According to W. Edwards Deming, American companies require nothing less than a transformation of management style and of governmental relations with industry. In Out of the Crisis, originally published in 1982, Deming offers a theory of management based on his famous 14 Points for Management. Management's failure to plan for the future, he claims, brings about loss of market, which brings about loss of jobs. Management must be judged not only by the quarterly dividend, but by innovative plans to stay in business, protect investment, ensure future dividends, and provide more jobs through improved product and service. In simple, direct language, he explains the principles of management transformation and how to apply them.

Out of the Crisis

Background
Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty.

Objectives
To assess the effects of decision aids for people facing treatment or screening decisions.

Search methods
For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008).

Selection criteria
We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions.

Data collection and analysis
Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:

A) 'choice made' attributes;

B) 'decision-making process' attributes.

Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model.

Main results
This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each.

Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).

A) Criteria involving 'choice made' attributes:

Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).

B) Criteria involving 'decision-making process' attributes:

Decision aids compared to usual care interventions resulted in:

a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);

b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); and

c) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).

Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.

C) Secondary outcomes

Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable.

The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive.

Authors' conclusions
There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values.

New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

/pdf/decision-aids-for-people-facing-health-treatment-or-1j1706q17l.pdf

Decision aids for people facing health treatment or screening decisions

https://cdr.lib.unc.edu/downloads/nz8061892

Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013

Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines

Incremental effect from integrating 3D-mammography (tomosynthesis) with 2D-mammography: Increased breast cancer detection evident for screening centres in a population-based trial

The risk of breast cancer (BC) overdiagnosis attributed to mammography screening is an unresolved issue, complicated by heterogeneity in the methodology of quantifying its magnitude, and both political and scientific elements surrounding interpretation of the evidence on this phenomenon. Evidence from randomized trials and also from observational studies shows that mammography screening reduces the risk of BC death; similarly, these studies provide sufficient evidence that overdiagnosis represents a serious harm from population breast screening. For both these outcomes of screening, BC mortality reduction and overdiagnosis, estimates of magnitude vary between studies however overdiagnosis estimates are associated with substantial uncertainty. The trade-off between the benefit and the collective harms of BC screening, including false-positives and overdiagnosis, is more finely balanced than initially recognized, however the snapshot of evidence presented on overdiagnosis does not mean that breast screening is worthless. Future efforts should be directed towards (a) ensuring that any changes in the implementation of BC screening optimize the balance between benefit and harms, including assessing how planned or actual changes modify the risk of overdiagnosis; (b) informing women of all the outcomes that may affect them when they participate in screening using well-crafted and balanced information; and

http://www.cancerbiomed.org/index.php/cocr/article/download/1376/1342

Overdiagnosis of breast cancer in population screening: does it make breast screening worthless?

The reduction in the incidence of contralateral breast cancer in women treated with adjuvant tamoxifen provided a model for prevention using endocrine agents. Oestrogen-receptor-positive cancer can be prevented with tamoxifen, but side effects limit its clinical utility, and the risk-benefit ratio is not sufficiently high to routinely recommend tamoxifen as a preventive agent. Agents being evaluated in prevention trials include raloxifene and the aromatase inhibitors; these are expected to be at least as effective as tamoxifen and to have fewer side effects. Core needle biopsy (providing histological information) and high-resolution breast ultrasound enhance preoperative assessment of breast cancer. Mammography remains the only screening test shown to reduce breast cancer deaths in randomised trials. Magnetic resonance imaging may have a role in screening women with inherited mutations of the breast cancer genes. Sentinel lymph node biopsy accurately assesses lymph node status and is associated with less morbidity than axillary dissection. Where the biopsy is negative (no histologic evidence of metastases), no further axillary treatment is necessary. Breast reconstruction after mastectomy can produce good cosmetic results, especially where autologous tissue is used. Myocutaneous flaps using latissimus dorsi or transverse rectus abdominus muscles are increasingly popular. Adjuvant trastuzumab therapy in patients whose tumours overexpress HER2 (growth factor receptor) can reduce recurrence rates and improve survival. Neoadjuvant endocrine therapy (as an initial treatment before surgery) is an underutilised treatment in postmenopausal women with oestrogen-receptor-positive large operable or locally advanced cancers. It makes more patients suitable for surgery and offers others the choice of breast conservation.

/pdf/the-prevention-detection-and-management-of-breast-cancer-3xpd2awzha.pdf

The prevention, detection, and management of breast cancer

Evidence relevant to the investigation of breast symptoms: the triple test

We review the evidence on computer-aided detection (CAD) as an adjunct to mammography interpretation, and discuss the complexity of its impact on decision-making and potential medico-legal aspects. CAD prompts the reader to review lesions on the mammogram and re-evaluate the decision on whether to recall CAD-prompted findings. Studies show that CAD can improve the sensitivity of a single reader, with an incremental cancer detection rate (from adding CAD to a single read) ranging between 1 and 19%. However, CAD will also substantially increase the recall rate (decrease the reader's specificity) causing additional recall in approximately 6-35% of women. Evidence indicates that CAD does not perform as well as double (human) reading in the context of organized breast screening where double reading is the standard of care. Although CAD can identify and prompt readers to missed cancers, the high number of false-positive prompts (1.5-4 false prompts per case) can have an adverse effect on clinical decision-making, and detracts from CAD's application in screening practice. Refinement in CAD algorithms, in combination with increasing implementation of digital mammography, may improve the potential use of CAD in mammography reading, but will require prospective evaluation.

Nehmat Houssami

Papers

Incremental effect from integrating 3D-mammography (tomosynthesis) with 2D-mammography: Increased breast cancer detection evident for screening centres in a population-based trial

Overdiagnosis of breast cancer in population screening: does it make breast screening worthless?

The prevention, detection, and management of breast cancer

Evidence relevant to the investigation of breast symptoms: the triple test

Early detection of breast cancer: overview of the evidence on computer-aided detection in mammography screening.