quality in that they reported both greater satisfaction with information regarding the breast reconstruction decision and lower decisional conflict. In terms of evaluating the content and format, intervention users reported high levels of user acceptability regarding overall satisfaction with the decision aid, and the appropriateness of the content for the target audience. Given that both conditions had access to quality information about breast reconstruction through the information booklet it is not surprising that knowledge was high in both groups at the 1-month follow-up. RESEARCH IMPLICATIONS: This is the first randomized controlled trial to assess a fully-integrated online decision aid that incorporates values clarification exercises in the breast reconstruction context. These findings provide evidence for the acceptability and efficacy of this decision support intervention in the short term. The intervention was equally as effective for women who had previously undergone mastectomy as for those about to have a mastectomy, suggesting the broad applicability of this decision aid. CLINICAL IMPLICATIONS: Online patient resources such as BRECONDA have the advantage of easy accessibility, particularly with increasing internet access across the broad population. These data support the feasibility and acceptability of implementing BRECONDA into oncological surgery practice. The easy-to-use self-guided format of the intervention will allow surgeons to refer their patients to this resource as an adjunct to medical consultations and to facilitate the decision-making process concerning both immediate and delayed breast reconstruction surgery following mastectomy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/361/CN-01011361/frame.html

Record #62 of 90
ID: CN-00529464
AU: Emery J
TI: The GRAIDS Trial: the development and evaluation of computer decision support for cancer genetic risk assessment in primary care
SO: Annals of human biology
YR: 2005
VL: 32
NO: 2
PG: 218-227
PM: PUBMED 16096220
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Attitude of Health Personnel;Attitude to Computers;Breast Neoplasms [genetics] [prevention & control];Colorectal Neoplasms [genetics] [prevention & control];Decision Making, Computer-Assisted;England;Genetics [education];Outcome Assessment (Health Care) [methods];Primary Health Care;Risk Assessment [methods];Female[checkword];Humans[checkword]
CC: SR-COLOCA
DOI: 10.1080/03014460500074921
AB: The development and evaluation of computer decision support for the assessment of cancer genetic risk in primary care is reported with two series of studies described: the RAGs (Risk Assessment in Genetics) studies and the GRAIDS (Genetic Risk Assessment in an Intranet and Decision Support) Trial. In the GRAIDS Trial, 45 general practices in Eastern England have been recruited and randomised. Comparison practices attend an educational session and receive clinical guidelines about familial breast and colorectal cancer. In the intervention practices a lead clinician is trained in cancer genetics and use of the GRAIDS software. The GRAIDS software is a simple pedigree-drawing program that implements clinical guidelines for familial breast and colorectal cancer and presents individualised information about breast cancer risk in a range of formats. Outcome measures of the trial include: frequency of software use, practitioners' attitudes towards the software, total number of referrals to secondary care about familial cancer and the proportion that meet regional referral criteria, and a patient-centred measure of informed decision making. The family history will become an increasingly important tool in primary care to assess genetic risk. This research evaluates an approach to support high-quality advice about cancer genetics in primary care which could be applied more broadly as our understanding of complex disease genetics increases.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/464/CN-00529464/frame.html

Record #63 of 90
ID: CN-01091958
AU: Sherman K
AU: Shaw L
AU: Winch C
AU: Harcourt D
AU: Cameron L
AU: Brown P
TI: Psychological distress, age and salience of physical appearance: Mediator and moderator effects of the BRECONDA web-based decision aid for women considering breast reconstruction following mastectomy.
SO: Psycho-oncology
YR: 2015
VL: 24
PG: 44
XR: EMBASE 71967879
PT: Journal: Conference Abstract
KY: *female; *human; *breast reconstruction; *mastectomy; *oncology; *distress syndrome; follow up; surgery; decision making; Internet; neoplasm; patient; breast cancer; randomized controlled trial; bootstrapping; exercise; model; breast; consultation; plastic surgery; population; surgeon; questionnaire
DOI: 10.1002/pon.3873
AB: BACKGROUND/PURPOSE: Women requiring mastectomy for breast cancer are faced with difficult decisions regarding whether, and how, to restore breast shape after surgery. We developed a web-based interactive decision aid, BRECONDA, to assist women with this decision making. Using data from the BRECONDA randomized controlled trial (RCT), this study examined moderators and mediators of decisional conflict and decisional regret. METHODS: Women diagnosed with breast cancer (N= 265) were recruited into the web-based RCT. Participants completed baseline questionnaires and were randomly assigned to either the BRECONDA Intervention (INT) or Usual Care (CONT) conditions. Age and psychological distress at study entry were assessed as moderators, and values about minimizing additional surgical intervention and physical appearance-related concerns were assessed as mediators of BRECONDA. Decisional conflict and decisional regret were assessed at 1- and 6-month follow-up. RESULTS: Linear mixed effects models demonstrated a moderating effect of age and cancer-specific distress on decisional conflict: INT participants who were older and more distressed demonstrated the greatest reduction in decisional conflict at 1- and 6-month follow-up. Mediation bootstrapping analysis revealed that participant values about physical appearancerelated concerns at 1-month follow-up mediated the impact of BRECONDA on decisional conflict and regret at 6-month follow-up. CONCLUSIONS: This is the first RCT to assess a fully integrated online decision aid that incorporates values clarification exercises in the breast reconstruction context. These findings delineate the characteristics of individuals most likely to benefit from the BRECONDA decision aid and a mechanism by which the intervention demonstrates decisional process benefits to women considering breast reconstruction. Research Implications: Prior research has identified the efficacy of the BRECONDA intervention in reducing decisional conflict and decisional regret in women faced with the breast reconstruction decision. These findings delineate the characteristics of individuals most likely to benefit from the BRECONDA decision aid and a mechanism by which the intervention facilitates the decision-making process. Older women, who are typically less extensive users of the Internet, and those experiencing greater levels of cancer-specific distress at the point of study entry, have particularly benefitted from the provision of quality, structured information concerning breast reconstruction options. The mediating effect of attitudinal change regarding the relative importance of physical appearance-related values when considering breast reconstruction highlights the key role of these views when making these surgical decisions. Practice Implications: Online patient resources such as BRECONDA have the advantage of easy accessibility, particularly with increasing Internet access across the broad population. These data support the use of this decisional support resource in oncological surgery practice and identify individuals for whom provision of this resource should be highly recommended and emphasized. The easy-to-use self-guided format of the intervention will allow surgeons to refer their patients to this resource as an adjunct to medical consultations and to facilitate the decision-making process concerning both immediate and delayed breast reconstruction surgery following mastectomy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/958/CN-01091958/frame.html

Record #64 of 90
ID: CN-00521495
AU: Green MJ
AU: Peterson SK
AU: Baker MW
AU: Friedman LC
AU: Harper GR
AU: Rubinstein WS
AU: Peters JA
AU: Mauger DT
TI: Use of an educational computer program before genetic counseling for breast cancer susceptibility: effects on duration and content of counseling sessions
SO: Genetics in medicine
YR: 2005
VL: 7
NO: 4
PG: 221-229
PM: PUBMED 15834239
PT: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
KY: Breast Neoplasms [genetics];Decision Making, Computer-Assisted;Genetic Counseling [methods];Genetic Testing [methods];Health Knowledge, Attitudes, Practice;Patient Education as Topic;Patient Satisfaction;Software;Female[checkword];Humans[checkword]
CC: SR-COMMUN: SR-HEALTHP
AB: METHODS: We developed and evaluated an interactive computer program that educates women about breast cancer, heredity, and genetic testing. Between May 2000 and September 2002, women at six study sites were randomized into either: Counselor Group (n = 105), who received standard genetic counseling, or Computer Group (n = 106), who used the interactive computer program before counseling. Clients and counselors both evaluated the effectiveness of counseling sessions, and counselors completed additional measures for the Computer Group. Counselors also recorded the duration of each session.RESULTS: Baseline characteristics did not differ significantly between groups. Participants and counselors both rated the counseling sessions as highly effective, whether or not the sessions were preceded by computer use. Computer use resulted in significantly shorter counseling sessions among women at low risk for carrying BRCA1/2 mutations. In approximately half of the sessions preceded by clients' computer use, counselors indicated that clients' use of the computer program affected the way they used the time, shifting the focus away from basic education toward personal risk and decision-making.CONCLUSION: This study shows that the interactive computer program "Breast Cancer Risk and Genetic Testing" is a valuable adjunct to genetic counseling. Its use before counseling can shorten counseling sessions and allow counselors to focus more on the clients' individual risks and specific psychological concerns. As the demand for counseling services increases, a program such as this can play a valuable role in enhancing counseling efficiency.PURPOSE: Patients seeking genetic testing for inherited breast cancer risk are typically educated by genetic counselors; however, the growing demand for cancer genetic testing will likely exceed the availability of counselors trained in this area. We compared the effectiveness of counseling alone versus counseling preceded by use of a computer-based decision aid among women referred to genetic counseling for a family or personal history of breast cancer.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/495/CN-00521495/frame.html

Record #65 of 90
ID: CN-00570834
AU: Wilson BJ
AU: Torrance N
AU: Mollison J
AU: Watson MS
AU: Douglas A
AU: Miedzybrodzka Z
AU: Gordon R
AU: Wordsworth S
AU: Campbell M
AU: Haites N
AU: Grant A
TI: Cluster randomized trial of a multifaceted primary care decision-support intervention for inherited breast cancer risk
SO: Family practice
YR: 2006
VL: 23
NO: 5
PG: 537-544
PM: PUBMED 16787957
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [genetics] [prevention & control];Clinical Competence;Decision Making, Computer-Assisted;Decision Support Systems, Clinical;Family Practice [education] [standards];Genetic Predisposition to Disease;Genetic Testing;Guideline Adherence;Patient Education as Topic [standards];Practice Guidelines as Topic;Referral and Consultation [utilization];Risk Assessment;Scotland;Software Design;Female[checkword];Humans[checkword]
CC: SR-BREASTCA: SR-COMMUN: SR-EPOC
DOI: 10.1093/fampra/cml026
AB: OBJECTIVETo evaluate the effectiveness of the intervention in improving GP confidence in managing patients concerned about genetic risk of breast cancer.METHODSDESIGNCluster randomized controlled trial.SETTINGGeneral practices in the Grampian region of Scotland.SUBJECTSGPs and the patients they referred for genetic counselling for risk of breast cancer.MAIN OUTCOME MEASURESGPs' self-reported confidence in four activities related to genetics; rates of referral of patients at elevated genetic risk; and referred patients' understanding of cancer risk factors.RESULTSNo statistically significant differences were observed between intervention and control arms in the primary or secondary outcomes. A possible effect of the intervention on the proportion of referred patients who were at elevated risk could not be discounted. Only a small proportion of intervention GPs attended the educational session, were aware or the software, or made use of it in practice.CONCLUSIONSNo convincing evidence of the effectiveness of the intervention was found, probably reflecting barriers to its use in routine practice.BACKGROUNDGPs are increasingly expected to meet the needs of patients concerned about their risk of inherited breast cancer, but may lack skills or confidence to use complex management guidelines. We developed an evidence-based, multifaceted intervention intended to promote confidence and skills in this area.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/834/CN-00570834/frame.html

Record #66 of 90
ID: CN-01259496
AU: Härter M
AU: Buchholz A
AU: Nicolai J
AU: Reuter K
AU: Komarahadi F
AU: Kriston L
AU: Kallinowski B
AU: Eich W
AU: Bieber C
TI: Shared Decision Making and the Use of Decision Aids
SO: Deutsches arzteblatt international
YR: 2015
VL: 112
NO: 40
PG: 672-679
PM: PUBMED 26517595
PT: Journal Article; Randomized Controlled Trial
KY: Clinical Decision-Making [methods];Evidence-Based Medicine;Germany [epidemiology];Neoplasms [epidemiology] [psychology] [therapy];Patient Participation [psychology] [statistics & numerical data];Patient Satisfaction [statistics & numerical data];Patient-Centered Care [statistics & numerical data];Physician-Patient Relations;Physicians [psychology] [statistics & numerical data];Prevalence;Quality Improvement [statistics & numerical data];Quality of Health Care [statistics & numerical data];Treatment Outcome;Adult[checkword];Female[checkword];Humans[checkword];Male[checkword];Middle Aged[checkword]
DOI: 10.3238/arztebl.2015.0672
AB: METHODSPhysicians who treat patients with cancer were invited to participate in a cluster-randomized trial and carry out SDM together with breast or colon cancer patients who faced decisions about their treatment. Decision-related physician-patient conversations were recorded. The patients filled out questionnaires immediately after the consultations (T1) and three months later (T2). The primary endpoints were the patients' confidence in and satisfaction with the decisions taken. The secondary endpoints were the process of decision making, anxiety, depression, quality of life, and externally assessed physician competence in SDM. The physicians in the intervention group underwent 12 hours of training in SDM, including the use of decision aids.RESULTSOf the 900 physicians invited to participated in the trial, 105 answered the invitation. 86 were randomly assigned to either the intervention group or the control group (44 and 42 physicians, respectively); 33 of the 86 physicians recruited at least one patient for the trial. A total of 160 patients participated in the trial, of whom 55 were treated by physicians in the intervention group. There were no intergroup differences in the primary endpoints. Trained physicians were more competent in SDM (Cohen's d = 0.56; p<0.05). Patients treated by trained physicians had lower anxiety and depression scores immediately after the consultation (d = -0.12 and -0.14, respectively; p<0.10), and markedly lower anxiety and depression scores three months later (d = -0.94 and -0.67, p<0.01).CONCLUSIONWhen physicians treating cancer patients improve their competence in SDM by appropriate training, their patients may suffer less anxiety and depression. These effects merit further study.BACKGROUNDIn shared decision making (SDM), the patient and the physician reach decisions in partnership. We conducted a trial of SDM training for physicians who treat patients with cancer.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/496/CN-01259496/frame.html

Record #67 of 90
ID: CN-00993547
AU: Wilson L
AU: Loucks A
AU: Stupar L
AU: O'Donnell S
AU: Moore D
AU: Belkora J
TI: Cost-benefit analysis of decision support methods for patients with breast cancer in a rural community.
SO: Community oncology
YR: 2013
VL: 10
NO: 2
PG: 47-57
XR: EMBASE 2014325834
PT: Journal: Article
KY: adult; article; audio recording; *breast cancer/dm [Disease Management]; cancer center; comparative study; consultation; controlled study; *cost benefit analysis; *decision support system; female; health care survey; human; major clinical study; middle aged; patient participation; randomized controlled trial; *rural population; sensitivity analysis
AB: Background Decision support interventions help patients who are facing difficult treatment decisions and improve shared decision making. There is little evidence of the economic impact of these interventions. Objective To determine the costs of providing a decision support intervention in the form of consultation planning (CP) and consultation planning with recording and summary (CPRS) to women with breast cancer and to compare the cost benefit of CP and CPRS by telephone versus in person. Methods Sixty-eight women with breast cancer who were being treated at a rural cancer resource center were randomized to CP in person or by telephone. All participants were then provided with an audio-recording of the physician consultation along with a typed summary for the full intervention (CPRS). Surveys completed by the participants and center staff provided data for measuring costs and willingness-to-pay (WTP) benefits. Societal perspective costs and incremental net benefit (INB) across delivery methods was determined. Results Total CP costs were $208.72 for telephone and $264.00 for in-person delivery. Significantly lower telephone-group costs (P < .001) were a result of lower participant travel expenses. Participants were willing to pay $154.12 for telephone and $144.03 for in-person CP (P = .85). WTP did not exceed costs of either delivery method compared with no intervention. INB of providing CP for telephone versus in person was $65.37, favoring telephone delivery. Sensitivity analysis revealed that with more efficient CP training, WTP became greater than the costs of delivering CP by telephone versus no intervention. Limitations There may be some income distribution effects in the measurement of WTP. Conclusions Providing CP by telephone was significantly less costly with no significant difference in benefit. Participants' WTP only exceeded the full cost of CP with more efficient training or higher participant volume. A positive INB showed telephone delivery is efficient and may increase accessibility to decision support services, particularly in rural communities. 2013 Frontline Medical Communications.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/547/CN-00993547/frame.html

Record #68 of 90
ID: CN-00331851
AU: Connelly MT
AU: Rusinak D
AU: Livingston W
AU: Raeke L
AU: Inui TS
TI: Patient knowledge about hormone replacement therapy: implications for treatment
SO: Menopause (new york, N.Y.)
YR: 2000
VL: 7
NO: 4
PG: 266-272
PM: PUBMED 10914620
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Alzheimer Disease [prevention & control];Breast Neoplasms [chemically induced];Colonic Neoplasms [prevention & control];Estrogen Replacement Therapy [adverse effects];Heart Diseases [prevention & control];Hip Fractures [prevention & control];Knowledge;Menopause;Osteoporosis, Postmenopausal [prevention & control];Patient Education as Topic;Placebos;Risk Factors;Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-CANCER: SR-COLOCA: SR-COMMUN
AB: DESIGNPreintervention telephone survey of 156 women enrolled in a randomized, placebo-controlled trial of HRT decision aids.RESULTSThe mean rating of menopause knowledge, on a scale from 1 to 10, with 10 indicating being "extremely knowledgeable," was 5.6 (range = 0-10) and of HRT was 4.2 (range = 0-9). The mean summary score for the explicit HRT knowledge test, on a 16-point scale, was 7.8 (range = 0-15). After adjustment for demographic characteristics and exposure to a provider conversation, higher income, white race, and the provider discussion were significant correlates of knowledge. Explicit knowledge was positively correlated with self-assessed menopause knowledge and HRT knowledge (Spearman's correlation coefficient = 0.39 and 0.52, respectively; p < 0.0001). Greater knowledge was not associated with intention to use HRT 1 year later. Women who had greater knowledge reported less conflict about the HRT decision (Spearman's correlation coefficient = -0.32; p < 0.0001).CONCLUSIONSA global question about level of knowledge is an effective clinical tool for identifying patients who are in need of additional education about HRT and menopause in this managed care population. Increased knowledge may decrease women's conflict about the HRT decision. Having had a previous conversation about menopause with a primary care provider is associated with greater knowledge about HRT.OBJECTIVETo determine whether women's global self-assessment of their knowledge about hormone replacement therapy (HRT) corresponds to their performance on an explicit knowledge test about HRT and to measure associations among knowledge, personal characteristics, decision conflict, and intention to use HRT.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/851/CN-00331851/frame.html

Record #69 of 90
ID: CN-01172522
AU: Cookson S
AU: Cawrse N
AU: Olsen S
TI: Evaluation of the benefits of breast reconstruction information evenings.
SO: European Journal of Surgical Oncology. Conference: Association of Breast Surgery Conference and AGM, ABS 2015 Bournemouth United Kingdom. Conference Start: 20150615 Conference End: 20150616. Conference Publication: (var.pagings)
YR: 2015
VL: 41
NO: 6
PG: S77
XR: EMBASE 72214451
PT: Journal: Conference Abstract
KY: *breast reconstruction; *breast surgery; human; female; peer group; medical audit; health care personnel; neoplasm; decision making; nursing staff; surgery; patient; medical specialist; support group; hospital design; volunteer; questionnaire; nurse; hospital
DOI: 10.1016/j.ejso.2015.03.220
AB: Introduction: Women considering breast reconstruction face many difficult choices. Breast reconstruction information evenings were initiated at the Royal Devon & Exeter Hospital (RD&E) in 2011 to provide information and peer support for women considering breast reconstruction. They are facilitated by the Breast Reconstruction Nurse Specialist and supported by medical and nursing staff. Information evenings are held three times a year at the local cancer support centre and are advertised in advance. The aim of the audit was assess the value of peer support and the benefit of providing information in a group setting. Method: Questionnaires were handed out to all women at consecutive information evenings between July 2011 and November 2014. The audit was based on the standard hospital design for auditing support groups. Results: 10 meetings have been held at the RD&E attended by a total of 171 women. The response rate was 58%. (100/171) 100% (100) of respondents would recommend the evening to other women considering breast reconstruction. 90% (90) women valued meeting and talking to the patient volunteers and seeing the results of surgery. 80% (80) women valued talking to healthcare professionals in this setting. 60% (60) women felt the evening supported their decision to go ahead with breast reconstruction. Conclusions: Women value peer support from women who have already had a breast reconstruction. This may help in their decision making. Women valued the opportunity to talk to healthcare professionals. Providing information on breast reconstruction in this format has been well received.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/522/CN-01172522/frame.html

Record #70 of 90
ID: CN-01288286
AU: Speck RM
AU: Neuman MD
AU: Resnick KS
AU: Mellers BA
AU: Fleisher LA
TI: Anticipated regret in shared decisionmaking: a randomized experimental study
SO: Perioperative medicine
YR: 2016
VL: 5
NO: 1) (no pagination
XR: EMBASE 613211560
PT: Journal: Article
KY: adult; article; *breast cancer; controlled study; female; health survey; human; human experiment; medical decision making; normal human; partial mastectomy; pilot study; priority journal; quality of life; randomized controlled trial; young adult; control group; controlled clinical trial; experimental model; *experimental study; lumpectomy; major clinical study; recipient; *Shared decision-making; statistical significance; surgery; surgical patient; volunteer
DOI: 10.1186/s13741-016-0031-6
AB: Background: Explicit consideration of anticipated regret is not part of the standard shared decision-making protocols. This pilot study aimed to compare decisions about a hypothetical surgery for breast cancer and examined whether regret is a consideration in treatment decisions. Methods: In this randomized experimental study, 184 healthy female volunteers were randomized to receive a standard decision aid (control) or one with information on post-surgical regret (experimental). The main outcome measures were the proportion of subjects choosing lumpectomy vs. mastectomy and the proportion reporting that regret played a role in the decision made. We hypothesized that a greater proportion of the experimental group (regret-incorporated decision aid) would make a surgical treatment preference that favored the less regret-inducing option and that they would be more likely to consider regret in their decision-making process as compared to the control group. Results: A significantly greater proportion of the experimental group subjects reported regret played a role in their decision-making process compared to the control counterparts (78 vs. 65 %; p = 0.039). Recipients of the regretincorporated experimental decision aid had a threefold increased odds of choosing the less regret-inducing surgery (OR = 2.97; 95 % CI = 1.25, 7.09; p value = 0.014). Conclusions: In this hypothetical context, the incorporation of regret in a decision aid for preference-sensitive surgery impacted decision-making. This finding suggests that keying in on anticipated regret may be an important element of shared decision-making strategies. Our results make a strong argument for applying this design and pursuing further research in a surgical patient population. Copyright © 2016 Speck et al.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/286/CN-01288286/frame.html

Record #71 of 90
ID: CN-01333689
AU: Collins K
AU: Wyld L
AU: Burton M
AU: Lifford K
AU: Armitage F
TI: Breast clinical nurse specialist perspective of decision support interventions
SO: European journal of surgical oncology. Conference: association of breast surgery conference, ABS 2016. United kingdom. Conference start: 20160516. Conference end: 20160517
YR: 2016
VL: 42
NO: 5
PG: S8
XR: EMBASE 614540583
PT: Journal: Conference Abstract
KY: *breast cancer; cancer therapy; *clinical nurse specialist; clinical practice; clinical study; consultation; controlled clinical trial; controlled study; *decision support system; doctor patient relation; female; human; interview; oncologist; questionnaire; randomized controlled trial; shared decision making; surgeon; telephone; validity; volunteer
DOI: 10.1016/j.ejso.2016.02.043
AB: Introduction: Treatment protocols for older women with breast cancer may vary from standard to accommodate co-morbidity and frailty. Supporting decision-making in older women may be challenging due to lack of informational resources and research evidence. We report development of tools to support shared decision making in older women from the perspective of the Clinical Nurse Specialist (CNS). Method: The information preferences of older women were studied using a multi-source intervention. CNS's, oncologists, surgeons, patients and healthy volunteers were recruited for questionnaires, audio recorded consultations, telephone and face to face interviews to determine the information needs of older women. Data were used to develop a series of decision support interventions (DESI's) to aid older women making breast cancer treatment decisions. These DESI's comprised patient booklets, a web based algorithm allowing clinicians to establish individual risks and option grids. User feedback on the tools was obtained to refine them further. Results: This abstract reports a re-interpretation of the data collected from a CNS perspective of the decision supports using framework analysis to identify common themes in the feedback to further refine the DESI's to facilitate clinical utility, acceptability, ease of use, practicality and facilitators and barriers to routine clinical practice. Conclusions: The decision tools were well received by CNSs whose feedback directed further amendments and addition of a 'frequently asked questions' section related to the sources and validity of underpinning data. This tool will now be tested as part of the Age Gap randomised trial.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/689/CN-01333689/frame.html

Record #72 of 90
ID: CN-01244748
AU: Speck RM
AU: Neuman MD
AU: Resnick KS
AU: Mellers BA
AU: Fleisher LA
TI: Anticipated regret in shared decisionmaking: a randomized experimental study
SO: Perioperative medicine
YR: 2016
VL: 5
NO: 1) (no pagination
XR: EMBASE 613211560
PT: Journal: Article
KY: *breast cancer; control group; controlled clinical trial; controlled study; experimental model; *experimental study; female; human; lumpectomy; major clinical study; randomized controlled trial; recipient; *shared decision making; statistical significance; surgery; surgical patient; volunteer
DOI: 10.1186/s13741-016-0031-6
AB: Background: Explicit consideration of anticipated regret is not part of the standard shared decision-making protocols. This pilot study aimed to compare decisions about a hypothetical surgery for breast cancer and examined whether regret is a consideration in treatment decisions. Methods: In this randomized experimental study, 184 healthy female volunteers were randomized to receive a standard decision aid (control) or one with information on post-surgical regret (experimental). The main outcome measures were the proportion of subjects choosing lumpectomy vs. mastectomy and the proportion reporting that regret played a role in the decision made. We hypothesized that a greater proportion of the experimental group (regret-incorporated decision aid) would make a surgical treatment preference that favored the less regret-inducing option and that they would be more likely to consider regret in their decision-making process as compared to the control group. Results: A significantly greater proportion of the experimental group subjects reported regret played a role in their decision-making process compared to the control counterparts (78 vs. 65 %; p = 0.039). Recipients of the regretincorporated experimental decision aid had a threefold increased odds of choosing the less regret-inducing surgery (OR = 2.97; 95 % CI = 1.25, 7.09; p value = 0.014). Conclusions: In this hypothetical context, the incorporation of regret in a decision aid for preference-sensitive surgery impacted decision-making. This finding suggests that keying in on anticipated regret may be an important element of shared decision-making strategies. Our results make a strong argument for applying this design and pursuing further research in a surgical patient population. Copyright © 2016 Speck et al.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/748/CN-01244748/frame.html

Record #73 of 90
ID: CN-01201031
AU: Fontein DB
AU: Klinten Grand M
AU: Nortier JW
AU: Seynaeve C
AU: Meershoek-Klein Kranenbarg E
AU: Dirix LY
AU: Velde CJ
AU: Putter H
TI: Dynamic prediction in breast cancer: proving feasibility in clinical practice using the TEAM trial.
SO: Annals of oncology : official journal of the European Society for Medical Oncology
YR: 2015
VL: 26
NO: 6
PG: 1254-62
PM: PUBMED 25862439
PT: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Antineoplastic Agents, Hormonal [adverse effects] [therapeutic use];Belgium;Biomarkers, Tumor [analysis];Breast Neoplasms [chemistry] [mortality] [pathology] [therapy];Chemotherapy, Adjuvant;Decision Support Techniques;Feasibility Studies;Mastectomy [adverse effects] [mortality];Neoplasm Recurrence, Local;Neoplasm Staging;Netherlands;Nomograms;Patient Selection;Predictive Value of Tests;Receptor, ErbB-2 [analysis];Risk Assessment;Risk Factors;Survival Analysis;Time Factors;Treatment Outcome;Adult[checkword];Aged[checkword];Aged, 80 and over[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1093/annonc/mdv146
AB: BACKGROUND: Predictive models are an integral part of current clinical practice and help determine optimal treatment strategies for individual patients. A drawback is that covariates are assumed to have constant effects on overall survival (OS), when in fact, these effects may change during follow-up (FU). Furthermore, breast cancer (BC) patients may experience events that alter their prognosis from that time onwards. We investigated the 'dynamic' effects of different covariates on OS and developed a nomogram to calculate 5-year dynamic OS (DOS) probability at different prediction timepoints (tP) during FU.METHODS: Dutch and Belgian postmenopausal, endocrine-sensitive, early BC patients enrolled in the TEAM trial were included. We assessed time-varying effects of specific covariates and obtained 5-year DOS predictions using a proportional baselines landmark supermodel. Covariates included age, histological grade, hormone receptor and HER2 status, T- and N-stage, locoregional recurrence (LRR), distant recurrence, and treatment compliance. A nomogram was designed to calculate 5-year DOS based on individual characteristics.RESULTS: A total of 2602 patients were included (mean FU 6.2 years). N-stage, LRR, and HER2 status demonstrated time-varying effects on 5-year DOS. Hazard ratio (HR) functions for LRR, high-risk N-stage (N2/3), and HER2 positivity were HR = (8.427 × 0.583[Formula: see text], HR = (3.621 × 0.816[Formula: see text], and HR = (1.235 × 0.851[Formula: see text], respectively. Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)]. All other covariates were time-constant.DISCUSSION: The current nomogram accounts for elapsed time since starting adjuvant endocrine treatment and optimizes prediction of individual 5-year DOS during FU for postmenopausal, endocrine-sensitive BC patients. The nomogram can facilitate in determining whether further therapy will benefit an individual patient, although validation in an independent dataset is still needed.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/031/CN-01201031/frame.html

Record #74 of 90
ID: CN-01139373
AU: Muhlbauer V
AU: Muhlhauser I
AU: Steckelberg A
TI: Analysis of prognostication and treatment benefit tools for women with early breast cancer as a prerequisite for informed shared decision making.
SO: Oncology Research and Treatment
YR: 2016
VL: 39
PG: 49
XR: EMBASE 72212444
PT: Journal: Conference Abstract
KY: *human; *female; *breast cancer; *decision making; German (citizen); risk; survival; death; randomized controlled trial (topic); cancer prognosis; data base; prognosis; Medline; Internet; adjuvant therapy; European; model; comorbidity; evidence based practice; randomized controlled trial; cancer mortality; cancer diagnosis; neoplasm; interpersonal communication; Germany; adjuvant
DOI: 10.1159/000444354
AB: Background: Shared decision making (SDM) is strongly recommended in the German treatment guideline for breast cancer. Following evidence-based criteria informed SDM requires decision aids that are based on individualized risk information rather than mere cancer prognosis such as 5-year relative survival. Treatment decisions should be based on individual prognostic data that include comorbidities and age-dependent risk of death from causes other than breast cancer. Methods: Systematic literature search in Pubmed and EMBASE and free internet search. Prognostication tools for women with early, ER-positive breast cancer were analyzed for incorporated variables, information on the prognosis without adjuvant therapy, underlying data base, model validation and being up-to-date. Results: We identified 3 relevant prognostication tools on survival: Adjuvant!, PREDICT and CancerMath. All tools consider age and tumor characteristics; 2 tools differentiate between cancer death and death from other causes but use US data and are outdated. Adjuvant! has shown to improve SDM and to change treatment decisions in a randomized controlled trial. Limitations of the identified tools include lack of variables as comorbidity, Her2 status or mode of cancer detection. No tools using German data could be identified; PREDICT uses European data. Conclusion: All tools have relevant limitations. A prognostication tool for individualized risk communication is not available for women with early breast cancer in Germany but is urgently needed. Otherwise informed shared decision making as recommended in guidelines cannot be realized.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/373/CN-01139373/frame.html

Record #75 of 90
ID: CN-01160494
AU: Schapira MM
AU: Hubbard R
AU: Seitz H
AU: Conant E
AU: Schnall M
AU: Capella J
AU: Harrington T
AU: Inge CA
AU: Armstrong K
TI: A randomized controlled trial of a risk based mammography screening decision aid for women 39-48 years of age.
SO: Journal of general internal medicine
YR: 2016
VL: 31
NO: 2 SUPPL. 1
PG: S105
XR: EMBASE 72288168
PT: Journal: Conference Abstract
KY: *human; *risk; *randomized controlled trial; *society; *mammography; *screening; *female; *internal medicine; follow up; breast cancer; decision making; control group; patient worry; hospital; informed consent; randomization; cancer screening; neoplasm; gynecology; statistical significance; obstetrics; general practice; personal value; bivariate analysis; primary medical care; cancer risk; risk assessment; patient; clinical practice; procedures
AB: BACKGROUND: Guidelines recommend that women in their 40's consider individual risk and personal values in deciding the age at which to begin breast cancer screening. However, it is unknown whether a decision aid (DA) that includes tailored risk information for younger women will increase the quality of decision making and impact the age at which women choose to start mammography screening. METHODS: We conducted a RCT in 2014-2015 to evaluate a web based decision aid (DA) delivered within a clinical practice network compared to usual care on knowledge, decisional conflict, and mammography intentions. Women were eligible if aged 39 to 48, enrolled in a participating primary care clinics (family practice, obstetrics and gynecology, and internal medicine), and had not had a previous mammogram. Recruitment took place in-clinic directly prior to the visit with randomization using concealed assignments occurring after obtainment of informed consent. A follow-up survey was conducted at 6 weeks. The DA tool was self-navigated by the patient, included risk estimates based on the NCI Breast Cancer Risk Assessment Tool, comparative risk information, value elicitation, and coaching to encourage shared decision making. Bivariate analysis was conducted to compare 3 pre-specified primary outcomes between groups; knowledge as measured on a 5-item scale (0-low to 5-high), decisional conflict as measured by the 16 item Decision Conflict Scale (DCS), and intended number of years before having a first mammogram. A p-value of 0.017 was considered significant. Exploratory analyses were conducted on outcomes of DC subdomains (Uncertainty, Informed, Values, Support, Effective Decision Making), anticipated regret, and breast cancer worry. RESULTS: There were 204 participants enrolled in the study; DA group (102) and control group (102) with 54.9 % (n = 112) completing the follow-up survey. The median age at the time of the follow-up survey was 40.1 years (range 39-49), 48 % were white, and 41 % were black. Ninety-one percent (91 %, n = 49) of women in the intervention group who completed the follow-up survey also completed the DA. At follow-up, knowledge (range 0-5) was greater in the DA vs. Control group (mean; difference, 95 %CI). (3.07 vs. 2.52, Diff: 0.57, 95 % CI: 0.14 to 0.98). A trend towards lower DCS scores was found in the DAvs. Control group (1.99 vs. 2.29, Diff: -0.30, 95 % CI: -0.63 to 0.38). There was no difference between groups in the intended number of years before having a first mammogram (2.6 vs. 1.6, Diff: 1.0, 95 %CI: -0.29 to 2.31). In exploratory analyses, women in the DA group trended towards decreased DCS scores in the Values domain (2.08 vs. 2.43, Diff: -0.36, 95 %CI: -0.73 to 0.01) and Support domain (1.83 vs. 2.13, Diff:-0.30, 95 %CI: -0.62 to 0.03). There was no difference in the other DCS subdomains. There was no difference between groups in anticipated regret (7 point scale from 1-low to 7-high) of not having a mammogram in your 40's and having cancer detected at a later date (5.45 vs. 5.70, Diff: -0.25, 95 %CI: -0.97 to 0.46) or having a mammogram in your 40's and facing unnecessary follow up tests or procedures: (3.47 vs. 3.28, Diff: 0.19, 95 %CI: -0.55 to 0.93). Breast cancer worry (1-low to 12-high) did not differ between groups (5.42 vs. 5.07, Diff: 0.36, 95 %CI: -0.36 to 1.07). CONCLUSIONS: A web based DA tailored to individualized risk and delivered in a practice setting increased knowledge and trended towards a decrease in decisional conflict when compared to a control of usual care. This study supports the use of a risk based DA to improve the quality of decision making regarding mammography initiation among younger women.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/494/CN-01160494/frame.html

Record #76 of 90
ID: CN-00780173
AU: Atkinson NL
AU: Massett HA
AU: Mylks C
AU: McCormack LA
AU: Kish-Doto J
AU: Hesse BW
AU: Wang MQ
TI: Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design
SO: Journal of the american medical informatics association : JAMIA
YR: 2011
VL: 18
NO: 1
PG: 24-31
PM: PUBMED 21169619
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
KY: Breast Neoplasms [therapy];Clinical Trials as Topic;Consumer Health Information;Health Services Research [methods];Internet;Patient Preference;Patient Satisfaction;Patient Selection;Program Development;Single-Blind Method;United States;User-Computer Interface;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1136/jamia.2010.006122
AB: DESIGN: Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order.MEASUREMENTS: The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better.RESULTS: Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions.CONCLUSION: By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy.OBJECTIVE: Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/173/CN-00780173/frame.html

Record #77 of 90
ID: CN-01172272
AU: Hahlweg P
AU: Witzel I
AU: Muller V
AU: Elwyn G
AU: Durand M-A
AU: Harter M
AU: Scholl I
TI: Evaluation of option grids to support shared decision-making in breast cancer treatment.
SO: Oncology Research and Treatment. Conference: 32. Deutscher Krebskongress, DKK 2016 Berlin Germany. Conference Start: 20160224 Conference End: 20160227. Conference Publication: (var.pagings)
YR: 2016
VL: 39
PG: 46
XR: EMBASE 72212436
PT: Journal: Conference Abstract
KY: *breast cancer; *cancer therapy; *decision making; human; German (citizen); patient; physician; Germany; interview; health care organization; adaptation; participant observation; information processing; cancer patient; oncology
DOI: 10.1159/000444354
AB: Background: Shared decision-making (SDM) is important in oncology, where many preference-sensitive treatment options exist. Many cancer patients wish active engagement in treatment decision-making. Despite evidence, SDM is not widely implemented in routine practice. Option Grids are short decision aids that help patients and physicians to compare treatment options. So far Option Grids are not available in German. The aims of this study are to translate and adapt two Grids on breast cancer treatment, to evaluate their acceptance and feasibility in routine care, and to assess needs for further Grids. Method: We have designed a two-phased study: 1) Translation of both Option Grids into German, comparison to German clinical standards, testing of patients' understanding via cognitive interviews. 2) Pilot testing including focus groups with patients and clinicians to assess acceptability, followed by real world testing in routine breast cancer care using participant observation. Results: First results show that physicians and patients valued the idea of Option Grids. However, several cycles of adaptation were found to be necessary in order to reach adequate acceptance. In addition, the feasibility of using Option Grids in Germany was questioned by several physicians. They expressed doubt if Option Grids can be used in current health care structures and if the options in the translated Option Grids are relevant in Germany. Final results, including pilot testing data, will be presented during the conference. Discussion: This study provided a German version of two Option Grids for breast cancer treatment to be used in Germany for the first time as well as an assessment of their acceptability and feasibility in routine clinical settings.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/272/CN-01172272/frame.html

Record #78 of 90
ID: CN-00733146
AU: Sanguinetti A
AU: Rosato L
AU: Cirocchi R
AU: Barberini F
AU: Pezzolla A
AU: Cavallaro G
AU: Parmeggiani D
AU: Ruggiero R
AU: Docimo G
AU: Procaccini E
AU: Santoriello A
AU: Rulli A
AU: Gubitosi A
AU: Canonico S
AU: Taffurelli M
AU: Sciannameo F
AU: Barbarisi A
AU: Docimo L
AU: Agresti M
AU: Toma G
AU: Noya G
AU: Parmeggiani U
AU: Avenia N
TI: Antibiotic prophylaxis in breast surgery. Preliminary resuls of a multicenter randomized study on 1400 cases
SO: Annali italiani di chirurgia
YR: 2009
VL: 80
NO: 4
PG: 275-279
PM: PUBMED 19967885
PT: Comparative Study; English Abstract; Journal Article; Multicenter Study; Randomized Controlled Trial
KY: Adolescent;Amoxicillin [administration & dosage] [therapeutic use];Anti-Bacterial Agents [administration & dosage] [therapeutic use];Antibiotic Prophylaxis;Breast Diseases [surgery];Breast Neoplasms [surgery];Cefazolin [administration & dosage] [therapeutic use];Clavulanic Acid [administration & dosage] [therapeutic use];Data Interpretation, Statistical;Mastectomy, Radical;Mastectomy, Segmental;Odds Ratio;Patient Selection;Surgical Wound Infection [drug therapy] [prevention & control];Treatment Outcome;Adult[checkword];Aged[checkword];Aged, 80 and over[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-WOUNDS
AB: CONCLUSIONThis study is only a preliminary RCT to be followed by a study which should be enrolled more patients in order to get the results as statistically significant.UNLABELLEDBreast surgery is classified among the procedures performed in clean surgery and is associated with a low incidence of wound infection (3-15%). The objective of this study was to evaluate the advantages antibiotic prophylaxis in patients undergoing breast surgery. A multicenter randomized controlled study was performed between January 2008 and November 2008. One thousand four hundred patients were enrolled in prospective randomized study; surgical wound infection was found in 41 patients (2.93%). In our RCT we have shown that in breast surgery antibiotic prophylaxis does not present significant advantages in patients with potential risk of infection (17 patients, 2.42%, subjected to antibiotic prophylaxis vs 24 patients, 3.43%, without antibiotic prophylaxis) (P = 0.27). In patients with drainage there is a significant minor incidence of wound infections in patients receiving antibiotic prophylaxis (5 patients, 0.92%, subjected to antibiotic prophylaxis vs 14 patients, 3.09%, without antibiotic prophylaxis) (P = 0.02).
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/146/CN-00733146/frame.html

Record #79 of 90
ID: CN-00065814
AU: Cuzick J
TI: Overview of adjuvant radiotherapy for breast cancer
SO: Recent results in cancer research
YR: 1989
VL: 115
PG: 220-225
PM: PUBMED 2696036
PT: Clinical Trial; Journal Article; Randomized Controlled Trial
KY: Breast Neoplasms [mortality] [radiotherapy] [surgery];Combined Modality Therapy;Data Collection [standards];Data Interpretation, Statistical;Mastectomy;Meta-Analysis as Topic;Randomized Controlled Trials as Topic;Survival Rate;Humans[checkword]
CC: SR-CANCER
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/814/CN-00065814/frame.html

Record #80 of 90
ID: CN-01023470
AU: Xiao T
AU: Crew KD
AU: Sivasubramanian PS
AU: Aguirre AN
AU: Smalletz CK
AU: Kukafka R
TI: Development of a patient-centered decision aid to improve accuracy of breast cancer risk perception.
SO: Cancer prevention research (Philadelphia, Pa.)
YR: 2013
VL: 6
NO: 11 SUPPL. 1
XR: EMBASE 71670373
PT: Journal: Conference Abstract
KY: *human; *breast cancer; *cancer risk; *cancer prevention; *patient; risk; female; lifespan; model; information processing; risk factor; exposure; United States; chemoprophylaxis; Internet; population; questionnaire; risk assessment; prevention; speech; genetic screening; narrative; feedback system; family history; Hispanic; Student t test; statistics; Likert scale; community; counseling; randomized controlled trial; primary medical care; McNemar test
AB: Background: Breast cancer risk assessment and interventions for prevention, such as chemoprevention, are underutilized in the U.S. Reasons for low uptake include inability to routinely screen for high-risk women in the primary care setting, inadequate time for counseling, and insufficient knowledge about risk-reducing strategies. We developed an initial prototype of a web-based decision aid (DA), RealRisks, which incorporates experience-based dynamic interfaces to communicate risk aimed at reducing inaccurate risk perceptions, particularly in low-numerate populations. Methods: RealRisks is a patient DA that models patient-provider dialogue with modules on breast cancer risk, genetic testing, and chemoprevention. Embedded within the narrative are 2 games of experience-based risk interfaces, demonstrating average 5-year and lifetime breast cancer risk. Both games ask players to sample from a pictograph of 100 clickable women to better learn the meaning of a pre-set probability (i.e., 12 out of 100 women or 12%). We conducted four focus groups of 7-9 English-speaking women over the age of 18, recruited from the local community in Upper Manhattan in New York City. These recorded sessions lasted about 90 minutes and involved use of RealRisks on a laptop, questionnaire completion before and after interacting with the DA, and a semi-structured group discussion. Questionnaires included information about demographics, numeracy, internet access, breast cancer risk factors, perceived breast cancer risk, and evaluation of RealRisks on a 7-point Likert scale. Descriptive statistics were generated to document baseline characteristics and frequencies of positive and negative attitudes about RealRisks. Paired t-test and McNemar's test were used to compare within-individual changes in accuracy of perceived breast cancer risk. During the group discussion, verbal responses were condensed into themes using a qualitative approach. Results: From May to June 2013, 34 women were enrolled. Median age was 53.5 (range, 35-75); 85% were either black or Hispanic; 41% met criteria for low numeracy; and 88% had internet access. After removing 3 women with a history of breast cancer, 3 (9.7%) met high-risk criteria for breast cancer according to the Gail model (>1.67% 5-year risk) and mean 5-year and lifetime breast cancer risk were 1.11% (+0.77) and 7.46% (+2.87), respectively. After interacting with RealRisks, the difference in perceived vs. actual breast cancer risk according to the Gail model significantly improved for 5-year risk (p=0.008), but not lifetime risk (p=0.20). Before exposure to RealRisks, 52% had accurate breast cancer risk perceptions (defined as within +5% of actual lifetime risk according to the Gail model) compared to 70% after RealRisks (p=0.10). In particular, 4 out of 5 women who overestimated their lifetime breast cancer risk by >30% had accurate risk perceptions after exposure to RealRisks. We found a significant association between numeracy and accuracy of risk perception after interacting with RealRisks (p=0.05). Over 85% of the participants thought RealRisks was useful, easy to use, increased their knowledge about breast cancer and understanding of breast cancer risk factors. From the focus group discussions, we found that knowledge about breast cancer risk factors, apart from family history, was limited. Participants were interested in receiving a personalized breast cancer risk assessment and found the interactive games engaging. Discussion: In a multi-ethnic low-numerate population, we demonstrated a significant improvement in accuracy of perceived breast cancer risk after exposure to RealRisks. Based upon feedback from our focus groups, we were able to identify information needed to fully represent the important issues of breast cancer risk to further develop our prototype for testing in a randomized controlled trial.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/470/CN-01023470/frame.html

Record #81 of 90
ID: CN-00680448
AU: Panzarella T
AU: Meakin JW
TI: Analysis of cause-specific failure endpoints using simple proportions: an example from a randomized controlled clinical trial in early breast cancer
SO: International journal of radiation oncology, biology, physics
YR: 1998
VL: 41
NO: 5
PG: 1093-1097
PM: PUBMED 9719120
PT: Clinical Trial; Journal Article; Randomized Controlled Trial
KY: Antineoplastic Agents, Hormonal [therapeutic use];Breast Neoplasms [drug therapy] [mortality] [pathology] [radiotherapy] [surgery];Combined Modality Therapy;Data Interpretation, Statistical;Prednisone [therapeutic use];Radiotherapy Dosage;Retrospective Studies;Time Factors;Treatment Failure;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-CANCER
AB: METHODS AND MATERIALSIn the comparison of treatment groups, time to first failure (in any site) was analyzed first, followed by an analysis of the pattern of first failure, preferably at the latest complete follow-up time common to each group.RESULTSA retrospective analysis of time to contralateral breast cancer in 777 early breast cancer patients was undertaken. Patients previously treated by mastectomy plus radiation therapy to the chest wall and regional nodal areas were randomized to receive further radiation and prednisone (R+P), radiation alone (R), or no further treatment (NT). Those randomized to R+P had a statistically significantly delayed time to first failure compared to the group randomized to NT (p = 0.0008). Patients randomized to R also experienced a delayed time to first failure compared to NT, but the difference was not statistically significant (p = 0.14). At 14 years from the date of surgery (the latest common complete follow-up time) the distribution of first failures was statistically significantly different between R+P and NT (p = 0.005), but not between R and NT (p = 0.09). The contralateral breast cancer first failure rate at 14 years from surgery was 7.2% for NT, 4.6% for R, and 3.7% for R+P. The corresponding Kaplan-Meier estimates were 13.2%, 8.2%, and 5.4%, respectively.CONCLUSIONAnalyzing cause-specific failure data using methods developed for survival endpoints is problematic. We encourage the use of the two-step analysis strategy described when, as in the example presented, competing causes of failure are not likely to be statistically independent, and when a treatment comparison at a single time-point is clinically relevant and feasible; that is, all patients have complete follow-up to this point.PURPOSETo describe a statistically valid method for analyzing cause-specific failure data based on simple proportions, that is easy to understand and apply, and outline under what conditions its implementation is well-suited.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/448/CN-00680448/frame.html

Record #82 of 90
ID: CN-00789609
AU: Schwartz MD
AU: Valdimarsdottir HB
AU: DeMarco TA
AU: Peshkin BN
AU: Lawrence W
AU: Rispoli J
AU: Brown K
AU: Isaacs C
AU: O'Neill S
AU: Shelby R
AU: Grumet SC
AU: McGovern MM
AU: Garnett S
AU: Bremer H
AU: Leaman S
AU: O'Mara K
AU: Kelleher S
AU: Komaridis K
TI: Randomized trial of a decision aid for BRCAL/BRCA2 mutation carriers: impact on measures of decision making and satisfaction
SO: Health psychology
YR: 2009
VL: 28
NO: 1
PG: 11-19
XR: EMBASE 2009044717
PT: Journal: Article
KY: *Decision Making; *Mastectomy; *Mutation; *Risk; *Satisfaction; Arm; Breast Cancer; Cancer Risk; Computer; Decision Support System; Family History; Female; Genetic Counseling; Genetic Screening; Randomization; Randomized Controlled Trial; Risk Management
AB: Objective: Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, the authors developed a computer-based interactive decision aid that was tested against usual care in a randomized controlled trial. Design: After the completion of genetic counseling, 214 female (aged 21-75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N = 114) or Usual Care plus Decision Aid (DA; N = 100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM DA to view at home. Main Outcome Measures: The authors measured final management decision, decisional conflict, decisional satisfaction, and receipt of risk reducing mastectomy at 1-, 6-, and 12-months postrandomization. Results: Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR = 3.09, 95% CI = 1.62, 5.90; p 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.Discussion: This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.Trial registration: The study is registered with the Australian and New Zealand Clinical Trials Group (Registration no: ACTRN12610000502033). 2012 Watts et al.; licensee BioMed Central Ltd.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/774/CN-01019774/frame.html

Record #87 of 90
ID: CN-00623065
AU: Wilkins EG
AU: Lowery JC
AU: Copeland LA
AU: Goldfarb SL
AU: Wren PA
AU: Janz NK
TI: Impact of an educational video on patient decision making in early breast cancer treatment
SO: Medical decision making
YR: 2006
VL: 26
NO: 6
PG: 589-598
PM: PUBMED 17099197
XR: EMBASE 44728775
PT: Journal: Article
KY: adult; anxiety; article; *breast cancer/su [Surgery]; cancer staging; cancer surgery; *cancer therapy; female; human; major clinical study; male; mastectomy; patient care; *patient decision making; patient satisfaction; statistical significance
CC: HS-UKCC: HS-HANDSRCH
DOI: 10.1177/0272989X06295355
AB: Previous research suggests that patient education programs promoting shared decision making (SDM) may improve patient satisfaction and outcomes, yet controlled clinical trials are lacking. The authors evaluate the impact of an early breast cancer treatment educational video on patients' decisional preferences and behavior. Newly diagnosed stage I/stage II breast cancer patients were assigned to SDM video program or control groups in alternating months. Surveys were administered prior to the provider visit and 1 week following the treatment decision. Variables assessed included autonomy preferences, perceived involvement in care, satisfaction, and treatment choice. There were no significant intervention effects on informational/decisional preferences, anxiety, knowledge, or satisfaction. Although 25% of SDM patients chose mastectomy compared to 14% of controls, this difference was not statistically significant. Eventhough enthusiasm for SDM programs remains high among some patients and providers, this study found only modest benefits.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/065/CN-00623065/frame.html

Record #88 of 90
ID: CN-01089056
AU: Sapienza LG
AU: Aiza AR
AU: Lins LAN
AU: Trigo CC
AU: Fogaroli RC
AU: Maia MAC
TI: A single-blinded RCT of the use of bolus in post mastectomy irradiation in breast cancer.
SO: Radiotherapy and oncology
YR: 2014
VL: 111
PG: S64
XR: EMBASE 71889434
PT: Journal: Conference Abstract
KY: *irradiation; *breast cancer; *European; *society; *radiotherapy; *oncology; *mastectomy; human; patient; radiation dermatitis; informed consent; toxicity; risk; dermatitis; diagnosis; low risk patient; skin ulcer; staging; photon; skin; neoplasm; Fisher exact test; cancer patient; statistical analysis; randomization; follow up; nurse; tissues; clinical study
AB: Purpose/Objective: There is a lack of clinical data about the use of bolus (tissue equivalent material) in post mastectomy irradiation in breast cancer patients treated with tangent photons fields. We designed a trial to evaluate toxicity, clinical impact and economic expenses of different frequencies of use of the bolus (NCT01925651). Materials and Methods: Fifty-four consecutive patients were recruited and are being followed prospectively. The inclusion criteria are breast cancer with histopathological diagnosis, more than 18 years old and no history of previous thoracic irradiation. All patients signed an informed consent form. The patients are categorized in high risk or low risk, based on the extension of the tumor to the skin in clinical and pathological staging. The low risk patients are then randomized to no use of bolus or use of a 0.5cm bolus in alternated day. The high risk ones are randomized to use a 0.5cm bolus daily or in alternated days. The patients are examined weekly to evaluate the grade of radiodermatitis according to Common Terminology Criteria for Adverse Events (CTCAE v4.0), the local care products, and treatment interruptions due to dermatitis. The evaluation was done by a nurse specialized in radiodermitis, without knowledge of patient randomization. for the statistical analysis weused the Fisher exact test. Results: With the accrual of 54 patients (july-november 2013), we present the results of the 29 patients with final follow-up until this interim analysis (november 2013). two patients removed the informed consent, being excluded from the study and not randomized. All patients had at least grade 1 radiodermatitis. Three patients in the no bolus group (3/7) and three patients in alternated bolus group have grade 2 radiodermatitis (p=0.3185). Comparing alternated bolus with daily bolus, no patient in first group developed grade 3 toxicity (0/16), but 66% (4/6) developed G3 radiodermatitis with daily bolus (p=0.0021). The patients with G3 radiodematitis were treated with a hidrocolloid curative and had the skin ulcers resolved in three weeks. No patient interrupted treatment until this analysis. Conclusions: There is a significant increase in G3 radiodermatitis in patients treated with daily 0.5cm bolus (p=0.0021). This translated in more expenses with curatives and patient suffering. No increase of interruption of treatment was detected until this interim analysis. The decision of indicating a higher frequency of bolus should be carefully evaluated due to the lack of evidence of clinical benefit in local control and the increased toxicity to the patient.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/056/CN-01089056/frame.html

Record #89 of 90
ID: CN-00842025
AU: Watts KJ
AU: Meiser B
AU: Mitchell G
AU: Kirk J
AU: Saunders C
AU: Peate M
AU: Duffy J
AU: Kelly PJ
AU: Gleeson M
AU: Barlow-Stewart K
AU: Rahman B
AU: Friedlander M
AU: Tucker K
TI: How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer.
SO: BMC cancer
YR: 2012
VL: 12
PG: 320
PM: PUBMED 22838957
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Age Factors;Breast Neoplasms [genetics] [psychology] [therapy];Clinical Protocols;Genes, BRCA1;Genes, BRCA2;Genetic Counseling [ethics];Genetic Testing [ethics];Mutation;Female[checkword];Humans[checkword]
DOI: 10.1186/1471-2407-12-320
AB: BACKGROUND: Germline BRCA1 and BRCA2 mutation testing offered shortly after a breast cancer diagnosis to inform women's treatment choices - treatment-focused genetic testing 'TFGT' - has entered clinical practice in specialist centers and is likely to be soon commonplace in acute breast cancer management, especially for younger women. Yet the optimal way to deliver information about TFGT to younger women newly diagnosed with breast cancer is not known, particularly for those who were not suspected of having a hereditary breast cancer syndrome prior to their cancer diagnosis. Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT. This trial aims to examine the impact and efficiency of two models of educating younger women newly diagnosed with breast cancer about genetic testing in order to provide evidence for a safe and effective future clinical pathway for this service.DESIGN/METHODS: In this non-inferiority randomized controlled trial, 140 women newly diagnosed with breast cancer (aged less than 50 years) are being recruited from nine cancer centers in Australia. Eligible women with either a significant family history of breast and/or ovarian cancer or with other high risk features suggestive of a mutation detection rate of > 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.DISCUSSION: This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/025/CN-00842025/frame.html

Record #90 of 90
ID: CN-01179376
AU: Cardoso F
AU: van't Veer LJ
AU: Bogaerts J
AU: Slaets L
AU: Viale G
AU: Delaloge S
AU: Pierga JY
AU: Brain E
AU: Causeret S
AU: DeLorenzi M
AU: Glas AM
AU: Golfinopoulos V
AU: Goulioti T
AU: Knox S
AU: Matos E
AU: Meulemans B
AU: Neijenhuis PA
AU: Nitz U
AU: Passalacqua R
AU: Ravdin P
AU: Rubio IT
AU: Saghatchian M
AU: Smilde TJ
AU: Sotiriou C
AU: Stork L
AU: Straehle C
AU: Thomas G
AU: Thompson AM
AU: Hoeven JM
AU: Vuylsteke P
AU: Bernards R
AU: Tryfonidis K
AU: Rutgers E
AU: Piccart M
TI: 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer
SO: New England journal of medicine
YR: 2016
VL: 375
NO: 8
PG: 717-729
PM: PUBMED 27557300
PT: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
KY: Antineoplastic Agents [therapeutic use];Breast Neoplasms [drug therapy] [genetics] [mortality] [surgery];Chemotherapy, Adjuvant;Disease-Free Survival;Gene Expression;Gene Expression Profiling;Genetic Predisposition to Disease;Genetic Testing;Kaplan-Meier Estimate;Mastectomy;Neoplasm Metastasis [prevention & control];Neoplasm Staging;Oligonucleotide Array Sequence Analysis;Prospective Studies;Risk;Risk Assessment;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1056/NEJMoa1602253
AB: METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher.RESULTS: A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemotherapy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease.CONCLUSIONS: Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemotherapy. (Funded by the European Commission Sixth Framework Program and others; ClinicalTrials.gov number, NCT00433589; EudraCT number, 2005-002625-31.).BACKGROUND: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/376/CN-01179376/frame.html

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