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

Jeevan and colleagues report that one in five women who have breast conserving surgery requires reoperation because of incomplete excision or inadequate clearance of margins.1 The first major review of surgical margins established that disease at the margins increased recurrence rates but concluded that wide margins compared with narrow margins did not reduce local …

https://www.bmj.com/content/bmj/345/bmj.e5855.full.pdf

Bigger margins are not better in breast conserving surgery

/pdf/overview-of-tomosynthesis-3d-mammography-for-breast-cancer-24ufym9jx2.pdf

Overview of tomosynthesis (3D mammography) for breast cancer screening

SUMMARY Axillary node status is an important prognostic factor in invasive breast cancer. Axillary lymph node dissection (ALND) was previously the primary management approach; however, sentinel node biopsy (SNB) has largely replaced ALND, which is currently predominantly used to manage SNB-positive patients. Preoperative imaging-based staging of the axilla (with ultrasound, PET or MRI) for the detection of suspicious nodes has been applied to inform and potentially streamline axillary surgical management. Ultrasound with ultrasound-guided needle biopsy is the most accurate imaging-based strategy and has been shown to have clinical utility for preoperative axillary staging. A meta-analysis has reported a median sensitivity of 79.4% and a specificity of 100% for ultrasound-based staging, and estimated that ultrasound-guided needle biopsy triages 55.2% of women with metastatic axillary nodes (or a median of 17.7% of patients) directly to ALND, thereby avoiding unnecessary SNB. Although ultrasound-based stagi...

Preoperative staging of the axilla in women with invasive breast cancer

Objectives To understand general practitioners’ (GPs’) awareness and knowledge of mammographic breast density (BD) and their perspectives around information and potential notification of BD for women. Design Qualitative study using semistructured telephone interviews. Interviews were audiorecorded, transcribed and analysed using framework analysis. Setting Australia. Participants Australian GPs (n=30). Results GPs had limited knowledge of BD and little experience discussing BD with women. There were mixed views on notification of BD with some GPs believing this information would help informed decision making about breast health and that women have the right to know any information about their bodies. While others were concerned about causing unnecessary anxiety and were worried about the uncertainty about what to advise women to do with this information, particularly in relation to supplemental breast screening. The need for an equitable system where all women are either notified or not, and also provided with publicly funded supplemental screening was raised by GPs. Overall, there was high interest in education, training and support around the topic of BD. Conclusions Australian GPs require education, support and evidence-based guidelines to have discussions with women with dense breasts and help manage their risk, especially if widespread notification is to be introduced in population-based screening programmes.

https://bmjopen.bmj.com/content/bmjopen/11/8/e047513.full.pdf

Nehmat Houssami

Papers

Bigger margins are not better in breast conserving surgery

Overview of tomosynthesis (3D mammography) for breast cancer screening

Preoperative staging of the axilla in women with invasive breast cancer

General practitioners' (GPs) understanding and views on breast density in Australia: a qualitative interview study.

The Effect of Supplemental Imaging on Interval Cancer Rates in Mammography Screening: Systematic Review